title: Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Treatment of Post-stroke Spasticity of the Lower Limb

acronym: PLUS

summary: The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg are effective in treating patients with increased muscle tension/uncontrollable muscle stiffness (spasticity) after a stroke.

lead_sponsor: Merz Pharmaceuticals GmbH

location_country:
Italy
United States
France
Poland
Russian Federation
Spain
Germany
Czech Republic
Canada

location_facility:
Merz Investigational Site #049304
Merz Investigational Site #049302
Merz Investigational Site #033018
Merz Investigational Site #420024
Investigational site #001188
Merz Investigational Site #049303
Merz Investigational Site #420031
Merz Investigational Site #048080
Merz Investigational Site #048022
Merz Investigational Site #049148
Merz Investigational Site #001204
Merz Investigational Site #001184
Merz Investigational Site #048055
Merz Investigational Site #048044
Merz Investigational Site #034026
Merz Investigational Site #049071
Merz Investigational Site #039012
Merz Investigational Site #001009
Merz Investigational Site #048023
Merz Investigational Site #049072
Merz Investigational Site #034028
Merz Investigational Site #034030
Merz Investigational Site # 001110
Merz Investigational Site #048033
Merz Investigational Site #048053
Merz Investigational Site #048031
Merz Investigational Site #001207
Merz Investigational Site #001198
Merz Investigational Site #001210
Merz Investigational Site #007011
Merz Investigational Site #007009
Merz Investigational Site #001206
Merz Investigational Site #033024
Merz Investigational Site #049022
Merz Investigational Site #049079
Merz Investigational Site #001209
Merz Investigational Site #034029
Merz Investigational Site #420030
Merz Investigational Site #001202
Merz Investigational Site #007010
Merz Investigational Site #039006
Merz Investigational Site #034027
Merz Investigational Site #420047
Merz Investigational Site #048054
Merz Investigational Site #001208
Merz Investigational Site #048057
Merz Investigational Site #048051
Merz Investigational Site #048056
Merz Investigational Site #039011
Merz Investigational Site #001183
Merz Investigational Site #048081
Merz Investigational Site #001244
Merz Investigational Site #007012


title: A Randomised Open-Label Phase II Study to Assess the Efficacy & Safety of AZD4547 Monotherapy Versus Paclitaxel in Patients With Advanced Gastric Adenocarcinoma (Inc. Adenocarcinoma of the Lower Third of the Oesophagus or the Gastro-Oesophageal Junction)With FGFR2 Polysomy or Gene Amplification.

acronym: SHINE

summary: The purpose of this study is to assess the efficacy, safety and tolerability of AZD4547 compared with paclitaxel in patients with advanced gastric or lower-oesophageal cancer whose tumours are found to have FGFR2 polysomy or gene amplification.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: AstraZeneca

location_country:
Italy
India
United Kingdom
Germany
France
Bulgaria
Japan
Romania
Hungary
Belgium
Spain
Canada
Czech Republic
Korea, Republic of
Taiwan
Ukraine

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Phase 1b/2 Randomized Study of MEDI-573 in Combination With an Aromatase Inhibitor (AI) Versus AI Alone in Women With Metastatic Breast Cancer (MBC)

summary: Study to evaluate the safety, tolerability, antitumor activity, and pharmacology of MEDI-573 in combination with an aromatase inhibitor (AI) in adult subjects with HR+, HER2-negative MBC.

study_start_date_type: Actual

status: Completed

lead_sponsor: MedImmune LLC

location_country:
United States
Spain
Germany
France
Poland
Israel
Hungary
Belgium
Bahamas
Canada
United Kingdom

status_simplified: Completed


title: Safety and Tolerability of ODM-201 in Patients With Castrate Resistant Prostate Cancer: Open, Non-randomised, Uncontrolled, Multicentre, Extension Study to Study 3104001

summary: The purpose of this study is to evaluate safety and tolerability of ODM-201 in patients with castrate resistant prostate cancer.

ReferenceType: derived

ReferenceCitation: Shore ND, Tammela TL, Massard C, Bono P, Aspegren J, Mustonen M, Fizazi K. Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Chemotherapy-naïve and CYP17 Inhibitor-naïve Patients: Follow-up from the ARADES and ARAFOR Trials. Eur Urol Focus. 2018 Jul;4(4):547-553. doi: 10.1016/j.euf.2017.01.015. Epub 2017 Feb 14.

family: Shore

full_name: Neal D. Shore

given: Neal D.

sequence: first

family: Tammela

full_name: Teuvo L. Tammela

given: Teuvo L.

sequence: additional

family: Massard

full_name: Christophe Massard

given: Christophe

family: Bono

full_name: Petri Bono

given: Petri

family: Aspegren

full_name: John Aspegren

given: John

family: Mustonen

full_name: Mika Mustonen

given: Mika

family: Fizazi

full_name: Karim Fizazi

given: Karim

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: European Urology Focus

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: University of Helsinki - Helda

repository_normalized: HELDA - Digital Repository of the University of Helsinki

repository_institution: Tampere University - Tampere University Institutional Repository

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Fizazi K, Massard C, Bono P, Kataja V, James N, Tammela TL, Joensuu H, Aspegren J, Mustonen M. Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Castration-resistant, CYP17 Inhibitor-naïve Prostate Cancer: Results from Extended Follow-up of the ARADES Trial. Eur Urol Focus. 2017 Dec;3(6):606-614. doi: 10.1016/j.euf.2017.01.010. Epub 2017 Feb 27.

family: Kataja

full_name: Vesa Kataja

given: Vesa

family: James

full_name: Nicholas James

given: Nicholas

family: Joensuu

full_name: Heikki Joensuu

given: Heikki

ReferenceCitation: Fizazi K, Massard C, Bono P, Jones R, Kataja V, James N, Garcia JA, Protheroe A, Tammela TL, Elliott T, Mattila L, Aspegren J, Vuorela A, Langmuir P, Mustonen M; ARADES study group. Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label phase 1 dose-escalation and randomised phase 2 dose expansion trial. Lancet Oncol. 2014 Aug;15(9):975-85. doi: 10.1016/S1470-2045(14)70240-2. Epub 2014 Jun 25.

repository_institution: Cardiff University - ORCA Online Research @Cardiff

location_country:
United Kingdom
Finland
France
Estonia
United States
Czech Republic

location_facility: Klinika onkologie a radioterapie LFUK a FN

location_facility: Eastern CT Hematology and Oncology Associates


type: Other Identifier

type: EudraCT Number

title: An Open-Label Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Etravirine (ETR) in Combination With Other Antiretrovirals (ARVs) in Antiretroviral Treatment-Experienced HIV-1 Infected Subjects

summary: The purpose of this study is to learn more about the safety and tolerability of etravirine. Etravirine is a type of non-nucleoside reverse transcriptase inhibitor (NNRTI) which has shown high activity against wild-type human immunodeficiency virus (HIV-1), and HIV strains resistant to other non-nucleotide agents.

ReferenceCitation: Arathoon E, Bhorat A, Silaghi R, Crauwels H, Lavreys L, Tambuyzer L, Vanveggel S, Opsomer M. Week 48 results of a Phase IV trial of etravirine with antiretrovirals other than darunavir/ritonavir in HIV-1-infected treatment-experienced adults. J Int AIDS Soc. 2014 Nov 2;17(4 Suppl 3):19783. doi: 10.7448/IAS.17.4.19783. eCollection 2014.

family: Arathoon

full_name: Eduardo Arathoon

given: Eduardo

family: Bhorat

full_name: Asad Bhorat

given: Asad

family: Silaghi

full_name: Rodica Silaghi

given: Rodica

family: Crauwels

full_name: Herta Crauwels

given: Herta

family: Lavreys

full_name: Ludo Lavreys

given: Ludo

family: Tambuyzer

full_name: Lotke Tambuyzer

given: Lotke

family: Vanveggel

full_name: Simon Vanveggel

given: Simon

family: Opsomer

full_name: Magda Opsomer

given: Magda

currency_apc_doaj: USD

journal_name: Journal of the International AIDS Society

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Janssen R&D Ireland

location_country:
South Africa
Peru
Guatemala
Mexico
France
Romania
Argentina
Puerto Rico
Russian Federation
United States
Ukraine


title: A Prospective, Randomized, Double-Blind Comparison of a Long-Acting Basal Insulin Analog LY2963016 to Lantus in Adult Patients With Type 2 Diabetes Mellitus: The ELEMENT 2 Study

acronym: ELEMENT 2

summary: The main purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus in controlling blood sugar levels in combination with two or more oral diabetes medications.

ReferenceCitation: Nishiyama H, Shingaki T, Suzuki Y, Ilag LL. Similar Intrapatient Blood Glucose Variability with LY2963016 and Lantus(®) Insulin Glargine in Patients with Type 1 (T1D) or Type 2 Diabetes, Including a Japanese T1D Subpopulation. Diabetes Ther. 2018 Aug;9(4):1469-1476. doi: 10.1007/s13300-018-0450-0. Epub 2018 May 31.

family: Nishiyama

full_name: Hiroshi Nishiyama

given: Hiroshi

family: Shingaki

full_name: Tomotaka Shingaki

given: Tomotaka

family: Suzuki

full_name: Yumi Suzuki

given: Yumi

family: Ilag

full_name: Liza L. Ilag

given: Liza L.

journal_name: Diabetes Therapy

license: cc-by-nc

license_normalized: cc-by-nc

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Similar Intrapatient Blood Glucose Variability with LY2963016 and Lantus® Insulin Glargine in Patients with Type 1 (T1D) or Type 2 Diabetes, Including a Japanese T1D Subpopulation

ReferenceCitation: Pollom RK, Costigan T, Lacaya LB, Ilag LL, Hollander PA. Similar Efficacy and Safety of Basaglar(®) and Lantus(®) in Patients with Type 2 Diabetes in Age Groups (< 65 Years, ≥ 65 Years): A Post Hoc Analysis from the ELEMENT-2 Study. Diabetes Ther. 2018 Apr;9(2):827-837. doi: 10.1007/s13300-018-0405-5. Epub 2018 Mar 14.

family: Pollom

full_name: Robyn K. Pollom

given: Robyn K.

family: Costigan

full_name: Timothy Costigan

given: Timothy

family: Lacaya

full_name: Lyndon B. Lacaya

given: Lyndon B.

family: Hollander

full_name: Priscilla A. Hollander

given: Priscilla A.

title: Similar Efficacy and Safety of Basaglar® and Lantus® in Patients with Type 2 Diabetes in Age Groups (< 65 Years, ≥ 65 Years): A Post Hoc Analysis from the ELEMENT-2 Study

location_country:
United States
Mexico
France
Poland
Greece
Hungary
Puerto Rico
Spain
Germany
Czech Republic
Korea, Republic of
Taiwan

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.


