title: Quality of Life in Patients With Congenital Afibrinogenemia

acronym: QualyAFIB

summary: The aim of this observational study is to evaluate the quality of life in patients with congenital afibrinogenemia using the Haemo-QoL SF for kids and the Haem-A-QoL for adult patients.

time_perspective: Cross-Sectional

ReferenceCitation: Casini A, von Mackensen S, Santoro C, Djambas Khayat C, Belhani M, Ross C, Dorgalaleh A, Naz A, Ünal E, Abdelwahab M, Lozeron ED, Trillot N, Susen S, Peyvandi F, de Moerloose P; QualyAfib Study Group. Clinical phenotype, fibrinogen supplementation, and health-related quality of life in patients with afibrinogenemia. Blood. 2021 Jun 3;137(22):3127-3136. doi: 10.1182/blood.2020009472.

name: Division of Angiology and Hemostasis, University Hospitals of Geneva, Geneva, Switzerland;

name: University of Geneva, Faculty of Medicine, Geneva, Switzerland;

family: Casini

full_name: Alessandro Casini

given: Alessandro

name: Department of Medical Psychology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany;

family: von Mackensen

full_name: Sylvia von Mackensen

given: Sylvia

name: Hematology Division, University Hospital Policlinico Umberto I, Rome, Italy;

family: Santoro

full_name: Cristina Santoro

given: Cristina

name: Hôtel-Dieu de France Hospital, Saint Joseph University, Beirut, Lebanon;

family: Djambas Khayat

full_name: Claudia Djambas Khayat

given: Claudia

name: Beni Messous University Hospital, Algiers, Algeria;

family: Belhani

full_name: Meriem Belhani

given: Meriem

name: Department of Hematology, St John’s Medical College and Hospital, Bangalore, India;

family: Ross

full_name: Cecil Ross

given: Cecil

name: Department of Hematology and Blood Transfusion, School of Allied Medicine, Iran University of Medical Sciences, Tehran, Iran;

family: Dorgalaleh

full_name: Akbar Dorgalaleh

given: Akbar

name: National Institute of Blood Diseases and Bone Marrow Transplantation, Karachi University of Bonn, Karachi, Pakistan;

family: Naz

full_name: Arshi Naz

given: Arshi

name: Division of Pediatric Hematology Oncology, Department of Pediatrics, Erciyes University Faculty of Medicine, Kayseri, Turkey;

name: Department of Molecular Biology and Genetic, GENKOK Stem Cell & Genome Center, Erciyes University Faculty of Medicine, Kayseri, Turkey;

family: Ünal

full_name: Ekrem Ünal

given: Ekrem

name: Department of Pediatrics and Pediatric Hematology, Cairo University Pediatric Hospital and Social and Preventive Medicine, Cairo University, Kasr Alainy Hospital, Cairo, Egypt;

family: Abdelwahab

full_name: Magy Abdelwahab

given: Magy

name: Clinical Research Centre and Division of Clinical Epidemiology, Geneva University Hospitals and Faculty of Medicine, University of Geneva, Geneva, Switzerland;

family: Lozeron

full_name: Elise Dupuis Lozeron

given: Elise Dupuis

name: CHU Lille, Department of Hematology and Transfusion, Pôle de Biologie Pathologie Génétique, Lille, France;

family: Trillot

full_name: Nathalie Trillot

given: Nathalie

name: Université Lille, INSERM, CHU Lille, Department of Hematology and Transfusion, Pôle de Biologie Pathologie Génétique, Institut Pasteur de Lille, Unité Mixte de Recherche 1011–European Genomic Institute for Diabetes (UMR1011-EGID), Lille, France; and

family: Susen

full_name: Sophie Susen

given: Sophie

name: Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Ca’ Granda Ospedale Maggiore Policlinico, Angelo Bianchi Bonomi Hemophilia and Thrombosis Center and Fondazione Luigi Villa, Milan, Italy

family: Peyvandi

full_name: Flora Peyvandi

given: Flora

family: de Moerloose

full_name: Philippe de Moerloose

given: Philippe

journal_name: Blood

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

lead_sponsor: University Hospital, Geneva

location_country:
India
Morocco
Pakistan
France
Japan
Poland
Slovakia
Kuwait
Canada
Switzerland
Netherlands
Algeria
Germany
United States
Italy
Serbia
Lebanon
Tunisia
Egypt
Spain
Turkey

location_facility: National Centre of Hemostasis and Thrombosis

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: National Institute Of Blood Disease and Bone Marrow Transplantation

location_facility: Institute of Hematology and Transfusion Medicine


title: A Confirmatory, Prospective, Open-label, Multi-centre Phase 3 Study to Evaluate Diagnostic Performance of Zirconium-labelled Girentuximab to Non-invasively Detect ccRCC by PET/CT Imaging in Patients With Indeterminate Renal Masses

summary: 89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Telix International Pty Ltd

location_country:
United States
Netherlands
France
Belgium
Australia
Turkey
Canada

location_facility: CHU de Bordeaux, Groupe hospitalier Pellegrin

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Advanced Molecular Imaging & Therapy, LLC

location_facility: Ankara University Medical Faculty Hospital

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: University of California, Los Angeles Campus,

location_facility: SEATTLE CANCER CARE ALLIANCE, University of Washington

location_facility: Centre De Recherche Centre hospitalier de l/Universite de Montreal (CrCHUM )

location_facility: Hacettepe University Faculty of Medicine

location_facility: CHU de Québec - Université Laval - L'Hôtel-Dieu de Québec

intervention_type: Diagnostic Test

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Randomized Phase II-III Multicenter Trial of Docetaxel Plus Cisplatin and Docetaxel Plus 5-FU Versus Cisplatin Plus 5-FU in 1st Line Treatment of Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck.

summary: The purpose of the study is to compare time to progression and overall survival after treatment with Taxotere plus cisplatin versus cisplatin plus 5-FU (PF treatment group) in the first line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.

status: Completed

study_completion_date_type: Actual

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Sanofi

location_country:
Italy
Austria
Brazil
South Africa
Switzerland
Guadeloupe
Spain
Germany
Uruguay
France
Réunion
Greece
Israel
Hungary
Argentina
Australia
Belgium
Russian Federation
United States
Canada

location_facility:
sanofi-aventis Germany
sanofi-aventis, Belgium
Sanofi-Aventis
sanofi-aventis Canada
sanofi-aventis, France
sanofi-aventis Switzerland
sanofi-aventis, Australia
sanofi-aventis Israel
sanofi-aventis Italy
sanofi-aventis US
Sanofi-Aventis Hungaria
sanofi-aventis South Africa
sanofi-aventis Greece

intervention_type: Drug

status_simplified: Completed


type: EudraCT Number

title: A Phase 1, Multinational Study of MCLA-117 in Acute Myelogenous Leukemia

summary: This is a First-in-Human, single arm, open-label, multi-national study designed to determine the safety, tolerability and preliminary efficacy of MCLA 117.

status: Active, not recruiting

lead_sponsor: Merus N.V.

location_country:
Italy
Netherlands
France
Belgium
United States

location_facility: Ziekenhuis Netwerk Antwerpen Campus Stuivenberg

location_facility: The University of Texas, MD Anderson Cancer Center

location_facility: Georgia Cancer Center, Augusta University


ReferenceType: background

ReferenceCitation: Frank DE, Schnell FJ, Akana C, El-Husayni SH, Desjardins CA, Morgan J, Charleston JS, Sardone V, Domingos J, Dickson G, Straub V, Guglieri M, Mercuri E, Servais L, Muntoni F; SKIP-NMD Study Group. Increased dystrophin production with golodirsen in patients with Duchenne muscular dystrophy. Neurology. 2020 May 26;94(21):e2270-e2282. doi: 10.1212/WNL.0000000000009233. Epub 2020 Mar 5.

ReferenceType: derived

ReferenceCitation: Servais L, Mercuri E, Straub V, Guglieri M, Seferian AM, Scoto M, Leone D, Koenig E, Khan N, Dugar A, Wang X, Han B, Wang D, Muntoni F; SKIP-NMD Study Group. Long-Term Safety and Efficacy Data of Golodirsen in Ambulatory Patients with Duchenne Muscular Dystrophy Amenable to Exon 53 Skipping: A First-in-human, Multicenter, Two-Part, Open-Label, Phase 1/2 Trial. Nucleic Acid Ther. 2021 Nov 17. doi: 10.1089/nat.2021.0043. [Epub ahead of print]

name: I-Motion Institute, Hôpital Armand Trousseau, Paris, France.

name: Division of Child Neurology, Centre de Références des Maladies Neuromusculaires, Department of Pediatrics, University Hospital Liège & University of Liège, Liège, Belgium.

name: MDUK Oxford Neuromuscular Centre, University of Oxford, Oxford, United Kingdom.

family: Servais

full_name: Laurent Servais

given: Laurent

sequence: first

name: Pediatric Neurology Unit, Università Cattolica del Sacro Cuore Roma, Rome, Italy.

name: Nemo Clinical Centre, Fondazione Policlinico Universitario A Gemelli IRCCS, Rome, Italy.

family: Mercuri

full_name: Eugenio Mercuri

given: Eugenio

sequence: additional

name: John Walton Muscular Dystrophy Research Centre, Newcastle University and Newcastle Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.

family: Straub

full_name: Volker Straub

given: Volker

family: Guglieri

full_name: Michela Guglieri

given: Michela

family: Seferian

full_name: Andreea M. Seferian

given: Andreea M.

name: Dubowitz Neuromuscular Centre, University College London, Great Ormond Street Institute of Child Health, London, United Kingdom.

name: National Institute for Health Research Great Ormond Street Hospital Biomedical Research Centre, London, United Kingdom.

family: Scoto

full_name: Mariacristina Scoto

given: Mariacristina

family: Leone

full_name: Daniela Leone

given: Daniela

name: Sarepta Therapeutics, Inc., Cambridge, Massachusetts, USA.

family: Koenig

full_name: Erica Koenig

given: Erica

family: Khan

full_name: Navid Khan

given: Navid

family: Dugar

full_name: Ashish Dugar

given: Ashish

family: Wang

full_name: Xiaodong Wang

given: Xiaodong

family: Han

full_name: Baoguang Han

given: Baoguang

full_name: Dan Wang

given: Dan

family: Muntoni

full_name: Francesco Muntoni

given: Francesco

family: Brusa

full_name: Chiara Brusa

given: Chiara

family: Antonaci

full_name: Laura Antonaci

given: Laura

family: Brogna

full_name: Claudia Brogna

family: Merli

full_name: Laura Merli

family: Monforte

full_name: Mauro Monforte

given: Mauro

family: Norcia

full_name: Giulia Norcia

given: Giulia

family: Pane

full_name: Marika Pane

given: Marika

family: Ferrantini

full_name: Gloria Ferrantini

given: Gloria

family: Dickson

full_name: George Dickson

given: George

family: Morgan

full_name: Jennifer Morgan

given: Jennifer

family: Sardone

full_name: Valentina Sardone

location_country:
Italy
United States
United Kingdom
France

location_facility: Great Ormond Street Hospital for Children NHS Foundation Trust

title: A 2-Part, Randomized, Double-Blind, Placebo-Controlled, Dose-Titration, Safety, Tolerability, and Pharmacokinetics Study (Part 1) Followed by an Open-Label Efficacy and Safety Evaluation (Part 2) of SRP-4053 in Patients With Duchenne Muscular Dystrophy Amenable to Exon 53 Skipping

summary: This is a first-in-human, multiple-dose 2-part study to assess the safety, tolerability, efficacy, and pharmacokinetics of SRP-4053 in Duchenne muscular dystrophy (DMD) patients with deletions amenable to exon 53 skipping.


title: Double-blind, Randomised, Placebo-controlled, Phase III Study Comparing the Efficacy and Safety of Bilastine 20 mg Once Daily and Levocetirizine 5 mg for the Treatment of Chronic Idiopathic Urticaria

summary: The objective of the study is to evaluate the efficacy and tolerability of Bilastine 20 mg Q.D., compared to Levocetirizine 5 mg Q.D. and placebo for the treatment of Chronic Idiopathic Urticaria.

