title: A Multicentre, Double Blind, Randomised, Placebo-controlled, Phase II Trial to Evaluate Resminostat for Maintenance Treatment of Patients With Advanced Stage (Stage IIB-IVB) Mycosis Fungoides (MF) or Sézary Syndrome (SS) That Have Achieved Disease Control With Systemic Therapy - the RESMAIN Study

acronym: RESMAIN

summary: The purpose of this study is to determine whether resminostat will be able to delay or prevent worsening of disease in patients with advanced stage mycosis fungoides or Sézary Syndrome that have recently achieved disease control with previous systemic therapy.

ReferenceCitation: Valipour A, Jäger M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7:CD008946. doi: 10.1002/14651858.CD008946.pub3.

name: Department of Dermatology, Venereology and Allergology; Johann Wolfgang Goethe-University Hospital; Frankfurt am Main Germany

name: Evidence-Based Medicine Frankfurt, Institute of General Practice; Goethe University; Frankfurt Germany

family: Valipour

full_name: Arash Valipour

given: Arash

name: Hautklinik; Städtisches Klinikum Karlsruhe; Karlsruhe Germany

family: Jäger

full_name: Manuel Jäger

given: Manuel

name: Department of Dermatology; University of California Davis; Sacramento CA USA

family: Wu

full_name: Peggy Wu

given: Peggy

name: Center for Evidence-Based Healthcare; Faculty of Medicine Carl Gustav Carus, Technischen Universität (TU) Dresden; Dresden Germany

family: Schmitt

full_name: Jochen Schmitt

given: Jochen

name: c/o Cochrane Skin Group; The University of Nottingham; Nottingham UK

family: Bunch

full_name: Charles Bunch

given: Charles

family: Weberschock

full_name: Tobias Weberschock

given: Tobias

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Interventions for mycosis fungoides

ipd_sharing: No

lead_sponsor: 4SC AG

location_country:
Italy
Austria
Switzerland
Netherlands
France
Japan
Greece
Poland
Belgium
Spain
Germany
United Kingdom

location_facility: Universitaetsklinikum Bochum - St. Josef-Hospital

location_facility: Centre hospitalier universitaire vaudois (CHUV)

location_facility: Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie

location_facility: Uniwersytecki Szpital Kliniczny im. WAM - CSW

location_facility: Hospital Uni. Nuestra Senora de Candelaria

location_facility: Klinikum der Stadt Ludwigshafen am Rhein

location_facility: Chu Paris-Gh St-Louis Lariboisiere F.Widal Hopital

location_facility: St John's Institute Of Dermatology - Guy's & St Thomas' Nhs Foundation Trust

location_facility: Niigata University Medical and Dental Hospital

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Leids Universitair Medisch Centrum (LUMC)

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Saint-André

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: ATTIKON Hospital and Cutaneous Lymphoma Clinic

location_facility: Universitaetsklinikum Schleswig-Holstein (UKSH), Campus Kiel


title: Historical Case Record Survey of Visual Acuity Data From Patients With Leber's Hereditary Optic Neuropathy (LHON)

summary: The purpose of this survey is to collect visual acuity data from patients with LHON in order to establish the clinical course (natural history) and visual acuity outcomes in patients with a genetically confirmed diagnosis of LHON. In addition, this survey will generate data that will serve as comparator for the open-label study SNT-IV-006.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

lead_sponsor: Santhera Pharmaceuticals

location_country:
Italy
Netherlands
France
Norway
Belgium
Germany
United Kingdom

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

lead_sponsor_type: industriel

status_simplified: Completed


ReferenceType: derived

ReferenceCitation: Castañón Alvarez E, Giallombardo M, Gil-Bazo I, Papadimitriou K, Pauwels P, Peeters M, Rolfo C. Looking into the "Garden of the Hesperides": new drugs for hepatocellular carcinoma. Minerva Chir. 2015 Apr;70(2):119-29. Epub 2015 Jan 23. Review.

design_allocation: Non-Randomized

intervention_type: Drug

study_start_date_type: Actual

study_type: Interventional

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

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

lead_sponsor: Novartis Pharmaceuticals

primary_purpose: Treatment

location_country:
Italy
United States
Hong Kong
Spain
France
Japan
Singapore
China
Germany
Korea, Republic of
Taiwan

location_facility: University of Texas MD Anderson Cancer Center

location_facility: University of California at Los Angeles Santa Monica Location

location_facility: Massachusetts General Hospital Oncology Dept

ipd_sharing: Yes

type: EudraCT Number

source: euctr

title: A Phase I/II, Multicenter, Open-label Study of Oral FGF401 in Adult Patients With Hepatocellular Carcinoma or Solid Malignancies Characterized by Positive FGFR4 and KLB Expression

summary: Estimate the maximum tolerated dose and/or recommended phase II dose and efficacy of FGF401 as single agent and in combination with PDR001 in patients with hepatocellular carcinoma and as single agent in patients with other solid malignancies based on RECIST 1.1.


title: A Cross-sectional Study of Patients With Immune Thrombocytopenic Purpura and Caregivers to Estimate the Proportion Who Administer Romiplostim Correctly After Receipt of Home Administration Training Materials

summary: Cross-sectional study, observation made by healthcare professionals of subjects or caregivers, administering romiplostim at their first standard-of-care visit 4 weeks after training with the home administration training pack. Further observations can also be recorded in the study if made within 16 weeks of enrolment. Data will be collected from the subjects' dose diary at their first standard of care visit to ensure there were no problems with administration while not at the clinic.

time_perspective: Prospective

lead_sponsor: Amgen

location_country:
Austria
Netherlands
France
Greece
Belgium
Spain
Germany
United Kingdom


title: A Sequential Two Phase Multicenter, Randomized Study to Optimize Dose Selection and Evaluate Safety After Treatment With the Holaira™ Lung Denervation System in Patients With Moderate to Severe COPD.

acronym: AIRFLOW

summary: The purpose of this study is to evaluate safety of Targeted Lung Denervation (or TLD) in patients suffering from moderate to severe COPD. It is hypothesized that TLD will have a similar safety profile and improved physiological and functional outcomes to a sham-control.

status: Unknown status

study_completion_date_type: Anticipated

design_allocation: Randomized

enrollment_type: Anticipated

ReferenceCitation: Valipour A, Shah PL, Herth FJ, Pison C, Schumann C, Hübner RH, Bonta PI, Kessler R, Gesierich W, Darwiche K, Lamprecht B, Perez T, Skowasch D, Deslee G, Marceau A, Sciurba FC, Gosens R, Hartman JE, Conway F, Duller M, Mayse M, Norman HS, Slebos DJ; AIRFLOW-2 Trial Study Group. Two-Year Outcomes for the Double-Blind, Randomized, Sham-Controlled Study of Targeted Lung Denervation in Patients with Moderate to Severe COPD: AIRFLOW-2. Int J Chron Obstruct Pulmon Dis. 2020 Nov 5;15:2807-2816. doi: 10.2147/COPD.S267409. eCollection 2020.

full_name: Arschang Valipour

given: Arschang

sequence: first

family: Shah

full_name: Pallav L Shah

given: Pallav L

sequence: additional

family: Herth

full_name: Felix J Herth

given: Felix J

family: Pison

full_name: Christophe Pison

given: Christophe

family: Schumann

full_name: Christian Schumann

given: Christian

family: Hübner

full_name: Ralf-Harto Hübner

given: Ralf-Harto

family: Bonta

full_name: Peter I Bonta

given: Peter I

family: Kessler

full_name: Romain Kessler

given: Romain

family: Gesierich

full_name: Wolfgang Gesierich

given: Wolfgang

family: Darwiche

full_name: Kaid Darwiche

given: Kaid

family: Lamprecht

full_name: Bernd Lamprecht

given: Bernd

family: Perez

full_name: Thierry Perez

given: Thierry

family: Skowasch

full_name: Dirk Skowasch

given: Dirk

family: Deslee

full_name: Gaetan Deslee

given: Gaetan

family: Marceau

full_name: Armelle Marceau

given: Armelle

family: Sciurba

full_name: Frank C Sciurba

given: Frank C

family: Gosens

full_name: Reinoud Gosens

given: Reinoud

family: Hartman

full_name: Jorine E Hartman

given: Jorine E

family: Conway

full_name: Francesca Conway

given: Francesca

family: Duller

full_name: Marina Duller

given: Marina

family: Mayse

full_name: Martin Mayse

given: Martin

family: Norman

full_name: Holly S Norman

given: Holly S

family: Slebos

full_name: Dirk-Jan Slebos

given: Dirk-Jan

journal_name: International Journal of Chronic Obstructive Pulmonary Disease

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

ReferenceCitation: Slebos DJ, Shah PL, Herth FJF, Pison C, Schumann C, Hübner RH, Bonta PI, Kessler R, Gesierich W, Darwiche K, Lamprecht B, Perez T, Skowasch D, Deslee G, Marceau A, Sciurba FC, Gosens R, Hartman JE, Srikanthan K, Duller M, Valipour A; AIRFLOW-2 Study Group. Safety and Adverse Events after Targeted Lung Denervation for Symptomatic Moderate to Severe Chronic Obstructive Pulmonary Disease (AIRFLOW). A Multicenter Randomized Controlled Clinical Trial. Am J Respir Crit Care Med. 2019 Dec 15;200(12):1477-1486. doi: 10.1164/rccm.201903-0624OC.

name: Royal Brompton & Harefield NHS Trust, Chelsea & Westminster Hospital and Imperial College London, London, United Kingdom

name: Department of Pneumology and Critical Care Medicine, Thoraxklinik, and

name: Translational Lung Research Center Heidelberg, University of Heidelberg, Heidelberg, Germany

name: CHU Grenoble Alpes, Service Universitaire Pneumologie Physiologie, Université Grenoble Alpes, Grenoble, France

name: Clinic of Pneumology, Thoracic Oncology, Sleep and Respiratory Critical Care, Klinikverbund Kempten-Oberallgäu, Kempten and Immenstadt, Germany

name: Charité Universitätsmedizin Berlin, Medizinische Klinik m. Schw. Infektiologie und Pneumologie, Campus Virchow, Berlin, Germany

