title: Seeing-Moving-Playing: Early Rehabilitation Utilizing Visual and Vestibular Technology Following Traumatic Brain Injury

acronym: SiMPlyRehab

summary:
The aim of this research program is to 1) Evaluate potential problems with vision, inner ear-eye reflexes and deficits of processing eye information that occur following TBI; and 2) Evaluate treatment programs for individuals with eye and inner ear problems that persist for greater than 10 days following injury.

This study will include 465 youth and young adults (aged 6-30 years old) who sustain a TBI of any severity. An initial evaluative phase using the best available technology to evaluate eye and inner ear function will be performed, and compared with typical tests that are used in the clinic. If symptoms and functional problems remain 10 days after injury, participants will be randomly placed into a treatment group (including eye movement, inner ear-eye reflex and attention exercises as per our pilot studies) or a control group (typical rehabilitation). Success will be measured in terms of return to sport (mild TBI), achievement of goals (moderate and severe TBI) and quality of life. It is expected that this program will inform clinical practice and future research leading to a treatment program in TBI that includes multiple components.

ReferenceCitation: Sorek G, Gagnon I, Schneider K, Chevignard M, Stern N, Fadida Y, Kalderon L, Shaklai S, Katz-Leurer M. The integrated functions of the cardiac autonomic and vestibular/oculomotor systems in adolescents following severe traumatic brain injury and typically developing controls. Brain Inj. 2020 Sep 18;34(11):1480-1488. doi: 10.1080/02699052.2020.1807055. Epub 2020 Aug 18.

name: Department of Physical Therapy, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv Israel

family: Sorek

full_name: Gilad Sorek

given: Gilad

name: Montreal Children’s Hospital, McGill University Health Center, Montreal, Canada

family: Gagnon

full_name: Isabelle Gagnon

given: Isabelle

name: Sport Injury Research Prevention Centre, Faculty of Kinesiology, University of Calgary, Calgary, Canada

family: Schneider

full_name: Kathryn Schneider

given: Kathryn

name: Laboratoire d’Imagerie Biomédicale, LIB, & GRC, Sorbonne Université, Paris, France

name: Rehabilitation Unit for Acquired Neurological Pathologies in Children, Saint-Maurice Hospital, Saint-Maurice, France

family: Chevignard

full_name: Mathilde Chevignard

given: Mathilde

name: Alyn Children’s Hospital and Rehabilitation Center, Jerusalem, Israel

family: Stern

full_name: Nurit Stern

given: Nurit

name: Children Rehabilitation Department, Lowenstein Rehabilitation Center Ra’anana, Israel

family: Fadida

full_name: Yahaloma Fadida

given: Yahaloma

family: Kalderon

full_name: Liran Kalderon

given: Liran

family: Shaklai

full_name: Sharon Shaklai

given: Sharon

family: Katz-Leurer

full_name: Michal Katz-Leurer

given: Michal

journal_name: Brain Injury

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

location_country: Israel Canada France

location_facility: Department of Physical Therapy, School of Health Professions, Sackler Faculty of Medicine

location_facility: Service de Rééducation des Pathologies Neurologiques de l'Enfant - Pôle de Rééducation et Réadaptation de l'Enfant Hôpitaux de Saint Maurice

location_facility: Sport Injury Prevention Research Centre, Faculty of Kinesiology, University of Calgary,


title: Randomised, Double-blind, Placebo-controlled Study of APD421 (Amisulpride for IV Injection) as Treatment of Established Post-operative Nausea and Vomiting, in Patients Who Have Had no Prior Prophylaxis

summary: Double-blind, randomised, parallel-group, placebo-controlled, adaptive, seamless, dose-selecting study to compare the efficacy of APD421 to placebo as treatment of established PONV, in patients who have not had prior PONV prophylaxis.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Candiotti KA, Kranke P, Bergese SD, Melson TI, Motsch J, Siddiqui N, Chung F, Rodriguez Y, Minkowitz HS, Ayad SS, Diemunsch P, Fox G. Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Amisulpride as Treatment of Established Postoperative Nausea and Vomiting in Patients Who Have Had No Prior Prophylaxis. Anesth Analg. 2019 Jun;128(6):1098-1105. doi: 10.1213/ANE.0000000000003733.

family: Candiotti

full_name: Keith A. Candiotti

given: Keith A.

sequence: first

family: Kranke

full_name: Peter Kranke

given: Peter

sequence: additional

family: Bergese

full_name: Sergio D. Bergese

given: Sergio D.

family: Melson

full_name: Timothy I. Melson

given: Timothy I.

family: Motsch

full_name: Johann Motsch

given: Johann

family: Siddiqui

full_name: Naveed Siddiqui

given: Naveed

family: Chung

full_name: Frances Chung

given: Frances

family: Rodriguez

full_name: Yiliam Rodriguez

given: Yiliam

family: Minkowitz

full_name: Harold S. Minkowitz

given: Harold S.

family: Ayad

full_name: Sabry S. Ayad

given: Sabry S.

family: Diemunsch

full_name: Pierre Diemunsch

given: Pierre

family: Fox

full_name: Gabriel Fox

given: Gabriel

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Anesthesia & Analgesia

oa_host_type: publisher

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ipd_sharing: No

lead_sponsor: Acacia Pharma Ltd

location_country:
Germany
United States
France

location_facility:
Universität Heidelberg
CHU de Hautepierre
Ohio State University
Jackson Memorial Hospital

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


lead_sponsor: Boehringer Ingelheim

location_country:
Canada
Russian Federation
France

location_facility: 1160.105.10002 Boehringer Ingelheim Investigational Site

location_facility: 1160.105.70005 Boehringer Ingelheim Investigational Site

location_facility: 1160.105.10003 Boehringer Ingelheim Investigational Site

location_facility: 1160.105.33001 Boehringer Ingelheim Investigational Site

type: EudraCT Number

source: euctr

title: Open-label, Single Dose, Tolerability, Pharmacokinetic/Pharmacodynamics and Safety Study of Dabigatran Etexilate Given at the End of Standard Anticoagulant Therapy in Children Aged Less Than 1 Year Old

summary: The aim of the study is to investigate the safety and tolerability of dabigatran etexilate solution in children aged less than 1 year, to demonstrate comparable PK/PD relationship to older children and adults and to confirm dabigatran etexilate dosing algorithm for children aged less than 1 year.


title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of a RARγ-Specific Agonist (Palovarotene) in the Treatment of Preosseous Flare-ups in Subjects With Fibrodysplasia Ossificans Progressiva (FOP)

summary: Fibrodysplasia ossificans progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result in abnormal bone formation in muscles, tendons, and ligaments. Flare-ups begin early in life and may occur spontaneously or after soft tissue trauma, vaccinations, or influenza infections. Recurrent flare-ups progressively restrict movement by locking joints leading to cumulative loss of function and disability. Mouse models of FOP have demonstrated the ability of retinoic acid receptor (RAR) gamma agonists to prevent heterotopic ossification (HO) following injury. The purpose of the study is to evaluate whether palovarotene, an RAR gamma agonist, will prevent HO during and following a flare-up in subjects with FOP.

study_start_date_type: Actual

ReferenceType: background

ReferenceCitation: Shimono K, Tung WE, Macolino C, Chi AH, Didizian JH, Mundy C, Chandraratna RA, Mishina Y, Enomoto-Iwamoto M, Pacifici M, Iwamoto M. Potent inhibition of heterotopic ossification by nuclear retinoic acid receptor-γ agonists. Nat Med. 2011 Apr;17(4):454-60. doi: 10.1038/nm.2334. Epub 2011 Apr 3. Erratum in: Nat Med. 2012 Oct;18(10):1592.

lead_sponsor: Clementia Pharmaceuticals Inc.

location_country:
United States
United Kingdom
France

location_facility: The Royal National Orthopaedic Hospital, Brockley Hill

location_facility: University of Pennsylvania, Center for Research in FOP & Related Disorders

location_facility: University of California San Francisco, Division of Endocrinology and Metabolism

location_facility: Hôpital Necker-Enfants Malades, Department of Genetics


title: Phase 3 Cluster Randomised Trial Testing the Efficacy of a Continence Promotion Intervention to Improve Urinary Symptoms and Quality of Life, and Reduce Stigma and Falls in Older Community-dwelling Women With Untreated Incontinence

acronym: CACTUS-D

summary: To determine whether women exposed to the continence promotion intervention will report improved urinary symptoms and quality of life, and lower incontinence-related stigma and falls than women who receive a control intervention at one-year post-intervention.

ReferenceCitation: Agnew R, van den Heuvel E, Tannenbaum C. Efficiency of using community organisations as catalysts for recruitment to continence promotion trials. Clin Trials. 2013 Feb;10(1):151-9. doi: 10.1177/1740774512460144. Epub 2012 Oct 5.

ReferenceCitation: Tannenbaum C, Agnew R, Benedetti A, Thomas D, van den Heuvel E. Effectiveness of continence promotion for older women via community organisations: a cluster randomised trial. BMJ Open. 2013 Dec 10;3(12):e004135. doi: 10.1136/bmjopen-2013-004135.

