title: A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Subjects With Non-infectious Intermediate, Posterior, or Pan-uveitis Currently Controlled With Systemic Treatment

acronym: EYEGUARD™-C

summary: The purpose of this study is to evaluate the efficacy of gevokizumab in reducing the risk of recurrent uveitic disease in subjects with non-infectious uveitis whose disease is currently controlled with systemic treatment.

lead_sponsor: XOMA (US) LLC

collaborators: Institut de Recherches Internationales Servier

location_country:
Germany
Poland
Argentina
Australia
Brazil
Armenia
Turkey
Canada
France
Portugal
United States
Tunisia
China
Italy
United Kingdom
Mexico
Spain
Greece
South Africa
Taiwan
Russian Federation
Israel


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Novartis Pharmaceuticals

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

status: Active, not recruiting

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

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

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

study_completion_date_type: Anticipated

location_country:
Finland
United Kingdom
Hong Kong
Romania
Singapore
Switzerland
United States
China
Thailand
Turkey
France

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Ongoing


lead_sponsor: Horizon Pharma USA, Inc.

summary:
The purpose of this study is to gather information about the effectiveness (how well it works to treat cystinosis) and safety of a new form of cysteamine bitartrate called RP103, compared to the already-approved drug cystinosis patients are taking called Cystagon®.

In cystinosis, the body builds up cystine. When taken regularly, the active ingredient of Cystagon® (cysteamine bitartrate) reduces cystine in the body. RP103 has the same active ingredient as Cystagon® and is designed to reduce cystine in a similar way that Cystagon® does. To decide if RP103 is better than Cystagon®, the study will look at two types of blood tests. One test is pharmacodynamics (PD), which measures the amount of white blood cell (WBC) cystine after taking study drug. WBC cystine is a laboratory test used to find out if cysteamine bitartrate is reducing cystine levels in the body. The second test is pharmacokinetics (PK), which measures the amount of cysteamine in the blood after taking the drug.

RP103 is different from Cystagon®: Instead of the cysteamine bitartrate being absorbed from the stomach, RP103 is designed to be absorbed from the small intestine. This may make the effects of the drug last longer, so that it can be taken twice a day instead of four times a day like Cystagon®.

Some cystinosis patients have bad breath (halitosis) when they take Cystagon®. Study participants who experience bad breath with Cystagon® will be asked if they would like to participate in an optional "halitosis substudy" to investigate this issue by collecting some extra PK blood samples.

ReferenceType: background

ReferenceCitation: Schwartz GJ, Munoz A, Schneider MF, Mak RH, Kaskel F, Warady BA, Furth SL. New equations to estimate GFR in children with CKD. J Am Soc Nephrol. 2009 Mar;20(3):629-37. doi: 10.1681/ASN.2008030287. Epub 2009 Jan 21.

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

location_facility: California Pacific Medical Center (CPMC) Research Institute

location_facility: Baylor College of Medicine / Texas Childrens Hospital

location_facility: Radboud University Nijmegen Medical Center

status: Completed

title: A Long-Term, Open-Label, Safety, Tolerability and Superior Effectiveness Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients With Cystinosis

study_completion_date_type: Actual

location_country:
Italy
United Kingdom
Netherlands
Belgium
United States
France

ipd_sharing: Undecided

status_simplified: Completed


type: Other Identifier

type: Registry Identifier

title: A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A

summary: This trial is conducted globally. The aim of the trial is to investigate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in children with severe haemophilia A who have undergone treatment with previous factor VIII (FVIII) products.

ReferenceType: result

ReferenceCitation: Tosetto A, Neff A, Lentz SR, Santagostino E, Nemes L, Sathar J, Meijer K, Chowdary P, Shen C, Landorph A, Hampton K. Turoctocog alfa pegol provides effective management for major and minor surgical procedures in patients across all age groups with severe haemophilia A: Full data set from the pathfinder 3 and 5 phase III trials. Haemophilia. 2020 May;26(3):450-458. doi: 10.1111/hae.13980. Epub 2020 Apr 15.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

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)

license_normalized: no license

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

version: submittedVersion

repositories_concat: PubMed Central;pure.rug.nl

unpaywall_oa_status: hybrid

publisher_dissemination: Wiley

ReferenceCitation: Saulyte Trakymiene S, Economou M, Kenet G, Landorph A, Shen C, Kearney S. Long-term safety and efficacy of N8-GP in previously treated pediatric patients with hemophilia A: Final results from pathfinder5. J Thromb Haemost. 2020 Sep;18 Suppl 1(Suppl 1):15-25. doi: 10.1111/jth.15036.

repositories_concat: PubMed Central

publisher_dissemination: Elsevier

lead_sponsor: Novo Nordisk A/S

location_country:
Italy
Lithuania
Portugal
Israel
United Kingdom
Japan
Brazil
Switzerland
United States
Greece
Malaysia
Turkey
Canada
Ukraine
Puerto Rico
France


title: A Randomized, Double-Blind Study of the Efficacy and Safety of Alirocumab Added on to Atorvastatin Versus Ezetimibe Added on to Atorvastatin Versus Atorvastatin Dose Increase Versus Switch to Rosuvastatin in Patients Who Are Not Controlled on Atorvastatin

summary: This is a randomized, double-blind, active-comparator, parallel-group study in patients at high cardiovascular risk with nonfamilial hypercholesterolemia or heterozygous familial hypercholesterolemia (heFH).

design_allocation: Randomized

ReferenceType: derived

ReferenceCitation: Mahmood T, Minnier J, Ito MK, Li QH, Koren A, Kam IW, Fazio S, Shapiro MD. Discordant responses of plasma low-density lipoprotein cholesterol and lipoprotein(a) to alirocumab: A pooled analysis from 10 ODYSSEY Phase 3 studies. Eur J Prev Cardiol. 2021 Jul 23;28(8):816-822. doi: 10.1177/2047487320915803. Epub 2020 Apr 10.

oa_host_type: publisher

evidence: open (via free article)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Oxford University Press

ReferenceCitation: Leiter LA, Tinahones FJ, Karalis DG, Bujas-Bobanovic M, Letierce A, Mandel J, Samuel R, Jones PH. Alirocumab safety in people with and without diabetes mellitus: pooled data from 14 ODYSSEY trials. Diabet Med. 2018 Dec;35(12):1742-1751. doi: 10.1111/dme.13817. Epub 2018 Oct 9.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories_concat: PubMed Central;www.repositoriosalud.es

ReferenceCitation: Ray KK, Ginsberg HN, Davidson MH, Pordy R, Bessac L, Minini P, Eckel RH, Cannon CP. Reductions in Atherogenic Lipids and Major Cardiovascular Events: A Pooled Analysis of 10 ODYSSEY Trials Comparing Alirocumab With Control. Circulation. 2016 Dec 13;134(24):1931-1943. doi: 10.1161/CIRCULATIONAHA.116.024604. Epub 2016 Oct 24.

evidence: open (via page says license)

license: cc-by

license_normalized: cc-by

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

repository_institution: Imperial College London - Spiral

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Bays H, Gaudet D, Weiss R, Ruiz JL, Watts GF, Gouni-Berthold I, Robinson J, Zhao J, Hanotin C, Donahue S. Alirocumab as Add-On to Atorvastatin Versus Other Lipid Treatment Strategies: ODYSSEY OPTIONS I Randomized Trial. J Clin Endocrinol Metab. 2015 Aug;100(8):3140-8. doi: 10.1210/jc.2015-1520. Epub 2015 Jun 1.

oa_colors: green other

evidence: open (via free pdf)

publisher_dissemination: The Endocrine Society

ReferenceCitation: Robinson JG, Colhoun HM, Bays HE, Jones PH, Du Y, Hanotin C, Donahue S. Efficacy and safety of alirocumab as add-on therapy in high-cardiovascular-risk patients with hypercholesterolemia not adequately controlled with atorvastatin (20 or 40 mg) or rosuvastatin (10 or 20 mg): design and rationale of the ODYSSEY OPTIONS Studies. Clin Cardiol. 2014 Oct;37(10):597-604. doi: 10.1002/clc.22327. Epub 2014 Sep 30.

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

repository_institution: University of Dundee - Discovery Research Portal

location_country:
Germany
Italy
United Kingdom
Australia
Mexico
United States
Spain
Canada
France


title: A Phase 3 Evaluation of Daclatasvir in Combination With Peginterferon Lambda-1a and Ribavirin (RBV) or Telaprevir in Combination With Peginterferon Alfa-2a and RBV in Patients With Chronic Hepatitis C Genotype 1b Who Are Treatment naïve or Prior Relapsers to Alfa/RBV Therapy (the STRUCTURE Study)

acronym: STRUCTURE

summary: The purpose of this study is to determine if treatment with Pegylated Interferon Lambda-1a, given in combination with Ribavirin and Daclatasvir for 24 weeks, is as safe and effective as the standard treatment with Pegylated Interferon Alfa-2a + Ribavirin + Telaprevir in subjects who are infected with Chronic Hepatitis C virus genotype 1b and have never received any prior anti-HCV treatment, or who have relapsed after an initial, successful treatment with Pegylated Interferon Alfa + Ribavirin

ReferenceCitation: Flisiak R, Kawazoe S, Znoyko O, Assy N, Gadano A, Kao JH, Lee KS, Zwirtes R, Portsmouth S, Dong Y, Xu D, Kumada H, Srinivasan S. Peginterferon Lambda-1a/Ribavirin with Daclatasvir or Peginterferon Alfa-2a/Ribavirin with Telaprevir for Chronic Hepatitis C Genotype 1b. J Interferon Cytokine Res. 2016 Nov;36(11):635-643. doi: 10.1089/jir.2015.0173. Epub 2016 Jun 21.

oa_host_type: closed

publisher_dissemination: Mary Ann Liebert Inc

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
France
Italy
Poland
United Kingdom
Argentina
Japan
United States
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

location_facility: Gastrointestinal Specialists Of Georgia Pc

location_facility: Premier Medical Group Of The Hudson Valley, Pc


title: A Randomized, Open-Label, Multicenter Phase II Study of Ipilimumab Retreatment Versus Chemotherapy for Subjects With Advanced Melanoma Who Progressed After Initially Achieving Disease Control With Ipilimumab Therapy

summary: The purpose of the study is to determine whether additional doses of ipilimumab have a positive effect on survival in the treatment of advanced melanoma that has progressed after successful initial treatment with ipilimumab.

