acronym: SHIFT

summary: The primary objective of this study is to demonstrate the superiority of ivabradine over placebo in the reduction of cardiovascular mortality or hospitalisation for worsening heart failure in patients with moderate to severe symptoms of chronic heart failure, a reduced left ventricular ejection fraction and currently receiving recommended therapy for this disease.

ReferenceCitation: Swedberg K, Komajda M, Böhm M, Borer JS, Ford I, Dubost-Brama A, Lerebours G, Tavazzi L; SHIFT Investigators. Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study. Lancet. 2010 Sep 11;376(9744):875-85. doi: 10.1016/S0140-6736(10)61198-1. Erratum in: Lancet. 2010 Dec 11;376(9757):1988. Lajnscak, M [corrected to Lainscak, M]; Rabanedo, I Roldan [corrected to Rabadán, I Roldan]; Leva, M [corrected to Ieva, M].

family: Swedberg

full_name: Karl Swedberg

given: Karl

family: Komajda

full_name: Michel Komajda

given: Michel

family: Böhm

full_name: Michael Böhm

given: Michael

family: Borer

full_name: Jeffrey S Borer

given: Jeffrey S

family: Ford

full_name: Ian Ford

given: Ian

family: Dubost-Brama

full_name: Ariane Dubost-Brama

given: Ariane

family: Lerebours

full_name: Guy Lerebours

given: Guy

family: Tavazzi

full_name: Luigi Tavazzi

given: Luigi

journal_name: The Lancet

ReferenceCitation: Böhm M, Swedberg K, Komajda M, Borer JS, Ford I, Dubost-Brama A, Lerebours G, Tavazzi L; SHIFT Investigators. Heart rate as a risk factor in chronic heart failure (SHIFT): the association between heart rate and outcomes in a randomised placebo-controlled trial. Lancet. 2010 Sep 11;376(9744):886-94. doi: 10.1016/S0140-6736(10)61259-7.

ReferenceCitation: Tyl B, Lopez Sendon J, Borer JS, Lopez De Sa E, Lerebours G, Varin C, De Montigny A, Pannaux M, Komajda M. Comparison of Outcome Adjudication by Investigators and by a Central End Point Committee in Heart Failure Trials: Experience of the SHIFT Heart Failure Study. Circ Heart Fail. 2020 Jul;13(7):e006720. doi: 10.1161/CIRCHEARTFAILURE.119.006720. Epub 2020 Jun 25.

name: CardioVascular & Metabolic Disease Center for Therapeutic Innovation (B.T., C.V.), Institut de Recherches Internationales Servier, Suresnes, France.

family: Tyl

full_name: Benoît Tyl

given: Benoît

name: Cardiology Department (J.L.S.), University Hospital La Paz, UAM, IdiPaz, CiberCV, Madrid, Spain.

family: Lopez Sendon

full_name: José Lopez Sendon

given: José

name: College of Medicine, School of Public Health, SUNY Downstate Medical Center, Brooklyn, New York (J.S.B.).

name: Weill Cornell Medicine, New York, NY (J.S.B.).

name: Acute Cardiac Care Unit (E.L.D.S.), University Hospital La Paz, UAM, IdiPaz, CiberCV, Madrid, Spain.

name: Health Value 92, Levallois-Perret, France (G.L.).

name: Center of Excellence Methodology and Valorisation of Data (A.D.M., M.P.), Institut de Recherches Internationales Servier, Suresnes, France.

name: Department of Cardiology, Hospital Saint Joseph, Paris, France (M.K.).

ReferenceCitation: Griffiths A, Paracha N, Davies A, Branscombe N, Cowie MR, Sculpher M. Analyzing Health-Related Quality of Life Data to Estimate Parameters for Cost-Effectiveness Models: An Example Using Longitudinal EQ-5D Data from the SHIFT Randomized Controlled Trial. Adv Ther. 2017 Mar;34(3):753-764. doi: 10.1007/s12325-016-0471-x. Epub 2017 Feb 15.

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

ipd_sharing_description:
Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies:

submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

location_facility:
Göteborg University
Hôpital Pitié-Salpétrière


title: Atorvastatin in Active Vitiligo: a Bicentric Prospective Randomized Trial

summary:
Condition:

Non segmental and active vitiligo of adulthood.

Main objective:

To evaluate the efficacy of a daily treatment with atorvastatin 80mg/d combined to UVB compared to UVB alone in active vitiligo after 6 months of treatment.

Methods:

Prospective interventional bicentric study with evaluation blinded to the treatment received.

Inclusion criteria:

Patients from 18 to 75 year-old with active non segmental vitiligo. Active is defined by the apparition or the modification of vitiligo lesions with the past 3 months and under Wood's lamp examination hypochromic borders and/or spotty depigmentation.

Interventions:

After central randomization

Arm A : atorvastatin 40mg/d for 1 months then 80mg/d for 5 months combined with twice weekly narrowband UVB treatment for 6 months.
Arm B: with twice weekly narrowband UVB treatment for 6 months.

Evaluation:

Main criteria: Decrease of VASI score expressed in percentage Secondary criteria: Decrease of VETF score expressed in percentage. Variation of PGA and DLQI scores. Clinical and biological tolerance. Variation of CXCL10 levels in the serum.

Length of the study:

Inclusion period: 12 months. Length of treatment: 6 months. Statistical analyses and drafting the article: 6 months. Total length: 24 months.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_country: Indonesia France

location_facility:
National Skin center - 1 Mandalay Rd
CHU de Nice

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Clinical Study of the TSP Crosser System For Transseptal Access and Left Atrial Catheter Navigation in Patients Undergoing Atrial Fibrillation Ablation

summary: The study is a prospective, multi-center, non-randomized single arm interventional investigation with the TSP Crosser Transseptal Access System, a new complete solution for transseptal puncture and left atrial access and catheter navigation, for patients with atrial fibrillation ablation referred for radiofrequency catheter ablation.

primary_purpose: Other

ipd_sharing: Undecided

lead_sponsor: Transseptal Solutions Ltd.

location_country: Germany France

location_facility:
CHU Bichat-Claude Bernard
Asklepios Klinik St. Georg

intervention_type: Device

lead_sponsor_type: industriel


title: Long Term Safety Follow up of Patients Enrolled in the Phase I/II Clinical Trial of Haematopoietic Stem Cell Gene Therapy for the Wiskott Aldrich Syndrome (GTG002-07 and GTG003-08).

acronym: WASFUP

summary: An open follow up study of patients enrolled in the Phase 1/2 clinical trial of haematopoietic stem cell gene therapy for the Wiskott-Aldrich Syndrome and treated with autologous CD34+ cells transduced with the w1.6_hWASP_WPRE (VSVg) lentiviral vector.

status: Active, not recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Genethon

location_country:
United Kingdom
France

location_facility:
UCL Institute of Child Health
Hopital Necker - Enfants Malades

intervention_type: Genetic

status_simplified: Ongoing


title: Prospective, Observational Study of Diagnostic Value of Lung Ultrasound for Ventilator-Associated Pneumonia

acronym: VPLUS

summary:
Ventilator-associated pneumonia (VAP) is the most common nosocomial infection acquired by mechanically-ventilated patients in the intensive care unit (ICU). It has significant clinical and economic consequences, as it is associated with considerable morbidity, increased mortality, and excess health care costs. Appropriate antibiotic therapy for patients with VAP significantly improves outcomes, making rapid identification of patients with VAP an important clinical goal.

This application is for support of a prospective, multi-centered study to evaluate the diagnostic value of lung ultrasound for VAP. The primary hypothesis is that the association of the Clinical Pulmonary Infection Score (CPIS) to specific lung ultrasound signs could allow for early and reliable diagnosis of bacterial VAP.

Objective 1: To evaluate the sensitivity, specificity, and diagnostic accuracy of lung ultrasound alone and in association with the CPIS.

Objective 2: To determine the frequency of specific lung ultrasound signs (subpleural consolidation, irregular B-lines) in VAP.

Objective 3: To promote development of a diagnostic pathway for VAP incorporating CPIS, lung ultrasound, and unprotected tracheal aspirate (UTA).

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Bouhemad B, Liu ZH, Arbelot C, Zhang M, Ferarri F, Le-Guen M, Girard M, Lu Q, Rouby JJ. Ultrasound assessment of antibiotic-induced pulmonary reaeration in ventilator-associated pneumonia. Crit Care Med. 2010 Jan;38(1):84-92. doi: 10.1097/CCM.0b013e3181b08cdb.

ReferenceCitation: Bouhemad B, Brisson H, Le-Guen M, Arbelot C, Lu Q, Rouby JJ. Bedside ultrasound assessment of positive end-expiratory pressure-induced lung recruitment. Am J Respir Crit Care Med. 2011 Feb 1;183(3):341-7. doi: 10.1164/rccm.201003-0369OC. Epub 2010 Sep 17.

ReferenceType: derived

ReferenceCitation: Wang G, Ji X, Xu Y, Xiang X. Lung ultrasound: a promising tool to monitor ventilator-associated pneumonia in critically ill patients. Crit Care. 2016 Oct 27;20(1):320. Review.

ReferenceCitation: Mongodi S, Via G, Girard M, Rouquette I, Misset B, Braschi A, Mojoli F, Bouhemad B. Lung Ultrasound for Early Diagnosis of Ventilator-Associated Pneumonia. Chest. 2016 Apr;149(4):969-80. doi: 10.1016/j.chest.2015.12.012. Epub 2015 Dec 22.

family: Mongodi

full_name: Silvia Mongodi

given: Silvia

sequence: first

family: Via

full_name: Gabriele Via

given: Gabriele

sequence: additional

family: Girard

full_name: Martin Girard

given: Martin

family: Rouquette

full_name: Isabelle Rouquette

given: Isabelle

family: Misset

full_name: Benoit Misset

given: Benoit

family: Braschi

full_name: Antonio Braschi

given: Antonio

family: Mojoli

full_name: Francesco Mojoli

given: Francesco

family: Bouhemad

full_name: Bélaïd Bouhemad

given: Bélaïd

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Chest

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

location_country: Italy France

location_facility: Rianimazione I, (Dipartement of Anesthesia and Intensive Care Unit) of Fondazione IRCCS Policlinico S. Matteo


summary: This study will evaluate the safety and efficacy of OPTIVE FUSION™ compared to VISMED® Multi for the management of dry eye.

ReferenceCitation: Labetoulle M, Chiambaretta F, Shirlaw A, Leaback R, Baudouin C. Osmoprotectants, carboxymethylcellulose and hyaluronic acid multi-ingredient eye drop: a randomised controlled trial in moderate to severe dry eye. Eye (Lond). 2017 Oct;31(10):1409-1416. doi: 10.1038/eye.2017.73. Epub 2017 Apr 28. Erratum in: Eye (Lond). 2017 Oct;31(10 ):1512.

lead_sponsor: Allergan

intervention_type: Drug


type: EudraCT Number

title: A Phase Ib Dose Escalation Study of Afatinib in Combination With Cetuximab in Patients With Advanced Solid Tumours

summary: The trial is divided in two parts, Part A and Part B. Part A will involve dose-finding of dose-limiting toxicity (DLT) and MTD in patients with advanced solid tumours. Part B will involve expansion of the MTD to 3 cohorts including non-small cell lung cancer squamous histology, recurrent/ metastatic squamous cell carcinoma of head and neck and other advanced solid tumours (except sarcomas).

