title: Multicenter, Double-blind, Placebo-controlled, Parallel-group, Phase IV Study to Assess the Effect of Rotigotine on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease

summary: The primary objective of this study was to demonstrate that Rotigotine improves non-motor symptoms compared to Placebo in subjects with Parkinson's Disease.

ReferenceCitation: Antonini A, Bauer L, Dohin E, Oertel WH, Rascol O, Reichmann H, Schmid M, Singh P, Tolosa E, Chaudhuri KR. Effects of rotigotine transdermal patch in patients with Parkinson's disease presenting with non-motor symptoms - results of a double-blind, randomized, placebo-controlled trial. Eur J Neurol. 2015 Oct;22(10):1400-7. doi: 10.1111/ene.12757. Epub 2015 Jun 22.

name: Parkinson and Movement Disorders Unit; IRCCS Hospital San Camillo; Venice Italy

family: Antonini

full_name: A. Antonini

given: A.

family: Bauer

full_name: L. Bauer

given: L.

family: Dohin

full_name: E. Dohin

given: E.

name: Department of Neurology; Philipps University; Marburg Germany

family: Oertel

full_name: W. H. Oertel

given: W. H.

name: Clinical Investigation Centre CIC1436; and Departments of Clinical Pharmacology and Neurosciences; INSERM and Toulouse University Hospital; Toulouse France

family: Rascol

full_name: O. Rascol

given: O.

name: Department of Neurology; University of Dresden; Dresden Germany

family: Reichmann

full_name: H. Reichmann

given: H.

family: Schmid

full_name: M. Schmid

given: M.

family: Singh

full_name: P. Singh

given: P.

name: Neurology Service; Hospital Clinic de Barcelona; Universitat de Barcelona; IDIBAPS; Centro de Investigacion Biomedica en Red sobre Enfermedades Neurodegenerativas (CIBERNED); Barcelona Catalonia Spain

family: Tolosa

full_name: E. Tolosa

name: National Parkinson Foundation International Centre of Excellence; King's College Hospital; Kings College and Kings Health Partners; London UK

family: Chaudhuri

full_name: K. Ray Chaudhuri

given: K. Ray

oa_host_type: repository

repository_institution: King's College London - Research Portal

location_country:
Italy
Austria
Switzerland
France
Bulgaria
Slovakia
Romania
Hungary
Belgium
Spain
Germany
Czech Republic

intervention_type: Other


type: EudraCT Number

type: Other Identifier

title: Empirical Versus Pre-emptive (Diagnostic-driven) Antifungal Therapy of Patients Treated for Haematological Malignancies or Receiving an Allogeneic Stem Cell Transplant. A Therapeutic Open Label Phase III Strategy Study of the EORTC Infectious Diseases and Leukemia Groups

summary:
RATIONALE: Caspofungin acetate may be effective in treating fungal infections in patients with acute myeloid leukemia or myelodysplastic syndrome who are receiving treatment for their cancer. It is not yet known whether caspofungin acetate is more effective when treatment starts after development of a fever or after the infection is shown in laboratory test, chest x-ray, or CT scan.

PURPOSE: This randomized phase III trial is studying the best time to start caspofungin acetate therapy in treating patients with acute myeloid leukemia or myelodysplastic syndrome that is newly diagnosed or in first relapse.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

enrollment_type: Actual

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country: Netherlands France Czechia Slovakia Belgium Germany

location_facility: Universitaetsklinikum Wuerzburg - Medizinische Klinik und Poliklinik II

location_facility: Radboud University Nijmegen Medical Centre

location_facility: Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of Dexpramipexole in Subjects With Amyotrophic Lateral Sclerosis

acronym: EMPOWER

summary: The purpose of this study is to determine whether dexpramipexole (150 mg twice daily) is safe and effective in the treatment of Amyotrophic Lateral Sclerosis (ALS).

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Cudkowicz ME, van den Berg LH, Shefner JM, Mitsumoto H, Mora JS, Ludolph A, Hardiman O, Bozik ME, Ingersoll EW, Archibald D, Meyers AL, Dong Y, Farwell WR, Kerr DA; EMPOWER investigators. Dexpramipexole versus placebo for patients with amyotrophic lateral sclerosis (EMPOWER): a randomised, double-blind, phase 3 trial. Lancet Neurol. 2013 Nov;12(11):1059-67. doi: 10.1016/S1474-4422(13)70221-7. Epub 2013 Sep 23. Erratum in: Lancet Neurol. 2013 Nov;12(11):1042. Carbonell, J G [corrected to Gamez, J].

family: Cudkowicz

full_name: Merit E Cudkowicz

given: Merit E

sequence: first

family: van den Berg

full_name: Leonard H van den Berg

given: Leonard H

sequence: additional

family: Shefner

full_name: Jeremy M Shefner

given: Jeremy M

family: Mitsumoto

full_name: Hiroshi Mitsumoto

given: Hiroshi

family: Mora

full_name: Jesus S Mora

given: Jesus S

family: Ludolph

full_name: Albert Ludolph

given: Albert

family: Hardiman

full_name: Orla Hardiman

given: Orla

family: Bozik

full_name: Michael E Bozik

given: Michael E

family: Ingersoll

full_name: Evan W Ingersoll

given: Evan W

family: Archibald

full_name: Donald Archibald

given: Donald

family: Meyers

full_name: Adam L Meyers

given: Adam L

family: Dong

full_name: Yingwen Dong

given: Yingwen

family: Farwell

full_name: Wildon R Farwell

given: Wildon R

family: Kerr

full_name: Douglas A Kerr

given: Douglas A

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Lancet Neurology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Knopp Biosciences

location_country:
United States
Sweden
Netherlands
Germany
France
Ireland
Belgium
Australia
Spain
Canada
United Kingdom

location_facility: University of Texas Health Sciences Center

location_facility: Research Foundation of the State University of New York

location_facility: Kings College Hospital NHS Foundation Trust

location_facility: University of Miami Miller School of Medicine

location_facility: University of Arkansas for Medical Sciences

location_facility: Washington University School of Medicine

location_facility: Sunnybrook and Women's College and Health Sciences Centre

location_facility: University of California at San Francisco - Fresno

location_facility: Walton Centre for Neurology & Neurosurgery

location_facility: Barrow Neurological Institute - St. Joseph's Hospital

location_facility: Johns Hopkins University School of Medicine

location_facility: Sheffield Institute for Transnational Neuroscience

location_facility: Newcastle University Hospital - Clinical Ageing Research Unit

location_facility: University of South Florida Medical Center


title: INFORM-SVR: A Randomized, Multi-Center Study of Interferon-Free Treatment With a Combination of a Polymerase Inhibitor (RO5024048) and a Ritonavir Boosted HCV Protease Inhibitor (RO5190591/r, DNV/r) With or Without Copegus® in Interferon Naïve HCV Genotype 1 Infected Patients

summary:
This multicenter, randomized, double-blind, parallel group study will evaluate the safety and efficacy of the combination RO5024048 and ritonavir-boosted danoprevir with and without Copegus (ribavirin) in patients with chronic hepatitis C genotype 1. In arm A and B, interferon treatment-naïve patients will receive 1000 mg RO5024048 orally twice daily and 100 mg danoprevir with 100 mg ritonavir orally twice daily plus either Copegus (1000 mg or 1200 mg orally daily) or placebo for 12 weeks. Depending on viral response and treatment arm patients will be re-randomized to continue assigned treatment for additional 12 weeks or stop all treatment. The anticipated time on study treatment is up to 24 weeks plus a 24-week follow-up.

As of 29. September 2011, Arm B patients (placebo-containing arm) will be offered, in conjunction with the current treatment, Pegasys (peginterferon alfa-2a) 180 mcg subcutaneously weekly plus Copegus 1000mg or 1200 mg orally daily for 24 weeks, with a 24-week follow-up.

ReferenceCitation: Tong X, Li L, Haines K, Najera I. Identification of the NS5B S282T resistant variant and two novel amino acid substitutions that affect replication capacity in hepatitis C virus-infected patients treated with mericitabine and danoprevir. Antimicrob Agents Chemother. 2014 Jun;58(6):3105-14. doi: 10.1128/AAC.02672-13. Epub 2014 Mar 17.

family: Tong

full_name: Xiao Tong

given: Xiao

family: Li

full_name: Lewyn Li

given: Lewyn

family: Haines

full_name: Kristin Haines

given: Kristin

family: Najera

full_name: Isabel Najera

given: Isabel

journal_name: Antimicrobial Agents and Chemotherapy

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: American Society for Microbiology

publisher_dissemination: American Society for Microbiology

publisher_group: American Society for Microbiology

publisher_normalized: American Society for Microbiology

title: Identification of the NS5B S282T Resistant Variant and Two Novel Amino Acid Substitutions That Affect Replication Capacity in Hepatitis C Virus-Infected Patients Treated with Mericitabine and Danoprevir

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
United States
France
New Zealand


ReferenceType: result

ReferenceCitation: Kolotkin RL, Fujioka K, Wolden ML, Brett JH, Bjorner JB. Improvements in health-related quality of life with liraglutide 3.0 mg compared with placebo in weight management. Clin Obes. 2016 Aug;6(4):233-42. doi: 10.1111/cob.12146. Epub 2016 May 19.

name: Quality of Life Consulting  Durham NC USA

name: Department of Community and Family Medicine Duke University Medical Center  Durham NC USA

name: Department of Health Studies Sogn og Fjordane University College  Førde Norway

name: Morbid Obesity Centre Vestfold Hospital Trust  Tønsberg Norway

family: Kolotkin

full_name: R. L. Kolotkin

given: R. L.

name: Nutrition and Metabolic Research Center Scripps Clinic Department of Endocrine  La Jolla CA USA

family: Fujioka

full_name: K. Fujioka

given: K.

family: Wolden

full_name: M. L. Wolden

given: M. L.

family: Brett

full_name: J. H. Brett

given: J. H.

name: National Research Centre for the Working Environment  Copenhagen Denmark

name: Department of Public Health, Section of Social Medicine University of Copenhagen  Copenhagen Denmark

family: Bjorner

full_name: J. B. Bjorner

given: J. B.

journal_name: Clinical Obesity

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Improvements in health‐related quality of life with liraglutide 3.0 mg compared with placebo in weight management

ReferenceCitation: Overgaard RV, Petri KC, Jacobsen LV, Jensen CB. Liraglutide 3.0 mg for Weight Management: A Population Pharmacokinetic Analysis. Clin Pharmacokinet. 2016 Nov;55(11):1413-1422.

