title: A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody in Subjects With Relapsed or Refractory Multiple Myeloma

summary: The purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for Teclistamab and to characterize the safety and tolerability of Teclistamab at the RP2Ds.

ReferenceCitation: Usmani SZ, Garfall AL, van de Donk NWCJ, Nahi H, San-Miguel JF, Oriol A, Rosinol L, Chari A, Bhutani M, Karlin L, Benboubker L, Pei L, Verona R, Girgis S, Stephenson T, Elsayed Y, Infante J, Goldberg JD, Banerjee A, Mateos MV, Krishnan A. Teclistamab, a B-cell maturation antigen × CD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma (MajesTEC-1): a multicentre, open-label, single-arm, phase 1 study. Lancet. 2021 Aug 21;398(10301):665-674. doi: 10.1016/S0140-6736(21)01338-6. Epub 2021 Aug 10.

family: Usmani

full_name: Saad Z Usmani

given: Saad Z

family: Garfall

full_name: Alfred L Garfall

given: Alfred L

family: van de Donk

full_name: Niels W C J van de Donk

given: Niels W C J

family: Nahi

full_name: Hareth Nahi

given: Hareth

family: San-Miguel

full_name: Jesus F San-Miguel

given: Jesus F

family: Oriol

full_name: Albert Oriol

given: Albert

family: Rosinol

full_name: Laura Rosinol

given: Laura

family: Chari

full_name: Ajai Chari

given: Ajai

family: Bhutani

full_name: Manisha Bhutani

given: Manisha

family: Karlin

full_name: Lionel Karlin

given: Lionel

family: Benboubker

full_name: Lotfi Benboubker

given: Lotfi

family: Pei

full_name: Lixia Pei

given: Lixia

family: Verona

full_name: Raluca Verona

given: Raluca

family: Girgis

full_name: Suzette Girgis

given: Suzette

family: Stephenson

full_name: Tara Stephenson

given: Tara

family: Elsayed

full_name: Yusri Elsayed

given: Yusri

family: Infante

full_name: Jeffrey Infante

given: Jeffrey

family: Goldberg

full_name: Jenna D Goldberg

given: Jenna D

family: Banerjee

full_name: Arnob Banerjee

given: Arnob

family: Mateos

full_name: María-Victoria Mateos

given: María-Victoria

family: Krishnan

full_name: Amrita Krishnan

given: Amrita

journal_name: The Lancet

ReferenceCitation: Pillarisetti K, Powers G, Luistro L, Babich A, Baldwin E, Li Y, Zhang X, Mendonça M, Majewski N, Nanjunda R, Chin D, Packman K, Elsayed Y, Attar R, Gaudet F. Teclistamab is an active T cell-redirecting bispecific antibody against B-cell maturation antigen for multiple myeloma. Blood Adv. 2020 Sep 22;4(18):4538-4549. doi: 10.1182/bloodadvances.2020002393.

name: Janssen Biotherapeutics, Janssen Research & Development, LLC, Spring House, PA;

name: Century Therapeutics, LLC, Philadelphia, PA

title: Teclistamab is an active T cell–redirecting bispecific antibody against B-cell maturation antigen for multiple myeloma

location_country:
Sweden
Netherlands
France
Spain
United States

location_facility: Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects


type: EudraCT Number

title: An Open-Label, Multi-Center, Randomized, Dose-Escalation, Phase 1b Study to Evaluate Safety, Pharmacokinetics and Therapeutic Activity of RO6874281 in Combination With Atezolizumab ± Bevacizumab in Patients With Unresectable Advanced and/or Metastatic Renal Cell Carcinoma

summary: This is an open-label, multi-center, randomized, Phase 1b, adaptive, clinical study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary therapeutic activity of RO6874281 in combination with atezolizumab with/without bevacizumab in participants with unresectable advanced and/or metastatic RCC. The study will consist of a dose-escalation part and an extension part.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Hoffmann-La Roche

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

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Northwestern Center for Clinical Research; Cancer Center

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: START Madrid-FJD, Hospital Fundacion Jimenez Diaz

location_facility: Universitätsklinikum Tübingen; Klinik für Urologie

location_facility: Uniklinikum, Comprehensive Cancer Center Mainfranken; Interdisziplinäres Studienzentrum mit ECTU

location_facility: Universita di Modena e Reggio Emilia;Dipartimento di Oncologia ed Ematologia

location_facility: University of Maryland Greenebaum Comprehensive Cancer Center

location_facility: Hospital Clínic i Provincial; Servicio de Oncología

location_facility: Fondazione IRCCS Policlinico San Matteo, Oncologia

location_facility: Southampton General Hospital; Medical Oncology

location_facility: Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes

location_facility: Barts & London School of Med; Medical Oncology

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Randomized Evaluation of BST-CarGel Versus Microfracture Alone On Recovery From Distal Femoral Cartilage Lesions

acronym: RECORD

summary: This multi-centre randomized, controlled trial will assess the impact of BST-CarGel scaffold with microfracture versus microfracture alone on short and long term clinical benefit in patients with cartilage lesions of the femoral condyle requiring operative management.

status: Terminated

primary_purpose: Basic Science

ReferenceType: result

ReferenceCitation: Shive MS, Stanish WD, McCormack R, Forriol F, Mohtadi N, Pelet S, Desnoyers J, Méthot S, Vehik K, Restrepo A. BST-CarGel® Treatment Maintains Cartilage Repair Superiority over Microfracture at 5 Years in a Multicenter Randomized Controlled Trial. Cartilage. 2015 Apr;6(2):62-72. doi: 10.1177/1947603514562064.

name: Piramal Healthcare (Canada) Ltd., Laval, Quebec, Canada

family: Shive

full_name: Matthew S. Shive

given: Matthew S.

sequence: first

name: Department of Surgery, Dalhousie University, Halifax, Nova Scotia, Canada

family: Stanish

full_name: William D. Stanish

given: William D.

sequence: additional

name: Department of Orthopedic Surgery, University of British Columbia, Vancouver, British Columbia, Canada

family: McCormack

full_name: Robert McCormack

given: Robert

name: School of Medicine, CEU San Pablo University, Madrid, Spain

family: Forriol

full_name: Francisco Forriol

given: Francisco

name: University of Calgary Sports Medicine Centre, Calgary, Alberta, Canada

family: Mohtadi

full_name: Nicholas Mohtadi

given: Nicholas

name: Department of Orthopedics, CHA-Pavillon Enfant-Jésus, Quebec, Quebec, Canada

family: Pelet

full_name: Stéphane Pelet

given: Stéphane

name: Hôpital Charles LeMoyne, Greenfield Park, Quebec, Canada

family: Desnoyers

full_name: Jacques Desnoyers

given: Jacques

family: Méthot

full_name: Stéphane Méthot

name: Department of Epidemiology and Biostatistics, University of South Florida, Tampa, Florida, USA

family: Vehik

full_name: Kendra Vehik

given: Kendra

family: Restrepo

full_name: Alberto Restrepo

given: Alberto

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: CARTILAGE

oa_host_type: repository

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

host_type: repository

license: implied-oa

license_normalized: implied-oa

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: publishedVersion

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

ReferenceCitation: Stanish WD, McCormack R, Forriol F, Mohtadi N, Pelet S, Desnoyers J, Restrepo A, Shive MS. Novel scaffold-based BST-CarGel treatment results in superior cartilage repair compared with microfracture in a randomized controlled trial. J Bone Joint Surg Am. 2013 Sep 18;95(18):1640-50. doi: 10.2106/JBJS.L.01345.

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Novel Scaffold-Based BST-CarGel Treatment Results in Superior Cartilage Repair Compared with Microfracture in a Randomized Controlled Trial

location_country:
Switzerland
France
Australia
Spain
Germany
United Kingdom
Canada

location_facility:
Banff Sport Medicine
Calvary Wakefield Hospital
The Royal Orthopaedic Hospital
Fowler Kennedy Sport Medicine Clinic
SportClinic Zurich / Hirslanden Clinic
Murdoch Orthopaedic Clinic
University Hospital Southampton
Hopital de La Croix-Rousse
Hôpital Maisonneuve-Rosemont
Hospital Quironsalud Barcelona
Hospital Universitario Miguel Servet
Hospital Universitari Vall d'Hebron
Hospital Universitari del Mar
University Medical Centre Regensburg
CHRU Nancy - Hospital Central


title: An Open-label, Multi-center Rollover Protocol for Patients Who Have Participated in a Novartis-sponsored Ribociclib (LEE011) Study and Are Continuing to Benefit From Ribociclib as Single Agent or in Combination With Other Investigational Treatments

summary: This study is to allow continued use of ribociclib (LEE011) as single agent or in combination with other investigational treatments in patients benefitting from treatment in an eligible Novartis-sponsored ribociclib (LEE011) study that has reached its primary objective(s) or has been halted for other reasons.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: Undecided

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
France
Singapore
Spain
United States
Taiwan

location_facility: The Regents of the University of Michigan

status_simplified: Ongoing


title: A Post-Market, Prospective, Multi-Center, Single-Arm Clinical Investigation of Phasix™ Mesh for VHWG Grade 3 Midline Hernia Repair

summary: The purpose of this study is to collect additional data on safety and performance of Phasix™ Mesh in subjects requiring Ventral Hernia Working Group (VHWG) Grade 3 midline hernia repair.

ReferenceType: derived

ReferenceCitation: Van Rooijen MMJ, Tollens T, Jørgensen LN, de Vries Reilingh TS, Piessen G, Köckerling F, Miserez M, Windsor ACJ, Berrevoet F, Fortelny RH, Dousset B, Woeste G, van Westreenen HL, Gossetti F, Lange JF, Tetteroo GWM, Koch A, Jeekel J. Slowly resorbable biosynthetic mesh: 2-year results in VHWG grade 3 hernia repair. Hernia. 2021 Jul 19. doi: 10.1007/s10029-021-02453-1. [Epub ahead of print]

family: Van Rooijen

full_name: M. M. J. Van Rooijen

given: M. M. J.

family: Tollens

full_name: T. Tollens

given: T.

family: Jørgensen

full_name: L. N. Jørgensen

given: L. N.

family: de Vries Reilingh

full_name: T. S. de Vries Reilingh

given: T. S.

family: Piessen

full_name: G. Piessen

given: G.

family: Köckerling

full_name: F. Köckerling

given: F.

family: Miserez

full_name: M. Miserez

given: M.

family: Windsor

full_name: A. C. J. Windsor

given: A. C. J.

family: Berrevoet

full_name: F. Berrevoet

family: Fortelny

full_name: R. H. Fortelny

given: R. H.

family: Dousset

full_name: B. Dousset

given: B.

family: Woeste

full_name: G. Woeste

family: van Westreenen

full_name: H. L. van Westreenen

given: H. L.

family: Gossetti

full_name: F. Gossetti

family: Lange

full_name: J. F. Lange

given: J. F.

family: Tetteroo

full_name: G. W. M. Tetteroo

given: G. W. M.

