title: Fertility Preservation in Cases of Spermatogenesis Failure : Prospective Study for Klinefelter Syndrome With Non-mosaic Karyotype (47, XXY, Homogeneous)

acronym: FERTIPRESERVE

summary:
Klinefelter Syndrome (KS) is the most common sex chromosomal abnormalities (1/600 newborn males), and is characterized by a hypergonadism hypogonadism. Until few years ago, mostly non-mosaic KS was considered as a model of a complete male infertility although few KS (4-8%) have an oligospermia. Recent studies in adult with non-mosaic KS reported the possibility of sperm retrieval by testicular biopsy (TESE) in around 50% cases and more than some pregnancies have been obtained after TESE with Intracytoplasmic Sperm Injection (ICSI). Since 1997, more than one hundred births are described.

As some studies shown a decrease of successful sperm retrieval with the increasing of age, we plan to compare the potential of sperm retrieval between two groups "adult" (23-55 years) and "young" after the onset of puberty (15-22 years). The study will be performed by searching spermatozoa on two seminal analyses spaced out 3 months followed by a testicular biopsy if the azoospermia is confirmed on semen analyses.

ReferenceCitation: Plotton I, Giscard d'Estaing S, Cuzin B, Brosse A, Benchaib M, Lornage J, Ecochard R, Dijoud F, Lejeune H; FERTIPRESERVE group. Preliminary results of a prospective study of testicular sperm extraction in young versus adult patients with nonmosaic 47,XXY Klinefelter syndrome. J Clin Endocrinol Metab. 2015 Mar;100(3):961-7. doi: 10.1210/jc.2014-3083. Epub 2014 Nov 25.

family: Plotton

full_name: Ingrid Plotton

given: Ingrid

family: d'Estaing

full_name: Sandrine Giscard d'Estaing

given: Sandrine Giscard

family: Cuzin

full_name: Beatrice Cuzin

given: Beatrice

family: Brosse

full_name: Aurélie Brosse

given: Aurélie

family: Benchaib

full_name: Medhi Benchaib

given: Medhi

family: Lornage

full_name: Jacqueline Lornage

given: Jacqueline

family: Ecochard

full_name: René Ecochard

given: René

family: Dijoud

full_name: Frederique Dijoud

given: Frederique

family: Lejeune

full_name: Hervé Lejeune

given: Hervé

journal_name: The Journal of Clinical Endocrinology & Metabolism

evidence: open (via free article)

publisher: The Endocrine Society

publisher_dissemination: The Endocrine Society

publisher_group: The Endocrine Society

publisher_normalized: The Endocrine Society

title: Preliminary Results of a Prospective Study of Testicular Sperm Extraction in Young Versus Adult Patients With Nonmosaic 47,XXY Klinefelter Syndrome

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'Endocrinologie Moléculaire et Maladies Rares, Centre de Biologie Est, Hospices Civils de Lyon

location_facility: Groupe de Médecine de la Reproduction - CECOS Midi-Pyrénées - Hôpital Paule de Viguier)

location_facility: Service de Biologie de la Reproduction - CECOS - Groupe Hospitalier Pellegrin

location_facility: Service de Biologie de la Reproduction - Hôpital de la Conception


type: Other Identifier

title: Study of the Role of Infection by Human Papillomavirus (HPV) in the Success Rate of Pregnancies Achieved Via Medically Assisted Procreation

acronym: PAPILLO-PMA

summary:
The main objective of this study is to investigate the association between the presence of HPV infection in one or both members of infertile/sub-infertile couples and the outcome of pregnancies obtained by assisted reproduction.

The success of assisted medical procreation is defined as achieving a pregnancy resulting in the birth of a living, viable child.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Montpellier - Hôpital Arnaud de Villeneuve

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau

lead_sponsor_type: academique

status_simplified: Completed


title: Diagnostic Value of Molecular Cytological Analysis (CMA) and Shear Wave Elastography ShearWave (SWE) in Patients With a Thyroid Nodule With Indeterminate Cytology: Feasibility Study

acronym: SWEETMAC

summary: The purpose of the study is to investigate the contribution of molecular cytological analysis (CMA) and shear wave elastography ShearWave (SWE) in the diagnosis of nodules with indeterminate cytology (IC)

study_type: Interventional

primary_purpose: Diagnostic

ReferenceType: derived

ReferenceCitation: Bardet S, Goardon N, Lequesne J, Vaur D, Ciappuccini R, Leconte A, Monpeyssen H, Saguet-Rysanek V, Clarisse B, Lasne-Cardon A, Ménégaux F, Leenhardt L, Buffet C. Diagnostic and prognostic value of a 7-panel mutation testing in thyroid nodules with indeterminate cytology: the SWEETMAC study. Endocrine. 2021 Feb;71(2):407-417. doi: 10.1007/s12020-020-02411-4. Epub 2020 Jul 7.

family: Bardet

full_name: Stéphane Bardet

given: Stéphane

sequence: first

family: Goardon

full_name: Nicolas Goardon

given: Nicolas

sequence: additional

family: Lequesne

full_name: Justine Lequesne

given: Justine

family: Vaur

full_name: Dominique Vaur

given: Dominique

family: Ciappuccini

full_name: Renaud Ciappuccini

given: Renaud

family: Leconte

full_name: Alexandra Leconte

given: Alexandra

family: Monpeyssen

full_name: Hervé Monpeyssen

family: Saguet-Rysanek

full_name: Virginie Saguet-Rysanek

given: Virginie

family: Clarisse

full_name: Bénédicte Clarisse

given: Bénédicte

family: Lasne-Cardon

full_name: Audrey Lasne-Cardon

given: Audrey

family: Ménégaux

full_name: Fabrice Ménégaux

given: Fabrice

family: Leenhardt

full_name: Laurence Leenhardt

given: Laurence

family: Buffet

full_name: Camille Buffet

given: Camille

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Endocrine

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

license_normalized: no license

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

repository_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Centre Francois Baclesse

location_facility:
Hôpital Américain de Paris
Hôpital Pitié-salpétrière
CHU
Centre François BACLESSE

intervention_type: Procedure

lead_sponsor_type: industriel


title: Telephonic Platform of Follow up, Therapeutical Education and Coordination in Secondary Prevention in Patients With Heart Failure and Coronary Disease

acronym: METISCARDIO

summary: A first therapeutic education is given before patient's discharge at the hospital, then a dedicated nurse follows patients through the phone,regularly according to patients' needs, continues to give advise on risk factors, information on medication and alert symptoms and therapeutic education.

design_allocation: Non-Randomized

primary_purpose: Prevention

lead_sponsor: Resicard

location_facility:
Institut Coeur Effort Sante
Hopital Saint Antoine
Centre Cardiologique Alfred Kastler
Clinique Turin

intervention_type: Behavioral


title: Programmed Intermittent Epidural Bolus Coupled With PCEA (PIEB-PCEA) Versus Continuous Epidural Infusion Coupled With PCEA (CEI-PCEA) for Labor Analgesia in Nulliparous: Effects on Labor Outcomes

acronym: PIEB

summary:
Epidural analgesia still have an impact on obstetric outcomes and especially on instrumented delivery rates.

To assess the best maintainance regimen of epidural analgesia during labor the investigators plan to include 300 nulliparous in this multicenter randomized, double blind trial. The primary outcome will be a composite set of criteria that can lead to instrumented delivery. Secondary outcome will focus on analgesia motor block and satisfaction.

status: Unknown status

study_completion_date_type: Anticipated

design_allocation: Randomized

primary_purpose: Health Services Research

enrollment_type: Anticipated

ReferenceCitation: Morau E, Jaillet M, Storme B, Nogue E, Bonnin M, Chassard D, Benhamou D, Nagot N, Dadure C. Does programmed intermittent epidural bolus improve childbirth conditions of nulliparous women compared with patient-controlled epidural analgesia?: A multicentre, randomised, controlled, triple-blind study. Eur J Anaesthesiol. 2019 Oct;36(10):755-762. doi: 10.1097/EJA.0000000000001053.

family: Morau

full_name: Estelle Morau

given: Estelle

family: Jaillet

full_name: Malaury Jaillet

given: Malaury

family: Storme

full_name: Brigitte Storme

given: Brigitte

family: Nogue

full_name: Erika Nogue

given: Erika

family: Bonnin

full_name: Martine Bonnin

given: Martine

family: Chassard

full_name: Dominique Chassard

family: Benhamou

full_name: Dan Benhamou

given: Dan

family: Nagot

full_name: Nicolas Nagot

family: Dadure

full_name: Christophe Dadure

given: Christophe

journal_name: European Journal of Anaesthesiology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: University Hospital, Montpellier

location_facility:
CHU Bicêtre
CHU of Montpellier
CHU d'Estaing
Hôpital Mère Enfant

intervention_type: Device

status_simplified: Unknown


title: Evaluation of Asymmetrical Lateral Decubitus for Rotation of Occipitoposterior Fetal Position During Labor : EVADELA Multicentre Randomized Trial

acronym: EVADELA

summary:
Maternal posturing is used during labor to facilitate the rotation of occipitoposterior fetal position in anterior.

Our study aims to evaluate the efficacy of asymmetrical lateral decubitus for rotation of the fetal head.

primary_purpose: Treatment

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Maternité du CH d'Avranches-Granville
bluets maternity Hospital
Port-Royal Maternity Hospital
CHU côte de nacre

intervention_type: Other


title: Frequency of Abnormal Glucose Metabolism (Diabetes, Impaired Glucose Tolerance, Impaired Fasting Glucose) in the Immediate Postpartum Period Following Gestational Diabetes Diagnosed Before or After 24 Weeks of Gestation

acronym: DG Post-Partum

summary: The main objective of the study is to estimate and compare the percentage of patients with abnormal glucose metabolism at 4-12 weeks postpartum between two groups: patients diagnosed with gestational diabetes before or after 24 weeks of pregnancy. Abnormal glucose metabolism is defined as type 2 diabetes, glucose intolerance or impaired fasting glucose.

study_start_date_type: Actual

ReferenceCitation: Cosma V, Imbernon J, Zagdoun L, Boulot P, Renard E, Brunet C, Mares P, Rodier M, Kabani S, Demattei C, Guedj AM. A prospective cohort study of postpartum glucose metabolic disorders in early versus standard diagnosed gestational diabetes mellitus. Sci Rep. 2021 May 17;11(1):10430. doi: 10.1038/s41598-021-89679-2.

family: Cosma

full_name: Valeria Cosma

given: Valeria

family: Imbernon

full_name: Jeanne Imbernon

given: Jeanne

family: Zagdoun

full_name: Léonore Zagdoun

given: Léonore

family: Boulot

full_name: Pierre Boulot

given: Pierre

family: Renard

full_name: Eric Renard

given: Eric

family: Brunet

full_name: Cécile Brunet

given: Cécile

family: Mares

full_name: Pierre Mares

family: Rodier

full_name: Michel Rodier

given: Michel

family: Kabani

full_name: Sarah Kabani

given: Sarah

family: Demattei

full_name: Christophe Demattei

family: Guedj

full_name: Anne-Marie Guedj

given: Anne-Marie

currency_apc_doaj: USD

journal_name: Scientific Reports

oa_colors: green gold

evidence: oa journal (via doaj)

intervention_type: Biological


title: Incidence of Respiratory Viral Infections During AML Induction and Consolidation Chemotherapy

acronym: LAMVIRE

summary: Infectious morbidity and mortality is a major complication of AML (Acute Myeloid Leukemia) induction and consolidation chemotherapies related aplasia. The main aim of this study is to measure incidence of respiratory viral infections during AML induction and consolidation chemotherapy related aplasia. Primary end point is a positive polymerase chain reaction(PCR)associated with clinical signs.