ReferenceCitation: Foeldvari I, Constantin T, Vojinović J, Horneff G, Chasnyk V, Dehoorne J, Panaviene V, Sušić G, Stanevicha V, Kobusinska K, Zuber Z, Dobrzyniecka B, Nikishina I, Bader-Meunier B, Breda L, Doležalová P, Job-Deslandre C, Rumba-Rozenfelde I, Wulffraat N, Pedersen RD, Bukowski JF, Vlahos B, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO). Etanercept treatment for extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis, or psoriatic arthritis: 6-year efficacy and safety data from an open-label trial. Arthritis Res Ther. 2019 May 23;21(1):125. doi: 10.1186/s13075-019-1916-9.

family: Foeldvari

full_name: Ivan Foeldvari

given: Ivan

name: for the Paediatric Rheumatology International Trials Organisation (PRINTO)

family: Constantin

full_name: Tamàs Constantin

given: Tamàs

family: Vojinović

full_name: Jelena Vojinović

given: Jelena

family: Horneff

full_name: Gerd Horneff

given: Gerd

family: Chasnyk

full_name: Vyacheslav Chasnyk

given: Vyacheslav

family: Dehoorne

full_name: Joke Dehoorne

given: Joke

family: Panaviene

full_name: Violeta Panaviene

given: Violeta

family: Sušić

full_name: Gordana Sušić

given: Gordana

family: Stanevicha

full_name: Valda Stanevicha

given: Valda

family: Kobusinska

full_name: Katarzyna Kobusinska

given: Katarzyna

family: Zuber

full_name: Zbigniew Zuber

given: Zbigniew

family: Dobrzyniecka

full_name: Bogna Dobrzyniecka

given: Bogna

family: Nikishina

full_name: Irina Nikishina

given: Irina

family: Bader-Meunier

full_name: Brigitte Bader-Meunier

given: Brigitte

family: Breda

full_name: Luciana Breda

given: Luciana

family: Doležalová

full_name: Pavla Doležalová

given: Pavla

family: Job-Deslandre

full_name: Chantal Job-Deslandre

given: Chantal

family: Rumba-Rozenfelde

full_name: Ingrida Rumba-Rozenfelde

given: Ingrida

family: Wulffraat

full_name: Nico Wulffraat

given: Nico

family: Pedersen

full_name: Ronald D. Pedersen

given: Ronald D.

family: Bukowski

full_name: Jack F. Bukowski

given: Jack F.

family: Vlahos

full_name: Bonnie Vlahos

given: Bonnie

family: Martini

full_name: Alberto Martini

given: Alberto

family: Ruperto

full_name: Nicolino Ruperto

given: Nicolino

currency_apc_doaj: GBP

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

repository_institution: Ghent University - Ghent University Academic Bibliography

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:
Italy
Serbia
Mexico
Netherlands
Spain
France
Czechia
Lithuania
Poland
Slovakia
Norway
Hungary
Belgium
Australia
Russian Federation
Slovenia
Germany
Latvia
Colombia

location_facility: Instytut Reumatologii im. prof. dr hab. med. Eleonory Reicher, Klinika i

location_facility: Fakultni nemocnice Brno - Detska nemocnice, Ambulance detske revmatologie

location_facility: Klinika detskeho a dorostoveho lekarstvi 1. LF UK a VFN v Praze

location_facility: Hamburger Zentrum fuer Kinder- und Jugendrheumatologie

location_facility: FGBNU Research Institute of Rheumatology n.a. V.A. Nasonovoy

location_facility: SBEI HPE Saint Petersburg State Pediatric Medical University

location_facility: Wojewodzki Szpital Dzieciecy im. J. Brudzinskiego

location_facility: Centro di Ricerca Clinica - Fondazione dell'Universita' degli Studi "G. D'Annunzio"

location_facility: Asklepios Klinik Sankt Augustin GmbH, Zentrum fuer Kinder- und Jugendrheumatologie

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie,

location_facility: University Medical Centre Ljubljana, University Children's Hospital

location_facility: Universitair Ziekenhuis Utrecht, Wilhelmina Kinderziekenhuis, Room number KC 03-063

location_facility: Children's Hospital at Vilnius University Hospital "Santaros klinikos"

location_facility: Szpital Specjalistyczny im. A. Falkiewicza we Wroclawiu, Oddzial Pediatryczno - Reumatologiczny

title: AN OPEN-LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND CLINICAL BENEFIT OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS-RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1-3338-WW(B1801014)

summary: This is a 8-year extension study in pediatric subjects who have been diagnosed with one of 3 subtypes of Juvenile Idiopathic Arthritis (JIA) [extended oligoarticular JIA, enthestitis related arthritis (ERA), or psoriatic arthritis (PsA)] who have completed approximately 96 weeks of participation in study 0881A1-3338 (B1801014). The study contains an active treatment period, withdrawal/re-treatment period and a observational period (non-treatment).


title: A Multi-center, Randomized, Phase 3 Study of Sequential Pralatrexate Versus Observation in Patients Previously Undiagnosed Peripheral T-cell Lymphoma Who Achieved an Objective Response After Initial Treatment With CHOP-based Chemotherapy

summary: The purpose of this study is to see if pralatrexate extends response and survival following CHOP-based chemotherapy (CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone) and if pralatrexate improves response in patients with partial response following CHOP-based chemotherapy. Patients will either receive pralatrexate or be under observation. All patients will receive vitamins B12 and folic acid and attend regular clinic visits to evaluate their disease and health.

lead_sponsor: Spectrum Pharmaceuticals, Inc

location_country:
Italy
United States
Spain
France
Poland
Israel
Ireland
Belgium
Australia
New Zealand
Puerto Rico
Canada
United Kingdom

location_facility: NHS Greater Glasgow and Clyde Western Infirmary

location_facility: UHCW (University Hospital Coventry and Warwickshire)

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

location_facility: Complejo Hospitalario de Navarra, Servicio de Hematologia

location_facility: Complejo Hospitalario Universitario A Coruña- Hospital A Coruña

location_facility: Auckland City Hospital / Auckland University

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Sandwell & West Birmingham Hospitals NHS Trust

location_facility: Az. Ospedaliera Universitaria S. Orsola Malpighi

location_facility: Poole Hospital NHS Foundation Trust, Poole General Hospital

location_facility: Klinika Nowotworów Ukladu Chlonnego Centrum Onkologii Instytut Marii Sklodowskiej-Curie


title: A Randomized, Double-blind, Double Dummy, Multicenter Study to Assess the Safety, Tolerability and Long-term Efficacy of Intravenous (10mg/kg) and Subcutaneous (300mg) Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Who Are Partial Responders to Secukinumab

acronym: STATURE

summary: The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Austria
India
Germany
France
Japan
Slovakia
United States
Canada


title: Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study

summary: The administration of Anamorelin HCl in patients with Non-Small Cell Lung Cancer-Cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.

ReferenceCitation: Currow D, Temel JS, Abernethy A, Milanowski J, Friend J, Fearon KC. ROMANA 3: a phase 3 safety extension study of anamorelin in advanced non-small-cell lung cancer (NSCLC) patients with cachexia. Ann Oncol. 2017 Aug 1;28(8):1949-1956. doi: 10.1093/annonc/mdx192.

family: Currow

full_name: D. Currow

given: D.

family: Temel

full_name: J.S. Temel

family: Abernethy

full_name: A. Abernethy

given: A.

family: Milanowski

full_name: J. Milanowski

given: J.

family: Friend

full_name: J. Friend

family: Fearon

full_name: K.C. Fearon

journal_name: Annals of Oncology

repository_institution: University of Hull - Repository@Hull (Worktribe)

lead_sponsor: Helsinn Therapeutics (U.S.), Inc

location_country:
Italy
United States
Serbia
Spain
Germany
France
Czechia
Poland
Israel
Hungary
Belgium
Australia
Russian Federation
Belarus
Canada
Slovenia
Ukraine


ReferenceType: background

ReferenceCitation: Young G, Collins P, Tehranchi R, Chuansumrit A, Hanabusa H, Lentz SR, Mahlangu J, Mauser-Bunschoten E, Negrier C, Oldenburg J, Patiroglu T, Santagostino E, Zak M, Abdul Karim F. Safety and efficacy of nonacog beta pegol (N9-GP) for prophylaxis and treatment of bleeding episodes in previously-treated patients with hemophilia B: results from an extension trial. American Society of Hematology - 56th Annual Meeting (ASH) in San Francisco, CA, US

ReferenceType: result

ReferenceCitation: Young G, Collins PW, Colberg T, Chuansumrit A, Hanabusa H, Lentz SR, Mahlangu J, Mauser-Bunschoten EP, Négrier C, Oldenburg J, Patiroglu T, Santagostino E, Tehranchi R, Zak M, Karim FA. Nonacog beta pegol (N9-GP) in haemophilia B: A multinational phase III safety and efficacy extension trial (paradigm™4). Thromb Res. 2016 May;141:69-76. doi: 10.1016/j.thromres.2016.02.030. Epub 2016 Mar 2.

family: Young

full_name: Guy Young

given: Guy

family: Collins

full_name: Peter W. Collins

given: Peter W.

family: Colberg

full_name: Torben Colberg

given: Torben

family: Chuansumrit

full_name: Ampaiwan Chuansumrit

given: Ampaiwan

family: Hanabusa

full_name: Hideji Hanabusa

given: Hideji

family: Lentz

full_name: Steven R. Lentz

given: Steven R.

family: Mahlangu

full_name: Johnny Mahlangu

given: Johnny

family: Mauser-Bunschoten

full_name: Evelien P. Mauser-Bunschoten

given: Evelien P.

family: Négrier

full_name: Claude Négrier

given: Claude

family: Oldenburg

full_name: Johannes Oldenburg

given: Johannes

family: Patiroglu

full_name: Turkan Patiroglu

given: Turkan

family: Santagostino

full_name: Elena Santagostino

given: Elena

family: Tehranchi

full_name: Ramin Tehranchi

given: Ramin

family: Zak

full_name: Marek Zak

given: Marek

family: Karim

full_name: Faraizah Abdul Karim

given: Faraizah Abdul

journal_name: Thrombosis Research

ReferenceCitation: Chowdary P, Kearney S, Regnault A, Hoxer CS, Yee DL. Improvement in health-related quality of life in patients with haemophilia B treated with nonacog beta pegol, a new extended half-life recombinant FIX product. Haemophilia. 2016 Jul;22(4):e267-74. doi: 10.1111/hae.12995. Epub 2016 Jun 28.

name: Katharine Dormandy Haemophilia Centre and Thrombosis Unit; Royal Free London NHS Foundation Trust; London UK

family: Chowdary

full_name: P. Chowdary

given: P.

name: CHCMN Hemophilia and Thrombosis Center Children's Hospital and Clinics of Minnesota; Minneapolis MN USA

family: Kearney

full_name: S. Kearney

given: S.

name: Patient-Centered Outcomes; Mapi; Lyon France

family: Regnault

full_name: A. Regnault

family: Hoxer

full_name: C. S. Hoxer

given: C. S.

name: Department of Pediatrics; Hematology-Oncology Section; Baylor College of Medicine; Texas Children's Hemophilia & Thrombosis Center; Houston TX USA

family: Yee

full_name: D. L. Yee

given: D. L.

journal_name: Haemophilia

location_country: Macedonia, The Former Yugoslav Republic of

title: Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B

summary:
This trial is conducted in Asia, Europe, Japan, North America and South Africa. The aim is to evaluate the safety and efficacy of nonacog beta pegol (NNC-0156-0000-0009) after long-term exposure in patients with haemophilia B.

This trial is an extension to trials NN7999-3747 (NCT01333111/paradigm™ 2) and NN7999-3773 (NCT01386528/paradigm™ 3).


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Maintenance Therapy In Subjects With Moderate To Severe Crohn's Disease

summary: This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease who completed the double-blind induction treatment in Study A3921083 and achieved clinical response-100 and/or clinical remission (CDAI<150) at Week 8.