ReferenceCitation: O'Neil PM, Garvey WT, Gonzalez-Campoy JM, Mora P, Ortiz RV, Guerrero G, Claudius B, Pi-Sunyer X; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. EFFECTS OF LIRAGLUTIDE 3.0 MG ON WEIGHT AND RISK FACTORS IN HISPANIC VERSUS NON-HIPANIC POPULATIONS: SUBGROUP ANALYSIS FROM SCALE RANDOMIZED TRIALS. Endocr Pract. 2016 Nov;22(11):1277-1287. Epub 2016 Aug 2.

ReferenceCitation: Fujioka K, O'Neil PM, Davies M, Greenway F, C W Lau D, Claudius B, Skjøth TV, Bjørn Jensen C, P H Wilding J. Early Weight Loss with Liraglutide 3.0 mg Predicts 1-Year Weight Loss and is Associated with Improvements in Clinical Markers. Obesity (Silver Spring). 2016 Nov;24(11):2278-2288. doi: 10.1002/oby.21629.

full_name: Ken Fujioka

given: Ken

name: Department of Psychiatry and Behavioral Sciences, Weight Management CenterMedical University of South CarolinaCharleston South Carolina USA

family: O'Neil

full_name: Patrick M. O'Neil

given: Patrick M.

name: Department of Health Sciences, Diabetes Research Centre, University of LeicesterLeicester UK

family: Davies

full_name: Melanie Davies

given: Melanie

name: Pennington Biomedical Research CenterBaton Rouge Louisiana USA

family: Greenway

full_name: Frank Greenway

given: Frank

name: Departments of Medicine, Biochemistry and Molecular Biology, University of Calgary Cumming School of MedicineCalgary Alberta Canada

family: C.W. Lau

full_name: David C.W. Lau

given: David

family: Claudius

full_name: Birgitte Claudius

given: Birgitte

family: Skjøth

full_name: Trine Vang Skjøth

given: Trine Vang

family: Bjørn Jensen

full_name: Christine Bjørn Jensen

given: Christine

name: Department of Obesity and Endocrinology, University of LiverpoolLiverpool UK.

family: P.H. Wilding

full_name: John P.H. Wilding

given: John

journal_name: Obesity

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

repository_institution: University of Leicester - Leicester Research Archive

repositories_institution: University of Leicester - Leicester Research Archive

title: Early Weight Loss with Liraglutide 3.0 mg Predicts 1‐Year Weight Loss and is Associated with Improvements in Clinical Markers

ReferenceCitation: Bays H, Pi-Sunyer X, Hemmingsson JU, Claudius B, Jensen CB, Van Gaal L. Liraglutide 3.0 mg for weight management: weight-loss dependent and independent effects. Curr Med Res Opin. 2017 Feb;33(2):225-229. doi: 10.1080/03007995.2016.1251892. Epub 2016 Nov 6.

name: Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY, USA;

name: New York Obesity Research Center, Columbia University, New York, NY, USA;

name: Capio St Goran’s Hospital/Karolinska Institutet, Stockholm, Sweden;

name: Department of Endocrinology, Diabetology and Metabolism, Faculty of Medicine, Antwerp University Hospital, Edegem, Belgium

ReferenceCitation: Wilding JP, Overgaard RV, Jacobsen LV, Jensen CB, le Roux CW. Exposure-response analyses of liraglutide 3.0 mg for weight management. Diabetes Obes Metab. 2016 May;18(5):491-9. doi: 10.1111/dom.12639. Epub 2016 Mar 1.

name: Department of Obesity and Endocrinology; University of Liverpool; Liverpool UK

name: Medical Affairs, GLP-1 and Obesity; Novo Nordisk A/S; Søborg Denmark

name: Diabetes Complications Research Centre, Conway Institute; University College Dublin; Dublin Ireland

name: Investigative Science; Imperial College London; London UK

ReferenceCitation: Pi-Sunyer X, Astrup A, Fujioka K, Greenway F, Halpern A, Krempf M, Lau DC, le Roux CW, Violante Ortiz R, Jensen CB, Wilding JP; SCALE Obesity and Prediabetes NN8022-1839 Study Group. A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management. N Engl J Med. 2015 Jul 2;373(1):11-22. doi: 10.1056/NEJMoa1411892.

ReferenceCitation: McEvoy BW. Missing data in clinical trials for weight management. J Biopharm Stat. 2016;26(1):30-6. doi: 10.1080/10543406.2015.1094814. Review.

title: Missing data in clinical trials for weight management

ReferenceCitation: Ard J, Cannon A, Lewis CE, Lofton H, Vang Skjøth T, Stevenin B, Pi-Sunyer X. Efficacy and safety of liraglutide 3.0 mg for weight management are similar across races: subgroup analysis across the SCALE and phase II randomized trials. Diabetes Obes Metab. 2016 Apr;18(4):430-5. doi: 10.1111/dom.12632. Epub 2016 Feb 11.

name: Wake Forest School of Medicine, Wake Forest Baptist Medical Center; Winston-Salem NC USA

name: Endocrine Metabolic Associates; Philadelphia PA USA

name: Division of Preventive Medicine; University of Alabama at Birmingham; Birmingham AL USA

name: New York University School of Medicine; New York NY USA

ReferenceCitation: le Roux CW, Astrup A, Fujioka K, Greenway F, Lau DCW, Van Gaal L, Ortiz RV, Wilding JPH, Skjøth TV, Manning LS, Pi-Sunyer X; SCALE Obesity Prediabetes NN8022-1839 Study Group. 3 years of liraglutide versus placebo for type 2 diabetes risk reduction and weight management in individuals with prediabetes: a randomised, double-blind trial. Lancet. 2017 Apr 8;389(10077):1399-1409. doi: 10.1016/S0140-6736(17)30069-7. Epub 2017 Feb 23. Erratum in: Lancet. 2017 Apr 8;389(10077):1398.

repository_institution: The University of Glasgow - Enlighten: Publications

repositories_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: von Scholten BJ, Davies MJ, Persson F, Hansen TW, Madsbad S, Endahl L, Jepsen CH, Rossing P. Effect of weight reductions on estimated kidney function: Post-hoc analysis of two randomized trials. J Diabetes Complications. 2017 Jul;31(7):1164-1168. doi: 10.1016/j.jdiacomp.2017.04.003. Epub 2017 Apr 11.

journal_name: Journal of Diabetes and its Complications

ReferenceCitation: O'Neil PM, Aroda VR, Astrup A, Kushner R, Lau DCW, Wadden TA, Brett J, Cancino AP, Wilding JPH; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Neuropsychiatric safety with liraglutide 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials. Diabetes Obes Metab. 2017 Nov;19(11):1529-1536. doi: 10.1111/dom.12963. Epub 2017 Jul 21.

name: Weight Management Center, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina; Charleston South Carolina

name: Department of Internal Medicine, Endocrinology, Diabetes & Metabolism, MedStar Health Research Institute; Georgetown University School of Medicine; Hyattsville Maryland

name: Department of Nutrition, Exercise and Sports; University of Copenhagen; Frederiksberg C Denmark

name: Department of Internal Medicine, Northwestern University Feinberg School of Medicine; Chicago Illinois

name: Departments of Medicine and Biochemistry & Molecular Biology, University of Calgary Cumming School of Medicine; Calgary Alberta Canada

name: Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania; Philadelphia Pennsylvania

name: Novo Nordisk Inc.; Plainsboro New Jersey

name: Department of Obesity and Endocrinology, Obesity and Endocrinology Clinical Research Group; University of Liverpool; Liverpool UK

name: on behalf of the Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups

repository_institution: University of Copenhagen - Research at the University of Copenhagen

ReferenceCitation: Davies MJ, Aronne LJ, Caterson ID, Thomsen AB, Jacobsen PB, Marso SP; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Liraglutide and cardiovascular outcomes in adults with overweight or obesity: A post hoc analysis from SCALE randomized controlled trials. Diabetes Obes Metab. 2018 Mar;20(3):734-739. doi: 10.1111/dom.13125. Epub 2017 Nov 1.

name: Diabetes Research Centre; University of Leicester; Leicester UK

name: Weill-Cornell Medical Center; New York New York

name: Boden Institute, Charles Perkins Centre; University of Sydney; Sydney New South Wales Australia

name: Department of Medical and Science; Novo Nordisk A/S; Søborg Denmark

name: Department of Global Medical Affairs; Novo Nordisk A/S; Søborg Denmark

name: HCA Midwest Health Heart and Vascular Institute; Kansas City Missouri

title: Liraglutide and cardiovascular outcomes in adults with overweight or obesity: Apost hoc analysis from SCALE randomized controlled trials

ReferenceCitation: Kolotkin RL, Gabriel Smolarz B, Meincke HH, Fujioka K. Improvements in health-related quality of life over 3 years with liraglutide 3.0 mg compared with placebo in participants with overweight or obesity. Clin Obes. 2018 Feb;8(1):1-10. doi: 10.1111/cob.12226. Epub 2017 Oct 16.

name: Quality of Life Consulting Durham NC USA

name: Department of Community and Family MedicineDuke University Medical Center Durham NC USA

name: Department of Health StudiesWestern Norway University of Applied Sciences Førde Norway

name: Morbid Obesity CentreVestfold Hospital Trust Tønsberg Norway

repository_institution: University of Oslo - Duo Research Archive

repositories_institution: University of Oslo - Duo Research Archive

title: Improvements in health‐related quality of life over 3 years with liraglutide 3.0 mg compared with placebo in participants with overweight or obesity

ReferenceCitation: le Roux C, Aroda V, Hemmingsson J, Cancino AP, Christensen R, Pi-Sunyer X. Comparison of Efficacy and Safety of Liraglutide 3.0 mg in Individuals with BMI above and below 35 kg/m²: A Post-hoc Analysis. Obes Facts. 2017;10(6):531-544. doi: 10.1159/000478099. Epub 2017 Nov 17.

location_country:
Finland
Australia
Belgium
Russian Federation
Denmark
India
France
Poland
Norway
Argentina
Canada
South Africa
Former Serbia and Montenegro
Hong Kong
Netherlands
Switzerland
Hungary
Ireland
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Israel
Spain
Turkey

title: Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, Multinational Trial With Stratification of Subject to Either 56 or 160 Weeks of Treatment Based on Pre-diabetes Status at Randomisation

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

The aim of this clinical trial is to evaluate the potential of liraglutide to induce and maintain weight loss over 56 weeks in obese subjects or overweight subjects with co-morbidities. Furthermore, the aim is to investigate the long term potential of liraglutide to delay the onset of type 2 diabetes in subjects diagnosed with pre-diabetes at baseline.

