title: Early Versus Late Intervention for Twin Reversed Arterial Perfusion Sequence: an Open-label Randomized Controlled Trial: TRAPIST - TRAP Intervention STudy

acronym: TRAPIST

summary: Multi-center open-label randomized controlled trial to assess if early intervention (12.0-14.0 weeks) (study group) improves the outcome of TRAP sequence as compared to late intervention (16.0-19.0 weeks) (control group). The investigators will randomly assign women diagnosed with TRAP sequence diagnosed between 12.0 and 13.6 weeks to an early or late intervention group (1:1), using a web-based application and a computer-generated list with random permuted blocks of sizes 2 or 4 (www.sealedenvelope.com), stratified by gestational age (GA) at inclusion (11.6 -12.6 weeks versus 13.0-13.6 weeks). Analysis will be by intention to treat.

ReferenceCitation: Moore TR, Gale S, Benirschke K. Perinatal outcome of forty-nine pregnancies complicated by acardiac twinning. Am J Obstet Gynecol. 1990 Sep;163(3):907-12.

ReferenceCitation: Pagani G, D'Antonio F, Khalil A, Papageorghiou A, Bhide A, Thilaganathan B. Intrafetal laser treatment for twin reversed arterial perfusion sequence: cohort study and meta-analysis. Ultrasound Obstet Gynecol. 2013 Jul;42(1):6-14. doi: 10.1002/uog.12495. Review.

ReferenceCitation: Hecher K, Lewi L, Gratacos E, Huber A, Ville Y, Deprest J. Twin reversed arterial perfusion: fetoscopic laser coagulation of placental anastomoses or the umbilical cord. Ultrasound Obstet Gynecol. 2006 Oct;28(5):688-91.

ReferenceCitation: Chaveeva P, Poon LC, Sotiriadis A, Kosinski P, Nicolaides KH. Optimal method and timing of intrauterine intervention in twin reversed arterial perfusion sequence: case study and meta-analysis. Fetal Diagn Ther. 2014;35(4):267-79. doi: 10.1159/000358593. Epub 2014 Apr 16.

ReferenceCitation: Lewi L, Valencia C, Gonzalez E, Deprest J, Nicolaides KH. The outcome of twin reversed arterial perfusion sequence diagnosed in the first trimester. Am J Obstet Gynecol. 2010 Sep;203(3):213.e1-4. doi: 10.1016/j.ajog.2010.04.018. Epub 2010 Jun 3.

ReferenceCitation: O'Donoghue K, Barigye O, Pasquini L, Chappell L, Wimalasundera RC, Fisk NM. Interstitial laser therapy for fetal reduction in monochorionic multiple pregnancy: loss rate and association with aplasia cutis congenita. Prenat Diagn. 2008 Jun;28(6):535-43. doi: 10.1002/pd.2025.

ReferenceCitation: Scheier M, Molina FS. Outcome of twin reversed arterial perfusion sequence following treatment with interstitial laser: a retrospective study. Fetal Diagn Ther. 2012;31(1):35-41. doi: 10.1159/000334156. Epub 2011 Dec 23.

ReferenceCitation: Berg C, Holst D, Mallmann MR, Gottschalk I, Gembruch U, Geipel A. Early vs late intervention in twin reversed arterial perfusion sequence. Ultrasound Obstet Gynecol. 2014 Jan;43(1):60-4. doi: 10.1002/uog.12578.

ReferenceCitation: Jelin E, Hirose S, Rand L, Curran P, Feldstein V, Guevara-Gallardo S, Jelin A, Gonzales K, Goldstein R, Lee H. Perinatal outcome of conservative management versus fetal intervention for twin reversed arterial perfusion sequence with a small acardiac twin. Fetal Diagn Ther. 2010;27(3):138-41. doi: 10.1159/000295176. Epub 2010 Mar 9.

ReferenceCitation: Lewi L, Gratacos E, Ortibus E, Van Schoubroeck D, Carreras E, Higueras T, Perapoch J, Deprest J. Pregnancy and infant outcome of 80 consecutive cord coagulations in complicated monochorionic multiple pregnancies. Am J Obstet Gynecol. 2006 Mar;194(3):782-9.

ReferenceCitation: Kerstjens JM, Nijhuis A, Hulzebos CV, van Imhoff DE, van Wassenaer-Leemhuis AG, van Haastert IC, Lopriore E, Katgert T, Swarte RM, van Lingen RA, Mulder TL, Laarman CR, Steiner K, Dijk PH. The Ages and Stages Questionnaire and Neurodevelopmental Impairment in Two-Year-Old Preterm-Born Children. PLoS One. 2015 Jul 20;10(7):e0133087. doi: 10.1371/journal.pone.0133087. eCollection 2015.

lead_sponsor: Universitaire Ziekenhuizen Leuven

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

location_facility: Centre Médico-Chirurgical et Obstétrical

location_facility: Universitätsklinik für Frauenheilkunde und Geburtshilfe

location_facility: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

location_facility: St. George's Hospital, University of London (UK sponsor)


type: Other Identifier

title: Phase II Trial of Nivolumab for Pediatric and Adult Relapsing/Refractory Anaplastic Large Cell Lymphoma, for Evaluation of Response in Patients With Progressive Disease Cohort 1 or as Consolidative Immunotherapy in Patients in Complete Remission After Relapse Cohort 2

acronym: NIVO-ALCL

summary: Prospective, non-randomized, single arm phase II trial with 2 cohorts of ALK+ ALCL treated with nivolumab

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_country: Denmark France Netherlands

location_facility:
CHU Bordeaux Hopital Pellegrin
Rigshospitalet
Princess Maxima center
Centre Léon Berard Lyon
Gustave Roussy
CHU Toulouse Hopital des enfants

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Ongoing


type: Other Grant/Funding Number

title: BIOMARGIN European, Ambispective Cohort of Adult and Paediatric Renal Transplant Patients for the Evaluation of the Diagnostic and Prognostic Performance of Biomarkers of Renal Graft Injuries

acronym: BECS

summary:
Biomargin is a European research program aimed at evaluating the diagnostic performance of biomarkers with respect to renal graft injuries, as well as their prognostic performance with respect to 3-year and 5-year graft outcomes.

Nucleic acids, proteins and metabolites previously identified as candidate biomarkers of individual kidney graft lesions will be determined systematically in urine and blood samples collected in patients from the time of transplantation onwards, as well as in the graft tissue when biopsies are required for medical causes or performed systematically in the investigation centres. Their diagnostic and prognostic performance will be checked against histological reading of the biopsies and evolution of the graft function over time.

status: Unknown status

study_type: Observational

ReferenceType: derived

ReferenceCitation: Van Loon E, Gazut S, Yazdani S, Lerut E, de Loor H, Coemans M, Noël LH, Thorrez L, Van Lommel L, Schuit F, Sprangers B, Kuypers D, Essig M, Gwinner W, Anglicheau D, Marquet P, Naesens M. Development and validation of a peripheral blood mRNA assay for the assessment of antibody-mediated kidney allograft rejection: A multicentre, prospective study. EBioMedicine. 2019 Aug;46:463-472. doi: 10.1016/j.ebiom.2019.07.028. Epub 2019 Aug 1.

family: Van Loon

full_name: Elisabet Van Loon

given: Elisabet

sequence: first

family: Gazut

full_name: Stéphane Gazut

given: Stéphane

sequence: additional

family: Yazdani

full_name: Saleh Yazdani

given: Saleh

family: Lerut

full_name: Evelyne Lerut

given: Evelyne

family: de Loor

full_name: Henriette de Loor

given: Henriette

family: Coemans

full_name: Maarten Coemans

given: Maarten

family: Noël

full_name: Laure-Hélène Noël

given: Laure-Hélène

family: Thorrez

full_name: Lieven Thorrez

given: Lieven

family: Van Lommel

full_name: Leentje Van Lommel

given: Leentje

family: Schuit

full_name: Frans Schuit

given: Frans

family: Sprangers

full_name: Ben Sprangers

given: Ben

family: Kuypers

full_name: Dirk Kuypers

given: Dirk

family: Essig

full_name: Marie Essig

given: Marie

family: Gwinner

full_name: Wilfried Gwinner

given: Wilfried

family: Anglicheau

full_name: Dany Anglicheau

given: Dany

family: Marquet

full_name: Pierre Marquet

given: Pierre

family: Naesens

full_name: Maarten Naesens

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: EBioMedicine

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: KU Leuven - Lirias

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

location_facility:
University of Leuven - KU Leuven
Medizinische Hochschule Hannover (MHH)
Necker Children University Hospital
University Hospital - INSERM
Purpan Children University Hospital


title: A New Adaptive Feeding Plan for Newborns: Effects on Gut Maturity and Gut Microbiota

summary: The purpose of this clinical trial is to identify the infant formula(s) for which the investigators get the closest gut maturation index compared to the one they get with breastfed babies.

status: Completed

study_completion_date_type: Actual

design_allocation: Randomized

lead_sponsor: Nestlé

location_country: Austria France Greece

location_facility: Alexandra Regional General Hospital, Department of Neonatology

location_facility: Maternité Régionale, Service de Néonatologie

location_facility: Hôpital Charles Nicolle, Département de Pédiatrie

location_facility: Service de Réanimation Néonatale et Néonatologie, Hôpital de la Croix Rousse

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Completed


title: A Study to Evaluate the Safety and the Efficacy of Transient Opening of the Blood-brain Barrier (BBB) by Low Intensity Pulsed Ultrasound With the SonoCloud-9 Implantable Device in Recurrent Glioblastoma Patients Eligible for Surgery and for Carboplatin Chemotherapy

summary:
Recurrent glioblastoma (GBM) is a disease with high unmet clinical need. The standard of care for patients with GBM includes surgery, radiotherapy and chemotherapy. Despite this aggressive treatment, the overall median survival of patients with GBM remains at 15-20 months.

In more than 95% of cases, tumor recurrence is observed within 2 cm to 3 cm of the resection cavity within 4-7 months after initial treatments. One of the main causes of recurrence is the inability of chemotherapies to enter the brain from the systemic circulation due to the blood-brain barrier (BBB). The BBB is unique to cerebral blood vessels and blocks most drugs from entering the brain in sufficient concentrations.