status: Terminated

location_country:
Germany
Italy
Austria
United States
France

location_facility: Investigative Clinical Research Of Indiana, Llc

location_facility: Birmingham Hematology & Oncology Associates Llc

status_simplified: Unknown


title: An Open-label Phase II Study of BKM120 in Subjects With Relapsed and Refractory Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma and Follicular Lymphoma

summary: This is a phase II study evaluating the safety, tolerability and efficacy of BKM120 in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) or follicular lymphoma (FL).

design_allocation: Non-Randomized

ReferenceCitation: Younes A, Salles G, Martinelli G, Bociek RG, Barrigon DC, Barca EG, Turgut M, Gerecitano J, Kong O, Pisal CB, Tavorath R, Kim WS. Pan-phosphatidylinositol 3-kinase inhibition with buparlisib in patients with relapsed or refractory non-Hodgkin lymphoma. Haematologica. 2017 Dec;102(12):2104-2112. doi: 10.3324/haematol.2017.169656. Epub 2017 Sep 29.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repositories_concat: PubMed Central;diposit.ub.edu

unpaywall_oa_status: gold

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

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

location_facility: University of Texas MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3)

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

location_facility: University of Nebraska Medical Center Univ Nebraska


title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 18-Month Safety and Efficacy Study of TRx0237 in Subjects With Mild Alzheimer's Disease

summary: The purpose of this study is to determine the safety and efficacy of TRx0237 in the treatment of subjects with mild Alzheimer's Disease.

lead_sponsor: TauRx Therapeutics Ltd

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

location_facility: Klinik und Poliklinik für Psychiatrie und Psychotherapie Zentrum für Nervenheilkunde - Universitätsklinikum Rostock

location_facility: Clinical Neurology Department of Neuroscience (DINOGMI) - University of Genoa

location_facility: University Hospital Gent Department of Neurology

location_facility: Research Foundation for Mental Hygiene, Inc.

location_facility: University Hospital Centre Zagreb, Department of Neurology

location_facility: Clinical Neuroscience Solutions CNS Healthcare

location_facility: Research Center for Clinical Studies, Inc

location_facility: University Medicine Berlin - Charité, CBF, Neurology

location_facility: Premiere Research Institute (Palm Beach Neurology)

location_facility: Memory Enhancement Centers of America, Inc

location_facility: University of Eastern Finland, Brain Research Unit Mediteknia

location_facility: Alzheimer's Research and Treatment Center

location_facility: Neurozentrum Achim Dr. med. Andreas Mahler

location_facility: Memory Assessment and Research Centre (MARC)

location_facility: Fondazione Universita 'G. D'Annunzio di Chieti

location_facility: Neurological Research Center - Hattiesburg Clinic

location_facility: Xenoscience, Inc / 21st Century Neurology

location_facility: Ruan Neurology Clinic and Research Center

location_facility: IRCCS San Giovanni di Dio - Fatebenefratelli

location_facility: Alzheimer Center Southwest Netherlands, Erasmus MC

location_facility: Institute for Neurodegenerative Disorders

location_facility: Alexian Brothers Neurosciences Institute

location_facility: Advanced Memory Research Institute of NJ PC

location_facility: Azienda Ospedaliera Universitaria Sant'Andrea di Roma - Unita' di Neurologia

location_facility: Neurological Associates of Albany, P. C.

location_facility: Kingshill Research Centre, Victoria Hospital

location_facility: Discipline of Psychiatry, University of Queensland

location_facility: Sussex Partnership NHS Foundation Trust, Cognitive Treatment and Research Unit

location_facility: University Hospital Brussels Department of Neurology

location_facility: University of British Columbia Hospital, Clinic for Alzheimer Disease and Related Disorders

location_facility: A.O.U. Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi


title: THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Atrial Fibrillation- Registry

summary: The primary purpose of this registry is to obtain "real world" clinical use of contact force measurements during ablation procedures.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: De Potter T, Van Herendael H, Balasubramaniam R, Wright M, Agarwal SC, Sanders P, Khaykin Y, Latcu DG, Maury P, Pani A, Hayes J, Kalman J, Nery P, Duncan E. Safety and long-term effectiveness of paroxysmal atrial fibrillation ablation with a contact force-sensing catheter: real-world experience from a prospective, multicentre observational cohort registry. Europace. 2018 Nov 1;20(FI_3):f410-f418. doi: 10.1093/europace/eux290.

lead_sponsor: Biosense Webster, Inc.

location_country:
Germany
Italy
United Kingdom
Australia
Belgium
Monaco
Canada
France

location_facility: University of Adelaide/Royal Adelaide Hospital

location_facility: Melbourne Health/Royal Melbourne Hospital

location_facility: OLV Hospital Aalst Cardiovascular Center


title: Observational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention Stage I (ILUMIEN I)

acronym: ILUMIEN I

summary: The purpose of this study is to define and evaluate optical coherence tomography (OCT) stent guidance parameters through prospective data collection in percutaneous coronary intervention (PCI) procedures of de novo lesions.

ReferenceCitation: Wijns W, Shite J, Jones MR, Lee SW, Price MJ, Fabbiocchi F, Barbato E, Akasaka T, Bezerra H, Holmes D. Optical coherence tomography imaging during percutaneous coronary intervention impacts physician decision-making: ILUMIEN I study. Eur Heart J. 2015 Dec 14;36(47):3346-55. doi: 10.1093/eurheartj/ehv367. Epub 2015 Aug 4.

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

ipd_sharing: No

lead_sponsor: Abbott Medical Devices

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

location_facility: University Hospital - Univ. of Alabama at Birmingham (UAB)

location_facility: University of Texas Medical Branch at Galveston

location_facility: Kobe University Graduate School of Medicine

intervention_type: Device


title: A Phase III Open-label, Multicenter, Pharmacokinetic, Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Previously Treated Children With Hemophilia B

summary: This study will examine the pharmacokinetics, safety and efficacy of rIX-FP for the control and prevention of bleeding episodes in children who have previously received factor replacement therapy for hemophilia B.

ReferenceCitation: Kenet G, Chambost H, Male C, Lambert T, Halimeh S, Chernova T, Mancuso ME, Curtin J, Voigt C, Li Y, Jacobs I, Santagostino E; PROLONG-9FP Investigator Study Group. Long-acting recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in children. Results of a phase 3 trial. Thromb Haemost. 2016 Sep 27;116(4):659-68. doi: 10.1160/TH16-03-0179. Epub 2016 Sep 1.

evidence: open (via page says Open Access)

license: implied-oa

license_normalized: implied-oa

publisher_dissemination: Georg Thieme

lead_sponsor: CSL Behring

location_country:
Germany
Italy
Israel
Australia
Austria
Spain
Canada
Czech Republic
Russian Federation
France

location_facility: IRCCS Ospendale Maggiore (Centro emofilia e Trombosi)

location_facility: C.R.T.H. Hopital de Bicentre (Hemophilie)

location_facility: FGU "Kirov Research Institute of Haemotology and Blood Trans)

location_facility: The Royal Children's Hospital, Melbourne

intervention_type: Biological


title: A Phase II Multicenter, Parallel-Group, Randomized, Dose-Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following 12 Weeks of Oral Administration of GSK2336805 With Pegylated Interferon and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 or 4 Hepatitis C Infection

summary:
GSK2336805 is a novel hepatitis C virus (HCV) non-structural 5A (NS5A) inhibitor being developed for the treatment of chronic HCV infection. This Phase II, multicenter, parallel-group, randomized, dose-ranging study will assess the safety and tolerability, antiviral activity, and pharmacokinetics of GSK2336805 at 2 dose levels (40 and 60 mg) in combination with pegylated interferon alfa-2a (PEG) and ribavirin (RIBA) in approximately 100 treatment-naïve subjects with chronic genotype 1 HCV infection.

In a separate nonrandomized single-arm cohort, up to 15 treatment-naïve subjects with genotype 4 chronic HCV infection will be enrolled in parallel at the dose level of 60 mg of GSK2336805.

ReferenceCitation: Protocol contains no citations

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

sponsor_collaborators: GlaxoSmithKline PPD

location_country:
Germany
Belgium
United States
Bulgaria
Puerto Rico
France


title: A Multi-center, Intra-patient Dose Escalation Phase II Study to Evaluate the Preliminary Efficacy, Safety and Pharmacokinetics of Pasireotide (SOM230) Subcutaneous (s.c.) Followed by Pasireotide LAR in Patients With Dumping Syndrome

summary: multi-center, phase II study evaluating efficacy, safety and pharmacokinetics of pasireotide in patients with dumping syndrome

location_country:
Germany
Netherlands
Belgium
United States
France

location_facility: Texas Tech University Health Science Center

location_facility: Stanford University Medical Center SC - SOM230X2203

location_facility: Ximed Center for Weight Management Ximed Research


title: A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab in Autoinjectors to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, Usability and Long-term Efficacy in Subjects With Chronic Plaque-type Psoriasis

acronym: JUNCTURE

summary: The purpose of this study was to demonstrate efficacy of autoinjector administered secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.

ReferenceCitation: Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

repositories_concat: PubMed Central;eprints.gla.ac.uk

publisher_dissemination: Springer-Nature

ReferenceCitation: Houghton K, Patil D, Gomez B, Feldman SR. Correlation Between Change in Psoriasis Area and Severity Index and Dermatology Life Quality Index in Patients with Psoriasis: Pooled Analysis from Four Phase 3 Clinical Trials of Secukinumab. Dermatol Ther (Heidelb). 2021 Aug;11(4):1373-1384. doi: 10.1007/s13555-021-00564-2. Epub 2021 Jun 10.

ReferenceCitation: Menter A, Cather JC, Jarratt M, Meng X, Guana A, Nyirady J. Efficacy of Secukinumab on Moderate-to-severe Plaque Psoriasis Affecting Different Body Regions: a Pooled Analysis of Four Phase 3 Studies. Dermatol Ther (Heidelb). 2016 Dec;6(4):639-647. doi: 10.1007/s13555-016-0140-7. Epub 2016 Aug 30.

ReferenceCitation: Kircik L, Fowler J, Weiss J, Meng X, Guana A, Nyirady J. Efficacy of Secukinumab for Moderate-to-Severe Head and Neck Psoriasis Over 52 Weeks: Pooled Analysis of Four Phase 3 Studies. Dermatol Ther (Heidelb). 2016 Dec;6(4):627-638. doi: 10.1007/s13555-016-0139-0. Epub 2016 Aug 30.

