title: Anticoagulant Clinic-based Shared-care Versus Usual Cate Management of Vitamin K Antagonist Therapy : the Open, Randomized Multicenter Study

acronym: COMPARE

summary:
Background: Whether the management of vitamin K antagonists (VKA) therapy by general practitioners with the collaboration of anticoagulation clinics (ACC) provides better clinical outcomes than that accomplished by general practitioners alone (usual care [UC] management) is not clear.

Objectives: To compare ACC-based shared-care management with UC management of VKA therapy with respect to clinical events.

Patients/Methods: Open, randomized, multicenter study in patients starting VKA therapy for at least three months. The primary study outcome is a composite of confirmed symptomatic thromboembolic or major bleeding events. All-cause mortality is a secondary outcome. All outcomes are reviewed by a central, independent adjudication committee.

location_facility:
Louis Pasteur Hospital
University Hospital
Dupuytren University Hospital
Rangueil University Hospital
Bellevue University Hospital


title: Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy

acronym: DONTBIOPCE

summary: This study will collect data from patients routinely undergoing a endoscopic surveillance and Cellvizio endomicroscopy procedure due to confirmed Barrett's esophagus. The objective is to determine if endomicroscopy images collected using the marketed Cellvizio device may help endoscopists more accurately diagnose, in conjunction with traditional tissue sampling techniques, whether a suspected lesion is malignant or benign.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Diagnostic

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Sharma P, Meining AR, Coron E, Lightdale CJ, Wolfsen HC, Bansal A, Bajbouj M, Galmiche JP, Abrams JA, Rastogi A, Gupta N, Michalek JE, Lauwers GY, Wallace MB. Real-time increased detection of neoplastic tissue in Barrett's esophagus with probe-based confocal laser endomicroscopy: final results of an international multicenter, prospective, randomized, controlled trial. Gastrointest Endosc. 2011 Sep;74(3):465-72. doi: 10.1016/j.gie.2011.04.004. Epub 2011 Jul 13.

family: Sharma

full_name: Prateek Sharma

given: Prateek

sequence: first

family: Meining

full_name: Alexander R. Meining

given: Alexander R.

sequence: additional

family: Coron

full_name: Emmanuel Coron

given: Emmanuel

family: Lightdale

full_name: Charles J. Lightdale

given: Charles J.

family: Wolfsen

full_name: Herbert C. Wolfsen

given: Herbert C.

family: Bansal

full_name: Ajay Bansal

given: Ajay

family: Bajbouj

full_name: Monther Bajbouj

given: Monther

family: Galmiche

full_name: Jean-Paul Galmiche

given: Jean-Paul

family: Abrams

full_name: Julian A. Abrams

given: Julian A.

family: Rastogi

full_name: Amit Rastogi

given: Amit

family: Gupta

full_name: Neil Gupta

given: Neil

family: Michalek

full_name: Joel E. Michalek

given: Joel E.

family: Lauwers

full_name: Gregory Y. Lauwers

given: Gregory Y.

family: Wallace

full_name: Michael B. Wallace

given: Michael B.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Gastrointestinal Endoscopy

oa_host_type: repository

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

host_type: repository

license_normalized: no license

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

version: publishedVersion

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ipd_sharing: No

lead_sponsor: Mauna Kea Technologies

location_country:
Germany
United States
France

location_facility: New York Presbyterian Hospital/Columbia University Medical Center

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


title: Phase 1 Targeted Combination Trial Of PF-00299804 And CP-751,871 In Patients With Advanced Solid Tumors

summary: This study will explore the combination of the oral drug PF-00299804 and intravenous CP-751,871 in patients with advanced solid tumor. Each of these drugs have been given separately to patients in prior studies, and this study is to establish the safety and efficacy of the combination.

design_allocation: Non-Randomized

primary_purpose: Treatment

lead_sponsor: Pfizer

location_country:
United States
France
Spain

intervention_type: Drug


title: Calcipotriol Plus Betamethasone Dipropionate Gel Compared to DAIVONEX/DOVONEX Scalp Solution in Patients With Scalp Psoriasis

summary:
The purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of calcipotriol plus betamethasone dipropionate gel is more effective than twice daily treatment of calcipotriol scalp solution in patients with scalp psoriasis. The primary outcome is patients with clear or minimal disease after 8 weeks treatment.

Further the occurrence of relapse and rebound after end of treatment in patients with clear or minimal disease will be investigated.

lead_sponsor: LEO Pharma

location_country: Sweden France Belgium Denmark Canada

location_facility: Hôpital de L'Archet, Service de Dermatologie

location_facility: Department of Dermatology, Marselisborg Centres

location_facility: Universitair Ziekenhuis Sint Raphaël, Dienst Dermatologie


type: Registry Identifier

title: A Phase II Study of VNP40101M For Patients With Acute Myelogenous Leukemia Or High-Risk Myelodysplasia

summary:
RATIONALE: Drugs used in chemotherapy, such as VNP40101M and hydroxyurea, work in different ways to stop cancer cells from dividing so they stop growing or die. Hydroxyurea may help VNP40101M kill more cancer cells by making cancer cells more sensitive to the drug.

PURPOSE: This phase II trial is studying how well giving VNP40101M with hydroxyurea works in treating patients with acute myelogenous leukemia or high-risk myelodysplasia.

enrollment_type: Anticipated

ReferenceCitation: Gerson SL, Karp J, Rizzieri D, et al.: Low levels of pre-treatment O6-alkylguanine transferase (AGT) in patients with AML correlate with response to Cloretazine® (VNP40101M) induction therapy. [Abstract] American Association for Cancer Research: 98th Annual Meeting, April 14-18, 2007, Los Angeles, CA. A-2640, 2007.

ReferenceCitation: Giles F, Rizzieri D, Karp J, Vey N, Ravandi F, Faderl S, Khan KD, Verhoef G, Wijermans P, Advani A, Roboz G, Kantarjian H, Bilgrami SF, Ferrant A, Daenen SM, Karsten V, Cahill A, Albitar M, Mufti G, O'Brien S. Cloretazine (VNP40101M), a novel sulfonylhydrazine alkylating agent, in patients age 60 years or older with previously untreated acute myeloid leukemia. J Clin Oncol. 2007 Jan 1;25(1):25-31. Epub 2006 Dec 4.

lead_sponsor: Vion Pharmaceuticals

location_country:
United States
United Kingdom
France

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: M.D. Anderson Cancer Center at University of Texas


title: A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes in Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate

summary: Study to evaluate whether there is sustained remission and productivity in subjects with early rheumatoid arthritis started on etanercept plus methotrexate treatment.

ReferenceType: derived

ReferenceCitation: Tanaka Y, Smolen JS, Jones H, Szumski A, Marshall L, Emery P. The effect of deep or sustained remission on maintenance of remission after dose reduction or withdrawal of etanercept in patients with rheumatoid arthritis. Arthritis Res Ther. 2019 Jul 5;21(1):164. doi: 10.1186/s13075-019-1937-4.

family: Tanaka

full_name: Yoshiya Tanaka

given: Yoshiya

family: Smolen

full_name: Josef S. Smolen

given: Josef S.

family: Jones

full_name: Heather Jones

given: Heather

family: Szumski

full_name: Annette Szumski

given: Annette

family: Marshall

full_name: Lisa Marshall

given: Lisa

family: Emery

full_name: Paul Emery

given: Paul

currency_apc_doaj: GBP

journal_name: Arthritis Research & Therapy

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

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

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Fleischmann RM, van der Heijde D, Gardiner PV, Szumski A, Marshall L, Bananis E. DAS28-CRP and DAS28-ESR cut-offs for high disease activity in rheumatoid arthritis are not interchangeable. RMD Open. 2017 Jan 30;3(1):e000382. doi: 10.1136/rmdopen-2016-000382. eCollection 2017.

family: Fleischmann

full_name: Roy M Fleischmann

given: Roy M

family: van der Heijde

full_name: Désirée van der Heijde

given: Désirée

family: Gardiner

full_name: Philip V Gardiner

given: Philip V

family: Bananis

full_name: Eustratios Bananis

given: Eustratios

journal_name: RMD Open

license: cc-by-nc

ReferenceCitation: Zhang W, Bansback N, Sun H, Pedersen R, Kotak S, Anis AH. Impact of etanercept tapering on work productivity in patients with early rheumatoid arthritis: results from the PRIZE study. RMD Open. 2016 Jul 7;2(2):e000222. doi: 10.1136/rmdopen-2015-000222. eCollection 2016.

ReferenceCitation: Wiland P, Dudler J, Veale D, Tahir H, Pedersen R, Bukowski J, Vlahos B, Williams T, Gaylord S, Kotak S. The Effect of Reduced or Withdrawn Etanercept-methotrexate Therapy on Patient-reported Outcomes in Patients with Early Rheumatoid Arthritis. J Rheumatol. 2016 Jul;43(7):1268-77. doi: 10.3899/jrheum.151179. Epub 2016 Jun 1.

ReferenceCitation: Zhang W, Bansback N, Sun H, Pedersen R, Kotak S, Anis AH. Estimating the monetary value of the annual productivity gained in patients with early rheumatoid arthritis receiving etanercept plus methotrexate: interim results from the PRIZE study. RMD Open. 2015 Apr 8;1(1):e000042. doi: 10.1136/rmdopen-2014-000042. eCollection 2015.

ReferenceCitation: Emery P, Hammoudeh M, FitzGerald O, Combe B, Martin-Mola E, Buch MH, Krogulec M, Williams T, Gaylord S, Pedersen R, Bukowski J, Vlahos B. Sustained remission with etanercept tapering in early rheumatoid arthritis. N Engl J Med. 2014 Nov 6;371(19):1781-92. doi: 10.1056/NEJMoa1316133.

title: Sustained Remission with Etanercept Tapering in Early Rheumatoid Arthritis

location_country:
Italy
Switzerland
Netherlands
United Kingdom
France
Poland
Romania
Ireland
Russian Federation
Spain
Germany
Monaco
Qatar


acronym: INTEGRA®

summary: Comparison of 2 techniques of surgery on patients with inferior limb traumatic wounds: the innovative technique Integra® and the technique of reference: the flap surgery.

lead_sponsor: University Hospital, Bordeaux

location_facility:
University Hospital
Saint Roch Hospital
Universiy Hospital Bordeaux,

lead_sponsor_type: academique


type: EudraCT Number

title: Safety, Antiviral Activity, and Pharmacokinetics of BI 207127 NA Administered in Combination With Peg-IFN and Ribavirin in Chronic HCV-infected Patients for 4 Weeks, a Randomised, Double-blind, Placebo Controlled Study

summary: The main purpose of this clinical trial with BI 207127 is to see the effect of 4 week combination of BI 207127 with Peginterferon alfa (Peg-IFN) and Ribavirin (RBV) on hepatitis C virus (HCV) virus load and how safe BI 207127 is in this combination in HCV infected patients.

