title: Efficacy of Transarterial Chemoembolization With DC-BeadsR Prior to Liver Transplantation for Hepatocellular Carcinoma on Patient Survival : A Prosepctive Multicentre and Randomized Study

acronym: CATCH

summary: The hope to treat more patients with hepatocellular carcinoma successfully is however tempered by the shortage of donors leading to an increasing waiting time for liver transplantation (LT). Intention-to-treat analysis have showed that the reported excellent long-term outcome is curtailed and significantly hampered by the growing incidence of patients who must be removed from the waiting list because of tumor progression. A way to face with this issue is to treat hepatocellular carcinoma prior to LT. Among therapeutic options to impede tumor progression, Transarterial Chemoembolization (TACE) is the most common modality used. While there are many studies concerning TACE in this setting, none are controlled studies and thus there is no firm evidence concerning its efficacy in reducing drop-out or increasing survival. Moreover TACE may induce risks (liver failure, arterial complications…) while waiting for LT. Most of the available data have been based upon analysis of patients who received a transplant and have not included patients who were eligible for LT but died, or showed progression, before it could be performed. Therefore, studies conducted on an intention-to-treat basis are needed to clarify the benefit and the risks of TACE prior to LT in patients with hepatocellular carcinoma.

lead_sponsor: Rennes University Hospital

location_facility: Hôpital Henri Mondor - Assistance Publique-Hôpitaux de Paris


title: Prospective Study About the Association of Radiotherapy and Cetuximab in the Treatment of Epidermoid Cancers, Locally Advanced, of the Head and Neck.

summary: This study evaluates the skin toxicities in patients with epidermoid cancer, treated by Radiotherapy in association with Cetuximab.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Centre Oscar Lambret

location_facility:
Centre Leonard de Vinci
Centre Joliot Curie
Centre Oscar Lambret
Centre Galilée
Clinique du Parc
Centre Bourgogne
Centre Gray

intervention_type: Radiation

lead_sponsor_type: industriel

status_simplified: Unknown


title: Determinants of the Consultation Delay in Cancers of the Upper Aero Digestive Tract

acronym: DEREDIA

summary: This study aims to determine the impact of sociocognitive and emotional factors on the time of the initial consult

status: Terminated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Prevention

ipd_sharing: No

location_facility: Centre Hospitalier Régional et Universitaire - Hopital HURIEZ

intervention_type: Behavioral


title: Effect of Total Salpingectomy During Conservative Hysterectomy for Benign Disease on Ovarian Function: Non Inferiority Randomized Controlled Trial

acronym: SALPINGOVA

summary: The study compares the effect of bilateral salpingectomy associated with conservative hysterectomy on ovarian function to the standard hysterectomy with conservation of both ovaries and tubes in terms of hormone assays, ovarian ultrasound evaluation, complications, quality of life.

status: Completed

study_completion_date_type: Actual

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: University Hospital, Tours

location_facility:
CHU
Hôpital Sud

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Completed


title: Evaluation of Wireless Capsule Endoscopy for the Detection and the Control of the Esophageal Varices in Children

acronym: PREVOCAP

summary:
The portal hypertension (PHT) is the main complication in patients presenting with cirrhosis. It can be the direct cause of bleeding by rupture of the esophageal or gastric varices and can also contribute to the development of ascites, hepatic encephalopathy and pleuropulmonary complications.

In the paediatric population presenting with the PHT, one of every two children develops varices and thus has a significant risk of bleeding. Safe and easy to use, the video capsule endoscopy (VCE) is now routinely used in children for the exploration of the small bowel. But the role of the VCE for examination of the other parts of digestive tract still needs to be evaluated.

For the esophagus, the VCE could allow the diagnosis without the need of general sedation. Recent studies have shown a good sensitivity and tolerance of this technique for the initial diagnosis of esophageal varices (EV) in adult patients presenting with portal hypertension, but it has not yet been validated for this indication.

The investigators hypothesize that the VCE could be used in children with similar results in term of efficacy, as for adults.

This prospective simple blind multicentre study (blind for the lecture of the capsule endoscopy record), will investigate the diagnostic value of the VCE compared to the conventional esophagogastroduodenoscopy (EGD) under general sedation for the detection and the control of esophageal varices in children.

If it is provided that the VCE is as efficient as it is for the adults, it could become a very interesting alternative to the conventional EGD because less expensive and less invasive. Moreover, this technique would be very useful as a means of early detection on the EV and/or their control.

primary_purpose: Diagnostic

ReferenceType: result

ReferenceCitation: Cardey J, Le Gall C, Michaud L, Dabadie A, Talbotec C, Bellaiche M, Lamireau T, Mas E, Bridoux-Henno L, Viala J, Restier-Miron L, Lachaux A. Screening of esophageal varices in children using esophageal capsule endoscopy: a multicenter prospective study. Endoscopy. 2019 Jan;51(1):10-17. doi: 10.1055/a-0647-1709. Epub 2018 Sep 5.

name: Gastroentérologie, hépatologie, nutrition pédiatrique, Hôpital Necker-Enfants malades, Paris, France

family: Cardey

full_name: Jacques Cardey

given: Jacques

sequence: additional

name: Hospices Civils de Lyon, Hôpital Femme Mère Enfant, Hépatologie, gastroentérologie et nutrition pédiatrique, Lyon, France

family: Le Gall

full_name: Catherine Le Gall

given: Catherine

name: Gastroentérologie pédiatrique, CHRU Lille, Lille, France

family: Michaud

full_name: Laurent Michaud

given: Laurent

name: Hépatologie, gastroentérologie et nutrition pédiatrique, CHU Hôpital Sud, Rennes, France

family: Dabadie

full_name: Alain Dabadie

given: Alain

family: Talbotec

full_name: Cécile Talbotec

given: Cécile

name: Gastroentérologie et nutrition pédiatrique, Hôpital Robert Debré, Paris, France

family: Bellaiche

full_name: Marc Bellaiche

given: Marc

name: Gastroentérologie pédiatrique, CHU Bordeaux, Bordeaux, France

family: Lamireau

full_name: Thierry Lamireau

given: Thierry

name: Gastroentérologie, hépatologie, nutrition, diabétologie pédiatrique, CHU Toulouse, Toulouse, France

family: Mas

full_name: Emmanuel Mas

given: Emmanuel

family: Bridoux-Henno

full_name: Laure Bridoux-Henno

given: Laure

family: Viala

full_name: Jerome Viala

given: Jerome

family: Restier-Miron

full_name: Lioara Restier-Miron

given: Lioara

name: Université Cl Bernard Lyon 1, Lyon, France

family: Lachaux

full_name: Alain Lachaux

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Endoscopy

publisher: Georg Thieme Verlag KG

publisher_dissemination: Georg Thieme

publisher_group: Georg Thieme

publisher_normalized: Georg Thieme

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Pédiatrie Médicale, Hôpital Pellegrin, CHU de Bordeaux

location_facility: Service de Hépato Gastroentérologie et Nutrition, Hôpital Necker Enfants Malades, AP-HP

location_facility: Service de Gastroentérologie, Mucoviscidose et Nutrition, Hôpital Robert Debré, AP-HP

location_facility: Service d'Hépatologie, gastroentérologie et nutrition pédiatrique, Hôpital Femme Mère Enfant, Hospices Civils de Lyon

location_facility: Service de Pédiatrie, Hôpital Sud, CHU de Rennes

location_facility: Service de Gastroentérologie, Hépatologie, Nutrition et Diabétologie, Hôpital des Enfants, CHU de Toulouse

location_facility: Clinique de Pédiatrie, Hôpital Jeanne de Flandre, CHU de Lille

intervention_type: Device


title: A Prospective, Multicentric Observational Study Evaluating the Long Term Efficacy and Safety of the CODMAN TRUFILL®'s Line of Coils in the Endovascular Treatment of Intracranial Aneurysms

acronym: TRULINE

summary: The objective of this study is to evaluate the long term efficacy and safety of the CODMAN TRUFILL®'s line of coils in the treatment of patients with intracranial ruptured or non-ruptured aneurysms in real-life routine clinical practice.

study_start_date_type: Actual

lead_sponsor: Codman & Shurtleff

location_facility:
Hopitaux Civils de Colmar
Hôpital Adullte La Timone
Fondation Rothschild
Clinique Clairval
CHU Clermont-Ferrand
CHU Pontchaillou
Hôpital Neurologique


title: Assessment of the Safety and Efficacy of the Danubio Paclitaxel-Eluting Balloon for the Treatment of Side Branches of de Novo Bifurcation Lesions in Native Coronary Arteries.

acronym: DEBSIDE

summary: The purpose of this study is to assess the safety and efficacy of the Danubio Paclitaxel Eluting Balloon for the treatment of side branches of de novo bifurcation lesions in native coronary arteries.

ReferenceType: derived

ReferenceCitation: Berland J, Lefèvre T, Brenot P, Fajadet J, Motreff P, Guerin P, Dupouy P, Schandrin C; DEBSIDE trial investigators. DANUBIO - a new drug-eluting balloon for the treatment of side branches in bifurcation lesions: six-month angiographic follow-up results of the DEBSIDE trial. EuroIntervention. 2015 Dec;11(8):868-76. doi: 10.4244/EIJV11I8A177.

family: Berland

full_name: Jacques Berland

sequence: first

family: Lefèvre

full_name: Thierry Lefèvre

family: Brenot

full_name: Philippe Brenot

given: Philippe

family: Fajadet

full_name: Jean Fajadet

given: Jean

family: Motreff

full_name: Pascal Motreff

given: Pascal

family: Guerin

full_name: Patrice Guerin

given: Patrice

family: Dupouy

full_name: Patrick Dupouy

given: Patrick

family: Schandrin

full_name: Christian Schandrin

given: Christian

journal_name: EuroIntervention

publisher: Europa Digital & Publishing

publisher_dissemination: Europa Digital & Publishing

publisher_group: Europa Digital & Publishing

publisher_normalized: Europa Digital & Publishing

lead_sponsor: MINVASYS

location_facility:
Pôle Santé République
Institut hospitalier Jacques Cartier
CHU Clermont-Ferrand
Clinique Pasteur
Centre Cardiologique d'Evecquemont
CHU Nantes
Clinique Saint-Hilaire


title: Search for Predictors of Therapeutic Response in Patients With Carcinoma of the Ovary, the Fallopian Tube or Peritoneal Serous-type Advanced

acronym: miRSa

summary: In order to search for predictors of response to chemotherapy in patients with ovarian carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced stage, we will define the comparative profiles of miRNA expression of serum polymorphisms and determine differential in 2 patient populations (with or without recurrence 6 months after completion of chemotherapy) with (i) the miRNA profile of serum before treatment and (ii) identification of polymorphisms or SNP (Single Nucleotide Polymorphism) in particular genes involved in the metabolism of chemotherapy agents In the case of miRNA, expression profiles will also be studied during the first course in response to chemotherapy. Indeed, the miRNA profile of serum may be different at baseline among the 2 types of populations (or non-recurrence at 6 months).

lead_sponsor: Centre Francois Baclesse

location_facility:
Centre Eugène Marquis
Institut de cancerologie de la loire
Centre Réné Gauducheau
Institut CURIE
Centre Oscar LAMBRET
Centre Henri Becquerel
Centre François BACLESSE

intervention_type: Other


type: Other Identifier

title: The Effect of Enzastaurin on CYP2C9: Enzastaurin - S-Warfarin Drug Interaction Study in Patients With Cancer

summary:
The purpose of this study is to assess the effect of enzastaurin (LY317615), on a protein (enzyme CYP2C9) which is involved in the metabolic pathway of warfarin in participants with solid tumors or lymphomas. Information about any side effects that may occur will also be collected. This is a drug interaction study so the treatment of the disease will not be the main purpose of the study.

