title: Evaluation of Liver Grafts With FibroScan® Before Organ Retrieval in Patients With Brain Death

acronym: FIBROSCAME

summary:
According to the French Biomedicine Agency annual report on retrieval activities and transplants, 1,164 liver transplants were performed in 2011 and 1,161 in 2012. If the amount of brain death donors and retrieved liver grafts appears relatively stable, it remains clearly insufficient compared to the increasing number of patients on the waiting list for liver transplantation (2,462 in 2011). The median time on the waiting list before liver transplantation which was established from the cohort of patients registered between 2007 and 2011 (excluding patients registered for emergency transplantation and for living related-donor transplantation) increased significantly from 4.4 months between 2007 and 2009 to 6.6 months between 2010 and 2011. In order to compensate for the lack of liver grafts, donors acceptance criteria were broadened. For example, alternative transplantation lists were created with liver grafts coming from so-called "marginal" donors. However, despite these efforts, livers were retrieved on only two out of three brain death donors, i.e. in 1,572 and 1,589 organ donors in 2011 and 2012, respectively. This is unfortunately not enough to meet the increasing needs in liver grafts and a growing number of patients wait each year for transplant. Strategic lines of improvement were defined in order to meet the "2012-2016 transplant perspective" which targets 5,700 transplants carried out in 2015 (+5% every year, all transplants included, with 5,023 transplants in 2012).

According to the last consensus conference on liver transplantation of the HAS (French High Authority of Health) the assessment of the degree of macrovacuolar and microvacuolar steatosis determines the possibility to retrieve the graft or not. Liver steatosis consists in an accumulation of fatty droplets in hepatocytes. Its prevalence is high, ranging from 16% to 31% in the general population, and increases up to 46% in heavy drinkers and to 50-80% in the obese population. Steatosis results mostly from alcohol consumption and from metabolic syndrome (obesity, type 2 diabetes, hypertriglyceridemia) called non-alcoholic fatty liver disease (NAFLD), and is more rarely secondary to viral hepatitis or exposure to certain medications. NAFLD involves up to 30% of the population in Western countries and its prevalence is increasing. NAFLD may lead to asymptomatic steatosis, but also to steatohepatitis or advanced fibrosis including cirrhosis and its complications Accordingly, the improvement of liver grafts selection based on objective quantitative criteria which takes into account the degree of liver steatosis appears crucial to increase the number of hepatic transplants.

lead_sponsor: University Hospital, Limoges

location_facility:
Estaing University Hospital
Croix Rousse Hospital
Univesity Hospital
AP-HP Henri MONDOR
AP-HP Kremlin Bicêtre
Nice University Hospital
University Hospital

appel_a_projets: PHRCN

region: Nouvelle-Aquitaine

nom_etablissement: CHU  DE  LIMOGES

acronyme: FIBROSCAME

titre: Evaluation des greffons hépatiques à l'aide du FibroScan® chez les sujets en état de mort encéphalique avant prélèvement d'organes.

discipline_principale: anesthésiologie / réanimation

nom_porteur: PICHON

prenom_porteur: Nicolas


type: Other Identifier

title: PROPHYLACTIC TREATMENT FOR CHEMO-INDUCED NEUTROPENIA. USE OF G-CSF BIOSIMILAR (NIVESTIM(REGISTERED)) ACCORDING TO THE CHEMOTHERAPY CONTEXT: ADJUVANT VERSUS METASTATIC.

acronym: VISTA

summary: The aim of this study is to describe in real-life conditions the determinants of use of GCSF (Granulocyte Colony-Stimulating Factor) Nivestim® in primary or secondary prophylaxis and in patients receiving chemotherapy for solid tumour according to the chemotherapy context: adjuvant or metastatic setting.

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: No

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

collaborators: Hospira, now a wholly owned subsidiary of Pfizer

location_facility: Hôpital de Saint-Avold Service Oncologie II

location_facility: Hôpital Morvan - CHU Institut de Cancérologie et d'Hématologie

location_facility: Centre Hospitalier Philippe le Bon Service de Medecine Interne - 3e Etage

location_facility: CH de Cornouaille Service d'Oncologie Médicale

location_facility: Hôpital Avicenne Service Gastro-Entérologie

location_facility: Hôpital Louis Pradel Service Pneumologie - Centre des Maladies Orphelines

location_facility: Hôpital Privé Jean Mermoz Service d'Oncologie Médicale

location_facility: CHI Fréjus Saint Raphaël Service d'Oncologie Médicale

location_facility: Centre Hospitalier Service de Pneumologie

location_facility: Centre Marie Curie A l'attention de Laëtitia

location_facility: Clinique Rambot La Provençale Tour d'Aygosi

location_facility: Clinique Claude Bernard Service de Chimiothérapie

location_facility: CHU - Hôpital Hôtel Dieu Unité de Gastroentérologie

location_facility: Centre Hospitalier Layne Service d'Oncologie

location_facility: Centre Hospitalier du Pays d'Aix Service d'Hématologie - Oncologie

location_facility: Clinique du Dr Maymard Service d'Oncologie

location_facility: CHU de Nantes - Hôpital Laënnec Service d'Oncologie Médicale

location_facility: ICO Centre Paul Papin Service d'Oncologie Médicale

location_facility: Hôpital Bretonneau Service d'Oncologie Médicale

location_facility: Centre Hospitalier Service de Médecine 2 - Hôpital de jour

location_facility: Institut Mutualiste Montsouris Service Oncologie Médicale

location_facility: Centre Hospitalier de la region d'Annecy Pole Medecine

location_facility: Centre Hospitalier Emile Durkheim Service Oncologie

location_facility: CH Saint-Joseph et Saint-Luc Service de Gastro-Entérologie

location_facility: Clinique Chirurgicale Pasteur Service Oncologie Médicale

location_facility: Centre Hospitalier de Cholet Service d'Hepato-Gastro-Enterologie

location_facility: Hôpital Louis Pasteur Service de Pneumologie - Médecine F

location_facility: Centre Hospitalier Annecy Genevois Service Pneumologie

location_facility: Centre Hospitalier de la Dracénie Service d'Oncologie

location_facility: CHU - Hôtel-Dieu Service Hépato-Gastro-entérologie

location_facility: Hôpital de Falconaja Furiani Service d'Oncologie

location_facility: Clinique Pasteur Lanroze Service Oncologie

location_facility: Clinique Clementville Service d'Oncologie

location_facility: Centre Léon Bérard Service d'Oncologie Médicale

location_facility: Centre Hospitalier de Belfort-Montbéliard Site du Mittan-Oncologie et radiothérapie