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
CHU CAEN
Chu Rouen
Chru Lille
Pr Marolleau


title: Care-related Pain and Discomfort in Children and Adults With Motor Disorder in Medical Establishments

acronym: DIS-HANDI

summary:
The combination of motor disabilities, chronic pain, cognitive disabilities limiting the possibilities of communications and repeated potentially painful rehabilitation, exposes patients with motor disabilities to a high risk of induced pain in the specialized establishments. Induced pain is difficult to detect and is therefore little assessed and treated. Currently, little is known about the prevalence and conditions of occurrence of such induced pain as the clinical characteristics of patients (children, adults, severity of disability), the types of care and the nature of the institutional admission (medical or medico-social). Secondary objectives are to identify risk factors related to the induced pain and patient characteristics, as well as to create an easy-to-use weekly continuous pain assessment tool in a routine clinical set-up.

All daily life procedures or treatment carried out in children and adults with motor disability are collected for 5 days and 1 night. Collected data are clinical and demographic characteristics of patients, the intensity of the pain assessed by the care professional (FLACC-r) or the patient himself (VAS).

Clinically, the uncomfortable and painful procedures and risk factors for pain identified by this study will help the development of targeted preventive measures within institutions. Meanwhile, the study should sensitize Breton teams involved with regards to the induced pain, leading them to observe the behavior of patients, to admit any pain related to an act of daily life, and to ask for the medical profession to anticipate the painful experience.

lead_sponsor: University Hospital, Brest

location_facility: Centre de Rééducation fonctionnelle de Kerpape


title: Cancer and Disorders of Cognitive Functions and Quality of Life: "Cognitive Rehabilitation in Patients Suffering From Cancer and Treated With Chemotherapy"

summary: Our study aims to measure the impact of cognitive rehabilitation workshops on the development of cognitive functions and quality of life of patients expressing a cognitive complaint

location_facility:
Centre Henri Becquerel
Institut Gustave Roussy
Centre François Baclesse
Centre Paul Strauss


ReferenceCitation: Biessels GJ, Verhagen C, Janssen J, van den Berg E, Wallenstein G, Zinman B, Espeland MA, Johansen OE. Effects of linagliptin vs glimepiride on cognitive performance in type 2 diabetes: results of the randomised double-blind, active-controlled CAROLINA-COGNITION study. Diabetologia. 2021 Jun;64(6):1235-1245. doi: 10.1007/s00125-021-05393-8. Epub 2021 Feb 9.

family: Biessels

full_name: Geert Jan Biessels

given: Geert Jan

family: Verhagen

full_name: Chloë Verhagen

given: Chloë

family: Janssen

full_name: Jolien Janssen

given: Jolien

family: van den Berg

full_name: Esther van den Berg

given: Esther

family: Wallenstein

full_name: Gudrun Wallenstein

given: Gudrun

family: Zinman

full_name: Bernard Zinman

given: Bernard

family: Espeland

full_name: Mark A. Espeland

given: Mark A.

family: Johansen

full_name: Odd Erik Johansen

given: Odd Erik

journal_name: Diabetologia

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Erasmus University, Rotterdam - RePub

ReferenceCitation: Rosenstock J, Kahn SE, Johansen OE, Zinman B, Espeland MA, Woerle HJ, Pfarr E, Keller A, Mattheus M, Baanstra D, Meinicke T, George JT, von Eynatten M, McGuire DK, Marx N; CAROLINA Investigators. Effect of Linagliptin vs Glimepiride on Major Adverse Cardiovascular Outcomes in Patients With Type 2 Diabetes: The CAROLINA Randomized Clinical Trial. JAMA. 2019 Sep 24;322(12):1155-1166. doi: 10.1001/jama.2019.13772. Erratum in: JAMA. 2019 Dec 3;322(21):2138.

name: Dallas Diabetes Research Center at Medical City, Dallas, Texas

name: University of Texas Southwestern Medical Center, Dallas

family: Rosenstock

full_name: Julio Rosenstock

given: Julio

name: Division of Metabolism, Endocrinology and Nutrition, Department of Medicine, VA Puget Sound Health Care System, Seattle, Washington

family: Kahn

full_name: Steven E. Kahn

given: Steven E.

name: Boehringer Ingelheim Norway KS, Asker, Norway

name: Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Canada

name: Division of Endocrinology, University of Toronto, Toronto, Canada

name: Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina

family: Woerle

full_name: Hans J. Woerle

given: Hans J.

name: Boehringer Ingelheim International GmbH & Co KG, Ingelheim, Germany

family: Pfarr

full_name: Egon Pfarr

given: Egon

family: Keller

full_name: Annett Keller

given: Annett

family: Mattheus

full_name: Michaela Mattheus

given: Michaela

name: Boehringer Ingelheim, Alkmaar, the Netherlands

family: Baanstra

full_name: David Baanstra

given: David

name: Boehringer Ingelheim International GmbH & Co KG, Biberach, Germany

name: Department of Internal Medicine I, University Hospital Aachen, RWTH Aachen University, Germany

ReferenceCitation: Janssen J, van den Berg E, Zinman B, Espeland MA, Geijselaers SLC, Mattheus M, Johansen OE, Biessels GJ. HbA(1c), Insulin Resistance, and β-Cell Function in Relation to Cognitive Function in Type 2 Diabetes: The CAROLINA Cognition Substudy. Diabetes Care. 2019 Jan;42(1):e1-e3. doi: 10.2337/DC18-0914.

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

title: HbA1c, Insulin Resistance, and β-Cell Function in Relation to Cognitive Function in Type 2 Diabetes: The CAROLINA Cognition Substudy

ReferenceCitation: Biessels GJ, Janssen J, van den Berg E, Zinman B, Espeland MA, Mattheus M, Johansen OE; CAROLINA® investigators. Rationale and design of the CAROLINA® - cognition substudy: a randomised controlled trial on cognitive outcomes of linagliptin versus glimepiride in patients with type 2 diabetes mellitus. BMC Neurol. 2018 Jan 15;18(1):7. doi: 10.1186/s12883-018-1014-7.

name: on behalf of the CAROLINA® investigators

ReferenceCitation: Marx N, Rosenstock J, Kahn SE, Zinman B, Kastelein JJ, Lachin JM, Espeland MA, Bluhmki E, Mattheus M, Ryckaert B, Patel S, Johansen OE, Woerle HJ. Design and baseline characteristics of the CARdiovascular Outcome Trial of LINAgliptin Versus Glimepiride in Type 2 Diabetes (CAROLINA®). Diab Vasc Dis Res. 2015 May;12(3):164-74. doi: 10.1177/1479164115570301. Epub 2015 Mar 15.

name: Department of Internal Medicine I, University Hospital Aachen, Aachen, Germany

name: Dallas Diabetes and Endocrine Center at Medical City and University of Texas, Southwestern Medical Center, Dallas, TX, USA

name: Division of Metabolism, Endocrinology and Nutrition, Department of Medicine, VA Puget Sound Health Care System and University of Washington, Seattle, WA, USA

name: Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, ON, Canada

name: University of Toronto, Toronto, ON, Canada

name: Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands

name: The Biostatistics Center, The George Washington University, Rockville, MD, USA

name: Department of Biostatistics, Wake Forest Baptist Medical Center, Winston-Salem, NC, USA

name: Boehringer Ingelheim, Ingelheim, Germany

name: Boehringer Ingelheim, Bruxelles, Belgium

ReferenceCitation: Chilton R. Linagliptin versus glimepiride add-on for the long-term treatment of Type 2 diabetes mellitus. Expert Rev Endocrinol Metab. 2013 Jul;8(4):345-349. doi: 10.1586/17446651.2013.811849.

journal_name: Expert Review of Endocrinology & Metabolism

location_country:
Peru
Finland
Malaysia
Greece
Romania
Belgium
Australia
Russian Federation
Taiwan
Ukraine
India
France
Japan
Slovakia
Norway
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Sweden
Hong Kong
Netherlands
Philippines
Switzerland
Bulgaria
Hungary
Ireland
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Serbia
Mexico
Czechia
Israel
Georgia
Tunisia
New Zealand
Spain

location_facility: Bangalore Diabetes Centre (BDC)- Medisys Clinical Research

location_facility: Centro de Investigaciones Médicas METABOLICARE SAC

location_facility: Fundación Centro de Investigaciones Biomédicas Riescard

location_facility: MMU City Outpatient Clinic no. 20, Saratov

location_facility: Northeast Clinical Research of San Antonio, LLC

location_facility: University General Hospital of Thessaloniki AHEPA

location_facility: Irmandade da Santa Casa de Misericórdia de São Paulo - IPEC - Instituto de Pesquisa Clínica

location_facility: Albany Medical Center / Albany Medical College

location_facility: Instituto Estadual de Diabetes e Endocrinologia

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Edith Wolfson Medical Center, Diabetic Unit, Holon

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: Clinical Trials of St. Jude Heritage Med. Group

location_facility: Univ.Multiprofile Hospital "Dr. Georgy Stranski" EAD, Pleven

location_facility: M V Hospital For Diabetes and Diabetes Research Centre

location_facility: Bodø Legesenter AS, avd. for med. studier

location_facility: National Health Insurance Service Ilsan Hospital

location_facility: Emergency County Clinical Hospital, Sibiu

location_facility: Instituto Nacional de Cardiologia Ignacio Chavez

location_facility: Unidad de Investigacion Clinica Cardiometabolica de Occident

location_facility: CIIGMA Institute of Medical Sciences Pvt Ltd

location_facility: Daishinkai Medical Corporation Ookuma Hospital

location_facility: Diabetologicka ambulancia MUDr. Lucia Gajdosikova s.r.o.

location_facility: Yalamanchi Hospitals & Research Centres Pvt Ltd.

location_facility: Policlinico Universitario Mater Domini, Universita di Catanzaro

location_facility: centro de Diagnostico Cardiologico para la Investigacion Bio

location_facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: Pharmacotherapy Research Associates, Inc

location_facility: Instituto Delgado de Investigacion Medica

location_facility: Kovai Diabetes Speciality Centre & Hospital

location_facility: Hospital de Servicios Médicos Godoy Ltda

location_facility: Instituto Cardiovascular de Corrientes Juana Francisca Cabra

location_facility: The Methodist Hospital d/b/a HMRI CCAT at Pearland

location_facility: Centro Hospitalar da Cova da Beira Hospital Pêro da Covilhã

location_facility: Noordwest Ziekenhuisgroep, location Den Helder

location_facility: Military Medical Academy, Clin. Endocrinology & Metab. Dis.

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Pusan National University Yangsan Hospital

location_facility: Institut für Stoffwechselforschung, Frankfurt

location_facility: Sunil's Diabetes care and Research Centre

location_facility: General Hospital Subotica, Internal Medicine

location_facility: Centro De Especialidades Medicas Santa Maria S.A.C

location_facility: South Carolina Nephrology and Hypertension Center, Inc

location_facility: Centro de Investigaciones Clínicas del Litoral

location_facility: City Clinical Hospital No. 6 of MoH of Udmurt Republic

location_facility: John H. Stroger Jr. Hospital of Cook Country

location_facility: CAB Mercey Y, MG, St Genies des Fontaines

location_facility: National Institute of Endocrinology, Tbilisi

location_facility: Southgate Medical Group/ Southgate Medical Park

location_facility: Multiprofile Hospital for Active Treatment "Zaritza Johanna"

location_facility: University Diabetes and Endocrine Consultants

location_facility: Chemotherapy & Immunotherapy Clinic 'Medulla', Tbilisi

location_facility: Consultorios Asociados de Endocrinología e Invest Clínica

location_facility: Internal & Diabetology Ambulance, Jablonec nad Nisou

location_facility: Lausmed Kft. Outpatient Unit of Internal Medicine

location_facility: Tristan Medical Enterprises, PC dba Regeneris

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Clinical Research Advantage, Inc./Rita B. Chuang, MD, LLC

location_facility: General Hopsital of Thessaloniki "Ippokrateio"

location_facility: SC Medical Centre "Sanatatea Ta" SRL, Bucharest

location_facility: The University of North Carolina at Chapel Hill

location_facility: Castlerock Clinical Research Consultants, LLC

location_facility: Clinic for Cardiology "Sertse i sudyny", Kiev

location_facility: National Center for Diabetes Research Ltd., Tbilisi

location_facility: Hop St Dié des Vosges, Diabéto, St Dié des Vosges

location_facility: Diamed Clinical Research Services Pvt. Ltd.