ReferenceCitation: Church MK. Safety and efficacy of bilastine: a new H(1)-antihistamine for the treatment of allergic rhinoconjunctivitis and urticaria. Expert Opin Drug Saf. 2011 Sep;10(5):779-93. doi: 10.1517/14740338.2011.604029. Epub 2011 Aug 11. Review. Erratum in: Expert Opin Drug Saf. 2012 Jan;11(1):175.

ReferenceType: result

ReferenceCitation: Zuberbier T, Oanta A, Bogacka E, Medina I, Wesel F, Uhl P, Antépara I, Jáuregui I, Valiente R; Bilastine International Working Group. Comparison of the efficacy and safety of bilastine 20 mg vs levocetirizine 5 mg for the treatment of chronic idiopathic urticaria: a multi-centre, double-blind, randomized, placebo-controlled study. Allergy. 2010 Apr;65(4):516-28. doi: 10.1111/j.1398-9995.2009.02217.x. Epub 2009 Oct 23.

family: Zuberbier

full_name: T. Zuberbier

given: T.

family: Oanta

full_name: A. Oanta

given: A.

family: Bogacka

full_name: E. Bogacka

given: E.

family: Medina

full_name: I. Medina

given: I.

family: Wesel

full_name: F. Wesel

given: F.

family: Uhl

full_name: P. Uhl

given: P.

family: Antépara

full_name: I. Antépara

family: Jáuregui

full_name: I. Jáuregui

family: Valiente

full_name: R. Valiente

given: R.

name: The Bilastine International Working Group

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Allergy

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Comparison of the efficacy and safety of bilastine 20 mgvslevocetirizine 5 mg for the treatment of chronic idiopathic urticaria: a multi-centre, double-blind, randomized, placebo-controlled study

lead_sponsor: Faes Farma, S.A.

location_country: France Poland Romania Belgium Argentina Spain Germany

location_facility:
Centre nº 704
Centre nº 802
Centre nº 506
Centre nº 411
Centre nº 500
Centre nº 406
Centre nº 700
Centre nº 301
Centre nº 702
Centre nº 707
Centre nº 108
Centre nº 201
Centre nº 703
Centre nº 307
Centre nº 101
Centre nº 102
Centre nº 501
Centre nº 100
Centre nº 503
Centre nº 109
Centre nº 104
Centre nº 706
Centre nº 804
Centre nº 701
Centre nº 705
Centre nº 202
Centre nº 507
Centre nº 801
Centre nº 103
Centre nº 200
Centre nº 800
Centre nº 407
Centre nº 404
Centre nº 505
Centre nº 803
Centre nº 203
Centre nº 308
Centre nº 303
Centre nº 107
Centre nº 502
Centre nº 806
Centre nº 305
Centre nº 204
Centre nº 400
Centre nº 106
Centre nº 504
Centre nº 805
Centre nº 105
Centre nº 302
Centre nº 410


type: Other Identifier

title: Asymptomatic Sexually Transmitted Infections (STI) : Comparison of Two Screening Strategies Routine Screening Versus Screening as Reported by the Risks Taken by the Patient, in a Cohort of HIV Outpatients Men Who Have Sex With Men

acronym: DRIVER

summary: Comparison of two screening strategies of asymptomatic sexually transmitted infections : routine screening versus screening as reported by the risks taken by the patient, in a cohort of HIV outpatients men who have sex with men. The aim of this study will be create and validate a simple tool for clinicians. A digital tool will be developed will allowed empowerment of HIV-positive men who have sex with men.

design_allocation: Non-Randomized

primary_purpose: Screening

lead_sponsor: Hopital Foch

location_facility: Hôpital Mignot-centre hospitalier de versailles

intervention_type: Other

lead_sponsor_type: academique


title: A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

summary:
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with NSCLC who have previously been treated. Change in disease activity and adverse events will be assessed.

Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 698 adult participants with c-Met overexpressing NSCLC will be enrolled in the study in approximately 250 sites worldwide.

Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 weeks until meeting study drug discontinuation criteria.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing: Yes

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

lead_sponsor: AbbVie

location_country:
Greece
Romania
Belgium
Taiwan
Ukraine
France
Japan
Poland
Slovakia
Argentina
Korea, Republic of
South Africa
Chile
Sweden
Netherlands
Hungary
China
Germany
United States
Italy
Austria
Mexico
Czechia
Israel
Turkey

location_facility: Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 239658

location_facility: Texas Tech University Health Sciences Center - Lubbock /ID# 238491

location_facility: Bagcilar Medipol Mega Universite Hastanesi /ID# 234211

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 231904

location_facility: Centro de Investigacion Clínica Chapultepec SA de CV /ID# 231928

location_facility: Universitair Ziekenhuis Antwerpen /ID# 239971

location_facility: National Taiwan University Hospital /ID# 238378

location_facility: Maastricht Universitair Medisch Centrum /ID# 233932

location_facility: Taizhou Hospital, Zhejiang Province /ID# 232021

location_facility: Tianjin Medical University General Hospital /ID# 231839

location_facility: CHA University Bundang Medical Center /ID# 233318

location_facility: Taipei Medical University Hospital /ID# 238380

location_facility: Medical Park Izmir Hastanesi /ID# 234209

location_facility: Fundacion Arturo Lopez Perez /ID# 231151

location_facility: National Hospital Organization Kyushu Medical Center /ID# 238533

location_facility: Sandton Oncology Medical Group PTY Ltd /ID# 230843

location_facility: Skane University Hospital Lund /ID# 229944

location_facility: Clinical Research & Oncology Oaxaca /ID# 231883

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 233801

location_facility: The First Affiliated Hospital of Guangzhou Medical University /ID# 238591

location_facility: Osaka Habikino Medical Center /ID# 239989

location_facility: Dept of Oncology Steve Biko Academic Hospital /ID# 230883

location_facility: Centro de Investigaciones Clinicas Clinica Viedma S.A. /ID# 232339

location_facility: CI Zaporizhzhia Regional Clinical Oncological Dispensary /ID# 232519

location_facility: Servicios de Oncologia Medica Integral /ID# 232098

location_facility: Guangxi Medical University Cancer Center /ID# 231855

location_facility: Azienda Ospedaliera di Perugia /ID# 238473

location_facility: Medical Center of "VISION PARTNER" LLC /ID# 233221

location_facility: Azienda Ospedaliera San Giovanni Addolorata /ID# 238618

location_facility: Nemocnice Novy Jicin, a. s., clen skupiny Agel /ID# 232427

location_facility: Wakayama Medical University Hospital /ID# 234004

location_facility: Eisenhower Health Lucy Curci Cancer Center /ID# 233189

location_facility: First Affiliated Hospital of Xi'an Jiaotong University /ID# 232023

location_facility: Vychodoslovensky onkologicky ustav, a.s. /ID# 230085

location_facility: Kaiser Permanente Moanalua Medical Center /ID# 238363

location_facility: Affiliated Hospital Of Guangdong Medical University /ID# 233317

location_facility: Edward-Elmhurst Cancer Center - Naperville /ID# 238552

location_facility: CNE Podillia Regional Oncology Center of Vinnytsia Regional Council /ID# 232520

location_facility: West China Hospital, Sichuan University /ID# 233703

location_facility: The Edith Wolfson Medical Center /ID# 233781

location_facility: Xiangya Hospital Central South University /ID# 232005

location_facility: The First Affiliated Hospital of Nanchang University /ID# 231934

location_facility: Kaiser Permanente - Northwest /ID# 234123

location_facility: I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 238696

location_facility: Tianjin Medical University Cancer Institute and Hospital /ID# 233176

location_facility: Gunma Prefectural Cancer Center /ID# 233723

location_facility: Inonu Universitesi Turgut Ozal /ID# 234038

location_facility: Clinica Universidad Catolica del Maule /ID# 231294

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde /ID# 238488

location_facility: Gyeongsang National University Hospital /ID# 234244

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 230084

location_facility: SC RTC Radiology Therapeutic Center SRL /ID# 240744

location_facility: Chung Shan Medical University Hospital /ID# 238444

location_facility: National Cancer Center Hospital East /ID# 233775

location_facility: Universitatsklinikum Mannheim /ID# 238331

location_facility: Roswell Park Comprehensive Cancer Center /ID# 238364

location_facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 232032

location_facility: Orebro Universitetssjukhuset /ID# 230864

location_facility: Univerzitna nemocnica Bratislava Nemocnica Ruzinov /ID# 232216

location_facility: Public Nonprofit Enterprise Regional Oncology Center of Kirovograd Regional Coun /ID# 233220

location_facility: Ege University Medical Faculty /ID# 234039

location_facility: S.C. Sigmedical Services SRL /ID# 239108

location_facility: Instytut Centrum Zdrowia Matki Polki /ID# 239024

location_facility: National Taiwan University Hospital - Hsinchu branch /ID# 238393

location_facility: Kansai Medical University Hospital /ID# 233476

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 231880

location_facility: Uludag University Medical Faculty /ID# 234205

location_facility: Iwate Medical University Hospital /ID# 239027

location_facility: Oncocenter - Oncologie Clinica Srl /Id# 239103

location_facility: Sociedad Prosalud Montes y Orlandi /ID# 231154

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 230824

location_facility: The Second Affiliated Hospital of Nanchang University /ID# 231935

location_facility: Communal non-profit enterprise Regional Center of Oncology /ID# 232518

location_facility: Baskent Universitesi Adana Dr. Turgut Noyan Uyg. Ve Arast. Merkezi /ID# 238337

location_facility: Fakultna nemocnica s poliklinikou Nove Zamky /ID# 230086

location_facility: Azienda Socio Sanitaria Territoriale di Cremona /ID# 238698

location_facility: Limited Liability Company "Medical Center "VERUM EXPERT " /ID# 233213

location_facility: Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL /ID# 240826

location_facility: Osaka City University Hospital /ID# 238895

location_facility: Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 239363

location_facility: Trakya University Medical Facu /ID# 234035

location_facility: Providence Alaska Medical Center /ID# 233324

location_facility: Ascension Providence Hospital /ID# 231970

location_facility: Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 232467

location_facility: Sahlgrenska University Hospital /ID# 229943

location_facility: Karolinska University Hospital /ID# 229853

location_facility: Medical Center "Mriya Med-Service" /ID# 232521


lead_sponsor: Ansun Biopharma, Inc.

location_country:
Hong Kong
France
Australia
China
Denmark
United States
Korea, Republic of
Taiwan

acronym: STOP PIV - Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects

location_facility: University of California San Diego Medical Center

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: University of California Davis Health System

location_facility: Froedtert Medical College Pulmonary Clinic

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: The First Affiliated Hospital, Zhejiang University School of Medicine

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: University of Pittsburgh Medical Center Health System

source: euctr

title: A Phase III Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Lower Respiratory Tract Parainfluenza Infection in Immunocompromised Subjects

summary:
This study will seek to enroll immunocompromised patients with Lower Tract parainfluenza infection.