ReferenceCitation: Tannenbaum C, van den Heuvel E, Fritel X, Southall K, Jutai J, Rajabali S, Wagg A. Continence Across Continents To Upend Stigma and Dependency (CACTUS-D): study protocol for a cluster randomized controlled trial. Trials. 2015 Dec 10;16:565. doi: 10.1186/s13063-015-1099-x.

family: Tannenbaum

full_name: Cara Tannenbaum

given: Cara

family: van den Heuvel

full_name: Eleanor van den Heuvel

given: Eleanor

family: Fritel

full_name: Xavier Fritel

given: Xavier

family: Southall

full_name: Kenneth Southall

given: Kenneth

family: Jutai

full_name: Jeffrey Jutai

given: Jeffrey

family: Rajabali

full_name: Saima Rajabali

given: Saima

family: Wagg

full_name: Adrian Wagg

given: Adrian

currency_apc_doaj: GBP

journal_name: Trials

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repository_institution: Brunel University London - Brunel University Research Archive (BURA)

version: submittedVersion

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

location_country:
Canada
United Kingdom
France

location_facility: Institut universitaire de gériatrie de Montréal

intervention_type: Behavioral

lead_sponsor_type: academique


type: Other Identifier

title: A Phase I/II Study of Cabazitaxel Combined With Abiraterone Acetate and Prednisone in Patients With Metastatic Castrate-Resistant Prostate Cancer (CRPC) Whose Disease Has Progressed After Docetaxel Chemotherapy

summary:
Primary Objectives:

To determine the maximum tolerated dose, and dose limiting toxicities of cabazitaxel administered as a 1-hour infusion every 3 weeks in combination with oral daily abiraterone acetate and prednisone in participants with metastatic Castrate-resistant prostate cancer (CRPC)
To estimate the anti-tumor activity of cabazitaxel in combination with abiraterone acetate and prednisone in terms of prostate-specific antigen (PSA) response rate.

Secondary Objectives:

To characterize the safety profile of the combination
To evaluate the pharmacokinetic profile of cabazitaxel and abiraterone in the proposed combination and dosing schedule
To assess preliminary antitumor activity of the combination in terms of progression-free survival, PSA progression free survival and objective response rate, and overall survival

design_allocation: Non-Randomized

ReferenceCitation: Massard C, Mateo J, Loriot Y, Pezaro C, Albiges L, Mehra N, Varga A, Bianchini D, Ryan CJ, Petrylak DP, Attard G, Shen L, Fizazi K, de Bono J. Phase I/II trial of cabazitaxel plus abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) progressing after docetaxel and abiraterone. Ann Oncol. 2017 Jan 1;28(1):90-95. doi: 10.1093/annonc/mdw441.

family: Massard

full_name: C. Massard

given: C.

family: Mateo

full_name: J. Mateo

given: J.

family: Loriot

full_name: Y. Loriot

given: Y.

family: Pezaro

full_name: C. Pezaro

family: Albiges

full_name: L. Albiges

given: L.

family: Mehra

full_name: N. Mehra

given: N.

family: Varga

full_name: A. Varga

given: A.

family: Bianchini

full_name: D. Bianchini

given: D.

family: Ryan

full_name: C.J. Ryan

family: Petrylak

full_name: D.P. Petrylak

family: Attard

full_name: G. Attard

given: G.

family: Shen

full_name: L. Shen

family: Fizazi

full_name: K. Fizazi

given: K.

family: de Bono

full_name: J. de Bono

journal_name: Annals of Oncology

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: Radboud University - Radboud Repository

repositories:
PubMed Central
UCL Discovery
repository.ubn.ru.nl

ReferenceCitation: Huang X, Chau CH, Figg WD. Challenges to improved therapeutics for metastatic castrate resistant prostate cancer: from recent successes and failures. J Hematol Oncol. 2012 Jul 2;5:35. doi: 10.1186/1756-8722-5-35. Review.

location_facility:
Investigational Site Number 840001
Investigational Site Number 250001
Investigational Site Number 840002
Investigational Site Number 826001


title: A Phase 1 First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 172 in Subjects With Relapsed / Refractory Renal Cell Carcinoma

summary: This is the first-in-human (Phase I) study of AMG 172, an antibody drug conjugate (ADC), in subjects with kidney cancer [Clear Cell Renal Cell Carcinoma (ccRCC)] who have relapsed or who have refractory disease following at least two prior therapies. The purpose of the study is to evaluate safety and pharmacokinetics (PK) of AMG 172, and also evaluate the objective response rate in patients with ccRCC receiving AMG 172. The study will be conducted in two Parts: Part 1 will explore doses of AMG 172 given every two weeks and every three weeks to determine the safety, tolerability and pharmacokinetics to establish a maximum tolerated dose (MTD), and Part 2 (dose expansion) will examine safety, tolerability, PK and overall response rate in subjects treated at the MTD established in Part 1 for either every two week or every three week dosing.

lead_sponsor: Amgen


title: Polymorphisms and Busulfan Pharmacokinetic Study in Pediatric Transplnatation

summary: Test the correlations between the pharmacogenetic and pharmacokinetic of Busulfan IV in children receiving hematopoietic stem cell transplantation.

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Other

enrollment_type: Anticipated

ReferenceCitation: Ansari M, Lauzon-Joset JF, Vachon MF, Duval M, Théoret Y, Champagne MA, Krajinovic M. Influence of GST gene polymorphisms on busulfan pharmacokinetics in children. Bone Marrow Transplant. 2010 Feb;45(2):261-7. doi: 10.1038/bmt.2009.143. Epub 2009 Jul 6.

ReferenceCitation: Ansari M, Krajinovic M. Can the pharmacogenetics of GST gene polymorphisms predict the dose of busulfan in pediatric hematopoietic stem cell transplantation? Pharmacogenomics. 2009 Nov;10(11):1729-32. doi: 10.2217/pgs.09.135.

ReferenceType: result

ReferenceCitation: Ansari M, Rezgui MA, Théoret Y, Uppugunduri CR, Mezziani S, Vachon MF, Desjean C, Rousseau J, Labuda M, Przybyla C, Duval M, Champagne M, Peters C, Bittencourt H, Krajinovic M; Pediatric Disease Working Parties of the European Blood and Marrow Transplant Group. Glutathione S-transferase gene variations influence BU pharmacokinetics and outcome of hematopoietic SCT in pediatric patients. Bone Marrow Transplant. 2013 Jul;48(7):939-46. doi: 10.1038/bmt.2012.265. Epub 2013 Jan 7.

family: Ansari

full_name: M Ansari

given: M

name: on behalf of the Pediatric Disease Working Parties of the European Blood and Marrow Transplant Group

family: Rezgui

full_name: M A Rezgui

given: M A

family: Théoret

full_name: Y Théoret

given: Y

family: Uppugunduri

full_name: C R S Uppugunduri

given: C R S

family: Mezziani

full_name: S Mezziani

given: S

family: Vachon

full_name: M-F Vachon

given: M-F

family: Desjean

full_name: C Desjean

given: C

family: Rousseau

full_name: J Rousseau

given: J

family: Labuda

full_name: M Labuda

family: Przybyla

full_name: C Przybyla

family: Duval

full_name: M Duval

family: Champagne

full_name: M Champagne

family: Peters

full_name: C Peters

family: Bittencourt

full_name: H Bittencourt

given: H

family: Krajinovic

full_name: M Krajinovic

journal_name: Bone Marrow Transplantation

evidence: open (via free pdf)

publisher_dissemination: Springer

publisher_group: Springer

ReferenceCitation: Ansari M, Théoret Y, Rezgui MA, Peters C, Mezziani S, Desjean C, Vachon MF, Champagne MA, Duval M, Krajinovic M, Bittencourt H; Pediatric Disease Working Parties of the European Blood and Marrow Transplant Group. Association between busulfan exposure and outcome in children receiving intravenous busulfan before hematopoietic stem cell transplantation. Ther Drug Monit. 2014 Feb;36(1):93-9. doi: 10.1097/FTD.0b013e3182a04fc7.

full_name: Marc Ansari

given: Marc

full_name: Yves Théoret

given: Yves

full_name: Mohamed Aziz Rezgui

given: Mohamed Aziz

full_name: Christina Peters

given: Christina

title: Association Between Busulfan Exposure and Outcome in Children Receiving Intravenous Busulfan Before Hematopoietic Stem Cell Transplantation

ReferenceCitation: Huezo-Diaz P, Uppugunduri CR, Tyagi AK, Krajinovic M, Ansari M. Pharmacogenetic aspects of drug metabolizing enzymes in busulfan based conditioning prior to allogenic hematopoietic stem cell transplantation in children. Curr Drug Metab. 2014 Mar;15(3):251-64. Review.

ReferenceCitation: Uppugunduri CR, Rezgui MA, Diaz PH, Tyagi AK, Rousseau J, Daali Y, Duval M, Bittencourt H, Krajinovic M, Ansari M. The association of cytochrome P450 genetic polymorphisms with sulfolane formation and the efficacy of a busulfan-based conditioning regimen in pediatric patients undergoing hematopoietic stem cell transplantation. Pharmacogenomics J. 2014 Jun;14(3):263-71. doi: 10.1038/tpj.2013.38. Epub 2013 Oct 29.

