title: SOLE, Study of Letrozole Extension, A Phase III Trial Evaluating the Role of Continuous Letrozole Versus Intermittent Letrozole Following 4 to 6 Years of Prior Adjuvant Endocrine Therapy for Postmenopausal Women With Hormone-Receptor Positive, Node Positive Early Stage Breast Cancer

acronym: SOLE

summary:
RATIONALE: Estrogen can cause the growth of breast cancer cells. Letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known which regimen of letrozole is more effective in postmenopausal women who have received hormone therapy for early-stage breast cancer.

PURPOSE: This randomized phase III trial is comparing two different regimens of letrozole in preventing cancer in postmenopausal women who have received 4-6 years of hormone therapy for hormone receptor-positive, lymph node-positive, early-stage breast cancer.

ReferenceCitation: Guerini-Rocco E, Gray KP, Fumagalli C, Reforgiato MR, Leone I, Rafaniello Raviele P, Munzone E, Kammler R, Neven P, Hitre E, Jerusalem G, Simoncini E, Gombos A, Deleu I, Karlsson P, Aebi S, Chirgwin J, Di Lauro V, Thompson A, Graas MP, Barber M, Fontaine C, Loibl S, Gavila J, Kuroi K, Muller B, O'Reilly S, Di Leo A, Goldhirsch A, Viale G, Barberis M, Regan MM, Colleoni M. Genomic Aberrations and Late Recurrence in Postmenopausal Women with Hormone Receptor-positive Early Breast Cancer: Results from the SOLE Trial. Clin Cancer Res. 2021 Jan 15;27(2):504-512. doi: 10.1158/1078-0432.CCR-20-0126. Epub 2020 Oct 20.

evidence: oa repository (via page says license)

repositories_institution: La Trobe University - OPAL (Open@LaTrobe)

ReferenceCitation: Colleoni M, Luo W, Karlsson P, Chirgwin J, Aebi S, Jerusalem G, Neven P, Hitre E, Graas MP, Simoncini E, Kamby C, Thompson A, Loibl S, Gavila J, Kuroi K, Marth C, Muller B, O'Reilly S, Di Lauro V, Gombos A, Ruhstaller T, Burstein H, Ribi K, Bernhard J, Viale G, Maibach R, Rabaglio-Poretti M, Gelber RD, Coates AS, Di Leo A, Regan MM, Goldhirsch A; SOLE Investigators. Extended adjuvant intermittent letrozole versus continuous letrozole in postmenopausal women with breast cancer (SOLE): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2018 Jan;19(1):127-138. doi: 10.1016/S1470-2045(17)30715-5. Epub 2017 Nov 17.

lead_sponsor: ETOP IBCSG Partners Foundation

sponsor_collaborators:
ETOP IBCSG Partners Foundation
Breast International Group

location_country:
Germany
New Zealand
Australia
Japan
Chile
France
Hungary
Denmark
Switzerland
United States
India
Belgium
Peru
Italy
United Kingdom
Austria
Spain
South Africa
Russian Federation
Sweden

location_facility: Kumamoto University Faculty of Medical and Pharmaceutical Sciences

location_facility: Allgemeinen Krankenhaus Celle Kinderklinik

location_facility: Praxis Dr. Wilke - Onkologie am Klinikum Fuerth

location_facility: National Institute of Oncology - Budapest

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Aarhus Universitetshospital - Aarhus Sygehus

location_facility: Gemeinschaftspraxis Gynaekologie & Geburtshilfe

location_facility: Brustzentrum Thurgau at Kantonsspital Frauenfeld

location_facility: Karolinska University Hospital - Huddinge

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman

location_facility: Algemeen Ziekenhuis Sint-Maarten - Campus Rooiberg

location_facility: Russian Academy of Medical Sciences Cancer Research Center

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

location_facility: Copenhagen County Herlev University Hospital

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Hospital Clinico Regional de Valdivia at University Austral de Chile

location_facility: Hospital Santiago Oriente Dr. Luis Tisne Brousse

location_facility: Allgemeines Krankenhaus - Universitatskliniken

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

location_facility: Centre Hospitalier Universitaire Brugmann

location_facility: Centro di Riferimento Oncologico - Aviano

location_facility: Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

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


title: A Study of INT 747 (6α-ethyl Chenodeoxycholic Acid (6-ECDCA)) in Combination With Ursodeoxycholic Acid (URSO®, UDCA) in Patients With Primary Biliary Cirrhosis

summary: The primary hypothesis is that INT-747 will cause a reduction in alkaline phosphatase levels in Primary Biliary Cirrhosis patients, over a 12 week treatment period, as compared to placebo.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Hirschfield GM, Mason A, Luketic V, Lindor K, Gordon SC, Mayo M, Kowdley KV, Vincent C, Bodhenheimer HC Jr, Pares A, Trauner M, Marschall HU, Adorini L, Sciacca C, Beecher-Jones T, Castelloe E, Bohm O, Shapiro D. Efficacy of obeticholic acid in patients with primary biliary cirrhosis and inadequate response to ursodeoxycholic acid. Gastroenterology. 2015 Apr;148(4):751-61.e8. doi: 10.1053/j.gastro.2014.12.005. Epub 2014 Dec 11.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

repositories_concat: Pure (Denmark)

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: Intercept Pharmaceuticals

location_country:
Germany
United Kingdom
Netherlands
Austria
United States
Spain
Canada
France

location_facility: University of Miami - Center for Liver Diseases

location_facility: University Medical Centre Hamburg-Eppendorf

location_facility: Centre de Recherche du CHUM / University of Montreal

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


lead_sponsor: Sumitomo Pharma America, Inc.

summary: Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.

ReferenceType: result

ReferenceCitation: Nasrallah HA, Silva R, Phillips D, Cucchiaro J, Hsu J, Xu J, Loebel A. Lurasidone for the treatment of acutely psychotic patients with schizophrenia: a 6-week, randomized, placebo-controlled study. J Psychiatr Res. 2013 May;47(5):670-7. doi: 10.1016/j.jpsychires.2013.01.020. Epub 2013 Feb 17.

oa_host_type: closed

repositories_concat: closed

ReferenceCitation: Hopkins SC, Ogirala A, Worden M, Koblan KS. Depicting Safety Profile of TAAR1 Agonist Ulotaront Relative to Reactions Anticipated for a Dopamine D2-Based Pharmacological Class in FAERS. Clin Drug Investig. 2021 Dec;41(12):1067-1073. doi: 10.1007/s40261-021-01094-7. Epub 2021 Nov 9.

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

publisher_dissemination: Springer-Nature

ReferenceCitation: Correll CU, Cucchiaro J, Silva R, Hsu J, Pikalov A, Loebel A. Long-term safety and effectiveness of lurasidone in schizophrenia: a 22-month, open-label extension study. CNS Spectr. 2016 Oct;21(5):393-402. doi: 10.1017/S1092852915000917. Epub 2016 Apr 6.

oa_host_type: publisher

evidence: open (via page says Open Access)

license: implied-oa

license_normalized: implied-oa

publisher_dissemination: Cambridge University Press

ReferenceCitation: Nasrallah HA, Cucchiaro JB, Mao Y, Pikalov AA, Loebel AD. Lurasidone for the treatment of depressive symptoms in schizophrenia: analysis of 4 pooled, 6-week, placebo-controlled studies. CNS Spectr. 2015 Apr;20(2):140-7. doi: 10.1017/S1092852914000285. Epub 2014 Jun 23.

evidence: open (via page says license)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

location_facility: Spitalul de Psihiatrie Titan "Dr. Constantin Gorgos"

location_facility: Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3

location_facility: Lv. St. Med. Univ. n. af. D. Halytskiy Oblast Clin. Psychon. Hosp

location_facility: City Psychiatric Hospital #3 of Skvortsov-Stepanov

location_facility: Odesa SMU, based on Odessa Reg. Psychiatric Hosp.#1

location_facility: Bekhterev Psychoneurological Research Institute

location_facility: City Psychoneurological Dispensary #7 (with Hospital)

location_facility: Dnipropetrovsk Regional Clinical Hospital named Mechnikov

location_facility: California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road

location_facility: K&S Professional Research Services, LLC.

location_facility: Reg. Clin. Psychiatric Hosp. DSMU n.af.M.Gorkiy

location_facility: Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia

location_facility: Segal Institute for Clinical Research, Fidelity Clinical Research, Inc.

location_facility: Centrul de Recuperare si Reabilitare Gura Ocnitei

location_facility: Spitalul Clinic Judetean de Urgenta Arad

location_facility: City Psyhiatric Hospital #2 of St. Nikolay Chudotvorets

location_facility: Madras Medical College & Government General Hospital

title: A Phase 3 Randomized, Placebo-Controlled, CLinical Trial to Study the Safety and Efficacy of Three Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia

type: EudraCT Number

source: euctr

location_country:
India
Romania
United States
Malaysia
Ukraine
Russian Federation
France


study_start_date_type: Actual

lead_sponsor: Pfizer

summary: The purpose of this study is to investigate the safety and efficacy of tanezumab in combination with opioids in treating pain due to cancer that has spread to bone.

ReferenceCitation: Sopata M, Katz N, Carey W, Smith MD, Keller D, Verburg KM, West CR, Wolfram G, Brown MT. Efficacy and safety of tanezumab in the treatment of pain from bone metastases. Pain. 2015 Sep;156(9):1703-1713. doi: 10.1097/j.pain.0000000000000211.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Bapat AA, Hostetter G, Von Hoff DD, Han H. Perineural invasion and associated pain in pancreatic cancer. Nat Rev Cancer. 2011 Sep 23;11(10):695-707. doi: 10.1038/nrc3131.

location_facility: Medical University of South Carolina, Department of Urology

location_facility: Chhatrapati Shahuji Maharaj Medical University

location_facility: Krankenhaus der Elisabethinen Linz, Institut fuer Anaesthesiologie und Intensivmedizin

location_facility: Shri Siddhivinayak Ganpati Cancer Hospital

location_facility: Severance Hospital, Yonsei University College of Medicine, Yonsei Cancer Center

location_facility: Fovarosi Onkormanyzat Jahn Ferenc Del-pesti Korhaz - Fajdalom Ambulancia

location_facility: 10th Department, Latvian Oncological Centre / Riga Eastern Clinical University Hospital

location_facility: Fovarosi Onkormanyzat Peterfy Sandor Utcai Korhaz - Fajdalom Ambulancia

location_facility: Fejer Megyei Szt. Gyorgy Korhaz - Rendelointezet/Aneszteziologiai es Intenziv Betegellato Osztaly

location_facility: Hospital Nacional Guillermo Almenara Irigoyen

location_facility: Samsung Medical Center, Division of Hematology-Oncology, Department of Medicine

location_facility: Rajiv Gandhi Cancer Institute and Research Centre,

location_facility: Landeskrankenhaus Graz - Universitaetsklinik fuer Orthopaedie und Orthopaedische Chirurgie

location_facility: Huntsman Cancer Institute at the University of Utah

location_facility: Fakultna Nemocnica s Poliklinikou F.D.Roosevelta

location_facility: Institute of Oncology, University Clinical Center Sarajevo

location_facility: WK River Cities Clinical Research Center

location_facility: Poradnia Medycyny Paliatywnej, Hospicjum Palium

location_facility: Willis Knighton Pierremont Health Center

location_facility: Hospicjum im. Ks. Eugeniusza Dutkiewicza SAC w Gdansku

title: PHASE II RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER EFFICACY AND SAFETY STUDY OF TANEZUMAB AS ADD-ON THERAPY TO OPIOID MEDICATION IN PATIENTS WITH PAIN DUE TO BONE METASTASES

type: Other Identifier

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.