ReferenceCitation: Gazzah A, Boni V, Soria JC, Calles A, Even C, Doger B, Mahjoubi L, Bahleda R, Ould-Kaci M, Esler A, Nazabadioko S, Calvo E. A phase 1b study of afatinib in combination with standard-dose cetuximab in patients with advanced solid tumours. Eur J Cancer. 2018 Nov;104:1-8. doi: 10.1016/j.ejca.2018.07.011. Epub 2018 Oct 1. Erratum in: Eur J Cancer. 2019 Sep;119:198.

family: Gazzah

full_name: Anas Gazzah

given: Anas

family: Boni

full_name: Valentina Boni

given: Valentina

family: Soria

full_name: Jean-Charles Soria

given: Jean-Charles

family: Calles

full_name: Antonio Calles

family: Even

full_name: Caroline Even

given: Caroline

family: Doger

full_name: Bernard Doger

given: Bernard

family: Mahjoubi

full_name: Linda Mahjoubi

given: Linda

family: Bahleda

full_name: Rastislav Bahleda

given: Rastislav

family: Ould-Kaci

full_name: Mahmoud Ould-Kaci

given: Mahmoud

family: Esler

full_name: Anne Esler

given: Anne

family: Nazabadioko

full_name: Serge Nazabadioko

given: Serge

family: Calvo

full_name: Emiliano Calvo

given: Emiliano

journal_name: European Journal of Cancer

lead_sponsor: Boehringer Ingelheim

location_country: France Spain

location_facility: 1200.122.34001 Boehringer Ingelheim Investigational Site

location_facility: 1200.122.33001 Boehringer Ingelheim Investigational Site


title: Randomised, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Prophylaxis Against Post-operative Nausea and Vomiting

summary: A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV.

primary_purpose: Prevention

lead_sponsor: Acacia Pharma Ltd

location_facility:
CHU de Hautepierre
University Hospitals of Würzburg


title: Investigation Into the Automated Drainage of Recurrent Effusions From the Pleural Space in Thoracic Malignancy.

acronym: ADEPT

summary: This is a research study examining the safety of a new, automated pump for the drainage of fluid in the chest cavity which is caused by cancer (also known as malignant pleural effusion, or MPE). The purpose of the trial is to assess whether the new pleurapump device is safe and effective in the management of patients with MPE. The study will try to identify what kind of problems may arise from using the device, how often they happen, and how severe they are if they occur.

status: Terminated

lead_sponsor: Sequana Medical N.V.

location_facility: Dept. of Respiratory Medicine, Southmead Hospital

location_facility: Oncologie Thoracique - Maladies de la Plèvre - Pneumologie Interventionnelle, Hôpital Nord

status_simplified: Unknown


title: A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention

acronym: WoundWand

lead_sponsor: Smith & Nephew, Inc.

location_facility:
Manchester Diabetes Centre
Hopital Lapeyronie


title: Impact of an Intervention Using a Web-based Tool to Improve the Reporting of Randomized Controlled Trials

acronym: WebCONSORT

summary: The CONSORT (Consolidated Standards of Reporting Trials) Statement aims to improve the reporting of randomized trials. If trials are not well reported it is difficult for clinicians to use best evidence to inform clinical practice and patients may not get the best care. A number of different CONSORT extensions have been developed which specify additional information needed for more complex trials. The aim of this project is to evaluate whether using a simple web-based tool (WEBCONSORT) improves the reporting of clinical trials. The tool combines different CONSORT extensions and allows authors to obtain a checklist and flow diagram which is specific to their individual trial. In this study authors of participating journals are requested, at the manuscript revision stage, to use a web-based tool to improve the reporting of their randomized trial. Authors registering to use the tool are randomized to intervention or control. In the intervention group authors are directed to the WebCONSORT tool. In the control group, authors are directed to a different version of the WebCONSORT tool which includes the flow diagram part of the tool but not the main checklist or elements relating to CONSORT extensions. The aim is that this tool should lead to improvements in the reporting of randomized trials, making it easier for clinicians to read and interpret published findings.

ReferenceCitation: Hopewell S, Boutron I, Altman DG, Barbour G, Moher D, Montori V, Schriger D, Cook J, Gerry S, Omar O, Dutton P, Roberts C, Frangou E, Clifton L, Chiocchia V, Rombach I, Wartolowska K, Ravaud P. Impact of a web-based tool (WebCONSORT) to improve the reporting of randomised trials: results of a randomised controlled trial. BMC Med. 2016 Nov 28;14(1):199.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
University of Oxford
Université Paris Descartes


title: Non Inferiority Randomized Trial of Standard Radiotherapy Versus Hypofractionated Split Course Radiotherapy in Elderly Vulnerable Patients With Inoperable Head and Neck Squamous Cell Carcinoma

acronym: ELAN-RT

summary: Randomized comparison between standard radiotherapy and hypofractionated split course schedule. Compared to standard radiotherapy, the investigators expect that hypofractionated split course (interruption of 2 weeks) radiotherapy will improve compliance to treatment, acute tolerance of treatment, preservation of autonomy, prevention of malnutrition, with the same efficacy, measured by the locoregional control rate.

ipd_sharing: Yes

ipd_sharing_description: Data Monitoring Committee will meet every year either by a physical meeting or by conference call. Data on the recruitment, toxicity and autonomy are submitted every year.

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou

location_country: Monaco France

location_facility:
Centre Hospitalier Princesse Grace
Institut Gustave Roussy

intervention_type: Radiation


title: Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on Cognition and Brain Networks in Healthy Subjects in 2 Sessions 15 Days Apart

summary:
Episodic and working memory processes are the most affected cognitive domains in Alzheimer's Disease (AD) and its early stage, Mild Cognitive Impairment (MCI).

Transcranial Magnetic Stimulation (TMS) is a unique tool to interfere with cognitive processes by inducing "virtual and transient lesions", mimicking those observed in MCI. It has proven repeatedly its capacity to interfere with encoding-retrieval memory task. However, to date, only few imaging data exist on the cerebral pathways involved in encoding memory task. Moreover, the stability of TMS effects over time remains to be investigated. If proven to be a stable interfering challenge, TMS could be used to investigate the potential restoring effect of new medication in AD.

The study is the pilot study of a larger clinical trial which aims to prove the utility of rTMS as a potential model for prediction of clinical efficacy using a combination of cognitive and neuroimaging endpoints.

lead_sponsor: Qualissima

location_facility: IDIBAPS Cic-Cpcet


title: A Multicentre, Open-label Study to Determine the Long Term Safety, Tolerability and Efficacy of ProSavin in Patients With Bilateral, Idiopathic Parkinson's Disease.

summary: The study is designed to assess the long term tolerability of ProSavin and whether it is safe and efficacious in patients administered ProSavin from the PS1/001/07 study .

ReferenceCitation: Palfi S, Gurruchaga JM, Ralph GS, Lepetit H, Lavisse S, Buttery PC, Watts C, Miskin J, Kelleher M, Deeley S, Iwamuro H, Lefaucheur JP, Thiriez C, Fenelon G, Lucas C, Brugières P, Gabriel I, Abhay K, Drouot X, Tani N, Kas A, Ghaleh B, Le Corvoisier P, Dolphin P, Breen DP, Mason S, Guzman NV, Mazarakis ND, Radcliffe PA, Harrop R, Kingsman SM, Rascol O, Naylor S, Barker RA, Hantraye P, Remy P, Cesaro P, Mitrophanous KA. Long-term safety and tolerability of ProSavin, a lentiviral vector-based gene therapy for Parkinson's disease: a dose escalation, open-label, phase 1/2 trial. Lancet. 2014 Mar 29;383(9923):1138-46. doi: 10.1016/S0140-6736(13)61939-X. Epub 2014 Jan 10.

family: Palfi

full_name: Stéphane Palfi

given: Stéphane

family: Gurruchaga

full_name: Jean Marc Gurruchaga

given: Jean Marc

family: Ralph

full_name: G Scott Ralph

given: G Scott

family: Lepetit

full_name: Helene Lepetit

given: Helene

family: Lavisse

full_name: Sonia Lavisse

given: Sonia

family: Buttery

full_name: Philip C Buttery

given: Philip C

family: Watts

full_name: Colin Watts

given: Colin

family: Miskin

full_name: James Miskin

given: James

family: Kelleher

full_name: Michelle Kelleher

given: Michelle

family: Deeley

full_name: Sarah Deeley

given: Sarah

family: Iwamuro

full_name: Hirokazu Iwamuro

given: Hirokazu

family: Lefaucheur

full_name: Jean Pascal Lefaucheur

given: Jean Pascal

family: Thiriez

full_name: Claire Thiriez

given: Claire

family: Fenelon

full_name: Gilles Fenelon

given: Gilles

family: Lucas

full_name: Cherry Lucas

given: Cherry

family: Brugières

full_name: Pierre Brugières

given: Pierre

family: Gabriel

full_name: Inanna Gabriel

given: Inanna

family: Abhay

full_name: Kou Abhay

given: Kou

family: Drouot

full_name: Xavier Drouot

given: Xavier

family: Tani

full_name: Naoki Tani

given: Naoki

family: Kas

full_name: Aurelie Kas

given: Aurelie

family: Ghaleh

full_name: Bijan Ghaleh

given: Bijan

family: Le Corvoisier

full_name: Philippe Le Corvoisier

given: Philippe

family: Dolphin

location_facility:
Addenbrookes Hospital
Henri Mondor Hospital


type: Other Identifier

title: S4 :RANDOMIZED CONTROLLED TRIAL OF FULLY CLOSED-LOOP VENTILATION IN ICU.

summary: Preliminary study to compare IntelliVent-ASV to conventional modes used from intubation to extubation or death in ICU patients requiring mechanical ventilation measuring duration of mechanical ventilation in order to design a multicenter large trial.

primary_purpose: Supportive Care

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Anestesia e Rianimazione 2, Fondazione IRCCS Policlinico S. Matteo


title: A Phase I Dose Finding Study of XRP6258 Administered as a Weekly 1-hour Intravenous Infusion to Patients With Advanced Solid Tumors

summary:
Primary Objective:

- To determine the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) of XRP6258 when given as a weekly 1-hour intravenous (i.v.) infusion for the first 4 consecutive weeks of each 5-week treatment cycle (Day 1, Day 8, Day 15, Day 22 of each 5-week treatment cycle).

Secondary Objectives :

To define the safety profile of the drug
To establish the recommended dose and time interval for future Phase II trials
To determine the pharmacokinetic (PK) profile of XRP6258 in man
To assess the absolute oral bioavailability of XRP6258 at the i.v. recommended dose (following Protocol Amendment No. 2)
To look for evidence of antitumor activity

design_allocation: Non-Randomized

ReferenceCitation: Fumoleau P, Trigo JM, Isambert N, Sémiond D, Gupta S, Campone M. Phase I dose-finding study of cabazitaxel administered weekly in patients with advanced solid tumours. BMC Cancer. 2013 Oct 7;13:460. doi: 10.1186/1471-2407-13-460.

family: Fumoleau

full_name: Pierre Fumoleau

family: Trigo

full_name: Jose Manuel Trigo

given: Jose Manuel

family: Isambert

full_name: Nicolas Isambert

given: Nicolas

family: Sémiond

full_name: Dorothée Sémiond

given: Dorothée

family: Gupta

full_name: Sunil Gupta

given: Sunil

family: Campone

full_name: Mario Campone

given: Mario

currency_apc_doaj: GBP

journal_name: BMC Cancer

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

lead_sponsor: Sanofi


title: An Open Non Comparative Multicenter Prospective Study to Evaluate Efficacy and Safety of Macrolane VRF20 in Treatment of Pectus Excavatum

summary:
This is a prospective, open, non-comparative and baseline-controlled study to evaluate efficacy and safety of Macrolane VRF20 treatment in 40 subjects with pectus excavatum deformity.