location_facility: CHU Dupuytren Limoges Service d'Oncologie

location_facility: CHRU Lille - Hôpital Huriez Unité d'Oncologie Médicale

location_facility: Hôpital Européen Georges Pompidou Service d'Oncologie Médicale

location_facility: Centre Hospitalier de Narbonne Oncologie / Hématologie

location_facility: Centre hospitalier Louis Pasteur Service de Pneumologie

location_facility: Centre Hospitalier de Carcassonne Service d'Oncologie

location_facility: CHP du Cotentin - Site de Cherbourg Service d'Oncologie

location_facility: Clinique Claude Bernard Service Chimiothérapie

location_facility: Hôpital Européen Georges Pompidou Service Oncologie Médicale - 4e étage (ascenseur B)

location_facility: Hôpital Tenon Service d'oncologie médicale

location_facility: CHU de Dijon - Hôpital du Bocage Service Hépato-Gastro-Entérologie

location_facility: Clinique Hartman Service de Radiothérapie

location_facility: Centre Hospitalier Privé Clairval Service de Cancérologie

location_facility: Hôpital Bichat Claude Bernard Service Hépato-Gastroentérologie et Cancérologie Digestive

location_facility: CH William Morey Service d'Oncologie Médicale

location_facility: CHI des Alpes du sud Site de Gap Muret Hôpital de Jour - Oncologie

location_facility: Centre Hospitalier Privé Saint-Grégoire Service d'Oncologie - Radiothérapie

location_facility: Centre Hospitalier Service Onco-Hématologie

location_facility: CHU Montpellier - Hôpital Arnaud de Villeneuve Service de Cancérologie

location_facility: Clinique Alleray Labrouste Service d'Oncologie Médicale

location_facility: Centre de Radiothérapie SCP Strasbourg Oncologie Libérale

location_facility: Hôpital Nord Service d'Oncologie Multidisciplinaires et Innovations Thérapeutiques

location_facility: Centre Clinical Service d'Oncologie-Radiothérapie

location_facility: CH de Mulhouse - Hôpital Emile Muller Hôpital de Jour - Oncologie

location_facility: Hôpital de Thionville Service Oncologie Médicale

location_facility: Polyclinique de Gentilly Service Oncologie Médicale

location_facility: Hôpital Augustin Morvan Institut de Cancérologie et d'Hématologie

location_facility: Centre François Baclesse Oncologie Médicale. Pathologie Mammaire et Recherche Clinique

location_facility: CHU - Hôpital Jean Minjoz Service Oncologie Médicale

location_facility: Centre Hospitalier Privé Saint Grégoire Service d'Oncologie - Radiothérapie

location_facility: Hôpital Rangueil Service d'Oncologie Médicale Digestive et Gynécologique

location_facility: Centre Hospitalier de Cholet Service d' Oncologie Médicale

location_facility: Institut Franco Britannique Service Oncologie Médicale

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Unknown


title: A 6-month, Open Label, Randomised, Efficacy Study to Evaluate Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) Inhalation Powder Delivered Once Daily Via the Dry Powder Inhaler ELLIPTA™ Compared With Usual ICS/LABA Maintenance Therapy Delivered by Dry Powder Inhaler in Subjects With Persistent Asthma

summary: The combination of FF, an ICS and VI, an orally inhaled LABA has been developed as a once-daily combination therapy for the long-term maintenance treatment of asthma in adults and children >=12 years of age. Pivotal phase III studies have demonstrated the safety and efficacy of FF/VI in asthma. However, it is increasingly acknowledged that randomised clinical trials tend to be highly controlled and enrol a more highly selected subject population than is expected to be prescribed the medication post-approval. There is a need for data in a more representative population in close to a 'real life' conditions, where physicians have the ability to choose the best treatment in their view for any individual subject and adapt treatments to subjects' characteristics and response. This multi-center, open-label, randomized, parallel group study will evaluate the efficacy and safety of FF/VI compared with two usual ICS/LABA fixed combination (fluticasone propionate/salmeterol [FP/S] or budesonide/formoterol [BUD/F]) in subjects with persistent asthma, in a "close to real life" settings. FF/VI will be administered once-daily (QD) via ELLIPTA dry powder inhaler (DPI) and FP/S or BUD/F will be administered twice daily (BID) via DISKUS™ and TURBUHALER™ DPI respectively. ELLIPTA is a new powder inhaler designed to be easy to use. The total duration of subject participation will be approximately 6 months (24 weeks). ELLIPTA and DISKUS are registered trademarks of the GSK group of companies. TURBUHALER is a registered trademark of AstraZeneca.

status: Completed

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Devillier P, Humbert M, Boye A, Zachgo W, Jacques L, Nunn C, West S, Nicholls A, Antoun Z, Spinu L, Grouin JM. Efficacy and safety of once-daily fluticasone furoate/vilanterol (FF/VI) versus twice-daily inhaled corticosteroids/long-acting beta2-agonists (ICS/LABA) in patients with uncontrolled asthma: An open-label, randomized, controlled trial. Respir Med. 2018 Aug;141:111-120. doi: 10.1016/j.rmed.2018.06.009. Epub 2018 Jun 9.

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: GlaxoSmithKline

location_country: Germany France

intervention_type: Drug

status_simplified: Completed


title: A Randomized Trial of Delayed Radiotherapy in Patients With Newly Diagnosed 1p/19q Codeleted Anaplastic Oligodendroglial Tumors: the POLCA Trial.

acronym: POLCA

summary: Patients with 1p/19q-codeleted anaplastic gliomas treated with RT + PCV are at risk of neurocognitive deterioration. Treating these patients with PCV alone (could reduce the risk of neurocognitive deterioration without impairing overall survival.

status: Active, not recruiting

study_completion_date_type: Anticipated

lead_sponsor: Assistance Publique - Hôpitaux de Paris

collaborators: Association de Neuro-Oncologues d'Expression Francaise

location_facility: GH Est-Institut d'hématologie et d'oncologie pédiatrique IHOP

location_facility: Centre Hospitalier de Bretagne Sud - Hôpital du Scorff

location_facility: ICM, Institut régional du Cancer de Montpellier

location_facility: Institut de Cancérologie de l'Ouest (ICO) - site CLCC René Gauducheau

location_facility: IUCT Oncopole - CLCC Institut Claudius Regaud

lead_sponsor_type: academique

status_simplified: Ongoing


title: A Multicomponent Intervention to Reduce Perceived Discomforts in Critically Ill Patients: a Randomized Controlled Trial

summary: Since critically ill patients are exposed to stressful conditions, the investigators evaluated the effectiveness of a multicomponent program to reduce perceived discomforts in the Intensive Care Unit (ICU) .

primary_purpose: Supportive Care

ReferenceType: background

ReferenceCitation: Kalfon P, Mimoz O, Auquier P, Loundou A, Gauzit R, Lepape A, Laurens J, Garrigues B, Pottecher T, Malledant Y. Development and validation of a questionnaire for quantitative assessment of perceived discomforts in critically ill patients. Intensive Care Med. 2010 Oct;36(10):1751-1758. doi: 10.1007/s00134-010-1902-9. Epub 2010 May 26.