ReferenceCitation: Larrey D, Lohse AW, de Ledinghen V, Trepo C, Gerlach T, Zarski JP, Tran A, Mathurin P, Thimme R, Arastéh K, Trautwein C, Cerny A, Dikopoulos N, Schuchmann M, Heim MH, Gerken G, Stern JO, Wu K, Abdallah N, Girlich B, Scherer J, Berger F, Marquis M, Kukolj G, Böcher W, Steffgen J. Rapid and strong antiviral activity of the non-nucleosidic NS5B polymerase inhibitor BI 207127 in combination with peginterferon alfa 2a and ribavirin. J Hepatol. 2012 Jul;57(1):39-46. doi: 10.1016/j.jhep.2012.02.015. Epub 2012 Mar 10.

family: Larrey

full_name: Dominique Larrey

given: Dominique

family: Lohse

full_name: Ansgar W. Lohse

given: Ansgar W.

family: de Ledinghen

full_name: Victor de Ledinghen

given: Victor

family: Trepo

full_name: Christian Trepo

given: Christian

family: Gerlach

full_name: Tilman Gerlach

given: Tilman

family: Zarski

full_name: Jean-Pierre Zarski

given: Jean-Pierre

family: Tran

full_name: Albert Tran

given: Albert

family: Mathurin

full_name: Philippe Mathurin

given: Philippe

family: Thimme

full_name: Robert Thimme

given: Robert

family: Arastéh

full_name: Keikawus Arastéh

given: Keikawus

family: Trautwein

full_name: Christian Trautwein

family: Cerny

full_name: Andreas Cerny

given: Andreas

family: Dikopoulos

full_name: Nektarios Dikopoulos

given: Nektarios

family: Schuchmann

full_name: Marcus Schuchmann

given: Marcus

family: Heim

full_name: Markus H. Heim

given: Markus H.

family: Gerken

full_name: Guido Gerken

given: Guido

family: Stern

full_name: Jerry O. Stern

given: Jerry O.

family: Wu

full_name: Katherine Wu

given: Katherine

family: Abdallah

full_name: Nasri Abdallah

given: Nasri

family: Girlich

full_name: Birgit Girlich

given: Birgit

family: Scherer

full_name: Joseph Scherer

given: Joseph

family: Berger

full_name: Frank Berger

given: Frank

family: Marquis

full_name: Martin Marquis

given: Martin

family: Kukolj

location_facility: 1241.7.49002 Boehringer Ingelheim Investigational Site

location_facility: 1241.7.49001 Boehringer Ingelheim Investigational Site

location_facility: 1241.7.49012 Boehringer Ingelheim Investigational Site

location_facility: 1241.7.49004 Boehringer Ingelheim Investigational Site

location_facility: 1241.7.49011 Boehringer Ingelheim Investigational Site

location_facility: 1241.7.49013 Boehringer Ingelheim Investigational Site

location_facility: 1241.7.49009 Boehringer Ingelheim Investigational Site

location_facility: 1241.7.41001 Boehringer Ingelheim Investigational Site

location_facility: 1241.7.41003 Boehringer Ingelheim Investigational Site

location_facility: 1241.7.41004 Boehringer Ingelheim Investigational Site

location_facility: 1241.7.49010 Boehringer Ingelheim Investigational Site


ReferenceCitation: Kiladjian JJ, Guglielmelli P, Griesshammer M, Saydam G, Masszi T, Durrant S, Passamonti F, Jones M, Zhen H, Li J, Gadbaw B, Perez Ronco J, Khan M, Verstovsek S. Efficacy and safety of ruxolitinib after and versus interferon use in the RESPONSE studies. Ann Hematol. 2018 Apr;97(4):617-627. doi: 10.1007/s00277-017-3225-1. Epub 2018 Feb 2.

family: Kiladjian

full_name: Jean-Jacques Kiladjian

given: Jean-Jacques

family: Guglielmelli

full_name: Paola Guglielmelli

given: Paola

family: Griesshammer

full_name: Martin Griesshammer

family: Saydam

full_name: Guray Saydam

given: Guray

family: Masszi

full_name: Tamas Masszi

given: Tamas

family: Durrant

full_name: Simon Durrant

given: Simon

family: Passamonti

full_name: Francesco Passamonti

given: Francesco

family: Jones

full_name: Mark Jones

given: Mark

family: Zhen

full_name: Huiling Zhen

given: Huiling

family: Li

full_name: Jingjin Li

given: Jingjin

family: Gadbaw

full_name: Brian Gadbaw

given: Brian

family: Perez Ronco

full_name: Julian Perez Ronco

given: Julian

family: Khan

full_name: Mahmudul Khan

given: Mahmudul

family: Verstovsek

full_name: Srdan Verstovsek

given: Srdan

journal_name: Annals of Hematology

ReferenceCitation: Passamonti F, Griesshammer M, Palandri F, Egyed M, Benevolo G, Devos T, Callum J, Vannucchi AM, Sivgin S, Bensasson C, Khan M, Mounedji N, Saydam G. Ruxolitinib for the treatment of inadequately controlled polycythaemia vera without splenomegaly (RESPONSE-2): a randomised, open-label, phase 3b study. Lancet Oncol. 2017 Jan;18(1):88-99. doi: 10.1016/S1470-2045(16)30558-7. Epub 2016 Dec 2.

family: Palandri

full_name: Francesca Palandri

given: Francesca

family: Egyed

full_name: Miklos Egyed

given: Miklos

family: Benevolo

full_name: Giulia Benevolo

given: Giulia

family: Devos

full_name: Timothy Devos

given: Timothy

family: Callum

full_name: Jeannie Callum

given: Jeannie

family: Vannucchi

full_name: Alessandro M Vannucchi

given: Alessandro M

family: Sivgin

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
India
Germany
France
Israel
Hungary
Belgium
Australia
Spain
Turkey
Canada
Korea, Republic of

title: Randomized, Open Label, Multicenter Phase IIIb Study Evaluating the Efficacy and Safety of Ruxolitinib Versus Best Available Therapy in Patients With Polycythemia Vera Who Are Hydroxyurea Resistant or Intolerant (Response 2)

summary: This study compared the efficacy and safety of ruxolitinib to Best Available Therapy (BAT) in patients with polycythemia vera (PV) who were hydroxyurea (HU) resistant or intolerant and did not have a palpable spleen.


title: Evaluation of Acute Pain in Maltreated Children : a Prospective, Multicentric and Controlled Study

acronym: ANTALPED

summary: The hypothesis of this study is nonrecognition by the medical team of pain in maltreated children. These children would have a particular painful behaviour, "quiet". The management of their pain would be then unsuited, which could explain their complex relation with the pain in the adulthood. A pilot study realized in the CHU of Nantes on 11 files of maltreated children showed that they had very low scores of evaluation of the pain, in spite of severe traumatisms. There is, at the moment, no data in the literature on the acute pain of the maltreated children.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Drouineau MH, Guenego E, Sebille-Rivain V, Vrignaud B, Balençon M, Blanchais T, Levieux K, Vabres N, Picherot G, Guen CG. Do abused young children feel less pain? Child Abuse Negl. 2017 Mar;65:248-254. doi: 10.1016/j.chiabu.2017.02.002. Epub 2017 Feb 11.

family: Drouineau

full_name: Marie-Hélène Drouineau

given: Marie-Hélène

family: Guenego

full_name: Elise Guenego

given: Elise

family: Sebille-Rivain

full_name: Véronique Sebille-Rivain

given: Véronique

family: Vrignaud

full_name: Bénédicte Vrignaud

given: Bénédicte

family: Balençon

full_name: Martine Balençon

given: Martine

family: Blanchais

full_name: Thomas Blanchais

given: Thomas

family: Levieux

full_name: Karine Levieux

given: Karine

family: Vabres

full_name: Nathalie Vabres

given: Nathalie

family: Picherot

full_name: Georges Picherot

given: Georges

family: Guen

full_name: Christèle Gras-le Guen

given: Christèle Gras-le

journal_name: Child Abuse & Neglect

lead_sponsor: Nantes University Hospital

location_facility:
Angers university Hospital
Ch Cholet
GHH
rennes university Hospital
CHD les oudairies
nantes University Hospital
CH Saint Nazaire


type: Other Identifier

title: An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Levemir® (Insulin Detemir) in Pregnant Women With Diabetes Mellitus

summary: This study is conducted in Europe and Asia. The purpose of the study (Diabetes Pregnancy Registry) is to evaluate the safety of treatment with insulin detemir in pregnant women with diabetes mellitus.

study_start_date_type: Actual

ReferenceCitation: Mathiesen ER, Andersen H, Kring SI, Damm P. Design and rationale of a large, international, prospective cohort study to evaluate the occurrence of malformations and perinatal/neonatal death using insulin detemir in pregnant women with diabetes in comparison with other long-acting insulins. BMC Pregnancy Childbirth. 2017 Jan 18;17(1):38. doi: 10.1186/s12884-016-1177-4.

family: Mathiesen

full_name: Elisabeth R. Mathiesen

given: Elisabeth R.

family: Andersen

full_name: Henning Andersen

given: Henning

family: Kring

full_name: Sofia I. I. Kring

given: Sofia I. I.

family: Damm

full_name: Peter Damm

given: Peter

journal_name: BMC Pregnancy and Childbirth

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

repository_normalized: Pure (Denmark)

repositories:
PubMed Central
Pure (Denmark)

ReferenceCitation: Mathiesen ER, Ali N, Alibegovic AC, Anastasiou E, Cypryk K, de Valk H, Dores J, Dunne F, Gall MA, Garcia SD, Hanaire HP, Husemoen LLN, Ivanišević M, Kempe HP, McCance DR, Damm P. Risk of Major Congenital Malformations or Perinatal or Neonatal Death With Insulin Detemir Versus Other Basal Insulins in Pregnant Women With Preexisting Diabetes: The Real-World EVOLVE Study. Diabetes Care. 2021 Sep;44(9):2069-2077. doi: 10.2337/dc21-0472. Epub 2021 Jul 30.

family: Ali

full_name: Norsiah Ali

given: Norsiah

family: Alibegovic

full_name: Amra C. Alibegovic

given: Amra C.

family: Anastasiou

full_name: Eleni Anastasiou

given: Eleni

family: Cypryk

full_name: Katarzyna Cypryk

given: Katarzyna

family: de Valk

full_name: Harold de Valk

given: Harold

family: Dores

full_name: Jorge Dores

given: Jorge

family: Dunne

full_name: Fidelma Dunne

given: Fidelma

family: Gall

full_name: Mari-Anne Gall

given: Mari-Anne

family: Garcia

full_name: Santiago Duran Garcia

location_country:
Italy
Netherlands
Spain
Finland
Croatia
France
Greece
Israel
Malaysia
Norway
Ireland
Poland
Romania
Portugal
Germany
United Kingdom


title: A Multicentre, Single Arm, Observational Phase IV Study to Assess the Safety and Efficacy of Nelarabine in Children and Young Adults (up to 21 Years of Age) With Relapsed or Refractory T-Lineage Acute Lymphoblastic Leukaemia or Lymphoblastic Lymphoma

summary: This international, multicentre, single arm, phase IV study will assess the safety and efficacy of nelarabine in children and young adults with relapsed or refractory T-lineage acute lymphoblastic leukaemia (T-ALL) or lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. It is a post-authorisation safety study (PASS) conducted for the purpose of confirming the safety profile and the clinical benefit of nelarabine under licensed conditions of use. The study is observational, non-interventional, and will include approximately 40 children and young adults (up to 21 years of age).

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Netherlands
France
Poland
Israel
Russian Federation
Spain
Denmark
Germany


title: Prevention of Central Veinous Device Related Sepsis Relapse With Taurolidine in Patients on Parenteral Nutrition in Long-term Home

acronym: Nutrilock

summary:
Home parenteral nutrition (HPN) is a validated technique for patients with various intestinal disease leading to chronic malabsorption or obstruction, whatever the aetiology. Intravascular catheter-related bloodstream infections (CRBSI) is the more frequent complication of patients with HPN and an important cause of morbidity and mortality in these patients. Moreover, CRBSI often recur after a first treatment of the catheter with a combination of an antibiotic lock on the catheter and systemic intravenous antibiotics. In more than 50 % of the cases, another CRBSI will occur in a median delay of 5 months.

The aim of the study is to evaluate the efficacy of a taurolidine lock secondary prophylaxis on CRBSI recurrence in HPN patients.

Study population is separated in 2 groups, the first one receiving the Taurolock and the second one receiving a placebo. This is a randomized double-blind six-month study.

status: Terminated

primary_purpose: Prevention

lead_sponsor: University Hospital, Rouen

location_facility:
APHP Beaujon Hospital
UH of Lyon
UH of Nice
UH of Lille
University Hospital of Rouen
UH of Toulouse
UH of Grenoble

status_simplified: Unknown


title: Analysis of the Expression of a Specific Set of Genes and Tumor Antigens in Patients With Non-small Cell Lung Cancer or Melanoma

summary: This study intends to analyze the expression of specific sets of markers in tumor samples and in serum from patients with Non-Small Cell lung Cancer (NSCLC) or Stage III or IV melanoma. The data obtained in this study will be used to guide future development of immunotherapies for melanoma or NSCLC patients. Moreover, the analyses will contribute to definition of markers potentially predictive of clinical response to specific anticancer therapies.

primary_purpose: Screening

location_country:
Italy
United States
Sweden
France
Germany

intervention_type: Procedure


title: Study of the Role of Tissular Maternofetal Alloimmunization in Placentation Pathologies

summary:
Justification:

We have recently demonstrated that maternofetal alloimmunization was not limited to blood cells: maternal alloimmunization against a glomerular podocyte antigen expressed by the placenta can induce neonatal membranous glomerulonephritis.