Each subject participating in the study will be treated with approximately 50-150 ml of Macrolane VRF20. The amount of study product used will be individually determined in order to achieve an optimal correction of the deformity in each subject.

lead_sponsor: Q-Med AB

location_country: Sweden France

location_facility:
Raphael Sinna
Per Heden


title: An Open-Label, Pharmacokinetic and Tolerability Study of SAR236553/REGN727 Given as a Single SC Dose in Subjects With Mild and Moderate Hepatic Impairment, and in Matched Subjects With Normal Hepatic Function

summary:
Primary Objective:

Study the effect of mild or moderate hepatic impairment on the pharmacokinetics of alirocumab SAR236553 (REGN727).

Secondary Objectives:

Assess the safety and tolerability of alirocumab SAR236553 (REGN727) in patients with mild and moderate hepatic impairment and in matched subjects with normal hepatic function.
Assess the pharmacodynamic profile of alirocumab SAR236553 (REGN727) in patients with hepatic impairment and in matched subjects with normal hepatic function.

primary_purpose: Basic Science

location_country:
Moldova, Republic of
France

location_facility:
Investigational Site Number 250001
Investigational Site Number 498001


title: A Phase I, Prospective, Bi-centric,Single -Arm, Open-label, Dose-escalating Clinical Trial to Evaluate the Safety of a Single Injection of Autologous Adipose Derived Mesenchymal Stromal Cells in the Treatment of Severe Osteoarthritis of the Knee Joint

summary:
Primary:

To study the safety of a single injection of autologous adipose derived mesenchymal stromal cells (ASCs) on patients with moderate or severe osteoarthritis of the knee (OA).

Secondary:

To study the efficacy of a single injection of autologous adipose derived mesenchymal stromal cells on patients with moderate or severe osteoarthritis of the knee (OA).

ReferenceCitation: Pers YM, Rackwitz L, Ferreira R, Pullig O, Delfour C, Barry F, Sensebe L, Casteilla L, Fleury S, Bourin P, Noël D, Canovas F, Cyteval C, Lisignoli G, Schrauth J, Haddad D, Domergue S, Noeth U, Jorgensen C; ADIPOA Consortium. Adipose Mesenchymal Stromal Cell-Based Therapy for Severe Osteoarthritis of the Knee: A Phase I Dose-Escalation Trial. Stem Cells Transl Med. 2016 Jul;5(7):847-56. doi: 10.5966/sctm.2015-0245. Epub 2016 May 23.

family: Pers

full_name: Yves-Marie Pers

given: Yves-Marie

family: Rackwitz

full_name: Lars Rackwitz

given: Lars

family: Ferreira

full_name: Rosanna Ferreira

given: Rosanna

family: Pullig

full_name: Oliver Pullig

given: Oliver

family: Delfour

full_name: Christophe Delfour

given: Christophe

family: Barry

full_name: Frank Barry

given: Frank

family: Sensebe

full_name: Luc Sensebe

given: Luc

family: Casteilla

full_name: Louis Casteilla

given: Louis

family: Fleury

full_name: Sandrine Fleury

given: Sandrine

family: Bourin

full_name: Philippe Bourin

family: Noël

full_name: Danièle Noël

given: Danièle

family: Canovas

full_name: François Canovas

given: François

family: Cyteval

full_name: Catherine Cyteval

given: Catherine

family: Lisignoli

full_name: Gina Lisignoli

given: Gina

family: Schrauth

full_name: Joachim Schrauth

given: Joachim

family: Haddad

full_name: Daniel Haddad

given: Daniel

family: Domergue

full_name: Sophie Domergue

given: Sophie

family: Noeth

full_name: Ulrich Noeth

given: Ulrich

family: Jorgensen

full_name: Christian Jorgensen

given: Christian

currency_apc_doaj: USD

journal_name: STEM CELLS Translational Medicine

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENSM-SE


summary: The purpose of this study is evaluate lip fullness 3 months following treatment with Juvéderm® Volbella with Lidocaine or Restylane-L®

ReferenceCitation: Raspaldo H, Chantrey J, Belhaouari L, Saleh R, Murphy DK. Juvéderm volbella with lidocaine for lip and perioral enhancement: a prospective, randomized, controlled trial. Plast Reconstr Surg Glob Open. 2015 Apr 7;3(3):e321. doi: 10.1097/GOX.0000000000000266. eCollection 2015 Mar.

lead_sponsor: Allergan Medical


title: A Validation Study of the OPTIMS Pharmacokinetic Calculator for Clinician Use in Prophylactic Treatment of Patients With Haemophilia A.

acronym: OPTIMS

summary:
OPTIMS is a non interventional validation study of the calculator developed by Bayer for clinician's use in the prophylactic treatment by factor VIII of patients with severe or moderate Haemophilia A with a severe clinical profile.

The study takes place during a single visit, at the time of patient enrollment in the study

lead_sponsor: Bayer


title: Study of Clinical and Radiological Changes in Patients With Duchenne Muscular Dystrophy Theoretically Treatable With Exon 53 Skipping

acronym: pre U7-53

summary: PreU7-53 is a natural history study. The objective is to monitor the clinical and radiological course of upper limb muscle impairment in patients with Duchenne Muscular Dystrophy (DMD), potentially treatable with AAV-mediated exon 53 skipping.

status: Unknown status

location_facility: Great ormond Street Hospital & University College London Hospital


title: InterSEPT: In-Tunnel SeptRx European PFO Trial: A Prospective, Multi-Center Study to Evaluate the Safety and Performance of the SeptRx IPO PFO Closure System

acronym: InterSEPT

summary: The objective of this study is to determine the safety, performance, and effectiveness of the SeptRx IPO PFO Closure System in the treatment of Patent Foramen Ovale (PFO) in patients who are amenable to percutaneous closure of their PFO defects.

ReferenceCitation: Zimmermann WJ, Heinisch C, Majunke N, Staubach S, Russell S, Wunderlich N, Sievert H. Patent foramen ovale closure with the SeptRx device initial experience with the first "In-Tunnel" device. JACC Cardiovasc Interv. 2010 Sep;3(9):963-7. doi: 10.1016/j.jcin.2010.04.019.

lead_sponsor: SeptRx, Inc.

location_facility:
ICPS: Institut Jacques Cartier
CardioVasculäres Centrum Frankfurt


ReferenceCitation: GSK has concluded that it is not feasible to publish this study in a peer-reviewed scientific journal because the nature of the study is unlikely to be of interest to a journal. GSK is providing the attached study results summary with a conclusion.

intervention_type: Biological

lead_sponsor: GlaxoSmithKline

ipd_sharing: No

source: euctr

title: Evaluation of the Safety and Tolerability of Re-dosing With Intravenous (iv) Otelixizumab in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus

summary: The purpose of this study to assess the safety and tolerability of re-dosing at 6 months with otelixizumab (given as an 8-day series of intravenous infusions) in adult subjects with newly diagnosed type 1 diabetes mellitus


title: Prospective Comparison of Capsule Endoscopy Pillcam II™ Versus Colonoscopy for the Detection of Adenomatous Polyps and Cancer in a High Risk Population

summary: The aim of the study is to perform a prospective, multicenter research comparing capsule endoscopy with the video colonoscopy in the detection of the adenomatous polyps and cancer specifically in a high risk population (sensibility, specificity, NPV, PPV and diagnostic accuracy). The investigators will used the Pillcam II™ colon capsule (second generation) and a high resolution colonoscope (with high definition). Both procedures will be perform in the same day with an adapted bowel preparation.

primary_purpose: Diagnostic

ReferenceCitation: Parodi A, Vanbiervliet G, Hassan C, Hebuterne X, De Ceglie A, Filiberti RA, Spada C, Conio M. Colon capsule endoscopy to screen for colorectal neoplasia in those with family histories of colorectal cancer. Gastrointest Endosc. 2018 Mar;87(3):695-704. doi: 10.1016/j.gie.2017.05.023. Epub 2017 May 26.

family: Parodi

full_name: Andrea Parodi

given: Andrea

family: Vanbiervliet

full_name: Geoffroy Vanbiervliet

given: Geoffroy

family: Hassan

full_name: Cesare Hassan

given: Cesare

family: Hebuterne

full_name: Xavier Hebuterne

given: Xavier

family: De Ceglie

full_name: Antonella De Ceglie

given: Antonella

family: Filiberti

full_name: Rosa Angela Filiberti

given: Rosa Angela

family: Spada

full_name: Cristano Spada

given: Cristano

family: Conio

full_name: Massimo Conio

given: Massimo

journal_name: Gastrointestinal Endoscopy

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Gastro entérology department
Digestive department - Archet hospital


title: Randomised Controlled Open-label Study to Evaluate Efficacy & Safety of Intravenous Ferric Carboxymaltose Versus no Treatment in Anaemic Subjects With Multiple Myeloma & Iron Restricted Erythropoiesis Receiving Chemotherapy

acronym: AOC-MM

summary: Anaemia and functional iron deficiency are common conditions in Multiple Myeloma (MM) patients, conditions which reduce significantly the quality of life and increase morbidity and mortality. Traditionally, Erythropoiesis Stimulating Agents (ESAs) have been used, but recently their use has been shown to have a negative impact on overall survival in different oncology populations. Recently published data suggest that intravenous (IV) iron can be effective in anaemia treatment, even without ESAs. This exploratory study is the first clinical project with ferric carboxymaltose (FCM) in patients with MM: the data generated may be used for further evaluations of the drug in larger populations. In this study, 1,000 mg of IV iron as FCM will be administered on the same day or within 24 hours before or after chemotherapy treatment. The primary objective is to evaluate the efficacy of FCM given without ESA, in the correction of haemoglobin levels in subjects with MM, undergoing chemotherapy. Secondary objectives aim to describe the safety and tolerability of FCM, and the effect of FCM treatment on iron status variables in MM subjects.

lead_sponsor: Vifor Pharma

location_country: France Greece

location_facility:
Theagenion Cancer Center
Hopital Sud


title: Prospective Study of Heart Failure With Preserved Left Ventricular Ejection Fraction: Prevalence, Characterisation and Prognostic Significance of Cardiac Desynchrony

acronym: KaRen

summary: The purpose of this study is to examine electrical and echocardiographic characteristics and prognosis of consecutive patients admitted with acute heart failure and diagnosed to have heart failure with preserved ejection fraction (HFPEF).