family: Koch

full_name: A. Koch

given: A.

family: Jeekel

full_name: J. Jeekel

given: J.

journal_name: Hernia

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

ReferenceCitation: van Rooijen MMJ, Jairam AP, Tollens T, Jørgensen LN, de Vries Reilingh TS, Piessen G, Köckerling F, Miserez M, Windsor ACJ, Berrevoet F, Fortelny RH, Dousset B, Woeste G, van Westreenen HL, Gossetti F, Lange JF, Tetteroo GWM, Koch A, Kroese LF, Jeekel J. A post-market, prospective, multi-center, single-arm clinical investigation of Phasix™ mesh for VHWG grade 3 midline incisional hernia repair: a research protocol. BMC Surg. 2018 Nov 20;18(1):104. doi: 10.1186/s12893-018-0439-7.

repository_institution: Ghent University - Ghent University Academic Bibliography

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

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

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
Netherlands
France
Belgium
Denmark
Germany
United Kingdom

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

location_facility: University College London Hospitals NHS Trust

location_facility: Centre Hospitalier Régional Universitaire de Lille


title: An Open-Label, Phase 2, Pilot Study Investigating the Safety, Clinical Activity, Pharmacokinetics, and Pharmacodynamics of Oral Treatment With the BTK Inhibitor PRN1008 in Patients With Newly Diagnosed or Relapsing Pemphigus Vulgaris

summary: Open-label cohort study in adult patients with newly diagnosed or relapsing pemphigus vulgaris, with intra-patient dose-adjustment based on clinical response and BTK occupancy, and with conventional immunosuppressive "rescue treatment", if indicated. The duration of therapy in Part A will be 12 weeks, followed by 12 weeks of follow up. The extension phase, Part B includes 24 weeks of therapy, followed by 4 weeks of follow-up.

lead_sponsor: Principia Biopharma, a Sanofi Company

location_country: Croatia France Greece Israel Australia

location_facility: Papageorgiou General Hospital of Thessaloniki

location_facility: Hospital of Venereal and Skin Diseases A.Syggros


title: A Phase II, Open-label, Randomized Controlled Study of PDR001 in Patients With Moderately Differentiated/Undifferentiated Locally Advanced Recurrent or Metastatic Nasopharyngeal Carcinoma Who Progressed on Standard Treatment

summary:
The purpose of this randomized controlled Phase II study is to assess the efficacy of PDR001 versus investigator's choice of chemotherapy in patients with advanced NPC.

By blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2, PDR001 leads to the activation of a T cell mediated antitumor immune response

location_country:
Hong Kong
France
Thailand
Singapore
China
United States
Taiwan

location_facility: NYU Laura and Isaac Perlmutter Cancer Center Laura & Isaac Perlmutter Ctr

location_facility: Northwest Georgia Oncology Center NWGA Onc - Carrollton


type: Other Identifier

title: An Open-label, Multicenter, Dose Escalation Phase 1b Study to Assess the Safety and Pharmacokinetics of Subcutaneous Delivery of Daratumumab With the Addition of Recombinant Human Hyaluronidase (rHuPH20) for the Treatment of Subjects With Relapsed or Refractory Multiple Myeloma

summary: The purpose of the study is to evaluate the pharmacokinetics and safety from the mixture of daratumumab and rHuPH20 prepared immediately before administration via Subcutaneous (SC) delivery (Part 1) and CF (co-formulated daratumumab and rHuPH20 preparation) administration via SC delivery of daratumumab (Part 2) and to evaluate the safety of Dara-CF 1800 milligram (mg) SC delivery without pre-dose and post-dose corticosteroids (Part 3).

status: Active, not recruiting

design_allocation: Non-Randomized

ReferenceCitation: Usmani SZ, Nahi H, Mateos MV, van de Donk NWCJ, Chari A, Kaufman JL, Moreau P, Oriol A, Plesner T, Benboubker L, Hellemans P, Masterson T, Clemens PL, Luo M, Liu K, San-Miguel J. Subcutaneous delivery of daratumumab in relapsed or refractory multiple myeloma. Blood. 2019 Aug 22;134(8):668-677. doi: 10.1182/blood.2019000667. Epub 2019 Jul 3.

name: Levine Cancer Institute/Atrium Health, Charlotte, NC;

family: Usmani

full_name: Saad Z. Usmani

given: Saad Z.

name: Division of Hematology, Department of Medicine, Karolinska Institute, Karolinska University Hospital at Huddinge, Stockholm, Sweden;

family: Nahi

full_name: Hareth Nahi

given: Hareth

name: University Hospital of Salamanca/IBSAL, Salamanca, Spain;

family: Mateos

full_name: Maria-Victoria Mateos

given: Maria-Victoria

name: Department of Hematology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands;

family: van de Donk

full_name: Niels W. C. J. van de Donk

given: Niels W. C. J.

name: Tisch Cancer Institute, Mount Sinai School of Medicine, New York, NY;

family: Chari

full_name: Ajai Chari

given: Ajai

name: Winship Cancer Institute, Emory University, Atlanta, GA;

family: Kaufman

full_name: Jonathan L. Kaufman

given: Jonathan L.

name: University Hospital of Nantes, Nantes, France;

family: Moreau

full_name: Philippe Moreau

given: Philippe

name: Institut Català d’Oncologia and Institut Josep Carreras, Hospital Germans Trias i Pujol, Barcelona, Spain;

family: Oriol

full_name: Albert Oriol

given: Albert

name: Vejle Hospital and University of Southern Denmark, Vejle, Denmark;

family: Plesner

full_name: Torben Plesner

given: Torben

name: Service d’Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours, France;

family: Benboubker

full_name: Lotfi Benboubker

given: Lotfi

name: Janssen Research & Development, LLC, Beerse, Belgium;

family: Hellemans

full_name: Peter Hellemans

given: Peter

name: Janssen Research & Development, LLC, Spring House, PA;

family: Masterson

full_name: Tara Masterson

given: Tara

family: Clemens

full_name: Pamela L. Clemens

given: Pamela L.

family: Luo

full_name: Man Luo

given: Man

name: Janssen Research & Development, LLC, Raritan, NJ; and

family: Liu

full_name: Kevin Liu

given: Kevin

name: Clínica Universidad de Navarra–CIMA, IDISNA, CIBERONC, Pamplona, Spain

family: San-Miguel

full_name: Jesus San-Miguel

given: Jesus

journal_name: Blood

evidence: open (via free article)

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

location_country:
Sweden
Netherlands
France
Spain
Denmark
United States


title: A Phase 1/2 Study of Cabiralizumab, an Anti-CSF1 Receptor Antibody, in Patients With Pigmented Villonodular Synovitis (PVNS)/ Diffuse Type Tenosynovial Giant Cell Tumor (Dt-TGCT)

summary: This is a phase 1/2 single arm, open-label, safety, tolerability, and PK study of cabiralizumab in PVNS/dt-TGCT patients.

ipd_sharing: No

lead_sponsor: Five Prime Therapeutics, Inc.

location_country:
Netherlands
Poland
France
United States
United Kingdom
Korea, Republic of

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Institut Bergonie- CRLCC de Bordeaux et du Sud-Ouest

location_facility: The University of Texas, MD Anderson Cancer Center

location_facility: Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow, Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie

intervention_type: Biological


type: Other Grant/Funding Number

title: Swiss Trial of Decompressive Craniectomy Versus Best Medical Treatment of Spontaneous Supratentorial Intracerebral Hemorrhage (SWITCH): a Randomized Controlled Trial

acronym: SWITCH

summary:
Spontaneous intracerebral hemorrhage (ICH) remains a devastating disease with mortality rates up to 52% at 30 days. It is a major public health problem with an annual incidence of 10-30 per 100'000 population, accounting for 2 million (10-15%) of about 15 million strokes worldwide each year. The strategy of decompressive craniectomy (DC) is beneficial in patients with malignant middle cerebral artery (MCA) infarction. Based on the common pathophysiological mechanisms of these two conditions, this procedure is also frequently performed in patients with ICH, but is has not yet been investigated in a randomized trial.

The primary objective of this randomized controlled trial is to determine whether decompressive surgery and best medical treatment in patients with spontaneous ICH will improve outcome compared to best medical treatment only.

Secondary objectives are to analyze mortality, dependency and quality of life. Safety endpoints are to determine cause of any mortality and the rate of medical and surgical complications after DC compared with best medical treatment alone.

lead_sponsor: University Hospital Inselspital, Berne

location_country: Austria Sweden Switzerland Netherlands Finland France Belgium Spain Germany

location_facility: Dep. of Neurosurgery, Klinikum rechts der Isar der Technischen Universität München

location_facility: Neurologische Klinik, Universitätsklinikum Erlangen

location_facility: Servicio de Neurocirurgía Bellvitge Hospital

location_facility: Universitätsklinik für Neurochirurgie, Kepler Universitätsklinikum Linz

location_facility: Klinik für Neurochirurgie, Universitätsklinikum Würzburg

location_facility: Klinik für Neurochirurgie, Universitätsklinikum Freiburg

location_facility: Servicio de Neurología, Hospital Universitario La Paz

location_facility: Department of Neurology, Helsinki University Central Hospital

location_facility: Academic Medical Center Amsterdam, Department of Neurology

location_facility: Klinik und Poliklinik für Neurochirurgie, Universitätsklinikum Bonn

location_facility: Servicios de Neurología, Neurocirugía y Cuidados Intensivos del Hospital Virgen del Rocío

location_facility: Klinik für Neurochirurgie Uniklinik RWTH Aachen

location_facility: Klinik für Neurochirurgie, Universitätsklinikum Schleswig Holstein

location_facility: Dep. of Neurosurgery, Kantonsspital Luzern

location_facility: Neurochirurgische Klinik, Universitätsklinikum Mannheim

location_facility: Klinik für Neurochirurgie, Universitätsklinikum Essen (AöR)

location_facility: Zentrum der Neurologie und Neurochirurgie, Universitätsklinikum Frankfurt

location_facility: Dep. of Clinical Neuroscience, Service of Neurosurgery

location_facility: Klinik für Neurochirugie, Helios Klinikum Erfurt

location_facility: Neurochirurgische Klinik, Universitätsmedizin Mainz

location_facility: Klinik für Allgemeine Neurologie, Universitätsklinikum Münster

location_facility: Dep. of Neurology / Dep. of Neurosurgery, Bern University Hospital

location_facility: Neurochirurgische Klinik, Universitätsklinikum Gießen und Marburg UKGM

location_facility: Klinik für Neurochirurgie, Universitätsmedizin Göttingen

location_facility: Department of Neurosurgery, Charité - Universitätsmedizin Berlin

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Dep. of Neurosurgery, University Hospital Zürich

location_facility: University Medical Center Utrecht, Department of Neurology, Department of Neurosurgery

location_facility: Servicio de Neurocirurgía Hospital de la Santa Creu i Sant Pau

location_facility: Universitätsklinik für Neurochirurgie, Medizinische Universität Innsbruck

location_facility: Dep. Neurosurgery, Ospedale Regionale di Lugano

location_facility: Klinik für Neurochirurgie, Klinikum Kassel

location_facility: Klinik für Neurochirurgie, Universitätsklinikum Düsseldorf

intervention_type: Procedure

lead_sponsor_type: academique


title: A Phase Ib, Open-label, Multicenter, Dose Escalation and Expansion Study, to Evaluate the Safety, Pharmacokinetics and Activity of INC280 in Combination With Cetuximab in c-MET Positive CRC and HNSCC Patients Who Have Progressed After Anti-EGFR Monoclonal Antibody Therapy.

summary:
This was an open-label, phase Ib, multicenter clinical trial to determine the MTD/RDE of the orally administered c-MET inhibitor INC280 in combination with cetuximab. This combination was to be explored in c-MET positive mCRC and HNSCC patients whose disease progressed on cetuximab or panitumumab treatment. The dose escalation part was to be guided by a Bayesian Logistic Regression Model with overdose control. At MTD/RDE, additional mCRC and HNSCC patients who progressed on cetuximab or panitumumab treatment were to be enrolled in two expansion groups to further assess the anti-tumor activity and the safety and tolerability of the combination of INC280 and cetuximab. Patients were to receive INC280 on a continuous bid dosing regimen and cetuximab every week. A treatment cycle was defined as 28 days with no scheduled break between cycles.