ReferenceCitation: Panés J, Sandborn WJ, Schreiber S, Sands BE, Vermeire S, D'Haens G, Panaccione R, Higgins PDR, Colombel JF, Feagan BG, Chan G, Moscariello M, Wang W, Niezychowski W, Marren A, Healey P, Maller E. Tofacitinib for induction and maintenance therapy of Crohn's disease: results of two phase IIb randomised placebo-controlled trials. Gut. 2017 Jun;66(6):1049-1059. doi: 10.1136/gutjnl-2016-312735. Epub 2017 Feb 16.

family: Panés

full_name: Julian Panés

given: Julian

family: Sandborn

full_name: William J Sandborn

given: William J

family: Schreiber

full_name: Stefan Schreiber

given: Stefan

family: Sands

full_name: Bruce E Sands

given: Bruce E

family: Vermeire

full_name: Séverine Vermeire

given: Séverine

family: D'Haens

full_name: Geert D'Haens

given: Geert

family: Panaccione

full_name: Remo Panaccione

given: Remo

family: Higgins

full_name: Peter D R Higgins

given: Peter D R

family: Colombel

full_name: Jean-Frederic Colombel

given: Jean-Frederic

family: Feagan

full_name: Brian G Feagan

given: Brian G

family: Chan

full_name: Gary Chan

given: Gary

family: Moscariello

full_name: Michele Moscariello

given: Michele

family: Wang

full_name: Wenjin Wang

given: Wenjin

family: Niezychowski

full_name: Wojciech Niezychowski

given: Wojciech

family: Marren

full_name: Amy Marren

given: Amy

family: Healey

full_name: Paul Healey

given: Paul

family: Maller

full_name: Eric Maller

given: Eric

journal_name: Gut

evidence: open (via page says license)

repository_institution: University of Oxford - Oxford Academic Notes & Queries

location_country:
Austria
United States
South Africa
Netherlands
Germany
France
Bulgaria
Greece
Israel
Japan
Hungary
Australia
Spain
Canada
Czech Republic
Korea, Republic of
Ukraine

location_facility: Hôpital Haut-Lévêque/Service d hépato-gastroentérologie

location_facility: Premier Medical Group of the Hudson Valley, PC

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Advanced Clinical Research Institute-Phase 1, LLC

location_facility: Donetsk National Medical University n.a M. Gorky, Faculty of Internal Medicine #2

location_facility: Metropolitan Gastroenterology Group, P C

location_facility: Gastroenterology Associates of Central Georgia, LLC

location_facility: London Health Sciences Centre - University Hospital

location_facility: Office of Drs. Ranjith Andrew Singh and Jamie D. Papp,

location_facility: ASAN Medical Center,Division of Gastroenterology,Department of Internal Medicine

location_facility: Severance Hospital, Yonsei University Health System

location_facility: East Ann Arbor Health and Geriatrics Center

location_facility: Laboratorium Kft. Fovarosi és Pest Megyei Mikrobiologiai Laboratorium

location_facility: Medical Clinical Research Center of Medical Center "Health Clinic" LLC

location_facility: Gasteroenterology Consultants of Clearwater

location_facility: The Hospital of Hyogo College of Medicine

location_facility: General Hospital of Athens "Evangelismos",1st Gastroenterology Department

location_facility: Gulfshore Endoscopy Center (Endoscopies Only)

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszat es Gastroenterologia

location_facility: Investigational Drug Services - University Hospitals Case Medical Center

location_facility: AKH Wien Universitaetsklinik fuer Innere Medizin III

location_facility: University of Florida - College of Medicine

location_facility: NYU Langone Nassau Gastroenterology Associates

location_facility: MBAL Sofiamed OOD, Otdelenie po gastroenterologia

location_facility: Peterfy Sandor Utcai Korhaz, Rendelointezet es Baleseti Kozpont, I. sz. Belgyogyaszat

location_facility: Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital

location_facility: Shands Hospital at the University of Florida

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: Universitaetsklinikum Ulm, Klinik Fuer Innere Medizin I

location_facility: Laboratórium Kft. Somogy Megyei Mikrobiológiai Laboratórium

location_facility: Cotton-O'Neil Clinical Research Center, Digestive Health

location_facility: Medial Pharma spol.s.r.o. (Pharmacy only)

location_facility: Samsung Medical Center, Division of Gastroenterology, Department of Internal Medicine

location_facility: Wisconsin Center for Advanced Research - GI Associates, LLC

location_facility: Bugat Pal Korhaz Egeszsegugyi Szolgaltato Kozhasznu Nonprofit Kft.,

location_facility: Municipal Institution "Odesa Regional Clinical Hospital", Odesa Regional Centre of Gastroenterology.

location_facility: Charite, Universitaetsmedizin Berlin, Campus Virchow-Klinikum

location_facility: North Florida Gastroenterology Research, LLC


title: Phase 3 Prospective, Randomized, Blinded, and Controlled Investigation of HepaSphere/QuadraSphere Microspheres for Delivery of Doxorubicin for the Treatment of Hepatocellular Carcinoma

acronym: HiQuality

summary: The purpose of this study is to evaluate overall survival in patients diagnosed with hepatocellular cancer (HCC) treated with HepaSphere/QuadraSphere Microspheres loaded with chemotherapeutic agent doxorubicin compared to conventional transarterial chemoembolization with particle PVA, lipiodol, and doxorubicin.

ipd_sharing: No

lead_sponsor: Merit Medical Systems, Inc.

location_country:
Italy
France
Greece
Belgium
United States

location_facility: Hospital of the University of Pennsylvania

location_facility: MUSC Medical Center (Medical University of South Carolina)

location_facility: Palo Alto Veterans Institute for Research

location_facility: University Hospitals K.U. Leuven (Dept of Hematology)

location_facility: VA Greater Los Angeles Healthcare System

intervention_type: Device


title: Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): A Randomized Double-Blind Placebo-Controlled Multicenter Phase III Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients With NSCLC-C

summary: The administration of Anamorelin in patients with Stage III-IV non-small cell lung cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.

family: Currow

full_name: D. Currow

given: D.

family: Temel

full_name: J.S. Temel

family: Abernethy

full_name: A. Abernethy

given: A.

family: Milanowski

full_name: J. Milanowski

given: J.

family: Friend

full_name: J. Friend

family: Fearon

full_name: K.C. Fearon

repositories_institution: University of Hull - Repository@Hull (Worktribe)

title: ROMANA 3: a phase 3 safety extension study of anamorelin in advanced non-small-cell lung cancer (NSCLC) patients with cachexia

ReferenceCitation: Temel JS, Abernethy AP, Currow DC, Friend J, Duus EM, Yan Y, Fearon KC. Anamorelin in patients with non-small-cell lung cancer and cachexia (ROMANA 1 and ROMANA 2): results from two randomised, double-blind, phase 3 trials. Lancet Oncol. 2016 Apr;17(4):519-531. doi: 10.1016/S1470-2045(15)00558-6. Epub 2016 Feb 20.

full_name: Jennifer S Temel

given: Jennifer S

full_name: Amy P Abernethy

given: Amy P

full_name: David C Currow

given: David C

full_name: John Friend

given: John

family: Duus

full_name: Elizabeth M Duus

given: Elizabeth M

family: Yan

full_name: Ying Yan

given: Ying

full_name: Kenneth C Fearon

given: Kenneth C

location_country:
Italy
United States
Serbia
Netherlands
Spain
Germany
France
Czechia
Poland
Hungary
Belgium
Russian Federation
Belarus
Canada
Slovenia
Ukraine


ReferenceCitation: Escobar M, Colberg T, Karim F, Caliskan U, Chowdary P, Giangrande P, Giermasz A, Mancuso ME, Serban M, Tsay W, Zak M and Mahlangu J. Perioperative hemostatic management of major surgery in hemophilia B with long-acting recombinant glycopegylated factor IX: results from the paradigm™3 clinical trial. Journal of Thrombosis and Haemostasis (Abstracts) 2015; 13 (Supplement S2): 1-997 [OR348]

design_allocation: Non-Randomized

lead_sponsor: Novo Nordisk A/S

acronym: paradigm™ 3

source: euctr

title: An Open-label, Multi-centre, Un-controlled Trial to Assess Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Patients With Haemophilia B

summary:
This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of the trial is to evaluate the safety and efficacy of NNC-0156-0000-0009 (nonacog beta pegol) during surgical procedures in patients with haemophilia B.


title: A Randomised, Double-blind, Dose-finding, Multicenter Study of the Safety, Tolerability, and Efficacy of GSK2251052 Therapy Compared to Imipenem-cilastatin in the Treatment of Adult Subjects With Febrile Complicated Lower Urinary Tract Infections and Acute Pyelonephritis

summary: This study is being conducted to evaluate the safety, efficacy (clinical and microbiological), pharmacokinetics/pharmacodynamics of GSK2251052 and to assess whether it would be a suitable antibiotic for the treatment for febrile lower cUTI and pyelonephritis(complicated and uncomplicated). GSK2251052 will be compared to imipenem-cilastatin, which is an antibiotic commonly used to treat serious cUTI infections. GSK2251052 has a spectrum of microbiological activity that includes pathogens responsible for cUTI.

ReferenceCitation: O'Dwyer K, Spivak AT, Ingraham K, Min S, Holmes DJ, Jakielaszek C, Rittenhouse S, Kwan AL, Livi GP, Sathe G, Thomas E, Van Horn S, Miller LA, Twynholm M, Tomayko J, Dalessandro M, Caltabiano M, Scangarella-Oman NE, Brown JR. Bacterial resistance to leucyl-tRNA synthetase inhibitor GSK2251052 develops during treatment of complicated urinary tract infections. Antimicrob Agents Chemother. 2015 Jan;59(1):289-98. doi: 10.1128/AAC.03774-14. Epub 2014 Oct 27.

family: O'Dwyer

full_name: Karen O'Dwyer

given: Karen

family: Spivak

full_name: Aaron T. Spivak

given: Aaron T.

family: Ingraham

full_name: Karen Ingraham

family: Min

full_name: Sharon Min

given: Sharon

family: Holmes

full_name: David J. Holmes

given: David J.

family: Jakielaszek

full_name: Charles Jakielaszek

given: Charles

family: Rittenhouse

full_name: Stephen Rittenhouse

given: Stephen

family: Kwan

full_name: Alan L. Kwan

given: Alan L.

family: Livi

full_name: George P. Livi

given: George P.

family: Sathe

full_name: Ganesh Sathe

given: Ganesh

family: Thomas

full_name: Elizabeth Thomas

given: Elizabeth

family: Van Horn

full_name: Stephanie Van Horn

given: Stephanie

family: Miller

full_name: Linda A. Miller

given: Linda A.

family: Twynholm

full_name: Monique Twynholm

given: Monique

family: Tomayko

full_name: John Tomayko

family: Dalessandro

full_name: Marybeth Dalessandro

given: Marybeth

family: Caltabiano

full_name: Madelyn Caltabiano

given: Madelyn

family: Scangarella-Oman

full_name: Nicole E. Scangarella-Oman

given: Nicole E.

family: Brown

full_name: James R. Brown

given: James R.

journal_name: Antimicrobial Agents and Chemotherapy

evidence: open (via free pdf)

title: Bacterial Resistance to Leucyl-tRNA Synthetase Inhibitor GSK2251052 Develops during Treatment of Complicated Urinary Tract Infections

location_country:
France
Greece
Russian Federation
Spain
United States
Canada


location_country:
Netherlands
France
Korea, Republic of
United States
Canada
Taiwan

acronym: Rollover study

title: MEK114375: A Rollover Study to Provide Continued Treatment With GSK1120212 to Subjects With Solid Tumors or Leukemia

summary: This was an open-label study to permit subjects with solid tumors or leukemia, who were clinically benefitting on another GSK sponsored trial with GSK1120212 either monotherapy or in combination continued access to GSK1120212.


title: A Post-Market Study to Evaluate the Safety and Performance of the Ovation™ or Ovation Prime™ Abdominal Stent Graft System

summary: This is a prospective observational post-market study of subjects receiving the Ovation™ or Ovation Prime™ Abdominal Stent Graft System ("Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market Study") in the treatment of abdominal aortic aneurysms (AAA). The Ovation™ or Ovation Prime™ Abdominal Stent Graft System Post-Market study is intended to expand the clinical knowledge base by collecting data on subjects treated with the Ovation™ or Ovation Prime™ Abdominal Stent Graft System in actual clinical practice following commercial approval.

study_type: Observational

time_perspective: Prospective

lead_sponsor: TriVascular, Inc.

location_country:
Italy
Austria
Sweden
France
Greece
Belgium
Germany
United Kingdom

location_facility: Universitäres Herz und Gefaßzentrum Hamburg

location_facility: "CA Gefäßchirurgie Theresienkrankenhaus/St. Hedwig"

location_facility: Univeristà La Sapienza/Policlinico Umberto I

location_facility: Università La Sapienza/Policlinico Umberto I

location_facility: Medical University of Vienna Dept. for Radiology, Section for Cardiovascular and Interventional Radiology

location_facility: Städtisches klinikum Karlsruhe Klinik für Gefäß- und Thoraxchirurgie

location_facility: A.O. Ospedale di Circolo e Fondazione Macchi

location_facility: Frimley Park Hospital NHS Foundation Trust


ReferenceCitation: Woodhouse L, Gandhi R, Warden SJ, Poiraudeau S, Myers SL, Benson CT, Hu L, Ahmad QI, Linnemeier P, Gomez EV, Benichou O; STUDY INVESTIGATORS. A Phase 2 Randomized Study Investigating the Efficacy and Safety of Myostatin Antibody LY2495655 versus Placebo in Patients Undergoing Elective Total Hip Arthroplasty. J Frailty Aging. 2016;5(1):62-70. doi: 10.14283/jfa.2016.81.