This is a Phase 1, open label, fixed sequence, 2 period study conducted in participants with solid tumors or lymphomas. The duration of participation in this study will be up to approximately 38 days not including screening, after which participants will be allowed to continue receiving enzastaurin. There is no planned duration for the extension phase of this study; participants will be allowed to continue to receive enzastaurin until fulfilling one of the criteria for discontinuation, such as unacceptable toxicity or disease progression.

primary_purpose: Other

lead_sponsor: Eli Lilly and Company

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

intervention_type: Drug


title: A Multi-Center Relative Bioavailability Study of Azacitidine 75 mg/m2 Subcutaneous Injection In Myelodysplastic Syndrome Patients Under Fasting Conditions

summary: The purpose of the study is to determine the bioavailability of Azacitidine for Injection relative to Vidaza® in MDS patients under fasting conditions. The data will be evaluated statistically to determine if the products meet bioequivalence criteria.

lead_sponsor: Bioniche Pharma USA LLC

location_country:
United States
France

location_facility: Centre régional de cancérologie Henry-Kaplan Service d'Hématologie et thérapie cellulaire

location_facility: Service d'hématologie clinique Hôpital Avicenne

location_facility: Service d'hématologie et de médecine interne CHU de Nancy Hôpital de Brabois


ReferenceCitation: Caron PJ, Bevan JS, Petersenn S, Flanagan D, Tabarin A, Prévost G, Maisonobe P, Clermont A; PRIMARYS Investigators. Tumor shrinkage with lanreotide Autogel 120 mg as primary therapy in acromegaly: results of a prospective multicenter clinical trial. J Clin Endocrinol Metab. 2014 Apr;99(4):1282-90. doi: 10.1210/jc.2013-3318. Epub 2013 Jan 1.

name: Department of Endocrinology and Metabolic Diseases (P.J.C.), Centre Hospitalier Universitaire Larrey, F-31059 Toulouse, France;

family: Caron

full_name: Philippe J. Caron

given: Philippe J.

name: Department of Endocrinology (J.S.B.), Aberdeen Royal Infirmary, Aberdeen AB25 2ZP, United Kingdom;

family: Bevan

full_name: John S. Bevan

given: John S.

name: ENDOC Center for Endocrine Tumors (S.P.), 20357 Hamburg, Germany;

family: Petersenn

full_name: Stephan Petersenn

given: Stephan

name: Department of Endocrinology (D.F.), Derriford Hospital, Plymouth PL6 8DH, United Kingdom;

family: Flanagan

full_name: Daniel Flanagan

given: Daniel

name: Department of Endocrinology, Diabetes, Metabolic Diseases, and Nutrition (A.T.), University of Bordeaux 2, CHU Bordeaux, 33076 Bordeaux, France;

family: Tabarin

full_name: Antoine Tabarin

given: Antoine

name: Department of Endocrinology, Diabetes, and Metabolic Diseases (G.P.), CHU Rouen, 76031 Rouen, France;

family: Prévost

full_name: Gaëtan Prévost

given: Gaëtan

name: Ipsen Pharma (P.M., A.C.), 92100 Boulogne-Billancourt, France

family: Maisonobe

full_name: Pascal Maisonobe

family: Clermont

full_name: Antoine Clermont

journal_name: The Journal of Clinical Endocrinology & Metabolism

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

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: The Endocrine Society

publisher_dissemination: The Endocrine Society

publisher_group: The Endocrine Society

publisher_normalized: The Endocrine Society

title: Tumor Shrinkage With Lanreotide Autogel 120 mg as Primary Therapy in Acromegaly: Results of a Prospective Multicenter Clinical Trial

ReferenceCitation: Caron PJ, Bevan JS, Petersenn S, Houchard A, Sert C, Webb SM; PRIMARYS Investigators Group. Effects of lanreotide Autogel primary therapy on symptoms and quality-of-life in acromegaly: data from the PRIMARYS study. Pituitary. 2016 Apr;19(2):149-57. doi: 10.1007/s11102-015-0693-y.

family: Houchard

full_name: Aude Houchard

given: Aude

family: Sert

full_name: Caroline Sert

given: Caroline

family: Webb

full_name: Susan M. Webb

given: Susan M.

journal_name: Pituitary

evidence: open (via page says license)

license: cc-by

license_normalized: cc-by

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

location_country:
Italy
Netherlands
Finland
France
Czechia
Belgium
Turkey
Germany
United Kingdom

location_facility: Università Federico II di Napoli, Dipartimento di Endocrinologia Molecolare e Clinicae Oncologia

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

location_facility: ENDOC Zentrum für Endokrine Tumoren und Praxis für Endokrinologie, Andrologie und medikamentöse Tumortherapie

location_facility: Università Cattolica del Sacro Cuore, Policlinico A. Gemelli, U.O.C. di Endocrinologia

location_facility: Všeobecná fakultní nemocnice, Karlova Univerzita

title: Phase IIIb, Multicentre, Open-label, Single-arm, Study to Assess the Efficacy and Safety of Lanreotide Autogel 120 mg Administered Every 28 Days as Primary Medical Treatment in Acromegalic Patients With Macroadenoma

summary:
Acromegaly is a chronic disease caused by excessive secretion of growth hormone (GH) and mainly due to benign tumour localized in the pituitary gland.

The disease develops insidiously, causing a gradual progression of symptoms; consequently most patients are diagnosed in their fourth decade of life.

Administration of somatostatin analogues such as lanreotide have been shown to result in normalisation or the decrease of GH and insulin growth factor (IGF-1) levels and improvement of clinical symptoms in acromegalic patients. The purpose of this study is to evaluate whether lanreotide is also effective on tumour volume reduction (tumour shrinkage) and the benefits of this potential tumour shrinkage on disease symptoms and patient's quality of life.


title: Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice Multinational, Prospective, Non-randomized, Multi-centre, Non-interventional Trial

acronym: ENERGY

summary: To evaluate the clinical performance of the PRO-Kinetic ENERGY® coronary bare metal stent system in a patient population within that defined in the Instructions for Use.

ReferenceCitation: Scheinert D, Schulte KL, Zeller T, Lammer J, Tepe G. Paclitaxel-releasing balloon in femoropopliteal lesions using a BTHC excipient: twelve-month results from the BIOLUX P-I randomized trial. J Endovasc Ther. 2015 Feb;22(1):14-21. doi: 10.1177/1526602814564383.

name: Park Hospital and Universitätsklinikum Leipzig, Germany

family: Scheinert

full_name: Dierk Scheinert

given: Dierk

name: Ev. Krankenhaus Königin Elisabeth Herzberge, Berlin, Germany

family: Schulte

full_name: Karl-Ludwig Schulte

given: Karl-Ludwig

name: Universitaets-Herzzentrum Freiburg-Bad Krozingen, Germany

family: Zeller

full_name: Thomas Zeller

given: Thomas

family: Lammer

full_name: Johannes Lammer

given: Johannes

family: Tepe

full_name: Gunnar Tepe

given: Gunnar

journal_name: Journal of Endovascular Therapy

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

title: Paclitaxel-Releasing Balloon in Femoropopliteal Lesions Using a BTHC Excipient

ReferenceCitation: Erbel R, Eggebrecht H, Roguin A, Schroeder E, Philipp S, Heitzer T, Schwacke H, Ayzenberg O, Serra A, Delarche N, Luchner A, Slagboom T; ENERGY Investigators. Prospective, multi-center evaluation of a silicon carbide coated cobalt chromium bare metal stent for percutaneous coronary interventions: two-year results of the ENERGY Registry. Cardiovasc Revasc Med. 2014 Nov-Dec;15(8):381-7. doi: 10.1016/j.carrev.2014.10.002. Epub 2014 Oct 15.

family: Erbel

full_name: Raimund Erbel

given: Raimund

family: Eggebrecht

full_name: Holger Eggebrecht

given: Holger

family: Roguin

full_name: Ariel Roguin

given: Ariel

family: Schroeder

full_name: Erwin Schroeder

given: Erwin

family: Philipp

full_name: Sebastian Philipp

given: Sebastian

family: Heitzer

full_name: Thomas Heitzer

family: Schwacke

full_name: Harald Schwacke

given: Harald

family: Ayzenberg

full_name: Oded Ayzenberg

given: Oded

family: Serra

full_name: Antonio Serra

given: Antonio

family: Delarche

full_name: Nicolas Delarche

given: Nicolas

family: Luchner

full_name: Andreas Luchner

given: Andreas

family: Slagboom

full_name: Ton Slagboom

given: Ton

oa_host_type: publisher

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Prospective, multi-center evaluation of a silicon carbide coated cobalt chromium bare metal stent for percutaneous coronary interventions: Two-year results of the ENERGY Registry

lead_sponsor: Biotronik AG

location_country: Austria Switzerland Netherlands France Israel Ireland Belgium Spain Germany Latvia

location_facility: Cliniques Universitaires UCL de Mont-Godinne

location_facility: Herz- und Diabeteszentrum Nordrhein-Westfalen

location_facility: Charité-Universitätsm. Berlin Campus Charité-Mitte

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Hospital Clinic I Provinvial de Barcelona


type: EudraCT Number

title: A Phase 1 Study of LY3434172, a Bispecific Antibody Monotherapy in Advanced Solid Tumors

summary: The main purpose of this study is to evaluate the safety and tolerability of the study drug LY3434172, a PD-1/PD-L1 bispecific antibody, in participants with advanced solid tumors.

location_country:
France
Belgium
Australia
United States
Korea, Republic of

location_facility: Institut Claudius Regaud - IUCT Oncopole

location_facility: University of Texas MD Anderson Cancer Center


title: CardioMEMS HF System OUS Post Market Study

summary: The purpose of this Post Market Study (PMS) is to evaluate the use of the CardioMEMS HF System in patients with Class III Heart Failure in a commercial setting.

status: Recruiting

enrollment_type: Anticipated

ReferenceCitation: Cowie MR, de Groote P, McKenzie S, Brett ME, Adamson PB; CardioMEMS Post-Market Study Investigators. Rationale and design of the CardioMEMS Post-Market Multinational Clinical Study: COAST. ESC Heart Fail. 2020 Jun;7(3):865-872. doi: 10.1002/ehf2.12646. Epub 2020 Feb 7.

name: Royal Brompton Hospital Imperial College London  Sydney Street London SW3 6LY UK

family: Cowie

full_name: Martin R. Cowie

given: Martin R.

name: Pôle Cardio‐Vasculaire et Pulmonaire, Hôpital Albert Calmette CHRU de Lille  Boulevard du Pr. Jules Leclercq 59037 Lille CEDEX France

family: Groote

full_name: Pascal Groote

given: Pascal

name: The Prince Charles Hospital and Holy Spirit Northside Hospital University of Queensland  Rode Road Chermside QLD 4032 Australia

family: McKenzie

full_name: Scott McKenzie

given: Scott

name: Heart Failure Division Abbott  15900 Valley View Ct. Sylmar CA 91342 United States

family: Brett

full_name: Marie‐Elena Brett

given: Marie‐Elena

family: Adamson

full_name: Philip B. Adamson

given: Philip B.

name: the CardioMEMS Post‐Market Study Investigators

journal_name: ESC Heart Failure

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: Imperial College London - Spiral

repositories_institution:
Imperial College London - Spiral
PubMed Central - Europe PMC

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Rationale and design of the CardioMEMS Post‐Market Multinational Clinical Study: COAST

lead_sponsor: Abbott Medical Devices

location_country:
France
Belgium
Australia
Denmark
United Kingdom

location_facility:
The Prince Charles Hospital
CHRU de Lille
Rigshospitalet
Royal Bromptom Hospital
CHR Citadelle

status_simplified: Ongoing


ReferenceType: background

ReferenceCitation: Steensma DP, Tefferi A. The myelodysplastic syndrome(s): a perspective and review highlighting current controversies. Leuk Res. 2003 Feb;27(2):95-120. Review. Erratum in: Leuk Res. 2005 Jan;29(1):117.