The trial was terminated because of difficulties in identifying patients who met the eligibility criteria.

ReferenceCitation: Delord JP, Argilés G, Fayette J, Wirth L, Kasper S, Siena S, Mesia R, Berardi R, Cervantes A, Dekervel J, Zhao S, Sun Y, Hao HX, Tiedt R, Vicente S, Myers A, Siu LL. A phase 1b study of the MET inhibitor capmatinib combined with cetuximab in patients with MET-positive colorectal cancer who had progressed following anti-EGFR monoclonal antibody treatment. Invest New Drugs. 2020 Dec;38(6):1774-1783. doi: 10.1007/s10637-020-00928-z. Epub 2020 May 14.

family: Delord

full_name: Jean-Pierre Delord

given: Jean-Pierre

family: Argilés

full_name: Guillem Argilés

given: Guillem

family: Fayette

full_name: Jerôme Fayette

given: Jerôme

family: Wirth

full_name: Lori Wirth

given: Lori

family: Kasper

full_name: Stefan Kasper

given: Stefan

family: Siena

full_name: Salvatore Siena

given: Salvatore

family: Mesia

full_name: Ricard Mesia

given: Ricard

family: Berardi

full_name: Rossana Berardi

given: Rossana

family: Cervantes

full_name: Andrés Cervantes

given: Andrés

family: Dekervel

full_name: Jeroen Dekervel

given: Jeroen

family: Zhao

full_name: Sylvia Zhao

given: Sylvia

family: Sun

full_name: Yongjian Sun

given: Yongjian

family: Hao

full_name: Huai-Xiang Hao

given: Huai-Xiang

family: Tiedt

full_name: Ralph Tiedt

given: Ralph

family: Vicente

full_name: Sergio Vicente

given: Sergio

family: Myers

full_name: Andrea Myers

given: Andrea

family: Siu

full_name: Lillian L. Siu

given: Lillian L.

journal_name: Investigational New Drugs

publisher_normalized: Springer

location_country:
Italy
United States
Germany
France
Belgium
Spain
Canada

location_facility: University of Utah / Huntsman Cancer Institute Onc Dept

location_facility: Massachusetts General Hospital Head & Neck

status_simplified: Unknown


intervention_type: Other

status: No longer available

study_type: Expanded Access

lead_sponsor: Amgen

location_country:
Italy
Austria
Switzerland
Germany
France
United States
United Kingdom

acronym: RIALTO

source: euctr

title: An Open-Label, Multi-center, Expanded Access Protocol of Blinatumomab for the Treatment of Pediatric and Adolescent Subjects With Relapsed and/or Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)

summary:
Primary Objective:

To estimate the incidence of treatment-emergent and treatment-related adverse events during treatment with blinatumomab in pediatric and adolescent subjects with B-precursor ALL in second or later bone marrow relapse, in any marrow relapse after alloHSCT, or refractory to other treatments

Secondary Objective(s):

To describe key efficacy outcomes, including incidence of complete response (CR) within 2 cycles of blinatumomab, minimal residual disease (MRD) remission within 2 cycles of blinatumomab, relapse free survival (RFS), overall survival (OS), incidence of alloHSCT, and 100-day mortality after alloHSCT.

Hypotheses:

A formal statistical hypothesis will not be tested. The incidence of treatment-emergent and treatment-related adverse events will be estimated.

Study Endpoints:

Incidence of treatment-emergent and treatment-related adverse events
Incidence of CR within 2 cycles of blinatumomab
MRD remission within 2 cycles of blinatumomab
RFS
OS
Incidence of alloHSCT
100-day mortality after alloHSCT

Study Design:

Multi-center, open-label, single-arm expanded access protocol


lead_sponsor: Octapharma

location_country:
India
France
Poland
Georgia
Moldova, Republic of
United States
United Kingdom
Canada
Ukraine

location_facility: The National Children Specialized Hospital "OHMATDET"

location_facility: Institute of Hematology and Transfusiology

location_facility: Great Ormond Street Hospital for Children

location_facility: Danylo Halytsky Lviv National Medical University

title: Extension Study for Patients Who Completed GENA-05 (NuProtect)- to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII

summary: The purpose of the study is to collect long-term data on the inhibitor development rate of Human-cl rhFVIII in previously untreated patients with severe Hemophilia A.


title: An Open-label, Multicenter, Multinational, Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Exploratory Efficacy of Repeated Biweekly Infusions of neoGAA in naïve and Alglucosidase Alfa Treated Late-onset Pompe Disease Patients.

summary:
Primary Objective:

To evaluate the safety and tolerability of neoGAA in treatment naïve and alglucosidase alfa treated late-onset Pompe disease patients.

Secondary Objective:

To evaluate the pharmacokinetics, pharmacodynamics of neoGAA in treatment naïve and alglucosidase alfa treated late-onset Pompe disease patients.

To evaluate the effect of neoGAA on exploratory efficacy endpoints in treatment naïve and alglucosidase alfa treated late-onset Pompe disease patients.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Netherlands
Germany
France
Belgium
Denmark
United States
United Kingdom

location_facility:
Investigational Site Number 250003
Investigational Site Number 276001
Investigational Site Number 840008
Investigational Site Number 840001
Investigational Site Number 840003
Investigational Site Number 840006
Investigational Site Number 276002
Investigational Site Number 208001
Investigational Site Number 250002
Investigational Site Number 826003
Investigational Site Number 056001
Investigational Site Number 840002
Investigational Site Number 276003
Investigational Site Number 840010
Investigational Site Number 840009
Investigational Site Number 250001
Investigational Site Number 528001


location_country:
United States
France
Japan
Malaysia
Spain
Germany
Korea, Republic of
Taiwan

title: A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab in Combination With Erlotinib as First-Line Treatment for Patients With MET-Positive Unresectable Stage IIIb or IV Non-Small Cell Lung Cancer (NSCLC) Carrying an Activating EGFR Mutation

summary: This multicenter, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of onartuzumab in combination with erlotinib in patients with previously untreated, unresectable stage IIIB or IV non-small cell lung cancer identified to carry and activating EGFR mutation and MET-positive. Patients will be randomized to receive either onartuzumab 15 mg/kg intravenously every 3 weeks in combination with erlotinib 150 mg orally daily or placebo in combination with erlotinib. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


title: A Blind Randomized Multicenter Study of Accelerated Fractionated Chemo-radiotherapy With or Without the Hypoxic Cell Radiosensitizer Nimorazole (Nimoral), Using a 15-gene Signature for Hypoxia in the Treatment of Squamous Cell Carcinoma of the Head and Neck.

summary:
The drug nimorazole belongs to a class of chemicals known as 5-nitroimidazoles. Drugs from this class are used against infection. In addition, nimorazole makes tumor cells more sensitive to radiotherapy.

Therefore, the investigators want to find out whether the addition of nimorazole to the standard treatment with radiotherapy in combination with chemotherapy with cisplatin shows activity against your type of head and neck cancer and is safe.

Furthermore the investigators will investigate if a specific examination done with your tumor tissue will help to predict whether the treatment will work or not.

To find out if the activity observed with this treatment is not caused by chance alone, the investigators need to obtain data from patients who receive this treatment and from patients who receive other treatments.

The data from these two groups of patients will be compared to see which treatment is better.

Participants will be split into 2 groups. Each group will receive different treatments. The treatment each group receives is determined by chance using a computer program. This works like flipping a coin and is called randomization. This helps to make sure that groups of patients are similar when the study starts. Neither you, your study doctor, nor the study staff can influence in which group you will be placed or which treatment you will receive.

If allocated to group 1, Patient will receive radiotherapy in combination with chemotherapy with cisplatin and nimorazole as a pill. This is considered the 'experimental' treatment.

If allocated to group 2, patient will receive radiotherapy in combination with chemotherapy with cisplatin and a so called 'placebo' as a pill. The placebo is a dummy treatment. It looks like the real one, but it is not. It contains no active ingredient/medicine.

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

location_country: Switzerland Netherlands France Poland Belgium Australia Germany

location_facility: Radboud University Medical Center Nijmegen

location_facility: Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet

location_facility: Ludwig-Maximilians-Universitaet Muenchen - Klinikum der Universitaet Muenchen - Campus Grosshadern

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie

location_facility: Princess Alexandra Hospital - University Of Queensland

location_facility: Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum

intervention_type: Radiation


title: A Phase 2 Single Arm Study to Investigate the Efficacy of Autologous EBV-specific T-cells for the Treatment of Patients With Aggressive EBV Positive Extranodal NK/T-cell Lymphoma (ENKTCL)

acronym: CITADEL

summary: To investigate the efficacy of autologous EBV-specific T-cells for the treatment of patients with aggressive EBV positive extranodal NK/T-cell lymphoma

lead_sponsor: Cell Medica Ltd

location_country:
United States
United Kingdom
Korea, Republic of
France

location_facility: The Ohio State University Comprehensive Cancer Center


title: Phase Ib Dose Finding Study of Abiraterone Acetate Plus BEZ235 or BKM120 in Patients With Castration-resistant Prostate Cancer.

summary: This is an open label study of abiraterone acetate in combination with BEZ235 and abiraterone acetate in combination with BKM120 in CRPC patients with abiraterone acetate failure.

location_country:
United States
France
Belgium
Spain
Canada
United Kingdom

location_facility: Hackensack University Medical Center Hackensack Univ


title: An Open-label, Phase I, Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0575 Administered Alone and in Combination With Gemcitabine in Patients With Refractory Solid Tumors or Lymphoma

summary: This open-label, multicenter, Phase I, dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics (PK) of GDC-0575 administered alone or in combination with gemcitabine in participants with refractory solid tumors or lymphoma. In Stage 1, cohorts of participants will receive multiple ascending oral doses of GDC-0575 alone or in combination with intravenous gemcitabine. In Stage 2, participants will receive GDC-0575 orally in combination with intravenous gemcitabine at or below the maximum tolerated dose determined in Stage 1. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs, up to approximately 5 years.