location_country:
Poland
India
Slovakia
Hungary
Austria
Mexico
United States
Bosnia and Herzegovina
Korea, Republic of
Latvia
Croatia
Peru
France

ipd_sharing: Yes


title: Extension Study of the BENEFIT (304747) and BENEFIT Follow-up (305207) Studies to Further Evaluate the Progress of Patients With First Demyelinating Event Suggestive of Multiple Sclerosis

summary: To assess the long-term effects of early therapeutic intervention, i.e. within two years following a first clinical demyelinating event suggestive of MS.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Nagtegaal GJ, Pohl C, Wattjes MP, Hulst HE, Freedman MS, Hartung HP, Miller D, Montalban X, Kappos L, Edan G, Pleimes D, Beckman K, Stemper B, Polman CH, Sandbrink R, Barkhof F. Interferon beta-1b reduces black holes in a randomised trial of clinically isolated syndrome. Mult Scler. 2014 Feb;20(2):234-42. doi: 10.1177/1352458513494491. Epub 2013 Jul 10.

publisher_dissemination: SAGE Publications

lead_sponsor: Bayer

location_country:
Finland
France
Germany
Italy
Poland
Slovenia
Hungary
Israel
Denmark
Norway
Sweden
Netherlands
Austria
Belgium
Switzerland
Spain
Canada
Czech Republic


title: A Multinational, Randomized, Double-Blind Study Comparing Aflibercept Versus Placebo in Patients Treated With Second-Line Docetaxel After Failure of One Platinum Based Therapy for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer

acronym: VITAL

summary:
The primary objective of the study was to demonstrate overall survival improvement for aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for participants with locally advanced or metastatic non-small cell lung cancer (NSCLC).

The secondary objectives were to compare other efficacy parameters, to assess the overall safety of the two treatment arms, to assess the pharmacokinetics of intravenous (IV) aflibercept in this participant population and to determine immunogenicity of IV aflibercept in all participants.

ReferenceCitation: Ramlau R, Gorbunova V, Ciuleanu TE, Novello S, Ozguroglu M, Goksel T, Baldotto C, Bennouna J, Shepherd FA, Le-Guennec S, Rey A, Miller V, Thatcher N, Scagliotti G. Aflibercept and Docetaxel versus Docetaxel alone after platinum failure in patients with advanced or metastatic non-small-cell lung cancer: a randomized, controlled phase III trial. J Clin Oncol. 2012 Oct 10;30(29):3640-7. doi: 10.1200/JCO.2012.42.6932. Epub 2012 Sep 10.

lead_sponsor: Sanofi

sponsor_collaborators:
Sanofi
Regeneron Pharmaceuticals

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Turkey
Chile
Canada
France
Czech Republic
Portugal
Hungary
Hong Kong
United States
India
Romania
China
Malaysia
Estonia
Italy
United Kingdom
Singapore
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation
Sweden

location_facility: sanofi-aventis Australia & New Zealand administrative office


acronym: CARE-MS I

intervention_type: Biological

lead_sponsor: Genzyme, a Sanofi Company

summary: The purpose of this study was to establish the efficacy and safety of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous (SC) interferon beta-1a (Rebif®). The study had enrolled participants who had not previously received MS disease-modifying therapies. Participants had monthly laboratory tests and comprehensive testing every 3 months.

ReferenceType: background

ReferenceCitation: Cohen JA, Coles AJ, Arnold DL, Confavreux C, Fox EJ, Hartung HP, Havrdova E, Selmaj KW, Weiner HL, Fisher E, Brinar VV, Giovannoni G, Stojanovic M, Ertik BI, Lake SL, Margolin DH, Panzara MA, Compston DA; CARE-MS I investigators. Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial. Lancet. 2012 Nov 24;380(9856):1819-28. doi: 10.1016/S0140-6736(12)61769-3. Epub 2012 Nov 1.

ReferenceCitation: Coles AJ, Jones JL, Vermersch P, Traboulsee A, Bass AD, Boster A, Chan A, Comi G, Fernandez O, Giovannoni G, Kubala Havrdova E, LaGanke C, Montalban X, Oreja-Guevara C, Piehl F, Wiendl H, Ziemssen T. Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data. Mult Scler. 2022 Apr;28(5):842-846. doi: 10.1177/13524585211061335. Epub 2021 Dec 9.

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

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

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

repository_institution: University of Cambridge - Apollo

version: submittedVersion

ReferenceCitation: Kuhle J, Daizadeh N, Benkert P, Maceski A, Barro C, Michalak Z, Sormani MP, Godin J, Shankara S, Samad TA, Jacobs A, Chung L, Rӧsch N, Kaiser C, Mitchell CP, Leppert D, Havari E, Kappos L. Sustained reduction of serum neurofilament light chain over 7 years by alemtuzumab in early relapsing-remitting MS. Mult Scler. 2022 Apr;28(4):573-582. doi: 10.1177/13524585211032348. Epub 2021 Aug 11.

ReferenceCitation: Coles AJ, Arnold DL, Bass AD, Boster AL, Compston DAS, Fernandez O, Havrdova EK, Nakamura K, Traboulsee A, Ziemssen T, Jacobs A, Margolin DH, Huang X, Daizadeh N, Chirieac MC, Selmaj KW. Efficacy and safety of alemtuzumab over 6 years: final results of the 4-year CARE-MS extension trial. Ther Adv Neurol Disord. 2021 Apr 23;14:1756286420982134. doi: 10.1177/1756286420982134. eCollection 2021.

oa_colors: green gold

evidence: oa journal (via doaj)

repositories_concat: PubMed Central;www.repository.cam.ac.uk

unpaywall_oa_status: gold

ReferenceCitation: Horakova D, Boster A, Bertolotto A, Freedman MS, Firmino I, Cavalier SJ, Jacobs AK, Thangavelu K, Daizadeh N, Poole EM, Baker DP, Margolin DH, Ziemssen T; CARE-MS I, CARE-MS II, and CAMMS03409 Investigators. Proportion of alemtuzumab-treated patients converting from relapsing-remitting multiple sclerosis to secondary progressive multiple sclerosis over 6 years. Mult Scler J Exp Transl Clin. 2020 Dec 18;6(4):2055217320972137. doi: 10.1177/2055217320972137. eCollection 2020 Oct-Dec.

ReferenceCitation: Ziemssen T, Bass AD, Berkovich R, Comi G, Eichau S, Hobart J, Hunter SF, LaGanke C, Limmroth V, Pelletier D, Pozzilli C, Schippling S, Sousa L, Traboulsee A, Uitdehaag BMJ, Van Wijmeersch B, Choudhry Z, Daizadeh N, Singer BA; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ investigators. Efficacy and Safety of Alemtuzumab Through 9 Years of Follow-up in Patients with Highly Active Disease: Post Hoc Analysis of CARE-MS I and II Patients in the TOPAZ Extension Study. CNS Drugs. 2020 Sep;34(9):973-988. doi: 10.1007/s40263-020-00749-x.

repositories_institution:
UHasselt - Document Server@UHasselt
University of Plymouth - PEARL

ReferenceCitation: Comi G, Alroughani R, Boster AL, Bass AD, Berkovich R, Fernandez O, Kim HJ, Limmroth V, Lycke J, Macdonell RA, Sharrack B, Singer BA, Vermersch P, Wiendl H, Ziemssen T, Jacobs A, Daizadeh N, Rodriguez CE, Traboulsee A; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators. Efficacy of alemtuzumab in relapsing-remitting MS patients who received additional courses after the initial two courses: Pooled analysis of the CARE-MS, extension, and TOPAZ studies. Mult Scler. 2020 Dec;26(14):1866-1876. doi: 10.1177/1352458519888610. Epub 2019 Nov 25.

repository_institution: University of Melbourne - Minerva Access

repository_normalized: University of Melbourne - Minerva Access

repositories: University of Melbourne - Minerva Access

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;www.repositoriosalud.es

repositories_institution: University of Melbourne - Minerva Access

ReferenceCitation: Van Wijmeersch B, Singer BA, Boster A, Broadley S, Fernandez O, Freedman MS, Izquierdo G, Lycke J, Pozzilli C, Sharrack B, Steingo B, Wiendl H, Wray S, Ziemssen T, Chung L, Margolin DH, Thangavelu K, Vermersch P. Efficacy of alemtuzumab over 6 years in relapsing-remitting multiple sclerosis patients who relapsed between courses 1 and 2: Post hoc analysis of the CARE-MS studies. Mult Scler. 2020 Nov;26(13):1719-1728. doi: 10.1177/1352458519881759. Epub 2019 Nov 1.

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

ReferenceCitation: Okai AF, Amezcua L, Berkovich RR, Chinea AR, Edwards KR, Steingo B, Walker A, Jacobs AK, Daizadeh N, Williams MJ; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators. Efficacy and Safety of Alemtuzumab in Patients of African Descent with Relapsing-Remitting Multiple Sclerosis: 8-Year Follow-up of CARE-MS I and II (TOPAZ Study). Neurol Ther. 2019 Dec;8(2):367-381. doi: 10.1007/s40120-019-00159-2. Epub 2019 Oct 25.

ReferenceCitation: Li Z, Richards S, Surks HK, Jacobs A, Panzara MA. Clinical pharmacology of alemtuzumab, an anti-CD52 immunomodulator, in multiple sclerosis. Clin Exp Immunol. 2018 Dec;194(3):295-314. doi: 10.1111/cei.13208. Epub 2018 Oct 1.

ReferenceCitation: Havrdova E, Arnold DL, Cohen JA, Hartung HP, Fox EJ, Giovannoni G, Schippling S, Selmaj KW, Traboulsee A, Compston DAS, Margolin DH, Thangavelu K, Rodriguez CE, Jody D, Hogan RJ, Xenopoulos P, Panzara MA, Coles AJ; CARE-MS I and CAMMS03409 Investigators. Alemtuzumab CARE-MS I 5-year follow-up: Durable efficacy in the absence of continuous MS therapy. Neurology. 2017 Sep 12;89(11):1107-1116. doi: 10.1212/WNL.0000000000004313. Epub 2017 Aug 23. Erratum In: Neurology. 2018 Apr 17;90(16):755.