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

name: Service de Pneumologie, Nouvel Hôpital Civil, Université de Strasbourg, Strasbourg, France

name: Asklepios-Fachkliniken Munich-Gauting, Comprehensive Pneumology Center Munich, Gauting, Germany

name: Department of Pulmonary Medicine, Section of Interventional Pneumology, Ruhrlandklinik–University Hospital Essen, University of Duisburg-Essen, Essen, Germany

name: Department of Pulmonary Medicine, Kepler Universitatsklinikum GmbH, Linz, Austria

name: CHU de Lille–Hôpital Calmette, Lille, France

name: Department of Internal Medicine II–Cardiology/Pneumology, University of Bonn, Bonn, Germany

name: CHU de Reims, Hôpital Maison Blanche, Service de Pneumologie, Reims, France

name: Service de Pneumologie, Hôpital Universitaire Bichat, Paris, France

name: Department of Molecular Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands

name: University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; and

name: Department of Respiratory and Critical Care Medicine, Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology, Krankenhaus Nord–Klinik Floridsdorf, Vienna, Austria

journal_name: American Journal of Respiratory and Critical Care Medicine

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

location_country:
Austria
Netherlands
France
Belgium
Germany
United Kingdom

location_facility: CHU de Paris - Hopital Bichat Claude Bernard

location_facility: AKH Allgemeines Krankenhaus der Stadt Linz GmbH

location_facility: Ruhrlandklinik - West German Lung Center


title: Randomized, Controlled, Open Label, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of CetuGEX™ Plus CT in Comparison to Cetuximab Plus CT in Patients With Stage III/IV Recurrent and/or Metastatic SCCHN

acronym: RESGEX

summary: The aim of the study is to evaluate the efficacy of CetuGEX™ for the treatment of patients with stage III/IV recurrent and/or metastatic SCCHN as compared to cetuximab (both in combination with platinum-based chemotherapy) in terms of progression-free survival (PFS).

lead_sponsor: Glycotope GmbH

location_country: Italy France Poland Romania Belgium Spain Germany

location_facility:
Glycotope-contracteed Research Facility
Gycotope-contracted Research Facility
Glycotope-contracted Research Facility
Glycotope-contracted Research Facillity


title: IntErnational Non-randomized, Single-arm, Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN

acronym: EnligHTN-II

summary: The purpose of this post market clinical investigation is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled hypertension.

status: Terminated

lead_sponsor: Abbott Medical Devices

location_country:
Italy
Sweden
Netherlands
France
Greece
Norway
Australia
New Zealand
Spain
Germany
United Kingdom

location_facility: University of Athens, Ippocration Hospital

location_facility: Uni-Klinik Leipzig, Intervent. Angiologie

location_facility: Hopital Civil - Universitaires de Strasbourg

location_facility: Sahlgrenska University Hospital Gothenburg

location_facility: NIHR Barts Cardiovascular Biomedical Research Unit

location_facility: Fondazione Toscana Gabriele Monasterio CNR

location_facility: Universitats-Herzzentrum Freiburg - Bad Krozingen

location_facility: Institute Cardio. Paris-Sud-Institut Jacques Cartier

intervention_type: Device

status_simplified: Unknown


ReferenceCitation: Salazar R, Garcia-Carbonero R, Libutti SK, Hendifar AE, Custodio A, Guimbaud R, Lombard-Bohas C, Ricci S, Klümpen HJ, Capdevila J, Reed N, Walenkamp A, Grande E, Safina S, Meyer T, Kong O, Salomon H, Tavorath R, Yao JC. Phase II Study of BEZ235 versus Everolimus in Patients with Mammalian Target of Rapamycin Inhibitor-Naïve Advanced Pancreatic Neuroendocrine Tumors. Oncologist. 2018 Jul;23(7):766-e90. doi: 10.1634/theoncologist.2017-0144. Epub 2017 Dec 14.

name: Department of Medical Oncology, Institut Català d'Oncologia‐IDIBELL-CIBERONC, Universitat de BarcelonaBarcelonaSpain

family: Salazar

full_name: Ramon Salazar

given: Ramon

name: Department of Medical Oncology, Hospital Universitario 12 de OctubreMadrid Spain

family: Garcia‐Carbonero

full_name: Rocio Garcia‐Carbonero

given: Rocio

name: Albert Einstein College of MedicineNew York City New York USA

family: Libutti

full_name: Steven K. Libutti

given: Steven K.

name: David Geffen School of Medicine and Cedars Sinai Medical CenterLos Angeles California USA

family: Hendifar

full_name: Andrew E. Hendifar

given: Andrew E.

name: Department of Medical Oncology, Hospital Universitario La PazMadrid Spain

family: Custodio

full_name: Ana Custodio

given: Ana

name: Department of Digestive Medical Oncology (IUCT‐RL), Centre Hospitalier Universitaire de ToulouseToulouse France

family: Guimbaud

full_name: Rosine Guimbaud

given: Rosine

name: Centre Hospitalier Lyon Sud, Pierre‐Bénite France

family: Lombard‐Bohas

full_name: Catherine Lombard‐Bohas

given: Catherine

name: Division of Medical Oncology, S Chiara University HospitalPisa Italy

family: Ricci

full_name: Sergio Ricci

given: Sergio

name: Department of Medical Oncology, Academic Medical CenterAmsterdam The Netherlands

family: Klümpen

full_name: Heinz‐Josef Klümpen

given: Heinz‐Josef

name: Vall Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO)Barcelona Spain

family: Capdevila

full_name: Jaume Capdevila

given: Jaume

name: Beatson West of Scotland Cancer CentreGlasgow Scotland

family: Reed

full_name: Nicholas Reed

given: Nicholas

name: University Medical Center Groningen, University of GroningenGroningen The Netherlands

family: Walenkamp

full_name: Annemiek Walenkamp

given: Annemiek

name: Department of Medical Oncology, Hospital Universitario Ramón y CajalMadrid Spain

family: Grande

full_name: Enrique Grande

given: Enrique

name: Department of Biochemistry, Kazan State Medical UniversityKazan Russia

family: Safina

full_name: Sufiya Safina

given: Sufiya

name: Royal Free HospitalLondon United Kingdom

family: Meyer

full_name: Tim Meyer

given: Tim

name: Novartis Pharmaceuticals CorporationEast Hanover New Jersey USA

family: Kong

full_name: Oliver Kong

given: Oliver

name: Novartis Pharma S.A.S.Rueil‐Malmaison France

family: Salomon

full_name: Herve Salomon

given: Herve

family: Tavorath

full_name: Ranjana Tavorath

given: Ranjana

name: The University of Texas MD Anderson Cancer CenterHouston Texas USA

family: Yao

full_name: James C. Yao

given: James C.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Oncologist

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

license: implied-oa

license_normalized: implied-oa

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

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

repository_institution: University College London - UCL Discovery

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

title: Phase II Study of BEZ235 versus Everolimus in Patients with Mammalian Target of Rapamycin Inhibitor‐Naïve Advanced Pancreatic Neuroendocrine Tumors

location_country:
Italy
Switzerland
Netherlands
France
Russian Federation
Spain
United States
United Kingdom

location_facility:
Cedars Sinai Medical Center SC-3
University of Kentucky Univ Kebtucky
Novartis Investigative Site
University of Colorado Univ Colorado
Montefiore Medical Center SC

title: Randomized Phase II Study of BEZ235 or Everolimus in Advanced Pancreatic Neuroendocrine Tumors

summary: This was a multicenter, open label, randomized phase II study to evaluate the efficacy and safety of BEZ235 as compared to everolimus in patients with advanced, low to intermediate grade pancreatic neuroendocrine tumor (pNET).


type: Other Identifier

title: REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Evaluation of Safety and Performance

summary: The purpose of this study is to evaluate the safety and performance of the Lotus™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.

ReferenceCitation: Meredith IT, Walters DL, Dumonteil N, Worthley SG, Tchétché D, Manoharan G, Blackman DJ, Rioufol G, Hildick-Smith D, Whitbourn RJ, Lefèvre T, Lange R, Müller R, Redwood S, Feldman TE, Allocco DJ, Dawkins KD. 1-Year Outcomes With the Fully Repositionable and Retrievable Lotus Transcatheter Aortic Replacement Valve in 120 High-Risk Surgical Patients With Severe Aortic Stenosis: Results of the REPRISE II Study. JACC Cardiovasc Interv. 2016 Feb 22;9(4):376-384. doi: 10.1016/j.jcin.2015.10.024.

family: Meredith

full_name: Ian T. Meredith

given: Ian T.

family: Walters

full_name: Darren L. Walters

given: Darren L.

family: Dumonteil

full_name: Nicolas Dumonteil

given: Nicolas

family: Worthley

full_name: Stephen G. Worthley

given: Stephen G.

family: Tchétché

full_name: Didier Tchétché

given: Didier

family: Manoharan

full_name: Ganesh Manoharan

given: Ganesh

family: Blackman

full_name: Daniel J. Blackman

given: Daniel J.

family: Rioufol

full_name: Gilles Rioufol

given: Gilles

family: Hildick-Smith

full_name: David Hildick-Smith

given: David

family: Whitbourn

full_name: Robert J. Whitbourn

given: Robert J.

family: Lefèvre

full_name: Thierry Lefèvre

given: Thierry

family: Lange

full_name: Rüdiger Lange

given: Rüdiger

family: Müller

full_name: Ralf Müller

given: Ralf

family: Redwood

full_name: Simon Redwood

given: Simon

family: Feldman

full_name: Ted E. Feldman

given: Ted E.

family: Allocco

full_name: Dominic J. Allocco

given: Dominic J.

family: Dawkins

full_name: Keith D. Dawkins

given: Keith D.

journal_name: JACC: Cardiovascular Interventions

oa_host_type: publisher

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Meredith Am IT, Walters DL, Dumonteil N, Worthley SG, Tchétché D, Manoharan G, Blackman DJ, Rioufol G, Hildick-Smith D, Whitbourn RJ, Lefèvre T, Lange R, Müller R, Redwood S, Allocco DJ, Dawkins KD. Transcatheter aortic valve replacement for severe symptomatic aortic stenosis using a repositionable valve system: 30-day primary endpoint results from the REPRISE II study. J Am Coll Cardiol. 2014 Sep 30;64(13):1339-48. doi: 10.1016/j.jacc.2014.05.067.

family: Meredith AM

full_name: Ian T. Meredith AM

journal_name: Journal of the American College of Cardiology

title: Transcatheter Aortic Valve Replacement for Severe Symptomatic Aortic Stenosis Using a Repositionable Valve System

location_country:
Italy
Sweden
Switzerland
Netherlands
France
Australia
Spain
Germany
United Kingdom

location_facility: Guys and St. Thomas NHS Foundation Trust


title: A Phase-II, Double-blind, Placebo-controlled, Randomised, Parallel-group,Multi-centre Study to Assess the Efficacy and Safety of Two Staggered Dose Levels of Inhaled Once Daily AZD5423 or Twice Daily Budesonide for 12 Weeks in COPD Patients on a Background Therapy of Formoterol.

summary: The purpose of the study is to assess the efficacy and safety of two staggered dose levels of inhaled once daily AZD5423 or twice daily budesonide for 12 weeks in COPD patients on a background therapy of formoterol.

lead_sponsor: AstraZeneca

location_country:
Italy
France
Bulgaria
Poland
Slovakia
Hungary
Russian Federation
Ukraine


type: Registry Identifier

title: A Randomized, Double Blind, Placebo Controlled Phase II Trial to Evaluate the Safety and Efficacy of recMAGE-A3 + AS15 ASCI in Patients With MAGE-A3 Positive Muscle Invasive Bladder Cancer After Cystectomy

acronym: MAGNOLIA

summary: The purpose of this clinical trial was to demonstrate the benefit of the immunotherapeutic product recMAGE-A3 + AS-15 given to patients with bladder cancer after removal of the bladder. A course of 13 injections was administered over 27 months.

