title: After Mapping Of The Axilla: Radiotherapy Or Surgery

acronym: AMAROS

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be a less invasive treatment and cause fewer side effects than complete axillary lymph node dissection. It is not yet known which treatment is more effective for invasive breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of complete axillary lymph node dissection with that of axillary radiation therapy in treating women who have invasive breast cancer.

ReferenceCitation: Straver ME, Meijnen P, van Tienhoven G, van de Velde CJ, Mansel RE, Bogaerts J, Demonty G, Duez N, Cataliotti L, Klinkenbijl J, Westenberg HA, van der Mijle H, Hurkmans C, Rutgers EJ. Role of axillary clearance after a tumor-positive sentinel node in the administration of adjuvant therapy in early breast cancer. J Clin Oncol. 2010 Feb 10;28(5):731-7. doi: 10.1200/JCO.2008.21.7554. Epub 2009 Dec 28.

name: From the Departments of Surgical Oncology and Radiation Oncology, the Netherlands Cancer Institute; Department of Radiation Oncology, Academic Medical Centre, Amsterdam; Department of Surgery, University Medical Centre, Leiden; Department of Surgery, Rijnstate Hospital; Department of Radiation Oncology, Arnhem Radiotherapy Institution Institute for Radiation Oncology, Arnhem; Department of Surgery, Nij Smellinghe Hospital, Drachten; Department of Radiation Oncology, Catherina Hospital, Eindhoven, the...

family: Straver

full_name: Marieke E. Straver

given: Marieke E.

family: Meijnen

full_name: Philip Meijnen

family: van Tienhoven

full_name: Geertjan van Tienhoven

given: Geertjan

family: van de Velde

full_name: Cornelis J.H. van de Velde

given: Cornelis J.H.

family: Mansel

full_name: Robert E. Mansel

given: Robert E.

family: Bogaerts

full_name: Jan Bogaerts

given: Jan

family: Demonty

full_name: Gaston Demonty

given: Gaston

family: Duez

full_name: Nicole Duez

given: Nicole

family: Cataliotti

full_name: Luigi Cataliotti

given: Luigi

family: Klinkenbijl

full_name: Jean Klinkenbijl

given: Jean

family: Westenberg

full_name: Helen A. Westenberg

given: Helen A.

family: van der Mijle

full_name: Huub van der Mijle

given: Huub

family: Hurkmans

full_name: Coen Hurkmans

given: Coen

family: Rutgers

full_name: Emiel J.T. Rutgers

given: Emiel J.T.

journal_name: Journal of Clinical Oncology

oa_host_type: repository

repository_institution: University of Florence - Florence Research

publisher: American Society of Clinical Oncology (ASCO)

title: Role of Axillary Clearance After a Tumor-Positive Sentinel Node in the Administration of Adjuvant Therapy in Early Breast Cancer

ReferenceCitation: Straver ME, Meijnen P, van Tienhoven G, van de Velde CJ, Mansel RE, Bogaerts J, Duez N, Cataliotti L, Klinkenbijl JH, Westenberg HA, van der Mijle H, Snoj M, Hurkmans C, Rutgers EJ. Sentinel node identification rate and nodal involvement in the EORTC 10981-22023 AMAROS trial. Ann Surg Oncol. 2010 Jul;17(7):1854-61. doi: 10.1245/s10434-010-0945-z. Epub 2010 Mar 19.

full_name: Cornelis J. H. van de Velde

repository_institution: Wiardi Beckman Foundation - Wiardi Beckman Foundation

title: Sentinel Node Identification Rate and Nodal Involvement in the EORTC 10981-22023 AMAROS Trial

ReferenceCitation: Straver ME, Meijnen P, van Tienhoven G, et al.: Technical aspects of the sentinel node biopsy in the EORTC AMAROS sentinel node trial. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-1006, 2008.

ReferenceCitation: Meijnen P, Rutgers EJT, van de Velde CJH, et al.: EORTC 10981-22023 trial. AMAROS: after mapping of the axilla: radiotherapy or surgery? Trial update. [Abstract] Eur J Cancer 2 (Suppl 3): A-79, 79, 2004.

ReferenceCitation: Hurkmans CW, Borger JH, Rutgers EJ, van Tienhoven G; EORTC Breast Cancer Cooperative Group; Radiotherapy Cooperative Group. Quality assurance of axillary radiotherapy in the EORTC AMAROS trial 10981/22023: the dummy run. Radiother Oncol. 2003 Sep;68(3):233-40.

ReferenceCitation: Donker M, Slaets L, van Tienhoven G, Rutgers EJ. [Axillary lymph node dissection versus axillary radiotherapy in patients with a positive sentinel node: the AMAROS trial]. Ned Tijdschr Geneeskd. 2015;159:A9302. Dutch.

ReferenceCitation: Donker M, van Tienhoven G, Straver ME, Meijnen P, van de Velde CJ, Mansel RE, Cataliotti L, Westenberg AH, Klinkenbijl JH, Orzalesi L, Bouma WH, van der Mijle HC, Nieuwenhuijzen GA, Veltkamp SC, Slaets L, Duez NJ, de Graaf PW, van Dalen T, Marinelli A, Rijna H, Snoj M, Bundred NJ, Merkus JW, Belkacemi Y, Petignat P, Schinagl DA, Coens C, Messina CG, Bogaerts J, Rutgers EJ. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial. Lancet Oncol. 2014 Nov;15(12):1303-10. doi: 10.1016/S1470-2045(14)70460-7. Epub 2014 Oct 15.

ReferenceCitation: Donker M, Straver ME, van Tienhoven G, van de Velde CJ, Mansel RE, Litière S, Werutsky G, Duez NJ, Orzalesi L, Bouma WH, van der Mijle H, Nieuwenhuijzen GA, Veltkamp SC, Helen Westenberg A, Rutgers EJ. Comparison of the sentinel node procedure between patients with multifocal and unifocal breast cancer in the EORTC 10981-22023 AMAROS Trial: identification rate and nodal outcome. Eur J Cancer. 2013 Jun;49(9):2093-100. doi: 10.1016/j.ejca.2013.02.017. Epub 2013 Mar 19.

title: Comparison of the sentinel node procedure between patients with multifocal and unifocal breast cancer in the EORTC 10981-22023 AMAROS Trial: Identification rate and nodal outcome

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

location_country:
Italy
Switzerland
Netherlands
United Kingdom
Poland
France
Turkey
Slovenia

location_facility: Hopital Cantonal Universitaire de Geneve

location_facility: Academisch Medisch Centrum at University of Amsterdam

location_facility: Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

location_facility: Universita Degli Studi di Florence - Policlinico di Careggi

location_facility: Universitair Medisch Centrum St. Radboud - Nijmegen

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital


title: Optimal Self-Management Of Asthma By Forced Oscillation Technique: a Randomised Controlled Trial

acronym: PIANOFORTE

summary:
Self-management strategies for asthma, including patients engagement and adherence to personalised action plans with advice on recognizing and responding to deterioration in control with effective treatments can improve asthma outcomes and possibly reduce the risk of future exacerbations. However, the real-life evidence is that asthma control remains sub-optimal in the majority of cases, thus increasing the related socio-economic costs worldwide.

Because an increased variability of lung function remains a hallmark of poor asthma control and exacerbations, its assessment over time could contribute to the success of self-management plans. Previous studies have shown the potential of Forced Oscillation Technique (FOT) as a tool for monitoring increased variability of airway obstruction and for identifying the onset of acute deterioration of airway function.

The aim of this study is to test the hypothesis that a personalised self-management plan including FOT improves asthma control and reduces number of days with increased symptoms compared to conventional asthma treatment.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

ipd_sharing_description: No Individual Participant Data (IPD) sharing planned at this stage

lead_sponsor: Restech Srl

location_country: Italy Australia France

location_facility: Azienda Unità Sanitaria Locale di Reggio Emilia

location_facility: Azienda Ospedaliero, Universitaria Meyer

location_facility: Istituto per la Ricerca e l'Innovazione del CNR

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Ongoing


intervention_type: Drug

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Netherlands
France
Belgium
Spain
Germany
United Kingdom

type: EudraCT Number

source: euctr

title: A Prospective, Open-label, Multicenter, Randomized Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Renal Allograft Recipients Aged 12 to Less Than 18 Years of Age to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications

summary: The purpose of this study is to evaluate the benefits and risks of conversion of existing adolescent kidney allograft recipients aged 12 to less than 18 years of age to a belatacept-based immunosuppressive regimen as compared to continuation of a calcineurin inhibitor-based regimen and their adherence to immunosuppressive medications.


title: A Single-arm, Open-label, Phase II Study of Sabatolimab in Combination With Azacitidine and Venetoclax in Adult Participants With High or Very High Risk Myelodysplastic Syndromes (MDS) as Per IPSS-R Criteria

summary: The purpose of the study is to find out if the new drug sabatolimab when given in combination with azacitidine and venetoclax, is safe and has beneficial effects in participants with high or very high risk myelodysplastic syndrome (MDS) who are not suitable for treatment with intensive chemotherapy or a stem-cell transplant (HSCT).

study_start_date_type: Actual

status: Recruiting

ipd_sharing: Yes

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 trial in line with applicable laws and regulations.

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

lead_sponsor: Novartis Pharmaceuticals

location_country: France Greece Hungary Belgium Spain Germany


title: A Study to Determine the Concordance of Key Actionable Genomic Alterations as Assessed in Tumor Tissue and Plasma From Patients With Non Small Cell Lung Carcinoma (NSCLC)

summary: A study to determine the concordance of key actionable genomic alterations as assessed in tumor tissue and plasma from patients with non small cell lung carcinoma (NSCLC)

status: Terminated

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Genomic Health®, Inc.

location_country:
Chile
France
Japan
Ireland
Spain
United States
United Kingdom

location_facility: Clatterbridge Cancer Center NHS Foundation Trust

location_facility: Cancer Care Associates d/b/a Torrance Memorial Physician Network

location_facility: Hospital Clinico Universitario Lozano Blesa

status_simplified: Unknown


ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

lead_sponsor: Amgen

location_country:
Italy
United States
Switzerland
France
Belgium
Spain
Canada

location_facility: Centre Hospitalier Universitaire Sainte Justine

location_facility: Institut Hematologie et Oncologie Pediatrique

location_facility: Cincinnati Childrens Hospital Medical Center

location_facility: Centre Hospitalier Universitaire de Marseille - Hopital de la Timone

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Hospital Universitario Infantil Niño Jesus

location_facility: Ann and Robert H Lurie Childrens Hospital of Chicago

title: A Phase 1, Multi-center, Open-label, Dose De-escalation Study to Evaluate the Safety and Efficacy of Talimogene Laherparepvec in Pediatric Subjects With Advanced Non Central Nervous System Tumors That Are Amenable to Direct Injection

summary: This is a phase 1 study to evaluate the safety of intralesional talimogene laherparepvec administration in pediatric subjects with advanced non-CNS tumors that are amenable to direct injection


title: A Multicenter, Open-Label, First-in-Human, Phase 1b/2a Trial of EO2401, a Novel Multipeptide Therapeutic Vaccine, With and Without Check Point Inhibitor, Following Standard Treatment in Patients With Progressive Glioblastoma

acronym: ROSALIE

summary: The purpose of this study is to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EO2401 in patients with unequivocal evidence of progressive or first recurrent glioblastoma.