The SonoCloud-9 (SC9) System delivers ultrasound to locally and transiently increase the permeability of the BBB to allow the passage of drugs into the cerebral parenchyma. The SC9 is dimensioned to cover the resection area and surrounding tissues in patients with recurrent GBM. The large sonicated volume covered by the SC9 device allows for broad BBB disruption and should allow for carboplatin chemotherapy to penetrate the surrounding tumor infiltrative area. By enhancing drug concentrations, it is hypothesized that further disease progression will be prevented.

status: Active, not recruiting

ReferenceType: background

ReferenceCitation: Carpentier A, Canney M, Vignot A, Reina V, Beccaria K, Horodyckid C, Karachi C, Leclercq D, Lafon C, Chapelon JY, Capelle L, Cornu P, Sanson M, Hoang-Xuan K, Delattre JY, Idbaih A. Clinical trial of blood-brain barrier disruption by pulsed ultrasound. Sci Transl Med. 2016 Jun 15;8(343):343re2. doi: 10.1126/scitranslmed.aaf6086.

ipd_sharing: No

lead_sponsor: CarThera

location_country:
United States
France

location_facility:
MD Anderson Cancer Center
Hôpital de La Timone
Hôpital Neurologique Pierre Wertheimer
Hôpital de la Pitié-Salpêtrière
CHU
Northwestern University

intervention_type: Device


type: EudraCT Number

title: A Multi-center, Open-label Study to Determine the Dose and Safety of Oral Asciminib in Pediatric Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia in Chronic Phase (Ph+ CML-CP), Previously Treated With One or More Tyrosine Kinase Inhibitors

summary: The aim of this study is to support development of asciminib in the pediatric population (1 to <18 years) previously treated with one or more TKIs. Full extrapolation of the efficacy of asciminib from adult to pediatric patients will be conducted. Full extrapolation is based on the concept that CML in the pediatric population has the same pathogenesis, similar clinical characteristics and progression pattern as in adults.

study_start_date_type: Anticipated

ipd_sharing: Yes

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country: Germany Hungary Thailand France


title: A Phase 1, First-in-Human, Double-Blind, Placebo-Controlled, Multicenter, Single and Multiple Ascending Dose Study of NI006 in Patients With Amyloid Transthyretin Cardiomyopathy Followed by an Open-Label Extension

summary: A phase 1, randomized, placebo-controlled, double-blind, dose escalation trial combining single-ascending dose and multiple-ascending dose phases of NI006 or placebo, followed by an open-label extension phase in subjects with Amyloid Transthyretin Cardiomyopathy (ATTR-CM).

lead_sponsor: Neurimmune AG

location_country: Spain Germany France Netherlands

location_facility: Hospital Universitario Puerta de Hierro Majadahonda


title: Creation of a Cohort for the Quantitation and Characterization of Circulating Viral RNAs as a New Biomarker of Hepatitis B Functional Cure.

acronym: CirB-RNA

summary: The " CirB-RNA " cohort aims to create a biological collection associated with clinical and biological data from patients with hepatitis B infection. This project is part of a much larger program that aims to characterize and quantify circulating viral RNAs as a possible new biomarker of hepatitis B functional cure.

time_perspective: Prospective

lead_sponsor: Hospices Civils de Lyon

location_country: Italy France

location_facility: Hôpital de la Croix-Rousse - Service de maladies infectieuses et tropicales

location_facility: Hepatology department - Groupement Hospitalier Nord - Hôpital de la Croix-Rousse

location_facility: Infectious diseases and hepatology unit - Azienda Ospedaliero

location_facility: Gastroenterology and Hepatology department - • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Gastroenterology and Hepatology department - • Università degli Studi di Palermo

location_facility: Department of Hepato-gastroenterology and pediatric nutrition - Hôpital Femme-Mère Enfant


title: A Phase I/II, Open-label, Dose-Escalating Study With a Proof of Concept Cohort to Evaluate the Safety, Tolerability and Efficacy of ARGX-110 in Combination With Azacytidine in Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) or High Risk Myelodysplatic Syndrome (MDS)

summary: The purpose of this study is to determine the maximum tolerated dose (MTD) of ARGX-110 and/or the recommended Phase II dose (RP2D) in combination with a standard dose of azacytidine (AZA) in Phase 1; and to evaluate efficacy of ARGX-110 when administered at a RP2D level established in Phase I in combination with a standard dose of AZA (proof-of concept) by evaluating overall response rate (ORR) in Phase 2.

enrollment_type: Actual

ReferenceCitation: Riether C, Pabst T, Höpner S, Bacher U, Hinterbrandner M, Banz Y, Müller R, Manz MG, Gharib WH, Francisco D, Bruggmann R, van Rompaey L, Moshir M, Delahaye T, Gandini D, Erzeel E, Hultberg A, Fung S, de Haard H, Leupin N, Ochsenbein AF. Targeting CD70 with cusatuzumab eliminates acute myeloid leukemia stem cells in patients treated with hypomethylating agents. Nat Med. 2020 Sep;26(9):1459-1467. doi: 10.1038/s41591-020-0910-8. Epub 2020 Jun 29.

family: Riether

full_name: Carsten Riether

given: Carsten

family: Pabst

full_name: Thomas Pabst

given: Thomas

family: Höpner

full_name: Sabine Höpner

given: Sabine

family: Bacher

full_name: Ulrike Bacher

given: Ulrike

family: Hinterbrandner

full_name: Magdalena Hinterbrandner

given: Magdalena

family: Banz

full_name: Yara Banz

given: Yara

family: Müller

full_name: Rouven Müller

given: Rouven

family: Manz

full_name: Markus G. Manz

given: Markus G.

family: Gharib

full_name: Walid H. Gharib

given: Walid H.

family: Francisco

full_name: David Francisco

given: David

family: Bruggmann

full_name: Remy Bruggmann

given: Remy

family: van Rompaey

full_name: Luc van Rompaey

given: Luc

family: Moshir

full_name: Mahan Moshir

given: Mahan

family: Delahaye

full_name: Tim Delahaye

given: Tim

family: Gandini

full_name: Domenica Gandini

given: Domenica

family: Erzeel

full_name: Ellen Erzeel

given: Ellen

family: Hultberg

full_name: Anna Hultberg

given: Anna

family: Fung

full_name: Samson Fung

given: Samson

family: de Haard

full_name: Hans de Haard

given: Hans

family: Leupin

full_name: Nicolas Leupin

given: Nicolas

family: Ochsenbein

full_name: Adrian F. Ochsenbein

given: Adrian F.

journal_name: Nature Medicine

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

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

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


title: An Open-label Study to Assess the Long-term Safety and Efficacy of ONO/GS-4059 in Subjects With Relapsed/Refractory B-cell Malignancies

summary: This study will determine the long-term safety, tolerability, and efficacy of tirabrutinib in adults in a prior tirabrutinib study and whose disease had not progressed on the parent study. The dosing regimen will be based on the prior dosing regimen from the parent study.

lead_sponsor: Gilead Sciences

location_country:
United Kingdom
France

location_facility:
CHRU de Lille
Centre Hospitalier Lyon Sud
University Hospital of Wales
Derriford Hospital
Hopital Saint Eloi
Leicester Royal Infirmary


title: A Phase 2, Open-label, Single-arm Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of 12 Weeks Treatment With Simeprevir and Daclatasvir in Subjects With Chronic Hepatitis C Virus Genotype 1b or 4 Infection and Either Severe Renal Impairment or End-stage Renal Disease on Hemodialysis.

summary: The purpose of this study is to evaluate the percentage of participants with sustained virologic response 12 weeks after the actual end of study treatment (SVR12)

status: Withdrawn

lead_sponsor: Janssen R&D Ireland

location_country: France Spain

status_simplified: Unknown


title: Post Market Study to Evaluate Safety and Effectiveness of the InnFocus Microshunt™ (MIDI Arrow) in Patients With Primary Open Angle Glaucoma

summary: Prospective, multicentric, single arm post market study to gather safety and effectiveness data on the CE Marked InnFocus MicroShunt (MIDI Arrow) device in primary open angle glaucoma patients

lead_sponsor: InnFocus Inc.

location_country: Spain France Switzerland Netherlands

location_facility: Clinicovision - Hospital Clinico San Carlos

location_facility: Groupe hospitalier Paris Saint-Joseph, Service d'Ophtalmologie

location_facility: Clinique Ophtalmologique Universitaire de Grenoble, Hôpital A. Michallon - CHU de Grenoble

location_facility: Hôpitaux Universitaires de Genève, Policlinique d'Ophtalmologie

location_facility: Pole Ophtalmologique de la Clinique Mutualiste


title: An Open-label, Multi-Center, Non-Randomised Phase I Dose-Escalation Study to Investigate the Safety and Tolerability of ONO-4059 (ONO/GS-4059) Given as Monotherapy in Patients With Relapsed/Refractory Non-Hodgkin's Lymphoma (NHL) and Relapsed/Refractory Chronic Lymphocytic Leukaemia (CLL)

summary: The primary objective of the study is to evaluate the safety and tolerability of tirabrutinib (formerly ONO/GS-4059) given as monotherapy to participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL).

ReferenceType: result

ReferenceCitation: Walter HS, Salles GA, Dyer MJ. New Agents to Treat Chronic Lymphocytic Leukemia. N Engl J Med. 2016 Jun 2;374(22):2185-6. doi: 10.1056/NEJMc1602674.

journal_name: New England Journal of Medicine

oa_host_type: repository

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

license_normalized: no license

repository_institution: University of Leicester - Leicester Research Archive

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

ReferenceCitation: Walter HS, Rule SA, Dyer MJ, Karlin L, Jones C, Cazin B, Quittet P, Shah N, Hutchinson CV, Honda H, Duffy K, Birkett J, Jamieson V, Courtenay-Luck N, Yoshizawa T, Sharpe J, Ohno T, Abe S, Nishimura A, Cartron G, Morschhauser F, Fegan C, Salles G. A phase 1 clinical trial of the selective BTK inhibitor ONO/GS-4059 in relapsed and refractory mature B-cell malignancies. Blood. 2016 Jan 28;127(4):411-9. doi: 10.1182/blood-2015-08-664086. Epub 2015 Nov 5.

name: Ernest and Helen Scott Haematological Research Institute, University of Leicester, Leicester, United Kingdom;

family: Walter

full_name: Harriet S. Walter

given: Harriet S.

name: Department of Haematology, Plymouth Hospitals NHS Trust, Plymouth, United Kingdom;

family: Rule

full_name: Simon A. Rule

given: Simon A.

family: Dyer

full_name: Martin J. S. Dyer

given: Martin J. S.

name: Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Service d’Hématologie, Pierre-Bénite, Université Claude Bernard Lyon 1, Lyon, France;

family: Karlin

full_name: Lionel Karlin

given: Lionel

name: Cardiff CLL Research Group, School of Medicine, Heath Park, Cardiff, Wales, United Kingdom;

family: Jones

full_name: Ceri Jones

given: Ceri

name: Department of Clinical Hematology, Centre Hospitalier Régional Universitaire (CHRU) de Lille, and Unité Groupe de Recherche sur les Formes Injectables et les Technologies Associées (GRITA), Université de Lille 2, Lille, France;

family: Cazin

full_name: Bruno Cazin

given: Bruno

name: Department of Clinical Hematology and Unité Mixte de Recherche (UMR)–Centre National de la Recherche Scientifique (CNRS) 5235, CHRU, Montpellier, France;

family: Quittet

full_name: Philippe Quittet

given: Philippe

family: Shah

full_name: Nimish Shah

given: Nimish

family: Hutchinson

full_name: Claire V. Hutchinson

given: Claire V.

name: ONO Pharmaceuticals Co Ltd, Osaka, Japan; and

family: Honda

full_name: Hideyuki Honda

given: Hideyuki

name: ONO Pharma UK Ltd, London, United Kingdom

family: Duffy

full_name: Kevin Duffy

given: Kevin

family: Birkett

full_name: Joseph Birkett

given: Joseph

family: Jamieson

full_name: Virginia Jamieson

given: Virginia

family: Courtenay-Luck

full_name: Nigel Courtenay-Luck

given: Nigel

family: Yoshizawa

full_name: Toshio Yoshizawa

given: Toshio

family: Sharpe

full_name: John Sharpe

given: John

family: Ohno

full_name: Tomoya Ohno

given: Tomoya

family: Abe

full_name: Shinichiro Abe

given: Shinichiro

family: Nishimura

full_name: Akihisa Nishimura

given: Akihisa

ReferenceCitation: Fegan, C, Bagshawe J, Salles G, et al. The Bruton's tyrosine kinase (BTK) inhibitor ONO-4059: promising single agent activity and well tolerated in patients with high risk chronic lymphocytic leukaemia (CLL). Paper presented at: 56th American Society of Hematology Annual Meeting and Exposition; December 6-9, 2014; San Franscisco, CA.