ReferenceCitation: Italiano A, Infante JR, Shapiro GI, Moore KN, LoRusso PM, Hamilton E, Cousin S, Toulmonde M, Postel-Vinay S, Tolaney S, Blackwood EM, Mahrus S, Peale FV, Lu X, Moein A, Epler J, DuPree K, Tagen M, Murray ER, Schutzman JL, Lauchle JO, Hollebecque A, Soria JC. Phase I study of the checkpoint kinase 1 inhibitor GDC-0575 in combination with gemcitabine in patients with refractory solid tumors. Ann Oncol. 2018 May 1;29(5):1304-1311. doi: 10.1093/annonc/mdy076.

family: Italiano

full_name: A. Italiano

given: A.

family: Infante

full_name: J.R. Infante

family: Shapiro

full_name: G.I. Shapiro

family: Moore

full_name: K.N. Moore

family: LoRusso

full_name: P.M. LoRusso

family: Hamilton

full_name: E. Hamilton

given: E.

family: Cousin

full_name: S. Cousin

given: S.

family: Toulmonde

full_name: M. Toulmonde

given: M.

family: Postel-Vinay

full_name: S. Postel-Vinay

family: Tolaney

full_name: S. Tolaney

family: Blackwood

full_name: E.M. Blackwood

family: Mahrus

full_name: S. Mahrus

family: Peale

full_name: F.V. Peale

family: Lu

full_name: X. Lu

given: X.

family: Moein

full_name: A. Moein

family: Epler

full_name: J. Epler

given: J.

family: DuPree

full_name: K. DuPree

given: K.

family: Tagen

full_name: M. Tagen

family: Murray

full_name: E.R. Murray

family: Schutzman

full_name: J.L. Schutzman

family: Lauchle

full_name: J.O. Lauchle

family: Hollebecque

full_name: A. Hollebecque

family: Soria

full_name: J.-C. Soria

journal_name: Annals of Oncology

oa_host_type: publisher

evidence: open (via page says license)

license: cc-by-nc-nd

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: University of Oklahoma Health Sciences Center


title: A Multicenter Pharmacogenomic Biomarker Study in Matched Patients With Severe Sepsis Treated With or Without Recombinant Human Activated Protein C [Xigris®, Drotrecogin Alfa (Activated)]

summary: The overall purpose of the study is to determine whether either of the Improved Response Polymorphisms (IRPs) individually predicts a differential DrotAA treatment effect in patients with severe sepsis and high risk of death. This will be an international, multicenter, "prospective-retrospective", nonrandomized, controlled, outcome-blinded, genotype-blinded, matched-patients study. No prospective enrollment or treatment of patients will occur under this protocol. Retrospectively collected clinical data and DNA samples will be analyzed for existing cohorts of patients with severe sepsis who were previously treated with DrotAA (treatment group) or not (control group) as part of their standard care in an ICU.

status: Unknown status

study_type: Observational

time_perspective: Retrospective

ReferenceCitation: Annane D, Mira JP, Ware LB, Gordon AC, Hinds CJ, Christiani DC, Sevransky J, Barnes K, Buchman TG, Heagerty PJ, Balshaw R, Lesnikova N, de Nobrega K, Wellman HF, Neira M, Mancini ADJ, Walley KR, Russell JA. Pharmacogenomic biomarkers do not predict response to drotrecogin alfa in patients with severe sepsis. Ann Intensive Care. 2018 Jan 31;8(1):16. doi: 10.1186/s13613-018-0353-2.

family: Annane

full_name: Djillali Annane

given: Djillali

family: Mira

full_name: Jean-Paul Mira

given: Jean-Paul

family: Ware

full_name: Lorraine B. Ware

given: Lorraine B.

family: Gordon

full_name: Anthony C. Gordon

given: Anthony C.

family: Hinds

full_name: Charles J. Hinds

given: Charles J.

family: Christiani

full_name: David C. Christiani

given: David C.

family: Sevransky

full_name: Jonathan Sevransky

given: Jonathan

family: Barnes

full_name: Kathleen Barnes

given: Kathleen

family: Buchman

full_name: Timothy G. Buchman

given: Timothy G.

family: Heagerty

full_name: Patrick J. Heagerty

given: Patrick J.

family: Balshaw

full_name: Robert Balshaw

given: Robert

family: Lesnikova

full_name: Nadia Lesnikova

given: Nadia

family: de Nobrega

full_name: Karen de Nobrega

given: Karen

family: Wellman

full_name: Hugh F. Wellman

given: Hugh F.

family: Neira

full_name: Mauricio Neira

given: Mauricio

family: Mancini

full_name: Alexandra D. J. Mancini

given: Alexandra D. J.

family: Walley

full_name: Keith R. Walley

given: Keith R.

family: Russell

full_name: James A. Russell

given: James A.

currency_apc_doaj: GBP

journal_name: Annals of Intensive Care

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

repository_institution: Queen Mary University of London - Queen Mary Research Online

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

location_country:
United States
United Kingdom
Canada
France

location_facility: Imperial College London, Charing Cross Hospital

location_facility: Johns Hopkins University, Bayview Medical Center

location_facility: University of British Columbia and Providence Health Care, St. Paul's Hospital

location_facility: Université Paris Descartes, Sorbonne Paris Cité, Cochin Hotel-Dieu University Hospital

location_facility: University of Versailles, Hospital Raymond Poincaré (AP-HP)

location_facility: Harvard University School of Public Health


title: Ingenio Device Algorithm Study

acronym: IVORY

summary: The purpose of the IVORY Study is to gather data to support global submissions/approvals for some models of the Ingenio device family.

lead_sponsor: Boston Scientific Corporation

location_country:
Italy
Austria
Sweden
Hong Kong
Netherlands
France
Malaysia
Belgium
Spain
Denmark
Germany
United Kingdom

location_facility: Azienda Ospedaliera Mater Domini Policlinico Universitario

intervention_type: Device


title: An Open Label, Multicentre, Single Arm Study to Characterise the Efficacy, Safety and Tolerability of Gefitinib 250 mg (IRESSA™) as First Line Treatment in Caucasian Patients, Who Have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

acronym: IFUM

summary: This study is carried out to see how Caucasian patients with lung cancer which has EGFR mutation will respond to gefitinib (IRESSA™) as a first line treatment. Safety data will also be collected and analysed to confirm that treatment with gefitinib is safe and well tolerated.

ReferenceCitation: Douillard JY, Ostoros G, Cobo M, Ciuleanu T, McCormack R, Webster A, Milenkova T. First-line gefitinib in Caucasian EGFR mutation-positive NSCLC patients: a phase-IV, open-label, single-arm study. Br J Cancer. 2014 Jan 7;110(1):55-62. doi: 10.1038/bjc.2013.721. Epub 2013 Nov 21.

family: Douillard

full_name: J-Y Douillard

given: J-Y

family: Ostoros

full_name: G Ostoros

given: G

family: Cobo

full_name: M Cobo

given: M

family: Ciuleanu

full_name: T Ciuleanu

given: T

family: McCormack

full_name: R McCormack

given: R

family: Webster

full_name: A Webster

given: A

family: Milenkova

full_name: T Milenkova

journal_name: British Journal of Cancer

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

publisher_dissemination: Springer

publisher_group: Springer

lead_sponsor: AstraZeneca

location_country:
Italy
Switzerland
Spain
France
Bulgaria
Greece
Poland
Norway
Hungary
Romania
Portugal
Turkey
United Kingdom


ReferenceCitation: Gálvez R, Schäfer M, Hans G, Falke D, Steigerwald I. Tapentadol prolonged release versus strong opioids for severe, chronic low back pain: results of an open-label, phase 3b study. Adv Ther. 2013 Mar;30(3):229-59. doi: 10.1007/s12325-013-0015-6. Epub 2013 Mar 7.

family: Gálvez

full_name: Rafael Gálvez

given: Rafael

family: Schäfer

full_name: Michael Schäfer

given: Michael

family: Hans

full_name: Guy Hans

given: Guy

family: Falke

full_name: Dietmar Falke

given: Dietmar

family: Steigerwald

full_name: Ilona Steigerwald

given: Ilona

journal_name: Advances in Therapy

evidence: open (via free pdf)

title: Tapentadol Prolonged Release Versus Strong Opioids for Severe, Chronic Low Back Pain: Results of an Open-Label, Phase 3b Study

ipd_sharing_description: Information available on the Grünenthal Web Site.

lead_sponsor: Grünenthal GmbH

location_country: Switzerland Netherlands France Czechia Poland Belgium Spain Germany

ipd_sharing: Yes

title: An Evaluation of the Effectiveness and Tolerability of Tapentadol Hydrochloride Prolonged Release, and Tapentadol Hydrochloride Immediate Release on Demand, in Subjects With Severe Chronic Nociceptive, Mixed or Neuropathic Low Back Pain Taking WHO Step III Analgesics But Showing a Lack of Tolerability

summary:
The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release in subjects suffering from severe chronic low back pain (LBP) who are taking WHO Step III analgesics and show lack of tolerability. This is a clinical effectiveness trial designed to establish a link between anticipated clinical outcomes and the clinical practice by means of selected measures of clinical and subject-reported outcome.

The trial will compare the effectiveness of previous analgesic treatment (WHO Step III) with that of tapentadol hydrochloride prolonged release treatment during defined periods of evaluation.


ReferenceCitation: Tive L, Bello AE, Radin D, Schnitzer TJ, Nguyen H, Brown MT, West CR. Pooled analysis of tanezumab efficacy and safety with subgroup analyses of phase III clinical trials in patients with osteoarthritis pain of the knee or hip. J Pain Res. 2019 Mar 19;12:975-995. doi: 10.2147/JPR.S191297. eCollection 2019. Erratum in: J Pain Res. 2020 Sep 14;13:2267-2268.

family: Tive

full_name: Leslie Tive

given: Leslie

family: Bello

full_name: Alfonso E Bello

given: Alfonso E

family: Radin

full_name: David Radin

given: David

family: Schnitzer

full_name: Thomas J Schnitzer

given: Thomas J

family: Nguyen

full_name: Ha Nguyen

given: Ha

family: Brown

full_name: Mark T Brown

given: Mark T

family: West

full_name: Christine R West

given: Christine R

currency_apc_doaj: USD

journal_name: Journal of Pain Research

license: cc-by-nc

license_normalized: cc-by-nc

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Hochberg MC, Tive LA, Abramson SB, Vignon E, Verburg KM, West CR, Smith MD, Hungerford DS. When Is Osteonecrosis Not Osteonecrosis?: Adjudication of Reported Serious Adverse Joint Events in the Tanezumab Clinical Development Program. Arthritis Rheumatol. 2016 Feb;68(2):382-91. doi: 10.1002/art.39492.

name: University of Maryland School of Medicine; Baltimore

family: Hochberg

full_name: Marc C. Hochberg

given: Marc C.

full_name: Leslie A. Tive

given: Leslie A.

name: New York University Medical Center; New York New York

family: Abramson

full_name: Steven B. Abramson

given: Steven B.

name: Université Claude Bernard Lyon 1; Lyon France

family: Vignon

full_name: Eric Vignon

given: Eric

family: Verburg

full_name: Kenneth M. Verburg

given: Kenneth M.

full_name: Christine R. West

given: Christine R.

family: Smith

full_name: Michael D. Smith

given: Michael D.

name: Johns Hopkins University School of Medicine, Johns Hopkins Hospital, and Good Samaritan Hospital; Baltimore Maryland

family: Hungerford

full_name: David S. Hungerford

given: David S.

journal_name: Arthritis & Rheumatology

ReferenceCitation: Balanescu AR, Feist E, Wolfram G, Davignon I, Smith MD, Brown MT, West CR. Efficacy and safety of tanezumab added on to diclofenac sustained release in patients with knee or hip osteoarthritis: a double-blind, placebo-controlled, parallel-group, multicentre phase III randomised clinical trial. Ann Rheum Dis. 2014 Sep;73(9):1665-72. doi: 10.1136/annrheumdis-2012-203164. Epub 2013 Jul 12.