location_facility: Multiprofile Hospital for Active Treatment

location_facility: Instituto de Investigaciones Clinicas de Rosario

location_facility: Taipei Medical University-Shuang Ho Hospital

location_facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião

location_facility: Klinische Forschung Management & Services GmbH

location_facility: Zhordania Institute of Human Reproduction, Tbilisi

location_facility: State Institution "Central Clinical Hospital of RAS", Moscow

location_facility: Centro Cientifico Asistencial Jose Luis Accini

location_facility: Internal & Diabetology Ambulance Dr. Vrkoc, Ostrava

location_facility: The Chaim Sheba Medical Center Tel Hashomer

location_facility: Hospital Universitari de Girona Doctor Josep Trueta

location_facility: San Diego Sports Medicine and Family Health Center

location_facility: Instituto de Investigaciones Clínicas de Bahía Blanca

location_facility: Seoul National University Bundang Hospital

location_facility: Instituto de Hematología y Medicina Clínica Dr. Rubén Davoli

location_facility: Centro de Investigacion Cardiometabolica de Aguascalientes

location_facility: Internal & Diabetology Ambulance, Prostejov

location_facility: IFG Institut für Gesundheitsförderung GmbH

location_facility: Hospital Strakonice, Internal Department

location_facility: MEDIVASA s.r.o., Outpatient Clinic, Zilina

location_facility: Dr. Samuel Diosszilagyi Hospital and Outpatient Clinic, Mako

location_facility: Japan Community Health care Organization Nihonmatsu Hospital

location_facility: LLC Clinic of new technologies of medicine

location_facility: Keimyung University Dongsan Medical Center

location_facility: Donetsk Regional Clinical Hosp, Therapy Department

location_facility: Detweiler Family Medicine & Associates, PC

location_facility: Hospital Universitário João de Barros Barreto

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: DIASTYLE s.r.o., Diabetology Outpatient Department

location_facility: Clinical Medical Center Zvezdara, Belgrade

location_facility: Shree Krishna Hospital and Heart Care Centre, Ahmedabad

location_facility: Instituto de Molestias Cardiovasculares - IMC

location_facility: Grant Medical Foundation, Ruby Hall Clinic

location_facility: Vinnitsia Regional Endocrinology Dispensary

location_facility: PFÜTZNER Science & Health Institute GmbH

location_facility: Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

location_facility: Grof Esterhazy Hospital and Outpatient Clinic

location_facility: Ivano-Frankivsk City Central Clinical Hospital

location_facility: Diabetes and Endocrine Center of Orlando

location_facility: Centro de Estudos em Diabetes e Hipertensão

location_facility: Global Hospital- Superspeciality & Transplant Centre

location_facility: Quality of Life Medical & Research Center

location_facility: Consulta Privada Maria Loreto Aguirre Coveña

location_facility: State Healthcare Institution, Regional hospital #2

location_facility: Royal Brisbane & Women's Hospital-Endocrinology

location_facility: Fundacion del Caribe de Investigacion Biomedica

location_facility: Limited Liability Company "CENTER DIABET", Samara

location_facility: Edinger Medical Group and Research Center

location_facility: UNIENDO Unidad Integral de Endocrinologia

location_facility: Office of Dr. Craig S. Thompson, MD, LLC

location_facility: New England Center for Clinical Research, Inc

location_facility: Forusakutten - Kolibri Medical, Avd. Stavanger

location_facility: Saitama Medical Cooperative Association Hanyu General Hospital

location_facility: University of Texas Southwestern Medical Center

title: A Multicentre, International, Randomised, Parallel Group, Double Blind Study to Evaluate Cardiovascular Safety of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes Mellitus at High Cardiovascular Risk.

summary: The aim of the study is to investigate the longterm impact on cardiovascular morbidity and mortality, relevant efficacy parameters (e.g., glycaemic parameters) and safety (e.g., weight and hypoglycaemia) of treatment with linagliptin in patients with type 2 diabetes at elevated cardiovascular risk receiving usual care, and compare outcome against glimepiride.


title: Microparticle's Procoagulant Activity to Identify Patients With Cancer and a High Risk for Venous Thrombosis

acronym: MICA

summary: Cancer patients are at increased risk of deep venous thrombosis and pulmonary embolism, collectively termed venous thromboembolism (VTE). Risk assessment scores for VTE in cancer patients have been previously developed by the groups of Khorana and Vienna CATS. However, routine thromboprophylaxis for ambulatory cancer patients based on these scores is currently not recommended. In the investigators prospective, observational cohort study, the investigators aim to identify cancer patients at high risk for VTE based on clinical characteristics, coagulation biomarkers and the coagulant activity of tissue factor bearing microparticles.

ReferenceCitation: van Es N, Di Nisio M, Cesarman G, Kleinjan A, Otten HM, Mahé I, Wilts IT, Twint DC, Porreca E, Arrieta O, Stépanian A, Smit K, De Tursi M, Bleker SM, Bossuyt PM, Nieuwland R, Kamphuisen PW, Büller HR. Comparison of risk prediction scores for venous thromboembolism in cancer patients: a prospective cohort study. Haematologica. 2017 Sep;102(9):1494-1501. doi: 10.3324/haematol.2017.169060. Epub 2017 May 26.

family: van Es

full_name: Nick van Es

given: Nick

family: Di Nisio

full_name: Marcello Di Nisio

given: Marcello

family: Cesarman

full_name: Gabriela Cesarman

given: Gabriela

family: Kleinjan

full_name: Ankie Kleinjan

given: Ankie

family: Otten

full_name: Hans-Martin Otten

given: Hans-Martin

family: Mahé

full_name: Isabelle Mahé

given: Isabelle

family: Wilts

full_name: Ineke T. Wilts

given: Ineke T.

family: Twint

full_name: Desirée C. Twint

given: Desirée C.

family: Porreca

full_name: Ettore Porreca

given: Ettore

family: Arrieta

full_name: Oscar Arrieta

given: Oscar

family: Stépanian

full_name: Alain Stépanian

given: Alain

family: Smit

full_name: Kirsten Smit

given: Kirsten

family: De Tursi

full_name: Michele De Tursi

given: Michele

family: Bleker

full_name: Suzanne M. Bleker

given: Suzanne M.

family: Bossuyt

full_name: Patrick M. Bossuyt

given: Patrick M.

family: Nieuwland

full_name: Rienk Nieuwland

given: Rienk

family: Kamphuisen

full_name: Pieter W. Kamphuisen

given: Pieter W.

family: Büller

full_name: Harry R. Büller

given: Harry R.

currency_apc_doaj: EUR

journal_name: Haematologica

license: publisher-specific license

license_normalized: publisher-specific

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

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

publisher: Ferrata Storti Foundation (Haematologica)

location_facility:
Slotervaart hospital
Hospital D'Annunziata
Academic Medical Center
University Medical Center Groningen
VU medical center
Instituto Nacional de Cancerología
Hopital Louis Mourier


ReferenceType: background

ReferenceCitation: Poon LC, Syngelaki A, Akolekar R, Lai J, Nicolaides KH. Combined screening for preeclampsia and small for gestational age at 11-13 weeks. Fetal Diagn Ther. 2013;33(1):16-27. doi: 10.1159/000341712. Epub 2012 Sep 13.

ReferenceCitation: Ayala DE, Ucieda R, Hermida RC. Chronotherapy with low-dose aspirin for prevention of complications in pregnancy. Chronobiol Int. 2013 Mar;30(1-2):260-79. doi: 10.3109/07420528.2012.717455. Epub 2012 Sep 24.

ReferenceCitation: Plasencia W, Maiz N, Poon L, Yu C, Nicolaides KH. Uterine artery Doppler at 11 + 0 to 13 + 6 weeks and 21 + 0 to 24 + 6 weeks in the prediction of pre-eclampsia. Ultrasound Obstet Gynecol. 2008 Aug;32(2):138-46. doi: 10.1002/uog.5402.

intervention_type: Drug

lead_sponsor: University Hospital, Tours

location_country: Martinique France

acronym: PERASTUN

location_facility: Service de Gynécologie-Obstétrique, Hôpital d'Estaing, CHU de Clermont-Ferrand

location_facility: Service de gynécologie-obstétrique, Maison de la Femme de la Mère et de l'Enfant, CHU de Fort de France

location_facility: Service de Gynécologie-Obstétrique, Hôpital Arnaud de Villeneuve, CHRU de Montpellier

location_facility: Service de gynécologie-obstétrique, Polyclinique de l'Atlantique

location_facility: Centre de dépistage PRIMA FACIE, Hôpital Necker, APHP

location_facility: Service de gynécologie-obstétrique, Polyclinique du PARC

location_facility: Service de gynécologie-obstétrique, Hôpital Couple Enfant, CHRU de Grenoble

location_facility: Service de Gynécologie-Obstétrique, Hôpital Porte Madeleine, CHR d'Orléans

location_facility: Service de gynécologie-obstétrique, CHR Le Mans

location_facility: Service de Gynécologie-Obstétrique, Hôpital Paule de Viguier, CHU de Toulouse

location_facility: Service de gynécologie-obstétrique, Hôpital Mère-Enfant, CHRU de Nantes

location_facility: Service de Gynécologie-Obstetrique, Centre Olympe de Gouges, CHRU de Tours

location_facility: Service de Gynécologie-Obstétrique, Groupe Hospitalier Pellegrin, CHRU de Bordeaux

location_facility: Service de Gynécologie-Obstétrique, HFME, Hospices Civils de Lyon

location_facility: Service de Gynécologie-Obstétrique, Hôpital Carémeau, CHRU de Nîmes

location_facility: Service de Gyénécologie-Obstétrique, Hôpital Jeanne de Flandre, CHRU de Lille

type: EudraCT Number

source: euctr

title: Prevention of Pre-eclampsia and SGA by Low-Dose Aspirin in Nulliparous Women With Abnormal First-trimester Uterine Artery Dopplers

summary: The objective of this study is to test the efficacy of low-dose aspirin (160 mg/day), given bedtime and started early during pregnancy (≤ 15 +6 weeks of gestation) in nulliparous pregnant women selected as "high-risk" by the presence of a bilateral uterine artery notch and/or bilateral uterine artery PI ≥ 1.7 during the first trimester ultrasound scan (11-13+6 weeks), to prevent the occurrence of pre-eclampsia or small for gestational age at birth.


title: Clinical Trial Protocol for Therapeutic MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids

summary:
This study is to confirm the safety and technical effectiveness of MRI guided High Intensity Focused Ultrasound (HIFU) in ablating uterine tissue associated with symptomatic leiomyomas. The importance of this therapy is that it offers a non-invasive, uterine sparing procedure for the treatment of uterine fibroids in pre- and peri- menopausal women.

MRI guided high intensity focused ultrasound uses ultrasound to heat and thermally ablate fibroid tissue. The MRI system identifies the ultrasound path and monitors heat rise in the fibroid tissue. The goal of the study is to show treatment safety and technical effectiveness. MR-guided HIFU will be performed in patients who pass inclusion/exclusion criteria. Safety, quality of life, and imaging endpoints will be evaluated in all study patients.

The goal of this study is to demonstrate that:

The safety profile is acceptable (safety)
Actual MR-HIFU ablated volumes (as measured with contrast enhanced MRI) match the intended volumes (technical effectiveness)
When intended, volumes greater than 20% of the fibroid volume can be successfully ablated (technical effectiveness)

The investigators' hypothesis is that greater than 70% of fibroids will have concordance between intended lesion volume and actual lesion volume while maintaining an acceptable safety profile.

ReferenceCitation: Spies JB, Coyne K, Guaou Guaou N, Boyle D, Skyrnarz-Murphy K, Gonzalves SM. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstet Gynecol. 2002 Feb;99(2):290-300.