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Colombel M, Heidenreich A, Martínez-Piñeiro L, Babjuk M, Korneyev I, Surcel C, Yakovlev P, Colombo R, Radziszewski P, Witjes F, Schipper R, Mulders P, Witjes WP. Perioperative chemotherapy in muscle-invasive bladder cancer: overview and the unmet clinical need for alternative adjuvant therapy as studied in the MAGNOLIA trial. Eur Urol. 2014 Mar;65(3):509-11. doi: 10.1016/j.eururo.2013.10.056. Epub 2013 Nov 11.

lead_sponsor: European Association of Urology Research Foundation

location_country:
Italy
Netherlands
France
Czechia
Poland
Romania
Russian Federation
Spain
Germany
Ukraine

location_facility: Oddzial Urologii Miedzyleski Szpital Specjalistyczny w Warszawie

location_facility: Federal State Institution "Moscow Research Oncology Institute named after P.A. Gertsen" of the Ministry of Healthcare and Social Development of the Russian Federation

location_facility: Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.

location_facility: Hospital Universitario Principe de Asturias

location_facility: Municipal Budget Institution of Health Care "Clinical Diagnostic Center "Zdorovie" of Rostov-on-Don city"

location_facility: Universitätsklinikum C.-G. Carus Dresden

location_facility: Institution of the Russian Academy of Medical Science Russian Oncology Research Center named after N.N. Blokhin of RAMS

location_facility: Kliniczny Dzial Urologii Swietokrzyskiego Centrum Onkologii

location_facility: Federal State Budget Institution "Scientific Research Institute of Urology" of the Ministry of Healthcare and Social Development of the Russian Federation

location_facility: Universitaria Policlinico Consorziale di Bari

location_facility: Saint Petersburg State Institution of Health Care "City Multi-Field Hospital #2"

location_facility: Hospital Universitario Central de Asturias

location_facility: Clinical County Emergency Hospital Craiova

location_facility: Hospital 12 de Octubre, Fundación de Investigación Biomédica

location_facility: Hospital Universitario Fundación Alcorcón

intervention_type: Biological


title: ALternate Site Cardiac ReSYNChronization Study

acronym: ALSYNC

summary:
The ALternate site cardiac reSYNChronization (ALSYNC) study, a non-comparative, prospective, non-randomized, multi-national clinical investigation.

The purpose of this clinical investigation is to evaluate the safety and performance of the investigational atrial transseptal endocardial LV lead delivery system and the implant procedure for delivering the SelectSecure® Model 3830 lead into the Left Ventricle via a superior approach, and to evaluate the performance of the SelectSecure® Model 3830 lead in the Left Ventricle.

ReferenceCitation: Biffi M, Defaye P, Jaïs P, Ruffa F, Leclercq C, Gras D, Yang Z, Gerritse B, Ziacchi M, Morgan JM; ALSYNC Investigators. Benefits of left ventricular endocardial pacing comparing failed implants and prior non-responders to conventional cardiac resynchronization therapy: A subanalysis from the ALSYNC study. Int J Cardiol. 2018 May 15;259:88-93. doi: 10.1016/j.ijcard.2018.01.030.

family: Biffi

full_name: Mauro Biffi

given: Mauro

family: Defaye

full_name: Pascal Defaye

given: Pascal

family: Jaïs

full_name: Pierre Jaïs

given: Pierre

family: Ruffa

full_name: Franco Ruffa

given: Franco

family: Leclercq

full_name: Christophe Leclercq

given: Christophe

family: Gras

full_name: Daniel Gras

given: Daniel

family: Yang

full_name: Zhongping Yang

given: Zhongping

family: Gerritse

full_name: Bart Gerritse

given: Bart

family: Ziacchi

full_name: Matteo Ziacchi

given: Matteo

family: Morgan

full_name: John M. Morgan

given: John M.

journal_name: International Journal of Cardiology

ReferenceCitation: Morgan JM, Biffi M, Gellér L, Leclercq C, Ruffa F, Tung S, Defaye P, Yang Z, Gerritse B, van Ginneken M, Yee R, Jais P; ALSYNC Investigators. ALternate Site Cardiac ResYNChronization (ALSYNC): a prospective and multicentre study of left ventricular endocardial pacing for cardiac resynchronization therapy. Eur Heart J. 2016 Jul 14;37(27):2118-27. doi: 10.1093/eurheartj/ehv723. Epub 2016 Jan 18.

family: Gellér

full_name: László Gellér

given: László

family: Tung

full_name: Stanley Tung

given: Stanley

family: van Ginneken

full_name: Mireille van Ginneken

given: Mireille

family: Yee

full_name: Raymond Yee

given: Raymond

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Italy
Netherlands
France
Hungary
Belgium
Canada
United Kingdom

location_facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant' Orsola - Malpighi

location_facility: Azienda Complesso Ospedaliero San Filippo Neri Ospedale San Filippo Neri

location_facility: University College London Hospitals NHS Foundation Trust - The Heart Hospital

location_facility: London Health Sciences Centre - University Campus

location_facility: Centre Hospitalier Regional de la Citadelle


ReferenceCitation: Ceklic L, Wolf-Schnurrbusch U, Gekkieva M, Wolf S. Visual acuity outcome in RADIANCE study patients with dome-shaped macular features. Ophthalmology. 2014 Nov;121(11):2288-9. doi: 10.1016/j.ophtha.2014.06.012. Epub 2014 Aug 8.

family: Ceklic

full_name: Lala Ceklic

given: Lala

family: Wolf-Schnurrbusch

full_name: Ute Wolf-Schnurrbusch

given: Ute

family: Gekkieva

full_name: Margarita Gekkieva

given: Margarita

family: Wolf

full_name: Sebastian Wolf

given: Sebastian

journal_name: Ophthalmology

title: Visual Acuity Outcome in RADIANCE Study Patients With Dome-Shaped Macular Features

ReferenceCitation: Wolf S, Balciuniene VJ, Laganovska G, Menchini U, Ohno-Matsui K, Sharma T, Wong TY, Silva R, Pilz S, Gekkieva M; RADIANCE Study Group. RADIANCE: a randomized controlled study of ranibizumab in patients with choroidal neovascularization secondary to pathologic myopia. Ophthalmology. 2014 Mar;121(3):682-92.e2. doi: 10.1016/j.ophtha.2013.10.023. Epub 2013 Dec 8.

family: Balciuniene

full_name: Vilma Jurate Balciuniene

given: Vilma Jurate

family: Laganovska

full_name: Guna Laganovska

given: Guna

family: Menchini

full_name: Ugo Menchini

given: Ugo

family: Ohno-Matsui

full_name: Kyoko Ohno-Matsui

given: Kyoko

family: Sharma

full_name: Tarun Sharma

given: Tarun

family: Wong

full_name: Tien Y. Wong

given: Tien Y.

family: Silva

full_name: Rufino Silva

given: Rufino

family: Pilz

full_name: Stefan Pilz

given: Stefan

title: RADIANCE: A Randomized Controlled Study of Ranibizumab in Patients with Choroidal Neovascularization Secondary to Pathologic Myopia

location_country:
Italy
Austria
India
Hong Kong
Spain
Switzerland
Germany
United Kingdom
France
Japan
Lithuania
Poland
Slovakia
Singapore
Hungary
Portugal
Turkey
Canada
Latvia
Korea, Republic of

title: A 12 Month, Phase III, Randomized, Double-masked, Multicenter, Active-controlled Study to Evaluate the Efficacy and Safety of Two Different Dosing Regimens of 0.5 mg Ranibizumab vs. Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia

summary: This study is designed to evaluate the efficacy and safety of two different dosing regimens of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (PM).


title: A Multicener, Randomised, Double-blind, Placebo-controlled Study, to Assess the Long Term Safety of 52 Weeks Treatment With QVA149 (110 ug Indacaterol/50ug Glycopyrrolate) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

acronym: ENLIGHTEN

summary: The study is designed to provide long-term safety data for QVA149 in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

ReferenceCitation: Buhl R, Gessner C, Schuermann W, Foerster K, Sieder C, Hiltl S, Korn S. Efficacy and safety of once-daily QVA149 compared with the free combination of once-daily tiotropium plus twice-daily formoterol in patients with moderate-to-severe COPD (QUANTIFY): a randomised, non-inferiority study. Thorax. 2015 Apr;70(4):311-9. doi: 10.1136/thoraxjnl-2014-206345. Epub 2015 Feb 12.

family: Buhl

full_name: R. Buhl

given: R.

family: Gessner

full_name: C. Gessner

given: C.

family: Schuermann

full_name: W. Schuermann

given: W.

family: Foerster

full_name: K. Foerster

given: K.

family: Sieder

full_name: C. Sieder

family: Hiltl

full_name: S. Hiltl

given: S.

family: Korn

full_name: S. Korn

journal_name: Thorax

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Dahl R, Chapman KR, Rudolf M, Mehta R, Kho P, Alagappan VK, Chen H, Banerji D. Safety and efficacy of dual bronchodilation with QVA149 in COPD patients: the ENLIGHTEN study. Respir Med. 2013 Oct;107(10):1558-67. doi: 10.1016/j.rmed.2013.05.016. Epub 2013 Jul 16.

family: Dahl

full_name: Ronald Dahl

given: Ronald

family: Chapman

full_name: Kenneth R. Chapman

given: Kenneth R.

family: Rudolf

full_name: Michael Rudolf

given: Michael

family: Mehta

full_name: Rajendra Mehta

given: Rajendra

family: Kho

full_name: Pearl Kho

given: Pearl

family: Alagappan

full_name: Vijay K.T. Alagappan

given: Vijay K.T.