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

location_country:
Austria
Sweden
France
Poland
Romania
Russian Federation
Spain
Germany
United Kingdom
Ukraine

location_facility: Institute of Urgent and Recovery Surgery named after V.K. Gusaka AMS Ukraine

location_facility: State Healthcare Institution of Moscow city "City Clinical Hospital #15 n.a. O. M. Filatov"

location_facility: Center polyclinic of Federal State Institution

location_facility: Central City Clinical Hospital#1, Department of Therapy,

location_facility: Communal institution "City Hospital #7", Department of Therapy,

location_facility: City communal clinical hospital #5, Dept. of Therapy, Danylo Galytskiy Lviv National Med. University

location_facility: St. Petersburg State Healthcare Institution "City Pokrovskaya Hospital"

location_facility: Schmerz- und Palliativzentrum Goeppingen

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: Klinische Forschung Hannover - Mitte GmbH

location_facility: St. Petersburg State Healthcare Institution "City Outpatient Clinical #51"

location_facility: 4th City Communal Clinical Hospital, Department of Rheumatology,

location_facility: City Clinical Hospital #8, Department of reumatology,

location_facility: Clinical Emergency Military Hospital "Dr. Carol Davila"

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej "POLIMEDICA"

location_facility: Communal Institution Ternopil regional council, "Ternopil Regional Clinical Hospital"

location_facility: Apotheke des Ernst von Bergmann Klinikums

location_facility: Chair of Hospital Therapy of Ryazan State Medical University

location_facility: "Centrum Medyczne MEDENS S.C. Niepubliczny Zaklad

location_facility: Chernivtsi Regional Clinical Hospital,Department of Rheumatology

location_facility: Road Clinical Hospital at Dnipropetrovsk station, Department of Rheumatology

location_facility: State Educational Institution of Additional Professional Education

location_facility: Vinnytsya regional clinical hospital named after M.I. Pyrogova

location_facility: Clinical Emergency County Hospital Constanta

location_facility: County Emergency Clinic Hospital "Sf. Apostol Andrei"

location_facility: Kyiv Central Basin Clinical Hospital, Department of cardiology,

location_facility: Institution of Russian Academy of Sciences "St. Petersburg Clinical Hospital of RAS"

location_facility: St. Petersburg State Healthcare Institution "City Hospital #25 City Rheumatology Center"

location_facility: State Institution "Institute of Gerontology AMS of Ukraine"

location_facility: Oleksandrivska Clinical Hospital in Kyiv-Department of Rheumatology # 1

title: A PHASE 3, RANDOMIZED, DOUBLE BLIND, CONTROLLED, MULTI CENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB ADDED ON TO DICLOFENAC SR IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP

summary: The purpose of this study is to investigate the analgesic efficacy and safety of tanezumab added on to diclofenac SR in patients with osteoarthritis of the knee or hip currently experiencing partial benefit from, and are tolerating, diclofenac 150 mg/day therapy.


title: A Multicenter, Open-Label Extension Study of the Long-Term Safety and Efficacy of Recombinant Human Acid α-Glucosidase (rhGAA) in Patients With Pompe Disease (Glycogen Storage Disease Type II) Who Were Previously Enrolled in Genzyme-Sponsored Enzyme Replacement Therapy Studies

summary: This extension study was to monitor the long-term safety and efficacy of rhGAA treatment in patients with infantile-onset Pompe disease who were previously treated with rhGAA derived from the Synpac cell line

location_country:
South Africa
United States
France

location_facility: Institute for Genetic Medicine, Saint Peter's University Hospital

location_facility: New York University [NYU] School of Medicine


title: Randomized Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) Versus Expectant Management During Pregnancy in Fetuses With Left Sided and Isolated Congenital Diaphragmatic Hernia and Moderate Pulmonary Hypoplasia.

acronym: TOTAL moderate

summary:
Isolated Congenital Diaphragmatic Hernia (CDH) can be diagnosed in the prenatal period, and remains associated with a 30 % chance of perinatal death and morbidity mainly because of pulmonary hypoplasia and pulmonary hypertension. In addition, in the survivors there is a high rate of morbidity with evidence of bronchopulmonary dysplasia in more than 70% of cases. The risk for these can be predicted prenatally by the ultrasonographic measurement of the observed/expected lung area to head circumference ratio (O/E LHR) which is a measure of pulmonary hypoplasia. Also position of the liver is predictive of outcome.

The proposing consortium has developed a prenatal therapeutic approach, which consists of percutaneous fetoscopic endoluminal tracheal occlusion (FETO) with subsequent removal of the balloon. Both procedures are performed percutaneously, there is now experience with more than 150 cases and it has been shown to be safe for the mother. We have witnessed an improvement of survival in fetuses with a predicted chance of survival of less than 30% (referred to as fetuses with severe pulmonary hypoplasia; O/E LHR <25% and liver herniation) to 55% on average. Also there is an apparent reduction in morbidity with the rate of bronchopulmonary dysplasia decreasing from the estimated rate of more than 70% to less than 40% in the same severity group.

Further we have shown that results of FETO are predicted by LHR measurement prior to the procedure, so that better results can be expected in fetuses with larger lung size. Therefore we now aim to offer FETO to fetuses with moderate CDH (=O/E LHR 25-34.9%, irrespective of the liver position as well as O/E LHR 35-44.9% with intrathoracic herniation of the liver). When managed expectantly the estimated rate of postnatal survival is 55%.

This trial will test whether temporary fetoscopic tracheal occlusion rather than expectant management during pregnancy, both followed by standardized postnatal management increases survival or decrease oxygen dependency at 6 months of age. The balloon will be placed between 30 and 31+6 weeks, and will be removed between 34 and 34+6 weeks.

ReferenceType: background

ReferenceCitation: Jani J, Nicolaides KH, Keller RL, Benachi A, Peralta CF, Favre R, Moreno O, Tibboel D, Lipitz S, Eggink A, Vaast P, Allegaert K, Harrison M, Deprest J; Antenatal-CDH-Registry Group. Observed to expected lung area to head circumference ratio in the prediction of survival in fetuses with isolated diaphragmatic hernia. Ultrasound Obstet Gynecol. 2007 Jul;30(1):67-71.

ReferenceCitation: Doné E, Gucciardo L, Van Mieghem T, Jani J, Cannie M, Van Schoubroeck D, Devlieger R, Catte LD, Klaritsch P, Mayer S, Beck V, Debeer A, Gratacos E, Nicolaides K, Deprest J. Prenatal diagnosis, prediction of outcome and in utero therapy of isolated congenital diaphragmatic hernia. Prenat Diagn. 2008 Jul;28(7):581-91. doi: 10.1002/pd.2033. Review.

ReferenceCitation: Deprest J, Jani J, Gratacos E, Vandecruys H, Naulaers G, Delgado J, Greenough A, Nicolaides K; FETO Task Group. Fetal intervention for congenital diaphragmatic hernia: the European experience. Semin Perinatol. 2005 Apr;29(2):94-103. Review.

ReferenceCitation: Deprest J, Gratacos E, Nicolaides KH; FETO Task Group. Fetoscopic tracheal occlusion (FETO) for severe congenital diaphragmatic hernia: evolution of a technique and preliminary results. Ultrasound Obstet Gynecol. 2004 Aug;24(2):121-6. Erratum in: Ultrasound Obstet Gynecol. 2004 Oct;24(5):594.

ReferenceCitation: Jani JC, Nicolaides KH, Gratacós E, Valencia CM, Doné E, Martinez JM, Gucciardo L, Cruz R, Deprest JA. Severe diaphragmatic hernia treated by fetal endoscopic tracheal occlusion. Ultrasound Obstet Gynecol. 2009 Sep;34(3):304-10. doi: 10.1002/uog.6450.

ReferenceCitation: Deprest JA, Gratacos E, Nicolaides K, Done E, Van Mieghem T, Gucciardo L, Claus F, Debeer A, Allegaert K, Reiss I, Tibboel D. Changing perspectives on the perinatal management of isolated congenital diaphragmatic hernia in Europe. Clin Perinatol. 2009 Jun;36(2):329-47, ix. doi: 10.1016/j.clp.2009.03.004. Review.

ReferenceCitation: Deprest JA, Hyett JA, Flake AW, Nicolaides K, Gratacos E. Current controversies in prenatal diagnosis 4: Should fetal surgery be done in all cases of severe diaphragmatic hernia? Prenat Diagn. 2009 Jan;29(1):15-9. doi: 10.1002/pd.2108.

ReferenceCitation: Gregoir C, Engels AC, Gomez O, DeKoninck P, Lewi L, Gratacos E, Deprest JA. Fertility, pregnancy and gynecological outcomes after fetoscopic surgery for congenital diaphragmatic hernia. Hum Reprod. 2016 Sep;31(9):2024-30. doi: 10.1093/humrep/dew160. Epub 2016 Jul 4.

ReferenceCitation: Snoek KG, Reiss IK, Greenough A, Capolupo I, Urlesberger B, Wessel L, Storme L, Deprest J, Schaible T, van Heijst A, Tibboel D; CDH EURO Consortium. Standardized Postnatal Management of Infants with Congenital Diaphragmatic Hernia in Europe: The CDH EURO Consortium Consensus - 2015 Update. Neonatology. 2016;110(1):66-74. doi: 10.1159/000444210. Epub 2016 Apr 15.

ReferenceCitation: Nawapun K, Eastwood MP, Diaz-Cobos D, Jimenez J, Aertsen M, Gomez O, Claus F, Gratacós E, Deprest J. In vivo evidence by magnetic resonance volumetry of a gestational age dependent response to tracheal occlusion for congenital diaphragmatic hernia. Prenat Diagn. 2015 Nov;35(11):1048-56. doi: 10.1002/pd.4642. Epub 2015 Sep 29.

