title: FIRE AND ICE Re-Ablations: Retrospective Data Collection on Re-ablations Performed Within the FIRE AND ICE Trial

acronym: Re-Do

summary: Retrospective data collection on re-ablations performed within the FIRE AND ICE Trial.

time_perspective: Retrospective

ReferenceCitation: Kuck KH, Albenque JP, Chun KJ, Fürnkranz A, Busch M, Elvan A, Schlüter M, Braegelmann KM, Kueffer FJ, Hemingway L, Arentz T, Tondo C, Brugada J; FIRE AND ICE Investigators. Repeat Ablation for Atrial Fibrillation Recurrence Post Cryoballoon or Radiofrequency Ablation in the FIRE AND ICE Trial. Circ Arrhythm Electrophysiol. 2019 May 22;12(6):e007247. doi: 10.1161/CIRCEP.119.007247.

name: Asklepios Klinik St Georg, Hamburg, Germany (K.-H.K., M.S.).

family: Kuck

full_name: Karl-Heinz Kuck

given: Karl-Heinz

name: Clinique Pasteur, Toulouse, France (J.-P.A.).

family: Albenque

full_name: Jean-Paul Albenque

given: Jean-Paul

name: Cardioangiologisches Centrum Bethanien, Frankfurt (K.R.J.C.).

family: Chun

full_name: K.R. Julian Chun

given: K.R. Julian

family: Fürnkranz

full_name: Alexander Fürnkranz

given: Alexander

name: Universitätsmedizin, Greifswald, Germany (M.B.).

family: Busch

full_name: Mathias Busch

given: Mathias

name: Isala Klinieken, Zwolle, the Netherlands (A.E.).

family: Elvan

full_name: Arif Elvan

given: Arif

family: Schlüter

full_name: Michael Schlüter

given: Michael

name: Medtronic, Inc, Minneapolis, MN (K.M.B., F.J.K., L.H.).

family: Braegelmann

full_name: Kendra M. Braegelmann

given: Kendra M.

family: Kueffer

full_name: Fred J. Kueffer

given: Fred J.

family: Hemingway

full_name: Lauren Hemingway

given: Lauren

name: University Heart Center Freiburg-Bad Krozingen, Germany (T.A.).

family: Arentz

full_name: Thomas Arentz

given: Thomas

name: Heart Rhythm Center at Centro Cardiologico Monzino, IRCCS Department of Clinical Sciences and Community Health, University of Milan, Italy (C.T.).

family: Tondo

full_name: Claudio Tondo

given: Claudio

name: Hospital Clínic de Barcelona, Spain (J.B.).

family: Brugada

full_name: Josep Brugada

given: Josep

family: Metzner

full_name: Andreas Metzner

given: Andreas

family: Fink

full_name: Thomas Fink

family: Lemes

full_name: Christine Lemes

given: Christine

full_name: Julian Chun

given: Julian

family: Chen

full_name: Shaojie Chen

given: Shaojie

family: Schmidt

full_name: Boris Schmidt

given: Boris

family: Bologna

full_name: Fabrizio Bologna

given: Fabrizio

family: Bordignon

full_name: Stefano Bordignon

given: Stefano

name: On behalf of the FIRE AND ICE Investigators

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

location_country: Switzerland Netherlands France Czechia Spain Germany

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Cardioangiologisches Centrum Bethanien CCB


title: An Open, Qualitative, Prospective, Multicenter Trial of a Novel Transanal Irrigation System in Spinal Cord Injured Patients.

summary: This study is designed as an open, prospective, non-controlled, qualitative, multicentre study of a novel transanal irrigation system performed in a population of 150 subjects suffering from spinal cord injury and confirmed neurological bowel dysfunction. The study is expected to last for a total of 1 year (treatment period) with a planned 12- month recruitment period and three scheduled site visits.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Other

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Emmanuel A, Kurze I, Krogh K, Ferreiro Velasco ME, Christensen P, Del Popolo G, Bazzocchi G, Hultling C, Perrouin Verbe B, Bothig R, Glott T, Gonzalez Viejo MA. An open prospective study on the efficacy of Navina Smart, an electronic system for transanal irrigation, in neurogenic bowel dysfunction. PLoS One. 2021 Jan 29;16(1):e0245453. doi: 10.1371/journal.pone.0245453. eCollection 2021.

family: Emmanuel

full_name: Anton Emmanuel

given: Anton

sequence: first

family: Kurze

full_name: Ines Kurze

given: Ines

sequence: additional

family: Krogh

full_name: Klaus Krogh

given: Klaus

family: Ferreiro Velasco

full_name: Maria Elena Ferreiro Velasco

given: Maria Elena

family: Christensen

full_name: Peter Christensen

given: Peter

family: Del Popolo

full_name: Giuilio Del Popolo

given: Giuilio

family: Bazzocchi

full_name: Gabriele Bazzocchi

given: Gabriele

family: Hultling

full_name: Claes Hultling

given: Claes

family: Perrouin Verbe

full_name: Brigitte Perrouin Verbe

given: Brigitte

family: Bothig

full_name: Ralf Bothig

given: Ralf

family: Glott

full_name: Thomas Glott

family: Gonzalez Viejo

full_name: Miguel Angel Gonzalez Viejo

given: Miguel Angel

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: PLOS ONE

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
PubMed Central
UCL Discovery

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

ipd_sharing: No

lead_sponsor: Dentsply International

location_country:
Italy
Sweden
France
Norway
Spain
Denmark
Germany
United Kingdom

location_facility: Montecatone Rehabilitation Institute, Università di Bologna

location_facility: Neurologiska kliniken, Avd R18 Karolinska Universitetssjukhuset, Solna

location_facility: Gastrointestinal Physiology Unit, University College London Hospital

location_facility: Azienda Ospedaliera- Universitaria Careggi

location_facility: Unidad de Lesionados Medulares Hospital Traumatología

location_facility: Complejo Hospitalario Universitario A Coruña

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


title: Belatacept Conversion Trial in Renal Transplantation

summary: The purpose of this study is to learn if conversion to belatacept from cyclosporine or tacrolimus will preserve kidney function in people who have had a kidney transplant. The safety and tolerability of this treatment will also be studied

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceCitation: Rostaing L, Massari P, Garcia VD, Mancilla-Urrea E, Nainan G, del Carmen Rial M, Steinberg S, Vincenti F, Shi R, Di Russo G, Thomas D, Grinyó J. Switching from calcineurin inhibitor-based regimens to a belatacept-based regimen in renal transplant recipients: a randomized phase II study. Clin J Am Soc Nephrol. 2011 Feb;6(2):430-9. doi: 10.2215/CJN.05840710. Epub 2010 Nov 4.

family: Rostaing

full_name: Lionel Rostaing

given: Lionel

family: Massari

full_name: Pablo Massari

given: Pablo

family: Garcia

full_name: Valter Duro Garcia

given: Valter Duro

family: Mancilla-Urrea

full_name: Eduardo Mancilla-Urrea

given: Eduardo

family: Nainan

full_name: Georgy Nainan

given: Georgy

family: Rial

full_name: Maria del Carmen Rial

given: Maria del Carmen

family: Steinberg

full_name: Steven Steinberg

given: Steven

family: Vincenti

full_name: Flavio Vincenti

given: Flavio

family: Shi

full_name: Rebecca Shi

given: Rebecca

family: Di Russo

full_name: Greg Di Russo

given: Greg

family: Thomas

full_name: Dolca Thomas

given: Dolca

family: Grinyó

full_name: Josep Grinyó

given: Josep

journal_name: Clinical Journal of the American Society of Nephrology

oa_colors: green other

evidence: open (via free pdf)

repository_institution: The Pennsylvania State University - CiteSeer X

repository_normalized: CiteSeerX

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

repository_institution: PubMed Central - Europe PMC

repositories:
CiteSeerX
PubMed Central

publisher: American Society of Nephrology (ASN)

publisher_dissemination: American Society of Nephrology

publisher_group: American Society of Nephrology

publisher_normalized: American Society of Nephrology

title: Switching from Calcineurin Inhibitor-based Regimens to a Belatacept-based Regimen in Renal Transplant Recipients: A Randomized Phase II Study

lead_sponsor: Bristol-Myers Squibb

location_country:
Brazil
India
Mexico
Germany
France
Poland
Belgium
Argentina
Australia
Spain
United States
Canada

location_facility: University Of North Carolina School Of Medicine

intervention_type: Drug


design_allocation: Non-Randomized

study_start_date_type: Actual

lead_sponsor: Puma Biotechnology, Inc.

location_country:
United States
France
Switzerland
China

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Cancer Hospital, Academy of Med Science and Peking Union Med

location_facility: LAC/USC Medical Center, USC/Norris Comprehensive Cancer Center

location_facility: University of Maryland, University of Maryland Medical Center

location_facility: Duke University, Duke University Medical Center

location_facility: 307 Hospital of Chinese People's Liberation Army

source: euctr

title: A Phase I/II Study of HKI-272 in Combination With Trastuzumab (Herceptin) in Subjects With Advanced Breast Cancer

summary: The purpose of this study is to determine the safety and efficacy of HKI-272 (neratinib) in combination with trastuzumab in patients with advanced breast cancer.


title: A Phase 2, Multicenter, Double-Blind, Randomized, Stratified, Controlled, Efficacy, Safety and Feasibility Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) as an Adjuvant Therapy in Closed Fractures of the Humerus

summary: The primary objective of this study is to assess whether fracture union is accelerated in subjects with humeral fractures (proximal,diaphyseal) treated with conservative therapy (standard of care) and a single dose of rhBMP-2/CPM compared to subjects who receive standard of care alone.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
Brazil
United States
Sweden
Mexico
Germany
Finland
France
Norway
Romania
Australia
Canada


title: A Phase 2, Multicenter, Single-Blind, Randomized, Stratified, Standard-Of-Care Controlled, Feasibility And Safety Study Of rhBMP-2/CPM As An Adjuvant Therapy For Fractures Of The Proximal Femur

summary: The primary objective of this study is to assess the safety of administering rhBMP-2/CPM as an adjuvant to internal fixation in subjects with fractures of the proximal femur.

location_country:
United States
Sweden
Germany
Finland
France
Norway
Hungary
Australia
Canada
United Kingdom

intervention_type: Other


title: Watchman FLX Left Atrial Appendage Closure Device Post Approval Study

study_type: Observational

time_perspective: Prospective

lead_sponsor: Boston Scientific Corporation

location_country:
Italy
Netherlands
France
Poland
Ireland
Spain
Denmark
Germany
United Kingdom

location_facility: Clinical Hospital University of Medicine

location_facility: Cardio Vasculares Centrum Sankt Katharinen


title: A Randomized Placebo-Controlled Trial Of The Efficacy And Tolerability Of Flexibly Dosed Pregabalin In The Treatment Of Cancer-Induced Bone Pain

acronym: COPE

summary: The purpose of this study is to assess the analgesic efficacy of flexibly-dosed pregabalin in the adjunctive treatment of subjects with cancer-induced bone pain.

status: Terminated

ReferenceCitation: Sjölund KF, Yang R, Lee KH, Resnick M. Randomized study of pregabalin in patients with cancer-induced bone pain. Pain Ther. 2013 Jun;2(1):37-48. doi: 10.1007/s40122-013-0009-8. Epub 2013 Feb 26.

family: Sjölund

full_name: Karl-Fredrik Sjölund

given: Karl-Fredrik

family: Yang

full_name: Ruoyong Yang

given: Ruoyong

family: Lee

full_name: Kyung-Hee Lee

given: Kyung-Hee

family: Resnick

full_name: Malca Resnick

given: Malca

journal_name: Pain and Therapy

license: cc-by-nc

license_normalized: cc-by-nc

license: implied-oa

license_normalized: implied-oa

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

title: Randomized Study of Pregabalin in Patients with Cancer-Induced Bone Pain

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
Italy
Peru
Sweden
Mexico
Philippines
Finland
France
Czechia
Korea, Republic of
Poland
Thailand
Venezuela
Hungary
Russian Federation
Egypt
Spain
United States
Canada
Taiwan

status_simplified: Unknown


title: A Prospective, Multi-center Trial of NovoTTF-100A Compared to Best Standard of Care in Patients With Progressive or Recurrent GBM

summary: The study is a randomized, controlled trial, designed to test the efficacy and safety of a new medical device, the NovoTTF-100A. The device is an experimental, portable, battery operated device for chronic treatment of patients with recurrent or progressive glioblastoma multiforme (GBM) using alternating electric fields (termed TTFields).