Based on body mass index (BMI) and pre-diabetes status, subjects will be randomised to either 68 weeks (56 weeks of randomised treatment followed by a 12 week re-randomised treatment period) or 160 weeks of treatment (160 week treatment will only be applicable to subjects with pre-diabetes status at baseline).


ReferenceCitation: Elborn JS, Flume PA, Cohen F, Loutit J, VanDevanter DR. Safety and efficacy of prolonged levofloxacin inhalation solution (APT-1026) treatment for cystic fibrosis and chronic Pseudomonas aeruginosa airway infection. J Cyst Fibros. 2016 Sep;15(5):634-40. doi: 10.1016/j.jcf.2016.01.005. Epub 2016 Feb 28.

family: Elborn

full_name: J. Stuart Elborn

given: J. Stuart

family: Flume

full_name: Patrick A. Flume

given: Patrick A.

family: Cohen

full_name: Fredric Cohen

given: Fredric

family: Loutit

full_name: Jeffery Loutit

given: Jeffery

family: VanDevanter

full_name: Donald R. VanDevanter

given: Donald R.

journal_name: Journal of Cystic Fibrosis

oa_host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

lead_sponsor: Horizon Pharma USA, Inc.

location_country:
United States
France
Israel
Ireland
Germany
United Kingdom

acronym: TIS

location_facility: Katharina-Kasper Kliniken GmbH St. Elisabethen-Krankenhaus Medizinische Klinik

location_facility: Universitätsklinik Gießen und Marburg GmbH Zentrum für Kinderheilkunde und Jugendmedizin

location_facility: Universitätsklinik für Kinder- und Jugendmedizin

location_facility: Kinderärztliche Gemeinschaftspraxis Dr. H. E. Heuer, Dr. C. Runge, W. Sextro

location_facility: Schneider Childrens Medical Center of Israel

location_facility: CRCM adulte Hôpital Larrey-CHU de Toulouse

location_facility: Ludwig-Maximilians Universität Klinikum Innenstadt

location_facility: CRCM adultes et enfants Service des maladies respiratoires et pédiatrie 1 CHU- Arnaud de Villeneuve

location_facility: Hôpital Pellegrin Enfants - CHU Bordeaux

location_facility: Dr. von Haunersches Kinderspital der Universität München Christiane Herzog Ambulanz

location_facility: Safra Childrens Hospital, Sheba Medical Center

source: euctr

title: Phase 3, Open-label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin) vs. Tobramycin Inhalation Solution (TIS) in Stable CF Patients

summary: Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.


title: A Randomized, Double-Blind Study of the Safety and Efficacy of GSK1349572 Plus Abacavir/Lamivudine Fixed-Dose Combination Therapy Administered Once Daily Compared to Atripla Over 96 Weeks in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects

summary: The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg plus Abacavir/Lamivudine once daily versus Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate (ATRIPLA® a trade mark of Bristol-Myers Squibb and Gilead Sciences LLC) over 48 weeks; non-inferiority will also be tested at Week 96. This study will be conducted in HIV-1 infected ART-naïve adult subjects. Long term antiviral activity, tolerability, safety, and development of viral resistance will be evaluated.

ReferenceType: background

ReferenceCitation: Brinson C, Walmsley S, Arasteh K, et al. Dolutegravir treatment response and safety by key subgroups in treatment naive HIV-infected individuals. Published at: Conference on Retroviruses and Opportunistic Infections - 20th Annual; March 3-6, 2013; Atlanta, GA.

ReferenceCitation: Walmsley S, Baumgarten A, Berenguer J, Felizarta F, Florence E, Khuong-Josses MA, Kilby JM, Lutz T, Podzamczer D, Portilla J, Roth N, Wong D, Granier C, Wynne B, Pappa K. Brief Report: Dolutegravir Plus Abacavir/Lamivudine for the Treatment of HIV-1 Infection in Antiretroviral Therapy-Naive Patients: Week 96 and Week 144 Results From the SINGLE Randomized Clinical Trial. J Acquir Immune Defic Syndr. 2015 Dec 15;70(5):515-9. doi: 10.1097/QAI.0000000000000790. Erratum in: J Acquir Immune Defic Syndr. 2016 Jan 1;71(1):e33.

family: Walmsley

full_name: Sharon Walmsley

given: Sharon

family: Baumgarten

full_name: Axel Baumgarten

given: Axel

family: Berenguer

full_name: Juan Berenguer

given: Juan

family: Felizarta

full_name: Franco Felizarta

given: Franco

family: Florence

full_name: Eric Florence

given: Eric

family: Khuong-Josses

full_name: Marie-Aude Khuong-Josses

given: Marie-Aude

family: Kilby

full_name: J. Michael Kilby

given: J. Michael

family: Lutz

full_name: Thomas Lutz

given: Thomas

family: Podzamczer

full_name: Daniel Podzamczer

given: Daniel

family: Portilla

full_name: Joaquin Portilla

given: Joaquin

family: Roth

full_name: Norman Roth

given: Norman

family: Wong

full_name: Deborah Wong

given: Deborah

family: Granier

full_name: Catherine Granier

given: Catherine

family: Wynne

full_name: Brian Wynne

given: Brian

family: Pappa

full_name: Keith Pappa

given: Keith

journal_name: JAIDS Journal of Acquired Immune Deficiency Syndromes

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Brief Report

ReferenceCitation: Walmsley SL, Antela A, Clumeck N, Duiculescu D, Eberhard A, Gutiérrez F, Hocqueloux L, Maggiolo F, Sandkovsky U, Granier C, Pappa K, Wynne B, Min S, Nichols G; SINGLE Investigators. Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection. N Engl J Med. 2013 Nov 7;369(19):1807-18. doi: 10.1056/NEJMoa1215541.

full_name: Sharon L. Walmsley

given: Sharon L.

family: Antela

full_name: Antonio Antela

given: Antonio

family: Clumeck

full_name: Nathan Clumeck

given: Nathan

repository_institution: Ghent University - Ghent University Academic Bibliography

title: Dolutegravir plus Abacavir–Lamivudine for the Treatment of HIV-1 Infection

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


title: A Phase III, Randomised, Double-blind and Open Label Phase, Active and Placebo Controlled Study Comparing the Short-term Efficacy of Two Formulations of Clostridium Botulinum Type A Toxin (Dysport and Dysport NG) to Placebo, and Assessing the Short and Long Term Efficacy and Safety of Dysport NG Following Repeated Treatments of Subjects With Cervical Dystonia

summary: The purpose of this study is to evaluate how well a new drug called Dysport NG works and how safe it is, when it is used for the treatment of cervical dystonia. Dysport NG will be compared to an approved drug called Dysport.

ReferenceCitation: Poewe W, Burbaud P, Castelnovo G, Jost WH, Ceballos-Baumann AO, Banach M, Potulska-Chromik A, Ferreira JJ, Bihari K, Ehler E, Bares M, Dzyak LA, Belova AN, Pham E, Liu WJ, Picaut P. Efficacy and safety of abobotulinumtoxinA liquid formulation in cervical dystonia: A randomized-controlled trial. Mov Disord. 2016 Nov;31(11):1649-1657. doi: 10.1002/mds.26760. Epub 2016 Sep 21.

name: Department of Neurology; Innsbruck Medical University/University Hospital; Innsbruck Austria

family: Poewe

full_name: Werner Poewe

given: Werner

name: Department of Clinical Neurophysiology; CHU de Bordeaux; Bordeaux France

name: Institut des Maladies Neurodégénératives; Université de Bordeaux; Bordeaux France

family: Burbaud

full_name: Pierre Burbaud

given: Pierre

name: Department of Neurology; University Hospital Caremeau; Nimes France

family: Castelnovo

full_name: Giovanni Castelnovo

given: Giovanni

name: Department of Neurology; University of Freiburg; Freiburg Germany

family: Jost

full_name: Wolfgang H. Jost

given: Wolfgang H.

name: Schön Klinik München Schwabing, Department of Neurology; Technische Universität München; München Germany

family: Ceballos-Baumann

full_name: Andres O. Ceballos-Baumann

given: Andres O.

name: Department of Neurology; Jagiellonian University Medical College; Kraków Poland

family: Banach

full_name: Marta Banach

given: Marta

name: Department of Neurology; Medical University of Warsaw; Warsaw Poland

family: Potulska-Chromik

full_name: Anna Potulska-Chromik

given: Anna

name: Clinical Pharmacology Unit, Instituto de Medicina Molecular, Faculty of Medicine; University of Lisbon; Lisbon Portugal

family: Ferreira

full_name: Joaquim J. Ferreira

given: Joaquim J.

name: National Institute of Clinical Neurosciences; Budapest Hungary

family: Bihari

full_name: Katalin Bihari

given: Katalin

name: Department of Neurology; County Hospital Pardubice; Pardubice Czech Republic

family: Ehler

full_name: Edvard Ehler

given: Edvard

name: 1st Department of Neurology, Faculty of Medicine; Masaryk University; Brno Czech Republic

name: St Anne's University Hospital; Brno Czech Republic

name: Department of Neurology, Medical School; University of Minnesota; Minneapolis Minnesota USA

family: Bares

full_name: Martin Bares

given: Martin

name: Dnipropetrovsk State Medical Academy, Dnipropetrovsk Regional Clinical Hospital Mechnykov; Mechnykov Ukraine

name: Department of Neurology; Zhovtneva Ploshcha Ukraine

family: Dzyak

full_name: Lyudmyla A. Dzyak

given: Lyudmyla A.

name: Research Institute of Traumatology and Orthopaedics; Nizhnyi Novgorod Russia

family: Belova

full_name: Anna N. Belova

given: Anna N.

family: Pham

full_name: Emmanuel Pham

given: Emmanuel

name: Ipsen Biopharmaceuticals Inc; Basking Ridge New Jersey USA

family: Liu

full_name: Wenzhong Jerry Liu

given: Wenzhong Jerry

family: Picaut

full_name: Philippe Picaut

given: Philippe

journal_name: Movement Disorders

lead_sponsor: Ipsen

location_country:
Austria
France
Czechia
Poland
Hungary
Australia
Belgium
Russian Federation
Portugal
Germany
Ukraine

location_facility: Nizhniy Novgorod Research Institute for Traumatology and Orthopaedics

location_facility: Research Medical Complex "Vashe Zdorovie"

location_facility: Smolensk State Medical Academy Smolensk Regional Clinical Hospital

location_facility: Department of Neurosciences Alfred Hospital

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Ukrainian State Institute of Medical and Social Problems of Disability

location_facility: Municipal Institution "Odesa Regional Clinical Hospital"

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Pomorskie Centrum Traumatologii im. M. Kopernika w Gdansku

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

location_facility: Jósa András Oktató Kórház Nonprofit Kft.

location_facility: Russian Medical Military Academy n.a. S.M.Kirov

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


title: A Phase 2B Pilot Study of Short-Term Treatment of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 2 or 3 Infection

summary: To identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of daclatasvir with pegylated interferon alfa-2a and ribavirin.