ReferenceCitation: Paul C, Lacour JP, Tedremets L, Kreutzer K, Jazayeri S, Adams S, Guindon C, You R, Papavassilis C; JUNCTURE study group. Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE). J Eur Acad Dermatol Venereol. 2015 Jun;29(6):1082-90. doi: 10.1111/jdv.12751. Epub 2014 Sep 22.

location_country:
Germany
United States
Canada
Estonia
France


title: Prospective, International, Multi-Center, Randomized Clinical Investigation of TransMedics Organ Care System (OCS LUNG) for Lung Preservation and Transplantation

acronym: INSPIRE

summary: A prospective, international, multi-center, randomized controlled trial comparing preservation of donor lungs using OCS-Lung perfusion device (Treatment Group) to cold flush and storage (Control Group).

ReferenceCitation: Warnecke G, Van Raemdonck D, Smith MA, Massard G, Kukreja J, Rea F, Loor G, De Robertis F, Nagendran J, Dhital KK, Moradiellos Diez FJ, Knosalla C, Bermudez CA, Tsui S, McCurry K, Wang IW, Deuse T, Leseche G, Thomas P, Tudorache I, Kuhn C, Avsar M, Wiegmann B, Sommer W, Neyrinck A, Schiavon M, Calabrese F, Santelmo N, Olland A, Falcoz PE, Simon AR, Varela A, Madsen JC, Hertz M, Haverich A, Ardehali A. Normothermic ex-vivo preservation with the portable Organ Care System Lung device for bilateral lung transplantation (INSPIRE): a randomised, open-label, non-inferiority, phase 3 study. Lancet Respir Med. 2018 May;6(5):357-367. doi: 10.1016/S2213-2600(18)30136-X. Epub 2018 Apr 9. Erratum In: Lancet Respir Med. 2018 Jun;6(6):e27.

ReferenceCitation: Bozso S, Freed D, Nagendran J. Successful transplantation of extended criteria lungs after prolonged ex vivo lung perfusion performed on a portable device. Transpl Int. 2015 Feb;28(2):248-50. doi: 10.1111/tri.12474. Epub 2014 Oct 27. No abstract available.

publisher_dissemination: Frontiers

lead_sponsor: TransMedics

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

location_facility: Groupe Hospitalier Hopitaux Universitaries

location_facility: University of California at San Francisco

location_facility: St. Joseph's Hospital and Medical Center


title: A Phase III, Multicentre, Randomized, Double-blind Clinical Study, Investigating the Efficacy and Safety of Repeated 12-week Courses of Daily 5mg or 10mg Doses of PGL4001 for the Long-term Management of Symptomatic Uterine Fibroids

acronym: PEARLIV

summary: Phase III, multicentre, randomized, double-blind, parallel group, long-term study investigating the efficacy and safety of the 5mg and 10mg doses of PGL4001 for the treatment of uterine myoma.

ReferenceCitation: Donnez J, Donnez O, Matule D, Ahrendt HJ, Hudecek R, Zatik J, Kasilovskiene Z, Dumitrascu MC, Fernandez H, Barlow DH, Bouchard P, Fauser BC, Bestel E, Loumaye E. Long-term medical management of uterine fibroids with ulipristal acetate. Fertil Steril. 2016 Jan;105(1):165-173.e4. doi: 10.1016/j.fertnstert.2015.09.032. Epub 2015 Oct 23.

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

ReferenceCitation: Donnez J, Hudecek R, Donnez O, Matule D, Arhendt HJ, Zatik J, Kasilovskiene Z, Dumitrascu MC, Fernandez H, Barlow DH, Bouchard P, Fauser BC, Bestel E, Terrill P, Osterloh I, Loumaye E. Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids. Fertil Steril. 2015 Feb;103(2):519-27.e3. doi: 10.1016/j.fertnstert.2014.10.038. Epub 2014 Dec 24.

lead_sponsor: PregLem SA

location_country:
Germany
Italy
Lithuania
Hungary
United Kingdom
Romania
Belgium
Latvia
Czechia
Ukraine
France

location_facility: Municipal Institution "Maternity Hospital #1" City Center of family planning

location_facility: Maternity Hospital#4 Department of Gynaecology

location_facility: Rethy Pal Korhaz és Rendelointezet Szuleszeti es Nogyogyaszati Osztaly

location_facility: CHU Bretonneau Service de Gynécologie Obstétrique

location_facility: CHU de Liège, CHR de la Citadelle Gynécologie-Obstétrique

location_facility: Centrum ambulantni gynekologie a primarni pece

location_facility: Policlinico Universitario "Agostino Gemelli"

location_facility: Hôpital Bichat, Service de Gynécologie Obstétrique

location_facility: Family Medicine Centre"Seimos Gydytojas"

location_facility: North Middlesex University Hospital NHS Trust

location_facility: Dipartimento di Ostetricia e Ginecologia, Università degli Studi di Catanzaro "Magna Graecia"

location_facility: Kharkiv City Perinatal Center Gynaecological Department #1

location_facility: Quantum Medical Center SRL Obstetrica-Ginecologie

location_facility: Medizinische Hochschule Hannover Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Women's Health, Royal Victoria Infirmary

location_facility: Fejer Megyei Szent Gyorgy Korhaz Szuleszeti es Nogyogyaszati Osztaly

location_facility: Centrul Medical EUROMED SRL, Departamentul de Obtetrica/Ginecologie

location_facility: Praxis für Frauenheilkunde, Klinische Forschung und Weiterbildung

location_facility: MRC Centre for Reproductive Health University of Edinburgh

location_facility: FN Brno Gynekologicko - porodnická klinika

location_facility: FN Olomouc, Porodnicko-Gynekologicka klinika

location_facility: Nemocnice Jihlava Gynekologicko - porodnicke oddeleni

location_facility: Cliniques Universitaires Saint-Luc Gynécologie-Obstétrique

location_facility: Spitalul Clinic Dr. I.Cantacuzino sectia Obstetrica-Ginecologie

location_facility: Fortis Medical Center SRL Obstetrica Ginecologie

location_facility: Szent Anna Szuleszeti, Nogyogyaszati es Ultrahang Maganrendelo


title: A Phase I/II Study of AZD5363 Combined With Paclitaxel in Patients With Advanced or Metastatic Breast Cancer. Comprising a Safety Run-In and a Placebo-controlled Randomised Expansion in ER+ve Patients Stratified by PIK3CA Mutation Status

acronym: BEECH

summary: The purpose of this study is to investigate the safety and efficacy of different doses and schedules of AZD5363, when in combination with paclitaxel, in treatment of patients with advanced or metastatic breast cancer. Also to investigate a selected dose and schedule of AZD5363 in combination with paclitaxel vs. paclitaxel in combination with placebo in treatment of patients with estrogen receptor-positive advanced or metastatic breast cancer, including a subgroup who have the phosphoinositide-3-kinase, catalytic, alpha polypeptide (PIK3CA) tumour mutation.

ReferenceCitation: Hrebien S, Citi V, Garcia-Murillas I, Cutts R, Fenwick K, Kozarewa I, McEwen R, Ratnayake J, Maudsley R, Carr TH, de Bruin EC, Schiavon G, Oliveira M, Turner N. Early ctDNA dynamics as a surrogate for progression-free survival in advanced breast cancer in the BEECH trial. Ann Oncol. 2019 Jun 1;30(6):945-952. doi: 10.1093/annonc/mdz085.

ReferenceCitation: Turner NC, Alarcon E, Armstrong AC, Philco M, Lopez Chuken YA, Sablin MP, Tamura K, Gomez Villanueva A, Perez-Fidalgo JA, Cheung SYA, Corcoran C, Cullberg M, Davies BR, de Bruin EC, Foxley A, Lindemann JPO, Maudsley R, Moschetta M, Outhwaite E, Pass M, Rugman P, Schiavon G, Oliveira M. BEECH: a dose-finding run-in followed by a randomised phase II study assessing the efficacy of AKT inhibitor capivasertib (AZD5363) combined with paclitaxel in patients with estrogen receptor-positive advanced or metastatic breast cancer, and in a PIK3CA mutant sub-population. Ann Oncol. 2019 May 1;30(5):774-780. doi: 10.1093/annonc/mdz086.

repository_institution: Consorci de Serveis Universitaris de Catalunya - RECERCAT

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared

lead_sponsor: AstraZeneca

location_country:
United Kingdom
Singapore
Japan
Mexico
Korea, Republic of
Spain
Czechia
Bulgaria
Canada
Peru
France


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy

acronym: ODYSSEY FH I

summary:
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo.

Secondary Objectives:

To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points
To evaluate the effects of alirocumab on other lipid parameters
To evaluate the safety and tolerability of alirocumab

ReferenceCitation: Kastelein JJ, Robinson JG, Farnier M, Krempf M, Langslet G, Lorenzato C, Gipe DA, Baccara-Dinet MT. Efficacy and safety of alirocumab in patients with heterozygous familial hypercholesterolemia not adequately controlled with current lipid-lowering therapy: design and rationale of the ODYSSEY FH studies. Cardiovasc Drugs Ther. 2014 Jun;28(3):281-9. doi: 10.1007/s10557-014-6523-z.

ReferenceCitation: Kastelein JJ, Ginsberg HN, Langslet G, Hovingh GK, Ceska R, Dufour R, Blom D, Civeira F, Krempf M, Lorenzato C, Zhao J, Pordy R, Baccara-Dinet MT, Gipe DA, Geiger MJ, Farnier M. ODYSSEY FH I and FH II: 78 week results with alirocumab treatment in 735 patients with heterozygous familial hypercholesterolaemia. Eur Heart J. 2015 Nov 14;36(43):2996-3003. doi: 10.1093/eurheartj/ehv370. Epub 2015 Sep 1.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

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

repository_normalized: dnet

repositories:
HAL
PubMed Central
dnet

repositories_concat: HAL;PubMed Central;dnet

repositories_pmh: HAL dnet europepmc.org

ReferenceCitation: Mahmood T, Minnier J, Ito MK, Li QH, Koren A, Kam IW, Fazio S, Shapiro MD. Discordant responses of plasma low-density lipoprotein cholesterol and lipoprotein(a) to alirocumab: A pooled analysis from 10 ODYSSEY Phase 3 studies. Eur J Prev Cardiol. 2021 Jul 23;28(8):816-822. doi: 10.1177/2047487320915803. Epub 2020 Apr 10.