design_allocation: Non-Randomized

lead_sponsor: Enterome

location_country:
Germany
United States
France
Spain

location_facility: Neurologische Klinik & Nationales Zentrum für Tumorenerkrankungen Heidelberg Universitätsklinikum Heidelberg

location_facility: Institit Catala D'Oncologia - Hospital Duran i Reynals

location_facility: Zentrum für Neuroonkologie Universitätsklinikum Tübingen

location_facility: Klinik und Poliklinik für Neurologie Universitätsklinikum Bonn

location_facility: Medizinische Fakultät Mannheim der Universität Heidelberg

location_facility: Universitätsklinikum Frankfurt Goethe-Universität Dr. Senckenbergisches Institut für Neuroonkologie

intervention_type: Biological


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.

location_country:
Italy
United States
France
Spain
Germany
United Kingdom

title: An Open-label, Non-randomized Extension Study to Evaluate the Long-term Efficacy, Safety and Tolerability of LNP023 in Subjects With C3 Glomerulopathy

summary: This is an open-label extension study to evaluate the long-term efficacy, safety and tolerability of LNP023 in subjects with C3 glomerulopathy


title: Phase I, Open Label, Non-randomised, Non-comparative, Multi-center Study, Evaluating S65487, a Bcl-2 Inhibitor Intravenously Administered, in Patients With Relapse or Refractory Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma or Chronic Lymphocytic Leukemia

summary: The purpose of this first in human study is to assess safety, tolerability, Pharmacokinetic (PK) and preliminary clinical activity and to estimate the Maximum Tolerated Doses (MTD(s))/ Recommended Phase 2 Doses (RP2D(s)) of S65487 as single agent administered intravenously (i.v.) in adult patients with refractory or relapsed Acute Myeloid Leukemia (AML), Non-Hodgkin Lymphoma (NHL), Multiple Myeloma (MM) or Chronic Lymphocytic Leukemia (CLL).

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

Access can be requested for all interventional clinical studies:

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

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

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

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
United Kingdom
Australia
France
Spain

location_facility: Clínica Universidad Navarra- Servicio de Hematología

location_facility: Centre Hospitalier Universitaire de Lille Hôpital Huriez

location_facility: Hospital Clínico Universitario de Salamanca- Servicio de Hematología (4a planta)

location_facility: Hospital Universitario La Fe - Servicio de Hematología - Torre F - Planta 7

location_facility: King's College Hospital NHS Foundation Trust


title: A Phase I/IIa Study of TG6002 (VV TK-RR-FCU1) Administered by Intravenous (IV) Infusions in Combination With Oral Flucytosine (5-FC) in Patients With Advanced Gastro-intestinal (GI) Tumors.

summary:
This study will include two parts:

In the phase I part: safety will be assessed in consecutive cohorts of 3 to 6 patients at increasing doses of TG6002 in combination with oral flucytosine (5-FC) in patients with advanced gastro-intestinal (GI) tumors.
In the phase IIa part: evaluation of efficacy and further evaluation of safety of multiple administrations of TG6002 in combination with flucytosine (5-FC) in patients with colorectal cancer and liver metastases.

In both parts, tumor response will be evaluated on local assessment using RECIST 1.1.

All patients will be followed up until disease progression or death due to any cause or the date of data cut-off, whichever occurs first.

ipd_sharing: Undecided

lead_sponsor: Transgene

location_country: Belgium France Spain

location_facility: Instituto de Investigación Sanitaria Fundación Jimenez Díaz

location_facility: Centro Integral Oncológico Clara Campal (CIOCC) Hospital


title: A Phase I Trial to Investigate the Effect of Nintedanib on the Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Female Patients With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)

summary: The main objective is to assess the potential influence of continuous intake of nintedanib on the systemic exposure of ethinylestradiol and levonorgestrel when administered in combination.

status: Completed

ReferenceType: derived

ReferenceCitation: Vonk MC, Guillén-Del-Castillo A, Kreuter M, Avis M, Marzin K, Mack SR, Wind S, Gahlemann M. A Drug-Drug Interaction Study to Investigate the Effect of Nintedanib on the Pharmacokinetics of Microgynon (Ethinylestradiol and Levonorgestrel) in Female Patients with Systemic Sclerosis-Associated Interstitial Lung Disease. Eur J Drug Metab Pharmacokinet. 2021 Oct 18. doi: 10.1007/s13318-021-00728-7. [Epub ahead of print]

family: Vonk

full_name: Madelon C. Vonk

given: Madelon C.

sequence: first

family: Guillén-Del-Castillo

full_name: Alfredo Guillén-Del-Castillo

given: Alfredo

sequence: additional

family: Kreuter

full_name: Michael Kreuter

given: Michael

family: Avis

full_name: Mandy Avis

given: Mandy

family: Marzin

full_name: Kristell Marzin

given: Kristell

family: Mack

full_name: Salome R. Mack

given: Salome R.

family: Wind

full_name: Sven Wind

given: Sven

family: Gahlemann

full_name: Martina Gahlemann

given: Martina

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: European Journal of Drug Metabolism and Pharmacokinetics

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: A Drug–Drug Interaction Study to Investigate the Effect of Nintedanib on the Pharmacokinetics of Microgynon (Ethinylestradiol and Levonorgestrel) in Female Patients with Systemic Sclerosis-Associated Interstitial Lung Disease

ipd_sharing_description:
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to:

find information in order to request access to clinical study data, for listed studies.
request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement'.

lead_sponsor: Boehringer Ingelheim

location_country: Netherlands Spain France Belgium Portugal Germany

location_facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

status_simplified: Completed


status: Active, not recruiting

primary_purpose: Other

location_country:
France
Japan
Spain
United States
United Kingdom

location_facility: University of Texas Southwestern Medical Center

location_facility: University of Texas MD Anderson Cancer Center

title: Long-term Follow-up Study of Patients Who Have Previously Been Exposed to UCART19 (Allogeneic Engineered T-cells Expressing a Lentiviral-based Anti-CD19 Chimeric Antigen Receptor)

summary: The purpose of this study is to evaluate the long-term safety and efficacy of UCART19 administration to patients with advanced lymphoid leukemia.


type: Other Grant/Funding Number

title: Development of Novel Clinical Endpoints for Interventional Clinical Trials With a Regulatory and Patient Access Intention in Patients With Intermediate Age-related Macular Degeneration (AMD)

acronym: MACUSTAR

summary: Development of novel clinical endpoints for interventional clinical trials with a regulatory and patient access intention in patients with intermediate age-related macular degeneration (AMD) - MACUSTAR

ReferenceCitation: Terheyden JH, Behning C, Lüning A, Wintergerst L, Basile PG, Tavares D, Melício BA, Leal S, Weissgerber G, Luhmann UFO, Crabb DP, Tufail A, Hoyng C, Berger M, Schmid M, Silva R, Martinho CV, Cunha-Vaz J, Holz FG, Finger RP; MACUSTAR consortium. Challenges, facilitators and barriers to screening study participants in early disease stages-experience from the MACUSTAR study. BMC Med Res Methodol. 2021 Mar 17;21(1):54. doi: 10.1186/s12874-021-01243-8.

family: Terheyden

full_name: Jan Henrik Terheyden

given: Jan Henrik

family: Behning

full_name: Charlotte Behning

given: Charlotte

family: Lüning

full_name: Anna Lüning

given: Anna

family: Wintergerst

full_name: Ludmila Wintergerst

given: Ludmila

family: Basile

full_name: Pier G. Basile

given: Pier G.

family: Tavares

full_name: Diana Tavares

given: Diana

family: Melício

full_name: Beatriz A. Melício

given: Beatriz A.

family: Leal

full_name: Sergio Leal

given: Sergio

family: Weissgerber

full_name: George Weissgerber

given: George

family: Luhmann

full_name: Ulrich F. O. Luhmann

given: Ulrich F. O.

family: Crabb

full_name: David P. Crabb

given: David P.

family: Tufail

full_name: Adnan Tufail

given: Adnan

family: Hoyng

full_name: Carel Hoyng

given: Carel

family: Berger

full_name: Moritz Berger

given: Moritz

family: Schmid

full_name: Matthias Schmid

given: Matthias

family: Silva

full_name: Rufino Silva

given: Rufino

family: Martinho

full_name: Cecília V. Martinho

given: Cecília V.

family: Cunha-Vaz

full_name: José Cunha-Vaz

given: José

family: Holz

full_name: Frank G. Holz

given: Frank G.

family: Finger

full_name: Robert P. Finger

given: Robert P.

currency_apc_doaj: GBP

journal_name: BMC Medical Research Methodology

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

repository_institution: Queen's University Belfast - Research Portal

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

repository_institution: University College London - UCL Discovery

repository_institution: City University London - City Research Online

ReferenceCitation: Terheyden JH, Holz FG, Schmitz-Valckenberg S, Lüning A, Schmid M, Rubin GS, Dunbar H, Tufail A, Crabb DP, Binns A, Sánchez CI, Hoyng C, Margaron P, Zakaria N, Durbin M, Luhmann U, Zamiri P, Cunha-Vaz J, Martinho C, Leal S, Finger RP; MACUSTAR consortium. Clinical study protocol for a low-interventional study in intermediate age-related macular degeneration developing novel clinical endpoints for interventional clinical trials with a regulatory and patient access intention-MACUSTAR. Trials. 2020 Jul 18;21(1):659. doi: 10.1186/s13063-020-04595-6.

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

title: Clinical study protocol for a low-interventional study in intermediate age-related macular degeneration developing novel clinical endpoints for interventional clinical trials with a regulatory and patient access intention—MACUSTAR

location_country:
Italy
Netherlands
France
Portugal
Denmark
Germany
United Kingdom

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: Centre d'Investigation Clinique Centre National d'Ophtalmologie des Quinze-Vingts

location_facility: Gloucestershire Hospitals NHS Foundation Trust

location_facility: Department of Ophthalmology, University of Freiburg


title: A Phase II, Multicenter, Open-label, Randomized Two-year Study to Evaluate the Efficacy and Safety of Deferasirox Film-coated Tablet Versus Phlebotomy in Patients With Hereditary Hemochromatosis.

summary:
The purpose of this study is to evaluate the efficacy and safety of deferasirox film coated tablet (FCT) versus phlebotomy for the management of iron overload in adults with HH at risk of iron-related morbidity. This evaluation will provide information on the two treatment options in terms of the rate of response of proportion of patients reaching the study target SF ≤ 100 μg/L and their associated safety profiles.

In addition to exploring the safety and efficacy of deferasirox FCT in hereditary hemochromatosis (HH), this study is being conducted to fulfill an FDA post-marketing requirement [PMC 750-10 (Exjade) /PMR 2888-8 (Jadenu)] to provide additional randomized data to confirm the ocular safety profile of deferasirox through detailed ocular assessments in patients treated with deferasirox FCT for 2 years.