It also contains a sub-study to enroll patients with severe COVID-19.


title: Comparison of Intubation Conditions After Induction With Propofol Associated With a Dose of Remifentanil or Sufentanil in Surgical Tooth Extraction.

acronym: REMIDENT

summary:
The main objective is the comparison of intubation conditions after anesthetic induction bolus of propofol-sufentanil when compared to injection of propofol-remifentanil in patients undergoing surgery for tooth extraction.

Intubation without myorelaxant with propofol and sufentanil is classic but less efficient than induction with curare on achieving perfect intubation conditions. The use of a protocol without curare is sometimes justified for short gestures or when you want to avoid allergia. Remifentanil often provides excellent intubation conditions without myorelaxant. However, remifentanil was never compared to sufentanil in terms of intubating conditions without muscle relaxant.

ReferenceCitation: Indications de la curarisation en anesthésie : conférence de consensus (texte court). Ann Fr Anesth Reanim 1999;19:34-7.

ReferenceCitation: Laxenaire MC, Auroy Y, Clergue F, Péquignot F, Jougla E, Lienhart A. [Organization and techniques of anesthesia]. Ann Fr Anesth Reanim. 1998;17(11):1317-23. French.

ReferenceCitation: Laxenaire MC. [Epidemiology of anesthetic anaphylactoid reactions. Fourth multicenter survey (July 1994-December 1996)]. Ann Fr Anesth Reanim. 1999 Aug;18(7):796-809. French.

ReferenceCitation: Combes X, Andriamifidy L, Dufresne E, Suen P, Sauvat S, Scherrer E, Feiss P, Marty J, Duvaldestin P. Comparison of two induction regimens using or not using muscle relaxant: impact on postoperative upper airway discomfort. Br J Anaesth. 2007 Aug;99(2):276-81. Epub 2007 Jun 15.

ReferenceCitation: Adamus M, Koutná J, Gabrhelík T, Zapletalová J. [Tracheal intubation without muscle relaxant--the impact of different sufentanil doses on the quality of intubating conditions: a prospective study]. Cas Lek Cesk. 2008;147(2):96-101. Czech.

ReferenceCitation: Hanna SF, Ahmad F, Pappas AL, Mikat-Stevens M, Jellish WS, Kleinman B, Avramov MN. The effect of propofol/remifentanil rapid-induction technique without muscle relaxants on intraocular pressure. J Clin Anesth. 2010 Sep;22(6):437-42. doi: 10.1016/j.jclinane.2009.12.004.

ReferenceCitation: Alexander R, Olufolabi AJ, Booth J, El-Moalem HE, Glass PS. Dosing study of remifentanil and propofol for tracheal intubation without the use of muscle relaxants. Anaesthesia. 1999 Nov;54(11):1037-40.

ReferenceCitation: Bouvet L, Stoian A, Rimmelé T, Allaouchiche B, Chassard D, Boselli E. Optimal remifentanil dosage for providing excellent intubating conditions when co-administered with a single standard dose of propofol. Anaesthesia. 2009 Jul;64(7):719-26. doi: 10.1111/j.1365-2044.2009.05916.x.

ReferenceCitation: Fujii Y, Itakura M. A comparison of pretreatment with fentanyl and lidocaine preceded by venous occlusion for reducing pain on injection of propofol: a prospective, randomized, double-blind, placebo-controlled study in adult Japanese surgical patients. Clin Ther. 2009 Oct;31(10):2107-12. doi: 10.1016/j.clinthera.2009.10.012. Retraction in: Clin Ther. 2018 Apr 30;:.

RetractionSource: Clin Ther. 2018 Apr 30;:

ReferenceCitation: Fattorini F, Romano R, Ciccaglioni A, Pascarella MA, Rocco A, Mariani V, Pietropaoli P. Effects of remifentanil on human heart electrical system. A transesophageal pacing electrophysiological study. Minerva Anestesiol. 2003 Sep;69(9):673-7, 677-9. English, Italian.

ReferenceCitation: Maruyama K, Nishikawa Y, Nakagawa H, Ariyama J, Kitamura A, Hayashida M. Can intravenous atropine prevent bradycardia and hypotension during induction of total intravenous anesthesia with propofol and remifentanil? J Anesth. 2010 Apr;24(2):293-6. doi: 10.1007/s00540-009-0860-2. Epub 2010 Jan 26.

ReferenceCitation: Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808.

ReferenceCitation: Egan TD, Brock-Utne JG. Asystole after anesthesia induction with a fentanyl, propofol, and succinylcholine sequence. Anesth Analg. 1991 Dec;73(6):818-20.

ReferenceCitation: Maryniak JK, Bishop VA. Sinus arrest after alfentanil. Br J Anaesth. 1987 Mar;59(3):390-1.

ReferenceCitation: Starr NJ, Sethna DH, Estafanous FG. Bradycardia and asystole following the rapid administration of sufentanil with vecuronium. Anesthesiology. 1986 Apr;64(4):521-3.

ReferenceCitation: Wang J, Winship S, Russell G. Induction of anaesthesia with sevoflurane and low-dose remifentanil: asystole following laryngoscopy. Br J Anaesth. 1998 Dec;81(6):994-5.

ReferenceCitation: Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7.

lead_sponsor: University Hospital, Toulouse


title: Digestive Tolerance and Postprandial Glycaemic and Insulinaemic Responses Evaluation of Different Maltitol/FOS Mixtures in Healthy Adults

summary: Digestive symptoms following consumption of low digestibe carbohydrates are generally assessed product by product but several ingredients can be used simultaneously. The study aimed at evaluating to digestive tolerance of maltitol and FOS used in a same food.

primary_purpose: Basic Science

lead_sponsor: Syral


status: Enrolling by invitation

lead_sponsor: Chiesi Farmaceutici S.p.A.

title: A Multi-center, Un-controlled, Open-labeled Trial of the Long-term Safety of Lamazym Aftercare Treatment of Subjects With Alpha-Mannosidosis Whom Previously Participated in Lamazym Trials

summary: The overall objective of this trial is to provide aftercare treatment with Lamazym and to evaluate the safety of repeated Lamzede i.v. treatment of subjects with alpha-Mannosidosis.

status_simplified: Unknown


summary:
The aim of this study is to explore a mechanism that could potentially explain why women with a pregnancy complicated by pre-eclampsia are described as having an increased risk of cardiovascular disease later in life.

If the hypothesis of this study turns out to be true, that is to say that women with pre-eclampsia have a higher level of oxidative stress than women with a normal pregnancy and that this difference persists after the delivery (6 months), a controlled randomized interventional study aiming to evaluate either therapeutic supplementation with antioxidant vitamins (Vit C and E) or modifications in diet could be envisaged.

lead_sponsor: Centre Hospitalier Universitaire Dijon


summary: This project will make it possible to better understand the natural history of Cohen Syndrom and the phenotypes associated with mutations in the VPS13B gene, to improve the therapeutic management of patients. It will also provide a better description of Cohen-like syndrome for genetic counselling for the families concerned.

study_type: Observational

time_perspective: Prospective


summary: To assess the prognostic value of a characteristic evaluation of gait in persons suffering from hip OA for subsequent indications for THR.

status: Unknown status

ReferenceCitation: Moissenet F, Naaim A, Ornetti P, Bourredjem A, Binquet C, Morisset C, Gouteron A, Maillefert JF, Laroche D. Is the Pelvis-Thorax Coordination a Valuable Outcome Instrument to Assess Patients With Hip Osteoarthritis? Front Bioeng Biotechnol. 2020 Jan 23;7:457. doi: 10.3389/fbioe.2019.00457. eCollection 2019.

family: Moissenet

full_name: Florent Moissenet

given: Florent

family: Naaim

full_name: Alexandre Naaim

given: Alexandre

family: Ornetti

full_name: Paul Ornetti

given: Paul

family: Bourredjem

full_name: Abderrahmane Bourredjem

given: Abderrahmane

family: Binquet

full_name: Christine Binquet

given: Christine

family: Morisset

full_name: Claire Morisset

given: Claire

family: Gouteron

full_name: Anais Gouteron

given: Anais

family: Maillefert

full_name: Jean-Francis Maillefert

given: Jean-Francis

family: Laroche

full_name: Davy Laroche

given: Davy

currency_apc_doaj: USD

journal_name: Frontiers in Bioengineering and Biotechnology

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_normalized: HAL

repository_institution: University of Geneva - Archive ouverte UNIGE

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central
unige.ch

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

intervention_type: Procedure


summary: The aim of the present work is to study the protein expressions profiles of neutropenic patients (with a high risk of invasive mycosis) who developed - versus who did not develop invasive mycosis (principally aspergillosis and candidosis) in order to identify biomarkers for the diagnosis, prognosis and /or prediction of invasive mycosis.

primary_purpose: Other


title: Physiopathology of Bone Loss in Young Patient With Anorexia Nervosa

summary:
Nutritional deprivation of adolescent girls with anorexia nervosa (AN) reduces the bone mass acquisition. A better understanding of this process would improve the medical treatment of bone alteration and its long-term consequences.

160 patients (age < 38 yr) with AN and 160 age-matched controls (CON) will be enrolled in this study. The areal bone mineral density (aBMD) will be determined using dual-X-ray absorptiometry. Calciotropic hormones, bone turnover markers will be concomitantly evaluated.

lead_sponsor: University Hospital, Montpellier

location_facility: CHU de Montpellier - Département d'Endocrinologie Diabète


acronym: compass

summary: In the prenatal period, les supernumerary marker chromosomes (SMC) and de novo apparently balanced reciprocal translocations are revealed by foetal karyotyping, which does not always make it possible to determine whether the anomaly is balanced or not and does not reveal uniparental disomy. The presence of these chromosomal rearrangements raises a difficult question for genetic counselling during pregnancy because of the risk of intellectual deficiency in the foetus. CGH+SNP-Array can provide information concerning 1) the balanced or not nature of these translocations 2) the presence or not of euchromatin in the SMC 3) the presence or not of uniparental disomy.


acronym: IMMUNOBEDIA

summary:
There is a link between activation of the immune response inducing chronic inflammation and both obesity and type 2 diabetes. To date, however, the cause(s) of this inflammation, the mechanisms of the inflammatory cascade and the type of cells involved are not completely known. The aim of our project is to study the principal cell types involved in the immune response from a quantitative and functional point of view in obese diabetic patients versus obese non-diabetic patients and healthy subjects who are neither diabetic nor obese.