ReferenceCitation: Kalfon P, Boucekine M, Estagnasie P, Geantot MA, Berric A, Simon G, Floccard B, Signouret T, Fromentin M, Nyunga M, Audibert J, Ben Salah A, Mauchien B, Sossou A, Venot M, Robert R, Follin A, Renault A, Garrouste-Orgeas M, Collange O, Levrat Q, Villard I, Thevenin D, Pottecher J, Patrigeon RG, Revel N, Vigne C, Azoulay E, Mimoz O, Auquier P, Baumstarck K; IPREA Study Group. Risk factors and events in the adult intensive care unit associated with pain as self-reported at the end of the intensive care unit stay. Crit Care. 2020 Dec 7;24(1):685. doi: 10.1186/s13054-020-03396-2.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

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

repository_institution: Research Square - Research Square

repository_normalized: Research Square

version: submittedVersion

repositories:
HAL
PubMed Central
Research Square

repositories_concat: HAL;PubMed Central;Research Square

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Baumstarck K, Boucekine M, Estagnasie P, Geantot MA, Berric A, Simon G, Floccard B, Signouret T, Fromentin M, Nyunga M, Sossou A, Venot M, Robert R, Follin A, Audibert J, Renault A, Garrouste-Orgeas M, Collange O, Levrat Q, Villard I, Thevenin D, Pottecher J, Patrigeon RG, Revel N, Vigne C, Azoulay E, Mimoz O, Auquier P, Kalfon P; IPREA Study group. Assessment of patients' self-perceived intensive care unit discomforts: Validation of the 18-item version of the IPREA. Health Qual Life Outcomes. 2019 Feb 7;17(1):29. doi: 10.1186/s12955-019-1101-5.

repository_institution: PubMed Central - Europe PMC

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

ReferenceCitation: Kalfon P, Baumstarck K, Estagnasie P, Geantot MA, Berric A, Simon G, Floccard B, Signouret T, Boucekine M, Fromentin M, Nyunga M, Sossou A, Venot M, Robert R, Follin A, Audibert J, Renault A, Garrouste-Orgeas M, Collange O, Levrat Q, Villard I, Thevenin D, Pottecher J, Patrigeon RG, Revel N, Vigne C, Azoulay E, Mimoz O, Auquier P; IPREA Study group. A tailored multicomponent program to reduce discomfort in critically ill patients: a cluster-randomized controlled trial. Intensive Care Med. 2017 Dec;43(12):1829-1840. doi: 10.1007/s00134-017-4991-x. Epub 2017 Nov 27.

oa_host_type: closed

ReferenceCitation: Kalfon P, Mimoz O, Loundou A, Geantot MA, Revel N, Villard I, Amour J, Azoulay E, Garrouste-Orgeas M, Martin C, Sharshar T, Baumstarck K, Auquier P. Reduction of self-perceived discomforts in critically ill patients in French intensive care units: study protocol for a cluster-randomized controlled trial. Trials. 2016 Feb 16;17:87. doi: 10.1186/s13063-016-1211-x.

location_facility: CHU Hôpital Européen Georges Pompidou APHP


title: Phase II/III Randomized Study to Improve Overall Survival in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus Mycophenolate Mofetil Prophylaxis of Graft Versus Host Disease in Allografted Patients in First CR : a Backbone InterGroup-1 Trial

summary: This open label, multicenter phase II/III study with multiple randomization phases at differents stages of AML treatment (induction, consolidation and HSCT where applicable) is designed to improve OS in younger (18 to 60 year-old) patients, with AML risk-adapted patient strategies. Within the intermediate risk AML group, optimal GvHD prophylaxis following allogeneic SCT in first CR, after either myeloablative (MAC) or reduced intensity (RIC) conditioning, will also be evaluated. With an adaptative design, this clinical trial could test up to 3 novel AML agents of interest.

status: Recruiting

enrollment_type: Anticipated

lead_sponsor: University Hospital, Angers

location_facility: Institut de Cancérologie Lucien Neuwirth


title: A Multicentric Survey on Patients Over 60 Admitted to Intensive Care for Severe Forms of COVID Infection: Search for Prognostic Criteria Associated With Survival

acronym: SeniorCOVIDRea

summary:
With the spread of COVID-19 epidemic since 2019 in Wuhan, China health plans have to be adapted continuously in response to the emergency. The first publications from the Chinese experience demonstrate an increase in the incidence of COVID-19 infections in patients over 60 years of age, a higher frequency of severe forms of the disease and therefore theoretical indications of orientation towards resuscitative care.

However, the first published data from Hubei province suggest a low benefit of resuscitation for patients between 70 and 80 years of age and null in patients over 80 years of age. These data question the individual benefit / risk balance of an orientation towards resuscitation for this category of patients, their quality of life and the concept of unreasonable obstinacy.

Among the covariates associated with resuscitation mortality described in the data published to date, cardiovascular comorbidities, certain biological covariates (LDH, creatinine, lymphocytes, neutrophils, TP, D-dimers, etc.), the time between the first symptoms and the entry into resuscitation have been identified.

The objective of this multicentric observational study is to determine the clinical and biological covariates predictive of mortality in the population of patients over 60 years of age admitted in intensive care unit, in particular by integrating functional and nutritional data from patients 1 month before COVID-19 infection.

status: Unknown status

time_perspective: Other

ReferenceCitation: Thiolliere F, Falandry C, Allaouchiche B, Geoffray V, Bitker L, Reignier J, Abraham P, Malaquin S, Balanca B, Boyer H, Seguin P, Guichon C, Simon M, Friggeri A, Vacheron CH; AZUREA Study Group. Intensive care-related loss of quality of life and autonomy at 6 months post-discharge: Does COVID-19 really make things worse? Crit Care. 2022 Apr 4;26(1):94. doi: 10.1186/s13054-022-03958-6.