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

location_country:
Switzerland
France
Slovakia
Romania
Russian Federation
Belgium
Spain

intervention_type: Procedure


lead_sponsor: Gilead Sciences

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Ohio State University, Wexner Medical Center

location_facility: Hospital Clinico Universitario de Valencia

title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Tolerability of Entospletinib, a Selective SYK Inhibitor, in Combination With Systemic Corticosteroids as First-Line Therapy in Subjects With Chronic Graft Versus Host Disease (cGVHD)

summary: The primary objective of this study is to evaluate the effect of entospletinib (ENTO) on the best overall response rate in adults with chronic graft versus host disease (cGVHD) who are currently receiving systemic corticosteroids as part of first-line therapy for cGVHD.


title: The European IPF Registry - an Internet-based, Pan-European Registry Linked to the European IPF Biobank (eurIPFbank)

acronym: eurIPFreg

summary:
Born out of the European Union 7th Framework Programme funded project European IPF Network (eurIPFnet), the European IPF Registry (eurIPFreg) has become Europe's leading database of longitudinal data from IPF patients, including control groups of patients with other lung diseases. The registry was initiated with the intention of creating a permanent and continuously growing record of well defined data on IPF in Europe, in order to increase the chances of finding better treatment options for this devastating disease.

Clinical colleagues who would like to actively participate (both in terms of patient recruitment and data analysis) are invited to contact us (http://www.pulmonary-fibrosis.net/).

time_perspective: Cross-Sectional

ReferenceType: background

ReferenceCitation: Guenther A; European IPF Network. The European IPF Network: towards better care for a dreadful disease. Eur Respir J. 2011 Apr;37(4):747-8. doi: 10.1183/09031936.00012111.

ReferenceCitation: Loeh B, Drakopanagiotakis F, Bandelli GP, von der Beck D, Tello S, Cordani E, Rizza E, Barrocu L, Markart P, Seeger W, Guenther A, Albera C. Intraindividual response to treatment with pirfenidone in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2015 Jan 1;191(1):110-3. doi: 10.1164/rccm.201406-1106LE.

ReferenceCitation: Krauss E, Haberer J, Barreto G, Degen M, Seeger W, Guenther A. Recognition of breathprints of lung cancer and chronic obstructive pulmonary disease using the Aeonose(®) electronic nose. J Breath Res. 2020 Jul 24;14(4):046004. doi: 10.1088/1752-7163/ab8c50.

family: Krauss

full_name: Ekaterina Krauss

given: Ekaterina

family: Haberer

full_name: Jana Haberer

given: Jana

family: Barreto

full_name: Guillermo Barreto

given: Guillermo

family: Degen

full_name: Maria Degen

given: Maria

family: Seeger

full_name: Werner Seeger

given: Werner

family: Guenther

full_name: Andreas Guenther

given: Andreas

journal_name: Journal of Breath Research

publisher: IOP Publishing

publisher_dissemination: IOP Publishing

publisher_group: IOP Publishing

publisher_normalized: IOP Publishing

title: Recognition of breathprints of lung cancer and chronic obstructive pulmonary disease using the Aeonose® electronic nose

ReferenceCitation: Krauss E, Gehrken G, Drakopanagiotakis F, Tello S, Dartsch RC, Maurer O, Windhorst A, von der Beck D, Griese M, Seeger W, Guenther A. Clinical characteristics of patients with familial idiopathic pulmonary fibrosis (f-IPF). BMC Pulm Med. 2019 Jul 18;19(1):130. doi: 10.1186/s12890-019-0895-6.

apc_source: openAPC

family: Gehrken

full_name: Godja Gehrken

given: Godja

family: Drakopanagiotakis

full_name: Fotios Drakopanagiotakis

given: Fotios

family: Tello

full_name: Silke Tello

given: Silke

family: Dartsch

full_name: Ruth C. Dartsch

given: Ruth C.

family: Maurer

full_name: Olga Maurer

given: Olga

family: Windhorst

full_name: Anita Windhorst

given: Anita

family: von der Beck

full_name: Daniel von der Beck

given: Daniel

family: Griese

full_name: Matthias Griese

journal_name: BMC Pulmonary Medicine

license: cc-by

license_normalized: cc-by

repository_institution: CERN European Organization for Nuclear Research - Zenodo

ReferenceCitation: Witt S, Krauss E, Barbero MAN, Müller V, Bonniaud P, Vancheri C, Wells AU, Vasakova M, Pesci A, Klepetko W, Seeger W, Crestani B, Leidl R, Holle R, Schwarzkopf L, Guenther A. Psychometric properties and minimal important differences of SF-36 in Idiopathic Pulmonary Fibrosis. Respir Res. 2019 Mar 1;20(1):47. doi: 10.1186/s12931-019-1010-5.

repository_institution: Università degli Studi di Milano - Institutional Research Information System

ReferenceCitation: Loeh B, Brylski LT, von der Beck D, Seeger W, Krauss E, Bonniaud P, Crestani B, Vancheri C, Wells AU, Markart P, Breithecker A, Guenther A. Lung CT Densitometry in Idiopathic Pulmonary Fibrosis for the Prediction of Natural Course, Severity, and Mortality. Chest. 2019 May;155(5):972-981. doi: 10.1016/j.chest.2019.01.019. Epub 2019 Feb 8.

ReferenceCitation: Guenther A, Krauss E, Tello S, Wagner J, Paul B, Kuhn S, Maurer O, Heinemann S, Costabel U, Barbero MAN, Müller V, Bonniaud P, Vancheri C, Wells A, Vasakova M, Pesci A, Sofia M, Klepetko W, Seeger W, Drakopanagiotakis F, Crestani B. The European IPF registry (eurIPFreg): baseline characteristics and survival of patients with idiopathic pulmonary fibrosis. Respir Res. 2018 Jul 28;19(1):141. doi: 10.1186/s12931-018-0845-5.

repository_institution: Justus-Liebig-Universität Gießen - University writing server of the Justus Liebig University Giessen

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

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

location_country:
Italy
Austria
France
Germany
United Kingdom

location_facility:
Hopital Bichat Paris
Medizinische Universität Wien
Centre Hospitalier Universitaire Dijon
Andreas Guenther
Royal Brompton Hospital
Università degli Studi di Catania
Lungenfachklinik Waldhof Elgershausen


title: STAR-LIFE Registry: STARflo Glaucoma Implant Clinical Experience Program in a Real-World Patient Population

summary: STARflo is a novel suprachoroidal Glaucoma Drainage Device (GDD), bleb-free, exhibiting anti-fibrotic properties. Release of this CE Marked implant has been limited to leading Glaucoma Centers in Europe.

time_perspective: Other

lead_sponsor: iSTAR Medical

location_country: France Hungary Belgium Spain Germany

location_facility: Bât. BC-3 OPHTALMOLOGIE - POLICLINIQUE C.H.U.

intervention_type: Device


type: Other Identifier

title: ACCELERATE (Advancing Castleman Care With an Electronic Longitudinal Registry, E-Repository, And Treatment/Effectiveness Research): An International Registry for Patients With Castleman Disease

acronym: ACCELERATE

summary: The purpose of this study is to collect clinical, laboratory, and patient survey data from patients with Castleman disease to improve understanding, diagnosis, and treatment of the disease.

ReferenceType: result

ReferenceCitation: Liu AY, Nabel CS, Finkelman BS, Ruth JR, Kurzrock R, van Rhee F, Krymskaya VP, Kelleher D, Rubenstein AH, Fajgenbaum DC. Idiopathic multicentric Castleman's disease: a systematic literature review. Lancet Haematol. 2016 Apr;3(4):e163-75. doi: 10.1016/S2352-3026(16)00006-5. Epub 2016 Mar 17. Review.

family: Liu

full_name: Amy Y Liu

given: Amy Y

family: Nabel

full_name: Christopher S Nabel

given: Christopher S

family: Finkelman

full_name: Brian S Finkelman

given: Brian S

family: Ruth

full_name: Jason R Ruth

given: Jason R

family: Kurzrock

full_name: Razelle Kurzrock

given: Razelle

family: van Rhee

full_name: Frits van Rhee

given: Frits

family: Krymskaya

full_name: Vera P Krymskaya

given: Vera P

family: Kelleher

full_name: Dermot Kelleher

given: Dermot

family: Rubenstein

full_name: Arthur H Rubenstein

given: Arthur H

family: Fajgenbaum

full_name: David C Fajgenbaum

given: David C

journal_name: The Lancet Haematology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Fajgenbaum DC, van Rhee F, Nabel CS. HHV-8-negative, idiopathic multicentric Castleman disease: novel insights into biology, pathogenesis, and therapy. Blood. 2014 May 8;123(19):2924-33. doi: 10.1182/blood-2013-12-545087. Epub 2014 Mar 12. Review.

name: Center for Orphan Disease Research and Therapy, Raymond and Ruth Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA;

full_name: David C. Fajgenbaum

given: David C.

name: Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences, Little Rock, AR; and

name: Department of Medicine, Raymond and Ruth Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA

full_name: Christopher S. Nabel

given: Christopher S.

journal_name: Blood

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

ReferenceCitation: Koa B, Borja AJ, Aly M, Padmanabhan S, Tran J, Zhang V, Rojulpote C, Pierson SK, Tamakloe MA, Khor JS, Werner TJ, Fajgenbaum DC, Alavi A, Revheim ME. Emerging role of 18F-FDG PET/CT in Castleman disease: a review. Insights Imaging. 2021 Mar 11;12(1):35. doi: 10.1186/s13244-021-00963-1. Review.

family: Koa

full_name: Benjamin Koa

given: Benjamin

family: Borja

full_name: Austin J. Borja

given: Austin J.

family: Aly

full_name: Mahmoud Aly

given: Mahmoud

family: Padmanabhan

full_name: Sayuri Padmanabhan

given: Sayuri

family: Tran

full_name: Joseph Tran

given: Joseph

repository_institution: University of Oslo - Duo Research Archive

repositories_institution: University of Oslo - Duo Research Archive

title: Emerging role of 18F-FDG PET/CT in Castleman disease: a review

ReferenceCitation: van Rhee F, Oksenhendler E, Srkalovic G, Voorhees P, Lim M, Dispenzieri A, Ide M, Parente S, Schey S, Streetly M, Wong R, Wu D, Maillard I, Brandstadter J, Munshi N, Bowne W, Elenitoba-Johnson KS, Fössa A, Lechowicz MJ, Chandrakasan S, Pierson SK, Greenway A, Nasta S, Yoshizaki K, Kurzrock R, Uldrick TS, Casper C, Chadburn A, Fajgenbaum DC. International evidence-based consensus diagnostic and treatment guidelines for unicentric Castleman disease. Blood Adv. 2020 Dec 8;4(23):6039-6050. doi: 10.1182/bloodadvances.2020003334.

