title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Ralinepag When Added to PAH Standard of Care or PAH Specific Background Therapy in Subjects With WHO Group 1 PAH

summary: Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.

lead_sponsor: United Therapeutics

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Romania
Czechia
Poland
Portugal
Austria
Australia
Argentina
Israel
Turkey
Mexico
Singapore
Sweden
Brazil
Canada
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Greece
Korea, Republic of
France
Chile
Netherlands

location_facility: Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran

location_facility: University General Hospital of Alexandroupolis

location_facility: Clinical Center Zemun. Clinic for internal medicine, Department of Cardiology

location_facility: Washington University School of Medicine

location_facility: SMBD Jewish General Hospital d/b/a Jewish General Hospital

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35

location_facility: Hospital Clinic de Barcelona, C/ Villarroel, 170

location_facility: CHU de Strasbourg - Nouvel Hôpital Civil, Ctre de competence Hypertension Arterielle Pulmona, 1 place de l Hopital

location_facility: Hospital PROVINCIAL "Dr. Jose Maria Cullen"

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: AHEPA General Hospital of Thessaloniki, A' Cardiology Clinic, 1 St. Kyriakidi Street

location_facility: Clinical Center of Serbia, Koste Todorovica 8

location_facility: Sentara Cardiovascular Research Institute

location_facility: Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa

location_facility: Ordensklinikum Linz GmbH - Elisabethinen, Fadingerstrasse 1

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia, S.C. di Cardiologia, Viale Luigi Pinto, 1

location_facility: AKH Wien, Innere Med. II, Kardiologie, Währingergürtel 18-20

location_facility: Clinical Hospital Dubrava Zagreb, Avenija G.Šuška 6

location_facility: Instituto Nacional de Cardiologia Dr Ignacio Chavez Rivera

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: Medical College of Wisconsin/Froedtert Hospital

location_facility: Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

location_facility: Unidad de Investigacion Clinica en Medicina, S.C.

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust, Sir William Leech Lung Research Centre, Freeman Hospital

location_facility: MHAT - "National Heart Hospital" EAD, 65, Konyovitza Str.

location_facility: Institutul Inimii "Niculae Stancioiu" Cluj-Napoca, Cardiologie, Str. Motilor nr. 19-21

location_facility: CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel, Service de Pneumologie, 59 Boulevard Pinel

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Oddzial Kardiologii - F, ul. Dluga 1/2

location_facility: Premium Clinic Wrocław CM, Podwale 83/17

location_facility: Weill-Cornell-New York Presbyterian Hospital

location_facility: Centro Hospitalar e Universitário de Coimbra, E.P.E.

location_facility: Universitaetsmedizin der Johannes-Gutenberg-Universitaet Mainz, Zentrum für Kardiologie I, Centrum für Thrombose und Hämostase (CTH), Langenbeckstrasse 1

location_facility: Uludag Universitesi Tip Fakültesi, Gorukle Kampusu

location_facility: Hospital Universitari Vall d'Hebron, Respiratory Dept., Passeig Vall d'Hebron,119-129, Neumologia

location_facility: Gachon University Hospital Gil Medical Center

location_facility: VA Greater Los Angeles Healthcare System

location_facility: Institute for Pulmonary Diseases of Vojvodina, Put Dr Goldmana 4

location_facility: Tel Aviv Sourasky Medical Center, 6 Weizmann St.

location_facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, Viale del Policlinico, 155

location_facility: CHU de Brest - Hôpital de la Cavale Blanche

location_facility: Piedmont Healthcare Pulmonary and Critical Care Research

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: Universitätsklinikum Leipzig, Medizinische Klinik II, Pneumologie

location_facility: University Health Network-Toronto General Hospital

location_facility: CHU Nancy - Hôpital de Brabois Adultes, Pneumologie- Oncologie Médicale, Rue du Morvan

location_facility: UZ Leuven, UZ Leuven Campus Gasthuisberg, Herestraat 49

location_facility: Hospital Privado Centro Medico de Cordoba S.A

location_facility: Institutul de Pneumoftiziologie "Marius Nasta", Sos. Viilor nr. 90, Sector 5

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II, Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego, Pradnicka 80

location_facility: Meir Medical Center, 59 Tshernichovski st.

location_facility: CE Dniprop RCC&C Center of Dniprop RC Dept of Card SI DMA of MOHU, Chair of Internal Medicine 3, 28, Knyazya Volodymyra Velykogo St.

location_facility: Communal Noncommercial Enterprise of Lviv Regional Council Lviv Clinical Hospital, Dept of Cardiology, D.Halytskyi Lviv NMU, Ch of Internal Medicine #1, 7, Chernihivska str.

location_facility: Royal Free London NHS Foundation Trust, Pond Street

location_facility: Hadassah Ein Kerem Medical Center, Kiryat Hadassah

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme

location_facility: Centro Hospitalar Universitário Lisboa Norte, E.P.E. Hospital Pulido Valente

location_facility: University Clinic for Pulmonary Diseases, Jordanovac 104

location_facility: The Ohio State University Wexner Medical Center

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: SI F.H.Yanovskyi National Institute of Phthisiology and Pulmonology of NAMSU, Clinical and Functional Dept, 10, Amosova St.

location_facility: Beijing Shijitan Hospital, Capital Medical University

location_facility: Fuwai Hospital, Chinese Academy of Medical Sciences

location_facility: Pecsi Tudomanyegyetem, Szivgyogyaszati Klinika, Ifjusag u. 13.

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Kardiologii z Oddzialem Intensywnego Nazdoru Kardiologicznego, M. Sklodowskiej 24a

location_facility: Copenhagen University Hospital (Rigshospitalet)

location_facility: Groupement Hospitalier Sud - Hôpital Bicêtre

location_facility: University of Iowa Hospitals and Clinics

location_facility: Institutul de Urgenta pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu", Sos. Fundeni nr. 258

location_facility: Thoraxklinik-Heidelberg Zentrum für Pulmonale Hypertonie

location_facility: HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás

location_facility: Marmara Universitesi Istanbul Pendik Egitim ve Arastirma Hastanesi, Fevzi Cakmak Mahallesi Muhsin Yazicioglu Cad. No: 10

location_facility: Dokuz Eylul Universitesi Tip Fakultesi, Mithatpasa caddesi Inciralti Balcova

location_facility: "Onasseio" Cardiosurgery Hospital, Hemodynamic Research and Interventional Cardiology Dept., 356, Syggrou Avenue

location_facility: Vseobecna fakultni nemocnice v Praze, II. interni klinika kardiologie a angiologie VFN a 1. LF UK, U nemocnice 2

location_facility: Universitaetsklinikum des Saarlandes, Innere Medizin V, IMED, Kirrberger Strasse 100, Gebäude 41

location_facility: University of Cincinnati-Medical Science Building

location_facility: University of California Davis Medical Center

location_facility: The Lady Davis Carmel Medical Center, 7 Michal st.

location_facility: The Methodist Hospital Research Institute

location_facility: Xiangya Hospital Central South University

location_facility: Spitalul Clinic de Boli Infectioase si Pneumoftiziologie "Dr. Victor Babes" Timisoara, Str. Gheorghe Adam nr. 13

location_facility: UNESP-Faculdade de Medicina da Universidade Estadual Paulista Campus Botucatu

location_facility: Rabin Medical Center-Beilinson Campus, Pulmonary Institute, 39 Jabotinsky St Ground floor

location_facility: NZOZ Europejskie Centrum Zdrowia, ul. Borowa 14/18

location_facility: CHU de Saint-Etienne - Hopital Nord, Service de Medecine vasculaire et therapeutique, 81 Avenue A. Raimond

location_facility: CHU de Grenoble - Hôpital Albert Michallon, Clinique de Cardiologie, Boulevrad de la Chantourne


title: Agreement Among Expert Radiologists in Diagnosing Primary Liver Tumors by Magnetic Resonance Imaging (MRI) in Non-Cirrhotic Patients - A Double Blind International Multicenter Study

acronym: MRevaluation

summary: The purpose of this multicenter study is to evaluate the agreement among expert radiologists in interpreting magnetic resonance images (MRI) assessing common primary liver tumours in non-cirrhotic patients.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

lead_sponsor: University of Zurich

location_country:
United Kingdom
New Zealand
Switzerland
United States
France
Germany

location_facility: Harvard Medical School, Massachusetts General Hospital, and Beth Israel Deaconess Medical Center

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: University Hospital Zurich, Department of Visceral and Transplant Surgery, Swiss Hepato-Pancreato-Biliary (HPB) Center

location_facility: University Hospital Zurich, Department of Interventional and Diagnostic Radiology

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: ORCHESTRA WP2 - Follow-up of Covid-19 Long Term Sequelae

summary:
The protocol, in accordance with the objectives of ORCHESTRA project - Work Package 2, aims at investigating the characteristics and determinants of COVID-19 long-term sequelae. This goal will be reached through the harmonization of follow-up strategies across the participating cohorts to allow a standardized collection of data on COVID-19 long-term sequelae. The result will be a platform including a set of data and biomaterials from large scale international cohorts, that will be uniformly recorded, prospectively tracked and analysed. The ultimate goal will be that of providing evidence to contribute to the optimization and improvement of the management and prevention of COVID-19 sequelae.

The follow-up will be organized in multiple levels of tests, according to the capability of each cohort, and will include questionnaires to collect demographic, epidemiological and clinical data, physical examination, radiological exams and biological sampling. The long-term follow-up will also allow the assessment of long-term immunological response to SARS-CoV-2 infection and its association to the vaccination and to different treatment strategies, including monoclonal antibodies.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: Undecided

location_country: Spain Congo Italy France Belgium Netherlands

location_facility: Fondation Congolaise pour la Recherche Médicale

location_facility: University of Antwerp - Laboratory of Medical Microbiology

location_facility: Hosp. Univ. Virgen Macarena / Universidad de Sevilla

location_facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

status_simplified: Ongoing


title: Efficacy of ADW S-100 Ionized Water Nasal Spray in Decreasing Symptoms of Allergic Rhinitis: Randomized, Double-blind, Placebo-controlled Trial

acronym: SPRA

summary:
A nasal spray based on Advanced Water S-100 ionized water would clean the nasal cavities, reduce the viscosity of mucus and facilitate its elimination and decongestion of the nose and the prevention of the bridging of the allergen to the epithelial cells of the cavity nose at the origin of the onset of symptoms.