Early recurrent pregnancy losses, preeclampsia and intervillositis are obstetrical pathologies which share an anomaly of placentation. Pathophysiology of these diseases is not yet fully understood; nevertheless the hypothesis of an incompatibility between mother and child is often mentioned. The aim of this project is to detect and study the cases of recurrent pregnancy losses, preeclamspia and intervillositis which could be induced by tissular maternofetal alloimmunization.

Materials and methods:

Patients suffering from recurrent pregnancy losses of unknown origin, preeclamspia or intervillositis will be included in this project. Mothers' sera will be studied by indirect immunofluorescence and Western Blot on placental biopsies from different origins and gestational ages. This stage will enable us to detect possible maternal allo-antibodies. After detecting and revealing antibodies, nature of the target antigen will be identified by immunoprecipitation of placental extracts, using the positive sera. Immunoprecipitation will be followed by a mass spectrometry analysis of detected proteins.

Expected results:

This study will enable us:

to detect new cases of tissular maternofetal alloimmunization
to improve our knowledge of mechanisms leading to anomalies of placentation
to carry out a specific, preventive therapeutic approach for cases induced by tissular alloimmunization.

Key words:

Recurrent pregnancy losses, Preeclampsia, Intervillositis, maternofetal alloimmunization.

lead_sponsor: University Hospital, Limoges

location_facility:
South Reunion Hospital
Tenon Hospital
LIMOGES University Hospital
Trousseau Hospital
Saint Antoine Hospital
Bordeaux University Hospital
Toulouse University Hospital


summary: Anti-cancer treatment is often inducing side-effects that can affect the compliance to the treatment protocol and quality of life of the patients. The researchers will study if the nutritional intervention with the product could abrogate the undesired effects in a preventive manner.

lead_sponsor: Nestlé

location_facility:
CH Béziers
CH Perpignan
CRLCC Léon Bérard
CHU Charles Nicolle
CHU Montpellier
Institut Sainte-Catherine
CRLC Val d'Aurelle


title: Noninvasive Ventilatory Support After Lung Surgery to Prevent Pulmonary Complications in COPD Patients

acronym: POPVNI

summary:
Rationale: respiratory complications are the most frequent complications following lung resection and represent a noticeable cause of mortality. Benefits from non-invasive ventilation (NIV) in acute respiratory failure are now clearly demonstrated. The use of preventive NIV after lung resection, in the absence of acute respiratory failure and/or hypercarbia, could be justified by the physiological benefits expected. The goal of this study is to assess the efficacy of post-operative NIV in moderate-to-severe COPD, for prevention of respiratory complications.

Material and Methods: This is a prospective randomised multicenter trial with an open parallel design in moderate-t-o-severe COPD patients hospitalised in thoracic surgery for lung resection.

Expected results: This study will determine whether post-operative NIV decreases the incidence of acute respiratory events (acute respiratory failure) and whether some subgroups of patients benefit more from this strategy.

Conclusion: This study should help evaluating the utility of post-operative NIV after lung resection.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Hopital Du Bocage
CHU Larrey
hopital de Pontoise
Hotel Dieu
HEGP
CHU strasbourg
Institut Mutualiste Montsouris


title: Phase I-II Clinical and Pharmacokinetic Study of Irofulven in Combination With Oxaliplatin in Patients With Advanced Solid Tumors

summary: The purpose of this study is to determine the maximum tolerated dose (MTD) and to investigate the efficacy, safety and pharmacokinetics of irofulven combined with oxaliplatin in patients with advanced solid tumors.

status: Unknown status

lead_sponsor: Eisai Inc.


title: A Phase II Trial Pemetrexed Carboplatin as First Line Chemotherapy for Advanced Non-Small Cell Lung Cancer (NSCLC) in Elderly Patients

summary: A phase II study to evaluate the efficacy and safety profile of the combination of Pemetrexed and Carboplatin in elderly patients with advanced non-small cell lung cancer

lead_sponsor: Eli Lilly and Company

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


title: Multicentric Phase II Study of Concomitant Chemo-radiotherapy in Locally Advanced Non Small Cell Lung Cancer, With :- Induction Chemotherapy by Cisplatin - Docetaxel- Concomitant Chemo-radiotherapy by Weekly Cisplatin - Docetaxel- Consolidation Chemotherapy by Docetaxel

acronym: BIB 01

summary: Feasibility of pragmatic concomitant chemo-radiotherapy association with 1 cycle of Induction chemotherapy, weekly chemo-radiotherapy, and consolidation chemotherapy.

lead_sponsor: Institut Bergonié

location_facility: Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: Multicentric Phase II Study to Evaluate Feasibility and Efficacy of Association of Imatinib Mesylate and Zoledronic Acid in Patients With Chronic Myeloid Leukaemia in Cytogenetic Response Without Molecular Response After One Year of Imatinib Mesylate Monotherapy

summary: Imatinib mesylate is standard treatment of Chronic myeloid leukaemia, complete cytogenetic response is obtained in most of cases but molecular response concerned only a small part of the patients. To increase molecular response ratio we decided to increase imatinib dose to limited resistance to this drug and to add zoledronate for it anti tumoral activity to increase anti leukemic effect. We plan to accrue 37 patients in 5 centers. We will analyse molecular expression of BCR-ABL transcript after 6 months of treatment, safety, duration of response, VEGF expression and LTgd production.

location_facility: Centre Hospitalier Universitaire de Poitiers


title: Efficacy and Safety of Chest Physiotherapy With Forced Expiratory Technique for Acute Bronchiolitis in Toddlers

acronym: BRONKINOU

summary: The purpose of this study is to determine whether chest physiotherapy with forced expiratory technique reduces delay of healing in acute bronchiolitis of children between 15 days and 24 months of age.

ReferenceType: background

ReferenceCitation: Perrotta C, Ortiz Z, Roque M. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD004873. Review. Update in: Cochrane Database Syst Rev. 2007;(1):CD004873.

ReferenceCitation: Gajdos V, Katsahian S, Beydon N, Abadie V, de Pontual L, Larrar S, Epaud R, Chevallier B, Bailleux S, Mollet-Boudjemline A, Bouyer J, Chevret S, Labrune P. Effectiveness of chest physiotherapy in infants hospitalized with acute bronchiolitis: a multicenter, randomized, controlled trial. PLoS Med. 2010 Sep 28;7(9):e1000345. doi: 10.1371/journal.pmed.1000345.

family: Gajdos

full_name: Vincent Gajdos

given: Vincent

family: Katsahian

full_name: Sandrine Katsahian

given: Sandrine

family: Beydon

full_name: Nicole Beydon

given: Nicole

family: Abadie

full_name: Véronique Abadie

given: Véronique

family: de Pontual

full_name: Loïc de Pontual

given: Loïc

family: Larrar

full_name: Sophie Larrar

given: Sophie

family: Epaud

full_name: Ralph Epaud

given: Ralph

family: Chevallier

full_name: Bertrand Chevallier

given: Bertrand

family: Bailleux

full_name: Sylvain Bailleux

given: Sylvain

family: Mollet-Boudjemline

full_name: Alix Mollet-Boudjemline

given: Alix

family: Bouyer

full_name: Jean Bouyer

given: Jean

family: Chevret

full_name: Sylvie Chevret

given: Sylvie

family: Labrune

full_name: Philippe Labrune

given: Philippe

currency_apc_doaj: USD

journal_name: PLoS Medicine

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IN2P3

repository_normalized: HAL

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

repository_institution: The Pennsylvania State University - CiteSeer X

repository_normalized: CiteSeerX

title: Effectiveness of Chest Physiotherapy in Infants Hospitalized with Acute Bronchiolitis: A Multicenter, Randomized, Controlled Trial

location_facility: Antoine Béclère Hospital - Pediatric Department


title: French Randomized Sentinel Node Multicentric Study

summary:
RATIONALE: It is not yet known whether injecting technetium Tc 99m sulfur colloid and blue dye near the tumor is more effective than injecting them near the nipple in identifying sentinel lymph nodes in patients with stage I or stage II breast cancer.

PURPOSE: Randomized diagnostic trial to compare the effectiveness of injecting technetium Tc 99m sulfur colloid and blue dye near the tumor with that of injections around the nipple in detecting sentinel lymph nodes in patients who have stage I or stage II breast cancer.

ReferenceCitation: Rodier JF, Velten M, Wilt M, Martel P, Ferron G, Vaini-Elies V, Mignotte H, Brémond A, Classe JM, Dravet F, Routiot T, de Lara CT, Avril A, Lorimier G, Fondrinier E, Houvenaeghel G, Avigdor S. Prospective multicentric randomized study comparing periareolar and peritumoral injection of radiotracer and blue dye for the detection of sentinel lymph node in breast sparing procedures: FRANSENODE trial. J Clin Oncol. 2007 Aug 20;25(24):3664-9. Epub 2007 May 7.

lead_sponsor: Centre Paul Strauss

location_facility:
Clinique Tivoli
Centre Regional Rene Gauducheau
Centre Jean Perrin
Centre Paul Strauss
Institut Claudius Regaud
Institut J. Paoli and I. Calmettes
Centre Leon Berard

intervention_type: Radiation


title: Characterization of Retinal Disease Progression in Eyes With Non Proliferative Diabetic Retinopathy (NPDR) in Diabetes Type 2 Using Non-invasive Procedures (CHART)

acronym: CHART

summary: To identify biomarkers, obtained using non-invasive procedures, that can predict disease progression and progression to sight-threatening stages of the disease and to characterize the retinal changes that occur in Non Proliferative Diabetic Retinopathy (NPDR).

status: Recruiting

study_completion_date_type: Anticipated

ipd_sharing: Yes

lead_sponsor: Association for Innovation and Biomedical Research on Light and Image

location_country: Italy France Portugal

location_facility: CS001 Centre for Clinical Trials - AIBILI

location_facility: CS063 - Excellence Eye Research Centre, University G. d'Annunzio of Chieti-Pescara

location_facility: CS042 - Department of Ophthalmology, University Hospital, CHU Dijon

location_facility: CS020 - G. B. Bietti Eye Foundation - IRCCS

location_facility: CS067- Department of Ophthalmology, University Vita Salute - Scientific Institute of San Raffael, Milan

intervention_type: Other

status_simplified: Ongoing


title: An Open-label, Single-dose, Safety and Pharmacokinetic Study of Regadenoson in Pediatric Patients

acronym: Rapiscan PIP

summary: This is a multi-centre, open-label, single-dose safety, tolerability and PK-pharmacodynamics (PD) study of the vasodilator regadenoson in 3 paediatric age groups for whom a pharmacologic stress perfusion CMR test is clinically indicated; adolescents aged 12 to <18 years (Cohort A), children aged 2 to <12 years (Cohort B), and infants aged 1 to <24 months and who weigh at least 3 kg (Cohort C). Regadenoson will be used as the pharmacologic stress agent in this study with MPI serving as both surrogate pharmacodynamic marker of the agent (MPR, MBF) and a clinically evaluable examination for the patient

lead_sponsor: GE Healthcare

location_country:
Italy
United Kingdom
France
Greece

location_facility: Paris Public Hospitals System; Necker Hospital for Sick Children


title: Prospective, Multi-centric, Comparative, Long-term Clinical Follow-Up Study for the Evidence of Safety and Performance Indicators of the Plasmafit® Revision Structan® Hip Endoprosthesis Cup

summary: The aim of this observational study is to collect clinical and radiological results of the new Plasmafit® Revision Structan® Hip Endoprosthesis Cup in a standard patient population and when used in routine clinical practice.

lead_sponsor: Aesculap AG

location_country: Germany France

location_facility:
Orthopädische Klinik König-Ludwig-Haus
Hôpital Pierre-Paul Riquet
Herzogin Elisabeth Hospital
Universitätsklinikum des Saarlandes
Gemeinschaftskrankenhaus Bonn


title: Open Label, Phase I Study to Assess and Compare the Pharmacokinetic Parameters After Single Oral Administration of MD1003 100 mg in Renal Impaired Patients and Healthy Subjects With Normal Renal Function

summary:
This is a Phase 1, multicentric, open-label,two arms to assess and compare the effect of single oral administration of MD1003 on the pharmacokinetic parameters in renal impaired patients and healthy subjects with normal renal function.