ReferenceCitation: Morschhauser F, Terriou L, Dyer M, et al. The Bruton's tyrosine kinase (BTK) inhibitor ONO-4059: promising single agent activity in patients with relapsed and refractory NHL. Haematologica. 2014 Jun; 99: 150.

location_facility:
CHU St Eloi
CHRU - Hopital Claude HURIEZ
Centre hospitalier Lyon Sud
University Hospital of Wales
Derriford Hospital
Leicester Royal Infirmary


title: A Randomised, Double-blind, Placebo-controlled, Multi National, Phase III Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablet, Starting 2 Months Before the Grass Pollen Season Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis

summary: The purpose of this study is to evaluate the efficacy and safety of sublingual tablets of grass pollen allergen extract when initiated 2 months before the grass pollen season compared with placebo for reduction of rhinoconjunctivitis symptoms and rescue medication usage.

lead_sponsor: Stallergenes Greer

location_country: Italy France Spain

location_facility:
Cab medical
Complejo Hospitalario de Caceres
HGU La Paz
Hop Montauban
Stallergenes Sa
Azienda Ospedaliera


title: Phase II Open-label Study to Investigate the Efficacy and Safety of PTK787/ZK 222584 Orally Administered Once Daily or Twice Daily at 1250 mg as Second-line Monotherapy in Patients With Stage IIIB or Stage IV Non-small-cell Lung Cancer (NSCLC)

summary: The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with non small cell lung cancer who have already received one platinum based chemotherapy.

ReferenceCitation: Gauler TC, Besse B, Mauguen A, Meric JB, Gounant V, Fischer B, Overbeck TR, Krissel H, Laurent D, Tiainen M, Commo F, Soria JC, Eberhardt WEE. Phase II trial of PTK787/ZK 222584 (vatalanib) administered orally once-daily or in two divided daily doses as second-line monotherapy in relapsed or progressing patients with stage IIIB/IV non-small-cell lung cancer (NSCLC). Ann Oncol. 2012 Mar;23(3):678-687. doi: 10.1093/annonc/mdr255. Epub 2011 May 26.

family: Gauler

full_name: T.C. Gauler

family: Besse

full_name: B. Besse

given: B.

family: Mauguen

full_name: A. Mauguen

given: A.

family: Meric

full_name: J.B. Meric

family: Gounant

full_name: V. Gounant

given: V.

family: Fischer

full_name: B. Fischer

family: Overbeck

full_name: T.R. Overbeck

family: Krissel

full_name: H. Krissel

given: H.

family: Laurent

full_name: D. Laurent

given: D.

family: Tiainen

full_name: M. Tiainen

given: M.

family: Commo

full_name: F. Commo

given: F.

family: Soria

full_name: J.C. Soria

family: Eberhardt

full_name: W.E.E. Eberhardt

journal_name: Annals of Oncology

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Bayer

location_country: Germany France


title: Outcome of Acquired Haemophilia With Steroid Combined With Cyclophosphamide Versus Steroid Combined With Rituximab (CREHA Study)

acronym: CREHA

summary: CREHA project is a study comparing steroid combined with cyclophosphamide versus steroid combined with rituximab in patients with acquired haemophilia. The study will test the hypothesis that steroid combined with cyclophosphamide is more effective than steroid plus rituximab for FVIII inhibitor eradication in acquired haemophilia.

lead_sponsor: University Hospital, Rouen

location_facility: University Hospital of Bordeaux - Hospital Haut-Lévêque

location_facility: University Hospital of Nantes, Hospital Hôtel-Dieu

location_facility: University Hospital of Brest - Hospital La cavale Blanche

location_facility: Regional Center of Haemophilia Treatment (CRTH) de Lorraine

location_facility: University Regional Hospital Hautepierre

location_facility: Europen Hospital of Georges Pompidou (HEGP)

location_facility: University Hospital of Dijon - Hospital Général

location_facility: AP-HM, University Hospital La Conception


title: Prospective, Multi-country, Observational Registry to Collect Clinical Information on Patients With Endogenous Cushing's Syndrome to Assess Drug Utilization Pattern and to Document the Safety and Effectiveness of Ketoconazole.

acronym: KetoPASS

summary: This is a non-interventional, prospective, multinational, multicentre, observational study, in which data collected are those derived from routine clinical practice via an European registry on CS: ERCUSYN.

lead_sponsor: HRA Pharma

location_country: Spain Sweden Croatia France

location_facility: Institut de Recerca de la Santa Creu i Sant Pau


title: R-One Efficiency For PCI Evolution With Robotic Assistance

acronym: R-EVOLUTION

summary: This study is a Prospective, Multi-center, Single-arm clinical study, in patients with Coronary Artery Disease, including patients with silent ischemia (excluding STEMI), who qualify for elective Percutaneous Coronary Intervention (PCI), aimed to assess the Safety and Efficacy of the R-One device in elective PCI.

lead_sponsor: Robocath

location_country: Luxembourg Belgium France Netherlands

location_facility:
INCCI
Maastad Ziekenhuis
Het Ziekenhuisnetwerk Antwerpen vzw
Clinique Pasteur
CHU Rouen
CHU Caen Normandie


primary_purpose: Basic Science

location_country:
United Kingdom
Belgium
France

location_facility: CHU Liège, Médecine de l'appareil locomoteur

location_facility: Hopital Saint Antoine AP-HP Rhumatologie

location_facility: Hopital Cochin AP-HP Evaluation et traitement de la Douleur

source: euctr

title: Validation Study to Investigate the Effect of a New Treatment in Patients With Osteoarthritic Pain of Knee or Hip

summary: The purpose of this clinical trial conducted in patients suffering from chronic pain is to study the relationship between individual patients' profile and their analgesic response


title: A Phase I , Open Label, Single Center, Dose Escalation Study to Assess the Pharmacokinetics, Safety and Tolerability of a Single Dose of a New Extended Long-acting Formulation of Octreotide Pamoate Administered i.m. in Healthy Cholecystectomized Volunteers

summary: This study will assess the pharmacokinetic profile, safety and tolerability of an octreotide extended long-acting formulation after a single dose in humans. It will investigate the profile of a single dose of drug in a healthy volunteer subject in order to understand the timing and extent of fluctuations in octreotide concentrations in the blood with this formulation, the relationship of drug concentration with dose, and how long the drug remains in the body system.

location_country: Italy Belgium France


title: A Phase I Trial Evaluating a Mutanome-directed Immunotherapy in Patients With High Grade Serous Carcinoma (HGSC) of the Ovary, Fallopian Tube or Peritoneum.

summary: This is a multicenter, open-label, single arm phase I study evaluating the safety and tolerability as well as some activity parameters of TG4050 in patients with ovarian, fallopian or peritoneal serous carcinoma.

lead_sponsor: Transgene

location_facility:
IUCT Toulouse
Mayo Clinic Jacksonville
Institut Curie
Mayo Clinic Rochester
Hôpital Pitié-Salpêtrière
Mayo Clinic Phoenix


title: An Open-Label, Multicenter, Dose-Escalation Phase Ib Study With Expansion Phase to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Therapeutic Activity of Emactuzumab and RO7009789 Administered in Combination in Patients With Advanced Solid Tumors

summary: This is an open-label, multicenter study designed to assess the safety, pharmacokinetics, pharmacodynamics, and therapeutic activity of emactuzumab and RO7009789 administered in combination in participants with locally advanced or metastatic solid tumors that are not amenable to standard treatment. This study will be conducted in two parts: a dose-finding stage (Part I) and an expansion stage (Part II).

ReferenceCitation: Machiels JP, Gomez-Roca C, Michot JM, Zamarin D, Mitchell T, Catala G, Eberst L, Jacob W, Jegg AM, Cannarile MA, Watson C, Babitzki G, Korski K, Klaman I, Teixeira P, Hoves S, Ries C, Meneses-Lorente G, Michielin F, Christen R, Rüttinger D, Weisser M, Delord JP, Cassier P. Phase Ib study of anti-CSF-1R antibody emactuzumab in combination with CD40 agonist selicrelumab in advanced solid tumor patients. J Immunother Cancer. 2020 Oct;8(2). pii: e001153. doi: 10.1136/jitc-2020-001153.

family: Machiels

full_name: Jean-Pascal Machiels

given: Jean-Pascal

family: Gomez-Roca

full_name: Carlos Gomez-Roca

given: Carlos

family: Michot

full_name: Jean-Marie Michot

given: Jean-Marie

family: Zamarin

full_name: Dmitriy Zamarin

given: Dmitriy

family: Mitchell

full_name: Tara Mitchell

given: Tara

family: Catala

full_name: Gaetan Catala

given: Gaetan

family: Eberst

full_name: Lauriane Eberst

given: Lauriane

family: Jacob

full_name: Wolfgang Jacob

given: Wolfgang

family: Jegg

full_name: Anna-Maria Jegg

given: Anna-Maria

family: Cannarile

full_name: Michael A Cannarile

given: Michael A

family: Watson

full_name: Carl Watson

given: Carl

family: Babitzki

full_name: Galina Babitzki

given: Galina

family: Korski

full_name: Konstanty Korski

given: Konstanty

family: Klaman

full_name: Irina Klaman

given: Irina

family: Teixeira

full_name: Priscila Teixeira

given: Priscila

family: Hoves

full_name: Sabine Hoves

given: Sabine

family: Ries

full_name: Carola Ries

given: Carola

family: Meneses-Lorente

full_name: Georgina Meneses-Lorente

given: Georgina

family: Michielin

full_name: Francesca Michielin

given: Francesca

family: Christen

full_name: Randolph Christen

given: Randolph

family: Rüttinger

full_name: Dominik Rüttinger

given: Dominik

family: Weisser

full_name: Martin Weisser

given: Martin

family: Delord

full_name: Jean-Pierre Delord

given: Jean-Pierre

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale


title: PHASE IA/IB, OPEN-LABEL, MULTICENTER, MULTIPLE ASCENDING DOSE STUDY FOLLOWED BY AN EXTENSION PHASE TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND ACTIVITY OF RO6927005, AN ANTI-MESOTHELIN (MSLN) RECOMBINANT CYTOLYTIC FUSION PROTEIN (cFP), ADMINISTERED EITHER ALONE (PART A) OR IN COMBINATION WITH GEMCITABINE AND NAB-PACLITAXEL (PART B) IN PATIENTS WITH MESOTHELIN-POSITIVE METASTATIC AND/OR LOCALLY ADVANCED MALIGNANT SOLID TUMORS

summary:
This is a first-in-human, open-label, multi-center, Phase 1 study of RO6927005. The study will establish the safety and tolerability profile of RO6927005 and will be conducted in two parts.

In Part A, the first dose escalations will be carried out using cohorts of 1 patient. Single patient cohorts will be used to investigate increasing doses until a first dose-limiting toxicity (DLT) is reached or until grade-2 related toxicity (except infusion-related reactions), whichever comes first. At least 3 patients will be enrolled in each cohort thereafter, which, if required, can be expanded with additional patients. Part B of the study will consist of a multiple ascending dose phase (multiple patients cohorts - >/= 3 patients) followed by an extension phase of RO6927005 given in combination with gemcitabine/nab-paclitaxel.

Preliminary clinical activity will be explored throughout the study. Patients will be treated until disease progression and/or lack of clinical benefit, unacceptable toxicities, withdrawal from treatment for other reasons, death, pregnancy or termination of the study by the Sponsor, whichever comes first.

status: Terminated

lead_sponsor: Hoffmann-La Roche

location_country:
Denmark
United States
Canada
France


title: A Phase II Study of Chronomodulated Preoperative Infusional Chemoradiation for Biliary Tract Cancer

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy with fluorouracil before surgery in treating patients who have primary or recurrent bile duct cancer.