ReferenceCitation: Dore GJ, Lawitz E, Hézode C, Shafran SD, Ramji A, Tatum HA, Taliani G, Tran A, Brunetto MR, Zaltron S, Strasser SI, Weis N, Ghesquiere W, Lee SS, Larrey D, Pol S, Harley H, George J, Fung SK, de Lédinghen V, Hagens P, McPhee F, Hernandez D, Cohen D, Cooney E, Noviello S, Hughes EA. Daclatasvir plus peginterferon and ribavirin is noninferior to peginterferon and ribavirin alone, and reduces the duration of treatment for HCV genotype 2 or 3 infection. Gastroenterology. 2015 Feb;148(2):355-366.e1. doi: 10.1053/j.gastro.2014.10.007. Epub 2014 Oct 13.

family: Dore

full_name: Gregory J. Dore

given: Gregory J.

family: Lawitz

full_name: Eric Lawitz

given: Eric

family: Hézode

full_name: Christophe Hézode

given: Christophe

family: Shafran

full_name: Stephen D. Shafran

given: Stephen D.

family: Ramji

full_name: Alnoor Ramji

given: Alnoor

family: Tatum

full_name: Harvey A. Tatum

given: Harvey A.

family: Taliani

full_name: Gloria Taliani

given: Gloria

family: Tran

full_name: Albert Tran

given: Albert

family: Brunetto

full_name: Maurizia R. Brunetto

given: Maurizia R.

family: Zaltron

full_name: Serena Zaltron

given: Serena

family: Strasser

full_name: Simone I. Strasser

given: Simone I.

family: Weis

full_name: Nina Weis

given: Nina

family: Ghesquiere

full_name: Wayne Ghesquiere

given: Wayne

family: Lee

full_name: Samuel S. Lee

given: Samuel S.

family: Larrey

full_name: Dominique Larrey

given: Dominique

family: Pol

full_name: Stanislas Pol

given: Stanislas

family: Harley

full_name: Hugh Harley

given: Hugh

family: George

full_name: Jacob George

given: Jacob

family: Fung

full_name: Scott K. Fung

given: Scott K.

family: de Lédinghen

full_name: Victor de Lédinghen

given: Victor

family: Hagens

full_name: Peggy Hagens

given: Peggy

family: McPhee

full_name: Fiona McPhee

given: Fiona

family: Hernandez

full_name: Dennis Hernandez

given: Dennis

title: Daclatasvir Plus Peginterferon and Ribavirin Is Noninferior to Peginterferon and Ribavirin Alone, and Reduces the Duration of Treatment for HCV Genotype 2 or 3 Infection

location_country:
Italy
United States
France
Australia
Denmark
Canada

location_facility:
Alamo Medical Research
Digestive Disease Associates, P.A.
Options Health Research, Llc
California Liver Institute
Local Institution


title: A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis Who Are Treated With Interferon-beta

acronym: TERACLES

summary:
The primary objective was to demonstrate the effect of teriflunomide, in comparison to placebo, on frequency of Multiple Sclerosis (MS) relapses in patients with relapsing forms of MS who are treated with Interferon-beta (IFN-beta).

The secondary objectives were:

Assess the effect of teriflunomide, in comparison to placebo, when added to IFN-beta on:

Disease activity as measured by brain Magnetic Resonance Imaging (MRI)
Disability progression
Burden of disease and disease progression as measured by brain MRI
Evaluate the safety and tolerability of teriflunomide when added to IFN-beta therapy
Assess the pharmacokinetics of teriflunomide in use in addition to baseline IFN-beta therapy
Assess associations between variations in genes and clinical outcomes (safety and efficacy)
Assess other measures of efficacy of teriflunomide such as fatigue and health-related quality of life
Assess measures of health economics (hospitalization due to relapse, including the length of stay and any admission to intensive care unit)

status: Terminated

lead_sponsor: Sanofi

location_country:
Finland
Greece
Australia
Belgium
Russian Federation
Denmark
France
Lithuania
Slovakia
Norway
Argentina
Canada
Korea, Republic of
Colombia
Chile
Sweden
Netherlands
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Tunisia
Spain
Estonia

location_facility:
Investigational Site Number 643018
Investigational Site Number 124007
Investigational Site Number 276023
Investigational Site Number 840016
Investigational Site Number 036010
Investigational Site Number 703001
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Investigational Site Number 528002
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Investigational Site Number 040001
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Investigational Site Number 152003
Investigational Site Number 152004
Investigational Site Number 036005
Investigational Site Number 170005
Investigational Site Number 440004
Investigational Site Number 276005
Investigational Site Number 643005
Investigational Site Number 643003
Investigational Site Number 380014
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Investigational Site Number 840012
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status_simplified: Unknown


study_start_date_type: Actual

lead_sponsor: Astellas Pharma Inc

location_country:
Italy
Austria
United Kingdom
Netherlands
Finland
France
Czechia
Greece
Poland
Slovakia
Romania
Hungary
Belgium
Ireland
Spain
Slovenia

acronym: STRIDE

title: A Multicentre, Single-Arm, Open-Label Study Of The Repeated Administration Of QUTENZA For The Treatment Of Peripheral Neuropathic Pain

summary: In this study all patients will be treated with the same medicine, the QUTENZA patch. Subjects will receive up to 6 QUTENZA patch applications over 12 months.


title: Phase III, Multi-center, Randomized, 12-week, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of RO4917838 in Patients With Sub-optimally Controlled Symptoms of Schizophrenia Treated With Antipsychotics Followed by a 40-week Double-blind, Parallel-group, Placebo-controlled Treatment Period.

summary: This randomized, multi-center, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 in patients with sub-optimally controlled symptoms of schizophrenia. Patients, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.

ReferenceCitation: Bugarski-Kirola D, Iwata N, Sameljak S, Reid C, Blaettler T, Millar L, Marques TR, Garibaldi G, Kapur S. Efficacy and safety of adjunctive bitopertin versus placebo in patients with suboptimally controlled symptoms of schizophrenia treated with antipsychotics: results from three phase 3, randomised, double-blind, parallel-group, placebo-controlled, multicentre studies in the SearchLyte clinical trial programme. Lancet Psychiatry. 2016 Dec;3(12):1115-1128. doi: 10.1016/S2215-0366(16)30344-3. Epub 2016 Nov 2.

family: Bugarski-Kirola

full_name: Dragana Bugarski-Kirola

given: Dragana

family: Iwata

full_name: Nakao Iwata

given: Nakao

family: Sameljak

full_name: Snjezana Sameljak

given: Snjezana

family: Reid

full_name: Carol Reid

given: Carol

family: Blaettler

full_name: Thomas Blaettler

given: Thomas

family: Millar

full_name: Laurie Millar

given: Laurie

family: Marques

full_name: Tiago Reis Marques

given: Tiago Reis

family: Garibaldi

full_name: George Garibaldi

given: George

family: Kapur

full_name: Shitij Kapur

given: Shitij

journal_name: The Lancet Psychiatry

location_country:
Sweden
India
Mexico
Finland
France
Romania
Hungary
Argentina
Australia
Russian Federation
United States
United Kingdom
Korea, Republic of
Colombia


title: A Phase III International, Randomized, Double-blind, Double-dummy Study to Evaluate the Efficacy and Safety of 300 mg or 600 mg of Intravenous Zanamivir Twice Daily Compared to 75 mg of Oral Oseltamivir Twice Daily in the Treatment of Hospitalized Adults and Adolescents With Influenza

acronym: ZORO

summary: The purpose of this study is to test the safety and efficacy of zanamivir given intravenously and how well it works at two different doses in hospitalized adolescents and adults with flu. Zanamivir will be compared with oseltamivir, which is used for treating flu.

ReferenceCitation: Marty FM, Vidal-Puigserver J, Clark C, Gupta SK, Merino E, Garot D, Chapman MJ, Jacobs F, Rodriguez-Noriega E, Husa P, Shortino D, Watson HA, Yates PJ, Peppercorn AF. Intravenous zanamivir or oral oseltamivir for hospitalised patients with influenza: an international, randomised, double-blind, double-dummy, phase 3 trial. Lancet Respir Med. 2017 Feb;5(2):135-146. doi: 10.1016/S2213-2600(16)30435-0. Epub 2017 Jan 14.

family: Marty

full_name: Francisco M Marty

given: Francisco M

family: Vidal-Puigserver

full_name: Joan Vidal-Puigserver

given: Joan

family: Clark

full_name: Carol Clark

family: Gupta

full_name: Sandeep K Gupta

given: Sandeep K

family: Merino

full_name: Esperanza Merino

given: Esperanza

family: Garot

full_name: Denis Garot

given: Denis

family: Chapman

full_name: Marianne J Chapman

given: Marianne J

family: Jacobs

full_name: Frédérique Jacobs

given: Frédérique

family: Rodriguez-Noriega

full_name: Eduardo Rodriguez-Noriega

given: Eduardo

family: Husa

full_name: Petr Husa

given: Petr

family: Shortino

full_name: Denise Shortino

given: Denise

family: Watson

full_name: Helen A Watson

given: Helen A

family: Yates

full_name: Phillip J Yates

given: Phillip J

family: Peppercorn

full_name: Amanda F Peppercorn

given: Amanda F

journal_name: The Lancet Respiratory Medicine

ipd_sharing: Yes

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
Greece
Belgium
Australia
Russian Federation
Denmark
Taiwan
India
France
Poland
Thailand
Slovakia
Norway
Canada
Korea, Republic of
Colombia
South Africa
Hong Kong
Netherlands
Hungary
China
United States
Germany
United Kingdom
Brazil
Mexico
Czechia
New Zealand
Spain


title: An Open-Label, Flexible-Dose Study of Retigabine Immediate Release (IR) as Adjunctive Therapy to Specified Monotherapy Antiepileptic Treatments in Adults With Partial -Onset Seizures

acronym: IR

summary: The purpose of this Phase III study is to evaluate the efficacy, safety and tolerability and health outcomes of retigabine Immediate Release (IR) as adjunctive therapy to each of the following monotherapy Antiepileptic Drug (AED) treatments: carbamazepine/oxcarbazepine, lamotrigine, levetiracetam, or valproic acid in adult subjects with partial-onset seizures (POS) using a flexible dosing regimen.