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Arnold DL, Fisher E, Brinar VV, Cohen JA, Coles AJ, Giovannoni G, Hartung HP, Havrdova E, Selmaj KW, Stojanovic M, Weiner HL, Lake SL, Margolin DH, Thomas DR, Panzara MA, Compston DA; CARE-MS I and CARE-MS II Investigators. Superior MRI outcomes with alemtuzumab compared with subcutaneous interferon beta-1a in MS. Neurology. 2016 Oct 4;87(14):1464-1472. doi: 10.1212/WNL.0000000000003169. Epub 2016 Sep 2.

repositories_institution:
PubMed Central - Europe PMC
University of Cambridge - Apollo

location_facility: University of Louisville Research Foundation

location_facility: Department of Neurology, 1st Faculty of Medicine and General Teaching Hospital

location_facility: Research Medical Complex "Your Health" Ltd

location_facility: Hospoital of the Directorate of the Medical Corps within the Ukrainian Security Service, Neurology Department

location_facility: Department Of Neurosciences, Addenbrookes Hospital

location_facility: Institute of Neurology, Psychiatry and Narcology under the Academy of Medical Sciences of Ukraine, Department of Neuroinfection and Multiple Sclerosis

location_facility: Moscow State Medical Institution City Clinical Hospital #11

location_facility: Independent Public Teaching Hospital No. 4 in Lublin

location_facility: Clinical Center Nis, Clinic for neurology

location_facility: Clinical Neurology Centre Sp. z o.o. (Ltd)

location_facility: Idaho Falls Multiple Sclerosis Center, PLLC

location_facility: Heliodor Swiecicki Teaching Hospital of the Poznan University of Medical Sciences

location_facility: Clinique Neuro rive-sud, Recherche Sepmus, Inc.

location_facility: Louisiana State University Health Sciences Center

location_facility: University of New Mexico, Health Sciences Center, MS Specialty Clinic

location_facility: Hospital Angeles del Pedregal, Camino de Santa Teresa

location_facility: Federal State Institution Siberian Rettitorial Medical Center under Federal Medical-Biological Agency of Russia

location_facility: Baylor College of Medicine, Maxine Mesinger MS Clinic

location_facility: North Central Neurology Associates, P.C.

location_facility: Lehigh Valley Hospital Neurosciences and Pain Research

location_facility: Clinical Centre of Vojvodina, Clinic for neurology

location_facility: Samara Regional Clinical Hospital n.a. Kalinin

location_facility: Clinical Centre Serbia, Institute for Neurology

location_facility: Hospital da Restauracao, Av Governador Agamenon Magalhaes

location_facility: Klinikum der Goethe Universität Frankfurt

location_facility: Royal Melbourne Hospital, Department of Neurology, Ward 4 East

location_facility: Danylo Halytsky Lviv National Medical University

location_facility: Clinical Hospital Centre "Sestre Milosrdnice"

location_facility: Independent Public Healthcare Facility, Norbert Barlicki University Hospital No. 1 of the Medical University of Lodz

location_facility: Krajska zdravotni a.s., Hospital Teplice

location_facility: State Medical Institution: Republican Clinical Hospital n.a. G.G. Kuvatov

location_facility: Centre for Neuroscience & Trauma, Blizard Institute of Cell and Molecular Science, Barts and The London School of Medicine and Dentistry

location_facility: Comprehensive Multiple Sclerosis Care Center at South Shore Neurologic Associates, P.C.

location_facility: University of Calgary and Foothills Medical Cenre

location_facility: The Ohio State University Medical Center, Multiple Sclerosis Center

location_facility: Carolinas Medical Center (CMC), Neurosciences & Spine Institute (NSSI)

location_facility: Universitätsklinik Carl Gustav Carus Dresden

location_facility: Barrow Neurological Institute, St. Joseph's Hospital & Medical Center

location_facility: St. Petersburg Pavlov State Medical University

title: A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Treatment-Naïve Patients With Relapsing-Remitting Multiple Sclerosis

location_country:
France
Germany
Poland
United Kingdom
Argentina
Australia
Brazil
Sweden
Mexico
United States
Croatia
Canada
Ukraine
Serbia
Russian Federation
Czech Republic


title: A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D

summary: The purpose of this Phase III study is to evaluate the efficacy and safety of oral salmon calcitonin in the treatment of patients with osteoporosis

ReferenceCitation: Henriksen K, Bay-Jensen AC, Christiansen C, Karsdal MA. Oral salmon calcitonin--pharmacology in osteoporosis. Expert Opin Biol Ther. 2010 Nov;10(11):1617-29. doi: 10.1517/14712598.2010.526104. Epub 2010 Oct 11.

lead_sponsor: Nordic Bioscience A/S

sponsor_collaborators:
Nordic Bioscience A/S
Novartis

location_country:
France
Italy
Lithuania
Poland
Hong Kong
Denmark
Romania
Brazil
United States
China
Estonia
Czech Republic

location_facility: Department of Internal Medicine, University of Florence


acronym: VENICE

summary:
Primary objective was to demonstrate overall survival improvement with aflibercept compared to placebo in patients receiving docetaxel / prednisone for metastatic androgen-independent prostate cancer (MAIPC).

The secondary objectives were:

To assess the efficacy of aflibercept compared to placebo on other parameters such prostate-specific antigen (PSA) level, cancer related pain, progression free survival (PFS), tumor-based and skeletal events and health-related quality of life (HRQL);
To assess the overall safety in both treatment arms;
To determine the pharmacokinetics of intravenous (IV) aflibercept in this population;
to determine immunogenicity of IV aflibercept.

ReferenceCitation: Tannock IF, Fizazi K, Ivanov S, Karlsson CT, Flechon A, Skoneczna I, Orlandi F, Gravis G, Matveev V, Bavbek S, Gil T, Viana L, Aren O, Karyakin O, Elliott T, Birtle A, Magherini E, Hatteville L, Petrylak D, Tombal B, Rosenthal M; VENICE investigators. Aflibercept versus placebo in combination with docetaxel and prednisone for treatment of men with metastatic castration-resistant prostate cancer (VENICE): a phase 3, double-blind randomised trial. Lancet Oncol. 2013 Jul;14(8):760-8. doi: 10.1016/S1470-2045(13)70184-0. Epub 2013 Jun 4.

ReferenceCitation: van Soest RJ, Templeton AJ, Vera-Badillo FE, Mercier F, Sonpavde G, Amir E, Tombal B, Rosenthal M, Eisenberger MA, Tannock IF, de Wit R. Neutrophil-to-lymphocyte ratio as a prognostic biomarker for men with metastatic castration-resistant prostate cancer receiving first-line chemotherapy: data from two randomized phase III trials. Ann Oncol. 2015 Apr;26(4):743-749. doi: 10.1093/annonc/mdu569. Epub 2014 Dec 15.

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

unpaywall_oa_status: bronze

ReferenceCitation: de Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

publisher_dissemination: Springer

title: A Multicenter, Randomized, Double Blind Study Comparing the Efficacy and Safety of Aflibercept Versus Placebo Administered Every 3 Weeks in Patients Treated With Docetaxel/ Prednisone for Metastatic Androgen-independent Prostate Cancer

location_country:
Germany
Poland
Argentina
Australia
Brazil
Turkey
Croatia
Chile
Canada
France
Czech Republic
Portugal
Hungary
Hong Kong
Denmark
Switzerland
United States
Ukraine
Belgium
Estonia
Italy
United Kingdom
Singapore
Sweden
Netherlands
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel


title: A Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-center Study, to Assess the Safety and Tolerability of 28 Days Treatment With NVA237 (100 or 200 µg Once a Day) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

summary: This study assessed the safety/tolerability of 28 days of treatment with NVA237 100 µg and 200 µg once a day, compared to placebo in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD).

ReferenceCitation: Vogelmeier C, Verkindre C, Cheung D, Galdiz JB, Guclu SZ, Spangenthal S, Overend T, Henley M, Mizutani G, Zeldin RK. Safety and tolerability of NVA237, a once-daily long-acting muscarinic antagonist, in COPD patients. Pulm Pharmacol Ther. 2010 Oct;23(5):438-44. doi: 10.1016/j.pupt.2010.04.005. Epub 2010 Apr 21.

lead_sponsor: Novartis

location_country:
Germany
Netherlands
United States
Spain
Turkey
France


title: A Phase 1-2, Randomized, Placebo-Controlled, Single-Blind, Dose Escalation Study to Evaluate the Safety, Tolerability, and Activity of Ascending Single Doses of MRX-801 With Continuous Ultrasound Administration in Subjects With Acute Ischemic Stroke Receiving Treatment With Intravenous Tissue Plasminogen Activator

acronym: TUCSON

summary: This is a randomized, placebo controlled, parallel group dose escalation trial to evaluate the safety, tolerability, and activity of four sequential dose tiers of MRX-801 and ultrasound as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.

status: Terminated

enrollment_type: Anticipated

lead_sponsor: ImaRx Therapeutics

location_country:
United States
France

location_facility: Bichat - Claude Bernard University Hospital and Medical School

location_facility: Barrow Neurology Clinics at St. Joseph's Hospital

location_facility: Methodist Hospital Neurological Institute

status_simplified: Unknown


title: A Phase 2 Study of Doripenem In The Treatment of Nosocomial and Ventilator-Associated Pneumonia In Hospitals

summary: The purpose of this study is to evaluate the effectiveness and safety of doripenem monohydrate in the treatment of patients with nosocomial (hospital-acquired) pneumonia.

lead_sponsor: PriCara, Unit of Ortho-McNeil, Inc.

location_country:
India
Argentina
United States
Croatia
Chile
Canada
Ukraine
Russian Federation
France


title: SR121463B in Cirrhotic Ascites Treatment With Hyponatraemia: A Placebo-Controlled, Dose-Comparison Study

acronym: Hypo~CAT

summary:
The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites and the correction of hyponatraemia when used concomitantly with a standard dose regimen of spironolactone.

The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites.

This Hypo~CAT study is followed by a single-blind, placebo-controlled, one-year long-term safety extension (Expo~CAT). The first extension is followed by another long-term study (PASCCAL-1).

ReferenceCitation: Gines P, Wong F, Watson H, Milutinovic S, del Arbol LR, Olteanu D; HypoCAT Study Investigators. Effects of satavaptan, a selective vasopressin V(2) receptor antagonist, on ascites and serum sodium in cirrhosis with hyponatremia: a randomized trial. Hepatology. 2008 Jul;48(1):204-13. doi: 10.1002/hep.22293.

location_country:
France
Germany
Italy
Hungary
Argentina
Romania
Australia
Belgium
United States
Spain
Croatia
Canada
Czech Republic


title: SR121463B in Cirrhotic Ascites Treatment With Normonatraemia: A Placebo-Controlled, Dose-Comparison Study

acronym: Normo~CAT

summary:
The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites when used concomitantly with a standard dose regimen of spironolactone and furosemide.

The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites.

location_country:
France
Germany
Italy
Hungary
Argentina
Romania
Australia
Belgium
Spain
Croatia
Canada
Czech Republic


title: Study for the Prevention of Ascites (SPA): Comparison of Fixed Doses of SR121463B Versus Placebo in the Reduction of Recurrence of Cirrhotic Ascites

acronym: SPA

summary:
The primary objective is to determine the optimal dose or range of doses of SR121463B for the reduction in recurrence of ascites, when used concomitantly with a standard dose regimen of spironolactone.

The secondary objective was to determine the tolerability of different fixed doses of SR121463B in cirrhotic ascites, over a 12-week treatment period.

This SPA study is followed by a single-blind, placebo-controlled, 40 weeks long-term safety extension (ExSPA). The first extension is followed by another long-term study (PASCCAL-1).