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

location_country:
United States
Belgium
France

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: Cancer Center at the University of Virginia

intervention_type: Radiation


title: A Retrospective Mapping of Health Care Utilisation and Current Quality of Life Status in Adult Subjects With a History of Chronic Otitis Media With or Without Cholesteatoma Who Have Undergone a Primary Tympanoplasty

summary: The objective of this multicentre study is to evaluate the standard of care of participants diagnosed with Chronic Otitis Media that have already gone through a first middle ear surgery but still have at least a moderate hearing loss. The study has a retrospective part (extraction of medical chart data) and a prospective part with a survey and three questionnaires collecting data on the use of health care services, on health related quality of life and hearing performance.

status: Not yet recruiting

time_perspective: Other

ipd_sharing_description: Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.

lead_sponsor: Cochlear

location_country: Germany France Spain

location_facility: Hôpital Bicêtre, Hôpitaux universitaires Paris Sud AP-HP

location_facility: Hals-, Nasen- und Ohrenklinik, Universitätsklinikum Heidelberg

location_facility: Universitätsklinik für Hals-, Nasen und Ohrenheilkunde

location_facility: ENT department - Bâtiment Pierre Paul Riquet - Hôpital Purpan


title: An Observational Study to Describe the Long-term Safety and Effectiveness of Namuscla in the Symptomatic Management of Myotonia in Adult Patients With Non-dystrophic Myotonic Disorders

summary: This is a non-interventional, prospective, observational, multicentre study to evaluate the long-term safety and effectiveness of Namuscla in adult patients with NDM.

lead_sponsor: Lupin Ltd.

location_country:
Germany
United Kingdom
France

location_facility: Universitätsklinikum Ulm, Klinik für Neurologie

location_facility: St. Josef-Hospital Klinikum der Ruhr Universitaet Bochum

location_facility: Hôpital Universitaire de La Pitié Salpêtrière

location_facility: Nottingham University Hospitals NHS Trust


title: A Pivotal, International, Randomised, Double-blind, Efficacy and Safety Trial of Sodium Valproate, in Paediatric and Adult Patients With Wolfram Syndrome

summary: This trial aims to investigate the efficacy, safety and tolerability of sodium valproate in the treatment of patients with Wolfram syndrome. 70 paediatric and adult patients will be randomised 2:1 to receive either sodium valproate or placebo at 6 international centres.

primary_purpose: Other

lead_sponsor: University of Birmingham

location_country:
Spain
United Kingdom
France
Poland

location_facility: CHU de Montpellier, Hopital Gui de Chauliac

location_facility: Unidad de Gestión Clínica Almería Periferia. Distrito Sanitario Almería


title: Medium Cost Effectiveness of Automated Non-Invasive Ventilation Outpatient Set Up vs Standard Fixed Level Non-Invasive Ventilation Inpatient Set Up In Obese Patients With Chronic Respiratory Failure

acronym: OPIP

summary:
Obesity is an escalating issue, with an accompanying increase in referrals of patients with obesity-related respiratory failure. Currently, these patients are electively admitted to hospital for initiation of non-invasive ventilation (NIV), but it is unknown whether outpatient initiation is as effective as inpatient set-up. The investigators hypothesise that outpatient set up using an auto-titrating NIV device will be more cost effective than nurse-led inpatient titration and set-up.

The investigators will undertake a multi-national, multi-centre randomised controlled trial.

Subjects will be randomised to receiving usual inpatient set-up, which will include nurse-led initiation of NIV or outpatient set-up with an automated NIV device. Subjects will be stratified according to trial site, gender and previous use of NIV or continuous positive airway pressure. Assuming 10% drop out rate, a total sample of 82 patients will be required. Cost effectiveness will be evaluated using standard treatment costs and health service utilisation and using health related quality of life measures (SRI and EQ5D). Change in the severe respiratory insufficiency (SRI) questionnaire will be based on analysis of covariance (ANCOVA) adjusting for the baseline measurements between the two arms of patients.

ipd_sharing_description: No plan to share individual participant data

lead_sponsor: Guy's and St Thomas' NHS Foundation Trust

location_facility: Royal Brompton and Harefield NHS Foundation Trust

location_facility: Leeds Teaching Hospital NHS Foundation Trust


title: Evaluation of Safety and Feasibility of Bone Marrow Derived Autologous MSCs to Enhance Bone Healing in Patients With Avascular Necrosis of the Femoral Head

summary: The purpose is to assess the safety and feasibility of cellular therapy derived from bone marrow, to help bone healing in patients with avascular necrosis of the hip.

ReferenceCitation: Gómez-Barrena E, Padilla-Eguiluz NG, Rosset P, Hernigou P, Baldini N, Ciapetti G, Gonzalo-Daganzo RM, Avendaño-Solá C, Rouard H, Giordano R, Dominici M, Schrezenmeier H, Layrolle P, On Behalf Of The Reborne Consortium. Osteonecrosis of the Femoral Head Safely Healed with Autologous, Expanded, Bone Marrow-Derived Mesenchymal Stromal Cells in a Multicentric Trial with Minimum 5 Years Follow-Up. J Clin Med. 2021 Feb 1;10(3). pii: 508. doi: 10.3390/jcm10030508.

family: Gómez-Barrena

full_name: Enrique Gómez-Barrena

given: Enrique

family: Padilla-Eguiluz

full_name: Norma Padilla-Eguiluz

given: Norma

family: Rosset

full_name: Philippe Rosset

given: Philippe

family: Hernigou

full_name: Philippe Hernigou

family: Baldini

full_name: Nicola Baldini

given: Nicola

family: Ciapetti

full_name: Gabriela Ciapetti

given: Gabriela

family: Gonzalo-Daganzo

full_name: Rosa Gonzalo-Daganzo

given: Rosa

family: Avendaño-Solá

full_name: Cristina Avendaño-Solá

given: Cristina

family: Rouard

full_name: Hélène Rouard

given: Hélène

family: Giordano

full_name: Rosaria Giordano

given: Rosaria

family: Dominici

full_name: Massimo Dominici

given: Massimo

family: Schrezenmeier

full_name: Hubert Schrezenmeier

given: Hubert

family: Layrolle

full_name: Pierre Layrolle

given: Pierre

currency_apc_doaj: CHF

journal_name: Journal of Clinical Medicine

license: cc-by

license_normalized: cc-by

repository_institution: Universidad Autónoma de Madrid - Biblos-e Archivo

evidence: oa repository (via pmcid lookup)

publisher: MDPI AG

publisher_dissemination: MDPI

publisher_group: MDPI

publisher_normalized: MDPI

lead_sponsor: Universidad Autonoma de Madrid

location_country: Italy Germany France Spain

location_facility: Department of Orthopaedic Surgery, Hôpital Henri Mondor

location_facility: Servicio de Cirugía Ortopédica y Traumatología "A", Hospital La Paz

location_facility: Department of Orthopaedic Surgery, CHU Tours

location_facility: Department of Orthopaedic Trauma, University of Ulm

intervention_type: Biological


title: A Multi-Center, Randomized, Double-Blind, Multiple Ascending Dose, Placebo-Controlled, Parallel Group 2-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of the HCV Nucleoside Inhibitor RO5428029 in Healthy Subjects and in CHC Genotype 1 Infected Patients

summary: This 2-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of RO5428029 in healthy volunteers and patients with hepatitis C infection. Cohorts will be randomized to receive either RO5428029 in ascending doses or placebo for up to 7 days (patients) or up to 14 days (healthy volunteers).

location_country: Poland France Netherlands


title: A Post Market Clinical Evaluation of Deep Brain Stimulation as an Adjunctive Treatment for Reducing Some of the Symptoms of Advanced, Levodopa-responsive Parkinson's Disease That Are Not Adequately Controlled With Medication

summary:
The objective of this study is to evaluate the effectiveness of Deep Brain Stimulation as an adjunctive treatment for reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication.

It is the first study in Parkinson patients outside the US with a Deep Brain Stimulation system using constant current instead of constant voltage and using a lead with an active electrode tip.

lead_sponsor: Abbott Medical Devices

location_country: Turkey Germany France

location_facility:
Erciyes University Medicine School
CHU Laennec
University Hospital Bonn
University Hospital of Duesseldorf
University Hospital Regensburg
Hopital Neurologique


lead_sponsor: Novartis Pharmaceuticals

title: A Phase Ib, Open-label, Multi-center Dose-finding Study of Oral Panobinostat (LBH589) in Combination With Ara-C and Mitoxantrone as Salvage Therapy for Refractory or Relapsed Acute Myeloid Leukemia

summary: The study will determine the maximal tolerated dose (MTD) of panobinostat administered in combination with a fixed combination of cytarabine (ara-C) and mitoxantrone in adult patients with relapsed or refractory acute myeloid leukemia (AML).


title: An International Phase III Randomised Trial Comparing the Propofol Consumption During General Anaesthesia With Xenon in Inspiratory Concentrations of 50% and 70% and Total I.V. Anaesthesia Alone in ASA III Patients With Increased Risk of Perioperative Cardiac Complications.

summary: The purpose of this study is to evaluate the quantity of propofol administered with Xenon in two inspiratory concentrations, to maintain comparable depth of anaesthesia during the maintenance period of general anaesthesia.

lead_sponsor: Air Liquide SA

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Groupe Hospitalier Universitaire Caremeau


title: A Phase I/II Clinical Trial of PXD101 in Combination With Idarubicin in Patients With AML Not Suitable for Standard Intensive Therapy

summary: An open-label, non-randomized, multi-centre, Phase I/II trial to assess the efficacy and safety of 2 schedules of PXD101 in combination with idarubicin in patients with AML not suitable for standard intensive therapy.

lead_sponsor: Onxeo

location_facility:
Universitätsklinikum Ulm
Christie Hospital NHS Trust
CHU Lapeyronie
Hôpital St. Louis
Uniklinik Homburg
Uni Hospital Marburg


title: A Prospective, Randomized, Double-blind, Double-dummy, Forced Titration, Parallel Group Comparison, Multicenter Trial to Compare the Effects of Either Telmisartan (40-80 mg p.o. Once Daily) or Ramipril (5-10 mg p.o. Once Daily) on Renal Endothelial Dysfunction in Hypertensive Patients With Type 2 Diabetes

summary: The primary objective is to evaluate the effect of 9 weeks treatment with either telmisartan or ramipril on NO bioavailability in the renal vasculature, measured as renal plasma flow (RPF) in response to NG-monomethyl-L-arginine (LNMMA) infusion.

lead_sponsor: Boehringer Ingelheim

location_facility: Boehringer Ingelheim Investigational Site


title: PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film

summary:
Intrauterine adhesions (IUA) are the major long-term complication of intrauterine procedures and are associated with pelvic pain, menstrual disorders, obstetrical complication and infertility.

Womed Leaf is a medical device specifically designed for intrauterine use that prevents intra-uterine adhesions. It is a film that acts as a mechanical barrier to keep uterus walls separated during healing. It is then naturally discharged through the cervix and vagina in less than 30 days.

The PREG1 clinical investigation is designed to evaluate Womed Leaf safety under clinical conditions, in women scheduled for a hysteroscopic myomectomy as well as its efficacy.

primary_purpose: Prevention

ipd_sharing_description: No sharing of individual participant data is planed

lead_sponsor: Womed

location_country: Belgium France Netherlands

location_facility:
Isala Zwolle
CHU Nîmes
Bergman Clinics
Zaans Medical Center
UZ Gent
CHU Bicêtre (APHP)


title: Randomized Controlled Clinical Trial to Assess the Efficacy of a Combination of Autologous Mesenchymal Stem Cells and Biomaterial in Jaw Bone Regeneration Prior to Dental Implant Placement in Comparison to Standard Autologous Bone Grafting

acronym: Maxibone

summary: A randomized controlled clinical multi center trial to assess the efficacy of a combination of autologous mesenchymal stem cells and biomaterial in jaw bone regeneration prior to dental implant placement in comparison to standard autologous bone block grafting.