location_country:
Italy
Netherlands
France
Bulgaria
Poland
Thailand
Belgium
Russian Federation
Spain
Denmark
Germany
Ukraine


title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24 Weeks of Response Guided Therapy With GS-9190, GS-9256, Ribavirin (Copegus®) and Peginterferon Alfa 2a (Pegasys®) in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection (Protocol No. GS-US-196-0123)

summary: This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of response-guided duration of therapy with GS-9190 and GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®). Additionally, the efficacy and safety of 24 weeks of GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) will be evaluated.

lead_sponsor: Gilead Sciences

location_country:
Italy
Austria
United States
United Kingdom
Germany
France
Poland
Belgium
Spain
Canada
Czech Republic

location_facility: University of Miami Center for Liver Diseases

location_facility: Wojewodzki Specjalistyczny Szpital im. Dr Wl. Bieganskiego w Lodzi

location_facility: Samodzielny Publiczny Wojewodzki Szpital Zespolony w Szczecinie

location_facility: Emory University, Infectious Disease Clinic

location_facility: Unità di Malattie Infettive ed Epatologia, Azienda Ospedaliero-Universitaria

location_facility: Wojewodzki Szpital Specjalistyczny im. K. Dluskiego Oddzial Obserwacyjno-Zakazny

location_facility: Liver Institute of Virginia, Bon Secours

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Medicina Generale - Azienda Ospedaliera di Padova

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej "Pol-SaNa-Med" Spolka z ograniczona odpowiedzialnoscia

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddział X

location_facility: Institute of Clinic and Experimental Medicine

location_facility: U. O. C. di Gastroenterologia - Azienda Ospedaliero-Universitaria Policlinico Paolo Giaccone

location_facility: Ottawa Hospital, Division of Infectious Diseases

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Virginia Mason Medical Center, Digestive Disease Institute

location_facility: Ifi - Institut fuer Interdisziplinaere Medizin - Studien und Projekte GmbH

location_facility: Cornell University Gastroenterology & Hepatology

location_facility: U.O. Gastroenterologia 1 - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Association of Physicians for Infection Diseases

location_facility: SGS - Clinical Pharmacology Unit Antwerpen

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddzial Dzienny

location_facility: Hospital General Universitario de Valencia

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: University Hospitals Case Medical Center

location_facility: Radomski Szpital Specjalistyczny im. Dr Tytusa Chalubinskiego Oddzial obserwacyjno-zakazny z odcinkiem jednego dnia leczenia chorob watroby

location_facility: Gordon & Leslie Diamond Health Care Centre

location_facility: Institute of Cellular Medicine (Hepatology)

location_facility: Gastroepatologia - Azienda Ospedaliero-Universitaria S. Giovanni Battista

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

location_facility: Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza Oddział Obserwacyjno-Zakazny

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie

location_facility: University of Alberta, Division of Gastroenterology

location_facility: Hospital Clínico Universitario San Cecilio

location_facility: Epatologia, Azienda Ospedaliero "Spedali Civili"

location_facility: Hospital Universitario Ntra. Sra. de Valme


title: Safety and Efficacy Evaluation of DOTAREM® in Magnetic Resonance Imaging (MRI) in Patients With Central Nervous System (CNS) Lesions.

acronym: SENTIO

summary: The purpose of this study is to look at the safety (what are the side effects)and efficacy (how well does it work) of Dotarem® when used in taking images of the brain / spine. The results will be compared to the results of MRI taken without Dotarem.

primary_purpose: Diagnostic

lead_sponsor: Guerbet

location_country:
Italy
Austria
Chile
Brazil
Germany
France
Argentina
Spain
United States
United Kingdom
Korea, Republic of

location_facility: University of Texas - Health Science Center

location_facility: Complejo Hospitalario Universitario de Vigo - Serviço de radiologia

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo

location_facility: Universidade Federal de São Paulo / UNIFESP

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Fédération d'Imagerie Médicale,Hôpital Pontchaillou

location_facility: Hospital Clinico Universitario San Carlos

location_facility: University of Alabama at Birmingham, UABMC

location_facility: Gruss Magnetic resonance Research Clinic


ReferenceCitation: Maloney DG, Ogura M, Fukuhara N, Davis J, Lasher J, Izquierdo M, Banerjee H, Tobinai K. A phase 3 randomized study (HOMER) of ofatumumab vs rituximab in iNHL relapsed after rituximab-containing therapy. Blood Adv. 2020 Aug 25;4(16):3886-3893. doi: 10.1182/bloodadvances.2020001942.

name: Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA;

family: Maloney

full_name: David G. Maloney

given: David G.

name: Department of Hematology/Oncology, Kasugai Municipal Hospital, Aichi, Japan;

family: Ogura

full_name: Michinori Ogura

given: Michinori

name: Department of Hematology and Rheumatology, Tohoku University Hospital, Miyagi, Japan;

family: Fukuhara

full_name: Noriko Fukuhara

given: Noriko

name: Novartis Pharmaceuticals Corporation, East Hanover, NJ;

family: Davis

full_name: Jaclyn Davis

given: Jaclyn

family: Lasher

full_name: Janet Lasher

given: Janet

name: Novartis Pharma AG, Basel, Switzerland; and

family: Izquierdo

full_name: Miguel Izquierdo

given: Miguel

family: Banerjee

full_name: Hiya Banerjee

given: Hiya

name: Department of Hematology, National Cancer Center Hospital, Tokyo, Japan

family: Tobinai

full_name: Kensei Tobinai

given: Kensei

journal_name: Blood Advances

oa_colors: green gold

evidence: oa journal (via observed oa rate)

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

intervention_type: Biological

lead_sponsor: Novartis Pharmaceuticals

location_country:
Brazil
United States
Peru
South Africa
France
Bulgaria
Czechia
Japan
Slovakia
Hungary
Belgium
Puerto Rico
China
Canada
Korea, Republic of
Ukraine

acronym: HOMER

title: Phase III Randomized, Open Label Study of Single Agent Ofatumumab Vs. Single Agent Rituximab in Indolent B-Cell Non Hodgkin Lymphoma Relapsed After Rituximab-Containing Therapy

summary:
This was a multi-center, parallel, active comparator controlled, open-label, randomized (1:1) phase III study of single agent ofatumumab compared to single agent rituximab in subjects with rituximab-sensitive indolent B-cell non hodgkin lymphoma that has relapsed at least 6 months after completing treatment with single agent rituximab or a rituximab-containing regimen. Subjects must have attained a Complete Response or Partial Response to their last prior rituximab containing therapy lasting at least six months beyond the end of rituximab therapy. Subjects were to receive four weekly doses of single agent ofatumumab (1000 mg) or rituximab (375 mg/m2), followed by ofatumumab (1000 mg) or rituximab (375 mg/m2) every 2 months for four additional doses. Therefore, subjects were to receive a total of eight doses of anti-CD20 antibody over 9 months. Subjects were evaluated for response after completion of the first four doses of therapy, after six doses of therapy, and after completion of study therapy. Subjects were to be followed until the end of the designated follow-up period (total study duration of 200 weeks) or until they meet the withdrawal criteria.

The primary objective of the study OMB157D 2303 was to demonstrate the efficacy of Arzerra based on the primary endpoint (Progression-free survival (PFS) as assessed by the IRC) in patients with Indolent B-cell Non-Hodgkin's Lymphoma Relapsed After Rituximab-Containing Regimen.

The Independent Data Monitoring Committee (IDMC) met on November 22, 2015 and recommended the termination of the study due to futility (cut-off date = 12Jun2015). The IDMC reviewed analyses results for progression free survival (PFS), overall response rate (ORR), and overall survival (OS). Novartis accepted this recommendation and the study was closed.

Final analysis was performed (cut-off date =19 Dec 2016). As the study was stopped for futility, the primary objective was not met and some secondary endpoints, supportive of primary objective (Duration of Response (DOR), time to next therapy, and pharmacokinetics) were removed as secondary end points.


title: A Long-term Assessment of Safety and Efficacy of AMG 827 Treatment in Subjects With Crohn's Disease

summary: This study is an open label extension of study 20090072 with subjects with Crohn's disease. Subjects will receive 350 mg AMG 827 intraveneously every 4 weeks for approximately 2 and a half years. The study will be evaluated for safety and efficacy of AMG 827.

lead_sponsor: Amgen

location_country:
United States
Netherlands
France
Poland
Belgium
Australia
Spain
Canada


ReferenceCitation: Naccarelli GV, Bhatt DL, Camm AJ, Le Heuzey JY, Lombardi F, Tamargo J, Martinez JM, Naditch-Brûlé L; ARTEMIS AF Investigators. Evaluation of the Switch From Amiodarone to Dronedarone in Patients With Atrial Fibrillation: Results of the ARTEMIS AF Studies. J Cardiovasc Pharmacol Ther. 2020 Sep;25(5):425-437. doi: 10.1177/1074248420926874. Epub 2020 Jun 5.

name: Division of Cardiology, Heart and Vascular Institute, Penn State University College of Medicine, Hershey, PA, USA

family: Naccarelli

full_name: Gerald V. Naccarelli

given: Gerald V.

name: Brigham and Women’s Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA, USA

family: Bhatt

full_name: Deepak L. Bhatt

given: Deepak L.