ReferenceCitation: Acosta-Martin AE, Antinori P, Uppugunduri CRS, Daali Y, Ansari M, Scherl A, Müller M, Lescuyer P. Detection of busulfan adducts on proteins. Rapid Commun Mass Spectrom. 2016 Dec 15;30(23):2517-2528. doi: 10.1002/rcm.7730.

name: Department of Human Protein Science, Faculty of Medicine; University of Geneva; Geneva Switzerland

name: Division of Laboratory Medicine; Geneva University Hospitals; Geneva Switzerland

name: Swiss Centre of Applied Human Toxicology; Geneva Switzerland

name: Onco-Hematology Unit, Department of Pediatrics; Geneva University Hospitals; Geneva Switzerland

name: Cansearch Research Laboratory; Geneva Medical University; Geneva Switzerland

name: Division of Clinical Pharmacology and Toxicology; Geneva University Hospitals; Geneva Switzerland

name: SIB-Swiss Institute of Bioinformatics; University of Geneva; Switzerland

journal_name: Rapid Communications in Mass Spectrometry

repository_institution: University of Geneva - Archive ouverte UNIGE

ReferenceCitation: Bartelink IH, Lalmohamed A, van Reij EM, Dvorak CC, Savic RM, Zwaveling J, Bredius RG, Egberts AC, Bierings M, Kletzel M, Shaw PJ, Nath CE, Hempel G, Ansari M, Krajinovic M, Théorêt Y, Duval M, Keizer RJ, Bittencourt H, Hassan M, Güngör T, Wynn RF, Veys P, Cuvelier GD, Marktel S, Chiesa R, Cowan MJ, Slatter MA, Stricherz MK, Jennissen C, Long-Boyle JR, Boelens JJ. Association of busulfan exposure with survival and toxicity after haemopoietic cell transplantation in children and young adults: a multicentre, retrospective cohort analysis. Lancet Haematol. 2016 Nov;3(11):e526-e536. doi: 10.1016/S2352-3026(16)30114-4. Epub 2016 Oct 13.

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Huezo-Diaz Curtis P, Uppugunduri CRS, Muthukumaran J, Rezgui MA, Peters C, Bader P, Duval M, Bittencourt H, Krajinovic M, Ansari M. Association of CTH variant with sinusoidal obstruction syndrome in children receiving intravenous busulfan and cyclophosphamide before hematopoietic stem cell transplantation. Pharmacogenomics J. 2018 Jan;18(1):64-69. doi: 10.1038/tpj.2016.65. Epub 2016 Oct 25.

name: on behalf of the Paediatric Disease Working Parties of the European Blood and Marrow Transplant group

ReferenceCitation: Ansari M, Curtis PH, Uppugunduri CRS, Rezgui MA, Nava T, Mlakar V, Lesne L, Théoret Y, Chalandon Y, Dupuis LL, Schechter T, Bartelink IH, Boelens JJ, Bredius R, Dalle JH, Azarnoush S, Sedlacek P, Lewis V, Champagne M, Peters C, Bittencourt H, Krajinovic M. GSTA1 diplotypes affect busulfan clearance and toxicity in children undergoing allogeneic hematopoietic stem cell transplantation: a multicenter study. Oncotarget. 2017 Aug 27;8(53):90852-90867. doi: 10.18632/oncotarget.20310. eCollection 2017 Oct 31.

name: Department of Pediatrics, CANSEARCH Research Laboratory, Faculty of Medicine, Geneva, Switzerland

name: Department of Pediatrics, Onco-Hematology Unit, Geneva University Hospital, Geneva, Switzerland

name: Charles-Bruneau Cancer Center, CHU Sainte-Justine Research Center, Montreal, Quebec, Canada

name: Clinical Pharmacology Unit, CHU Sainte-Justine, Montreal, Quebec, Canada

name: Faculty of Medicine, Federal University of Rio Grande do Sul, Porto Alegre, Brazil

name: Department of Pharmacology, Faculty of Medicine, University of Montreal, Montreal, Quebec, Canada

name: Department of Medical Specialties, Division of Hematology, Geneva University Hospital, Geneva, Switzerland

name: Department of Haematology/Oncology, Blood and Marrow Transplant Unit, The Hospital for Sick Children, Toronto, Ontario, Canada

name: Pediatric Blood and Marrow Transplantation Program, University Medical Center, Utrecht, The Netherlands

name: Department of Medicine, The University of California San Francisco, San Francisco, CA, USA

name: Department of Pediatrics, Center of Infectious Diseases, Leiden University Medical Center, Leiden, The Netherlands

name: Pediatric Hematology Department, Robert Debré Hospital, Assistance Publique, Hôpitaux de Paris, Paris, France

name: Department of Pediatric Hematology and Oncology Teaching Hospital, 2nd Medical School, Charles University, Prague, Czech Republic

name: Department of Pediatrics, Alberta Children’s Hospital, Calgary, Alberta, Canada

name: Department of Hematology, Hospital Verdun, Montreal, Quebec, Canada

name: Department of Pediatrics, Stem Cell Transplantation Unit, St Anna Children’s Hospital, Vienna, Austria

name: Department of Pediatrics, Faculty of Medicine, University of Montreal, Montreal, Quebec, Canada

name: On Behalf of the Pediatric Disease Working Party of the European Society for Blood and Marrow Transplantation, Leiden, The Netherlands

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

ReferenceCitation: Jurkovic Mlakar S, Uppugunduri SCR, Nava T, Mlakar V, Golay H, Robin S, Waespe N, Rezgui MA, Chalandon Y, Boelens JJ, Bredius RGM, Dalle JH, Peters C, Corbacioglu S, Bittencourt H, Krajinovic M, Ansari M; paediatric diseases working party of the European society for blood and marrow transplantation. GSTM1 and GSTT1 double null genotypes determining cell fate and proliferation as potential risk factors of relapse in children with hematological malignancies after hematopoietic stem cell transplantation. J Cancer Res Clin Oncol. 2021 Sep 9. doi: 10.1007/s00432-021-03769-2. [Epub ahead of print] Erratum in: J Cancer Res Clin Oncol. 2021 Oct 30;:.

full_name: Chakradhara Rao Uppugunduri Satyanarayana

name: the paediatric diseases working party of the European society for blood and marrow transplantation

journal_name: Journal of Cancer Research and Clinical Oncology

repository_institution: University of Bern - Bern Open Repository and Information System

ReferenceCitation: Uppugunduri CRS, Storelli F, Mlakar V, Huezo-Diaz Curtis P, Rezgui A, Théorêt Y, Marino D, Doffey-Lazeyras F, Chalandon Y, Bader P, Daali Y, Bittencourt H, Krajinovic M, Ansari M. The Association of Combined GSTM1 and CYP2C9 Genotype Status with the Occurrence of Hemorrhagic Cystitis in Pediatric Patients Receiving Myeloablative Conditioning Regimen Prior to Allogeneic Hematopoietic Stem Cell Transplantation. Front Pharmacol. 2017 Jul 11;8:451. doi: 10.3389/fphar.2017.00451. eCollection 2017.

location_facility:
Hopital Cantonal de Genève
Hopital Rebert Debré
Alberta children's hospital
Chu St Justine


summary: This study will evaluate the safety and efficacy of botulinum toxin type A compared to placebo for the treatment of Crow's Feet Lines and Frown Lines (Facial Rhytides) for patients who successfully completed Study 191622-099.

lead_sponsor: Allergan

location_country:
Germany
United States
Canada
France


title: Dietary Protein in the Very-low-birth-weight Infant: Effects of the Level of Dietary Protein on Growth and Feeding Tolerance

summary:
In this randomized study The investigators aim to compare the growth of very-low-birth-weight (VLBW) infants fed either a high protein or a standard protein preterm infant formula.

Babies will be fed the assigned formula between the time they achieve full enteral feeds and hospital discharge, for a minimum of 3 weeks. The weight gain (g/d) will be measured and compared between groups. Feeding tolerance, protein-energy status and body composition between the study groups will also be analysed.

After discharge, babies will be fed a post-discharge preterm infant formula (PDF) between hospital discharge and 3 m corrected age.

status: Terminated

lead_sponsor: Nestlé

location_country:
United States
United Kingdom
Belgium
France

location_facility: Service de néonatologie Hôpital de la Croix Rousse

location_facility: Service Universitaire de Néonatologie CHR de la Citadelle

location_facility: Department of Pediatrics St Louis University

location_facility: Department of Child Health Royal Victoria Infirmary

intervention_type: Other

status_simplified: Unknown


summary: This study will evaluate the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of Crow's Feet Lines and Frown Lines (Facial Rhytides)

ReferenceCitation: Moers-Carpi M, Carruthers J, Fagien S, Lupo M, Delmar H, Jones D, Somogyi C, Lee E, Lei X, MacKinnon S, Davis PG, Yalamanchili R, Campo A, Beddingfield FC 3rd. Efficacy and safety of onabotulinumtoxinA for treating crow's feet lines alone or in combination with glabellar lines: a multicenter, randomized, controlled trial. Dermatol Surg. 2015 Jan;41(1):102-12. doi: 10.1097/DSS.0000000000000220.


type: Other Grant/Funding Number

title: Analgesia of Acute Coronary Syndromes With ST-segment Elevation in a Pre-hospital Setting. Randomized Non-inferiority Trial of the Association MEOPA + Paracetamol Versus Morphine.

acronym: SCADOLII

summary: In the management of acute coronary syndromes with ST-segment elevation (STEMI), early analgesia reduces the effects of hyperadrenalism which increases the size of myocardial infarction. In order to reduce pain intensity, the recommendations advocate emergency use of morphine. In STEMI patients, other analgesic treatments could provide analgesia that is at least as effective as morphine. The equimolar oxygen/nitrous oxide mixture (MEOPA) is widely used in emergency medicine and has minor secondary effects that are very rapidly reversible when inhalation is discontinued. Used in association with paracetamol, it could be an at least equally effective alternative to the use of morphine.