Despite possible inter-individual heterogeneity of immune cells, the fact that this work will be carried out by an accredited team with considerable expertise in the study of almost all the different types of immune cells will probably make it possible to know whether cell dysfunction and inflammation are associated with obesity or rather linked to insulin resistance. This study will be completed later by a second study on cell infiltration in adipose tissues in the 3 groups defined above. Better understanding of the physiopathology and especially the mechanisms and type of cells involved in obesity-related inflammation could quickly lead to the development of appropriate therapies that could act specifically on the cells involved and thus preclude the onset of complications.


title: Social and Prognostic Inequalities in Patients Hospitalised for Cerebrovascular Accident (CVA) in Four Contrasting French Departments: Côte d'Or, Martinique, Guadeloupe and French Guyana Analysis of Their Impact on Vascular Risk Factors and the Management of CVA

acronym: INDIA

summary: This study should also raise questions about the interest and feasibility of establishing a permanent registry of CVA in the Antilles and Guyana. Indeed in coming decades, the expected doubling of the population of persons aged over 60 years and the foreseeable changes in lifestyle will increase the burden of this disease, in particular since the region is marked by a high prevalence of arterial hypertension and diabetes and a high level of precarity. In addition, this study will provide epidemiological information on CVA, its risk factors and management, which are non-existent for the department of French Guyana where the health environment is manifestly insufficient. These data should make it possible to better evaluate the resources available and the healthcare needs in Guyana.


title: A Randomized, Double-blind, Placebo-controlled, First-in-human, 3-Part Study of Orally Administered ALS-008176 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Dosing, Multiple Ascending Dosing and Food-effect in Healthy Volunteers

summary: This study will assess the safety, tolerability, and pharmacokinetics (PK) of orally administered ALS-008176 in healthy volunteers.

lead_sponsor: Alios Biopharma Inc.


title: Resynchronisation Therapy of Right Ventricle in Pulmonary Arterial Hypertension

acronym: RETRIEVE

summary:
Pulmonary arterial hypertension is a disease characterised by pathological changes in the pulmonary arteries leading to a progressive increase in pulmonary vascular resistance and pulmonary artery pressure. Right ventricular failure is the main cause of death in patients with pulmonary arterial hypertension, and the ability of the right ventricle to adapt to the progressive increase in pulmonary vascular resistance associated with changes to the pulmonary vasculature in pulmonary arterial hypertension is the main determinant of a patient's functional capacity and survival.

Right ventricular dyssynchrony was present in a substantial proportion of patients with pulmonary arterial hypertension and this dyssynchrony adversely affected right ventricular function.

lead_sponsor: University Hospital, Caen


summary:
We conducted a preliminary study in 2010 using the innovative Illumina GoldenGate (methylation assay) which has enabled us to characterize the level of methylation of 807 potential markers on a series of 200 adenocarcinomas of the colon (C18) and rectosigmoid junction (C19) resected between 1998 and 2001. The results, validated by pyrosequencing, allowed us to establish a panel of 12 markers to assess the level of methylation. The aim of this project is to validate the prognostic value of this panel in a second cohort of patients with adenocarcinomas (stage I to IV) resected between 2002 and 2006 in public and private hospitals (n=685).

This study relies on an original collection of surgical specimens of colorectal cancers resected in public and private hospitals among patients resident in the département of Côte-d'Or and followed by the cancer registry of Burgundy. Samples obtained from each cancer and from adjacent normal mucosa are stored in liquid nitrogen in the Ferdinand Cabane Biological Resources Centre(certified S 96900). Annotations are collected by the cancer registry staff from multiple sources (pathologists, gastroenterologists, oncologists and radiotherapists).

Pyrosequencing will be used to quantify the level of methylation. The percentage of methylated allele for each marker on cancerous DNA and the ratio of methylated markers to the number of markers analyzed will be determined. The molecular status of MSI, BRAF, KRAS, and PI3K will be taken into consideration.

To study the prognosis, relative and relapse free-survival will be calculated. A multivariate relative survival analysis will be performed to determine independent prognostic factors taking into account the characteristics of patients and tumours and epigenetic and molecular alterations. Epigenetic alterations will be described according to age group, sex and subsite. The epigenetic phenotypes will be evaluated according to already known molecular status using logistic regression models.

status: Withdrawn

time_perspective: Retrospective


summary:
The results of this study will make it possible, thanks to better understanding of the natural history of colorectal cancer, to define new treatment and surveillance strategies for colorectal cancers resected with curative intent, so as to improve management and thus improve patient survival.

These data will also make it possible to calculate the prevalence of patients who require treatment or surveillance because of their disease.


title: Evaluation of the Psychometric Properties of the 400m-walk-test at a Self-selected Speed (400m WT) for Stable Coronary Patients

acronym: TML 400 m

summary:
The objective of this project is to clarify and improve the efficiency of the standardized walk-test in Cardiovascular Rehabilitation. The psycho-metric properties of the 400m walk test at a self-selected speed will be evaluated. Such tests, made at a self-selected ("comfortable", "free") speed particularly assess the endurance capacities. The results of the physiological measurements during the tests will be compared with those of TM6min of Test of Fast Walking of 200m (TMR200m) and a maximal treadmill exercise. Stable coronary patients, aged over 55 years old, will be included.

This study should permit a simplification and a better understanding of the clinical-use of walk tests. In the future, two kinds of tests might be proposed with different distances, 1- 200m-fast-walking-test aimed to evaluate the performance closed to the maximum capacity, 2- self-selected-walk-test on a doubled distance (400m) aimed to evaluate the aerobic capacities of the adaptation of the body in response to effort.


acronym: EQUAL

summary: Systemic lupus erythematosus is a complex disease whose evaluation in everyday practice and in clinical research requires several aspects to be taken into account, in particular the impact of disease activity on quality of life. To date, the effect of systemic lupus on quality of life has only been described using generic questionnaires. Among the specific questionnaires for systemic lupus, the LupusQol, which has been validated in French, shows interesting psychometric properties. The determinants of quality of life specifically related to the disease are still unknown and could be studied using a longitudinal cohort thanks to the French version of the LupusQol.

primary_purpose: Health Services Research

ReferenceCitation: Corneloup M, Maurier F, Wahl D, Muller G, Aumaitre O, Seve P, Blaison G, Pennaforte JL, Martin T, Magy-Bertrand N, Berthier S, Arnaud L, Bourredjem A, Amoura Z, Devilliers H; EQUAL Study Group. Disease-specific quality of life following a flare in systemic lupus erythematosus: an item response theory analysis of the French EQUAL cohort. Rheumatology (Oxford). 2020 Jun 1;59(6):1398-1406. doi: 10.1093/rheumatology/kez451.

name: Clinical Investigation Center, INSERM CIC-EC 1432, University Hospital Dijon-Burgundy, Dijon

family: Corneloup

full_name: Marie Corneloup

given: Marie

name: Department of Internal Medicine and Clinical Immunology, Site Belle Isle, Metz

family: Maurier

full_name: François Maurier

given: François

name: Vascular Medicine Division and Regional Competence Center for Rare Vascular and Systemic Autoimmune Diseases, CHRU de Nancy

name: Inserm UMR_S 1116 at Lorraine University, Nancy

family: Wahl

full_name: Denis Wahl

given: Denis

name: Internal Medicine and Systemic Diseases Unit, University Hospital Centre Dijon, Dijon

family: Muller

full_name: Geraldine Muller

given: Geraldine

name: Department of Internal Medicine, Centre Hospitalier Universitaire, Hôpital Gabriel Montpied, Clermont-Ferrand

family: Aumaitre

full_name: Olivier Aumaitre

given: Olivier

name: Department of Internal Medicine, University Hospital, Hôpital Croix Rousse, Lyon

family: Seve

full_name: Pascal Seve

given: Pascal

name: Department of Internal Medicine, Hopital Louis Pasteur, Colmar, Alsace

family: Blaison

full_name: Gilles Blaison

given: Gilles

name: Department of Internal Medicine, CHU de Reims, Reims

family: Pennaforte

full_name: Jean-Loup Pennaforte

given: Jean-Loup

name: Internal Medicine and Clinical Immunology Department, Strasbourg University Hospital, Strasbourg

family: Martin

full_name: Thierry Martin

given: Thierry

name: Internal Medicine, CHRU Besançon, Besançon

family: Magy-Bertrand

full_name: Nadine Magy-Bertrand

given: Nadine

name: Internal Medicine and Clinical Immunology Unit, University Hospital Dijon-Burgundy, Dijon

family: Berthier

full_name: Sabine Berthier

given: Sabine

name: Department of Rheumatology, Hôpitaux Universitaires de Strasbourg

family: Arnaud

full_name: Laurent Arnaud

given: Laurent

name: Department of Internal Medicine, National Referral Center for Systemic Lupus Erythematosus and Anti-Phospholipid Syndrome, Pitie-Salpetriere University Hospital, Paris, France

family: Amoura

full_name: Zahir Amoura

given: Zahir

family: Devilliers

full_name: Hervé Devilliers

given: Hervé

journal_name: Rheumatology

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press


acronym: Casper

summary:
After a CVA, all of the cognitive functions can be affected and analysed, but the presence of a language disorder may considerably hamper the evaluation of other functions.

The battery of rapid tests to screen for and quantify cognitive disorders, including the MMSE, the MOCA, the R-CAMCOG or the RBANS, are not suitable for aphasic patients because they contain items with a strictly verbal response. Because of this, inexperienced doctors cannot evaluate higher functions (other than language) of aphasics in routine practice. For the same reason, aphasics are regularly excluded from post-cva therapeutic protocols, whether or not the trial bears on the evolution of cognitive functions.

Nonetheless, it is possible to evaluate, at least roughly, all of the cognitive functions without resorting to language.

The investigator have developed , from validated tests and classical clinical manoeuvers, the Cognitive Assessment for Stroke Patients (CASP) :

for the rapid screening (less than 15 minutes) and quantification of post-cva cognitive disorders (6 functions: language, apraxia, short-term memory, temporal orientation, impaired spatial/visio-construction and executive functions);
the CASP can be used in most patients, including those with severe disorders of expression and moderate problems with comprehension, The format of these tests has been adapted so that severe disorders of expression (essentially left-hemisphere CVA), and left spatial impairment (right-hemisphere CVA) do not affect the ability to take the test. Its validity in terms of appearance and content were verified in 2011.


title: Monocentric, Prospective, Comparative and Randomised Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children

acronym: HemORL

summary:
The long-term objective of this study is to prove:

the equivalence of the number of post-operation hemorrhages, and maybe a decrease of the number of secondary hemorrhages
the decrease of pain and quicker re-feeding
an easier haemostasis
the simplification of the tonsillectomy surgical kit
the decrease of dissection time

ReferenceCitation: Guerrero K, Moreau-Gaudry A, Porcu P, Blin D. An innovative technique to control bleeding with vacuum device. Eur J Cardiothorac Surg. 2011 Jun;39(6):1070-2. doi: 10.1016/j.ejcts.2010.09.047. Epub 2010 Nov 12.

ReferenceCitation: Brichon PY, Porcu P, Moreau-Gaudry A, Blin D. Extraction of substernal goitre using an innovative vacuum device. Eur J Cardiothorac Surg. 2012 Jul;42(1):178-9. doi: 10.1093/ejcts/ezs018. Epub 2012 Feb 13.