ReferenceCitation: Stewart EA, Gedroyc WM, Tempany CM, Quade BJ, Inbar Y, Ehrenstein T, Shushan A, Hindley JT, Goldin RD, David M, Sklair M, Rabinovici J. Focused ultrasound treatment of uterine fibroid tumors: safety and feasibility of a noninvasive thermoablative technique. Am J Obstet Gynecol. 2003 Jul;189(1):48-54.

ReferenceCitation: Hindley J, Gedroyc WM, Regan L, Stewart E, Tempany C, Hynyen K, Mcdannold N, Inbar Y, Itzchak Y, Rabinovici J, Kim HS, Geschwind JF, Hesley G, Gostout B, Ehrenstein T, Hengst S, Sklair-Levy M, Shushan A, Jolesz F. MRI guidance of focused ultrasound therapy of uterine fibroids: early results. AJR Am J Roentgenol. 2004 Dec;183(6):1713-9. Erratum in: AJR Am J Roentgenol. 2005 Jan;184(1):348. Hynnen, Kullvro [corrected to Hynyen, Kullervo]; Macdanold, Nathan [corrected to Mcdannold, Nathan]; Kim, Kevin [corrected to Kim, Hyun S]; Gostout, Brian [corrected to Gostout, Bobbie].

ReferenceCitation: Leon-Villapalos J, Kaniorou-Larai M, Dziewulski P. Full thickness abdominal burn following magnetic resonance guided focused ultrasound therapy. Burns. 2005 Dec;31(8):1054-5. Epub 2005 Jun 20.

ReferenceCitation: Fennessy FM, Tempany CM. MRI-guided focused ultrasound surgery of uterine leiomyomas. Acad Radiol. 2005 Sep;12(9):1158-66. Review.

ReferenceCitation: Stewart EA, Rabinovici J, Tempany CM, Inbar Y, Regan L, Gostout B, Hesley G, Kim HS, Hengst S, Gedroyc WM. Clinical outcomes of focused ultrasound surgery for the treatment of uterine fibroids. Fertil Steril. 2006 Jan;85(1):22-9. Erratum in: Fertil Steril. 2006 Apr;85(4):1072. Gastout, Bobbie [corrected to Gostout, Bobbie]; Gedroye, Wladyslaw M [corrected to Gedroyc, Wladyslaw M].

ReferenceCitation: Fennessy FM, Tempany CM, McDannold NJ, So MJ, Hesley G, Gostout B, Kim HS, Holland GA, Sarti DA, Hynynen K, Jolesz FA, Stewart EA. Uterine leiomyomas: MR imaging-guided focused ultrasound surgery--results of different treatment protocols. Radiology. 2007 Jun;243(3):885-93. Epub 2007 Apr 19.

ReferenceCitation: Mara M, Fucikova Z, Maskova J, Kuzel D, Haakova L. Uterine fibroid embolization versus myomectomy in women wishing to preserve fertility: preliminary results of a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2006 Jun 1;126(2):226-33. Epub 2005 Nov 15.

lead_sponsor: Philips Healthcare

location_country:
Germany
Korea, Republic of
France
Netherlands

location_facility:
Hospital St. Andre
University Medical Center
Samsung Medical Center
University Hospital Schleswig-Holstein


title: Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Symptomatic Pulmonary Hypertension Associated With Sickle Cell Disease

summary: The study will assess the effect of bosentan on pulmonary vascular resistance and exercise capacity in Sickle Cell Disease (SCD) patients diagnosed with Pulmonary Hypertension. It consists of 3 phases: screening, treatment and follow-up. During the screening visit, the study doctor will decide if patients meet the study requirements. All potential patients will have a diagnosis of increased pulmonary artery pressures that is shown by right heart catheterization conducted shortly prior to start of study treatment. Patients will be asked to perform exercise capacity test (walking as far as possible for 6 minutes). Following the baseline visit the treatment phase consists of 4 additional clinic visits during which the good and bad effects of the drug are reviewed and exercise capacity test will be repeated. Patients will be treated for 16 weeks. Blood samples will be collected every month, or more often, if needed. At the end of the study some of the patients will be asked to repeat the right heart catheterization. All patients will repeat an exercise capacity test. After completion of the study, patients will have the option of enrolling in a long-term follow-up study where all patients will receive active drug. Patients electing not to participate in the extension study will be followed up for safety assessments for about 28 days after the end of the study treatment.

status: Terminated

ReferenceCitation: Barst RJ, Mubarak KK, Machado RF, Ataga KI, Benza RL, Castro O, Naeije R, Sood N, Swerdlow PS, Hildesheim M, Gladwin MT; ASSET study group*. Exercise capacity and haemodynamics in patients with sickle cell disease with pulmonary hypertension treated with bosentan: results of the ASSET studies. Br J Haematol. 2010 May;149(3):426-35. doi: 10.1111/j.1365-2141.2010.08097.x. Epub 2010 Feb 17.

family: Barst

full_name: Robyn J. Barst

given: Robyn J.

family: Mubarak

full_name: Kamal K. Mubarak

given: Kamal K.

family: Machado

full_name: Roberto F. Machado

given: Roberto F.

family: Ataga

full_name: Kenneth I. Ataga

given: Kenneth I.

family: Benza

full_name: Raymond L. Benza

given: Raymond L.

family: Castro

full_name: Oswaldo Castro

given: Oswaldo

family: Naeije

full_name: Robert Naeije

given: Robert

family: Sood

full_name: Namita Sood

given: Namita

family: Swerdlow

full_name: Paul S. Swerdlow

given: Paul S.

family: Hildesheim

full_name: Mariana Hildesheim

given: Mariana

family: Gladwin

full_name: Mark T. Gladwin

given: Mark T.

journal_name: British Journal of Haematology

oa_host_type: repository

version: acceptedVersion

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

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

version: submittedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Actelion

location_country:
United States
United Kingdom
France
Netherlands

location_facility: Duke University Medical Center; Duke University Health Systems

location_facility: Royal Free Hospital, Rheumatology Department

location_facility: Columbia University Medical Center; Pediatric Cardiology

location_facility: University of Colorado Health Sciences Center

location_facility: University of Texas Medical School; Division of Pulmonary and Critical Care Medicine

location_facility: Henry Ford Hospital; Dept. of Pulmonology

location_facility: Harper University Hospital/Wayne State University

location_facility: Boston Medical Center/Boston University School of Medicine

location_facility: Virginia Commonwealth University Medical Center

location_facility: The Methodist Hospital/Baylor College of Medicine; Pulmonary and Critical Care Medicine

location_facility: Royal Hallamshire Hospital, Pulmonary Vascular Medicine

location_facility: Amsterdam Medical Center, Department of Hematology

location_facility: University of Tennessee Health Science Center


title: Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Symptomatic Pulmonary Arterial Hypertension Associated With Sickle Cell Disease

summary: The study will assess the effect of bosentan on pulmonary vascular resistance and exercise capacity in sickle cell disease (SCD) patients diagnosed with pulmonary arterial hypertension. It consists of 3 phases: Screening, Treatment and Follow-up. During the Screening visit, the study doctor will decide if patients meet the study requirements. All potential patients will have a diagnosis of increased pulmonary artery pressures that is shown by right heart catheterization conducted shortly prior to start of study treatment. Patients will be asked to perform exercise capacity test (walking as far as possible for 6 minutes). Following the Baseline visit, the treatment phase consists of 4 additional clinic visits during which the good and bad effects of the drug are reviewed and exercise capacity test will be repeated. Patients will be treated for 16 weeks. Blood samples will be collected every month, or more often, if needed. At the end of the study, patients will be asked to repeat the right heart catheterization and exercise capacity test. After completion of the study, patients will have the option of enrolling in a long-term follow-up study where all patients will receive active drug. Patients electing not to participate in the extension study will be followed up for safety assessments for about 28 days after the end of the study treatment.

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

title: Exercise capacity and haemodynamics in patients with sickle cell disease with pulmonary hypertension treated with bosentan: results of the ASSET studies


title: Characterisation of Patients With Severe Asthma in Primary and Secondary Care Settings in Europe Reported to be Eligible for Biological Therapy

acronym: RECOGNISE

summary: This is a multi-country, multicentre, observational cross-sectional one-visit study of patients suffering from severe asthma in primary and secondary care settings in Europe

time_perspective: Retrospective

lead_sponsor: AstraZeneca

location_country: Italy Netherlands France Czechia Bulgaria Greece Poland Romania Hungary Spain Germany Slovenia


ReferenceType: result

ReferenceCitation: Ghesquieres H, Chevrier M, Laadhari M, Chinot O, Choquet S, Moluçon-Chabrot C, Beauchesne P, Gressin R, Morschhauser F, Schmitt A, Gyan E, Hoang-Xuan K, Nicolas-Virelizier E, Cassoux N, Touitou V, Le Garff-Tavernier M, Savignoni A, Turbiez I, Soumelis V, Houillier C, Soussain C. Lenalidomide in combination with intravenous rituximab (REVRI) in relapsed/refractory primary CNS lymphoma or primary intraocular lymphoma: a multicenter prospective 'proof of concept' phase II study of the French Oculo-Cerebral lymphoma (LOC) Network and the Lymphoma Study Association (LYSA)†. Ann Oncol. 2019 Apr 1;30(4):621-628. doi: 10.1093/annonc/mdz032.

family: Ghesquieres

full_name: H. Ghesquieres

given: H.

family: Chevrier

full_name: M. Chevrier

given: M.

family: Laadhari

full_name: M. Laadhari

family: Chinot

full_name: O. Chinot

given: O.

family: Choquet

full_name: S. Choquet

given: S.

family: Moluçon-Chabrot

full_name: C. Moluçon-Chabrot

given: C.

family: Beauchesne

full_name: P. Beauchesne

given: P.

family: Gressin

full_name: R. Gressin

given: R.

family: Morschhauser

full_name: F. Morschhauser

given: F.

family: Schmitt

full_name: A. Schmitt

given: A.

family: Gyan

full_name: E. Gyan

given: E.

family: Hoang-Xuan

full_name: K. Hoang-Xuan

given: K.

family: Nicolas-Virelizier

full_name: E. Nicolas-Virelizier

family: Cassoux

full_name: N. Cassoux

given: N.

family: Touitou

full_name: V. Touitou

given: V.

family: Le Garff-Tavernier

full_name: M. Le Garff-Tavernier

family: Savignoni

full_name: A. Savignoni

family: Turbiez

full_name: I. Turbiez

given: I.

family: Soumelis

full_name: V. Soumelis

family: Houillier

full_name: C. Houillier

family: Soussain

full_name: C. Soussain

journal_name: Annals of Oncology

oa_host_type: publisher

evidence: open (via page says license)

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Lenalidomide in combination with intravenous rituximab (REVRI) in relapsed/refractory primary CNS lymphoma or primary intraocular lymphoma: a multicenter prospective ‘proof of concept’ phase II study of the French Oculo-Cerebral lymphoma (LOC) Network and the Lymphoma Study Association (LYSA)

location_facility:
Institut curie - Hôpital René Huguenin
Chu La Timone
Chu Michallon
Centre Léon Bérard
CHU Amiens -Hôpital Sud
Hôpital Central
CHU Estaing
CHRU Lille - Hôpital Claude Huriez
CHU Bretonneau - Centre Henry Kaplan
Institut Bergonié
Centre Henri Becquerel
Hôpital de la Pitié Salpétrière

title: Phase II Study Evaluating the Efficacy of Lenalidomide in Association With Rituximab in Refractory or Relapse of Primary Central Nervous System Lymphoma (PCNSL)

summary:
Because Primary Central Nervous System Lymphoma (PCNSL) are mainly diffuse large B-cell lymphoma of the activated B cells (ABC) type, the investigators hypothesize that the synergy of lenalidomide with rituximab shown in systemic non-Hodgkin's lymphoma (NHL) could be observed in PCNSL.