ReferenceCitation: Danchin N, Puymirat E, Aissaoui N, Adavane S, Durand E. [Epidemiology of acute coronary syndromes in France and in Europe]. Ann Cardiol Angeiol (Paris). 2010 Dec;59 Suppl 2:S37-41. doi: 10.1016/S0003-3928(10)70008-1. French.

ReferenceCitation: Myocardial infarction redefined--a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. Eur Heart J. 2000 Sep;21(18):1502-13. Review.

ReferenceCitation: Task Force for Diagnosis and Treatment of Non-ST-Segment Elevation Acute Coronary Syndromes of European Society of Cardiology, Bassand JP, Hamm CW, Ardissino D, Boersma E, Budaj A, Fernández-Avilés F, Fox KA, Hasdai D, Ohman EM, Wallentin L, Wijns W. Guidelines for the diagnosis and treatment of non-ST-segment elevation acute coronary syndromes. Eur Heart J. 2007 Jul;28(13):1598-660. Epub 2007 Jun 14.

ReferenceCitation: Van de Werf F, Bax J, Betriu A, Blomstrom-Lundqvist C, Crea F, Falk V, Filippatos G, Fox K, Huber K, Kastrati A, Rosengren A, Steg PG, Tubaro M, Verheugt F, Weidinger F, Weis M; ESC Committee for Practice Guidelines (CPG). Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation: the Task Force on the Management of ST-Segment Elevation Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J. 2008 Dec;29(23):2909-45. doi: 10.1093/eurheartj/ehn416. Epub 2008 Nov 12.

ReferenceCitation: Canadian Cardiovascular Society; American Academy of Family Physicians; American College of Cardiology; American Heart Association, Antman EM, Hand M, Armstrong PW, Bates ER, Green LA, Halasyamani LK, Hochman JS, Krumholz HM, Lamas GA, Mullany CJ, Pearle DL, Sloan MA, Smith SC Jr, Anbe DT, Kushner FG, Ornato JP, Pearle DL, Sloan MA, Jacobs AK, Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Halperin JL, Hunt SA, Lytle BW, Nishimura R, Page RL, Riegel B, Tarkington LG, Yancy CW. 2007 focused update of the ACC/AHA 2004 guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2008 Jan 15;51(2):210-47. doi: 10.1016/j.jacc.2007.10.001. Review. Erratum in: J Am Coll Cardiol. 2008 Mar 4;51(9):977.

ReferenceCitation: Charpentier S, Galinski M, Bounes V, Ricard-Hibon A, El-Khoury C, Elbaz M, Ageron FX, Manzo-Silberman S, Soulat L, Lapostolle F, Gérard A, Bregeaud D, Bongard V, Bonnefoy-Cudraz E; SCADOL II investigators. Nitrous oxide/oxygen plus acetaminophen versus morphine in ST elevation myocardial infarction: open-label, cluster-randomized, non-inferiority study. Scand J Trauma Resusc Emerg Med. 2020 May 12;28(1):36. doi: 10.1186/s13049-020-00731-y.

family: Charpentier

full_name: Sandrine Charpentier

given: Sandrine

family: Galinski

full_name: Michel Galinski

given: Michel

family: Bounes

full_name: Vincent Bounes

given: Vincent

family: Ricard-Hibon

full_name: Agnès Ricard-Hibon

given: Agnès

family: El-Khoury

full_name: Carlos El-Khoury

given: Carlos

family: Elbaz

full_name: Meyer Elbaz

given: Meyer

family: Ageron

full_name: François-Xavier Ageron

given: François-Xavier

family: Manzo-Silberman

full_name: Stéphane Manzo-Silberman

given: Stéphane

family: Soulat

full_name: Louis Soulat

given: Louis

family: Lapostolle

full_name: Frédéric Lapostolle

given: Frédéric

family: Gérard

full_name: Alexandre Gérard

given: Alexandre

family: Bregeaud

full_name: Delphine Bregeaud

given: Delphine

family: Bongard

full_name: Vanina Bongard

given: Vanina

family: Bonnefoy-Cudraz

full_name: Eric Bonnefoy-Cudraz

given: Eric

journal_name: Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

location_facility: Groupe hospitamier Lariboisière-Fernand Widal-St-Louis

location_facility: Centre Hospitalier Poulon la Seyne-sur-mer

location_facility: Centre Hospitalier Départemental La Roche/Yon


title: An Observational Study to Assess the Natural History Including Growth and Hearing in Patients With Cockayne Syndrome

summary:
This is an Observational Study of children under the age of 11 diagnosed with Cockayne Syndrome to assess the natural progression of Cockayne Syndrome disease, with special attention to hearing and physical changes in length or height, weight, head circumference, and arm span during standard treatment.

The primary analytical objective is to determine the rate of linear growth over a 6-month period in children < 2 years of age and over a 12-month period in children ≥ 2 years of age.

lead_sponsor: DNage B.V.

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

location_facility: Hopitaux Universitaires de Strasbourg, Service de Pédiatrie 1

location_facility: Harvard medical School, Children's Hospital Boston, Division of Genetics & Metabolism


title: An Extension to a Phase I Multicenter, Dose Escalation Study of Nilotinib in Combination With Imatinib on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-Resistant Gastrointestinal Stromal Tumors (GIST)

summary: To provide study drug to patients that benefit from treatment judged by the investigator - to obtain additional long-term safety and efficacy data of this combination regimen in GIST

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
France

location_facility:
Fox Chase Cancer Center
Dana Farber Cancer Institute
Novartis Investigative Site


title: Longitudinal Study of Brain Amyloid imaGing in MEMENTO

acronym: MEMENTOAmyGing

summary: A Multicenter national longitudinal cohort study including at least 800 individuals consecutively recruited from French Research Memory Centers and followed-up over 24 month and included in Memento.

status: Unknown status

primary_purpose: Diagnostic

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Bordeaux - Hôpital Xavier-Arnozan

location_facility: CHU de Saint-Etienne - Hôpital de la charité


ReferenceCitation: Garcia P, Phillips D, Johnson J, Martin K, Randolph LM, Rosenfeld H, Harmatz P. Long-term outcomes of patients with mucopolysaccharidosis VI treated with galsulfase enzyme replacement therapy since infancy. Mol Genet Metab. 2021 May;133(1):100-108. doi: 10.1016/j.ymgme.2021.03.006. Epub 2021 Mar 14.

family: Garcia

full_name: Paula Garcia

given: Paula

family: Phillips

full_name: Dawn Phillips

given: Dawn

family: Johnson

full_name: JoAnn Johnson

given: JoAnn

family: Martin

full_name: Kenneth Martin

given: Kenneth

family: Randolph

full_name: Linda M. Randolph

given: Linda M.

family: Rosenfeld

full_name: Howard Rosenfeld

given: Howard

family: Harmatz

full_name: Paul Harmatz

given: Paul

journal_name: Molecular Genetics and Metabolism

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Harmatz PR, Garcia P, Guffon N, Randolph LM, Shediac R, Braunlin E, Lachman RS, Decker C. Galsulfase (Naglazyme®) therapy in infants with mucopolysaccharidosis VI. J Inherit Metab Dis. 2014 Mar;37(2):277-87. doi: 10.1007/s10545-013-9654-7. Epub 2013 Oct 10.

full_name: Paul R. Harmatz

given: Paul R.

family: Guffon

full_name: Nathalie Guffon

given: Nathalie

family: Shediac

full_name: Renée Shediac

given: Renée

family: Braunlin

full_name: Elizabeth Braunlin

given: Elizabeth

family: Lachman

full_name: Ralph S. Lachman

given: Ralph S.

family: Decker

full_name: Celeste Decker

given: Celeste

journal_name: Journal of Inherited Metabolic Disease

evidence: open (via page says license)

repository_institution: California Digital Library - eScholarship

location_facility:
Children's Hospital Los Angeles
Hospital Femme Mere Enfant Centre
Hospital PediAtrico de Coimbra
Children's Hospital Oakland

title: A Phase 4 Multi-center, Multi-national, Open-label, Randomized, Two Dose Level Study of Naglazyme(TM) (Galsulfase) in Infants With Maroteaux-Lamy Syndrome (MPS VI)

summary: The purpose of the study is to evaluate the safety and efficacy of two dose levels of Naglazyme in infants under the age of one year who have MPS VI by monitoring physical appearance, x-ray of the skeletal system and growth.


title: An Open-label, Multicenter, Pharmacokinetic Study of a FimH Blocker, EB8018, in Crohn's Disease Patients

summary: Enterome small molecule drug EB8018 is a first-in-class FimH blocker to be studied in Crohn's disease patients. The proposed indication for EB8018, as an add-on therapy, will be the treatment of adult patients suffering from Crohn's disease.

lead_sponsor: Enterome

location_country: Italy Austria Germany France

location_facility: Universitätsklinikum Schleswig-Holstein Campus Kiel


title: A Phase 2, Open Label Study to Evaluate The Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) Tablet for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection

summary: This study will evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for 12 or 24 weeks in adults with chronic genotype 1 or genotype 4 hepatitis C virus (HCV) infection who have had a kidney transplant.