ReferenceType: result

ReferenceCitation: Donal E, Lund LH, Linde C, Edner M, Lafitte S, Persson H, Bauer F, Ohrvik J, Ennezat PV, Hage C, Löfman I, Juilliere Y, Logeart D, Derumeaux G, Gueret P, Daubert JC. Rationale and design of the Karolinska-Rennes (KaRen) prospective study of dyssynchrony in heart failure with preserved ejection fraction. Eur J Heart Fail. 2009 Feb;11(2):198-204. doi: 10.1093/eurjhf/hfn025.

name: Cardiology, CHU Pontchaillou; 35033 Rennes France

family: Donal

full_name: Erwan Donal

given: Erwan

name: Cardiology, Karolinska University Hospital; Stockholm Sweden

family: Lund

full_name: Lars H. Lund

given: Lars H.

family: Linde

full_name: Cecilia Linde

given: Cecilia

name: Cardiology, Danderyd University Hospital; Stockholm Sweden

family: Edner

full_name: Magnus Edner

given: Magnus

name: Cardiology, Haut-Lévêque University Hospital; Pessac France

family: Lafitte

full_name: Stéphane Lafitte

given: Stéphane

family: Persson

full_name: Hans Persson

given: Hans

name: Cardiology, Charles Nicolle University Hospital; Rouen France

family: Bauer

full_name: Fabrice Bauer

given: Fabrice

family: Öhrvik

full_name: John Öhrvik

given: John

name: Cardiology, Hôpital Cardiologique; CHU Lille France

family: Ennezat

full_name: Pierre-Vladimir Ennezat

given: Pierre-Vladimir

family: Hage

full_name: Camilla Hage

given: Camilla

family: Löfman

full_name: Ida Löfman

given: Ida

family: Juilliere

full_name: Yves Juilliere

given: Yves

name: Cardiology, Hôpital Lariboisière; Paris France

family: Logeart

full_name: Damien Logeart

given: Damien

name: Cardiology, Hôpital Louis Pradel; Lyon France

family: Derumeaux

full_name: Geneviève Derumeaux

given: Geneviève

name: Cardiology, CHU Henri-Mondor; Créteil France

family: Gueret

full_name: Pascal Gueret

given: Pascal

family: Daubert

full_name: Jean-Claude Daubert

given: Jean-Claude

journal_name: European Journal of Heart Failure

oa_colors: green hybrid

evidence: open (via free pdf)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Donal E, Lund L, Linde C, Daubert JC; KaRen investigators. Is cardiac resynchronization therapy an option in heart failure patients with preserved ejection fraction? Justification for the ongoing KaRen project. Arch Cardiovasc Dis. 2010 Jun-Jul;103(6-7):404-10. doi: 10.1016/j.acvd.2010.01.009. Epub 2010 Jun 23. Review.

ReferenceCitation: Donal E, Lund LH, Oger E, Hage C, Persson H, Reynaud A, Ennezat PV, Bauer F, Sportouch-Dukhan C, Drouet E, Daubert JC, Linde C; KaRen Investigators. Baseline characteristics of patients with heart failure and preserved ejection fraction included in the Karolinska Rennes (KaRen) study. Arch Cardiovasc Dis. 2014 Feb;107(2):112-21. doi: 10.1016/j.acvd.2013.11.002. Epub 2013 Dec 30.

ReferenceCitation: Lund LH, Donal E, Oger E, Hage C, Persson H, Haugen-Löfman I, Ennezat PV, Sportouch-Dukhan C, Drouet E, Daubert JC, Linde C; KaRen Investigators. Association between cardiovascular vs. non-cardiovascular co-morbidities and outcomes in heart failure with preserved ejection fraction. Eur J Heart Fail. 2014 Sep;16(9):992-1001. doi: 10.1002/ejhf.137. Epub 2014 Jul 21.

name: Karolinska Institutet; Department of Medicine; Stockholm Sweden

name: Karolinska University Hospital; Department of Cardiology; Stockholm Sweden

name: Département de Cardiologie & CIC-IT U 804; Centre Hospitalier Universitaire de Rennes; France

name: LTSI; Université Rennes 1, INSERM 1099 Rennes France

name: INSERM; Clinical Investigation Center CIC-1414 Rennes France

name: Karolinska Institutet; Department of Clinical Sciences Danderyd; Stockholm Sweden

name: Danderyd Hospital; Department of Cardiology; Stockholm Sweden

name: Service de Cardiologie; CHU Lille; France

name: Département de Cardiologie; CHU Montpellier; France

name: Société Française de Cardiologie; Paris France

ReferenceCitation: Donal E, Lund LH, Oger E, Hage C, Persson H, Reynaud A, Ennezat PV, Bauer F, Drouet E, Linde C, Daubert C; KaRen investigators. New echocardiographic predictors of clinical outcome in patients presenting with heart failure and a preserved left ventricular ejection fraction: a subanalysis of the Ka (Karolinska) Ren (Rennes) Study. Eur J Heart Fail. 2015 Jul;17(7):680-8. doi: 10.1002/ejhf.291. Epub 2015 May 29.

name: Cardiology department & CIC-IT U 804, Hôpital Pontchaillou-CHU Rennes; Rennes University Health Centre, rue Henri Le Guillou; 35000 Rennes France

name: LTSI, Rennes 1 University; INSERM 1099 Rennes France

name: Department of Medicine, Karolinska Institutet and Department of Cardiology; Karolinska University Hospital; Stockholm Sweden

name: Clinical Investigation Center INSERM CIC-1414; CHU Rennes France

name: Karolinska Institutet, Department of Clinical Sciences; Danderyd Hospital; Stockholm Sweden

name: Cardiology Department; Lille University Health Centre; Lille France

name: Cardiology Department; Rouen University Health Centre; Rouen France

name: French Society of Cardiology; Paris France

ReferenceCitation: Donal E, Lund LH, Oger E, Reynaud A, Schnell F, Persson H, Drouet E, Linde C, Daubert C; KaRen investigators. Value of exercise echocardiography in heart failure with preserved ejection fraction: a substudy from the KaRen study. Eur Heart J Cardiovasc Imaging. 2016 Jan;17(1):106-13. doi: 10.1093/ehjci/jev144. Epub 2015 Jun 16.

journal_name: European Heart Journal – Cardiovascular Imaging

ReferenceCitation: Hage C, Lund LH, Donal E, Daubert JC, Linde C, Mellbin L. Copeptin in patients with heart failure and preserved ejection fraction: a report from the prospective KaRen-study. Open Heart. 2015 Nov 3;2(1):e000260. doi: 10.1136/openhrt-2015-000260. eCollection 2015.

ReferenceCitation: Savarese G, Donal E, Hage C, Oger E, Persson H, Daubert JC, Linde C, Lund LH; KaRen investigators. Changes in natriuretic peptides after acute hospital presentation for heart failure with preserved ejection fraction: A feasible surrogate trial endpoint? A report from the prospective Karen study. Int J Cardiol. 2017 Jan 1;226:65-70. doi: 10.1016/j.ijcard.2016.10.035. Epub 2016 Oct 17. Erratum in: Int J Cardiol. 2018 Mar 27;:.

ReferenceCitation: Bosseau C, Donal E, Lund LH, Oger E, Hage C, Mulak G, Daubert JC, Linde C; KaRen investigators. The prognostic significance of atrial fibrillation in heart failure with preserved ejection function: insights from KaRen, a prospective and multicenter study. Heart Vessels. 2017 Jun;32(6):735-749. doi: 10.1007/s00380-016-0933-8. Epub 2016 Dec 27.

ReferenceCitation: Hage C, Michaëlsson E, Linde C, Donal E, Daubert JC, Gan LM, Lund LH. Inflammatory Biomarkers Predict Heart Failure Severity and Prognosis in Patients With Heart Failure With Preserved Ejection Fraction: A Holistic Proteomic Approach. Circ Cardiovasc Genet. 2017 Feb;10(1). pii: e001633. doi: 10.1161/CIRCGENETICS.116.001633.

name: From the Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden (C.H., C.L., L.H.L.); Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden (C.H., C.L., L.H.L.); Cardiovascular and Metabolic Diseases, Innovative Medicines and Early Development Biotech Unit, AstraZeneca R&D, Mölndal, Sweden (E.M., L.-M.G.); Département de Cardiologie and CIC-IT U 804, Centre Hospitalier Universitaire de Rennes, France (E.D., J.-C.D.); and Department of Molecular and Clinical...

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Donal E, Lund LH, Oger E, Bosseau C, Reynaud A, Hage C, Drouet E, Daubert JC, Linde C; KaRen Investigators. Importance of combined left atrial size and estimated pulmonary pressure for clinical outcome in patients presenting with heart failure with preserved ejection fraction. Eur Heart J Cardiovasc Imaging. 2017 Jun 1;18(6):629-635. doi: 10.1093/ehjci/jex005.

name: Cardiologie, CHU Rennes, 35000 RENNES, France

name: CIC-IT 1414, Université Rennes-1, 35000 Rennes, France

name: Department of Medicine, Karolinska Institutet and Department of Cardiology, Karolinska University Hospital, 171 77 Stockholm, Sweden

name: Pharmacologie Clinique et CIC-IP 1414, CHU Rennes et Université Rennes-1

name: Cellule Registres, Société Française de Cardiologie et URC Paris Est., 75012 Paris, France

journal_name: European Heart Journal - Cardiovascular Imaging

ReferenceCitation: Nagy AI, Hage C, Merkely B, Donal E, Daubert JC, Linde C, Lund LH, Manouras A. Left atrial rather than left ventricular impaired mechanics are associated with the pro-fibrotic ST2 marker and outcomes in heart failure with preserved ejection fraction. J Intern Med. 2018 Apr;283(4):380-391. doi: 10.1111/joim.12723. Epub 2018 Feb 12.

name: Heart and Vascular Center; Semmelweis University; Budapest Hungary

name: Theme of Heart and Vessels; Karolinska University Hospital; Stockholm Sweden

name: Institution for Medicine; Karolinska Institutet; Stockholm Sweden

name: Département de Cardiologie & CIC-IT U 804; Centre Hospitalier Universitaire de Rennes; Rennes France

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

repository_institution: Library of the Hungarian Academy of Sciences - Repository of the Academy's Library

repository_institution: Semmelweis University - Semmelweis University Repository

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repositories_institution: Semmelweis University - Semmelweis University Repository

ReferenceCitation: Savarese G, Donal E, Hage C, Oger E, Persson H, Daubert JC, Linde C, Lund LH; KaRen investigators. Corrigendum to "Changes in natriuretic peptides after acute hospital presentation for heart failure with preserved ejection fraction: A feasible surrogate trial endpoint? A report from the prospective Karen study" [Int. J. Cardiol. 226 (2017) 65-70]. Int J Cardiol. 2018 Jun 15;261:240. doi: 10.1016/j.ijcard.2018.03.075. Epub 2018 Mar 27.

title: Corrigendum to “Changes in natriuretic peptides after acute hospital presentation for heart failure with preserved ejection fraction: A feasible surrogate trial endpoint? A report from the prospective Karen study” [Int. J. Cardiol. 226 (2017) 65–70]

ReferenceCitation: Faxén UL, Hage C, Donal E, Daubert JC, Linde C, Lund LH. Patient reported outcome in HFpEF: Sex-specific differences in quality of life and association with outcome. Int J Cardiol. 2018 Sep 15;267:128-132. doi: 10.1016/j.ijcard.2018.04.102.