This study will assess the efficiency of the the combination of lenalidomide and rituximab in relapsed/refractory PCNSL, and the efficiency of a maintenance treatment with lenalidomide alone in maintaining the response.


title: Salvage Cryoablation of the Prostate (SCAP) vs High Intensity Focal Ultrasounds (HIFU) for Recurrent Prostate Cancer After Radiation Therapy

acronym: SALVPROST

summary:
The evidence base relating to the use of SCAP and HIFU is poor, with significant uncertainties relating to long-term oncological outcomes. One of the main limitations when the few studies reported are analyzed is the lack of information about the histopathology both before starting treatment and at the time of recurrence after cryotherapy. The vast majority of studies refer only to BCR-free survival as end point, thus limiting interpretation of real oncological performance of this technique. Furthermore, side effects vary widely from study to study and there are uncertainties about the real morbidity associated to cryotherapy in the salvage setting.

Another important hot issue in this scenario is the potential benefit that new imaging and diagnosis techniques (MRI, targeted biopsy, PSMA) may add for a more accurate indication. This could provide the possibility of better results for SCAP. The clinical value of this new diagnostic tools is unknown in this scenario and needs to be explored.

study_start_date_type: Anticipated

status: Recruiting

ipd_sharing: Undecided

lead_sponsor: University Hospital Virgen de las Nieves

location_country: France Spain

location_facility: Hospital Universitario Virgen de las Nieves

status_simplified: Ongoing


title: A Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn's Disease

summary:
In Crohn's Disease Patients

To evaluate the efficacy of TRK-170
To evaluate the PK characteristics of TRK-170
To assess the safety of TRK-170

lead_sponsor: Toray Industries, Inc

location_country:
Sweden
Serbia
Netherlands
France
Bulgaria
Poland
Norway
Hungary
Belgium
Latvia
Romania
Czech Republic
Ukraine

location_facility:
Sweden
Serbia
The Netherlands
France
Bulgaria
Poland
Norway
Hungary
Belgium
Latvia
Romania
Czech Republic
Ukraine


title: An Open-label, Single Treatment, Safety and Efficacy, Long-term Study of Deferiprone in Subjects With Friedreich's Ataxia

summary:
The primary objective of this study is to evaluate the long-term safety and tolerability of deferiprone in subjects with Friedreich's ataxia (FRDA).

The secondary objective is to evaluate the long-term efficacy of deferiprone for the treatment of FRDA.

The tertiary objectives are to evaluate the effect of deferiprone on:

cardiac function,
quality of life, and
functional status.

lead_sponsor: ApoPharma

location_country: Italy Belgium France Spain

location_facility: Fondazione IRCCS Istituto Neurologico "C. Besta"

location_facility: La Fundacion Para la Investigacion Biomedica


title: International Multicenter Study of Ventilator Associated Tracheobronchitis.

acronym: TAVeM

summary:
Justification and background Ventilator-associated complications (VACs) are those complications that develop during a period of intubation of a patient . Pneumonia is the second most frequent infectious complication in the hospital, and ranks first in ICU, whose risk is increased more than 20 times by the presence of invasive mechanical ventilation and is called ventilator-associated pneumonia (VAP) . Whereas the information published regarding VAP in terms of diagnosis, treatment and impact on the outcome of critically ill patients is enormous.Ventilator-associated tracheobronchitis (VAT) incidence is lacking and complicated in part, since the definition remains controversial. In addition, the significance of tracheobronchial colonization as a risk factor for subsequent lower respiratory tract infection remains unclear . The upper and lower airways can become colonized . Several factors have been taken into account and do not differ from those involved in VAT and VAP development in patients under mechanical ventilation.

Definition VAT diagnosis is controversial and represents an actual problem in order to define the real incidence of VAT , There is currently no valid, reliable definition for VAT, and even the most widely-used VAT criteria and definitions are neither sensitive nor specific. The diagnosis of VAT is considered when a patient under invasive mechanical ventilation starts with fever, leukocytosis and new or increased purulent secretions by the endotracheal tube. A particular difficulty with much commonly used VAT definition (in order to distinguish from VAP) is the key point of the absence of pulmonary consolidation. Evidence suggests that chest radiograph findings do not accurately role out VAP. A taskforce on hospital-acquired pneumonia, and VAP has been recently published (European Respiratory Society (ERS), European Society of Clinical Microbiology and Infectious Diseases (ESCMID) and European Society of Intensive Care Medicine (ESICM)). Nosocomial tracheobronchitis definition includes occurrence of purulent tracheal secretion after ≥48 h of hospitalisation or mechanical ventilation plus ≥2 of the following: fever (≥38.5°C) or hypothermia (<36°C), leukocytosis (≥12 × 109/L), significant bacteriologic counts in respiratory secretions (≥103 cfu/mL for protected brush specimen (PBS) and ≥105 cfu/mL for endotracheal aspirates); absence of new pulmonary infiltrates compatible with pneumonia and absence of other causes of fever are mandatory. This definition needs to be further validated and can overdiagnose the incidence of VAT (and overuse of antibiotics) because the positive culture of respiratory secretions is not a mandatory item RATIONALE Given the possible high incidence of VAT, and its importance as a risk factor for VAP, and a potential target to treat in order to reduce VAP incidence, a large multicentre

ReferenceCitation: Martin-Loeches I, Torres A, Povoa P, Zampieri FG, Salluh J, Nseir S, Ferrer M, Rodriguez A; TAVeM study Group. The association of cardiovascular failure with treatment for ventilator-associated lower respiratory tract infection. Intensive Care Med. 2019 Dec;45(12):1753-1762. doi: 10.1007/s00134-019-05797-6. Epub 2019 Oct 16.

family: Martin-Loeches

full_name: Ignacio Martin-Loeches

given: Ignacio

family: Torres

full_name: Antoni Torres

given: Antoni

family: Povoa

full_name: Pedro Povoa

given: Pedro

family: Zampieri

full_name: Fernando G. Zampieri

given: Fernando G.

family: Salluh

full_name: Jorge Salluh

given: Jorge

family: Nseir

full_name: Saad Nseir

given: Saad

family: Ferrer

full_name: Miquel Ferrer

given: Miquel

family: Rodriguez

full_name: Alejandro Rodriguez

given: Alejandro

full_name: I. Martin-Loeches

full_name: P. Povoa

full_name: Fernando Zampieri

given: Fernando

family: Rodríguez

full_name: A. Rodríguez

family: Curcio

full_name: D. Curcio

given: D.

family: Mira

full_name: J. P. Mira

given: J. P.

family: Cordero

full_name: M. L. Cordero

given: M. L.

family: Lepecq

full_name: R. Lepecq

family: Girault

full_name: C. Girault

family: Candeias

full_name: C. Candeias

family: Seguin

full_name: P. Seguin

family: Paulino

full_name: C. Paulino

family: Messika

full_name: J. Messika

given: J.

family: Castro

repository_institution: University of Liège - Open Repository and Bibliography

ReferenceCitation: Martin-Loeches I, Povoa P, Rodríguez A, Curcio D, Suarez D, Mira JP, Cordero ML, Lepecq R, Girault C, Candeias C, Seguin P, Paulino C, Messika J, Castro AG, Valles J, Coelho L, Rabello L, Lisboa T, Collins D, Torres A, Salluh J, Nseir S; TAVeM study. Incidence and prognosis of ventilator-associated tracheobronchitis (TAVeM): a multicentre, prospective, observational study. Lancet Respir Med. 2015 Nov;3(11):859-68. doi: 10.1016/S2213-2600(15)00326-4. Epub 2015 Oct 22.

location_country: Ecuador Brazil Spain France Bolivia Argentina Portugal Colombia

location_facility: Corporació Sanitària I Universitaria Parc Taulí - Hospital de Sabadell


title: European, Observational, Prospective Study to Evaluate the Benefit/Risk of Vandetanib in RET Mutation Negative and Positive Patients With Symptomatic, Aggressive, Sporadic, Unresectable, Locally Advanced/Metastatic Medullary Thyroid Cancer

summary: This is a European multinational, multicenter, non-interventional (observational) and prospective study. It is carried on to confirm in real life conditions the benefit/risk of vandetanib (CAPRELSA™) 300 mg, both in RET negative and RET positive patients with symptomatic, aggressive, sporadic, unresectable, locally advanced/metastatic MTC.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Italy
Luxembourg
Netherlands
France
Belgium
Spain
Germany
United Kingdom

location_facility:
investigational Site Luxembourg
investigational Site France
investigational Site Italy
investigational Site Netherlands
investigational Site Spain
investigational Site Belgium
investigational Site United Kingdom
investigational Site Germany


title: A Multicenter, Randomized, Double-Masked, 3 Parallel Arms, Placebo Controlled Study to Assess the Efficacy and Safety of NOVA22007 1mg/mL (Ciclosporin/Cyclosporine) Eye Drops, Emulsion Administered in Paediatric Patients With Active Severe Vernal Keratoconjunctivitis With Severe Keratitis

summary: The objective of this study is to compare the efficacy of two different dosing regimen of NOVA22007 (1mg/ml ciclosporin/cyclosporine) eye drops, emulsion versus placebo (vehicle of the formulation) administered four times a day in patients with severe vernal keratoconjunctivitis after 4 months of treatment.

lead_sponsor: Santen SAS

location_country:
Italy
United States
India
Spain
Croatia
France
Greece
Israel
Hungary
Portugal
Germany

location_facility: New Delhi, National Capitol Territory, IN


title: A Phase 2b Randomized Trial of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) Plus Best Supportive Care Versus Best Supportive Care in Patients With Advanced Hepatocellular Carcinoma Who Have Failed Sorafenib Treatment

acronym: TRAVERSE

summary: This study is to determine whether JX-594 (Pexa-Vec) plus best supportive care is more effective in improving survival than best supportive care in patients with advanced Hepatocellular Carcinoma (HCC) who have failed sorafenib.

ReferenceCitation: Moehler M, Heo J, Lee HC, Tak WY, Chao Y, Paik SW, Yim HJ, Byun KS, Baron A, Ungerechts G, Jonker D, Ruo L, Cho M, Kaubisch A, Wege H, Merle P, Ebert O, Habersetzer F, Blanc JF, Rosmorduc O, Lencioni R, Patt R, Leen AM, Foerster F, Homerin M, Stojkowitz N, Lusky M, Limacher JM, Hennequi M, Gaspar N, McFadden B, De Silva N, Shen D, Pelusio A, Kirn DH, Breitbach CJ, Burke JM. Vaccinia-based oncolytic immunotherapy Pexastimogene Devacirepvec in patients with advanced hepatocellular carcinoma after sorafenib failure: a randomized multicenter Phase IIb trial (TRAVERSE). Oncoimmunology. 2019 Jun 3;8(8):1615817. doi: 10.1080/2162402X.2019.1615817. eCollection 2019.

name: First Department of Medicine, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany

family: Moehler

full_name: M. Moehler

given: M.

name: College of Medicine, Pusan National University and Medical Research Institute, Pusan National University Hospital, Busan, Republic of Korea

family: Heo

full_name: J. Heo

name: Asan Medical Center, University of Ulsan College of Medicine, Ulsan, Republic ofKorea

family: Lee

full_name: H.C. Lee

name: School of Medicine, Kyungpook National University Medical Center, Daegu, Republic of Korea

family: Tak

full_name: W.Y. Tak

name: Department of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan

family: Chao

full_name: Y. Chao

given: Y.

name: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea

family: Paik

full_name: S.W. Paik

name: Department of Internal Medicine, Korea University Ansan Hospital, Ansan-si, Republic of Korea

family: Yim

full_name: H.J. Yim

name: Department of Internal Medicine, Korea UniversityCollege of Medicine, Seoul, Republic of Korea

family: Byun

full_name: K.S. Byun

name: Department of Medicine, California Pacific Medical Center, San Francisco, CA, USA

family: Baron

full_name: A. Baron

given: A.

name: Department of Medical Oncology, National Center for Tumor Diseases (NCT) and Heidelberg University Hospital, Heidelberg, Germany

family: Ungerechts

full_name: G. Ungerechts

given: G.

name: The Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Canada

family: Jonker

full_name: D. Jonker

name: Department of Surgery, Juravinski Hospital and Cancer Centre, McMaster University, Hamilton, Canada

family: Ruo

full_name: L. Ruo

given: L.