ReferenceCitation: Wong F, Gines P, Watson H, Horsmans Y, Angeli P, Gow P, Minini P, Bernardi M. Effects of a selective vasopressin V2 receptor antagonist, satavaptan, on ascites recurrence after paracentesis in patients with cirrhosis. J Hepatol. 2010 Aug;53(2):283-90. doi: 10.1016/j.jhep.2010.02.036. Epub 2010 May 24.

location_country:
France
Germany
Italy
Argentina
Australia
Belgium
Spain
Croatia
Taiwan
Canada
Czech Republic


title: Efficacy and Safety of 2 mg/Day of M100907 on Sleep Maintenance Insomnia With a Sub-study of the Effect of M100907 on Stable Type II Diabetes Mellitus: a 12-week, Multi-center, Randomized, Double-blind, Placebo-controlled Study

summary: The purpose of this study is to assess efficacy and safety of volinanserin in the population of patients complaining of sleep maintenance insomnia. The objective of the substudy is to assess glycemic control in the subgroup of patients with type II diabetes mellitus.

location_country:
Finland
France
Italy
Colombia
Brazil
Netherlands
Switzerland
United States
Greece
Malaysia
South Africa
Taiwan
Turkey
Canada
Russian Federation
Czech Republic


title: Comparison of an Incremental Weight-Based Dose Regimen With an Individualized Dosage Adjusted According to the IGF-I Response in Adults With Growth Hormone Deficiency

summary: This study tested whether a dose regimen of growth hormone based on body weight is equivalent or better than starting with a low dose and gradually increasing the dose according to individual patient needs. Efficacy of the two regimens were assessed from changes in body fat measured by dual-energy x-ray absorptiometry (DXA) scanning, performed at the beginning of the study and at the completion of the study eight months later.

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Italy
United Kingdom
United States
Puerto Rico
France

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


title: Randomized Double Blind Trial to Evaluate the Efficacy and Safety of Dronedarone (400mg BID) Versus Amiodarone (600mg Daily for 28 Days, Then 200mg Daily Thereafter) for at Least 6 Months for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation (AF)

acronym: DIONYSOS

summary: The objective of this study is to compare the efficacy and safety of dronedarone to that of amiodarone for the treatment of patients with atrial fibrillation.

ReferenceCitation: Le Heuzey JY, De Ferrari GM, Radzik D, Santini M, Zhu J, Davy JM. A short-term, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of dronedarone versus amiodarone in patients with persistent atrial fibrillation: the DIONYSOS study. J Cardiovasc Electrophysiol. 2010 Jun 1;21(6):597-605. doi: 10.1111/j.1540-8167.2010.01764.x. Epub 2010 Apr 6.

ReferenceCitation: Ezekowitz MD. Maintaining sinus rhythm--making treatment better than the disease. N Engl J Med. 2007 Sep 6;357(10):1039-41. doi: 10.1056/NEJMe078148. No abstract available.

location_country:
Finland
Germany
Poland
Argentina
Australia
Turkey
Chile
Canada
France
Czech Republic
United States
Morocco
Tunisia
Belgium
China
Estonia
Italy
Netherlands
Austria
Mexico
Korea, Republic of
Russian Federation
Sweden


lead_sponsor: Novo Nordisk A/S

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

The aim of this trial is to evaluate the safety and efficacy of activated recombinant human factor VII analogue (vatreptocog alfa (activated)) in haemophilia patients with inhibitors.

ReferenceCitation: de Paula EV, Kavakli K, Mahlangu J, Ayob Y, Lentz SR, Morfini M, Nemes L, Salek SZ, Shima M, Windyga J, Ehrenforth S, Chuansumrit A; 1804 (adept(TM)1) Investigators. Recombinant factor VIIa analog (vatreptacog alfa [activated]) for treatment of joint bleeds in hemophilia patients with inhibitors: a randomized controlled trial. J Thromb Haemost. 2012 Jan;10(1):81-9. doi: 10.1111/j.1538-7836.2011.04549.x.

title: A Multi-centre, Randomised, Double-blinded, Controlled, Dose-escalation Trial on Safety and Efficacy of Activated Recombinant FVII Analogue (NN1731) in the Treatment of Joint Bleeds in Congenital Haemophilia Patients With Inhibitors

location_country:
Italy
Poland
Hungary
Argentina
Israel
Japan
Brazil
United Kingdom
United States
Spain
Thailand
Malaysia
Croatia
South Africa
Taiwan
Turkey
Canada
France


lead_sponsor: Grünenthal GmbH

summary:
The purpose of this study will be to determine whether tapentadol (CG5503) is effective and safe in the treatment of chronic tumor related pain compared to placebo. In addition tapentadol (CG5503) will also be compared to morphine controlled release, also referred to as slow release (SR).

*Tapentadol prolonged-release (PR) is the term used in the European Union and is referred to as extended release (ER) in the United States.

ReferenceCitation: Kress HG, Koch ED, Kosturski H, Steup A, Karcher K, Lange B, Dogan C, Etropolski MS, Eerdekens M. Tapentadol prolonged release for managing moderate to severe, chronic malignant tumor-related pain. Pain Physician. 2014 Jul-Aug;17(4):329-43.

ReferenceCitation: Kress HG, Koch ED, Kosturski H, Steup A, Karcher K, Dogan C, Etropolski M, Eerdekens M. Direct conversion from tramadol to tapentadol prolonged release for moderate to severe, chronic malignant tumour-related pain. Eur J Pain. 2016 Oct;20(9):1513-8. doi: 10.1002/ejp.875. Epub 2016 Apr 7.

publisher_dissemination: Wiley

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

title: A Randomized Withdrawal, Active- and Placebo-controlled, Double-blind, Multi-center Phase III Trial Assessing Safety and Efficacy of Oral CG5503 (Tapentadol) PR* in Subjects With Moderate to Severe Chronic Malignant Tumor-related Pain

location_country:
Germany
Italy
Moldova, Republic of
Poland
Slovakia
Hungary
Romania
Sweden
Austria
Spain
Croatia
Czechia
Bulgaria
Serbia
Russian Federation
France


title: CABG Off or On Pump Revascularization Study (CORONARY)

acronym: CORONARY

summary:
I. Main Research Question:

To compare the risks and benefits of Off-pump Coronary artery bypass surgery (CABG) to On-pump CABG and to determine if one is better than the other.
The purpose of this pilot study is also to see the rate of recruitment with expertise-based randomization across different hospital settings.

II. Small RCT studies and meta-analyses done so far have not been able to conclusively say which of the procedure is better. A large randomized study is required to establish the risks and benefits associated with both the off-pump and on-pump CABG surgical procedures.

III. The study will look at which of the two techniques reduce major risks associated with CABG.

ReferenceCitation: Hebert M, Lamy A, Noiseux N, Stevens LM; CORONARY Investigators. Impact of early quantitative morbidity on 1-year outcomes in coronary artery bypass graft surgery. Interact Cardiovasc Thorac Surg. 2022 Mar 31;34(4):523-531. doi: 10.1093/icvts/ivab316.

publisher_dissemination: Oxford University Press

ReferenceCitation: Conen D, Wang MK, Devereaux PJ, Whitlock R, McIntyre WF, Healey JS, Yuan F, Yusuf S, Lamy A. New-Onset Perioperative Atrial Fibrillation After Coronary Artery Bypass Grafting and Long-Term Risk of Adverse Events: An Analysis From the CORONARY Trial. J Am Heart Assoc. 2021 Jun 15;10(12):e020426. doi: 10.1161/JAHA.120.020426. Epub 2021 May 29.

ReferenceCitation: Lamy A, Devereaux PJ, Prabhakaran D, Taggart DP, Hu S, Straka Z, Piegas LS, Avezum A, Akar AR, Lanas Zanetti F, Jain AR, Noiseux N, Padmanabhan C, Bahamondes JC, Novick RJ, Tao L, Olavegogeascoechea PA, Airan B, Sulling TA, Whitlock RP, Ou Y, Gao P, Pettit S, Yusuf S; CORONARY Investigators. Five-Year Outcomes after Off-Pump or On-Pump Coronary-Artery Bypass Grafting. N Engl J Med. 2016 Dec 15;375(24):2359-2368. doi: 10.1056/NEJMoa1601564. Epub 2016 Oct 23.

oa_colors: green other

evidence: open (via free article)

version: acceptedVersion

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Lamy A, Tong W, Devereaux PJ, Gao P, Gafni A, Singh K, Taggart D, Straka Z, Akar AR, Piegas L, Ou Y, Yusuf S. The cost implications of off-pump versus on-pump coronary artery bypass graft surgery at one year. Ann Thorac Surg. 2014 Nov;98(5):1620-5. doi: 10.1016/j.athoracsur.2014.06.046. Epub 2014 Sep 24.

ReferenceCitation: Garg AX, Devereaux PJ, Yusuf S, Cuerden MS, Parikh CR, Coca SG, Walsh M, Novick R, Cook RJ, Jain AR, Pan X, Noiseux N, Vik K, Stolf NA, Ritchie A, Favaloro RR, Parvathaneni S, Whitlock RP, Ou Y, Lawrence M, Lamy A; CORONARY Investigators. Kidney function after off-pump or on-pump coronary artery bypass graft surgery: a randomized clinical trial. JAMA. 2014 Jun 4;311(21):2191-8. doi: 10.1001/jama.2014.4952. Erratum In: JAMA. 2014 Jul 2;312(1):97.

evidence: open (via free pdf)

publisher_dissemination: American Medical Association

ReferenceCitation: Lamy A, Devereaux PJ, Prabhakaran D, Taggart DP, Hu S, Paolasso E, Straka Z, Piegas LS, Akar AR, Jain AR, Noiseux N, Padmanabhan C, Bahamondes JC, Novick RJ, Vaijyanath P, Reddy SK, Tao L, Olavegogeascoechea PA, Airan B, Sulling TA, Whitlock RP, Ou Y, Pogue J, Chrolavicius S, Yusuf S; CORONARY Investigators. Effects of off-pump and on-pump coronary-artery bypass grafting at 1 year. N Engl J Med. 2013 Mar 28;368(13):1179-88. doi: 10.1056/NEJMoa1301228. Epub 2013 Mar 11.

repositories_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Garg AX, Devereaux PJ, Yusuf S, Cuerden MS, Parikh CR, Coca SG, Walsh M, Cook RJ, Whitlock RP, Noiseux N, Novick RJ, Ou Y, Lamy A; CORONARY Investigators. Coronary Artery Bypass Grafting Surgery Off- or On-pump Revascularisation Study (CORONARY): kidney substudy analytic protocol of an international randomised controlled trial. BMJ Open. 2012 Apr 18;2(2):e001080. doi: 10.1136/bmjopen-2012-001080. Print 2012.

ReferenceCitation: Lamy A, Devereaux PJ, Prabhakaran D, Taggart DP, Hu S, Paolasso E, Straka Z, Piegas LS, Akar AR, Jain AR, Noiseux N, Padmanabhan C, Bahamondes JC, Novick RJ, Vaijyanath P, Reddy S, Tao L, Olavegogeascoechea PA, Airan B, Sulling TA, Whitlock RP, Ou Y, Ng J, Chrolavicius S, Yusuf S; CORONARY Investigators. Off-pump or on-pump coronary-artery bypass grafting at 30 days. N Engl J Med. 2012 Apr 19;366(16):1489-97. doi: 10.1056/NEJMoa1200388. Epub 2012 Mar 26.

ReferenceCitation: Lamy A, Devereaux PJ, Prabhakaran D, Hu S, Piegas LS, Straka Z, Paolasso E, Taggart D, Lanas F, Akar AR, Jain A, Noiseux N, Ou Y, Chrolavicius S, Ng J, Yusuf S. Rationale and design of the coronary artery bypass grafting surgery off or on pump revascularization study: a large international randomized trial in cardiac surgery. Am Heart J. 2012 Jan;163(1):1-6. doi: 10.1016/j.ahj.2011.10.007.

lead_sponsor: Population Health Research Institute

collaborators: Instituto Dante Pazzanese de Cardiologia

collaborators: Centre for Chronic Disease Control, India

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

collaborators: Centre hospitalier de l'Université de Montréal (CHUM)

location_country:
France
Italy
Poland
Colombia
India
United Kingdom
Argentina
Brazil
China
Turkey
Chile
Canada
Czech Republic

location_facility: Braile Clinica de Servicos de Assistencia Medico

location_facility: Fakultni nemocnice Kralovske Vinohrady (FNKV)

location_facility: International Center of Cardiovascular and Thoracic Diseases

location_facility: Federal University of Sao Paulo School of Medicine

location_facility: Irmande Santa Casa De Misericordia De Curtiba

location_facility: Amrita Institute of Medical Sciences and Research Center

location_facility: Service de chirurgie thoracique et cardio-vasculaire

location_facility: Escorts Heart Institute and Research Centre

location_facility: Hospital Sao Francisco Complexo Hospitalar Santa Casa

location_facility: Irmandade da Santa Casa de Misericordia de Sao Paulo

location_facility: Basildon and Thurrock University Hospital NHS FT

location_facility: Instituto do Coracao do Hospital das Clinicas da

intervention_type: Procedure


title: Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of Tezosentan in Patients With Pre-operative Pulmonary Hypertension, Due to Left Heart Disease, Undergoing Cardiac Surgery

summary: Endothelin-1 is a powerful substance that may be involved in causing hemodynamic instability (problems related to unstable blood pressure) during and after open heart surgery. Tezosentan is an investigational intravenous drug that blocks the endothelin receptors. This clinical trial will assess the potential benefit of tezosentan compared with placebo in the treatment of patients undergoing open heart surgery with cardiopulmonary bypass (CPB). Treatment time is from the start of surgery up to 24 hours.

ReferenceCitation: Denault AY, Pearl RG, Michler RE, Rao V, Tsui SS, Seitelberger R, Cromie M, Lindberg E, D'Armini AM. Tezosentan and right ventricular failure in patients with pulmonary hypertension undergoing cardiac surgery: the TACTICS trial. J Cardiothorac Vasc Anesth. 2013 Dec;27(6):1212-7. doi: 10.1053/j.jvca.2013.01.023. Epub 2013 Mar 21.

lead_sponsor: Idorsia Pharmaceuticals Ltd.

location_country:
Germany
Italy
Poland
India
Slovakia
Israel
United Kingdom
Sweden
Austria
United States
Czechia
Canada
Serbia
France

location_facility: London Health Sciences Centre-University Hospital

location_facility: Institute for Clinical and Experimental Medicine (IKEM)

location_facility: Texas Heart Institute/St. Luke's Episcopal Hospital/Baylor College

location_facility: Fondazione IRCCS San Matteo Hospital, Cardiac Surgery

location_facility: Azienda Sanitaria Ospedaliera "San Giovanni Battista", Cardiac Surgery Division

location_facility: National Institute of Cardiovascular Diseases, Clinic of Heart Surgery

location_facility: Medical University of Silesia, 2nd Dept of Cardiac Surgery

location_facility: Montefiore Medical Center/Albert Einstein College of Medicine

location_facility: Klinika Chirurgii Serca, Naczyn I Transplantologii, Szpital Jana Pawla II

location_facility: Zentrum der Chirugie-Zchir-des Universitatsklinikums


summary: Pompe disease (also known as glycogen storage disease Type II) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. The objective of this extension study is to assess the long-term safety and efficacy of alglucosidase alfa treatment in patients with Late-Onset Pompe Disease who were previously treated under the placebo-controlled, double-blind study AGLU02704 (NCT00158600).

title: An Open-Label Extension Study of Patients With Late-Onset Pompe Disease Who Were Previously Enrolled in Protocol AGLU02704

design_allocation: Non-Randomized

location_country:
Australia
Netherlands
United States
Canada
France


title: Study to Evaluate the Dose, Safety and Effectiveness of Modified-Release Recombinant Human Thyroid Stimulating Hormone (MRrhTSH) When Used in Conjunction With Radioiodine for the Treatment of Multinodular Goiter.

summary: The purpose of this study is to determine the safety and effectiveness of 2 different doses of modified-release recombinant human thyroid stimulating hormone (MRrhTSH) when administered with radioiodine in patients with multinodular goiter, a condition that involves the enlargement of the thyroid gland. We will also evaluate the safety and effectiveness of radioiodine therapy alone in these patients. The goal of the treatment is to determine if there was a reduction in the size of the goiter and to study if goiter symptoms have improved after 6 months and after 36 months.

ReferenceCitation: Fast S, Hegedus L, Pacini F, Pinchera A, Leung AM, Vaisman M, Reiners C, Wemeau JL, Huysmans DA, Harper W, Rachinsky I, de Souza HN, Castagna MG, Antonangeli L, Braverman LE, Corbo R, Duren C, Proust-Lemoine E, Marriott C, Driedger A, Grupe P, Watt T, Magner J, Purvis A, Graf H. Long-term efficacy of modified-release recombinant human thyrotropin augmented radioiodine therapy for benign multinodular goiter: results from a multicenter, international, randomized, placebo-controlled, dose-selection study. Thyroid. 2014 Apr;24(4):727-35. doi: 10.1089/thy.2013.0370. Epub 2014 Mar 4.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Mary Ann Liebert Inc

ReferenceCitation: Huo Y, Xie J, Chen S, Wang H, Ma C. Recombinant human thyrotropin (rhTSH)-aided radioiodine treatment for non-toxic multinodular goitre. Cochrane Database Syst Rev. 2021 Dec 28;12(12):CD010622. doi: 10.1002/14651858.CD010622.pub2.

location_country:
Germany
Italy
Denmark
Brazil
Netherlands
United States
Canada
France


title: A Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of Topical Terbinafine Hydrogen Chloride (HCl) Formulation for 24 or 48 Weeks of Treatment in Patients With Mild to Moderate Toenail Onychomycosis

summary: This study is designed to assess the efficacy, safety and tolerability of a topical formulation of terbinafine solution applied daily in patients with toenail fungus. This trial will study patients with mild to moderate toenail fungus disease of the big toenail and their responses to two treatment durations, 24 or 48 weeks.

lead_sponsor: Novartis Pharmaceuticals

location_country:
United States
Germany
France

location_facility:
Dr. Mark Ling
Dr. John Mallory
Dr. Richard Pollak
Dr. Linda Stein-Gold
Dr. Rich Phoebe
Dr. Robert P. Dunne
Dr. Jay Lifshen
Dr. Patricia Westmorland
Dr. Patrick Agnew
Dr. Jesse Plasencia
Dr. Fred D. Youngswick
Dr. David Horowitz
Dr.Michael Kaye
Dr. Max Weisfeld
Dr. Larry Doehring
Dr. Anne Lucky
Novartis Investigative Site
Dr. Joseph Jorrizo
Dr. Richard Scher
Dr. Jeffrey Conrow
Dr. Anna Glaser
Novartis


title: EnRhythm MRI™ SureScan™ Pacing System Clinical Investigation

summary: The purpose of this clinical study is to confirm safety and efficacy in the clinical magnetic resonance imaging (MRI) environment of the investigational EnRhythm MRI™ SureScan™ Pacing System (used in support of Revo MRI™ SureScan Pacing System launch).

primary_purpose: Diagnostic

ReferenceCitation: Sutton R, Kanal E, Wilkoff BL, Bello D, Luechinger R, Jenniskens I, Hull M, Sommer T. Safety of magnetic resonance imaging of patients with a new Medtronic EnRhythm MRI SureScan pacing system: clinical study design. Trials. 2008 Dec 2;9:68. doi: 10.1186/1745-6215-9-68.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
France
Germany
Italy
United Kingdom
Netherlands
Austria
Belgium
Switzerland
United States
Canada
Czech Republic

intervention_type: Device


title: Multi-Center Pivotal Study of Motor-Point Stimulation for Conditioning the Diaphragm of Patients With Amyotrophic Lateral Sclerosis (ALS)

summary:
The overall goal of this research is to delay the respiratory decline of patients with Amyotrophic Lateral Sclerosis (ALS) thereby increasing their lifespan by conditioning the diaphragm with laparoscopically placed electrodes.

This device currently holds an Investigational Device Exemption No. G040142 in the United States and is currently undergoing clinical trials at University Hospitals (Cleveland), Johns Hopkins, Mayo Clinic Jacksonville, California Pacific Medical Center (CPMC), Henry Ford Health System, The Methodist Hospital, and Stanford University.

status: Unknown status

study_completion_date_type: Anticipated

ReferenceCitation: Gonzalez-Bermejo J, Morelot-Panzini C, Salachas F, Redolfi S, Straus C, Becquemin MH, Arnulf I, Pradat PF, Bruneteau G, Ignagni AR, Diop M, Onders R, Nelson T, Menegaux F, Meininger V, Similowski T. Diaphragm pacing improves sleep in patients with amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2012 Jan;13(1):44-54. doi: 10.3109/17482968.2011.597862. Epub 2011 Oct 24.

lead_sponsor: Synapse Biomedical

collaborators: University Hospitals Cleveland Medical Center

location_facility: Forbes Norris - California Pacific Medical Center (CPMC)


title: Stroke in Young Fabry Patients (sifap1): Frequency of Fabry Disease in an Unselected Group of Young Stroke Patients: an International, Multicentre Prevalence Study

summary: More than one million people in Europe suffer from a stroke every day. Normally older people have a stroke, but also a significant number of younger people between 18 and 55 years. Usually, these cannot be explained by the classical risk factors such as diabetes, overweight and high blood pressure. New studies indicate that in about 1 - 2 % of the younger stroke patients the cause could have been an undiagnosed genetic disease, the so called Fabry disease. The purpose of this study is to determine in a large number of young stroke patients, how many strokes were caused by Fabry Disease.

ReferenceCitation: Rolfs A, Bottcher T, Zschiesche M, Morris P, Winchester B, Bauer P, Walter U, Mix E, Lohr M, Harzer K, Strauss U, Pahnke J, Grossmann A, Benecke R. Prevalence of Fabry disease in patients with cryptogenic stroke: a prospective study. Lancet. 2005 Nov 19;366(9499):1794-6. doi: 10.1016/S0140-6736(05)67635-0. Erratum In: Lancet. 2006 Dec 23;368(9554):2210.

ReferenceCitation: Rolfs A, Martus P, Heuschmann PU, Grittner U, Holzhausen M, Tatlisumak T, Bottcher T, Fazekas F, Enzinger C, Ropele S, Schmidt R, Riess O, Norrving B; sifap1 Investigators. Protocol and methodology of the Stroke in Young Fabry Patients (sifap1) study: a prospective multicenter European study of 5,024 young stroke patients aged 18-55 years. Cerebrovasc Dis. 2011;31(3):253-62. doi: 10.1159/000322153. Epub 2010 Dec 21.