ReferenceCitation: Persson H, Donal E, Lund LH, Matan D, Oger E, Hage C, Daubert JC, Linde C; KaRen Investigators. Importance of structural heart disease and diastolic dysfunction in heart failure with preserved ejection fraction assessed according to the ESC guidelines - A substudy in the Ka (Karolinska) Ren (Rennes) study. Int J Cardiol. 2019 Jan 1;274:202-207. doi: 10.1016/j.ijcard.2018.06.078. Epub 2018 Jun 20.

ReferenceCitation: Löfström U, Hage C, Savarese G, Donal E, Daubert JC, Lund LH, Linde C. Prognostic impact of Framingham heart failure criteria in heart failure with preserved ejection fraction. ESC Heart Fail. 2019 Aug;6(4):830-839. doi: 10.1002/ehf2.12458. Epub 2019 Jun 17.

name: Department of CardiologyCapio St. Göran's Hospital 112 81 Stockholm Sweden

name: Department of MedicineKarolinska Institutet Stockholm Sweden

name: Département de Cardiologie and CIC‐IT U 804Centre Hospitalier Universitaire de Rennes Rennes France

name: Faculté de MédecineUniversity of Rennes 1 Rennes France

name: Heart and Vascular ThemeKarolinska University Hospital Stockholm Sweden

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

ReferenceCitation: Najjar E, Faxén UL, Hage C, Donal E, Daubert JC, Linde C, Lund LH. ST2 in heart failure with preserved and reduced ejection fraction. Scand Cardiovasc J. 2019 Feb;53(1):21-27. doi: 10.1080/14017431.2019.1583363. Epub 2019 Mar 8.

name: Department of Medicine, Karolinska Institutet, Stockholm, Sweden;

name: Heart and Vascular Theme, Karolinska University Hospital, Stockholm, Sweden;

name: Perioperative Medicine and Intensive Care Function, Karolinska University Hospital, Stockholm, Sweden;

name: Département de Cardiologie & CIC-IT U 804, Centre Hospitalier Universitaire de Rennes, France

title: ST2 in heart failure with preserved and reduced ejection fraction

ReferenceCitation: Donal E, Thebault C, Lund LH, Kervio G, Reynaud A, Simon T, Drouet E, Nonotte E, Linde C, Daubert JC. Heart failure with a preserved ejection fraction additive value of an exercise stress echocardiography. Eur Heart J Cardiovasc Imaging. 2012 Aug;13(8):656-65. doi: 10.1093/ehjci/jes010. Epub 2012 Jan 29.

location_facility:
Pontchaillou Hospital
Karolinska University Hospital


title: A Registry Study to Determine Utilisation Patterns in Patients Receiving Angiox®, and Collect Descriptive Safety and Outcome Data to Inform the Risk Management Strategy for Europe.

acronym: EURO-vision

summary: The objective of this study is to determine utilisation patterns in patients receiving Angiox® in participating European centres. Additionally, through the collection of descriptive safety and outcomes data, this study will contribute to the Risk Management strategy for Europe

lead_sponsor: The Medicines Company

location_facility: Medizinische Klinik I Kardiologie/Pneumologie/Internistische

location_facility: Centre Hospitalier Universitaire de Caen


title: Intra-ductal Confocal Endomicroscopy for Characterization of Pancreas and Bile Duct Tumor

acronym: EMID

summary: The endomicroscopy is an adaptation of traditional optical microscopy in the digestive endoscopy. Furthermore, with the integration of a miniaturized laser confocal microscope to a videoendoscope, it's possible to study the digestive mucous by "optical biopsy". This monocentric, non randomized and prospective study uses the Intra-ductal confocal endomicroscopy for the characterization of pancreas and bile duct tumor.

lead_sponsor: Institut Paoli-Calmettes

location_facility:
Centre Hospitalier Princesse Grasse
Institut PAOLI-CALMETTES

intervention_type: Procedure


title: A Multicenter, Open Label Study To Investigate The Feasibility And Efficacy Of A Smoking Cessation Program With Varenicline In Patients Undergoing Elective Surgery

summary: It is possible to offer smoking cessation treatment including varenicline to patients scheduled for elective surgery. This study will evaluate whether or not this will enable some patients to quit smoking for up to 4 weeks prior to surgery and in turn, whether this may lead to reductions in post-operative complication such as wound infections.

lead_sponsor: Pfizer


title: Anodal & Cathodal tDCS for Treatment of Resistant Auditory Hallucinations in Schizophrenia

summary: The purpose of this study is to determine whether trans Direct Current Stimulation (tDCS) is effective in the treatment of auditory hallucinations in schizophrenia.

ReferenceCitation: Brunelin J, Mondino M, Gassab L, Haesebaert F, Gaha L, Suaud-Chagny MF, Saoud M, Mechri A, Poulet E. Examining transcranial direct-current stimulation (tDCS) as a treatment for hallucinations in schizophrenia. Am J Psychiatry. 2012 Jul;169(7):719-24. doi: 10.1176/appi.ajp.2012.11071091. Erratum in: Am J Psychiatry. 2012 Dec 1;169(12):1321.

family: Brunelin

full_name: Jerome Brunelin

given: Jerome

family: Mondino

full_name: Marine Mondino

given: Marine

family: Gassab

full_name: Leila Gassab

given: Leila

family: Haesebaert

full_name: Frederic Haesebaert

given: Frederic

family: Gaha

full_name: Lofti Gaha

given: Lofti

family: Suaud-Chagny

full_name: Marie-Françoise Suaud-Chagny

given: Marie-Françoise

family: Saoud

full_name: Mohamed Saoud

given: Mohamed

family: Mechri

full_name: Anwar Mechri

given: Anwar

family: Poulet

full_name: Emmanuel Poulet

given: Emmanuel

journal_name: American Journal of Psychiatry

publisher: American Psychiatric Association Publishing

title: Examining Transcranial Direct-Current Stimulation (tDCS) as a Treatment for Hallucinations in Schizophrenia

lead_sponsor: Hôpital le Vinatier

location_country: Tunisia France

location_facility: Laboratoire de Recherche " Vulnérabilité Aux Psychoses "


title: Effect of Dietary Supplementation With Fructo-oligosaccharides on Visceral Sensitivity and on Taxonomic and Functional Composition of Intestinal Microbiota of IBS Patients

summary: Fructo-oligosaccharides are known as prebiotic ingredients to modulate the composition of the intestinal microbiota and particularly to stimulate the growth of Bifidobacteria. Imbalance of the intestinal microbiota such as reduction of Bifidobacteria is implicated in Irritable Bowel Syndrome (IBS). Thus the objective of the study is to evaluate the effect of fructo-oligosaccharides to improve IBS score and to explore which modifications of the microbiota are responsible of this improvement.

lead_sponsor: Beghin-Meiji

location_facility:
Vall Hebron Hospital
CHU Clermont Ferrand

intervention_type: Dietary Supplement


title: Topical Treatment of Cutaneous Leishmaniasis With WR 279,396: a Phase 2 Study in the Old World

summary: This study is to determine the effectiveness and safety of WR 279,396, a topical cream for the treatment of cutaneous leishmaniasis. This study is to be conducted with a placebo control under double-blind conditions in a local population group in Tunisia where leishmaniasis is endemic.

ReferenceCitation: Ben Salah A, Buffet PA, Morizot G, Ben Massoud N, Zâatour A, Ben Alaya N, Haj Hamida NB, El Ahmadi Z, Downs MT, Smith PL, Dellagi K, Grögl M. WR279,396, a third generation aminoglycoside ointment for the treatment of Leishmania major cutaneous leishmaniasis: a phase 2, randomized, double blind, placebo controlled study. PLoS Negl Trop Dis. 2009;3(5):e432. doi: 10.1371/journal.pntd.0000432. Epub 2009 May 5.

family: Ben Salah

full_name: Afif Ben Salah

given: Afif

family: Buffet

full_name: Pierre A. Buffet

given: Pierre A.

family: Morizot

full_name: Gloria Morizot

given: Gloria

family: Ben Massoud

full_name: Nathalie Ben Massoud

given: Nathalie

family: Zâatour

full_name: Amor Zâatour

given: Amor

family: Ben Alaya

full_name: Nissaf Ben Alaya

given: Nissaf

family: Haj Hamida

full_name: Nabil Bel Haj Hamida

given: Nabil Bel

family: Ahmadi

full_name: Zaher El Ahmadi

given: Zaher El

family: Downs

full_name: Matthew T. Downs

given: Matthew T.

family: Smith

full_name: Philip L. Smith

given: Philip L.

family: Dellagi

full_name: Koussay Dellagi

given: Koussay

family: Grögl

full_name: Max Grögl

given: Max

journal_name: PLoS Neglected Tropical Diseases

license: implied-oa

license_normalized: implied-oa

repository_normalized: CiteSeerX

version: submittedVersion

repository_normalized: HAL

repositories:
CiteSeerX
HAL
PubMed Central

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

title: WR279,396, a Third Generation Aminoglycoside Ointment for the Treatment of Leishmania major Cutaneous Leishmaniasis: A Phase 2, Randomized, Double Blind, Placebo Controlled Study

lead_sponsor: U.S. Army Medical Research and Development Command

location_facility:
Institue Pasteur
Medical Center Institut Pasteur


title: A Phase I/II Study of the Safety, Efficacy and Dose Evaluation of ProSavin®, Administered Using Stereotactic Injection to the Striatum of Patients With Bilateral, Idiopathic Parkinson's Disease.

summary:
The primary objectives of the trial are to assess the safety and efficacy of ProSavin.

Patients in the trial will have been diagnosed with Parkinson's disease and will be failing on current treatment with L-DOPA but they will not have progressed to drug-induced dyskinesias. The first stage is an open-label dose escalation to evaluate up to three dose levels of ProSavin in cohorts of three patients each. Following a recommendation by the DMC the study may proceed to the second stage of the trial, a further 12 patients will be recruited to confirm efficacy of the optimal dose in the randomized phase of the study.

The efficacy of ProSavin will be assessed using the Unified Parkinson's Disease Rating Score (UPDRS). Patients will be monitored at regular intervals, with the primary endpoint being an efficacy assessment at six months after treatment. The secondary objective of the trial is to asses the extent to which patients' current therapy (L-DOPA) can be reduced following administration of ProSavin.