The planned enrollment is 36 subjects (18 impaired patients and 18 healthy subjects).

primary_purpose: Other

lead_sponsor: MedDay Pharmaceuticals SA

location_country: Hungary France

location_facility: University of Debrecen Medical and Health Center

location_facility: Semmelweis University Faculty of Medicine


title: Post-Market Follow-up Clinical Trial to Investigate Safety and Efficacy of a Trifocal Intraocular Lens (IOL) POD L GF In Comparison With a Multifocal (TECNIS Symfony® Extended Range of Vision IOL) and a Monofocal (AcrySof® IQ Monofocal IOL)

summary: The objectives of the Post-Market Follow-up (PMCF) clinical investigation are to determine the safety and performance of a hydrophobic trifocal intraocular lens POD L GF in comparison with two comparator lenses: another multifocal intraocular lens (Johnson & Johnson TECNIS Symfony® Extended Range of Vision IOL); and a monofocal intraocular lens (Alcon AcrySof® IQ Monofocal IOL) through one year of post-operative assessments.

lead_sponsor: Beaver-Visitec International, Inc.

location_country: Germany France Spain


title: A 2-year Multicentre, EU, Exploratory Study Without Therapeutic Benefit in Patients With Knee Osteoarthritis to Describe, Validate, and Predict Phenotypes of Knee Osteoarthritis by Use of Clinical, Imaging, and Biochemical (Bio)Markers.

acronym: APPROACH

summary:
Rationale: Despite a large and growing disease burden in osteoarthritis (OA), many pharmaceutical companies have abandoned OA drug development. This is mainly due to the lack of appropriate outcome measures that can robustly identify patients that can benefit from a specific therapy. Different phenotypes of OA may benefit from different types of treatment. Therefore, novel markers to identify selected phenotypes of osteoarthritis may encourage drug development.

Objective: To prospectively describe in detail pre-identified progressing phenotypes of patients with knee OA by use of conventional and novel clinical, imaging, and biochemical (bio)markers, and to validate and refine a predictive model for these (and new) progressing phenotypes based on these markers.

Study design: APPROACH is an exploratory, European, five-centre, 2-year prospective follow-up, cohort study, with extensive measurements. In this study patients are treated according to regular care by their own physician with no study related treatment prescribed. Study related diagnostic and/or monitoring procedures are applied to the patients.

Study population: Patients with tibiofemoral knee osteoarthritis, according to the clinical ACR classification criteria, pre-identified based on demographic (e.g. age), clinical (e.g. Pain NRS) and tissue structure (e.g. radiographic joint space width) parameters.

Main study parameters/endpoints: Joint tissue structure based on radiographs, MRI, and biochemical (bio)markers as well as symptoms (pain, function) and quality of life by questionnaires.

Secondary parameters: A multitude of (novel and conventional) clinical, imaging, and biochemical parameters related to osteoarthritis.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The participants will not have any direct benefit from their participation in this study other than that their OA is maximally diagnosed and followed in detail for up to 2 years (screening, baseline, 6 months, 12 months, 24 months).

status: Active, not recruiting

ReferenceCitation: Taylor J, Dekker S, Jurg D, Skandsen J, Grossman M, Marijnissen AK, Ladel C, Mobasheri A, Larkin J, Weinans H, Kanter-Schlifke I; APPROACH research consortium and APPROACH Principal Investigators. Making the patient voice heard in a research consortium: experiences from an EU project (IMI-APPROACH). Res Involv Engagem. 2021 May 10;7(1):24. doi: 10.1186/s40900-021-00267-0.

family: Taylor

full_name: Jane Taylor

given: Jane

name: on behalf of the APPROACH research consortium and APPROACH Principal Investigators

family: Dekker

full_name: Sjouke Dekker

given: Sjouke

family: Jurg

full_name: Diny Jurg

given: Diny

family: Skandsen

full_name: Jon Skandsen

given: Jon

family: Grossman

full_name: Maureen Grossman

given: Maureen

family: Marijnissen

full_name: Anne-Karien Marijnissen

given: Anne-Karien

family: Ladel

full_name: Christoph Ladel

given: Christoph

family: Mobasheri

full_name: Ali Mobasheri

given: Ali

family: Larkin

full_name: Jon Larkin

family: Weinans

full_name: Harrie Weinans

given: Harrie

family: Kanter-Schlifke

full_name: Irene Kanter-Schlifke

given: Irene

bso_classification:
Earth, Ecology,
Energy and applied biology

journal_name: Research Involvement and Engagement

ReferenceCitation: van Helvoort EM, van Spil WE, Jansen MP, Welsing PMJ, Kloppenburg M, Loef M, Blanco FJ, Haugen IK, Berenbaum F, Bacardit J, Ladel CH, Loughlin J, Bay-Jensen AC, Mobasheri A, Larkin J, Boere J, Weinans HH, Lalande A, Marijnissen ACA, Lafeber FPJG. Cohort profile: The Applied Public-Private Research enabling OsteoArthritis Clinical Headway (IMI-APPROACH) study: a 2-year, European, cohort study to describe, validate and predict phenotypes of osteoarthritis using clinical, imaging and biochemical markers. BMJ Open. 2020 Jul 28;10(7):e035101. doi: 10.1136/bmjopen-2019-035101.

family: van Helvoort

full_name: Eefje M van Helvoort

given: Eefje M

family: van Spil

full_name: Willem E van Spil

given: Willem E

family: Jansen

full_name: Mylène P Jansen

given: Mylène P

family: Welsing

full_name: Paco M J Welsing

given: Paco M J

family: Kloppenburg

full_name: Margreet Kloppenburg

given: Margreet

family: Loef

full_name: Marieke Loef

given: Marieke

family: Blanco

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

repository_institution: Newcastle Univesity - Newcastle University ePrints

location_facility:
Leiden University Medical Center
UMC Utrecht
Diakonhjemmet hospital
Saint-Antoine hospital, AP-HP
SERGAS


title: FIRE AND ICE II Trial Pilot

summary: The FIRE AND ICE II Trial (Pilot) is the pilot phase of a prospective, randomized, single-blinded, multi-center, interventional post-market clinical trial, comparing efficacy and safety of isolation of the pulmonary veins (PVI) using a Cryoballoon catheter or radiofrequency ablation with a ThermoCool® Smarttouch® catheter in subjects with persistent atrial fibrillation (AF).

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck

location_facility: Cardioangiologisches Centrum Bethanien CCB


title: A Prospective, Multi-center, Single-arm, Open-label Study Designed to Evaluate Safety and Performance Profile of the CG-100 Intraluminal Bypass Device in Patients Undergoing Colorectal Surgery

summary: The purpose of this study is to evaluate the CG-100 device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic)

lead_sponsor: Colospan Ltd.

location_country: Israel Germany France Switzerland

location_facility:
CHUV, University Hospital Vaudois
University Hospital of Hamburg
Soroka Medical Center
Hospital Beaujon
Carmel Medical Center


title: Prospective, Randomised, Double-blind Study to Assess the Therapeutic Potential of Omega-3 Fatty Acids Supplementation in Dry Macular Degeneration and Stargardt Disease (Macular Degeneration Omega-3 Study - MADEOS

acronym: MADEOS

summary: Prospective, randomised, double-blind study to assess the Therapeutic Potential of Omega-3 Fatty Acids Supplementation in Dry Macular Degeneration and Stargardt Disease (Macular Degeneration Omega-3 Study - MADEOS.

lead_sponsor: Ophthalmos Research and Education Institute

location_country: Italy Germany France

location_facility: Centre National d'Ophtalmologie des Quinze-Vingts

location_facility: Università degli Studi G. d'Annunzio Chieti-Pescara

location_facility: Department of Ophthalmology, Justus-Liebig-University-Giessen

location_facility: Department of Ophthalmology, University Vita Salute

intervention_type: Dietary Supplement


title: Prospective Multicenter Observational Evaluation of the Use of the G7 BiSpherical Acetabular Shell

summary: The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available G7 BiSpherical Acetabular Shell.

lead_sponsor: Zimmer Biomet

location_country: Germany France Switzerland Netherlands

location_facility:
Orthopädische Chirurgie Müchen OCM
Reinier de Graaf Groep
Orthoprax AG
Cabinet du Dr. Miazzolo
Herzogin Elisabeth Hospital


lead_sponsor: Idorsia Pharmaceuticals Ltd.

location_facility: Kleinwachau, Sächsisches Epilepsiezentrum Radeberg

source: euctr

title: A Phase 2a, Multi-center, Single-blind, Within-subject, Placebo-controlled Study to Assess the Pharmacodynamics of ACT-709478 in Subjects With Photosensitive Epilepsy

summary: The main study objective is to assess the effect of ACT-709478 in male and female subjects with photosensitive epilepsy following single dose administration


title: International Psychometric Validation Study of the Intestinal Gas Questionnaire (IGQ)

acronym: PRoVING

summary:
Objective: To confirm the psychometrics properties of the Intestinal Gas Questionnaire (IGQ) in subjects with Irritable Bowel Syndrome (IBS) diagnosis and General population both complaining of Gas-Related Symptoms (GRS).

IGQ has been developed previously simultaneously in UK English, French and Spanish through qualitative research with subject interviews. The conceptual framework of the IGQ assesses both GRS and their impact on daily life. Similar concepts were identified for both subjects with IBS diagnosis and general population and complaining of gas-related symptoms.

The IGQ consists of a 24-hour recall symptom diary assessing 7 gas-related symptoms (17 items) and a 7-day recall questionnaire which assesses the impact of those symptoms (26 items)

ReferenceCitation: Chassany O, Tugaut B, Marrel A, Guyonnet D, Arbuckle R, Duracinsky M, Whorwell PJ, Azpiroz F. The Intestinal Gas Questionnaire: development of a new instrument for measuring gas-related symptoms and their impact on daily life. Neurogastroenterol Motil. 2015 Jun;27(6):885-98. doi: 10.1111/nmo.12565. Epub 2015 Apr 6.

lead_sponsor: University Paris 7 - Denis Diderot

location_country:
United Kingdom
France
Spain

location_facility: Horta, Hospital Universitari Vall d'Hebron


title: Orphans Unite: chILD Better Together - European Management Platform for Childhood Interstitial Lung Diseases / chILD-EU - International Register and Biobank for Children´s Interstital Lung Disease

acronym: chILD-EU

summary: Generation of a common European database and biobank Continous assessment and implementation of guidelines and treatment protocols Establishment of a large observational cohort of chILD patients Determination the value of outcomes used in child Assess treatment variations used, deliver data from defined protocols and linked outcomes

ReferenceCitation: Griese M, Seidl E, Hengst M, Reu S, Rock H, Anthony G, Kiper N, Emiralioğlu N, Snijders D, Goldbeck L, Leidl R, Ley-Zaporozhan J, Krüger-Stollfuss I, Kammer B, Wesselak T, Eismann C, Schams A, Neuner D, MacLean M, Nicholson AG, Lauren M, Clement A, Epaud R, de Blic J, Ashworth M, Aurora P, Calder A, Wetzke M, Kappler M, Cunningham S, Schwerk N, Bush A; the other chILD-EU collaborators. International management platform for children's interstitial lung disease (chILD-EU). Thorax. 2018 Mar;73(3):231-239. doi: 10.1136/thoraxjnl-2017-210519. Epub 2017 Oct 22.

family: Griese

full_name: Matthias Griese

given: Matthias

family: Seidl

full_name: Elias Seidl

given: Elias

family: Hengst

full_name: Meike Hengst

given: Meike

family: Reu

full_name: Simone Reu

given: Simone

family: Rock

full_name: Hans Rock

given: Hans

family: Anthony

full_name: Gisela Anthony

given: Gisela

family: Kiper

full_name: Nural Kiper

given: Nural

family: Emiralioğlu

full_name: Nagehan Emiralioğlu

given: Nagehan

family: Snijders

full_name: Deborah Snijders

given: Deborah

family: Goldbeck

full_name: Lutz Goldbeck

given: Lutz

family: Leidl

full_name: Reiner Leidl

given: Reiner

family: Ley-Zaporozhan

full_name: Julia Ley-Zaporozhan

given: Julia

family: Krüger-Stollfuss

full_name: Ingrid Krüger-Stollfuss

given: Ingrid

family: Kammer

full_name: Birgit Kammer

given: Birgit

family: Wesselak

full_name: Traudl Wesselak

given: Traudl

family: Eismann

full_name: Claudia Eismann

given: Claudia

family: Schams

full_name: Andrea Schams

given: Andrea

family: Neuner

full_name: Doerthe Neuner

given: Doerthe

family: MacLean

full_name: Morag MacLean

given: Morag

family: Nicholson

full_name: Andrew G Nicholson

given: Andrew G

family: Lauren

full_name: McCann Lauren

given: McCann

family: Clement

full_name: Annick Clement

given: Annick

family: Epaud

full_name: Ralph Epaud

given: Ralph

repository_institution: hacettepe.edu.tr - Hacettepe University Institutional Repository

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repository_institution: University of Edinburgh - Edinburgh Research Explorer

title: International management platform for children’s interstitial lung disease (chILD-EU)

location_country:
Italy
France
Turkey
Germany
United Kingdom

location_facility:
University of Padova
University of Edinburgh
Université Pierre et Marie Curie
Hacettepe University, Medical Faculty
Medizinische Hochschule Hannover


title: Developing Tools for Assessing the Natural History of Ambulant and Non-ambulant DMD Individuals to Assist in Antisense-oligomer Clinical Trials

summary: Novel emerging therapies for Duchenne Muscular Dystrophy (DMD) require a deeper understanding of DMD natural history. This study aim to assess the natural history of DMD through a composite assessment tool capable of capturing disease progression linking ambulant and non-ambulant phases of the disease.