ReferenceCitation: Leiter LA, Tinahones FJ, Karalis DG, Bujas-Bobanovic M, Letierce A, Mandel J, Samuel R, Jones PH. Alirocumab safety in people with and without diabetes mellitus: pooled data from 14 ODYSSEY trials. Diabet Med. 2018 Dec;35(12):1742-1751. doi: 10.1111/dme.13817. Epub 2018 Oct 9.

ReferenceCitation: Defesche JC, Stefanutti C, Langslet G, Hopkins PN, Seiz W, Baccara-Dinet MT, Hamon SC, Banerjee P, Kastelein JJP. Efficacy of alirocumab in 1191 patients with a wide spectrum of mutations in genes causative for familial hypercholesterolemia. J Clin Lipidol. 2017 Nov-Dec;11(6):1338-1346.e7. doi: 10.1016/j.jacl.2017.08.016. Epub 2017 Sep 4. Erratum In: J Clin Lipidol. 2020 Sep - Oct;14(5):742.

repository_institution: INFN Catania - INFM-OAR

ReferenceCitation: Kastelein JJ, Hovingh GK, Langslet G, Baccara-Dinet MT, Gipe DA, Chaudhari U, Zhao J, Minini P, Farnier M. Efficacy and safety of the proprotein convertase subtilisin/kexin type 9 monoclonal antibody alirocumab vs placebo in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2017 Jan-Feb;11(1):195-203.e4. doi: 10.1016/j.jacl.2016.12.004. Epub 2016 Dec 28.

ReferenceCitation: Ray KK, Ginsberg HN, Davidson MH, Pordy R, Bessac L, Minini P, Eckel RH, Cannon CP. Reductions in Atherogenic Lipids and Major Cardiovascular Events: A Pooled Analysis of 10 ODYSSEY Trials Comparing Alirocumab With Control. Circulation. 2016 Dec 13;134(24):1931-1943. doi: 10.1161/CIRCULATIONAHA.116.024604. Epub 2016 Oct 24.

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

location_country:
France
Israel
Norway
Denmark
United Kingdom
Sweden
Netherlands
Austria
United States
Spain
South Africa
Canada
Russian Federation
Czech Republic

location_facility:
Investigational Site Number 643413
Investigational Site Number 040402
Investigational Site Number 250403
Investigational Site Number 840401
Investigational Site Number 840410
Investigational Site Number 710402
Investigational Site Number 840417
Investigational Site Number 376405
Investigational Site Number 724401
Investigational Site Number 752404
Investigational Site Number 528402
Investigational Site Number 376404
Investigational Site Number 578401
Investigational Site Number 840426
Investigational Site Number 840409
Investigational Site Number 840406
Investigational Site Number 826405
Investigational Site Number 376402
Investigational Site Number 124407
Investigational Site Number 840429
Investigational Site Number 840428
Investigational Site Number 840452
Investigational Site Number 840424
Investigational Site Number 840404
Investigational Site Number 840461
Investigational Site Number 203401
Investigational Site Number 643402
Investigational Site Number 724404
Investigational Site Number 124404
Investigational Site Number 208401
Investigational Site Number 840456
Investigational Site Number 710405
Investigational Site Number 040403
Investigational Site Number 724402
Investigational Site Number 724408
Investigational Site Number 710406
Investigational Site Number 826408
Investigational Site Number 376401
Investigational Site Number 124401
Investigational Site Number 528406
Investigational Site Number 840408
Investigational Site Number 752401
Investigational Site Number 826403
Investigational Site Number 710401
Investigational Site Number 643407
Investigational Site Number 250402
Investigational Site Number 643412
Investigational Site Number 250401
Investigational Site Number 840415
Investigational Site Number 528409
Investigational Site Number 840419
Investigational Site Number 724403
Investigational Site Number 724406
Investigational Site Number 528411
Investigational Site Number 203403
Investigational Site Number 724407
Investigational Site Number 643408
Investigational Site Number 710407
Investigational Site Number 840421
Investigational Site Number 724409
Investigational Site Number 643409
Investigational Site Number 124406
Investigational Site Number 826409
Investigational Site Number 840430
Investigational Site Number 840407
Investigational Site Number 040405
Investigational Site Number 643410
Investigational Site Number 710408
Investigational Site Number 840418
Investigational Site Number 840422
Investigational Site Number 840460
Investigational Site Number 710409
Investigational Site Number 840455
Investigational Site Number 528416
Investigational Site Number 826402
Investigational Site Number 840425
Investigational Site Number 203402
Investigational Site Number 840412
Investigational Site Number 643404
Investigational Site Number 724405
Investigational Site Number 643406
Investigational Site Number 840411
Investigational Site Number 203405
Investigational Site Number 528412
Investigational Site Number 710403
Investigational Site Number 124403
Investigational Site Number 710404
Investigational Site Number 528408
Investigational Site Number 643401
Investigational Site Number 208403
Investigational Site Number 528410


title: A Phase 3, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Crossover Study With an Open-Label Period to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Who Have a Non-G551D CFTR Gating Mutation

acronym: KONNECTION

summary: The purpose of this study is to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis (CF) who have a non-G551D cystic fibrosis transmembrane regulator (CFTR) gating mutation (any one of the following CFTR mutations: G178R, G551S, S549N, S549R, G970R, G1244E, S1251N, S1255P, or G1349D).

lead_sponsor: Vertex Pharmaceuticals Incorporated

sponsor_collaborators:
Vertex Pharmaceuticals Incorporated
Cystic Fibrosis Foundation

location_country:
United States
Belgium
France


title: Prospective, Open-label, Non-randomized, Single-arm, Multi-center Dose Titration Study to Investigate the Safety and Efficacy of NT 201 in Subjects Deemed to Require Total Body Doses of 800 U of NT 201 During the Course of the Study for the Treatment of Upper and Lower Limb Spasticity of the Same Body Side Due to Cerebral Causes

summary: The purpose of this study is to determine whether injections with increasing doses (up to 800 units) of Botulinum toxin type A into muscles of the leg and/or arm are safe and effective in treating patients with spasticity on one body side due to cerebral causes.

ReferenceCitation: Wissel J, Bensmail D, Ferreira JJ, Molteni F, Satkunam L, Moraleda S, Rekand T, McGuire J, Scheschonka A, Flatau-Baque B, Simon O, Rochford ET, Dressler D, Simpson DM; TOWER study investigators. Safety and efficacy of incobotulinumtoxinA doses up to 800 U in limb spasticity: The TOWER study. Neurology. 2017 Apr 4;88(14):1321-1328. doi: 10.1212/WNL.0000000000003789. Epub 2017 Mar 10.

ReferenceCitation: Fheodoroff K, Scheschonka A, Wissel J. Goal analysis in patients with limb spasticity treated with incobotulinumtoxinA in the TOWER study. Disabil Rehabil. 2022 Apr;44(8):1367-1373. doi: 10.1080/09638288.2020.1804627. Epub 2020 Aug 17.

oa_host_type: repository

repository_institution: University of Illinois at Chicago - INDIGO

unpaywall_oa_status: green

publisher_dissemination: Informa

ReferenceCitation: Fheodoroff K, Rekand T, Medeiros L, Kossmehl P, Wissel J, Bensmail D, Scheschonka A, Flatau-Baque B, Simon O, Dressler D, Simpson DM. Quality of life in subjects with upper- and lower-limb spasticity treated with incobotulinumtoxinA. Health Qual Life Outcomes. 2020 Mar 4;18(1):51. doi: 10.1186/s12955-020-01304-4.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repositories:
HAL
PubMed Central
repositorio.chlc.min-saude.pt

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

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

lead_sponsor: Merz Pharmaceuticals GmbH

location_country:
Germany
Italy
Portugal
Norway
United States
Spain
Canada
France

location_facility:
Merz Investigational Site # 001235
Merz Investigational Site # 039017
Merz Investigational Site #049296
Merz Investigational Site # 001232
Merz Investigational Site #049298
Merz Investigational Site # 001191
Merz Investigational Site # 351001
Merz Investigational Site #049191
Merz Investigational Site #049297
Merz Investigational Site #034024
Merz Investigational Site #049300
Merz Investigational Site #034025
Merz Investigational Site #034022
Merz Investigational Site # 001203
Merz Investigational site #001195
Merz Investigational Site # 039010
Merz Investigational Site #047001
Merz Investigational Site #033049
Merz Investigational Site # 351003
Merz Investigational Site #039016
Merz Investigational Site #039013
Merz Investigational Site #049295
Merz Investigational Site # 033018
Merz Investigational Site #001237
Merz Investigational Site #049022
Merz Investigational Site # 039005
Merz Investigational Site #001238
Merz Investigational Site # 039015
Merz Investigational Site # 049153
Merz Investigational Site # 001197
Merz Investigational Site # 033050
Merz Investigational Site #039014
Merz Investigational Site #034007


summary: This study is divided into two parts; Part 1 of the study is a dose escalation phase to select the recommended dose for Part 2 based on the safety, pharmacokinetic, and pharmacodynamic profiles observed after oral administration of GSK525762 in the following subjects: NMC, small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), neuroblastoma (NB), castration resistant prostate cancer (CRPC), triple negative breast cancer (TNBC), estrogen receptor positive (ER positive) breast cancer, and MYCN driven solid tumor subjects. Part 2 of the study will explore the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of the recommended dose from Part 1 in cohorts comprised of NMC, small cell lung cancer (SCLC), castration resistant prostate cancer (CRPC), triple negative breast cancer (TNBC), and estrogen receptor positive (ER positive) breast cancer subjects. Approximately 60 subjects will be enrolled in the Part 1 and approximately 150 subjects will be enrolled in Part 2. A sub-study will be opened in Part 1 to approximately 10-12 subjects in the United States to investigate the relative bioavailability of the besylate tablet compared to the amorphous free-base tablet at the maximum tolerated dose (MTD) or recommended phase 2 dosing (RP2D), the effect of high-fat high-calorie meal on the bioavailability of the besylate tablet at the MTD or RP2D and the dose proportionality of 2 doses of GSK525762 administered as besylate tablet.