ReferenceCitation: Palfi S, Gurruchaga JM, Ralph GS, Lepetit H, Lavisse S, Buttery PC, Watts C, Miskin J, Kelleher M, Deeley S, Iwamuro H, Lefaucheur JP, Thiriez C, Fenelon G, Lucas C, Brugières P, Gabriel I, Abhay K, Drouot X, Tani N, Kas A, Ghaleh B, Le Corvoisier P, Dolphin P, Breen DP, Mason S, Guzman NV, Mazarakis ND, Radcliffe PA, Harrop R, Kingsman SM, Rascol O, Naylor S, Barker RA, Hantraye P, Remy P, Cesaro P, Mitrophanous KA. Long-term safety and tolerability of ProSavin, a lentiviral vector-based gene therapy for Parkinson's disease: a dose escalation, open-label, phase 1/2 trial. Lancet. 2014 Mar 29;383(9923):1138-46. doi: 10.1016/S0140-6736(13)61939-X. Epub 2014 Jan 10.

family: Palfi

full_name: Stéphane Palfi

given: Stéphane

family: Gurruchaga

full_name: Jean Marc Gurruchaga

given: Jean Marc

family: Ralph

full_name: G Scott Ralph

given: G Scott

family: Lepetit

full_name: Helene Lepetit

given: Helene

family: Lavisse

full_name: Sonia Lavisse

given: Sonia

family: Buttery

full_name: Philip C Buttery

given: Philip C

family: Watts

full_name: Colin Watts

given: Colin

family: Miskin

full_name: James Miskin

given: James

family: Kelleher

full_name: Michelle Kelleher

given: Michelle

family: Deeley

full_name: Sarah Deeley

given: Sarah

family: Iwamuro

full_name: Hirokazu Iwamuro

given: Hirokazu

family: Lefaucheur

full_name: Jean Pascal Lefaucheur

given: Jean Pascal

family: Thiriez

full_name: Claire Thiriez

given: Claire

family: Fenelon

full_name: Gilles Fenelon

given: Gilles

family: Lucas

full_name: Cherry Lucas

given: Cherry

family: Brugières

full_name: Pierre Brugières

given: Pierre

family: Gabriel

full_name: Inanna Gabriel

given: Inanna

family: Abhay

full_name: Kou Abhay

given: Kou

family: Drouot

full_name: Xavier Drouot

given: Xavier

family: Tani

full_name: Naoki Tani

given: Naoki

family: Kas

full_name: Aurelie Kas

given: Aurelie

family: Ghaleh

full_name: Bijan Ghaleh

given: Bijan

family: Le Corvoisier

full_name: Philippe Le Corvoisier

given: Philippe

family: Dolphin


title: A Randomized, Multicenter, Two-arm, Open-label, Phase IIIb Study to Evaluate the Satisfaction in Relapsing Multiple Sclerosis Subjects Transitioning to Rebif® New Formulation From Rebif® (Interferon Beta-1a) With Ibuprofen When Necessary (PRN) or as Prophylaxis

acronym: TRANSFER

summary: To assess patient satisfaction with respect to the incidence of flu-like symptoms (FLS) in patients with multiple sclerosis transitioned from current Rebif (subcutaneously injected interferon beta-1a, 44 mcg three-times-weekly) to the new formulation of Rebif (RNF) while receiving ibuprofen either prophylactically or only when necessary (PRN) after the occurence of flu-like symptoms.

lead_sponsor: Merck KGaA, Darmstadt, Germany


lead_sponsor: Novartis

title: An Exploratory, Multi-centre, Double-blind, Placebocontrolled Crossover Study, to Investigate the Bronchodilatory Efficacy of a Single Dose of Indacaterol in Fixed Combination With Mometasone Furoate Delivered Via a MDDPI (Twisthaler®) in Adult Patients With Persistent Asthma Using Open Label Seretide® Accuhaler® (50/250 Mcg b.i.d.) as an Active Control

summary: This study is designed to evaluate the bronchodilatory efficacy of indacaterol maleate 500 μg/mometasone furoate 400 μg via the Twisthaler® device in adult patients with persistent asthma.


ReferenceCitation: Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11:CD005613. doi: 10.1002/14651858.CD005613.pub4.

name: Institute of General Practice and Evidence-Based Health Services Research; Medical University of Graz; Graz Austria

family: Semlitsch

full_name: Thomas Semlitsch

given: Thomas

name: Institute for General Practice; Goethe University; Frankfurt am Main Germany

family: Engler

full_name: Jennifer Engler

given: Jennifer

name: Institute of General Practice and Evidence-Based Health Services Research, Medical University of Graz; Graz, Austria / Institute of General Practice, Goethe University; Frankfurt am Main Austria

family: Siebenhofer

full_name: Andrea Siebenhofer

given: Andrea

name: Institute of General Practice and Evidence-Based Health Services Research / Institute for Medical Informatics, Statistics and Documentation; Medical University of Graz; Graz Austria

family: Jeitler

full_name: Klaus Jeitler

given: Klaus

family: Berghold

full_name: Andrea Berghold

name: Institute of General Practice and Evidence-Based Health Services Research / Department of Internal Medicine, Division of Endocrinology and Metabolism; Medical University of Graz; Graz Austria

family: Horvath

full_name: Karl Horvath

given: Karl

journal_name: Cochrane Database of Systematic Reviews

lead_sponsor: Novo Nordisk A/S

title: The Effect of Insulin Detemir on Glucose Control in Ageing Subjects With Type 2 Diabetes.

summary: This trial is conducted in Europe. The aim of the trial is to compare insulin detemir once daily to NPH insulin once daily as measured by blood sugar control in ageing subjects with type 2 diabetes naive to previous insulin therapy.


title: Immunogenicity and Safety of PEDIACEL®, a Combined Diphtheria, Tetanus, Five Component Acellular Pertussis, Inactivated Poliomyelitis and Haemophilus Influenzae Type b Conjugate Vaccine (Adsorbed), Compared to Infanrix®-IPV+Hib When Both Vaccines Are Co-Administered With Prevenar® to Infants and Toddlers at 2, 3, 4 and 12-18 Months of Age

summary:
The purpose of this study is to evaluate safety and immunogenicity of Pediacel® in infants and toddlers when given at 2,3,4 and 12-18 months of age.

Primary Objectives:

To compare the post-dose 3 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both are co-administered with Prevenar®.
To describe the post-dose 3 pertussis antibody responses.

Secondary Objectives:

To compare the post-dose 4 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both are co-administered with Prevenar®.
To describe the safety after each vaccination following co-administration with Prevenar®.

ReferenceCitation: Grimprel E, Wysocki J, Boisnard F, Thomas S, Mwawasi G, Reynolds D. Immunogenicity and safety of fully liquid DTaP₅-IPV-Hib compared with DTaP₃-IPV/Hib when both coadministered with a heptavalent pneumococcal conjugate vaccine (PCV7) at 2, 3, 4, and 12 to 18 months of age: a phase III, single-blind, randomised, controlled, multicentre study. Vaccine. 2011 Oct 6;29(43):7370-8. doi: 10.1016/j.vaccine.2011.07.078. Epub 2011 Jul 30.

family: Grimprel

full_name: Emmanuel Grimprel

given: Emmanuel

family: Wysocki

full_name: Jacek Wysocki

given: Jacek

family: Boisnard

full_name: Florence Boisnard

given: Florence

family: Thomas

full_name: Stéphane Thomas

given: Stéphane

family: Mwawasi

full_name: Grace Mwawasi

given: Grace

family: Reynolds

full_name: Donna Reynolds

given: Donna

journal_name: Vaccine

title: Immunogenicity and safety of fully liquid DTaP5-IPV-Hib compared with DTaP3-IPV/Hib when both coadministered with a heptavalent pneumococcal conjugate vaccine (PCV7) at 2, 3, 4, and 12 to 18 months of age: A phase III, single-blind, randomised, controlled, multicentre study

lead_sponsor: Sanofi Pasteur, a Sanofi Company

location_country: France Poland


title: A Phase I Study of Ixabepilone in Combination With Epirubicin in Patients With Metastatic Breast Cancer

summary: Tumor response information was obtained for all participants who received at least 2 cycles of study drug, underwent requisite baseline and on-treatment disease assessments and had at least one post-treatment assessment. Tumor response assessment in evaluable participants was done according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

lead_sponsor: R-Pharm


title: Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic Vasculitis

summary:
The aim of IMPROVE is to define the optimal maintenance therapy for ANCA-associated vasculitides (AASV) by comparing the AZA (standard regimen) with MMF in terms of efficacy, i.e. in preventing relapses.

HYPOTHESIS :

MMF might be more effective than azathioprine as maintenance drug in AASV patients, reducing by 50% relapse rate, with a same frequency of adverse effects

ReferenceCitation: Morgan MD, Szeto M, Walsh M, Jayne D, Westman K, Rasmussen N, Hiemstra TF, Flossmann O, Berden A, Höglund P, Harper L; European Vasculitis Society. Negative anti-neutrophil cytoplasm antibody at switch to maintenance therapy is associated with a reduced risk of relapse. Arthritis Res Ther. 2017 Jun 7;19(1):129. doi: 10.1186/s13075-017-1321-1.

family: Morgan

full_name: Matthew David Morgan

given: Matthew David

name: on behalf of the European Vasculitis Society

family: Szeto

full_name: Matthew Szeto

given: Matthew

family: Walsh

full_name: Michael Walsh

given: Michael

family: Jayne

full_name: David Jayne

given: David

family: Westman

full_name: Kerstin Westman

given: Kerstin

family: Rasmussen

full_name: Niels Rasmussen

given: Niels

family: Hiemstra

full_name: Thomas F. Hiemstra

given: Thomas F.

family: Flossmann

full_name: Oliver Flossmann

given: Oliver

family: Berden

full_name: Annelies Berden

given: Annelies

family: Höglund

full_name: Peter Höglund

given: Peter

family: Harper

full_name: Lorraine Harper

given: Lorraine

journal_name: Arthritis Research & Therapy

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

repository_institution: University of Cambridge - Apollo

repositories:
PubMed Central
Pure (Denmark)
www.repository.cam.ac.uk

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

ReferenceCitation: Hiemstra TF, Walsh M, Mahr A, Savage CO, de Groot K, Harper L, Hauser T, Neumann I, Tesar V, Wissing KM, Pagnoux C, Schmitt W, Jayne DR; European Vasculitis Study Group (EUVAS). Mycophenolate mofetil vs azathioprine for remission maintenance in antineutrophil cytoplasmic antibody-associated vasculitis: a randomized controlled trial. JAMA. 2010 Dec 1;304(21):2381-8. doi: 10.1001/jama.2010.1658. Epub 2010 Nov 8.

full_name: for the European Vasculitis Study Group (EUVAS)

title: Mycophenolate Mofetil vs Azathioprine for Remission Maintenance in Antineutrophil Cytoplasmic Antibody–Associated Vasculitis

location_facility: Addenbrooke's Hospital - Departement of Medecine


title: A Phase 2, Open-Label, Single Dose Level, 24-Week Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AT1001 in Patients With Fabry Disease

summary: Study to evaluate the safety, tolerability, and pharmacodynamics of migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease.