ReferenceCitation: Porcu P, Moreau-Gaudry A, Chavanon O, Blin D. Haemostasis of a right ventricle-gunshot wound using a novel haemostatic vacuum device. Interact Cardiovasc Thorac Surg. 2012 Aug;15(2):294-6. doi: 10.1093/icvts/ivs103. Epub 2012 May 7.

lead_sponsor: University Hospital, Grenoble

intervention_type: Device


title: Identification of GENEtic Markers of Aggressiveness and Malignancy by Array Comparative Genomic Hybrization Analysis (CGH)

acronym: PITUIGENE

summary:
Recent studies estimate that the prevalence of pituitary adenomas is approximately 1/1500 persons. Pituitary tumours are usually considered as benign. However, local invasion is reported in 35-40% of pituitary adenomas; resistance to medical treatment or recurrence leading to multimodal therapy is reported in about 15% of cases. These tumours are considered as aggressive pituitary tumours and present a distinct biological and clinical entity with continued growth despite multimodal therapy, including surgery and radiotherapy (McCormack et al., 2011). Whilst these tumours have malignant potential, the term of pituitary carcinoma is strictly reserved for those rare tumours (0.2%) with demonstrated craniospinal or systemic metastases (Heaney, 2011).

Pituitary aggressive and malignant tumours are very difficult to control and ultimately prove to be lethal. It was suggested that early aggressive treatments (chemotherapy, radiotherapy) may control progression and occurrence of metastases. However, these therapeutic options are associated with important side effects limiting their use and the prediction of pituitary tumor behaviour remains a challenge. At the diagnosis, clinical signs are not specific and the results concerning proliferative factors (Ki-67 and P53), putative oncogenes (PTTG) conflict from one series to another.

In a case-control retrospective study of a cohort of 410 patients (HYPOPRONOS), we validated a prognostic pathological classification based on histological and radiological data (J. Trouillas 2012 in preparation). Tumours were classified into 3 grades: grade 1= non-invasive tumour, grade 2= invasive tumour and grade 3 = aggressive-invasive tumor with the combination of radiological signs of invasion and 2 of 3 signs of increased proliferation (Ki-67 index>3%, number of mitoses>2 per 10 fields at 400X, P53 nuclear detection).

It is now widely accepted that cancer is a clonal disease, which arises from a single normal cell and progresses thanks to the accumulation of DNA alterations (Sanson et al., 2011). To identify the role of these DNA alterations, we conducted array CGH analysis limited to 13 prolactin pituitary tumours, from frozen fragments, and identified allelic loss of chromosome 11 associated with aggressiveness and malignancy (Wierinckx et al., 2011).

To confirm these encouraging results we propose to conduct a study on a large series of tumours, fixed and embed, and to be correlated the results to clinical data.

ReferenceCitation: Lasolle H, Raverot G. Letter to the Editor From Helene Lasolle and Gérald Raverot: "USP8 and TP53 Drivers Are Associated With CNV in a Corticotroph Adenoma Cohort Enriched for Aggressive Tumors". J Clin Endocrinol Metab. 2021 Jul 13;106(8):e3285-e3286. doi: 10.1210/clinem/dgab217.

name: Fédération d’Endocrinologie, Hospices Civils de Lyon, Groupement Hospitalier Est, Bron, France

name: INSERM U1052, CNRS UMR5286, Cancer Research Center of Lyon, Lyon, France

family: Lasolle

full_name: Hélène Lasolle

given: Hélène

family: Raverot

full_name: Gérald Raverot

given: Gérald

journal_name: The Journal of Clinical Endocrinology & Metabolism

publisher: The Endocrine Society

publisher_dissemination: The Endocrine Society

publisher_group: The Endocrine Society

publisher_normalized: The Endocrine Society

title: Letter to the Editor From Helene Lasolle and Gérald Raverot: “USP8 and TP53 Drivers Are Associated With CNV in a Corticotroph Adenoma Cohort Enriched for Aggressive Tumors”

ReferenceCitation: Lasolle H, Alix E, Bonnefille C, Elsensohn MH, Michel J, Sanlaville D, Roy P, Raverot G, Bardel C. Centralization errors in comparative genomic hybridization array analysis of pituitary tumor samples. Genes Chromosomes Cancer. 2018 Jun;57(6):320-328. doi: 10.1002/gcc.22534. Epub 2018 Mar 9.

name: Department of endocrinology, Hospices Civils de Lyon, Groupement Hospitalier Est; Bron France

name: Univ Lyon, Université Lyon 1; Lyon France

name: Department of biostatistics, Hospices Civils de Lyon; Lyon France

name: CNRS UMR 5558, Laboratoire de Biométrie et Biologie Évolutive, Équipe Biostatistique-Santé; Villeurbanne France

name: Department of cytogenetics, Centre de Biologie et Pathologie Est, Hospices Civils de Lyon; Bron France

family: Alix

full_name: Eudeline Alix

given: Eudeline

family: Bonnefille

full_name: Clément Bonnefille

given: Clément

family: Elsensohn

full_name: Mad-Hélénie Elsensohn

given: Mad-Hélénie

family: Michel

full_name: Jessica Michel

given: Jessica

family: Sanlaville

full_name: Damien Sanlaville

given: Damien

family: Roy

full_name: Pascal Roy

name: INSERM U1052, CNRS UMR5286, Cancer Research Center of Lyon; Lyon F-69372 France

name: Sequencing platfom haut débit, Hospices Civils de Lyon; Bron France

family: Bardel

full_name: Claire Bardel

given: Claire

journal_name: Genes, Chromosomes and Cancer

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Groupement Hospitalier Est


title: Kinetics of Inflammation Markers in Maternal Plasma (Interleukins, Matrix Metalloproteinases -MMP): Study of the Correlation With the Diagnosis of Chorioamnionitis in Women Hospitalized for Spontaneous Rupture of the Fetal Membranes (SPROM) Before 34 Weeks of Amenorrhea (WA) With no Modification in the Usual Therapy.

summary:
The principal aim of this study is to help obstetricians to diagnose chorioamniotic infection early, in cases of premature rupture of the fetal membranes before 34 WA, by proposing earlier and more specific markers of infection than FBC and CRP. The aim is to reduce vital and functional risk of acute chorioamnionitis for the mother, the fetus or the newborn,.

If the kinetics profile of one or several markers correlates strongly with the diagnosis of chorioamnionitis, it could be used in clinical practice, possibly in the context of another clinical study.

The results of the study presented here are destined to be published in obstetrics journals.

status: Terminated


summary:
Principal objective: to evaluate the effect of the combination pravastatin - sorafenib versus sorafenib alone on overall survival in patients with hepatocellular carcinoma developing on Child-Pugh A cirrhosis who are unsuitable for curative treatment.

Secondary objectives: evaluate the effect of this treatment on progression-free survival, the time to progression, the time to treatment failure and quality of life (QLQ-C30 et FACT HEP)


summary: The mechanisms of oxidative stress and inflammation involved in mood disorders are factors of chronicity and severity. These mechanisms induce a phenomenon of accelerated cellular senescence and are reflected by alterations in systemic gene expression detectable in leukocytes in peripheral blood. The genetic markers of these mechanisms are clinically significant markers. The identification of new genetic markers will make it possible to improve evaluations of the severity and somatic consequences of depressive syndromes.


acronym: Proteome

summary: The hypotheses of our research are based on the fact that various pathological states, infection, cancer, inflammatory disease, can induce an inflammatory syndrome, through different pathways, even though the clinical presentation can be identical. The identification of biological markers specific to an etiology would therefore allow a faster diagnosis and improve care for patients. We thus took an interest in the three groups of diseases most frequently responsible for an inflammatory syndrome, infections, cancers and auto-immune diseases. To achieve this, various methods will be used.


title: Phase II Study of Feasibility of Focal Therapy for Prostate Cancer of Good Prognosis With Permanent I125 Localized Implant.

acronym: CURIEFOCALE

summary:
This is a pilot prospective biomedical study of interventional type which includes 17 patients on 24 months (12 months of inclusion and 12 months of follow-up).

The objective of this study is to verify that the focal therapy technique used (with the help of Koelis® system) allows to obtain optimal dosimetric coverage of the prostate target (ie dose of 160 Gy +-5% delivered on the envelope isodose) evaluated by CT scan performed 30 days after implantation.

lead_sponsor: Institut Claudius Regaud

intervention_type: Radiation


title: Evaluation of an Oral Nutrition Supplement

summary: The objective of this study is to capture gastrointestinal tolerance (GI) information on a nutrient dense oral nutritional supplement (ONS) in healthy elderly subjects.

lead_sponsor: Abbott Nutrition


title: A Randomized, Single Dose, Open-label, Two Parts, Two and Three Period Cross-over Study to Investigate the Relative Bioavailability of Two Tablet Formulations and the Effect of Fasting Following Oral Administration of RO4995819 in Healthy Subjects

summary: This randomized, open-label, cross-over study will assess the bioavailability and safety of RO4995819 in healthy volunteers. Volunteers will receive two different formulations (tablet and capsule) of the study drug under fed and fasting conditions.

lead_sponsor: Hoffmann-La Roche


title: SEDATIVE PREMEDICATION: EFFICACY ON PATIENT EXPERIENCE

acronym: PremedX

summary: Seven French university hospitals will participate in this multicentric prospective, blinded and randomized study. The investigators designed 3 study groups: Lorazepam 2.5mg, Placebo (microcrystalline celluloses) and no premedication at all. The third group (no premedication) is necessary in order to evaluate a placebo response, which may be significant on anxiety level and patients perceptions of care. It was calculated that 969 patients had to be included in order to obtain a 5 point difference between groups on the EVAN score with 80 % statistical power, leading to the inclusion of 1200 patients with an estimated maximum dropout rate of 15 %. All adults below 70 years and scheduled for elective surgery under general anesthesia can be included after information by an anesthesiologist in charge of the study and written informed consent. Non inclusion criterions are: a weight below 45 Kg, a counter indication to benzodiazepine, surgeries that could impair cognitive functions (cardiac or neurologic surgery), usual use of neuroleptics or lithium, drug addiction or former cognitive disease. The technique of anesthesia will be decided by the attending anesthesiologist, who will be unaware of the premedication technique, independently of the study protocol.

ReferenceCitation: Maurice-Szamburski A, Auquier P, Viarre-Oreal V, Cuvillon P, Carles M, Ripart J, Honore S, Triglia T, Loundou A, Leone M, Bruder N; PremedX Study Investigators. Effect of sedative premedication on patient experience after general anesthesia: a randomized clinical trial. JAMA. 2015 Mar 3;313(9):916-25. doi: 10.1001/jama.2015.1108.

name: Service d’Anesthésie Réanimation, Hôpital de la Timone Adulte, Marseille, France

family: Maurice-Szamburski

full_name: Axel Maurice-Szamburski

given: Axel

name: Laboratoire Universitaire EA 3279, Santé Publique et Maladies Chroniques, Université Aix-Marseille, Marseille, France

family: Auquier

full_name: Pascal Auquier

given: Pascal

family: Viarre-Oreal

full_name: Véronique Viarre-Oreal

given: Véronique

name: Service d’Anesthésie, Institut du Cancer, Université Montpellier 1, Montpellier, France

family: Cuvillon

full_name: Philippe Cuvillon

given: Philippe

name: Service d’Anesthésie Réanimation, Hôpital Archet, Université Nice Sophia-Antipolis, Nice, France

family: Carles

full_name: Michel Carles

given: Michel

name: Service d’Anesthésie, Pôle ARDU, Hôpital Universitaire Carémeau, Nîmes, Université Montpellier 1, Montpellier, France

family: Ripart

full_name: Jacques Ripart

given: Jacques

name: Expertise Pharmaceutique, Hôpital de la Timone Adulte, Université Aix, Marseille, France

family: Honore

full_name: Stéphane Honore

given: Stéphane

family: Triglia

full_name: Thibaut Triglia

given: Thibaut

name: Unité d’Aide Méthodologique, Direction de la Recherche Clinique, AP-HM, Marseille, France

family: Loundou

full_name: Anderson Loundou

given: Anderson

name: Service d’Anesthésie Réanimation, Hôpital Nord, Pavillon de l’Etoile, Université Aix-Marseille, Marseille, France

family: Leone

full_name: Marc Leone

given: Marc

family: Bruder

full_name: Nicolas Bruder

given: Nicolas

journal_name: JAMA

oa_host_type: publisher

evidence: open (via free pdf)

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Effect of Sedative Premedication on Patient Experience After General Anesthesia

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Evaluation of Bevacizumab in Combination With First-Line Chemotherapy in Patients Aged 75 Years of Older With Metastatic Colorectal Adenocarcinoma

summary:
To evaluate tolerance to and efficacy of bevacizumab in the treatment of MCRC in elderly patients, we propose a phase II randomised study comparing a chemotherapy + bevacizumab arm with a chemotherapy alone arm in the first-line treatment of MCRC in patients aged 75 years and older.

This study is destined to continue as a phase III trial if both arms meet the selection criteria to show or not the benefits of treatment with bevacizumab combined with chemotherapy.

ReferenceCitation: Dohan A, Gallix B, Guiu B, Le Malicot K, Reinhold C, Soyer P, Bennouna J, Ghiringhelli F, Barbier E, Boige V, Taieb J, Bouché O, François E, Phelip JM, Borel C, Faroux R, Seitz JF, Jacquot S, Ben Abdelghani M, Khemissa-Akouz F, Genet D, Jouve JL, Rinaldi Y, Desseigne F, Texereau P, Suc E, Lepage C, Aparicio T, Hoeffel C; PRODIGE 9 Investigators and PRODIGE 20 Investigators. Early evaluation using a radiomic signature of unresectable hepatic metastases to predict outcome in patients with colorectal cancer treated with FOLFIRI and bevacizumab. Gut. 2020 Mar;69(3):531-539. doi: 10.1136/gutjnl-2018-316407. Epub 2019 May 17.

family: Dohan

full_name: Anthony Dohan

given: Anthony

family: Gallix

full_name: Benoit Gallix

given: Benoit

family: Guiu

full_name: Boris Guiu

given: Boris

family: Le Malicot

full_name: Karine Le Malicot

given: Karine

family: Reinhold

full_name: Caroline Reinhold

given: Caroline

family: Soyer

full_name: Philippe Soyer

family: Bennouna

full_name: Jaafar Bennouna

given: Jaafar

family: Ghiringhelli

full_name: Francois Ghiringhelli

given: Francois

family: Barbier

full_name: Emilie Barbier

given: Emilie

family: Boige

full_name: Valérie Boige

given: Valérie

family: Taieb

full_name: Julien Taieb

given: Julien

family: Bouché

full_name: Olivier Bouché

given: Olivier

family: François

full_name: Eric François

given: Eric

family: Phelip

full_name: Jean-Marc Phelip

given: Jean-Marc

family: Borel

full_name: Christian Borel

given: Christian

family: Faroux

full_name: Roger Faroux

given: Roger

family: Seitz

full_name: Jean-Francois Seitz

given: Jean-Francois

family: Jacquot

full_name: Stéphane Jacquot

family: Ben Abdelghani

full_name: Meher Ben Abdelghani

given: Meher

family: Khemissa-Akouz

full_name: Faiza Khemissa-Akouz

given: Faiza

family: Genet

full_name: Dominique Genet

given: Dominique

family: Jouve

full_name: Jean Louis Jouve

given: Jean Louis

family: Rinaldi

full_name: Yves Rinaldi

given: Yves


title: Vestibular and Multisensory Influence on Bodily and Spatial Representations. Behavioral and Electrophysiological Investigations in Vestibular-defective Patients and Healthy Volunteers

summary:
The present project aims at describing how vestibular signals contribute to the multisensory mechanisms of bodily self-consciousness.

There is a large body of data regarding the sensory and neural mechanisms of self-consciousness, but most studies have so far demonstrated the contribution of visual, tactile and proprioceptive signals to bodily self-consciousness. Thus, most studies have neglected the contribution of the vestibular system, a major sensory system for spatial and bodily representations. The vestibular system is sensitive to head motions in space and head inclinations with respect to gravity and it should therefore contribute significantly to several bodily experiences. This contribution should be put under neuroscientific scrutiny. We believe that the current neuroscientific models of bodily self-consciousness will be incomplete until they incorporate the contribution of vestibular signals.

The present project specifically aims at testing the hypothesis according to which vestibular signals significantly influence bodily self-consciousness, in particular first-person and third-person perspective taking and the internal body models (i.e. the body schema and body image). The present project also aims at describing how cortical vestibular processing is modified during experimental changes of perspective taking and viewpoint. In addition, the present project will describe whether vestibular disorders change performances in third-person perspective taking tasks and modify internal body models. This should help understanding bodily symptoms in vestibular-defective patients. To this end, we will combine approaches from psychophysics and electrophysiology (electromyography, electroencephalography) in healthy volunteers and behavioral approached in patients with vestibular disorders.

These studies should further the understanding of how the brain processes vestibular signals, which is to date poorly understood. In addition, the outcome of the present project should help understanding the multiple and complex symptoms reported by patients with vestibular diseases, and should therefore improve their treatment.


title: Part 1: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Ascending Single Dose and Food Influence Study of QGC001 Administered Orally To Healthy Adult Subjects, Part 2: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Ascending Multiple Dose Study of QGC001 Administered Orally To Healthy Adult Subjects.

summary: 1QG2 is a Phase 1 study aiming to assess the safety and tolerability of ascending single/multiple oral doses (SAD & MAD) in healthy young subjects, the preliminary food interaction and the effect of QGC001 on blood pressure and heart rate, but also to determine pharmacokinetic preliminary profiles of QGC001 and its metabolite EC33 and pharmacodynamic preliminary profiles of QGC001 and its metabolite EC33 especially effects on the renin-angiotensin-aldosterone and copeptin systems.

lead_sponsor: Quantum Genomics SA


title: A Phase I, Double-blind, Placebo-controlled, Ascending Single-dose, Safety, Tolerability and Pharmacokinetic Study of QGC001 in Healthy Male Subjects.

summary: QGC001/1QG1 is a Phase I "first time in man" study aiming to determine the overall safety and tolerability of single ascending oral doses of QGC001 in healthy male subjects compared to placebo, as well as the pharmacokinetics of QGC001 and its metabolite EC33 and the pharmacodynamic properties of QGC001 (effects on the renin-angiotensin-aldosterone system, blood pressure and heart rate) in healthy male subjects.


title: Cognitive Assessment of Patients With Brain Injuries by the Mean of Event

acronym: PEC

summary: The main objective of this study is to describe differential cognitive processing of various stimuli by a population of control subjects and a population of patients with selective cognitive deficits or altered states of consciousness by using dedicated ERP paradigms and high-density EEG picked up system.

lead_sponsor: University Hospital, Limoges

intervention_type: Behavioral


title: Prospective Physiological Study of Lung Elastance in Recruitment and Derecruitment in Early Onset Mechanically Ventilated Acute Respiratory Distress Syndrome (ARDS)Patients

acronym: ELASTANCE

summary: The recruitment strategy in Acute respiratory distress syndrome (ARDS) patients mechanically ventilated combines recruitment maneuvers and positive end expiratory pressure (PEEP). Recruitment maneuvers promote alveolar recruitment leading to increased end-expiratory lung volume in order to prevent repetitive opening and closing of unstable lung units and reduce the strain induced by ventilation. In addition, recruitment is effective in improving oxygenation. Variety of recruitment maneuver have been described, the most commonly used is the application of sustained continuous positive airway pressure at 40 cmH2O for 40 seconds. Staircase recruitment maneuver (SRM) is an alternative with good hemodynamic tolerance. Staircase recruitment maneuver (SRM) involves a progressive increase in positive end expiratory pressure (PEEP) (up to 40 cmH2O), in pressure control ventilation, in order to increase end-expiratory lung volume (EELV); then a decreasing PEEP trial is performed. The positive end expiratory pressure (PEEP) to prevent alveolar collapse depends on ratio between lung elastance and chest wall elastance. If chest wall elastance is high, the PEEP to obtain a positive end-expiratory transpulmonary pressure is high. The only way for the time being to know the transpulmonary pressure and the ratio between lung and chest wall elastance is the use of esophageal catheter. A non-invasive method for measuring the lung elastance by measuring volume recruited during a change of pressure (∆PEEP/∆EELV) could be used to avoid the use of esophageal catheter.

primary_purpose: Supportive Care

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Centre Hospitalier Intercommunal de Toulon La Seyne sur mer


title: Phospholipase A2 Receptor (PLA2R1) Autoantibodies in Membranous Nephropathy in Kidney Transplantation

acronym: PRAM-KT

summary:
The Membranous nephropathy (GEM)idiopatic is the most frequent cause of syndrome néphrotique at the adult and represent approximately 2 % of the causes of terminal chronic renal insufficiency. A etiology balance assessment must be systematically realized to eliminate a secondary cause. Antibodies managed against the receiver of phospholipases A2 secreted by type M (PLA2R1) was recently detected in a population of GEM idiopatic, but not secondary GEM. PLA2R1 is expressed by the podocytes of the glomerules of healthy subjects, and this receiver co-is located with the deposits of extramembraneous IgG of the expanding subjects of idiopathique GEM. The good IgG the extramembraneous depositsof GEM idiopathic recognize PLA2R1. At some patients, the activity anti-PLA2R1 seems to decrease or to disappear during the stake in forgiveness of the disease.

Some cases of second offense of GEM idiopathique after renal transplantation presenting antibodies anti-PLA2R1 have also described. The appearance of antibody anti-PLA2R1 seems parallel to the increase of a proteinurie in touch with a second offense of GEM, and antibodies sometimes disappeared after a therapeutic strengthening by Rituximab allowing to obtain a forgiveness.

A GEM can also appear of novo on the renal transplant, it is to say without notion of GEM on the native loins. The physiopathology of this affection remains unknown.

Working hypothesis and objectives We shall look in which proportion the presence of antibody anti-PLA2R1 is associated with the second offense of GEM idiopathic in renal transplantation. We anticipate that the GEM of novo of the renal transplant answers a different physiopathology, and will not be associated with the presence of antibody anti-PLA2R1. We hope to demonstrate that at the expanding patients of antibody anti-PLA2R1, the title of these antibodies is correlated in the activity of the disease and in the renal survival, and that the longitudinal follow-up of the title of these antibodies has an interest forecast and therapeutics.

ReferenceCitation: Seitz-Polski B, Dahan K, Debiec H, Rousseau A, Andreani M, Zaghrini C, Ticchioni M, Rosenthal A, Benzaken S, Bernard G, Lambeau G, Ronco P, Esnault VLM. High-Dose Rituximab and Early Remission in PLA2R1-Related Membranous Nephropathy. Clin J Am Soc Nephrol. 2019 Aug 7;14(8):1173-1182. doi: 10.2215/CJN.11791018. Epub 2019 Jul 24.

family: Seitz-Polski

full_name: Barbara Seitz-Polski

given: Barbara

family: Dahan

full_name: Karine Dahan

given: Karine

family: Debiec

full_name: Hanna Debiec

given: Hanna

family: Rousseau

full_name: Alexandra Rousseau

given: Alexandra

family: Andreani

full_name: Marine Andreani

given: Marine

family: Zaghrini

full_name: Christelle Zaghrini

given: Christelle

family: Ticchioni

full_name: Michel Ticchioni

given: Michel

family: Rosenthal

full_name: Alessandra Rosenthal

given: Alessandra

family: Benzaken

full_name: Sylvia Benzaken

given: Sylvia

family: Bernard

full_name: Ghislaine Bernard

given: Ghislaine

family: Lambeau

full_name: Gérard Lambeau

given: Gérard

family: Ronco

full_name: Pierre Ronco

given: Pierre

family: Esnault

full_name: Vincent L.M. Esnault

given: Vincent L.M.

journal_name: Clinical Journal of the American Society of Nephrology

oa_colors: green other

publisher: American Society of Nephrology (ASN)

publisher_dissemination: American Society of Nephrology

publisher_group: American Society of Nephrology

publisher_normalized: American Society of Nephrology

ReferenceCitation: Seitz-Polski B, Dolla G, Payré C, Tomas NM, Lochouarn M, Jeammet L, Mariat C, Krummel T, Burtey S, Courivaud C, Schlumberger W, Zorzi K, Benzaken S, Bernard G, Esnault VL, Lambeau G. Cross-reactivity of anti-PLA2R1 autoantibodies to rabbit and mouse PLA2R1 antigens and development of two novel ELISAs with different diagnostic performances in idiopathic membranous nephropathy. Biochimie. 2015 Nov;118:104-15. doi: 10.1016/j.biochi.2015.08.007. Epub 2015 Aug 19.

family: Dolla

full_name: Guillaume Dolla

given: Guillaume

family: Payré

full_name: Christine Payré

given: Christine

family: Tomas

full_name: Nicola M. Tomas

given: Nicola M.

family: Lochouarn

full_name: Marine Lochouarn

lead_sponsor: Centre Hospitalier Universitaire de Nice


summary: ALS is a severe progressive neurodegenerative disease characterized by degeneration motor neurons leading to death in 3 to 5 years. Gradually in time, the patient deprived of all motor skills as well as the possibility of communication written and oral developing a state close Locked In Syndrome (LIS). The main objective is to establish the feasibility of brain-computer interface using the pathological condition, with dependent disabled subjects as a means of communication.


type: Registry Identifier

title: Study of the Consumption of Nutriose on Satiety, Weight Loss and Fat Mass Reducing in Overweight Subjects

summary:
NUTRIOSE is a food ingredient defined as a carbohydrate polymer of vegetable origin (wheat starch or corn) with a degree of polymerization ≥ 3 and chemically transformed. It is soluble in aqueous solution, very poorly digested in the small intestine, it mostly reaches the colon where it stimulates fermentation. AFSSA, in its opinion of July 30, 2007, considers that this ingredient is a "soluble dietary fiber." Recent work in China in overweight volunteers have shown an effect of NUTRIOSE on satiation and satiety, and demonstrate an effect on reducing weight and fat mass. By its action on satiety and reduced food intake, the NUTRIOSE be of interest in the management of overweight or obese. Among the possible mechanisms of action, are the metabolites produced by colonic fermentation of NUTRIOSE.

The goal of this biomedical research is to study the effect of a dose of 14g/day of NUTRIOSE FB06 for 12 weeks on the evolution of weight, percentage of body fat and digestive tolerance in Caucasians overweight subjects. To gather evidence to support mechanisms of action, it is proposed to measure before consumption, then every 4 weeks, the effects of NUTRIOSE FB06 on satiety and satiation and changes in colonic flora and its metabolites.

ReferenceCitation: Li S, Guerin-Deremaux L, Pochat M, Wils D, Reifer C, Miller LE. NUTRIOSE dietary fiber supplementation improves insulin resistance and determinants of metabolic syndrome in overweight men: a double-blind, randomized, placebo-controlled study. Appl Physiol Nutr Metab. 2010 Dec;35(6):773-82. doi: 10.1139/H10-074.

ReferenceCitation: Slavin JL, Savarino V, Paredes-Diaz A, Fotopoulos G. A review of the role of soluble fiber in health with specific reference to wheat dextrin. J Int Med Res. 2009 Jan-Feb;37(1):1-17. Review.

ReferenceCitation: Guerin-Deremaux L, Li S, Pochat M, Wils D, Mubasher M, Reifer C, Miller LE. Effects of NUTRIOSE® dietary fiber supplementation on body weight, body composition, energy intake, and hunger in overweight men. Int J Food Sci Nutr. 2011 Sep;62(6):628-35. doi: 10.3109/09637486.2011.569492. Epub 2011 May 19.

ReferenceCitation: Haarman M, Knol J. Quantitative real-time PCR assays to identify and quantify fecal Bifidobacterium species in infants receiving a prebiotic infant formula. Appl Environ Microbiol. 2005 May;71(5):2318-24.

ReferenceCitation: Suzuki K, Simpson KA, Minnion JS, Shillito JC, Bloom SR. The role of gut hormones and the hypothalamus in appetite regulation. Endocr J. 2010;57(5):359-72. Epub 2010 Apr 14. Review.

ReferenceCitation: Ruskoné-Fourmestraux A, Attar A, Chassard D, Coffin B, Bornet F, Bouhnik Y. A digestive tolerance study of maltitol after occasional and regular consumption in healthy humans. Eur J Clin Nutr. 2003 Jan;57(1):26-30.

lead_sponsor: Nealth Sarl

location_facility: CRNH, service de diabétologie-endocrinologie-nutrition hôpital Jean Verdier

intervention_type: Dietary Supplement


acronym: TRANSBioHIV

summary: This project aims at characterizing HIV-1 viral biofilms structural and functional properties and at deciphering its role as a new viral reservoir and as a new mode of viral spread. The prospective national study will be conducted on cells isolated from blood samples from 20 patients infected with HIV.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility: Service de Médecine Interne, CHU Kremlin-Bicêtre


type: Other Grant/Funding Number

title: Assessment of Sperm Morphology by High Magnification (x6000) With Interference Contrast Microscopy in Fertile Men.

acronym: FERTIFORT

summary: A new concept for observing the fine morphology of spermatozoa at high magnification (x6000) with an inverted microscope, a numeric camera using differential interference contrast has been developed (1). This technique called Motile Sperm Organellar Morphology Examination allows to see some abnormalities, mainly vacuoles on the head of spermatozoa. These vacuoles appear to be related to sperm DNA damage and to affect embryo developmental potential (2, 3, 4). The application of Motile Sperm Organellar Morphology Examination may represent an improvement in the evaluation of semen quality, with some potential clinical repercussions at the diagnostic/prognostic level. First of all, the investigators need data on fertile men in order to define " normality " of sperm morphology at high magnification. The aim of this study is therefore to better characterize these vacuoles (number, surface, position) in a population of men fertile in order to establish normality criteria.

lead_sponsor: University Hospital, Toulouse


title: Impact of Vitamin D Supplementation on Immune Functions: Study in Subjects Aged Over 65 Years Vaccinated Against Influenza

summary:
The main objective is to assess the variation in plasma levels of cathelicidin before and after influenza vaccination.

All bibliographic data suggests that supplementation vitamin D in the elderly often deficient in this vitamin may have a double interest:

By induction of cathelicidin, assist in anti-infective response in particular to the influenza virus
The normalization of vitamin D status, promote the return to an appropriate immune response limiting excess inflammation and improving capacity to respond.

The entire project will collect new information on the merits of the use of vitamin D in aging. A better knowledge of mechanisms involved and the impact of aging on them is a necessary prerequisite the definition of a new strategy using this drug in the elderly particularly fragile in order to improve its autonomy. This definition seems a sociological interest obvious economic knowing the current aging population and its impact future of our health system.

primary_purpose: Prevention

ReferenceCitation: Goncalves-Mendes N, Talvas J, Dualé C, Guttmann A, Corbin V, Marceau G, Sapin V, Brachet P, Evrard B, Laurichesse H, Vasson MP. Impact of Vitamin D Supplementation on Influenza Vaccine Response and Immune Functions in Deficient Elderly Persons: A Randomized Placebo-Controlled Trial. Front Immunol. 2019 Feb 8;10:65. doi: 10.3389/fimmu.2019.00065. eCollection 2019.

family: Goncalves-Mendes

full_name: Nicolas Goncalves-Mendes

given: Nicolas

family: Talvas

full_name: Jérémie Talvas

given: Jérémie

family: Dualé

full_name: Christian Dualé

given: Christian

family: Guttmann

full_name: Aline Guttmann

given: Aline

family: Corbin

full_name: Violaine Corbin

given: Violaine

family: Marceau

full_name: Geoffroy Marceau

given: Geoffroy

family: Sapin

full_name: Vincent Sapin

given: Vincent

family: Brachet

full_name: Patrick Brachet

given: Patrick

family: Evrard

full_name: Bertrand Evrard

given: Bertrand

family: Laurichesse

full_name: Henri Laurichesse

given: Henri

family: Vasson

full_name: Marie-Paule Vasson

given: Marie-Paule

journal_name: Frontiers in Immunology

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut Pasteur

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut | Nicod


title: Effect of Transcranial Direct Current Stimulation (tDCS) on Acutely Induced Dyspnea in Healthy Volunteers : a Pilot Study

acronym: tDCS-Dyspnea

summary: Dyspnea is a frequent, mostly unpleasant and long-lasting, but also often undertreated symptom. Transcranial direct current stimulation (tDCS), a new non invasive method to modify brain activation has shown good efficacy in the treatment of pain especially in the clinical context. Given the fact that dyspnea has many common characteristics with pain, especially concerning the brain areas involved in its central processing, we hypothesize that tDCS may also modify the perception of dyspnea. In order to test this, we first shall determine whether tDCS has a significant effect on acutely induced dyspnea in healthy volunteers. In case of promising results of this pilot study, the next step will be the evaluation of the benefit of tDCS in patients with severe dyspnea.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Feasibility Study on the Contribution of Guided Puncture With Echoendoscopy in Evaluation of Hypermetabolic Lymphadenopathy Mediastinum Lower, Rear and Middle, Detected in PET-CT to 18 FDG (PET)

acronym: APOGEE

summary:
Impact of screening nodes mediastinal by PET, at different times of the management of cancer disease, remain unclear.

Benefits of combined PET and puncture with echoendoscopy for the diagnosis subsequent therapeutic management should be evaluated in these different contexts.

We would like to demonstrate the clinical utility of this association to replace more invasive diagnostic procedures and to assess the impact of the puncture on a possible modification of the therapeutic management.

It is a single center prospective diagnostic assessment

lead_sponsor: Institut Bergonié


title: Transsphenoidal Surgery for Pituitary Adenomas: Influence of the Ventilation Mode on Intraoperative Bleeding

acronym: Vent-Hyp

summary: The risk of bleeding is important during transsphenoidal surgery. This study aims to find if the ventilation mode, controlled pressure and controlled volume, modifies the risk of bleeding.