ReferenceCitation: Catapano F, Scaglioni D, Maresh K, Ala P, Domingos J, Selby V, Ricotti V, Phillips L, Servais L, Seferian A, Groot I, Krom YD, Voit T, Verschuuren JJGM, Niks EH, Straub V, Morgan J, Muntoni F. Novel free-circulating and extracellular vesicle-derived miRNAs dysregulated in Duchenne muscular dystrophy. Epigenomics. 2020 Nov;12(21):1899-1915. doi: 10.2217/epi-2020-0052. Epub 2020 Nov 20.

name: The Dubowitz Neuromuscular Centre, UCL Great Ormond Street Institute of Child Health, 30 Guildford Street, London, WC1N 1EH, United Kingdom

family: Catapano

full_name: Francesco Catapano

given: Francesco

family: Scaglioni

full_name: Dominic Scaglioni

given: Dominic

family: Maresh

full_name: Kate Maresh

given: Kate

family: Ala

full_name: Pierpaolo Ala

given: Pierpaolo

family: Domingos

full_name: Joana Domingos

given: Joana

family: Selby

full_name: Victoria Selby

given: Victoria

name: National Institute for Health Research, Great Ormond Street Institute of Child Health Biomedical Research Centre, University College London, London WC1N 1EH, United Kingdom

family: Ricotti

full_name: Valeria Ricotti

given: Valeria

name: John Walton Muscular Dystrophy Research Centre, MRC Centre for Neuromuscular Diseases, Institute of Genetic Medicine, Newcastle University, Newcastle upon Tyne, United Kingdom

family: Phillips

full_name: Lauren Phillips

given: Lauren

name: Institute I-Motion, Hôpital Armand Trousseau, Paris, France

name: Centre de Référence des maladies Neuromusculaires, CHU de Liège, Liège, Belgium

family: Servais

full_name: Laurent Servais

given: Laurent

family: Seferian

full_name: Andreea Seferian

given: Andreea

name: Department of Rehabilitation, Amalia Children's Hospital, Radboud university medical centre, Nijmegen, Netherlands

family: Groot

full_name: Imelda de Groot

given: Imelda de

name: Department of Neurology, Leiden University Medical Center, RC Leiden, Netherlands

family: Krom

full_name: Yvonne D. Krom

given: Yvonne D.

family: Voit

full_name: Thomas Voit

given: Thomas

family: Verschuuren

full_name: J.J.G.M. Verschuuren

family: Niks

full_name: E.H. Niks

name: Northern Genetics Service, Newcastle upon Tyne Hospitals NHS Foundation Trust, Institute of Human Genetics, International Centre for Life, Central Parkway, Newcastle upon Tyne, United Kingdom

family: Straub

full_name: Volker Straub

given: Volker

family: Morgan

full_name: Jennifer Morgan

given: Jennifer

family: Muntoni

full_name: Francesco Muntoni

journal_name: Epigenomics

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

lead_sponsor: University College, London

location_country:
United Kingdom
France
Netherlands

location_facility: John Walton Muscular Dystrophy Research Centre, Newcastle University

location_facility: Institut de Myologie, Groupe Hospitalier Pitié Salpêtrière

location_facility: Dubowitz Neuromuscular Centre, UCL-Institute of Child Health


title: Performance of an Omics-signature in the Diagnosis and Prognosis of Endocrine and Primary Hypertension

acronym: ENSAT-HT

summary: The purpose of this study is to assess the validity and usefulness of omics signatures for improved identification and risk stratification of patients with endocrine hypertension and stratification of patients with primary hypertension.

lead_sponsor: Radboud University

location_country:
Italy
United Kingdom
France
Netherlands

location_facility:
University of Glasgow
University of Padua
Raddboudumc
European Georges Pompidou Hospital
University of Torino


title: Fecal Transplantation Using a Novel Conditioning Method for Donor and Recipient in Mild to Moderate Treatment Refractory Colitis in Inflammatory Bowel Disease

summary: Changing the microbiota has become the most intriguing target for intervention in inflammatory bowel disease (IBD). Dietary therapy is successful in mild to moderate Crohn's disease and may be effective in mild to moderate ulcerative colitis (UC) as well, though dietary interventions in UC are just getting underway. However these interventions are less likely to be effective for the more severely inflamed or refractory end of the spectrum. Fecal transplantation (FT) has been suggested as a method to treat refractory IBD, but most studies have been unsuccessful in establishing remission and especially sustained remission. The investigators hypothesize that this is due to selection of random donors and the inability to maintain an optimal microbiota eco system post transplant. Diet is a powerful tool to modulate the microbiota. The investigators propose that use of a donor and recipient diet designed for UC during fecal transplantation will be superior to diet alone of fecal transplantation alone and will improve patient outcomes.The investigators propose to modify FT using a novel protocol and approach that we have developed. We have developed a unique diet that is geared to rectify dysbiosis in UC and damage to the mucous layer in active UC. The investigators intend to condition both donor and recipient with the diet to achieve optimal conditions for transplant to succeed for both donor and recipient .The investigators intend to evaluate this protocol in adults with active UC that are refractory to medications. The investigators will start with a randomized controlled trial involving 76 transplanted patients+ 20 subjects for dietary controls with the UC diet alone.

lead_sponsor: Wolfson Medical Center

location_country: Israel Italy France

location_facility: Saint-Antoine Hospital, Universite Pierre et Marie Curie


title: Evaluation of Physician and Patient Knowledge of Safety and Safe Use Information for Aflibercept in Europe: An Observational Postauthorisation Study

summary: The study will be an observational, cross-sectional study of knowledge, understanding, and self-reported behavior among a sample of physicians and patients with recent aflibercept experience in a total of up to five European countries.

time_perspective: Cross-Sectional

lead_sponsor: Bayer

location_country:
Italy
France
Spain
Germany
United Kingdom

intervention_type: Behavioral


title: Phase II Trial of Linsitinib (Anti-IGF-1R/IR) in Patients With Relapsed and/or Refractory Ewing Sarcoma

acronym: LINES

summary: This is an international, multi-centre, single arm Bayesian designed phase 2 study to identify and determine the safety and activity of anti-IGF-1/IR inhibition in patients with relapsed and/or refractory ESFT. Approximately 40 patients will be recruited from 5-7 European centres. Each patient will be treated with single agent linsitinib, 600 mg orally once a day for days 1-3, 8-10 and 15-17 on a 21 day cycle until disease progression or undue toxicity.

lead_sponsor: University of Oxford

location_country:
Italy
Netherlands
France
Germany
United Kingdom

location_facility: Pediatric Hematology and Oncology, University Hospital Münster

location_facility: Department of Clinical Oncology, Leiden University Medical Center

location_facility: Oxford University Hospitals NHS Foundation Trust


title: Effect of Stress-dose Steroids on Post-resuscitation Infectious (Septic) Complications After In-hospital Cardiac Arrest. Individual Patient Data-based Re-analysis of Synthesized Prior Randomized Clinical Trial Data

summary: Postresuscitation disease is characterized by post-insult systemic inflammation, adrenal insufficiency, and circulatory failure. Such severe pathology may be associated with increased susceptibility to infectious complications and increased risk of death due to postresuscitation septic shock. The latter may be attenuated by stress-dose steroids. In this re-analysis of synthesized randomized clinical trial (RCT) data, the investigators will use individual patient data from two prior RCTs of in-hospital cardiac arrest (NCT00411879 & NCT00729794), in order to determine the effect of stress-dose steroids on the severity of postresuscitation infectious complications, and more specifically, on the risk of septic shock-associated death.

time_perspective: Retrospective

ReferenceCitation: Adrie C, Adib-Conquy M, Laurent I, Monchi M, Vinsonneau C, Fitting C, Fraisse F, Dinh-Xuan AT, Carli P, Spaulding C, Dhainaut JF, Cavaillon JM. Successful cardiopulmonary resuscitation after cardiac arrest as a "sepsis-like" syndrome. Circulation. 2002 Jul 30;106(5):562-8.

ReferenceCitation: Adrie C, Laurent I, Monchi M, Cariou A, Dhainaou JF, Spaulding C. Postresuscitation disease after cardiac arrest: a sepsis-like syndrome? Curr Opin Crit Care. 2004 Jun;10(3):208-12. Review.

ReferenceCitation: Pene F, Hyvernat H, Mallet V, Cariou A, Carli P, Spaulding C, Dugue MA, Mira JP. Prognostic value of relative adrenal insufficiency after out-of-hospital cardiac arrest. Intensive Care Med. 2005 May;31(5):627-33. Epub 2005 Apr 19.

ReferenceCitation: Kim JJ, Lim YS, Shin JH, Yang HJ, Kim JK, Hyun SY, Rhoo I, Hwang SY, Lee G. Relative adrenal insufficiency after cardiac arrest: impact on postresuscitation disease outcome. Am J Emerg Med. 2006 Oct;24(6):684-8.

ReferenceCitation: Hékimian G, Baugnon T, Thuong M, Monchi M, Dabbane H, Jaby D, Rhaoui A, Laurent I, Moret G, Fraisse F, Adrie C. Cortisol levels and adrenal reserve after successful cardiac arrest resuscitation. Shock. 2004 Aug;22(2):116-9.

ReferenceCitation: Tsai MS, Huang CH, Chang WT, Chen WJ, Hsu CY, Hsieh CC, Yang CW, Chiang WC, Ma MH, Chen SC. The effect of hydrocortisone on the outcome of out-of-hospital cardiac arrest patients: a pilot study. Am J Emerg Med. 2007 Mar;25(3):318-25.

ReferenceCitation: Schultz CH, Rivers EP, Feldkamp CS, Goad EG, Smithline HA, Martin GB, Fath JJ, Wortsman J, Nowak RM. A characterization of hypothalamic-pituitary-adrenal axis function during and after human cardiac arrest. Crit Care Med. 1993 Sep;21(9):1339-47. Review.

ReferenceCitation: Nolan JP, Deakin CD, Soar J, Böttiger BW, Smith G; European Resuscitation Council. European Resuscitation Council guidelines for resuscitation 2005. Section 4. Adult advanced life support. Resuscitation. 2005 Dec;67 Suppl 1:S39-86. Review.

ReferenceCitation: Keh D, Boehnke T, Weber-Cartens S, Schulz C, Ahlers O, Bercker S, Volk HD, Doecke WD, Falke KJ, Gerlach H. Immunologic and hemodynamic effects of "low-dose" hydrocortisone in septic shock: a double-blind, randomized, placebo-controlled, crossover study. Am J Respir Crit Care Med. 2003 Feb 15;167(4):512-20. Epub 2002 Nov 8.

ReferenceCitation: American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416.