name: Myeloma Center, University of Arkansas for Medical Sciences, Little Rock, AR;

name: Department of Clinical Immunology, Hospital Saint-Louis, Paris, France;

name: Sparrow Cancer Center, Edward W. Sparrow Hospital Association, Lansing, MI;

name: Department of Hematologic Oncology and Blood Disorders, Levine Cancer Institute, Atrium Health, Charlotte, NC;

name: Department of Pathology & Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA;

name: Division of Hematology, Mayo Clinic, Rochester, MN;

name: Department of Hematology, Takamatsu Red Cross Hospital, Takamatsu, Japan;

name: Division of Translational Medicine and Human Genetics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA;

name: Guy’s and St Thomas’ NHS Foundation Trust, London, United Kingdom;

name: Sir Y.K. Pao Centre for Cancer, Department of Medicine & Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong;

name: Department of Laboratory Medicine, University of Washington, Seattle, WA;

name: Divison of Hematology/Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA;

name: Department of General Surgery and Surgical Oncology, Thomas Jefferson University, Philadelphia, PA;

name: Department of Oncology, Oslo University Hospital–Norwegian Radium Hospital, Oslo, Norway;

name: Department of Hematology and Medical Oncology, Emory University, Atlanta, GA;

name: Aflac Cancer and Blood Disorders Center, Children’s Healthcare of Atlanta, Emory University, Atlanta, GA;

name: Department of Organic Fine Chemicals, Institute of Scientific and Industrial Research, Osaka University, Osaka, Japan;

name: Center for Personalized Therapy and Clinical Trials Office, Moores Cancer Center, UC San Diego, La Jolla, CA;

name: Fred Hutchinson Cancer Research Center and Medical Oncology, University of Washington, Seattle, WA;

name: Infectious Disease Research Institute, Department of Medicine and Global Health, University of Washington, Seattle, WA; and

name: Department of Pathology and Laboratory Medicine, Weill Cornell Medical College, New York, NY

repository_institution: Thomas Jefferson University - Jefferson Digital Commons

repositories_institution: Thomas Jefferson University - Jefferson Digital Commons

ReferenceCitation: Dispenzieri A, Fajgenbaum DC. Overview of Castleman disease. Blood. 2020 Apr 16;135(16):1353-1364. doi: 10.1182/blood.2019000931. Review.

name: Division of Hematology, Mayo Clinic, Rochester, MN; and

title: Overview of Castleman disease

ReferenceCitation: van Rhee F, Voorhees P, Dispenzieri A, Fosså A, Srkalovic G, Ide M, Munshi N, Schey S, Streetly M, Pierson SK, Partridge HL, Mukherjee S, Shilling D, Stone K, Greenway A, Ruth J, Lechowicz MJ, Chandrakasan S, Jayanthan R, Jaffe ES, Leitch H, Pemmaraju N, Chadburn A, Lim MS, Elenitoba-Johnson KS, Krymskaya V, Goodman A, Hoffmann C, Zinzani PL, Ferrero S, Terriou L, Sato Y, Simpson D, Wong R, Rossi JF, Nasta S, Yoshizaki K, Kurzrock R, Uldrick TS, Casper C, Oksenhendler E, Fajgenbaum DC. International, evidence-based consensus treatment guidelines for idiopathic multicentric Castleman disease. Blood. 2018 Nov 15;132(20):2115-2124. doi: 10.1182/blood-2018-07-862334. Epub 2018 Sep 4.

name: Division of Hematology/Oncology, Mayo Clinic, Rochester, MN;

name: Herbert-Herman Cancer Center, Michigan State University College of Human Medicine, Lansing, MI;

name: Department of Hematology, Takamatsu Red Cross Hospital, Takamatsu, Kagawa, Japan;

name: Dana-Farber Cancer Institute, VA Boston Healthcare System, Harvard Medical School, Boston, MA;

name: Guys and St. Thomas' NHS Foundation Trust, London, United Kingdom;

name: Department of Hematology and Medical Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH;

name: Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA;

name: Department of Hematology and Medical Oncology, and

name: Department of Medicine, Baylor College of Medicine, Houston, TX;

name: National Cancer Institute, National Institutes of Health, Bethesda, MD;

name: Division of Hematology, Department of Medicine, St. Paul’s Hospital, University of British Columbia, Vancouver, BC, Canada;

name: Division of Cancer Medicine, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX;

name: Department of Pathology, Weill Cornell Medical College, New York, NY;

name: Department of Pathology and Laboratory Medicine, and

name: Penn Center for Pulmonary Biology, Pulmonary, Allergy, and Critical Care Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA;

name: Division of Hematology/Oncology, Department of Medicine, University of California San Diego, La Jolla, CA;

name: University of Schleswig Holstein, Campus Kiel, Kiel, Germany;

name: Institute of Hematology “L. e A. Seràgnoli,” University of Bologna, Bologna, Italy;

name: Division of Hematology, Department of Molecular Biotechnologies and Health Sciences University of Torino/AOU “Città della Salute e della Scienza di Torino,” Turin, Italy;

name: Department of Internal Medicine–Hematology, Hôpital Claude Huriez–CHRU Lille, Lille, France;

name: Division of Pathophysiology, Okayama University Graduate School of Health Sciences, Okayama, Japan;

name: North Shore Hospital, Auckland, New Zealand;

name: Sir Y. K. Pao Centre for Cancer and Department of Medicine & Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong;

name: Department of Hematology, CHU de Montpellier, INSERM U1040, Université Montpellier I, Montpellier, France;

name: Division of Hematology/Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA;

name: Department of Organic Fine Chemicals, The Institute of Scientific and Industrial Research, Osaka University, Osaka, Japan;

name: Center for Personalized Therapy and Clinical Trials Office, UC San Diego Moore’s Cancer Center, La Jolla, CA;

name: Fred Hutch Global Oncology, Fred Hutchinson Cancer Research Center, Seattle, WA;

name: Infectious Disease Research Institute, Departments of Medicine and Global Health, University of Washington, Seattle, WA; and

name: Department of Clinical Immunology, Hôpital Saint-Louis, Paris, France

repository_institution: University of Turin - Institutional Research Information System University of Turin

ipd_sharing_description: Qualified Researchers, who apply for access to the database and are subsequently approved, will be given access to a limited dataset with direct identifiers removed in an Excel compatible file format or single SAS data files. The Certification & Access Subcommittee will review applications from qualified researchers on an ongoing basis.

location_country:
Italy
United States
France
Norway
Spain
Germany
United Kingdom

location_facility: King's College Hospital (Oncology & Haematology Clinic)


title: A Phase 1b (Open-Label)/Phase 2 (Randomized, Double-Blinded) Study Evaluating Gemcitabine and Docetaxel With or Without Olaratumab in the Treatment of Advanced Soft Tissue Sarcoma

acronym: ANNOUNCE 2

summary: The main purpose of this study is to evaluate the safety and efficacy of two anti-cancer drugs (gemcitabine and docetaxel) with and without the study drug known as olaratumab in participants with advanced soft tissue sarcoma (STS) or STS that has spread to another part(s) of the body.

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

lead_sponsor: Eli Lilly and Company

location_country:
Italy
United States
France
Poland
Israel
Hungary
Australia
Spain
Germany
United Kingdom

location_facility: Centrum Onkologii-Instytut im Marii Sklodowskiej-Curie

location_facility: Oklahoma Cancer Specialists & Research Institute, LLC

location_facility: Fondazione Piemonte l'Oncologia-Istituto Ricerca Cura Cancro

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz

location_facility: Johns Hopkins University School of Medicine


title: Automated Pupillometry for Coma Prognostication After Cardiac Arrest

summary:
Background: Sedation and therapeutic hypothermia (TH) delay neurological responses and might reduce the accuracy of clinical examination to predict outcome after cardiac arrest (CA). Electroencephalography (EEG) and somato-sensory evoked potentials (SSEP) might significantly improve prognostication of post-CA coma, however, EEG and SSEP are not always available and require specific expertise for their interpretation. Automated video pupillometry is a novel electronic device that contains an infrared light camera which enables to measure quantitatively the percentage of pupillary reaction to a calibrated light stimulation. In a recent study of a cohort of comatose CA survivors (n=50 patients) it was found that quantitative PLR was more accurate than standard PLR (manual pen light) in predicting 3-month outcome, irrespective of temperature and sedation, and had comparable prognostic accuracy than electrophysiological exams, including electroencephalography (EEG) and somato-sensory evoked potentials (SSEP).

Aim of the study: In light of these promising results, the investigators would like to confirm the prognostic value of quantitative PLR in a large multicenter cohort of comatose post-CA patients.

Design of the study: Prospective, multicenter, observational outcome trial.

lead_sponsor: Centre Hospitalier Universitaire Vaudois

location_country: Italy Luxembourg Sweden Switzerland Netherlands France Belgium Germany

location_facility: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

location_facility: Azienda Ospedaliera San Gerardo di Monza

lead_sponsor_type: academique


ReferenceCitation: Bang YJ, Ruiz EY, Van Cutsem E, Lee KW, Wyrwicz L, Schenker M, Alsina M, Ryu MH, Chung HC, Evesque L, Al-Batran SE, Park SH, Lichinitser M, Boku N, Moehler MH, Hong J, Xiong H, Hallwachs R, Conti I, Taieb J. Phase III, randomised trial of avelumab versus physician's choice of chemotherapy as third-line treatment of patients with advanced gastric or gastro-oesophageal junction cancer: primary analysis of JAVELIN Gastric 300. Ann Oncol. 2018 Oct 1;29(10):2052-2060. doi: 10.1093/annonc/mdy264.

family: Bang

full_name: Y.-J Bang

family: Ruiz

full_name: E.Yañez Ruiz

family: Van Cutsem

full_name: E. Van Cutsem

given: E.

family: Lee

full_name: K.-W Lee

family: Wyrwicz

full_name: L. Wyrwicz

given: L.

family: Schenker

full_name: M. Schenker

given: M.

family: Alsina

full_name: M. Alsina

family: Ryu

full_name: M.-H Ryu

family: Chung

full_name: H.-C Chung

family: Evesque

full_name: L. Evesque

family: Al-Batran

full_name: S.-E Al-Batran

family: Park

full_name: S.H. Park

family: Lichinitser

full_name: M. Lichinitser

family: Boku

full_name: N. Boku

given: N.

family: Moehler

full_name: M.H. Moehler

family: Hong

full_name: J. Hong

given: J.

family: Xiong

full_name: H. Xiong

given: H.

family: Hallwachs

full_name: R. Hallwachs

given: R.

family: Conti

full_name: I. Conti

given: I.

family: Taieb

full_name: J. Taieb

journal_name: Annals of Oncology

oa_colors: green hybrid

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

title: Phase III, randomised trial of avelumab versus physician’s choice of chemotherapy as third-line treatment of patients with advanced gastric or gastro-oesophageal junction cancer: primary analysis of JAVELIN Gastric 300

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Italy
Germany
France
Czechia
Poland
Belgium
Australia
Spain
United States
Korea, Republic of

location_facility: Metairie Oncologist, LLC Office of Jayne Gurtler MD, Laura Brinz MD, Janet Burroff MD 3939 Houma Blvd, Suite 6

location_facility: Florida Cancer Specialists 560 Jackson Street, Suite 220

location_facility: Carle Cancer Center 509 W. University Avenue

location_facility: Nemocnice Rudolfa a Stefanie Benesov, a. s.