ReferenceType: background

ReferenceCitation: Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95.

ReferenceCitation: Kirson ED, Dbalý V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. Epub 2007 Jun 5.

ReferenceCitation: Salzberg M, Kirson E, Palti Y, Rochlitz C. A pilot study with very low-intensity, intermediate-frequency electric fields in patients with locally advanced and/or metastatic solid tumors. Onkologie. 2008 Jul;31(7):362-5. doi: 10.1159/000137713. Epub 2008 Jun 24.

ReferenceCitation: Stupp R, Wong ET, Kanner AA, Steinberg D, Engelhard H, Heidecke V, Kirson ED, Taillibert S, Liebermann F, Dbalý V, Ram Z, Villano JL, Rainov N, Weinberg U, Schiff D, Kunschner L, Raizer J, Honnorat J, Sloan A, Malkin M, Landolfi JC, Payer F, Mehdorn M, Weil RJ, Pannullo SC, Westphal M, Smrcka M, Chin L, Kostron H, Hofer S, Bruce J, Cosgrove R, Paleologous N, Palti Y, Gutin PH. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012 Sep;48(14):2192-202. doi: 10.1016/j.ejca.2012.04.011. Epub 2012 May 18.

family: Stupp

full_name: Roger Stupp

given: Roger

family: Wong

full_name: Eric T. Wong

given: Eric T.

family: Kanner

full_name: Andrew A. Kanner

given: Andrew A.

full_name: David Steinberg

given: David

family: Engelhard

full_name: Herbert Engelhard

given: Herbert

family: Heidecke

full_name: Volkmar Heidecke

given: Volkmar

family: Kirson

full_name: Eilon D. Kirson

given: Eilon D.

family: Taillibert

full_name: Sophie Taillibert

given: Sophie

family: Liebermann

full_name: Frank Liebermann

given: Frank

family: Dbalý

full_name: Vladimir Dbalý

given: Vladimir

family: Ram

full_name: Zvi Ram

given: Zvi

family: Villano

full_name: J. Lee Villano

given: J. Lee

family: Rainov

full_name: Nikolai Rainov

given: Nikolai

family: Weinberg

full_name: Uri Weinberg

given: Uri

family: Schiff

full_name: David Schiff

family: Kunschner

full_name: Lara Kunschner

given: Lara

family: Raizer

full_name: Jeffrey Raizer

given: Jeffrey

family: Honnorat

full_name: Jerome Honnorat

given: Jerome

family: Sloan

full_name: Andrew Sloan

given: Andrew

family: Malkin

full_name: Mark Malkin

given: Mark

family: Landolfi

full_name: Joseph C. Landolfi

given: Joseph C.

family: Payer

full_name: Franz Payer

given: Franz

family: Mehdorn

full_name: Maximilian Mehdorn

title: NovoTTF-100A versus physician’s choice chemotherapy in recurrent glioblastoma: A randomised phase III trial of a novel treatment modality

location_country:
Austria
Switzerland
Germany
France
Israel
United States
Czech Republic

location_facility: University of Pittsburgh Medical Center (UPMC)

location_facility: University Hospital of Schleswig-Holstein

location_facility: Hospital of Neurology Lyon - University Claude Bernard Lyon 1

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: NJ Neuroscience Institute - JFK Medical Center


title: A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multicenter Dose Ranging Study With the Beta-3 Agonist YM178 in Patients With Symptomatic Overactive Bladder

summary: The study will examine which dose of YM178 is best in terms of efficacy, safety and tolerability compared to placebo and compared to tolterodine, a marketed product.

lead_sponsor: Astellas Pharma Inc

location_country:
Italy
Sweden
United Kingdom
Netherlands
France
Poland
Greece
Norway
Hungary
Belgium
Russian Federation
Spain
Denmark
Germany
Czech Republic

location_facility:
7 Sites
2 Sites
3 Sites


type: Other Identifier

title: Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Safety, Tolerability and Effect on MRI Lesion Parameters of FTY720 vs Placebo in Patients With Relapsing Multiple Sclerosis Including 18 Month Extension Phase

summary: This study evaluated the safety, tolerability and effect on MRI lesion parameters of FTY720 in patients with relapsing multiple sclerosis.

ReferenceCitation: Zarbin MA, Jampol LM, Jager RD, Reder AT, Francis G, Collins W, Tang D, Zhang X. Ophthalmic evaluations in clinical studies of fingolimod (FTY720) in multiple sclerosis. Ophthalmology. 2013 Jul;120(7):1432-9. doi: 10.1016/j.ophtha.2012.12.040. Epub 2013 Mar 24.

family: Zarbin

full_name: Marco A. Zarbin

given: Marco A.

family: Jampol

full_name: Lee M. Jampol

given: Lee M.

family: Jager

full_name: Rama D. Jager

given: Rama D.

family: Reder

full_name: Anthony T. Reder

given: Anthony T.

family: Francis

full_name: Gordon Francis

given: Gordon

family: Collins

full_name: William Collins

given: William

family: Tang

full_name: Dejun Tang

given: Dejun

family: Zhang

full_name: Xiaoli Zhang

given: Xiaoli

journal_name: Ophthalmology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Ophthalmic Evaluations in Clinical Studies of Fingolimod (FTY720) in Multiple Sclerosis

ReferenceCitation: Kappos L, Antel J, Comi G, Montalban X, O'Connor P, Polman CH, Haas T, Korn AA, Karlsson G, Radue EW; FTY720 D2201 Study Group. Oral fingolimod (FTY720) for relapsing multiple sclerosis. N Engl J Med. 2006 Sep 14;355(11):1124-40.

lead_sponsor: Novartis

location_country:
Italy
Switzerland
Spain
Germany
Finland
France
Poland
Portugal
Denmark
Canada
United Kingdom


type: EudraCT Number

title: Prospective Donor-specific Cellular Alloresponse Assessment for Immunosuppression Minimization in de Novo Renal Transplantation

summary: The main objective of the study is to demonstrate the utility and safety of the IFN-γ (Interferon Gamma) ELISPOT (Enzyme-linked immunosorbent spot) marker for the stratification of kidney transplant recipients into low and high IS (Immunosuppression) regimens. The enrichment study will test non-inferiority of low IS regimen compared to high IS regimen, assuming 10% of BPAR at 6-months in the control group, and allowing a non-inferiority limit of maximum 10%.

lead_sponsor: Prof. Dr. Petra Reinke

location_country:
Netherlands
France
Czechia
Spain
Germany
United Kingdom

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Department Nephrology and BCRT, Charité Universitätsmedizin Berlin

location_facility: Institut klinické a experimentální mediciny

location_facility: Academisch Medisch Centrum bij de Universiteit van Amsterdam


intervention_type: Radiation

lead_sponsor: Gilead Sciences

location_country:
Italy
France
Greece
Romania
Belgium
Spain
United Kingdom

acronym: Not applicable

location_facility: Cliniques Universitaries Saint- Luc, Departem Pediatrie

location_facility: Institutul de Gastrenterologie si Hepatologie Iasi

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Birmingham Children's Hospital NHS Trust

location_facility: Grigore Alexandrescu Childrens Emergency Clinical Hospital

location_facility: Azienda Ospedaliero-Universitaria di Bologna

location_facility: Spitatul Clinic de Boli Infectioase Constanta

title: Pharmacoepidemiology Study to Define the Long-term Safety Profile of Tenofovir Disoproxil Fumarate (Tenofovir DF, Viread®) and Describe the Management of Tenofovir DF-associated Renal and Bone Toxicity in Chronic Hepatitis B (CHB)-Infected Adolescents Aged 12 to <18 Years in Europe

summary: The primary objective of this study is to characterize the long term (ie, 96 weeks of follow up) bone safety profile of open-label tenofovir disoproxil fumarate (tenofovir DF) treatment in CHB-infected adolescents. This includes prospectively evaluating and comparing the bone mineral density (BMD) change between CHB-infected adolescents 12 to < 18 years of age treated with tenofovir DF in European treatment centers who are assigned to one of two schedules for renal and bone laboratory monitoring and BMD measurement.


title: A Phase II Trial of Pemetrexed and Cisplatin or Carboplatin in Combination With TTFields (150 kHz) as First-line Treatment in Malignant Pleural Mesothelioma

summary: The study is a prospective, single arm, non-randomized, open label phase II trial, designed to study the safety and efficacy of a medical device, the NovoTTF-100L concomitant with Pemetrexed and cisplatin or carboplatin in Malignant Pleural Mesothelioma patients. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

family: Stupp

full_name: Roger Stupp

given: Roger

family: Wong

full_name: Eric T. Wong

given: Eric T.

family: Kanner

full_name: Andrew A. Kanner

given: Andrew A.

family: Steinberg

full_name: David Steinberg

given: David

family: Engelhard

full_name: Herbert Engelhard

given: Herbert

family: Heidecke

full_name: Volkmar Heidecke

given: Volkmar

family: Kirson

full_name: Eilon D. Kirson

given: Eilon D.

family: Taillibert

full_name: Sophie Taillibert

given: Sophie

family: Liebermann

full_name: Frank Liebermann

given: Frank

family: Dbalý

full_name: Vladimir Dbalý

given: Vladimir

family: Ram

full_name: Zvi Ram

given: Zvi

family: Villano

full_name: J. Lee Villano

given: J. Lee

family: Rainov

full_name: Nikolai Rainov

given: Nikolai

family: Weinberg

full_name: Uri Weinberg

family: Schiff

full_name: David Schiff

given: Maximilian

ReferenceCitation: Pless M, Droege C, von Moos R, Salzberg M, Betticher D. A phase I/II trial of Tumor Treating Fields (TTFields) therapy in combination with pemetrexed for advanced non-small cell lung cancer. Lung Cancer. 2013 Sep;81(3):445-450. doi: 10.1016/j.lungcan.2013.06.025. Epub 2013 Jul 23.