ReferenceCitation: Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O'Grady NP, Raad II, Rijnders BJ, Sherertz RJ, Warren DK. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jul 1;49(1):1-45. doi: 10.1086/599376. Erratum in: Clin Infect Dis. 2010 Apr 1;50(7):1079. Dosage error in article text. Clin Infect Dis. 2010 Feb 1;50(3):457.

name: Division of Infectious Diseases, Warren Alpert Medical School of Brown University, Providence, Rhode Island

family: Mermel

full_name: Leonard A. Mermel

given: Leonard A.

name: University of Alabama-Birmingham Hospital, Birmingham, Alabama

family: Allon

full_name: Michael Allon

given: Michael

name: Servicio de Microbiología Cliínica y E. Infecciosas Hospital General “Gregorio Marañón,”  Madrid, Spain

family: Bouza

full_name: Emilio Bouza

given: Emilio

name: Tufts University School of Medicine, Lahey Clinic Medical Center, Burlington, Massachusetts

family: Craven

full_name: Donald E. Craven

given: Donald E.

name: St. Jude Children's Research Hospital, Children's Infection Defense Center, Memphis, Tennessee

family: Flynn

full_name: Patricia Flynn

given: Patricia

name: National Institutes of Health, Critical Care Medicine Department, Bethesda, Maryland

family: O'Grady

full_name: Naomi P. O'Grady

given: Naomi P.

name: Section of Infectious Diseases, University of Texas-Cancer Center, Houston

family: Raad

full_name: Issam I. Raad

given: Issam I.

name: Internal Medicine and Infectious Diseases, Erasmus University Medical Center, Rotterdam, the Netherlands

family: Rijnders

full_name: Bart J. A. Rijnders

given: Bart J. A.

name: Section of Infectious Diseases, Wake Forest University School of Medicine, Winston-Salem, North Carolina

family: Sherertz

full_name: Robert J. Sherertz

given: Robert J.

name: Division of Infectious Diseases, Washington University School of MedicineSt Louis, Missouri

family: Warren

full_name: David K. Warren

given: David K.

journal_name: Clinical Infectious Diseases

oa_colors: green hybrid

evidence: open (via free pdf)

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Clinical Practice Guidelines for the Diagnosis and Management of Intravascular Catheter-Related Infection: 2009 Update by the Infectious Diseases Society of America

ReferenceCitation: Hooton TM, Bradley SF, Cardenas DD, Colgan R, Geerlings SE, Rice JC, Saint S, Schaeffer AJ, Tambayh PA, Tenke P, Nicolle LE; Infectious Diseases Society of America. Diagnosis, prevention, and treatment of catheter-associated urinary tract infection in adults: 2009 International Clinical Practice Guidelines from the Infectious Diseases Society of America. Clin Infect Dis. 2010 Mar 1;50(5):625-63.

ReferenceCitation: Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb S, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including The Pediatric Subgroup. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock, 2012. Intensive Care Med. 2013 Feb;39(2):165-228. doi: 10.1007/s00134-012-2769-8. Epub 2013 Jan 30.

ReferenceCitation: ARDS Definition Task Force, Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.

journal_name: JAMA

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Acute Respiratory Distress Syndrome

ReferenceCitation: A randomized clinical trial of calcium entry blocker administration to comatose survivors of cardiac arrest. Design, methods, and patient characteristics. The Brain Resuscitation Clinical Trial II Study Group. Control Clin Trials. 1991 Aug;12(4):525-45.

ReferenceCitation: Vollmar B, Menger MD. Intestinal ischemia/reperfusion: microcirculatory pathology and functional consequences. Langenbecks Arch Surg. 2011 Jan;396(1):13-29. doi: 10.1007/s00423-010-0727-x. Epub 2010 Nov 19. Review.

ReferenceCitation: Davies KJ, Walters JH, Kerslake IM, Greenwood R, Thomas MJ. Early antibiotics improve survival following out-of hospital cardiac arrest. Resuscitation. 2013 May;84(5):616-9. doi: 10.1016/j.resuscitation.2012.11.004. Epub 2012 Nov 12.

ReferenceCitation: Chalkias A, Scheetz MH, Gulati A, Xanthos T. Periarrest intestinal bacterial translocation and resuscitation outcome. J Crit Care. 2016 Feb;31(1):217-20. doi: 10.1016/j.jcrc.2015.09.015. Epub 2015 Sep 25.

ReferenceCitation: Haller B, Schmidt G, Ulm K. Applying competing risks regression models: an overview. Lifetime Data Anal. 2013 Jan;19(1):33-58. doi: 10.1007/s10985-012-9230-8. Epub 2012 Sep 26. Review.

ReferenceCitation: Trzeciak S, Jones AE, Kilgannon JH, Milcarek B, Hunter K, Shapiro NI, Hollenberg SM, Dellinger P, Parrillo JE. Significance of arterial hypotension after resuscitation from cardiac arrest. Crit Care Med. 2009 Nov;37(11):2895-903; quiz 2904.

ReferenceCitation: Tsai MS, Chuang PY, Yu PH, Huang CH, Tang CH, Chang WT, Chen WJ. Glucocorticoid use during cardiopulmonary resuscitation may be beneficial for cardiac arrest. Int J Cardiol. 2016 Nov 1;222:629-635. doi: 10.1016/j.ijcard.2016.08.017. Epub 2016 Aug 4.

ReferenceCitation: Callaway CW, Soar J, Aibiki M, Böttiger BW, Brooks SC, Deakin CD, Donnino MW, Drajer S, Kloeck W, Morley PT, Morrison LJ, Neumar RW, Nicholson TC, Nolan JP, Okada K, O'Neil BJ, Paiva EF, Parr MJ, Wang TL, Witt J; Advanced Life Support Chapter Collaborators. Part 4: Advanced Life Support: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2015 Oct 20;132(16 Suppl 1):S84-145. doi: 10.1161/CIR.0000000000000273. Review.

ReferenceCitation: Mentzelopoulos SD, Zakynthinos SG, Tzoufi M, Katsios N, Papastylianou A, Gkisioti S, Stathopoulos A, Kollintza A, Stamataki E, Roussos C. Vasopressin, epinephrine, and corticosteroids for in-hospital cardiac arrest. Arch Intern Med. 2009 Jan 12;169(1):15-24. doi: 10.1001/archinternmed.2008.509.

title: Vasopressin, Epinephrine, and Corticosteroids for In-Hospital Cardiac Arrest

ReferenceCitation: Mentzelopoulos SD, Malachias S, Chamos C, Konstantopoulos D, Ntaidou T, Papastylianou A, Kolliantzaki I, Theodoridi M, Ischaki H, Makris D, Zakynthinos E, Zintzaras E, Sourlas S, Aloizos S, Zakynthinos SG. Vasopressin, steroids, and epinephrine and neurologically favorable survival after in-hospital cardiac arrest: a randomized clinical trial. JAMA. 2013 Jul 17;310(3):270-9. doi: 10.1001/jama.2013.7832.

title: Vasopressin, Steroids, and Epinephrine and Neurologically Favorable Survival After In-Hospital Cardiac Arrest

ReferenceCitation: Mentzelopoulos SD, Mongardon N, Xanthos T, Zakynthinos SG. Possible significance of hemodynamic and immunomodulatory effects of early stress-dose steroids in cardiac arrest. Crit Care. 2016 Jul 20;20(1):211. doi: 10.1186/s13054-016-1384-4.

location_facility: President Hellenic Society of Cardiopulmonary Resuscitation

location_facility: Service d'anesthésie et des réanimations chirurgicales, ôHôpitaux Universitaires Henri Mondor, Assistance Publique des Hôpitaux de Paris, Université Paris Est, Faculté de Médecine

location_facility: Department of Intensive Care Medicine, Evaggelismos Hospital


title: Duragen® Secure Post Marketing Clinical Follow-up (PMCF)

summary: The purpose of this study is to gather information about post-market performance of DuraGen Secure.The aim of this post market clinical follow-up (PMCF) is to obtain post market clinical data to evaluate the presence of unintended residual risks associated with the use of DuraGen Secure that were not anticipated or identified in the animal studies, bench studies or clinical evaluation report.

lead_sponsor: Integra LifeSciences Corporation

location_country:
Germany
United Kingdom
France
Spain

location_facility: die Charité - Universitätsmedizin Berlin

location_facility: National Hospital for Neurology and Neurosurgery


title: Retrospective Multi-centre, Post-marketing Study to Evaluate the Incidence and Aetiology of Reoperations With Allergan Natrelle® Breast Implants in Primary Augmentation (RANBI)

acronym: RANBI

summary: Retrospective multi-center, post-marketing study to evaluate the incidence and etiology of reoperations with Allergan Natrelle® Breast Implants in primary augmentation (RANBI)

lead_sponsor: Allergan

location_country:
France
Israel
Spain
Germany
United Kingdom


title: An Open-Label, Multi-Centre, Randomised Study to Investigate Integrase Inhibitor Versus Boosted Protease Inhibitor Antiretroviral Therapy for Patients With Advanced HIV Disease

acronym: LAPTOP

summary:
The main purpose of this study is to compare two different types of HIV treatments, in terms of effectiveness and improvement of side effects, for patients who are diagnosed with a more advanced HIV infection. Patients with advanced HIV infections are otherwise known as 'late presenters'.

There are many effective treatments for HIV available; however, for late presenting patients the investigators do not know which type of treatment performs best. This is the first large study to compare treatments for patients in this situation, and the investigators hope that the results of this study will help doctors decide which treatments to use in the future.

The two different types of treatment the investigators are comparing both contain a mixture of drugs that work together to combat HIV:

The Boosted Protease Inhibitor combination (PI) which is a combination tablet containing: darunavir, cobicistat, emtricitabine and tenofovir alafenamide. It was approved for use in Europe under the brand name Symtuza®.

The Integrase Inhibitor combination (INI). Which is a combination tablet containing: bictegravir, emtricitabine and tenofovir alafenamide. This is a a newer combination which was approved for use in Europe in June 2018 under the brand name of Biktarvy®.

The main difference between the two treatments is how each one fights a HIV infection. They both stop a part of the virus from working (i.e. inhibit it), to prevent it from making copies of itself. The PI treatment contains drugs to stop the protease part of the virus, whereas the INI treatment contains drugs to stop the integrase part.

In recent studies, it appears that treatments containing integrase inhibitors may be better for late presenting patients. They have been shown to quickly bring down the amount of virus in the body, and the side effects may be more acceptable to late presenters.

To compare the two treatments, half of the participants on this study will be given the PI treatment, and the other half will be given the INI treatment.

ReferenceCitation: DeJesus E, Rockstroh JK, Henry K, Molina JM, Gathe J, Ramanathan S, Wei X, Yale K, Szwarcberg J, White K, Cheng AK, Kearney BP; GS-236-0103 Study Team. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus co-formulated emtricitabine and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet. 2012 Jun 30;379(9835):2429-2438. doi: 10.1016/S0140-6736(12)60918-0.

family: DeJesus

full_name: Edwin DeJesus

given: Edwin

family: Rockstroh

full_name: Jürgen K Rockstroh

given: Jürgen K

family: Henry

full_name: Keith Henry

given: Keith

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

family: Gathe

full_name: Joseph Gathe

given: Joseph

family: Ramanathan

full_name: Srinivasan Ramanathan

given: Srinivasan

family: Wei

full_name: Xuelian Wei

given: Xuelian

family: Yale

full_name: Kitty Yale

given: Kitty

family: Szwarcberg

full_name: Javier Szwarcberg

given: Javier

family: White

full_name: Kirsten White

given: Kirsten

family: Cheng

full_name: Andrew K Cheng

given: Andrew K

family: Kearney

full_name: Brian P Kearney

given: Brian P

journal_name: The Lancet

ReferenceCitation: Raffi F, Rachlis A, Stellbrink HJ, Hardy WD, Torti C, Orkin C, Bloch M, Podzamczer D, Pokrovsky V, Pulido F, Almond S, Margolis D, Brennan C, Min S; SPRING-2 Study Group. Once-daily dolutegravir versus raltegravir in antiretroviral-naive adults with HIV-1 infection: 48 week results from the randomised, double-blind, non-inferiority SPRING-2 study. Lancet. 2013 Mar 2;381(9868):735-43. doi: 10.1016/S0140-6736(12)61853-4. Epub 2013 Jan 8.