name: Department of Internal Medicine, Pusan National University Yangsan Hospital, Busan, Republic of Korea

family: Cho

full_name: M. Cho

name: Department of Medicine, Montefiore Medical Center, New York, NY, USA

family: Kaubisch

full_name: A. Kaubisch

name: Department of Medicine, Gastroenterology and Hepatology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany

family: Wege

full_name: H. Wege

given: H.

name: Hepatology Unit, Croix-Rousse Hospital, Lyon, France

family: Merle

full_name: P. Merle

given: P.

name: Klinik und Poliklinik für Innere Medizin II, Klinikum rechts der Isar, Technical University, Munich, Germany

family: Ebert

full_name: O. Ebert

given: O.

name: Pôle Hépato-Digestif, Hôpitaux Universitaires de Strasbourg, INSERM 1110, IHU de Strasbourg and Université de Strasbourg, Strasbourg, France

family: Habersetzer

full_name: F. Habersetzer

given: F.

name: Hepato-Gastroenterology and Digestive Oncology Department, CHU Bordeaux, Bordeaux, France

family: Blanc

full_name: J.F. Blanc

name: Sorbonne Université, AP-HP, Hôpital Paul Brousse, Villejuif, France

family: Rosmorduc

full_name: Olivier Rosmorduc

given: Olivier

name: Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, FL, USA

family: Lencioni

full_name: R. Lencioni

given: R.

family: Patt

full_name: R. Patt

name: Department of Pediatrics, Baylor College of Medicine, Houston, TX, USA

family: Leen

full_name: A.M. Leen

family: Foerster

full_name: F. Foerster

name: Medical Affairs, Transgene S.A., Illkirch-Graffenstaden, France

family: Homerin

full_name: M. Homerin

name: Clinical Operations, Transgene S.A., 400 Bd Gonthier d’Andernach, Parc d’Innovation, 67405 Illkirch-Graffenstaden, France

name: Program Management, Transgene S.A., 400 Bd Gonthier d’Andernach, Parc d’Innovation, 67405 Illkirch-Graffenstaden, France

name: Medical Affairs, Transgene S.A., 400 Bd Gonthier d’Andernach, Parc d’Innovation, 67405 Illkirch-Graffenstaden, France

name: Biostatistics, Transgene S.A., 400 Bd Gonthier d’Andernach, Parc d’Innovation, 67405 Illkirch-Graffenstaden, France

name: Clinical Assays, SillaJen Inc., San Francisco, CA, USA

name: Analytical Development and Quality Control, SillaJen Inc., San Francisco, CA, USA

name: Clinical, SillaJen Inc., San Francisco, CA, USA

location_country:
United States
Hong Kong
France
Korea, Republic of
Germany
Canada
Taiwan

location_facility: Centre Hospitalier Universitaire Hôpital Saint André

location_facility: Moores University of California San Diego Cancer Center

location_facility: Severance Hospital,Yonsei University Health System

location_facility: University Hospitals Case Medical Center

location_facility: Hôpitaux Universitaires de Strasbourg - Hôpital Civil

location_facility: Klinikum Rechts der Isar der Technischen Universität München

location_facility: Hôpital Saint Antoine, CPP Ile de France V

location_facility: The Methodist Hospital Department of Surgery


title: Bacterial DNA Detection as a Diagnostic Tool of Infection in Critical Ill Patients With SIRS

summary:
Sepsis is a common cause of morbidity and death in intensive care units. Clinical and laboratory signs of systemic inflammation, including changes in body temperature, tachycardia, or leukocytosis, are neither sensitive nor specific enough for the diagnosis of sepsis. The diagnosis of sepsis is difficult, because clinical signs are unspecific. These signs include tachycardia, leucocytosis, tachypnoea, and pyrexia, which are collectively termed a systemic inflammatory response syndrome (SIRS). SIRS is very common in critically ill patients, being found in various conditions including trauma, surgery, burns, pancreatitis, post-cardiac arrest syndrome, cardiac surgery. Microbiological culture can be used to distinguish sepsis from non-infectious conditions. However, this method lacks sensitivity and specificity, and there is often a substantial time delay. So these signs can also be misleading because critically ill patients often present with the systemic inflammatory response syndrome without infection. This issue is of paramount importance, since therapy and outcome differ greatly between patients with and those without sepsis; clinicians are often prone to overuse antibiotic therapy being afraid of not treating a potential infection or superinfection. Moreover, the widespread use of antibiotics for all such patients is likely to increase antibiotic resistance, toxicity, and costs. On the opposite, any delay in administration of antibiotics can be extremely detrimental for the infected patient with an exponential increase of the odd ratio for death. Search for early biomarker tools for the diagnosis of infection, initially promising, are quite challenged and controversial nowadays because they can be more related to the inflammation response, irrespective to the insult. Furthermore up to 40% of the infections remain strongly suspected but not bacteriologically documented. Persisting researches are ongoing to find new markers to better discriminate SIRS related to infection process from to SIRS not related to infection. Cytokine profiles using multiplex analysis seems more related to the severity of the SIRS than the trigger of the SIRS (infectious or non infectious diseases). Thus, new tools have been developed to identify bacteria by detecting their DNA by various techniques. These techniques have many potential interests over conventional microbiologic tests by decreasing turnaround time (within a few hours 2-6 hours), reducing inhibitory effects of prior use of antibiotics, detection of slow or fastidious growing organisms. However these tests remain to be validated in a clinical setting.

The goal of the current study is to evaluate the diagnostic value of plasma detection of bacterial DNA in ICU patients with a clinical suspicion of bacterial infection.

lead_sponsor: Delafontaine Hospital

location_facility:
Saint louis Hospital
Saint Joseph Hospital
Jacques Cartier Institute
Pasteur Institute
Delafontaine Hospital


lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
India
France
Poland
Hungary
Belgium
Turkey
Germany

location_facility:
Sites in France
Sites in Poland
Sites in USA
Sites in Italy
Sites in Belgium
Sites in Turkey
Sites in Hungary
Sites in India
Sites in Germany

title: An Extension to Study Protocol CVAL489K2302 to Evaluate the Long Term Safety, Tolerability and Efficacy of Valsartan in Children 6 to 17 Years of Age With Hypertension, Versus Enalapril Treatment for 14 Weeks, or Combined With Enalapril Versus Enalapril for 66 Weeks in Chronic Kidney Disease Patients.

summary: The purpose of this extension study is to compare the long-term safety of valsartan versus enalapril, and the effectiveness of the combination of valsartan and enalapril versus enalapril alone in children with hypertension.


title: PREPIC 2 : Interruption of Inferior Vena Cava by a Retrievable Filter for the Prevention of Recurrent Pulmonary Embolism : a Randomised, Open Label Study

summary: The purpose of this study is to assess efficacy and safety of optional vena cava filter implanted 3 months in prevention of recurrent pulmonary embolism in patients presenting with acute pulmonary embolism associated with thrombotic risk factors

ReferenceCitation: Decousus H, Leizorovicz A, Parent F, Page Y, Tardy B, Girard P, Laporte S, Faivre R, Charbonnier B, Barral FG, Huet Y, Simonneau G. A clinical trial of vena caval filters in the prevention of pulmonary embolism in patients with proximal deep-vein thrombosis. Prévention du Risque d'Embolie Pulmonaire par Interruption Cave Study Group. N Engl J Med. 1998 Feb 12;338(7):409-15.

ReferenceCitation: PREPIC Study Group. Eight-year follow-up of patients with permanent vena cava filters in the prevention of pulmonary embolism: the PREPIC (Prevention du Risque d'Embolie Pulmonaire par Interruption Cave) randomized study. Circulation. 2005 Jul 19;112(3):416-22. Epub 2005 Jul 11.

ReferenceCitation: Mismetti P, Laporte S, Pellerin O, Ennezat PV, Couturaud F, Elias A, Falvo N, Meneveau N, Quere I, Roy PM, Sanchez O, Schmidt J, Seinturier C, Sevestre MA, Beregi JP, Tardy B, Lacroix P, Presles E, Leizorovicz A, Decousus H, Barral FG, Meyer G; PREPIC2 Study Group. Effect of a retrievable inferior vena cava filter plus anticoagulation vs anticoagulation alone on risk of recurrent pulmonary embolism: a randomized clinical trial. JAMA. 2015 Apr 28;313(16):1627-35. doi: 10.1001/jama.2015.3780.

name: Service de Médecine Vasculaire et Thérapeutique, Centre Hospitalier Universitaire de Saint-Etienne, France2Université Jean Monnet, Groupe d’Investigation et de Recherche Clinique sur la Thrombose, Saint-Etienne, France3Unité de Pharmacologie Clinique, Cen

family: Mismetti

full_name: Patrick Mismetti

given: Patrick

name: Université Jean Monnet, Groupe d’Investigation et de Recherche Clinique sur la Thrombose, Saint-Etienne, France3Unité de Pharmacologie Clinique, Centre Hospitalier Universitaire de Saint-Etienne, France

family: Laporte

full_name: Silvy Laporte

given: Silvy

name: Faculté de Médecine, Université Paris Descartes, Sorbonne Paris Cité, France5Service de Radiologie Interventionnelle, Hôpital Européen Georges Pompidou, Assistance Publique—Hôpitaux de Paris, France

family: Pellerin

full_name: Olivier Pellerin

name: Département de Cardiologie, Centre Hospitalier Universitaire de Grenoble, La Tronche, France

family: Ennezat

full_name: Pierre-Vladimir Ennezat

given: Pierre-Vladimir

name: Département de Médecine Interne et Pneumologie, Hôpital La Cavale Blanche, Université De Bretagne occidentale, Brest, France

family: Couturaud

full_name: Francis Couturaud

given: Francis

name: Service de Médecine Vasculaire et Médecine Interne, Pôle Cardiologie-Vasculaire, Hôpital Sainte Musse, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer, France

family: Elias

full_name: Antoine Elias

given: Antoine

name: Département de Pathologie Vasculaire, Centre Hospitalier Universitaire Dijon Bocage, France

family: Falvo

full_name: Nicolas Falvo

given: Nicolas

name: Département de Cardiologie, Centre Hospitalier Régional Universitaire Hôpital Jean Minjoz, Besançon, France

family: Meneveau

full_name: Nicolas Meneveau

name: Service de Médecine Vasculaire, Centre Hospitalier Universitaire de Montpellier, Université de Montpellier I, France

family: Quere

full_name: Isabelle Quere

given: Isabelle

name: Cardioprotection, Remodelage, et Thrombose and Service des Urgences, Centre Hospitalier Universitaire d'Angers, France 13Université Nantes Angers Le Mans, France

family: Roy

full_name: Pierre-Marie Roy

given: Pierre-Marie

name: Service de Pneumologie, Hôpital Européen Georges Pompidou, Université Paris Descartes, Sorbonne Paris Cité, France

family: Sanchez

full_name: Olivier Sanchez

name: Pôle Urgences, Centre Hospitalier Universitaire Gabriel Montpied, Clermont-Ferrand, France16Université 1 d'Auvergne, Clermont Ferrand, France

family: Schmidt

full_name: Jeannot Schmidt

given: Jeannot

name: Service de Médecine Vasculaire, Centre Hospitalier Universitaire de Grenoble, France

family: Seinturier

full_name: Christophe Seinturier

given: Christophe

name: Service de Médecine Vasculaire, Centre Hospitalier Universitaire d'Amiens, France

family: Sevestre

full_name: Marie-Antoinette Sevestre

given: Marie-Antoinette

name: Service de Radiologie, Hôpital Cardiologique, Centre Hospitalier Universitaire de Lille, France

family: Beregi

full_name: Jean-Paul Beregi

given: Jean-Paul

name: Centre Hospitalier Universitaire de Saint-Etienne, Hôpital Nord, Service Médecine d’Urgences et Réanimation, France21Université de Lyon, Université de Saint-Etienne, France

family: Tardy

full_name: Bernard Tardy

given: Bernard

name: Service de Médecine Vasculaire, Centre Hospitalier Universitaire de Limoges, France

family: Lacroix

full_name: Philippe Lacroix

given: Philippe

family: Presles

full_name: Emilie Presles

given: Emilie

name: Unité Mixte de Recherche/Centre National de la Recherche Scientifique, University of Lyon, France

family: Leizorovicz

full_name: Alain Leizorovicz

given: Alain

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

family: Decousus

full_name: Hervé Decousus

given: Hervé

name: Service de Radiologie, Centre Hospitalier Universitaire de Saint-Etienne, France 26Université Jean Monnet, Saint-Etienne, France

family: Barral

full_name: Fabrice-Guy Barral

given: Fabrice-Guy

family: Meyer

full_name: Guy Meyer

given: Guy

title: Effect of a Retrievable Inferior Vena Cava Filter Plus Anticoagulation vs Anticoagulation Alone on Risk of Recurrent Pulmonary Embolism