ReferenceCitation: Pless M, Weinberg U. Tumor treating fields: concept, evidence and future. Expert Opin Investig Drugs. 2011 Aug;20(8):1099-106. doi: 10.1517/13543784.2011.583236. Epub 2011 May 9. Review.

ReferenceCitation: Kirson ED, Giladi M, Gurvich Z, Itzhaki A, Mordechovich D, Schneiderman RS, Wasserman Y, Ryffel B, Goldsher D, Palti Y. Alternating electric fields (TTFields) inhibit metastatic spread of solid tumors to the lungs. Clin Exp Metastasis. 2009;26(7):633-40. doi: 10.1007/s10585-009-9262-y. Epub 2009 Apr 23.

ReferenceCitation: Ceresoli GL, Aerts JG, Dziadziuszko R, Ramlau R, Cedres S, van Meerbeeck JP, Mencoboni M, Planchard D, Chella A, Crinò L, Krzakowski M, Rüssel J, Maconi A, Gianoncelli L, Grosso F. Tumour Treating Fields in combination with pemetrexed and cisplatin or carboplatin as first-line treatment for unresectable malignant pleural mesothelioma (STELLAR): a multicentre, single-arm phase 2 trial. Lancet Oncol. 2019 Dec;20(12):1702-1709. doi: 10.1016/S1470-2045(19)30532-7. Epub 2019 Oct 15. Erratum in: Lancet Oncol. 2020 Feb;21(2):e70.

location_country: Italy Netherlands France Poland Belgium Spain Germany

location_facility: Goustave Roussy - Cancer Campus Grand Paris

location_facility: Vall d' Hebron Institute of Oncology (VHIO) Hospital Vall d'Hebron

location_facility: Antwerp University Hospital, Thoracic Oncology

location_facility: A.S.O. "SS Antonio e Biagio e Cesare Arrigo"

location_facility: Katedra i Klinika Onkologii Uniwersytetu Medycznegi im. Karola Marcinkowskiego w Poznaniu

location_facility: Klinika Nowotworów Pluca I Klatki Piersiowej


title: Cyclophosphamide, Doxorubicin, Vincristine, Prednisone Plus Rituximab (CHOP-R) and Cyclophosphamide, Pixantrone, Vincristine, Prednisone Plus Rituximab (CPOP-R) in Patients With Diffuse Large-B-cell Lymphoma: A Phase II, Randomized, Multicenter, Comparative Trial

acronym: RAPID

summary: The purpose of this study is to compare the standard CHOP-R regimen of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, and Rituximab to CPOP-R (same regimen, but substituting Doxorubicin with Pixantrone). The objective is to show that CPOP-R is not inferior to CHOP-R.

ReferenceType: result

ReferenceCitation: Herbrecht R, Cernohous P, Engert A, Le Gouill S, Macdonald D, Machida C, Myint H, Saleh A, Singer J, Wilhelm M, van der Jagt R. Comparison of pixantrone-based regimen (CPOP-R) with doxorubicin-based therapy (CHOP-R) for treatment of diffuse large B-cell lymphoma. Ann Oncol. 2013 Oct;24(10):2618-2623. doi: 10.1093/annonc/mdt289. Epub 2013 Aug 14.

family: Herbrecht

full_name: R. Herbrecht

given: R.

family: Cernohous

full_name: P. Cernohous

given: P.

family: Engert

full_name: A. Engert

given: A.

family: Le Gouill

full_name: S. Le Gouill

given: S.

family: Macdonald

full_name: D. Macdonald

given: D.

family: Machida

full_name: C. Machida

given: C.

family: Myint

full_name: H. Myint

given: H.

family: Saleh

full_name: A. Saleh

family: Singer

full_name: J. Singer

given: J.

family: Wilhelm

full_name: M. Wilhelm

given: M.

family: van der Jagt

full_name: R. van der Jagt

journal_name: Annals of Oncology

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

lead_sponsor: CTI BioPharma

location_country:
Italy
United States
France
Germany
Canada

location_facility: Cancer Treatment & Research Mid-Dakota Clinic

location_facility: Mid-Illinois Hematology & Oncology Associates

location_facility: Hopitaux Universitaires de Strabourg - Hopital Hautepierre

location_facility: Instituto di Ematologia "Lorenzo e Ariosto"

location_facility: Our Lady of the Lake Regional Medial Center, Hematology Oncology

location_facility: The Center for Cancer and Blood Disorders

location_facility: New Mexico Hematology/Oncology Consultants

location_facility: Consultants in Blood Disorders and Cancer

location_facility: Multicare Oncology Hematology Specialists

location_facility: London Health Science Center Regional Care Program

location_facility: Oncology Hematology Associates of West Broward

location_facility: Hazel Hawkins Hospital, Dept. of Medical Oncology

location_facility: Watson Clinic for Cancer Care and Research

location_facility: Frederick Memorial Hospital Cancer Center

location_facility: North Missssppi Hematology Oncology Associates

location_facility: UCSD Moore's Cancer Center-Blood & Marrow Transplantation Division

location_facility: Western Kentucky Hematology/Oncology Group

location_facility: Berks Hematology-Oncology Associates Ltd.

location_facility: Southeast Nebraska Hematology and Oncology Consultants, P.C.

location_facility: Oncology Hematology of Northern Illinois

location_facility: Brody School of Medicine at East Carolina University - Leo W. Jenkins Cancer Center

location_facility: Center for Cancer and Blood Disorders, P.C.

location_facility: Tufts-New England Medical Center-The Neely Ctr for Clinical Cancer Research

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: Hematology/Oncology Group of Orange County

location_facility: Farmacia Osepdaliera, Odpedale Umberto I

location_facility: Maryland Hematology/Oncology Associates, PA


title: A Phase Ib/II Study of the ALK Inhibitor Ceritinib in Combination With the CDK4/6 Inhibitor LEE011 in Patients With ALK-positive Non-Small Cell Lung Cancer

summary:
This was a Phase Ib/II study of the ALK inhibitor ceritinib in combination with the CDK4/6 inhibitor LEE011 in patients with ALK-positive non-small cell lung cancer.

The purpose of the study was to determine the MTD/RP2D of the LEE011 and ceritinib combination and evaluate whether the combination was safe and had beneficial effects in ALK-positive advanced non-small cell lung cancer patients.

This trial did not progress to Phase II. Trial population terminated before reaching Phase II

ipd_sharing: Undecided

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
France
Spain
United States
Korea, Republic of
Taiwan


title: Resect and Discard Extension to Fuji Intelligent Color Enhancement (FICE) of Narrow Band Imaging International Colorectal Endoscopic (NicE) Classification

acronym: FICE;NICE

summary: The purpose of this prospective, non-interventional study is to validate the Narrow Band Imaging International Colorectal Endoscopic (NICE) classification for differentiating subcentimetric hyperplastic and adenomatous polyps by using Fuji Intelligent Color Enhancement (FICE) technology with high-definition without optical magnification.

status: Unknown status

study_completion_date_type: Anticipated

ReferenceCitation: Hewett DG, Kaltenbach T, Sano Y, Tanaka S, Saunders BP, Ponchon T, Soetikno R, Rex DK. Validation of a simple classification system for endoscopic diagnosis of small colorectal polyps using narrow-band imaging. Gastroenterology. 2012 Sep;143(3):599-607.e1. doi: 10.1053/j.gastro.2012.05.006. Epub 2012 May 15.

lead_sponsor: Istituto Clinico Humanitas

location_country:
Italy
France
Belgium
Germany
United Kingdom

location_facility: Dept of Gastroenterology, Edouard Herriot Hospital, Hospices Civils of Lyon

location_facility: Dept of Gastroenterology and interventional Endoscopy, Krankenhaus Barmherzige Brüder

location_facility: Digestive Endoscopy Unit, Nuovo Regina Margherita Hospital

location_facility: Solent Centre for Digestive Diseases , Royal Alexandra Hospital

location_facility: Department of Medicine I, University of Erlangen-Nürnberg Medical School

location_facility: Dept of Gastroenterology and Endoscopy, University Hospital

location_facility: Endoscopy Unit, Humanitas Research Hospital

intervention_type: Procedure


title: Assessment of Surgical Mediastinal sTaging in cN1 Lung canceR

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

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

family: Decaluwé

full_name: Herbert Decaluwé

given: Herbert

family: Dooms

full_name: Christophe Dooms

given: Christophe

family: D'Journo

full_name: Xavier Benoit D'Journo

given: Xavier Benoit

family: Call

full_name: Sergi Call

given: Sergi

family: Sanchez

full_name: David Sanchez

given: David

family: Haager

full_name: Benedikt Haager

given: Benedikt

family: Beelen

full_name: Roel Beelen

given: Roel

family: Kara

full_name: Volkan Kara

given: Volkan

family: Klikovits

full_name: Thomas Klikovits

given: Thomas

family: Aigner

full_name: Clemens Aigner

given: Clemens

family: Tournoy

full_name: Kurt Tournoy

given: Kurt

family: Zahin

full_name: Mahmood Zahin

given: Mahmood

family: Moons

full_name: Johnny Moons

given: Johnny

family: Brioude

full_name: Geoffrey Brioude

given: Geoffrey

family: Trujillo

full_name: Juan Carlos Trujillo

given: Juan Carlos

family: Klepetko

full_name: Walter Klepetko

given: Walter

family: Turna

full_name: Akif Turna

given: Akif

family: Passlick

full_name: Bernward Passlick

given: Bernward

family: Molins

full_name: Laureano Molins

given: Laureano

family: Rami-Porta

full_name: Ramon Rami-Porta

given: Ramon

family: Thomas

full_name: Pascal Thomas

given: Pascal

family: Leyn

full_name: Paul De Leyn

given: Paul De

journal_name: European Respiratory Journal

location_country: Switzerland France Belgium Spain Turkey Germany

location_facility: Istanbul University, Cerrahpasa Medical Faculty

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

location_facility: University Hospital, Division of Thoracic Surgery


title: The VENUS Clinical Study (Verifying the Effectiveness of the NUsurface® System) A Multi-center, Prospective, Randomized, Interventional, Superiority Clinical Study

acronym: VENUS

summary: The NUsurface® Meniscus Implant Randomized Study is a multi-center, prospective randomized, interventional clinical trial to test the hypothesis that the NUsurface implant is superior to the non-surgical standard of care in treating the target population.The rationale for performing this clinical study is to gather clinical data to evaluate the safety and effectiveness of the NUsurface device compared to the Standard of Care.

ReferenceCitation: Shemesh M, Asher R, Zylberberg E, Guilak F, Linder-Ganz E, Elsner JJ. Viscoelastic properties of a synthetic meniscus implant. J Mech Behav Biomed Mater. 2014 Jan;29:42-55. doi: 10.1016/j.jmbbm.2013.08.021. Epub 2013 Sep 3.

ReferenceCitation: Zur G, Linder-Ganz E, Elsner JJ, Shani J, Brenner O, Agar G, Hershman EB, Arnoczky SP, Guilak F, Shterling A. Chondroprotective effects of a polycarbonate-urethane meniscal implant: histopathological results in a sheep model. Knee Surg Sports Traumatol Arthrosc. 2011 Feb;19(2):255-63. doi: 10.1007/s00167-010-1210-5. Epub 2010 Jul 16.