ReferenceCitation: Greenberg P, Cox C, LeBeau MM, Fenaux P, Morel P, Sanz G, Sanz M, Vallespi T, Hamblin T, Oscier D, Ohyashiki K, Toyama K, Aul C, Mufti G, Bennett J. International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood. 1997 Mar 15;89(6):2079-88. Erratum in: Blood 1998 Feb 1;91(3):1100.

ReferenceCitation: List AF. New approaches to the treatment of myelodysplasia. Oncologist. 2002;7 Suppl 1:39-49. Review.

ReferenceCitation: McHugh SM, Deighton J, Stewart AG, Lachmann PJ, Ewan PW. Bee venom immunotherapy induces a shift in cytokine responses from a TH-2 to a TH-1 dominant pattern: comparison of rush and conventional immunotherapy. Clin Exp Allergy. 1995 Sep;25(9):828-38.

ReferenceCitation: Bellamy WT. Expression of vascular endothelial growth factor and its receptors in multiple myeloma and other hematopoietic malignancies. Semin Oncol. 2001 Dec;28(6):551-9. Review.

ReferenceCitation: Bartlett JB, Dredge K, Dalgleish AG. The evolution of thalidomide and its IMiD derivatives as anticancer agents. Nat Rev Cancer. 2004 Apr;4(4):314-22. doi: 10.1038/nrc1323. Review.

ReferenceCitation: List A, Kurtin S, Roe DJ, Buresh A, Mahadevan D, Fuchs D, Rimsza L, Heaton R, Knight R, Zeldis JB. Efficacy of lenalidomide in myelodysplastic syndromes. N Engl J Med. 2005 Feb 10;352(6):549-57.

ReferenceCitation: List A, Dewald G, Bennett J, Giagounidis A, Raza A, Feldman E, Powell B, Greenberg P, Thomas D, Stone R, Reeder C, Wride K, Patin J, Schmidt M, Zeldis J, Knight R; Myelodysplastic Syndrome-003 Study Investigators. Lenalidomide in the myelodysplastic syndrome with chromosome 5q deletion. N Engl J Med. 2006 Oct 5;355(14):1456-65.

ReferenceCitation: List A, Gordon W, Dewald G, Bennett J, Giagounidis A, Raza A et al. Long-term clinical benefit of lenalidomide (Revlimid) treatment in patients with myelodysplastic syndrome and chromosome deletion 5q [Abstract]. Blood. 2006;108:251A.

ReferenceCitation: Mallo M, Cervera J et al. Prognostic impact of additional chromosomal aberrations to 5q- in patients with primary myelodysplastic syndromes. Oral comunication, 0906, 13th Congress of the European Hematology Association. Haematologica | 2008; 93(s1), pag. 360

ReferenceCitation: Fenaux P, Kelaidi C. Treatment of the 5q- syndrome. Hematology Am Soc Hematol Educ Program. 2006:192-8. Review.

ReferenceCitation: Kelaidi C, Eclache V, Fenaux P. The role of lenalidomide in the management of myelodysplasia with del 5q. Br J Haematol. 2008 Feb;140(3):267-78. doi: 10.1111/j.1365-2141.2007.06910.x. Review.

ReferenceCitation: List, AF. Active treatment-improving outcomes in del 5q patients. Leukemia Research, (2007)31(Suppl. 1), S9.

status: Active, not recruiting

lead_sponsor: Fundación General de la Universidad de Salamanca

location_country: Germany France Spain

acronym: SINTRA-REV

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden

location_facility: Hospital Universitari Germans Trias i Pujol (ICO Badalona)

location_facility: Instituto Catalán de Oncología de Gerona

location_facility: Hospital General Universitario José Maria Morales Meseguer

location_facility: Centre Hospitalier Universitaire Brabois

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Centre Hospitalier Universitaire de Nîmes

location_facility: Centre Hospitalier Universitaire d'Angers

source: euctr

title: Multicenter, Randomized, Double-blind, Phase III Study of REVLIMID (Lenalidomide) Versus Placebo in Patients With Low Risk Myelodysplastic Syndrome (Low and Intermediate-1 IPSS) With Alteration in 5q- and Anemia Without the Need of Transfusion.

summary:
Trial Design:

This clinical trial is a phase III multicenter, randomized, double blind and controlled with placebo trial and with two arms designed to assess the efficiency and toxicity of the scheme Lenalidomide versus observation in a series of 60 patients with low risk myelodysplastic syndrome associated to 5q deletion with anemia (Hb≤12g/dL) but without the need of transfusion. Patients are randomized in the study in a 2:1 ratio. They will receive treatment for 104 weeks until progression of the disease, which implies that the patient suffering from anemia due to myelodysplastic syndrome requires transfusion of at least 2 UCH/56 days (2 months) with a minimum follow up of 112 days (4 months), or unacceptable toxicity.

Disease:

Low risk myelodysplastic syndrome associated to the loss of 5q without transfusion requirements.

Total number of patients:

In total 60 patients will be included, 40 assigned to the treatment branch and 20 to the placebo branch.

Calendar:

First patient first visit: February 2010, and Last patient last visit expected in February 2016. (Recruitment was initially expected to take place over a period of 24 months and was expected to be finished in February 2012, but due to low rate of recruitment it was extended until the population sample is included in the trial).


title: Evaluation and Prospective Validation of Clini-biological Parameters Including Initial Hemostasis, Which Improve the Prediction of Death at 1 Month Among Patients Entering Intensive Care Units for Septic Shock

acronym: SEPSICOAG

summary:
A prognostic score was proposed by the investigative team to predict death at 1 month. This score is based on certain biological markers, scored under emergency conditions in the first 24 hours of routine clinical practice management for septic shock.

The main objective of this multicenter study is to validate the performance of the score in terms of area under the ROC curve and negative predictive value.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: CHU de Clermont Ferrand - Hôpital Estaing

intervention_type: Biological


title: Open-Label Safety Study of a 1-Year 20 mg Dose Regimen of Tasimelteon for Treatment of Non-24-Hour-Sleep-Wake Disorder (N24HSWD) in Blind Individuals With No Light Perception

summary: The purpose of this study is to evaluate the safety of a one year open-label treatment of tasimelteon in male and female subjects with Non-24-Hour Sleep-Wake Disorder.

lead_sponsor: Vanda Pharmaceuticals


title: Transversal Multiaxial Evaluation and 5-year Follow-up of a Cohort of French Gamblers.

summary: This study is divided into two stages. The first stage is a transversal study and corresponds to the recruitment of participants, which will last about two years. Three groups of gamblers will be constituted : Non-problematic gamblers (NPG), Problematic gamblers Not in Care (PGNC) and Problematic gamblers in Care (PGC).The second stage is a prospective 5-year follow-up study of the cohort (only the initial NPG and PGNC groups are concerned by the follow-up study), that consists on an annual follow-up evaluation. The main objective of the first stage of the study is to compare the characteristics of the three groups of gamblers on some socio-demographic and clinical data. These comparisons will allow us to identify, among all data, those that will be most likely to explain the evolution of the practice of gambling (appearance or resolution of a gambling problem), and recourse to specific care. These such isolated data will be tested in the second stage of the study, in order to determine those that are predictive factors of three steps of the gambling course of some gamblers : evolution of a controlled gambling practice into a problematic gambling practice, resolution of the problematic gambling practice without intervention of care, and first recourse to specific care.

ReferenceCitation: Guillou Landreat M, Chereau Boudet I, Perrot B, Romo L, Codina I, Magalon D, Fatseas M, Luquiens A, Brousse G, Challet-Bouju G, Grall-Bronnec M; JEU-Group. Problem and non-problem gamblers: a cross-sectional clustering study by gambling characteristics. BMJ Open. 2020 Feb 18;10(2):e030424. doi: 10.1136/bmjopen-2019-030424.

family: Guillou Landreat

full_name: Morgane Guillou Landreat

given: Morgane

family: Chereau Boudet

full_name: Isabelle Chereau Boudet

given: Isabelle

family: Perrot

full_name: Bastien Perrot

given: Bastien

family: Romo

full_name: Lucia Romo

given: Lucia

family: Codina

full_name: Irene Codina

given: Irene

family: Magalon

full_name: David Magalon

given: David

family: Fatseas

full_name: Melina Fatseas

given: Melina

family: Luquiens

full_name: Amandine Luquiens

given: Amandine

family: Brousse

full_name: Georges Brousse

given: Georges

family: Challet-Bouju

full_name: Gaëlle Challet-Bouju

given: Gaëlle

family: Grall-Bronnec

full_name: Marie Grall-Bronnec

given: Marie

currency_apc_doaj: GBP

journal_name: BMJ Open

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

repositories:
HAL
PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Challet-Bouju G, Hardouin JB, Vénisse JL, Romo L, Valleur M, Magalon D, Fatséas M, Chéreau-Boudet I, Gorsane MA; JEU Group, Grall-Bronnec M. Study protocol: the JEU cohort study--transversal multiaxial evaluation and 5-year follow-up of a cohort of French gamblers. BMC Psychiatry. 2014 Aug 20;14:226. doi: 10.1186/s12888-014-0226-7.

family: Hardouin

full_name: Jean-Benoit Hardouin

title: Study protocol: the JEU cohort study – transversal multiaxial evaluation and 5-year follow-up of a cohort of French gamblers

location_facility:
Clermont Ferrand university Hospital
Louis Mourier hospital
Marseille University Hospital
Nantes University Hospital
Marmottan hospital
Bordeaux University Hospital
Paul Brousse hospital


title: GNE-Myopathy Disease Monitoring Program (GNEM-DMP): A Registry and Prospective Observational Natural History Study to Assess GNE Myopathy or Hereditary Inclusion Body Myopathy (HIBM)

summary: HIBM is a severe progressive myopathy that typically presents in early adulthood as weakness in the distal muscles of the lower extremities and progresses proximally, leading to a loss of muscle strength and function, and ultimately a wheelchair-bound state. The rate of progression is gradual and variable over the course of 10-20 years or longer. There is a need to better understand the disease-specific features of HIBM to heighten disease awareness; facilitate early diagnosis; identify patients; expand knowledge of the clinical presentation, progression and variation of the disease; identify and validate biomarkers and other efficacy measures; inform on the design and interpretation of clinical studies of investigational products; and eventually to optimize patient management.

lead_sponsor: Ultragenyx Pharmaceutical Inc

location_country:
France
Bulgaria
United States
United Kingdom
Canada

location_facility: Bulgarian Neuromuscular Disease Association


title: A Multicenter, Open-Label, Crossover Trial to Assess Non-Inferiority of Dual Energy Contrast-Enhanced Digital Mammography (DE-CEDM) Compared to Contrast-Enhanced Breast Magnetic Resonance Imaging (CE-BMRI) for Identifying a Change in Patient Management in Women With Newly Diagnosed Breast Cancer

summary: Enrolled women will undergo a bilateral Contrast-Enhanced Breast Magnetic Resonance Imaging (CE-BMRI) as per usual clinical practice within 30 days of breast cancer diagnosis. Up to 8 weeks after the CE-BMRI exam, subjects will undergo a Dual Energy Contrast Enhanced Digital Mammograph (DE-CEDM).

lead_sponsor: GE Healthcare

location_country:
United States
Germany
France
Belgium
Canada

location_facility:
Sunnybrook Health Science Centre
Institut Goustave Roussy
AZ St-Jan Brugge AV
Seattle Cancer Care Alliance
Institut fur Radiologie, Charite


title: Prospective Randomized Double Blind Study Comparing the Effect of Oropharyngeal Decontamination by Povidone-iodine to Placebo on Ventilator-associated Pneumonia in Patients With Head Trauma or Cerebral Hemorrhage

acronym: SPIRIT-ICU

summary: Head trauma and severe cerebral hemorrhage are major risk factors for development of ventilator-associated pneumonia. In a previous open labelled, single center study the investigators showed that repeated oropharyngeal decontamination with povidone-iodine may be an effective strategy to decrease the prevalence of ventilator-associated pneumonia in patients with head trauma. The present study aims to confirm these results in a multicenter, double blind study including patients suffering from head trauma or cerebral hemorrhage.