family: Chen

full_name: Hungta Chen

given: Hungta

family: Banerji

full_name: Donald Banerji

given: Donald

title: Safety and efficacy of dual bronchodilation with QVA149 in COPD patients: The ENLIGHTEN study

location_country:
South Africa
India
United Kingdom
France
Lithuania
Romania
Hungary
Canada
Latvia
Korea, Republic of


lead_sponsor: MEDA Pharma GmbH & Co. KG

location_country: Austria Germany France

acronym: LEIDA

location_facility: Science, Onco & Beauty GbR, Practice for Dermatology and Medical Cosmetics

location_facility: Clinic and Medical Faculty of Johann Wolfgang Goethe-University, Center for Dermatology and Venereology

location_facility: Medical practice for Dermatology and Venerology

location_facility: Hospital Feldkirch, Department for Dermatology and Venereology

location_facility: University Clinic Münster, Clinic and Polyclinic for Skin Diseases

location_facility: Clinic University Regensburg, Clinic and Polyclinic for Dermatology

location_facility: Hospital Sainte Marguerite, Department for Dermatology and Venereology, Pavilion 3, First Floor

location_facility: CHU Nice - Hospital Archet 2, Department for Dermatology

location_facility: Medical University Innsbruck, University Clinic for Dermatology and Venereology

location_facility: Department of Dermatology J. Gutenberg-University Mainz, Clinical Research Center

location_facility: University Clinic Düsseldorf, Clinic for Dermatology

location_facility: University Clinic Schleswig-Holstein, Campus Kiel, Clinic for Dermatology, Venereology and Allergology

location_facility: Medical Department of Otto-von-Guericke-University Magdeburg, University Clinic for Dermatology and Venereology

location_facility: Charite - Medicine University Berlin, Dermatoma Center, Clinic for Dermatology, Allergology and Venereology

location_facility: Medical University Graz, University Clinic for Dermatology and Venereology

location_facility: Hospital Saint-Louis, Derpartment for Dermatology

location_facility: Hospital Center Lyon South, Department for Dermatology and Immuno-Allergology

location_facility: Medical University Vienna, Department for General Dermatology

location_facility: CHU St Jacques, Department for Dermatology

title: Long-term Effects of Aldara® 5% Cream and Solaraze® 3% Gel in the Treatment of Actinic Keratoses on the Face or Scalp (LEIDA)

summary: This clinical trial serves the purpose to compare the long-term effects of a treatment of actinic keratosis - your skin disorder - using Aldara® 5% cream or Solaraze® 3% gel on the face or the scalp. In particular, it should be found out whether the healing effect of these two medications on the skin lesions (i.e. the damaged skin parts) can be maintained for a prolonged period.


title: Phase IIIb/IV Randomized, Controlled Study Evaluating an Intensification Treatment Strategy of Adding Enfuvirtide (ENF) to an Oral Highly Active AntiRetroviral Therapy (HAART) in Treatment Experienced Patients

acronym: INTENSE

summary: To assess the efficacy of enfuvirtide (Fuzeon) added to HAART compared to treatment with HAART alone in achieving and maintaining viral load suppression.

ReferenceCitation: Clotet B, Capetti A, Soto-Ramirez LE, Gatell JM, Rowell L, Salgo M, Schapiro JM. A randomized, controlled study evaluating an induction treatment strategy in which enfuvirtide was added to an oral, highly active antiretroviral therapy regimen in treatment-experienced patients: the INTENSE study. J Antimicrob Chemother. 2008 Dec;62(6):1374-8. doi: 10.1093/jac/dkn377. Epub 2008 Sep 8.

family: Clotet

full_name: Bonaventura Clotet

given: Bonaventura

family: Capetti

full_name: Amedeo Capetti

given: Amedeo

family: Soto-Ramirez

full_name: Luis E. Soto-Ramirez

given: Luis E.

family: Gatell

full_name: Jose M. Gatell

given: Jose M.

family: Rowell

full_name: Lucy Rowell

given: Lucy

family: Salgo

full_name: Miklos Salgo

given: Miklos

family: Schapiro

full_name: Jonathan M. Schapiro

given: Jonathan M.

journal_name: Journal of Antimicrobial Chemotherapy

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
United States
Switzerland
Mexico
Netherlands
France
Israel
Spain
Germany
Canada


title: An Open-label, Randomized, Controlled Phase-II Trial Evaluating the Efficacy and Safety of EndoTAG-1 in Triple Receptor Negative Breast Cancer Patients

summary: The purpose of this study is to assess the efficacy, safety and tolerability of a therapy with EndoTAG-1 + paclitaxel in combination and EndoTAG-1 alone as a rescue therapy for patients with relapsed or metastatic triple receptor negative breast cancer (a special subgroup of breast cancer).

ReferenceCitation: Awada A, Bondarenko IN, Bonneterre J, Nowara E, Ferrero JM, Bakshi AV, Wilke C, Piccart M; CT4002 study group. A randomized controlled phase II trial of a novel composition of paclitaxel embedded into neutral and cationic lipids targeting tumor endothelial cells in advanced triple-negative breast cancer (TNBC). Ann Oncol. 2014 Apr;25(4):824-831. doi: 10.1093/annonc/mdu025.

family: Awada

full_name: A. Awada

given: A.

family: Bondarenko

full_name: I.N. Bondarenko

family: Bonneterre

full_name: J. Bonneterre

given: J.

family: Nowara

full_name: E. Nowara

given: E.

family: Ferrero

full_name: J.M. Ferrero

family: Bakshi

full_name: A.V. Bakshi

family: Wilke

full_name: C. Wilke

given: C.

family: Piccart

full_name: M. Piccart

given: M.

journal_name: Annals of Oncology

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

lead_sponsor: MediGene

location_country: India France Poland Romania Belgium Ukraine

location_facility: Centrum Onkologii Instytut im. M. Sklodowskiej-Curie

location_facility: Institute of Medical Radiology of Acedamy of Medical Sciences

location_facility: Institute of Oncology "Prof. Dr. I. Chiricuta"

location_facility: Regional Clinical Oncological Dispensary

location_facility: Institute of Oncology "Prof. Dr. Al. Trestioreanu"

location_facility: Institut Jules Bordet - Centre des Tumeurs de l'Université Libre de Bruxelles


title: A Randomized, Double-blind, Placebo Controlled, Phase IIA Study to Assess the Effect on Gastroesophageal Reflux Disease (GERD) Symptoms, Pharmacokinetics, Safety and Tolerability of 4 Weeks Treatment With AZD3355 65 mg Bid as add-on Treatment to a Proton Pump Inhibitor (PPI) in Patients With an Incomplete Response to PPI.

summary: The purpose of this study is to estimate the effect of AZD3355 as an add-on treatment to a Proton Pump Inhibitor (PPI) on Gastroesophageal reflux disease (GERD) symptoms in patients with an incomplete response to PPI treatment.

ReferenceCitation: Boeckxstaens GE, Beaumont H, Hatlebakk JG, Silberg DG, Björck K, Karlsson M, Denison H. A novel reflux inhibitor lesogaberan (AZD3355) as add-on treatment in patients with GORD with persistent reflux symptoms despite proton pump inhibitor therapy: a randomised placebo-controlled trial. Gut. 2011 Sep;60(9):1182-8. doi: 10.1136/gut.2010.235630. Epub 2011 Mar 14.

family: Boeckxstaens

full_name: G. E. Boeckxstaens

given: G. E.

family: Beaumont

full_name: H. Beaumont

given: H.

family: Hatlebakk

full_name: J. G. Hatlebakk

given: J. G.

family: Silberg

full_name: D. G. Silberg

given: D. G.

family: Bjorck

full_name: K. Bjorck

given: K.

family: Karlsson

full_name: M. Karlsson

family: Denison

full_name: H. Denison

journal_name: Gut

oa_host_type: repository

repository_institution: Wiardi Beckman Foundation - Wiardi Beckman Foundation

version: submittedVersion

location_country: Netherlands France Norway Hungary Belgium Australia Romania Germany


title: A Phase 2, Multicenter, Multi Arm, Study to Evaluate Pembrolizumab (MK-3475) or MK-1308A (Co-formulated Quavonlimab (MK-1308)/Pembrolizumab) in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer: (MK-1308A-008)

summary: The purpose of this study is to assess the efficacy and safety of pembrolizumab or co-formulated pembrolizumab/quavonlimab in participants with MSI-H or dMMR Metastatic Stage IV Colorectal Cancer.

status: Recruiting

lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Italy
United States
Germany
France
Poland
Belgium
Russian Federation
Spain
Turkey
Canada
Korea, Republic of

location_facility: The Moncton Hospital-Oncology ( Site 0307)

location_facility: Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0102)

location_facility: Asan Medical Center-Department of Oncology ( Site 1105)

location_facility: Hospital Clinico San Carlos-Oncology Department ( Site 1204)

location_facility: Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0604)

location_facility: Seoul National University Hospital-Internal Medicine ( Site 1101)

location_facility: Luxmed Onkologia sp. z o. o. ( Site 0915)

location_facility: Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1104)

location_facility: Kyungpook National University Chilgok Hospital-Hematology/oncology ( Site 1103)

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 0601)

location_facility: Hôpital Saint Antoine-Oncologie médicale ( Site 0508)

location_facility: Hospital Universitari Vall d'Hebron ( Site 1201)

location_facility: Republican Clinical Oncology Dispensary-Chemotherapy #3 ( Site 1006)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale-Department of Abdominal Oncology ( Site 0803)

location_facility: Hacettepe Universitesi-oncology hospital ( Site 1301)

location_facility: Samsung Medical Center-Division of Hematology/Oncology ( Site 1102)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Onkologii i Radioterapii ( Site

location_facility: Northwest Medical Specialties, PLLC ( Site 1546)

location_facility: Hopital Claude Huriez - CHU de Lille ( Site 0510)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1305)

location_facility: Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service d'Hepato-Gastro-Enterologie et

location_facility: HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1206)

location_facility: Korea University Anam Hospital ( Site 1107)

location_facility: CHU Rangueil-Digestive oncology department ( Site 0502)

location_facility: Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology-Clinical Pharmacology and Chemotherapy

location_facility: Centre Hospitalier Universitaire de Poitiers ( Site 0511)

location_facility: Hospital Universitario Central de Asturias-Medical Oncology ( Site 1203)

location_facility: Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0903)

location_facility: First Moscow State Medical University I.M. Sechenov-Interhospital Institution Health Management Cl

location_facility: Rostov Cancer Research Institute ( Site 1014)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0802)

location_facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital-Medical Oncology ( Site 1106)

location_facility: Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 1001)

location_facility: Hospital Universitario Marqués de Valdecilla ( Site 1202)

location_facility: University Cancer & Blood Center, LLC ( Site 1521)

status_simplified: Ongoing


ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Takeda

location_country:
Italy
Austria
Switzerland
Germany
France
Japan
Poland
Spain
United States
United Kingdom

location_facility: Samodzielny Publiczny Dzieciecy Szpital Kliniczny

location_facility: Universitaetsklinikum Jena, Klinik fuerKinder-und Jugendmedizin

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Medical Hospital,Tokyo Medical and Dental University

title: A Phase 3b, Prospective, Open-label, Multicenter, Single Treatment Arm, Continuation Study of the Safety and Efficacy of TAK-755 (rADAMTS-13, Also Known as BAX 930/SHP655) in the Prophylactic and On-demand Treatment of Subjects With Severe Congenital Thrombotic Thrombocytopenic Purpura (cTTP; Upshaw-Schulman Syndrome, or Hereditary Thrombotic Thrombocytopenic Purpura)

summary:
The main aim of the study is to check for side effects of TAK-755. Participants will either receive TAK-755 every week or every other week to prevent bleeds (prophylactic arm) or they will receive TAK-755 to treat an acute bleed (on-demand arm).

Participants in the prophylactic arm will receive treatment in the clinic or at home for 3 years. They will visit the clinic at least every 12 weeks.

Participants in the on-demand arm will receive treatment for the acute bleed until the bleed has stopped. They will have a follow-up visit at the clinic 4 weeks later.


title: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)

summary: A Phase Ib/II, open-label, multicenter, randomized, umbrella study in participants with cisplatin-ineligible MIBC and in participants with locally advanced or metastatic Urothelial Carcinoma (UC) who have progressed during or following a platinum-containing regimen. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the participant population (e.g., with regard to prior anti-cancer treatment or biomarker status). Participants in the mUC Cohort who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment regimen for Stage 2.

location_country:
France
Greece
Spain
United States
United Kingdom
Korea, Republic of

location_facility: START Madrid. Centro Integral Oncologico Clara Campal; CIOCC

location_facility: Attiko Hospital University of Athens; 2Nd Dept. of Propaedeutic Medicine

location_facility: University Hospital of Patras Medical Oncology

location_facility: Alexandras General Hospital of Athens; Oncology Department

location_facility: ICO I Hospitalet Hospital Duran i Reynals Instituto Catalan de Oncologia de Hospitalet ICO

location_facility: Vall d´Hebron Institute of Oncology (VHIO), Barcelona

location_facility: Hospital General Universitario Gregorio Mara

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

location_facility: Hospital Clinico Universitario de Valencia


title: A Prospective, Randomized, Double-Blinded, Placebo-Controlled, Multinational, Multicenter, Parallel-group, Phase III Study to Evaluate the Efficacy and Safety of Apatinib Plus Best Supportive Care (BSC) Compared to Placebo Plus BSC in Patients With Advanced or Metastatic Gastric Cancer

acronym: ANGEL

summary: The purpose of this study is to evaluate the clinical benefit and safety of Apatinib plus Best Supportive Care in comparison to Placebo plus Best Supportive Care in patients with advanced or metastatic gastric cancer

lead_sponsor: Elevar Therapeutics

location_country:
Italy
United States
France
Japan
Poland
Romania
Russian Federation
Germany
United Kingdom
Korea, Republic of
Taiwan
Ukraine

location_facility: State institution "Zaporizhzhia Medical Academy of Postgraduate Education MOH Ukraine", Department of oncology based on Municipal Institution "Zaporizhzhia Regional Clinical Oncology Dispensary" Zaporizhzhia Regional Assembly

location_facility: Teo Health S.A., Sectia Oncologie Medicala

location_facility: "Dnipropetrovsk City Multifunctional Clinical Hospital #4", "Dnipropetrovsk regional council", Department of Chemotherapy, State Institution "Dnipropetrovsk Medical Academy, Ministry of Health of Ukraine", Department of Oncology and Medical Radiology

location_facility: Centrul de Oncologie "Sf. Nectarie", Sectia de Oncologie Medicala

location_facility: Policlinico di Modena-Azienda Ospedaliero Universitaria di Modena.Oncologia ed Ematologia.

location_facility: Fondazione IRCCS-Istituto Nazionale Tumori

location_facility: Veneto Oncology Institute (IOV-IRCCS), Melanoma & Esophageal Oncology Unit

location_facility: Communal Institution "Transcarpathian Regional Clinical Oncological Center"

location_facility: Centre Hospitalier Franco-Britannique; Oncologie Médicale

location_facility: Institut Regional du Cancer Montpellier (ICM)

location_facility: Communal Institution "Vinnytsia Regional Clinical Oncology Dispensary"

location_facility: Chi Mei Medical Center - LiouYing Branch

location_facility: "Institut für Klinisch-Onkologische Forschung (IKF) Krankenhaus Nordwest gGmbH UCT - Universitäres Centrum für Tumorerkrankungen Frankfurt

location_facility: Chang Gung Memorial Hospital - Linko Branch

location_facility: Szpital Uniwersytecki w Krakowie, Odział Kliniczny Onkologii

location_facility: Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie, Klinika Gastroenterologii Onkologicznej

location_facility: Budgetary Healthcare Institution of Orel Region "Orel Oncology Dispensary"

location_facility: Severence Hospital, Yonsei University Health System

location_facility: State Budgetary Healthcare Institution of Stavropol Territory "Pyatigorsk Oncology Dispensary"

location_facility: Charite - Universitaetsmedizin Berlin - Medizinische Klinik mit Schwerpunkt Haematologie, Onkologie und Tumorimmunologie

location_facility: Veterans Health Service (VHS) Medical Center

location_facility: Kyungpook National University Medical Center

location_facility: Chungbuk National University Medical Center

location_facility: State Budgetary Healthcare Institution "Republican Clinical Oncology Dispensary"

location_facility: Seoul National University Bundang Hospital

location_facility: Municipal Institution Kryvyi Rig Oncology Dispensary", Chemotherapy Department

location_facility: Magna Graecia University- Department of Experimental and Clinical Medicine

location_facility: Municipal Institution "Kyiv City Clinical Oncological Center"

location_facility: Saku Central Hospital Advanced Care Center

location_facility: State Healthcare Institution "Kursk Regional Clinical Oncology Dispensary"

location_facility: Communal Institution "Kharkiv Regional Clinical Oncology Center ", Chemotherapy department #1, Medical Academy of Postgraduate Education, Oncology and Pediatric Oncology

location_facility: Federal State Budgetary Educational Institution of Higher Education "Academician I.P. Pavlov First St. Petersburg State Medical University" of the Ministry of Heaithcare of the Russian Federation

location_facility: Ospedali Riuniti di Ancona - SOD Clinica Oncologica

location_facility: Ospedale di Piacenza - Oncology and heamatology

location_facility: Communal Institution "Ivano-Frankivsk Regional Oncological Center"

location_facility: The Cancer Institute Hospital of Japanese Foundation For Cancer Research

location_facility: Universitätsklinik Marburg, Klinik fur Innere Medizin, Schwerpunkt Haematologie, Onkologie und Immunologie

location_facility: Facharztzentrum Eppendorf - Haematologisch-Onkologische Praxis Eppendorf (HOPE)

location_facility: Keimyung University Dongsan Medical Center

location_facility: Japan Community Health Care Organization Kyushu Hospital

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca, Sectia de Radioterapie I

location_facility: State Budgetary Healthcare Institution of Arkhangelsk Region "Arkhangelsk Clinical Oncology Dispensary"

location_facility: Chang Gung Memorial Hospital - Kaohsiung Branch

intervention_type: Other


title: The Sorbact® Antimicrobial Dressing in the Holistic Wound Management Of Diabetic Foot ulCers (Phase III Study)

acronym: ADHOC

summary: The aim of this study is to demonstrate, during a 12-week follow-up, a greater efficacy of using Sorbact® dressing technology in addition to best local cares compared to best local cares alone in the management of diabetic foot ulcers

lead_sponsor: INRESA Pharma

location_country: France Czechia Poland

location_facility: Cardiologic and pediatric ambulance s.r.o.

location_facility: Institute for Clinical and Experimental Medicine

location_facility: Maison de santé protestante de Bordeaux Bagatelle

location_facility: Faculty of Medicine MU a FH St. Ann Brno

location_facility: Podiatrie - Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha


lead_sponsor: CSL Behring

location_country:
Italy
Austria
Switzerland
Lebanon
Netherlands
Germany
Philippines
Spain
France
Malaysia
Poland
Thailand
Georgia
Romania
Australia
Portugal
Turkey
United States
Ukraine

title: A Phase III Open-label Pharmacokinetic, Efficacy and Safety Study of rVIII-SingleChain in a Pediatric Population With Severe Hemophilia A

summary: This is an international, multicenter, open-label study to assess the efficacy, safety, and pharmacokinetic (PK) profile of rVIII-SingleChain in pediatric patients with severe hemophilia A. A minimum of 25 previously treated subjects ≥ 6 to < 12 years of age and at least 25 subjects < 6 years of age who have undergone > 50 exposure days (EDs) with a previous Factor VIII (FVIII) product are planned to be enrolled. Subjects will be assigned to either an on-demand or prophylaxis treatment regimen and will receive rVIII-SingleChain at a dose to be determined by the investigator. Hemostatic efficacy will be assessed by the subject/caregiver and the investigator who will assess overall efficacy by a 4-point scale.


title: A Phase IV, Open-label, Multicenter Study of Dasatinib in Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients With Chronic, Low-grade Non-Hematologic Toxicity to Imatinib

summary: This study proposes to evaluate the number of chronic, Grade 1 or 2, non-hematologic Adverse Events (AEs) that reduce in grade or resolve at 3 months after switching therapy from imatinib to dasatinib.

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
United States
France
Germany
Korea, Republic of

location_facility: Promedica Hematology & Oncology Assoicates

location_facility: The University Of Texas Md Anderson Cancer Center


title: A Phase 1b/2 Study With Gemcitabine and LY2157299 for Patients With Metastatic Cancer (Phase 1b) and Advanced or Metastatic Unresectable Pancreatic Cancer (Phase 2)

summary:
Phase 1b: To determine the safe and tolerable dose of galunisertib in combination with gemcitabine in patients with solid malignancy

Phase 2a: To compare the overall survival (OS) of patients with Stage II to IV unresectable pancreatic cancer when treated with a combination of galunisertib and gemcitabine with that of gemcitabine plus placebo.

ReferenceCitation: Smith CL, Thomas Z, Enas N, Thorn K, Lahn M, Benhadji K, Cleverly A. Leveraging historical data into oncology development programs: Two case studies of phase 2 Bayesian augmented control trial designs. Pharm Stat. 2020 May;19(3):276-290. doi: 10.1002/pst.1990. Epub 2020 Jan 5.

family: Smith

full_name: Claire L. Smith

given: Claire L.

family: Thomas

full_name: Zachary Thomas

given: Zachary

family: Enas

full_name: Nathan Enas

given: Nathan

family: Thorn

full_name: Katharine Thorn

given: Katharine

family: Lahn

full_name: Michael Lahn

given: Michael

family: Benhadji

full_name: Karim Benhadji

given: Karim

family: Cleverly

full_name: Ann Cleverly

given: Ann

journal_name: Pharmaceutical Statistics

ReferenceCitation: Melisi D, Garcia-Carbonero R, Macarulla T, Pezet D, Deplanque G, Fuchs M, Trojan J, Kozloff M, Simionato F, Cleverly A, Smith C, Wang S, Man M, Driscoll KE, Estrem ST, Lahn MMF, Benhadji KA, Tabernero J. TGFβ receptor inhibitor galunisertib is linked to inflammation- and remodeling-related proteins in patients with pancreatic cancer. Cancer Chemother Pharmacol. 2019 May;83(5):975-991. doi: 10.1007/s00280-019-03807-4. Epub 2019 Mar 18.

family: Melisi

full_name: Davide Melisi

given: Davide

family: Garcia-Carbonero

full_name: Rocio Garcia-Carbonero

given: Rocio

family: Macarulla

full_name: Teresa Macarulla

given: Teresa

family: Pezet

full_name: Denis Pezet

given: Denis

family: Deplanque

full_name: Gael Deplanque

given: Gael

family: Fuchs

full_name: Martin Fuchs

given: Martin

family: Trojan

full_name: Jorg Trojan

given: Jorg

family: Kozloff

full_name: Mark Kozloff

given: Mark

family: Simionato

full_name: Francesca Simionato

given: Francesca

full_name: Claire Smith

given: Claire

family: Wang

full_name: Shuaicheng Wang

given: Shuaicheng

family: Man

full_name: Michael Man

family: Driscoll

full_name: Kyla E. Driscoll

location_country:
Italy
United States
France
Belgium
Spain
Germany

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

location_facility: Florida Hospital Tampa HPG and Foregut Surgery


title: A Phase I-II, Open-label Study of RAD001 in Combination With Glivec®/Gleevec™ (Imatinib) in Patients With Glivec/Gleevec-refractory/Resistant Gastrointestinal Stromal Tumors.

summary: This trial was a Phase I/II, non-randomized, open label, multi-center study, following a sequential 2-part design.

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

This trial data will be available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Germany
United States
Belgium
France

location_facility: Dana Farber Cancer Institute Dept of Sarcoma Oncology

location_facility: College of Physicians and Surgeons of Columbia University


title: An International, Prospective, Open-label, Multicenter, Pharmacoepidemiological Study to Determine Predictors of Clinical Outcomes in Haemodialysis Patients With Anaemia Treated With Biosimilar Epoetin Alfa

summary: MONITOR-CKD5 is an observational, pharmaco-epidemiological study to evaluate the multi-level factors and outcomes associated with the treatment of renal anaemia with biosimilar epoetin alfa in Stage 5 CKD patients requiring haemodialysis.

ReferenceCitation: Combe C, Mann J, Goldsmith D, Dellanna F, Zaoui P, London G, Denhaerynck K, Krendyukov A, Abraham I, MacDonald K. Potential life-years gained over a 5-year period by correcting DOPPS-identified modifiable practices in haemodialysis: results from the European MONITOR-CKD5 study. BMC Nephrol. 2019 Mar 5;20(1):81. doi: 10.1186/s12882-019-1251-z.

family: Combe

full_name: Christian Combe

given: Christian

family: Mann

full_name: Johannes Mann

given: Johannes

family: Goldsmith

full_name: David Goldsmith

given: David

family: Dellanna

full_name: Frank Dellanna

given: Frank

family: Zaoui

full_name: Philippe Zaoui

given: Philippe

family: London

full_name: Gérard London

given: Gérard

family: Denhaerynck

full_name: Kris Denhaerynck

given: Kris

family: Krendyukov

full_name: Andriy Krendyukov

given: Andriy

family: Abraham

full_name: Ivo Abraham

given: Ivo

family: MacDonald

full_name: Karen MacDonald

given: Karen

currency_apc_doaj: GBP

journal_name: BMC Nephrology

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: The University of Arizona - UA Campus Repository

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

repository_normalized: HAL

repository_institution: Kooperativer Bibliotheksverbund Berlin-Brandenburg (KOBV), on behalf of the Universitätsbibliothek Erlangen-Nürnberg - OPUS FAU - Online-Publikationssystem der Friedrich-Alexander-Universität Erlangen-Nürnberg

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Gesualdo L, London G, Turner M, Lee C, Macdonald K, Goldsmith D, Covic A, Zaoui P, Combe C, Mann J, Dellanna F, Muenzberg M, Abraham I. A pharmacoepidemiological study of the multi-level determinants, predictors, and clinical outcomes of biosimilar epoetin alfa for renal anaemia in haemodialysis patients: background and methodology of the MONITOR-CKD5 study. Intern Emerg Med. 2013 Aug;8(5):389-99. doi: 10.1007/s11739-011-0622-7. Epub 2011 May 18.

family: Gesualdo

full_name: Loreto Gesualdo

given: Loreto

location_country:
Italy
Austria
Switzerland
United Kingdom
France
Poland
Romania
Spain
Germany
Slovenia


title: Multi-centre Randomised Trial to Evaluate the Effect of Early Hypothermia on Neurological Function in Patients With Severe Traumatic Brain Injury. Including Renal Sub Study

acronym: POLAR-RCT

summary:
Traumatic brain injury (TBI) is a leading cause of death and long term disability, particularly in young adults. Studies from Australia have shown that approximately half of those with severe traumatic brain injury will be severely disabled or dead 6 months post injury. Given the young age of many patients with severe TBI and the long term prevalence of major disability, the economic and more importantly the social cost to the community is very high.

Pre-hospital and hospital management of patients with severe brain injury focuses on prevention of additional injury due primarily to lack of oxygen and insufficient blood pressure. This includes optimising sedation and ventilation, maintaining the fluid balance and draining Cerebrospinal Fluid (CSF) and performing surgery where appropriate. In recent years there has been a research focus on specific pharmacologic interventions, however, to date, there has been no treatment that has been associated with improvement of neurological outcomes.

One treatment that shows promise is the application of hypothermia (cooling). This treatment is commonly used in Australia to decrease brain injury in patients with brain injury following out-of-hospital cardiac arrest. Cooling is thought to protect the brain using a number of mechanisms. There have been a number of animal studies that have looked at how cooling is protective and also some clinical research that suggests some benefit. However at the current time there is insufficient evidence to provide enough proof that cooling should be used routinely for patients with brain injury and like all treatments there can be some risks and side effects.

The POLAR trial has been developed to investigate whether early cooling of patients with severe traumatic brain injury is associated with better outcomes. It is a randomised controlled trial, which is a type of trial that provides the highest quality of evidence.

The null hypothesis is that there is no difference in the proportion of favourable neurological outcomes six months after severe traumatic brain injury in patients treated with early and sustained hypothermia, compared to standard normothermic management.

ReferenceCitation: Nichol A, Gantner D, Presneill J, Murray L, Trapani T, Bernard S, Cameron P, Capellier G, Forbes A, McArthur C, Newby L, Rashford S, Rosenfeld JV, Smith T, Stephenson M, Varma D, Walker T, Webb S, Cooper DJ. Protocol for a multicentre randomised controlled trial of early and sustained prophylactic hypothermia in the management of traumatic brain injury. Crit Care Resusc. 2015 Jun;17(2):92-100.

ReferenceCitation: Presneill J, Gantner D, Nichol A, McArthur C, Forbes A, Kasza J, Trapani T, Murray L, Bernard S, Cameron P, Capellier G, Huet O, Newby L, Rashford S, Rosenfeld JV, Smith T, Stephenson M, Varma D, Vallance S, Walker T, Webb S, James Cooper D; POLAR investigators and the ANZICS Clinical Trials Group. Statistical analysis plan for the POLAR-RCT: The Prophylactic hypOthermia trial to Lessen trAumatic bRain injury-Randomised Controlled Trial. Trials. 2018 Apr 27;19(1):259. doi: 10.1186/s13063-018-2610-y.

ReferenceCitation: Ridley EJ, Davies AR, Bernard S, McArthur C, Murray L, Paul E, Trapani A, Cooper DJ; ANZICS Clinical Trials Group. Measured energy expenditure in mildly hypothermic critically ill patients with traumatic brain injury: A sub-study of a randomized controlled trial. Clin Nutr. 2021 Jun;40(6):3875-3882. doi: 10.1016/j.clnu.2021.05.012. Epub 2021 May 24.

family: Ridley

full_name: Emma J. Ridley

given: Emma J.

family: Davies

full_name: Andrew R. Davies

given: Andrew R.

family: Bernard

full_name: Stephen Bernard

given: Stephen

family: McArthur

full_name: Colin McArthur

given: Colin

family: Murray

full_name: Lynne Murray

given: Lynne

family: Paul

full_name: Eldho Paul

given: Eldho

family: Trapani

full_name: Antony Trapani

given: Antony

family: Cooper

full_name: D James Cooper

given: D James

journal_name: Clinical Nutrition

ReferenceCitation: Cooper DJ, Nichol AD, Bailey M, Bernard S, Cameron PA, Pili-Floury S, Forbes A, Gantner D, Higgins AM, Huet O, Kasza J, Murray L, Newby L, Presneill JJ, Rashford S, Rosenfeld JV, Stephenson M, Vallance S, Varma D, Webb SAR, Trapani T, McArthur C; POLAR Trial Investigators and the ANZICS Clinical Trials Group. Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury: The POLAR Randomized Clinical Trial. JAMA. 2018 Dec 4;320(21):2211-2220. doi: 10.1001/jama.2018.17075.

name: Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia

name: Departments of Intensive Care, Alfred Hospital, Melbourne, Victoria, Australia

full_name: D. James Cooper

given: D. James

name: Irish Critical Care Clinical Trials Network, University College Dublin-Clinical Research Centre at St Vincent’s University Hospital, Dublin, Ireland

name: Department of Anaesthesia and Intensive Care Medicine, St Vincent's University Hospital, Dublin, Ireland

name: School of Medicine and Medical Sciences, University College Dublin, Dublin, Ireland

family: Nichol

full_name: Alistair D. Nichol

given: Alistair D.

family: Bailey

full_name: Michael Bailey

given: Michael

name: Ambulance Victoria, Melbourne, Victoria, Australia

name: School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia

name: Centre of Excellence in Traumatic Brain Injury Research, Monash University, Melbourne, Victoria, Australia

name: Emergency Medicine, Hamad Medical Corporation, Dhueta, Qatar

name: Emergency and Trauma Centre, Alfred Hospital, Melbourne, Victoria, Australia

family: Cameron

full_name: Peter A. Cameron

given: Peter A.

name: Service de Réanimation Chirurgicale, Pôle d'Anesthésie et Réanimation Chirurgicale, Centre Hospitalier Universitaire de Besancon, Besançon, France

family: Pili-Floury

full_name: Sébastien Pili-Floury

given: Sébastien

family: Forbes

full_name: Andrew Forbes

given: Andrew

family: Gantner

full_name: Dashiell Gantner

given: Dashiell

family: Higgins

full_name: Alisa M. Higgins

given: Alisa M.

name: Department of Anaesthesia and Intensive Care Medicine, Hôpital de La Cavale Blanche, CHRU de Brest, Brest, France

name: UFR de médecine et des sciences de la santé, Université de Bretagne Occidenta, Brest, France

family: Huet

full_name: Olivier Huet

given: Olivier

family: Kasza

full_name: Jessica Kasza

given: Jessica

name: Department of Critical Care Medicine, Auckland City Hospital, Auckland, New Zealand

name: Intensive Care Unit, Royal Melbourne Hospital, Melbourne, Victoria, Australia

name: Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia

name: Queensland Ambulance Service, Brisbane, Queensland, Australia

name: Neurosurgery, Alfred Hospital, Melbourne, Victoria, Australia

name: Department of Surgery, Monash University, Melbourne, Victoria, Australia

name: Department of Surgery, F. Edward Hébert School of Medicine, Uniformed Services University of the Health Sciences, Bethesda, Maryland

name: Radiology, Alfred Hospital, Melbourne, Victoria, Australia

name: Intensive Care Unit, Royal Perth Hospital, Perth, Western Australia, Australia

name: for the POLAR Trial Investigators and the ANZICS Clinical Trials Group

ReferenceCitation: Moore EM, Nichol AD, Bernard SA, Bellomo R. Therapeutic hypothermia: benefits, mechanisms and potential clinical applications in neurological, cardiac and kidney injury. Injury. 2011 Sep;42(9):843-54. doi: 10.1016/j.injury.2011.03.027. Epub 2011 Apr 9. Review.

title: Therapeutic hypothermia: Benefits, mechanisms and potential clinical applications in neurological, cardiac and kidney injury

location_country:
Saudi Arabia
Switzerland
France
Australia
New Zealand
Qatar

location_facility: Hôpitaux Universitaires de Strasbourg, Hôpital de Hautepierre

location_facility: Hôpital Gabriel Montpied + CHU Clermont-Ferrand


ReferenceType: result

ReferenceCitation: Nelson M, Stellbrink HJ, Podzamczer D, Banhegyi D, Gazzard B, Hill A, van Delft Y, Vingerhoets J, Stark T, Marks S. A comparison of neuropsychiatric adverse events during 12 weeks of treatment with etravirine and efavirenz in a treatment-naive, HIV-1-infected population. AIDS. 2011 Jan 28;25(3):335-40. doi: 10.1097/QAD.0b013e3283416873.

family: Nelson

full_name: Mark Nelson

given: Mark

family: Stellbrink

full_name: Hans-Jürgen Stellbrink

given: Hans-Jürgen

family: Podzamczer

full_name: Daniel Podzamczer

given: Daniel

family: Banhegyi

full_name: Dénes Banhegyi

given: Dénes

family: Gazzard

full_name: Brian Gazzard

given: Brian

family: Hill

full_name: Andrew Hill

family: van Delft

full_name: Yvon van Delft

given: Yvon

family: Vingerhoets

full_name: Johan Vingerhoets

given: Johan

family: Stark

full_name: Thomas Stark

given: Thomas

family: Marks

full_name: Stephan Marks

given: Stephan

journal_name: AIDS

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Gazzard B, Duvivier C, Zagler C, Castagna A, Hill A, van Delft Y, Marks S. Phase 2 double-blind, randomized trial of etravirine versus efavirenz in treatment-naive patients: 48-week results. AIDS. 2011 Nov 28;25(18):2249-58. doi: 10.1097/QAD.0b013e32834c4c06.

family: Duvivier

full_name: Claudine Duvivier

given: Claudine

family: Zagler

full_name: Christian Zagler

given: Christian

family: Castagna

full_name: Antonella Castagna

given: Antonella

full_name: Yvonne van Delft

given: Yvonne

ReferenceCitation: Fätkenheuer G, Duvivier C, Rieger A, Durant J, Rey D, Schmidt W, Hill A, van Delft Y, Marks S; SENSE Study Team. Lipid profiles for etravirine versus efavirenz in treatment-naive patients in the randomized, double-blind SENSE trial. J Antimicrob Chemother. 2012 Mar;67(3):685-90. doi: 10.1093/jac/dkr533. Epub 2011 Dec 29.

family: Fatkenheuer

full_name: G. Fatkenheuer

given: G.

full_name: C. Duvivier

given: C.

family: Rieger

full_name: A. Rieger

given: A.

family: Durant

location_country:
Austria
Switzerland
France
Israel
Romania
Hungary
Russian Federation
Spain
Denmark
Germany
United Kingdom

title: A Phase IIb, Multi-centre, Randomised, Double-blind, Active-controlled Trial Comparing the Neuropsychiatric Adverse Event Profile of Etravirine 400mg qd Versus Efavirenz 600mg qd in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in ARV Therapy-naive HIV-1 Infected Subjects

summary: The purpose of this study is to compare the neuropsychiatric adverse event profiles of etravirine 400mg once daily versus efavirenz 600mg once daily, in combination with 2 N(t)RTIs, in approximately 150 treatment-naÃ-ve HIV-1 infected patients. Safety, tolerability and efficacy of both treatment arms will be assessed throughout the study.


title: A Randomised, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Dutasteride (AVODART™) 0.5 mg in Extending the Time to PSA Doubling in Men With Prostate Cancer and Biochemical Failure (PSA Increase) After Radical Therapy With Curative Intent

acronym: ARTS

summary: ARI109924 will be a 2-year, multicentre, randomised, double-blind, placebo-controlled trial assessing the efficacy and safety of dutasteride in extending time to prostate specific antigen (PSA) doubling in men who have been treated for clinically localised prostate cancer (PCa) with a radical therapy (radical prostatectomy, primary radiotherapy or salvage radiotherapy) with curative intent but who experience a biochemical failure (PSA rise) afterwards without signs or symptoms of metastases.

ReferenceCitation: Schröder F, Bangma C, Angulo JC, Alcaraz A, Colombel M, McNicholas T, Tammela TL, Nandy I, Castro R. Dutasteride treatment over 2 years delays prostate-specific antigen progression in patients with biochemical failure after radical therapy for prostate cancer: results from the randomised, placebo-controlled Avodart After Radical Therapy for Prostate Cancer Study (ARTS). Eur Urol. 2013 May;63(5):779-87. doi: 10.1016/j.eururo.2012.11.006. Epub 2012 Nov 12.

family: Schröder

full_name: Fritz Schröder

given: Fritz

family: Bangma

full_name: Chris Bangma

given: Chris

family: Angulo

full_name: Javier C. Angulo

given: Javier C.

family: Alcaraz

full_name: Antonio Alcaraz

given: Antonio

family: Colombel

full_name: Marc Colombel

given: Marc

family: McNicholas

full_name: Tom McNicholas

given: Tom

family: Tammela

full_name: Teuvo L. Tammela

given: Teuvo L.

family: Nandy

full_name: Indrani Nandy

given: Indrani

family: Castro

full_name: Ramiro Castro

given: Ramiro

journal_name: European Urology

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

title: Dutasteride Treatment Over 2 Years Delays Prostate-specific Antigen Progression in Patients with Biochemical Failure After Radical Therapy for Prostate Cancer: Results from the Randomised, Placebo-controlled Avodart After Radical Therapy for Prostate Cancer Study (ARTS)

lead_sponsor: GlaxoSmithKline

location_country:
Sweden
Netherlands
Finland
France
Russian Federation
Spain
Estonia
Germany
United Kingdom


title: Observational Study to Determine the Incidence of New-Onset Valvulopathy in Patients Treated With Pergolide as Second-Line Therapy for Parkinson's Disease

summary:
The primary objective of this study is to estimate the incidence of new-onset valvulopathy, determined by baseline and follow-up echocardiograms, in patients with Parkinson's Disease who are receiving pergolide as second-line therapy.

The secondary objective of the study is to estimate the prevalence of valvulopathy, as determined by baseline echocardiograms, among all patients who have Parkinson's Disease and are being considered for pergolide as second-line therapy.

time_perspective: Other

lead_sponsor: Eli Lilly and Company

location_country: Italy Germany Belgium France


title: A Phase 2 Study of Oral Enzastaurin HCl in Patients With Relapsed Mantle Cell Lymphoma

summary: The purposes of this study are to determine the safety of oral enzastaurin and any side effects that might be associated with it and whether enzastaurin can help participants with mantle cell lymphoma.

ReferenceCitation: Dolan P. Modeling valuations for EuroQol health states. Med Care. 1997 Nov;35(11):1095-108.

location_country: Germany Australia France Netherlands

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician


title: Three Dimensional Conformal Radiotherapy / Intensity Modulated Radiotherapy Alone Vs Three Dimensional Conformal Therapy / Intensity Modulated Radiotherapy Plus Adjuvant Hormonal Therapy In Localized T1b-c, T2a, N0, M0 Prostatic Carcinoma. A Phase III Randomized Study

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Bicalutamide and goserelin may fight prostate cancer by reducing the production of testosterone. It is not yet known if radiation therapy is more effective with or without bicalutamide and goserelin in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide and goserelin in treating patients who have localized prostate cancer.

ReferenceCitation: Matzinger O, Poortmans P, Giraud JY, Maingon P, Budiharto T, van den Bergh AC, Davis JB, Musat E, Ataman F, Huyskens DP, Gulyban A, Bolla M; EORTC Radiation Oncology Group. Quality assurance in the 22991 EORTC ROG trial in localized prostate cancer: dummy run and individual case review. Radiother Oncol. 2009 Mar;90(3):285-90. doi: 10.1016/j.radonc.2008.10.022. Epub 2008 Nov 27.

ReferenceCitation: Matzinger O, Duclos F, van den Bergh A, Carrie C, Villà S, Kitsios P, Poortmans P, Sundar S, van der Steen-Banasik EM, Gulyban A, Collette L, Bolla M; EORTC Radiation Oncology Group. Acute toxicity of curative radiotherapy for intermediate- and high-risk localised prostate cancer in the EORTC trial 22991. Eur J Cancer. 2009 Nov;45(16):2825-34. doi: 10.1016/j.ejca.2009.07.009. Epub 2009 Aug 12.

family: Matzinger

full_name: O. Matzinger

given: O.

family: Duclos

full_name: F. Duclos

given: F.

family: Bergh

full_name: A. van den Bergh

given: A. van den

family: Carrie

full_name: C. Carrie

family: Villà

full_name: S. Villà

given: S.

family: Kitsios

full_name: P. Kitsios

given: P.

family: Poortmans

full_name: P. Poortmans

family: Sundar

full_name: S. Sundar

family: van der Steen-Banasik

full_name: E.M. van der Steen-Banasik

family: Gulyban

full_name: A. Gulyban

family: Collette

full_name: L. Collette

given: L.

family: Bolla

full_name: M. Bolla

given: M.

journal_name: European Journal of Cancer

ReferenceCitation: Bolla M, Neven A, Maingon P, Carrie C, Boladeras A, Andreopoulos D, Engelen A, Sundar S, van der Steen-Banasik EM, Armstrong J, Peignaux-Casasnovas K, Boustani J, Herrera FG, Pieters BR, Slot A, Bahl A, Scrase CD, Azria D, Jansa J, O'Sullivan JM, Van Den Bergh ACM, Collette L; EORTC Radiation Oncology Group. Short Androgen Suppression and Radiation Dose Escalation in Prostate Cancer: 12-Year Results of EORTC Trial 22991 in Patients With Localized Intermediate-Risk Disease. J Clin Oncol. 2021 Sep 20;39(27):3022-3033. doi: 10.1200/JCO.21.00855. Epub 2021 Jul 26.

name: Radiotherapy Department Grenoble, Grenoble Alpes University, Centre Hospitalier Universitaire de Grenoble, Grenoble, France

full_name: Michel Bolla

given: Michel

name: European Organization for Research and Treatment of Cancer, Brussels, Belgium

family: Neven

full_name: Anouk Neven

given: Anouk

name: Sorbonne University, APHP Sorbonne University, La Pitié Salpêtrière, Paris, France

family: Maingon

full_name: Philippe Maingon

given: Philippe

name: Radiotherapy Department, Leon Bérard Center, Lyon, France

full_name: Christian Carrie

name: Radiation Oncology Department, Catalan Institute of Oncology—University Hospital Germans Trias I Pujol, Badalona, Barcelona, Catalonia, Spain

family: Boladeras

full_name: Ana Boladeras

given: Ana

name: Radiotherapy Department, Bank of Cyprus Oncology Centre, Nicosia, Cyprus

family: Andreopoulos

full_name: Demetrios Andreopoulos

given: Demetrios

name: Institute Verbeeten, Tilburg, the Netherlands

family: Engelen

full_name: Antoine Engelen

given: Antoine

name: Nottingham University Hospitals NHS Trust—City Hospital, Consultant Medical Oncologist, Nottingham, United Kingdom

full_name: Santhanam Sundar

given: Santhanam

name: Radiotherapiegroep Arnhem, Arnhem, the Netherlands

full_name: Elzbieta M. van der Steen-Banasik

given: Elzbieta M.

name: Radiation Oncology Department, All Ireland Cooperative Oncology Research Group, St Luke's Hospital, Dublin, Ireland

name: Radiotherapy Department, Georges-Francois-Leclerc Centre, Dijon, France

name: Radiotherapy Department, University Hospital of Besancon—Jean Minjoz Hospital, Besancon, France

name: Radiation Oncology and Immuno-Oncology Service, University Hospital of Lausanne, Lausanne, Switzerland

name: Department of Radiation Oncology, Amsterdam University Medical Centers/University of Amsterdam, Amsterdam, the Netherlands

name: Radiotherapeutisch Instituut Friesland, Leeuwarden, the Netherlands

name: University Hospitals Bristol National Health Service Foundation Trust-Bristol Haematology and Oncology Centre, Bristol Avon, United Kingdom

name: Ipswich Hospital National Health Services Trust, Ipswich, United Kingdom

name: Institut du Cancer de Montpellier, Université de Montpellier, INSERM U1194, Montpellier, France

name: Klinika Onkologie a Radioterapie—Fakultni nemocnice Hradec Kralove, Hradec Kralove, Czech Republic

name: Patrick G Johnston Centre for Cancer Research, Queen's University Belfast, Belfast, Ireland

name: Radiotherapy Department, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands

publisher: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Bolla M, Maingon P, Carrie C, Villa S, Kitsios P, Poortmans PM, Sundar S, van der Steen-Banasik EM, Armstrong J, Bosset JF, Herrera FG, Pieters B, Slot A, Bahl A, Ben-Yosef R, Boehmer D, Scrase C, Renard L, Shash E, Coens C, van den Bergh AC, Collette L. Short Androgen Suppression and Radiation Dose Escalation for Intermediate- and High-Risk Localized Prostate Cancer: Results of EORTC Trial 22991. J Clin Oncol. 2016 May 20;34(15):1748-56. doi: 10.1200/JCO.2015.64.8055. Epub 2016 Mar 14.

name: Michel Bolla, Centre Hospitalier Universitaire de Grenoble, Grenoble; Philippe Maingon, Georges-Francois-Leclerc Centre, Dijon; Christian Carrie, Leon Bérard Center, Lyon; Jean-François Bosset, University Hospital of Besancon–Jean Minjoz Hospital, Besancon, France; Salvador Villa, University Hospital Germans Trias I Pujol, Barcelona, Spain; Petros Kitsios, Bank of Cyprus Oncology Centre, Nicosia, Cyprus; Philip M.P. Poortmans, Radboud University Medical Center Nijmegen, Nijmegen; Elzbieta M. van der...

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

location_country:
Italy
Luxembourg
United Kingdom
Netherlands
Cyprus
France
Poland
Ireland
Belgium
Spain
Czech Republic

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Institut Catala d'Oncologia - Hospital Duran i Reynals

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: Belfast City Hospital Trust Incorporating Belvoir Park Hospital

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel


title: A Phase III Randomized Study On Low-Dose Total Body Irradiation And Involved Field Radiotherapy In Patients With Localized, Stages I and II, Low Grade Non-Hodgkin's Lymphoma

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may kill more tumor cells. It is not yet known which regimen of radiation therapy is more effective for non-Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the involved area with or without total-body irradiation in treating patients who have low-grade stage I or stage II non-Hodgkin's lymphoma that has not previously been treated.

location_country: Netherlands Croatia France Belgium Egypt Denmark

location_facility: Universitair Medisch Centrum St. Radboud - Nijmegen

location_facility: Rigshospitalet - Copenhagen University Hospital

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

intervention_type: Radiation


ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country:
South Africa
Sweden
Saudi Arabia
France
Norway
Russian Federation
Spain
Denmark
United States
Canada
Colombia

title: Effect of Subcutaneous Semaglutide 2.4 mg Once-weekly Compared to Placebo in Subjects With Obesity and Knee Osteoarthritis

summary:
This study will look at participants body weight from the start to the end of the study. It will also look at how much pain participants have in participants knee from the start to the end of the study and how this affects participants daily life. This is to compare the effect on body weight and pain in the knee in people taking semaglutide with people taking "dummy" medicine. Participants will either get semaglutide or "dummy" medicine. Which treatment participants get is decided by chance.

Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. During the study, participants will have talks with study staff about how to eat healthy food and how to be more physically active. The study will last for about 1 ½ years. Participants will have 14 clinic visits with the study staff. At the first clinic visit participants will have a blood sample taken. Participants will have an X-ray of participants knee taken at the first visit. If participants have had an X-ray recently, this may not be needed.

At 6 of the clinic visits participants cannot take pain medications for 3 days before the visit. Participants cannot take part if participants have had a joint replacement surgery in participants knee. Participants cannot take part if participants have or have had diabetes. Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.


title: A Multinational, Open-label, Randomised, Controlled Study to Investigate Efficacy and Safety of NNC0365-3769 (Mim8) in Adults and Adolescents With Haemophilia A With or Without Inhibitors

summary:
This study is investigating how Mim8 works compared to other medicines in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used for prevention of bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII).

When and how often participants will receive Mim8 is dependent on their previous treatment - but is otherwise decided by chance. The study will last for 72-124 weeks (17-29 months) depending on how long participants will be followed before it is decided when they start receiving Mim8 - the period before this is decided is called the 'run-in'. Participants will have 13-17 clinic visits. Mim8 will be injected into a skinfold on the stomach with a thin needle either once a week or once a month.

study_start_date_type: Anticipated

status: Not yet recruiting

location_country:
Belgium
Denmark
Taiwan
France
Japan
Lithuania
Poland
Slovakia
Korea, Republic of
South Africa
Saudi Arabia
Switzerland
Netherlands
Ireland
China
United States
United Kingdom
Italy
Austria
Serbia
Czechia
Israel
Spain
Turkey
Latvia


title: A Multi-arm Phase 1b Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma

summary: The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens.

ipd_sharing_description:
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Netherlands
France
Belgium
Australia
United States
United Kingdom

location_facility: Institut Universitaire du cancer de Toulouse-Oncopole

location_facility: Washington University School of Medicine


title: Efficacy and Safety of Oral Semaglutide 50 mg Once Daily in Subjects With Overweight or Obesity (OASIS 1)

acronym: OASIS 1

summary:
This study is being conducted to see if semaglutide tablets can be used as a treatment to help people living with overweight or obesity lose weight.

This study will look at the change in participants body weight. Participants will either get semaglutide tablets (new medicine) or placebo tablets ('dummy' medicine that looks like semaglutide but has no effect on the body). For a fair comparison, people are divided into two groups at random by a computer. This process is called randomisation.

Semaglutide tablets are new medicine being tested to treat overweight and obesity. Doctors in many countries can already prescribe semaglutide tablets at lower doses to treat type 2 diabetes.

Participants will get semaglutide or placebo tablets for 68 weeks and will need to take 1 tablet every morning

In addition to taking the medicine, participants will have talks with study staff about:

healthy food choices
how to be more physically active
what participants can do to lose weight The study will last for about 1½ year.Participants will have 14 clinic visits and 7 phone calls with the study doctor. Blood samples will be taken at 10 visits.

Participants will have a test to check their heart done at 3 visits. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. If participant is a woman and is able to become pregnant, participant will be checked for pregnancy via urine tests.

ipd_sharing_description: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"

location_country:
Germany
Finland
France
Japan
Poland
Russian Federation
Denmark
United States
Canada


title: Efficacy and Safety Investigation of NNC0194-0499 Co-administered With Semaglutide in Subjects With Non-alcoholic Steatohepatitis: a Dose-ranging, Placebo Controlled Trial

summary:
This study is being done to see if a combination of 2 medicines (called NNC0194-0499 and semaglutide) can reduce liver damage in patients with non alcoholic steatohepatitis (NASH).

NNC0194-0499 is a new medicine which works in the liver. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries. It also helps with weight loss and may reduce liver damage, and so prevent future liver complications. It works in a different way to NNC0194 0499. The 2 medicines may work better together than on their own.

The study will also look at a combination of semaglutide and another weight-loss medicine called NNC0174-0833, which may be another treatment option for NASH.

Each week, participants will get 2 injections. These could be 2 of the 3 medicines OR 1 of the medicines and a placebo OR 2 placebo injections. Which treatment participants get is decided by chance. A placebo is a dummy medicine which looks like the real medicine but doesn't contain any active medicine.

The study will last for about 19 months. Participants will have 14 clinic visits and 9 phone calls with the study doctor.

Participants will have 1 or 2 liver biopsies (tiny pieces of liver tissue) - one at the start (if participants have not had a biopsy recently) and one at the end of the study treatment.

Women: Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

location_country:
Italy
United States
India
Germany
France
Bulgaria
Greece
Japan
Malaysia
Poland
Singapore
Belgium
Australia
Puerto Rico
Spain
Canada
United Kingdom
Korea, Republic of


title: A 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Daily Insulin Glargine 100 Units/mL Combined With Insulin Aspart, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With Daily Basal Insulin. COMBINE 3

summary:
This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine taken daily with insulin aspart in people with type 2 diabetes.The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to insulin glargine taken with insulin aspart. Participants will either get IcoSema or insulin glargine taken with insulin aspart. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine and insulin aspart in many countries.

Participants will get IcoSema or insulin glargine together with insulin aspart. Participants must inject IcoSema once a week or inject insulin glargine once daily and insulin aspart 2-4 times a day. Participants will inject the medicines with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach. The study will last for about 1 year and 1 month. Participants will be asked to wear a sensor that measures participants blood sugar level all the time during an 8 week period at the beginning of the study and a 4 week period at the end of the study.

Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

location_country:
Italy
South Africa
France
Czechia
Japan
Malaysia
Hungary
United States
Slovenia