ReferenceCitation: Colombo M, Aghemo A, Liu H, Dvory-Sobol H, Hyland RH, Yun C, Brainard DM, McHutchison JG, Bourliere M, Peck-Radosavljevic M, Manns M, Pol S. Ledipasvir/Sofosbuvir (LDV/SOF) for 12 or 24 Weeks Is Safe and Effective in Kidney Transplant Recipients With Chronic Genotype 1 or 4 HCV Infection. Journal of Hepatology. 2016;64 pp S183-S212. (GS 13, oral presentation).

ReferenceCitation: Colombo M, Aghemo A, Liu H, Zhang J, Dvory-Sobol H, Hyland R, Yun C, Massetto B, Brainard DM, McHutchison JG, Bourlière M, Peck-Radosavljevic M, Manns M, Pol S. Treatment With Ledipasvir-Sofosbuvir for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic Hepatitis C Virus Genotype 1 or 4 Infection: A Randomized Trial. Ann Intern Med. 2017 Jan 17;166(2):109-117. doi: 10.7326/M16-1205. Epub 2016 Nov 15.

name: From Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy; Gilead Sciences, Foster City, California; Hôpital Saint Joseph, Marseilles, and Hôpital Cochin, Paris, France; Medical University of Vienna, Vienna, Austria; and Hannover Medical School, Hannover, Germany.

family: Colombo

full_name: Massimo Colombo

given: Massimo

family: Aghemo

full_name: Alessio Aghemo

given: Alessio

family: Liu

full_name: Hong Liu

given: Hong

family: Zhang

full_name: Jie Zhang

given: Jie

family: Dvory-Sobol

full_name: Hadas Dvory-Sobol

given: Hadas

family: Hyland

full_name: Robert Hyland

given: Robert

family: Yun

full_name: Chohee Yun

given: Chohee

family: Massetto

full_name: Benedetta Massetto

given: Benedetta

family: Brainard

full_name: Diana M. Brainard

given: Diana M.

family: McHutchison

full_name: John G. McHutchison

given: John G.

family: Bourlière

full_name: Marc Bourlière

given: Marc

family: Peck-Radosavljevic

full_name: Markus Peck-Radosavljevic

given: Markus

family: Manns

full_name: Michael Manns

given: Michael

family: Pol

full_name: Stanislas Pol

given: Stanislas

journal_name: Annals of Internal Medicine

publisher: American College of Physicians

publisher_dissemination: American College of Physicians

publisher_group: American College of Physicians

publisher_normalized: American College of Physicians

title: Treatment With Ledipasvir–Sofosbuvir for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic Hepatitis C Virus Genotype 1 or 4 Infection

ipd_sharing: Yes

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

lead_sponsor: Gilead Sciences


title: Clinical Evaluation of Integrative Practices Units Infant and Child Care for Unit Children With Typical or Atypical Autism (AUTISM)

acronym: AUTISM

summary: The research project is part of the evaluation of the therapeutic approaches in mental health. Its framework infant and juvenile units that have developed "integrative devices," taking into account recent advances in knowledge and providing care, education and pedagogical approach. The evolution of autistic children receiving these integrative devices is studied to determine the validity of the devices mentioned. The methodology is based on case studies in a natural situation. Clinicians are committed to network among themselves and with researchers in a multicenter study.

time_perspective: Prospective

lead_sponsor: Nantes University Hospital

location_facility: Unité de soins précoces HJ René Diatkine ASM13


title: A Prospective, Multicenter, Randomized, Open-label, Active-controlled, Two-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib to Sunitinib in Patients With Gastrointestinal Stromal Tumor After Progression With Imatinib at 400mg as First Line Treatment

summary: The objective is to compare the efficacy and safety of masitinib at 12 mg/kg/day to sunitinib at 50 mg/day in the treatment of patients with gastro-intestinal stromal tumor (GIST) after progression with imatinib.

lead_sponsor: AB Science

location_country:
Italy
United States
France
Netherlands

location_facility: Hôpital l'Archet 2- Service de Cancérologie Digestive

location_facility: Washington University School of Medicine

location_facility: Istituto per la Ricerca e la Cura del Cancro (IRCC)


ReferenceCitation: Middleton G, Crack LR, Popat S, Swanton C, Hollingsworth SJ, Buller R, Walker I, Carr TH, Wherton D, Billingham LJ. The National Lung Matrix Trial: translating the biology of stratification in advanced non-small-cell lung cancer. Ann Oncol. 2015 Dec;26(12):2464-9. doi: 10.1093/annonc/mdv394. Epub 2015 Sep 25.

apc_source: openAPC

family: Middleton

full_name: G. Middleton

given: G.

family: Crack

full_name: L.R. Crack

family: Popat

full_name: S. Popat

given: S.

family: Swanton

full_name: C. Swanton

given: C.

family: Hollingsworth

full_name: S.J. Hollingsworth

family: Buller

full_name: R. Buller

given: R.

family: Walker

full_name: I. Walker

given: I.

family: Carr

full_name: T.H. Carr

family: Wherton

full_name: D. Wherton

given: D.

family: Billingham

full_name: L.J. Billingham

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

evidence: oa repository (semantic scholar lookup)

repositories:
PubMed Central
Pure (Denmark)
pdfs.semanticscholar.org

status: Active, not recruiting

lead_sponsor: UNICANCER

location_facility: Centre Hopsitalier Intercommunal de Créteil

location_facility: Centre Hospitalier Universitaire de Besancon - Hopital Jean Minjoz

location_facility: CHU Clermont Ferrand - Hôpital Gabriel Montpied

location_facility: Hospices Civils de Lyon- Hôpital Louis Pradel

ipd_sharing: Undecided

title: Intergroup Trial UNICANCER UC 0105-1305/ IFCT 1301: SAFIR02_Lung - Evaluation of the Efficacy of High Throughput Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Non-small Cell Lung Cancer

summary: Open label multicentric randomized phase II trial, using high throughput genome analysis as a therapeutic decision tool, aimed at comparing a targeted treatment administered according to the identified molecular anomalies of the tumor with a standard treatment (pemetrexed in Non-squamous patients and erlotinib in squamous cells, targeted substudy 1) as well as immunotherapy with maintenance therapy in patients without actionable genomic alterations or non eligible to substudy 1 (immune substudy 2).

status_simplified: Ongoing


title: An Open-label, Multicenter, Phase I/II Dose Escalation Study of Oral GW572016 in Combination With Docetaxel (Taxotere) Plus Trastuzumab (Herceptin) in Subjects Previously Untreated for ErbB2-overexpressing Metastatic Breast Cancer

summary:
This study was designed to be two-part study (Phase I/Phase II). Part I was designed to find the optimal (best) doses of GW572016, docetaxel, and trastuzumab when given together, Part II was designed to evaluate the tumor response rate (shrinkage or lack of growth) in patients receiving all three drugs compared to patients receiving only docetaxel and trastuzumab.

However, the phase II part was cancelled before it started. Participants were only enrolled in the phase I part and NOT the phase II part.

ReferenceCitation: Crown J, Kennedy MJ, Tresca P, Marty M, Espie M, Burris HA, DeSilvio M, Lau MR, Kothari D, Koch KM, Diéras V. Optimally tolerated dose of lapatinib in combination with docetaxel plus trastuzumab in first-line treatment of HER2-positive metastatic breast cancer. Ann Oncol. 2013 Aug;24(8):2005-11. doi: 10.1093/annonc/mdt222.

family: Crown

full_name: J. Crown

given: J.

family: Kennedy

full_name: M.J. Kennedy

family: Tresca

full_name: P. Tresca

given: P.

family: Marty

full_name: M. Marty

given: M.

family: Espie

full_name: M. Espie

family: Burris

full_name: H.A. Burris

family: DeSilvio

full_name: M. DeSilvio

family: Lau

full_name: M.R. Lau

family: Kothari

full_name: D. Kothari

family: Koch

full_name: K.M. Koch

family: Diéras

full_name: V. Diéras

given: V.

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

location_country:
United States
Ireland
France


type: Registry Identifier

title: A Phase III Randomized, Double-Blinded Study of Nevirapine for the Prevention of Maternal-Fetal Transmission in Pregnant HIV-Infected Women

summary:
The purpose of this study is to see if giving the anti-HIV drug nevirapine (NVP) to HIV-positive pregnant women and their babies can help reduce the chance that a mother will give HIV to her baby during delivery.

Previous studies suggest that NVP is a promising medication for blocking HIV transmission from HIV-positive mothers to their babies.

primary_purpose: Prevention

ReferenceCitation: Cunningham CK, Balasubramanian R, Delke I, Maupin R, Mofenson L, Dorenbaum A, Sullivan JL, Gonzalez-Garcia A, Thorpe E, Rathore M, Gelber RD. The impact of race/ethnicity on mother-to-child HIV transmission in the United States in Pediatric AIDS Clinical Trials Group Protocol 316. J Acquir Immune Defic Syndr. 2004 Jul 1;36(3):800-7.