family: WOODHOUSE

full_name: L. WOODHOUSE

given: L.

family: GANDHI

full_name: R. GANDHI

given: R.

family: WARDEN

full_name: S.J. WARDEN

family: POIRAUDEAU

full_name: S. POIRAUDEAU

given: S.

family: MYERS

full_name: S.L. MYERS

family: BENSON

full_name: C.T. BENSON

family: HU

full_name: L. HU

family: AHMAD

full_name: Q.I. AHMAD

family: LINNEMEIER

full_name: P. LINNEMEIER

given: P.

family: GOMEZ

full_name: E.V. GOMEZ

family: BENICHOU

full_name: O. BENICHOU

given: O.

journal_name: The Journal of Frailty & Aging

publisher: SERDI

publisher_dissemination: SERDI

publisher_group: SERDI

publisher_normalized: SERDI

title: A PHASE 2 RANDOMIZED STUDY INVESTIGATING THE EFFICACY AND SAFETY OF MYOSTATIN ANTIBODY LY2495655 VERSUS PLACEBO IN PATIENTS UNDERGOING ELECTIVE TOTAL HIP ARTHROPLASTY

lead_sponsor: Eli Lilly and Company

location_country:
Austria
United States
Sweden
Finland
France
Japan
Belgium
Spain
Estonia
Denmark
Canada

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

title: A Phase 2 Randomized Study to Investigate the Efficacy and Safety of LY2495655 Versus Placebo in Older Patients Undergoing Elective Total Hip Arthroplasty

summary: The primary objective of this study is to test the hypothesis that appendicular lean body mass (aLBM) will increase after 12 weeks of LY2495655 treatment versus placebo in older participants undergoing elective total hip arthroplasty (eTHA).


title: An Open-label, Phase 2a Study to Evaluate Pazopanib Eye Drops Administered for 12 Weeks to Patients With Neovascular Age-related Macular Degeneration

summary: The purpose of this 12 week, open-label study is to investigate the safety and efficacy of a single dose regimen of pazopanib eye drop for neovascular AMD.

ReferenceCitation: Singh R, Wurzelmann JI, Ye L, Henderson L, Hossain M, Trivedi T, Kelly DS. Clinical evaluation of pazopanib eye drops in healthy subjects and in subjects with neovascular age-related macular degeneration. Retina. 2014 Sep;34(9):1787-95. doi: 10.1097/IAE.0000000000000179.

family: Singh

full_name: Rishi Singh

given: Rishi

family: Wurzelmann

full_name: John I. Wurzelmann

given: John I.

family: Ye

full_name: Li Ye

given: Li

family: Henderson

full_name: Linda Henderson

given: Linda

family: Hossain

full_name: Mohammad Hossain

given: Mohammad

family: Trivedi

full_name: Trupti Trivedi

given: Trupti

family: Kelly

full_name: Deborah S. Kelly

given: Deborah S.

journal_name: Retina

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: CLINICAL EVALUATION OF PAZOPANIB EYE DROPS IN HEALTHY SUBJECTS AND IN SUBJECTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION

lead_sponsor: GlaxoSmithKline

location_country:
Germany
United States
France


ReferenceCitation: Bailey DB Jr, Berry-Kravis E, Wheeler A, Raspa M, Merrien F, Ricart J, Koumaras B, Rosenkranz G, Tomlinson M, von Raison F, Apostol G. Mavoglurant in adolescents with fragile X syndrome: analysis of Clinical Global Impression-Improvement source data from a double-blind therapeutic study followed by an open-label, long-term extension study. J Neurodev Disord. 2016;8:1. doi: 10.1186/s11689-015-9134-5. Epub 2015 Dec 15.

family: Bailey

full_name: Donald B. Bailey

given: Donald B.

suffix: Jr.

family: Berry-Kravis

full_name: Elizabeth Berry-Kravis

given: Elizabeth

family: Wheeler

full_name: Anne Wheeler

given: Anne

family: Raspa

full_name: Melissa Raspa

given: Melissa

family: Merrien

full_name: Florence Merrien

given: Florence

family: Ricart

full_name: Javier Ricart

given: Javier

family: Koumaras

full_name: Barbara Koumaras

given: Barbara

family: Rosenkranz

full_name: Gerd Rosenkranz

given: Gerd

family: Tomlinson

full_name: Mark Tomlinson

given: Mark

family: von Raison

full_name: Florian von Raison

given: Florian

family: Apostol

full_name: George Apostol

given: George

journal_name: Journal of Neurodevelopmental Disorders

ReferenceCitation: Berry-Kravis E, Des Portes V, Hagerman R, Jacquemont S, Charles P, Visootsak J, Brinkman M, Rerat K, Koumaras B, Zhu L, Barth GM, Jaecklin T, Apostol G, von Raison F. Mavoglurant in fragile X syndrome: Results of two randomized, double-blind, placebo-controlled trials. Sci Transl Med. 2016 Jan 13;8(321):321ra5. doi: 10.1126/scitranslmed.aab4109.

family: Des Portes

full_name: Vincent Des Portes

given: Vincent

family: Hagerman

full_name: Randi Hagerman

given: Randi

family: Jacquemont

full_name: Sébastien Jacquemont

given: Sébastien

family: Charles

full_name: Perrine Charles

given: Perrine

family: Visootsak

full_name: Jeannie Visootsak

given: Jeannie

publisher: American Association for the Advancement of Science (AAAS)

location_country:
Italy
United States
Sweden
Switzerland
Netherlands
Germany
Indonesia
France
Israel
Belgium
Australia
Spain
Turkey
Denmark
Canada
United Kingdom

title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of AFQ056 in Adolescent Patients With Fragile X Syndrome

summary: This Phase IIb study is designed to assess whether 3 doses of AFQ056 are safe and effective in treating the behavioral symptoms of Fragile X Syndrome.


location_country:
Italy
United States
Switzerland
Germany
France
Australia
Spain
Denmark
Canada
United Kingdom

title: An Open-label Study to Evaluate the Long-term Safety, Tolerability and Efficacy of AFQ056 in Adult Patients With Fragile X Syndrome

summary: The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in eligible adult patients with FXS who have participated in the CAFQ056A2212 (NCT01253629).study and patients who have participated in the previous proof-of-concept study CAFQ056A2204 (NCT00718341).


title: A Multicenter Open-label Extension Study For Subjects Who Participated In Study B0151003 (Andante Ii)

acronym: ANDANTE II

summary: This is a multi-center Phase 2, open label, safety extension study in subjects with moderate to severe CD who are anti-TNF inadequate responders. Subjects eligible for this study will have completed the 12-week induction period of study B0151003 and will be enrolled as either responders or non responders.

ReferenceCitation: Danese S, Vermeire S, Hellstern P, Panaccione R, Rogler G, Fraser G, Kohn A, Desreumaux P, Leong RW, Comer GM, Cataldi F, Banerjee A, Maguire MK, Li C, Rath N, Beebe J, Schreiber S. Randomised trial and open-label extension study of an anti-interleukin-6 antibody in Crohn's disease (ANDANTE I and II). Gut. 2019 Jan;68(1):40-48. doi: 10.1136/gutjnl-2017-314562. Epub 2017 Dec 15.

family: Danese

full_name: Silvio Danese

given: Silvio

family: Vermeire

full_name: Séverine Vermeire

given: Séverine

family: Hellstern

full_name: Paul Hellstern

given: Paul

family: Panaccione

full_name: Remo Panaccione

given: Remo

family: Rogler

full_name: Gerhard Rogler

given: Gerhard

family: Fraser

full_name: Gerald Fraser

given: Gerald

family: Kohn

full_name: Anna Kohn

given: Anna

family: Desreumaux

full_name: Pierre Desreumaux

given: Pierre

family: Leong

full_name: Rupert W Leong

given: Rupert W

family: Comer

full_name: Gail M Comer

given: Gail M

family: Cataldi

full_name: Fabio Cataldi

given: Fabio

family: Banerjee

full_name: Anindita Banerjee

given: Anindita

family: Maguire

full_name: Mary K Maguire

given: Mary K

family: Li

full_name: Cheryl Li

given: Cheryl

family: Rath

full_name: Natalie Rath

given: Natalie

family: Beebe

full_name: Jean Beebe

given: Jean

family: Schreiber

full_name: Stefan Schreiber

given: Stefan

repository_institution: University of Zurich - Zurich Open Repository and Archive

repositories:
LIRIAS (KU Leuven)
PubMed Central
www.zora.uzh.ch

title: Randomised trial and open-label extension study of an anti-interleukin-6 antibody in Crohn’s disease (ANDANTE I and II)

location_country:
Italy
United States
Brazil
Switzerland
United Kingdom
Germany
France
Israel
Hungary
Belgium
Australia
Ireland
New Zealand
Denmark
Canada
Czech Republic

location_facility: Weill Cornell Medical College of Cornell University-Greenberg

location_facility: The University of Chicago Medical Center

location_facility: Oklahoma Foundation for Digestive Research

location_facility: Azienda Ospedaliera - Universita di Padova

location_facility: Vanderbilt University Medical Center: IBD Clinic

location_facility: Vanderbilt University Medical Center-IDS

location_facility: Vanderbilt University Medical Center-GI Research

location_facility: Gastroenterology Associates of Western Michigan

location_facility: University Hospital Leuven, Campus Gasthuisberg

location_facility: Setor de Cardiologia do Hospital Nossa Senhora das Gracas

location_facility: IBD Center-Vanderbilt University Medical Center

location_facility: Medical Research Center of Connecticut, LLC

location_facility: Aarhus Universitetshospital, Aarhus Sygehus

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: Heritage Medical Research Clinic - University of Calgary

location_facility: Clinical Pathologiy Laboratories, Inc, DBA DRL Labs

location_facility: Rocky Mountain Gastroenterology Associates

location_facility: The University of Texas Health Science Center at Houston

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: Laboratório de Análises Clínicas do HUCFF/UFRJ

location_facility: Hadassah university Hospital (HUH) - Ein Karem, Hadassah Medical Organization (HMO)

location_facility: International Clinical Research - US, LLC

location_facility: Mater Misericordiae Hospital, Department of Clinical Chemistry and Clinical Haematology

location_facility: Hopital Saint-Antoine - Service De Gastroenterologie

location_facility: New York Presbyterian Hospital - Weill Cornell Medical College Investigational Pharmacy

location_facility: London Health Science Centre - University Hospital

location_facility: Weill Cornell Imaging at New York Presbyterian Hospital

location_facility: "Kirurgisk Afdeling 0143 Hilleroed Hospital

location_facility: Research Protocol Management Specialists

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: Hospital Universitário Fraga Filho da UFRJ

location_facility: Gastointestinal Specialists of Georgia, PC

location_facility: Colonoscopy and X-rays: OU Physicians Building

location_facility: Hepato-Gastroenterologie HK, s.r.o. Poliklinika III

location_facility: Universita Campus Biomedico UOC di Gastroenterologia

location_facility: Setor de Endoscopia Digestiva do Hospital Nossa Senhora das Gracas

location_facility: Medicinsk Afdeling, Gastroenterologisk Sektion

location_facility: The University of TX Health Sci. Ctr at Houston

location_facility: St Bartholomew's Hospital (Barts Health NHS Trust)

location_facility: VC Medical Center Investigative Drug Service (IDS) [Ship Drug To]

location_facility: University of Kentucky Chandler Medical Center

location_facility: Gastroenterology Consultants of Clearwater

location_facility: Atlanta Center for Gastroenterology, P.C.

location_facility: Institut klinicke a experimentalni mediciny

location_facility: Szegedi Tudomanyegyetem altalanos Orvostudomanyi Kar / I. sz. Belgyogyaszati Klinika

location_facility: Pathology, Haematology and Biochemistry Laboratories, St. Vincent's Healthcare Group

location_facility: Barts Health NHS Trust-Royal London Hospital


title: A Multicenter, Randomized, Double-Blind, Placebo and Active Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-639 to Placebo in Subjects With Diabetic Neuropathic Pain

summary: People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.