Indeed, a water-based nasal spray ionized Advanced Water S-100 would modify the electrostatic environment of all the interactions ensuring this bridging. Negative ions (OH-) contained in water ionized Advanced Water S-100 competes with negative ions from acids negatively charged amino acids and also neutralize basic amino acids positively charged. The destabilization of all the links governing the process of epitope/IgE association would prevent the bridging of the FcɛRI receptors of the mast cell and thus the cascade of cellular responses that cause symptoms.

The purpose of this study is to assess whether the use of ionized water nasal spray ADW S-100 allows to sufficiently reduce the intensity of the symptoms of allergic rhinitis and thus improve the quality of life of people with allergies.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: P & B Group

location_facility:
Alyatec
CHU Montpellier
CHR Metz-Thionville
Cabinet libéral
Cabinet Libéral
Hôpital Saint Vincent

intervention_type: Device

lead_sponsor_type: industriel


title: Biomarkers Predictive of Thymic Evolution and Therapeutic Response at 2 Years in Patients With a First Psychotic Episode

acronym: PEPAMARKER

summary:
Psychosis is a severe, common, and disabling psychological disorder. An epidemiological study conducted in England reported an incidence of 34 new cases per 100,000 person-years, with a peak between 16 and 19 years of age. Following a first psychotic episode, two clinical evolutions are possible: thymic psychosis (17%) and non thymic psychosis (83%). The first includes bipolar disorders with a psychotic component and major depressive disorders with a psychotic component; the second, other psychotic disorders, mainly schizophrenia. One of the major difficulties encountered is the frequent impossibility of specifying the type of psychosis at the beginning of the psychotic episode. However, these disorders require different therapies, particularly medication. This leads to a delay in diagnosis with a high risk of relapse.

The semiological study of these diseases being carried out within the framework of interviews, it seems interesting to be able to record these and to obtain a quantitative and objective measurement through the study of language. The use of machine learning has made it possible to distinguish patients with schizophrenia from those with bipolar disorder by graphical analysis of language in a more efficient way than with clinical scales.Moreover, it is possible to identify linguistic markers: thus, an alteration of syntactic structures and prosody would be more present in non-thymic than in thymic psychoses.

Paraclinical markers are also emerging. In particular, the link between inflammation and mental disorders.For example, an increase in IL-8 has been found only in thymic psychoses.

At the radiological level, distinct changes in the volume of grey matter have been shown between thymic and nonthymic psychoses.

In this context, it seems essential to be able to distinguish these disorders as early as possible through the combined use of clinical and paraclinical markers, and to be able to better understand their pathophysiology.

study_start_date_type: Anticipated

status: Not yet recruiting

primary_purpose: Diagnostic

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
Dr Anne SAUVAGET
Dr Sonia MARSELLA
Dr Dominique DRAPIER
Dr Florian STEPHAN
Dr Vincent CAMUS
Dr Bénédicte GOHIER

intervention_type: Biological


title: Evaluation of the Safety and Performance of SYMATESE AESTHETICS ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants in the Breast Augmentation, Primary Intention (EMMA Study)

acronym: EMMA

summary:
The purpose of this study is to collect clinical data to evaluate the safety and performance of ESTYME® MATRIX Round microtextured breast implants in patients who receive these silicone gel-filled implants as part of their breast augmentation surgery in primary intention. This study also aims to measure patient and surgeon satisfaction.

An initial study of all ESTYME® MATRIX implants was conducted between 2018 and 2021. The purpose of the current EMMA study is to complete the data from this first study on a larger number of implants, and only on the ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants range for primary intention breast augmentation, with a view to obtaining marketing authorization (CE marking).

primary_purpose: Other

ipd_sharing: No

lead_sponsor: Symatese Aesthetics

location_facility: Clinique du Rond Point des Champs Elysées


title: Nivolumab and Ipilimumab in Patients With dMMR and/or MSI Metastatic Colorectal Cancer Resistant to Anti-PD1 Monotherapy: An Open-label Phase II GERCOR Trial

acronym: NIPIRESCUE

summary: NIPIRESCUE is a national, single-arm, open-label phase II study. The study aims to evaluate the clinical activity of nivolumab and ipilimumab in patients with MSI/dMMR mCRC resistant to anti-PD1 monotherapy and previously treated with fluoropyrimidine, oxaliplatine, irinotecan, and anti- vascular endothelial growth factor (VEGF) or anti- epidermal growth factor receptor (EGFR) therapy.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
ICM Val d'Aurelle
CHU Jean Minjoz
Hôpital Saint Antoine
CHU Poitiers
Centre Léon Bérard
CHRU Lille

intervention_type: Drug


type: Registry Identifier

type: Other Identifier

title: Intérêt du méchage Pour la Chirurgie Ossiculaire et la Myringoplastie : Essai contrôlé randomisé Multicentrique de Non-infériorité

acronym: MECH-ORL

summary: Myringoplasties and ossicular surgery are very common procedures. Following these otological surgeries, most surgeons install a wicking. This intervention consists of placing a wick, absorbable or not, in the external acoustic meatus, after having replaced the tympanomeatal flap.

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Tours

location_facility:
Hospital La Pitié Salpêtrière-APHP
University Hospital TOURS
University Hospital BREST
Hospital Blois
Hospital Le Mans
University Hospital NANTES

intervention_type: Procedure


title: ANRS EP69 BICTEVOIR : A Prospective Study to Determine the Cartography of Virologic Reservoir Related to Antiretroviral Concentrations in HIV-1 Chronic Patients Treated by a First Line Treatment Containing bictégravir, Emtricitabine and ténofovir alafénamide

summary: The main objective of the study is to evaluate the diffusion of bictegravir and associated backbone (tenofovir alafenamide and emtricitabine) in HIV-1 chronic patients in the main putative reservoirs, namely inguinal lymph nodes, rectal, fat tissues and sperm.

primary_purpose: Basic Science

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility:
Necker Hospital
Antoine-Beclere Hospita
Pitie Salpetriere Hospital
Hotel Dieu Hospital
Bicetre Hospital
Saint Antoine Hospital


title: Determinants of Daily Physical Activity Level in Patients With Cystic Fibrosis - Pilot Study. Protocol

acronym: APM

summary: The aim of the study is to analyze the determinants (barriers and facilitators) of the daily physical activity level in a population of patients with cystic fibrosis. A population of patients will be included in order to realize an assessment of their daily physical activity level over an entire week. A specific questionnaire, designed from 3 different questionnaires, will be associated to the physical activity evaluation and will allow to asses psycho-social and environmental factors.

lead_sponsor: University Hospital, Limoges

location_facility: CHU DE BORDEAUX Hôpital des Enfants-Pellegrin - CRCM Pédiatrique

location_facility: CHU DE BORDEAUX Hôpital Haut-Lévêque - CRCM Adulte

location_facility: CHU DE LIMOGES Hôpital Dupuytren 2 - CRCM Adulte

location_facility: CHU DE LIMOGES Hôpital Mère Enfant - CRCM Pédiatrique

location_facility: CHU DE TOULOUSE Hôpital des Enfants - CRCM Pédiatrique

location_facility: CHU DE TOULOUSE Hôpital Larrey - CRCM Adulte


title: Flow Cytometric Analysis of Peripheral Blood Neutrophil Myeloperoxidase Expression for Ruling Out Myelodysplastic Syndromes: Protocol for a Diagnostic Accuracy Study

acronym: MPO-MDS-Valid

summary:
Myelodysplastic syndromes (MDS) are clonal bone marrow neoplasms characterized by dysplasia and ineffective hematopoiesis leading to peripheral blood cytopenias, with an increased risk of progression to acute myeloid leukemia. The conventional diagnostic work-up of MDS relies on cytomorphological evaluation of bone marrow, which may be complemented by conventional cytogenetic, flow cytometry, and molecular analysis by next generation sequencing techniques.

Suspicion of MDS is the commonest reason for bone marrow aspirate in older patients with unexplained peripheral blood cytopenias. Yet many patients are exposed to unnecessary bone marrow aspiration-related discomfort and harms, because of the limited prevalence of disease among subjects referred for suspected MDS. In this context, a valid and reliable assay based on peripheral blood sample that accurately discriminates MDS from other cytopenia etiologies without requiring invasive bone marrow aspiration is warranted.

The accuracy of peripheral blood neutrophil myeloperoxidase expression quantified by flow cytometric analysis for the diagnosis of MDS is supported by three primary studies totaling 211 individuals. An intra-individual robust coefficient of variation (RCV) value for neutrophil myeloperoxidase expression lower than 30.0% accurately ruled out MDS, with both sensitivity and negative predictive value point estimates of 100%, in consecutive patients with suspected disease. This biomarker might obviate the need for cytomorphological evaluation of bone marrow aspirate for up to 35% of patients referred for suspected MDS. Although promising, these preliminary results require replication in an independent external validation sample.

The broad aim of the multicenter MPO-MDS-Valid study project is to prospectively validate the diagnostic accuracy of intra-individual RCV for peripheral blood neutrophil myeloperoxidase expression quantified by flow cytometric analysis among consecutive patients referred for suspected MDS.

time_perspective: Cross-Sectional

ipd_sharing_description: The principal investigator will respond directly to data requests by providing a de-identified data set. Individual participant data that underlie the results reported in the published articles (i.e., main text, tables, figures, and appendices) will be supplied.

lead_sponsor: University Hospital, Grenoble

location_facility:
Institut Paoli Calmettes
University Hospital, Clermont-Ferrand
University Hospital Lyon Sud, HCL
Grenoble_Alpes UniversityHospital
University Hospital Saint-Eloi
University Hospital, Saint-Étienne

intervention_type: Diagnostic Test


title: A Prospective, Multi-Center, Single Arm, Feasibility Study to Evaluate the DAISe Thrombectomy System During Neurointervention for Acute Ischemic Stroke; DAISe 1 Study

summary: The study is a prospective, multi-center, single arm, feasibility study that will enroll a maximum of 36 subjects. The maximum enrollment is 10 subjects per site. A maximum of 6 investigational centers in Europe will participate. Enrollment is expected to take about 9 months, subject participation will last about 3 months.

lead_sponsor: MIVI Neuroscience, Inc.

location_facility:
CHU Bicetre Paris
Groupe Hospitalier Pitie-Salpetriere
CHU Pellegrin
CHU Montpellier
CHU Urbains
Hôpital Purpan


title: Simplified Bowel Preparation Versus Standard Bowel Preparation Before Capsule Endoscopy in Patients With Crohn's Disease: a Prospective Randomized Controlled Multicenter Study

acronym: CROHN-PREP

summary:
The European guidelines currently recommend to use 2 L of polyethylene glycol and free residue diet before any capsule endoscopy. However, up to now, no studies have been conducted to specifically evaluate bowel preparation modalities before small bowel capsule endoscopy in patients with Crohn's disease.