name: Cardiology Clinical Academic Group Molecular & Clinical Sciences Institute, St George’s University of London, London, UK

family: Camm

full_name: A. John Camm

given: A. John

name: Hôpital Européen Georges Pompidou, Université Paris V René Descartes, Paris, France

family: Le Heuzey

full_name: Jean-Yves Le Heuzey

given: Jean-Yves

name: Cardiologia, Fondazione IRCCS Ospedale Maggiore Policlinico, Milan, Italy

name: Department of Clinical Science and Health Community, University of Milan, Milan, Italy

family: Lombardi

full_name: Federico Lombardi

given: Federico

name: Department of Pharmacology and Toxicology, School of Medicine, CIBERCV, University Complutense, Madrid, Spain

family: Tamargo

full_name: Juan Tamargo

given: Juan

family: Martinez

full_name: Jean-Marie Martinez

given: Jean-Marie

family: Naditch-Brûlé

full_name: Lisa Naditch-Brûlé

given: Lisa

journal_name: Journal of Cardiovascular Pharmacology and Therapeutics

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

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

version: acceptedVersion

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

location_country:
Mexico
France
Spain
Denmark
Germany
Czech Republic
Colombia

acronym: ARTEMIS AF LT

location_facility:
Investigational Site Number 208-002
Investigational Site Number 276-005
Investigational Site Number 250-005
Investigational Site Number 250-006
Investigational Site Number 484003
Investigational Site Number 203005
Investigational Site Number 208-001
Investigational Site Number 276-001
Investigational Site Number 250-002
Investigational Site Number 276-003
Investigational Site Number 276-002
Investigational Site Number 484002
Investigational Site Number 208-003
Investigational Site Number 724001
Investigational Site Number 203007
Investigational Site Number 170006
Investigational Site Number 170003
Investigational Site Number 170002
Investigational Site Number 203006
Investigational Site Number 724006
Investigational Site Number 250-004
Investigational Site Number 484004
Investigational Site Number 203001
Investigational Site Number 724004
Investigational Site Number 170007
Investigational Site Number 276-004
Investigational Site Number 203008
Investigational Site Number 170005
Investigational Site Number 724003
Investigational Site Number 484006
Investigational Site Number 250-003
Investigational Site Number 724005
Investigational Site Number 203004
Investigational Site Number 484005
Investigational Site Number 203003
Investigational Site Number 170001
Investigational Site Number 203002
Investigational Site Number 724002
Investigational Site Number 484001
Investigational Site Number 250-001

title: A Randomized, International, Multi-center, Open-label Study to Document Pharmacokinetics and Optimal Timing of Initiation of Dronedarone Treatment Following Long-term Amiodarone in Patients With Paroxysmal or Persistent Atrial Fibrillation Whatever the Reason for the Change of Treatment.

summary:
Primary Objective:

- Explore Dronedarone and active metabolite pharmacokinetic (PK) profiles according to different timings of Dronedarone initiation.

Secondary Objective:

Explore potential PK interaction between Dronedarone and Amiodarone
Evaluate the rate of Atrial Fibrillation (AF) recurrence during the study period (from randomization up to 60 days after)
To assess the safety of the change from Amiodarone to Dronedarone and Dronedarone safety


title: A Phase III Trial to Compare the Safety and Efficacy of Lapatinib Plus Trastuzumab Plus an Aromatase Inhibitor (AI) vs. Trastuzumab Plus an AI vs. Lapatinib Plus an AI as 1st- or 2nd- Line Therapy in Postmenopausal Subjects With Hormone Receptor+, HER2-positive Metastatic Breast Cancer (MBC) Who Received Prior Trastuzumab and Endocrine Therapies

summary: A study to compare the safety and efficacy of an aromatase inhibitor in combination with lapatinib, trastuzumab or both for the treatment of hormone receptor positive, HER2+ metastatic breast cancer (MBC).

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: Updated Results of ALTERNATIVE. J Clin Oncol. 2021 Jan 1;39(1):79-89. doi: 10.1200/JCO.20.01894. Epub 2020 Aug 21.

name: The Royal Marsden NHS Foundation Trust, London, United Kingdom

family: Johnston

full_name: Stephen R. D. Johnston

given: Stephen R. D.

name: Centro de Referência da Saúde da Mulher, São Paulo, Brazil

family: Hegg

full_name: Roberto Hegg

given: Roberto

name: Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea

family: Im

full_name: Seock-Ah Im

given: Seock-Ah

family: Park

full_name: In Hae Park

given: In Hae

name: Regional Oncology Dispensary, Arkhangelsk, Russia

family: Burdaeva

full_name: Olga Burdaeva

given: Olga

name: University Cancer Center Hospital, Sofia, Bulgaria

family: Kurteva

full_name: Galina Kurteva

given: Galina

name: University of Southern California, Los Angeles, Los Angeles, CA

family: Press

full_name: Michael F. Press

given: Michael F.

name: N.N. Blokhin Russian Cancer Research Center, Moscow, Russia

family: Tjulandin

full_name: Sergei Tjulandin

given: Sergei

name: Aichi Cancer Center Hospital, Aichi, Japan

family: Iwata

full_name: Hiroji Iwata

given: Hiroji

family: Simon

full_name: Sergio D. Simon

given: Sergio D.

family: Kenny

full_name: Sarah Kenny

given: Sarah

family: Sarp

full_name: Severine Sarp

given: Severine

full_name: Miguel A. Izquierdo

given: Miguel A.

family: Williams

full_name: Lisa S. Williams

given: Lisa S.

name: Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL

family: Gradishar

full_name: William J. Gradishar

given: William J.

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor–Positive Metastatic Breast Cancer: Updated Results of ALTERNATIVE

ReferenceCitation: Johnston SRD, Hegg R, Im SA, Park IH, Burdaeva O, Kurteva G, Press MF, Tjulandin S, Iwata H, Simon SD, Kenny S, Sarp S, Izquierdo MA, Williams LS, Gradishar WJ. Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: ALTERNATIVE. J Clin Oncol. 2018 Mar 10;36(8):741-748. doi: 10.1200/JCO.2017.74.7824. Epub 2017 Dec 15. Retraction in: J Clin Oncol. 2021 Jan 1;39(1):95.

name: Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer...

full_name: Stephen R.D. Johnston

given: Stephen R.D.

title: Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor–Positive Metastatic Breast Cancer: ALTERNATIVE

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:
Peru
Greece
Romania
Belgium
Australia
Russian Federation
Taiwan
Ukraine
India
Croatia
France
Japan
Lithuania
Poland
Norway
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Hong Kong
Philippines
Bulgaria
Singapore
Hungary
Ireland
Puerto Rico
China
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Serbia
Israel
Spain
Turkey


title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Moderate to Severe Crohn's Disease

summary: The study will examine the safety and effectiveness of AMG 827 for the treatment of moderate to severe Crohn's disease. Patients will randomly receive either AMG 827 or placebo (a lookalike liquid that doesn't have any drug in it) and neither the doctor nor the patient will know what treatment is being given.


title: Extension Study to the Multicenter, Open-label, Randomized, Controlled Study CRAD001H2304 to Evaluate the Long-term Efficacy and Safety of Concentration-controlled Everolimus in Liver Transplant Recipient

summary: The reason for this extension is to evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients. The most important long-term safety assessments include evaluation of renal function, progression of HCV related allograft fibrosis, and other treatment related effects at Month 36 post-transplantation compared to extension baseline (Months 24 post-transplantation).

location_country:
Italy
Brazil
Sweden
Netherlands
Spain
Germany
France
Czechia
Ireland
Belgium
Argentina
Australia
Russian Federation
United States
United Kingdom
Colombia


title: PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study To Evaluate Real World Clinical Outcomes Data for the PROMUS™ Element™ Coronary Stent System in Unselected Patients in Routine Clinical Practice

acronym: PE-Prove

summary: The goal of the PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study is to evaluate real world clinical outcomes data for the PROMUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Thomas MR, Birkemeyer R, Schwimmbeck P, Legrand V, Moreno R, Briguori C, Werner N, Bramucci E, Ungi I, Richardt G, Underwood PL, Dawkins KD. One-year outcomes in 1,010 unselected patients treated with the PROMUS Element everolimus-eluting stent: the multicentre PROMUS Element European Post-Approval Surveillance Study. EuroIntervention. 2015 Mar;10(11):1267-71. doi: 10.4244/EIJY15M01_07.

family: Thomas

full_name: Martyn R. Thomas

given: Martyn R.

family: Birkemeyer

full_name: Ralf Birkemeyer

given: Ralf

family: Schwimmbeck

full_name: Peter Schwimmbeck

given: Peter

family: Legrand

full_name: Victor Legrand

given: Victor

family: Moreno

full_name: Raul Moreno

given: Raul

family: Briguori

full_name: Carlo Briguori

given: Carlo

family: Werner

full_name: Nikos Werner

given: Nikos

family: Bramucci

full_name: Ezio Bramucci

given: Ezio

family: Ungi

full_name: Imre Ungi

given: Imre

family: Richardt

full_name: Gert Richardt

given: Gert

family: Underwood

full_name: Paul L. Underwood

given: Paul L.

family: Dawkins

full_name: Keith D. Dawkins

given: Keith D.

journal_name: EuroIntervention

repository_institution: University of Liège - Open Repository and Bibliography

publisher: Europa Digital & Publishing

publisher_dissemination: Europa Digital & Publishing

publisher_group: Europa Digital & Publishing

publisher_normalized: Europa Digital & Publishing

ipd_sharing: No

ipd_sharing_description: Data are presented at the 2013 EuroPCR congress.

lead_sponsor: Boston Scientific Corporation

location_country:
Italy
Austria
Netherlands
France
Hungary
Belgium
Ireland
Spain
Denmark
Germany
United Kingdom

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Centre Hôpital Universitaire Sart Tilman

location_facility: Dept. of Internal Medicine and Cardiological Center

location_facility: Centre Hospitalier Privé Saint Martin gds

location_facility: Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH

location_facility: Schwarzwald Baar Klinikum Villingen-Schwenningen

intervention_type: Device


title: A 24-month Randomized Multicenter Study Evaluating Efficacy, Safety, Tolerability and Pharmacokinetics of Sotrastaurin and Tacrolimus vs. a Tacrolimus/Mycophenolate Mofetil-based Control Regimen in de Novo Liver Transplant Recipients

summary: This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo liver transplantation.

primary_purpose: Prevention

ReferenceCitation: Pascher A, De Simone P, Pratschke J, Salamé E, Pirenne J, Isoneimi H, Bijarnia M, Krishnan I, Klupp J. Protein kinase C inhibitor sotrastaurin in de novo liver transplant recipients: a randomized phase II trial. Am J Transplant. 2015 May;15(5):1283-92. doi: 10.1111/ajt.13175. Epub 2015 Feb 12.

name: Charité - Universitaetsmedizin Berlin; Berlin Germany

family: Pascher

full_name: A. Pascher

given: A.

name: Azienda Ospedaliero-Universitaria Pisana; Pisa Italy

family: De Simone

full_name: P. De Simone

given: P.

name: Medical University of Innsbruck; Innsbruck Austria

family: Pratschke

full_name: J. Pratschke

given: J.

name: CHU Tours, Hôpital Trousseau; Tours France

family: Salamé

full_name: E. Salamé

given: E.

name: Gasthuisber University Hospital; Leuven Belgium

family: Pirenne

full_name: J. Pirenne

name: Helsinki University Hospital; Helsinki Finland

family: Isoneimi

full_name: H. Isoneimi

given: H.