ReferenceCitation: Seguin P, Laviolle B, Dahyot-Fizelier C, Dumont R, Veber B, Gergaud S, Asehnoune K, Mimoz O, Donnio PY, Bellissant E, Malledant Y; Study of Povidone Iodine to Reduce Pulmonary Infection in Head Trauma and Cerebral Hemorrhage Patients (SPIRIT) ICU Study Group; AtlanRéa Group. Effect of oropharyngeal povidone-iodine preventive oral care on ventilator-associated pneumonia in severely brain-injured or cerebral hemorrhage patients: a multicenter, randomized controlled trial. Crit Care Med. 2014 Jan;42(1):1-8. doi: 10.1097/CCM.0b013e3182a2770f.

family: Seguin

full_name: Philippe Seguin

given: Philippe

family: Laviolle

full_name: Bruno Laviolle

given: Bruno

family: Dahyot-Fizelier

full_name: Claire Dahyot-Fizelier

given: Claire

family: Dumont

full_name: Romain Dumont

given: Romain

family: Veber

full_name: Benoit Veber

given: Benoit

family: Gergaud

full_name: Soizic Gergaud

given: Soizic

family: Asehnoune

full_name: Karim Asehnoune

given: Karim

family: Mimoz

full_name: Olivier Mimoz

given: Olivier

family: Donnio

full_name: Pierre-Yves Donnio

given: Pierre-Yves

family: Bellissant

full_name: Eric Bellissant

given: Eric

family: Malledant

full_name: Yannick Malledant

given: Yannick

journal_name: Critical Care Medicine

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Effect of Oropharyngeal Povidone-Iodine Preventive Oral Care on Ventilator-Associated Pneumonia in Severely Brain-Injured or Cerebral Hemorrhage Patients

location_facility: Réanimation chirurgical Hopital Hotel Dieu-CHU de Nantes

location_facility: Surgical Intensive Care Unit - CHU de Rennes


title: A Prospective, Observational Study in Patients With Late-Onset Pompe Disease

summary:
Pompe disease (also known as glycogen storage disease type II, "GSD-II") is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function.

This study is being conducted to collect prospective, observational data on patients with late-onset Pompe disease. Approximately 60 subjects with late-onset Pompe disease will be enrolled.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
United States
France
Netherlands

location_facility: Institut de Myologie, Groupe Hospitalier Pitie-Salpetriere, Batimant Babinski

location_facility: Children's Hospital & Regional Medical Center


lead_sponsor: Alexion Pharmaceuticals

location_country:
Italy
France
Japan
Spain
United States
Korea, Republic of

acronym: Ravulizumab in TMA after HSCT

location_facility:
Clinical Trial Site
Clinical Study Site
Clinical Trial Manager

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Ravulizumab in Adult and Adolescent Participants Who Have Thrombotic Microangiopathy (TMA) After Hematopoietic Stem Cell Transplant (HSCT)

summary: This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab in adult and adolescent participants with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). In Stage 1, an open-label, single-arm period, the dosing regimen will be confirmed. In Stage 2, participants will be randomized to receive either blinded ravulizumab plus best supportive care or matching placebo plus best supportive care. The treatment period is 26 weeks (open-label for Stage 1, and randomized, double-blind, and placebo-controlled for Stage 2) followed by a 26-week follow-up period.


location_country:
Italy
Brazil
France
Japan
Thailand
Spain
United States
United Kingdom
Korea, Republic of

title: A Phase 3 Study of Danicopan (ALXN2040) as Add-on Therapy to a C5 Inhibitor (Eculizumab or Ravulizumab) in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascular Hemolysis (EVH)

summary: The main objective of this study is to evaluate the efficacy of danicopan as add-on therapy to a complement component 5 (C5) inhibitor (eculizumab or ravulizumab) in participants with PNH who have clinically evident EVH.


title: Early Identification of SEPsis SIGNs in Emergency Department

acronym: SepSIGN

summary: Objective of SepSIGN project is to validate biomarkers able to predict the clinical worsening of patients freshly admitted at Emergency Department. Targeted population is adult patients, freshly admitted at ED, with a suspected or confirmed infection.

lead_sponsor: BioMérieux

location_country:
United States
Monaco
France

location_facility: University of Colorado School of Medicine


ReferenceCitation: Novello S, Mazières J, Oh IJ, de Castro J, Migliorino MR, Helland Å, Dziadziuszko R, Griesinger F, Kotb A, Zeaiter A, Cardona A, Balas B, Johannsdottir HK, Das-Gupta A, Wolf J. Alectinib versus chemotherapy in crizotinib-pretreated anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer: results from the phase III ALUR study. Ann Oncol. 2018 Jun 1;29(6):1409-1416. doi: 10.1093/annonc/mdy121.

family: Novello

full_name: S. Novello

given: S.

family: Mazières

full_name: J. Mazières

given: J.

family: Oh

full_name: I.-J. Oh

family: de Castro

full_name: J. de Castro

family: Migliorino

full_name: M.R. Migliorino

family: Helland

full_name: Å. Helland

given: Å.

family: Dziadziuszko

full_name: R. Dziadziuszko

given: R.

family: Griesinger

full_name: F. Griesinger

given: F.

family: Kotb

full_name: A. Kotb

given: A.

family: Zeaiter

full_name: A. Zeaiter

family: Cardona

full_name: A. Cardona

family: Balas

full_name: B. Balas

given: B.

family: Johannsdottir

full_name: H.K. Johannsdottir

family: Das-Gupta

full_name: A. Das-Gupta

family: Wolf

full_name: J. Wolf

journal_name: Annals of Oncology

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Hong Kong
Spain
France
Bulgaria
Poland
Slovakia
Norway
Hungary
Belgium
Russian Federation
Portugal
Turkey
Germany
Korea, Republic of

location_facility: CHVNG/E_Unidade 1; Servico de Pneumologia

location_facility: Evang. Lungenklinik Berlin Klinik für Pneumologie

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale; U.O.C. Oncologia Medica Toraco Polmonare

location_facility: Semmelweis Egyetem X; Pulmonologiai Klinika

location_facility: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

location_facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

location_facility: A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii

location_facility: Hospital de Cruces; Servicio de Oncologia

location_facility: FSBI"National Medical Research Center of Oncology named after N.N.Petrov" MHRF

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Hopital Du Haut Leveque; Service Des Maladies Respiratoires

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Irccs Ospedale San Raffaele;Oncologia Medica

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati

location_facility: Korea University Guro Hospital; Oncology

location_facility: Istanbul Uni Capa Medical Faculty; Inst. of Oncology

location_facility: Ege University Medical Faculty; Chest Diseases

location_facility: Adana Acıbadem Hospital Oncology Department

location_facility: Queen Elizabeth Hospital; Clinical Oncology

location_facility: FNsP F. D. Roosevelta Banska Bystrica, II.Ocna klinika SZU

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Queen Mary Hospital; Dept. of Clinical Oncology

location_facility: Oslo Universitetssykehus HF; Radiumhospitalet

location_facility: Main Military Clinical Hospital named after N.N. Burdenko

location_facility: Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

location_facility: Hopital Bichat Claude Bernard ; Service de Pneumologie

location_facility: POLICLINICO RODOLICO, U.O. di Oncologia Medica

location_facility: Chonnam National University Hwasun Hospital

location_facility: Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Zentralklinik Bad Berka GmbH; Abteilung Onkologie und Hämatologie

location_facility: AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico

location_facility: Pius-Hospital; Klinik fuer Haematologie und Onkologie

title: Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase-Positive Advanced Non Small Cell Lung Cancer Patients Previously Treated With Platinum-Based Chemotherapy and Crizotinib

summary: This randomized active-controlled multicenter Phase III open-label study will evaluate and compare between treatment groups the efficacy of alectinib versus chemotherapy in participants with ALK-positive advanced NSCLC who were previously treated with chemotherapy and crizotinib, as measured by investigator-assessed progression-free survival (PFS) and to evaluate and compare between treatment groups the central nervous system (CNS) objective response rate (C-ORR) in participants with measurable CNS metastases at baseline, as assessed by an Independent Review Committee (IRC).


title: A Randomized, Open-Label, Multicenter Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab

summary: This is a randomized, open-label, active-control, multicenter Phase 2 study of VELCADE+fludarabine in comparison with rituximab+fludarabine in subjects with relapsed advanced follicular lymphoma. Eligible subjects will be randomized in a 1:1 ratio between the 2 treatment arms (55 subjects per arm).

lead_sponsor: Millennium Pharmaceuticals, Inc.

location_country: Italy Switzerland France Greece Israel Spain Germany

location_facility: Laiko Hospital - 1st Dept. of Propaedeutic Internal Medicine

location_facility: Clinica di Ematologia DIMI - A.O. Ospedale S. Martino

location_facility: Hospital Clinico Universitario Salamanca, Servicio de Hematología, 4º Planta

location_facility: Azienda Ospedaliera Santa Maria di Terni

location_facility: Rabin Medical Center - Hematology Institute

location_facility: Haemek Medical Center - Hematology Department

location_facility: Rambam Med.Center - Hematology Institute

location_facility: University Hospital of Heraklion- Department of Hematology

location_facility: Istituto Di Ematologia E Oncologia Medica - L.A. Seragnoli - Policlinico S.Orsola Malpighi

location_facility: Hospital Puerta del Mar, Secretaría de Hematología, 1ª planta

location_facility: Kantonsspital St.Gallen Department of Oncology/Hematology

location_facility: Universitatsklinikum Gottingen, zentrum Innere medicin

location_facility: Hospital General Universitario Morales Meseguer, Secretaría de Hematología, 1ª planta

location_facility: Università La Sapienza, Dipartimento di Biotecnologie Cellulari ed Ematologia, Via Benevento, 6

location_facility: Klinikum der Stadt Villinger-Schwenningen

location_facility: Divisione di Ematologia Ospedale San Bortolo - Hematology

location_facility: Hadassah University Hospital - Hematology Department


title: Randomized Phase III Trial Comparing Induction Chemotherapy Followed by Radiotherapy to Concomitant Chemoradiotherapy for Laryngeal Preservation in T3MO Pyriform Sinus Carcinoma

summary:
Patients were eligible if they had biopsy proven, previously untreated T3 with fixed cord involvement squamous cell carcinoma of the pyriform sinus.