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Service d'Urgences et de Réanimation Medicale, CHU de Saint-Etienne

location_facility: Service d'Accueil des Urgences, CHU d'Angers

location_facility: Service de Medecine Interne et Vasculaire, CHU de Nancy

location_facility: Département de Pneumologie, Hôpital Européen Georges Pompidou, AP HP

location_facility: Service d'Urgences Soins Intensifs cardiologiques, CHU de Lille

location_facility: Service d'Accueil des Urgences, CHU de Clermont Ferrand

location_facility: Service de Pneumologie, Hôpital Antoine Beclere

location_facility: Service de Médecine Vasculaire, CHU Amiens

location_facility: Département de Medecine Interne et Pneumologie, CHU de Brest

location_facility: Service de Medecine Interne et Maladies Vasculaires, CHU de Montpellier

location_facility: Service de Medecine et Therapeutique - CHU de Saint-Etienne

location_facility: Unité de Médecine Vasculaire, CHU de Grenoble

location_facility: Service de Médecine Vasculaire, CH Toulon


status: Active, not recruiting

lead_sponsor: UNICANCER

acronym: MOVIE

location_facility: Institut de Cancérologie de l'Ouest - Site René Gauducheau

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

title: A Phase I/II Basket Trial Evaluating a Combination of Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumour

summary: This is a phase I/II national, multicentre, multiple cohort, prospective open-label, non-randomised and non-comparative study, to evaluate the safety and activity of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy for the treatment of advanced solid tumours.


title: Stool Biobanking and Impact of Antimicrobials on the Gut Microbiota in Patients With Bone and Joint Infection

acronym: GUMIBONE

summary:
Bone and joint infections (BJI) is a public health issue in industrialized countries.

Implant-associated BJI, are complex hospital-acquired infections and eradication of the pathogen is challenging in such patients.

A prolonged antimicrobial therapy is usually required from 6 weeks to 3 months, but some patients are eligible to several years of treatment and most of patients report gastrointestinal troubles, such as nausea and mild to severe diarrhea (but very few developed C. difficile diarrhea).

Moreover, the host gut microbiota is probably largely affected in abundance, richness and diversity. Indeed, it is known, that few days of antibiotics are sufficient to induce significant alterations of the gut microbiota, also called dysbiosis.

Severe dysbiosis, which is potentially irreversible and associated with a definitive shift in the gut microbiota metabolism and host homeostasis, may lead to and/or promote a large panel of severe diseases such as Clostridium difficile infection, diabetes mellitus, obesity, inflammatory bowel disease (IBD), cirrhosis, neurological disorders and cancer. It may also be associated with BJI recurrence and then impact global health costs.

The main objective of this study is to constitute biobanking of stools and perform DNA sequencing of the gut microbiota in patients with acute or sub-acute implant-related Bone and Joint Infection (BJI), caused by Staphylococcus aureus.

primary_purpose: Basic Science

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre Hospitalier Lyon Sud-Service des maladies infectieuses

location_facility: Hôpital de la Croix Rousse-Service de chirurgie orthopédique

location_facility: Centre Hospitalier Lyon Sud-Service de Chirurgie Orthopédique

location_facility: Hôpital de la Croix Rousse-Service des Maladies Infectieuses et Tropicales


title: Combination of MK3475 and Metronomic Cyclophosphamide in Patients With Advanced Sarcomas : Multicentre Phase II Trial

acronym: PEMBROSARC

summary: This is a multicenter study assessing the efficacy of different therapeutic strategy in patients with advanced sarcomas.

ReferenceCitation: Le Cesne A, Marec-Berard P, Blay JY, Gaspar N, Bertucci F, Penel N, Bompas E, Cousin S, Toulmonde M, Bessede A, Fridman WH, Sautes-Fridman C, Kind M, Le Loarer F, Pulido M, Italiano A. Programmed cell death 1 (PD-1) targeting in patients with advanced osteosarcomas: results from the PEMBROSARC study. Eur J Cancer. 2019 Sep;119:151-157. doi: 10.1016/j.ejca.2019.07.018. Epub 2019 Aug 21.

family: Le Cesne

full_name: A. Le Cesne

given: A.

family: Marec-Berard

full_name: P. Marec-Berard

given: P.

family: Blay

full_name: J.-Y. Blay

family: Gaspar

full_name: N. Gaspar

given: N.

family: Bertucci

full_name: F. Bertucci

given: F.

family: Penel

full_name: N. Penel

family: Bompas

full_name: E. Bompas

given: E.

family: Cousin

full_name: S. Cousin

given: S.

family: Toulmonde

full_name: M. Toulmonde

given: M.

family: Bessede

full_name: A. Bessede

family: Fridman

full_name: W.H. Fridman

family: Sautes-Fridman

full_name: C. Sautes-Fridman

given: C.

family: Kind

full_name: M. Kind

family: Le Loarer

full_name: F. Le Loarer

family: Pulido

full_name: M. Pulido

family: Italiano

full_name: A. Italiano

journal_name: European Journal of Cancer

ReferenceCitation: Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14. Review.

name:
Laboratory of Experimental Oncology, Pharmacogenomics and Pharmacogenetics Research Unit, IRCCS Istituto Ortopedico Rizzoli,
      Bologna, Italy

family: Hattinger

full_name: Claudia Maria Hattinger

given: Claudia Maria

family: Patrizio

full_name: Maria Pia Patrizio

given: Maria Pia

family: Magagnoli

full_name: Federica Magagnoli

given: Federica

family: Luppi

full_name: Silvia Luppi

given: Silvia

family: Serra

full_name: Massimo Serra

ReferenceCitation: Toulmonde M, Penel N, Adam J, Chevreau C, Blay JY, Le Cesne A, Bompas E, Piperno-Neumann S, Cousin S, Grellety T, Ryckewaert T, Bessede A, Ghiringhelli F, Pulido M, Italiano A. Use of PD-1 Targeting, Macrophage Infiltration, and IDO Pathway Activation in Sarcomas: A Phase 2 Clinical Trial. JAMA Oncol. 2018 Jan 1;4(1):93-97. doi: 10.1001/jamaoncol.2017.1617.

name: Department of Medical Oncology, Institut Bergonié, Bordeaux, France

name: Department of Medical Oncology, Centre Oscar Lambret, Bordeaux, France

name: Department of Pathology, Gustave Roussy, Villejuif, France

name: Department of Medical Oncology, Oncopole Toulouse, Toulouse France

name: Department of Medical Oncology, Centre Leon Berard, Lyon, France

name: Department of Medical Oncology, Institut Gustave Roussy, Villejuif, France

name: Department of Medical Oncology, Institut de Cancérologie de l’Ouest, Nantes, France

name: Department of Medical Oncology, Institut Curie, Paris, France

name: Department of Medical Oncology, Centre Oscar Lambret, Lille, France

name: Unité de Recherche et d’Epidémiologie Cliniques, Institut Bergonié, Bordeaux, France

location_facility:
Centre Léon Bérard
Institut de Cancérologie de l'Ouest
Centre Oscar Lambret
Institut Claudius Regaud
Institut Curie
Institut Paoli Calmettes
Institut Bergonié
Institut Gustave Roussy


title: Prevention of Atrial Fibrillation by the Prescription of Inhibition Conversion Enzyme (ICE) After Radiofrequency Ablation of Atrial Flutter

acronym: PREFACE

summary:
Atrial Flutter [AFL] is a relatively frequent arrhythmia, considered as benign, but associated with both invalidating symptoms and thromboembolic risk. The objective of the treatment consists to on the one hand the sinus rhythm [SR] restoration and on the other hand the prevention of the long-term recurrence. In this clinical setting, AFL radiofrequency ablation [RFA] became the first line therapy due to its both high effectiveness and safety. The effectiveness of AFL RFA is attenuated by the subsequent risk of atrial fibrillation [AFib] close to 25% at 1 year. This risk of subsequent AFib is related to the common substrate between both arrhythmias.

When AFib occurs, the interest to maintain the SR is still required, even if recent studies did not show a significant difference in term of total mortality between rate or rhythm control strategies [AFFIRM, RACE and PIAF studies]. The studies published underlined the anti-arrhythmic drugs limits in patients with both arrhythmias [AFib and AFL]. After years centered on the mechanisms and the electric treatments of AFib, researchers are nowadays focusing on the study's evaluation of the atrial tissue substrate.

Accordingly, the renin-angiotensin system role was investigated in many works. Indeed, angiotensin II plays a role in the modification of atrial pressure and in the fibers stretching ["stretch"], conditions required for the development of AFib. Angiotensin II is also a factor implied in the tissue fibrosis leading to tissue proliferation and collagen alteration. These mechanisms lead to atria cells conduction disorders and refractory periods modification. Moreover, the enzyme of conversion expression and the angiotensin II receptors deterioration were observed in patients with AFib.

This brings to the concept of AFib treatment while interfering on tissue remodeling by the way of renin-angiotensin system. Drugs such as the angiotensin converting enzyme inhibition [ACEI] may reduce AFib in patients with heart failure. No randomized study so far has compared the ACEI drugs against placebo among high-risk patients of AFib in post AFL RFA area. On the basis of experimental and clinical study, the investigators seek to evaluate the ACEI use in the prevention of AFib in an AFL post RFA ablation.

ReferenceCitation: Da Costa A, Thévenin J, Roche F, Romeyer-Bouchard C, Abdellaoui L, Messier M, Denis L, Faure E, Gonthier R, Kruszynski G, Pages JM, Bonijoly S, Lamaison D, Defaye P, Barthélemy JC, Gouttard T, Isaaz K; Loire-Ardèche-Drôme-Isère-Puy-de-Dôme Trial of Atrial Flutter Investigators. Results from the Loire-Ardèche-Drôme-Isère-Puy-de-Dôme (LADIP) trial on atrial flutter, a multicentric prospective randomized study comparing amiodarone and radiofrequency ablation after the first episode of symptomatic atrial flutter. Circulation. 2006 Oct 17;114(16):1676-81. Epub 2006 Oct 9.

ReferenceCitation: Da Costa A, Romeyer-Bouchard C, Zarqane-Sliman N, Messier M, Samuel B, Kihel A, Faure E, Isaaz K. Impact of first line radiofrequency ablation in patients with lone atrial flutter on the long term risk of subsequent atrial fibrillation. Heart. 2005 Jan;91(1):97-8.

ReferenceCitation: Madrid AH, Peng J, Zamora J, Marín I, Bernal E, Escobar C, Muños-Tinoco C, Rebollo JM, Moro C. The role of angiotensin receptor blockers and/or angiotensin converting enzyme inhibitors in the prevention of atrial fibrillation in patients with cardiovascular diseases: meta-analysis of randomized controlled clinical trials. Pacing Clin Electrophysiol. 2004 Oct;27(10):1405-10.