name: Novartis Healthcare Pvt. Ltd.; Hyderabad India

family: Bijarnia

full_name: M. Bijarnia

given: M.

family: Krishnan

full_name: I. Krishnan

given: I.

family: Klupp

full_name: J. Klupp

journal_name: American Journal of Transplantation

title: Protein Kinase C Inhibitor Sotrastaurin inDe NovoLiver Transplant Recipients: A Randomized Phase II Trial

location_country:
Italy
Austria
United States
Switzerland
Germany
Finland
France
Czechia
Argentina
Belgium
Spain
Canada


ReferenceCitation: Sitbon O, Channick R, Chin KM, Frey A, Gaine S, Galiè N, Ghofrani HA, Hoeper MM, Lang IM, Preiss R, Rubin LJ, Di Scala L, Tapson V, Adzerikho I, Liu J, Moiseeva O, Zeng X, Simonneau G, McLaughlin VV; GRIPHON Investigators. Selexipag for the Treatment of Pulmonary Arterial Hypertension. N Engl J Med. 2015 Dec 24;373(26):2522-33. doi: 10.1056/NEJMoa1503184.

family: Sitbon

full_name: Olivier Sitbon

given: Olivier

family: Channick

full_name: Richard Channick

given: Richard

family: Chin

full_name: Kelly M. Chin

given: Kelly M.

family: Frey

full_name: Aline Frey

given: Aline

family: Gaine

full_name: Sean Gaine

given: Sean

family: Galiè

full_name: Nazzareno Galiè

given: Nazzareno

family: Ghofrani

full_name: Hossein-Ardeschir Ghofrani

given: Hossein-Ardeschir

family: Hoeper

full_name: Marius M. Hoeper

given: Marius M.

family: Lang

full_name: Irene M. Lang

given: Irene M.

family: Preiss

full_name: Ralph Preiss

given: Ralph

family: Rubin

full_name: Lewis J. Rubin

given: Lewis J.

family: Di Scala

full_name: Lilla Di Scala

given: Lilla

family: Tapson

full_name: Victor Tapson

family: Adzerikho

full_name: Igor Adzerikho

given: Igor

family: Liu

full_name: Jinming Liu

given: Jinming

family: Moiseeva

full_name: Olga Moiseeva

given: Olga

family: Zeng

full_name: Xiaofeng Zeng

given: Xiaofeng

family: Simonneau

full_name: Gérald Simonneau

given: Gérald

family: McLaughlin

full_name: Vallerie V. McLaughlin

given: Vallerie V.

journal_name: New England Journal of Medicine

endpoint_id: fhisxppmrqpajgzqkvft

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

repository_institution: University of Geneva - Archive ouverte UNIGE

repositories_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

repositories_institution: University of Geneva - Archive ouverte UNIGE

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Selexipag for the Treatment of Pulmonary Arterial Hypertension

ReferenceCitation: Galiè N, Gaine S, Channick R, Coghlan JG, Hoeper MM, Lang IM, McLaughlin VV, Lassen C, Rubin LJ, Hsu Schmitz SF, Sitbon O, Tapson VF, Chin KM. Long-Term Survival, Safety and Tolerability with Selexipag in Patients with Pulmonary Arterial Hypertension: Results from GRIPHON and its Open-Label Extension. Adv Ther. 2021 Oct 30. doi: 10.1007/s12325-021-01898-1. [Epub ahead of print]

ReferenceCitation: Gaine S, Sitbon O, Channick RN, Chin KM, Sauter R, Galiè N, Hoeper MM, McLaughlin VV, Preiss R, Rubin LJ, Simonneau G, Tapson V, Ghofrani HA, Lang I. Relationship Between Time From Diagnosis and Morbidity/Mortality in Pulmonary Arterial Hypertension: Results From the Phase III GRIPHON Study. Chest. 2021 Jul;160(1):277-286. doi: 10.1016/j.chest.2021.01.066. Epub 2021 Feb 3.

ReferenceCitation: Chin KM, Rubin LJ, Channick R, Di Scala L, Gaine S, Galiè N, Ghofrani HA, Hoeper MM, Lang IM, McLaughlin VV, Preiss R, Simonneau G, Sitbon O, Tapson VF. Association of N-Terminal Pro Brain Natriuretic Peptide and Long-Term Outcome in Patients With Pulmonary Arterial Hypertension. Circulation. 2019 May 21;139(21):2440-2450. doi: 10.1161/CIRCULATIONAHA.118.039360.

name: Division of Internal Medicine, UT Southwestern Medical Center, Dallas, TX (K.M.C.).

name: Division of Pulmonary and Critical Care Medicine, University of California, San Diego (L.J.R.).

name: David Geffen School of Medicine, University of California Los Angeles (R.C.).

name: Actelion Pharmaceuticals Ltd, Allschwil, Switzerland (L.D.S., R.P.).

name: National Pulmonary Hypertension Unit, Mater Misericordiae University Hospital, Dublin, Ireland (S.G.).

name: Department of Experimental, Diagnostic, and Specialty Medicine – DIMES, University of Bologna, Italy (N.G.).

name: University of Giessen and Marburg Lung Center, Giessen, Germany, member of the German Center of Lung Research, and Department of Medicine, Imperial College London, London, UK (H.-A.G.).

name: Department of Respiratory Medicine, Hannover Medical School and German Center of Lung Research, Hannover (M.M.H.).

name: Medical University of Vienna, Department of Internal Medicine II, Division of Cardiology, Allgemeines Krankenhaus, Austria (I.M.L.).

name: Department of Internal Medicine, Division of Cardiovascular Medicine, University of Michigan, Ann Arbor (V.V.M.).

name: APHP Centre de Référence de l’Hypertension Pulmonaire, Service de Pneumologie et Soins Intensifs, CHU Bicêtre, Université Paris-Sud, Le Kremlin Bicêtre, France (G.S., O.S.).

name: Division of Pulmonary and Critical Care Medicine, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, CA (V.F.T.).

ReferenceCitation: McLaughlin VV, Hoeper MM, Channick RN, Chin KM, Delcroix M, Gaine S, Ghofrani HA, Jansa P, Lang IM, Mehta S, Pulido T, Sastry BKS, Simonneau G, Sitbon O, Souza R, Torbicki A, Tapson VF, Perchenet L, Preiss R, Verweij P, Rubin LJ, Galiè N. Pulmonary Arterial Hypertension-Related Morbidity Is Prognostic for Mortality. J Am Coll Cardiol. 2018 Feb 20;71(7):752-763. doi: 10.1016/j.jacc.2017.12.010.

journal_name: Journal of the American College of Cardiology

repositories_institution:
INFN Catania - INFM-OAR
KU Leuven - Lirias

ReferenceCitation: Coghlan JG, Channick R, Chin K, Di Scala L, Galiè N, Ghofrani HA, Hoeper MM, Lang IM, McLaughlin V, Preiss R, Rubin LJ, Simonneau G, Sitbon O, Tapson VF, Gaine S. Targeting the Prostacyclin Pathway with Selexipag in Patients with Pulmonary Arterial Hypertension Receiving Double Combination Therapy: Insights from the Randomized Controlled GRIPHON Study. Am J Cardiovasc Drugs. 2018 Feb;18(1):37-47. doi: 10.1007/s40256-017-0262-z.

journal_name: American Journal of Cardiovascular Drugs

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

repositories_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

ReferenceCitation: Gaine S, Chin K, Coghlan G, Channick R, Di Scala L, Galiè N, Ghofrani HA, Lang IM, McLaughlin V, Preiss R, Rubin LJ, Simonneau G, Sitbon O, Tapson VF, Hoeper MM. Selexipag for the treatment of connective tissue disease-associated pulmonary arterial hypertension. Eur Respir J. 2017 Aug 17;50(2). pii: 1602493. doi: 10.1183/13993003.02493-2016. Print 2017 Aug.

ReferenceCitation: Krause A, Machacek M, Lott D, Hurst N, Bruderer S, Dingemanse J. Population Modeling of Selexipag Pharmacokinetics and Clinical Response Parameters in Patients With Pulmonary Arterial Hypertension. CPT Pharmacometrics Syst Pharmacol. 2017 Jul;6(7):477-485. doi: 10.1002/psp4.12202. Epub 2017 May 27.

name: Department of Clinical Pharmacology; Actelion Pharmaceuticals Ltd; Allschwil Switzerland

name: Lixoft, Modelling and Pharmacology; Antony France

journal_name: CPT: Pharmacometrics & Systems Pharmacology

ReferenceCitation: Skoro-Sajer N, Lang IM. Selexipag for the treatment of pulmonary arterial hypertension. Expert Opin Pharmacother. 2014 Feb;15(3):429-36. doi: 10.1517/14656566.2014.876007. Epub 2014 Jan 7. Review.

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

title: Selexipag for the treatment of pulmonary arterial hypertension

location_country:
Peru
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
India
Spain
France
Poland
Thailand
Slovakia
Argentina
Canada
Korea, Republic of
Colombia
Chile
Sweden
Switzerland
Netherlands
Singapore
Hungary
Ireland
China
Germany
United States
United Kingdom
Italy
Austria
Serbia
Mexico
Czechia
Israel
Belarus
Turkey

location_facility: University Hospital Basel Division of Pneumology

location_facility: "Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ, II. sz. Belgyógyászati klinika és Kardiológiai központ"

location_facility: ISMETT - Istituto Mediterraneo Trapianti e Terapie ad Alta Specializzazione - Dipartimento di Medicina - Divisione di Pneumologia

location_facility: Umeå University Hospital, Cardiology (Umeå)

location_facility: Cardiovascular Institute & Fuwai Hospital-Pulmonary Vascular Center

location_facility: Public Institution "F.H. Yanovski Phthisiology and Pulmonology National Institute Under Ukrainian Academy of Medical Sciences"

location_facility: Tomsk Regional Clinical Hospital/ Pulmonology Unit

location_facility: Linköping University Hospital, Cardiology

location_facility: Scientific Research Institute of Pulmonology of the Federal Medical and Biological Agency of Russia

location_facility: CARE Hospitals Nampally, Cardiology Dep. Hyderabad

location_facility: "Instytut Gruźlicy i Chorób Płuc Klinika Chorób Wewnętrznych Klatki Piersiowej"

location_facility: Royal Hobart Hospital, Centre for Clinical Research

location_facility: Johns Hopkins University School of Medicine

location_facility: Pontificia Universidad Catolica de Chile-Departmento De Enfermedades Cardiovasculares

location_facility: Cardiology Scientific Research Institute of Tomsk Scientific Center of RAMs, Siberian Branch / Cardiovascular Surgery Department

location_facility: Erasmus Medisch Centrum Rotterdam afdeling longziekten

location_facility: V. A. Almazov Institute of Cardiology, Russian Ministry of Healthcare and Social Development / Medical Treatment and Rehabilitation Complex

location_facility: Royal Adelaide Hospital, Cardiovascular Investigation Unit (CVIU)

location_facility: Yonsei University Health System Dept of Cardiology

location_facility: Dokuz Eylül Üniversitesi Tıp Fakültesi Kardiyoloji Anabilim Dalı

location_facility: Uppsala Akademiska Sjukhuset, Kardiologkliniken 50F

location_facility: Peking Union Medical College Hospital, Rheumatology Department

location_facility: Istanbul Üniversitesi Kardiyoloji Enstitisü

location_facility: Hospital Privado Centro Medico de Cordoba S.A.