The study compare conventional radiotherapy with concurrent cisplatin to induction chemotherapy with cisplatin fluorouracil followed by conventional radiotherapy. The primary end point was the preservation of the larynx. The secondary end points included toxicity, causes of death and survival rates.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: LACHEB CALLOC'H PIGNAT Crampette Lallemant LITAS MAYAUD


title: Extension Study to Establish Safety, Pharmacokinetics and Efficacy of BIBF 1120 in Patients With Previous Clinical Benefit From BIBF 1120

summary:
The primary objective of this trial is to evaluate the long-term safety of BIBF 1120 in terms of incidence and intensity of Adverse Events and changes in safety laboratory parameters.

Secondary objectives are the collection of further safety data (vital signs), efficacy data and the determination of pharmacokinetic characteristics during long-term therapy with BIBF 1120.

lead_sponsor: Boehringer Ingelheim

location_country: Germany France

location_facility: 1199.16.3313A Boehringer Ingelheim Investigational Site

location_facility: 1199.16.49005 Boehringer Ingelheim Investigational Site

location_facility: 1199.16.49001 Boehringer Ingelheim Investigational Site

location_facility: 1199.16.49004 Boehringer Ingelheim Investigational Site

location_facility: 1199.16.3306A Boehringer Ingelheim Investigational Site

location_facility: 1199.16.3313E Boehringer Ingelheim Investigational Site

location_facility: 1199.16.3312A Boehringer Ingelheim Investigational Site

location_facility: 1199.16.3311B Boehringer Ingelheim Investigational Site

location_facility: 1199.16.49008 Boehringer Ingelheim Investigational Site

location_facility: 1199.16.3311A Boehringer Ingelheim Investigational Site

location_facility: 1199.16.3302A Boehringer Ingelheim Investigational Site


title: A 24-Week Multicentre, Randomized, Double-Blind, Controlled, Parallel Group Non-Inferiority Study to Assess the Efficacy and Safety of Olmesartan Medoxomil Versus Candesartan Cilexetil in Patients With Symptomatic Heart Failure (NYHA II-IV)

acronym: OLMEBNP

summary: This study will compare olmesartan medoxomil to candesartan cilexetil in reducing BNP, a prognostic biomarker of heart failure, at week 24

ipd_sharing: Yes

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

location_country: Germany France Netherlands


title: Interest of Treatment of Polytraumatisms With Corticoids (Hydrocortisone) for Patient With Relative Adrenocortical Insufficiency

acronym: Hypolyte

summary: Interest of treatment of polytraumatisms with corticoids (hydrocortisone) for patient with relative adrenocortical insufficiency on frequency of nosocomial infection, and hemodynamic complications and organs injuries.

ReferenceCitation: Le Bras M, Roquilly A, Deckert V, Langhi C, Feuillet F, Sébille V, Mahé PJ, Bach K, Masson D, Lagrost L, Costet P, Asehnoune K, Cariou B. Plasma PCSK9 is a late biomarker of severity in patients with severe trauma injury. J Clin Endocrinol Metab. 2013 Apr;98(4):E732-6. doi: 10.1210/jc.2012-4236. Epub 2013 Feb 28.

name: Institut National de la Santé et de la Recherche Médicale (INSERM) Unité Mixte de Recherche (UMR) 1087 (M.L.B., C.L., P.C., B.C.), F-44000 Nantes, France

family: Le Bras

full_name: Maëlle Le Bras

given: Maëlle

name: Departments of Anesthesiology and Intensive Care Medicine (A.R., P.-J.M., K.A.), University Hospital of Nantes, F-44000 Nantes, France

family: Roquilly

full_name: Antoine Roquilly

given: Antoine

name: INSERM UMR 866-Lipides (V.D., L.L.), Nutrition et Cancer, Faculté de Médecine, Universite de Bourgogne, F-21079 Dijon, France

family: Deckert

full_name: Valérie Deckert

given: Valérie

family: Langhi

full_name: Cédric Langhi

given: Cédric

name: Department of Biostatistics and Biometry (F.F., V.S.), University of Nantes, F-44000 Nantes, France

family: Feuillet

full_name: Fanny Feuillet

given: Fanny

family: Sébille

full_name: Véronique Sébille

given: Véronique

family: Mahé

full_name: Pierre-Joachim Mahé

given: Pierre-Joachim

name: Department of Biology (K.B., D.M.), University Hospital of Nantes, F-44000 Nantes, France

family: Bach

full_name: Kalyane Bach

given: Kalyane

family: Masson

full_name: Damien Masson

given: Damien

family: Lagrost

full_name: Laurent Lagrost

given: Laurent

family: Costet

full_name: Philippe Costet

given: Philippe

family: Asehnoune

full_name: Karim Asehnoune

name: Department of Endocrinology, l'Institut du Thorax (M.L.B., B.C.), University Hospital of Nantes, F-44000 Nantes, France

family: Cariou

full_name: Bertrand Cariou

given: Bertrand

title: Plasma PCSK9 Is a Late Biomarker of Severity in Patients With Severe Trauma Injury

ReferenceCitation: Asehnoune K, Mahe PJ, Seguin P, Jaber S, Jung B, Guitton C, Chatel-Josse N, Subileau A, Tellier AC, Masson F, Renard B, Malledant Y, Lejus C, Volteau C, Sébille V, Roquilly A. Etomidate increases susceptibility to pneumonia in trauma patients. Intensive Care Med. 2012 Oct;38(10):1673-82. Epub 2012 Jul 10.

ReferenceCitation: Roquilly A, Mahe PJ, Seguin P, Guitton C, Floch H, Tellier AC, Merson L, Renard B, Malledant Y, Flet L, Sebille V, Volteau C, Masson D, Nguyen JM, Lejus C, Asehnoune K. Hydrocortisone therapy for patients with multiple trauma: the randomized controlled HYPOLYTE study. JAMA. 2011 Mar 23;305(12):1201-9. doi: 10.1001/jama.2011.360.

journal_name: JAMA

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Hydrocortisone Therapy for Patients With Multiple Trauma

lead_sponsor: Nantes University Hospital

location_facility:
CHU Morvan de Brest
CHU Caen
CHU Pontchaillou
CHU Bordeaux
CH La Roche Sur Yon
Hôtel Dieu
CHU Trousseau


type: Registry Identifier

title: A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphataemic Chronic Kidney Disease (CKD) Patients Not on Dialysis

acronym: ASPIRE

summary: Approximately 207 hyperphosphatemic CKD patients not on dialysis will be entered into this study at approximately 50 sites within approximately 9 European countries. The purpose of this study is to determine if sevelamer carbonate tablets dosed three times a day (TID) is a safe and effective treatment for the control of serum phosphorous levels in hyperphosphatemic CKD patients not on dialysis. Total length of participation is approximately 24 weeks.

location_country: Italy Austria Sweden Spain France Greece Hungary Portugal Germany

location_facility: Universitätsklinik für Innere Medizin III, Klinische Abteilung für Nephrologie und Dialyse

location_facility: Servicio de nefrología Hospital de Galdakao

location_facility: Krankenhaus der Elisabethinen Linz, 3. Abteilung Schwerpunkt Nephrologie

location_facility: Hospital de São João EPE - Serviço de Nefrologia

location_facility: Service de Néphrologie Hémodialyse Clinique de l'Orangerie

location_facility: Hôpital Pellegrin Service de Néphrologie

location_facility: Servicio de Nefrología, Hospital Universitario Dr Peset,

location_facility: Fondazione Salvatore Maugeri, Divisione Nefrologia ed Emodialisi

location_facility: Centro Hospitalar de Coimbra - Serviço de Nefrologia

location_facility: Unita' Operativa Complessa Di Nefrologia e Dialisi San Camillo Forlanini

location_facility: Njurmedicinska Kliniken, Karolinska Universitetssjukhuset, Solna

location_facility: Kaposi Mór County Hospital Department of Nephrology

location_facility: Uniklinik für Innere Medizin IV, Nephrologie und Hypertensiologie, Zentrum für Innere Medizin, Medizinische Universität Innsbruck

location_facility: Universitätsklinik für Innere Medizin, Klinische Abteilung für Nephrologie und Hämodialyse

location_facility: Klinikum rechts der Isar der TU München, Nephrologie

location_facility: Hôpital Européen G. Pompidou Département de Physiologie - Explorations Fonctionnelles et Radio-Isotopes

location_facility: Servicio de nefrología Fundacion Puigvert

location_facility: Department of Nephrology Sahlgrenska University Hospital

location_facility: Servicio de nefrología H. Arquitecto Marcide

location_facility: Szekszárd EuroCare Dialysis Centre Number 7

location_facility: Petz Aladár County Teaching hospital, Department ofimmunonephrology and hypertension

location_facility: Servicio de nefrología Fundación Hospital Alcorcón

location_facility: Hospital da Universidade de Coimbra - Serviço de Nefrologia, Av.


title: Phase II Study Evaluating the Effectiveness of the Association of Chemotherapy LV5FU2 Simplified and Cetuximab With Intra-arterial Hepatic Chemotherapy Using Oxaliplatin in Patients With Colorectal Cancer and Nonresectable Hepatic Metastases

summary:
RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one drug (combination chemotherapy) and giving them together with cetuximab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving leucovorin together with fluorouracil, cetuximab, and oxaliplatin works in treating patients with stage IV colorectal cancer and liver metastases that cannot be removed by surgery.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc


ReferenceCitation: Niskanen L, Leiter LA, Franek E, Weng J, Damci T, Muñoz-Torres M, Donnet JP, Endahl L, Skjøth TV, Vaag A. Comparison of a soluble co-formulation of insulin degludec/insulin aspart vs biphasic insulin aspart 30 in type 2 diabetes: a randomised trial. Eur J Endocrinol. 2012 Aug;167(2):287-94. doi: 10.1530/EJE-12-0293. Epub 2012 Jun 1. Erratum in: Eur J Endocrinol. 2012 Sep;167(3):453.

family: Niskanen

full_name: Leo Niskanen

given: Leo

family: Leiter

full_name: Lawrence A Leiter

given: Lawrence A

family: Franek

full_name: Edward Franek

given: Edward

family: Weng

full_name: Jianping Weng

given: Jianping

family: Damci

full_name: Taner Damci

given: Taner

family: Muñoz-Torres

full_name: Manuel Muñoz-Torres

given: Manuel

family: Donnet

full_name: Jean-Paul Donnet

given: Jean-Paul

family: Endahl

full_name: Lars Endahl

given: Lars

family: Skjøth

full_name: Trine Vang Skjøth

given: Trine Vang

family: Vaag

full_name: Allan Vaag

given: Allan

journal_name: European Journal of Endocrinology

license: implied-oa

license_normalized: implied-oa

publisher: Bioscientifica

publisher_dissemination: Bioscientifica

publisher_group: Bioscientifica

publisher_normalized: Bioscientifica

ReferenceCitation: Ma Z, Parkner T, Christiansen JS, Laursen T. IDegAsp: a novel soluble insulin analogs combination. Expert Opin Biol Ther. 2012 Nov;12(11):1533-40. doi: 10.1517/14712598.2012.722203. Epub 2012 Sep 4. Review.