ReferenceCitation: Heart Outcomes Prevention Evaluation Study Investigators, Yusuf S, Sleight P, Pogue J, Bosch J, Davies R, Dagenais G. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. N Engl J Med. 2000 Jan 20;342(3):145-53. Erratum in: 2000 May 4;342(18):1376. N Engl J Med 2000 Mar 9;342(10):748.

location_facility:
CHU de Saint-Etienne
CHU de Clermont-Ferrand
CHU de Rouen
Polyclinique des Fleurs
CHU de Montpellier
CHU de Grenoble
CHU de Rennes
CHU de Brest


lead_sponsor: Kyowa Kirin, Inc.

location_country:
Brazil
Peru
France
Belgium
United States
United Kingdom

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

location_facility: Washington University School of Medicine

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: Hospital Universitario Professor Edgard Santos- UFBA

location_facility: University of Miami / Sylvester Comprehensive Cancer Center

title: Multi-Center, Open-Label, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)

summary: The purpose of this study is to estimate the overall response rate of subjects with relapsed or refractory Adult T-cell Leukemia-Lymphoma (ATL).


title: A Prospective Epidemiological Multicenter Cohort Study on Patients Clinically Suspected of Deep Vein Thrombosis or Pulmonary Embolism

acronym: OPTIMEV

summary:
The purpose of this study is to determine different risk factors of thromboembolic disease. Different points will be studied

do different types of thromboembolic disease (distal Deep Vein Thrombosis (DVT), proximal DVT, Pulmonary Embolism (PE) and DVT, PE without DVT) have the same clinical significance (risk factors and prognosis) ?
Is it necessary to obtain a detailed history of thromboembolic disease ?
Do older patients have particular risk factors ?
Do preventive treatments modify the level of risk factors and the clinical signs of thromboembolic disease ?
Do predictive clinical scores have the same performance for both in and outpatients ?
Can patients with a potential high level of thromboembolic risk (surgery, pregnancy) but no clinical thromboembolic symptoms, develop a low risk ?
The evolution of the disease in patients with negative or positive Venous ThromboEmbolism (VTE) exploratory tests.

ReferenceCitation: Bosson JL, Labarere J, Sevestre MA, Belmin J, Beyssier L, Elias A, Franco A, Le Roux P. Deep vein thrombosis in elderly patients hospitalized in subacute care facilities: a multicenter cross-sectional study of risk factors, prophylaxis, and prevalence. Arch Intern Med. 2003 Nov 24;163(21):2613-8.

ReferenceCitation: Samama MM. An epidemiologic study of risk factors for deep vein thrombosis in medical outpatients: the Sirius study. Arch Intern Med. 2000 Dec 11-25;160(22):3415-20.

ReferenceCitation: Goldhaber SZ, Visani L, De Rosa M. Acute pulmonary embolism: clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER). Lancet. 1999 Apr 24;353(9162):1386-9.

ReferenceCitation: Stein PD, Hull RD, Ghali WA, Patel KC, Olson RE, Meyers FA, Kalra NK. Tracking the uptake of evidence: two decades of hospital practice trends for diagnosing deep vein thrombosis and pulmonary embolism. Arch Intern Med. 2003 May 26;163(10):1213-9.

ReferenceCitation: Sevestre MA, Labarere J, Brin S, Carpentier P, Constans J, Degeilh M, Deslandes B, Elgrishi I, Lanoye P, Laroche JP, Le Roux P, Pichot O, Quéré I, Bosson JL; OPTIMEV study. [Optimizing history taking for evaluating the risk of venous thromboembolism: the OPTIMEV study]. J Mal Vasc. 2005 Sep;30(4 Pt 1):217-27. French.

ReferenceCitation: Galanaud JP, Arnoult AC, Sevestre MA, Genty C, Bonaldi M, Guyard A, Giordana P, Pichot O, Colonna M, Quéré I, Bosson JL; OPTIMEV-SFMV Investigators. Impact of anatomical location of lower limb venous thrombus on the risk of subsequent cancer. Thromb Haemost. 2014 Dec;112(6):1129-36. doi: 10.1160/TH14-04-0351. Epub 2014 Aug 7.

family: Arnoult

full_name: Anne Cécile Arnoult

given: Anne Cécile

family: Sevestre

full_name: Marie-Antoinette Sevestre

given: Marie-Antoinette

family: Genty

full_name: Céline Genty

given: Céline

family: Bonaldi

full_name: Michael Bonaldi

given: Michael

family: Guyard

full_name: Audrey Guyard

given: Audrey

family: Giordana

full_name: Pascal Giordana

given: Pascal

family: Pichot

full_name: Olivier Pichot

given: Olivier

family: Colonna

full_name: Marc Colonna

given: Marc

family: Quéré

full_name: Isabelle Quéré

given: Isabelle

family: Bosson

full_name: Jean-Luc Bosson

given: Jean-Luc

family: Galanaud

full_name: Jean-Philippe Galanaud

given: Jean-Philippe

journal_name: Thrombosis and Haemostasis

publisher: Georg Thieme Verlag KG

publisher_dissemination: Georg Thieme

publisher_group: Georg Thieme

publisher_normalized: Georg Thieme

ReferenceCitation: Le Moigne E, Genty C, Meunier J, Arnoult AC, Righini M, Bressollette L, Bosson JL, Le Gal G; OPTIMEV Investigators. Validation of the LEFt score, a newly proposed diagnostic tool for deep vein thrombosis in pregnant women. Thromb Res. 2014 Sep;134(3):664-7. doi: 10.1016/j.thromres.2014.07.009. Epub 2014 Jul 17.

family: Le Moigne

full_name: Emmanuelle Le Moigne

given: Emmanuelle

full_name: Celine Genty

given: Celine

family: Meunier

full_name: Julie Meunier

given: Julie

full_name: Anne-Cecile Arnoult

given: Anne-Cecile

family: Righini

full_name: Marc Righini

family: Bressollette

full_name: Luc Bressollette

given: Luc

family: Le Gal

full_name: Gregoire Le Gal

given: Gregoire

ReferenceCitation: Galanaud JP, Bosson JL, Genty C, Presles E, Cucherat M, Sevestre MA, Quere I, Decousus H, Leizorovicz A. Superficial vein thrombosis and recurrent venous thromboembolism: a pooled analysis of two observational studies. J Thromb Haemost. 2012 Jun;10(6):1004-11. doi: 10.1111/j.1538-7836.2012.04704.x.

ReferenceCitation: Galanaud JP, Sevestre MA, Genty C, Laroche JP, Zizka V, Quéré I, Bosson JL; OPTIMEV SFMV investigators. Comparison of the clinical history of symptomatic isolated muscular calf vein thrombosis versus deep calf vein thrombosis. J Vasc Surg. 2010 Oct;52(4):932-8, 938.e1-2. doi: 10.1016/j.jvs.2010.05.019. Epub 2010 Jul 13.

location_facility: University Hospital ND des Bruyeres Liege

location_facility: Office-based Specialist in vascular medecine


type: Other Grant/Funding Number

title: Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation (CHACRY-1501)

summary: The aim of the study is to perform a French multicenter prospective interventional study in order to assess the feasibility and safety of ovarian hyperstimulation for oocyte / embryo cryopreservation in young women with breast cancer. The oncologic and reproductive benefit / risk ratio will be investigated in the oncology and reproductive area.

lead_sponsor: Centre Oscar Lambret

location_facility: Centre Aliénor d'Aquitaine, Hôpital Pellegrin


title: Atezolizumab Combined With BDB001 AnD Immunogenic Radiotherapy in Patients With Advanced Solid Tumors

acronym: AGADIR

summary: Basket trial concept to independently and simultaneously assess the effects of the association of atezolizumab + BDB001 + radiotherapy in multiple solid tumors.

lead_sponsor: Institut Bergonié


title: Screening for Occult Malignancy Using 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG PET/CT) in Patients With Unprovoked Venous Thromboembolism

summary:
Venous thromboembolism (VTE) can be the earliest sign of cancer. Identifying occult cancers at the time of VTE diagnosis may lead to significant improvement of patients' care. This is also an upmost issue for patients who want to know if an underlying cancer might have triggered the VTE.

An individual patient-level data meta-analysis (IPDMA) supports extensive screening strategies for occult cancer especially based on FDG PET/CT, and suggests that the best target population for cancer screening would be patients with unprovoked VTE older than 50 years of age (6.7% in patients aged 50 years or more vs. 1.0% in patients of less than 50 years (OR: 7.1, 95% CI: 3.1 to 16%).

primary_purpose: Screening

ReferenceCitation: Robin P, Le Roux PY, Planquette B, Accassat S, Roy PM, Couturaud F, Ghazzar N, Prevot-Bitot N, Couturier O, Delluc A, Sanchez O, Tardy B, Le Gal G, Salaun PY; MVTEP study group. Limited screening with versus without (18)F-fluorodeoxyglucose PET/CT for occult malignancy in unprovoked venous thromboembolism: an open-label randomised controlled trial. Lancet Oncol. 2016 Feb;17(2):193-199. doi: 10.1016/S1470-2045(15)00480-5. Epub 2015 Dec 8.

family: Robin

full_name: Philippe Robin

given: Philippe

family: Le Roux

full_name: Pierre-Yves Le Roux

given: Pierre-Yves

family: Planquette

full_name: Benjamin Planquette

given: Benjamin

family: Accassat

full_name: Sandrine Accassat

given: Sandrine

family: Roy

full_name: Pierre-Marie Roy

given: Pierre-Marie

family: Couturaud

full_name: Francis Couturaud

given: Francis

family: Ghazzar

full_name: Nadia Ghazzar

given: Nadia

family: Prevot-Bitot

full_name: Nathalie Prevot-Bitot

given: Nathalie

family: Couturier

full_name: Olivier Couturier

family: Delluc

full_name: Aurélien Delluc

given: Aurélien

family: Sanchez

full_name: Olivier Sanchez

family: Tardy

full_name: Bernard Tardy

given: Bernard

full_name: Grégoire Le Gal

given: Grégoire

family: Salaun

full_name: Pierre-Yves Salaun

journal_name: The Lancet Oncology

title: Limited screening with versus without 18F-fluorodeoxyglucose PET/CT for occult malignancy in unprovoked venous thromboembolism: an open-label randomised controlled trial

ReferenceCitation: Carrier M, Lazo-Langner A, Shivakumar S, Tagalakis V, Zarychanski R, Solymoss S, Routhier N, Douketis J, Danovitch K, Lee AY, Le Gal G, Wells PS, Corsi DJ, Ramsay T, Coyle D, Chagnon I, Kassam Z, Tao H, Rodger MA; SOME Investigators. Screening for Occult Cancer in Unprovoked Venous Thromboembolism. N Engl J Med. 2015 Aug 20;373(8):697-704. doi: 10.1056/NEJMoa1506623. Epub 2015 Jun 22.

ReferenceCitation: van Es N, Le Gal G, Otten HM, Robin P, Piccioli A, Lecumberri R, Jara-Palomares L, Religa P, Rieu V, Rondina M, Beckers MM, Prandoni P, Salaun PY, Di Nisio M, Bossuyt PM, Büller HR, Carrier M. Screening for Occult Cancer in Patients With Unprovoked Venous Thromboembolism: A Systematic Review and Meta-analysis of Individual Patient Data. Ann Intern Med. 2017 Sep 19;167(6):410-417. doi: 10.7326/M17-0868. Epub 2017 Aug 22. Review.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_country: Canada France

location_facility:
CHU Angers
Hôpital Saint Musse - CH Toulon
University of Manitoba
McMaster University
Ottawa Hospital Research Institute
Sunnybrook Research Institute
Brest University Hospital
University of Calgary
CHU de Dijon
CH Agen
CHU de Limoges
CH des Pays de Morlaix
CHU de Clermont-Ferrand
McGill University Health Centre
Jewish General Hospital
CHU Saint-Etienne
Hopital Montfort
Hôpital Européen Georges Pompidou
University Health Network
London Health Sciences Centre

intervention_type: Diagnostic Test


title: A Phase I/II, Open-Label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Tor Kinase Inhibitor AZD8055 Administered Orally to Patients With Advanced Solid Tumours.

summary: The purpose of the study is to assess the safety, tolerability and pharmacokinetics of AZD8055 and determine the maximum tolerated dose to take into phase II trials.

location_country:
United States
United Kingdom
France