ReferenceCitation: Ziegler D, Duan WR, An G, Thomas JW, Nothaft W. A randomized double-blind, placebo-, and active-controlled study of T-type calcium channel blocker ABT-639 in patients with diabetic peripheral neuropathic pain. Pain. 2015 Oct;156(10):2013-2020. doi: 10.1097/j.pain.0000000000000263.

family: Ziegler

full_name: Dan Ziegler

given: Dan

family: Duan

full_name: W. Rachel Duan

given: W. Rachel

family: An

full_name: Guohua An

given: Guohua

family: Thomas

full_name: James W. Thomas

given: James W.

family: Nothaft

full_name: Wolfram Nothaft

given: Wolfram

journal_name: Pain

oa_host_type: repository

license: implied-oa

license_normalized: implied-oa

lead_sponsor: AbbVie (prior sponsor, Abbott)

location_country:
United States
Mexico
France
Germany
Czech Republic

location_facility:
Site Reference ID/Investigator# 52744
Site Reference ID/Investigator# 51468
Site Reference ID/Investigator# 51425
Site Reference ID/Investigator# 52346
Site Reference ID/Investigator# 51504
Site Reference ID/Investigator# 51924
Site Reference ID/Investigator# 51263
Site Reference ID/Investigator# 52743
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ReferenceCitation: Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asadi-Pooya AA. Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: Post hoc pooled analysis. Epilepsy Res. 2021 Oct;176:106694. doi: 10.1016/j.eplepsyres.2021.106694. Epub 2021 Jun 24.

family: Moseley

full_name: Brian D. Moseley

given: Brian D.

family: Dimova

full_name: Svetlana Dimova

given: Svetlana

family: Elmoufti

full_name: Sami Elmoufti

given: Sami

family: Laloyaux

full_name: Cédric Laloyaux

given: Cédric

family: Asadi-Pooya

full_name: Ali A. Asadi-Pooya

given: Ali A.

journal_name: Epilepsy Research

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

repository_institution: Oxford - Oxford Academix

ReferenceCitation: Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6. Review.

family: Markham

full_name: Anthony Markham

given: Anthony

journal_name: Drugs

title: Brivaracetam: First Global Approval

ReferenceCitation: Klein P, Schiemann J, Sperling MR, Whitesides J, Liang W, Stalvey T, Brandt C, Kwan P. A randomized, double-blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of adjunctive brivaracetam in adult patients with uncontrolled partial-onset seizures. Epilepsia. 2015 Dec;56(12):1890-8. doi: 10.1111/epi.13212. Epub 2015 Oct 16.

name: Mid‐Atlantic Epilepsy and Sleep Center Bethesda Maryland U.S.A

family: Klein

full_name: Pavel Klein

given: Pavel

family: Schiemann

full_name: Jimmy Schiemann

given: Jimmy

name: Thomas Jefferson University Philadelphia Pennsylvania U.S.A

family: Sperling

full_name: Michael R. Sperling

given: Michael R.

family: Whitesides

full_name: John Whitesides

given: John

family: Liang

full_name: Wei Liang

given: Wei

family: Stalvey

full_name: Tracy Stalvey

given: Tracy

name: Bethel Epilepsy Centre Mara Hospital Bielefeld Germany

family: Brandt

full_name: Christian Brandt

given: Christian

name: University of Melbourne and Royal Melbourne Hospital Parkville Victoria Australia

name: Chinese University of Hong Kong Hong Kong Hong Kong SAR China

family: Kwan

full_name: Patrick Kwan

given: Patrick

journal_name: Epilepsia

oa_host_type: publisher

title: A randomized, double‐blind, placebo‐controlled, multicenter, parallel‐group study to evaluate the efficacy and safety of adjunctive brivaracetam in adult patients with uncontrolled partial‐onset seizures

location_country:
Finland
Belgium
Russian Federation
Taiwan
India
France
Japan
Lithuania
Poland
Canada
Korea, Republic of
Sweden
Hong Kong
Netherlands
Bulgaria
Hungary
Puerto Rico
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Spain
Estonia
Latvia

title: An Open-label, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older With Epilepsy

summary: This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and single arm study of brivaracetam (BRV).


lead_sponsor: Actelion

location_country:
Italy
South Africa
India
Serbia
Mexico
Spain
Germany
France
Czechia
Poland
Israel
Belarus
Australia
Hungary
Russian Federation
China
United States
Ukraine

acronym: FUTURE 3 Ext

location_facility: Instituto Nacional de Cardiologia (INC) Ignacio Chavez - Site 8401

location_facility: Columbia University Medical Center Children's Hospital of New York Presbyterian - Site 9101

location_facility: Fakultní nemocnice v Motole, dětské kardiocentrum - Site 3301

location_facility: Royal Children's Hospital Melbourne, Cardiology - Site 5001

location_facility: Cardiovascular Institute and Fuwai Hospital

location_facility: Children's National Medical Center - Site 9104

location_facility: Clinical Diagnostic Center - Pediatric Cardiovascular and ANES and Intensive Care Department - Site 4103

location_facility: Gover INS - Scientific Practical Cardiovascular Pediatric Center - MOH Ukraine - Site 4102

location_facility: Ospedale Pediatrico "Bambino Gesù" - Dipartimento Medico Chirurgico di Cardiologia Pediatrica - Site 1502

location_facility: Hospital Universitatario Vall d'Hebron, Neumologia - Site 1907

location_facility: Scientific Center of Cardiovascular Surgery named after A.N.Bakulev of the RAMS - Site 3803

location_facility: Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ, Gyermekgyógyászati Klinika és Gyermekegészségügyi Központ - Site 3402

location_facility: Moscow Scientific Research Institute for Pediatrics and Childrens Surgery of Rosmedtechnologies - Site 3804

location_facility: Institut za zdravstvenu zaštitu majke i deteta Srbije "Dr Vukan Čupić", Služba za ispitivanje i lečenje bolesti srca i krvnih sudova - Site 3902

location_facility: Hospital Universitario La Paz - Paediatric Cardiology Department - Site 1906

location_facility: Gusak Ins Urgent and Recovery SUR AMS - Cardiovascular Rehabilitation Pediatric Department - Site 4101

location_facility: Università Degli Studi di Padova - Dipartimento di Pediatria - Servizio di Cardiologia Pediatrica - Site 1501

location_facility: Department of Paediatric Cardiology University of the Free State - Site 6001

location_facility: Univerzitetska dečja klinika, Služba za kardiologiju - Site 3901

location_facility: Division of Paediatric Cardiology, Steve Biko Academic Hospital - Site 6002

location_facility: Wojewódzki Szpital Specjalistyczny we Wrocławiu Oddział Kardiologii Dziecięcej z pododdziałem Intensywnego Nadzoru Kardiologicznego - Site 3605

location_facility: The Republican Scientific-Practical Center "Cardiology" - Site 3001

location_facility: Universitätsklinikum Bonn Abteilung für Kinderkardiologie - Site 1404

location_facility: Shanghai Children's Medical Center - Site 5102

location_facility: Gottsegen György Országos Kardiológiai Intézet, Gyermekszív Központ, Gyermek Kardiológiai osztály - Site 3401

location_facility: Uniwersyteckie Centrum Kliniczne Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca - Site 3604

location_facility: Hopital Necker-Enfants Malades, Service de Cardiologie Pédiatrique - Site 2201

location_facility: Deutsches Herzzentrum Kinderkardiologie - Site 1401

location_facility: RAMS Institution, Research Institute for complex issues of cardiovascular diseases, Siberian branch of the Russian Academy of Medical Sciences - Site 3805

location_facility: State Educational Institution of Higher Professional Education "Saint Petersburg State Pediatric Medical Academy of Roszdrav" - Site 3801

location_facility: Justus-Liebig-Universität Giessen, Kinderherzzentrum - Site 1403

location_facility: CARE Hospitals, Cardiology Dep. Hyderabad - Site 5302

location_facility: CHU de Toulouse - Hôpital des Enfants, Service de Cardiologie Pédiatrique - Site 2202

location_facility: Federal State Institution "Federal center of Heart, Blood and Endocrinology named after V.A.Almazov Rosmedtekhnologies" - Site 3802

location_facility: Schneider Children's Medical Center- Institute of pediatric cardiology - Site 7101

title: A Prospective, Multicenter, Open-label Extension of FUTURE 3 to Assess the Safety, Tolerability and Efficacy of the Pediatric Formulation of Bosentan Two Versus Three Times a Day in Children With Pulmonary Arterial Hypertension

summary: The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with Pulmonary Arterial Hypertension (PAH).


ReferenceCitation: Collins PW, Young G, Knobe K, Karim FA, Angchaisuksiri P, Banner C, Gürsel T, Mahlangu J, Matsushita T, Mauser-Bunschoten EP, Oldenburg J, Walsh CE, Negrier C; paradigm 2 Investigators. Recombinant long-acting glycoPEGylated factor IX in hemophilia B: a multinational randomized phase 3 trial. Blood. 2014 Dec 18;124(26):3880-6. doi: 10.1182/blood-2014-05-573055. Epub 2014 Sep 26.

acronym: paradigm™ 2

title: A Multi-centre, Single-blind Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC-0156-0000-0009 When Used for Treatment and Prophylaxis of Bleeding Episodes in Patients With Haemophilia B

summary: This trial is conducted in Africa, Asia, Europe, Japan and North America. The aim of this trial is to evaluate the safety and efficacy, including pharmacokinetics (the rate at which the body eliminates the trial drug), of NNC-0156-0000-0009 (nonacog beta pegol) when used for treatment and prophylaxis of bleeding episodes in patients with haemophilia B.


title: Safety and Pharmacokinetics of ODM-201 in Patients With Castrate Resistant Prostate Cancer: Open, Non-randomised, Uncontrolled, Multicentre, Multiple Dose Escalation Study With a Randomised Phase II Expansion Component

summary: The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of ODM-201 in patients with castrate resistant prostate cancer.