family: Ma

full_name: Zhulin Ma

given: Zhulin

family: Parkner

full_name: Tina Parkner

given: Tina

family: Christiansen

full_name: Jens Sandahl Christiansen

given: Jens Sandahl

family: Laursen

full_name: Torben Laursen

given: Torben

journal_name: Expert Opinion on Biological Therapy

publisher: Informa Healthcare

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: Novo Nordisk A/S

title: A 16 Week Randomised, Open Labelled, 3-armed, Parallel Group, Treat-to-target Trial Comparing Twice Daily (BID) Injections of SIAC 30 (B), SIAC 45 (B) and NovoMix®30, All in Combination With Metformin in Subjects With Type 2 Diabetes Failing on OAD Treatment

summary: This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (Soluble Insulin Analogue Combination [SIAC], insulin degludec/insulin aspart) formulations with each other and with biphasic insulin aspart 30, all in combination with metformin in insulin naive subjects with type 2 diabetes.


title: A Phase IV Randomised, Double-blind, Placebo-controlled, Dose Titration Trial With 0.125-0.75 mg/Day Pramipexole (Sifrol®, Mirapexin®) Orally for 12 Weeks to Investigate the Safety and Efficacy in Out-patients With Idiopathic Restless Legs Syndrome Associated With Mood Disturbances

summary: The primary objective of this study is to determine the efficacy of pramipexole 0.125 mg to 0.75 mg daily versus placebo on RLS symptoms and on associated mood disturbances and depressive symptoms, after 12 weeks of treatment

ReferenceCitation: Hornyak M, Sohr M, Busse M; 604 and 615 Study Groups. Evaluation of painful sensory symptoms in restless legs syndrome: experience from two clinical trials. Sleep Med. 2011 Feb;12(2):186-9. doi: 10.1016/j.sleep.2010.11.007. Epub 2011 Jan 21.

family: Hornyak

full_name: Magdolna Hornyak

given: Magdolna

family: Sohr

full_name: Mandy Sohr

given: Mandy

family: Busse

full_name: Michael Busse

given: Michael

journal_name: Sleep Medicine

title: Evaluation of painful sensory symptoms in restless legs syndrome: Experience from two clinical trials

location_country:
Italy
Sweden
Finland
France
Ireland
Spain
Germany
United Kingdom
Korea, Republic of

location_facility: 248.604.3301A HOP Le Vinatier,Psychiat,Bron

location_facility: 248.604.82003 Boehringer Ingelheim Investigational Site

location_facility: 248.604.3908 Azienda Sanitaria San Giovanni Battista

location_facility: 248.604.82001 Boehringer Ingelheim Investigational Site

location_facility: 248.604.35302 Boehringer Ingelheim Investigational Site

location_facility: 248.604.3909 IRCCS Fondazione "Salvatore Maugeri"

location_facility: 248.604.44009 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4908 Boehringer Ingelheim Investigational Site

location_facility: 248.604.44006 Boehringer Ingelheim Investigational Site

location_facility: 248.604.44001 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4903 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4906 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4909 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4905 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4910 Boehringer Ingelheim Investigational Site

location_facility: 248.604.44002 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4605 Boehringer Ingelheim Investigational Site

location_facility: 248.604.44005 Boehringer Ingelheim Investigational Site

location_facility: 248.604.35802 Boehringer Ingelheim Investigational Site

location_facility: 248.604.82002 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4901 Boehringer Ingelheim Investigational Site

location_facility: 248.604.35803 Boehringer Ingelheim Investigational Site

location_facility: 248.604.44007 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4601 Boehringer Ingelheim Investigational Site

location_facility: 248.604.35801 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4907 Boehringer Ingelheim Investigational Site

location_facility: 248.604.3901 Università degli Studi di Bologna

location_facility: 248.604.4902 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4604 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4606 Boehringer Ingelheim Investigational Site

location_facility: 248.604.44004 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4904 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4911 Boehringer Ingelheim Investigational Site

location_facility: 248.604.82004 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4603 Boehringer Ingelheim Investigational Site

location_facility: 248.604.4602 Boehringer Ingelheim Investigational Site

location_facility: 248.604.35805 Boehringer Ingelheim Investigational Site


title: An Open-label, Randomized Study of Dasatinib vs High-dose (800-mg) Imatinib in the Treatment of Subjects With Chronic Phase Chronic Myeloid Leukemia Who Have Had a Suboptimal Response After at Least 3 Months of Therapy With 400 mg Imatinib

summary: The purpose of this study is to compare the efficacy of dasatinib with that of high-dose (800-mg) imatinib in participants with chronic phase chronic myeloid leukemia who achieved only a suboptimal response after at least 3 months of monotherapy with 400-mg imatinib. The safety of these treatments will also be evaluated.

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Sweden
Spain
Finland
France
Norway
Belgium
Russian Federation
Portugal
Germany
United Kingdom


title: A Multicenter, Open-label Phase I/II Trial of the Safety and Efficacy of the dHER2 Recombinant Protein Combined With Immunological Adjuvant AS15 in Patients With Metastatic Breast Cancer Overexpressing HER2/Neu

summary: Patients will receive a maximum of 18 injections of dHER2 vaccine in a treatment schedule that will last for up to about a year, and thereafter there will be a follow-up period of about one more year.

ReferenceCitation: Curigliano G, Romieu G, Campone M, Dorval T, Duck L, Canon JL, Roemer-Becuwe C, Roselli M, Neciosup S, Burny W, Callegaro A, de Sousa Alves PM, Louahed J, Brichard V, Lehmann FF. A phase I/II trial of the safety and clinical activity of a HER2-protein based immunotherapeutic for treating women with HER2-positive metastatic breast cancer. Breast Cancer Res Treat. 2016 Apr;156(2):301-10. doi: 10.1007/s10549-016-3750-y. Epub 2016 Mar 14.

ipd_sharing_description: IPD is available via the Clinical Study Data Request site (click on the link provided below)

lead_sponsor: GlaxoSmithKline

location_country: Italy Peru France Belgium Colombia


title: Phase III Trial on Convergent Beam Irradiation of Cerebral Metastases

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Adjuvant radiation therapy may kill any remaining tumor cells following surgery or radiosurgery for brain metastases.

PURPOSE: This randomized phase III trial is studying surgery or radiosurgery alone to see how well it works compared to surgery or radiosurgery and whole-brain radiation therapy in treating brain metastases in patients with solid tumors.

ReferenceCitation: Kocher M, Soffietti R, Abacioglu U, Villà S, Fauchon F, Baumert BG, Fariselli L, Tzuk-Shina T, Kortmann RD, Carrie C, Ben Hassel M, Kouri M, Valeinis E, van den Berge D, Collette S, Collette L, Mueller RP. Adjuvant whole-brain radiotherapy versus observation after radiosurgery or surgical resection of one to three cerebral metastases: results of the EORTC 22952-26001 study. J Clin Oncol. 2011 Jan 10;29(2):134-41. doi: 10.1200/JCO.2010.30.1655. Epub 2010 Nov 1.

name: From the University of Cologne, Cologne; University Hospital, Leipzig, Germany; Azienda Ospedaliera San Giovanni Battista di Torino and University of Torino, Torino; Istituto Nazionale Neurologico Carlo Besto, Milano, Italy; Marmara University Hospital, Istanbul, Turkey; Hospital Universitari Germans Trías, Institut Català d'Oncologia, Badalona, Spain; Centre Haute Energie, Nice; Centre Leon Bérard, Lyon; Centre Eugène Marquis-Rennes, Rennes, France; Maastricht University Medical Centre, Maastricht, the...

family: Kocher

full_name: Martin Kocher

given: Martin

family: Soffietti

full_name: Riccardo Soffietti

given: Riccardo

family: Abacioglu

full_name: Ufuk Abacioglu

given: Ufuk

family: Villà

full_name: Salvador Villà

given: Salvador

family: Fauchon

full_name: Francois Fauchon

given: Francois

family: Baumert

full_name: Brigitta G. Baumert

given: Brigitta G.

family: Fariselli

full_name: Laura Fariselli

given: Laura

family: Tzuk-Shina

full_name: Tzahala Tzuk-Shina

given: Tzahala

family: Kortmann

full_name: Rolf-Dieter Kortmann

given: Rolf-Dieter

family: Carrie

full_name: Christian Carrie

given: Christian

family: Hassel

full_name: Mohamed Ben Hassel

given: Mohamed Ben

family: Kouri

full_name: Mauri Kouri

given: Mauri

family: Valeinis

full_name: Egils Valeinis

given: Egils

family: van den Berge

full_name: Dirk van den Berge

given: Dirk

family: Collette

full_name: Sandra Collette

given: Sandra

full_name: Laurence Collette

given: Laurence

family: Mueller

full_name: Rolf-Peter Mueller

given: Rolf-Peter

journal_name: Journal of Clinical Oncology

oa_host_type: repository

publisher: American Society of Clinical Oncology (ASCO)

title: Adjuvant Whole-Brain Radiotherapy Versus Observation After Radiosurgery or Surgical Resection of One to Three Cerebral Metastases: Results of the EORTC 22952-26001 Study

ReferenceCitation: Mekhail T, Sombeck M, Sollaccio R. Adjuvant whole-brain radiotherapy versus observation after radiosurgery or surgical resection of one to three cerebral metastases: results of the EORTC 22952-26001 study. Curr Oncol Rep. 2011 Aug;13(4):255-8. doi: 10.1007/s11912-011-0180-1.

family: Mekhail

full_name: Tarek Mekhail

given: Tarek

family: Sombeck

full_name: Michael Sombeck

title: Adjuvant Whole-Brain Radiotherapy Versus Observation after Radiosurgery or Surgical Resection of One to Three Cerebral Metastases: Results of the EORTC 22952-26001 Study

ReferenceCitation: Mueller RP, Soffietti R, Abacioglu MU, et al.: Adjuvant whole-brain radiotherapy versus observation after radiosurgery or surgical resection of 1-3 cerebral metastases: results of the EORTC 22952-26001 study. [Abstract] J Clin Oncol 27 (Suppl 15): A-2008, 2009.

ReferenceCitation: Churilla TM, Chowdhury IH, Handorf E, Collette L, Collette S, Dong Y, Alexander BM, Kocher M, Soffietti R, Claus EB, Weiss SE. Comparison of Local Control of Brain Metastases With Stereotactic Radiosurgery vs Surgical Resection: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2019 Feb 1;5(2):243-247. doi: 10.1001/jamaoncol.2018.4610.

name: Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania

name: Department of Radiation Oncology, Tufts Medical Center, Boston, Massachusetts

name: Biostatistics and Bioinformatics Facility, Fox Chase Cancer Center, Philadelphia, Pennsylvania

name: Dana-Farber/Brigham and Women’s Cancer Center, Boston, Massachusetts

name: Department of Stereotaxy and Functional Neurosurgery, University Hospital of Cologne, Cologne, Germany

name: Department of Neuro-oncology, University of Turin and City of Health and Science Hospital, Torino, Italy

name: Yale School of Public Health, New Haven, Connecticut

name: Department of Neurosurgery, Brigham and Women’s Hospital, Boston, Massachusetts

ReferenceCitation: Churilla TM, Handorf E, Collette S, Collette L, Dong Y, Aizer AA, Kocher M, Soffietti R, Alexander BM, Weiss SE. Whole brain radiotherapy after stereotactic radiosurgery or surgical resection among patients with one to three brain metastases and favorable prognoses: a secondary analysis of EORTC 22952-26001. Ann Oncol. 2017 Oct 1;28(10):2588-2594. doi: 10.1093/annonc/mdx332.