ReferenceCitation: Watts DH, Balasubramanian R, Maupin RT Jr, Delke I, Dorenbaum A, Fiore S, Newell ML, Delfraissy JF, Gelber RD, Mofenson LM, Culnane M, Cunningham CK; PACTG 316 Study Team. Maternal toxicity and pregnancy complications in human immunodeficiency virus-infected women receiving antiretroviral therapy: PACTG 316. Am J Obstet Gynecol. 2004 Feb;190(2):506-16.

lead_sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

location_country: Italy Spain France Bahamas

location_facility:
CHRU de Nantes
Hopital Hotel Dieu de Lyon
Universita Frederico II
Hosp Doce De Octubre
Princess Margaret Hosp


title: Evaluation of the Non-inferiority of TulleGras M.S.® Versus Urgotul® in Pain Associated With Removal of Wound Dressing During Care of Venous Leg Ulcer. An Open-label, Multicenter, Randomized, Controlled, Crossover Study With Blinded Reading of Healing Criteria.

summary: Evaluation of the non-inferiority of TulleGras M.S.® versus Urgotul® in pain associated with removal of wound dressing during care of venous leg ulcer

lead_sponsor: Mylan Inc.

location_facility:
Research facility ID ORG-001215
Research Facility ID ORG-000850
Research facility ID ORG-001082
Research Facility ID ORG-000869
Research facility ID ORG-001083
Research facility ID ORG-001216
Research Facility ID ORG-000862
Research facility ID ORG-000835
Research facility ID ORG-000853
Research Facility ID ORG-000832
Research facility ID ORG-000865
Research facility ID ORG-000981
Research facility ORG-001362
Research Facility ID ORG-000857
Research Facility ID ORG-000859
Research facility ID ORG-001081
Research facility ID ORG-000831
Research facility ORG-001361
Research facility ID ORG-000845
Research Facility ID ORG-001183
Research facility ID ORG-000856
Research Facility ID ORG-000830
Research Facility ID ORG-001182
Research Facility ID ORG-001181
Research Facility ID ORG-000844
Research facility ID ORG-000836
Research facility ID ORG-000855

intervention_type: Device


title: RONNIE - A Multi-Center, Multi-National, Retrospective Medical Record Review to Describe Treatment Patterns and Outcomes for Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

summary: This multi-center, observational study involves reviewing the medical records of approximately 100 adult participants diagnosed with advanced BCC from 01 January 2005 until 31 December 2010. Participant records will be analyzed to identify participant characteristics, treatment patterns and clinical outcomes.

time_perspective: Retrospective

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Germany
United Kingdom
France

location_facility: Hopital Bichat Claude Bernard; Sce Dermatologie

location_facility: Centre Hospitalier Lyon Sud; Dermatologie

location_facility: Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie

location_facility: Hopital de Haut-Leveque; Dermatologie Serv.

location_facility: Azienda Sanitaria di Firenze Presidio Palagi - SC Dermatologia II e Fisioterapia Dermatologica

location_facility: Western Infirmary; Division of Cardiovascular and Medical Sciences

location_facility: Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie

location_facility: Hopital Saint Andre CHU De Bordeaux; Dermatologie

location_facility: Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie

location_facility: Hôpital Albert Michallon; Derm Phlebologie Allergologie

location_facility: Chi Emile Durkheim Site Epinal; Oncologie

location_facility: A.O. Univ. Senese Policlinico S. Maria alle Scotte; Dip. Medicina clinica e Scienze Immunologiche

location_facility: Manchester Royal Infirmary; Department Of Medicine

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, Hautklinik und Poliklinik

location_facility: Klinikum Dorothea Ch.Erxleben; Klinik für Dermatologie und Allergologie

location_facility: Università del Piemonte Orientale; Dipartimento di Dermatologia

location_facility: Arcispedale Santa Maria Nuova; Dermatologia

location_facility: Policlinico Le Molinette; Clinica Dermatologica

location_facility: Hôpital St Jacques de Besançon; (Dermatology)

location_facility: Universitätsmedizin Greifswald; Klinik für Mund-Kiefer-Gesichtschirurgie/Plastische Operationen

location_facility: Hopital Saint Vincent; Consult Dermatologie Enfants

location_facility: SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie

location_facility: Hopital Timone Adultes; Radiotherapie Oncologie

location_facility: Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie

location_facility: HELIOS Klinikum Erfurt, Klinik für Hautkrankheiten und Allergologie


title: A French Cohort of Transplant Recipients With CMV Infection : Risk Factors for Antiviral Resistance in the Prophylaxis Era. Survey of Pharmacological and Virological Resistance of Cytomegalovirus to Antiviral Therapy in Transplantation.

acronym: ORPHAVIC

summary:
Resistance to antivirals is a growing problem in transplantation.that may concerns up to 5% of patients treated for cytomegalovirus (CMV) syndrome or disease in recent per-protocol studies. This prevalence vary with the organ transplanted and the degree of viral replication and immunosuppression. Less data are available to date from real-life cohorts of patients, and there is no systematic survey of resistance in Europe or in the US. Non response to treatment concerns a larger group of patients and can result either from emergence of a resistant strain (virological resistance), from inadequate dosage of antivirals, or a high degree of immunosuppression, with a poor CMV immune response. The respective clinical impact of virological resistance and clinical resistance (of pharmacological or immunological origin) on graft outcome and long-term survival of patients has never been assessed. High viral loads and persistent replication associated to prolonged exposure to antivirals are known to favor the emergence of resistant strains. Though epidemiology of resistant strains, role of multiple infections, impact of various mutations on degree of resistance to antivirals and outcome remains to be further studied. Most studies are per-protocol studies or short-term studies conducted on limited populations. There are no data in real-life of transplanted patients at the era of enlarged prophylaxis except those from the French survey for cytomegalovirus resistance cohort opened at the end of 2006. From the first data collected on 346 patients we shown a 10,6% prevalence of non-response to therapy with 5,2% of virological resistance (6,1% incidence at one year on 214 patients) with a trend to poorer outcome in case of virological resistance and to the absence of impact of prophylaxis versus preemptive therapy, though larger populations and prolonged follow-up are requested to fulfill all objectives.

We therefore aim to constitute a prolonged survey cohort for CMV resistance with a large number of patients and a prolonged follow-up, to gather data on resistance to antivirals in real-life of transplant patients in an organized data bank, This cohort is in the continuum of our previous cohort started in 2006, granted by the Hospital Clinical Research Program Interregional (PHRC), with the same major objectives and prolonged follow-up of patients.

lead_sponsor: University Hospital, Limoges

location_facility: HCLYON - Virologie - Hôpital La Croix Rousse

location_facility: Virologie - Hôpital La Pitié Salpétrière

location_facility: AP-HP - Hôpital Saint-Antoine - Virologie

location_facility: AP-HP - Hôpital Georges Pompidou - Virologie

intervention_type: Biological


ReferenceCitation: Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Porcari A, Raskob GE, Weitz JI; AMPLIFY-EXT Investigators. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):699-708. doi: 10.1056/NEJMoa1207541. Epub 2012 Dec 8.

family: Agnelli

full_name: Giancarlo Agnelli

given: Giancarlo

full_name: Harry R. Buller

given: Harry R.

family: Cohen

full_name: Alexander Cohen

given: Alexander

family: Curto

full_name: Madelyn Curto

given: Madelyn

family: Gallus

full_name: Alexander S. Gallus

given: Alexander S.

family: Johnson

full_name: Margot Johnson

given: Margot

family: Porcari

full_name: Anthony Porcari

given: Anthony

family: Raskob

full_name: Gary E. Raskob

given: Gary E.

family: Weitz

full_name: Jeffrey I. Weitz

given: Jeffrey I.

journal_name: New England Journal of Medicine

oa_host_type: repository

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repositories_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Apixaban for Extended Treatment of Venous Thromboembolism

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family: Attal

full_name: Michel Attal

given: Michel

family: Lauwers-Cances

full_name: Valerie Lauwers-Cances

given: Valerie

family: Marit

full_name: Gerald Marit

given: Gerald

family: Caillot

full_name: Denis Caillot

given: Denis

family: Moreau

full_name: Philippe Moreau

given: Philippe

family: Facon

full_name: Thierry Facon

given: Thierry

family: Stoppa

full_name: Anne Marie Stoppa

given: Anne Marie

family: Hulin

full_name: Cyrille Hulin

given: Cyrille

family: Benboubker

full_name: Lofti Benboubker

given: Lofti

family: Garderet

full_name: Laurent Garderet

given: Laurent

family: Decaux

full_name: Olivier Decaux

given: Olivier

title: Lenalidomide Maintenance after Stem-Cell Transplantation for Multiple Myeloma

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repository_institution: The University of Queensland - Queensland's institutional digital repository

repository_institution: Nova Science Publishers, Inc. - Nova Science Publishers

repositories_institution: Nova Science Publishers, Inc. - Nova Science Publishers

repositories_institution: The University of Queensland - Queensland's institutional digital repository

title: Rivaroxaban for Thromboprophylaxis in Acutely Ill Medical Patients

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title: Apixaban in Patients with Atrial Fibrillation

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repository_institution: University of Debrecen - University of Debrecen Electronic Archive

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

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

repositories_institution: University of Debrecen - University of Debrecen Electronic Archive

title: Apixaban versus Enoxaparin for Thromboprophylaxis in Medically Ill Patients

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title: Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial

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location_facility:
Chu Poitiers
Chu Grenoble
Chru Hopital Huriez
Chd Vendee
Ch de Perigueux
Centre Hospitalier
Chru de Tours
Hopital Pitie Salpetriere
Ch Lyon Sud
Groupe Hospitalier Du Havre
Hia Percy
Hopital de L'Archet
Hopital St Vincent - Ghicl
Centre Leon Berard
Ch La Cote Basque
Chu Hopital Henri Mondor
Chu Bordeaux
Clinique Victor Hugo
CHRA

title: Evaluation of the Use of an Oral Direct Anti-Xa Anticoagulant, Apixaban, in Prevention of Venous Thromboembolic Disease in Patients Treated With IMiDs During Myeloma : a Pilot Study

summary:
To evaluate:

the incidence of venous thromboembolic event (VTE)
the incidence of hemorrhagic complications, In a population of patients with myeloma who are treated with IMiDs and require thromboprophylaxis for 6 months, using an oral anti-Xa anticoagulant, Apixaban, in a preventive scheme, 2.5 mg x2/day


title: Risk Factors for Thromboembolic and Infectious Complications Related to Percutaneous Central Venous Catheters in Cancer - Prospective Multicenter Study

acronym: ONCOCIP

summary: The purpose of this study is to identify risk factors for thromboembolic and /or infectious complications in 3,000 patients with solid tumor and receiving a Percutaneous Central Venous Catheter (PCVC). A better understanding of the risk factors for these complications in this population would then allow interventional studies to be proposed to assess the benefit of prophylactic procedures in a sub-group of patients at most risk.

ReferenceCitation: Agnelli G, George DJ, Kakkar AK, Fisher W, Lassen MR, Mismetti P, Mouret P, Chaudhari U, Lawson F, Turpie AG; SAVE-ONCO Investigators. Semuloparin for thromboprophylaxis in patients receiving chemotherapy for cancer. N Engl J Med. 2012 Feb 16;366(7):601-9. doi: 10.1056/NEJMoa1108898.

family: Agnelli

full_name: Giancarlo Agnelli

given: Giancarlo

family: George

full_name: Daniel J. George

given: Daniel J.

family: Kakkar

full_name: Ajay K. Kakkar

given: Ajay K.

family: Fisher

full_name: William Fisher

given: William

family: Lassen

full_name: Michael R. Lassen

given: Michael R.

family: Mismetti

full_name: Patrick Mismetti

given: Patrick

family: Mouret

full_name: Patrick Mouret

family: Chaudhari

full_name: Umesh Chaudhari

given: Umesh

family: Lawson

full_name: Francesca Lawson

given: Francesca

family: Turpie

full_name: Alexander G.G. Turpie

given: Alexander G.G.

title: Semuloparin for Thromboprophylaxis in Patients Receiving Chemotherapy for Cancer

ReferenceCitation: Debourdeau P, Farge D, Beckers M, Baglin C, Bauersachs RM, Brenner B, Brilhante D, Falanga A, Gerotzafias GT, Haim N, Kakkar AK, Khorana AA, Lecumberri R, Mandala M, Marty M, Monreal M, Mousa SA, Noble S, Pabinger I, Prandoni P, Prins MH, Qari MH, Streiff MB, Syrigos K, Büller HR, Bounameaux H. International clinical practice guidelines for the treatment and prophylaxis of thrombosis associated with central venous catheters in patients with cancer. J Thromb Haemost. 2013 Jan;11(1):71-80. doi: 10.1111/jth.12071. Review.

ReferenceCitation: Saber W, Moua T, Williams EC, Verso M, Agnelli G, Couban S, Young A, De Cicco M, Biffi R, van Rooden CJ, Huisman MV, Fagnani D, Cimminiello C, Moia M, Magagnoli M, Povoski SP, Malak SF, Lee AY. Risk factors for catheter-related thrombosis (CRT) in cancer patients: a patient-level data (IPD) meta-analysis of clinical trials and prospective studies. J Thromb Haemost. 2011 Feb;9(2):312-9. doi: 10.1111/j.1538-7836.2010.04126.x.

ReferenceCitation: Akl EA, Kamath G, Yosuico V, Kim SY, Barba M, Sperati F, Cook DJ, Schünemann HJ. Thromboprophylaxis for patients with cancer and central venous catheters: a systematic review and a meta-analysis. Cancer. 2008 Jun;112(11):2483-92. doi: 10.1002/cncr.23479. Review.

ReferenceCitation: Mollee P, Jones M, Stackelroth J, van Kuilenburg R, Joubert W, Faoagali J, Looke D, Harper J, Clements A. Catheter-associated bloodstream infection incidence and risk factors in adults with cancer: a prospective cohort study. J Hosp Infect. 2011 May;78(1):26-30. doi: 10.1016/j.jhin.2011.01.018. Epub 2011 Apr 2.

ReferenceCitation: Chaukiyal P, Nautiyal A, Radhakrishnan S, Singh S, Navaneethan SD. Thromboprophylaxis in cancer patients with central venous catheters. A systematic review and meta-analysis. Thromb Haemost. 2008 Jan;99(1):38-43. doi: 10.1160/TH07-07-0446. Review.

ReferenceCitation: Khorana AA, Francis CW, Blumberg N, Culakova E, Refaai MA, Lyman GH. Blood transfusions, thrombosis, and mortality in hospitalized patients with cancer. Arch Intern Med. 2008 Nov 24;168(21):2377-81. doi: 10.1001/archinte.168.21.2377.

ReferenceCitation: Schwarz RE, Groeger JS, Coit DG. Subcutaneously implanted central venous access devices in cancer patients: a prospective analysis. Cancer. 1997 Apr 15;79(8):1635-40.

ReferenceCitation: Decousus H, Bourmaud A, Fournel P, Bertoletti L, Labruyère C, Presles E, Merah A, Laporte S, Stefani L, Piano FD, Jacquin JP, Meyer G, Chauvin F; ONCOCIP Investigators. Cancer-associated thrombosis in patients with implanted ports: a prospective multicenter French cohort study (ONCOCIP). Blood. 2018 Aug 16;132(7):707-716. doi: 10.1182/blood-2018-03-837153. Epub 2018 Jul 6.

name: INSERM, Centre d’Investigation Clinique 1408, Saint-Etienne, France;

name: F-Crin, INNOVTE (Investigation Network On Venous Thrombo-Embolism), Saint-Etienne, France;

name: Centre Hospitalier Universitaire Saint-Etienne, Hôpital Nord, Service Médecine Vasculaire et Thérapeutique, Saint-Etienne, France;

name: Université Jean Monet-Saint-Etienne, INSERM, SAINBIOSE (SAnté, INgénierie, BIOlogie, Saint-Étienne) U1059, Saint-Etienne, France;

family: Decousus

full_name: Hervé Decousus

given: Hervé

name: Hygée Center, Saint Priest en Jarez, France;

name: Medical Oncology Lucien Neuwirth Cancer Institute, Saint-Priest en Jarez, France;

family: Bourmaud

full_name: Aurélie Bourmaud

given: Aurélie

family: Fournel

full_name: Pierre Fournel

given: Pierre

family: Bertoletti

full_name: Laurent Bertoletti

name: Department of Clinical Pharmacology, University Hospital, Saint-Etienne, France;

family: Labruyère

full_name: Carine Labruyère

given: Carine

family: Presles

full_name: Emilie Presles

given: Emilie

family: Merah

full_name: Adel Merah

given: Adel

family: Laporte

full_name: Silvy Laporte

given: Silvy

name: Oncology Department, Centre Hospitalier Annecy Genevois, Pringy, France;

family: Stefani

full_name: Laetitia Stefani

name: Service de Gynécologie, Hôpitaux du Léman, Thonon Les Bains, France; and

name: Service de Pneumologie, Hôpital Européen Georges Pompidou, Assistance Publique des Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, INSERM Unité Mixte de Recherche S 970, Paris, France

location_facility: CHU Saint-Etienne Service de Gynécologie

location_facility: CHU Saint-Etienne Service de Gastroentérologie


title: A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients With Erythropoietic Protoporphyria (EPP)

summary:
Afamelanotide is a man-made drug being studied for use as a preventative medication for EPP sufferers. It is a synthetically produced analogue of human alpha melanocyte stimulating hormone (alpha-MSH) and is not yet available on the market.

The purpose of this study is to look at whether afamelanotide can reduce the number and severity of EPP symptoms when patients are exposed to light. This study will also look at how the drug is tolerated when taken by people with EPP.

The study will involve the use of an implant, which comes in the form of a small rod (approximately 2 cm x 0.15 cm) to be administered under the skin. The implant may contain the study drug afamelanotide or a placebo (inactive medication).

Over 450 subjects have been treated with afamelanotide to date with no serious safety concerns identified. For this study, afamelanotide has been formulated as a controlled release depot injection (implant). This means that the afamelanotide will be released slowly into the body over a few days. Once inserted, the implant will remain in the body after afamelanotide has been released and will slowly dissolve.

This study will help to provide more information about afamelanotide. This information will be used to determine the safety and efficacy (the ability of the drug to produce an effect) of this drug in EPP sufferers.

Up to 70 people will participate in this study from study sites across Europe.