ReferenceCitation: Thijs V, Grittner U, Fazekas F, McCabe DJH, Giese AK, Kessler C, Martus P, Norrving B, Ringelstein EB, Schmidt R, Tanislav C, Putaala J, Tatlisumak T, von Sarnowski B, Rolfs A, Enzinger C; Stroke in Fabry (SIFAP1) Investigators. Dolichoectasia and Small Vessel Disease in Young Patients With Transient Ischemic Attack and Stroke. Stroke. 2017 Sep;48(9):2361-2367. doi: 10.1161/STROKEAHA.117.017406. Epub 2017 Jul 28.

ReferenceCitation: Aigner A, Grittner U, Rolfs A, Norrving B, Siegerink B, Busch MA. Contribution of Established Stroke Risk Factors to the Burden of Stroke in Young Adults. Stroke. 2017 Jul;48(7):1744-1751. doi: 10.1161/STROKEAHA.117.016599. Epub 2017 Jun 15.

ReferenceCitation: von Sarnowski B, Schminke U, Grittner U, Tanislav C, Bottcher T, Hennerici MG, Tatlisumak T, Putaala J, Kaps M, Fazekas F, Enzinger C, Rolfs A, Kessler C; sifap1 Investigators. Posterior versus Anterior Circulation Stroke in Young Adults: A Comparative Study of Stroke Aetiologies and Risk Factors in Stroke among Young Fabry Patients (sifap1). Cerebrovasc Dis. 2017;43(3-4):152-160. doi: 10.1159/000454840. Epub 2017 Jan 14.

publisher_dissemination: S. Karger AG

ReferenceCitation: Huber R, Grittner U, Weidemann F, Thijs V, Tanislav C, Enzinger C, Fazekas F, Wolf M, Hennerici MG, McCabe DJ, Putaala J, Tatlisumak T, Kessler C, von Sarnowski B, Martus P, Kolodny E, Norrving B, Rolfs A; Stroke in Young Fabry Patients (SIFAP) Investigators. Patent Foramen Ovale and Cryptogenic Strokes in the Stroke in Young Fabry Patients Study. Stroke. 2017 Jan;48(1):30-35. doi: 10.1161/STROKEAHA.116.013620. Epub 2016 Nov 29.

ReferenceCitation: Tatlisumak T, Putaala J, Innila M, Enzinger C, Metso TM, Curtze S, von Sarnowski B, Amaral-Silva A, Jungehulsing GJ, Tanislav C, Thijs V, Rolfs A, Norrving B, Fazekas F, Suomalainen A, Kolodny EH. Frequency of MELAS main mutation in a phenotype-targeted young ischemic stroke patient population. J Neurol. 2016 Feb;263(2):257-262. doi: 10.1007/s00415-015-7969-z. Epub 2015 Nov 14.

repository_institution: RCAAP Project by FCT - Portuguese National Funding Agency for Science, Research and Technology - RCAAP Search Portal

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

ReferenceCitation: Wolf ME, Grittner U, Bottcher T, Norrving B, Rolfs A, Hennerici MG; sifap1 TM investigators. Phenotypic ASCO Characterisation of Young Patients with Ischemic Stroke in the Prospective Multicentre Observational sifap1 Study. Cerebrovasc Dis. 2015;40(3-4):129-35. doi: 10.1159/000434760. Epub 2015 Jul 25.

ReferenceCitation: Thijs V, Grittner U, Dichgans M, Enzinger C, Fazekas F, Giese AK, Kessler C, Kolodny E, Kropp P, Martus P, Norrving B, Ringelstein EB, Rothwell PM, Schmidt R, Tanislav C, Tatlisumak T, von Sarnowski B, Rolfs A; Stroke in Fabry Investigators. Family History in Young Patients With Stroke. Stroke. 2015 Jul;46(7):1975-8. doi: 10.1161/STROKEAHA.115.009341. Epub 2015 Jun 2.

ReferenceCitation: Fazekas F, Enzinger C, Schmidt R, Grittner U, Giese AK, Hennerici MG, Huber R, Jungehulsing GJ, Kaps M, Kessler C, Martus P, Putaala J, Ropele S, Tanislav C, Tatlisumak T, Thijs V, von Sarnowski B, Norrving B, Rolfs A; SIFAP 1 Investigators. Brain magnetic resonance imaging findings fail to suspect Fabry disease in young patients with an acute cerebrovascular event. Stroke. 2015 Jun;46(6):1548-53. doi: 10.1161/STROKEAHA.114.008548. Epub 2015 Apr 21.

ReferenceCitation: Tanislav C, Kropp P, Grittner U, Holzhausen M, Fazekas F, Jungehulsing GJ, Tatlisumak T, von Sarnowski B, Putaala J, Huber R, Thijs V, Schmidt R, Kaps M, Enzinger C, Dichgans M, Norrving B, Rolfs A. Clinically relevant depressive symptoms in young stroke patients - results of the sifap1 study. Neuroepidemiology. 2015;44(1):30-8. doi: 10.1159/000371389. Epub 2015 Jan 31.

repository_institution: Ludwid Maxmilian's Universitat Munchen - Open access LMU

ReferenceCitation: Kaps M, Grittner U, Jungehulsing G, Tatlisumak T, Kessler C, Schmidt R, Jukka P, Norrving B, Rolfs A, Tanislav C; sifap1 Investigators. Clinical signs in young patients with stroke related to FAST: results of the sifap1 study. BMJ Open. 2014 Nov 7;4(11):e005276. doi: 10.1136/bmjopen-2014-005276.

repository_institution: Lund University - Lund University Publications

repository_institution: Universitätsbibliothek der Freien Universität Berlin - Refubium

repositories_institution: Lund University - Lund University Publications

ReferenceCitation: Tanislav C, Grittner U, Misselwitz B, Jungehuelsing GJ, Enzinger C, von Sarnowski B, Putaala J, Kaps M, Kropp P, Rolfs A, Tatlisumak T, Fazekas F, Kolodny E, Norrving B. Lessons from everyday stroke care for clinical research and vice versa: comparison of a comprehensive and a research population of young stroke patients. BMC Neurol. 2014 Mar 7;14:45. doi: 10.1186/1471-2377-14-45.

ReferenceCitation: Fazekas F, Enzinger C, Schmidt R, Dichgans M, Gaertner B, Jungehulsing GJ, Hennerici MG, Heuschmann P, Holzhausen M, Kaps M, Kessler C, Martus P, Putaala J, Ropele S, Tanislav C, Tatlisumak T, Norrving B, Rolfs A; sifap1 Investigators. MRI in acute cerebral ischemia of the young: the Stroke in Young Fabry Patients (sifap1) Study. Neurology. 2013 Nov 26;81(22):1914-21. doi: 10.1212/01.wnl.0000436611.28210.ec. Epub 2013 Nov 1.

ReferenceCitation: Kropp P, Holzhausen M, Kolodny E, Becker U, Dichgans M, Diez-Tejedor E, Enzinger C, Fazekas F, Fuentes B, Karpinska A, Meyer W, Tanislav C, Bottcher T, Rolfs A; Stroke in Young Fabry Patients (sifap) Investigators. Headache as a symptom at stroke onset in 4,431 young ischaemic stroke patients. Results from the "Stroke in Young Fabry Patients (SIFAP1) study". J Neural Transm (Vienna). 2013 Oct;120(10):1433-40. doi: 10.1007/s00702-013-1014-0. Epub 2013 Jun 9.

ReferenceCitation: von Sarnowski B, Schminke U, Tatlisumak T, Putaala J, Grittner U, Kaps M, Tobin WO, Kinsella JA, McCabe DJ, Hennerici MG, Fazekas F, Norrving B, Kessler C, Rolfs A; sifap1 investigators. Prevalence of stenoses and occlusions of brain-supplying arteries in young stroke patients. Neurology. 2013 Apr 2;80(14):1287-94. doi: 10.1212/WNL.0b013e31828ab2ed. Epub 2013 Mar 6.

ReferenceCitation: Rolfs A, Fazekas F, Grittner U, Dichgans M, Martus P, Holzhausen M, Bottcher T, Heuschmann PU, Tatlisumak T, Tanislav C, Jungehulsing GJ, Giese AK, Putaala J, Huber R, Bodechtel U, Lichy C, Enzinger C, Schmidt R, Hennerici MG, Kaps M, Kessler C, Lackner K, Paschke E, Meyer W, Mascher H, Riess O, Kolodny E, Norrving B; Stroke in Young Fabry Patients (sifap) Investigators. Acute cerebrovascular disease in the young: the Stroke in Young Fabry Patients study. Stroke. 2013 Feb;44(2):340-9. doi: 10.1161/STROKEAHA.112.663708. Epub 2013 Jan 10.

ReferenceCitation: von Sarnowski B, Putaala J, Grittner U, Gaertner B, Schminke U, Curtze S, Huber R, Tanislav C, Lichy C, Demarin V, Basic-Kes V, Ringelstein EB, Neumann-Haefelin T, Enzinger C, Fazekas F, Rothwell PM, Dichgans M, Jungehulsing GJ, Heuschmann PU, Kaps M, Norrving B, Rolfs A, Kessler C, Tatlisumak T; sifap1 Investigators. Lifestyle risk factors for ischemic stroke and transient ischemic attack in young adults in the Stroke in Young Fabry Patients study. Stroke. 2013 Jan;44(1):119-25. doi: 10.1161/STROKEAHA.112.665190. Epub 2012 Nov 13.

ReferenceCitation: Steinicke R, Gaertner B, Grittner U, Schmidt W, Dichgans M, Heuschmann PU, Tanislav C, Putaala J, Kaps M, Endres M, Schmidt R, Fazekas F, Norrving B, Rolfs A, Martus P, Tatlisumak T, Enzinger C, Jungehulsing GJ. Kidney function and white matter disease in young stroke patients: analysis of the stroke in young fabry patients study population. Stroke. 2012 Sep;43(9):2382-8. doi: 10.1161/STROKEAHA.111.645713. Epub 2012 Jun 21.