ReferenceCitation: Gjerde C, Mustafa K, Hellem S, Rojewski M, Gjengedal H, Yassin MA, Feng X, Skaale S, Berge T, Rosen A, Shi XQ, Ahmed AB, Gjertsen BT, Schrezenmeier H, Layrolle P. Cell therapy induced regeneration of severely atrophied mandibular bone in a clinical trial. Stem Cell Res Ther. 2018 Aug 9;9(1):213. doi: 10.1186/s13287-018-0951-9.

ReferenceCitation: Rojewski MT, Lotfi R, Gjerde C, Mustafa K, Veronesi E, Ahmed AB, Wiesneth M, Körper S, Sensebé L, Layrolle P, Hellem S, Schrezenmeier H. Translation of a standardized manufacturing protocol for mesenchymal stromal cells: A systematic comparison of validation and manufacturing data. Cytotherapy. 2019 Apr;21(4):468-482. doi: 10.1016/j.jcyt.2019.03.001. Epub 2019 Mar 27.

ipd_sharing_description: De-identified individual participants data for all primary and secondary outcome measures will be made available

lead_sponsor: University of Bergen

location_country: Denmark Norway France Spain

location_facility: University of Bergen, Institute of Clonical Dentistry

location_facility: Syddansk Universitet SDU (University Hospital of Southern Denmark)

intervention_type: Combination Product


title: A Phase 1/2, Open-label, Multicenter, Non-randomized Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Burosumab in Pediatric Patients From Birth to Less Than 1 Year of Age With X-linked Hypophosphatemia (XLH)

summary: A Phase 1/2, Open-label, Multicenter, Non-randomized Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Burosumab in Paediatric Patients from Birth to Less than 1 Year of Age with X-linked Hypophosphatemia (XLH)

lead_sponsor: Kyowa Kirin Pharmaceutical Development Ltd

location_country:
Italy
Austria
France
Spain
United Kingdom

location_facility: Evelina London Children's Hospital - Guy's & St Thomas' NHS Foundation Trust

location_facility: Centre de reference des maladies renales rares-Hospices Civils de Lyon-Hopital Femme Mere Enfant


title: A Randomized Phase I Trial in Patients With Newly Diagnosed, Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) Evaluating a Mutanome-directed Immunotherapy.

summary: This is a multicenter, open-label, two arms, randomized, phase I study evaluating the safety and tolerability as well as some activity parameters of TG4050 in patients with squamous cell carcinoma of the head and neck (SCCHN).

location_country:
United States
United Kingdom
France

location_facility: Aintree University Hospital NHS Fondation Trust


title: Phase 1b/2 Study of LY3200882 and Pembrolizumab in Patients With Advanced Cancer

summary: The main purpose of this study is to see if the drug LY3200882 which is an inhibitor of transforming growth factor-β (TGFβ) receptor 1 in combination with pembrolizumab is safe and effective in participants with cancer that has spread to other parts of the body.

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

lead_sponsor: Eli Lilly and Company

location_country:
United States
France
Spain

location_facility:
Dana Farber Cancer Institute
Hospital Madrid Norte Sanchinarro
Hospital Clinic I Provincial
CHU de Besancon Hopital Jean Minjoz
Institut Catala d'Oncologia
Gustave Roussy


title: Is Ablation of All Inducible Atrial Tachycardias an Appropriate Endpoint During Redo Procedures After Initial Persistent AF Ablation? A Multi-center, Randomised, Single-blind Study

acronym: INDUCATH

summary:
In the treatment of symptomatic drug resistant persistent atrial fibrillation (Ps AF), catheter ablation has a class IIA indication. During the follow-up, a significant amount of patients (~50%) will experience atrial tachycardias (AT) recurrence. The endpoint of AT ablation during the second procedure has not been validated. At present, several strategies are considered as good clinical practice.

Main objective: To evaluate if ablation of all inducible AT post AF ablation (ATPAFA) offers as substantial benefit in comparison with ablation of the clinical ATPAF only during a redo procedure post initial persistent AF ablation.

Secondary objectives:

To evaluate the prognosis of non-inducibility during a redo procedure for ATPAFA

lead_sponsor: AZ Sint-Jan AV

location_country:
Germany
United Kingdom
Belgium
France

location_facility: Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz

intervention_type: Procedure


title: SYNTAX III REVOLUTION Trial: A Randomized Study to Evaluate the Feasibility of Heart-Team Clinical Decision Making Regarding the Optimal (Surgical or Percutaneous Based) Revascularization Strategy in Patients With Complex Coronary Artery Disease, Based on Non-invasive Coronary CT Angiography (CTA) Imaging Utilising High-definition GE RevolutionTM Multi-slice CT and HeartFlow FFRCT Compared to the Current Standard of Care With Conventional Invasive Coronary Angiography (CA)

acronym: SYNTAX III

summary:
The SYNTAX III Revolution trial is a randomized diagnostic research study that investigates the use of CT scan and angiogram of the heart to help doctors decide which method is the best to improve blood supply to the heart in patients with complex coronary artery disease. Each patient will undergo an angiogram and CT scan per standard of care. The randomization strategy in this study is not between patients but between two teams of doctors, the so-called "Heart Teams", will be randomized: in the first round, team 1 assesses the angiogram, and team 2 assesses the CT scan. Then they make a decision about which treatment would be the best to treat complex coronary artery disease. In the second round, both teams see the imaging method that they did not see in the first round, and make the decision again. The final decision on the clinical treatment strategy is at the sole discretion of the Heart Team and there are no criteria described in SYNTAXIII Revolution protocol leading influencing this final decision.

Hypothesis: Determination of the best treatment strategy for coronary artery disease based on a CT scan will result in similar decisions as based on invasive coronary angiography.

time_perspective: Cross-Sectional

ReferenceCitation: Andreini D, Modolo R, Katagiri Y, Mushtaq S, Sonck J, Collet C, De Martini S, Roberto M, Tanaka K, Miyazaki Y, Czapla J, Schoors D, Plass A, Maisano F, Kaufmann P, Orry X, Metzdorf PA, Folliguet T, Färber G, Diamantis I, Schönweiß M, Bonalumi G, Guglielmo M, Ferrari C, Olivares P, Cavallotti L, Leal I, Lindeboom W, Onuma Y, Serruys PW, Bartorelli AL; SYNTAX III REVOLUTION Investigators. Impact of Fractional Flow Reserve Derived From Coronary Computed Tomography Angiography on Heart Team Treatment Decision-Making in Patients With Multivessel Coronary Artery Disease: Insights From the SYNTAX III REVOLUTION Trial. Circ Cardiovasc Interv. 2019 Dec;12(12):e007607. doi: 10.1161/CIRCINTERVENTIONS.118.007607. Epub 2019 Dec 13.

name: Centro Cardiologico Monzino, IRCCS, Milan, Italy (D.A., S.M., S.d.M., M.R., G.B., M.G., C.F., P.O., L.C., A.L.B.).

name: Department of Clinical Sciences and Community Health, Cardiovascular Section (D.A.), University of Milan, Italy.

family: Andreini

full_name: Daniele Andreini

given: Daniele

name: Department of Cardiology, Amsterdam University Medical Center, the Netherlands (R.M., Y.K.).

name: Department of Internal Medicine, Cardiology Division, Hospital de Clinicas, University of Campinas, SP, Brazil (R.M.).

family: Modolo

full_name: Rodrigo Modolo

given: Rodrigo

family: Katagiri

full_name: Yuki Katagiri

given: Yuki

family: Mushtaq

full_name: Saima Mushtaq

given: Saima

name: Cardiovascular Center Aalst, OLV Hospital, Belgium (J.S., C.C.).

family: Sonck

full_name: Jeroen Sonck

given: Jeroen

family: Collet

full_name: Carlos Collet

given: Carlos

family: De Martini

full_name: Stefano De Martini

given: Stefano

family: Roberto

full_name: Maurizio Roberto

given: Maurizio

name: Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Belgium (K.T., J.C., D.S.).

family: Tanaka

full_name: Kaoru Tanaka

given: Kaoru

name: Thoraxcenter, Erasmus MC, the Netherlands (Y.M., Y.O.).

family: Miyazaki

full_name: Yosuke Miyazaki

given: Yosuke

family: Czapla

full_name: Jens Czapla

given: Jens

family: Schoors

full_name: Danny Schoors

given: Danny

name: University of Zurich, Switzerland (A.P., F.M., P.K.).

family: Plass

full_name: Andre Plass

given: Andre

family: Maisano

full_name: Francesco Maisano

given: Francesco

family: Kaufmann

full_name: Philipp Kaufmann

given: Philipp

name: CHRU Nancy and Universite de Lorraine, Nancy, France (X.O., P.-A.M., T.F.).

family: Orry

full_name: Xavier Orry

given: Xavier

family: Metzdorf

full_name: Pierre-Adrien Metzdorf

given: Pierre-Adrien

family: Folliguet

full_name: Thierry Folliguet

given: Thierry

name: Jena University Hospital, Friedrich Schiller University of Jena, Germany (G.F., I.D.).

family: Färber

full_name: Gloria Färber

given: Gloria

family: Diamantis

full_name: Ioannis Diamantis

given: Ioannis

name: Heinrich Braun Klinikum, Zwickau, Germany (M.S.).

family: Schönweiß

full_name: Marc Schönweiß

given: Marc

family: Bonalumi

full_name: Giorgia Bonalumi

given: Giorgia

family: Guglielmo

full_name: Marco Guglielmo

given: Marco

name: Cardialysis BV, Rotterdam, the Netherlands (I.L., W.L.).

name: Department of Cardiology, Royal Brompton and Harefield Hospitals, Imperial College London, United Kingdom (P.W.S.).

name: Department of Biomedical and Clinical Sciences “Luigi Sacco” (A.L.B.), University of Milan, Italy.

name: for the SYNTAX III REVOLUTION Investigators

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: University of Zurich - Zurich Open Repository and Archive

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Collet C, Onuma Y, Andreini D, Sonck J, Pompilio G, Mushtaq S, La Meir M, Miyazaki Y, de Mey J, Gaemperli O, Ouda A, Maureira JP, Mandry D, Camenzind E, Macron L, Doenst T, Teichgräber U, Sigusch H, Asano T, Katagiri Y, Morel MA, Lindeboom W, Pontone G, Lüscher TF, Bartorelli AL, Serruys PW. Coronary computed tomography angiography for heart team decision-making in multivessel coronary artery disease. Eur Heart J. 2018 Nov 1;39(41):3689-3698. doi: 10.1093/eurheartj/ehy581.

name: Department of Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands

name: Department of Cardiology, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Laarbeeklaan 101, 1090 Jette, Brussel, Belgium

name: Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Doctor Molewaterplein 40, 3015 GD Rotterdam, the Netherlands

name: Cardialysis BV, Westblaak 98, 3012 KM Rotterdam, the Netherlands

name: Centro Cardiologico Monzino, University of Milan, Via Carlo Parea, 4, Milano, Italy

name: Department of Cardiology, University of Zurich, Rämistrasse 71, Zürich, Switzerland

name: Department of Radiology, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Laarbeeklaan 101, Jette, Brussel, Belgium

name: Department of Cardiovascular Surgery, University of Zurich, Rämistrasse 71, Zürich, Switzerland

name: Department of Cardiovascular Surgery, CHRU Nancy and University of Lorraine, Avenue du Maréchal de Lattre, Rue Charles Welche, Nancy, France

name: Department of Radiology, CHRU Nancy and University of Lorraine, Avenue du Maréchal de Lattre, Rue Charles Welche, Nancy, France

name: Department of Cardiology, CHRU Nancy and University of Lorraine, Avenue du Maréchal de Lattre, Rue Charles Welche, Nancy, France

name: Department of Cardiology, Centre cardiologique du nord, 36 Rue des Moulins Gémeaux, Saint-Denis, France

name: Department of Cardiovascular Surgery, Jena University Hospital, Friedrich Schiller University of Jena, Fürstengraben 1, Jena, Germany

name: Department of Radiology, Jena University Hospital, Friedrich Schiller University of Jena, Fürstengraben 1, Jena, Germany

name: Department of Cardiology, Heinrich Braun Klinikum, Karl-Keil-Straße 35, Zwickau, Germany

name: Department of Cardiology, Royal Brompton and Harefield Hospitals, Imperial College of London, Kensington, London SW7, UK

name: Department of Biomedical and Clinical Sciences “Luigi Sacco”, University of Milan, Via Festa del Perdono, 7, Milano MI, Italy

ipd_sharing_description:
The research data will be entered on separate forms and stored under a code number, according to prevailing legal requirements. No names or other personal data will be stored. Only the study doctor will hold the information to link the code to the patients. The encoded data will be processed, analysed and reported by the research employees of this study, who have an obligation of secrecy.