ReferenceCitation: Fizazi K, Massard C, Bono P, Jones R, Kataja V, James N, Garcia JA, Protheroe A, Tammela TL, Elliott T, Mattila L, Aspegren J, Vuorela A, Langmuir P, Mustonen M; ARADES study group. Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label phase 1 dose-escalation and randomised phase 2 dose expansion trial. Lancet Oncol. 2014 Aug;15(9):975-85. doi: 10.1016/S1470-2045(14)70240-2. Epub 2014 Jun 25.

family: Fizazi

full_name: Karim Fizazi

given: Karim

family: Massard

full_name: Christophe Massard

given: Christophe

family: Bono

full_name: Petri Bono

given: Petri

family: Jones

full_name: Robert Jones

given: Robert

family: Kataja

full_name: Vesa Kataja

given: Vesa

family: James

full_name: Nicholas James

given: Nicholas

family: Garcia

full_name: Jorge A Garcia

given: Jorge A

family: Protheroe

full_name: Andrew Protheroe

given: Andrew

family: Tammela

full_name: Teuvo L Tammela

given: Teuvo L

family: Elliott

full_name: Tony Elliott

given: Tony

family: Mattila

full_name: Leena Mattila

given: Leena

family: Aspegren

full_name: John Aspegren

family: Vuorela

full_name: Annamari Vuorela

given: Annamari

family: Langmuir

full_name: Peter Langmuir

given: Peter

family: Mustonen

full_name: Mika Mustonen

given: Mika

journal_name: The Lancet Oncology

repository_normalized: https

version: acceptedVersion

repositories_institution: Cardiff University - ORCA Online Research @Cardiff

lead_sponsor: Orion Corporation, Orion Pharma

location_country:
United Kingdom
Finland
France
Estonia
United States
Czech Republic

location_facility: Klinika onkologie a radioterapie LFUK a FN

location_facility: Eastern CT Hematology and Oncology Associates

location_facility: Oddeleni Radiacni a Klinicke Onkologie Nemocnice Znojmo


ReferenceCitation: Bilton D, Fajac I, Pressler T, Clancy JP, Sands D, Minic P, Cipolli M, Galeva I, Solé A, Quittner AL, Jumadilova Z, Ciesielska M, Konstan MW; CLEAR-110 Study Group. Long-term amikacin liposome inhalation suspension in cystic fibrosis patients with chronic P. aeruginosa infection. J Cyst Fibros. 2021 Jun 15. pii: S1569-1993(21)00164-8. doi: 10.1016/j.jcf.2021.05.013. [Epub ahead of print]

family: Bilton

full_name: Diana Bilton

given: Diana

family: Fajac

full_name: Isabelle Fajac

given: Isabelle

family: Pressler

full_name: Tacjana Pressler

given: Tacjana

family: Clancy

full_name: John Paul Clancy

given: John Paul

family: Sands

full_name: Dorota Sands

given: Dorota

family: Minic

full_name: Predrag Minic

given: Predrag

family: Cipolli

full_name: Marco Cipolli

given: Marco

family: Galeva

full_name: Ivanka Galeva

given: Ivanka

family: Solé

full_name: Amparo Solé

given: Amparo

family: Quittner

full_name: Alexandra L. Quittner

given: Alexandra L.

family: Jumadilova

full_name: Zhanna Jumadilova

given: Zhanna

family: Ciesielska

full_name: Monika Ciesielska

given: Monika

family: Konstan

full_name: Michael W. Konstan

given: Michael W.

journal_name: Journal of Cystic Fibrosis

lead_sponsor: Insmed Incorporated

location_country:
Italy
Austria
Serbia
Netherlands
Germany
France
Bulgaria
Greece
Poland
Slovakia
Hungary
Belgium
Ireland
Spain
Denmark
Canada
United Kingdom

title: Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (ARIKACE™) in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa

summary: The purpose of this study is to evaluate the long term safety and tolerability of Liposomal Amikacin for Inhalation (LAI) 590 mg once daily (QD) in Cystic Fibrosis patients with chronic infection due to pseudomonas aeruginosa. This long-term, open-label, multi-cycle extension study enrolled subjects who had successfully completed study TR02-108, were compliant with the study protocol, and did not meet any of the listed study discontinuation criteria. The safety and tolerability of LAI were evaluated for up to approximately 2 years.


title: Multi-centric Observational Study to Analyse the Diagnostic Molecular Features in the Clinical Setting of Kidney Allograft Biopsies

summary: The current standard for biopsy-based diagnoses of dysfunction of kidney transplants is the Banff Classification which represents arbitrary international consensus. Recent data-driven approaches using molecular and conventional technologies indicate that mere consensus produces frequently incorrect diagnoses with potential harm to patients due to inappropriate treatment. To address this unmet need and improve diagnostics in the area of organ transplantation, the Alberta Transplant Applied Genomics Centre (ATAGC) has developed a new diagnostic system that combines the molecular and histopathological features of transplant biopsies, plus clinical and laboratory parameters, to create the first Integrated Diagnostic System. The present study will validate and refine this system in 500 prospectively unselected biopsies for clinical indications from American, Canadian and European centres in addition to 300 biopsies already collected. Due to a considerable interest and support from participating Centers, the study is further extended to 1500 prospective biopsies. Thus this is the extension of the INTERCOM study (INTERCOMEX). In addition to demonstrating the feasibility and value of this System in routine patient care and clinical trials, the study will develop and optimize a transparent and user-friendly reporting format to communicate this information to clinicians and obtain detailed feedback on how this system can best improve patient care.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Halloran PF, Famulski KS, Reeve J. Molecular assessment of disease states in kidney transplant biopsy samples. Nat Rev Nephrol. 2016 Sep;12(9):534-48. doi: 10.1038/nrneph.2016.85. Epub 2016 Jun 27. Review.

ReferenceCitation: Einecke G, Reeve J, Gupta G, Böhmig GA, Eskandary F, Bromberg JS, Budde K, Halloran PF; INTERCOMEX investigators. Factors associated with kidney graft survival in pure antibody-mediated rejection at the time of indication biopsy: Importance of parenchymal injury but not disease activity. Am J Transplant. 2021 Apr;21(4):1391-1401. doi: 10.1111/ajt.16161. Epub 2020 Jul 31.

ReferenceCitation: Halloran PF, Pereira AB, Chang J, Matas A, Picton M, De Freitas D, Bromberg J, Serón D, Sellarés J, Einecke G, Reeve J. Potential impact of microarray diagnosis of T cell-mediated rejection in kidney transplants: The INTERCOM study. Am J Transplant. 2013 Sep;13(9):2352-63. doi: 10.1111/ajt.12387. Epub 2013 Aug 5.

family: Halloran

full_name: P. F. Halloran

given: P. F.

family: Pereira

full_name: A. B. Pereira

given: A. B.

name: Alberta Transplant Applied Genomics Centre; University of Alberta; Edmonton; AB; Canada

family: Chang

full_name: J. Chang

given: J.

name: University of Minnesota; Minneapolis; MN

family: Matas

full_name: A. Matas

given: A.

name: Department of Renal Medicine; Manchester Royal Infirmary; Manchester; England

family: Picton

full_name: M. Picton

given: M.

family: De Freitas

full_name: D. De Freitas

given: D.

name: University of Maryland School of Medicine; Baltimore; MD

family: Bromberg

full_name: J. Bromberg

name: Servei de Nefrologia; Hospital Vall d'Hebron; Barcelona; Spain

family: Serón

full_name: D. Serón

family: Sellarés

full_name: J. Sellarés

name: Medical School of Hannover; Hannover; Germany

family: Einecke

full_name: G. Einecke

given: G.

family: Reeve

full_name: J. Reeve

journal_name: American Journal of Transplantation

title: Potential Impact of Microarray Diagnosis of T Cell-Mediated Rejection in Kidney Transplants: The INTERCOM Study

ReferenceCitation: Halloran PF, Pereira AB, Chang J, Matas A, Picton M, De Freitas D, Bromberg J, Serón D, Sellarés J, Einecke G, Reeve J. Microarray diagnosis of antibody-mediated rejection in kidney transplant biopsies: an international prospective study (INTERCOM). Am J Transplant. 2013 Nov;13(11):2865-74. doi: 10.1111/ajt.12465. Epub 2013 Oct 3.

name: Alberta Transplant Applied Genomics Center; University of Alberta; Edmonton AB Canada

name: Department of Medicine, Division of Nephrology and Transplant Immunology; University of Alberta; Edmonton AB Canada

name: Department of Nephrology; Santa Casa de Misericordia de Belo Horizonte; Belo Horizonte Brazil

name: Department of Renal Medicine; Manchester Royal Infirmary; Manchester England

name: University of Maryland School of Medicine; Baltimore MD

name: Servei de Nefrologia; Hospital Vall d'Hebron; Barcelona Spain

name: Medical School of Hannover; Hannover Germany

name: Department of Laboratory Medicine and Pathology; University of Alberta; Edmonton AB Canada

title: Microarray Diagnosis of Antibody-Mediated Rejection in Kidney Transplant Biopsies: An International Prospective Study (INTERCOM)

ReferenceCitation: Loupy A, Lefaucheur C, Vernerey D, Chang J, Hidalgo LG, Beuscart T, Verine J, Aubert O, Dubleumortier S, Duong van Huyen JP, Jouven X, Glotz D, Legendre C, Halloran PF. Molecular microscope strategy to improve risk stratification in early antibody-mediated kidney allograft rejection. J Am Soc Nephrol. 2014 Oct;25(10):2267-77. doi: 10.1681/ASN.2013111149. Epub 2014 Apr 3.

journal_name: Journal of the American Society of Nephrology

title: Molecular Microscope Strategy to Improve Risk Stratification in Early Antibody-Mediated Kidney Allograft Rejection

ReferenceCitation: Halloran PF, Chang J, Famulski K, Hidalgo LG, Salazar ID, Merino Lopez M, Matas A, Picton M, de Freitas D, Bromberg J, Serón D, Sellarés J, Einecke G, Reeve J. Disappearance of T Cell-Mediated Rejection Despite Continued Antibody-Mediated Rejection in Late Kidney Transplant Recipients. J Am Soc Nephrol. 2015 Jul;26(7):1711-20. doi: 10.1681/ASN.2014060588. Epub 2014 Nov 6.

ReferenceCitation: Halloran PF, Merino Lopez M, Barreto Pereira A. Identifying Subphenotypes of Antibody-Mediated Rejection in Kidney Transplants. Am J Transplant. 2016 Mar;16(3):908-20. doi: 10.1111/ajt.13551. Epub 2016 Jan 6.

name: Alberta Transplant Applied Genomics Centre; Edmonton; Alberta Canada

name: Department of Medicine, Division of Nephrology and Transplant Immunology; University of Alberta; Edmonton Alberta Canada

name: Hospital Santa Julia; Manaus; Amazonas Brazil

ReferenceCitation: Reeve J, Chang J, Salazar ID, Lopez MM, Halloran PF. Using Molecular Phenotyping to Guide Improvements in the Histologic Diagnosis of T Cell-Mediated Rejection. Am J Transplant. 2016 Apr;16(4):1183-92. doi: 10.1111/ajt.13572. Epub 2016 Jan 5.

name: Alberta Transplant Applied Genomics Centre; University of Alberta; Edmonton Alberta Canada

name: Department of Medicine; Viedma Hospital; Cochabamba Bolivia

ReferenceCitation: Eskandary F, Bond G, Kozakowski N, Regele H, Marinova L, Wahrmann M, Kikić Ž, Haslacher H, Rasoul-Rockenschaub S, Kaltenecker CC, König F, Hidalgo LG, Oberbauer R, Halloran PF, Böhmig GA. Diagnostic Contribution of Donor-Specific Antibody Characteristics to Uncover Late Silent Antibody-Mediated Rejection-Results of a Cross-Sectional Screening Study. Transplantation. 2017 Mar;101(3):631-641. doi: 10.1097/TP.0000000000001195.

title: Diagnostic Contribution of Donor-Specific Antibody Characteristics to Uncover Late Silent Antibody-Mediated Rejection—Results of a Cross-Sectional Screening Study

ReferenceCitation: Aubert O, Loupy A, Hidalgo L, Duong van Huyen JP, Higgins S, Viglietti D, Jouven X, Glotz D, Legendre C, Lefaucheur C, Halloran PF. Antibody-Mediated Rejection Due to Preexisting versus De Novo Donor-Specific Antibodies in Kidney Allograft Recipients. J Am Soc Nephrol. 2017 Jun;28(6):1912-1923. doi: 10.1681/ASN.2016070797. Epub 2017 Mar 2.

title: Antibody-Mediated Rejection Due to Preexisting versusDe NovoDonor-Specific Antibodies in Kidney Allograft Recipients

ReferenceCitation: Halloran PF, Reeve J, Akalin E, Aubert O, Bohmig GA, Brennan D, Bromberg J, Einecke G, Eskandary F, Gosset C, Duong Van Huyen JP, Gupta G, Lefaucheur C, Malone A, Mannon RB, Seron D, Sellares J, Weir M, Loupy A. Real Time Central Assessment of Kidney Transplant Indication Biopsies by Microarrays: The INTERCOMEX Study. Am J Transplant. 2017 Nov;17(11):2851-2862. doi: 10.1111/ajt.14329. Epub 2017 May 30.