ReferenceCitation: Langendonk JG, Balwani M, Anderson KE, Bonkovsky HL, Anstey AV, Bissell DM, Bloomer J, Edwards C, Neumann NJ, Parker C, Phillips JD, Lim HW, Hamzavi I, Deybach JC, Kauppinen R, Rhodes LE, Frank J, Murphy GM, Karstens FPJ, Sijbrands EJG, de Rooij FWM, Lebwohl M, Naik H, Goding CR, Wilson JHP, Desnick RJ. Afamelanotide for Erythropoietic Protoporphyria. N Engl J Med. 2015 Jul 2;373(1):48-59. doi: 10.1056/NEJMoa1411481.

name: From the Department of Internal Medicine, Center of Lysosomal and Metabolic Diseases, Erasmus Medical Center, Rotterdam (J.G.L., F.P.J.K., E.J.G.S., F.W.M.R., J.H.P.W.), and the Department of Dermatology, Maastricht University Medical Center, Maastricht (J.F.) — both in the Netherlands; the Departments of Genetics and Genomic Sciences (M.B., H.N., R.J.D.) and Dermatology (M.L.), Icahn School of Medicine at Mount Sinai, New York; the Departments of Preventive Medicine and Community Health, and Internal...

family: Langendonk

full_name: Janneke G. Langendonk

given: Janneke G.

family: Balwani

full_name: Manisha Balwani

given: Manisha

family: Anderson

full_name: Karl E. Anderson

given: Karl E.

family: Bonkovsky

full_name: Herbert L. Bonkovsky

given: Herbert L.

family: Anstey

full_name: Alexander V. Anstey

given: Alexander V.

family: Bissell

full_name: D. Montgomery Bissell

given: D. Montgomery

family: Bloomer

full_name: Joseph Bloomer

given: Joseph

family: Edwards

full_name: Chris Edwards

given: Chris

family: Neumann

full_name: Norbert J. Neumann

given: Norbert J.

family: Parker

full_name: Charles Parker

given: Charles

family: Phillips

full_name: John D. Phillips

given: John D.

family: Lim

full_name: Henry W. Lim

given: Henry W.

family: Hamzavi

full_name: Iltefat Hamzavi

given: Iltefat

family: Deybach

full_name: Jean-Charles Deybach

given: Jean-Charles

family: Kauppinen

full_name: Raili Kauppinen

given: Raili

family: Rhodes

full_name: Lesley E. Rhodes

given: Lesley E.

family: Frank

full_name: Jorge Frank

given: Jorge

family: Murphy

full_name: Gillian M. Murphy

given: Gillian M.

family: Karstens

full_name: Francois P.J. Karstens

given: Francois P.J.

family: Sijbrands

full_name: Eric J.G. Sijbrands

given: Eric J.G.

family: de Rooij

full_name: Felix W.M. de Rooij

given: Felix W.M.

family: Lebwohl

full_name: Mark Lebwohl

given: Mark

family: Naik

full_name: Hetanshi Naik

given: Hetanshi

family: Goding

location_country:
Netherlands
Finland
France
Ireland
Germany
United Kingdom

location_facility: Photobiology Unit - Hope Hospital, University of Manchester

location_facility: HUS:n Iho-ja allergiasairaala (Skin and Allergy Hospital)

location_facility: Centre Français des Porphyries, Hôpital Louis Mourier

location_facility: Department of Dermatology , Heinrich-Heine-University Duesseldorf

location_facility: Beaumont Hospital, Department of Dermatology


title: Impact of Drug Reconciliation at Discharge and Pharmaceutical Communication Between Hospital and Community Pharmacists on Drug Related Problems: Study Protocol for a Cluster Randomized Cross-over Trial

acronym: REPHVIM

summary: This study will evaluate the impact of a communication between hospital pharmacist and community pharmacists in addition to drugs reconciliation procedure at discharge. It will be conducted in 21 french public hospitals.

ReferenceCitation: Pourrat X, Roux C, Bouzige B, Garnier V, Develay A, Allenet B, Fraysse M, Halimi JM, Grassin J, Giraudeau B. Impact of drug reconciliation at discharge and communication between hospital and community pharmacists on drug-related problems: study protocol for a randomized controlled trial. Trials. 2014 Jun 30;15:260. doi: 10.1186/1745-6215-15-260.

family: Pourrat

full_name: Xavier Pourrat

given: Xavier

family: Roux

full_name: Clarisse Roux

given: Clarisse

family: Bouzige

full_name: Brigitte Bouzige

given: Brigitte

family: Garnier

full_name: Valérie Garnier

given: Valérie

family: Develay

full_name: Armelle Develay

given: Armelle

family: Allenet

full_name: Benoit Allenet

given: Benoit

family: Fraysse

full_name: Martial Fraysse

given: Martial

family: Halimi

full_name: Jean-Michel Halimi

given: Jean-Michel

family: Grassin

full_name: Jacqueline Grassin

given: Jacqueline

family: Giraudeau

full_name: Bruno Giraudeau

given: Bruno

lead_sponsor: University Hospital, Tours

location_facility:
Centre Hospitalier Pierre Bérégovoy
Hopital Archet
Hopital de Mercy Metz-Thionville
CHU Conception
Hopital ESTAING
Centre Hospitalier
Hopital de la Cavale Blanche
Hopital de Hautepierre
Hopital Inter Armées
Centre Hospitalier Alès-Cévennes
Hopitaux civils de Colmar
Centre Hospitalier Universitaire
Centre Hospitalier Compiègne-Noyon
Hopital Jacques Monod


title: A Randomized Study Comparing the Incidence of Acute Clinical or Subclinical Rejection With Two Dosing Regimens of CellCept in de Novo Renal Transplant Recipients Receiving Induction, Cyclosporine and Brief Steroid Therapy

summary: This study will compare the incidence of acute clinical or subclinical rejection between immunosuppression with CellCept at a starting dose of 3mg po daily with therapeutic drug monitoring and standard immunosuppression with CellCept and a fixed dose of 2g po daily, in kidney transplant recipients receiving induction by anti-IRL2, cyclosporine therapy, and early discontinuation of steroids. Patients will be randomized to one of the two treatment arms. The anticipated time on study treatment is 52 weeks.


title: A Multi-Center Open-Label Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Tocilizumab in Tocilizumab-Naive Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARD and/or Biologic Therapy

acronym: TOSCA

summary: This two part, multi-center, open-label, single-arm study will evaluate the efficacy and safety of tocilizumab as a monotherapy or in combination with methotrexate or other conventional synthetic disease modifying antirheumatic drugs (csDMARDs) in participants with moderate to severe active rheumatoid arthritis who have an inadequate response or are intolerant to non-biologic csDMARDs and/or biologic therapy.

ReferenceCitation: Choy E, Caporali R, Xavier R, Fautrel B, Sanmarti R, Bao M, Devenport J, Pethö-Schramm A. Effects of concomitant glucocorticoids in TOZURA, a common-framework study programme of subcutaneous tocilizumab in rheumatoid arthritis. Rheumatology (Oxford). 2019 Jun 1;58(6):1056-1064. doi: 10.1093/rheumatology/key393.

name: Division of Infection and Immunity, CREATE Centre, Cardiff University, Cardiff, UK

family: Choy

full_name: Ernest Choy

given: Ernest

name: Division of Rheumatology, University of Pavia and Fondazione IRCCS Policlinico S. Matteo Foundation, Pavia, Italy

family: Caporali

full_name: Roberto Caporali

given: Roberto

name: Department of Medicine, Universidade Federal do Rio Grande do Sul Porto Alegre, Rio Grande do Sul, Brazil

family: Xavier

full_name: Ricardo Xavier

given: Ricardo

name: Department of Rheumatology, AP-HP, Pitié-Salpêtrière Hospital, Pierre and Marie Curie University, Paris, France

family: Fautrel

full_name: Bruno Fautrel

name: Department of Rheumatology, Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona, Spain

family: Sanmarti

full_name: Raimon Sanmarti

given: Raimon

name: Genentech, Inc., South San Francisco, CA, USA

family: Bao

full_name: Min Bao

given: Min

family: Devenport

full_name: Jenny Devenport

given: Jenny

name: F. Hoffmann-La Roche Ltd, Basel, Switzerland

family: Pethö-Schramm

full_name: Attila Pethö-Schramm

given: Attila

journal_name: Rheumatology

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

repository_institution: Cardiff University - ORCA Online Research @Cardiff

repository_normalized: https

version: acceptedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Choy E, Caporali R, Xavier R, Fautrel B, Sanmarti R, Bao M, Bernasconi C, Pethö-Schramm A. Subcutaneous tocilizumab in rheumatoid arthritis: findings from the common-framework phase 4 study programme TOZURA conducted in 22 countries. Rheumatology (Oxford). 2018 Mar 1;57(3):499-507. doi: 10.1093/rheumatology/kex443. Erratum in: Rheumatology (Oxford). 2018 Jun 1;57(6):1129.

name: CREATE Centre, Division of Infection and Immunity, Cardiff University, Cardiff, UK

name: Division of Rheumatology, University of Pavia and IRCCS Policlinico S. Matteo Foundation, Pavia, Italy

name: Department of Rheumatology, APHP, Pitie Salpetriere Hospital, Pierre and Marie Curie University, Paris, France

name: F. Hoffmann-La Roche, Basel, Switzerland

repository_institution: Universidade Federal do Rio Grande do Sul - Lume