Representatives of the sponsor or members of the Ethics Committee (EC) and regulatory authorities within Europe can have access to the medical files in order to inspect the correctness of the research data. Data may be provided to representatives and affiliates of the industries supporting the study: General Electric and HeartFlow Inc. It is possible that the results of this study are presented or published in medical journals; this will always be without mention of the identity of the patients.

location_country: Italy Switzerland France Belgium Germany


title: Treatment of REfractory Overactive BLadder With the AXonics Sacral Neuromodulation System: RELAX-OAB

acronym: RELAX-OAB

summary: The RELAX-OAB (Treatment of REfractory Overactive BLadder with the AXonics Sacral Neuromodulation System) is a post-market clinical follow-up (PMCF) study designed to confirm the performance of the Axonics Sacral Neuromodulation (SNM) System as an aid in the treatment of the symptoms of overactive bladder (OAB) as well as capturing patient satisfaction and quality of life data.

lead_sponsor: Axonics Modulation Technologies, Inc.

location_country:
United Kingdom
Belgium
France
Netherlands

location_facility:
UZ Leuven
Maastricht University Medical Center
Chu De Nantes - Hôtel-Dieu
Hospices Civils de Lyon
University College London Hospital
Erasmus Medical Center


title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Trial, Investigating the Efficacy and Safety of Repeated Lamazym Treatment of Subjects With Alpha-Mannosidosis.

summary: The overall objective of this trial is to evaluate the efficacy and safety of repeated Lamazym i.v. treatment, compared with placebo, in subjects 5-35 years of age with alpha-Mannosidosis

ReferenceCitation: Borgwardt L, Stensland HM, Olsen KJ, Wibrand F, Klenow HB, Beck M, Amraoui Y, Arash L, Fogh J, Nilssen Ø, Dali CI, Lund AM. Alpha-mannosidosis: correlation between phenotype, genotype and mutant MAN2B1 subcellular localisation. Orphanet J Rare Dis. 2015 Jun 6;10:70. doi: 10.1186/s13023-015-0286-x.

ReferenceCitation: Borgwardt L, Thuesen AM, Olsen KJ, Fogh J, Dali CI, Lund AM. Cognitive profile and activities of daily living: 35 patients with alpha-mannosidosis. J Inherit Metab Dis. 2015 Nov;38(6):1119-27. doi: 10.1007/s10545-015-9862-4. Epub 2015 May 28.

ReferenceCitation: Harmatz P, Cattaneo F, Ardigò D, Geraci S, Hennermann JB, Guffon N, Lund A, Hendriksz CJ, Borgwardt L. Enzyme replacement therapy with velmanase alfa (human recombinant alpha-mannosidase): Novel global treatment response model and outcomes in patients with alpha-mannosidosis. Mol Genet Metab. 2018 Jun;124(2):152-160. doi: 10.1016/j.ymgme.2018.04.003. Epub 2018 Apr 18.

ReferenceCitation: Borgwardt L, Guffon N, Amraoui Y, Dali CI, De Meirleir L, Gil-Campos M, Heron B, Geraci S, Ardigò D, Cattaneo F, Fogh J, Van den Hout JMH, Beck M, Jones SA, Tylki-Szymanska A, Haugsted U, Lund AM. Efficacy and safety of Velmanase alfa in the treatment of patients with alpha-mannosidosis: results from the core and extension phase analysis of a phase III multicentre, double-blind, randomised, placebo-controlled trial. J Inherit Metab Dis. 2018 Nov;41(6):1215-1223. doi: 10.1007/s10545-018-0185-0. Epub 2018 May 30.

name: Department of Paediatrics and Adolescent Medicine; Centre for Inherited Metabolic Diseases; Copenhagen Denmark

name: ; Center for Genomic Medicine; Copenhagen University Hospital; Rigshospitalet Copenhagen Denmark

name: ; Department of Clinical Genetics, Centre for Inherited Metabolic Diseases; Copenhagen University Hospital; Rigshospitalet Copenhagen Denmark

family: Borgwardt

full_name: Line Borgwardt

given: Line

name: ; Centre de Référence des Maladies Héréditaires du Métabolisme; Hôpital Femme Mère Enfant; Lyon France

family: Guffon

full_name: Nathalie Guffon

given: Nathalie

name: ; Center for Pediatric and Adolescent Medicine; University Medical Center Mainz; Villa Metabolica Mainz Germany

family: Amraoui

full_name: Yasmina Amraoui

given: Yasmina

family: Dali

full_name: Christine I. Dali

given: Christine I.

name: ; Paediatric Neurology and Metabolism; Universitair Ziekenhuis; Brussel Belgium

family: De Meirleir

full_name: Linda De Meirleir

given: Linda

name: ; Unidad de Metabolismo e Investigación Pediátrica, Hospital Universitario Reina Sofía, IMIBIC; Universidad de Córdoba, CIBERObn; Córdoba Spain

family: Gil-Campos

full_name: Mercedes Gil-Campos

given: Mercedes

name: Department of Pediatric Neurology, Reference Center for Lysosomal Diseases; Trousseau Hospital, APHP, and GRC ConCer-LD, Sorbonne Universities, UPMC University 06; Paris France

family: Heron

full_name: Bénédicte Heron

given: Bénédicte

name: ; Chiesi Farmaceutici S.p.A; Parma Italy

family: Geraci

full_name: Silvia Geraci

given: Silvia

family: Ardigò

full_name: Diego Ardigò

given: Diego

family: Cattaneo

full_name: Federica Cattaneo

given: Federica

family: Fogh

full_name: Jens Fogh

name: ; Center for Lysosomal and Metabolic Diseases (Department of Pediatrics); Erasmus MC University Medical Center - Sophia Children's Hospital; Rotterdam The Netherlands

family: Van den Hout

full_name: J. M. Hannerieke Van den Hout

given: J. M. Hannerieke

name: ; Institute of Human Genetics; University Medical Center; Mainz Germany

family: Beck

full_name: Michael Beck

given: Michael

name: ; Manchester Centre for Genomic Medicine; Central Manchester University Hospitals NHS Foundation Trust; Manchester UK

family: Jones

full_name: Simon A. Jones

given: Simon A.

name: ; Department of Paediatric, Nutrition and Metabolic Diseases; The Children's Memorial Health Institute; Warsaw Poland

family: Tylki-Szymanska

full_name: Anna Tylki-Szymanska

given: Anna

name: ; Department of Occupational Therapy and Physiotherapy; Copenhagen University Hospital; Rigshospitalet Copenhagen Denmark

family: Haugsted

full_name: Ulla Haugsted

given: Ulla

family: Lund

full_name: Allan M. Lund

given: Allan M.

journal_name: Journal of Inherited Metabolic Disease

oa_colors: green hybrid

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

location_country:
France
Poland
Denmark
Germany
United Kingdom

location_facility: The Children's Memorial Health Institute Warsaw, Department of Metabolic Diseases, Al Dzieci Polskich 20

location_facility: Hôpital Trousseau, Service de neuropédiatrie, Centre Référence des Maladies Lysosomales, 26 avenue du Docteur Arnold Netter

location_facility: Universitätsmedizin Mainz, Zentrum für Kinder- und Jugendmedizin, Langenbeckstrasse 1

location_facility: Hôpital Femme Mère Enfant, Lyon, 59 boulevard Pinel

location_facility: Center for Metabolic Diseases, Department of Clinical Genetics, Juliane Marie Centre, Copenhagen University Hospital, Blegdamsvej 9

location_facility: Genetic Medicine, 6th floor, St Mary's Hospital, Oxford Road,


title: A Multi-centre, Open Labelled, Multiple Dosing Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC 0172-2021 Administered Subcutaneously to Healthy Male Subjects and Haemophilia Subjects

summary: This trial is conducted in Europe. The aim of this trial is to investigate safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC 0172-2021 administered subcutaneously to healthy male subjects and subjects with haemophilia.

ReferenceCitation: Waters EK, Sigh J et al.: Trombin generation is increased in plasma from healthy males who have received concizumab, an antibody against tissue factor pathway inhibitor (ExplorerTM 2); Journal of Thrombosis and Haemostasis, Abstracts 2015; 13(Suppl. S2): 1-997(AS019)

lead_sponsor: Novo Nordisk A/S

location_country:
Austria
France
Spain
Germany
United Kingdom


title: A Multi-centre, Two-stage, Open Label Phase II Study to Assess the Efficacy and Safety of APO866 in the Treatment of Patients With Advanced Melanoma.

summary: This phase II study is designed to determine the efficacy and safety of APO866 for the treatment of patients with advanced cutaneous melanoma. APO866 has shown to induce growth inhibition in cultures of human melanoma cells as well as in animal models with subcutaneously implanted melanoma tumors. APO866 was considered to be safe and well tolerated in a phase I study that treated 24 patients with advanced cancer. In that study one of the two patients with advanced melanoma had a stable disease for 5 months with size reduction of some lesions. APO866 is administered by intravenous infusion continuously for 96 hours that is repeated every 4 weeks. Patients will receive 3 cycles of treatment and the primary efficacy endpoint will be assessed at Week 16. Patients will be follow-up for 12 months.

location_country: Austria Germany France Switzerland

location_facility: Department of Dermatology, Hopital Henri Modor

location_facility: University Clinic for Dermatology, Medical Faculty of Mannheim of the Heidelberg University

location_facility: Department of Dermatology, Charité University Hospital Berlin

location_facility: Department of Dermatology, University Hospital of Zürich

location_facility: Department of Dermatology, Medical University Graz


title: Point-of-care Regional Anaesthesia in Intensive Care Unit. A Multicentric Professional Practice Evaluation

acronym: Week'ALR

summary:
Pain is a major problem in Intensive Care Unit (ICU). Adequate pain management not only means decreasing the pain intensity, but also improving the functionality and allowing the early mobilization that is a prerequisite for improving recovery and decreasing the risk of complications in ICU. The complex problems involved in pain, analgesic interventions, and outcome have been emphasized in several surveys over the past decades, but apparently with only small improvements, despite the existence of several guidelines for perioperative pain management.

Regional analgesia techniques (peripheral and neuraxial nerve blocks) have the potential to decrease the physiological stress response to trauma or surgery, reducing the possibility of surgical complications and improving the outcomes. Recent studies suggested that surgical and trauma ICU patients receive opioid-hypnotics continuous infusions to prevent pain and agitation that could increase the risk of posttraumatic stress disorder and chronic neuropathic pain symptoms, and chronic opioid use. Also they may reduce the total amount of opioid analgesics necessary to achieve adequate pain control and the development of potentially dangerous side effects. The use of the regional anesthesia technique in the ICU, however, can, in part, be limited by the presence of hemodynamic instability, bleeding diathesis, and by the fear of the performing procedures potentially associated with significant side effects in heavily sedated patients.