ReferenceCitation: Fellgiebel A, Keller I, Martus P, Ropele S, Yakushev I, Bottcher T, Fazekas F, Rolfs A. Basilar artery diameter is a potential screening tool for Fabry disease in young stroke patients. Cerebrovasc Dis. 2011;31(3):294-9. doi: 10.1159/000322558. Epub 2010 Dec 22.

sponsor_collaborators:
CENTOGENE GmbH Rostock
Shire Human Genetic Therapies, Inc.

location_country:
Finland
Germany
Ireland
Italy
Poland
Portugal
United Kingdom
Malta
Austria
Belgium
Spain
Croatia
Georgia
France

location_facility: Krankenhaus der Barmherzigen Brüder, Abteilung für Neurologie

location_facility: Department of Neurology, Universitaetsklinik fuer Neurologie Innsbruck

location_facility: Dept. of Neurology, Johann-Wolfgang-Goethe-Universität

location_facility: Wagner-Jauregg Linz, Department of Neurology

location_facility: Dept. of Neurology, Vivantes Netzwerk für Gesundheit GmbH, Klinikum Neukölln

location_facility: Department of Neurology, S. Khechinashvili University clinic of Tbilisi state medical university

location_facility: Charite Campus Benjamin Franklin, Dept. of Neurology

location_facility: Klinikum Bremen Mitte gGmbH, Neurologische Klinik

location_facility: Department of Neurology, University Tuebingen

location_facility: Stroke Prevention Research Unit, Dept. of Clinical Neurology, University of Glasgow, Southern General Hospital

location_facility: Hopital Neurologique de Lyon, Service d'urgences Neurovasculaires

location_facility: University of Rostock, Department of Neurology

location_facility: Department of Neurology, Ernst-Moritz-Arndt-University

location_facility: Department of Neurology, Universitaetsklinikum Leipzig

location_facility: Department of Neurology, Universitaetsklinikum Giessen und Marburg GmbH

location_facility: University of Muenster, Dept. of Neurology

location_facility: University Schleswig-Holstein, Dept. of Neurology

location_facility: Department of Neurology, Klinikum Chemnitz gGmbH

location_facility: Department of Neurology S10, Universitaetsklinikum Hamburg-Eppendorf

location_facility: Christian-Doppler-Klinik, Department für medizin. Studien

location_facility: Heinrich-Heine University Duesseldorf, Dept. of Neurology

location_facility: Institute of Psychiatry and Neurology, Dept. of Neurology

location_facility: The Adelaide and Meath Hospital, Department of Neurology

location_facility: Department of Neurology, Klinik und Poliklinik fuer Neurologie

location_facility: Centro Hospitalar de Lisboa Central, Servico de Neurologia

location_facility: Stroke Prevention Research Unit, John Radcliffe Hospital

location_facility: Department of Neurology, Kreiskrankenhaus Altenburg

location_facility: Ludwig-Maximilians-University of Munich, Dept. of Neurology

location_facility: Dept. of Neurology, Ospoedale Maggiore Policlinico

location_facility: University of Giessen-Marburg Dept. of Neurology

location_facility: University of Ulm, Department of Neurology

location_facility: University of Heidelberg, Department of Neurology

location_facility: Department of Neurology, Universitaetsklinikum Carl Gustav Carus

location_facility: Department of Neurology, Klinikum Hohe Warte

location_facility: Department of Neurology, Universitaetsklinikum Jena

location_facility: Department of Neurology, University Hospital Sestre Milosrdnice

location_facility: Middelheim General Hospital, Dept. of Neurology/Memory Clinic

location_facility: Dept. of Neurology, Ökumenisches Hainich Klinikum gGmbH

location_facility: Department of Neurology, Hospital Universitario La Paz

location_facility: Dept. of Neurology, Martin-Luther-Universität, Universitätsklinik und Poliklinik für Neurologie

location_facility: Department of Neurology, Allgemeines Krankenhaus Celle

location_facility: Helsinki University Central Hospital, Department of Neurology


type: Other Grant/Funding Number

title: Argus® II Retinal Stimulation System Feasibility Protocol

summary:
Investigational Phase of the Study:

The objective of this feasibility study is to evaluate the safety and utility of the Argus II Retinal Stimulation System in providing visual function to blind subjects with retinitis pigmentosa.

Post-Approval Phase of the Study:

To collect post-approval data in order to monitor the ongoing safety and reliability of the Argus II System

ReferenceCitation: Weiland JD, Faraji B, Greenberg RJ, Humayun MS, Shellock FG. Assessment of MRI issues for the Argus II retinal prosthesis. Magn Reson Imaging. 2012 Apr;30(3):382-9. doi: 10.1016/j.mri.2011.12.005. Epub 2012 Jan 20.

ReferenceCitation: Humayun MS, Dorn JD, da Cruz L, Dagnelie G, Sahel JA, Stanga PE, Cideciyan AV, Duncan JL, Eliott D, Filley E, Ho AC, Santos A, Safran AB, Arditi A, Del Priore LV, Greenberg RJ; Argus II Study Group. Interim results from the international trial of Second Sight's visual prosthesis. Ophthalmology. 2012 Apr;119(4):779-88. doi: 10.1016/j.ophtha.2011.09.028. Epub 2012 Jan 11.

ReferenceCitation: Barry MP, Dagnelie G; Argus II Study Group. Use of the Argus II retinal prosthesis to improve visual guidance of fine hand movements. Invest Ophthalmol Vis Sci. 2012 Aug 1;53(9):5095-101. doi: 10.1167/iovs.12-9536.

ReferenceCitation: Ahuja AK, Dorn JD, Caspi A, McMahon MJ, Dagnelie G, Dacruz L, Stanga P, Humayun MS, Greenberg RJ; Argus II Study Group. Blind subjects implanted with the Argus II retinal prosthesis are able to improve performance in a spatial-motor task. Br J Ophthalmol. 2011 Apr;95(4):539-43. doi: 10.1136/bjo.2010.179622. Epub 2010 Sep 29.

ReferenceCitation: Arevalo JF, Al Rashaed S, Alhamad TA, Al Kahtani E, Al-Dhibi HA; KKESH Collaborative Retina Study Group. Argus II retinal prosthesis for retinitis pigmentosa in the Middle East: The 2015 Pan-American Association of Ophthalmology Gradle Lecture. Int J Retina Vitreous. 2021 Oct 27;7(1):65. doi: 10.1186/s40942-021-00324-6.

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

repositories_concat: PubMed Central;iris.unife.it

ReferenceCitation: Sabbah N, Authie CN, Sanda N, Mohand-Said S, Sahel JA, Safran AB. Importance of eye position on spatial localization in blind subjects wearing an Argus II retinal prosthesis. Invest Ophthalmol Vis Sci. 2014 Nov 20;55(12):8259-66. doi: 10.1167/iovs.14-15392.

publisher_dissemination: Association for Research in Vision and Ophthalmology (ARVO)

ReferenceCitation: Ahuja AK, Yeoh J, Dorn JD, Caspi A, Wuyyuru V, McMahon MJ, Humayun MS, Greenberg RJ, Dacruz L. Factors Affecting Perceptual Threshold in Argus II Retinal Prosthesis Subjects. Transl Vis Sci Technol. 2013 Apr;2(4):1. doi: 10.1167/tvst.2.4.1. Epub 2013 Apr 12.

ReferenceCitation: de Juan E Jr, Spencer R, Barale PO, da Cruz L, Neysmith J. Extraction of retinal tacks from subjects implanted with an epiretinal visual prosthesis. Graefes Arch Clin Exp Ophthalmol. 2013 Oct;251(10):2471-6. doi: 10.1007/s00417-013-2452-y. Epub 2013 Sep 8.

ReferenceCitation: Stronks HC, Barry MP, Dagnelie G. Electrically elicited visual evoked potentials in Argus II retinal implant wearers. Invest Ophthalmol Vis Sci. 2013 Jun 6;54(6):3891-901. doi: 10.1167/iovs.13-11594.

ReferenceCitation: Dorn JD, Ahuja AK, Caspi A, da Cruz L, Dagnelie G, Sahel JA, Greenberg RJ, McMahon MJ; gus II Study Group. The Detection of Motion by Blind Subjects With the Epiretinal 60-Electrode (Argus II) Retinal Prosthesis. JAMA Ophthalmol. 2013 Feb;131(2):183-9. doi: 10.1001/2013.jamaophthalmol.221.

ReferenceCitation: Ahuja AK, Behrend MR. The Argus II retinal prosthesis: factors affecting patient selection for implantation. Prog Retin Eye Res. 2013 Sep;36:1-23. doi: 10.1016/j.preteyeres.2013.01.002. Epub 2013 Mar 14.

ReferenceCitation: Olson JL, Velez-Montoya R, Mandava N, Stoldt CR. Intravitreal silicon-based quantum dots as neuroprotective factors in a model of retinal photoreceptor degeneration. Invest Ophthalmol Vis Sci. 2012 Aug 17;53(9):5713-21. doi: 10.1167/iovs.12-9745.

ReferenceCitation: Perez Fornos A, Sommerhalder J, da Cruz L, Sahel JA, Mohand-Said S, Hafezi F, Pelizzone M. Temporal properties of visual perception on electrical stimulation of the retina. Invest Ophthalmol Vis Sci. 2012 May 4;53(6):2720-31. doi: 10.1167/iovs.11-9344.

sponsor_collaborators:
Second Sight Medical Products
National Eye Institute (NEI)

location_country:
United Kingdom
Switzerland
Mexico
United States
France

location_facility: Columbia University, Department of Ophthalmology, Edward S. Harkness Eye Institute

location_facility: University of Pennsylvania, Scheie Eye Institute

location_facility: Puerta de Hierro, Centro Medico, Centro de Retina

location_facility: Centre d'Investigation Clinique, Service d'Ophtalmologie, Quinze-Vingts National Eye Hospital, 28 rue de Charenton, 75557 Cedex 12

location_facility: Moorfields Eye Hospital, Vitreoretinal Research Unit

location_facility: Clinique d'Ophthalmologie Hopitaux, Universitaires de Geneve 22 rue Alcide Jentzer 1205


title: Multi-Center Clinical Performance Evaluation of a Rapid In Vitro Diagnostic Device for Direct Detection of Staphylococcus Aureus Nasal Colonization: Comparative Analysis to Culture Screening Methods

summary: To establish the clinical test performance characteristics of sensitivity, specificity and predictive values for direct detection of nasal Staphylococcus aureus colonization against clinical microbiology laboratory culture methods.

location_country:
United States
Netherlands
Germany
France

location_facility: University of Muenster Hospital and Clinics

location_facility: Wake Forest University Baptist Medical Center


type: U.S. NIH Grant/Contract

title: A Phase III Randomized, Multicenter Trial Comparing Sirolimus/Tacrolimus With Tacrolimus/Methotrexate as Graft-versus-Host Disease (GVHD) Prophylaxis After HLA-Matched, Related Peripheral Blood Stem Cell Transplantation (BMT CTN #0402)

summary: The study is designed as a phase III, randomized, open label, multicenter, prospective, comparative trial of sirolimus and tacrolimus versus tacrolimus and methotrexate as graft-versus-host disease (GVHD) prophylaxis after human leukocyte antigen (HLA)-matched, related, peripheral blood stem cell transplantation in individuals with hematologic cancer. Participants will be stratified by transplant center and will be randomly assigned to the sirolimus/tacrolimus or tacrolimus/methotrexate arms at a 1:1 ratio.

ReferenceCitation: Cutler C, Logan B, Nakamura R, Johnston L, Choi S, Porter D, Hogan WJ, Pasquini M, MacMillan ML, Hsu JW, Waller EK, Grupp S, McCarthy P, Wu J, Hu ZH, Carter SL, Horowitz MM, Antin JH. Tacrolimus/sirolimus vs tacrolimus/methotrexate as GVHD prophylaxis after matched, related donor allogeneic HCT. Blood. 2014 Aug 21;124(8):1372-7. doi: 10.1182/blood-2014-04-567164. Epub 2014 Jun 30.

publisher_dissemination: American Society of Hematology

ipd_sharing_description: Findings will be published in a manuscript.

lead_sponsor: Medical College of Wisconsin

collaborators: National Heart, Lung, and Blood Institute (NHLBI)

collaborators: Blood and Marrow Transplant Clinical Trials Network

location_country:
United States
France

location_facility: University of Wisconsin Hospital & Clinics

location_facility: University of Pittsburgh Cancer Institute

location_facility: University of Iowa Hospitals and Clinics

location_facility: Ohio State, Arthur G. James Cancer Hospital

location_facility: University Hospitals of Cleveland/Case Western

location_facility: University of Florida College of Medicine (Shands)

location_facility: Virginia Commonwealth University/MCV Hospital

location_facility: Washington University/Barnes Jewish Hospital

location_facility: University of Pennsylvania Cancer Center


title: A Pan-European Randomized, Parallel Group, Two-arm Placebo-controlled, Double-blind Multicenter Study of Rimonabant 20mg Once Daily in the Treatment of Abdominally Obese Patients With Impaired Fasting Blood Glucose With or Without Other Comorbidities

acronym: PRADO

summary:
Primary objective:

To determine the effect of Rimonabant 20mg on the co-primary endpoint including Fasting Plasma Glucose (FPG), HDL-Cholesterol (HDL-C) and triglyceride (TG) levels over a period of 12 months when prescribed with a mild hypocaloric diet in abdominally obese patients with impaired fasting blood glucose and with or without associated comorbidities.