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

repository_institution: University of Turin - Institutional Research Information System University of Turin

ReferenceCitation: Soffietti R, Kocher M, Abacioglu UM, Villa S, Fauchon F, Baumert BG, Fariselli L, Tzuk-Shina T, Kortmann RD, Carrie C, Ben Hassel M, Kouri M, Valeinis E, van den Berge D, Mueller RP, Tridello G, Collette L, Bottomley A. A European Organisation for Research and Treatment of Cancer phase III trial of adjuvant whole-brain radiotherapy versus observation in patients with one to three brain metastases from solid tumors after surgical resection or radiosurgery: quality-of-life results. J Clin Oncol. 2013 Jan 1;31(1):65-72. doi: 10.1200/JCO.2011.41.0639. Epub 2012 Dec 3.

name: Riccardo Soffietti, University of Torino and San Giovanni Battista Hospital, Turin; Laura Fariselli, Fondazione Istituto Neurologico “Carlo Besta,” Milan; Gloria Tridello, Azienda Ospedaliera Universitaria Verona, Verona, Italy; Martin Kocher and Rolf-Peter Mueller, University of Cologne, Cologne; Rolf-Dieter Kortmann, University Hospital, Leipzig, Germany; Ufuk M. Abacioglu, Marmara University Hospital, Istanbul, Turkey; Salvador Villa, Hospital Germans Trias i Pujol, ICO, Barcelona, Spain; François...

title: A European Organisation for Research and Treatment of Cancer Phase III Trial of Adjuvant Whole-Brain Radiotherapy Versus Observation in Patients With One to Three Brain Metastases From Solid Tumors After Surgical Resection or Radiosurgery: Quality-of-Life Results

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

location_country:
Italy
Switzerland
Netherlands
Spain
United Kingdom
Finland
France
Israel
Belgium
Portugal
Turkey
Germany
Latvia

location_facility: Edinburgh Cancer Centre at Western General Hospital

location_facility: Azienda Sanitaria Ospedaliera Ordine Mauriziano

location_facility: Medizinische Universitaetsklinik I at the University of Cologne

location_facility: Centre Hospitalier Regional et Universitaire de Lille

location_facility: Paula Stradina Kliniskas Universitates Slimnica

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Istituto Nazionale Neurologico Carlo Besta

location_facility: Oncology Institute of Southern Switzerland

location_facility: Ospedale Ostetrico Ginecologica Sant Anna

location_facility: Institut Catala d'Oncologia - Hospital Duran i Reynals

location_facility: Medizinische Klinik und Poliklinik III - Universitaetsklinikum Leipzig

location_facility: Southend University Hospital NHS Foundation Trust

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

location_facility: Royal Marsden NHS Foundation Trust - Surrey


title: Open-label, Non-randomized Phase 1, Multicenter Study to Assess Radium- 223 Biodistribution in Participants With Bone Metastatic Castration Resistant Prostate Cancer (CRPC) Receiving Radium-223 Dichloride Treatment.

summary: In this study researcher want to gain more information on how the study drug (radium-223) is distributed in the bone, particularly in the tumor free bone in participants with prostate cancer. The study plans to enroll 60 patients with the age of at least 18 years and suffering from prostate cancer which has spread to the bones. Researcher will divide the study participants into 2 groups. Patients in Group 1 should have up to 6 bone metastases and patients for group 2 should have more than 6 bone metastases. The study medication will be given as injection into a vein every 4 weeks up to a maximum of 6 times. To study how radium distributes in the body and particularly in the bones, participants will undergo after study medication intake MRI or CT Scans (imaging techniques).

ipd_sharing: Undecided

ipd_sharing_description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

lead_sponsor: Bayer

location_country:
Italy
Austria
Finland
France
Lithuania
Israel
Germany
United Kingdom

location_facility: Institut Claudius Regaud - iUCT Oncopole

location_facility: Uniklinikum Salzburg - Landeskrankenhaus

location_facility: Guy's and St. Thomas' NHS Trust, St. Thomas' Hospital

location_facility: Institut de Cancérologie de l'Ouest - Saint Herblain

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Vilnius University Hospital Santaros Klinikos

location_facility: Institut du Cancer de Montpellier - Val d'Aurelle


title: New Dietary Strategies Addressing the Specific Needs of Elderly Population for an Healthy Aging in Europe

acronym: NU-AGE

summary: NU-AGE is a large multidisciplinary consortium (31 partners, from 17 EU countries) involving nutritionists, bio-gerontologists, immunologists and molecular biologists from the most prestigious institutions in Europe, 5 large food industries, 8 traditional food companies and 1 biotech SME, SPES GEIE and CIAA, covering the SME Food Industrial Associations of 13 European countries and the European Confederation the food and drink industry. NU-AGE aims are: 1. to counteract the physical/cognitive decline occurring in the elderly as a consequence of the progressive alteration of different organs/systems (immune and cardiovascular systems, bone, brain, muscle and intestine) by one year elderly-tailored whole diet intervention on 1250 healthy elderly men and women aged 65-79 years (half diet, half control) from 5 different EU regions; 2. to assess the effect of the newly designed food pyramid specific for 65+ EU citizens on the different organs/systems using a large set of biomarkers related to nutrition and aging, with particular attention to the low grade, chronic, systemic inflammatory status named inflammageing, a major risk factor for common age-related diseases; 3. to perform in a subgroup of 120 subjects in depth studies and high throughput "omics" to identify cellular/molecular targets/mechanisms responsible for whole diet effect; 4. to perform genetic and epigenetic studies to assess the role of individual variability on the response to diet; 5. to adopt an integrative comprehensive approach (systems biology) to analyze the whole set of data. The results of dietary intervention will be used to develop elderly-tailored prototypes of functional foods and to improve traditional foods. The research activity will be accompanied and followed by a strong activity of dissemination and industrial exploitation to support EU strategies on nutritional recommendations, thus contributing to the implementation of legislation related to nutritional and health claims for elderly in Europe.

ReferenceCitation: Grootswagers P, Mensink M, Berendsen AAM, Deen CPJ, Kema IP, Bakker SJL, Santoro A, Franceschi C, Meunier N, Malpuech-Brugère C, Bialecka-Debek A, Rolf K, Fairweather-Tait S, Jennings A, Feskens EJM, de Groot LCPGM. Vitamin B-6 intake is related to physical performance in European older adults: results of the New Dietary Strategies Addressing the Specific Needs of the Elderly Population for Healthy Aging in Europe (NU-AGE) study. Am J Clin Nutr. 2021 Apr 6;113(4):781-789. doi: 10.1093/ajcn/nqaa368.

name: TI Food and Nutrition, Wageningen, Netherlands

name: Division of Human Nutrition and Health, Wageningen University, Wageningen, Netherlands

family: Grootswagers

full_name: Pol Grootswagers

given: Pol

family: Mensink

full_name: Marco Mensink

given: Marco

family: Berendsen

full_name: Agnes A M Berendsen

given: Agnes A M

name: Department of Laboratory Medicine, University of Groningen, University Medical Center Groningen, Groningen, Netherlands

family: Deen

full_name: Carolien P J Deen

given: Carolien P J

family: Kema

full_name: Ido P Kema

given: Ido P

name: Department of Internal Medicine, University of Groningen, University Medical Center Groningen, Groningen, Netherlands

family: Bakker

full_name: Stephan J L Bakker

given: Stephan J L

name: Department of Experimental, Diagnostic, and Specialty Medicine and CIG Interdepartmental Center “L. Galvani,” Alma Mater Studiorum, University of Bologna, Bologna, Italy

family: Santoro

full_name: Aurelia Santoro

given: Aurelia

name: Department of Experimental, Diagnostic, and Specialty Medicine, Alma Mater Studiorum, University of Bologna, Bologna, Italy

name: Department of Applied Mathematics, Institute of Information Technology, Mathematics, and Mechanics, Lobachevsky State University of Nizhny Novgorod–National Research University, Nizhny Novgorod, Russia

family: Franceschi

full_name: Claudio Franceschi

given: Claudio

name: CHU Clermont-Ferrand, CRNH Auvergne, Clermont-Ferrand, France

family: Meunier

full_name: Nathalie Meunier

given: Nathalie

name: Université Clermont Auvergne, INRA, UNH, Unité de Nutrition Humaine, CRNH Auvergne, F-63000 Clermont-Ferrand, France

family: Malpuech-Brugère

full_name: Corinne Malpuech-Brugère

given: Corinne

name: Department of Human Nutrition, Warsaw University of Life Sciences–SGGW, Warsaw, Poland

family: Bialecka-Debek

full_name: Agata Bialecka-Debek

given: Agata

family: Rolf

full_name: Katarzyna Rolf

given: Katarzyna

family: Fairweather-Tait

full_name: Susan Fairweather-Tait

given: Susan

family: Jennings

full_name: Amy Jennings

given: Amy

family: Feskens

full_name: Edith J M Feskens

given: Edith J M

family: de Groot

full_name: Lisette C P G M de Groot

given: Lisette C P G M

journal_name: The American Journal of Clinical Nutrition

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

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

repository_institution: University of East Anglia - UEA Digital Repository

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

repositories_institution: University of East Anglia - UEA Digital Repository

ReferenceCitation: Jennings A, Tang J, Gillings R, Perfecto A, Dutton J, Speakman J, Fraser WD, Nicoletti C, Berendsen AAM, de Groot LCPGM, Pietruszka B, Jeruszka-Bielak M, Caumon E, Caille A, Ostan R, Franceschi C, Santoro A, Fairweather-Tait SJ. Changing from a Western to a Mediterranean-style diet does not affect iron or selenium status: results of the New Dietary Strategies Addressing the Specific Needs of the Elderly Population for Healthy Aging in Europe (NU-AGE) 1-year randomized clinical trial in elderly Europeans. Am J Clin Nutr. 2020 Jan 1;111(1):98-109. doi: 10.1093/ajcn/nqz243.

name: Norwich Medical School, University of East Anglia, Norwich, United Kingdom

name: Bioanalytical Facility, Cheshire, United Kingdom

name: Quadram Institute Bioscience, Norwich, United Kingdom

name: Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy

name: Wageningen University and Research, Division of Human Nutrition and Health, Wageningen, Netherlands

name: Department of Human Nutrition, Warsaw University of Life Sciences-SGGW, Warsaw, Poland

name: CHU Clermont Ferrand, CRNH Auvergne, Clermont-Ferrand, France

name: CIG Interdepartmental Centre “L. Galvani,” Alma Mater Studiorum, University of Bologna, Bologna, Italy

name: Institute of Neurological Sciences, Bologna, Italy

repository_institution: University of Florence - Florence Research

repositories_institution: University of Florence - Florence Research

ReferenceCitation: Giampieri E, Ostan R, Guidarelli G, Salvioli S, Berendsen AAM, Brzozowska A, Pietruszka B, Jennings A, Meunier N, Caumon E, Fairweather-Tait S, Sicinska E, Feskens EJM, de Groot LCPGM, Franceschi C, Santoro A. A Novel Approach to Improve the Estimation of a Diet Adherence Considering Seasonality and Short Term Variability - The NU-AGE Mediterranean Diet Experience. Front Physiol. 2019 Mar 5;10:149. doi: 10.3389/fphys.2019.00149. eCollection 2019.

title: A Novel Approach to Improve the Estimation of a Diet Adherence Considering Seasonality and Short Term Variability – The NU-AGE Mediterranean Diet Experience

ReferenceCitation: Pujos-Guillot E, Pétéra M, Jacquemin J, Centeno D, Lyan B, Montoliu I, Madej D, Pietruszka B, Fabbri C, Santoro A, Brzozowska A, Franceschi C, Comte B. Identification of Pre-frailty Sub-Phenotypes in Elderly Using Metabolomics. Front Physiol. 2019 Jan 24;9:1903. doi: 10.3389/fphys.2018.01903. eCollection 2018.