name: Alberta Transplant Applied Genomics Centre; Edmonton AB Canada

name: Division of Nephrology and Transplant Immunology; Department of Medicine; University of Alberta; Edmonton AB Canada

name: Paris Translational Research Center for Organ Transplantation; INSERM; Uss-S970; Paris France

name: Medizinische Universität Wien; Vienna Austria

name: Washington University at St. Louis; St. Louis MO

name: Division of Nephrology; Department of Medicine; University of Maryland School of Medicine; Baltimore MD

name: Medizinische Hochschule Hannover; Hannover Germany

name: Saint-Louis Hospital; Assistance Publique-Hôpitaux de Paris; Paris France

name: Virginia Commonwealth University; Richmond VA

name: University of Alabama at Birmingham; Birmingham AL

name: Hospital Universitari Vall D'Hebron; Barcelona Spain

name: Necker Hospital; Assistance Publique-Hôpitaux de Paris; Paris France

ReferenceCitation: Reeve J, Böhmig GA, Eskandary F, Einecke G, Lefaucheur C, Loupy A, Halloran PF; MMDx-Kidney study group. Assessing rejection-related disease in kidney transplant biopsies based on archetypal analysis of molecular phenotypes. JCI Insight. 2017 Jun 15;2(12). pii: 94197. doi: 10.1172/jci.insight.94197. eCollection 2017 Jun 15.

publisher: American Society for Clinical Investigation

publisher_dissemination: American Society for Clinical Investigation

publisher_group: American Society for Clinical Investigation

publisher_normalized: American Society for Clinical Investigation

ReferenceCitation: Madill-Thomsen KS, Wiggins RC, Eskandary F, Böhmig GA, Halloran PF. The Effect of Cortex/Medulla Proportions on Molecular Diagnoses in Kidney Transplant Biopsies: Rejection and Injury Can Be Assessed in Medulla. Am J Transplant. 2017 Aug;17(8):2117-2128. doi: 10.1111/ajt.14233. Epub 2017 Mar 23.

name: Nephrology Division; Department of Internal Medicine; University of Michigan; Ann Arbor MI

name: Division of Nephrology and Dialysis; Department of Medicine III; Medical University Vienna; Vienna Austria

name: Department of Medicine; University of Alberta; Edmonton AB Canada

repositories_institution:
PubMed Central - Europe PMC
University of Michigan - Deep Blue

ReferenceCitation: Halloran PF, Venner JM, Famulski KS. Comprehensive Analysis of Transcript Changes Associated With Allograft Rejection: Combining Universal and Selective Features. Am J Transplant. 2017 Jul;17(7):1754-1769. doi: 10.1111/ajt.14200. Epub 2017 Feb 25.

ReferenceCitation: Halloran PF, Matas A, Kasiske BL, Madill-Thomsen KS, Mackova M, Famulski KS. Molecular phenotype of kidney transplant indication biopsies with inflammation in scarred areas. Am J Transplant. 2019 May;19(5):1356-1370. doi: 10.1111/ajt.15178. Epub 2018 Dec 13.

name: Alberta Transplant Applied Genomics Centre Edmonton AlbertaCanada

name: Division of Nephrology and Transplant Immunology Department of Medicine University of Alberta Edmonton AlbertaCanada

name: Department of Surgery University of Minnesota at Fairview Minneapolis Minnesota

name: The Hennepin County Medical Center Minneapolis Minnesota

ReferenceCitation: Reeve J, Böhmig GA, Eskandary F, Einecke G, Gupta G, Madill-Thomsen K, Mackova M, Halloran PF; INTERCOMEX MMDx-Kidney Study Group. Generating automated kidney transplant biopsy reports combining molecular measurements with ensembles of machine learning classifiers. Am J Transplant. 2019 Oct;19(10):2719-2731. doi: 10.1111/ajt.15351. Epub 2019 Apr 10. Erratum in: Am J Transplant. 2020 Feb;20(2):620-621.

name: Alberta Transplant Applied Genomics Centre Alberta Canada

name: Department of Laboratory Medicine and Pathology University of Alberta Edmonton Alberta Canada

name: Division of Nephrology and Dialysis Department of Medicine III Medical University of Vienna Vienna Austria

name: Department of Nephrology Medizinische Hochschule Hannover Hannover Germany

name: Division of Nephrology Virginia Commonwealth University Richmond Virginia

name: Department of Medicine Division of Nephrology and Transplant Immunology University of Alberta Edmonton Alberta Canada

bso_classification:
Earth, Ecology,
Energy and applied biology

ReferenceCitation: Madill-Thomsen K, Perkowska-Ptasińska A, Böhmig GA, Eskandary F, Einecke G, Gupta G, Halloran PF; MMDx-Kidney Study Group. Discrepancy analysis comparing molecular and histology diagnoses in kidney transplant biopsies. Am J Transplant. 2020 May;20(5):1341-1350. doi: 10.1111/ajt.15752. Epub 2020 Jan 23.

name: Medical University of Warsaw Warsaw Poland

name: Alberta Transplant Applied Genomics Centre Edmonton Alberta Canada

ReferenceCitation: Halloran PF, Madill-Thomsen KS, Böhmig GA, Myslak M, Gupta G, Kumar D, Viklicky O, Perkowska-Ptasinska A, Famulski KS; INTERCOMEX Investigators. A 2-fold Approach to Polyoma Virus (BK) Nephropathy in Kidney Transplants: Distinguishing Direct Virus Effects From Cognate T Cell-mediated Inflammation. Transplantation. 2021 Nov 1;105(11):2374-2384. doi: 10.1097/TP.0000000000003884.

title: A Two-fold Approach to Polyoma Virus (BK) Nephropathy in Kidney Transplants

ReferenceCitation: Madill-Thomsen KS, Böhmig GA, Bromberg J, Einecke G, Eskandary F, Gupta G, Hidalgo LG, Myslak M, Viklicky O, Perkowska-Ptasinska A, Halloran PF; INTERCOMEX Investigators. Donor-Specific Antibody Is Associated with Increased Expression of Rejection Transcripts in Renal Transplant Biopsies Classified as No Rejection. J Am Soc Nephrol. 2021 Nov;32(11):2743-2758. doi: 10.1681/ASN.2021040433. Epub 2021 Jul 12.

title: Donor-Specific Antibody is Associated with Increased Expression of Rejection Transcripts in Renal Transplant Biopsies Classified As No Rejection

ReferenceCitation: Halloran PF. Integrating molecular and histologic interpretation of transplant biopsies. Clin Transplant. 2021 Apr;35(4):e14244. doi: 10.1111/ctr.14244. Epub 2021 Feb 17.

name: Alberta Transplant Applied Genomics Centre Edmonton AB Canada

name: Division of Nephrology and Transplant Immunology Department of Medicine University of Alberta Edmonton AB Canada

title: Integrating molecular and histologic interpretation of transplant biopsies

ReferenceCitation: Halloran PF, Böhmig GA, Bromberg JS, Budde K, Gupta G, Einecke G, Eskandary F, Madill-Thomsen K, Reeve J; INTERCOMEX investigators. Discovering novel injury features in kidney transplant biopsies associated with TCMR and donor aging. Am J Transplant. 2021 May;21(5):1725-1739. doi: 10.1111/ajt.16374. Epub 2020 Nov 30.

name: University of Maryland Baltimore Maryland

name: Charite‐Medical University of Berlin Berlin Germany

name: Medical University of Hannover Hannover Germany

ReferenceCitation: Venner JM, Famulski KS, Reeve J, Chang J, Halloran PF. Relationships among injury, fibrosis, and time in human kidney transplants. JCI Insight. 2016 Jan 21;1(1):e85323. doi: 10.1172/jci.insight.85323.

title: Relationships among injury, fibrosis, and time in human kidney transplants

location_country:
Austria
Switzerland
United Kingdom
Germany
Croatia
Czechia
France
Korea, Republic of
Poland
Ireland
Spain
United States
Slovenia
Canada

location_facility: Virginia Commonwealth University School of Medicine

location_facility: Department of Surgery, University of Usan, College of Medicine

location_facility: University of British Columbia, St. Paul's Hospital

location_facility: Pomeranian Medical University in Szczecin

location_facility: University of Wisconsin School of Medicine and Public Health

location_facility: Department of Medicine, University of Alberta

location_facility: Texas Transplant Institute - Methodist Healthcare System

location_facility: Institute for Experimental and Clinical Medicine (IKEM)

location_facility: University of Maryland School of Medicine


title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Study of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease.

acronym: TALISMAN 201

summary: This study is a double-blind study to evaluate the efficacy and safety of NV1FGF, a pCOR plasmid constructed by inserting the gene coding for the FGF compared to placebo in patients with severe Peripheral Arterial Occlusive Disease, Fontaine's stage IV. The efficacy was assessed by the complete healing of at least one ulcer in the treated limb, 25 week post-baseline and secondary by the rate of amputation and death.

ReferenceCitation: Nikol S, Baumgartner I, Van Belle E, Diehm C, Visoná A, Capogrossi MC, Ferreira-Maldent N, Gallino A, Wyatt MG, Wijesinghe LD, Fusari M, Stephan D, Emmerich J, Pompilio G, Vermassen F, Pham E, Grek V, Coleman M, Meyer F; TALISMAN 201 investigators. Therapeutic angiogenesis with intramuscular NV1FGF improves amputation-free survival in patients with critical limb ischemia. Mol Ther. 2008 May;16(5):972-8. doi: 10.1038/mt.2008.33. Epub 2008 Apr 1.

family: Nikol

full_name: Sigrid Nikol

given: Sigrid

family: Baumgartner

full_name: Iris Baumgartner

given: Iris

family: Van Belle

full_name: Eric Van Belle

given: Eric

family: Diehm

full_name: Curt Diehm

given: Curt

family: Visoná

full_name: Adriana Visoná

given: Adriana

family: Capogrossi

full_name: Maurizio C Capogrossi

given: Maurizio C

family: Ferreira-Maldent

full_name: Nicole Ferreira-Maldent

given: Nicole

family: Gallino

full_name: Augusto Gallino

given: Augusto

family: Graham Wyatt

full_name: Michael Graham Wyatt

given: Michael

family: Dinesh Wijesinghe

full_name: Lasantha Dinesh Wijesinghe

given: Lasantha

family: Fusari

full_name: Melissa Fusari

given: Melissa

family: Stephan

full_name: Dominique Stephan

given: Dominique

family: Emmerich

full_name: Joseph Emmerich

given: Joseph

family: Pompilio

full_name: Giulio Pompilio

given: Giulio

family: Vermassen

full_name: Frank Vermassen

given: Frank

family: Pham

full_name: Emmanuel Pham

given: Emmanuel

family: Grek

full_name: Vincent Grek

given: Vincent

family: Coleman

full_name: Michael Coleman

family: Meyer

full_name: François Meyer

given: François

journal_name: Molecular Therapy

title: Therapeutic Angiogenesis With Intramuscular NV1FGF Improves Amputation-free Survival in Patients With Critical Limb Ischemia

ReferenceCitation: Niebuhr A, Henry T, Goldman J, Baumgartner I, van Belle E, Gerss J, Hirsch AT, Nikol S. Long-term safety of intramuscular gene transfer of non-viral FGF1 for peripheral artery disease. Gene Ther. 2012 Mar;19(3):264-70. doi: 10.1038/gt.2011.85. Epub 2011 Jun 30.

location_country:
Italy
Switzerland
France
Belgium
Germany
United Kingdom

location_facility:
St George's Hospital
Klinikum Karlsbad-Langensteinbach
Istituto Dermopatico dell'Immacolata
Universitätsklinik
Hôpital Européen Georges Pompidou
Ghent University Hospital


title: User Evaluation New Ambient Experience Content

summary:
The study aims to investigate the effect of Philips Ambient Experience with specially designed paediatric content on the experience of pediatric patients undergoing an MRI examination, their caregiver, and clinical staff, on workflow and on clinical outcome. The designed paediatric content exists of personal selection of a character, video projection on the wall and/or a screen visible when in the bore, audio, and room ambience lighting.