Main Secondary objectives:

To determine the effect of 12 months Rimonabant treatment versus placebo on changes in waist circumference (WC), body weight, glycemic parameters and lipid parameters.

To assess the safety of 12 months Rimonabant treatment versus placebo in these patients.

location_country:
Finland
Ireland
Brazil
Luxembourg
Turkey
Canada
France
Czech Republic
Lithuania
Portugal
Slovakia
Hungary
Denmark
Switzerland
Belgium
Egypt
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
Greece
Bulgaria
Israel


title: A Double-Masked, Placebo-Controlled, Parallel-Group, Multi-Center, Dose-Ranging Study With an Optional Extension to Assess the Efficacy and Safety of LX211 as Therapy in Subjects With Active Sight Threatening, Non-infectious Anterior Uveitis

acronym: LUMINATE

summary: The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with active non-infectious anterior uveitis

lead_sponsor: Lux Biosciences, Inc.

location_country:
Germany
India
United Kingdom
Austria
United States
Canada
France

location_facility: Aravind Eye Hospitals and Postgraduate Institute of Ophthalmology

location_facility: Bristol Eye Hospital and University of Bristol

location_facility: Vittala International Institute of Ophthalmology

location_facility: Klinik für Augenheilkunde, Dept. of Ophthalmology

location_facility: Massachusetts Eye Research and Surgery Institute

location_facility: Advanced Eye Centre, Postgraduate Institute of Medical Education and Research (PGIMER)

location_facility: Hôpital Pitié Salpétrière, Service d'Ophtalmologie


title: A Prospective, Randomized, Multicenter Trial Investigating Matrix 2® and GDC® Detachable Coils for the Treatment of Intracranial Saccular Aneurysms

acronym: MAPS

summary:
Primary Objectives:

To establish Target Aneurysm Recurrence (TAR) rates for Matrix 2® and GDC® Coils used for the treatment of intracranial saccular aneurysms. TAR is defined as clinically relevant recurrence resulting in: target aneurysm reintervention, rupture/re-rupture and/or death from an unknown cause.
To correlate defined angiographic endpoints with TAR rates and assess their predictive value, thereby providing a framework to establish clinically relevant endpoints for future studies.

Secondary Objectives:

To evaluate device characteristics, incidence and severity of device-related adverse events, including death, neurological deterioration and changes in functional abilities.
To establish angiographic recurrence rates for Matrix 2® and GDC® Coils used for the treatment of intracranial saccular aneurysms.
To explore an experimental, quantitative and volumetric endpoint and correlate these with existing qualitative assessments.

ReferenceCitation: McDougall CG, Johnston SC, Gholkar A, Barnwell SL, Vazquez Suarez JC, Masso Romero J, Chaloupka JC, Bonafe A, Wakhloo AK, Tampieri D, Dowd CF, Fox AJ, Imm SJ, Carroll K, Turk AS; MAPS Investigators. Bioactive versus bare platinum coils in the treatment of intracranial aneurysms: the MAPS (Matrix and Platinum Science) trial. AJNR Am J Neuroradiol. 2014 May;35(5):935-42. doi: 10.3174/ajnr.A3857. Epub 2014 Jan 30.

repository_institution: University of California - eScholarship University of California

repositories_concat: PubMed Central;escholarship.org

publisher_dissemination: American Society of Neuroradiology (ASNR)

ReferenceCitation: Hetts SW, Turk A, English JD, Dowd CF, Mocco J, Prestigiacomo C, Nesbit G, Ge SG, Jin JN, Carroll K, Murayama Y, Gholkar A, Barnwell S, Lopes D, Johnston SC, McDougall C; Matrix and Platinum Science Trial Investigators. Stent-assisted coiling versus coiling alone in unruptured intracranial aneurysms in the matrix and platinum science trial: safety, efficacy, and mid-term outcomes. AJNR Am J Neuroradiol. 2014 Apr;35(4):698-705. doi: 10.3174/ajnr.A3755. Epub 2013 Nov 1.

repository_institution: California Digital Library - eScholarship

lead_sponsor: Stryker Neurovascular

location_country:
Germany
Norway
United Kingdom
Australia
Mexico
United States
China
Spain
Turkey
Canada
France

location_facility: University of New Mexico Department of Neurosurgery

location_facility: Clinica Ntra Sra Del Rosario Hospital Ruber Internacional

location_facility: Montreal Neurological Institute and Hospital

location_facility: Barnes Jewish Mallinckrodt Institute of Radiology

location_facility: Instituto Nacional de Neurologia e Neurocirurgia

location_facility: Carolina Neurosurgery & Spine Associates, PA

location_facility: St. Joseph's Hospital Barrow Neurological Institute

location_facility: University of Washington Harborview Medical Center

location_facility: University of Wisconsin Hospital and Center

location_facility: Istanbul University Cerrahpaşa Tıp Fakültesi

location_facility: Newcastle General Hospital Department of Neuroradiology

location_facility: University of Texas Southwestern Medical Center


acronym: CLARINET

lead_sponsor: Sanofi

summary:
Contemporary management of cyanotic congenital heart disease includes three stages of surgery. Incidence of shunt thrombosis and death between the two first stages of palliation remains important.

The primary objective of the study is to evaluate the efficacy of Clopidogrel 0.2 mg/kg/day for the reduction of all cause mortality and shunt related morbidity in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt (e.g. modified Blalock Taussig Shunt [BTS]).

The secondary objective was to assess the safety of Clopidogrel in the study population.

ReferenceCitation: Wessel DL, Berger F, Li JS, Dahnert I, Rakhit A, Fontecave S, Newburger JW; CLARINET Investigators. Clopidogrel in infants with systemic-to-pulmonary-artery shunts. N Engl J Med. 2013 Jun 20;368(25):2377-84. doi: 10.1056/NEJMoa1114588.

sponsor_collaborators:
Sanofi
Bristol-Myers Squibb

location_facility:
Sanofi-Aventis Administrative Office
Sanofi-Aventis Admnistrative Office
Sanofi-Aventis Administraive Office

title: International Randomized Double Blind Study Evaluating the Efficacy and the Safety of Clopidogrel 0.2 mg/kg Once Daily Versus Placebo in Neonates and Infants With Cyanotic Congenital Heart Disease Palliated With Systemic to Pulmonary Artery Shunt

location_country:
Finland
Germany
Poland
Argentina
Brazil
Thailand
Canada
France
Portugal
Hungary
Hong Kong
Denmark
United States
India
Belgium
China
Malaysia
Egypt
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel


type: Registry Identifier

title: A Phase I/II Open Label, Dose Escalation Trial and a Six Month Extension to Explore the Safety and Efficacy of ICL670 in Patients With Iron Overload Resulting From Hereditary Hemochromatosis.

summary: Brief Summary: This study was designed to explore a safe dose and characterize the preliminary safety and efficacy of ICL670 in adult patients with previously documented history of homozygous C282Y.

location_country:
Germany
Italy
Australia
United States
Canada
France

location_facility:
Mayo Clinic
Novartis Investigative Site
University of Connecticut Health Center
St. Louis University
Henry Ford Health System
Rochester General Hospital
UC Irvine/Long Beach
Ohio State University Medical Center
Three Medical Park
Carolinas Medical Center


title: An Open-Label, Phase Ib Study to Assess the Long Term Safety Profile of Pazopanib in Cancer Patients

summary: This study was a rollover study to evaluate the long term safety of pazopanib and to continue to provide pazopanib to patients who participated in a GSK sponsored pazopanib study until pazopanib is available commercially.

ipd_sharing: No

location_country:
United States
United Kingdom
Singapore
France


title: A Multi-Center, Open-Label Extension Study to Protocol AC-052-405 to Evaluate the Safety and Efficacy of Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology

summary: This 6-month open label study will evaluate the long term safety of bosentan (via oxygen saturation) and efficacy (exercise capacity) in patients who have completed the BREATHE-5 study (PAH related to Eisenmenger physiology). Treatment duration is 6 months.

lead_sponsor: Actelion

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

location_facility: Royal Prince Alfred Hospital - Central Clinical School

location_facility: Universitatsklinikum fur Innere Medizin II

location_facility: Unidad Medico Quirurgica de Cardiologia - Edificio General

location_facility: Scottish Vascular Unit - Western Infirmary


title: Satavaptan in the Prevention of Ascites Recurrence: a Double-blind, Randomised, Parallel-group Comparison of Satavaptan at 5 to 10 mg Daily Versus Placebo in the Absence of Diuretics in Patients With Recurrent Ascites Due to Cirrhosis of the Liver.

summary:
Primary:

To evaluate the efficacy of satavaptan in the absence of concomitant diuretic drugs in reducing the recurrence of ascites.

Secondary:

To evaluate the tolerability and safety of satavaptan in the absence of concomitant diuretic drugs over a 52-week treatment period in patients with cirrhosis of the liver and recurrent ascites.

The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).

ReferenceCitation: Wong F, Watson H, Gerbes A, Vilstrup H, Badalamenti S, Bernardi M, Gines P; Satavaptan Investigators Group. Satavaptan for the management of ascites in cirrhosis: efficacy and safety across the spectrum of ascites severity. Gut. 2012 Jan;61(1):108-16. doi: 10.1136/gutjnl-2011-300157. Epub 2011 Aug 11.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Bosnia and Herzegovina
Turkey
Chile
Canada
Serbia
France
Czech Republic
United States
Romania
Belgium
Malaysia
Singapore
Mexico
Spain
Bulgaria
Russian Federation


title: Satavaptan in the Prevention of Ascites Recurrence: a Double-blind, Randomised, Parallel-group Comparison of Satavaptan at 5 to 10 mg Daily Versus Placebo With Concomitant Diuretics in Patients With Recurrent Ascites Due to Cirrhosis of the Liver.

summary:
Primary To evaluate the efficacy of satavaptan on top of diuretic drugs in reducing the recurrence of ascites.

Secondary To evaluate the tolerability and safety of satavaptan on top of diuretic drugs over a 52-week treatment period in participants with cirrhosis of the liver and recurrent ascites.

The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).

location_country:
Germany
Argentina
Australia
Bosnia and Herzegovina
Croatia
Canada
Serbia
France
Czech Republic
Portugal
Hungary
United States
Romania
Belgium
Malaysia
Italy
United Kingdom
Singapore
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Israel