location_facility: Fondazione del Piemonte per l'Oncologia IRCC Candiolo

location_facility: Penn State University Milton S. Hershey Medical Center 500 University Drive

location_facility: Rocky Mountain Cancer Centers 1800 Williams Street, Suite 100

location_facility: Illinois Cancer Specialists 8915 W. Golf Rd.

location_facility: Rocky Mountain Cancer Centers, LLP 3676 Parker Blvd #350

location_facility: Ocala Oncology Center, P.L. 433 S.W. 10th Street

location_facility: Schwerpunktpraxis für Haematologie und OnkologieOnkologische Schwerpunktpraxis Eppendorf

location_facility: Minnesota Oncology Hematology, P.A. 910 East 26th Street, Suites 100 and 200

location_facility: Oncology Specialists, S.C. 1700 Luther Ln, Ste 2200, Park Ridge, IL 60068 7900 Milwaukee Ave, Ste 16

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: Hospital Universitario la Paz - site 546

location_facility: Ingalls Memorial Hospital One Ingalls Drive, W741

location_facility: Seoul National University Bundang Hospital

location_facility: Texas Oncology Bedford 1609 Hospital Parkway

location_facility: Texas Oncology, P.A. 3410 Worth Street, Suites 300 & 400

location_facility: Oncology Consultants, P.A. 2130 W. Holcombe Blvd. 10th Floor

location_facility: Hematology and Oncology Associates of SC, LLC 900 West Faris Rd, 3rd Floor

location_facility: Scott and White Memorial Hospital and Clinic 2401 South 31st Street

location_facility: New York Oncology Hematology, P.C. 400 Patroon Creek Blvd, Suite 1

location_facility: Texas Oncology, P.A. - Denton 3720 South I-35 East

location_facility: A.O.U. Ospedali Riuniti Ancona- Clinica Oncologica

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

location_facility: Cotton-O'Neil Clinical Research Center, Hematology and Oncology and Stormont Vail Cancer Center 1414 SW 8th St

location_facility: Henry Ford Health System 2799 West Grand Boulevard

location_facility: Chonnam National University Hwasun Hospital

location_facility: Advanced Medical Specialties 8940 North Kendall Drive, Suite 300E

location_facility: Kyungpook National University Medical Center

location_facility: Texas Oncology, P.A. - Tyler 910 E. Houston St, Suite 100

location_facility: Southern Nevada Cancer Research Foundation 601 S Rancho Drive

location_facility: Northwest Cancer Specialists, P.C. 265 N Broadway

location_facility: Texas Oncology, P.A. - McAllen 1901 South 2nd Street

location_facility: Sanford Roger Maris Cancer Center - Fargo 801 Broadway North Route 1058

title: A Phase III Open-label, Multicenter Trial of Avelumab (MSB0010718C) as a Third-line Treatment of Unresectable, Recurrent, or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

summary: The purpose of this study was to demonstrate superiority of treatment with avelumab plus best supportive care (BSC) versus physician's choice (chosen from a pre-specified list of therapeutic options) plus BSC.


title: AIPAC (Active Immunotherapy PAClitaxel): A Multicentre, Phase IIb, Randomised,Double Blind, Placebo-controlled Study in Hormone Receptor-positive Metastatic Breast Carcinoma Patients Receiving IMP321 (LAG-3Ig Fusion Protein) or Placebo as Adjunctive to a Standard Chemotherapy Treatment Regimen of Paclitaxel

summary: The proposed Phase IIb clinical study aims to investigate the safety and efficacy of the active immunotherapy IMP321 in combination (adjunctive) with paclitaxel chemotherapy in patients with hormone receptor-positive metastatic breast cancer.

lead_sponsor: Immutep S.A.S.

location_country:
Netherlands
France
Poland
Hungary
Belgium
Germany
United Kingdom

location_facility: The Christie NHS Foundation Trust The Christie Clinic - Medical Oncology

location_facility: Universitair Ziekenhuis Antwerpen Breast and Gynecological Oncology Unit

location_facility: UZ Leuven, campus Gasthuisberg Department of General Medical Oncology and Multidisciplinary Breast Centre

location_facility: NCT - Nationales Centrum für Tumorerkrankungen

location_facility: Institut Claudius Regaud - IUC Toulouse - Oncopôle

location_facility: Cliniques universitaires Saint-Luc - Institut Roi Albert II - Cancérologie et Hématologie Oncologie clinique

location_facility: UFKT - Universitäts-Frauenklinik Tübingen

location_facility: Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus Centrum für Hämatologie und Onkologie

location_facility: Kierownik Oddziału Onkologii i Radioterapii Szpital Morski im. PCK w Gdyni

location_facility: Nottingham University Hospitals NHS Trust

location_facility: GZA Ziekenhuizen campus Sint-Augustinus Oncologische Research

location_facility: KEM- Brustzentrum der Kliniken Essen-Mitte

location_facility: MH Egészségügyi Központ Onkológiai Osztály


ReferenceCitation: Sekeres MA, Watts J, Radinoff A, Sangerman MA, Cerrano M, Lopez PF, Zeidner JF, Campelo MD, Graux C, Liesveld J, Selleslag D, Tzvetkov N, Fram RJ, Zhao D, Bell J, Friedlander S, Faller DV, Adès L. Randomized phase 2 trial of pevonedistat plus azacitidine versus azacitidine for higher-risk MDS/CMML or low-blast AML. Leukemia. 2021 Jul;35(7):2119-2124. doi: 10.1038/s41375-021-01125-4. Epub 2021 Jan 22.

family: Sekeres

full_name: Mikkael A. Sekeres

given: Mikkael A.

family: Watts

full_name: Justin Watts

given: Justin

family: Radinoff

full_name: Atanas Radinoff

given: Atanas

family: Sangerman

full_name: Montserrat Arnan Sangerman

given: Montserrat Arnan

family: Cerrano

full_name: Marco Cerrano

given: Marco

family: Lopez

full_name: Patricia Font Lopez

given: Patricia Font

family: Zeidner

full_name: Joshua F. Zeidner

given: Joshua F.

family: Campelo

full_name: Maria Diez Campelo

given: Maria Diez

family: Graux

full_name: Carlos Graux

given: Carlos

family: Liesveld

full_name: Jane Liesveld

given: Jane

family: Selleslag

full_name: Dominik Selleslag

given: Dominik

family: Tzvetkov

full_name: Nikolay Tzvetkov

given: Nikolay

family: Fram

full_name: Robert J. Fram

given: Robert J.

family: Zhao

full_name: Dan Zhao

given: Dan

family: Bell

full_name: Jill Bell

given: Jill

family: Friedlander

full_name: Sharon Friedlander

given: Sharon

family: Faller

full_name: Douglas V. Faller

given: Douglas V.

family: Adès

full_name: Lionel Adès

given: Lionel

journal_name: Leukemia

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: Millennium Pharmaceuticals, Inc.

location_country:
Italy
United States
Netherlands
Germany
France
Czechia
Bulgaria
Israel
Ireland
Belgium
Spain
Canada

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: Cliniques Universitaires UCL de Mont-Godinne

location_facility: University of Miami Miller School of Medicine

location_facility: University of North Carolina at Chapel Hill

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

location_facility: Hospital Regional Universitario de Malaga - Hospital Universitario Virgen de la Victoria

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Azienda Ospedaliero Universitaria San Giovanni Battista Di Torino

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

location_facility: Smilow Cancer Center at Yale New Haven Hospital

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Specialized Hospital for Active Treatment of Haematological Diseases - Sofia

location_facility: Azienda Ospedaliera Bianchi Melacrino Morelli

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Compassionate Cancer Care Medical Group Incorporated

location_facility: Marien Hospital Akademisches Lehrkrankenhaus

location_facility: University Multi-Profile Hospital for Active Treatment Dr Georgi Stranski

location_facility: University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD

location_facility: Hospital Clinico Universitario de Valencia

title: A Phase 2, Randomized, Controlled, Open-Label, Clinical Study of the Efficacy and Safety of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia and Low-Blast Acute Myelogenous Leukemia

summary: The purpose of this study is to evaluate the efficacy and safety of pevonedistat plus azacitidine versus single-agent azacitidine in participants with HR-MDS or CMML, or low-blast AML.


ReferenceCitation: Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo Español de Médula Ósea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68.

ReferenceCitation: Locke F, Wang M, Siddiqi T, Castro J, Shah B, Lee H, et al. ZUMA-2: A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-C19 (Anti-CD19 CAR T cells) in Subjects with Relapsed/Refractory Mantle Cell Lymphoma (r/r MCL). American Society Of Clinical Oncology (ASCO) Annual Meeting 2016.

ReferenceCitation: Wang M, Locke F, Siddiqi T, Castro J, Shah B, Lee H, et al. ZUMA-2: A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-C19 (Anti-CD19 CAR T cells) in Subjects with Relapsed/Refractory Mantle Cell Lymphoma (r/r MCL). European Society for Medical Oncology (ESMO) Congress 2016;Abstract 3305

ReferenceCitation: Wang M, Locke FL, Munoz J, Goy A, Holmes HE, Siddiqi T, et al. ZUMA-2: Phase 2 Multicenter Study Evaluating Efficacy of Kte-C19 in Patients with Relapsed/Refractory Mantle Cell Lymphoma [Abstract]. J Clin Oncol 2018;36 (Suppl 15):TPS3102.

ReferenceCitation: Wang M, Munoz J, Goy A, Locke FL, Jacobson CA, Hill BT, Timmerman JM, Holmes H, Jaglowski S, Flinn IW, McSweeney PA, Miklos DB, Pagel JM, Kersten MJ, Milpied N, Fung H, Topp MS, Houot R, Beitinjaneh A, Peng W, Zheng L, Rossi JM, Jain RK, Rao AV, Reagan PM. KTE-X19 CAR T-Cell Therapy in Relapsed or Refractory Mantle-Cell Lymphoma. N Engl J Med. 2020 Apr 2;382(14):1331-1342. doi: 10.1056/NEJMoa1914347.

name: From the University of Texas M.D. Anderson Cancer Center, Houston (M.W.), and Texas Oncology, Dallas (H.H.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J.M.); John Theurer Cancer Center, Hackensack, NJ (A.G.); Moffitt Cancer Center, Tampa (F.L.L.), and the University of Miami, Miami (A.B.) — both in Florida; Dana–Farber Cancer Institute, Boston (C.A.J.); Cleveland Clinic Foundation, Cleveland (B.T.H.), and the Ohio State University Comprehensive Cancer Center, Columbus (S.J.); David Geffen School...

family: Wang

full_name: Michael Wang

given: Michael

family: Munoz

full_name: Javier Munoz

given: Javier

family: Goy

full_name: Andre Goy

given: Andre

family: Locke

full_name: Frederick L. Locke

given: Frederick L.

family: Jacobson

full_name: Caron A. Jacobson

given: Caron A.

family: Hill

full_name: Brian T. Hill

given: Brian T.

family: Timmerman

full_name: John M. Timmerman

given: John M.

family: Holmes

full_name: Houston Holmes

given: Houston

family: Jaglowski

full_name: Samantha Jaglowski

given: Samantha

family: Flinn

full_name: Ian W. Flinn

given: Ian W.

family: McSweeney

full_name: Peter A. McSweeney

given: Peter A.

family: Miklos

full_name: David B. Miklos

given: David B.

family: Pagel

full_name: John M. Pagel

family: Kersten

full_name: Marie-Jose Kersten

given: Marie-Jose

family: Milpied

full_name: Noel Milpied

given: Noel

family: Fung

full_name: Henry Fung

given: Henry

family: Topp

full_name: Max S. Topp

given: Max S.

family: Houot

full_name: Roch Houot

given: Roch

family: Beitinjaneh

full_name: Amer Beitinjaneh

given: Amer

family: Peng

full_name: Weimin Peng

given: Weimin

family: Zheng

full_name: Lianqing Zheng

given: Lianqing

family: Rossi

full_name: John M. Rossi

family: Jain

full_name: Rajul K. Jain

given: Rajul K.

family: Rao

full_name: Arati V. Rao

given: Arati V.