The study will be conducted in collaboration with six partner hospitals within the EU. At each hospital, 50 pediatric patients between 6 and 12 years old will be included in the study.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Supportive Care

lead_sponsor: Philips Electronics Nederland B.V. acting through Philips CTO organization

location_country: Netherlands Poland France Belgium Spain Denmark

location_facility: Polish Mother's Hospital / Institute of Polish Mother's Health Center

intervention_type: Behavioral

status_simplified: Ongoing


title: Multinational, Observational, Retrospective Study to Evaluate Coagulation Changes and the Influence of Antithrombin III Treatment in Patients With Severe COVID-19 Infection

summary: Multicentre, multinational, non-interventional, observational, retrospective, patient record study to evaluate changes in coagulation parameters in patients with severe COVID-19 infection receiving/not treatment with antithrombin (AT) III

status: Active, not recruiting

time_perspective: Retrospective

lead_sponsor: Octapharma

location_country: Austria Germany Sweden France

location_facility:
Octapharma Research Site
ECMO Centre Karolinska


title: Study of CNGB1 Retinitis Pigmentosa and Allied Hereditary Disorders

summary: Mutations in the rod-expressed gene, cyclic nucleotide-gated channel beta subunit (CNGB1) and associated inborn errors in metabolism are causes of retinal disease that causes progressive loss of vision. Retinitis pigmentosa (RP) is a major cause of untreatable blindness associated with CNGB1 (CNGB1-RP). RP involves the death of photoreceptor cells that can be caused by mutations in a number of different genes. Treatment by gene therapy could prevent blindness in cases of inherited retinal dystrophies including RP. In the future RP due to mutations in CNGB1 may be treatable by gene therapy since this form of photoreceptor degeneration involves a slow loss of rod photoreceptor cells. This provides a wide window of opportunity for the identification of patients and initiation of treatment. Our efforts are directed toward developing gene therapy as a treatment. To this end, our objective is to better understand the disease process of CNGB1-RP and other allied inherited disorders so that we can develop clinical tests to measure the outcomes of treatment.

lead_sponsor: Columbia University

location_country:
Germany
United States
United Kingdom
France

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: Klinikum der Universität München University Eye Hospital, Ludwig-Maximilians-University (LMU) Munich

location_facility: Institut de la Vision/Centre de maladies rares du Centre Hospitalier National Ophtalmologique des Quinze-Vingts

intervention_type: Other

lead_sponsor_type: academique


title: The CorNeat EverPatch - a First-In-Man Clinical Study for Demonstrating the Safety of a Synthetic Tissue Substitute for Concealment of Artificial Implants and Glaucoma Tube Shunts

summary:
Study Name: The CorNeat EverPatch - a First-In-Man Clinical Study for demonstrating the Safety of a Synthetic Tissue Substitute for concealment of artificial implants and glaucoma tube shunts

Objective: The objective of this clinical trial is to demonstrate the Safety of the Corneat Everpatch for concealment of artificial implants and glaucoma tube shunts

The study will consist 10 subjects requiring concealment of a glaucoma shunt or other ophthalmic implant. Eligible subjects who signs an ICF will be enrolled to the study. Subjects will be implanted with the Corneart EverPatch as part of a glaucoma shunt surgery or during a corrective surgery to repair a breached conjunctiva over an implanted device. Subjects will be monitored for a period of 12 months post-op during which follow up visits will occur at 1 week, 1, 2, 3, 6, 9 & 12 months following surgery including clinical examination of the operated eye using slit-lamp biomicroscopy and imaging using OCT or UBM (will be performed only at the 6 & 12 months follow up visits).

lead_sponsor: CorNeat Vision Ltd.

location_country: Canada France Kenya

location_facility: University Health Network - Toronto Western Hospital

location_facility: Hospital Foundation Adolphe De Rothschild


title: The Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis

summary: The purpose of the Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis (MS) is to continuously monitor, evaluate, and assess for major and minor teratogenic effects in the offspring of women exposed to Gilenya before (up to 8 weeks before last menstrual period) and during pregnancy in routine clinical practice. The overall aim is to collect and evaluate data on maternal, fetal, and infant outcomes and compare it with reference populations.

location_country:
Finland
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
France
Poland
Slovakia
Norway
Argentina
Canada
Slovenia
Colombia
Sweden
United Arab Emirates
Saudi Arabia
Switzerland
Netherlands
Hungary
Ireland
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Lebanon
Mexico
Cyprus
Czechia
Israel
Spain


title: An Interventional, Multicenter, Single Arm, Phase I/IIa Clinical Trial to Investigate the Efficacy and Safety of Allo-APZ2-EB on Epidermolysis Bullosa (EB)

summary: The aim of this clinical trial is to investigate the efficacy (by monitoring overall improvement of EB symptoms) and safety (by monitoring adverse events) of three doses of allo-APZ2-EB administered intravenously to patients with recessive dystrophic epidermolysis bullosa (RDEB).

ReferenceCitation: Kiritsi D, Dieter K, Niebergall-Roth E, Fluhr S, Daniele C, Esterlechner J, Sadeghi S, Ballikaya S, Erdinger L, Schauer F, Gewert S, Laimer M, Bauer JW, Hovnanian A, Zambruno G, El Hachem M, Bourrat E, Papanikolaou M, Petrof G, Kitzmüller S, Ebens CL, Frank MH, Frank NY, Ganss C, Martinez AE, McGrath JA, Tolar J, Kluth MA. Clinical trial of ABCB5-positive mesenchymal stem cells for recessive dystrophic epidermolysis bullosa. JCI Insight. 2021 Oct 19. pii: e151922. doi: 10.1172/jci.insight.151922. [Epub ahead of print]

family: Kiritsi

full_name: Dimitra Kiritsi

given: Dimitra

family: Dieter

full_name: Kathrin Dieter

given: Kathrin

family: Niebergall-Roth

full_name: Elke Niebergall-Roth

given: Elke

family: Fluhr

full_name: Silvia Fluhr

given: Silvia

family: Daniele

full_name: Cristina Daniele

given: Cristina

family: Esterlechner

full_name: Jasmina Esterlechner

given: Jasmina

family: Sadeghi

full_name: Samar Sadeghi

given: Samar

family: Ballikaya

full_name: Seda Ballikaya

given: Seda

family: Erdinger

full_name: Leoni Erdinger

given: Leoni

family: Schauer

full_name: Franziska Schauer

given: Franziska

family: Gewert

full_name: Stella Gewert

given: Stella

family: Laimer

full_name: Martin Laimer

given: Martin

family: Bauer

full_name: Johann W. Bauer

given: Johann W.

family: Hovnanian

full_name: Alain Hovnanian

given: Alain

family: Zambruno

full_name: Giovanna Zambruno

given: Giovanna

family: El Hachem

full_name: May El Hachem

given: May

family: Bourrat

full_name: Emmanuelle Bourrat

given: Emmanuelle

family: Papanikolaou

full_name: Maria Papanikolaou

given: Maria

family: Petrof

full_name: Gabriela Petrof

given: Gabriela

family: Kitzmüller

full_name: Sophie Kitzmüller

given: Sophie

family: Ebens

full_name: Christen L. Ebens

given: Christen L.

family: Frank

full_name: Markus H. Frank

given: Markus H.

full_name: Natasha Y. Frank

given: Natasha Y.

family: Ganss

ReferenceCitation: Kerstan A, Niebergall-Roth E, Esterlechner J, Schröder HM, Gasser M, Waaga-Gasser AM, Goebeler M, Rak K, Schrüfer P, Endres S, Hagenbusch P, Kraft K, Dieter K, Ballikaya S, Stemler N, Sadeghi S, Tappenbeck N, Murphy GF, Orgill DP, Frank NY, Ganss C, Scharffetter-Kochanek K, Frank MH, Kluth MA. Ex vivo-expanded highly pure ABCB5(+) mesenchymal stromal cells as Good Manufacturing Practice-compliant autologous advanced therapy medicinal product for clinical use: process validation and first in-human data. Cytotherapy. 2021 Feb;23(2):165-175. doi: 10.1016/j.jcyt.2020.08.012. Epub 2020 Oct 1.

title: Ex vivo-expanded highly pure ABCB5+ mesenchymal stromal cells as Good Manufacturing Practice-compliant autologous advanced therapy medicinal product for clinical use: process validation and first in-human data

location_country:
Austria
Germany
France
United States
United Kingdom

location_facility: Department of Dermatology, Medical Center-University of Freiburg

location_facility: King's College London; St John's Institute of Dermatology;

location_facility: University of Minnesota, Masonic Cancer Center and Medical Center

location_facility: EB-Haus Austria; Salzburger Landeskliniken (SALK); Paracelsus Medizinische Privatuniversität Salzburg (PMU)

location_facility: Hôpital Saint-Louis; Département de dermatologie

location_facility: Great Ormond Street Hospital; Dermatology Department


title: Comprehensive Nano Post Market Data Collection

summary: This data collection project is intended to provide clinical outcomes data to engineering, marketing as well as fulfill the post market surveillance requirements of various regulatory authorities. The study will be a prospective and one-arm.

lead_sponsor: Zimmer Biomet

location_country:
Austria
France
Canada
United Kingdom
Korea, Republic of

location_facility:
Chonnam National University Hospital
Samsung Medical Centre
Kingston General Hospital
Hospial Lapeyronie
Privatklinik Leech
University of Liverpool


ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

lead_sponsor: Institut de Recherches Internationales Servier

location_country: Belgium France Japan Netherlands

location_facility: UZ Leuven Campus Gasthuisberg Dept. of General Medical

location_facility: Erasmus MC Section Clinical Pharmacology

location_facility: Institut de Cancérologie de l'Ouest site Saint Herblain

location_facility: Institut Jules Bordet Clinique Oncologie Médicale

ipd_sharing: Yes

title: Phase I/II Trial of S 81694 Administered Intravenously in Combination With Paclitaxel to Evaluate the Safety, Pharmacokinetic and Efficacy in Metastatic Breast Cancer

summary: The purpose of this study is to determine the safety profile, the maximum tolerated dose (MTD) and the associated dose-limiting toxicities (DLTs) of S 81694 in combination with paclitaxel in metastatic breast cancer (mBC) patients, and to investigate the antitumour activity of the combination in metastatic triple negative breast cancer (mTNBC) patients.


lead_sponsor: Worldwide Innovative Networking Association

location_country:
Luxembourg
France
Israel
Spain
United States

acronym: SPRING

location_facility:
UCSD Moores Cancer Center
Centre Léon Bérard
Centre Hospitalier Luxembourg
Vall Hebron Institute of Oncology
Chiam Sheba Medical Center
Avera Cancer Center

title: A Proof of Concept Study to Explore Safety and Efficacy of Tri-therapy Approach in Advanced/Metastatic NSCLC and Retrospectively Assess the Ability of Integrated Genomics and Transcriptomics to Match Patients to the Combination

summary: Patients with advanced/metastatic non-small cell lung cancer (NSCLC) with no documented targetable alterations (Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic Lymphoma Kinase (ALK) translocation, ROS1 mutation if available or MET exon 14 skipping mutation if available) will receive a tri-therapy associating avelumab, axitinib and palbociclib.


lead_sponsor: Chiesi Farmaceutici S.p.A.

location_country: Italy Austria France Denmark Germany

title: A 24-month Multicenter, Open-label Phase II Trial Investigating the Safety and Efficacy of Repeated Velmanase Alfa (Recombinant Human Alpha-mannosidase) Treatment in Pediatric Patients Below 6 Years of Age With Alpha-Mannosidosis

summary: The main objectives of the study are to evaluate safety and efficacy of repeated treatment with recombinant human alfa-mannosidase of patients with alfa-mannosidosis aged less than 6 years


title: A Phase I, Multi-center, Open-label, Study of LXS196, an Oral Protein Kinase C Inhibitor, in Patients With Metastatic Uveal Melanoma

summary: This study is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumor activity of LXS196 as a single agent and in combination with HDM201 in patients with metastatic uveal melanoma.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Netherlands
France
Norway
Australia
Spain
United States

location_facility:
Novartis Investigative Site
Columbia University Medical Center