ReferenceCitation: Walmsley SL, Antela A, Clumeck N, Duiculescu D, Eberhard A, Gutiérrez F, Hocqueloux L, Maggiolo F, Sandkovsky U, Granier C, Pappa K, Wynne B, Min S, Nichols G; SINGLE Investigators. Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection. N Engl J Med. 2013 Nov 7;369(19):1807-18. doi: 10.1056/NEJMoa1215541.

family: Walmsley

full_name: Sharon L. Walmsley

given: Sharon L.

family: Antela

full_name: Antonio Antela

given: Antonio

family: Clumeck

full_name: Nathan Clumeck

given: Nathan

family: Duiculescu

full_name: Dan Duiculescu

given: Dan

family: Eberhard

full_name: Andrea Eberhard

given: Andrea

family: Gutiérrez

full_name: Felix Gutiérrez

given: Felix

family: Hocqueloux

full_name: Laurent Hocqueloux

given: Laurent

family: Maggiolo

full_name: Franco Maggiolo

given: Franco

repository_institution: Ghent University - Ghent University Academic Bibliography

title: Dolutegravir plus Abacavir–Lamivudine for the Treatment of HIV-1 Infection

ReferenceCitation: Sax et al. Phase 3 Randomized, Controlled, Clinical Trial of Bictegravir Coformulated With FTC/TAF in a Fixed-Dose Combination vs Dolutegravir + FTC/TAF in Treatment-Naïve HIV-1-Positive Adults: Week 48 Results. 9th IAS Conference on HIV Science; Paris, France; July 23-26, 2017

ReferenceCitation: Gallant et al. A phase 3 randomized controlled clinical trial of bictegravir in a fixed dose combination, B/F/TAF, vs ABC/DTG/3TC in treatment-naïve adults at week 48. 9th IAS Conference on HIV Science; Paris, France; July 23-26, 2017. MOAB0105LB

ReferenceCitation: Camoni L, Raimondo M, Regine V, Salfa MC, Suligoi B; regional representatives of the HIV Surveillance System. Late presenters among persons with a new HIV diagnosis in Italy, 2010-2011. BMC Public Health. 2013 Mar 27;13:281. doi: 10.1186/1471-2458-13-281.

ReferenceCitation: Montlahuc C, Guiguet M, Abgrall S, Daneluzzi V, de Salvador F, Launay O, Martinez V, Partisani M, Pradier C, Rouveix E, Valin N, Grabar S, Costagliola D; French Hospital Database ANRS CO4 cohort. Impact of late presentation on the risk of death among HIV-infected people in France (2003-2009). J Acquir Immune Defic Syndr. 2013 Oct 1;64(2):197-203. doi: 10.1097/QAI.0b013e31829cfbfa.

ReferenceCitation: Antinori A, Coenen T, Costagiola D, Dedes N, Ellefson M, Gatell J, Girardi E, Johnson M, Kirk O, Lundgren J, Mocroft A, D'Arminio Monforte A, Phillips A, Raben D, Rockstroh JK, Sabin C, Sönnerborg A, De Wolf F; European Late Presenter Consensus Working Group. Late presentation of HIV infection: a consensus definition. HIV Med. 2011 Jan;12(1):61-4. doi: 10.1111/j.1468-1293.2010.00857.x.

ReferenceCitation: Raffetti E, Postorino MC, Castelli F, Casari S, Castelnuovo F, Maggiolo F, Di Filippo E, D'Avino A, Gori A, Ladisa N, Di Pietro M, Sighinolfi L, Zacchi F, Torti C. The risk of late or advanced presentation of HIV infected patients is still high, associated factors evolve but impact on overall mortality is vanishing over calendar years: results from the Italian MASTER Cohort. BMC Public Health. 2016 Aug 25;16(1):878. doi: 10.1186/s12889-016-3477-z.

ReferenceCitation: Sobrino-Vegas P, Rodríguez-Urrego J, Berenguer J, Caro-Murillo AM, Blanco JR, Viciana P, Moreno S, Bernardino I, del Amo J; CoRIS. Educational gradient in HIV diagnosis delay, mortality, antiretroviral treatment initiation and response in a country with universal health care. Antivir Ther. 2012;17(1):1-8. doi: 10.3851/IMP1939.

ReferenceCitation: Late presenters working group in COHERE in EuroCoord, Mocroft A, Lundgren J, Antinori A, Monforte Ad, Brännström J, Bonnet F, Brockmeyer N, Casabona J, Castagna A, Costagliola D, De Wit S, Fätkenheuer G, Furrer H, Jadand C, Johnson A, Lazanas M, Leport C, Moreno S, Mussini C, Obel N, Post F, Reiss P, Sabin C, Skaletz-Rorowski A, Suarez-Loano I, Torti C, Warszawski J, Wittkop L, Zangerle R, Chene G, Raben D, Kirk O. Late presentation for HIV care across Europe: update from the Collaboration of Observational HIV Epidemiological Research Europe (COHERE) study, 2010 to 2013. Euro Surveill. 2015;20(47). doi: 10.2807/1560-7917.ES.2015.20.47.30070.

ReferenceCitation: Abdool Karim SS, Naidoo K, Grobler A, Padayatchi N, Baxter C, Gray AL, Gengiah T, Gengiah S, Naidoo A, Jithoo N, Nair G, El-Sadr WM, Friedland G, Abdool Karim Q. Integration of antiretroviral therapy with tuberculosis treatment. N Engl J Med. 2011 Oct 20;365(16):1492-501. doi: 10.1056/NEJMoa1014181.

ReferenceCitation: Blanc FX, Sok T, Laureillard D, Borand L, Rekacewicz C, Nerrienet E, Madec Y, Marcy O, Chan S, Prak N, Kim C, Lak KK, Hak C, Dim B, Sin CI, Sun S, Guillard B, Sar B, Vong S, Fernandez M, Fox L, Delfraissy JF, Goldfeld AE; CAMELIA (ANRS 1295-CIPRA KH001) Study Team. Earlier versus later start of antiretroviral therapy in HIV-infected adults with tuberculosis. N Engl J Med. 2011 Oct 20;365(16):1471-81. doi: 10.1056/NEJMoa1013911.

ReferenceCitation: Zolopa A, Andersen J, Powderly W, Sanchez A, Sanne I, Suckow C, Hogg E, Komarow L. Early antiretroviral therapy reduces AIDS progression/death in individuals with acute opportunistic infections: a multicenter randomized strategy trial. PLoS One. 2009;4(5):e5575. doi: 10.1371/journal.pone.0005575. Epub 2009 May 18.

ReferenceCitation: Mussini C, Manzardo C, Johnson M, Monforte Ad, Uberti-Foppa C, Antinori A, Gill MJ, Sighinolfi L, Borghi V, Lazzarin A, Miró JM, Sabin C; Late Presenter Investigators. Patients presenting with AIDS in the HAART era: a collaborative cohort analysis. AIDS. 2008 Nov 30;22(18):2461-9. doi: 10.1097/QAD.0b013e328314b5f1.

ReferenceCitation: Demarest J, Underwood M, St Clair M, Dorey D, Brown D, Zolopa A. Short Communication: Dolutegravir-Based Regimens Are Active in Integrase Strand Transfer Inhibitor-Naive Patients with Nucleoside Reverse Transcriptase Inhibitor Resistance. AIDS Res Hum Retroviruses. 2018 Apr;34(4):343-346. doi: 10.1089/AID.2017.0184. Epub 2018 Mar 22.

ReferenceCitation: Wijting I et al. Integrase Inhibitors are an Independent Risk Factor for IRIS: An ATHENA Cohort Study. Conference on Retroviruses and Opportunistic Infections. February 2017. Seattle, WA, USA. Abstract 731.

ReferenceCitation: Dutertre M et al. Initiation of ART Based on Integrase Inhibitors Increases the Risk of IRIS. Conference on Retroviruses and Opportunistic Infections. February 2017. Seattle, WA, USA. Abstract 732.

ReferenceCitation: Psichogiou M, Basoulis D, Tsikala-Vafea M, Vlachos S, Kapelios CJ, Daikos GL. Integrase Strand Transfer Inhibitors and the Emergence of Immune Reconstitution Inflammatory Syndrome (IRIS). Curr HIV Res. 2017;15(6):405-410. doi: 10.2174/1570162X15666171122155708.

ReferenceCitation: Hill AM, Mitchell N, Hughes S, Pozniak AL. Risks of cardiovascular or central nervous system adverse events and immune reconstitution inflammatory syndrome, for dolutegravir versus other antiretrovirals: meta-analysis of randomized trials. Curr Opin HIV AIDS. 2018 Mar;13(2):102-111. doi: 10.1097/COH.0000000000000445. Review.

ReferenceCitation: Paredes R, Tzou PL, van Zyl G, Barrow G, Camacho R, Carmona S, Grant PM, Gupta RK, Hamers RL, Harrigan PR, Jordan MR, Kantor R, Katzenstein DA, Kuritzkes DR, Maldarelli F, Otelea D, Wallis CL, Schapiro JM, Shafer RW. Collaborative update of a rule-based expert system for HIV-1 genotypic resistance test interpretation. PLoS One. 2017 Jul 28;12(7):e0181357. doi: 10.1371/journal.pone.0181357. eCollection 2017.

ReferenceCitation: Levy et al. ANRS 146 - GeSIDA 7211 OPTIMAL phase III trial: maraviroc plus cART in advanced HIV-1-infected individuals. Journal Of The International Aids Society (Vol. 20, Pp. 6-7)

ReferenceCitation: Slama L, Landman R, Assoumou L, Benalycherif A, Samri A, Joly V, Pialoux G, Valin N, Cabié A, Duvivier C, Lambert-Niclot S, Marcelin AG, Peytavin G, Costagliola D, Girard PM; IMEA 040 DATA Study Group. Efficacy and safety of once-daily ritonavir-boosted atazanavir or darunavir in combination with a dual nucleos(t)ide analogue backbone in HIV-1-infected combined ART (cART)-naive patients with severe immunosuppression: a 48 week, non-comparative, randomized, multicentre trial (IMEA 040 DATA trial). J Antimicrob Chemother. 2016 Aug;71(8):2252-61. doi: 10.1093/jac/dkw103. Epub 2016 Apr 10.

location_country:
Italy
France
Ireland
Belgium
Spain
Germany
United Kingdom

location_facility: Medizinische Klinik und Poliklinik Universitätsklinikum Bonn

location_facility: University Hospital Klinikum rechts der Isar der TUM

location_facility: Hospital General Universitatrio de Elche


title: Prospective, Multicentre Evaluation of the Vanguard Rocc Rotating Platform Knee Prosthesis - Clinical and Radiographic Outcomes

summary: The objective of this project is to obtain prospective, multi-center, long term (10 year) clinical data on the Vanguard Rocc knee prosthesis. Patient and knee function will be collected along with knee stability, the knee motion, functional recuperation, radiographic and survivorship data.

location_country:
Denmark
United Kingdom
Belgium
France

location_facility: South West London Elective Orthopaedic centre - EPSOM General Hospital


title: An Open-Label Phase II Study in Anti-GBM Disease (Goodpasture's Disease) With Adverse Renal Prognosis to Evaluate the Efficacy and Safety of IdeS --GOOD-IDES

acronym: GOOD-IDES

summary: This study will evaluate the safety and tolerability of IdeS in patients with severe anti-GBM (Glomerular Basement Membrane) disease receiving standard care consisting of pulse-methylprednisolone, oral prednisolone and intravenous cyclophosphamide combined with plasma exchange (PLEX).

lead_sponsor: Mårten Segelmark

location_country: Austria Sweden France Czechia Denmark

location_facility: Department of Nephrology and Organ Transplant, CHU Rangueil

location_facility: Department of Nephrology, Hemodialysis, Apheresis, and Transplantation, CHUGA (centre hospitalier universitaire Grenoble-Alpes)

location_facility: Department of Department of nephrology, First Faculty of Medicine and General Teaching Hospital and Charles University in Prague, Czech Republic,

location_facility: Department of Internal Medicine IV (Nephrology and Hypertension)

location_facility: Department of Department of Nephrology, Rigshospitalet, Copenhagen

location_facility: PH USI UNTR, service du Pr Rondeau, Hôpital Tenon

location_facility: Department of Nephrology, Uppsala University Hospital

location_facility: Centre Hospitalier Régional Universitaire de Lille, Nephrology Service

intervention_type: Biological


title: A 52-Week, Open-Label, Prospective, Multicenter, International Study of a Transition to the Paliperidone Palmitate 3-Month Formulation In Patients With Schizophrenia Previously Stabilized on the Paliperidone Palmitate 1-Month Formulation

summary: The purpose of this study is to estimate the proportion of participants fulfilling criteria for symptomatic remission following a transition to 12 months treatment with flexible-dose paliperidone palmitate 3 month formulation (PP3M) in participants with schizophrenia previously adequately treated with paliperidone palmitate 1 month formulation (PP1M) for at least 4 months.

lead_sponsor: Janssen-Cilag Ltd.

location_country:
Saudi Arabia
Netherlands
Croatia
France
Greece
Israel
Malaysia
Russian Federation
Spain
Turkey
Denmark
Germany
United Kingdom
Korea, Republic of
Taiwan


title: A Randomized, Multicenter, Open-label, Phase II Trial to Evaluate the Efficacy and Safety of Palbociclib in Combination With Fulvestrant or Letrozole in Patients With HER2 Negative, ER+ Metastatic Breast Cancer

acronym: PARSIFAL

summary: This is an international, randomized, open-label, controlled, multicenter phase II clinical trial to investigate and compare the safety and efficacy of palbociclib combined with fulvestrant or letrozole in women with ER+, HER2- locally advanced or metastatic breast cancer.