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

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

title: Identification of Pre-frailty Sub-Phenotypes in Elderly Using Metabolomics

ReferenceCitation: Jennings A, Berendsen AM, de Groot LCPGM, Feskens EJM, Brzozowska A, Sicinska E, Pietruszka B, Meunier N, Caumon E, Malpuech-Brugère C, Santoro A, Ostan R, Franceschi C, Gillings R, O' Neill CM, Fairweather-Tait SJ, Minihane AM, Cassidy A. Mediterranean-Style Diet Improves Systolic Blood Pressure and Arterial Stiffness in Older Adults. Hypertension. 2019 Mar;73(3):578-586. doi: 10.1161/HYPERTENSIONAHA.118.12259.

name: From the Department of Nutrition and Preventive Medicine, Norwich Medical School, University of East Anglia, Norwich, United Kingdom (A.J., R.G., C.M.O., S.J.F.-T., A.-M.M., A.C.)

name: Department of Human Nutrition, Wageningen University, The Netherlands (A.M.B., L.C.P.G.M.d.G., E.J.M.F.)

name: Department of Human Nutrition, Warsaw University of Life Sciences—SGGW, Poland (A.B., E.S., B.P.)

name: Centre Hospitalier Universitaire (N.M., E.C.), Centre de Recherches en Nutrition Humaine (CRNH) d’Auvergne, Clermont-Ferrand, France

name: Université Clermont Auvergne, Institut National de la Recherche Agronomique (INRA), Unité de Nutrition Humaine (C.M.-B.), Centre de Recherches en Nutrition Humaine (CRNH) d’Auvergne, Clermont-Ferrand, France

name: Department of Experimental, Diagnostic and Specialty Medicine (A.S., C.F.), Alma Mater Studiorum, University of Bologna, Italy.

name: Interdepartmental Centre “L. Galvani” (A.S., R.O.), Alma Mater Studiorum, University of Bologna, Italy.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris 1 Panthéon-Sorbonne

repository_institution: Queen's University Belfast - Research Portal

repositories_institution: Queen's University Belfast - Research Portal

ReferenceCitation: Ostan R, Guidarelli G, Giampieri E, Lanzarini C, Berendsen AAM, Januszko O, Jennings A, Lyon N, Caumon E, Gillings R, Sicinska E, Meunier N, Feskens EJM, Pietruszka B, de Groot LCPGM, Fairweather-Tait S, Capri M, Franceschi C, Santoro A. Cross-Sectional Analysis of the Correlation Between Daily Nutrient Intake Assessed by 7-Day Food Records and Biomarkers of Dietary Intake Among Participants of the NU-AGE Study. Front Physiol. 2018 Oct 1;9:1359. doi: 10.3389/fphys.2018.01359. eCollection 2018.

ReferenceCitation: Maijo M, Ivory K, Clements SJ, Dainty JR, Jennings A, Gillings R, Fairweather-Tait S, Gulisano M, Santoro A, Franceschi C, Carding SR, Nicoletti C. One-Year Consumption of a Mediterranean-Like Dietary Pattern With Vitamin D3 Supplements Induced Small Scale but Extensive Changes of Immune Cell Phenotype, Co-receptor Expression and Innate Immune Responses in Healthy Elderly Subjects: Results From the United Kingdom Arm of the NU-AGE Trial. Front Physiol. 2018 Jul 26;9:997. doi: 10.3389/fphys.2018.00997. eCollection 2018.

ReferenceCitation: Jennings A, Cashman KD, Gillings R, Cassidy A, Tang J, Fraser W, Dowling KG, Hull GLJ, Berendsen AAM, de Groot LCPGM, Pietruszka B, Wierzbicka E, Ostan R, Bazzocchi A, Battista G, Caumon E, Meunier N, Malpuech-Brugère C, Franceschi C, Santoro A, Fairweather-Tait SJ. A Mediterranean-like dietary pattern with vitamin D3 (10 µg/d) supplements reduced the rate of bone loss in older Europeans with osteoporosis at baseline: results of a 1-y randomized controlled trial. Am J Clin Nutr. 2018 Sep 1;108(3):633-640. doi: 10.1093/ajcn/nqy122.

name: Cork Center for Vitamin D and Nutrition Research, School of Food and Nutritional Sciences

name: Department of Medicine, University College Cork, Cork, Ireland

name: Division of Human Nutrition, Wageningen University, Netherlands

name: Department of Human Nutrition, Warsaw University of Life Sciences (WULS-SGGW), Warsaw, Poland

name: Diagnostic and Interventional Radiology, “Rizzoli” Orthopedic Institute, Bologna, Italy

name: Department of Experimental, Diagnostic, and Speciality Medicine, Alma Mater Studorium, University of Bologna, Bologna, Italy

name: Université Clermont Auvergne, Institut National de la Recherche Agronomique (INRA), Unité de Nutrition Humaine, Centre de Recherches en Nutrition Humaine (CRNH) d'Auvergne, Clermont-Ferrand, France

name: Institute of Neurological Sciences (IRCCS), Bologna, Italy

repository_institution: Dublin Institute of Technology - Arrow@dit

repositories_institution: Dublin Institute of Technology - Arrow@dit

ReferenceCitation: Marseglia A, Xu W, Fratiglioni L, Fabbri C, Berendsen AAM, Bialecka-Debek A, Jennings A, Gillings R, Meunier N, Caumon E, Fairweather-Tait S, Pietruszka B, De Groot LCPGM, Santoro A, Franceschi C. Effect of the NU-AGE Diet on Cognitive Functioning in Older Adults: A Randomized Controlled Trial. Front Physiol. 2018 Apr 4;9:349. doi: 10.3389/fphys.2018.00349. eCollection 2018.

ReferenceCitation: Fairweather-Tait SJ, Jennings A, Harvey LJ, Berry R, Walton J, Dainty JR. Modeling tool for calculating dietary iron bioavailability in iron-sufficient adults. Am J Clin Nutr. 2017 Jun;105(6):1408-1414. doi: 10.3945/ajcn.116.147389. Epub 2017 Apr 5.

ReferenceCitation: Hooper L, Bunn DK, Abdelhamid A, Gillings R, Jennings A, Maas K, Millar S, Twomlow E, Hunter PR, Shepstone L, Potter JF, Fairweather-Tait SJ. Water-loss (intracellular) dehydration assessed using urinary tests: how well do they work? Diagnostic accuracy in older people. Am J Clin Nutr. 2016 Jul;104(1):121-31. doi: 10.3945/ajcn.115.119925. Epub 2016 May 25.

name: School of Agriculture and Food Science, University College Dublin, Dublin, Ireland

ReferenceCitation: Hooper L, Abdelhamid A, Ali A, Bunn DK, Jennings A, John WG, Kerry S, Lindner G, Pfortmueller CA, Sjöstrand F, Walsh NP, Fairweather-Tait SJ, Potter JF, Hunter PR, Shepstone L. Diagnostic accuracy of calculated serum osmolarity to predict dehydration in older people: adding value to pathology laboratory reports. BMJ Open. 2015 Oct 21;5(10):e008846. doi: 10.1136/bmjopen-2015-008846.

ReferenceCitation: Berendsen A, Santoro A, Pini E, Cevenini E, Ostan R, Pietruszka B, Rolf K, Cano N, Caille A, Lyon-Belgy N, Fairweather-Tait S, Feskens E, Franceschi C, de Groot CP. Reprint of: A parallel randomized trial on the effect of a healthful diet on inflammageing and its consequences in European elderly people: design of the NU-AGE dietary intervention study. Mech Ageing Dev. 2014 Mar-Apr;136-137:14-21. doi: 10.1016/j.mad.2014.03.001. Epub 2014 Mar 20.

title: Reprint of: A parallel randomized trial on the effect of a healthful diet on inflammageing and its consequences in European elderly people: Design of the NU-AGE dietary intervention study

ReferenceCitation: Hooper L, Bunn D, Jimoh FO, Fairweather-Tait SJ. Water-loss dehydration and aging. Mech Ageing Dev. 2014 Mar-Apr;136-137:50-8. doi: 10.1016/j.mad.2013.11.009. Epub 2013 Dec 9. Review.

title: Water-loss dehydration and aging

ReferenceCitation: Fairweather-Tait SJ, Wawer AA, Gillings R, Jennings A, Myint PK. Iron status in the elderly. Mech Ageing Dev. 2014 Mar-Apr;136-137:22-8. doi: 10.1016/j.mad.2013.11.005. Epub 2013 Nov 22. Review.

repository_institution: Aberdeen University - Aberdeen University Research Archive

repositories_institution: Aberdeen University - Aberdeen University Research Archive

title: Iron status in the elderly

location_country:
Italy
Netherlands
Poland
France
United Kingdom

location_facility: Auvergne Research Center on Human Nutrition

location_facility: University of Bologna-Department of Speciality, Diagnostic and Experimental Medicine

location_facility: University of Wageningen-Division of Human Nutrition

location_facility: Warsaw University of Life Science SGGW-WULS-Department of Human Nutrition

location_facility: Department of Nurition-University of East Anglia


title: A Multi-center, Randomized, Double Blind, Dose Escalation Safety Study of MP4CO in Clinically Stable Adult Sickle Cell Patients

summary:
Sickle Cell Anemia is caused by an inherited hemoglobin disorder. Healthy red blood cells are discoid and can deform and move through small blood vessels to carry oxygen to all parts of the body. In sickle cell disease, as red blood cells circulate and oxygen is released in the circulatory system, the deoxygenated abnormal hemoglobin S can begin to polymerize. When this occurs, the red blood cells can become sticky and elongated. These sickled red blood cells are less flexible and will obstruct small blood vessels and block normal red blood cells from traveling through the circulatory system, which limits oxygen delivery to tissues and organs. This is known as a "sickle crisis".

Patients suffering from a sickle crisis experience severe pain and are at risk of stroke, heart attack or even death. By lowering the level of oxygen pressure at which sickling occurs and opening the vasculature and rapidly delivering oxygen directly to ischemic tissues, the addition of MP4CO to existing treatment protocols may alleviate pain associated with a sickle cell crisis, abort a crisis and/or potentially reduce the duration of a crisis. This could mean less time in the hospital and an improved quality of life for patients with sickle cell anemia.

lead_sponsor: Sangart

location_country:
Jamaica
United Kingdom
France
Lebanon

location_facility: Sickle Cell Unit, University of West Indies


location_country: Italy France Switzerland Netherlands

acronym: EORTC protocol 26083

title: Randomized Phase II of Lomustine Versus Lomustine-Dasatinib in Patients With Recurrent Glioblastoma

summary: To determine whether dasatinib plus lomustine are effective for treatment of recurrent glioblastoma


title: A Phase I Study to Determine the Pharmacokinetic Profile, Safety and Tolerability of a Single Dose (50IU/kg) of KW-3357 in Subjects With Congenital Antithrombin Deficiency.

summary: The aim of this study is to determine the pharmacokinetics, safety and tolerability of KW-3357 in asymptomatic subjects with congenital antithrombin deficiency.

lead_sponsor: Kyowa Hakko Kirin UK, Ltd.

location_country:
Italy
Sweden
France
Germany
United Kingdom