location_facility: John Hunter Hospital Autoimmune Resource and Research Centre

location_facility: Samsung Medical Center, Division of Cardiology

location_facility: Policlinico S. Orsola-Malpighi - Dipartimento Cardio-Toraco-Vascolare

location_facility: Kemerovo Cardiology Dispensary / Kemerovo Regional Hospital

location_facility: Minsk Regional Clinical Hospital of the Red Banner of Labour

location_facility: Lung Health & Sleep Emhancement Center, LLC

location_facility: Klinik Löwenstein gGmbH, Medizinische Klinik 1, Pneumologie - Kardiologie

location_facility: Medical University of Vienna and AKH Cardiology

location_facility: University of Wisconsin Hospital-Department of Medicine

location_facility: Seconda Università Degli Studi di Napoli - Azienda Universitaria Policlinico - Dipartimento Assistenziale di medicina Generale, Angiologia, Endocrinologia, Epatogastroenterologia e Reumatologia - Unità Operativa di Reumatologia

location_facility: University of Texas-Houston Health Center Department of Pulmonary & Critical Care

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Emory University School of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine

location_facility: The Institution of the Clinical Cardiology named after A. L. Myaskinov

location_facility: The Ohio State University Medical Center

location_facility: Universität Greifswald / Klinik für Innere Medizin B

location_facility: Universitätsklinikum Carl Gustav Carus, Medizinische Klinik1-Pneumologie/MK1-A13

location_facility: Limited liability company, Consultative diagnostic centre Healthy Joints

location_facility: Royal Melbourne Hospital, Department of Respiratory and Sleep Medicine

location_facility: "Dnipropetrovsk State Medical Academy, Municipal Institution ""Dnipropetrovsk Regional Clinic Diagnostic Center""

location_facility: Massachusetts General Hospital - Pulmonary Critical Care Unit

location_facility: Centro de Investigacion y Prevencion Cardiovascular (CIPREC)

location_facility: Rigshospitalet, Hjertemedicinsk klinik - Cardiology

location_facility: "Justus-Liebig-Universität Gießen Zentrum für Innere Medizin Medizinische Klinik II"

location_facility: "Pécsi Tudományegyetem Klinikai Központ,

location_facility: Hospital Nacional Edgardo Rebagliati / Unidad de Investigacion Cardiologia 2

location_facility: Shanghai Pulmonary Hospital, Department of Pulmonary Circulation

location_facility: Kantonsspital St. Gallen Klinik für Pneumologie

location_facility: Washington University School of Medicine

location_facility: University Hospitals Case Medical Center

location_facility: Instituto de Enfermedades Respiratorias Clinica San Gabriel

location_facility: Municipal Medical Institution City Hospital #5

location_facility: Newark Beth Isreal Medical Center-Department of Pulmonary Medicine

location_facility: Hosp A. Beclere - Dept Pulmo & Resp Intensive Care

location_facility: Montefiore Medical Center, Weiler Division

location_facility: St. Vincent's Hospital / Heart and Lung Transplant Unit

location_facility: Prince Charles Hospital Lung Transplant, Thoracic Department

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: "Institutul de Pneumologie "Marius Nasta", I. Clinica de Pneumoftiziologie"

location_facility: Frontier Lifeline Hospitals, Dr KM Cherian Heart Foundation, Chennai

location_facility: VU Medisch Centrum / Afdeling longziekten, secretariaat 4A 48

location_facility: The University of Arizona, Clinical and Translational Science (CATS) Research Center

location_facility: Instituto Nacional del Torax Teaching Dept

location_facility: "Klinički Centar Srbije, Klinika za pulmologiju"

location_facility: St. Antonius Ziekenhuis afdeling Longziekten

location_facility: Instituto Nacional de Cardiologia (INC) Ignacio Chavez

location_facility: Flinders Medical Centre, Pulmonary Hypertension, c/- Cardiology

location_facility: Health Care Municipal Institution, City Clinical Hospital #13

location_facility: HUG Hôpitaux Universitaires de Genève; Pneumology, PAH

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubrian

location_facility: Academisch Ziekenhuis Maastricht / Department of Pulmonary Diseases

location_facility: "Universitätsklinikum Köln Herzzentrum / Klinik III für Innere Medizin (Kardiologie, Pneumologie, Angiologie und Intensivmedizin)"

location_facility: "Instytut Kardiologii Collegium Medium UJ Krakowski Szpital Specjalistyczny im Jana Pawła II Klinika Chorób Serca i Naczyń"

location_facility: Boston University School of Medicine / Boston University Medical Center

location_facility: Universitätsklinkum Regensburg / Innere Medizin II

location_facility: "Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály"

location_facility: Pulmonology Institute, Hadassah University Hospital at Ein Karem

location_facility: "The Catholic University of Korea, Seoul St. Mary's Hospital Department of Cardiology"

location_facility: Srinagarind Hospital, Khon Kaen University, Division of Allergy-Immunology and Rheumatology, Department of Medicine

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg

location_facility: National Taiwan University Hospital / Department of Surgery

location_facility: Froedtert Hospital - Medical College of Wisconsin

location_facility: State Institution, "Institute fo Rheumatology of RAMS"

location_facility: Guangdong General Hospital, Cardiology Department

location_facility: The Republican Scientific-Practical Center "Cardiology"

location_facility: Kaohsiung Veterans General Hospital (KVGH)

location_facility: Národný ústav srdcových a cievnych chorôb, a.s. - NÚSCH a.s.

location_facility: Massachusetts General Hospital-Pulmonary Critical Care Unit

location_facility: Egészségügyi Járóbeteg Központ Kardiológiai Intézete - Debrecen

location_facility: Medizinische Hochschule Hannover / Klinik für Pneumologie

location_facility: University of California San Diego Medical Center (La Jolla)

location_facility: "Spitalul Clinic de Pneumoftiziologie Iasi Sectia Clinica I de Pneumoftiziologie"

location_facility: "Wojewódzki Specjalistyczny Szpital im. dr Władysława Biegańskiego Oddział Kardiologiczny, II Katedra i Klinika Kardiologii UM"

location_facility: "Uniwersyteckie Centrum Kliniczne II Klinika Kardiologii i Elektroterapii Serca"

location_facility: Çukurova Üniversitesi Tıp Fakültesi Kardiyoloji Anabilim Dalı

location_facility: Columbia University Medical Center, Pediatric Cardiology

location_facility: Marmara Üniversitesi Tip Fakultesi Kardiyoloji Anabilim Dali

location_facility: Institut Jantung Negara (National Heart Institute)

location_facility: Hopital General Juif (Jewish General Hospital)

location_facility: "Semmelweis Egyetem, Pulmonológiai Klinika"

location_facility: University Hospital Gasthuisberg - Pneumologie

location_facility: University of Alberta Hospital - Children's Centre

location_facility: "Kliničko-bolnički centar Zemun, Kardiološko odeljenje"

location_facility: Universitätsspital Bern, Clinic for Pneumology (Inselspital)

location_facility: Hosp Vall D'Hebron - Barcelona - Pneumology

location_facility: Sanjivani Hospitals - Department of Cardiology

location_facility: University of California, Davis, UC Davis Medical Center

title: A Multicenter, Double-blind, Placebo-controlled Phase 3 Study Assessing the Safety and Efficacy of Selexipag on Morbidity and Mortality in Patients With Pulmonary Arterial Hypertension

summary: The AC-065A302 (GRIPHON) study is an event-driven Phase 3 study to demonstrate the effect of selexipag on time to first morbidity or mortality event in patients with pulmonary arterial hypertension.


location_country:
Austria
Switzerland
Finland
France
Belgium
Spain
Germany
United Kingdom

location_facility: Chu de Bordeaux - Hopital Du Haut Leveque

location_facility: Charite - Universitaetsmedizin Berlin - Campus Mitte

location_facility: Medical University Vienna - General Hospital

location_facility: Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet

location_facility: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre

location_facility: Guy'S and St Thomas' Nhs - St Thomas Hospital

location_facility: Helsinky University Central Hospital - Skin & Allergy Hospital

location_facility: UniversitaetsSpital Zurich - Division of Oncology

location_facility: Nottingham University Hospitals NHS Trust - City Hospital campus

location_facility: Csu de Bellvitge (Institut Catala D'Oncologia)

title: A Phase III Study of Lenalidomide Maintenance After Debulking Therapy in Patients With Advanced Cutaneous T-Cell Lymphoma

summary:
RATIONALE: Observation is watching a patient's condition but not giving treatment unless symptoms appear or change. Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. It is not yet known whether observation or lenalidomide is more effective in treating patients who are in complete or partial response after receiving previous gemcitabine hydrochloride or doxorubicin hydrochloride liposome for cutaneous T-cell lymphoma or mycosis fungoides/Sézary syndrome.

PURPOSE: This randomized phase III trial is studying observation to see how well it works compared with lenalidomide in treating patients who are in complete or partial response after receiving previous gemcitabine hydrochloride or doxorubicin hydrochloride liposome for stage IIB, stage III, or stage IV cutaneous T-cell lymphoma or stage IIB, stage III, or stage IV mycosis fungoides/Sézary syndrome.


title: A Phase 2 Clinical Study to Evaluate Daily Oral Doses of LY500307 for 24 Weeks in Men With Lower Urinary Tract Symptoms (LUTS) and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia (BPH)

summary: The purpose of the study is to determine whether LY500307 helps symptoms of Benign Prostatic Hyperplasia (BPH)

lead_sponsor: Eli Lilly and Company

location_country:
Italy
United States
Germany
France
Greece
Australia
Russian Federation
Canada

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.