ReferenceCitation: Benjamin ER, Della Valle MC, Wu X, Katz E, Pruthi F, Bond S, Bronfin B, Williams H, Yu J, Bichet DG, Germain DP, Giugliani R, Hughes D, Schiffmann R, Wilcox WR, Desnick RJ, Kirk J, Barth J, Barlow C, Valenzano KJ, Castelli J, Lockhart DJ. The validation of pharmacogenetics for the identification of Fabry patients to be treated with migalastat. Genet Med. 2017 Apr;19(4):430-438. doi: 10.1038/gim.2016.122. Epub 2016 Sep 22.

family: Benjamin

full_name: Elfrida R. Benjamin

given: Elfrida R.

family: Della Valle

full_name: Maria Cecilia Della Valle

given: Maria Cecilia

family: Wu

full_name: Xiaoyang Wu

given: Xiaoyang

family: Katz

full_name: Evan Katz

given: Evan

family: Pruthi

full_name: Farhana Pruthi

given: Farhana

family: Bond

full_name: Sarah Bond

given: Sarah

family: Bronfin

full_name: Benjamin Bronfin

given: Benjamin

family: Williams

full_name: Hadis Williams

given: Hadis

family: Yu

full_name: Julie Yu

given: Julie

family: Bichet

full_name: Daniel G. Bichet

given: Daniel G.

family: Germain

full_name: Dominique P. Germain

given: Dominique P.

family: Giugliani

full_name: Roberto Giugliani

given: Roberto

family: Hughes

full_name: Derralynn Hughes

given: Derralynn

family: Schiffmann

full_name: Raphael Schiffmann

given: Raphael

family: Wilcox

full_name: William R. Wilcox

given: William R.

family: Desnick

full_name: Robert J. Desnick

given: Robert J.

family: Kirk

full_name: John Kirk

given: John

family: Barth

full_name: Jay Barth

given: Jay

family: Barlow

full_name: Carrolee Barlow

given: Carrolee

family: Valenzano

full_name: Kenneth J. Valenzano

given: Kenneth J.

family: Castelli

full_name: Jeff Castelli

given: Jeff

family: Lockhart

full_name: David J. Lockhart

given: David J.

journal_name: Genetics in Medicine

repository_institution: University College London - UCL Discovery

ReferenceCitation: Germain DP, Giugliani R, Hughes DA, Mehta A, Nicholls K, Barisoni L, Jennette CJ, Bragat A, Castelli J, Sitaraman S, Lockhart DJ, Boudes PF. Safety and pharmacodynamic effects of a pharmacological chaperone on α-galactosidase A activity and globotriaosylceramide clearance in Fabry disease: report from two phase 2 clinical studies. Orphanet J Rare Dis. 2012 Nov 24;7:91. doi: 10.1186/1750-1172-7-91.

repository_institution: University of Melbourne - Minerva Access

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository


title: Trial to Assess the Use of the Cypher TM Stent in Acute Myocardial Infarction Treated With Balloon Angioplasty

acronym: TYPHOON

summary: The main objective of this study is to assess the effectiveness and safety of the CYPHER™ (CYPHER SELECT™) (Sirolimus-eluting) stent in reducing the occurrence of a composite endpoint of target vessel failure (TVF) in subjects treated for acute myocardial infarction as compared to a bare metal stent.

ReferenceCitation: Spaulding C, Henry P, Teiger E, Beatt K, Bramucci E, Carrié D, Slama MS, Merkely B, Erglis A, Margheri M, Varenne O, Cebrian A, Stoll HP, Snead DB, Bode C; TYPHOON Investigators. Sirolimus-eluting versus uncoated stents in acute myocardial infarction. N Engl J Med. 2006 Sep 14;355(11):1093-104.

ReferenceCitation: Rozenman Y, Witzling V, Tamari I, Turkisher V, Kriviski M, Bode C, Henry P, Teiger E, Cebrian A, Stoll HP, Spaulding C. Impact of stent length on restenosis in patients with acute myocardial infarction treated with primary percutaneous coronary intervention: analysis based on data from the Trial to Assess the Use of the Cypher Stent in Acute Myocardial Infarction Treated with Balloon Angioplasty (TYPHOON). EuroIntervention. 2009 Jun;5(2):219-23.

ReferenceCitation: Spaulding C, Teiger E, Commeau P, Varenne O, Bramucci E, Slama M, Beatt K, Tirouvanziam A, Polonski L, Stella PR, Clugston R, Fajadet J, de Boisgelin X, Bode C, Carrié D, Erglis A, Merkely B, Hosten S, Cebrian A, Wang P, Stoll HP, Henry P. Four-year follow-up of TYPHOON (trial to assess the use of the CYPHer sirolimus-eluting coronary stent in acute myocardial infarction treated with BallOON angioplasty). JACC Cardiovasc Interv. 2011 Jan;4(1):14-23. doi: 10.1016/j.jcin.2010.10.007.

family: Spaulding

full_name: Christian Spaulding

given: Christian

family: Teiger

full_name: Emmanuel Teiger

given: Emmanuel

family: Commeau

full_name: Philippe Commeau

given: Philippe

family: Varenne

full_name: Olivier Varenne

given: Olivier

family: Bramucci

full_name: Ezio Bramucci

given: Ezio

family: Slama

full_name: Michel Slama

given: Michel

family: Beatt

full_name: Keavin Beatt

given: Keavin

family: Tirouvanziam

full_name: Ashok Tirouvanziam

given: Ashok

family: Polonski

full_name: Lech Polonski

given: Lech

family: Stella

full_name: Pieter R. Stella

given: Pieter R.

family: Clugston

full_name: Richard Clugston

given: Richard

family: Fajadet

full_name: Jean Fajadet

given: Jean

family: de Boisgelin

full_name: Xavier de Boisgelin

given: Xavier

family: Bode

full_name: Christophe Bode

given: Christophe

family: Carrié

full_name: Didier Carrié

given: Didier

family: Erglis

full_name: Andrejs Erglis

given: Andrejs

family: Merkely

full_name: Bela Merkely

given: Bela

family: Hosten

full_name: Stefan Hosten

given: Stefan

family: Cebrian

full_name: Ana Cebrian

given: Ana

family: Wang

full_name: Patrick Wang

given: Patrick

family: Stoll

full_name: Hans-Peter Stoll

given: Hans-Peter

family: Henry

full_name: Patrick Henry

title: Four-Year Follow-Up of TYPHOON (Trial to Assess the Use of the CYPHer Sirolimus-Eluting Coronary Stent in Acute Myocardial Infarction Treated With BallOON Angioplasty)

location_facility: University of Freiburg, Albert-Ludwigs-Universitätskliniken

location_facility: HOPITAL COCHIN, René Descartes University


title: Continuous Dosing Phase I Study of BMS-599626 in Patients With HER2-Expressing Advanced Solid Malignancies

summary: This is a continuous dosing Phase I Study of BMS-599626 in patients with HER2-expressing advanced solid malignancies.

lead_sponsor: Bristol-Myers Squibb


title: Phase II Study of the Combination of Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents at Diagnosis or in Relapse

summary: The purpose of this study is to determine whether the combination of Temozolomide and Cisplatinum is effective in the treatment of malignant glial tumours of children and adolescents

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility:
Bristol Royal Hospital for Children
Institut Gustave-Roussy


title: Phase I Clinical Trial of Recombinant Viscumin (rViscumin, rMistletoe Lectin, rML) Administered Twice Weekly By The Intravenous Route In Patients With Solid Tumors After Failure of Standard Therapy

summary:
RATIONALE: Mistletoe lectin may slow the growth of cancer cells and be an effective treatment for solid tumors.

PURPOSE: Phase I trial to study the effectiveness of mistletoe lectin in treating patients who have advanced solid tumors that have not responded to previous therapy.

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

location_facility:
Centre Regional Rene Gauducheau
Medizinische Hochschule Hannover


type: Registry Identifier

title: A European Randomized Multicenter Study of Interferon Alfa-2b Versus No Treatment After Intensive Therapy and Autologous Hematopoietic Stem Cell Transplantation for Relapsing Lymphoma Patients (Non-Hodgkin Lymphomas and Hodgkin's Disease)

summary:
RATIONALE: Interferon-alfa may interfere with the growth of cancer cells. Giving interferon-alfa following chemotherapy and peripheral stem cell transplantation may be an effective treatment for Hodgkin's disease or non-Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to determine the effectiveness of interferon alfa-2b following chemotherapy and stem cell transplantation in treating patients who have recurrent or refractory Hodgkin's disease or non-Hodgkin's lymphoma.

lead_sponsor: Lymphoma Study Association

location_facility: Hopital Jules Courmont - Centre Hospitalier Lyon Sud


title: FAB LMB 96 -- Treatment of Mature B-CELL Lymphoma/Leukemia: A SFOP LMB 96/CCG 5961/UKCCSG NHL 9600 Cooperative Study

summary:
RATIONALE: Less intensive therapy may attain in the same results as intensive therapy in children with non-Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to study the effectiveness of less intensive therapy for children who have non-Hodgkin's lymphoma.

ReferenceCitation: Lones MA, Raphael M, Perkins SL, Wotherspoon A, Auperin A, Terrier-Lacombe MJ, Sposto R, Weston C, Gerrard M, Patte C, Cairo MS, McCarthy K. Mature B-cell lymphoma in children and adolescents: International group pathologist consensus correlates with histology technical quality. J Pediatr Hematol Oncol. 2006 Sep;28(9):568-74.

ReferenceCitation: Cairo MS, Sposto R, Gerrard M, Auperin A, Goldman SC, Harrison L, Pinkerton R, Raphael M, McCarthy K, Perkins SL, Patte C. Advanced stage, increased lactate dehydrogenase, and primary site, but not adolescent age (≥ 15 years), are associated with an increased risk of treatment failure in children and adolescents with mature B-cell non-Hodgkin's lymphoma: results of the FAB LMB 96 study. J Clin Oncol. 2012 Feb 1;30(4):387-93. doi: 10.1200/JCO.2010.33.3369. Epub 2012 Jan 3.

name: Mitchell S. Cairo and Lauren Harrison, New York Medical College, Valhalla, NY; Richard Sposto, Keck School of Medicine, University of Southern California, Los Angeles, CA; Mary Gerrard, Sheffield Children's Hospital, Sheffield; Ross Pinkerton, Royal Marsden Hospital, Sutton, Surrey; Keith McCarthy, Gloucestershire Hospitals, National Health Service Foundation Trust, Gloucestershire, United Kingdom; Anne Auperin and Catherine Patte, Institut Gustave Roussy; Martine Raphael, Centre Hospitalier...

family: Cairo

full_name: Mitchell S. Cairo

given: Mitchell S.

family: Sposto

full_name: Richard Sposto

family: Gerrard

full_name: Mary Gerrard

given: Mary

family: Auperin

full_name: Anne Auperin

given: Anne

family: Goldman

full_name: Stanton C. Goldman

given: Stanton C.

family: Harrison

full_name: Lauren Harrison

given: Lauren

family: Pinkerton

full_name: Ross Pinkerton

given: Ross

family: Raphael

full_name: Martine Raphael

given: Martine

family: McCarthy

full_name: Keith McCarthy

given: Keith

family: Perkins

full_name: Sherrie L. Perkins

given: Sherrie L.

family: Patte

full_name: Catherine Patte

given: Catherine

journal_name: Journal of Clinical Oncology

oa_host_type: repository

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

publisher: American Society of Clinical Oncology (ASCO)

title: Advanced Stage, Increased Lactate Dehydrogenase, and Primary Site, but Not Adolescent Age (≥ 15 Years), Are Associated With an Increased Risk of Treatment Failure in Children and Adolescents With Mature B-Cell Non-Hodgkin's Lymphoma: Results of the FAB LMB 96 Study

ReferenceCitation: Shiramizu B, Goldman S, Kusao I, Agsalda M, Lynch J, Smith L, Harrison L, Morris E, Gross TG, Sanger W, Perkins S, Cairo MS. Minimal disease assessment in the treatment of children and adolescents with intermediate-risk (Stage III/IV) B-cell non-Hodgkin lymphoma: a children's oncology group report. Br J Haematol. 2011 Jun;153(6):758-63. doi: 10.1111/j.1365-2141.2011.08681.x. Epub 2011 Apr 18.

family: Shiramizu

full_name: Bruce Shiramizu

given: Bruce

full_name: Stanton Goldman

given: Stanton

family: Kusao

full_name: Ian Kusao

given: Ian

family: Agsalda

full_name: Melissa Agsalda

given: Melissa

family: Lynch

full_name: James Lynch

given: James

family: Smith

full_name: Lynette Smith

given: Lynette

title: Minimal disease assessment in the treatment of children and adolescents with intermediate-risk (Stage III/IV) B-cell non-Hodgkin lymphoma: a children’s oncology group report

ReferenceCitation: Nelson M, Perkins SL, Dave BJ, Coccia PF, Bridge JA, Lyden ER, Heerema NA, Lones MA, Harrison L, Cairo MS, Sanger WG. An increased frequency of 13q deletions detected by fluorescence in situ hybridization and its impact on survival in children and adolescents with Burkitt lymphoma: results from the Children's Oncology Group study CCG-5961. Br J Haematol. 2010 Feb;148(4):600-10. doi: 10.1111/j.1365-2141.2009.07967.x. Epub 2009 Nov 4.

title: An increased frequency of 13q deletions detected by fluorescencein situhybridization and its impact on survival in children and adolescents with Burkitt lymphoma: results from the Children’s Oncology Group study CCG-5961

ReferenceCitation: Poirel HA, Cairo MS, Heerema NA, Swansbury J, Aupérin A, Launay E, Sanger WG, Talley P, Perkins SL, Raphaël M, McCarthy K, Sposto R, Gerrard M, Bernheim A, Patte C; FAB/LMB 96 International Study Committee. Specific cytogenetic abnormalities are associated with a significantly inferior outcome in children and adolescents with mature B-cell non-Hodgkin's lymphoma: results of the FAB/LMB 96 international study. Leukemia. 2009 Feb;23(2):323-31. doi: 10.1038/leu.2008.312. Epub 2008 Nov 20.

name: on behalf of the FAB/LMB 96 International Study Committee

ReferenceCitation: Gerrard M, Cairo MS, Weston C, Auperin A, Pinkerton R, Lambilliote A, Sposto R, McCarthy K, Lacombe MJ, Perkins SL, Patte C; FAB LMB96 International Study Committee. Excellent survival following two courses of COPAD chemotherapy in children and adolescents with resected localized B-cell non-Hodgkin's lymphoma: results of the FAB/LMB 96 international study. Br J Haematol. 2008 Jun;141(6):840-7. doi: 10.1111/j.1365-2141.2008.07144.x. Epub 2008 Mar 26.

name: On Behalf of the FAB LMB96 International Study Committee12

title: Excellent survival following two courses of COPAD chemotherapy in children and adolescents with resected localized B-cell non-Hodgkin’s lymphoma: results of the FAB/LMB 96 international study

ReferenceCitation: Miles RR, Raphael M, McCarthy K, Wotherspoon A, Lones MA, Terrier-Lacombe MJ, Patte C, Gerrard M, Auperin A, Sposto R, Davenport V, Cairo MS, Perkins SL; SFOP/LMB96/CCG5961/UKCCSG/NHL 9600 Study Group. Pediatric diffuse large B-cell lymphoma demonstrates a high proliferation index, frequent c-Myc protein expression, and a high incidence of germinal center subtype: Report of the French-American-British (FAB) international study group. Pediatr Blood Cancer. 2008 Sep;51(3):369-74. doi: 10.1002/pbc.21619.

name: From the SFOP/LMB96/CCG5961/UKCCSG/NHL 9600 Study Group

ReferenceCitation: Cairo MS, Gerrard M, Sposto R, Auperin A, Pinkerton CR, Michon J, Weston C, Perkins SL, Raphael M, McCarthy K, Patte C; FAB LMB96 International Study Committee. Results of a randomized international study of high-risk central nervous system B non-Hodgkin lymphoma and B acute lymphoblastic leukemia in children and adolescents. Blood. 2007 Apr 1;109(7):2736-43.

ReferenceCitation: Patte C, Auperin A, Gerrard M, Michon J, Pinkerton R, Sposto R, Weston C, Raphael M, Perkins SL, McCarthy K, Cairo MS; FAB/LMB96 International Study Committee. Results of the randomized international FAB/LMB96 trial for intermediate risk B-cell non-Hodgkin lymphoma in children and adolescents: it is possible to reduce treatment for the early responding patients. Blood. 2007 Apr 1;109(7):2773-80.

ReferenceCitation: Goldman S, Gerrard M, Sposto R, et al.: Excellent results in children and adolescents with isolated mature B-acute lymphoblastic leukemia (B-ALL) (Burkitt): report from the French-American-British (FAB) international LMB study FAB/LMB96. [Abstract] Blood 106 (11): A-234, 2005.

ReferenceCitation: Poirel HA, Heerema NA, Swansbury J, et al.: In pediatric mature B-cell non Hodgkin's lymphoma (NHL), complex karyotype or del(13q) are linked prognostic factors in Burkitt lymphoma (BL) while 8q24/c-myc rearrangement is associated with a strong adverse effect in diffuse large B-cell lymphoma (DLBCL). [Abstract] Blood 106 (11): A-1905, 2005.

ReferenceCitation: Lones M, Perkins S, Sposto R, et al.: T-cell-rich large B-cell lymphoma (TCRLBCL) in children and adolescents treated on a B-large cell lymphoma trial: a report from the Children's Cancer Group (CCG) study CCG-5961. [Abstract] Ann Oncol 13(suppl 2): A-137, 45, 2002.

ReferenceCitation: Perkins S, Lones M, Sposto R, et al.: B-cell non-Hodgkin lymphoma (NHL) in children and adolescents: central phenotype results from Children's Cancer Group (CCG) study CCG-5961 and implications for future targeted bio-immune therapy (TBIT). [Abstract] Ann Oncol 13(suppl 2): A-136, 45, 2002.

ReferenceCitation: Sanger W, Lones M, Perkins S, et al.: Chromosome abnormalities in B-cell non-Hodgkin lymphoma (NHL) of children and adolescents: a report from Children's Cancer Group (CCG)study CCG-5961. [Abstract] Ann Oncol 13(suppl 2): A-138, 45, 2002.

ReferenceCitation: Perkins SL, Lones MA, Cairo MS, et al.: B-cell lymphoma/leukemia in children and adolescents: central phenotype results from Children's Cancer Group study (CCG)-5961 and implications for future Targeted Bio-Immune Therapy (TBIT). [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1520, 2001.

ReferenceCitation: Lones MA, Cairo MS, Perkins SL. T-cell-rich large B-cell lymphoma in children and adolescents: a clinicopathologic report of six cases from the Children's Cancer Group Study CCG-5961. Cancer. 2000 May 15;88(10):2378-86.

location_facility:
Children's Hospital - Sheffield
Institut Gustave Roussy


title: Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma. Efficacy of Seocalcitol (EB 1089) Enteric-Coated Capsules (5ug) or Placebo in the Treatment of Patients With Hepatocellular Carcinoma Not Amenable to Curative Treatment

summary: The purpose of the study is to determine whether seocalcitol is effective in the treatment of advanced primary liver cancer (hepatocellular carcinoma [HCC]).

primary_purpose: Educational/Counseling/Training

lead_sponsor: LEO Pharma

location_country:
Italy
France
Spain
Canada
United Kingdom

location_facility: E.g. University Health Network Toronto General Hospital (numerous facilities are recruiting in Canada)

location_facility: E.g. The University of Edinburgh Royal Infirmary (numerous facilities are recruiting in UK)

location_facility: E.g. Hospital Clinic Provincial de Barcelona (numerous facilities are recruiting in Spain)

location_facility: E.g. Notre-Dame de Bon Secours, Service d´Hepato-Gastro-Enterologie (numerous facilities are recruiting in France)

location_facility: E.g. Osp. Maggiore, Policlinico di Milano (numerous facilities are recruiting in Italy)


title: Phase 2 Study of TAK-659 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma After at Least 2 Prior Lines of Chemotherapy

summary: The purpose of this study is to assess the efficacy of TAK-659 measured by independent radiologic review committee (IRC)-assessed overall response rate (ORR) in participants with relapsed or refractory DLBCL.

ipd_sharing_description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

lead_sponsor: Millennium Pharmaceuticals, Inc.

location_country:
Italy
France
Spain
United States
United Kingdom
Canada

location_facility: CHU de Quebec -Universite Laval-Hopital de L'Enfant Jesus

location_facility: Azienda Ospedaliero-Universitaria "Maggiore della Carita"

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

location_facility: University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital

location_facility: Azienda Ospedaliero Universitaria Santa Maria della Misericordia di Udine

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Institut Paoli Calmettes Departement de Recherche Clinique et de l'Innovation

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: University of Washington, Hutchinson Cancer Research Center

location_facility: Groupe Hospitalier - Hopitaux Universitaires Pitie-Salpetriere - Charles-Foix - Pitie-Salpetriere

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: London North West Healthcare NHS Trust, Imperial College London

location_facility: New York University Langone Medical Center

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Newcastle Hospitals NHS Foundation Trust


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus-Host Disease in Subjects Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

summary: The purpose of this study is to evaluate the efficacy of vedolizumab when added to background aGvHD prophylaxis regimen compared to placebo and background aGvHD prophylaxis regimen on intestinal aGvHD-free survival by Day +180 in participants who receive allo-HSCT as treatment for a hematologic malignancy or myeloproliferative disorder.

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

location_country:
Greece
Romania
Australia
Belgium
Russian Federation
Taiwan
France
Japan
Poland
Norway
Argentina
Canada
Korea, Republic of
Sweden
Switzerland
Singapore
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Israel
Spain

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: Centre Hospitalier Universitaire de Limoges

location_facility: Instituto Brasileiro de Controle do Cancer

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Emory University - Winship Cancer Institute

location_facility: Hospital Universitario Walter Cantidio - Universidade Federal do Ceara

location_facility: Fundacion Favaloro Hospital Universitario

location_facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil

location_facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Marlene and Stewart Greenebaum Cancer Center

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Rambam Health Care Campus - Rambam Medical Center

location_facility: David Geffen School of Medicine at University of California Los Angeles

location_facility: Daegu Catholic University Medical Center

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

location_facility: Instituto do Cancer e Transplante de Curitiba

location_facility: Istituto Clinico Humanitas Humanitas Cancer Center

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Centre Hospitalier Universitaire Nantes - Hotel Dieu

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel

location_facility: Fundacao Antonio Prudente - A.C.Camargo Cancer Center

location_facility: Sverdlovsk Regional Clinical Hospital #1

location_facility: Centro Hospitalar de Lisboa Norte EPE- Hospital Santa Maria

location_facility: Centre Hospitalier Universitaire Amiens-Picardie

location_facility: Seoul National University Bundang Hospital

location_facility: Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital

location_facility: Azienda Grande Ospedale Metropolitano Bianchi Melacrino Morelli

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: National Research Center for Hematology, Dept. of Hematology/Oncology and BMT

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: University Regional General Hospital of Patras

location_facility: Cardiff and Vale University Health Board

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center

location_facility: University of Kentucky Chandler Medical Center

location_facility: Columbia University Medical Center - The Columbia Center for Translational Immunology

location_facility: Japanese Red Cross Nagoya Daiichi Hospital

location_facility: Oslo University Hospital - Rikshospitalet