ReferenceCitation: Piha-Paul SA, Hann CL, French CA, Cousin S, Brana I, Cassier PA, Moreno V, de Bono JS, Harward SD, Ferron-Brady G, Barbash O, Wyce A, Wu Y, Horner T, Annan M, Parr NJ, Prinjha RK, Carpenter CL, Hilton J, Hong DS, Haas NB, Markowski MC, Dhar A, O'Dwyer PJ, Shapiro GI. Phase 1 Study of Molibresib (GSK525762), a Bromodomain and Extra-Terminal Domain Protein Inhibitor, in NUT Carcinoma and Other Solid Tumors. JNCI Cancer Spectr. 2019 Nov 6;4(2):pkz093. doi: 10.1093/jncics/pkz093. eCollection 2020 Apr.

ReferenceCitation: Cousin S, Blay JY, Garcia IB, de Bono JS, Le Tourneau C, Moreno V, Trigo J, Hann CL, Azad AA, Im SA, Cassier PA, French CA, Italiano A, Keedy VL, Plummer R, Sablin MP, Hemming ML, Ferron-Brady G, Wyce A, Khaled A, Datta A, Foley SW, McCabe MT, Wu Y, Horner T, Kremer BE, Dhar A, O'Dwyer PJ, Shapiro GI, Piha-Paul SA. Safety, pharmacokinetic, pharmacodynamic and clinical activity of molibresib for the treatment of nuclear protein in testis carcinoma and other cancers: Results of a Phase I/II open-label, dose escalation study. Int J Cancer. 2022 Mar 15;150(6):993-1006. doi: 10.1002/ijc.33861. Epub 2021 Nov 26.

repository_institution: University of Melbourne - Minerva Access

ReferenceCitation: Krishnatry AS, Voelkner A, Dhar A, Prohn M, Ferron-Brady G. Population pharmacokinetic modeling of molibresib and its active metabolites in patients with solid tumors: A semimechanistic autoinduction model. CPT Pharmacometrics Syst Pharmacol. 2021 Jul;10(7):709-722. doi: 10.1002/psp4.12639. Epub 2021 Jun 4.

license: cc-by-nd

license_normalized: cc-by-nd

ReferenceCitation: Parikh SA, French CA, Costello BA, Marks RS, Dronca RS, Nerby CL, Roden AC, Peddareddigari VG, Hilton J, Shapiro GI, Molina JR. NUT midline carcinoma: an aggressive intrathoracic neoplasm. J Thorac Oncol. 2013 Oct;8(10):1335-8. doi: 10.1097/JTO.0b013e3182a00f41.

license: publisher-specific-oa

license_normalized: publisher-specific

title: A Phase I/II Open-Label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects With NUT Midline Carcinoma (NMC) and Other Cancers

location_country:
United Kingdom
Australia
Netherlands
United States
Korea, Republic of
Spain
France


lead_sponsor: Sanofi

summary:
Primary Objective:

The purpose of this study was to determine the long term safety and tolerability of SAR245408 and SAR245409 as a monotherapy or as part of a combination regimen in participants who were benefiting from treatment.

location_facility:
Investigational Site Number 250004
Investigational Site Number 840009
Investigational Site Number 840004
Investigational Site Number 840002
Investigational Site Number 840104
Investigational Site Number 840022
Investigational Site Number 840007
Investigational Site Number 250005
Investigational Site Number 840003
Investigational Site Number 724001
Investigational Site Number 840006
Investigational Site Number 840015
Investigational Site Number 840017
Investigational Site Number 840018
Investigational Site Number 840020
Investigational Site Number 840010
Investigational Site Number 840008
Investigational Site Number 250003
Investigational Site Number 840021
Investigational Site Number 840005
Investigational Site Number 056001

title: International, Multicenter, Open-label, Treatment-extension Study for Subjects Who Completed a Phase 1 or Phase 2 Parental Study to Continue Receiving Treatment With SAR245408 or SAR245409 as a Monotherapy or as a Combination Regimen

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

location_country:
United States
Spain
Belgium
France


title: A Phase II, Open-Label, Randomized Study of MEDH7945A Versus Cetuximab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck Who Have Progressed During or Following Platinum-based Chemotherapy

summary: This phase II, open-label, randomized study will evaluate the efficacy and safety of MEHD7945A versus cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck who have progressed during or following platinum-based chemotherapy. Patients will be randomized to receive either MEHD7945A 1100 mg intravenously (iv) every 2 weeks or cetuximab 400 mg/m2 iv loading dose followed by 250 mg/m2 iv weekly. Patients treated with cetuximab (Arm B) may cross-over to MEHD7945A (Arm A) upon central confirmation of progressive disease and upon meeting eligibility criteria. Anticipated time on study treatment is until disease progression or intolerable toxicity occurs.

lead_sponsor: Genentech, Inc.

location_country:
Germany
Italy
Hungary
United Kingdom
Romania
Australia
Belgium
United States
Spain
Bulgaria
France


acronym: GIOP

lead_sponsor: Amgen

summary: This is a 2-year study to evaluate the effect of denosumab versus risedronate in adults with glucocorticoid-induced osteoporosis.

ReferenceCitation: Saag KG, Wagman RB, Geusens P, Adachi JD, Messina OD, Emkey R, Chapurlat R, Wang A, Pannacciulli N, Lems WF. Denosumab versus risedronate in glucocorticoid-induced osteoporosis: a multicentre, randomised, double-blind, active-controlled, double-dummy, non-inferiority study. Lancet Diabetes Endocrinol. 2018 Jun;6(6):445-454. doi: 10.1016/S2213-8587(18)30075-5. Epub 2018 Apr 6.

ReferenceCitation: Saag KG, Pannacciulli N, Geusens P, Adachi JD, Messina OD, Morales-Torres J, Emkey R, Butler PW, Yin X, Lems WF. Denosumab Versus Risedronate in Glucocorticoid-Induced Osteoporosis: Final Results of a Twenty-Four-Month Randomized, Double-Blind, Double-Dummy Trial. Arthritis Rheumatol. 2019 Jul;71(7):1174-1184. doi: 10.1002/art.40874. Epub 2019 May 25.

title: A Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals

location_country:
Germany
Poland
Colombia
Hungary
Argentina
Denmark
Netherlands
Mexico
Belgium
United States
Korea, Republic of
Spain
Czechia
Canada
Russian Federation
France


title: A Multi-center, Open Label, Flexible Dose, Extension Study of Lurasidone Adjunctive to Lithium or Divalproex in Subjects With Bipolar I Disorder

acronym: PERSISTExt

summary: This is an open-label, multi-center,12 week extension study designed to evaluate the longer term safety, tolerability and effectiveness of lurasidone, flexibly dosed, adjunctive to lithium or divalproex for the treatment of subjects with bipolar I disorder, who have either completed the core study D1050296 or experienced a protocol defined recurrence of a mood event in the double-blind phase of the core study D1050296

lead_sponsor: Sumitomo Pharma America, Inc.

location_country:
France
Poland
Slovakia
Hungary
Argentina
Japan
United States
Chile
Bulgaria
Serbia
Russian Federation
Czech Republic

location_facility: Clinical Centre Kragujevac, Psychiatric Hospital

location_facility: Instituto Nacional de Psicopatología (INAPSI)

location_facility: Mental Health Research Institute of Siberian Branch of RAMS

location_facility: Psychiatricke oddelenie, Vseobecna nemocnica Rimavska Sobota NaP n.o.

location_facility: Kutvolgyi Klinikai Tomb SOTE IIIsz Belgyogyaszati Klinika

location_facility: Clinica Privada de Salud Mental Santa Teresa de Avila

location_facility: Centre Hospitalier Spécialisé du Jura - Centre Médico Psychiatrique

location_facility: Clinic for Mental Health Protection, Clinical Centre Nis

location_facility: Nizhny Novgorod Regional State Institution of Healthcare

location_facility: Centre Hospitalier Régional Universitaire

location_facility: NZOZ Prywatna Klinika Psychiatryczna Inventiva

location_facility: Neuropsychiatric Research Center of Orange County

location_facility: State Healthcare and Forensic Psychiatric Expertise Institution

location_facility: Centro de Investigacion y Asistencia en Psiquiatria (CIAP)

location_facility: St. Petersburg State Healthcare Institution "City Clinical Hospital #4"

location_facility: Specialized Hospital for Psychiatric Diseased "Sveti Vracevi"

location_facility: Multiprofiled Hospital for Active Treatment "Alexandrovska"

location_facility: Stanford University School of Medicine Research Program VA Palo Alto Health Care System

location_facility: St Petersburg State Government Healthcare Institution

location_facility: Saint Petersburg State Healthcare Institution "City psycho-neurology Dispanser #7"

location_facility: Psychoneuroendocrinology Research Group, Dept of Psychiatry, UT Southwestern Medical Center

location_facility: Saint Anne, s.r.o., Psychiatricke oddeleni

location_facility: Fundacion para el estudio y tratamiento de las enfermedades mentales (FETEM)

location_facility: Clinical Hospital Centre Dragisa Misovic


title: A 2-Week, Randomized, Placebo-Controlled, Fixed Dose Period Followed by a 6-Month, Single-Arm, Open-Label, Dose Titration Period Study to Investigate the Efficacy and Safety of Sevelamer Carbonate in Hyperphosphatemic Pediatric Patients With Chronic Kidney Disease

summary:
Objective: In hyperphosphatemic pediatric participants with chronic kidney disease (CKD) to

Evaluate the safety and tolerability of sevelamer carbonate
Evaluate the efficacy of sevelamer carbonate on the control of serum phosphorus

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Germany
Lithuania
Poland
United States
France

location_facility:
Investigational Site Number 8023
Investigational Site Number 8025
Investigational Site Number 8302
Investigational Site Number 8007
Investigational Site Number 8019
Investigational Site Number 8202
Investigational Site Number 8026
Investigational Site Number 8201
Investigational Site Number 8018
Investigational Site Number 8008
Investigational Site Number 8009
Investigational Site Number 8006
Investigational Site Number 8016
Investigational Site Number 8001
Investigational Site Number 8002
Investigational Site Number 8101
Investigational Site Number 8103
Investigational Site Number 8005
Investigational Site Number 8020
Investigational Site Number 8022
Investigational Site Number 8012
Investigational Site Number 8013
Investigational Site Number 8401
Investigational Site Number 8014
Investigational Site Number 8017
Investigational Site Number 8011
Investigational Site Number 8003
Investigational Site Number 8010
Investigational Site Number 8301
Investigational Site Number 8102
Investigational Site Number 8027
Investigational Site Number 8402


title: A Multi-centre, Randomised, Double-blind, Parallel Groups, Placebocontrolled Trial on Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Treatment of Bleeding in Patients Following Stem Cell Transplantation (SCT)

summary: This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate the efficacy of placebo and activated recombinant human factor VII in patients having undergone allogeneic or autologous stem cell transplantation.