In patients with Crohn's disease and small bowel ulcers, polyethylene glycol may remove some fibrin from these ulcers and alter bowel preparation. Moreover, it is important to select the most acceptable bowel preparation because patients with Crohn's disease will have to repeat capsule endoscopy several times after initiating treatment, for monitoring under treatment, or for detection of post-operative recurrence.

In a preliminary retrospective study, it has been suggested that a simplified bowel preparation with liquid diet the evening before and water on the morning of the capsule endoscopy induced a better bowel preparation than the standard method with polyethylene glycol.

Thus, the aim of the study is to demonstrate the superiority of this simplified bowel preparation compared to the standard preparation modality in terms of quality of bowel preparation, patient's acceptability and diagnostic yield.

lead_sponsor: Nantes University Hospital

location_facility:
Vendée departmental hospital
Brest University hospital
Rennes University hospital
Cholet hospital
Angers University Hospital
Nantes University Hospital


title: Towards an Algorithmic Approach to Asthma Management: Collaborative Definition of Algorithm Objectives With Families

acronym: COPA

summary:
Using "big data" and artificial intelligence techniques, it becomes possible to envision algorithms for managing childhood asthma on a daily basis.

In order to develop such tools, it is necessary to determine with asthma stakeholders (children, parents, doctors) the parameters that future algorithms should seek to maximize / minimize.

The main objective of the study is to quantify the respective importance of each of the goals that children with asthma, parents, and their doctors seek to achieve when taking / supervising / prescribing a background therapy.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


type: EudraCT Number

title: Targeting ATR in Soft-tissue Sarcomas: a Randomized Phase II Study. TARSARC Study

acronym: TARSARC

summary: Multicenter, prospective, open-labeled, 2-arm, non-comparative randomized phase II trial to assess the antitumor activity of berzosertib in association with gemcitabine

lead_sponsor: Institut Bergonié

location_facility:
Institut Bergonié
IUCT Oncopôle
CHU Poitiers
Institut de Cancérologie de l'Ouest
Institut Gustave Roussy
Centre Leon Berard


title: Development of Predictive Indicators of Homogeneous Propagation of Ultrasound and Elastic Waves During VCTE Examination

summary: This is an European, prospective, interventional, and multicenter exploratory clinical investigation that will take place in 6 French sites and 200 patients will be included (adults and children). The study objective is to develop predictive indicators of homogeneous propagation of ultrasound and elastic waves to define an optimal region of interest for the measurement of liver stiffness during VCTE examination.

lead_sponsor: Echosens

location_facility:
CHU d'Amiens
CHU de Nice
CHU d'Angers
Hôpital Saint Eloi
CHU de Lille
CHU de Nancy


title: Performance Evaluation of a 3D PSIR Sequence in MRI at 1.5T in the Detection and Characterization of Spinal Cord Injuries in Patients With Multiple Sclerosis

summary:
Inclusion visit (D0):

verification of inclusion and non-inclusion criteria
information and collection of consent
standard imaging protocol prescribed as part of the usual treatment: sagittal T1 and T2 slices after injection of contrast product (Gadolinium), o 3D STIR sequence.
3D PSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 45 minutes (instead of 35 minutes).

location_facility: Fondation Ophtalmologique Adolphe de Rothschild (FOR)


title: e-SEP Cognition: Effectiveness of a Remediation Program Via a "Serious Game" on the Cognitive Functions of Multiple Sclerosis Patients: Controlled, Randomized, Multicentric Trial

acronym: E-SEP

summary: The main goal of this study is to assess the effectiveness of a cognitive remediation program based on a "serious game" on the information processing speed evolution and the process of learning via episodic memory in multiple sclerosis patients.

lead_sponsor: Lille Catholic University

location_facility:
CH d'Arras
CHRU
Saint Vincent hospital
Charles Nicolle Hospital
CHU Amiens-Picardie
Saint-Philibert hospital


title: Acceptability Assessment of an "Organization of Care Integrating Artificial Intelligence and a Solution of Telemedicine" on Care of the Nursing Home Residents Located in a Medical Desert: Pilot Study INTEL@MED-POC

summary: While depend elderly people needs are important in Nursing Home, the medical resources are weak from both inside and outside residences located in a medical desert. The goal of this project is to measure the acceptability of Artificial Intelligence and Telemedicine in Nursing Home located in medical desert for patients, nurses, and medical doctor

primary_purpose: Prevention

location_facility:
EHPAD Le Bois Joli
EHPAD La Porte d'Aquitaine
EHPAD Ernest Coulaud
EHPAD Le Chant des Rivières
EHPAD J et M Colaud
Ehpad Le Chavanon


title: Safety and Efficiency of the YEARS Algorithm Versus Computed Tomography Pulmonary Angiography Alone for Suspected Pulmonary Embolism in Patients With Malignancy : HYDRA Study

acronym: HYDRA

summary: The aim of this study is to prospectively validate the safety and efficiency of management according to the YEARS algorithm to safely rule out clinically suspected PE in patients with active malignancy to be compared with 'standard' management by computed tomography pulmonary angiography (CTPA) alone in a randomized study.

location_facility:
CHU Clermont-Ferrand
CHU Saint-Etienne
CHU Angers
CHRU Brest
Hôpital Louis Mourier - APHP
HEGP


title: Evaluation of the Activating Consciousness Technique (Hypnosis) in Anxiety in a General Practice

acronym: MG HYPNOSIS

summary:
Anxiety is an emotion considered unpleasant but resulting from a normal phenomenon. It corresponds to an adaptive response to events, to stress and helps to ensure our survival.

On the other hand, it becomes embarrassing when it becomes uncontrollable. It can even lead to interfere with activities of daily living. Thus, we can speak of anxiety disorder.

Anxiety disorders are among the most prevalent psychiatric disorders. They are often associated with other comorbidities such as depression, which makes them more difficult to treat and diagnose.

Different treatments are offered to best treat the patient with anxiety : drug treatment (antidepressants, anxiolytics) ; non-drug (psychotherapy, meditation, cognitive behavioral therapies).

The emergence of hypnosis in medical practice in recent years seems to be a technique that can bring benefits to the patient.

A review of clinical studies does not seem to find a benefit to hypnosis in anxiety disorders. In contrast, a study in children with school phobia showed the effectiveness of hypnosis. The limits addressed by this review seem to relate to the number of people included in the studies. Contrariwise, it has been pointed out that hypnosis can have a beneficial effect in the long term.

Thus, it seems interesting to deepen this technique in the practice of a general practitioner exercising the activating consciousness technique in anxiety.

The study will be composed of patients presenting with anxiety and consulting their general practitioner, with: Group 1, patients consulting a doctor not practicing hypnosis Versus Group 2, patients consulting a doctor practicing hypnosis.

During the first consultation and the following 2 consultations scheduled by the general practitioner (spaced 15 days apart), the following data are noted, in addition to the monitoring usually performed by the doctor:

COVI scale
Comfort scale 0 to 10
Management: drugs, TAC, others
Quality of life survey SF36 Patients will be called back at 6 months to reassess quality of life (self-administered survey SF 36) The primary endpoint is to evaluated the change of anxiety from inclusion (J0) to 6 months using COVI scale in the two different groups.

For secondary endpoints, the consumption of drug medicine will be quantified and the quality of life will be measured using Quality of life survey SF36.

ReferenceType: background

ReferenceCitation: Pelissolo A. [Hypnosis for anxiety and phobic disorders: A review of clinical studies]. Presse Med. 2016 Mar;45(3):284-90. doi: 10.1016/j.lpm.2015.12.002. Epub 2016 Mar 2. Review. French.

lead_sponsor: Hospices Civils de Lyon

location_facility:
Dr Christian SAINT-CYR
Dr Céline HUMBERT
Dr Aurélien BARADEL
Dr Matthieu DEMOURGUES
Dr Stéphane FOLACHER
Dr Maud BINARD

intervention_type: Behavioral


title: PETRA: PErtuzumab and Trastuzumab Biosimilars Real Life Association for the First Line Treatment of HER2-positive Metastatic Breast Cancer, an Observational Prospective Multicenter Study

acronym: PETRA

summary:
Currently there are five trastuzumab biosimilars approved by EMA (Ogivri® Mylan , Herzuma® Biogaran, Ontruzant® MSD, Trazimera® Pfizer, and Kanjinti® Amgen) for the treatment of HER2-positive breast cancer. EMA's approvals were obtained on phase I pharmacokinetic equivalence trials and phase III clinical trials based on efficacy primary endpoints in the neoadjuvant setting and on Overall Response Rate in metastatic setting. Safety was a secondary endpoints in these trials.

Phase III pivotal trials compared trastuzumab biosimilars to Herceptin® in combination with chemotherapy in the neoadjuvant setting and in the metastatic setting. The trials were designed before the approval of pertuzumab (in the neoadjuvant and metastatic settings). Thus, there is no available prospective data on the safety and efficacy of trastuzumab biosimilars in combination with pertuzumab.

A biosimilar compound can obtain an extrapolation of its indications to those of the reference biological product since bio-similarity has been demonstrated (ie pharmacokinetic equivalence and clinical studies in the most "sensitive" indications). To date, the use of trastuzumab biosimilar in combination with pertuzumab is allowed, but this combination is not supported by neither scientific evidence nor clinical guidelines.

PETRA aims at evaluate the efficacy and safety of the combination of pertuzumab and a trastuzumab biosimilar in real life.

location_facility: Centre de lutte contre le Cancer JEAN PERRIN, CLERMONT-FERRAND


title: The Integrated Support and Palliative in Cancer Day-care Hospital for Patients With Advanced Cancers: Impact on Quality of Life, Care Pathways and Support for Caregivers

summary: The main objective is to show the impact on the quality of life (QoL) for adults patients with advanced cancer managed in day hospital of integrated palliative care of cancer center (HDJ-SPI).

ReferenceType: derived

ReferenceCitation: Thery L, Anota A, Waechter L, Laouisset C, Marchal T, Burnod A, Angellier E, Djoumakh OEK, Thebaut C, Brédart A, Dolbeault S, Mino JC, Bouleuc C. Palliative care in day-hospital for advanced cancer patients: a study protocol for a multicentre randomized controlled trial. BMC Palliat Care. 2021 Apr 17;20(1):61. doi: 10.1186/s12904-021-00754-x.

lead_sponsor: Institut Curie

location_facility:
Institut Bergonie
Institut de Cancerologie de L'Ouest
Centre Paul Strauss
Centre Antoine Lacassagne
INSTITUT CURIE Saint-Cloud
Institutcurie Paris


title: Identification of Outcome Predictors and Stratification of Responder Profiles Implanted With Spinal Cord Stimulation. An AI-based-pathway & Algorithmic Approach to Treat Failed Back Surgery Syndrome Patients

acronym: PREDIBACK 2

summary:
Failed Back Surgery Syndrome is commonly defined as new, recurrent, or persistent pain in the back and/or leg(s) of at least 6-month duration following spinal surgery. The literature estimates that 10-50% of patients undergoing spinal surgery are likely to develop such pain, representing a substantial financial burden. Among them, 5-10% would suffer from severe pain, which are intense, neuropathic and generally refractory to conventional therapeutic strategies considerably affect patients' functional capacity as well as their psychological and social well-being.

Spinal Cord Stimulation (SCS) is a well-established therapy to alleviate severe intractable neuropathic pain such as FBSS. SCS is a safe and reversible treatment option, which leads to improvement in pain relief and quality of life for patients with FBSS. Despite encouraging results in a chronic painful patient population that is refractory to conventional therapies, the literature estimates that only 58% [53% - 64%] of patients implanted with SCS devices achieved adequate pain relief.

FBSS population characterization and stratification and predictive modeling of SCS outcome are thus crucial to delineate future treatment options and to deliver neuromodulation therapy to the right patient.

The investigators designed a clinical prospective project based on SCS outcome optimization and SCS candidates' stratification: PREDIBACK 2.

This study would be a following part of a continuous project (PREDIBACK) that aims to better understand and stratify the therapies (drugs, surgery, psychological therapy or SCS) proposed to FBSS patients. The goal of PREDIBACK 1 was to develop a decision tool that simplifies the therapeutic decision process.

PREDIBACK 2 will focus on the neuromodulation pathway. Easing and helping patient orientation should improve referral yielding to specialists and accelerate patient flow through care pathway. Hence, facilitating access to adequate therapies for FBSS patients who usually have a longstanding history of pain.

primary_purpose: Screening

lead_sponsor: Poitiers University Hospital

location_facility: Nice University Hospital, Cimiez Hospital


title: Evaluation of the Impact of Wearing a Millimetre Wave Bracelet for 3 Months on the Frequency in Number of Days of Migraines in Patients With Episodic Migraines Without Aura

acronym: MISTIC

summary:
Migraine is a neurovascular disease whose prevalence is estimated at almost 20% of the adult population. Currently, there is no treatment for migraine.

Millimeter stimulation of the wrist subcutaneous receptors allows the release of endorphin in the brain.

MISTIC is a prospective, controlled, multicenter, double-blind, randomized study in which the research team are investigating whether millimeter stimulation of subcutaneous wrist receptors reduces the frequency of migraine crisis.

status: Active, not recruiting

lead_sponsor: Remedee SA

location_facility:
CHU Grenoble Alpes
Cabinet Saint Ismier
CH Voiron
CH Fondation Rotschild
Cabinet Mornant
Cabinet Neuralpes


title: Immunogénicité de la Vaccination Anti-pneumococcique Dans la leucémie aiguë et le Lymphome Chez l'Adulte

acronym: HEMATOVAC

summary: The French Public Health Council recommended pneumococcal vaccination combined strategy for all immunocompromised patients in 2012. This strategy consisted in conjugated 13-valent pneumococcal injection followed 2 months later by polysaccharide 23-valent vaccine injection. General practitioners are usually in charge of this vaccination. Conjugated pneumococcal vaccine enhances the immunogenicity of the polysaccharide vaccine. Acute leukemia and lymphoma are treated with multiple courses of chemotherapy, impairing the immune system and potentially the response to vaccination. These patients are more at risk for developing pneumococcal invasive diseases than the general population. However, efficacy of pneumococcal vaccination is poorly documented in this setting. We assume that 70% of the patients are non-responders to vaccination, according to their anti-pneumococcal immunoglobulin G titers and the opsonophagocytic activity. To assess the immunogenicity of the pneumococcal vaccination combined strategy in adult population of acute leukemia and lymphoma, the investigator will measure anti-pneumococcal serotype-specific immunoglobulin G titers and opsonophagocytic activity at different time-points after completion of the combined vaccine strategy. The primary objective is to assess the immunogenicity of pneumococcal vaccination combined strategy at 3 months after the 13-valent pneumococcal injection (corresponding to 1 month after the end of the combined strategy) using immunoglobulin G titers and opsonophagocytic activity. At different time points (day 0, 1 month after the 13-valent pneumococcal injection, the day of the injection of the polysaccharide 23-valent vaccine, one month after the injection of the polysaccharide 23-valent vaccine, 3-6 months after the polysaccharide 23-valent vaccine,9-12 months after the polysaccharide 23-valent vaccine), the immunological response to vaccination will be monitored using specific-serotype immunoglobulin G titers, opsonophagocytic activity, and total anti-pneumococcal Immunoglobulin. The investigator will determine predictive factors of non-response to vaccination by comparing demographic data, biological data and treatment received by both acute myeloblastic leukemia and lymphoma patients. The tolerance and safety of the vaccination strategy will also be assessed in this specific hematological population.

ipd_sharing_description: Undecided

location_facility:
CHU Tours
CHU Poitiers
CHU Bordeaux
CHU Limoges
Ch Perigueux
Chu Nantes


title: A Randomized, Open-labelled, Controlled Trial Evaluating the Efficacy of a Physical Therapy-yoga-patient Educational Program for Breast Cancer Patients With Pain Due to Hormonal Therapy Treatment.

summary:
As much as 50% of patients treated with hormonotherapy (HT) for breast cancer (BC) suffer from osteoarticular pain during treatment. Secondary effects have become a real issue because of their consequences on the patients' quality of life, but also on treatment efficacy and survival when they induce dose reduction or premature withdrawal of treatment.

Additional medicines (acupuncture, hypnosis, yoga) have become more and more popular these last years. 48 to 80% of patients with BC eventually choose them. A review comparing efficacy of various therapies to decrease osteoarticular pain concludes to a highest efficacy of anti-inflammatory treatments, paracetamol and yoga.

It thus appears innovative to complete this care with a patient educational project (PEP) in postural yoga instructed by a trained physical therapist, which will enable patients to practice yoga postures at home by themselves.

The investigators conducted a pilot study "SKYPE" with 24 algic patients treated with HT after BC, whose results are very promising.

The investigators now propose in the continuity of the pilot study a multicenter randomized controlled study comparing the efficacy of SKYPE care on pain reduction, an educative care combining physical therapy and yoga, to a control group in patients treated with HT for a BC with osteoarticular and/or musculoskeletal pain.

Furthermore, in order to examine whether yoga interventions may influence inflammation through their effects on the level of a wide range of pro- and anti-inflammatory cytokines (30), the investigators will Change in circulating cytokines' level between baseline level (T0) and post-treatment level (T2) in both groups will be analyzed and if so correlation will be established.

ReferenceCitation: Lintermans A, Van Asten K, Wildiers H, Laenen A, Paridaens R, Weltens C, Verhaeghe J, Vanderschueren D, Smeets A, Van Limbergen E, Leunen K, Christiaens MR, Neven P. A prospective assessment of musculoskeletal toxicity and loss of grip strength in breast cancer patients receiving adjuvant aromatase inhibitors and tamoxifen, and relation with BMI. Breast Cancer Res Treat. 2014 Jul;146(1):109-16. doi: 10.1007/s10549-014-2986-7. Epub 2014 May 11.

ReferenceCitation: Peppone LJ, Janelsins MC, Kamen C, Mohile SG, Sprod LK, Gewandter JS, Kirshner JJ, Gaur R, Ruzich J, Esparaz BT, Mustian KM. The effect of YOCAS©® yoga for musculoskeletal symptoms among breast cancer survivors on hormonal therapy. Breast Cancer Res Treat. 2015 Apr;150(3):597-604. doi: 10.1007/s10549-015-3351-1. Epub 2015 Mar 27.

ReferenceCitation: Crew KD, Greenlee H, Capodice J, Raptis G, Brafman L, Fuentes D, Sierra A, Hershman DL. Prevalence of joint symptoms in postmenopausal women taking aromatase inhibitors for early-stage breast cancer. J Clin Oncol. 2007 Sep 1;25(25):3877-83.

ReferenceCitation: Lyman GH, Greenlee H, Bohlke K, Bao T, DeMichele AM, Deng GE, Fouladbakhsh JM, Gil B, Hershman DL, Mansfield S, Mussallem DM, Mustian KM, Price E, Rafte S, Cohen L. Integrative Therapies During and After Breast Cancer Treatment: ASCO Endorsement of the SIO Clinical Practice Guideline. J Clin Oncol. 2018 Sep 1;36(25):2647-2655. doi: 10.1200/JCO.2018.79.2721. Epub 2018 Jun 11.

ReferenceCitation: Lombard JM, Zdenkowski N, Wells K, Beckmore C, Reaby L, Forbes JF, Chirgwin J. Aromatase inhibitor induced musculoskeletal syndrome: a significant problem with limited treatment options. Support Care Cancer. 2016 May;24(5):2139-2146. doi: 10.1007/s00520-015-3001-5. Epub 2015 Nov 10.

ReferenceCitation: Galantino ML, Desai K, Greene L, Demichele A, Stricker CT, Mao JJ. Impact of yoga on functional outcomes in breast cancer survivors with aromatase inhibitor-associated arthralgias. Integr Cancer Ther. 2012 Dec;11(4):313-20. doi: 10.1177/1534735411413270. Epub 2011 Jul 6.

ReferenceCitation: Sharma M, Lingam VC, Nahar VK. A systematic review of yoga interventions as integrative treatment in breast cancer. J Cancer Res Clin Oncol. 2016 Dec;142(12):2523-2540. Epub 2016 Sep 15. Review.

ReferenceCitation: Cramer H, Lauche R, Klose P, Lange S, Langhorst J, Dobos GJ. Yoga for improving health-related quality of life, mental health and cancer-related symptoms in women diagnosed with breast cancer. Cochrane Database Syst Rev. 2017 Jan 3;1:CD010802. doi: 10.1002/14651858.CD010802.pub2. Review.

ReferenceCitation: Kiecolt-Glaser JK, Bennett JM, Andridge R, Peng J, Shapiro CL, Malarkey WB, Emery CF, Layman R, Mrozek EE, Glaser R. Yoga's impact on inflammation, mood, and fatigue in breast cancer survivors: a randomized controlled trial. J Clin Oncol. 2014 Apr 1;32(10):1040-9. doi: 10.1200/JCO.2013.51.8860. Epub 2014 Jan 27.

ReferenceCitation: Chandwani KD, Perkins G, Nagendra HR, Raghuram NV, Spelman A, Nagarathna R, Johnson K, Fortier A, Arun B, Wei Q, Kirschbaum C, Haddad R, Morris GS, Scheetz J, Chaoul A, Cohen L. Randomized, controlled trial of yoga in women with breast cancer undergoing radiotherapy. J Clin Oncol. 2014 Apr 1;32(10):1058-65. doi: 10.1200/JCO.2012.48.2752. Epub 2014 Mar 3.

ReferenceCitation: Greenlee H, Balneaves LG, Carlson LE, Cohen M, Deng G, Hershman D, Mumber M, Perlmutter J, Seely D, Sen A, Zick SM, Tripathy D; Society for Integrative Oncology. Clinical practice guidelines on the use of integrative therapies as supportive care in patients treated for breast cancer. J Natl Cancer Inst Monogr. 2014 Nov;2014(50):346-58. doi: 10.1093/jncimonographs/lgu041. Review. Erratum in: J Natl Cancer Inst Monogr. 2015 May;2015(51):98.

ReferenceCitation: Olsson Möller U, Beck I, Rydén L, Malmström M. A comprehensive approach to rehabilitation interventions following breast cancer treatment - a systematic review of systematic reviews. BMC Cancer. 2019 May 20;19(1):472. doi: 10.1186/s12885-019-5648-7.

ReferenceCitation: Felson DT, Cummings SR. Aromatase inhibitors and the syndrome of arthralgias with estrogen deprivation. Arthritis Rheum. 2005 Sep;52(9):2594-8. Review.

ReferenceCitation: Bower JE, Irwin MR. Mind-body therapies and control of inflammatory biology: A descriptive review. Brain Behav Immun. 2016 Jan;51:1-11. doi: 10.1016/j.bbi.2015.06.012. Epub 2015 Jun 23. Review.

ReferenceCitation: Djalilova DM, Schulz PS, Berger AM, Case AJ, Kupzyk KA, Ross AC. Impact of Yoga on Inflammatory Biomarkers: A Systematic Review. Biol Res Nurs. 2019 Mar;21(2):198-209. doi: 10.1177/1099800418820162. Epub 2018 Dec 20.

ReferenceCitation: Bower JE, Greendale G, Crosswell AD, Garet D, Sternlieb B, Ganz PA, Irwin MR, Olmstead R, Arevalo J, Cole SW. Yoga reduces inflammatory signaling in fatigued breast cancer survivors: a randomized controlled trial. Psychoneuroendocrinology. 2014 May;43:20-9. doi: 10.1016/j.psyneuen.2014.01.019. Epub 2014 Jan 30.

ReferenceCitation: Long Parma D, Hughes DC, Ghosh S, Li R, Treviño-Whitaker RA, Ogden SM, Ramirez AG. Effects of six months of Yoga on inflammatory serum markers prognostic of recurrence risk in breast cancer survivors. Springerplus. 2015 Mar 26;4:143. doi: 10.1186/s40064-015-0912-z. eCollection 2015.

ReferenceCitation: Rao RM, Vadiraja HS, Nagaratna R, Gopinath KS, Patil S, Diwakar RB, Shahsidhara HP, Ajaikumar BS, Nagendra HR. Effect of Yoga on Sleep Quality and Neuroendocrine Immune Response in Metastatic Breast Cancer Patients. Indian J Palliat Care. 2017 Jul-Sep;23(3):253-260. doi: 10.4103/IJPC.IJPC_102_17.

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

location_facility:
Institut du sein Basque
CH Libourne
Insitut de Cancérologie de Lorraine
Icm Val D'Aurelle
Institut de Cancérologie de l'Ouest
CHU Nîmes


title: French Validation Study of a New Scale for Neuropsychiatric Fluctuations in Parkinson Disease

acronym: EFN-VALID

summary: Neuropsychiatric fluctuations (NF) are among the most disabling non motor fluctuations in Parkinson disease (PD). The investigators developed the NF-scale for acute assessment of non-motor neuropsychiatric fluctuations between the off- and on-medication conditions in PD. The main goal of this project is to validate the NF-scale in french language in a multicenter approach.

location_facility:
CHU Clermont-Ferrand
CHRU Strasbourg
CHU de Bordeaux-Hôpital Pellegrin
Hospices Civils Lyon (HCL)
CHU Amiens
University hospital grenoble


title: Evaluation of a Transfusion Therapy Using Whole Blood Versus Fractionated Blood Products in the Management of Coagulopathy in Patients Admitted to Hospital for Acute Traumatic Hemorrhage

acronym: T-STORHM

summary:
The prognosis of traumatized hemorrhages is correlated with the nature of transfusion therapy: a 50% reduction in mortality for an early and massive supply of plasma, and 20% for an early and massive supply of platelets. However, this strategy encounters logistical difficulties, particularly in a context of collective emergency (attacks). The use of whole blood, widely documented by the Armed Forces, improves the availability of plasma and platelets, and simplifies handling by the various actors in the chain.

T-STORHM is a randomized, controlled, parallel clinical trial.This study tests non-inferiority of whole blood transfusion therapy in the management of coagulopathy in patients with acute traumatic hemorrhage.

ReferenceCitation: Spinella PC. Zero preventable deaths after traumatic injury: An achievable goal. J Trauma Acute Care Surg. 2017 Jun;82(6S Suppl 1):S2-S8. doi: 10.1097/TA.0000000000001425.

ReferenceCitation: Bhangu A, Nepogodiev D, Doughty H, Bowley DM. Meta-analysis of plasma to red blood cell ratios and mortality in massive blood transfusions for trauma. Injury. 2013 Dec;44(12):1693-9. doi: 10.1016/j.injury.2012.07.193. Epub 2012 Sep 25. Review.

ReferenceCitation: Johansson PI, Oliveri RS, Ostrowski SR. Hemostatic resuscitation with plasma and platelets in trauma. J Emerg Trauma Shock. 2012 Apr;5(2):120-5. doi: 10.4103/0974-2700.96479.

ReferenceCitation: Cap A, Hunt B. Acute traumatic coagulopathy. Curr Opin Crit Care. 2014 Dec;20(6):638-45. doi: 10.1097/MCC.0000000000000158. Review.

ReferenceCitation: Cap AP, Pidcoke HF, Spinella P, Strandenes G, Borgman MA, Schreiber M, Holcomb J, Tien HC, Beckett AN, Doughty H, Woolley T, Rappold J, Ward K, Reade M, Prat N, Ausset S, Kheirabadi B, Benov A, Griffin EP, Corley JB, Simon CD, Fahie R, Jenkins D, Eastridge BJ, Stockinger Z. Damage Control Resuscitation. Mil Med. 2018 Sep 1;183(suppl_2):36-43. doi: 10.1093/milmed/usy112.

ReferenceCitation: Spahn DR, Bouillon B, Cerny V, Duranteau J, Filipescu D, Hunt BJ, Komadina R, Maegele M, Nardi G, Riddez L, Samama CM, Vincent JL, Rossaint R. The European guideline on management of major bleeding and coagulopathy following trauma: fifth edition. Crit Care. 2019 Mar 27;23(1):98. doi: 10.1186/s13054-019-2347-3.

ReferenceCitation: Godier A, Bacus M, Kipnis E, Tavernier B, Guidat A, Rauch A, Drumez E, Susen S, Garrigue-Huet D. Compliance with evidence-based clinical management guidelines in bleeding trauma patients. Br J Anaesth. 2016 Nov;117(5):592-600.

ReferenceCitation: Stanworth SJ, Davenport R, Curry N, Seeney F, Eaglestone S, Edwards A, Martin K, Allard S, Woodford M, Lecky FE, Brohi K. Mortality from trauma haemorrhage and opportunities for improvement in transfusion practice. Br J Surg. 2016 Mar;103(4):357-65. doi: 10.1002/bjs.10052. Epub 2016 Feb 3.

ReferenceCitation: Carli P, Pons F, Levraut J, Millet B, Tourtier JP, Ludes B, Lafont A, Riou B. The French emergency medical services after the Paris and Nice terrorist attacks: what have we learnt? Lancet. 2017 Dec 16;390(10113):2735-2738. doi: 10.1016/S0140-6736(17)31590-8. Epub 2017 Jul 25.

ReferenceCitation: Eastridge BJ, Mabry RL, Seguin P, Cantrell J, Tops T, Uribe P, Mallett O, Zubko T, Oetjen-Gerdes L, Rasmussen TE, Butler FK, Kotwal RS, Holcomb JB, Wade C, Champion H, Lawnick M, Moores L, Blackbourne LH. Death on the battlefield (2001-2011): implications for the future of combat casualty care. J Trauma Acute Care Surg. 2012 Dec;73(6 Suppl 5):S431-7. doi: 10.1097/TA.0b013e3182755dcc. Erratum in: J Trauma Acute Care Surg. 2013 Feb;74(2):706. Kotwal, Russell S [corrected to Kotwal, Russ S].

ReferenceCitation: Eastridge BJ, Hardin M, Cantrell J, Oetjen-Gerdes L, Zubko T, Mallak C, Wade CE, Simmons J, Mace J, Mabry R, Bolenbaucher R, Blackbourne LH. Died of wounds on the battlefield: causation and implications for improving combat casualty care. J Trauma. 2011 Jul;71(1 Suppl):S4-8. doi: 10.1097/TA.0b013e318221147b.

ReferenceCitation: Glasgow S, Davenport R, Perkins Z, Tai N, Brohi K. A comprehensive review of blood product use in civilian mass casualty events. J Trauma Acute Care Surg. 2013 Sep;75(3):468-74. doi: 10.1097/TA.0b013e318298efb9. Review.

ReferenceCitation: Doughty H, Glasgow S, Kristoffersen E. Mass casualty events: blood transfusion emergency preparedness across the continuum of care. Transfusion. 2016 Apr;56 Suppl 2:S208-16. doi: 10.1111/trf.13488. Review.

ReferenceCitation: Glasgow SM, Allard S, Rackham R, Doughty H. Going for gold: blood planning for the London 2012 Olympic Games. Transfus Med. 2014 Jun;24(3):145-53. doi: 10.1111/tme.12116. Epub 2014 Apr 18. Review.

ReferenceCitation: Glasgow SM, Allard S, Doughty H, Spreadborough P, Watkins E. Blood and bombs: the demand and use of blood following the London Bombings of 7 July 2005--a retrospective review. Transfus Med. 2012 Aug;22(4):244-50. doi: 10.1111/j.1365-3148.2012.01173.x. Review.

ReferenceCitation: Radwan ZA, Bai Y, Matijevic N, del Junco DJ, McCarthy JJ, Wade CE, Holcomb JB, Cotton BA. An emergency department thawed plasma protocol for severely injured patients. JAMA Surg. 2013 Feb;148(2):170-5. doi: 10.1001/jamasurgery.2013.414.

ReferenceCitation: de Biasi AR, Stansbury LG, Dutton RP, Stein DM, Scalea TM, Hess JR. Blood product use in trauma resuscitation: plasma deficit versus plasma ratio as predictors of mortality in trauma (CME). Transfusion. 2011 Sep;51(9):1925-32. doi: 10.1111/j.1537-2995.2010.03050.x. Epub 2011 Feb 18.

ReferenceCitation: Cardenas JC, Zhang X, Fox EE, Cotton BA, Hess JR, Schreiber MA, Wade CE, Holcomb JB; PROPPR Study Group. Platelet transfusions improve hemostasis and survival in a substudy of the prospective, randomized PROPPR trial. Blood Adv. 2018 Jul 24;2(14):1696-1704. doi: 10.1182/bloodadvances.2018017699.

ReferenceCitation: Holcomb JB, Tilley BC, Baraniuk S, Fox EE, Wade CE, Podbielski JM, del Junco DJ, Brasel KJ, Bulger EM, Callcut RA, Cohen MJ, Cotton BA, Fabian TC, Inaba K, Kerby JD, Muskat P, O'Keeffe T, Rizoli S, Robinson BR, Scalea TM, Schreiber MA, Stein DM, Weinberg JA, Callum JL, Hess JR, Matijevic N, Miller CN, Pittet JF, Hoyt DB, Pearson GD, Leroux B, van Belle G; PROPPR Study Group. Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial. JAMA. 2015 Feb 3;313(5):471-82. doi: 10.1001/jama.2015.12.

ReferenceCitation: Holcomb JB, del Junco DJ, Fox EE, Wade CE, Cohen MJ, Schreiber MA, Alarcon LH, Bai Y, Brasel KJ, Bulger EM, Cotton BA, Matijevic N, Muskat P, Myers JG, Phelan HA, White CE, Zhang J, Rahbar MH; PROMMTT Study Group. The prospective, observational, multicenter, major trauma transfusion (PROMMTT) study: comparative effectiveness of a time-varying treatment with competing risks. JAMA Surg. 2013 Feb;148(2):127-36.

ReferenceCitation: Cap AP, Spinella PC, Borgman MA, Blackbourne LH, Perkins JG. Timing and location of blood product transfusion and outcomes in massively transfused combat casualties. J Trauma Acute Care Surg. 2012 Aug;73(2 Suppl 1):S89-94. doi: 10.1097/TA.0b013e318260625a.

ReferenceCitation: Fox EE, Holcomb JB, Wade CE, Bulger EM, Tilley BC; PROPPR Study Group. Earlier Endpoints are Required for Hemorrhagic Shock Trials Among Severely Injured Patients. Shock. 2017 May;47(5):567-573. doi: 10.1097/SHK.0000000000000788.

ReferenceCitation: Novak DJ, Bai Y, Cooke RK, Marques MB, Fontaine MJ, Gottschall JL, Carey PM, Scanlan RM, Fiebig EW, Shulman IA, Nelson JM, Flax S, Duncan V, Daniel-Johnson JA, Callum JL, Holcomb JB, Fox EE, Baraniuk S, Tilley BC, Schreiber MA, Inaba K, Rizoli S, Podbielski JM, Cotton BA, Hess JR; PROPPR Study Group. Making thawed universal donor plasma available rapidly for massively bleeding trauma patients: experience from the Pragmatic, Randomized Optimal Platelets and Plasma Ratios (PROPPR) trial. Transfusion. 2015 Jun;55(6):1331-9. doi: 10.1111/trf.13098. Epub 2015 Mar 30.

ReferenceCitation: Daban JL, Kerleguer A, Clavier B, Salliol A, Ausset S. [Fresh whole blood transfusion for war surgery: the experience of the Kabul French combat support hospital from 2006 to 2009]. Ann Fr Anesth Reanim. 2012 Nov;31(11):850-6. doi: 10.1016/j.annfar.2012.07.014. Epub 2012 Sep 1. French.

ReferenceCitation: Esnault P, Cungi PJ, Romanat PE, D'Aranda E, Cotte J, Bordes J, Vichard A, Aguillon P, Sailliol A, Meaudre E. [Blood transfusion on battlefield. The Kabul hospital experience]. Ann Fr Anesth Reanim. 2013 Oct;32(10):670-5. doi: 10.1016/j.annfar.2013.06.007. Epub 2013 Aug 13. French.

ReferenceCitation: Ausset S, Meaudre E, Kaiser E, Sailliol A, Hugard L, Jeandel P. [Acute traumatic haemorrhagic shock and transfusion: the French army policy]. Ann Fr Anesth Reanim. 2009 Jul-Aug;28(7-8):707-9. doi: 10.1016/j.annfar.2009.05.011. Epub 2009 Jul 3. French.

ReferenceCitation: McGuigan R, Spinella PC, Beekley A, Sebesta J, Perkins J, Grathwohl K, Azarow K. Pediatric trauma: experience of a combat support hospital in Iraq. J Pediatr Surg. 2007 Jan;42(1):207-10.

ReferenceCitation: Sailliol A, Clavier B, Cap A, Ausset S. [French European military haemovigilance guidelines]. Transfus Clin Biol. 2010 Dec;17(5-6):315-7. doi: 10.1016/j.tracli.2010.09.001. Epub 2010 Nov 3. French.

ReferenceCitation: Nair PM, Pidcoke HF, Cap AP, Ramasubramanian AK. Effect of cold storage on shear-induced platelet aggregation and clot strength. J Trauma Acute Care Surg. 2014 Sep;77(3 Suppl 2):S88-93. doi: 10.1097/TA.0000000000000327.

ReferenceCitation: Pidcoke HF, Spinella PC, Ramasubramanian AK, Strandenes G, Hervig T, Ness PM, Cap AP. Refrigerated platelets for the treatment of acute bleeding: a review of the literature and reexamination of current standards. Shock. 2014 May;41 Suppl 1:51-3. doi: 10.1097/SHK.0000000000000078. Review.

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ReferenceCitation: Cotton BA, Podbielski J, Camp E, Welch T, del Junco D, Bai Y, Hobbs R, Scroggins J, Hartwell B, Kozar RA, Wade CE, Holcomb JB; Early Whole Blood Investigators. A randomized controlled pilot trial of modified whole blood versus component therapy in severely injured patients requiring large volume transfusions. Ann Surg. 2013 Oct;258(4):527-32; discussion 532-3. doi: 10.1097/SLA.0b013e3182a4ffa0. Erratum in: Ann Surg. 2014 Jul;260(1):178.

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ReferenceCitation: Seheult JN, Triulzi DJ, Alarcon LH, Sperry JL, Murdock A, Yazer MH. Measurement of haemolysis markers following transfusion of uncrossmatched, low-titre, group O+ whole blood in civilian trauma patients: initial experience at a level 1 trauma centre. Transfus Med. 2017 Feb;27(1):30-35. doi: 10.1111/tme.12372. Epub 2016 Oct 12.

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ReferenceCitation: Einersen PM, Moore EE, Chapman MP, Moore HB, Gonzalez E, Silliman CC, Banerjee A, Sauaia A. Rapid thrombelastography thresholds for goal-directed resuscitation of patients at risk for massive transfusion. J Trauma Acute Care Surg. 2017 Jan;82(1):114-119. doi: 10.1097/TA.0000000000001270.

ReferenceCitation: Gonzalez E, Moore EE, Moore HB, Chapman MP, Chin TL, Ghasabyan A, Wohlauer MV, Barnett CC, Bensard DD, Biffl WL, Burlew CC, Johnson JL, Pieracci FM, Jurkovich GJ, Banerjee A, Silliman CC, Sauaia A. Goal-directed Hemostatic Resuscitation of Trauma-induced Coagulopathy: A Pragmatic Randomized Clinical Trial Comparing a Viscoelastic Assay to Conventional Coagulation Assays. Ann Surg. 2016 Jun;263(6):1051-9. doi: 10.1097/SLA.0000000000001608.

ReferenceCitation: Ince C, Boerma EC, Cecconi M, De Backer D, Shapiro NI, Duranteau J, Pinsky MR, Artigas A, Teboul JL, Reiss IKM, Aldecoa C, Hutchings SD, Donati A, Maggiorini M, Taccone FS, Hernandez G, Payen D, Tibboel D, Martin DS, Zarbock A, Monnet X, Dubin A, Bakker J, Vincent JL, Scheeren TWL; Cardiovascular Dynamics Section of the ESICM. Second consensus on the assessment of sublingual microcirculation in critically ill patients: results from a task force of the European Society of Intensive Care Medicine. Intensive Care Med. 2018 Mar;44(3):281-299. doi: 10.1007/s00134-018-5070-7. Epub 2018 Feb 6.

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ReferenceCitation: Tanaka S, Harrois A, Nicolaï C, Flores M, Hamada S, Vicaut E, Duranteau J. Qualitative real-time analysis by nurses of sublingual microcirculation in intensive care unit: the MICRONURSE study. Crit Care. 2015 Nov 6;19:388. doi: 10.1186/s13054-015-1106-3.

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ReferenceCitation: Hamada SR, Rosa A, Gauss T, Desclefs JP, Raux M, Harrois A, Follin A, Cook F, Boutonnet M; Traumabase® Group, Attias A, Ausset S, Boutonnet M, Dhonneur G, Duranteau J, Langeron O, Paugam-Burtz C, Pirracchio R, de St Maurice G, Vigué B, Rouquette A, Duranteau J. Development and validation of a pre-hospital "Red Flag" alert for activation of intra-hospital haemorrhage control response in blunt trauma. Crit Care. 2018 May 5;22(1):113. doi: 10.1186/s13054-018-2026-9.

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ReferenceCitation: Pommerening MJ, Goodman MD, Holcomb JB, Wade CE, Fox EE, Del Junco DJ, Brasel KJ, Bulger EM, Cohen MJ, Alarcon LH, Schreiber MA, Myers JG, Phelan HA, Muskat P, Rahbar M, Cotton BA; MPH on behalf of the PROMMTT Study Group. Clinical gestalt and the prediction of massive transfusion after trauma. Injury. 2015 May;46(5):807-13. doi: 10.1016/j.injury.2014.12.026. Epub 2015 Feb 4.

ReferenceCitation: Yazer MH, Delaney M, Doughty H, Dunbar NM, Al-Riyami AZ, Triulzi DJ, Watchko JF, Wood EM, Yahalom V, Emery SP. It is time to reconsider the risks of transfusing RhD negative females of childbearing potential with RhD positive red blood cells in bleeding emergencies. Transfusion. 2019 Dec;59(12):3794-3799. doi: 10.1111/trf.15569. Epub 2019 Oct 18.

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lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility:
CHU de La Pitié-Salpêtrière
HIA Percy
HIA Sainte Anne
CHU du Kremlin Bicêtre
CHU de Grenoble
CHU de La Cavale Blanche - Brest


title: Effect of IntraoperatiVe High Positive End-ExpirAtory Pressure (PEEP) With ReCruitment MAneuveRs vs Low PEEP on Major Postoperative Pulmonary Complications and Death After On-pump Cardiac Surgery in High-risk Patients: the VACARM Study

acronym: VACARM

summary: Controversies remain concerning the best intraoperative mechanical ventilation regimen for major cardiac surgery. While the use of intra operative low tidal volumes is now standard practice, the optimal level of positive end-expiratory pressure (PEEP) and the use of recruitment maneuvers (RM) remain controversial. The aim of this study is to compare two regimens of intraoperative mechanical ventilation on postoperative outcomes in cardiac surgery patients at risk of postoperative pulmonary complications

lead_sponsor: Rennes University Hospital

location_facility:
CHU Nantes
CHRU Tours
CHU Poitiers
CHU Angers
CHU Rennes
CHRU Brest


title: Interest of PET-PSMA Imaging Potentiated by Androgen Blockade in Patients With Biological Relapse or Persistent Biological Disease of a Localized Prostatic Adenocarcinoma After Initial Treatment

acronym: PREFAcE

summary: Evaluation of the interest of PET-PSMA imaging potentiated by androgen blockade in patients with biological relapse or persistent biological disease of a localized prostatic adenocarcinoma after initial treatment

lead_sponsor: Centre Leon Berard

location_facility: Centre Hospitalier de Grenoble Hôpital Nord Michallon


title: Doxycycline Versus Placebo in COVID-19 + Patients Without Hospitalization Criteria: Prospective, Multicenter, Randomized, Double-blind Study

acronym: DYNAMIC

summary:
The aim of the study is to compare a treatment with doxycycline vs a placebo as soon as the patient is confirmed COVID-19 + and before the onset of oxygen dependence with the aim of reducing or even abolishing the cytokine explosion and thus the evolution towards a serious form of the disease which can lead to death.

Three criteria support the rational use of tetrcycline in COVI-19 (1) The coronaviruses is known to bind to metalloproteases (MMPs) of the host, in particular to ensure viral survival. Tetracyclines are known to chelate zinc from MMPs. Their chelating activity may help inhibit COVID19 infection by limiting its ability to replicate in the host. (2) Tetracyclines may also be able to inhibit the replication of positive-polarity single-stranded RNA viruses, such as COVID19 (demonstrated on the dengue virus). (3) In addition, tetracyclines are modulators of innate immunity (anti-inflammatory activity), a property used in the treatment of inflammatory skin diseases for many years. These modulating effects are noted on several targets of innate immunity: They can decrease the expression of NFKB, the release of inflammatory cytokines such as TNF-α, IL-1β and IL-6, inhibit granulomas inflammatory and free radical release.

Tetracyclines could therefore participate in limiting the cytokine release induced by COVID19. Their lipophilic nature and their strong pulmonary penetration could allow them to inhibit viral replication.

status: Withdrawn

location_facility:
CHU Nantes
CHU Avicenne - APHP
CHU Caen
CHU Bordeaux
CHU Grenoble
CHU Dijon

status_simplified: Unknown


title: Prospective Description Study of the Impact of Long-term Protease Inhibitors in Patients Living With HIV on the Incidence of COVID-19

summary:
This is a prospective multicenter cohort study. The question arises as to whether treatment with protease inhibitors (PIs) could have a preventive role for COVID-19 infection, especially since patients living with HIV (PLWHIV) have not been described as more at risk of developing COVID-19 infection.

The aim of our study will therefore be to assess the impact of long-term protease inhibitors in PLWHIV on the incidence of COVID-19.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility:
CHI Villeneuve St Georges
CHU Henri Mondor
Centre hospitalier de Melun (GHSIF)
CHI Créteil
Hopital universitaire de Hotel Dieu
Hopital Universitaire de Necker


title: Phenotype Identification Based on Multimodal MRI Analysis of Patients With Bronchial Obstructive Diseases

acronym: PIMABOD

summary:
The hypothesis is that pulmonary and cardiac proton MRI allows phenotyping of patients with bronchial obstruction by cluster analysis based on quantitative multimodal imaging of bronchi, pulmonary vessels, pulmonary parenchyma, right and left ventricular function, myocardial fibrosis and pulmonary arterial pressure.

Such imaging will also offer the advantage of being non-irradiating and without contrast products, which will ultimately allow CT to be replaced by MRI in the follow-up of bronchial obstructive patients, thus avoiding the risks associated with repeated exposure to ionizing radiation.

design_allocation: Non-Randomized

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre de Pneumologie Bordeaux Rive droite


title: Circulating DNA to Improve Outcome of Oncology PatiEnt: A Randomized Study - COPE Study

acronym: COPE

summary:
COPE is a biology driven protocol with 2 independent, multicentric, two-arm non-comparative randomized (2:1) phase II trials in 2 distinct populations: colorectal cancer patients and non-small-lung cancer patients.

For each phase II trial, patient will be randomized between two arms with two patients randomized in arm A for one patient randomized in arm B:

Arm A (Experimental - initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up combining standard imaging and ctDNA analysis)
Arm B (Standard - initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up based on standard imaging).

location_facility:
Institut Bergonie
Polyclinique Marzet
Clinique Tivoli-Ducos
Polyclinique Bordeaux Nord Aquitaine
CHRU Brest
Centre hospitalier de la Côte Basque

intervention_type: Genetic


title: Efficacy of an Infrared Visualization Technique for the Identification of the Peripheral Venous Access Site in Patients With Cystic Fibrosis Aged 12 Years and Older

acronym: MUCOVEINE

summary:
Cystic fibrosis is a rare chronic genetic disease that mainly affects the respiratory tract and the digestive system. Their management includes multi-year intravenous antibiotic treatments and repeated venous sampling. The venous access is a source of difficulties that nurses who take care of these patients face on a daily basis. In addition, multiple attempts at punctures can induce anxiety and pain in patients. It is therefore important to limit failures.

Vein visualization technologies exist: guidance echo, portable trans lumination or infrared visualization can guide venipuncture and limit failures.

Compared with the guided echo or the portable trans lumination, the infrared visualization is easy to use and does not pose a risk for the patient. Nevertheless, studies evaluating this technique are few in chronic diseases and mainly conducted in young children.

This study aims to show that the use of a vein illumination system (VIS) should improve the peripheral venous access at the first attempt (thus limiting venous lesions) in adolescent and adult patients with cystic fibrosis, and improve comfort of the patient (pain, apprehension of the gesture).

primary_purpose: Health Services Research

location_facility: Hôpital enfant la Timone - CRCM pédiatrique Marseille


title: EXOME Analysis Position in the Strategy of Genetic Predisposition Factors Identification in Early-onset Cancer

summary: 5 to 10% of cancers are due to the presence of a constitutional genetic alteration. It can be inherited from parents (family form) or by accident, in the first moments of life after fertilization (sporadic form). In both cases, this genetic alteration is constitutional and transmissible to descendants. It is hereditary. When an hereditary early form is suspected, several well-known genes generally involved in genetic predispositions to cancer are found by a technique called " gene panel ". However, this analysis does not always identify the genetic predisposing factors for cancer. New techniques called "high-throughput exome sequencing (SHD-E)", allow more than the analysis of the the gene panel. These analysis allow to identify alterations in other genes that could contribute to the development of cancer. The objective of the Ex²trican study is to show, from patients with early cancer (sporadic or familial form), that this approach to exome sequencing can be effective to identify new genetic risk of cancer, when the first panel analysis of genes is negative.

lead_sponsor: Centre Georges Francois Leclerc

location_facility:
CHRU Jean Minjoz
CH de Troyes
Polyclinique de Courlancy
CHU de Dijon
Centre Georges-François Leclerc
CHU de Reims


acronym: MegaMOST

title: MegaMOST - A Multicenter, Open-label, Biology Driven, Phase II Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations /Characteristics in Advanced / Metastatic Tumors.

source: euctr

location_facility:
Institut Bergonié
Institut Paoli Calmettes
Centre Antoine LACASSAGNE
Centre Léon Bérard
Institut Claudius Regaud
Institut Curie

summary:
This trial is a multicenter, open-label, biology driven, phase II study using a sequential Bayesian design, aiming to assess the efficacy and safety of different Matched Targeted Therapy (MTT) in independent and parallel cohorts of treatment.

Patients will be assigned to a treatment cohort based on molecular alterations/characteristics detected on tumor sample from primary tumor or metastatic lesion.

In this protocol, several MTTs treatment cohorts are planned. This study is designed with the flexibility to open new MTTs treatment cohorts and to close existing MTTs treatment cohorts that demonstrate no clinical benefit. Each treatment cohort will be driven separately even though procedures, quality control and reporting, will be common. The protocol will be amended in order to include new treatments or combinations that emerge as being of interest for patients with advanced/metastatic cancers.

All eligible patients will receive study drugs as long as patient experiences clinical benefit in the opinion of the investigator, or until unacceptable toxicity, or until symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status, or withdrawal of consent.

Patients will be permitted to continue study treatment after progressive disease according to RECIST v1.1 if they meet all of the following criteria and following validation of the Sponsor:

Evidence of clinical benefit as assessed by the investigators,
Absence of symptoms and signs (including worsening of laboratory values; e.g., new or worsening hypercalcemia) that indicate unequivocal progression of disease,
No decline in ECOG Performance Status (PS) that can be attributed to disease progression.


title: Phase III Study of F-18-PSMA-1007 vs F-18-Fluorocholine PET to Compare the Detection Rate of Prostate Cancer Lesions in Patients With Biochemical Recurrence After Previous Definitive Treatment for Localized Prostate Cancer

lead_sponsor: ABX advanced biochemical compounds GmbH

location_facility: Hôpitaux de Brabois (Vandoeuvre-les-Nancy)

summary: This study evaluates the diagnostic performance and safety of F-18-PSMA-1007 and F-18-Fluorocholine PET/CT imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment.


title: Coats Plus Syndrome and LCC Syndrome: Series of 10 Pediatric Cases. Review of Literature and Natural History

acronym: COATS+

summary:
Coats plus syndrome is a very rare and serious disease, caused by premature telomere shortening. It is a pediatric, multi-systemic disease, the main features of which are retinal vasculopathy and neurological disorders, associated with brain calcification and leukodystrophy. Its precise genetic etiology was discovered in 2012: autosomal recessive mutation of the CTC1 gene.

Publications about this syndrome are very few, and consist only of case reports, or small series of cases. This is explained by the rarity of occurrence of this syndrome. Since 1988, 57 cases of Coats plus syndrome have been published, with case series of up to 13 patients. Only 28 cases were detailed concerning the precise clinical presentation in the literature.

The general characteristics of this syndrome are known and, in addition to the ophthalmological and neurological damage, the various publications have been able to report a digestive attack (hemorrhages), hematological damage (central cytopenias), or increased bone fragility. No treatment is currently available to cure patients.

The natural history of this disease is poorly known. However, the most accurate knowledge possible of this disease, and its natural history, is essential. It would allow an easier identification of this rare syndrome, the establishment of a management (monitoring and therapeutic) adapted, and a more accurate genetic counseling in case of need of a prenatal diagnosis.

The description of a new series of unpublished cases, as well as a comprehensive review of the literature on Coats plus syndrome, will provide a more comprehensive and informed view of this disease.

Moreover, LCC syndrome (leukoencephalopathy with calcifications and cysts) is an autosomal recessive disorder linked to a mutation in the SNORD118 gene, which has the particularity of presenting the same neurological (neuro-radiological and clinical) characteristics, but without associating the others. ophthalmological and systemic disorders. It constitutes the differential radiological diagnosis of Coats plus syndrome. In this, the collection of medical data of French pediatric cases presenting this syndrome will allow a more detailed analysis of the differences and similarities between these two syndromes.

lead_sponsor: University Hospital, Limoges

location_facility:
Fondation Adolphe de ROTHSCHILD
Hopital Kremlin Bicêtre
CHU de Limoges
Hopital Robert Debré
Hospices civils de Lyon
CHU de Rennes


title: Phase II Trial of Weekly Carboplatin-Paclitaxel Adjuvant Chemotherapy After Intensity Modulated Extended-field Chemoradiation in the Treatment of Locally Advanced Cervical Cancer With Para-aortic Positive Nodes

acronym: ACCRAPAN

summary: This is a mutlicentric, open-label non-randomized, national, 2-stage phase II trial to assess efficacy and safety of a weekly Carboplatin-Paclitaxel adjuvant chemotherapy after intensity modulated extended-field chemoradiation in patient suffering from of locally advanced cervical cancer with para-aortic positive nodes.

ReferenceCitation: Shayne M, Crawford J, Dale DC, Culakova E, Lyman GH; ANC Study Group. Predictors of reduced dose intensity in patients with early-stage breast cancer receiving adjuvant chemotherapy. Breast Cancer Res Treat. 2006 Dec;100(3):255-62. Epub 2006 May 17.

ReferenceCitation: Chemoradiotherapy for Cervical Cancer Meta-Analysis Collaboration. Reducing uncertainties about the effects of chemoradiotherapy for cervical cancer: a systematic review and meta-analysis of individual patient data from 18 randomized trials. J Clin Oncol. 2008 Dec 10;26(35):5802-12. doi: 10.1200/JCO.2008.16.4368. Epub 2008 Nov 10. Review.

ReferenceCitation: Gouy S, Morice P, Narducci F, Uzan C, Gilmore J, Kolesnikov-Gauthier H, Querleu D, Haie-Meder C, Leblanc E. Nodal-staging surgery for locally advanced cervical cancer in the era of PET. Lancet Oncol. 2012 May;13(5):e212-20. doi: 10.1016/S1470-2045(12)70011-6. Review.

ReferenceCitation: Leblanc E, Narducci F, Frumovitz M, Lesoin A, Castelain B, Baranzelli MC, Taieb S, Fournier C, Querleu D. Therapeutic value of pretherapeutic extraperitoneal laparoscopic staging of locally advanced cervical carcinoma. Gynecol Oncol. 2007 May;105(2):304-11. Epub 2007 Jan 29.

ReferenceCitation: Grigsby PW. The prognostic value of PET and PET/CT in cervical cancer. Cancer Imaging. 2008 Jul 24;8:146-55. doi: 10.1102/1470-7330.2008.0022. Review.

ReferenceCitation: Tsai CS, Chang TC, Lai CH, Tsai CC, Ng KK, Hsueh S, Yen TC, Hong JH. Preliminary report of using FDG-PET to detect extrapelvic lesions in cervical cancer patients with enlarged pelvic lymph nodes on MRI/CT. Int J Radiat Oncol Biol Phys. 2004 Apr 1;58(5):1506-12.

ReferenceCitation: Ahmed RS, Kim RY, Duan J, Meleth S, De Los Santos JF, Fiveash JB. IMRT dose escalation for positive para-aortic lymph nodes in patients with locally advanced cervical cancer while reducing dose to bone marrow and other organs at risk. Int J Radiat Oncol Biol Phys. 2004 Oct 1;60(2):505-12.

ReferenceCitation: Rotman M, Pajak TF, Choi K, Clery M, Marcial V, Grigsby PW, Cooper J, John M. Prophylactic extended-field irradiation of para-aortic lymph nodes in stages IIB and bulky IB and IIA cervical carcinomas. Ten-year treatment results of RTOG 79-20. JAMA. 1995 Aug 2;274(5):387-93.

ReferenceCitation: Eifel PJ, Winter K, Morris M, Levenback C, Grigsby PW, Cooper J, Rotman M, Gershenson D, Mutch DG. Pelvic irradiation with concurrent chemotherapy versus pelvic and para-aortic irradiation for high-risk cervical cancer: an update of radiation therapy oncology group trial (RTOG) 90-01. J Clin Oncol. 2004 Mar 1;22(5):872-80.

ReferenceCitation: Morris M, Eifel PJ, Lu J, Grigsby PW, Levenback C, Stevens RE, Rotman M, Gershenson DM, Mutch DG. Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer. N Engl J Med. 1999 Apr 15;340(15):1137-43.

ReferenceCitation: Grigsby PW, Heydon K, Mutch DG, Kim RY, Eifel P. Long-term follow-up of RTOG 92-10: cervical cancer with positive para-aortic lymph nodes. Int J Radiat Oncol Biol Phys. 2001 Nov 15;51(4):982-7.

ReferenceCitation: Mundt AJ, Mell LK, Roeske JC. Preliminary analysis of chronic gastrointestinal toxicity in gynecology patients treated with intensity-modulated whole pelvic radiation therapy. Int J Radiat Oncol Biol Phys. 2003 Aug 1;56(5):1354-60.

ReferenceCitation: Cihoric N, Tapia C, Krüger K, Aebersold DM, Klaeser B, Lössl K. IMRT with ¹⁸FDG-PET\CT based simultaneous integrated boost for treatment of nodal positive cervical cancer. Radiat Oncol. 2014 Mar 25;9:83. doi: 10.1186/1748-717X-9-83.

ReferenceCitation: Vargo JA, Kim H, Choi S, Sukumvanich P, Olawaiye AB, Kelley JL, Edwards RP, Comerci JT, Beriwal S. Extended field intensity modulated radiation therapy with concomitant boost for lymph node-positive cervical cancer: analysis of regional control and recurrence patterns in the positron emission tomography/computed tomography era. Int J Radiat Oncol Biol Phys. 2014 Dec 1;90(5):1091-8. doi: 10.1016/j.ijrobp.2014.08.013. Epub 2014 Oct 8.

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lead_sponsor: Centre Oscar Lambret

location_facility:
Centre Léonard de Vinci
Clinique des dentellières
Centre Pierre Curie
Centre Hospitalier de Lens
Centre Oscar Lambret
Centre Marie Curie


title: Evaluation of Sensitivity, Specificity, Positive and Negative Predictive Values of the Chewing Gum Test for the Diagnosis of Giant Cell Arteritis (Horton's Disease) - ChewingHort

acronym: ChewingHort

summary: It is hypothesized that chewing-gums may be a useful test to unmask jaws intermittent claudication in order to enhance the diagnosis of Giant Cell Arteritis (GCA).

location_facility:
CH Avignon
CHU Tours
CH Valenciennes
CHU de Nantes
CH St Antoine
CHU Limoges


title: Use of Infrared Spectroscopy in Fast Septic Arthritis Diagnosis

acronym: SYNOFRESH

summary: To study the diagnostic performance of infrared spectroscopy on fresh synovial fluids in early septic arthritis diagnosis in patients with acute joint effusion

location_facility:
CHU Nantes
CHU Clermont-Ferrand
CHRU Tours
CHU Angers
CHRU Brest
CHU de Rennes


title: Validity, Reliability and Responsiveness to Change of the French Version of the Drooling Impact Scale in a Pediatric Cerebral Palsy Population.

summary: The aim of this study is to present the French translation of the Drooling Impact Scale (DIS-F) and to explore its validity, reliability and responsiveness to change in a group of children with Cerebral Palsy (CP)

lead_sponsor: Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française

location_facility: Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues

location_facility: Centre d'Education Motrice Jean-Marie Arnion - Odynéo

location_facility: Centre Hospitalier Universitaire Hôpital Nord

location_facility: Centre Hospitalier Universitaire de Nîmes

location_facility: Centre d'Education Motrice Henry Gormand