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

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UJM - Université Jean Monnet

ReferenceCitation: Falandry C, Malapert A, Roche M, Subtil F, Berthiller J, Boin C, Dubreuil J, Ravot C, Bitker L, Abraham P, Collange V, Balanca B, Goutte S, Guichon C, Gadea E, Argaud L, Dayde D, Jallades L, Lepape A, Pialat JB, Friggeri A, Thiolliere F; Senior-COVID-Rea study Group. Risk factors associated with day-30 mortality in patients over 60 years old admitted in ICU for severe COVID-19: the Senior-COVID-Rea Multicentre Survey protocol. BMJ Open. 2021 Jul 6;11(7):e044449. doi: 10.1136/bmjopen-2020-044449.

license: cc-by-nc

license_normalized: cc-by-nc

publisher_dissemination: British Medical Journal

lead_sponsor: Hospices Civils de Lyon

location_facility: - Resuscitation unit of the Groupement Hospitalier Sud - Hospices Civils de Lyon

location_facility: Resuscitation unit at Hospital Emile Roux

location_facility: Resuscitation unit of the Groupement Hospitalier Centre - Hospices Civils de Lyon

location_facility: Service de Réanimation de l'Hôpital Nord Ouest

location_facility: - Resuscitation unit of the Groupement Hospitalier Nord - Hospices Civils de Lyon

intervention_type: Other


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:
CHRU Brest
CHU Nantes
CHU Rennes
CHU Poitiers
CHU Amiens-Picardie
CHRU Tours
CHU Angers

intervention_type: Procedure

appel_a_projets: PHRIP

region: Bretagne

nom_etablissement: CHRU RENNES

type_etablissement: CHUR

acronyme: VACARM

titre: VentilAtion per opératoire en chirurgie CARdiaque avec pression expiratoire positive élévée associée à des Manuvres de recrutement alvéolaire : impact sur le devenir post-opératoire.

nom_porteur: DEMAURE

prenom_porteur: Nathalie


title: Impact of SARS-CoV-2 Infection on the Incidence of ICU Acquired Colonization Related to Multidrug-resistant Bacteria

acronym: COVID-BMR

summary: This multicenter before-after study aimed to determine the impact of infection related to SARS-CoV-2 on the incidence of ICU-acquired multidrug resistant (MDR) bacteria.

lead_sponsor: University Hospital, Lille

location_facility: Hospices Civils de Lyon (Pierre Bénite,Edouard Herriot, La Croix Rousse)


title: Blood Innate Biomarkers as Predictors of COVID-19 Disease Progression in Recently Infected Kidney Transplant Patients

acronym: PredictCovidT

summary:
SARS-CoV-2 induces over-production of inflammatory cytokines, and especially interleukin-6 (IL-6). The apparently strong association between blood levels of inflammaory cytokines and SARS-CoV-2 disease severity has led clinicians to evaluate the administration of steroids or anti-IL-6 antagonists in severely ill patients. As of this day, biomarkers capable of predicting clinical disease progression in Covid-19 patients with mild-to-moderate symptoms have not yet been formally identified. Identifying such markers and evaluating their predictive value may be exploited to guide patient care management, and as such forms the core objective of this proposal.

Because of strong inter-individual variations in the ability of innate immune cells to produce cytokines, the hypothesis formulate and intend to test is that innate IL-6 responsiveness varies between recently infected Covid-19 patients and could predict disease outcome.

To test this hypothesis, the investigator propose to follow recently infected kidney transplant patients with moderate Covid-19 symptoms. These patients stand a higher risk to progress to severe disease. The staff plan to collect a blood sample in these patients using a system whereby ex vivo cytokine production is initiated in the very same blood collection tube without prior separation and centrifugation, thus reducing labour and operator bias. After incubation with or without known innate immune stimuli, the cell-free phase from each collection-culture tube will be assayed for IL-6 content. Associations between IL-6 content and disease outcome (encephalopathy, transfer to acute care or death) will be determined in 115 Covid-19 kidney transplant patients with moderate symptoms followed in 9 centers.

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Montpellier University Hospital
Saint Etienne University Hospital
Lyon Univerity Hospital
APHP
Strasbourg Univeristy Hospital
University Nice Hospital
APHM


title: COVID-19 Serodiagnosis in Oncology

acronym: EVIDENCE

summary: EVIDENCE is a non interventional, French, multicenter study. Patients will be screened by local severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoassay in their oncology department (rapid diagnostic test (RDT) or enzyme-linked immunosorbent assay (ELISA)). In patients with positive local SARS-CoV-2 immunoassay, a centralized SARS-CoV-2 ELISA will be performed in order to double check the immune response of all patients considered immune by local immunoassay.

ipd_sharing_description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

lead_sponsor: UNICANCER

location_facility:
Hôpital Universitaire Pitié Salpêtrière
Centre Hospitalier de Boulogne sur Mer
Centre Eugène Marquis
Hopitaux Civils de Colmar
Centre Jean Perrin
Institut Curie


title: Subcutaneous Injections of Cultured Adipose-derived Stroma/ Stem Cells to Heal Refractory Ischemic Digital Ulcers in Patients With Scleroderma

acronym: ADUSE

summary: Ischemic digital ulcers (DUs) are a frequent complication in systemic sclerosis with a major impact on hand function and quality of life. Digital injection of cultured adipose-derived stromal cell (AdMSC) constitutes a promising approach to treat scleroderma-induced refractory ischemic DUs where no alternative therapy is validated. The aim of this phase 2 study is to compare efficacy and safety of digital injection of AdMSC versus placebo for healing refractory active ischemic digital ulcers in patients with systemic sclerosis.

lead_sponsor: University Hospital, Toulouse

location_facility:
Marseille Hospital
Nantes Hospital
Lille Hopsital
Montpellier Hospital
CHU de Toulouse - Hôpital PURPAN-TSA
Grenoble Hospital
Poitiers Hospital

region: Occitanie

nom_etablissement: CHU TOULOUSE

type_etablissement: CH

acronyme: ADUSE

titre: Injection de cellules souches mesenchymateuses issues du tissu adipeux pour la cicatrisation des ulceres digitaux ischemiques de la sclerodermie systemique etude de phase ii

discipline_principale: médecine interne

nom_porteur: Pugnet

prenom_porteur: Grégory


acronym: SYMPTOMS

lead_sponsor: University Hospital, Brest

summary:
Venous thromboembolism (VTE) is a frequent condition, affecting 1.8 per 1,000 people every year. Admission to hospital is one of the main risk factors for VTE, and could account for up to 20% of all VTE, making VTE prevention in admitted patients an appealing option to reduce VTE global burden.

The landmark MEDENOX trial and others demonstrated the efficacy of low molecular weight heparins (LMWH) in reducing a composite outcome of symptomatic and asymptomatic events, the latter accounting for the vast majority of events.

Publication of these trials led to the implementation of thromboprophylaxis policies in hospitals, which acceptance has been variable. More recently, the use of thromboprophylaxis has been challenged after the publication of 1) a negative trial that used 'death from any cause' as main outcome, 2) a systematic review showing the lack of a clear efficacy on the risk of pulmonary embolism or death, 3) negative trials using new oral anticoagulants, 4) the last version of the American College of Chest Physicians Guidelines, focusing on symptomatic events only, downgraded its recommendation for thromboprophylaxis in medical patients to a 1B recommendation, restricting its use to patients 'at increased risk of thrombosis' and recommending against the use of thromboprophylaxis in patients at low risk of thrombosis, patients bleeding or at high risk of bleeding.

However, a limitation of this interpretation of the data is that in most trials, patients with screened asymptomatic events were treated with anticoagulants, preventing the occurrence of symptomatic events during follow-up. Moreover, subgroup analyses showed that elderly patients were at high risk of thrombosis in these trials, and that LMWH could be particularly efficient in this subgroup of patients. Conversely, their risk of bleeding is also higher than in younger patients and the current trials were not powered to detect a difference in the bleeding risk between groups. Finally, the diagnostic and therapeutic management of VTE is more challenging in the elderly. Therefore, we planned a randomized controlled trial on the efficacy of LMWH for the prevention of symptomatic VTE in elderly patients.

location_facility: Clinique Mutualiste Médico-chirurgical "Beau Soleil"

location_facility: CHU Strasbourg - Service de Médecine Interne

location_facility: CHRU Strasbourg- Service HTA et Maladies Vasculaires

location_facility: CH Intercommunal Toulon La Seyne sur Mer

title: Prevention of Symptomatic Venous Thromboembolism by Low Molecular Weight Heparin in Hospitalized Medical Patients Aged 70 Years and Older : a Randomized Placebo-Controlled Study The SYMPTOMS (SYstematic Elderly Medical Patients Thromboprophylaxis : Efficacy on Symptomatic OutcoMeS) Study

primary_purpose: Prevention

type: EudraCT Number

source: euctr

location_country: Switzerland France

nom_etablissement: CHRU BREST

acronyme: SYMPTOMS

titre: Prévention de la maladie veineuse thromboembolique symptomatique par héparine de bas poids moléculaire chez les patients médicaux hospitalisés de 75 ans et plus (essai randomisé contrôlé versus placebo)

nom_porteur: MOTTIER

prenom_porteur: Dominique


title: Consultations Reason for Genital, Urinary or Psychological Humans in General Practice

acronym: GETUP

summary: Many male patients complain about their ejaculation: 21-30% of men aged between 18 and 59 have admitted suffering from a decrease in, or loss of control of, their ejaculation. The quality of life of patients and their partners is impaired compared to men not suffering from premature ejaculation. Economically, the impact of the disease are significant. In the year preceding the detection of premature ejaculation patients visit twice their physician. The majority of men interviewed anonymously, in their General Practitioner's ( GP's) waiting room, considered it important to talk with their GP about their sexual concerns. Almost half of them preferred that their GP initiate any discussions about sexuality. More than two thirds of the respondents would have liked their GP to signal his or her open-mindedness by directly addressing sexual topics during the consultation. In 2008 a qualitative study brought to the fore the strategies used by GPs to initiate the discussion on premature ejaculation . GPs who mentioned premature ejaculation with their patient described three attitude-related strategies and three investigative strategies.

primary_purpose: Diagnostic

ReferenceCitation: Barais M, Vaillant Roussel H, Costa D, Derriennic J, Pereira B, Cadier S. Premature ejaculation in primary care: communication strategies versus usual care for male patients consulting for a sexual, urogenital or psychological reason - GET UP: study protocol for a cluster randomised controlled trial. Trials. 2018 Nov 12;19(1):622. doi: 10.1186/s13063-018-2947-2.

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

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

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

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

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

location_facility: Cabinet médical - 39 rue Saint Philibert

location_facility: Cabinet médical du 5 Descente des Oliviers

location_facility: Cabinet médical - Esplanade Mitterrand 5

location_facility: Cabinet médical - 89 Bis Rue de la Calade


acronym: BEVABEL

summary: Open-label, non-randomized, multicenter, phase II, single arm non comparative trial evaluating toxicity and efficacy of gemcitabine plus platinum salt in combination with bevacizumab in first-line setting in metastatic collecting duct carcinoma.

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

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

location_facility: Gustave Roussy, Cancer Campus, Grand Paris

title: Prospective Phase II Study of Gemcitabine Plus Platinum Salt in Combination With Bevacizumab (Avastin®) for Metastatic Collecting Duct Carcinoma


title: Initiation of Non- Invasive Ventilation at Home Versus Hospital Among Patients With Overlap Syndrome: Randomized Controlled Non-inferiority Study

acronym: OVNI-Dom

summary: The study is based on the assumption that in the Overlap Syndrome, the introduction at home of the NIV is as effective in terms of compliance and clinical and gazometric improvement, and life quality, that setting hospital start up. The investigators will study the initiation of NIV at home versus in hospital in two randomized Overlap Syndrome patient groups. The main objective of the study is to demonstrate the non-inferiority of the initiation of the NIV at home versus hospital in terms of compliance.

lead_sponsor: IP Santé Domicile

location_facility: CHU de Grenoble site Nord - Hôpital Albert Michallon


title: Multicenter, Controlled, Randomized, Open Label, Clinical Study to Assess the Efficacy of Auto-Adjustable MOBIDERM® Autofit NIGHT-time Compression Armsleeve in the Management of Upper Limb LYMphedema in Maintenance Phase: LYMphoNIGHT Study

acronym: LYMphoNIGHT

summary:
This study aims to assess Auto-Adjustable MOBIDERM® Autofit Armsleeve effect on upper limb volume excess after 3 months of maintenance phase treatment in patients with secondary upper limb lymphedema following breast cancer.

Half of the patient will wear a day-time and night time compression garment (MOBIDERM Autofit) for 3 months during the maintenance phase, while the other half will only wear day-time compression garment.

ReferenceCitation: Quere I, Presles E, Coupe M, Vignes S, Vaillant L, Eveno D, Laporte S, Leizorovicz A; POLIT Study investigators. Prospective multicentre observational study of lymphedema therapy: POLIT study. J Mal Vasc. 2014 Jul;39(4):256-63. doi: 10.1016/j.jmv.2014.05.004. Epub 2014 Jun 12.

ReferenceCitation: Mestre S, Calais C, Gaillard G, Nou M, Pasqualini M, Ben Amor C, Quere I. Interest of an auto-adjustable nighttime compression sleeve (MOBIDERM(R) Autofit) in maintenance phase of upper limb lymphedema: the MARILYN pilot RCT. Support Care Cancer. 2017 Aug;25(8):2455-2462. doi: 10.1007/s00520-017-3652-5. Epub 2017 Mar 9.

ReferenceCitation: Brown JC, Cheville AL, Tchou JC, Harris SR, Schmitz KH. Prescription and adherence to lymphedema self-care modalities among women with breast cancer-related lymphedema. Support Care Cancer. 2014 Jan;22(1):135-43. doi: 10.1007/s00520-013-1962-9. Epub 2013 Sep 7.

lead_sponsor: Thuasne

collaborators: International Clinical Trials Association

location_country: Turkey France

location_facility:
Chu Grenoble
Nimes
Chu Toulouse
Chu Montpellier
Ghr Mulhouse
Turkey
CHRU Tours
CHU NICE

intervention_type: Device


title: Prospective Observational Clinical Study Conducted Over a 10-year Period on Patients Who Received the ESOP 2 Stem to Restore Joint Function, in Order to Confirm Security and Performance of the Device

summary: This study is a post-market clinical follow-up conducted in order to collect long-term data on security and performance of the ESOP 2 stem, which is intended to be implanted in case of total hip replacement, when used in real life conditions according to the instructions for use.

lead_sponsor: FH ORTHO

location_facility:
Nouvelle Clinique Bel-Air
CH Pasteur
CH de Haguenau
CH Raymond POINCARE
Groupe Hospitalier Pitié-Salpêtrière
Clinique du Val d'Ouest
Clinique Tivoli Ducos


title: Respiratory Impairment in Mucopolysaccharidosis Patients: Impact of Glycosaminoglycans (GAG) on the Proteases/Antiproteases Balance

acronym: RespiGAG

summary: Mucopolysaccharidosis (MPS) are a group of inherited, metabolic diseases caused by a deficiency of lysosomal enzymes that degrade glycosaminoglycans (GAGs). Loss of their activity results in cellular accumulation of GAGs fragments leading to progressive multi-system manifestations, with respiratory impairment. The cellular and molecular mechanisms responsible for the pulmonary impairment remain largely unknown. Specific GAGs, such as those accumulating in MPS, may act as potent inhibitors of some respiratory enzymes, like lysosomal cathepsins, depending on the nature of GAGs and their concentration. It is well established that deregulation of cathepsins levels plays a major role in the pathophysiology of some chronic respiratory diseases, such as cystic fibrosis. The role of cathepsins and their inhibitors in respiratory samples of MPS patients has never been studied. This study will focus on the status/activity of these proteases and their endogenous inhibitors in the sputum or tracheal aspiration of patients with MPS. Our main hypothesis is that high levels of GAGs in MPS patients impair the physiological activity of cathepsins and their inhibitors.

ReferenceCitation: Khan SA, Peracha H, Ballhausen D, Wiesbauer A, Rohrbach M, Gautschi M, Mason RW, Giugliani R, Suzuki Y, Orii KE, Orii T, Tomatsu S. Epidemiology of mucopolysaccharidoses. Mol Genet Metab. 2017 Jul;121(3):227-240. doi: 10.1016/j.ymgme.2017.05.016. Epub 2017 May 26.

ReferenceCitation: Rapoport DM, Mitchell JJ. Pathophysiology, evaluation, and management of sleep disorders in the mucopolysaccharidoses. Mol Genet Metab. 2017 Dec;122S:49-54. doi: 10.1016/j.ymgme.2017.08.008. Epub 2017 Aug 25.

ReferenceCitation: Kobayashi H. Recent trends in mucopolysaccharidosis research. J Hum Genet. 2019 Feb;64(2):127-137. doi: 10.1038/s10038-018-0534-8. Epub 2018 Nov 19.

ReferenceCitation: Wilson S, Hashamiyan S, Clarke L, Saftig P, Mort J, Dejica VM, Bromme D. Glycosaminoglycan-mediated loss of cathepsin K collagenolytic activity in MPS I contributes to osteoclast and growth plate abnormalities. Am J Pathol. 2009 Nov;175(5):2053-62. doi: 10.2353/ajpath.2009.090211. Epub 2009 Oct 15.

ReferenceCitation: Lalmanach G, Saidi A, Marchand-Adam S, Lecaille F, Kasabova M. Cysteine cathepsins and cystatins: from ancillary tasks to prominent status in lung diseases. Biol Chem. 2015 Feb;396(2):111-30. doi: 10.1515/hsz-2014-0210.

ReferenceCitation: Bromme D, Lecaille F. Cathepsin K inhibitors for osteoporosis and potential off-target effects. Expert Opin Investig Drugs. 2009 May;18(5):585-600. doi: 10.1517/13543780902832661.

ReferenceCitation: Baldo G, Tavares AM, Gonzalez E, Poletto E, Mayer FQ, Matte UD, Giugliani R. Progressive heart disease in mucopolysaccharidosis type I mice may be mediated by increased cathepsin B activity. Cardiovasc Pathol. 2017 Mar-Apr;27:45-50. doi: 10.1016/j.carpath.2017.01.001. Epub 2017 Jan 6.

ReferenceCitation: Sage J, Mallevre F, Barbarin-Costes F, Samsonov SA, Gehrcke JP, Pisabarro MT, Perrier E, Schnebert S, Roget A, Livache T, Nizard C, Lalmanach G, Lecaille F. Binding of chondroitin 4-sulfate to cathepsin S regulates its enzymatic activity. Biochemistry. 2013 Sep 17;52(37):6487-98. doi: 10.1021/bi400925g. Epub 2013 Sep 4.

ReferenceCitation: Kubaski F, Tomatsu S, Patel P, Shimada T, Xie L, Yasuda E, Mason R, Mackenzie WG, Theroux M, Bober MB, Oldham HM, Orii T, Shaffer TH. Non-invasive pulmonary function test on Morquio patients. Mol Genet Metab. 2015 Aug;115(4):186-92. doi: 10.1016/j.ymgme.2015.06.007. Epub 2015 Jun 23.

lead_sponsor: University Hospital, Tours

location_facility: Metabolic Disease Competence Centre - Pediatrics Department - University Hospital, Rennes

location_facility: Metabolic Disease Reference Centre - Pediatrics Department - University Hospital, Toulouse

location_facility: Metabolic Disease Competence Centre - Medical Genetics Department - University Hospital, Brest

location_facility: Metabolic Disease Reference Centre - Pediatrics Department - University Hospital, Tours

location_facility: Pediatric Resuscitation Unit - Universty Hospital, Tours

location_facility: Metabolic Disease Reference Centre - Medical Genetics Department - University Hospital, Bordeaux

location_facility: Metabolic Disease Competence Centre - Medical Genetics Department - University Hospital, Angers


title: Efficiency of an Optimized Care Organization for Fibromyalgia Patients Within the Group of Hospitals of Loire Territory. Interventional Study Aimed at Changing Behaviour in Terms of Physical Activity and Sedentary

acronym: FIMOUV 2

summary:
Fibromyalgia affects 2 to 5% of adults in the general population. Patients describe a combination of symptoms centred around fatigue not induced by exercise and not relieved by rest.

The diagnosis of fibromyalgia is self-perpetuating by the deconditioning, consequence of a reduced muscle mass due to inactivity and periods of prolonged rest.

Thus, it seems fundamental to develop other non-drug approaches: among them, adapted physical activity is recommended by most learned societies because of a good level of evidence (Level 1, Grade A). The question remains, however, whether simple advice to resume physical activity is sufficient (routine care with medical assessment at 3 months) or whether a physical activity supervised inside and outside the hospital is not more relevant.

ReferenceCitation: Colas C, Jumel A, Vericel MP, Barth N, Manzanares J, Goutte J, Fontana L, Feasson L, Hupin D, Guyot J. Understanding Experiences of Fibromyalgia Patients Involved in the Fimouv Study During COVID-19 Lockdown. Front Psychol. 2021 Jul 20;12:645092. doi: 10.3389/fpsyg.2021.645092. eCollection 2021.

repositories_concat: PubMed Central

publisher_dissemination: Frontiers

ReferenceCitation: Colas C, Goutte J, Creac'h C, Fontana L, Vericel MP, Manzanares J, Peuriere M, Akrour M, Martin C, Presles E, Barth N, Guyot J, Garros M, Trombert B, Massoubre C, Roche F, Feasson L, Marotte H, Cathebras P, Hupin D. Efficiency of an Optimized Care Organization in Fibromyalgia Patients: The From Intent to Move (FIMOUV) Study Protocol of a Randomized Controlled Trial. Front Public Health. 2021 May 25;9:554291. doi: 10.3389/fpubh.2021.554291. eCollection 2021.

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

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

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
Chu Saint Etienne
CH de Firminy
CH du Gier
CH de Rive de Gier
CH d'ANNONAY
CH de ROANNE
CH de MONTBRISON


title: Multiparametric Imaging for Analysis of MVNT (Multinodular and Vacuolating Neuronal Tumor)

acronym: MIAM

summary: Differential diagnoses of MVNT include DNT (dysembryoplastic neuroepithelial tumor), low-grade gliomas, cortical dysplasias or even hamartomas.

time_perspective: Cross-Sectional

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility:
Hôpital Laennec
Groupe Hospitalier Pellegrin
Hôpital Pierre Paul Riquet, CHU Purpan
CHU Rennes
CHU de Rouen
Centre Hospitalier Lyon Sud
Fondation Adolphe de Rothschild


acronym: EUROPE

lead_sponsor: Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

summary: There are currently no licensed drugs in the EU to treat thrombocytopenia in MDS patients classified as IPSS low/int-1. Prior studies with romiplostim (a TPO receptor agonist) in MDS found that baseline concentration of TPO as well as transfusion history were predictive of subsequent response in a retrospective model. The current prospective study has the aim to explore whether both pretreatment variables (endogenous TPO, TPO-level, platelet transfusion history) can predict the response to subsequent short-term treatment with romiplostim.

location_facility: Universitätsklinikum Dresden / Medizinische Klinik I

location_facility: Universitätsklinikum Hamburg-Eppendorf /Onkologisches Zentrum

location_facility: Medizinische Hochschule Hannover / Hämatologie u. Onkologie

location_facility: MVZ Onkologischer Schwerpunkt am Oskar-Helene-Heim

location_facility: Universitätsklinikum Mannheim / Klinik III / Hämatologie, Onkologie

location_facility: Marienhospital Düsseldorf GmbH / Innere Medizin u. Hämatologie

location_facility: Vivantes Klinikum am Urban / Hämatologie Onkologie

location_facility: Klinikum Rechts der Isar, Tumortherapiezentrum

location_facility: Universitätsklinikum Ulm / Klinik Innere Medizin III

location_facility: Klinikum Chemnitz gGmbH / Klinik für Innere Medizin III

location_facility: Rems-Murr-Kliniken Winnenden / Hämatologie, Onkologie

location_facility: Universitätsklinikum Halle (Saale) / Klinik für Innere Medizin IV

title: Prospective Validation of a Predictive Model of Response to Romiplostim in Patients With IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) and Thrombocytopenia - the EUROPE-trial

design_allocation: Non-Randomized


title: Multicentre, Randomized, Parallel Group, Non-inferiority, Open-label Study Aiming at Comparing the Healing Rates (With Blinded Assessment Based on Photographs) of TULLEGRAS M.S.® With URGOTUL® in the Treatment of Surgical Acute Wounds.

summary: Evaluation of non-inferiority on healing rates of two dressings Urgotul and TulleGras MS in the treatment of surgical acute wounds.

lead_sponsor: Mylan Inc.

sponsor_collaborators:
Mylan Inc.
Fovea

location_facility:
Research facility ORG-001360
Research facility ID ORG-001133
Research facility ID ORG-001088
Research facility ORG-001093
Research facility ORG-001089
Research facility ID ORG-001099
Research facility ORG-001096
Research facility ID ORG-001189
Research facility ID ORG-001263
Research facility ORG-001137
Research facility ORG-001099
Research facility ORG-001107
Research facility ORG-001166
Research facility ORG-001136
Research facility ORG-001088
Research facility ORG-001090
Research facility ORG-001133
Research facility ID ORG-001222
Research facility ID ORG-001221
Research facility ORG-001097
Research facility ID ORG-001134
Research facility ID ORG-001278
Research facility ORG-001101
Research facility ID ORG-001264
Research facility ORG-001102
Research facility ID ORG-001265
Research facility ID ORG-001223
Research facility ID ORG-001190
Research facility ID ORG-001105
Research facility ORG-001105
Research facility ID ORG-001220
Research facility ORG-001132
Research facility ID ORG-001276


title: Treatment of Ectopic Calcification / Ossification With Sodium Thiosulfate (CATSSO)

summary:
Ectopic calcification and ossification complicate many diseases, which are rare for the most part. These calcifications (or ossifications) are generally classified according to their apparent formation mechanism. Even if very different diseases can be at the origin, these calcifications (or ossifications) have as common points: an unknown physiopathology, a composition of calcium pyrophosphate for the most part and l no curative treatment validated to date.