ReferenceCitation: Wang, Michael; Rossi, John M.; Munoz, Javier; Goy, Andre; Lundry Locke, Frederick; Michael Reagan, Patrick; Jacobson, Caron A.; Hill, Brian T; Holmes, Houston; Mary Jaglowski, Samantha; Peng, Weimin; Zheng, Lianqing; Fang, Xiang; Xue, Allen; Rao, Arati V.; Bot, Adrian

ReferenceCitation: Wang, Michael(1); Munoz, Javier(2); Goy, Andre(3); Locke, Frederick L.(4); Jacobson, Caron A.(5); Hill, Brian T.(6); Timmerman, John M.(7); Holmes, Houston(8); Jaglowski, Samantha(9); Flinn, Ian W.(10); McSweeney, Peter A.(11); Miklos, David B.(12); Pagel, John M.(13); José Kersten, Marie(14); Peng, Weimin(15); Zheng, Lianqing(15); Rossi, John M.(15); Jain, Rajul K.(15); Rao, Arati V.(15); Reagan, Patrick M.(16)

ReferenceCitation: Wang, M.(1); Munoz, J.(2); Goy, A.(3); Locke, F.(4); Jacobson, C.(5); Hill, B.(6); Timmerman, J.(7); Holmes, H.(8); Jaglowski, S.(9); Flinn, I.(10); McSweeney, P.(11); Miklos, D.(12); Pagel, J.(13); Kersten, M. J.(14)(15)

ReferenceCitation: Michael Wang,1 Javier Munoz,2 Andre Goy,3 Frederick L. Locke,4 Caron A. Jacobson,5 Brian T. Hill,6 John M. Timmerman,7 Houston Holmes,8 Samantha Jaglowski,9 Ian W. Flinn,10 Peter A. McSweeney,11 David B. Miklos,12 John M. Pagel,13 Marie José Kersten,14 Noel Milpied,15 Henry Fung,16 Max S. Topp,17 Roch Houot,18 Amer Beitinjaneh,19 Weimin Peng,20 Lianqing Zheng,20 John M. Rossi,20 Rajul K. Jain,20 Arati V. Rao,20 and Patrick M. Reagan21

ReferenceCitation: Wang, Michael L., MD(1); Munoz, Javier, MD(2); Goy, Andre, MD(3); Locke, Frederick L., MD(4); Jacobson, Caron A., MD, MMSc(5); Hill, Brian T., MD(6); Timmerman, John M., MD(7); Holmes, Houston, MD(8); Jaglowski, Samantha, MD, MPH(9); Flinn, Ian W., MD, PhD(10); McSweeney, Peter A., MD(11); Miklos, David B., MD, PhD(12); Pagel, John M., MD, PhD, DSc(13); Jose Kersten, Marie, MD, PhD(14); Peng, Weimin, MS(15); Zheng, Lianqing, PhD(15); Rossi, John M., MS(15); Jain, Rajul K., MD(15); Rao, Arati V., MD(15); Reagan, Patrick M, MD(16)

ReferenceCitation: Wang, Michael; Lundry Locke, Frederick; Munoz, Javier; Goy, Andre; Eccleston Holmes, Houston; Siddiqi, Tanya; Flinn, Ian; McSweeney, Peter A; Michael Reagan, Patrick; Thomas Hill, Brian; Jacobson, Caron A.; Rizzieri, David A.; Heffner, Leonard T.; Mary Jaglowski, Samantha; Bernard Miklos, David; Shaughnessy, Paul; Unabia, Sherry; Rossi, John M.; Jiang, Yizhou; Jain, Rajul K.

ReferenceCitation: Wang M, Jain P, Chi TL, Chen SE, Heimberger A, Weathers SP, Zheng L, Rao AV, Rossi JM. Management of a patient with mantle cell lymphoma who developed severe neurotoxicity after chimeric antigen receptor T-cell therapy in ZUMA-2. J Immunother Cancer. 2020 Oct;8(2). pii: e001114. doi: 10.1136/jitc-2020-001114.

location_country:
Germany
United States
France
Netherlands

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Winship Cancer Institute of Emory University

location_facility: University California Los Angeles (UCLA)

title: A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma

summary: The primary objective of the study is to evaluate the efficacy of brexucabtagene autoleucel (KTE-X19) in participants with relapsed/refractory mantle cell lymphoma (MCL)


title: A Non-interventional Retrospective Study of the Current Treatment Practice in European Haemophilia Care

summary: To describe the current treatment practice during 12 months for previously treated patients diagnosed with haemophilia A or haemophilia B.

time_perspective: Retrospective

lead_sponsor: Swedish Orphan Biovitrum

location_country:
Italy
Sweden
France
Belgium
Spain
Germany
United Kingdom

location_facility: Swedish Orphan Biovitrum Investigational Site


lead_sponsor: Bayer

primary_purpose: Diagnostic

location_country:
United States
Switzerland
France
New Zealand
Germany
United Kingdom
Korea, Republic of

acronym: GadaCAD 1

title: Multicenter Open-label Study to Evaluate Efficacy of Gadobutrol-enhanced Cardiac Magnetic Resonance Imaging (CMRI) for Detection of Significant Coronary Artery Disease (CAD) in Subjects With Known or Suspected CAD by a Blinded Image Analysis

summary:
Participants being evaluated for suspected or known Coronary artery Disease (CAD) based on signs and/or symptoms, will be invited to participate in the study. The duration for a participant in the study may range from 2 days to 4-6 weeks. One to four visits to the study doctor will be required.

This study will investigate the diagnostic results of gadobutrol-enhanced Cardiac Magnetic Resonance Imaging (CMRI) images regarding the detection (sensitivity) and exclusion (specificity) of coronary artery disease utilizing a uniform image acquisition software. The CMR images will be tested either against the results from routine clinical Coronary Angiography (CA) or those from Computed Tomography Angiography (CTA), which is used as the standard of reference. The CA/CTA may have been performed up to 4 weeks prior to enrollment or be scheduled up to 4/6 weeks after the study.

CMRI and CA/CTA images will be collected for an independent image review (blinded read).


title: SD01 Master Study (Safety and Efficacy Study)

summary: The study is designed to confirm safety and efficacy of the SD01 ICD (implantable cardioverter-defibrillator) lead.

lead_sponsor: Biotronik SE & Co. KG

location_country: France Czechia Hungary Germany Latvia

location_facility: Bovas P. Stradina KUS Latvian Center of Cardiology

location_facility: Städtisches Klinikum München Bogenhausen


title: A Phase II Randomized Study of TTField Therapy (150 kHz) Versus Supportive Care in Non-small Cell Lung Cancer Patients With 1-5 Brain Metastases Following Optimal Standard Local Treatment

summary: The study is a prospective, randomly controlled phase II trial, designed to test the efficacy, safety and neurocognitive outcomes of a medical device, the NovoTTF-100A, in the treatment of NSCLC patients with controlled systemic disease, following optimal standard local treatment for 1-5 brain metastases (BM). The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

status: Unknown status

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

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

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

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

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

family: Stupp

full_name: Roger Stupp

given: Roger

family: Wong

full_name: Eric T. Wong

given: Eric T.

family: Kanner

full_name: Andrew A. Kanner

given: Andrew A.

family: Steinberg

full_name: David Steinberg

given: David

family: Engelhard

full_name: Herbert Engelhard

given: Herbert

family: Heidecke

full_name: Volkmar Heidecke

given: Volkmar

family: Kirson

full_name: Eilon D. Kirson

given: Eilon D.

family: Taillibert

full_name: Sophie Taillibert

given: Sophie

family: Liebermann

full_name: Frank Liebermann

given: Frank

family: Dbalý

full_name: Vladimir Dbalý

given: Vladimir

family: Ram

full_name: Zvi Ram

given: Zvi

family: Villano

full_name: J. Lee Villano

given: J. Lee

family: Rainov

full_name: Nikolai Rainov

given: Nikolai

family: Weinberg

full_name: Uri Weinberg

given: Uri

family: Schiff

full_name: David Schiff

family: Kunschner

full_name: Lara Kunschner

given: Lara

family: Raizer

full_name: Jeffrey Raizer

given: Jeffrey

family: Honnorat

full_name: Jerome Honnorat

given: Jerome

family: Sloan

full_name: Andrew Sloan

given: Andrew

family: Malkin

full_name: Mark Malkin

given: Mark

family: Landolfi

full_name: Joseph C. Landolfi

given: Joseph C.

family: Payer

full_name: Franz Payer

given: Franz

family: Mehdorn

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

ReferenceCitation: Pless, M., et al. A Phase II Study of Tumor Treating Fields (TTFields) in Combination with Pemetrexed for Advanced Non Small Cell Lung Cancer (NSCLC). in ESMO 2010. 2010. Milan: Ann Oncol.

ReferenceCitation: Weinberg, U., et al. An Open Label Pilot Study of Tumor Treating Fields (TTFields) in Combination with Pemetrexed for Advanced Non-small Cell Lung Cancer (NSCLC). in ERS Annual Congress. 2010. Publisher: Abstract 363.

location_country:
Italy
France
Poland
Spain
Czech Republic

location_facility: Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: ICO L'Hospitalet - Hospital Duran i Reynals


title: A Phase I/II Dose Schedule Finding Study of ch14.18/CHO Continuous Infusion Combined With Subcutaneous Aldesleukin (IL-2) in Patients With Primary Refractory or Relapsed Neuroblastoma

acronym: LTI

summary: The main aim of this clinical trial is to find a way of giving ch14.18/CHO, in combination with subcutaneous aldesleukin (IL-2) and oral isotretinoin (13-cis-RA), to children and young people with primary refractory or relapsed neuroblastoma without intravenous morphine.

lead_sponsor: St. Anna Kinderkrebsforschung

location_country:
Italy
Austria
France
Israel
Spain
Germany
United Kingdom

location_facility: University College Hospitals NHS Foundation Trust

location_facility: Alder Hey Children's NHS Foundation Trust

location_facility: Birmingham Children's Hospital NHS Foundation Trust

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Schneider Children's Medical Centre of Israel

location_facility: Great Ormond Street Hospital for Children NHS Foundation Trust


title: Sidus(TM) Stem-Free Shoulder - A Multi-center, Prospective, Non-controlled Post Market Clinical Follow-up Study.

summary:
This post market clinical follow-up study is designed to confirm safety and performance of the Sidus Stem-Free Shoulder when used in hemi or total shoulder arthroplasty.

The safety of the implant will be evaluated by monitoring the frequency and incidence of all kinds of adverse events.

The performance will be determined by analyzing the implant survival, overall pain and functional performances (based on Constant & Murley score and ASES score), subject quality of life (EuroQol EQ5D) and radiographic parameters (e.g. radiolucencies, osteolysis, component migration) of study subjects who received the Sidus Stem-Free Shoulder.

The Sidus Stem-Free Shoulder is not approved for use in the US.

lead_sponsor: Zimmer Biomet

location_facility: Centre Hospitalier Universitaire Toulouse

location_facility: Azienda Ospedaliera Universitaria Careggi


ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Italy
United States
France
Czechia
Slovakia
Australia
Spain
Germany
United Kingdom
Korea, Republic of
Taiwan

acronym: ASSENT

location_facility: Oregon Health Sciences University Hospital

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Universittsklinikum Essen AR Klinik fr Neurologie

location_facility: Ospedale Guglielmo da Saliceto Via Taverna

location_facility: Ospedaliero di Albenga - Pietra Ligure Dept Neurology

location_facility: Hospital Clinico Universitario Lozano Blesa de Zaragoza

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: University of South Alabama USA Health System

location_facility: Seoul National University Bundang Hospital

location_facility: University of Kentucky Chandler Medical Center

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Svet zdravia a.s.,Vseobecna nemocnica Rimavska Sobota

location_facility: Chang Gung Memorial Hospital-Linkou Branch

location_facility: Klinikum der Johann Wolfgang Goethe-Universitat

location_facility: Chattanooga Center for Neurologic Research

title: A Phase 1b/2, Multi-Center, Double-Blind (Principal Investigators and Study Subjects Blinded, Sponsor Unblinded), Placebo-Controlled, Randomized, Single-Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects With Acute Ischemic Stroke

summary: This is a Phase 1b/2, double-blind (study participants and Investigators), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DS-1040b in participants with Acute Ischemic Stroke (AIS).


title: ALFApump® System Versus Large Volume Paracentesis in the Treatment of Refractory Ascites. A Multicentre Randomised Controlled Study.

summary: This is a multicentre, open, randomised, and controlled trial conducted in sixty (60) patients diagnosed with refractory or recurrent ascites. Patients will be randomised (enrolled) to either treatment arm A- implanted with the ALFApump System or treatment arm B-standard of care with evacuation large volume paracentesis. The main aims of the study are to determine the paracentesis free survival, defined as the time to the first large volume therapeutic paracentesis > 5 litres. The secondary aims are to assess non-inferiority of cirrhosis-related complications in the group of patients randomized to the ALFApump system group, as well as nutritional effects, resource utilisation, patient quality of life and survival non-inferiority.

ReferenceCitation: Stepanova M, Nader F, Bureau C, Adebayo D, Elkrief L, Valla D, Peck-Radosavljevic M, McCune A, Vargas V, Simon-Talero M, Cordoba J, Angeli P, Rossi S, MacDonald S, Capel J, Jalan R, Younossi ZM. Patients with refractory ascites treated with alfapump® system have better health-related quality of life as compared to those treated with large volume paracentesis: the results of a multicenter randomized controlled study. Qual Life Res. 2018 Jun;27(6):1513-1520. doi: 10.1007/s11136-018-1813-8. Epub 2018 Feb 19.

family: Stepanova

full_name: Maria Stepanova

given: Maria

family: Nader

full_name: Fatema Nader

given: Fatema

family: Bureau

full_name: Christophe Bureau

given: Christophe

family: Adebayo

full_name: Danielle Adebayo

given: Danielle

family: Elkrief

full_name: Laure Elkrief

given: Laure

family: Valla

full_name: Dominique Valla

given: Dominique

family: Peck-Radosavljevic

full_name: Markus Peck-Radosavljevic

given: Markus

family: McCune

full_name: Anne McCune

given: Anne

family: Vargas

full_name: Victor Vargas

given: Victor

family: Simon-Talero

full_name: Macarena Simon-Talero

given: Macarena

family: Cordoba

full_name: Juan Cordoba

given: Juan

family: Angeli

full_name: Paolo Angeli

given: Paolo

family: Rossi

full_name: Silvia Rossi

given: Silvia

family: MacDonald

full_name: Stewart MacDonald

given: Stewart

family: Capel

full_name: Jeroen Capel

given: Jeroen

family: Jalan

full_name: Rajiv Jalan

given: Rajiv

family: Younossi

full_name: Zobair M. Younossi

given: Zobair M.

journal_name: Quality of Life Research

repository_normalized: UCL Discovery

version: submittedVersion

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Bureau C, Adebayo D, Chalret de Rieu M, Elkrief L, Valla D, Peck-Radosavljevic M, McCune A, Vargas V, Simon-Talero M, Cordoba J, Angeli P, Rosi S, MacDonald S, Malago M, Stepanova M, Younossi ZM, Trepte C, Watson R, Borisenko O, Sun S, Inhaber N, Jalan R. Alfapump® system vs. large volume paracentesis for refractory ascites: A multicenter randomized controlled study. J Hepatol. 2017 Nov;67(5):940-949. doi: 10.1016/j.jhep.2017.06.010. Epub 2017 Jun 21. Erratum in: J Hepatol. 2018 Jan 29;:. J Hepatol. 2020 Mar;72(3):595-596.

family: Chalret de Rieu

location_country:
Italy
Austria
France
Spain
United Kingdom

location_facility: Vienna General Hospital and Medical School, AKH

location_facility: Centre Hospitalier Universitaire de Toulouse


title: A Multi-center, Parallel-group, Double-blind, Placebo-controlled Single and Multiple Dose Escalation Study to Assess the Safety and Tolerability and the Pharmacokinetic Properties of SAR228810 Given as IV Infusion or as SC Injection in Patients With Mild to Moderate Alzheimer's Disease.

summary:
Primary Objective:

- To assess the safety and tolerability of escalating single and multiple doses of SAR228810 in patients with Alzheimer's disease (AD)

Secondary Objective:

- To evaluate the pharmacokinetic properties of SAR228810 after escalating single and multiple doses of SAR228810 in AD patients

lead_sponsor: Sanofi

location_country:
South Africa
Sweden
Netherlands
France
Bulgaria

location_facility:
Investigational Site Number 752002
Investigational Site Number 752001
Investigational Site Number 752003
Investigational Site Number 250002
Investigational Site Number 250001
Investigational Site Number 100001
Investigational Site Number 710001
Investigational Site Number 528001


title: Randomized Controlled Study on the Effect of the Hemodiafiltration Plasma Sodium Biofeedback System on Cardiovascular Stability in Hemodialysis Patients

acronym: AIMS

summary: Aim of the present randomized controlled multinational trial is the comparison of a novel biofeedback system on sodium profiling applied to a endogenous hemodiafiltration therapy, with the standard (no sodium profiling) hemodiafiltration technique on the intradialytic overall and cardiovascular stability.

lead_sponsor: Azienda Ospedaliera di Lecco

location_country: Italy France Belgium Spain Germany

location_facility: Dept. of Nephrology and Dialysis Centre Pasteur Vallery Radat

location_facility: UO Nefrologia Dialisi e Trapianto Policlinico S. Orsola Malpighi

location_facility: Nephrology and Dialysis Unit Ospedali Riuniti


ReferenceCitation: Geoerger B, Zwaan CM, Marshall LV, Michon J, Bourdeaut F, Casanova M, Corradini N, Rossato G, Farid-Kapadia M, Shemesh CS, Hutchinson KE, Donaldson F, Liao M, Caron H, Trippett T. Atezolizumab for children and young adults with previously treated solid tumours, non-Hodgkin lymphoma, and Hodgkin lymphoma (iMATRIX): a multicentre phase 1-2 study. Lancet Oncol. 2020 Jan;21(1):134-144. doi: 10.1016/S1470-2045(19)30693-X. Epub 2019 Nov 25.

family: Geoerger

full_name: Birgit Geoerger

given: Birgit

family: Zwaan

full_name: C Michel Zwaan

given: C Michel

family: Marshall

full_name: Lynley V Marshall

given: Lynley V

family: Michon

full_name: Jean Michon

given: Jean

family: Bourdeaut

full_name: Franck Bourdeaut

given: Franck

family: Casanova

full_name: Michela Casanova

given: Michela

family: Corradini

full_name: Nadège Corradini

given: Nadège

family: Rossato

full_name: Gianluca Rossato

given: Gianluca

family: Farid-Kapadia

full_name: Mufiza Farid-Kapadia

given: Mufiza

family: Shemesh

full_name: Colby S Shemesh

given: Colby S

family: Hutchinson

full_name: Katherine E Hutchinson

given: Katherine E

family: Donaldson

full_name: Francis Donaldson

given: Francis

family: Liao

full_name: Minlei Liao

given: Minlei

family: Caron

full_name: Hubert Caron

given: Hubert

family: Trippett

full_name: Tanya Trippett

given: Tanya

journal_name: The Lancet Oncology

title: Atezolizumab for children and young adults with previously treated solid tumours, non-Hodgkin lymphoma, and Hodgkin lymphoma (iMATRIX): a multicentre phase 1–2 study

ReferenceCitation: Shemesh CS, Chanu P, Jamsen K, Wada R, Rossato G, Donaldson F, Garg A, Winter H, Ruppel J, Wang X, Bruno R, Jin J, Girish S. Population pharmacokinetics, exposure-safety, and immunogenicity of atezolizumab in pediatric and young adult patients with cancer. J Immunother Cancer. 2019 Nov 21;7(1):314. doi: 10.1186/s40425-019-0791-x.

full_name: Colby S. Shemesh

given: Colby S.

family: Chanu

full_name: Pascal Chanu

given: Pascal

family: Jamsen

full_name: Kris Jamsen

given: Kris

family: Wada

full_name: Russ Wada

given: Russ

family: Garg

full_name: Amit Garg

given: Amit

family: Winter

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

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Leeds General Infirmary; Paediatric Oncology & Haematology

location_facility: Azienda Ospedaliera di Padova; Clinica di Onco-ematologia pediatrica

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Rigshospitalet; BØRNEUNGEKLINIKKEN, Ambulatoriet for kræft- og Blodsygdomme hos børn og unge

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Centre Léon Bérard, Institut d'Hémato-Oncologie Pédiatrique

location_facility: Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino

location_facility: The Royal Victoria Infirmary; Paediatric and Adolescent Oncology Unit

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori; Struttura Complessa di Pediatria Oncologica

location_facility: Institut Gustave Roussy; Service Pediatrique

location_facility: Ospedale Pediatrico Bambino Gesù - IRCCS; Dipartimento di Onco-Ematologia Pediatrica

location_facility: Stanford University/Lucile Packard Children's Hospital

location_facility: IRCCS Istituto Giannina Gaslini; Unità Operativa Oncologica Pediatrica

location_facility: Erasmus MC / location Sophia Kinderziekenhuis

location_facility: Universitäts-Kinderspital; Abteilung für Onkologie

title: An Early-Phase, Multicenter, Open-Label Study of the Safety and Pharmacokinetics of Atezolizumab (MPDL3280A) In Pediatric and Young Adult Patients With Previously Treated Solid Tumors

summary: This early phase, multicenter, open-label, single-arm study evaluated the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of atezolizumab in pediatric and young adult participants with solid tumors for which prior treatment was proven to be ineffective.


ReferenceCitation: Insogna KL, Briot K, Imel EA, Kamenický P, Ruppe MD, Portale AA, Weber T, Pitukcheewanont P, Cheong HI, Jan de Beur S, Imanishi Y, Ito N, Lachmann RH, Tanaka H, Perwad F, Zhang L, Chen CY, Theodore-Oklota C, Mealiffe M, San Martin J, Carpenter TO; AXLES 1 Investigators. A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial Evaluating the Efficacy of Burosumab, an Anti-FGF23 Antibody, in Adults With X-Linked Hypophosphatemia: Week 24 Primary Analysis. J Bone Miner Res. 2018 Aug;33(8):1383-1393. doi: 10.1002/jbmr.3475. Epub 2018 Jun 26.

name: Yale School of Medicine; New Haven CT USA

family: Insogna

full_name: Karl L Insogna

given: Karl L

name: Centre d'Evaluation des Maladies Osseuses; Hôpital Cochin; Paris France

family: Briot

full_name: Karine Briot

given: Karine

name: Indiana University School of Medicine; Indianapolis IN USA

family: Imel

full_name: Erik A Imel

given: Erik A

name: Université Paris-Sud; Le Kremlin Bicêtre France

family: Kamenický

full_name: Peter Kamenický

given: Peter

name: Houston Methodist Hospital; Houston TX USA

family: Ruppe

full_name: Mary D Ruppe

given: Mary D

name: University of California; San Francisco CA USA

family: Portale

full_name: Anthony A Portale

given: Anthony A

name: Duke University Medical Center; Durham NC USA

family: Weber

full_name: Thomas Weber

given: Thomas

name: Children's Hospital Los Angeles; University of Southern California Keck School of Medicine; Los Angeles CA USA

family: Pitukcheewanont

full_name: Pisit Pitukcheewanont

given: Pisit

name: Seoul National University Children's Hospital; Seoul South Korea

family: Cheong

full_name: Hae Il Cheong

given: Hae Il

name: Johns Hopkins University School of Medicine; Baltimore MD USA

family: Jan de Beur

full_name: Suzanne Jan de Beur

given: Suzanne

name: Osaka City University Graduate School of Medicine; Osaka Japan

family: Imanishi

full_name: Yasuo Imanishi

given: Yasuo

name: University of Tokyo Hospital; Tokyo Japan

family: Ito

full_name: Nobuaki Ito

given: Nobuaki

name: University College London Hospitals; London UK

family: Lachmann

full_name: Robin H Lachmann

given: Robin H

name: Okayama Saiseikai General Hospital; Okayama Japan

family: Tanaka

full_name: Hiroyuki Tanaka

given: Hiroyuki

family: Perwad

full_name: Farzana Perwad

given: Farzana

name: Ultragenyx Pharmaceutical Inc.; Novato CA USA

family: Zhang

full_name: Lin Zhang

given: Lin

family: Chen

full_name: Chao-Yin Chen

given: Chao-Yin

family: Theodore-Oklota

full_name: Christina Theodore-Oklota

given: Christina

family: Mealiffe

full_name: Matt Mealiffe

given: Matt

family: San Martin

full_name: Javier San Martin

given: Javier

family: Carpenter

full_name: Thomas O Carpenter

given: Thomas O

journal_name: Journal of Bone and Mineral Research

ReferenceCitation: Portale AA, Carpenter TO, Brandi ML, Briot K, Cheong HI, Cohen-Solal M, Crowley R, Jan De Beur S, Eastell R, Imanishi Y, Imel EA, Ing S, Ito N, Javaid M, Kamenicky P, Keen R, Kubota T, Lachmann R, Perwad F, Pitukcheewanont P, Ralston SH, Takeuchi Y, Tanaka H, Weber TJ, Yoo HW, Zhang L, Theodore-Oklota C, Mealiffe M, San Martin J, Insogna K. Continued Beneficial Effects of Burosumab in Adults with X-Linked Hypophosphatemia: Results from a 24-Week Treatment Continuation Period After a 24-Week Double-Blind Placebo-Controlled Period. Calcif Tissue Int. 2019 Sep;105(3):271-284. doi: 10.1007/s00223-019-00568-3. Epub 2019 Jun 4.

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

ReferenceCitation: Briot K, Portale AA, Brandi ML, Carpenter TO, Cheong HI, Cohen-Solal M, Crowley RK, Eastell R, Imanishi Y, Ing S, Insogna K, Ito N, Jan de Beur S, Javaid MK, Kamenicky P, Keen R, Kubota T, Lachmann RH, Perwad F, Pitukcheewanont P, Ralston SH, Takeuchi Y, Tanaka H, Weber TJ, Yoo HW, Nixon A, Nixon M, Sun W, Williams A, Imel EA. Burosumab treatment in adults with X-linked hypophosphataemia: 96-week patient-reported outcomes and ambulatory function from a randomised phase 3 trial and open-label extension. RMD Open. 2021 Sep;7(3). pii: e001714. doi: 10.1136/rmdopen-2021-001714.

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

location_country:
Italy
France
Japan
Ireland
United States
United Kingdom
Korea, Republic of

location_facility: University of California-San Francisco Medical Center

location_facility: Indiana University Department of Medicine

location_facility: Northern General Hospital, Metabolic Bone Centre (Sorby Wing)

location_facility: Azienda Ospedaliero Universitaria Careggi - Neurofarba

location_facility: The Ohio State University Wexner Medical Center

location_facility: CHU de Bicêtre, Service d'Endocrinologie et des Maladies de la Reproduction

location_facility: University of Edinburgh Edinburgh Clinical Trials Unit (ECTU) - Western General Hospital

location_facility: Hôpital Lariboisière, Dept. of Rheumatology

title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study With Open-Label Extension to Assess the Efficacy and Safety of KRN23 in Adults With X-linked Hypophosphatemia (XLH)

summary: The primary efficacy objective of this study is to establish the effect of burosumab treatment compared with placebo on increasing serum phosphorus levels in adults with XLH.


title: An Open-label, Single Arm, Phase III Study to Assess the Self-administration of AOP2014 Using a Pre-filled Pen, Developed for the Treatment of Polycythemia Vera Patients

acronym: PEN-PV

summary:
Polycythemia Vera (PV) is a disease of bone marrow stem cells that manifests in a drastic increase of red blood cells and frequently also of white blood cells. The "thickening" of the blood in relation with a modified function of the cells has several consequences like increased blood pressure, pruritus of the skin, fatigue, disturbed blood circulation in the brain as well as fingers and toes and an increased risk of arterial and venous thrombosis (thrombosis is the formation of a blood clot in a vessel); like stroke, cardiac infarction, deep vein thrombosis in the legs. In case of a strong increase of platelets there is an additional risk of bleedings. As the disease progresses the size of spleen and liver increased in most cases and the bone marrow shows signs of fibrosis. In some cases of PV a progression at a later time point to a leukemia (increased formation of white blood cells) can occur.

The aim of this study is to assess the ease of AOP2014 self-administration using dedicated questionnaires.

To assess safety and tolerability: adverse events (AEs), laboratory parameters, electrocardiogram (ECG) throughout study.
To assess maintenance of the blood efficacy parameters Hct (Hematocrit), WBC (white blood cells) and PLTs (platelets) and spleen size (comparing values at Visit P7 vs. values at Visit P1).
To assess the feasibility of AOP2014 self-administration: defined as the ability of the patients to use the pen as a self-administration tool (ease of handling, safety, tolerability and efficacy).

lead_sponsor: AOP Orphan Pharmaceuticals AG

location_country:
Austria
France
Bulgaria
Poland
Slovakia
Hungary
Czech Republic
Ukraine

location_facility: Andrzej Mielecki Independent Public Clinical Hospital of Medical University of Silesia in Katowice

location_facility: Independent Public Teaching Hospital No.1 in Lublin

location_facility: Saint Cyril and Metod University Hospital Bratislava

location_facility: University Hospital with Outpatient Clinic F.D. Roosevelt

location_facility: Institute of Hematology and Blood Transfusion

location_facility: University of Szeged, Albert Szent-Gyorgyi Clinical Center, Koranyi fasor 6

location_facility: Fryderyk Chopin Provincial Specialized Hospital

location_facility: National Research Center for Radiation Medicine, Institute of Clinical Radiology

location_facility: O.F. Herbachevskyi Regional Clinical Hospital

location_facility: St Istvan and St Laszlo Hospital of Budapest

location_facility: Cherkasy Regional Oncology Center, Regional Treatment and Diagnostics Hematology Center

location_facility: Institute of Blood Pathology and Transfusion Medicine

location_facility: Dnipropetrovsk City Multispecialty Clinical Hospital #4

location_facility: Multiprofile Hospital for Active Treatment - Hristo Botev, Vratsa, First Department of Internal Medicine

location_facility: Nicolaus Copernicus Municipal Specialist Hospital

location_facility: Institute of Hematology and Transfusion Medicine

location_facility: Specialized Hospital for Active Treatment of Hematological Diseases

location_facility: Bekes County Pandy Kalman Hospital, 1st Department of Medicine, Hematology


title: A Multi-center, Double-blind, Randomized, Three-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants

summary: The study will evaluate the effect of NTRA-2112 on intestinal malabsorption in preterm infants.

lead_sponsor: Nutrinia

location_country:
Italy
United States
Netherlands
France
Israel
Hungary
Belgium
Spain
Germany
United Kingdom

location_facility: UMC Groningen (UMCG), Beatrix Kinderziekenhuis

location_facility: Klinik fuer Kinder und Jugendliche, Helios Klinikum Pforzheim

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Ospedale F. Del Ponte - Azienda Ospedaliera di Varese

location_facility: Klinik fur Neugeborene, Kinder und Jugendliche, Universitatsklinik der Paracelsus Medizinischen Privatuniversitat

location_facility: Ospedale dei Bambini "V.Buzzi"- Azienda ICP

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Kinderklinik, Evangelisches Waldkrankenhaus Spandau

location_facility: CHUS - Complejo Hospitalario Universitario de Santiago

location_facility: Szegedi Tudomanyegyetem Szent Gyorgyi Albert Klinikai Kozpont Gyermekgyogyaszati klinika Koraszulott Intenzív Osztaly

location_facility: Fejéktató Kórhz Újszülött, Csecsemő és Gyermekosztály - Megyei Szent György Egyetemi

location_facility: University Hospital of Leicester NHS Trust- Royal Infirmary

location_facility: University of Oklahoma Health Sciences Center

location_facility: Presidio Ospedaliero G. Salesi - AOUI Ospedali Riuniti di Ancona

location_facility: Klinik und Poliklinik fur Kinder-und Jugendmedizin, Universitaetsklinikum Carl Gustav Carus Dresden