Although regional anesthesia emerges as a new and very interesting player for pain management in ICU, today very few data exists about the use of RA (including PNB and neuraxial nerves blocks) by the practicians in ICU/stepdown units. The main objective of this study is to assess the use of RA for pain management both initiates in the operative room for surgical patients then transferred in ICU/stepdown units and performs directly by the practicians in ICU/stepdown units, in several french units.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
APHM la Timone
CH
HCL Centre des Grands Brulés
Centre Jean-Perrin
APHM Nord
HCL Hôpital Sud
CHU
AHPH Saint-Antoine
APHP Bichat


title: Loco-regional Anaesthesia in Video or Robot-assisted Thoracic Pulmonary Surgery

acronym: ARTIST

summary:
Currently, there is no data on the part and type of Loco-regional Anaesthesia used for Video or Robot-assisted Thoracic Pulmonary Surgery. The experience and habits of each team taking charge of the perioperative period seem to be the determining factors for the achievement of one type of Loco-regional Anaesthesia over another.

The aim of this epidemiological study is to identify, 6 months after the publication of the SFAR / SFCTCV 2019 recommendations, the proportion and type of Loco-regional Anaesthesia used in Video or Robot-assisted Thoracic Pulmonary Surgery within French teams.

lead_sponsor: Société Française d'Anesthésie et de Réanimation

location_facility: CHRU de Lille _Clinique Cardiothoracique et Vasculaire

location_facility: centre de Lutte Contre le Cancer Jean Perrin

location_facility: Clinique de l'Infirmerie Protestante de Lyon


title: Biological Characterization of Advanced ALK-rearranged Non-small Cell Lung (NSCLC) Cancer Included in EXPLOREALK Study

acronym: BIOEXALK

summary:
BioEXALK is a prospective study evaluating the biological characteristics of advanced ALK-rearranged NSCLC treated with next generation TKIs in first line, included in the national EXPLORE ALK cohort (GFPC 03-2019), a non-interventional, national, multi-center cohort of ALK-rearranged NSCLC patients.

BioExALK study will be proposed to every patient included in the Explore ALK GFPC 03-2019 study.

Biological analysis will be performed on tumor tissue at diagnosis and at the time of disease progression when available and on circulating tumor DNA (ctDNA).

For plasma testing, after obtained patient consent, blood samples will be taken and analyzed at the Léon Bérard Center (Lyon).

Biological analysis on tissue obtained at diagnosis and at disease progression will be collected and be sent for centralized analysis to the Rouen University Hospital.

lead_sponsor: Groupe Francais De Pneumo-Cancerologie

location_facility: Centre Hospitalier de Villefranche sur Saone

location_facility: Hôpital d'Instruction des Armées Ste Anne

location_facility: Oncologie Institut du Cancer de Montpellier

location_facility: Centre Hospitalier Intercommunal de Créteil

intervention_type: Genetic


title: Observatory of Patients With Haemophilia B Treated by IdElvion®

acronym: OrPHEe

summary: OrPHEe is a non-interventional, prospective and national study which aim is to record real life data in haemophilia B French patients treated with Idelvion® to confirm the efficacy and safety of this product established in clinical development studies.

lead_sponsor: CSL Behring

location_facility:
Hôpital Edouard Herriot
CH Annecy Genevois
CHU Bordeaux - Hôpital Pellegrin
CHRU Brest
Hôpital Simone Veil
CHRU Lille
CHU Rennes
CHRU Nancy
CHU Caen
CHRU Besançon
CHU Clermont-Ferrand
Hôpital Necker Enfants Malades
CHU Montpellier
CHU Saint-Etienne
CHU Dijon
CHU Nantes
CRC-MHC Hôpital Kremlin Bicêtre
CHU Rouen
CH du Mans
Hôpital André Mignot - CH Versailles


title: Randomized Phase III Trial of Standard Immunotherapy (IO) by Checkpoint Inhibitors, Versus Reduced Dose Intensity of IO in Patients With Metastatic Cancer in Response After 6 Months of Standard IO

acronym: MOIO

summary: Immunotherapy (IO), such as treatment with anti-PD-1, PD-L1, or CTLA-4 inhibitors, is a rapidly expanding treatment for multiple metastatic cancers with improved survival for certain cancers. However, the optimal duration of immunotherapies is currently unknown. Our hypothesis is that a reduced dose intensity of IO could be as effective as the current standard treatment in term of prevention of the disease progression. If proved right, this study will have a positive medico-economic impact by reduction of the costs associated with the treatment and the toxicity, and an increase of the patients' quality of life.

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

lead_sponsor: UNICANCER

location_facility:
Insitut Godinot
CHU Poitiers
Centre Jean Perrin
Hôpital Pitié Salpêtrière
Institut Curie
ICANS
Centre Antoine Lacassagne
Clinique Chenieux
Clinique Sainte Catherine
Hôpital Foch
Centre Hospitalier Intercommunal
Hospices Civils de Lyon
Centre Eugene Marquis
CHU Henri Mondor
CHU Bretonneau
CHU Besançon
Hôpital La Timone -APHM
Centre François Baclesse
Hôpital Saint Louis
Institut de cancérologie de l'Ouest
Centre Georges François Leclerc
IUCT
Centre Hospitalier de la Côte Basque
Hôpital Européen Georges Pompidou


title: Three Weeks Versus Six Weeks Antibiotic Therapy for Nonsurgically Treated Diabetic Foot Osteomyelitis : a Multicenter, Randomized, Open-label and Controlled Study

summary: The aim of this clinical study is to compare the efficacy and tolerance of 3 versus 6 weeks of antibiotherapy in patients with diabetic foot osteomyelitis treated medically.

lead_sponsor: Tourcoing Hospital

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Centre Hopitalier Universitaire de Brest

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Centre Hospitalier Universitaire de Rouen


title: Multicenter Retrospective Observatory of Patients With Acute Myeloid Leukemia to Core Binding Factor

acronym: RETRO-CBF

summary:
Acute Core Binding Factor leukemias represent a specific category of acute myeloid leukemias that share prognostic factors, a specific mutational profile, and a favorable response to chemotherapy. Their management now follows the reference pattern from the French trial CBF-2006 closed to inclusions since November 2010. This includes intensive chemotherapy and intensification by allogeneic marrow transplant depending on the residual disease measured by RT qPCR . These leukemias have not been the subject of multicenter clinical trials since that date.

The results of this treatment regimen need to be evaluated. Known prognostic factors such as signaling mutations, clonal interference or residual disease follow-up (MRD) will be analyzed and updated in this recent cohort. The interaction between residual disease and mutational profile will be evaluated on the prognosis. Treatment with gemtuzumab-ozogamycin and first-line allogeneic transplantation will be investigated, depending on prognostic factors including associated mutations and residual disease. The course and early treatment of molecular relapses will be analyzed. The treatment and prognosis of cytological relapses will be described with in particular the role of tyrosine kinase inhibitors and therapeutic intensification.

time_perspective: Retrospective

lead_sponsor: Acute Leukemia French Association

location_facility: Centre Hospitalier de Versailles André Mignot


title: Study of the Criteria for Choosing Speedicath Catheters During the Initiation of Self-catheterization

acronym: Eva

summary: To date, there is no objective data to help in the choice of the type of catheter to offer to the patient according to his or her needs. Although it is now known that the quality of life of patients practicing intermittent self catheterisation is dependent on multiple factors, there is little data on the factors that facilitate or hinder adherence to intermittent self catheterisation during the first six months after initiation of intermittent self catheterisation. The prospective multicenter exploratory observational study that the sponsor wishes to conduct aims to determine what criteria preside over patient choice of SpeedyCath (SC) leads. This information would allow us to set up a personalized advice with each patient in the future, with the aim of proposing the SC catheter best adapted to his needs. The study population will consist of adults with neurogenic or non-neurogenic urinary disorders that warrant the use of intermittent self catheterisation, with intermittent self catheterisation education occurring at the time of inclusion. Patients should be autonomous in the practice of intermittent self catheterisation, and the minimum expected duration of follow-up should be greater than or equal to 6 months. Only patients who choose to use SpeediCath leads will be included in the study.

lead_sponsor: Laboratoires Coloplast S.A.S

location_facility: Centre Hospitalier Intercommunal Robert Ballanger

location_facility: Institut Mutualiste Montpelliérain- Beau soleil

location_facility: Centre de medecine physique et réadaptation Ladapt Amilly


title: Observational Prospective Study of Quality of Life in Unresectable TNM Stage III NSCLC (OBSTINATE)

acronym: OBSTINATE

summary:
OBSTINATE is an observational, national, prospective, multicentric study on Quality of life in patients with unresecable stade III non-small cell lung cancers.

Locally advanced non-small cell lung cancers (NSCLCs with a Tumor, Node and Metastasis [TNM] stage III) patients represent approximately a third of newly discovered NSCLCs every year, and a very heterogeneous group of clinical situations. Therapies are multidisciplinary and very heterogeneous across oncology centers. Patients with locally advanced NSCLC have a high symptom burden that is known to affect their quality of life. Health-related quality of life (HR-QoL) is a specific and multidimensional type of patient-reported outcome (PRO) related to the physical, psychological and social impact of the disease and its treatment as perceived by patients. HR-QoL allows, together with data of efficacy and safety, a more complete assessment of risks and benefits of each treatment. Therefore, QoL maintenance is a valuable consideration for treatment decisions, especially in the rapidly evolving therapeutic landscape of unresectable NSCLC.

The study is designed to collect PROs HR-QoL data from every new patient diagnosed with an unresectable stage III NSCLC over a period of 18 months. We also aim to describe clinical characteristics of these patients, the therapeutic strategies conducted, and outcomes in a "real-word" oncological practice.

location_facility: Centre Hospitalier Universitaire DUPUYTREN

location_facility: Centre Hospitalier d'Elbeuf - Pneumologie

location_facility: Centre Hospitalier Intercommunal de Quimper


ipd_sharing_description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

acronym: InTTercePT

location_facility: Centre Hospitalier Universitaire de Limoges

location_facility: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire de Tours

location_facility: Institut de Cancérologie de l'Ouest - Site Paul Papin

location_facility: CARIO - Centre Armoricain Radiothérapie Imagerie Médicale et Oncologi

location_facility: Institut Universitaire de Cancérologie AP-HP. Sorbonne Université, Hôpital Tenon

location_facility: Centre de Cancerologie du Grand Montpellier

title: Treatment With Tucatinib in Addition to Pertuzumab and Trastuzumab in Patients With HER2-positive Metastatic Breast Cancer After Local Therapy of Isolated Brain Progression

summary:
The overall survival of patients with metastatic breast cancer has steadily improved over the past decades, mainly due to advances in systemic treatment. Despite these advances, the development of brain metastases remains a serious and devastating complication that decreases quality of life and increases morbidity and mortality. The HER2CLIMB randomized study demonstrated that adding the investigational drug tucatinib to the standard treatment trastuzumab and capecitabine improved both progression-free survival and overall survival in people diagnosed with human epidermal growth factor 2 (HER2)-positive metastatic breast cancer, previously treated with trastuzumab, pertuzumab, and T-DM1. In patients with brain metastases, the 1-year progression-free survival was 25% in the tucatinib group and 0% in the placebo group.

These results suggest that tucatinib may be a new standard treatment for HER2-positive metastatic disease.

The aim of the non-randomized phase II study, InTTercePT, is to evaluate the effectiveness of adding tucatinib to trastuzumab and pertuzumab in the event of cerebral progression, after the end of local treatment.


title: A Multi-center Open-label Phase 2 Study of Ixazomib, Iberdomide and Dexamethasone in Elderly Patients With Multiple Myeloma at First Relapse."

summary:
This is a phase II, multicenter, open-label study to evaluate the rate of patients achieving very good partial response (VGPR) or better to the oral combination Iberdomide Ixazomib Dexamethasone in elderly patients with multiple myeloma at first relapse .

The patient population will consist of adult men and women more than 70 years, who meet eligibility criteria.

Following the screening period, patients will be enrolled and treated then, they will receive therapy with Iberdomide, Ixazomib and Dexaméthasone during 6 cycles and Iberdomide and Ixazomib until progression.

lead_sponsor: Nantes University Hospital

location_facility:
CHRU Lille
ICANS
CHU Henri Mondor
Hopital St Louis APHP
CHD les Oudairies
Hopital St Antoine
CH de la cote basque
University Hospital
Hopital de l'archet
CHR
CHRU Hopital Haut Lévêque
CHRU
CHU de Brest
CHU
CH Lyon Sud


title: A Phase II Study of CPX-351 Monotherapy in Acute Myeloid Leukemia

acronym: CPX-351 TA-SMP

summary:
The three classic myeloproliferative neoplasms (MPNs) include polycythemia Vera (PV), essential thrombocythemia (ET) and primary myelofibrosis (PMF). The natural history of these MPNs is the possible progression to acute myeloid leukemia (MPN-blast phase) at variable percentage depending the entity. Leukemic transformation of MPN occurs in 8% to 23% of primary myelofibrosis (PMF) patients in the first 10 years after diagnosis and in 4% to 8% of polycythemia vera (PV) and essential thrombocytosis (ET) patients within 18 years after diagnosis. The risk for leukemic transformation is increased by exposure to cytotoxic chemotherapy. The molecular pathogenesis of MPN-blast phase remains an area of active research.

The prognosis of blast phase MPNs is very poor : approximately 50% of the patients are deemed eligible for intensive treatment (ie. conventional induction chemotherapy regimen with anthracyclines and cytarabine). The patients who are not fit for such intensive treatment approach due to age or comorbidities, are treated with Hypomethylating agents, low dose palliative chemotherapy, or supportive care. Nevertheless, there is a need for more effective and better tolerated treatment approaches in order to increase the response rate and hence, the transplant rates which should translate into improved survival.

CPX-351 is a new formulation of cytarabine and daunorubicin encapsulated at a fixed 5:1 molar-ratio in liposomes that exploits molar ratio-dependent drug-drug synergy to enhance antileukemic efficacy.

Based on similarities between post-myelodysplastic syndrome (MDS) and post-MPN secondary AML in terms of disease resistance to chemotherapy, of fragile patient profile, The hypotheses made is that CPX-351 may improve the results of induction chemotherapy without increasing its toxicity and therefore may increase the proportion of patients who could benefit from an allogeneic Stem Cell Transplantation (SCT).

ReferenceCitation: Courtier F, Carbuccia N, Garnier S, Guille A, Adélaïde J, Cervera N, Gelsi-Boyer V, Mozziconacci MJ, Rey J, Vey N, Chaffanet M, Birnbaum D, Murati A. Genomic analysis of myeloproliferative neoplasms in chronic and acute phases. Haematologica. 2017 Jan;102(1):e11-e14. doi: 10.3324/haematol.2016.152363. Epub 2016 Oct 14.

ReferenceCitation: Luque Paz D, Jouanneau-Courville R, Riou J, et al. Leukemic evolution of polycythemia vera and essential thrombocythemia: genomic profiles predict time to transformation. Blood Adv. 2020;4(19):4887-4897. Blood Adv. 2020 Nov 24;4(22):5651. doi: 10.1182/bloodadvances.2020003711.

lead_sponsor: French Innovative Leukemia Organisation

location_facility: REIMS - Hôpital Robert Debré - Hématologie Clinique

location_facility: NANTES - Hôpital Hôtel Dieu - Hématologie Clinique

location_facility: BAYONNE - CH de la Côte Basque - Hématologie

location_facility: RENNES - Hôpital Pontchaillou - Hématologie

location_facility: Toulouse - IUCT Oncopole - Service d'Hématologie

location_facility: CLAMART - Hôpital d'Instruction des Armées de Percy

location_facility: MONTPELLIER - Hôpital Saint-Eloi - Hématologie Clinique

location_facility: POITIERS - Hôpital La Milétrie - Hématologie Clinique


title: A Phase II Randomized Study to Assess the Efficacy on Outcome of Venetoclax Combined With Cytarabine Versus Idarubicin Combined With Cytarabine Administered as Post-remission Therapy to Elderly Patients With Acute Myeloid Leukemia in First Remission

summary:
For the FILO group, the standard of care for induction chemotherapy of elderly fit patients with AML is represented by the combination of Cytarabine, Idarubicin and Lomustine. The superiority of this combination was confirmed in a larger prospective study the LAMSA-2007. This induction treatment, followed by six courses of consolidation (Idarubicin and Cytarabine) followed then by a period of 6-month maintenance therapy, allows up to 80 % of remission, and a RFS of 46 % at 2 years.

The aim of the study is to assess the efficacy on outcome of Venetoclax combined with Cytarabine versus Idarubicin combined with Cytarabine administered as post-remission therapy to elderly patients with acute myeloid leukemia in first complete remission (CR) following induction chemotherapy.

location_facility: BEZIERS - Centre Hospitalier - Hématologie

location_facility: BESANCON - Hôpital Jean Minjoz - Hématologie

location_facility: ANNECY - Centre Hospitalier Annecy-Genevois

location_facility: MULHOUSE - Hôpital E. Muller - Hématologie

location_facility: ST ETIENNE - Institut De Cancérologie Lucien Neuwirth

location_facility: PERPIGNAN - CH St Jean - Hématologie Clinique


title: STop and Restart Acalabrutinib In fRail Patients With Previously Untreated Chronic Lymphocytic Leukemia

acronym: STAIR

summary:
The irreversible Bruton's Tyrosine Kinase (BTK) inhibitor acalabrutinib (ACA) has potent clinical activity as a single agent in patients with treatment naive and Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL).

However, a growing body of concerns is raising regarding the unlimited administration of targeted therapy as BTKi. First, long-term treatments expose the patients to increased risk of specific adverse events (infections, bleeding events or cardiovascular problems). Second, continuous administration might also increase the risk of clonal evolution and therapeutic resistance resulting from genetic alterations such as BTK or PLCG2 mutations. Discontinuation of therapy after a fixed period is expected to prevent these events.

Rapid and deep responses yielded by ACA in elderly patients pave the way of investigating a limited 18-months period schedule. This study aims to investigate the 1-year PFS upon ACA discontinuation and efficacy of restarting ACA upon symptomatic relapse.

location_facility: Hôpital Bretonneau - Hématologie et Thérapie Cellulaire

location_facility: CHU Pontchaillou - Hématologie Clinique BMT-HC

location_facility: Centre Henri Becquerel - Service Hématologie Clinique

location_facility: ARGENTEUIL - Centre hospitalier Victor Dupouy

location_facility: Hôpital de la Milétrie - Hématologie et Thérapie Cellulaire

location_facility: Centre Hospitalier Regional Metz Thionville

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Institut Paoli-Calmettes - Hématologie Clinique

location_facility: Hopital Pitie Salpetriere Service Hematologie Clinique - Pavillon de L'Enfant Et Adolescent

location_facility: CHU Estaing - Hématologie Clinique Adulte

location_facility: CERGY-PONTOISE - Centre Hospitalier René Dubos

location_facility: CENTRE HOSPITALIER SAINTJEAN - Hématologie Clinique

location_facility: Hôpital Saint-Eloi - Hématologie Clinique


title: Impact of a Decision-making Tool to Guide the Use of Physical Restraints in Intensive Care Unit Patients. A Multicentre Randomized Stepped-wedge Trial.

acronym: ARBORéa

summary:
The use of physical restraints is common practice in Intensive Care Units (ICU). This medically prescribed procedure requires full attention of medical and paramedical teams for its implementation, monitoring and ending, as a major restriction of patients' individual freedom. French highest authority for health has defined, for geriatrics and psychiatric units, ten criteria of good practice for physical restraints' use. Routine practice reports critically ill patients' safety as main reason of use. This decision, often left to the sole discretion of nurses, varies according to their own representation of this risk, and depends on several factors: seniority in ICU, nurse to patient ratio and personal workload.

In order to reduce practices subjectivity and heterogeneity, we have developed a decision-making tool for physical restraints implementation. This tool is based on objective scales used on a daily basis concerning neurological status (Richmond Agitation-Sedation Scale (RASS) and Confusion Assessment Method for the ICU (CAM-ICU)). Disorientation or delirium can lead to severe incidents by promoting accidental removing of important devices such as arterial of venous line, drains among others. However, physical restraints are recognized as a major cause of delirium and agitation.

Critically ill patients require rigorous evaluation of organ dysfunctions necessitating adequate invasive equipments, with associated risks of unexpected removal or alteration. Such events could urge caregivers to use physical restraints. Based on recent literature, about a third of ICU patients are restrained, and accidental deconditioning is mainly observed within these particular patients.

In addition, three categories of patients have been defined according to the invasive nature of their equipment and therefore according to the risk associated with an unexpected withdrawal. Finally, presence of patient's family and their adherence to its surveillance were also implemented into the tool. Main study objective is to jointly investigate effectiveness and tolerance of a decision-making tool guiding physical restraints use in ICU patients.

ipd_sharing_description: Individual participant data will be shared upon reasonable request, and after steering committee deliberation.

location_facility: Assistance Publique-Hôpitaux de Marseille - La Timone

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Centre de Lutte Contre le Cancer Jean-Perrin

location_facility: Centre Hospitalier Universitaire de Saint-Etienne

location_facility: Centre Hospitalier Universitaire de Strasbourg

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Assistance Publique-Hôpitaux de Marseille - Hôpital Nord

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Centre Hospitalier Universitaire - Hospices Civils de Lyon - Hôpital Edouard Herriot


title: Support for the Resumption of Training of High-level Athletes Post-epidemic COVID-19

summary:
As of March 2020, COVID-19 has become a global pandemic, halting athletic competition worldwide.

Reports from China show a high prevalence of cardiac involvement in patients with severe SARS-CoV-2 infection. These cardiac forms were found to be closely associated with adverse outcomes. The use of Magnetic resonance Imaging (MRI) had allowed to show that cardiac dysfunction could be mediated by myocardial inflammation (i.e. myocarditis). The direct implication of the virus was demonstrated with Severe Acute Respiratory Syndrome (SARS)-CoV-2 being detected on myocardial biopsies in a patient with severe heart failure.

The experience with other viruses causing acute myocarditis shows that there is a high rate of undetected injuries. Indeed, although severe heart failure can be present at the acute stage, acute viral myocarditis is most commonly pauci or asymptomatic, but still leaving occult myocardial scars visible on MRI, and exposing to higher risks of ventricular arrhythmia and sudden cardiac death over the long term.

Although athletes are younger and have fewer comorbidities than the general population and therefore are at lower risk for severe disease or death, there is a critical and urgent need to assess the prevalence of occult scars in the population of high-level athletes returning to training after the SARS-CoV-2 pandemia.

lead_sponsor: University Hospital, Bordeaux

location_facility: Aviron Bayonnais Rugby Pro Training Center

location_facility: Bordeaux University Hospital - Service UDH - Hôpital Pellegrin

location_facility: Biarritz Olympique Pays Basque training center

location_facility: Training center Valence Romans Drôme Rugby

location_facility: Bordeaux University Hospital - CRB medical office - Hôpital du Tondu

location_facility: Union Sportive Colomiers Rugby training center

location_facility: Training center Soyaux Angoulême XV Rugby