ReferenceCitation: Elsner JJ, Portnoy S, Guilak F, Shterling A, Linder-Ganz E. MRI-based characterization of bone anatomy in the human knee for size matching of a medial meniscal implant. J Biomech Eng. 2010 Oct;132(10):101008. doi: 10.1115/1.4002490.

ReferenceCitation: Elsner JJ, Portnoy S, Zur G, Guilak F, Shterling A, Linder-Ganz E. Design of a free-floating polycarbonate-urethane meniscal implant using finite element modeling and experimental validation. J Biomech Eng. 2010 Sep;132(9):095001. doi: 10.1115/1.4001892.

ReferenceCitation: Linder-Ganz E, Elsner JJ, Danino A, Guilak F, Shterling A. A novel quantitative approach for evaluating contact mechanics of meniscal replacements. J Biomech Eng. 2010 Feb;132(2):024501. doi: 10.1115/1.4000407.

ReferenceCitation: Elsner JJ, Shemesh M, Shefy-Peleg A, Gabet Y, Zylberberg E, Linder-Ganz E. Quantification of in vitro wear of a synthetic meniscus implant using gravimetric and micro-CT measurements. J Mech Behav Biomed Mater. 2015 Sep;49:310-20. doi: 10.1016/j.jmbbm.2015.05.017. Epub 2015 May 28.

ReferenceCitation: De Coninck T, Elsner JJ, Linder-Ganz E, Cromheecke M, Shemesh M, Huysse W, Verdonk R, Verstraete K, Verdonk P. In-vivo evaluation of the kinematic behavior of an artificial medial meniscus implant: A pilot study using open-MRI. Clin Biomech (Bristol, Avon). 2014 Sep;29(8):898-905. doi: 10.1016/j.clinbiomech.2014.07.001. Epub 2014 Jul 17.

family: De Coninck

full_name: Tineke De Coninck

given: Tineke

family: Elsner

full_name: Jonathan J. Elsner

given: Jonathan J.

family: Linder-Ganz

full_name: Eran Linder-Ganz

given: Eran

family: Cromheecke

full_name: Michiel Cromheecke

given: Michiel

family: Shemesh

full_name: Maoz Shemesh

given: Maoz

family: Huysse

full_name: Wouter Huysse

given: Wouter

family: Verdonk

full_name: René Verdonk

given: René

family: Verstraete

full_name: Koenraad Verstraete

given: Koenraad

full_name: Peter Verdonk

given: Peter

journal_name: Clinical Biomechanics

lead_sponsor: Active Implants

location_country: Italy Netherlands France Israel Belgium Germany

location_facility:
Assaf Harofeh Medical Center
Ospedale Sacro Cuore - Don Calabria
AZ Monica
Centre Hospitalier de Versailles
Academisch Ziekenhuis Maastricht
Ichilov Hospital
University Hospital of Munich


title: A Clinical Evaluation of the Tension-Free Vaginal Tape Obturator System For Treatment of Stress Urinary Incontinence

summary: Stress urinary incontinence affects nearly 30 million women worldwide and the main goal of surgical treatment is to stop urinary incontinence (urinary leakage) that occurs with physical activity, coughing, sneezing, etc.Patients in the study will have an operation to improve urinary incontinence symptoms. This will involve inserting a mesh sling to help support the urethra (tube leading into your bladder). During the operation, the study doctor will use tension-free vaginal obturator system. The study will include women diagnosed with Stress Urinary Incontinence who have completed their families.

lead_sponsor: Ethicon, Inc.

location_country:
United States
France
Korea, Republic of
Singapore
Germany
United Kingdom
Canada

location_facility: The Institute for Female Pelvic Medicine & Reconstructive Surgery

location_facility: University of Ulsan College of Medicine and Asan Medical Center

location_facility: Sunnybrook & Women's College Health Sciences Center


type: Other Grant/Funding Number

title: European Clinical Study for the Application of Regenerative Heart Valves - ESPOIR

acronym: ESPOIR

summary:
This is a prospective, non-randomized, single-arm, multicentre surveillance study to be conducted in Europe. The Surveillance is designed as a study, where

ESPOIR pulmonary valve (PV) is prescribed in the usual manner in accordance with the terms of the approval.
The assignment of the patient to a particular therapeutic strategy is not decided in advance by this Surveillance Protocol but falls within current practice and the prescription of ESPOIR PV is clearly separated from the decision to include the patient in the Surveillance.
No additional diagnostic or monitoring procedures shall be applied to the patients
and epidemiological methods shall be used for the analysis of collected data.

Evaluation of decellularized human heart valves for pulmonary heart valve replacement in comparison to current valve substitutes. Safety endpoints include cardiovascular adverse events, time to re-operation, re-intervention and explantation. Efficacy endpoints include freedom from valve dysfunction and hemodynamic performance.

ReferenceCitation: Boethig D, Horke A, Hazekamp M, Meyns B, Rega F, Van Puyvelde J, Hübler M, Schmiady M, Ciubotaru A, Stellin G, Padalino M, Tsang V, Jashari R, Bobylev D, Tudorache I, Cebotari S, Haverich A, Sarikouch S. A European study on decellularized homografts for pulmonary valve replacement: initial results from the prospective ESPOIR Trial and ESPOIR Registry data†. Eur J Cardiothorac Surg. 2019 Sep 1;56(3):503-509. doi: 10.1093/ejcts/ezz054.

name: Department of Cardiac, Thoracic, Transplantation, and Vascular Surgery, Hannover Medical School, Hannover, Germany

family: Boethig

full_name: Dietmar Boethig

given: Dietmar

family: Horke

full_name: Alexander Horke

given: Alexander

name: Department of Congenital Cardiac Surgery, Leiden University Medical Center, Leiden, Netherlands

family: Hazekamp

full_name: Mark Hazekamp

given: Mark

name: Department of Cardiac Surgery, Katholieke Universiteit Leuven, Leuven, Belgium

family: Meyns

full_name: Bart Meyns

given: Bart

family: Rega

full_name: Filip Rega

given: Filip

family: Van Puyvelde

full_name: Joeri Van Puyvelde

given: Joeri

name: Division of Congenital Cardiovascular Surgery, University Children’s Hospital, Zurich, Switzerland

family: Hübler

full_name: Michael Hübler

given: Michael

family: Schmiady

full_name: Martin Schmiady

given: Martin

name: Cardiac Surgery Center, State Medical and Pharmaceutical University, Chisinau, Moldova

family: Ciubotaru

full_name: Anatol Ciubotaru

given: Anatol

name: Pediatric and Congenital Cardiac Surgery Unit, Azienda Ospedaliera di Padova, University of Padua Medical School, Padova, Italy

family: Stellin

full_name: Giovanni Stellin

given: Giovanni

family: Padalino

full_name: Massimo Padalino

given: Massimo

name: Department of Cardiothoracic Surgery, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK

family: Tsang

full_name: Viktor Tsang

given: Viktor

name: European Homograft Bank, Clinique Saint-Jean, Bruessels, Belgium

family: Jashari

full_name: Ramadan Jashari

given: Ramadan

family: Bobylev

full_name: Dmitry Bobylev

given: Dmitry

family: Tudorache

full_name: Igor Tudorache

given: Igor

family: Cebotari

full_name: Serghei Cebotari

given: Serghei

family: Haverich

full_name: Axel Haverich

given: Axel

family: Sarikouch

full_name: Samir Sarikouch

given: Samir

journal_name: European Journal of Cardio-Thoracic Surgery

oa_colors: green hybrid

repository_institution: University of Padua - Padua Research Archive

repositories:
LIRIAS (KU Leuven)
PubMed Central
www.research.unipd.it

location_country:
Italy
Switzerland
Netherlands
France
Belgium
Moldova, Republic of
Germany
United Kingdom

location_facility: Great Ormond Street Hospital for Children NHS Trust, GOSH

location_facility: Leids Universitair Medisch Centrum, LUMC

location_facility: Università degli studi di Padova, Azienda Ospedaliera di Padova, UNIPD/AOP

location_facility: Universitatea de Stat de Medicina si Farmacie "Nicolae Testemitanu", SMPHU


title: A Multicenter, Randomized, Addition to Baseline Treatment, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) in Patients With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)

summary: The objective of this study is to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic, and immunogenic profiles of satralizumab, compared with placebo, in addition to baseline immunosuppressive treatment in participants with NMO and NMOSD.

status: Active, not recruiting

ReferenceCitation: Yamamura T, Kleiter I, Fujihara K, Palace J, Greenberg B, Zakrzewska-Pniewska B, Patti F, Tsai CP, Saiz A, Yamazaki H, Kawata Y, Wright P, De Seze J. Trial of Satralizumab in Neuromyelitis Optica Spectrum Disorder. N Engl J Med. 2019 Nov 28;381(22):2114-2124. doi: 10.1056/NEJMoa1901747.

name: From the Department of Immunology, National Institute of Neuroscience, and the Multiple Sclerosis Center, National Center of Neurology and Psychiatry (T.Y.), and Chugai Pharmaceutical (H.Y., Y.K.), Tokyo, and the Department of Multiple Sclerosis Therapeutics, Fukushima Medical University, and the Multiple Sclerosis and Neuromyelitis Optica Center, Southern Tohoku Research Institute for Neuroscience, Koriyama (K.F.) — all in Japan; the Department of Neurology, St. Josef Hospital, Ruhr University Bochum,...

family: Yamamura

full_name: Takashi Yamamura

given: Takashi

family: Kleiter

full_name: Ingo Kleiter

given: Ingo

family: Fujihara

full_name: Kazuo Fujihara

given: Kazuo

family: Palace

full_name: Jacqueline Palace

given: Jacqueline

family: Greenberg

full_name: Benjamin Greenberg

given: Benjamin

family: Zakrzewska-Pniewska

full_name: Beata Zakrzewska-Pniewska

given: Beata

family: Patti

full_name: Francesco Patti

given: Francesco

family: Tsai

full_name: Ching-Piao Tsai

given: Ching-Piao

family: Saiz

full_name: Albert Saiz

given: Albert

family: Yamazaki

full_name: Hayato Yamazaki

given: Hayato

family: Kawata

full_name: Yuichi Kawata

given: Yuichi

family: Wright

full_name: Padraig Wright

given: Padraig

family: De Seze

full_name: Jerome De Seze

given: Jerome

journal_name: New England Journal of Medicine

evidence: open (via free article)

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
United States
France
Japan
Poland
Hungary
Spain
Germany
United Kingdom
Taiwan
Ukraine