ReferenceCitation: Pihusch M, Bacigalupo A, Szer J, von Depka Prondzinski M, Gaspar-Blaudschun B, Hyveled L, Brenner B; F7BMT-1360 Trial Investigators. Recombinant activated factor VII in treatment of bleeding complications following hematopoietic stem cell transplantation. J Thromb Haemost. 2005 Sep;3(9):1935-44. doi: 10.1111/j.1538-7836.2005.01523.x.

lead_sponsor: Novo Nordisk A/S

location_country:
Finland
Germany
Italy
Poland
Israel
Singapore
Denmark
Australia
Sweden
Switzerland
Austria
United Kingdom
United States
Spain
Thailand
France

intervention_type: Procedure


title: A Phase 2, Proof-Of-Concept, Multicenter, Randomized, Double-Blind, Placebo- Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Pomalidomide (CC-4047) in Subjects With Systemic Sclerosis With Interstitial Lung Disease

summary: The primary objective of this study is to evaluate the safety, tolerability, and efficacy of pomalidomide in the treatment of patients with systemic sclerosis with interstitial lung disease.

ReferenceCitation: Hsu VM, Denton CP, Domsic RT, Furst DE, Rischmueller M, Stanislav M, Steen VD, Distler JHW, Korish S, Cooper A, Choi S, Schafer PH, Horan G, Hough DR. Pomalidomide in Patients with Interstitial Lung Disease due to Systemic Sclerosis: A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study. J Rheumatol. 2018 Mar;45(3):405-410. doi: 10.3899/jrheum.161040. Epub 2017 Nov 1.

ReferenceCitation: Hsu V, et al. A Phase 2 Study of Pomalidomide (CC-4047) to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effectiveness in Subjects with Systemic Sclerosis with Interstitial Lung Disease. Presented at the 2016 ACR/ARHP Annual Meeting, November 11-16, 2016, Washington, DC. Abstract No. 823.

lead_sponsor: Celgene

location_country:
Germany
Italy
Poland
United Kingdom
Australia
Switzerland
United States
Spain
Russian Federation
France

location_facility: SPSK Nr 7 Slaskiego Uniwersytetu Medycznego, Oddzial Chorob Wewnetrznych i Reumatologii

location_facility: LaPorte County Institute for Clinical Research, Inc

location_facility: Royal Brompton Hospital - Interstitial Lung Disease Unit

location_facility: University of Toledo College of Medicine

location_facility: Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Penza Regional Clinical Hospital n.a. N.N. Burdenko

location_facility: North Shore-LIJ Health System-Division of Rheumatology

location_facility: Azienda Ospedaliera Universitaria S. Martino di Genova

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Centrum Miriada Prywatny Gabinet Specjalistyczny Profesora Dra Stanislawa Sierakowskiego

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 im. prof.Tadeusza Sokolowskiego Pomorskiego UM w Szczec

location_facility: Groupe Hospitalier Saint Vincent de Paul

location_facility: Klinikum der J.W. Gothe-Universitat Frankfurt

location_facility: Instytut Reumatologii, Klinika i Poliklinika Ukladowych Chorób Tkanki Lacznej

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Institution of the Russian Academy of Medical Sciences Research Institute of Rheumatology of the Ru

location_facility: University of Texas Health Science Center at Houston

location_facility: Akademicki Szpital Kliniczny Klinika Reumatologii i Chorob Wewnetrznych

location_facility: St. Petersburg State Healthcare Institution "Clinical Rheumatology Hospital # 25"

location_facility: UMDNJ-Robert Wood Johnson Medical School Clinical Research Center

location_facility: Georgetown University School of Medicine


lead_sponsor: PTC Therapeutics

summary: Duchenne/Becker muscular dystrophy (DBMD) is a genetic disorder that develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is important for maintaining normal muscle structure and function. Loss of dystrophin causes muscle fragility that leads to weakness and loss of walking ability during childhood and teenage years. A specific type of mutation, called a nonsense (premature stop codon) mutation, is the cause of DBMD in approximately 10-15% of boys with the disease. Ataluren is an orally delivered, investigational drug that has the potential to overcome the effects of the nonsense mutation. This study comprises a Phase 3, open-label study of ataluren in participants with nmDBMD who previously received ataluren at an Investigator site in a prior PTC-sponsored clinical study. A separate open-label study (PTC124-GD-016-DMD; NCT01247207) is being conducted for nmDBMD participants who previously received ataluren at an Investigator site in the United States (US).

ReferenceCitation: Welch EM, Barton ER, Zhuo J, Tomizawa Y, Friesen WJ, Trifillis P, Paushkin S, Patel M, Trotta CR, Hwang S, Wilde RG, Karp G, Takasugi J, Chen G, Jones S, Ren H, Moon YC, Corson D, Turpoff AA, Campbell JA, Conn MM, Khan A, Almstead NG, Hedrick J, Mollin A, Risher N, Weetall M, Yeh S, Branstrom AA, Colacino JM, Babiak J, Ju WD, Hirawat S, Northcutt VJ, Miller LL, Spatrick P, He F, Kawana M, Feng H, Jacobson A, Peltz SW, Sweeney HL. PTC124 targets genetic disorders caused by nonsense mutations. Nature. 2007 May 3;447(7140):87-91. doi: 10.1038/nature05756. Epub 2007 Apr 22.

ReferenceCitation: Hirawat S, Welch EM, Elfring GL, Northcutt VJ, Paushkin S, Hwang S, Leonard EM, Almstead NG, Ju W, Peltz SW, Miller LL. Safety, tolerability, and pharmacokinetics of PTC124, a nonaminoglycoside nonsense mutation suppressor, following single- and multiple-dose administration to healthy male and female adult volunteers. J Clin Pharmacol. 2007 Apr;47(4):430-44. doi: 10.1177/0091270006297140.

ReferenceCitation: McDonald CM, Muntoni F, Penematsa V, Jiang J, Kristensen A, Bibbiani F, Goodwin E, Gordish-Dressman H, Morgenroth L, Werner C, Li J, Able R, Trifillis P, Tulinius M; Study 019 investigators. Ataluren delays loss of ambulation and respiratory decline in nonsense mutation Duchenne muscular dystrophy patients. J Comp Eff Res. 2022 Feb;11(3):139-155. doi: 10.2217/cer-2021-0196. Epub 2021 Nov 18.

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: California Digital Library - eScholarship

repositories:
PubMed Central
UCL Discovery
escholarship.org

publisher_dissemination: Becaris Publishing Limited

location_facility: University of Newcastle Institute of Human Genetics

location_facility: Institute For Neuromuscular Research, The Children's Hospital at Westmead

location_facility: University of Essen - Clinic for Children

location_facility: U.O. Complessa di Neuropsichiatria Infantile

location_facility: Hadassah Medical Center, Hebrew University Hospital

title: An Open-Label Study for Previously Treated Ataluren (PTC124®) Patients With Nonsense Mutation Dystrophinopathy

location_country:
Germany
Italy
Israel
United Kingdom
Australia
Sweden
Belgium
Spain
Canada
France


lead_sponsor: Pfizer

summary: The objective of the study is to find out if the medicine fesoterodine is a useful treatment in children with bladder muscle overactivity caused by a neurological condition. Children will be aged 6 to 17 years old. This is done by finding out how well it works, what the body does to fesoterodine, what side effects are experienced and the safety of fesoterodine. It will be compared with the medicine oxybutynin, which is already available for treating the condition.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Ankara Universitesi Tip Fakultesi Ibni Sina Hastanesi

location_facility: Children's Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas klinikos

location_facility: I.R.C.C.S. - Ospedale "Casa Sollievo della Sofferenza" - Dipartimento Scienze Chirurgiche

location_facility: Children's Republican Clinical Hospital, Department of Pediatric Surgery

location_facility: Sheffield Children's NHS Foundation Trust

location_facility: Hôpital Universitaire des Enfants Reine Fabiola

location_facility: Centre hospitalier universitaire (CHU) Sainte-Justine

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval

location_facility: Klinika Chorob Nerek i Nadcisnienia Dzieci i Mlodziezy

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Azienda Ospedaliera G. Brotzu, Dipartimento di Medicina interna-

location_facility: Hospital Infantil Universitario Niño Jesus

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Specjalistyczny Gabinet Lekarski Paweł Kroll

location_facility: Hyogo prefectural Kobe Children's Hospital

location_facility: Pusan National University Yangsan Hospital

location_facility: Department of Pediatrics, Christian Medical College and Hospital

location_facility: Dokkyo Medical University Koshigaya Hospital

location_facility: ULSS 6 VICENZA - Ospedale San Bortolo di Vicenza

location_facility: FGBNU Scientific center of children health

location_facility: Dokkyo Medical University Hospital / Urology

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: The University of Tokyo Hospital / Urology

location_facility: SSS - Research Clinical Institute of Pediatrics n.a. Academician Y.E.Veltishchev GBOU VPO

location_facility: Universitair Ziekenhuis Antwerpen, Urologie

location_facility: Urological Associates of Southern Arizona

location_facility: Scientific Research Institute of Urology named after N.A.Lopatkin of the Hertsen Federal Medical

location_facility: Groupement Hospitalier Est - Hopital Femme Mere Enfant

location_facility: Aichi Children's Health and Medical Center

location_facility: Osaka Medical Center and Research Institute for Maternal and Child Health

location_facility: University General Hospital of Larisa/ Urology Department

location_facility: Hacettepe Universitesi Tip Fakultesi Uroloji Anabilim Dali

title: A 24-WEEK RANDOMIZED, OPEN-LABEL, STUDY TO EVALUATE THE SAFETY AND EFFICACY OF FESOTERODINE IN SUBJECTS AGED 6 TO 17 YEARS WITH SYMPTOMS OF DETRUSOR OVERACTIVITY ASSOCIATED WITH A NEUROLOGICAL CONDITION (NEUROGENIC DETRUSOR OVERACTIVITY)

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:
Finland
Germany
Poland
Japan
Turkey
Canada
France
Lithuania
Slovakia
Switzerland
United States
India
Belgium
Malaysia
Estonia
Philippines
Italy
United Kingdom
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation
Sweden


title: Aneurysm Study of Pipeline in an Observational Registry

acronym: ASPIRE

summary: The primary objective of this study is to further expand the body of clinical knowledge in patients undergoing Pipeline Embolization Device (Pipeline or PED) placement for intracranial aneurysms (IAs or ICAs) according to Pipeline's labeled indication.

lead_sponsor: Medtronic Neurovascular Clinical Affairs

location_country:
Germany
Italy
Argentina
Switzerland
Belgium
United States
Canada
France

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Neurosurgical Associates at Central Baptist

location_facility: The Ohio State University Wexner Medical Center

location_facility: University of Buffalo Neurosurgery, Buffalo General Hospital

location_facility: Medical College Of Wisconsin/Froedtert Hospital

location_facility: Radiology Imaging Associates / Colorado Neurological Institute

location_facility: University of Wisconsin Hospital and Clinics

location_facility: The State University of New York, Stony Brook

location_facility: Abbott Northwestern Hospital/Consulting Radiologists

location_facility: Ospedale San Giovanni Bosco ASL Napoli 1 Centro


title: A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Determine the Effect of 12 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5/5 µg and 5/5 µg) Delivered by the Respimat® Inhaler, on Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease (COPD)[Torracto (TM)]

summary: The primary objective of this study is to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5/5 µg; 5/5 µg) with placebo on exercise tolerance after 12 weeks of treatment in patients with COPD.