ReferenceCitation: Le Guen M, Paternot A, Declerck A, Feliot E, Gayat E, Gaillard S, Fischler M. Impact of the modality of mechanical ventilation on bleeding during pituitary surgery: A single blinded randomized trial. Medicine (Baltimore). 2019 Sep;98(38):e17254. doi: 10.1097/MD.0000000000017254.

family: Le Guen

full_name: Morgan Le Guen

given: Morgan

family: Paternot

full_name: Alexis Paternot

given: Alexis

family: Declerck

full_name: Agnes Declerck

given: Agnes

family: Feliot

full_name: Elodie Feliot

given: Elodie

family: Gayat

full_name: Etienne Gayat

given: Etienne

family: Gaillard

full_name: Stephan Gaillard

given: Stephan

family: Fischler

full_name: Marc Fischler

given: Marc

journal_name: Medicine

license: cc-by-nc

license_normalized: cc-by-nc

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Hopital Foch


title: Continuous Preperitoneal Infusion of Ropivacaine After Open Liver Resection: Effect on Post-operative Recovery and Morbidity

acronym: ROPIHEP

summary:
Intravenous morphine Patient-Controlled analgesia is gold standard on post - operative liver resection. But, opioids tend to be ineffective for pain that is associated with movement and have significant short-term side effects including nausea, vomiting, sedation, pruritus, constipation, urinary, retention, and respiratory depression, which are factors that often hinder a patient's recovery. Prospective randomized trials has found continuous wound catheter analgesia as an accepted alternative to IV morphine PCA.

The researchers will investigate whether ropivacaine, administered through a wound catheter placed by the surgeon, will reduce morbidity and provide a better recovery.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Antifungal Prophylaxis With Micafungin After Cord Blood Allogeneic Stem Cell Transplantation

acronym: MycaCOORD

summary:
Infections due to post transplant immune deficiency are a major problem following allogeneic stem cell transplantation (Allo-SCT), particularly in patients receiving cord blood transplant (CB). Duration of neutropenia is one of the most important risk factor for invasive fungal infection (IFI). In this setting, Micafungin has been approved for antifungal prophylaxis for patients undergoing Allo-SCT. In a randomized, double-blind, comparative, phase III trial, the overall efficacy of micafungin was superior to that of fluconazole as antifungal prophylaxis during the neutropenic phase after Allo-SCT. However, very few patients in this study received a CB transplant.

This is phase IIb, prospective, open-label, non-comparative study to assess the safety of micafungin when use in prevention of IFI in neutropenic patients receiving allo-SCT using CB as source of stem cells.

lead_sponsor: Nantes University Hospital


title: Study of Words Generation in Compulsives Gamblers and Healthy Volunteers: Comparison With a Study of Parkinson's Disease Patients

acronym: FLUENCE

summary:
The pathophysiology of compulsive disorders as gambling could be close to behavior problems encountered in Parkinson's disease associated with a hyperactivity of the motivational system.

Thanks to the words generation test, which reflects the cortico-subcortical loop functioning, involved in motivation, we want to evaluate and compare using tools (words generation and behavioral tests) the motivational functioning of gamblers and healthy volunteers that we can then compare to that of Parkinson's patients with and without behavioral hyperdopaminergic disorders which were explored in another study.


title: SUBclavian Central Venous Catheters Guidance and Examination by UltraSound : a Randomized Controlled Study Versus Landmark Method

acronym: SUBGEUS

summary: Prospective, randomized controlled clinical unicentric study, in ICU, Cannulation of the subclavian venous and examination guided with ultrasound

ReferenceCitation: Perbet S, Pereira B, Grimaldi F, Dualé C, Bazin JE, Constantin JM. Guidance and examination by ultrasound versus landmark and radiographic method for placement of subclavian central venous catheters: study protocol for a randomized controlled trial. Trials. 2014 May 20;15:175. doi: 10.1186/1745-6215-15-175.

family: Perbet

full_name: Sébastien Perbet

given: Sébastien

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Grimaldi

full_name: Florian Grimaldi

given: Florian

family: Bazin

full_name: Jean-Etienne Bazin

given: Jean-Etienne

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

currency_apc_doaj: GBP

journal_name: Trials

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

lead_sponsor: University Hospital, Clermont-Ferrand


title: Phase II Study Assessing Everolimus as Fist Line Treatment in Patients With Metastatic Kidney Cancer of Bad Prognosis

acronym: POORTOR

summary:
It is a an open label, multicentric, phase II study assessing the efficacy of everolimus (given per os) as a first line treatment in kidney cancer of bad prognosis.

92 patients will be included (anticipated). The treatment by everolimus will continue until progression, significant toxicity or withdraw of consent

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Evaluation of Rectal Tumor Margin Using Confocal Endomicroscopy and Comparison to Histopathology

acronym: TRaMA

summary:
This innovative study will involve the use of probe-based confocal laser endomicroscopy, a new medical imaging technology never used for surgical indications to date. Virtual biopsies (pCLE images) will be compared to histopathology analysis.

This study focuses on the evaluation of rectal tumor margins. The hypothesis is that pCLE will allow identification of rectal tumor margin, comparable to that of histopathology. In the future, decision of resection margin could rely on intraoperative pCLE exam.

The proposed study is a feasibility study, first in the indication of rectal cancer.

ReferenceCitation: Wijsmuller AR, Ghnassia JP, Varatharajah S, Schaeffer M, Leroy J, Marescaux J, Ignat M, Mutter D. Prospective Trial on Probe-Based Confocal Laser Endomicroscopy for the Identification of the Distal Limit in Rectal Adenocarcinoma. Surg Innov. 2018 Aug;25(4):313-322. doi: 10.1177/1553350618773011. Epub 2018 May 7.

name: Institut Hospitalo-Universitaire, Institut de Recherche contre les Cancers de l’Appareil Digestif, Strasbourg, France

name: NHC, University Hospital of Strasbourg, Strasbourg, France

family: Wijsmuller

full_name: Arthur R. Wijsmuller

given: Arthur R.

name: Centre de Lutte contre le Cancer Paul Strauss, Strasbourg, France

family: Ghnassia

full_name: Jean-Pierre Ghnassia

given: Jean-Pierre

family: Varatharajah

full_name: Sharmini Varatharajah

given: Sharmini

family: Schaeffer

full_name: Mickael Schaeffer

given: Mickael

family: Leroy

full_name: Joel Leroy

given: Joel

family: Marescaux

full_name: Jacques Marescaux

given: Jacques

family: Ignat

full_name: Mihaela Ignat

given: Mihaela

family: Mutter

full_name: Didier Mutter

given: Didier

journal_name: Surgical Innovation

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

lead_sponsor: IHU Strasbourg

location_facility: Service de chirurgie digestive et endocrinienne - Nouvel Hôpital Civil


title: Therapeutic Strategy Guided by PET-TDM for Patients With Grade I or Metastatic Seminoma

acronym: SEMITEP

summary: The purpose of the study is to evaluate the ration of patients getting an lighten therapeutic strategy after 18F-fluoro-désoxyglucose positron emission tomography (PET-TDM) in grade I (cohort 1) or metastatic (cohort 2) seminoma


title: A Single-blind, Randomized Study to Compare Impacts of Intraperitoneal Pressure (8mmHg Versus 12 mmHg) and CO2 Gas (Cool, Dry CO2 Gas Versus Warmed; Humidified Co2 Gas) on Surgical Peritoneal Environment During Laparoscopic Surgery

summary:
Use lay language.

The primary purpose is to compare the impacts of intraperitoneal pressure (8mmHg versus 12 mmHg) and CO2 gas (cool, dry CO2 gas versus warmed, humidified CO2 gas) on gene expression in peritoneal tissues during laparoscopic surgery. We hypothesize that combined use of a low Intraperitoneal pressure (8mmHg) and warmed, humidified CO2 gas during CO2 pneumoperitoneum may be better in minimizing adverse effects on surgical peritoneal environment and improving clinical outcomes compared to the standard intraperitoneal pressure (12mmHg) and standard cool, dry CO2 gas.


title: Early Nasal High Flow Oxygen Therapy for Prevention of Postoperative Hypoxemia After Abdominal Surgery: A Multicenter Randomized Controlled Trial

acronym: OPERA

summary: To evaluate whether early application of nasal high flow oxygen therapy after extubation can reduce the incidence of postoperative hypoxemia (defined as a PaO2/FiO2 ratio <300) after abdominal surgery in patients with intermediate to high risk of postoperative pulmonary complications.

ReferenceCitation: Futier E, Paugam-Burtz C, Godet T, Khoy-Ear L, Rozencwajg S, Delay JM, Verzilli D, Dupuis J, Chanques G, Bazin JE, Constantin JM, Pereira B, Jaber S; OPERA study investigators. Effect of early postextubation high-flow nasal cannula vs conventional oxygen therapy on hypoxaemia in patients after major abdominal surgery: a French multicentre randomised controlled trial (OPERA). Intensive Care Med. 2016 Dec;42(12):1888-1898. doi: 10.1007/s00134-016-4594-y. Epub 2016 Oct 22.

family: Futier

full_name: Emmanuel Futier

given: Emmanuel

family: Paugam-Burtz

full_name: Catherine Paugam-Burtz

given: Catherine

family: Godet

full_name: Thomas Godet

given: Thomas

family: Khoy-Ear

full_name: Linda Khoy-Ear

given: Linda

family: Rozencwajg

full_name: Sacha Rozencwajg

given: Sacha

family: Delay

full_name: Jean-Marc Delay

given: Jean-Marc

family: Verzilli

full_name: Daniel Verzilli

given: Daniel

family: Dupuis

full_name: Jeremie Dupuis

given: Jeremie

family: Chanques

full_name: Gerald Chanques

given: Gerald

family: Jaber

full_name: Samir Jaber

given: Samir

journal_name: Intensive Care Medicine

oa_host_type: repository

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Savoie Mont Blanc

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Sorbonne Paris Nord

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

ReferenceCitation: Futier E, Paugam-Burtz C, Constantin JM, Pereira B, Jaber S. The OPERA trial - comparison of early nasal high flow oxygen therapy with standard care for prevention of postoperative hypoxemia after abdominal surgery: study protocol for a multicenter randomized controlled trial. Trials. 2013 Oct 18;14:341. doi: 10.1186/1745-6215-14-341.


title: 4-10 Week Observational Study Comparing 3 Management Strategies for Obstructive Chronic BronchoPneumopathy (OCBP) in Common Clinical Practice

acronym: OBALPA

summary:
The management of patients with Obstructive Chronic BronchoPneumopathy (OCBP) is based on a progression of therapeutic options and on a sensitization to physical activity.

For these patients selected on OCBP stage 2, the treatment options include Long Acting Beta-Agonist Bronchodilator (LABA) or Long Acting Muscarinic Antagonist Anticholinergic (LAMA) or both (LAMA+LABA).

The purpose of this study is to observe in common clinical practice the benefit of physical activity on quality of life, dyspnoea and walking distance for these patients under treatment (LABA and/or LAMA) and to determine whether these 3 medical strategies (LABA/LAMA/LABA+LAMA) benefit from physical activity.

lead_sponsor: Hospices Civils de Lyon


title: Evaluation of a Distraction-rotation Knee Unloader Brace in Patients With Medial Knee Osteoarthritis.

acronym: ORFEVRE

summary: The aim of this study is to confirm the biomechanical effects and evaluate functional benefits of a new knee brace combining valgus inducing effect on medial compartment and leg external rotation during the stance phase in patients with symptomatic medial knee osteoarthritis.

lead_sponsor: Centre Hospitalier Universitaire Dijon