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

location_facility: Azienda Ospedaliera Sant'Andrea-Universitr di Roma La Sapien

location_facility: Samodzielny Publiczny Centralny Szpital Klinicznyi

location_facility: Tokyo Women's Medical University Hospital; Neurology

location_facility: Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Neurology

location_facility: Szpital Kliniczny im. H.Swiecickiego UM im.K.Marcinkowskiego

location_facility: National Cheng Kung University Hospital; Neurology

location_facility: The National Hospital for Neurology & Neurosurgery

location_facility: Niigata University Medical and Dental Hospital; Neurology

location_facility: KZ "Dnipropetrovska oblasna dytiacha klinichna likarnia" DOR

location_facility: NeuroCure Clinical Research Center (NCRC)

location_facility: Kagoshima University Medical And Dental Hospital; Neurology and Geriatorics

location_facility: NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS

location_facility: Hopital de Hautepierre CHRU de Strasbourg

location_facility: Taipei Veterans General Hospital-Neurology

location_facility: M.A. - LEK A. M. Maciejowscy SC. Centrum Terapii SM

location_facility: PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania

location_facility: Fukushima Medical University Hospital; Neurology

location_facility: Great Ormand Street Hospital For Children; Neurology

location_facility: St. Josef-Hospital, Klinik für Neurologie

location_facility: National Taiwan University Hospital; Neurology

location_facility: Hospital Clinico San Carlos; Servicio de Nefrologia

location_facility: University Hospital of Wales; Dept of Neurology

location_facility: China Medical University Hospital; Neurology - Taichung

status_simplified: Ongoing


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

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

lead_sponsor: Amgen

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


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

acronym: CLOT-AF

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

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

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

family: Lip

full_name: Gregory Y.H. Lip

given: Gregory Y.H.

family: Hammerstingl

full_name: Christoph Hammerstingl

given: Christoph

family: Marin

full_name: Francisco Marin

given: Francisco

family: Cappato

full_name: Riccardo Cappato

given: Riccardo

family: Meng

full_name: Isabelle Ling Meng

given: Isabelle Ling

family: Kirsch

full_name: Bodo Kirsch

given: Bodo

family: Morandi

full_name: Eolo Morandi

given: Eolo

family: van Eickels

full_name: Martin van Eickels

given: Martin

family: Cohen

full_name: Ariel Cohen

given: Ariel

journal_name: American Heart Journal

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

version: submittedVersion

lead_sponsor: Bayer

location_country:
France
Bulgaria
Poland
Russian Federation
Turkey
Germany
Ukraine


title: Women's INternational Transcatheter Aortic Valve Implantation Registry

acronym: WINTAVI

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

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

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

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

name: The BARC represents a collaboration of independent academic research organizations (Cardialysis, Rotterdam, the Netherlands; Cardiovascular Research Foundation, New York City, NY; Duke Clinical Research Institute, Durham, NC; TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, and Harvard Medical School, Boston, MA; Harvard Clinical Research Institute, Boston, MA; Green Lane Coordinating Centre, Auckland, New Zealand; Cleveland Clinic Coordinating Center for Clinical Research,...

family: Mehran

full_name: Roxana Mehran

given: Roxana

family: Rao

full_name: Sunil V. Rao

given: Sunil V.

family: Bhatt

full_name: Deepak L. Bhatt

given: Deepak L.

family: Gibson

full_name: C. Michael Gibson

given: C. Michael

family: Caixeta

full_name: Adriano Caixeta

given: Adriano

family: Eikelboom

full_name: John Eikelboom

given: John

family: Kaul

full_name: Sanjay Kaul

given: Sanjay

family: Wiviott

full_name: Stephen D. Wiviott

given: Stephen D.

family: Menon

full_name: Venu Menon

given: Venu

family: Nikolsky

full_name: Eugenia Nikolsky

given: Eugenia

family: Serebruany

full_name: Victor Serebruany

given: Victor

family: Valgimigli

full_name: Marco Valgimigli

given: Marco

family: Vranckx

full_name: Pascal Vranckx

given: Pascal

family: Taggart

full_name: David Taggart

given: David

family: Sabik

full_name: Joseph F. Sabik

given: Joseph F.

family: Cutlip

full_name: Donald E. Cutlip

given: Donald E.

family: Krucoff

full_name: Mitchell W. Krucoff

given: Mitchell W.

family: Ohman

full_name: E. Magnus Ohman

given: E. Magnus

family: Steg

full_name: Philippe Gabriel Steg

given: Philippe Gabriel

family: White

full_name: Harvey White

given: Harvey

journal_name: Circulation

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

title: Standardized Bleeding Definitions for Cardiovascular Clinical Trials

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

location_country:
Italy
Netherlands
France
Spain
United States
United Kingdom

location_facility: Department cardiovascular Sciences Policlinico Umberto I

location_facility: Radboud University Nijmegen Medical Center


title: Treatment of Congenital Factor VII Deficiency. A Prospective Observational Study

summary:
This study is conducted globally. The aim of this study is to describe the treatment modalities and outcomes of bleeding episodes, surgery and prophylaxis in patients with factor VII (FVII) deficiency in addition to evaluate the presence (in already treated patients) and/or the appearance of inhibiting antibodies to FVII and/or therapy-related thrombosis.

Due to a Novo Nordisk commitment to the Committee for Medicinal Products for Human Use (CHMP), Novo Nordisk receives data on treatment with activated recombinant human FVII (rFVIIa, NovoSeven®) in patients with FVII deficiency from the Seven Treatment Evaluation Registry (STER, NCT01269138). These patients can also have been treated with other haemostatics for systemic administration.

ReferenceCitation: Mariani G, Dolce A, Batorova A, Auerswald G, Schved JF, Siragusa S, Napolitano M, Knudsen JB, Ingerslev J; STER and the International Factor VII Deficiency Study Groups. Recombinant, activated factor VII for surgery in factor VII deficiency: a prospective evaluation - the surgical STER. Br J Haematol. 2011 Feb;152(3):340-6. doi: 10.1111/j.1365-2141.2010.08287.x. Epub 2010 Dec 16.

family: Mariani

full_name: Guglielmo Mariani

given: Guglielmo

family: Dolce

full_name: Alberto Dolce

given: Alberto

family: Batorova

full_name: Angelika Batorova

given: Angelika

family: Auerswald

full_name: Günter Auerswald

given: Günter

family: Schved

full_name: Jean Francois Schved

given: Jean Francois

family: Siragusa

full_name: Sergio Siragusa

given: Sergio

family: Napolitano

full_name: Mariasanta Napolitano

given: Mariasanta

family: Knudsen

full_name: Jens Bjerre Knudsen

given: Jens Bjerre

family: Ingerslev

full_name: Jørgen Ingerslev

given: Jørgen

name: on behalf of the STER and the International Factor VII Deficiency Study Groups

journal_name: British Journal of Haematology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Mariani G, Dolce A, Napolitano M, Ingerslev J, Giansily-Blaizot M, Di Minno MD, Auerswald G, De Saez AR, Tagliaferri A, Batorova A; STER (Seven Treatment Evaluation Registry). Invasive procedures and minor surgery in factor VII deficiency. Haemophilia. 2012 May;18(3):e63-5. doi: 10.1111/j.1365-2516.2012.02751.x. Epub 2012 Feb 22.

family: MARIANI

full_name: G. MARIANI

given: G.

family: DOLCE

full_name: A. DOLCE

given: A.

family: NAPOLITANO

full_name: M. NAPOLITANO

given: M.

family: INGERSLEV

full_name: J. INGERSLEV

given: J.

family: GIANSILY-BLAIZOT

full_name: M. GIANSILY-BLAIZOT

family: DI MINNO

full_name: M. D. DI MINNO

given: M. D.

family: AUERSWALD

full_name: G. AUERSWALD

family: DE SAEZ

full_name: A. R. DE SAEZ

given: A. R.

family: TAGLIAFERRI

full_name: A. TAGLIAFERRI

family: BATOROVA

full_name: A. BATOROVA

name: ON BEHALF OF THE STER (SEVEN TREATMENT EVALUATION REGISTRY); OTHER AUTHORS ARE LISTED AT THE END OF THE MANUSCRIPT

journal_name: Haemophilia

location_country:
Italy
United States
India
Serbia
Hong Kong
Pakistan
France
Thailand
Greece
Israel
Slovakia
Venezuela
Spain
Turkey
Germany
Iran, Islamic Republic of


title: Phased RF Evaluation of Acute Pulmonary Vein Isolation in Paroxysmal AF With New GENius UI and PVAC GOLD

summary: PRECISION GOLD is a prospective, multi-center, single arm, unblinded interventional post market clinical study conducted in Europe. The purpose of the study is to evaluate asymptomatic cerebral embolic (ACE) lesions in subjects with symptomatic paroxysmal atrial fibrillation undergoing ablation with the Pulmonary Vein Ablation Catheter (PVAC) GOLD.

ReferenceCitation: De Greef Y, Dekker L, Boersma L, Murray S, Wieczorek M, Spitzer SG, Davidson N, Furniss S, Hocini M, Geller JC, Csanádi Z; PRECISION GOLD investigators. Low rate of asymptomatic cerebral embolism and improved procedural efficiency with the novel pulmonary vein ablation catheter GOLD: results of the PRECISION GOLD trial. Europace. 2016 May;18(5):687-95. doi: 10.1093/europace/euv385. Epub 2016 Jan 29.

family: De Greef

full_name: Yves De Greef

given: Yves

family: Dekker

full_name: Lukas Dekker

given: Lukas

family: Boersma

full_name: Lucas Boersma

given: Lucas

family: Murray

full_name: Stephen Murray

given: Stephen

family: Wieczorek

full_name: Marcus Wieczorek

given: Marcus

family: Spitzer

full_name: Stefan G. Spitzer

given: Stefan G.

family: Davidson

full_name: Neil Davidson

given: Neil

family: Furniss

full_name: Steve Furniss

given: Steve

family: Hocini

full_name: Mélèze Hocini

given: Mélèze

family: Geller

full_name: J. Christoph Geller

given: J. Christoph

family: Csanádi

full_name: Zoltan Csanádi

given: Zoltan

journal_name: Europace

evidence: open (via page says Open Access)

evidence: oa repository (semantic scholar lookup)

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Netherlands
France
Hungary
Belgium
Germany
United Kingdom

location_facility: Zentrum fuer klinische Pruefungen in der Facharztzentrum Dresden-Neustadt GbR


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

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

Primary Objective:

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

Secondary Objective(s):

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

Exploratory Objective(s):

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

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

family: Reynolds

full_name: JV Reynolds

given: JV

family: Preston

full_name: SR Preston

given: SR

family: O’Neill

full_name: B O’Neill

given: B

family: Baeksgaard

full_name: L Baeksgaard

given: L

family: Griffin

full_name: SM Griffin

given: SM

family: Mariette

full_name: C Mariette

given: C

family: Cuffe

full_name: S Cuffe

given: S

family: Cunningham

full_name: M Cunningham

given: M

family: Crosby

full_name: T Crosby

given: T

family: Parker

full_name: I Parker

given: I

family: Hofland

full_name: K Hofland

given: K

family: Hanna

full_name: G Hanna

given: G

family: Svendsen

full_name: LB Svendsen

given: LB

family: Donohoe

full_name: CL Donohoe

given: CL

family: Muldoon

full_name: C Muldoon

family: O’Toole

full_name: D O’Toole

given: D

family: Johnson

full_name: C Johnson

family: Ravi

full_name: N Ravi

given: N

family: Jones

full_name: G Jones

family: Corkhill

full_name: AK Corkhill

given: AK

family: Illsley

full_name: M Illsley

family: Mellor

full_name: J Mellor

given: J

family: Lee

full_name: K Lee

family: Dib

full_name: M Dib

repository_institution: Trinity College Dublin - Trinity's Access to Research Output (TARA)

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

repository_institution: Dr Steevens Hospital Library - Lenus, The Irish Health Repository

repository_institution: Newcastle Univesity - Newcastle University ePrints

repository_institution: University of Southampton - ePrints Soton

location_country:
Sweden
France
Ireland
Denmark
United Kingdom

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

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

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

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

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

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

location_facility: SLRON- St Luke's Radiation Oncology Network

location_facility: Oxford University Hospital NHS Trust Churchill Hospital

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Karolinska Institutet and Karolinska University Hospital

location_facility: University Hospitals Coventry & Warwickshire

location_facility: University Hospitals Bristol NHS Foundation Trust


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

acronym: EUROCONDOR

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

primary_purpose: Prevention

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

name: Association for Innovation and Biomedical Research on Light and Image (AIBILI), Coimbra, Portugal

family: Cunha-Vaz

full_name: José Cunha-Vaz

given: José

family: Ribeiro

full_name: Luísa Ribeiro

given: Luísa

family: Costa

full_name: Miguel Costa

given: Miguel

name: Vall d'Hebron Research Institute (VHIR) and CIBERDEM (Instituto de Salud Carlos III), Barcelona, Spain

family: Simó

full_name: Rafael Simó

given: Rafael

journal_name: Investigative Opthalmology & Visual Science

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

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

family: Santos

full_name: Ana Rita Santos

given: Ana Rita

family: Bandello

full_name: Francesco Bandello

given: Francesco

family: Lattanzio

full_name: Rosangela Lattanzio

given: Rosangela

family: Egan

full_name: Catherine Egan

given: Catherine

family: Frydkjaer-Olsen

full_name: Ulrik Frydkjaer-Olsen

given: Ulrik

family: García-Arumí

full_name: José García-Arumí

family: Gibson

full_name: Jonathan Gibson

given: Jonathan

family: Grauslund

full_name: Jakob Grauslund

given: Jakob

family: Harding

full_name: Simon P. Harding

given: Simon P.

family: Lang

full_name: Gabriele E. Lang

given: Gabriele E.

family: Massin

full_name: Pascale Massin

given: Pascale

family: Midena

full_name: Edoardo Midena

given: Edoardo

family: Scanlon

full_name: Peter Scanlon

given: Peter

family: Aldington

full_name: Stephen J. Aldington

given: Stephen J.

family: Simão

full_name: Sílvia Simão

given: Sílvia

repository_institution: University of Gloucestershire - Research Repository

repository_institution: Aston University - Aston Publications Explorer

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

location_country:
Italy
Spain
France
Portugal
Denmark
Germany
United Kingdom

location_facility: Gloucestershire Hospitals NHS Foundation Trust (CHGH)

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

location_facility: Universita degli Study di Padova(UPadova)

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

location_facility: Moorfields Eye Hospital NHS Foundation Trust (MEH)

location_facility: Universita Vita-Salute San Raffaele (USR)


title: A Study to Evaluate the Safety and Efficacy of Zoledronic Acid in the Prevention or Delaying of Bone Metastasis in Patients With Stage IIIA and IIIB Non-small Cell Lung Cancer

summary: 30-40% of patients with lung cancer will develop bone metastases during the course of their disease, which can lead to pain, decreased mobility and skeletal complications. This study will investigate the effect of zoledronic acid on preventing or delaying the development of bone metastases and the impact on disease progression/survival in patients with stage IIIA and IIIB Non-small Cell Lung Cancer (NSCLC).

ReferenceCitation: Scagliotti GV, Kosmidis P, de Marinis F, Schreurs AJM, Albert I, Engel-Riedel W, Schallier D, Barbera S, Kuo HP, Sallo V, Perez JR, Manegold C. Zoledronic acid in patients with stage IIIA/B NSCLC: results of a randomized, phase III study. Ann Oncol. 2012 Aug;23(8):2082-2087. doi: 10.1093/annonc/mds128. Epub 2012 Jun 22.

family: Scagliotti

full_name: G.V. Scagliotti

family: Kosmidis

full_name: P. Kosmidis

given: P.

family: de Marinis

full_name: F. de Marinis

given: F.

family: Schreurs

full_name: A.J.M. Schreurs

family: Albert

full_name: I. Albert

given: I.

family: Engel-Riedel

full_name: W. Engel-Riedel

given: W.

family: Schallier

full_name: D. Schallier

given: D.

family: Barbera

full_name: S. Barbera

given: S.

family: Kuo

full_name: H.-P. Kuo

family: Sallo

full_name: V. Sallo

given: V.

family: Perez

full_name: J.R. Perez

family: Manegold

full_name: C. Manegold

given: C.

location_country:
Italy
Netherlands
Spain
France
Poland
Greece
Thailand
Hungary
Belgium
China
Germany
United Kingdom
Korea, Republic of
Taiwan
Portugal


title: A Multi-centre, Randomised, Double-blind, Placebocontrolled, Dose Escalation Trial on Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Treatment of Post-operative Bleeding in Patients Following Cardiac Surgery Requiring Cardiopulmonary Bypass

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

The trial is planned to investigate the safety and efficacy of NovoSeven® in the management of post-operative bleeding in patients following cardiac surgery.

ReferenceCitation: Gill R, Herbertson M, Vuylsteke A, Olsen PS, von Heymann C, Mythen M, Sellke F, Booth F, Schmidt TA. Safety and efficacy of recombinant activated factor VII: a randomized placebo-controlled trial in the setting of bleeding after cardiac surgery. Circulation. 2009 Jul 7;120(1):21-7. doi: 10.1161/CIRCULATIONAHA.108.834275. Epub 2009 Jun 22.

name: From Cardiac Anaesthesia and Intensive Care Medicine, Southampton University Hospitals, Southampton, UK (R.G., M.H.); Department of Anaesthesia and Intensive Care, Papworth Hospital, Cambridge, UK (A.V.); Department of Cardiothoracic Surgery, RT Rigshospitalet, University of Copenhagen, Copenhagen, Denmark (P.S.O.); Department of Anesthesiology and Intensive Care Medicine, Charité-University Medicine Berlin, Berlin, Germany (C.v.H.); Centre for Anaesthesia, Critical Care and Pain Management,...

family: Gill

full_name: Ravi Gill

given: Ravi

family: Herbertson

full_name: Mike Herbertson

given: Mike

family: Vuylsteke

full_name: Alain Vuylsteke

given: Alain

family: Olsen

full_name: Peter Skov Olsen

given: Peter Skov

family: von Heymann

full_name: Christian von Heymann

given: Christian

family: Mythen

full_name: Monty Mythen

given: Monty

family: Sellke

full_name: Frank Sellke

given: Frank

family: Booth

full_name: Frank Booth

family: Schmidt

full_name: Thomas Andersen Schmidt

given: Thomas Andersen

repositories_institution: The Pennsylvania State University - CiteSeer X

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Safety and Efficacy of Recombinant Activated Factor VII

lead_sponsor: Novo Nordisk A/S

location_country:
Italy
Brazil
South Africa
Sweden
India
Germany
France
Malaysia
Singapore
Argentina
Spain
Denmark
United States
United Kingdom


title: A Randomized Two-Way Blinded Crossover-Design Study to Establish the Bioequivalence of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII,Refacto AF) With a Full Length Recombinant Factor VIII Preparation (FLrFVIII,Advate), Followed by an Open-Label Trial of the Safety and Efficacy of ReFacto AF in Previously Treated Patients With Hemophilia A.

summary: The study will consist of two parts: a safety and efficacy period in which all subjects will participate and a pharmacokinetic analysis period, in which 30 eligible subjects will participate to compare ReFacto AF and Advate bioequivalency and safety and efficacy of ReFacto AF in patients with Hemophilia A.

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
Italy
Sweden
Netherlands
Germany
Finland
France
Poland
Hungary
Belgium
Australia
New Zealand
Spain
United States

intervention_type: Genetic


title: Double-Blind, Triple Dummy, Parallel-Group, Randomized, Six-Month Study To Compare Celecoxib (200 Mg BID) With Diclofenac Sr (75 Mg BID) Plus Omeprazole (20 Mg QD) For Gastrointestinal Events In Subjects With Osteoarthritis And Rheumatoid Arthritis At High-Risk Of Gastrointestinal Adverse Events

acronym: CONDOR

summary: To determine whether celecoxib is superior to combined therapy with diclofenac and omeprazole in the incidence of clinically significant upper and/or lower gastrointestinal (GI) events in high GI risk subjects with osteoarthritis and/or rheumatoid arthritis.

ReferenceCitation: Kellner HL, Li C, Essex MN. Celecoxib and Diclofenac Plus Omeprazole are Similarly Effective in the Treatment of Arthritis in Patients at High GI Risk in the CONDOR Trial. Open Rheumatol J. 2013 Nov 13;7:96-100. doi: 10.2174/1874312901307010096. eCollection 2013.

family: Kellner

full_name: Herbert L. Kellner

given: Herbert L.

family: Li

full_name: Chunming Li

given: Chunming

family: Essex

full_name: Margaret N. Essex

given: Margaret N.

journal_name: The Open Rheumatology Journal

evidence: open (via page says license)

publisher: Bentham Science Publishers Ltd.

publisher_dissemination: Bentham Science Publishers Ltd.

publisher_group: Bentham Science Publishers Ltd.

publisher_normalized: Bentham Science Publishers Ltd.

title: Celecoxib and Diclofenac Plus Omeprazole are Similarly Effective in the Treatment of Arthritis in Patients at High GI Risk in the CONDOR Trial§

ReferenceCitation: Chan FK, Lanas A, Scheiman J, Berger MF, Nguyen H, Goldstein JL. Celecoxib versus omeprazole and diclofenac in patients with osteoarthritis and rheumatoid arthritis (CONDOR): a randomised trial. Lancet. 2010 Jul 17;376(9736):173-9. doi: 10.1016/S0140-6736(10)60673-3. Epub 2010 Jun 16. Erratum in: Lancet. 2011 Jul 16;378(9787):228.

family: Chan

full_name: Francis KL Chan

given: Francis KL

family: Lanas

full_name: Angel Lanas

given: Angel

family: Scheiman

full_name: James Scheiman

given: James

family: Berger

full_name: Manuela F Berger

given: Manuela F

family: Nguyen

full_name: Ha Nguyen

given: Ha

family: Goldstein

full_name: Jay L Goldstein

given: Jay L

journal_name: The Lancet

location_country:
Peru
Guatemala
Greece
Belgium
Russian Federation
Taiwan
Ukraine
Ecuador
India
Costa Rica
Croatia
France
Lithuania
Panama
Canada
Korea, Republic of
Colombia
South Africa
Sweden
Hong Kong
Netherlands
Singapore
China
Portugal
Germany
United Kingdom
Brazil
Serbia
Czechia
Spain
Estonia
Latvia


title: A Randomized, Open-Label, Comparative Evaluation of the Safety and Efficacy of Sirolimus Versus Cyclosporine When Combined in a Regimen Containing Basiliximab, Mycophenolate Mofetil, and Corticosteroids in Primary De Novo Renal Allograft Recipients

summary: The purpose of this study is to determine if one drug is superior to another with regard to safety and the preservation of renal function after a kidney transplant.