ReferenceCitation: Maltais F, O'Donnell D, Galdiz Iturri JB, Kirsten AM, Singh D, Hamilton A, Tetzlaff K, Zhao Y, Casaburi R. Effect of 12 weeks of once-daily tiotropium/olodaterol on exercise endurance during constant work-rate cycling and endurance shuttle walking in chronic obstructive pulmonary disease. Ther Adv Respir Dis. 2018 Jan-Dec;12:1753465818755091. doi: 10.1177/1753465818755091.

repository_institution: PubMed Central - Europe PMC

repository_institution: University of California - eScholarship University of California

repositories_concat: PubMed Central;escholarship.org

publisher_dissemination: SAGE Publications

lead_sponsor: Boehringer Ingelheim

location_country:
Finland
Germany
Italy
Hungary
Argentina
United Kingdom
United States
Spain
Canada
France

location_facility: 1237.15.01503 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01504 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01506 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.54502 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.35853 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.33504 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.49507 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.33501 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.34506 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.34001 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01508 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01514 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.39506 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.54501 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.39512 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.39511 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.44155 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01516 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.49508 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.39509 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.44151 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.34501 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.35851 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.39504 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01511 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.11504 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.44154 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01502 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.54503 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.11505 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.34009 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.44153 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01510 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.11501 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.36502 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01509 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01501 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.49501 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.49506 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.36504 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01513 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.36503 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.39508 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.34507 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01512 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.35852 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.39501 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.49509 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.33502 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.49504 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.36501 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.49502 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.49505 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.11503 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01505 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.11502 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.39503 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.44158 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.01507 Boehringer Ingelheim Investigational Site

location_facility: 1237.15.44152 Boehringer Ingelheim Investigational Site


title: A Phase I, Open Label, Parallel Group, Pharmacokinetic Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function

summary: This open-label, parallel group study will evaluate the pharmacokinetics and safety of trastuzumab emtansine in patients with HER2-positive metastatic breast cancer and normal or reduced hepatic function. Patients will receive trastuzumab emtansine intravenously on Day 1 of each 3-week cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
United States
Spain
Canada
France


title: A Multicenter, Single-arm Trial Evaluating the Safety and Efficacy of DEB025/Alisporivir in Combination With Pegylated Interferon-α2a and Ribavirin (Peg-IFNα2a/RBV) in Protease Inhibitor Treatment Failure Patients With Chronic Hepatitis C Genotype 1

summary: This study is to evaluate the overall efficacy, and safety profile of the triple combination therapy of alisporivir (ALV; DEB025) plus peginterferon alfa-2a (PEG) and ribavirin (RBV) patients with chronic hepatitis C (HCV) genotype 1 who failed prior treatment with a protease inhibitor (PI).

lead_sponsor: Debiopharm International SA

location_country:
Germany
Italy
United Kingdom
United States
Spain
Canada
Puerto Rico
France

location_facility:
Novartis Investigational Site
Novartis Investigative Site
Novartis Investigational site


title: A Phase 3, Open-label, Multicentre Study to Provide Access to Guanfacine Hydrochloride Extended-release for European Subjects With Attention-deficit/Hyperactivity Disorder (ADHD) Who Participated in Study SPD503-315 or SPD503-316

summary: For subjects in Europe that have already participated in either Study SPD503-315 or SPD503-316. This is an extension study that will allow participants access to Extended-release Guanfacine Hydrochloride (HCl) for up to 2 years. This study will help the sponsor evaluate long-term safety and tolerability of Extended-release Guanfacine HCl (SPD503).

ReferenceCitation: Huss M, Dirks B, Gu J, Robertson B, Newcorn JH, Ramos-Quiroga JA. Long-term safety and efficacy of guanfacine extended release in children and adolescents with ADHD. Eur Child Adolesc Psychiatry. 2018 Oct;27(10):1283-1294. doi: 10.1007/s00787-018-1113-4. Epub 2018 Feb 13.

lead_sponsor: Shire

location_country:
Germany
Ireland
Italy
Poland
United Kingdom
Romania
Sweden
Netherlands
Austria
Belgium
Spain
Ukraine
France

location_facility: Institut fur Ganzheitliche Medizin und Wissenschaft GmbH

location_facility: Centre de Reference Neuropediatrique Multidisciplinaire

location_facility: Institute of Health Care for Children and Teenagers

location_facility: Somni bene GmbH Institut fur Medizinische Forschung und Schlatmedizin

location_facility: Gabinet Psychiatrii Doroslych, Dzieci i Mlodziezy

location_facility: Klinik und Poliklinik fur Kinder-und Jugendpsychiatrie un psychotherapie

location_facility: Zlekenhuis Inkendaal Koninklijke Instelling v.z.w.

location_facility: Instituto Valenciano de Neurologia Pediatrica

location_facility: Indywidualna Specjalisyczna Praktyka Lekarska

location_facility: Odesa Regional Psychoneurological Dispensary

location_facility: Medizinische Universitat Graz Univ fur Kinder

location_facility: Institute of Neurology, Psychiatry and Narcology

location_facility: Poltava Regional Clinical Psychiatric Hospital

location_facility: Azienda Ospedallera G Salvini - Ospedale Di Circolo de RHO

location_facility: Friedrich Schiller Universitat Jena Klinik fur Kinder und Jugendpsychiatrie

location_facility: Alder Hey Children's NHS Foundation Trust

location_facility: Centenary House Child and Adolescent Mental Health Services

location_facility: Hospital Infanta Leonor, Servicio de Psiquiatria

location_facility: Lviv Regional Clinical Psychiatric Hospital

location_facility: Centrum Badari Klinicznych House Sp. z.o.o.

location_facility: Vinnitsya regional psychoneurological hospital


title: A Randomized, Open Label Phase 3 Study of MM-398, With or Without 5-Fluorouracil and Leucovorin, Versus 5 Fluorouracil and Leucovorin in Patients With Metastatic Pancreatic Cancer Who Have Failed Prior Gemcitabine-based Therapy

summary: The study is an open label, randomized phase 3 study of MM-398 with or without 5-Fluorouracil (5-FU) and Leucovorin (also known as folinic acid), versus 5-FU and leucovorin in metastatic pancreatic cancer patients who have progressed on prior gemcitabine based therapy.

ReferenceCitation: Chen LT, Macarulla T, Blanc JF, Mirakhur B, de Jong FA, Belanger B, Bekaii-Saab T, Siveke JT. Early dose reduction/delay and the efficacy of liposomal irinotecan with fluorouracil and leucovorin in metastatic pancreatic ductal adenocarcinoma (mPDAC): A post hoc analysis of NAPOLI-1. Pancreatology. 2021 Jan;21(1):192-199. doi: 10.1016/j.pan.2020.10.029. Epub 2020 Oct 10.

ReferenceCitation: Macarulla Mercade T, Chen LT, Li CP, Siveke JT, Cunningham D, Bodoky G, Blanc JF, Lee KH, Dean A, Belanger B, Wang-Gillam A. Liposomal Irinotecan + 5-FU/LV in Metastatic Pancreatic Cancer: Subgroup Analyses of Patient, Tumor, and Previous Treatment Characteristics in the Pivotal NAPOLI-1 Trial. Pancreas. 2020 Jan;49(1):62-75. doi: 10.1097/MPA.0000000000001455. Erratum In: Pancreas. 2020 Mar;49(3):e27.

ReferenceCitation: Bang YJ, Li CP, Lee KH, Chiu CF, Park JO, Shan YS, Kim JS, Chen JS, Shim HJ, Rau KM, Choi HJ, Oh DY, Belanger B, Chen LT. Liposomal irinotecan in metastatic pancreatic adenocarcinoma in Asian patients: Subgroup analysis of the NAPOLI-1 study. Cancer Sci. 2020 Feb;111(2):513-527. doi: 10.1111/cas.14264. Epub 2019 Dec 20.

ReferenceCitation: Macarulla T, Blanc JF, Wang-Gillam A, Chen LT, Siveke JT, Mirakhur B, Chen J, de Jong FA. Liposomal irinotecan and 5-fluorouracil/leucovorin in older patients with metastatic pancreatic cancer - A subgroup analysis of the pivotal NAPOLI-1 trial. J Geriatr Oncol. 2019 May;10(3):427-435. doi: 10.1016/j.jgo.2019.02.011. Epub 2019 Mar 4.

ReferenceCitation: Wang-Gillam A, Hubner RA, Siveke JT, Von Hoff DD, Belanger B, de Jong FA, Mirakhur B, Chen LT. NAPOLI-1 phase 3 study of liposomal irinotecan in metastatic pancreatic cancer: Final overall survival analysis and characteristics of long-term survivors. Eur J Cancer. 2019 Feb;108:78-87. doi: 10.1016/j.ejca.2018.12.007. Epub 2019 Jan 14.