ReferenceCitation: Llombart-Cussac A, Pérez-García JM, Bellet M, Dalenc F, Gil-Gil M, Ruíz-Borrego M, Gavilá J, Sampayo-Cordero M, Aguirre E, Schmid P, Marmé F, Di Cosimo S, Gligorov J, Schneeweiss A, Albanell J, Zamora P, Wheatley D, Martínez-de Dueñas E, Amillano K, Malfettone A, Cortés J; PARSIFAL Steering Committee and Trial Investigators. Fulvestrant-Palbociclib vs Letrozole-Palbociclib as Initial Therapy for Endocrine-Sensitive, Hormone Receptor-Positive, ERBB2-Negative Advanced Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2021 Oct 7. doi: 10.1001/jamaoncol.2021.4301. [Epub ahead of print]

name: Hospital Arnau de Vilanova, Universidad Católica, Valencia, Spain

name: Medica Scientia Innovation Research, Barcelona, Spain

name: Medica Scientia Innovation Research, Ridgewood, New Jersey

family: Llombart-Cussac

full_name: Antonio Llombart-Cussac

name: International Breast Cancer Center Quiron Group, Barcelona

family: Pérez-García

full_name: José Manuel Pérez-García

given: José Manuel

name: Vall d’Hebrón Institute of Oncology, Medical Oncology Department, Vall d’Hebrón University Hospital, Barcelona, Spain

family: Bellet

full_name: Meritxell Bellet

given: Meritxell

name: Medical Oncology Department, Institut Claudius Regaud, Institut Universitaire du Cancer de Toulouse-Oncopole, Centre de recherches en cancérologie, Inserm, Toulouse, France

family: Dalenc

full_name: Florence Dalenc

given: Florence

name: Medical Oncology Department, Institut Català d’Oncología, Insitut d’Investigació Biomèdica Bellvitge, Barcelona, Spain

family: Gil-Gil

full_name: Miguel Gil-Gil

given: Miguel

name: Hospital Universitario Virgen del Rocío, Sevilla, Spain

family: Ruíz-Borrego

full_name: Manuel Ruíz-Borrego

given: Manuel

name: Medical Oncology Department, Fundación Instituto Valenciano de Oncología, Valencia, Spain

family: Gavilá

full_name: Joaquín Gavilá

given: Joaquín

family: Sampayo-Cordero

full_name: Miguel Sampayo-Cordero

family: Aguirre

full_name: Elena Aguirre

given: Elena

name: Barts Experimental Cancer Medicine Centre, Barts Cancer Institute, Queen Mary University of London, and Barts Hospital, NHS Trust, London, United Kingdom

family: Schmid

full_name: Peter Schmid

given: Peter

name: University Hospital Heidelberg, Medical Faculty Mannheim Heidelberg University, Heidelberg, Germany

family: Marmé

full_name: Frederik Marmé

given: Frederik

family: Di Cosimo

full_name: Serena Di Cosimo

given: Serena

name: Biomarkers Unit, Department of Applied Research and Technological Development, Fondazione Istituto Di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milano, Italy

name: Institut Universitaire de Cancérologie Assistance Publique–Hôpitaux de Paris, Sorbonne Université, Paris, France

family: Gligorov

full_name: Joseph Gligorov

name: National Center for Tumor Diseases, Heidelberg University Hospital and German Cancer Research Center, Heidelberg, Germany

family: Schneeweiss

full_name: Andreas Schneeweiss

given: Andreas

name: Cancer Research Program, Hospital del Mar Research Institute, Barcelona, Spain

name: Medical Oncology Department, Hospital del Mar, Barcelona, Spain

name: Universitat Pompeu Fabra, Barcelona, Spain

name: Centro de Investigación Biomédica en Red de Oncología, Madrid, Spain

family: Albanell

full_name: Joan Albanell

given: Joan

name: Medical Oncology Department, Hospital Universitario La Paz, Madrid, Spain

family: Zamora

full_name: Pilar Zamora

given: Pilar

name: Royal Cornwall Hospitals NHS Trust, Truro, United Kingdom

family: Wheatley

full_name: Duncan Wheatley

given: Duncan

name: Medical Oncology Department, Hospital Provincial Castellón, Castelló De La Plana, Spain

family: Martínez-de Dueñas

full_name: Eduardo Martínez-de Dueñas

given: Eduardo

name: Medical Oncology Department, Hospital Universitari Sant Joan de Reus, Reus, Spain

family: Amillano

full_name: Kepa Amillano

given: Kepa

family: Malfettone

full_name: Andrea Malfettone

name: Vall d’Hebrón Institute of Oncology, Barcelona, Spain

family: Cortés

full_name: Javier Cortés

name: for the PARSIFAL Steering Committee and Trial Investigators

family: Antón

full_name: Antonio Antón

family: Moiseyenko

full_name: Vladimir Moiseyenko

title: Fulvestrant-Palbociclib vs Letrozole-Palbociclib as Initial Therapy for Endocrine-Sensitive, Hormone Receptor–Positive, ERBB2-Negative Advanced Breast Cancer

location_country:
Italy
France
Czechia
Russian Federation
Spain
Germany
United Kingdom

location_facility:
MedSIR investigative site B
MedSIR investigative site


title: A Phase 1b Dose Escalation and Dose Expansion Study of Tirabrutinib (ONO/GS-4059) in Combination With Other Targeted Anti-cancer Therapies in Subjects With B-cell Malignancies

summary:
The primary objectives of this study are to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of tirabrutinib (ONO/GS-4059) in combination with other targeted anti-cancer therapies and to evaluate the long-term safety of tirabrutinib as a monotherapy and in combination with other targeted anti-cancer therapies in adults with relapsed or refractory B-cell lymphoproliferative malignancies.

This study consists of three parts: Dose Escalation, Dose Expansion, and Long-term Safety Monitoring. During the Dose Escalation phase, participants will be sequentially enrolled in a standard 3 + 3 dose escalation study design, to receive oral tirabrutinib combined with idelalisib entospletinib +/- obinutuzumab. The Dose Expansion Phase will enroll additional participants with a single B-cell lymphoproliferative malignancy disease type to further evaluate efficacy, safety, tolerability, PK, and pharmacodynamics. The Long-term Safety Monitoring phase will evaluate the long-term safety of tirabrutinib both as a monotherapy and in combination with other anti-cancer therapies. As of Amendment 9, all participants currently on the study who have no clinical evidence of disease progression will transition into long-term safety monitoring. Participants from the ongoing Study GS-US-401-1787 and participants who came off Study GS-US-401-1757 and Study GS-US-401-1787 but continued to receive treatment via named patient use (or individual expanded use) will be enrolled into the long-term safety monitoring group (Group VI). Participants enrolled in Group VI will continue the same treatment regimen in Study GS-US-401-1787 or named patient use (or individual expanded use). As of Protocol Amendment 8, the maximum treatment duration for any participant is an additional 6 years from the date of this amendment (ie. until November 2025). As of Amendment 9, entospletinib will be provided until 31 December 2020 to participants who are currently receiving entospletinib. Participants treated with entospletinib as part of a combination regimen with tirabrutinib will stop receiving entospletinib by 31 December 2020 but may continue to be treated with tirabrutinib monotherapy. Idelalisib will be provided as 50 mg tablets until 31 December 2020 and 100 mg tablets until study completion. Participants assigned to the 50 mg tablet will be given the option, at the investigator's discretion, to switch to 100 mg once daily idelalisib dose.

ReferenceCitation: Danilov AV, Herbaux C, Walter HS, Hillmen P, Rule SA, Kio EA, Karlin L, Dyer MJS, Mitra SS, Yi PC, Humeniuk R, Huang X, Zhou Z, Bhargava P, Jürgensmeier JM, Fegan CD. Phase Ib Study of Tirabrutinib in Combination with Idelalisib or Entospletinib in Previously Treated Chronic Lymphocytic Leukemia. Clin Cancer Res. 2020 Jun 15;26(12):2810-2818. doi: 10.1158/1078-0432.CCR-19-3504. Epub 2020 Mar 10.

family: Danilov

full_name: Alexey V. Danilov

given: Alexey V.

family: Herbaux

full_name: Charles Herbaux

given: Charles

family: Walter

full_name: Harriet S. Walter

given: Harriet S.

family: Hillmen

full_name: Peter Hillmen

family: Rule

full_name: Simon A. Rule

given: Simon A.

family: Kio

full_name: Ebenezer A. Kio

given: Ebenezer A.

family: Karlin

full_name: Lionel Karlin

given: Lionel

family: Dyer

full_name: Martin J.S. Dyer

given: Martin J.S.

family: Mitra

full_name: Siddhartha S. Mitra

given: Siddhartha S.

family: Yi

full_name: Ping Cheng Yi

given: Ping Cheng

family: Humeniuk

full_name: Rita Humeniuk

given: Rita

family: Huang

full_name: Xi Huang

given: Xi

family: Zhou

full_name: Ziqian Zhou

given: Ziqian

family: Bhargava

full_name: Pankaj Bhargava

given: Pankaj

family: Jürgensmeier

full_name: Juliane M. Jürgensmeier

given: Juliane M.

family: Fegan

full_name: Christopher D. Fegan

given: Christopher D.

journal_name: Clinical Cancer Research

oa_host_type: publisher

publisher: American Association for Cancer Research (AACR)

ReferenceCitation: Yahiaoui A, Meadows SA, Sorensen RA, Cui ZH, Keegan KS, Brockett R, Chen G, Quéva C, Li L, Tannheimer SL. PI3Kδ inhibitor idelalisib in combination with BTK inhibitor ONO/GS-4059 in diffuse large B cell lymphoma with acquired resistance to PI3Kδ and BTK inhibitors. PLoS One. 2017 Feb 8;12(2):e0171221. doi: 10.1371/journal.pone.0171221. eCollection 2017.

family: Yahiaoui

full_name: Anella Yahiaoui

given: Anella

family: Meadows

full_name: Sarah A. Meadows

given: Sarah A.

family: Sorensen

full_name: Rick A. Sorensen

given: Rick A.

family: Cui

full_name: Zhi-Hua Cui

given: Zhi-Hua

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: University Hospitals of Leicester NHS Trust

location_facility: Cardiff and Vale Health Board, Clinical Research Facility

location_facility: Institut Universitaire du Cancer-Oncopole I.U.C.T-O

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Indiana University Health Goshen Center for Cancer Care

location_facility: Leeds Teaching Hosptials NHS Trust, Dept of Haematology


title: A Phase I/IB Randomized, Double-blind, Placebo Controlled, Dose-finding Study to Evaluate Safety, Tolerability of TG1050 Single/Multiple Doses, and Evaluation of TG1050 Immunologic/Antiviral Activity in Patients With Chronic Hep B Infection

summary:
Methodology:

This is a double-blind, randomized, placebo-controlled, multi-cohort Phase 1/1b study in patients that are currently being treated for chronic HBV infection. For all cohorts, patients must be receiving antiviral treatment with either tenofovir disoproxil fumarate (TDF) or entecavir (ENT) for at least two years, and have their HBV infection well-controlled

lead_sponsor: Transgene

location_country: Germany Canada France