ReferenceCitation: Flechner SM, Gurkan A, Hartmann A, Legendre CM, Russ GR, Campistol JM, Schena FP, Hahn CM, Li H, Korth-Bradley JM, Tai SS, Schulman SL. A randomized, open-label study of sirolimus versus cyclosporine in primary de novo renal allograft recipients. Transplantation. 2013 May 27;95(10):1233-41. doi: 10.1097/TP.0b013e318291a269.

family: Flechner

full_name: Stuart M. Flechner

given: Stuart M.

family: Gurkan

full_name: Alihan Gurkan

given: Alihan

family: Hartmann

full_name: Anders Hartmann

given: Anders

family: Legendre

full_name: Christophe M. Legendre

given: Christophe M.

family: Russ

full_name: Graeme R. Russ

given: Graeme R.

family: Campistol

full_name: Josep M. Campistol

given: Josep M.

family: Schena

full_name: Francesco P. Schena

given: Francesco P.

family: Hahn

full_name: Carolyn M Hahn

given: Carolyn M

full_name: Huihua Li

given: Huihua

family: Korth-Bradley

full_name: Joan M. Korth-Bradley

given: Joan M.

family: Tai

full_name: Sandi See Tai

given: Sandi See

family: Schulman

full_name: Seth L. Schulman

given: Seth L.

journal_name: Transplantation

title: A Randomized, Open-Label Study of Sirolimus Versus Cyclosporine in Primary De Novo Renal Allograft Recipients

location_country:
Greece
Australia
Taiwan
France
Norway
Argentina
Canada
South Africa
Chile
Sweden
Singapore
Hungary
Portugal
United States
Germany
United Kingdom
Italy
Austria
Cyprus
Spain
Turkey


title: Phase 3 Multi-Center, Double-Blind, Randomized, Parallel Group, Carotid B-Mode Ultrasound Evaluation of the Anti-Atherosclerotic Efficacy, Safety and Tolerability of Fixed Combination CP-529,414/Atorvastatin, Administered Orally, Once Daily (QD) for 24 Months, Compared With Maximally Tolerated Atorvastatin Therapy Alone, in Subjects With Heterozygous Familial Hypercholesterolemia.

acronym: RADIANCE 1

summary:
The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

To look at ultrasound images taken in the carotid arteries and to look at various lipids in the blood of people with heterozygous familial hypercholesterolemia

ReferenceCitation: Tajik P, Meijer R, Duivenvoorden R, Peters SA, Kastelein JJ, Visseren FJ, Crouse JR 3rd, Palmer MK, Raichlen JS, Grobbee DE, Bots ML. Asymmetrical distribution of atherosclerosis in the carotid artery: identical patterns across age, race, and gender. Eur J Prev Cardiol. 2012 Aug;19(4):687-97. doi: 10.1177/1741826711410821. Epub 2011 May 25.

name: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.

name: Department of Epidemiology & Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.

family: Tajik

full_name: Parvin Tajik

given: Parvin

family: Meijer

full_name: Rudy Meijer

given: Rudy

name: Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.

family: Duivenvoorden

full_name: Raphaël Duivenvoorden

given: Raphaël

family: Peters

full_name: Sanne AE Peters

given: Sanne AE

family: Kastelein

full_name: John J Kastelein

given: John J

name: Department of Vascular Medicine, University Medical Center Utrecht, Utrecht, The Netherlands.

family: Visseren

full_name: Frank J Visseren

given: Frank J

name: Division of Public Health Sciences, Wake Forest University, Winston Salem, USA.

family: Crouse

full_name: John R Crouse

given: John R

suffix: III

family: Palmer

full_name: Mike K Palmer

given: Mike K

family: Raichlen

full_name: Joel S Raichlen

given: Joel S

family: Grobbee

full_name: Diederick E Grobbee

given: Diederick E

family: Bots

full_name: Michiel L Bots

given: Michiel L

journal_name: European Journal of Preventive Cardiology

ReferenceCitation: Dogan S, Duivenvoorden R, Grobbee DE, Kastelein JJ, Shear CL, Evans GW, Visseren FL, Bots ML; Radiance 1 and Radiance 2 Study Groups. Ultrasound protocols to measure carotid intima-media thickness in trials; comparison of reproducibility, rate of progression, and effect of intervention in subjects with familial hypercholesterolemia and subjects with mixed dyslipidemia. Ann Med. 2010 Sep;42(6):447-64. doi: 10.3109/07853890.2010.499132.

name: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands

family: Dogan

full_name: Soner Dogan

given: Soner

name: Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands

full_name: Diederick E. Grobbee

given: Diederick E.

full_name: John J. P. Kastelein

given: John J. P.

family: Shear

full_name: Charles L. Shear

given: Charles L.

name: Division of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA

family: Evans

full_name: Greg W. Evans

given: Greg W.

name: Department of Vascular Medicine, University Medical Center Utrecht, Utrecht, the Netherlands

full_name: Frank L. Visseren

given: Frank L.

full_name: Michiel L. Bots

given: Michiel L.

name: on behalf of the RADIANCE 1 and RADIANCE 2 Study Groups

journal_name: Annals of Medicine

publisher: Informa UK Limited

ReferenceCitation: Dogan S, Duivenvoorden R, Grobbee DE, Kastelein JJ, Shear CL, Evans GW, Visseren FL, Bots ML; Radiance 1 and 2 Study Groups. Completeness of carotid intima media thickness measurements depends on body composition: the RADIANCE 1 and 2 trials. J Atheroscler Thromb. 2010 May;17(5):526-35. Epub 2010 Mar 13.

ReferenceCitation: Vergeer M, Bots ML, van Leuven SI, Basart DC, Sijbrands EJ, Evans GW, Grobbee DE, Visseren FL, Stalenhoef AF, Stroes ES, Kastelein JJ. Cholesteryl ester transfer protein inhibitor torcetrapib and off-target toxicity: a pooled analysis of the rating atherosclerotic disease change by imaging with a new CETP inhibitor (RADIANCE) trials. Circulation. 2008 Dec 9;118(24):2515-22. doi: 10.1161/CIRCULATIONAHA.108.772665. Epub 2008 Nov 24. Erratum in: Circulation. 2009 Feb 10;119(5):e197.

name: From the Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands (M.V., S.I.v.L., E.S.S., J.J.P.K.); Julius Center for Health Sciences and Primary Care (M.L.B., D.E.G.) and Department of Vascular Medicine (F.L.V.), University Medical Center Utrecht, Utrecht, The Netherlands; Westfries Gasthuis, Hoorn, The Netherlands (D.C.B.); Department of Internal Medicine, Erasmus University Medical Centre, Rotterdam, The Netherlands (E.J.S.); Division of Public Health Sciences, Wake Forest...

title: Cholesteryl Ester Transfer Protein Inhibitor Torcetrapib and Off-Target Toxicity

ReferenceCitation: Kastelein JJ, van Leuven SI, Evans GW, Riley WA, Revkin JH, Shear CL, Bots ML; RADIANCE 1 and 2 Study Investigators. Designs of RADIANCE 1 and 2: carotid ultrasound studies comparing the effects of torcetrapib/atorvastatin with atorvastatin alone on atherosclerosis. Curr Med Res Opin. 2007 Apr;23(4):885-94.

ReferenceCitation: Kastelein JJ, van Leuven SI, Burgess L, Evans GW, Kuivenhoven JA, Barter PJ, Revkin JH, Grobbee DE, Riley WA, Shear CL, Duggan WT, Bots ML; RADIANCE 1 Investigators. Effect of torcetrapib on carotid atherosclerosis in familial hypercholesterolemia. N Engl J Med. 2007 Apr 19;356(16):1620-30. Epub 2007 Mar 26.

location_country:
Italy
South Africa
Netherlands
Finland
France
United States
Czech Republic
Canada


title: A Randomised, Placebo-controlled, Parallel Group Single Dose Study of SB681323 in Patients With Active RA to Investigate the CRP Dose Response Relationship

summary: This study is designed to compare a range of doses of SB-681323 with prednisolone, which has known effects on rheumatoid arthritis patients. By comparing the two drugs and their effects on blood proteins that indicate for rheumatoid arthritis, we hope to ascertain information on the most effective dose of SB-681323 to use in future.

lead_sponsor: GlaxoSmithKline

location_country:
France
Russian Federation
Australia
Germany
United Kingdom


title: A Long-Term Continuation Study of Patients With Infantile-Onset Pompe Disease Who Were Previously Enrolled in Protocol AGLU01602

summary: Pompe disease (also known as glycogen storage disease type II) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. The overall objective of this study is to evaluate the long-term safety and efficacy of Myozyme treatment in patients with infantile-onset Pompe disease.

ReferenceCitation: Kishnani PS, Goldenberg PC, DeArmey SL, Heller J, Benjamin D, Young S, Bali D, Smith SA, Li JS, Mandel H, Koeberl D, Rosenberg A, Chen YT. Cross-reactive immunologic material status affects treatment outcomes in Pompe disease infants. Mol Genet Metab. 2010 Jan;99(1):26-33. doi: 10.1016/j.ymgme.2009.08.003.

family: Kishnani

full_name: Priya S. Kishnani

given: Priya S.

family: Goldenberg

full_name: Paula C. Goldenberg

given: Paula C.

family: DeArmey

full_name: Stephanie L. DeArmey

given: Stephanie L.

family: Heller

full_name: James Heller

given: James

family: Benjamin

full_name: Danny Benjamin

given: Danny

family: Young

full_name: Sarah Young

given: Sarah

family: Bali

full_name: Deeksha Bali

given: Deeksha

family: Smith

full_name: Sue Ann Smith

given: Sue Ann

family: Li

full_name: Jennifer S. Li

given: Jennifer S.

family: Mandel

full_name: Hanna Mandel

given: Hanna

family: Koeberl

full_name: Dwight Koeberl

given: Dwight

family: Rosenberg

full_name: Amy Rosenberg

given: Amy

family: Chen

full_name: Y-T Chen

given: Y-T

journal_name: Molecular Genetics and Metabolism

oa_host_type: repository

version: acceptedVersion

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Italy
United States
Netherlands
France
Israel
Germany
Taiwan

location_facility: Chi-Mei Medical Center Dept of Pediatrics

location_facility: Shands Hospital at the University of Florida

intervention_type: Biological


title: VANTAGE STUDY Vercise™ Implantable Stimulator for Treating Parkinson's Disease

acronym: VANTAGE

summary: The purpose of this study is to document patient outcomes, including effectiveness, safety, and health economic data, for the Boston Scientific implantable deep brain stimulation (DBS) Vercise™ system for bilateral stimulation of the subthalamic nucleus (STN) in the treatment of moderate to severe idiopathic Parkinson's Disease (PD).

ReferenceCitation: Timmermann L, Jain R, Chen L, Maarouf M, Barbe MT, Allert N, Brücke T, Kaiser I, Beirer S, Sejio F, Suarez E, Lozano B, Haegelen C, Vérin M, Porta M, Servello D, Gill S, Whone A, Van Dyck N, Alesch F. Multiple-source current steering in subthalamic nucleus deep brain stimulation for Parkinson's disease (the VANTAGE study): a non-randomised, prospective, multicentre, open-label study. Lancet Neurol. 2015 Jul;14(7):693-701. doi: 10.1016/S1474-4422(15)00087-3. Epub 2015 May 28.

family: Timmermann

full_name: Lars Timmermann

given: Lars

family: Jain

full_name: Roshini Jain

given: Roshini

full_name: Lilly Chen

given: Lilly

family: Maarouf

full_name: Mohamed Maarouf

given: Mohamed

family: Barbe

full_name: Michael T Barbe

given: Michael T

family: Allert

full_name: Niels Allert

given: Niels

family: Brücke

full_name: Thomas Brücke

given: Thomas

family: Kaiser

full_name: Iris Kaiser

given: Iris

family: Beirer

full_name: Sebastian Beirer

given: Sebastian

family: Sejio

full_name: Fernando Sejio

given: Fernando

family: Suarez

full_name: Esther Suarez

given: Esther

family: Lozano

full_name: Beatriz Lozano

given: Beatriz

family: Haegelen

full_name: Claire Haegelen

given: Claire

family: Vérin

full_name: Marc Vérin

given: Marc

family: Porta

full_name: Mauro Porta

given: Mauro

family: Servello

full_name: Domenico Servello

given: Domenico

family: Gill

full_name: Steven Gill

given: Steven

family: Whone

full_name: Alan Whone

given: Alan

family: Van Dyck

full_name: Nic Van Dyck

given: Nic

family: Alesch

full_name: Francois Alesch

given: Francois

journal_name: The Lancet Neurology

lead_sponsor: Boston Scientific Corporation

location_country:
Italy
Austria
France
Spain
Germany
United Kingdom

location_facility:
IRCCS Istituto Ortopedico Galeazzi
Uniklinik Köln
CHU de Rennes-Pontchaillou
Hospital Central de Asturias
Southmead Hospital Bristol
Frenchay Hospital
Allgemeines Krankenhaus AKH


title: Randomized, Double-Blind, and Placebo-Controlled Study Using Eculizumab in Transfusion Dependent PNH Patients

summary: The primary objective is to evaluate the safety and efficacy of eculizumab in transfusion dependent patients with hemolytic PNH.

primary_purpose: Educational/Counseling/Training

ReferenceCitation: Hillmen P, Young NS, Schubert J, Brodsky RA, Socié G, Muus P, Röth A, Szer J, Elebute MO, Nakamura R, Browne P, Risitano AM, Hill A, Schrezenmeier H, Fu CL, Maciejewski J, Rollins SA, Mojcik CF, Rother RP, Luzzatto L. The complement inhibitor eculizumab in paroxysmal nocturnal hemoglobinuria. N Engl J Med. 2006 Sep 21;355(12):1233-43.

ReferenceCitation: Hill A, Rother RP, Wang X, Morris SM Jr, Quinn-Senger K, Kelly R, Richards SJ, Bessler M, Bell L, Hillmen P, Gladwin MT. Effect of eculizumab on haemolysis-associated nitric oxide depletion, dyspnoea, and measures of pulmonary hypertension in patients with paroxysmal nocturnal haemoglobinuria. Br J Haematol. 2010 May;149(3):414-25. doi: 10.1111/j.1365-2141.2010.08096.x. Epub 2010 Mar 8.

family: Hill

full_name: Anita Hill

given: Anita

family: Rother

full_name: Russell P. Rother

given: Russell P.

family: Wang

full_name: Xunde Wang

given: Xunde

family: Morris, Jr

full_name: Sidney M. Morris, Jr

given: Sidney M.

family: Quinn-Senger

full_name: Kerry Quinn-Senger

given: Kerry

family: Kelly

full_name: Richard Kelly

given: Richard

family: Richards

full_name: Stephen J. Richards

given: Stephen J.

family: Bessler

full_name: Monica Bessler

given: Monica

family: Bell

full_name: Leonard Bell

given: Leonard

family: Hillmen

full_name: Peter Hillmen

given: Peter

family: Gladwin

full_name: Mark T. Gladwin

given: Mark T.

lead_sponsor: Alexion Pharmaceuticals

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

location_facility: St. James Hospital, Haematology Department

location_facility: Universitatsklinik Greifswald, Innere Medizin C - Hamato-Onkologie

location_facility: Ospedale Maggiore di Milano, Divisione di Ematologia

location_facility: Leeds General Infirmary, D Floor Brotherton Wing

location_facility: National Heart, Blood, and Lung Institute, National Institutes of Health

location_facility: The Royal Perth Hosptial, Department of Haematology/Level 2

location_facility: Queen Elizabeth Hospital, Dept. of Haematology

location_facility: Universitatsklinikum Essen, Zentrum fur Innere Medizin

location_facility: Duke University Health System, Division of Cell Therapy, Heme Malignancies Program

location_facility: St. George's Hospital, Department of Haematology

location_facility: Medizinische Hochschule Hannover, Abt. Hamatologie/Onkologie, Zentrum fur Innere Medizin

location_facility: Institut fur Klinische Transfusionmedizin und Immungenetik, Abtlg. Transfusionsmedizin des Universitatskinikums Ulm

location_facility: University of Alberta, Cross Cancer Institute

location_facility: Hospital De L'Hotel Dieu, Hematologie et Oncologie Medicale

location_facility: Hopital Saint-Louis, Centre G. Hayem-Secteur Bleu Porte 7, Laboratoire De Pathologie/Greffe de Moelle

location_facility: Universitatsklinik Basel, Division of Hematology

location_facility: Royal Melbourne Hospital, Dept. of Clinical Haematology & Medical Oncology

location_facility: Royal Cornwall Hospital, Haematology Dept.

location_facility: Ospedale San Bortolo, Divisione di Ematologia

location_facility: Presbyterian Medical Center, PENN Comprehensive Hemophilia & Thrombosis Program

location_facility: Hartford Hospital, Cancer Clinical Research Office

location_facility: Universitar degli Studi di Napoli, Divisione di Ematologia, Azienda Universitar Policlinico

location_facility: Princess Alexandra Hospital, Oncology Haematology Radiation Department

location_facility: Saarland University Medical School, Internal Medicine 1

location_facility: Belfast City Hospital, Dept. of Haematology C Floor

location_facility: Washington University School of Medicine, Dept. of Internal Medicine/Division of Hematology

location_facility: Stanford University Medical Center, Division of Hematology

location_facility: Indiana University Cancer Pavilion, Div. of Hematology-Oncology, Hematological Malignancy Program/Immunology

location_facility: Cleveland Clinic, Dept. of Clinical Research

location_facility: Lund University Hospital, Department of Internal Medicine, Section of Hematology

location_facility: Umea University Hospital, Dept. of Internal Medicine 3, Section for Hematology

location_facility: Azienda Ospedaliera Universitaria Careggi, Dipartimento di area critica medico-chirurgica

location_facility: Ospedale San Martino, Dept. of Hematology

location_facility: City of Hope National Medical Center, Div. of Hematology & Bone Marrow Transplant


title: Phase 2 Study of Pemetrexed in Combination With Cisplatin and Cetuximab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

summary: The purpose of this trial is to estimate progression free survival in patients with recurrent or metastatic head and neck cancer that have not received chemotherapy in this setting.

ReferenceCitation: Cristy M, Eckerman KF. 1987. Specific absorbed fractions of energy at various ages from internal sources: I. methods. Prepared by the Oak Ridge National Laboratory, Oak Ridge, Tenn.

ReferenceCitation: Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55.

ReferenceCitation: Vermorken JB, Licitra L, Stöhlmacher-Williams J, Dietz A, Lopez-Picazo JM, Hamid O, Hossain AM, Chang SC, Gauler TC. Phase II study of pemetrexed in combination with cisplatin and cetuximab in recurrent or metastatic squamous cell carcinoma of the head and neck. Eur J Cancer. 2013 Sep;49(13):2877-83. doi: 10.1016/j.ejca.2013.05.002. Epub 2013 May 30.

family: Vermorken

full_name: J.B. Vermorken

family: Licitra

full_name: L. Licitra

given: L.

family: Stöhlmacher-Williams

full_name: J. Stöhlmacher-Williams

given: J.

family: Dietz

full_name: A. Dietz

given: A.

family: Lopez-Picazo

full_name: J.M. Lopez-Picazo

family: Hamid

full_name: O. Hamid

given: O.

family: Hossain

full_name: A.M. Hossain

family: Chang

full_name: S.-C. Chang

family: Gauler

full_name: T.C. Gauler

journal_name: European Journal of Cancer

lead_sponsor: Eli Lilly and Company

location_country:
Italy
France
Belgium
Spain
Germany
United Kingdom

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.

intervention_type: Dietary Supplement


title: Phase 2 Study Of SU011248 As Consolidation Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

summary: The purpose of this study is to find out if SU011248 (sunitinib) provides additional benefit when it is given after treatment with two chemotherapy drugs carboplatin and paclitaxel and also if sunitinib is safe for patients with locally advanced and metastatic Non Small Cell Lung Cancer (NSCLC).

lead_sponsor: Pfizer

location_country:
United States
Canada
France


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

summary: The purpose of this study is to evaluate the safety and efficacy of AeriSeal treatment in patients with advanced emphysema.

ReferenceCitation: Magnussen H, Kramer MR, Kirsten AM, Marquette C, Valipour A, Stanzel F, Bonnet R, Behr J, Fruchter O, Refaely Y, Eberhardt R, Herth FJ. Effect of fissure integrity on lung volume reduction using a polymer sealant in advanced emphysema. Thorax. 2012 Apr;67(4):302-8. doi: 10.1136/thoraxjnl-2011-201038. Epub 2012 Feb 28.

family: Magnussen

full_name: Helgo Magnussen

given: Helgo

family: Kramer

full_name: Mordechai R Kramer

given: Mordechai R

family: Kirsten

full_name: Anne-Marie Kirsten

given: Anne-Marie

family: Marquette

full_name: Charles Marquette

given: Charles

family: Valipour

full_name: Arschang Valipour

given: Arschang

family: Stanzel

full_name: Franz Stanzel

given: Franz

family: Bonnet

full_name: Reiner Bonnet

given: Reiner

family: Behr

full_name: Juergen Behr

given: Juergen

family: Fruchter

full_name: Oren Fruchter

given: Oren

family: Refaely

full_name: Yael Refaely

given: Yael

family: Eberhardt

full_name: Ralf Eberhardt

given: Ralf

family: Herth

full_name: Felix J F Herth

given: Felix J F

journal_name: Thorax

repository_institution: University of Oxford - Oxford Academic Notes & Queries

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

title: Effect of fissure integrity on lung volume reduction using a polymer sealant* in advanced emphysema

lead_sponsor: Aeris Therapeutics

location_country: Israel Austria Germany France

location_facility: Otto Wagner Spital Wien Interne Lungenabteilung

location_facility: Medizinische Klinik und Poliklinik Klinikum Großhadern

location_facility: Rabin Medical Center, Beilinson Hospital

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