ReferenceCitation: Deprest J, Brady P, Nicolaides K, Benachi A, Berg C, Vermeesch J, Gardener G, Gratacos E. Prenatal management of the fetus with isolated congenital diaphragmatic hernia in the era of the TOTAL trial. Semin Fetal Neonatal Med. 2014 Dec;19(6):338-48. doi: 10.1016/j.siny.2014.09.006. Epub 2014 Nov 11. Review.

ReferenceCitation: Done E, Debeer A, Gucciardo L, Van Mieghem T, Lewi P, Devlieger R, De Catte L, Lewi L, Allegaert K, Deprest J. Prediction of neonatal respiratory function and pulmonary hypertension in fetuses with isolated congenital diaphragmatic hernia in the fetal endoscopic tracleal occlusion era: a single-center study. Fetal Diagn Ther. 2015;37(1):24-32. doi: 10.1159/000364805. Epub 2014 Nov 8.

ReferenceCitation: DeKoninck P, Gomez O, Sandaite I, Richter J, Nawapun K, Eerdekens A, Ramirez JC, Claus F, Gratacos E, Deprest J. Right-sided congenital diaphragmatic hernia in a decade of fetal surgery. BJOG. 2015 Jun;122(7):940-6. doi: 10.1111/1471-0528.13065. Epub 2014 Sep 17.

ReferenceCitation: Windrim R, Ryan G, Lebouthillier F, Campisi P, Kelly EN, Baud D, Yoo SJ, Deprest J. Development and use of a high-fidelity simulator for fetal endotracheal balloon occlusion (FETO) insertion and removal. Prenat Diagn. 2014 Feb;34(2):180-4. doi: 10.1002/pd.4284. Epub 2013 Dec 27.

ReferenceCitation: Engels AC, DeKoninck P, van der Merwe JL, Van Mieghem T, Stevens P, Power B, Nicolaides KH, Gratacos E, Deprest JA. Does website-based information add any value in counseling mothers expecting a baby with severe congenital diaphragmatic hernia? Prenat Diagn. 2013 Nov;33(11):1027-32. doi: 10.1002/pd.4190. Epub 2013 Aug 29.

ReferenceCitation: Dekoninck P, Gratacos E, Van Mieghem T, Richter J, Lewi P, Ancel AM, Allegaert K, Nicolaides K, Deprest J. Results of fetal endoscopic tracheal occlusion for congenital diaphragmatic hernia and the set up of the randomized controlled TOTAL trial. Early Hum Dev. 2011 Sep;87(9):619-24. doi: 10.1016/j.earlhumdev.2011.08.001.

ReferenceCitation: Deprest JA, Benachi A, Gratacos E, Nicolaides KH, Berg C, Persico N, Belfort M, Gardener GJ, Ville Y, Johnson A, Morini F, Wielgoś M, Van Calster B, DeKoninck PLJ; TOTAL Trial for Moderate Hypoplasia Investigators. Randomized Trial of Fetal Surgery for Moderate Left Diaphragmatic Hernia. N Engl J Med. 2021 Jul 8;385(2):119-129. doi: 10.1056/NEJMoa2026983. Epub 2021 Jun 8.

name: From the Department of Obstetrics and Gynecology, University Hospitals KU Leuven (J.A.D., P.L.J.D.) and Academic Department of Development and Regeneration, Biomedical Sciences, KU Leuven, Leuven, Belgium (J.A.D., B.V.C., P.L.J.D.); Hospital Antoine–Béclère, Université Paris–Saclay, Clamart (A.B.), and Necker–Enfants Malades Hospital, Paris (Y.V.) — both in France; Hospital Clinic and Sant Joan de Déu, Barcelona (E.G.); Institute for Women’s Health, University College London Hospital (J.A.D.) and King’s...

family: Deprest

full_name: Jan A. Deprest

given: Jan A.

family: Benachi

full_name: Alexandra Benachi

given: Alexandra

family: Gratacos

full_name: Eduard Gratacos

given: Eduard

family: Nicolaides

full_name: Kypros H. Nicolaides

given: Kypros H.

family: Berg

full_name: Christoph Berg

given: Christoph

family: Persico

full_name: Nicola Persico

given: Nicola

family: Belfort

full_name: Michael Belfort

given: Michael

family: Gardener

full_name: Glenn J. Gardener

given: Glenn J.

family: Ville

full_name: Yves Ville

given: Yves

family: Johnson

full_name: Anthony Johnson

given: Anthony

family: Morini

full_name: Francesco Morini

given: Francesco

family: Wielgoś

full_name: Mirosław Wielgoś

given: Mirosław

family: Van Calster

full_name: Ben Van Calster

given: Ben

family: DeKoninck

full_name: Philip L.J. DeKoninck

given: Philip L.J.

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

lead_sponsor: University Hospital, Gasthuisberg

location_country:
Italy
United States
Germany
France
Poland
Belgium
Australia
Spain
Canada
United Kingdom

location_facility: University of Texas Health Science Center

location_facility: Baylor College of Medicine/Texas Children's Hospital

location_facility: 1st Department of Obstetrics and Gynecology, Medical University of Warsaw


ReferenceCitation: Murray KF, Szenborn L, Wysocki J, Rossi S, Corsa AC, Dinh P, McHutchison J, Pang PS, Luminos LM, Pawlowska M, Mizerski J. Randomized, placebo-controlled trial of tenofovir disoproxil fumarate in adolescents with chronic hepatitis B. Hepatology. 2012 Dec;56(6):2018-26. doi: 10.1002/hep.25818. Epub 2012 Aug 27.

family: Murray

full_name: Karen F. Murray

given: Karen F.

family: Szenborn

full_name: Leszek Szenborn

given: Leszek

family: Wysocki

full_name: Jacek Wysocki

given: Jacek

family: Rossi

full_name: Stephen Rossi

given: Stephen

family: Corsa

full_name: Amoreena C. Corsa

given: Amoreena C.

family: Dinh

full_name: Phillip Dinh

given: Phillip

family: McHutchison

full_name: John McHutchison

given: John

family: Pang

full_name: Phillip S. Pang

given: Phillip S.

family: Luminos

full_name: Luminita M. Luminos

given: Luminita M.

family: Pawlowska

full_name: Malgorzata Pawlowska

given: Malgorzata

family: Mizerski

full_name: Jacek Mizerski

journal_name: Hepatology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Gilead Sciences

location_country:
France
Bulgaria
Poland
Romania
Spain
Turkey
United States

location_facility: Multiprofile Hospital for Active Treatment Sveti Georgi

location_facility: Samodzielny Publiczny Szpital Kliniczny im. Karola Johschera

location_facility: Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem

location_facility: Samodzielny Publiczny Dzieciecy Szpital Kliniczny Akademii Medycznej w Bialymstoku

location_facility: Children's Hospital & Regional Medical Center, d/b/a Seattle Children's Research Institute

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II

location_facility: Hosp Univ y Politecnico La Fe de Valencia

location_facility: Clinic of Gastroenterology, Specialized Hospital for Active Treatment of Pediatric Diseases, Sofia

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: Children's Hospital & Research Center at Oakland

location_facility: Wojewodzki Szpital Obserwacyjno-Zakazny im. T. Browicza

location_facility: Wojewodzki Specjalistyczny Szpital im Bieganskiego

title: A Randomized, Double-Blind Evaluation of the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Adolescents With Chronic Hepatitis B Infection

summary:
The primary purpose of the study is to evaluate the effectiveness, safety, and tolerability of tenofovir disoproxil fumarate (TDF) in adolescents (aged 12-17 years) with chronic hepatitis B virus (HBV) infection.

The optimal treatment for adolescents with chronic HBV infection is currently unknown. Treatment with interferon alfa, lamivudine, and adefovir dipivoxil in pediatric populations has been shown to be less than optimal. Further, the safety and efficacy of entecavir and telbivudine have not been established in patients < 16 years of age. A study evaluating TDF in adolescents (ages 12-17) was needed to assess the safety and efficacy of this agent in the treatment of chronic hepatitis B in this patient population. In addition, the study will help to further elucidate the pharmacokinetic (PK) and resistance profiles of TDF. Through their participation, study participants will help generate critical new information to help guide the most optimal treatment of chronic HBV infection in adolescents.

This is a randomized, double-blind study to evaluate the antiviral efficacy, safety, and tolerability of TDF versus placebo in adolescents with chronic HBV infection. TDF treatment-naive participants were randomized in a 1:1 ratio to TDF or placebo. After 72 weeks of blinded treatment, participants were to switch to open-label TDF for an additional 2.5 years of treatment, provided that no safety concerns are identified by the Independent Data Monitoring Committee monitoring the study.


title: A Multi-center, Open-label, Phase I Study of Single Agent R7112 Administered Orally in Patients With Advanced Malignancies, Except All Forms of Leukaemia

summary: This study will determine the maximum tolerated dose and the optimal associated 4 weekly dosing schedule of RO5045337, administered as monotherapy in patients with advanced solid tumors. A first cohort of patients will receive the starting dose of 20mg/m2/day, once daily for 10 days in each 28 day cycle. Subsequent cohorts of patients will receive dose escalations, and possible changes in dosing schedule, based on tolerability and pharmacokinetic knowledge gained from prior treatment cohorts. The anticipated time on study treatment is until disease progression or intolerable toxicity.

location_country:
United States
France


title: Phase II Study of Dasatinib (BMS-354825) for Advanced 'Triple-negative' Breast Cancer

summary: This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced triple-negative breast cancer.

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
United States
France
Spain

location_facility: University Of Texas Md Anderson Cancer Ctr


title: Phase II Study Of SKI-606 In Subjects With Advanced Or Metastatic Breast Cancer

summary: The purpose of this study is to determine if SKI-606 (Bosutinib) is effective in the treatment of advanced or metastatic breast cancer. Patients must have current Stage IIIB, IIIC or IV breast cancer and have progressed after 1 to 3 prior chemotherapy regimens.

lead_sponsor: Pfizer

location_country:
Hong Kong
France
Poland
Malta
Australia
Russian Federation
United States
Ukraine


title: Follow-up of Thyroid Cancer Patients From Study THYR-008-00 Who Received Thyroid Remnant Ablation Using Either the Hypothyroid or the Thyrogen Method.

summary:
Patients diagnosed with thyroid cancer are commonly treated with surgery to remove their thyroid gland followed by radioiodine ablation to destroy any remaining parts of the thyroid gland that may have been missed during surgery. It is thought that ablation with radioiodine destroys normal remaining thyroid tissue as well as cancerous cells either in the thyroid area or at other sites.

Following successful treatment, patients are then monitored by their physicians at regular intervals with testing to detect any recurrence of thyroid cancer throughout the body. If thyroid cells are detected by these follow up tests, the physician will decide the best method to re-treat the patient.

In 2001-2003 Genzyme conducted a clinical study to test if Thyrogen® can be used to accomplish radioiodine ablation treatment. This study aimed to determine that the success rates of radioiodine ablation were comparable when patients were prepared for ablation with Thyrogen® while being maintained on their normal thyroid hormone therapy, or, alternatively, by thyroid hormone withdrawal. Thyroid hormone withdrawal commonly causes uncomfortable side effects for patients, and these might be avoided by the use of Thyrogen.

Eight months after the initial Thyrogen plus radioiodine treatment to achieve ablation, all patients in both groups were given Thyrogen® to test for any remaining thyroid tissue. The results of this testing showed that all patients (in both groups) had successfully achieved remnant ablation and had no detectable thyroid tissue remaining.

In order to confirm these remnant ablation results we will conduct follow up testing in this study for all patients that were enrolled in the previous study and we also will determine if their thyroid cancer has recurred. Only patients who completed this previous Thyrogen ablation study are eligible for entry into this study.

ReferenceCitation: Elisei R, Schlumberger M, Driedger A, Reiners C, Kloos RT, Sherman SI, Haugen B, Corone C, Molinaro E, Grasso L, Leboulleux S, Rachinsky I, Luster M, Lassmann M, Busaidy NL, Wahl RL, Pacini F, Cho SY, Magner J, Pinchera A, Ladenson PW. Follow-up of low-risk differentiated thyroid cancer patients who underwent radioiodine ablation of postsurgical thyroid remnants after either recombinant human thyrotropin or thyroid hormone withdrawal. J Clin Endocrinol Metab. 2009 Nov;94(11):4171-9. doi: 10.1210/jc.2009-0869. Epub 2009 Oct 22.

name: Department of Endocrinology and Metabolism (R.E., E.M., L.G., A.P.), University of Pisa, 56124 Pisa, Italy

family: Elisei

full_name: R. Elisei

given: R.

name: Institut Gustave Roussy and University of Paris-Sud XI (M.S., S.L.), 94805 Villejuif, France

family: Schlumberger

full_name: M. Schlumberger

given: M.

name: Division of Nuclear Medicine (A.D., I.R.), University of Western Ontario, London, Ontario, Canada N6A 4G5

family: Driedger

full_name: A. Driedger

given: A.

name: Department of Nuclear Medicine (C.R., M.Lu., M.La.), University of Wuerzburg, 97070 Wuerzburg, Germany

family: Reiners

full_name: C. Reiners

given: C.

name: The Ohio State University (R.T.K.), Columbus, Ohio 43210

family: Kloos

full_name: R. T. Kloos

given: R. T.

name: The University of Texas M. D. Anderson Cancer Center (S.I.S., N.L.B.), Houston, Texas 77030

family: Sherman

full_name: S. I. Sherman

given: S. I.

name: University of Colorado Denver (B.H.), Aurora, Colorado 80045

family: Haugen

full_name: B. Haugen

given: B.

name: Centre Rene Huguenin (C.C.), 92210 Saint Cloud, France

family: Corone

full_name: C. Corone

family: Molinaro

full_name: E. Molinaro

given: E.

family: Grasso

full_name: L. Grasso

given: L.

family: Leboulleux

full_name: S. Leboulleux

given: S.

family: Rachinsky

full_name: I. Rachinsky

given: I.

family: Luster

full_name: M. Luster

family: Lassmann

full_name: M. Lassmann

family: Busaidy

full_name: N. L. Busaidy

given: N. L.

name: Division of Nuclear Medicine (R.L.W., S.Y.C.), Johns Hopkins University, Baltimore, Maryland 21287

family: Wahl

full_name: R. L. Wahl

given: R. L.

name: Section of Endocrinology and Metabolism (F.P.), University of Siena, Siena 53100, Italy

family: Pacini

full_name: F. Pacini

given: F.

family: Cho

full_name: S. Y. Cho

given: S. Y.

name: Genzyme Corp. (J.M.), Cambridge, Massachusetts 02142

family: Magner

full_name: J. Magner

given: J.

family: Pinchera

full_name: A. Pinchera

name: Division of Endocrinology and Metabolism (P.W.L.), Johns Hopkins University, Baltimore, Maryland 21287

family: Ladenson

full_name: P. W. Ladenson

given: P. W.

journal_name: The Journal of Clinical Endocrinology & Metabolism

title: Follow-Up of Low-Risk Differentiated Thyroid Cancer Patients Who Underwent Radioiodine Ablation of Postsurgical Thyroid Remnants after Either Recombinant Human Thyrotropin or Thyroid Hormone Withdrawal

location_country:
Italy
United States
France
Germany
Canada

location_facility: University of Colorado Health Sciences Centre


title: An Open Label Extension, Investigator Initiated Trial to Examine Radiographic Progression , Efficacy and Safety of Long-Term Treatment With Infliximab in Patients With Ankylosing Spondylitis. EASIC (European Ankylosing Spondylitis Infliximab Cohort)

summary: Ankylosing spondylitis (AS) is a chronic inflammatory disease that involves the sacroiliac joints, axial skeleton, entheses and peripheral joints. Current therapy for AS is mainly NSAIDs and physiotherapy which are oft insufficient. Treatment with the TNF-alpha blocking agent infliximab was shown to have definite clinical efficacy in patients with active AS on a short- and a long-term-basis over 2 years. We want to show that treatment with infliximab on a long-term basis over 4 years is safe and efficient and can prevent radiographic progression over a long period of time. Further we want to learn about the outcome after discontinuation of anti-TNF-alpha therapy.

ReferenceCitation: Webers C, Essers I, van Tubergen A, Braun J, Heldmann F, Baraliakos X, Boonen A. Valuing Treatment With Infliximab for Ankylosing Spondylitis Using a Willingness-to-Pay Approach. Arthritis Care Res (Hoboken). 2018 Apr;70(4):608-616. doi: 10.1002/acr.23299. Epub 2018 Feb 18.

name: Maastricht University Medical Center and School for Public Health and Primary Care (CAPHRI); Maastricht University; Maastricht The Netherlands

family: Webers

full_name: Casper Webers

given: Casper

family: Essers

full_name: Ivette Essers

given: Ivette

family: van Tubergen

full_name: Astrid van Tubergen

given: Astrid

family: Braun

full_name: Jürgen Braun

given: Jürgen

name: Zeisigwaldkliniken Bethanien; Chemnitz Germany

family: Heldmann

full_name: Frank Heldmann

given: Frank

family: Baraliakos

full_name: Xenofon Baraliakos

given: Xenofon

family: Boonen

full_name: Annelies Boonen

given: Annelies

journal_name: Arthritis Care & Research

lead_sponsor: Rheumazentrum Ruhrgebiet

location_country:
Netherlands
Finland
France
Belgium
Germany
United Kingdom

location_facility: University Central Hospital, Division of Rheumatology

location_facility: Universitair Ziekenhuis, Afdeling Rheumatologie

location_facility: Universitat R. Descartes, Hopital Cochin


title: A Pharmacokinetic Study to Assess Nevirapine Levels in HIV-infected Patients With Impaired Hepatic Function

summary: The objective of this study was to evaluate the steady-state clearance of nevirapine among HIV-1 positive patients with hepatic fibrosis, and to examine whether the degree of hepatic impairment influences clearance.

lead_sponsor: Boehringer Ingelheim

location_country:
United States
France
Spain

location_facility: Boehringer Ingelheim Investigational Site

location_facility: Hospital Clinico y Provincial de Barcelona - HIV


title: Multicenter Prospective Study of Low-Flow Low-Gradient Aortic Stenosis (TOPAS Study Phase III)

summary:
Low-flow, low-gradient (LF-LG) aortic stenosis (AS) may occur with depressed (i.e. Classical LF; CLF) or preserved (i.e. Paradoxical LF; PLF) LV ejection fraction (LVEF) and both situations are amongst the most challenging encountered in patients with valvular heart disease. Although, CLF-LG AS is recognized has an important clinical entity, current ACC/AHA-ESC guidelines however do not provide precise recommendations for clinical management of these patients . PLF-LG AS is a new entity recently described by our group, which is characterized by more pronounced LV concentric remodeling with smaller LV cavity size and a restrictive physiology leading to impaired LV filling, altered myocardial function, and a low-flow state. Up to recently, this entity was often misdiagnosed, leading to underestimation of AS severity and inappropriate delays for aortic valve replacement surgery (SAVR). The two main challenges in patients with CLF- or PLF- LG AS are to distinguish between a true-severe (TS) versus a pseudo-severe (PS) stenosis and to accurately quantify the extent of myocardial impairment. Unfortunately, the traditional resting and stress echocardiographic parameters currently used to assess the severity of valvular and myocardial dysfunction in patients with LF-LG AS are far from being optimal, and as a consequence, quantification of disease severity and therapeutic management may not be appropriate in a substantial proportion of these patients.

THE GENERAL OBJECTIVES of the TOPAS study are to develop and validate new parameters and biomarkers to improve the assessment of stenosis severity and myocardial impairment, the risk-stratification, and the clinical decision making in patients with LF-LG AS and to assess the impact of the different therapeutic strategies on patient outcomes.

time_perspective: Prospective

ReferenceCitation: Blais C, Dumesnil JG, Baillot R, Simard S, Doyle D, Pibarot P. Impact of valve prosthesis-patient mismatch on short-term mortality after aortic valve replacement. Circulation. 2003 Aug 26;108(8):983-8. Epub 2003 Aug 11.

ReferenceCitation: Mohty D, Dumesnil JG, Echahidi N, Mathieu P, Dagenais F, Voisine P, Pibarot P. Impact of prosthesis-patient mismatch on long-term survival after aortic valve replacement: influence of age, obesity, and left ventricular dysfunction. J Am Coll Cardiol. 2009 Jan 6;53(1):39-47. doi: 10.1016/j.jacc.2008.09.022.

ReferenceCitation: Hachicha Z, Dumesnil JG, Bogaty P, Pibarot P. Paradoxical low-flow, low-gradient severe aortic stenosis despite preserved ejection fraction is associated with higher afterload and reduced survival. Circulation. 2007 Jun 5;115(22):2856-64. Epub 2007 May 28.

ReferenceCitation: Hachicha Z, Dumesnil JG, Pibarot P. Usefulness of the valvuloarterial impedance to predict adverse outcome in asymptomatic aortic stenosis. J Am Coll Cardiol. 2009 Sep 8;54(11):1003-11. doi: 10.1016/j.jacc.2009.04.079.

ReferenceCitation: Pibarot P, Dumesnil JG. Low-flow, low-gradient aortic stenosis with normal and depressed left ventricular ejection fraction. J Am Coll Cardiol. 2012 Nov 6;60(19):1845-53. doi: 10.1016/j.jacc.2012.06.051. Epub 2012 Oct 10. Review.

ReferenceCitation: Dumesnil JG, Pibarot P, Carabello B. Paradoxical low flow and/or low gradient severe aortic stenosis despite preserved left ventricular ejection fraction: implications for diagnosis and treatment. Eur Heart J. 2010 Feb;31(3):281-9. doi: 10.1093/eurheartj/ehp361. Epub 2009 Sep 8. Review.

ReferenceCitation: Dumesnil JG, Pibarot P. Evaluation of aortic stenosis severity: new challenges, new solutions. J Am Soc Echocardiogr. 2011 Sep;24(9):992-4. doi: 10.1016/j.echo.2011.07.011.

ReferenceCitation: Pibarot P, Dumesnil JG. Assessment of aortic stenosis severity: when the gradient does not fit with the valve area. Heart. 2010 Sep;96(18):1431-3. doi: 10.1136/hrt.2010.195149.

ReferenceCitation: Pibarot P, Dumesnil JG. Paradoxical low-flow, low-gradient aortic stenosis adding new pieces to the puzzle. J Am Coll Cardiol. 2011 Jul 19;58(4):413-5. doi: 10.1016/j.jacc.2011.01.057.

ReferenceCitation: Pibarot P, Dumesnil JG. Improving assessment of aortic stenosis. J Am Coll Cardiol. 2012 Jul 17;60(3):169-80. doi: 10.1016/j.jacc.2011.11.078. Review.

ReferenceCitation: Picano E, Pibarot P, Lancellotti P, Monin JL, Bonow RO. The emerging role of exercise testing and stress echocardiography in valvular heart disease. J Am Coll Cardiol. 2009 Dec 8;54(24):2251-60. doi: 10.1016/j.jacc.2009.07.046.

ReferenceCitation: Rodriguez-Gabella T, Nombela-Franco L, Auffret V, Asmarats L, Islas F, Maes F, Ferreira-Neto AN, Paradis JM, Dumont E, Côté M, Jiménez-Quevedo P, Macaya C, Pibarot P, Rodés-Cabau J. Transcatheter Aortic Valve Implantation in Patients With Paradoxical Low-Flow, Low-Gradient Aortic Stenosis. Am J Cardiol. 2018 Aug 15;122(4):625-632. doi: 10.1016/j.amjcard.2018.04.044. Epub 2018 May 17.

ReferenceCitation: Annabi MS, Clisson M, Clavel MA, Pibarot P. Workup and Management of Patients With Paradoxical Low-Flow, Low-Gradient Aortic Stenosis. Curr Treat Options Cardiovasc Med. 2018 May 2;20(6):49. doi: 10.1007/s11936-018-0642-y. Review.

ReferenceCitation: Ribeiro HB, Lerakis S, Gilard M, Cavalcante JL, Makkar R, Herrmann HC, Windecker S, Enriquez-Sarano M, Cheema AN, Nombela-Franco L, Amat-Santos I, Muñoz-García AJ, Garcia Del Blanco B, Zajarias A, Lisko JC, Hayek S, Babaliaros V, Le Ven F, Gleason TG, Chakravarty T, Szeto WY, Clavel MA, de Agustin A, Serra V, Schindler JT, Dahou A, Puri R, Pelletier-Beaumont E, Côté M, Pibarot P, Rodés-Cabau J. Transcatheter Aortic Valve Replacement in Patients With Low-Flow, Low-Gradient Aortic Stenosis: The TOPAS-TAVI Registry. J Am Coll Cardiol. 2018 Mar 27;71(12):1297-1308. doi: 10.1016/j.jacc.2018.01.054.

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name: From the Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart and Lung Institute, Laval University, Québec, Canada (M.A.C., J.R.-C., E.D., R.D.L., D.D., S.B., J.G.D., R.B., P.M., P.P.); St Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada (J.G.W., J.B.M., R.M., R.G.); Munster Adult Congenital and Valvular Heart Disease Center, Department of Cardiology and Angiology, University of Muenster, Germany (H.B., A.K.); University of Ottawa Heart...

family: Clavel

full_name: M.A. Clavel

family: Webb

full_name: J.G. Webb

family: Rodés-Cabau

full_name: J. Rodés-Cabau

family: Masson

full_name: J.B. Masson

family: Dumont

full_name: E. Dumont

given: E.

family: De Larochellière

full_name: R. De Larochellière

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family: Doyle

full_name: D. Doyle

given: D.

family: Bergeron

full_name: S. Bergeron

family: Baumgartner

full_name: H. Baumgartner

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family: Burwash

full_name: I.G. Burwash

family: Dumesnil

full_name: J.G. Dumesnil

family: Mundigler

full_name: G. Mundigler

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family: Moss

full_name: R. Moss

family: Kempny

full_name: A. Kempny

given: A.

family: Bagur

full_name: R. Bagur

family: Bergler-Klein

full_name: J. Bergler-Klein

family: Gurvitch

full_name: R. Gurvitch

title: Comparison Between Transcatheter and Surgical Prosthetic Valve Implantation in Patients With Severe Aortic Stenosis and Reduced Left Ventricular Ejection Fraction

ReferenceCitation: Clavel MA, Fuchs C, Burwash IG, Mundigler G, Dumesnil JG, Baumgartner H, Bergler-Klein J, Beanlands RS, Mathieu P, Magne J, Pibarot P. Predictors of outcomes in low-flow, low-gradient aortic stenosis: results of the multicenter TOPAS Study. Circulation. 2008 Sep 30;118(14 Suppl):S234-42. doi: 10.1161/CIRCULATIONAHA.107.757427.

name: From the Laval Hospital Research Center/Québec Heart Institute (M.A.C., C.F., J.M., J.G.D., P.M., P.P.), Laval University, Québec, Canada; Vienna General Hospital (C.F., G.M., H.B., J.B.K.), Medical University of Vienna, Vienna, Austria; and the University of Ottawa Heart Institute (I.G.B., R.B.), Ottawa, Ontario, Canada.

title: Predictors of Outcomes in Low-Flow, Low-Gradient Aortic Stenosis

ReferenceCitation: Bergler-Klein J, Mundigler G, Pibarot P, Burwash IG, Dumesnil JG, Blais C, Fuchs C, Mohty D, Beanlands RS, Hachicha Z, Walter-Publig N, Rader F, Baumgartner H. B-type natriuretic peptide in low-flow, low-gradient aortic stenosis: relationship to hemodynamics and clinical outcome: results from the Multicenter Truly or Pseudo-Severe Aortic Stenosis (TOPAS) study. Circulation. 2007 Jun 5;115(22):2848-55. Epub 2007 May 21.

ReferenceCitation: Burwash IG, Lortie M, Pibarot P, de Kemp RA, Graf S, Mundigler G, Khorsand A, Blais C, Baumgartner H, Dumesnil JG, Hachicha Z, DaSilva J, Beanlands RS. Myocardial blood flow in patients with low-flow, low-gradient aortic stenosis: differences between true and pseudo-severe aortic stenosis. Results from the multicentre TOPAS (Truly or Pseudo-Severe Aortic Stenosis) study. Heart. 2008 Dec;94(12):1627-33. doi: 10.1136/hrt.2007.135475. Epub 2008 Apr 1.

ReferenceCitation: Clavel MA, Webb JG, Pibarot P, Altwegg L, Dumont E, Thompson C, De Larochellière R, Doyle D, Masson JB, Bergeron S, Bertrand OF, Rodés-Cabau J. Comparison of the hemodynamic performance of percutaneous and surgical bioprostheses for the treatment of severe aortic stenosis. J Am Coll Cardiol. 2009 May 19;53(20):1883-91. doi: 10.1016/j.jacc.2009.01.060.

journal_name: Journal of the American College of Cardiology

title: Comparison of the Hemodynamic Performance of Percutaneous and Surgical Bioprostheses for the Treatment of Severe Aortic Stenosis

ReferenceCitation: Clavel MA, Rodés-Cabau J, Dumont É, Bagur R, Bergeron S, De Larochellière R, Doyle D, Larose E, Dumesnil JG, Pibarot P. Validation and characterization of transcatheter aortic valve effective orifice area measured by Doppler echocardiography. JACC Cardiovasc Imaging. 2011 Oct;4(10):1053-62. doi: 10.1016/j.jcmg.2011.06.021.

title: Validation and Characterization of Transcatheter Aortic Valve Effective Orifice Area Measured by Doppler Echocardiography

ReferenceCitation: Clavel MA, Dumesnil JG, Capoulade R, Mathieu P, Sénéchal M, Pibarot P. Outcome of patients with aortic stenosis, small valve area, and low-flow, low-gradient despite preserved left ventricular ejection fraction. J Am Coll Cardiol. 2012 Oct 2;60(14):1259-67. doi: 10.1016/j.jacc.2011.12.054. Epub 2012 May 30.

title: Outcome of Patients With Aortic Stenosis, Small Valve Area, and Low-Flow, Low-Gradient Despite Preserved Left Ventricular Ejection Fraction

ReferenceCitation: Annabi MS, Côté N, Dahou A, Bartko PE, Bergler-Klein J, Burwash IG, Orwat S, Baumgartner H, Mascherbauer J, Mundigler G, Fukui M, Cavalcante J, Ribeiro HB, Rodès-Cabau J, Clavel MA, Pibarot P. Comparison of Early Surgical or Transcatheter Aortic Valve Replacement Versus Conservative Management in Low-Flow, Low-Gradient Aortic Stenosis Using Inverse Probability of Treatment Weighting: Results From the TOPAS Prospective Observational Cohort Study. J Am Heart Assoc. 2020 Dec 15;9(24):e017870. doi: 10.1161/JAHA.120.017870. Epub 2020 Dec 8.

name: Institut Universitaire de Cardiologie et de Pneumologie de Québec‐Université Laval Québec Canada

name: Division of Cardiology Department of Internal Medicine II Medical University of ViennaVienna General Hospital Vienna Austria

name: University of Ottawa Heart Institute Ottawa Ontario Canada

name: Department of Cardiology III–Adult Congenital and Valvular Heart Disease University Hospital Muenster Muenster Germany

name: Cardiology Minneapolis Heart Institute Minneapolis MN

name: Division of Cardiology University of Pittsburgh PA

name: Heart Institute of São Paulo (InCor)University of São Paulo Brazil

journal_name: Journal of the American Heart Association

repository_institution: Université Laval - Corpus Université Laval

title: Comparison of Early Surgical or Transcatheter Aortic Valve Replacement Versus Conservative Management in Low‐Flow, Low‐Gradient Aortic Stenosis Using Inverse Probability of Treatment Weighting: Results From the TOPAS Prospective Observational Cohort Study

ReferenceCitation: Dahou A, Clavel MA, Capoulade R, O'Connor K, Ribeiro HB, Côté N, Le Ven F, Rodés-Cabau J, Dumesnil JG, Mathieu P, Pibarot P. B-Type Natriuretic Peptide and High-Sensitivity Cardiac Troponin for Risk Stratification in Low-Flow, Low-Gradient Aortic Stenosis: A Substudy of the TOPAS Study. JACC Cardiovasc Imaging. 2018 Jul;11(7):939-947. doi: 10.1016/j.jcmg.2017.06.018. Epub 2017 Oct 5.

location_country:
Austria
United States
Germany
France
Belgium
Canada