ReferenceCitation: Chen LT, Siveke JT, Wang-Gillam A, Li CP, Bodoky G, Dean AP, Shan YS, Jameson GS, Macarulla T, Lee KH, Cunningham D, Blanc JF, Chiu CF, Schwartsmann G, Braiteh FS, Mamlouk K, Belanger B, de Jong FA, Hubner RA. Survival with nal-IRI (liposomal irinotecan) plus 5-fluorouracil and leucovorin versus 5-fluorouracil and leucovorin in per-protocol and non-per-protocol populations of NAPOLI-1: Expanded analysis of a global phase 3 trial. Eur J Cancer. 2018 Dec;105:71-78. doi: 10.1016/j.ejca.2018.09.010. Epub 2018 Nov 8.

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

ReferenceCitation: Wang-Gillam A, Li CP, Bodoky G, Dean A, Shan YS, Jameson G, Macarulla T, Lee KH, Cunningham D, Blanc JF, Hubner RA, Chiu CF, Schwartsmann G, Siveke JT, Braiteh F, Moyo V, Belanger B, Dhindsa N, Bayever E, Von Hoff DD, Chen LT; NAPOLI-1 Study Group. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial. Lancet. 2016 Feb 6;387(10018):545-557. doi: 10.1016/S0140-6736(15)00986-1. Epub 2015 Nov 29. Erratum In: Lancet. 2016 Feb 6;387(10018):536.

lead_sponsor: Merrimack Pharmaceuticals

location_country:
France
Germany
Italy
Hungary
Argentina
United Kingdom
Australia
Brazil
United States
Korea, Republic of
Spain
South Africa
Taiwan
Canada
Czech Republic


title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and the Effect of BMS-241027 on Cerebrospinal Fluid Biomarkers in Subjects With Mild Alzheimer's Disease

summary: The purpose of the study is to evaluate safety and the pharmacodynamic effects of BMS-241027 on cerebrospinal fluid (CSF) Tau, connectivity magnetic resonance imaging (MRI), and computerized cognitive tests in mild Alzheimer's disease (AD) subjects, following 9 weekly intravenous (IV) infusions of BMS-241027

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
France
United States
Canada
Sweden

location_facility: Alexian Brothers Neurosciences Institute Clinical Research

location_facility: Hospital Of The University Of Pennsylvania

location_facility: Associated Neurologists Of Southern Connecticut, P.C.

location_facility: Palm Beach Neurological Center Advanced Research Consultants


title: An Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

summary: This study is to evaluate long-term safety, tolerability and efficacy for AFQ056 in patients who have completed an AFQ056A study in Parkinson's disease L-dopa induced dyskinesias (PD-LID).

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Italy
Slovakia
Hungary
Switzerland
Austria
United States
Spain
Canada
France


title: A Multi-center, Open Label, Uncontrolled, Phase IIA Clinical Trial Evaluating the Safety and Efficacy of NOX A12 in Combination With a Background Therapy of Bendamustine and Rituximab (BR) in Previously Treated Patients With Chronic Lymphocytic Leukemia (CLL)

summary: The purpose of this study is to evaluate the safety and efficacy of NOX A12 in combination with a background therapy of bendamustine and rituximab (BR) chemotherapy in previously treated patients with chronic lymphocytic leukemia (CLL).

ReferenceCitation: Steurer M, Montillo M, Scarfo L, Mauro FR, Andel J, Wildner S, Trentin L, Janssens A, Burgstaller S, Fromming A, Dummler T, Riecke K, Baumann M, Beyer D, Vauleon S, Ghia P, Foa R, Caligaris-Cappio F, Gobbi M. Olaptesed pegol (NOX-A12) with bendamustine and rituximab: a phase IIa study in patients with relapsed/refractory chronic lymphocytic leukemia. Haematologica. 2019 Oct;104(10):2053-2060. doi: 10.3324/haematol.2018.205930. Epub 2019 May 16.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

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

lead_sponsor: TME Pharma AG

location_country: Italy Austria Belgium France

location_facility: Hospital Wels-Grieskrichen, Department of Internal Medicine IV (Hematology and Oncology)

location_facility: Azienda Sanitaria Locale 8, Department of Oncology

location_facility: University Scientific Research Institute San Raffaele

location_facility: Medical University Innsbruck, Division of Hematology and Oncology

location_facility: Landeskrankenhaus Steyr, Department of Internal Medicine II (Hematology and Oncology)

location_facility: University Hospital Salzburg, Department of Medicine III, Center of Oncology and Hematology

location_facility: University Hospital Gasthuisberg, Department of Hematology

location_facility: Centre Hospitalier Universitaire Clémenceau, Department of Hematology

location_facility: Hospices Civils, Department of Hematology

location_facility: Centre Hospitalier Universitaire de la Milétrie, Department of Hematology

location_facility: University Hospital San Martino, Department of Hematology and Oncology

location_facility: Institute Jules Bordet, Department of Hematology

location_facility: University School of Medicine, Department of Hematology

location_facility: University La Sapienza, Department of Cellular Biotechnologies and Hematology

location_facility: University Hospital, Institute of Hematology and Oncology


title: Open-label, Single Arm, Study Evaluating Tolerability and Efficacy of Lacosamide When Added to Levetiracetam With Withdrawal of Concomitant Sodium Channel Blocking Antiepileptic Drug in Subjects With Uncontrolled Partial-onset Seizures

acronym: VERVE

summary: The main purpose of this study is to evaluate the effectiveness of the study drug lacosamide (200-600 mg/day) when added to a stable dose of levetiracetam (1000-3000 mg/day) with withdrawal of the concomitant sodium channel blocking-antiepileptic drug (AEDs) in subjects not well controlled on their current regimen.

ReferenceCitation: Baulac M, Byrnes W, Williams P, Borghs S, Webster E, De Backer M, Dedeken P. Lacosamide and sodium channel-blocking antiepileptic drug cross-titration against levetiracetam background therapy. Acta Neurol Scand. 2017 Apr;135(4):434-441. doi: 10.1111/ane.12691. Epub 2016 Oct 6.

endpoint_id: HAL

repository_institution: HAL

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

publisher_dissemination: Hindawi

lead_sponsor: UCB Pharma

location_country:
Germany
Denmark
Australia
Romania
Sweden
United States
Spain
Bulgaria
France


title: A Multiple Ascending Dose Study of Tadalafil to Assess the Pharmacokinetics and Safety in a Pediatric Population With Pulmonary Arterial Hypertension

summary: The purpose of this study is to see how much study drug is in the blood of children with pulmonary arterial hypertension (PAH) after dosing to establish the correct dose for further clinical research.

ReferenceCitation: Ferguson-Sells L, Velez de Mendizabal N, Li B, Small D. Population Pharmacokinetics of Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension: A Combined Adult/Pediatric Model. Clin Pharmacokinet. 2022 Feb;61(2):249-262. doi: 10.1007/s40262-021-01052-8. Epub 2021 Aug 11.

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Eli Lilly and Company

location_country:
Poland
United Kingdom
United States
Spain
Canada
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.

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

location_facility: Children's Heathcare of Atlanta, Inc. at Egleston


title: A Phase II, Randomized, Double-Blind, Multicenter, Parallel Group Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug RO5024048 in Combination With Boceprevir and Pegasys®/Copegus® in Patients With Chronic Hepatitis C Genotype 1 Virus Infection Who Were Prior Null Responders to Treatment With Pegylated Interferon/Ribavirin

summary: This randomized, double-blind, multi-center, placebo-controlled, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) in combination with boceprevir and Pegasys/Copegus in patients with chronic hepatitis C infection. The anticipated time on study treatment is up to 48 weeks.

ReferenceCitation: Wedemeyer H, Forns X, Hezode C, Lee SS, Scalori A, Voulgari A, Le Pogam S, Najera I, Thommes JA. Mericitabine and Either Boceprevir or Telaprevir in Combination with Peginterferon Alfa-2a plus Ribavirin for Patients with Chronic Hepatitis C Genotype 1 Infection and Prior Null Response: The Randomized DYNAMO 1 and DYNAMO 2 Studies. PLoS One. 2016 Jan 11;11(1):e0145409. doi: 10.1371/journal.pone.0145409. eCollection 2016.

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

publisher_dissemination: Public Library of Science

location_country:
Germany
Italy
United States
Spain
Canada
Puerto Rico
France


title: A Phase II, Randomized, Double-Blind, Multicenter, Parallel Group Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug RO5024048 in Combination With Telaprevir and Pegasys®/Copegus® in Patients With Chronic Hepatitis C Genotype 1 Virus Infection Who Were Prior Null Responders to Treatment With Pegylated Interferon/Ribavirin

summary: This randomized, double-blind, multi-center, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) (MCB) in combination with telaprevir (TVR) and peginterferon Alfa-2a (PEG-IFN) / ribavirin (RBV) in participants with chronic Hepatitis C infection.

repositories_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

location_country:
Germany
Italy
United Kingdom
United States
Spain
Canada
France

location_facility: Hospital Carlos III; Laboratorio de Biologia Molecular

location_facility: Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I

location_facility: Royal Bournemouth Hospital, Gastroenterology

location_facility: Uni of Cincinnati College of Medicine; Div. of Digestive Diseases

location_facility: Imperial College Healthcare NHS Trust; Hepatology Clinical Research Facility

location_facility: Hospital Clinic I Provincial; Servicio de Digestivo

location_facility: Kaiser Permanente Sacramento Medical Center

location_facility: Universitäts Klinikum; Schleswig-Holstein Kiel

location_facility: Saint Louis University Gastroenterology & Hepatology; Clinical Research Unit

location_facility: Gordon & Leslie Diamond Health Care Centre; Dept. of Medicine - Division of Gastroenterology

location_facility: University Health Network - Toronto Western Hospital; Hepatology

location_facility: McGill University, Montreal Chest Institute; Viral and other Infectious

location_facility: King'S College Hospital; Institute of Liver Studies

location_facility: ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Divisione Malattie Infettive

location_facility: Uniklinik Freiburg; Abteilung Innere Medizin II

location_facility: Baylor Uni Medical Center; Division Of Hepatology/Transplantation; Annette C. and Harold C. Simmons

location_facility: GI Research Institute; Gastroenterology & Hepatology

location_facility: Fondation Hopital Saint Joseph; Gastro-Enterologie

location_facility: Hopital Purpan;Gastro Enterologie Hepatologie

location_facility: Hospital Universitario de Canarias; Servicio de Digestivo

location_facility: Hospital Universitari Vall d'Hebron; Departamento de Enfermedades Infecciosas

location_facility: UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In

location_facility: Winnipeg Regional Health Authority; Section of Hepatology

location_facility: Hopital Claude Huriez;Gastro Enterologie

location_facility: Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia