title: Post-authorization Safety Study to Prospectively Monitor the Incidence of Relevant Drug-related Adverse Events and EPO-related Lack of Efficacy Among CKD Subjects Receiving HX575 Recombinant Human Erythropoietin Alfa i.v.

acronym: EPO-PASS

summary: Cumulative follow-up with HX575 epoetin alfa to prospectively monitor the incidence of relevant drug-related adverse events and EPO-related lack of efficacy among Chronic Kidney Disease (CKD) subjects receiving HX575 epoetin alfa i.v.

ReferenceCitation: Hörl WH, Locatelli F, Haag-Weber M, Ode M, Roth K; Epo-PASS study group. Prospective multicenter study of HX575 (biosimilar epoetin-α) in patients with chronic kidney disease applying a target hemoglobin of 10--12 g/dl. Clin Nephrol. 2012 Jul;78(1):24-32.

ipd_sharing: Undecided

lead_sponsor: Sandoz

location_country: Macedonia, The Former Yugoslav Republic of

location_facility: Ospedaliero Universitaria Policlinico S. Orsola Malpighi

location_facility: Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel

location_facility: KfH Kuratorium für Nierentranplantation und Dialyse e.V.

location_facility: Wojewodzki Szpital Specjalistyczny im. Najswietszej maryi Panny

location_facility: Tsentralnyi miskyi klinichnyi hospital, Viddilennia gemodializu

location_facility: Ministry of Interior-Central Clinical Base

location_facility: Azienda Ospdealiero "Istituti Ospitalieri"

location_facility: Szpital Powiatowy im. Lekarza Z. Koprowskiego

location_facility: Ternopilska Oblasna Klinichna Likarnia, Viddilennia Nefrologii ta Gemodializu

location_facility: FGUZ Clinical hospital No. 83 of FMBA of Russia

location_facility: Alwall Praxis für Nieren- und Hochdruckkrankheiten

location_facility: GUZ "Yaroslavl regional clinical hospital"

location_facility: Mykolaivska Oblasna Klinichna Likarnia, Viddilennia Gemodializu

location_facility: U.O. Nefrologia e Dialisi, P.O. Ospedale Casati, Centro Dialisi

location_facility: Azienda Ospedaliera Carlo Poma di Mantova

location_facility: Azienda Ospedaliera Ospedale San Carlo Borromeo

location_facility: Miska klinichna likarnia#3, Miskyi nefrologichnyi tsentr

location_facility: Diabetes- und Dialysezentrum Merker, Vogt

location_facility: Nieren- und Diabeteszentrum Viersen-Nettetal

location_facility: Facharzt für Innere Medizin und Nephrologie, Dialyse Centrum

location_facility: Dialysezentrum und Schwerpunktpraxis für Nieren- und Hochdruckerkrankungen

location_facility: Multiprofile Hospital for Active Treatment Rousse

location_facility: Praxis für Innere Medizin und Nephrologie

location_facility: Multiprofile Hospital for Active Treatment Pazardzhik

location_facility: Fachpraxis für Nieren und Hochdruckerkrankungen

location_facility: Specjalistyczny Szpital Wojewodzki w Ciechanowie

location_facility: Azienda Ospedaliera Ospedale Niguarda Ca Granda

location_facility: Azienda Ospedaliera ospedale S. Salvatore

location_facility: Multiprofile Hospital for Active Treatment Dr. Kiro Popov

location_facility: Kuratorium ür Dialyse und Nierentransplantation e.V.

location_facility: Multiprofile Hospital for Active Treatment Sv. Ivan Rilski

location_facility: Szpital Specjalistyczny Sw. W. Adalberta

location_facility: Instytut nefrologii AMN Ukrainy viddil nefrologii ta dializu

location_facility: Multiprofile Hospital for Active Treatment Dr. Tota Venkova

location_facility: Universitätsklinik für Innere Medizin III

location_facility: Oblasna klinichna likarnia imeni I.I.Mechnikova

location_facility: Samodzielnym Publicznym Zakladzie Opieki Zdrowotnej Dzialdowo

location_facility: Oblasna klinikchna likarnia, tsentr transplantologii ta gemodializu

location_facility: Azienda Ospedaliera CTO - Maria Adelaide

location_facility: Radomski Szpital Specjalistyszny im. Dr Tytusa Chalubinskiego

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4

location_facility: PHO Clinical Hospital Dr. Trifun Panovski

location_facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V.

location_facility: Universitaria Degli Studi di Genova Clinica Nefrologica, Dialisi e Trapianto

location_facility: U.O.C. Nefrologia e Dialisi, C.G. Mazzoni

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej AVITUM


title: A Single-Masked, Randomized, Multi-Center, 2-Arm Parallel Study Comparing the Safety and Effectiveness of Bulkamid® and Contigen® as Bulking Agents for the Treatment of Stress Urinary Incontinence in Females

summary: The primary purpose of this study is to demonstrate the safety and effectiveness of Bulkamid® in the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) in adult women who have SUI or stress predominant mixed incontinence

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Contura

location_country:
United States
Canada
France

location_facility: Hospital for the University of Pennsylvannia - Penn Center for Continence and Public Health: Division of Urology

location_facility: Medical University of South Carolina - Department of Urology

location_facility: Tower Urology - Institute for Continence - Cedars-Sinai Medical Office

location_facility: South California Permanente Medical Group

location_facility: Stanford UniveritySchool of Medicine - Departmert of OB/GYN

location_facility: University of Vermont - The Continence Center

location_facility: Virgina Mason Medical Center - Section of Urology and Renal Transplantation

location_facility: UT Southwestern Medical Center at Dallas - Department of Urology

location_facility: University of Miami and Jackson Memorial Hospital

location_facility: Midwest Institute for Research & Education

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


intervention_type: Drug

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

lead_sponsor: Bayer

location_country:
Italy
Brazil
Hong Kong
Spain
Germany
France
Bulgaria
Korea, Republic of
Poland
Belgium
Australia
New Zealand
China
United States
United Kingdom
Canada
Taiwan
Colombia
Ukraine

acronym: STEP

ipd_sharing: No

type: EudraCT Number

source: euctr

title: Sorafenib Long Term Extension Program

summary:
The primary purpose of program was to enable patients, currently receiving sorafenib (Nexavar) in a Bayer/Onyx sponsored clinical trial, to continue sorafenib treatment after their respective study had met its primary endpoint and/or had reached the end as defined in the original protocol. Patients were able to continue treatment until (i) the treating physician felt the patient was no longer benefiting from the treatment or (ii) the treatment becomes commercially available and reimbursed for the respective indication as applicable in the country in which the patient lived and the patient could obtain suitable amounts of drug for treatment through standard mechanisms of commercial availability (ie, there should be no interruption in the patient's treatment schedule when switching to commercially available product) or (iii) the patient could join a Post-Trial-Access Program, another study or can receive sorafenib through any other mechanism (e.g. local access program) in accordance with local legal and compliance rules, with no cost to the patient with respect to sorafenib.

An additional objective was the assessment of the safety of Nexavar or Nexavar combination treatment.


title: A Two-arm, Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Study to Evaluate Safety and Tolerability and to Explore the Neuroprotective Effect of Atacicept as Assessed by Optical Coherence Tomography (OCT) in Subjects With Optic Neuritis (ON) as Clinically Isolated Syndrome (CIS) Over a 36-week Treatment Course

summary: This study was intended to evaluate the efficacy, safety and tolerability of atacicept compared to placebo and to explore the neuroprotective effect of atacicept as assessed by OCT in subjects with ON as CIS. The study was randomized. Study medication was administered via subcutaneous (under the skin) injections.

status: Terminated

lead_sponsor: EMD Serono

location_country:
United States
Switzerland
Lebanon
United Kingdom
Germany
France
Belgium
Australia
Spain
Canada
Czech Republic

status_simplified: Unknown


title: A Multicenter, Open-Label, Randomized Study Comparing Efficacy and Safety of S-1 as Single Agent Versus 5-FU Bolus for the Treatment of Patients With Metastatic Pancreatic Cancer Previously Treated With a Gemcitabine-Based Regimen

acronym: S-1 Pancreas

summary:
The primary objective of this study is to determine whether S-1 increases overall survival when compared to 5-Fluorouracil (5-FU) in patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy.

The secondary objectives are to compare: progression free survival, overall response rate, clinical benefit and improvement in tumor related symptoms and also to assess overall safety and pharmacokinetics of S-1.

lead_sponsor: Sanofi

location_country:
Austria
Brazil
Guatemala
Peru
Costa Rica
South Africa
Sweden
France
Panama
Greece
Israel
Tunisia
Romania
Hungary
Denmark
United States
Canada


acronym: AVERT

summary: The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis (PVE).

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Schaff H, Carrel T, Steckelberg JM, Grunkemeier GL, Holubkov R. Artificial Valve Endocarditis Reduction Trial (AVERT): protocol of a multicenter randomized trial. J Heart Valve Dis. 1999 Mar;8(2):131-9.

ReferenceType: result

ReferenceCitation: Dávila-Román VG, Waggoner AD, Kennard ED, Holubkov R, Jamieson WR, Englberger L, Carrel TP, Schaff HV; Artificial Valve Endocarditis Reduction Trial echocardiography study. Prevalence and severity of paravalvular regurgitation in the Artificial Valve Endocarditis Reduction Trial (AVERT) echocardiography study. J Am Coll Cardiol. 2004 Oct 6;44(7):1467-72.

ReferenceCitation: Schaff HV, Carrel TP, Jamieson WR, Jones KW, Rufilanchas JJ, Cooley DA, Hetzer R, Stumpe F, Duveau D, Moseley P, van Boven WJ, Grunkemeier GL, Kennard ED, Holubkov R; Artificial Valve Endocarditis Reduction Trial. Paravalvular leak and other events in silzone-coated mechanical heart valves: a report from AVERT. Ann Thorac Surg. 2002 Mar;73(3):785-92.

ReferenceCitation: Englberger L, Carrel T, Schaff HV, Kennard ED, Holubkov R; AVERT Investigators. Differences in heart valve procedures between North American and European centers: a report from the Artificial Valve Endocarditis Reduction Trial (AVERT). J Heart Valve Dis. 2001 Sep;10(5):562-71.

ReferenceCitation: Englberger L, Schaff HV, Jamieson WR, Kennard ED, Im KA, Holubkov R, Carrel TP; AVERT Investigators. Importance of implant technique on risk of major paravalvular leak (PVL) after St. Jude mechanical heart valve replacement: a report from the Artificial Valve Endocarditis Reduction Trial (AVERT). Eur J Cardiothorac Surg. 2005 Dec;28(6):838-43. Epub 2005 Nov 7.

lead_sponsor: Abbott Medical Devices

location_country:
Italy
United States
Switzerland
Netherlands
France
Spain
Germany
Canada

location_facility:
Fond Ne Centro S. Raffaele
Hospital 12 de Octubre
University of British Columbia
Brigham and Womens Hospital
University of Alberta Hospital
Mayo Clinic
Hôpital G. Et R. Laënnec
Florida Heart Group
LDS Hospital
Inselspital
Sisters of Providence Health System
Texas Heart Institute
Hopital Regional-Service de Cardiologie
St. Antonius Ziekenhuis
Massachusetts General Hospital
Deutches Herzzentrum Berlin


location_country:
Malaysia
Romania
Belgium
Australia
Taiwan
Croatia
France
Poland
Argentina
Colombia
Chile
Switzerland
Philippines
Hungary
Puerto Rico
Portugal
China
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Spain

title: A Double-blind, Randomized, Placebo-controlled, Parallel Group Study of Rimonabant 20 mg Daily for the Treatment of Type 2 Diabetic Patients With Nonalcoholic Steatohepatitis (NASH).

summary: The purpose of this study is to assess the effect of rimonabant treatment on the histological features of Nonalcoholic Steatohepatitis (NASH) in patients with Type 2 diabetes.


title: A Double-blind, Randomized, Placebo-controlled, Parallel Group Study of Rimonabant 20 mg Daily for the Treatment of Non-diabetic Patients With Nonalcoholic Steatohepatitis (NASH)

summary: The purpose of this study is to assess the effect of Rimonabant treatment on the histological features of Nonalcoholic Steatohepatitis (NASH).


title: A Multinational, Randomized, Double-blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks Versus Placebo in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer

acronym: VANILLA

summary:
The main objective of the study was to evaluate the effectiveness of aflibercept treatment by comparison to placebo in increasing the overall survival (OS) in participants with metastatic pancreatic cancer, treated with gemcitabine.

The secondary objectives were to evaluate progression free survival, clinical benefit, overall response, safety and immunogenicity of aflibercept, in the two treatment arms (Arm 1: Aflibercept and Gemcitabine; Arm 2: Placebo and Gemcitabine).

The study included an interim analysis of OS. In accordance with the study protocol, an interim analysis was performed for the purpose of futility and overwhelming efficacy. On the basis of the interim analysis, the Data Monitoring Committee (DMC) recommended that this study be terminated for futility based on predefined boundary rules.

ReferenceCitation: Rougier P, Riess H, Manges R, Karasek P, Humblet Y, Barone C, Santoro A, Assadourian S, Hatteville L, Philip PA. Randomised, placebo-controlled, double-blind, parallel-group phase III study evaluating aflibercept in patients receiving first-line treatment with gemcitabine for metastatic pancreatic cancer. Eur J Cancer. 2013 Aug;49(12):2633-42. doi: 10.1016/j.ejca.2013.04.002. Epub 2013 Apr 30.

family: Rougier

full_name: Philippe Rougier

given: Philippe

sequence: first

family: Riess

full_name: Hanno Riess

given: Hanno

sequence: additional

family: Manges

full_name: Robert Manges

given: Robert

family: Karasek

full_name: Petr Karasek

given: Petr

family: Humblet

full_name: Yves Humblet

given: Yves

family: Barone

full_name: Carlo Barone

given: Carlo

family: Santoro

full_name: Armando Santoro

given: Armando

family: Assadourian

full_name: Sylvie Assadourian

given: Sylvie

family: Hatteville

full_name: Laurence Hatteville

given: Laurence

family: Philip

full_name: Philip A. Philip

given: Philip A.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: European Journal of Cancer

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

location_country:
Greece
Romania
Belgium
Russian Federation
Czech Republic
India
France
Poland
Slovakia
Argentina
Canada
Colombia
Chile
Switzerland
Bulgaria
Hungary
Puerto Rico
Germany
United States
Italy
Austria
Mexico
Cyprus
Spain


ReferenceCitation: Van Belle E, Nikol S, Norgren L, Baumgartner I, Driver V, Hiatt WR, Belch J. Insights on the role of diabetes and geographic variation in patients with critical limb ischaemia. Eur J Vasc Endovasc Surg. 2011 Sep;42(3):365-73. doi: 10.1016/j.ejvs.2011.04.030. Epub 2011 Jun 21.

family: Van Belle

full_name: E. Van Belle

given: E.

family: Nikol

full_name: S. Nikol

given: S.

family: Norgren

full_name: L. Norgren

given: L.

family: Baumgartner

full_name: I. Baumgartner

given: I.

family: Driver

full_name: V. Driver

given: V.

family: Hiatt

full_name: W.R. Hiatt

family: Belch

full_name: J. Belch

given: J.

journal_name: European Journal of Vascular and Endovascular Surgery

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

title: Insights on the Role of Diabetes and Geographic Variation in Patients with Criticial Limb Ischaemia

ReferenceCitation: Belch J, Hiatt WR, Baumgartner I, Driver IV, Nikol S, Norgren L, Van Belle E; TAMARIS Committees and Investigators. Effect of fibroblast growth factor NV1FGF on amputation and death: a randomised placebo-controlled trial of gene therapy in critical limb ischaemia. Lancet. 2011 Jun 4;377(9781):1929-37. doi: 10.1016/S0140-6736(11)60394-2. Epub 2011 May 28.

full_name: Jill Belch

given: Jill

full_name: William R Hiatt

given: William R

full_name: Iris Baumgartner

given: Iris

full_name: I Vickie Driver

given: I Vickie

full_name: Sigrid Nikol

given: Sigrid

full_name: Lars Norgren

given: Lars

full_name: Eric Van Belle

given: Eric

journal_name: The Lancet

oa_host_type: repository

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

host_type: repository

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University of Valladolid - University of Valladolid Documentary Repository

version: submittedVersion

intervention_type: Biological

location_country:
Finland
Greece
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Ukraine
Spain
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Turkey
South Africa
Chile
Sweden
Hong Kong
Switzerland
Singapore
Hungary
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Belarus
Estonia

acronym: TAMARIS

title: A Randomized Double-Blind Placebo-Controlled Parallel Group Study of the Efficacy and Safety of XRP0038/NV1FGF on Amputation or Any Death in Critical Limb Ischemia Patients With Skin Lesions

summary:
Primary objective is to demonstrate the superiority of riferminogene pecaplasmid (XRP0038/NV1FGF) over placebo in the prevention of major amputation above the ankle of the treated leg or of death from any cause, whichever comes first, in critical limb ischemia (CLI) patients with skin lesions.

Secondary objectives are to evaluate:

The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to major amputation;
The efficacy of riferminogene pecaplasmid versus placebo for delaying the time to death;
The safety of riferminogene pecaplasmid in the study population.


type: Registry Identifier

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

acronym: SOLE

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

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

ReferenceType: derived

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

family: Guerini-Rocco

full_name: Elena Guerini-Rocco

given: Elena

family: Gray

full_name: Kathryn P. Gray

given: Kathryn P.

family: Fumagalli

full_name: Caterina Fumagalli

given: Caterina

family: Reforgiato

full_name: Marta Rita Reforgiato

given: Marta Rita

family: Leone

full_name: Isabella Leone

given: Isabella

family: Rafaniello Raviele

full_name: Paola Rafaniello Raviele

given: Paola

family: Munzone

full_name: Elisabetta Munzone

given: Elisabetta

family: Kammler

full_name: Roswitha Kammler

given: Roswitha

family: Neven

full_name: Patrick Neven

given: Patrick

family: Hitre

full_name: Erika Hitre

given: Erika

family: Jerusalem

full_name: Guy Jerusalem

given: Guy

family: Simoncini

full_name: Edda Simoncini

given: Edda

family: Gombos

full_name: Andrea Gombos

given: Andrea

family: Deleu

full_name: Ines Deleu

given: Ines

family: Karlsson

full_name: Per Karlsson

given: Per

family: Aebi

full_name: Stefan Aebi

given: Stefan

family: Chirgwin

full_name: Jacquie Chirgwin

given: Jacquie

family: Di Lauro

full_name: Vincenzo Di Lauro

given: Vincenzo

family: Thompson

full_name: Alastair Thompson

given: Alastair

family: Graas

full_name: Marie-Pascale Graas

given: Marie-Pascale

family: Barber

full_name: Matthew Barber

given: Matthew

family: Fontaine

full_name: Christel Fontaine

given: Christel

family: Loibl

full_name: Sibylle Loibl

publisher: American Association for Cancer Research (AACR)

title: Genomic Aberrations and Late Recurrence in Postmenopausal Women with Hormone Receptor–positive Early Breast Cancer: Results from the SOLE Trial

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

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

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Kumamoto University Faculty of Medical and Pharmaceutical Sciences

location_facility: Centre Hospitalier Universitaire Brugmann

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

location_facility: Karolinska University Hospital - Huddinge

location_facility: Russian Academy of Medical Sciences Cancer Research Center

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: Algemeen Ziekenhuis Sint-Maarten - Campus Rooiberg

location_facility: Aarhus Universitetshospital - Aarhus Sygehus

location_facility: Centro di Riferimento Oncologico - Aviano

location_facility: Hospital Clinico Universitario de Valencia

location_facility: National Institute of Oncology - Budapest

location_facility: Gemeinschaftspraxis Gynaekologie & Geburtshilfe

location_facility: Copenhagen County Herlev University Hospital

location_facility: Praxis Dr. Wilke - Onkologie am Klinikum Fuerth

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

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

location_facility: Allgemeines Krankenhaus - Universitatskliniken

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

location_facility: Allgemeinen Krankenhaus Celle Kinderklinik

location_facility: Hospital Santiago Oriente Dr. Luis Tisne Brousse

location_facility: Brustzentrum Thurgau at Kantonsspital Frauenfeld

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman

location_facility: Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni


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

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

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

family: Hirschfield

full_name: Gideon M. Hirschfield

given: Gideon M.

family: Mason

full_name: Andrew Mason

given: Andrew

family: Luketic

full_name: Velimir Luketic

given: Velimir

family: Lindor

full_name: Keith Lindor

given: Keith

family: Gordon

full_name: Stuart C. Gordon

given: Stuart C.

family: Mayo

full_name: Marlyn Mayo

given: Marlyn

family: Kowdley

full_name: Kris V. Kowdley

given: Kris V.

family: Vincent

full_name: Catherine Vincent

given: Catherine

family: Bodhenheimer

full_name: Henry C. Bodhenheimer

given: Henry C.

suffix: Jr.

family: Parés

full_name: Albert Parés

given: Albert

family: Trauner

full_name: Michael Trauner

given: Michael

family: Marschall

full_name: Hanns-Ulrich Marschall

given: Hanns-Ulrich

family: Adorini

full_name: Luciano Adorini

given: Luciano

family: Sciacca

full_name: Cathi Sciacca

given: Cathi

family: Beecher-Jones

full_name: Tessa Beecher-Jones

given: Tessa

family: Castelloe

full_name: Erin Castelloe

given: Erin

family: Böhm

full_name: Olaf Böhm

given: Olaf

family: Shapiro

full_name: David Shapiro

given: David

journal_name: Gastroenterology

oa_colors: green hybrid

oa_host_type: publisher;repository

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

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

title: Efficacy of Obeticholic Acid in Patients With Primary Biliary Cirrhosis and Inadequate Response to Ursodeoxycholic Acid

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

location_facility: University of Miami - Center for Liver Diseases

location_facility: University Medical Centre Hamburg-Eppendorf

location_facility: Centre de Recherche du CHUM / University of Montreal


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

family: Nasrallah

full_name: Henry A. Nasrallah

given: Henry A.

family: Silva

full_name: Robert Silva

given: Robert

family: Phillips

full_name: Debra Phillips

given: Debra

family: Cucchiaro

full_name: Josephine Cucchiaro

given: Josephine

family: Hsu

full_name: Jay Hsu

given: Jay

family: Xu

full_name: Jane Xu

given: Jane

family: Loebel

full_name: Antony Loebel

given: Antony

journal_name: Journal of Psychiatric Research

title: Lurasidone for the treatment of acutely psychotic patients with schizophrenia: A 6-week, randomized, placebo-controlled study

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

family: Hopkins

full_name: Seth C. Hopkins

given: Seth C.

family: Ogirala

full_name: Ajay Ogirala

given: Ajay

family: Worden

full_name: MaryAlice Worden

given: MaryAlice

family: Koblan

full_name: Kenneth S. Koblan

given: Kenneth S.

journal_name: Clinical Drug Investigation

license: cc-by-nc

license_normalized: cc-by-nc

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

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

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

full_name: Josephine B. Cucchiaro

given: Josephine B.

family: Mao

full_name: Yongcai Mao

given: Yongcai

family: Pikalov

full_name: Andrei A. Pikalov

given: Andrei A.

full_name: Antony D. Loebel

given: Antony D.

journal_name: CNS Spectrums

evidence: open (via page says Open Access)

location_country:
India
France
Malaysia
Romania
Russian Federation
United States
Ukraine

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

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

location_facility: Dnipropetrovsk Regional Clinical Hospital named Mechnikov

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

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

location_facility: K&S Professional Research Services, LLC.

location_facility: Madras Medical College & Government General Hospital

location_facility: Spitalul Clinic Judetean de Urgenta Arad

location_facility: Centrul de Recuperare si Reabilitare Gura Ocnitei

location_facility: City Psychiatric Hospital #3 of Skvortsov-Stepanov

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

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

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

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

location_facility: Bekhterev Psychoneurological Research Institute

location_facility: City Psychoneurological Dispensary #7 (with Hospital)

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

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

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


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

family: Sopata

full_name: Maciej Sopata

given: Maciej

family: Katz

full_name: Nathaniel Katz

given: Nathaniel

family: Carey

full_name: William Carey

given: William

family: Smith

full_name: Michael D. Smith

given: Michael D.

family: Keller

full_name: David Keller

family: Verburg

full_name: Kenneth M. Verburg

given: Kenneth M.

family: West

full_name: Christine R. West

given: Christine R.

family: Wolfram

full_name: Gernot Wolfram

given: Gernot

family: Brown

full_name: Mark T. Brown

given: Mark T.

journal_name: Pain

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

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

family: Bapat

full_name: Aditi A. Bapat

given: Aditi A.

family: Hostetter

full_name: Galen Hostetter

given: Galen

family: Von Hoff

full_name: Daniel D. Von Hoff

given: Daniel D.

family: Han

full_name: Haiyong Han

given: Haiyong

journal_name: Nature Reviews Cancer

publisher_dissemination: Springer

publisher_group: Springer

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

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

location_facility: Rajiv Gandhi Cancer Institute and Research Centre,

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

location_facility: Medical University of South Carolina, Department of Urology

location_facility: Shri Siddhivinayak Ganpati Cancer Hospital

location_facility: Chhatrapati Shahuji Maharaj Medical University

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

location_facility: Institute of Oncology, University Clinical Center Sarajevo

location_facility: Huntsman Cancer Institute at the University of Utah

location_facility: Fovarosi Onkormanyzat Peterfy Sandor Utcai Korhaz - Fajdalom Ambulancia

location_facility: WK River Cities Clinical Research Center

location_facility: Fakultna Nemocnica s Poliklinikou F.D.Roosevelta

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

location_facility: Landeskrankenhaus Graz - Universitaetsklinik fuer Orthopaedie und Orthopaedische Chirurgie

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

location_facility: Hospital Nacional Guillermo Almenara Irigoyen

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

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

location_facility: Poradnia Medycyny Paliatywnej, Hospicjum Palium

location_facility: Willis Knighton Pierremont Health Center

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

ipd_sharing: Yes

type: Other Identifier

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

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


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

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

study_type: Observational

time_perspective: Prospective

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

name: Department of Radiology and Nuclear Medicine, VU University Medical Centre, The Netherlands

family: Nagtegaal

full_name: Gijsbert JA Nagtegaal

given: Gijsbert JA

name: Global Clinical Development, Bayer Pharma AG, Germany

name: Department of Neurology, University Hospital of Bonn, Germany

family: Pohl

full_name: Christoph Pohl

given: Christoph

family: Wattjes

full_name: Mike P Wattjes

given: Mike P

family: Hulst

full_name: Hanneke E Hulst

given: Hanneke E

name: Department of Medicine, Ottawa Hospital Research Institute, Canada

family: Freedman

full_name: Mark S Freedman

given: Mark S

name: Neurology Clinic, Heinrich-Heine-Universität, Germany

family: Hartung

full_name: Hans-Peter Hartung

given: Hans-Peter

name: Institute of Neurology, National Hospital for Neurology and Neurosurgery, UK

family: Miller

full_name: David Miller

given: David

name: MS Centre of Catalonia, Hospital Vall d’Hebron, Spain

family: Montalban

full_name: Xavier Montalban

given: Xavier

name: Department of Neurology, University of Basel and University Hospital, Switzerland

family: Kappos

full_name: Ludwig Kappos

given: Ludwig

name: Service de Neurologie, Université of Rennes, France

family: Edan

full_name: Gilles Edan

given: Gilles

name: Global Medical Affairs, Bayer HealthCare Pharmaceuticals, USA

family: Pleimes

full_name: Dirk Pleimes

given: Dirk

family: Beckman

full_name: Karola Beckman

given: Karola

family: Stemper

full_name: Brigitte Stemper

given: Brigitte

family: Polman

full_name: Christoph H Polman

given: Christoph H

family: Sandbrink

full_name: Rupert Sandbrink

given: Rupert

family: Barkhof

full_name: Frederik Barkhof

given: Frederik

journal_name: Multiple Sclerosis Journal

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

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


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

acronym: VITAL

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

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

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

name: Rodryg Ramlau, Wielkopolskie Centrum Pulmonologii i Torakochirurgii, Poznań University of Medical Sciences, Poznań, Poland; Vera Gorbunova, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Tudor Eliade Ciuleanu, Institute of Oncology, Cluj-Napoca, Romania; Silvia Novello and Giorgio Scagliotti, University of Turin, S. Luigi Hospital, Orbassano, Italy; Mustafa Ozguroglu, Istanbul University Cerrahpasa Medical Faculty, Istanbul; Tuncay Goksel, Ege Universitesi Tip Fakultesi, Bornova/Izmir,...

family: Ramlau

full_name: Rodryg Ramlau

given: Rodryg

family: Gorbunova

full_name: Vera Gorbunova

given: Vera

family: Ciuleanu

full_name: Tudor Eliade Ciuleanu

given: Tudor Eliade

family: Novello

full_name: Silvia Novello

given: Silvia

family: Ozguroglu

full_name: Mustafa Ozguroglu

given: Mustafa

family: Goksel

full_name: Tuncay Goksel

given: Tuncay

family: Baldotto

full_name: Clarissa Baldotto

given: Clarissa

family: Bennouna

full_name: Jaafar Bennouna

given: Jaafar

family: Shepherd

full_name: Frances A. Shepherd

given: Frances A.

family: Le-Guennec

full_name: Solenn Le-Guennec

given: Solenn

family: Rey

full_name: Augustin Rey

given: Augustin

full_name: Vincent Miller

given: Vincent

family: Thatcher

full_name: Nicholas Thatcher

given: Nicholas

family: Scagliotti

full_name: Giorgio Scagliotti

given: Giorgio

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Aflibercept and Docetaxel Versus Docetaxel Alone After Platinum Failure in Patients With Advanced or Metastatic Non–Small-Cell Lung Cancer: A Randomized, Controlled Phase III Trial

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

location_facility: sanofi-aventis Australia & New Zealand administrative office


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

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

name: Neurologic Clinic and Policlinic, MS Center and Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Departments of Medicine, Biomedicine, and Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland

family: Kuhle

full_name: Jens Kuhle

given: Jens

family: Daizadeh

full_name: Nadia Daizadeh

given: Nadia

name: Clinical Trial Unit Basel, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland

family: Benkert

full_name: Pascal Benkert

given: Pascal

family: Maceski

full_name: Aleksandra Maceski

given: Aleksandra

name: Neurologic Clinic and Policlinic, MS Center and Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel, University of Basel, Basel, Switzerland Current affiliation: Ann Romney Center for Neurologic Diseases, Brigham & Women’s Hospital, Harvard Medical School, Boston, MA, USA

family: Barro

full_name: Christian Barro

given: Christian

name: Neurologic Clinic and Policlinic, MS Center and Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel, University of Basel, Basel, Switzerland Current affiliation: F. Hoffmann-La Roche Ltd., Basel, Switzerland

family: Michalak

full_name: Zuzanna Michalak

given: Zuzanna

name: Department of Health Sciences, University of Genoa and IRCCS Ospedale Policlinico San Martino, Genoa, Italy

family: Sormani

full_name: Maria Pia Sormani

given: Maria Pia

family: Godin

full_name: Jean Godin

given: Jean

family: Shankara

full_name: Srinivas Shankara

given: Srinivas

name: Current affiliation: Immunitas Therapeutics, Inc., Cambridge, MA, USA

family: Samad

full_name: Tarek A Samad

given: Tarek A

name: Current affiliation: Immunovant, New York, NY, USA

family: Jacobs

full_name: Alan Jacobs

given: Alan

name: Current affiliation: Immune-Onc Therapeutics, Palo Alto, CA, USA

family: Chung

full_name: Luke Chung

given: Luke

family: Rӧsch

full_name: Nora Rӧsch

given: Nora

family: Kaiser

full_name: Carina Kaiser

given: Carina

family: Mitchell

full_name: Colin P Mitchell

given: Colin P

family: Leppert

full_name: David Leppert

given: David

family: Havari

full_name: Evis Havari

given: Evis

family: Kappos

full_name: Ludwig Kappos

given: Ludwig

evidence: open (via page says license)

title: Sustained reduction of serum neurofilament light chain over 7 years by alemtuzumab in early relapsing–remitting MS

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

name: Department of Clinical Neurosciences, University of Cambridge, Box 165, Addenbrooke’s Hospital, Cambridge CB2 0QQ, UK

family: Coles

full_name: Alasdair J. Coles

given: Alasdair J.

name: NeuroRx Research, Montréal, Québec, Canada

name: Department of Neurology and Neurosurgery, Montréal Neurological Institute, McGill University, Montréal, Québec, Canada

family: Arnold

full_name: Douglas L. Arnold

given: Douglas L.

name: Neurology Center of San Antonio, San Antonio, TX, USA

family: Bass

full_name: Ann D. Bass

name: Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK

name: Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain

name: Department of Neurology and Center for Clinical Neuroscience, First Medical Faculty, Charles University, Prague, Czech Republic

name: Department of Biomedical Engineering, Cleveland Clinic, Cleveland, OH, USA

name: The University of British Columbia, Vancouver, British Columbia, Canada

name: Vertex Pharmaceuticals, Inc., Boston, MA, USA

name: Department of Neurology, University of Warmia and Mazury, Olsztyn, Poland

journal_name: Therapeutic Advances in Neurological Disorders

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

name: Department of Neurology and Center of Clinical Neuroscience, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic

name: The Boster Center for Multiple Sclerosis, Columbus, USA

name: University of Ottawa and the Ottawa Hospital Research Institute, Ottawa, Canada

name: Center of Clinical Neuroscience, Carl Gustav Carus University Hospital, Dresden,  Germany  *Employees of Sanofi  during study conduct  and analysis.

name: on behalf of the CARE-MS I, CARE-MS II, and CAMMS03409 Investigators

journal_name: Multiple Sclerosis Journal - Experimental, Translational and Clinical

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

name: CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ investigators

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

name: Department of Neurology, University Vita-Salute San Raffaele, Milan, Italy

name: Department of Medicine, Amiri Hospital, Sharq, Kuwait

name: OhioHealth Neurological Physicians, Columbus, OH, USA

name: Keck School of Medicine, University of Southern California, Los Angeles, CA, USA/Regina Berkovich, MD, PhD, Inc., West Hollywood, CA, USA

name: Research Institute and Hospital, National Cancer Center, Goyang, South Korea

name: Klinik für Neurologie und Palliativmedizin, Cologne, Germany

name: Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden

name: Department of Neurology, Austin Health and Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia

name: NIHR Sheffield Biomedical Research Centre, Sheffield Teaching Hospitals, University of Sheffield, Sheffield, UK

name: Univ. Lille, INSERM U995, CHU Lille, FHU Imminent, F-59000 Lille, France

name: Department of Neurology, University of Münster, Münster, Germany

name: Division of Neurology, Department of Medicine, The University of British Columbia, Vancouver, BC, Canada

repository_normalized: University of Melbourne - Minerva Access

repositories: University of Melbourne - Minerva Access

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

name: Rehabilitation and MS Center Overpelt; BIOMED, Hasselt University, Hasselt, Belgium

name: The MS Center for Innovations in Care, Missouri Baptist Medical Center, St Louis, MO, USA

name: School of Medicine, Griffith University, Southport, QLD, Australia

name: Fundación IMABIS, Hospital Universitario Carlos Haya, Málaga, Spain

name: University of Ottawa and The Ottawa Hospital Research Institute, Ottawa, ON, Canada

name: Virgen Macarena University Hospital, Seville, Spain

name: Institution of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden

name: Sapienza University of Rome, Rome, Italy

name: Fort Lauderdale Multiple Sclerosis Center, Fort Lauderdale, FL, USA

name: Sanofi, Cambridge, MA, USA; Cerevance, Boston, MA, USA

name: Sanofi, Cambridge, MA, USA; EMD Serono, Billerica, MA, USA

name: University of Lille, INSERM U995, CHU Lille, FHU Imminent, Lille, France

title: Efficacy of alemtuzumab over 6 years in relapsing–remitting multiple sclerosis patients who relapsed between courses 1 and 2: Post hoc analysis of the CARE-MS studies

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

name: the CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators

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

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

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

location_facility: Department Of Neurosciences, Addenbrookes Hospital

location_facility: Independent Public Teaching Hospital No. 4 in Lublin

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

location_facility: Baylor College of Medicine, Maxine Mesinger MS Clinic

location_facility: Louisiana State University Health Sciences Center

location_facility: Lehigh Valley Hospital Neurosciences and Pain Research

location_facility: University of Louisville Research Foundation

location_facility: Research Medical Complex "Your Health" Ltd

location_facility: Hospital Angeles del Pedregal, Camino de Santa Teresa

location_facility: Samara Regional Clinical Hospital n.a. Kalinin

location_facility: Clinical Hospital Centre "Sestre Milosrdnice"

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

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

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

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

location_facility: Clinical Center Nis, Clinic for neurology

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

location_facility: Danylo Halytsky Lviv National Medical University

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

location_facility: Clinical Centre of Vojvodina, Clinic for neurology

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

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

location_facility: Moscow State Medical Institution City Clinical Hospital #11

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

location_facility: Hospital da Restauracao, Av Governador Agamenon Magalhaes

location_facility: St. Petersburg Pavlov State Medical University

location_facility: Clinical Centre Serbia, Institute for Neurology

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

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

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

location_facility: University of Calgary and Foothills Medical Cenre

location_facility: Krajska zdravotni a.s., Hospital Teplice

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

location_facility: Universitätsklinik Carl Gustav Carus Dresden

location_facility: North Central Neurology Associates, P.C.

location_facility: Idaho Falls Multiple Sclerosis Center, PLLC

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

location_facility: Klinikum der Goethe Universität Frankfurt

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

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


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

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

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

family: Henriksen

full_name: Kim Henriksen

given: Kim

family: Bay-Jensen

full_name: Anne-Christine Bay-Jensen

given: Anne-Christine

family: Christiansen

full_name: Claus Christiansen

given: Claus

family: Karsdal

full_name: Morten Asser Karsdal

given: Morten Asser

journal_name: Expert Opinion on Biological Therapy

publisher: Informa Healthcare

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

title: Oral salmon calcitonin – pharmacology in osteoporosis

lead_sponsor: Nordic Bioscience A/S

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

location_facility: Department of Internal Medicine, University of Florence


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

family: Tannock

full_name: Ian F Tannock

given: Ian F

family: Fizazi

full_name: Karim Fizazi

given: Karim

family: Ivanov

full_name: Sergey Ivanov

given: Sergey

family: Karlsson

full_name: Camilla Thellenberg Karlsson

given: Camilla Thellenberg

family: Fléchon

full_name: Aude Fléchon

given: Aude

family: Skoneczna

full_name: Iwona Skoneczna

given: Iwona

family: Orlandi

full_name: Francisco Orlandi

given: Francisco

family: Gravis

full_name: Gwenaelle Gravis

given: Gwenaelle

family: Matveev

full_name: Vsevolod Matveev

given: Vsevolod

family: Bavbek

full_name: Sevil Bavbek

given: Sevil

family: Gil

full_name: Thierry Gil

given: Thierry

family: Viana

full_name: Luciano Viana

given: Luciano

family: Arén

full_name: Osvaldo Arén

given: Osvaldo

family: Karyakin

full_name: Oleg Karyakin

given: Oleg

family: Elliott

full_name: Tony Elliott

given: Tony

family: Birtle

full_name: Alison Birtle

given: Alison

family: Magherini

full_name: Emmanuelle Magherini

given: Emmanuelle

family: Hatteville

full_name: Laurence Hatteville

given: Laurence

family: Petrylak

full_name: Daniel Petrylak

given: Daniel

family: Tombal

full_name: Bertrand Tombal

given: Bertrand

family: Rosenthal

full_name: Mark Rosenthal

given: Mark

journal_name: The Lancet Oncology

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

family: van Soest

full_name: R.J. van Soest

family: Templeton

full_name: A.J. Templeton

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

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

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

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

The secondary objectives were:

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


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

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

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

family: Vogelmeier

full_name: C. Vogelmeier

given: C.

family: Verkindre

full_name: C. Verkindre

family: Cheung

full_name: D. Cheung

given: D.

family: Galdiz

full_name: J.B. Galdiz

family: Güçlü

full_name: S.Z. Güçlü

family: Spangenthal

full_name: S. Spangenthal

given: S.

family: Overend

full_name: T. Overend

given: T.

family: Henley

full_name: M. Henley

given: M.

family: Mizutani

full_name: G. Mizutani

given: G.

family: Zeldin

full_name: R.K. Zeldin

journal_name: Pulmonary Pharmacology & Therapeutics

lead_sponsor: Novartis

location_country:
United States
Netherlands
France
Spain
Turkey
Germany


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

acronym: TUCSON

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

enrollment_type: Anticipated

lead_sponsor: ImaRx Therapeutics

location_country:
United States
France

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

location_facility: Bichat - Claude Bernard University Hospital and Medical School

location_facility: Methodist Hospital Neurological Institute


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

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

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

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


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

acronym: Hypo~CAT

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

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

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

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

family: Ginès

full_name: Pere Ginès

given: Pere

family: Wong

full_name: Florence Wong

given: Florence

family: Watson

full_name: Hugh Watson

given: Hugh

family: Milutinovic

full_name: Slobodan Milutinovic

given: Slobodan

family: Ruiz del Arbol

full_name: Luis Ruiz del Arbol

given: Luis

family: Olteanu

full_name: Dan Olteanu

given: Dan

journal_name: Hepatology

evidence: open (via free pdf)

license_normalized: no license

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Effects of satavaptan, a selective vasopressin V2receptor antagonist, on ascites and serum sodium in cirrhosis with hyponatremia: A randomized trial

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


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

acronym: Normo~CAT

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

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

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


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

acronym: SPA

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

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

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

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

family: Gines

full_name: Pere Gines

family: Horsmans

full_name: Yves Horsmans

given: Yves

family: Angeli

full_name: Paolo Angeli

given: Paolo

family: Gow

full_name: Paul Gow

given: Paul

family: Minini

full_name: Pascal Minini

given: Pascal

family: Bernardi

full_name: Mauro Bernardi

given: Mauro

journal_name: Journal of Hepatology

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


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

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

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


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

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

lead_sponsor: Eli Lilly and Company

location_country:
Italy
United States
France
Puerto Rico
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.


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

acronym: DIONYSOS

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

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

family: LE HEUZEY

full_name: JEAN-YVES LE HEUZEY

given: JEAN-YVES

family: DE FERRARI

full_name: GAETANO M. DE FERRARI

given: GAETANO M.

family: RADZIK

full_name: DAVID RADZIK

given: DAVID

family: SANTINI

full_name: MASSIMO SANTINI

given: MASSIMO

family: ZHU

full_name: JUNREN ZHU

given: JUNREN

family: DAVY

full_name: JEAN-MARC DAVY

given: JEAN-MARC

journal_name: Journal of Cardiovascular Electrophysiology

title: A Short-Term, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Dronedarone versus Amiodarone in Patients with Persistent Atrial Fibrillation: The DIONYSOS Study

ReferenceCitation: Ezekowitz MD. Maintaining sinus rhythm--making treatment better than the disease. N Engl J Med. 2007 Sep 6;357(10):1039-41.

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


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

lead_sponsor: Novo Nordisk A/S

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

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

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

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


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

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

name: Department of Special Anesthesia and Pain Therapy Medical University of Vienna/AKH Vienna Austria

family: Kress

full_name: H.G. Kress

family: Koch

full_name: E.D. Koch

family: Kosturski

full_name: H. Kosturski

given: H.

family: Steup

full_name: A. Steup

given: A.

name: Janssen Research & Development, LLC Raritan NJ USA

family: Karcher

full_name: K. Karcher

given: K.

family: Dogan

full_name: C. Dogan

given: C.

family: Etropolski

full_name: M. Etropolski

given: M.

family: Eerdekens

full_name: M. Eerdekens

journal_name: European Journal of Pain

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

title: Direct conversion from tramadol to tapentadol prolonged release for moderate to severe, chronic malignant tumour‐related pain

lead_sponsor: Grünenthal GmbH

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

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

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

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


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

acronym: CORONARY

summary:
I. Main Research Question:

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

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

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

ReferenceCitation: Hébert M, Lamy A, Noiseux N, Stevens LM. Impact of early quantitative morbidity on 1-year outcomes in coronary artery bypass graft surgery. Interact Cardiovasc Thorac Surg. 2021 Nov 11. pii: ivab316. doi: 10.1093/icvts/ivab316. [Epub ahead of print]

bso_classification: Mathematics

journal_name: Interactive Cardiovascular and Thoracic Surgery

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: OUP accepted manuscript

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

name: Population Health Research Institute McMaster University Hamilton Canada

name: Department of Medicine McMaster University Hamilton Ontario Canada

name: Department of Health Research Methods, Evidence, and Impact McMaster University Hamilton Ontario Canada

family: Conen

full_name: David Conen

given: David

family: Wang

full_name: Michael K. Wang

given: Michael K.

family: Devereaux

full_name: P. J. Devereaux

given: P. J.

name: Department of Surgery McMaster University Hamilton Ontario Canada

family: Whitlock

full_name: Richard Whitlock

given: Richard

family: McIntyre

full_name: William F. McIntyre

given: William F.

family: Healey

full_name: Jeff S. Healey

given: Jeff S.

family: Yuan

full_name: Fei Yuan

given: Fei

family: Yusuf

full_name: Salim Yusuf

given: Salim

family: Lamy

full_name: Andre Lamy

given: Andre

currency_apc_doaj: USD

journal_name: Journal of the American Heart Association

oa_colors: green gold

evidence: oa journal (via doaj)

title: New‐Onset Perioperative Atrial Fibrillation After Coronary Artery Bypass Grafting and Long‐Term Risk of Adverse Events: An Analysis From the CORONARY Trial

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

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

family: Tong

full_name: Wesley Tong

given: Wesley

full_name: P.J. Devereaux

family: Gao

full_name: Peggy Gao

given: Peggy

family: Gafni

full_name: Amiram Gafni

given: Amiram

family: Singh

full_name: Kavita Singh

given: Kavita

family: Taggart

full_name: David Taggart

title: The Cost Implications of Off-Pump Versus On-Pump Coronary Artery Bypass Graft Surgery at One Year

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

name: Division of Nephrology, Department of Medicine, Western University, London, Ontario, Canada2Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada3Department of Clinical Epidemiology and Biostatistics, McMaster Universit

name: Division of Nephrology, Department of Medicine, Western University, London, Ontario, Canada5Department of Statistics and Actuarial Science, University of Waterloo, Waterloo, Ontario, Canada

name: Section of Nephrology, Yale University School of Medicine, New Haven, Connecticut

name: Division of Cardiac Surgery, Western University, London, Ontario, Canada

name: SAL Hospital and Medical Institute, Ahmadabad, India

name: Department of Cardiovascular Surgery, Fuiwai Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China

name: Department of Cardiac Surgery, Centre Hospitalier de l’Université de Montréal CHUM, Montreal, Quebec, Canada

name: University Hospital Motol, Praha, Czech Republic

name: Instituto do Coracao do Hospital das Clinicas da, São Paulo, Brazil

name: Essex Cardiothoracic Centre and Anglia Ruskin University, Essex, England

name: Department of Cardiovascular Surgery, Hospital Universitario Fundacion Favaloro, Buenos Aires, Argentina

name: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada4Population Health Research Institute, Hamilton, Ontario, Canada16Division of Cardiac Surgery, McMaster University, Hamilton, Ontario, Canada

title: Kidney Function After Off-Pump or On-Pump Coronary Artery Bypass Graft Surgery

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

repository_institution: University of Zurich - Zurich Open Repository and Archive

title: Effects of Off-Pump and On-Pump Coronary-Artery Bypass Grafting at 1 Year

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

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

title: Off-Pump or On-Pump Coronary-Artery Bypass Grafting at 30 Days

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

title: Rationale and design of The Coronary Artery Bypass Grafting Surgery Off or On Pump Revascularization Study: A large international randomized trial in cardiac surgery

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

location_facility: Irmandade da Santa Casa de Misericordia de Sao Paulo

location_facility: Irmande Santa Casa De Misericordia De Curtiba

location_facility: Braile Clinica de Servicos de Assistencia Medico

location_facility: Escorts Heart Institute and Research Centre

location_facility: Hospital Sao Francisco Complexo Hospitalar Santa Casa

location_facility: International Center of Cardiovascular and Thoracic Diseases

location_facility: Fakultni nemocnice Kralovske Vinohrady (FNKV)

location_facility: Federal University of Sao Paulo School of Medicine

location_facility: Amrita Institute of Medical Sciences and Research Center

location_facility: Service de chirurgie thoracique et cardio-vasculaire

location_facility: Basildon and Thurrock University Hospital NHS FT

location_facility: Instituto Dante Pazzanese de Cardiologia


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

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

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

family: Denault

full_name: André Y. Denault

given: André Y.

family: Pearl

full_name: Ronald G. Pearl

given: Ronald G.

family: Michler

full_name: Robert E. Michler

given: Robert E.

family: Rao

full_name: Vivek Rao

given: Vivek

family: Tsui

full_name: Steven S.L. Tsui

given: Steven S.L.

family: Seitelberger

full_name: Rainald Seitelberger

given: Rainald

family: Cromie

full_name: Matt Cromie

given: Matt

family: Lindberg

full_name: Elisabet Lindberg

given: Elisabet

family: D’Armini

full_name: Andrea M. D’Armini

given: Andrea M.

journal_name: Journal of Cardiothoracic and Vascular Anesthesia

title: Tezosentan and Right Ventricular Failure in Patients With Pulmonary Hypertension Undergoing Cardiac Surgery: The TACTICS Trial

lead_sponsor: Idorsia Pharmaceuticals Ltd.

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

location_facility: Institute for Clinical and Experimental Medicine (IKEM)

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

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

location_facility: Montefiore Medical Center/Albert Einstein College of Medicine

location_facility: Zentrum der Chirugie-Zchir-des Universitatsklinikums

location_facility: London Health Sciences Centre-University Hospital

location_facility: Fondazione IRCCS San Matteo Hospital, Cardiac Surgery

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

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

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


design_allocation: Non-Randomized

lead_sponsor: Genzyme, a Sanofi Company

location_country:
United States
Netherlands
France
Australia
Canada

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

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


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

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

location_country:
Italy
Brazil
Netherlands
Germany
France
Denmark
United States
Canada

intervention_type: Other


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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
United States
France

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


title: EnRhythm MRI™ SureScan™ Pacing System Clinical Investigation

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

primary_purpose: Diagnostic

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

family: Sutton

full_name: Richard Sutton

given: Richard

family: Kanal

full_name: Emanuel Kanal

given: Emanuel

family: Wilkoff

full_name: Bruce L Wilkoff

given: Bruce L

family: Bello

full_name: David Bello

given: David

family: Luechinger

full_name: Roger Luechinger

given: Roger

family: Jenniskens

full_name: Inge Jenniskens

given: Inge

family: Hull

full_name: Michael Hull

given: Michael

family: Sommer

full_name: Torsten Sommer

given: Torsten

currency_apc_doaj: GBP

journal_name: Trials

license: cc-by

license_normalized: cc-by

repository_institution: ETH Zurich - Repository for Publications and Research Data

version: acceptedVersion

repositories_institution: University of Zurich - Zurich Open Repository and Archive

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

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


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

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

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

status: Unknown status

study_completion_date_type: Anticipated

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

family: Gonzalez-Bermejo

full_name: Jesus Gonzalez-Bermejo

given: Jesus

family: Morélot-Panzini

full_name: Capucine Morélot-Panzini

given: Capucine

family: Salachas

full_name: François Salachas

given: François

family: Redolfi

full_name: Stefania Redolfi

given: Stefania

family: Straus

full_name: Christian Straus

given: Christian

family: Becquemin

full_name: Marie-Hélène Becquemin

given: Marie-Hélène

family: Arnulf

full_name: Isabelle Arnulf

given: Isabelle

family: Pradat

full_name: Pierre-François Pradat

given: Pierre-François

family: Bruneteau

full_name: Gaëlle Bruneteau

given: Gaëlle

family: Ignagni

full_name: Anthony R. Ignagni

given: Anthony R.

family: Diop

full_name: Moustapha Diop

given: Moustapha

family: Onders

full_name: Raymond Onders

given: Raymond

family: Nelson

full_name: Teresa Nelson

given: Teresa

family: Menegaux

full_name: Fabrice Menegaux

given: Fabrice

family: Meininger

full_name: Vincent Meininger

given: Vincent

family: Similowski

full_name: Thomas Similowski

given: Thomas

journal_name: Amyotrophic Lateral Sclerosis

publisher: Informa UK Limited

lead_sponsor: Synapse Biomedical

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