Indeed, although several reported cases suggest the potential efficacy of different treatments , none of these treatments is currently recognized as effective because of the absence of confirmation data or because of contradictory results.

Sodium thiosulfate (STS) has been used for a long time as an antidote to cyanide poisoning and as a protective agent against cytotoxic side effects such as ifosphamide. More recently, STS has been reported in the treatment of renal calcification. vascular or even subcutaneous. First prospective studies on animal models and in humans seem to confirm the interest of this product in the treatment of these abnormal calcifications.

For several months, a magistral preparation in the form of ointment based on STS has been developed by the pharmacy of Limoges University Hospital in order to combine the local effect of STS while avoiding the side effects of an administration of this treatment by systemic way. The first uses of this preparation appear promising and some preliminary results have already been published. The benefit / risk ratio of this approach seems to be advantageous for clinicians since preparations whose composition is close are currently validated by the FDA and the World Health Organisation for the treatment of benign pathologies such as cutaneous dermatophytes or pityriasis versicolor.

time_perspective: Retrospective

lead_sponsor: University Hospital, Limoges

location_facility:
HEGP
Robert Debré Hospital
CHU de Limoges
Lariboisière Hospital
Kremlin Bicetre Hospital
Necker Hospital
Grenoble university hospital


title: Randomized, Multicenter, Open-Label, Two-period, Two-sequence Crossover Comparative Pharmacokinetic Study of Generic Tacrolimus (Sandoz) and Advagraf® in Stable Renal Transplant Patients (TODAY)

acronym: TODAY

summary: Study to compare pharmacokinetics of tacrolimus prolonged-release (PR) capsules and Advagraf® PR capsules in stable kidney transplant patients.

study_start_date_type: Anticipated

status: Withdrawn

lead_sponsor: Sandoz


title: A Multicenter Open Label Phase 2 Study of Carfilzomib Weekly Plus Melphalan and Prednisone in Untreated Symptomatic Elderly Multiple Myeloma

summary: IFM 2012-03 protocol is a Phase 2 multicenter nonrandomized open in elderly patients with multiple myeloma at diagnosis. Study primary objectives are in the first step to determine Maximum tolerated dose (MTD) of Carfilzomib Weekly based on definition of Dose-limiting toxicities (DLTs) and in the second step to expanded cohort, to determine the VGPR (Very Good Partial Response) + CR (Complete Response) rate of Carfilzomib Weekly at the MTD in combination with Melphalan Prednisone at the end of the 9 induction cycles.

ipd_sharing: Undecided

sponsor_collaborators:
University Hospital, Lille
Amgen

location_facility: Hématologie Clinique, Hôpital Robert Debré, CHU Reims

location_facility: Hématologie Clinique, CHU, Hôpital d'Enfants

location_facility: Centre hospitalier départemental La Roche sur Yon

location_facility: Unité de Recherche Clinique - CH Perigueux


summary: Open label multicentric phase II randomized trial, using high throughput genome analysis as a therapeutic decision tool, which aims at comparing a targeted treatment administered according to the identified molecular anomalies of the tumor with maintenance chemotherapy (targeted substudy 1) as well as immunotherapy with maintenance chemotherapy in patients without actionable genomic alterations or non eligible to substudy 1 (immune substudy 2).

ReferenceCitation: Mosele F, Stefanovska B, Lusque A, Tran Dien A, Garberis I, Droin N, Le Tourneau C, Sablin MP, Lacroix L, Enrico D, Miran I, Jovelet C, Bieche I, Soria JC, Bertucci F, Bonnefoi H, Campone M, Dalenc F, Bachelot T, Jacquet A, Jimenez M, Andre F. Outcome and molecular landscape of patients with PIK3CA-mutated metastatic breast cancer. Ann Oncol. 2020 Mar;31(3):377-386. doi: 10.1016/j.annonc.2019.11.006. Epub 2020 Jan 24.

license: publisher-specific-oa

license_normalized: publisher-specific

sponsor_collaborators:
UNICANCER
Fondation ARC
AstraZeneca

location_facility: Institut de Cancérologie de l'Ouest/ René Gauducheau

location_facility: Institut de Cancérologie de l'Ouest/Paul Papin

location_facility: Institut Régional du Cancer Montpellier Val d'Aurelle

location_facility: Hopitaux Universitaire de Strasbourg - Hopital Civil

title: PERSONALIZED MEDICINE GROUP / UCBG UC-0105/1304: SAFIR02_Breast - Evaluation of the Efficacy of High Throughput Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer

collaborators:
Fondation ARC
AstraZeneca


title: Comparison of the Performance Indicators (Sensitivity and Specificity) of qSOFA, SIRS, NEWS, and RETTS Scores, for Diagnosis of the Infected Patient at the Emergency Department Triage

acronym: DIAGNOSED

summary:
Septic pathology is an extremely frequent reason for consultation in our emergency services, with an annual incidence of severe forms between 50 to 95 cases per 100,000 inhabitants and a constant increase estimated at 9% per year. Diagnosing these patients early and precisely is a major challenge for the clinician, as this diagnosis will lead to more or less aggressive medical management.

The criteria of S.I.R.S, used to define and to sort patients in sepsis according to the old definition, were completely abandoned in the last recommendations for lack of specificity but also of sensitivity. The latest recommendations suggest using another score, the "Quick Sepsis Related Organ Failure Assesment (qSOFA) score", in order to early detect septic patients at risk of poor progress. However, the recent literature highlights a very low sensitivity of the qSOFA score for the screening of septic patients, ranging from 30 to 60% according to the studies. In addition to qSOFA, other scores are described in the literature with apparently higher sensitivity, and thus seem more suitable for our daily practice. Among them is the NEWS score or the RETTS score.

Each of these scores is again based upon the values of vital signs recorded as soon as the patient arrives in the emergency department. To date, very few studies have been interested, in a prospective way, in the sensitivity and the specificity of these different scores to diagnose the "infected" patients in the emergency departments.

Therefore a non-interventional, prospective, multicenter cohort study is carried out here, in order to be able to compare, on the same cohort of patients admitted into emergency services, the diagnostic performance of these different scores with respect to the presence or absence of an infection.

The aim of this study is to define the best clinical score to use in emergency medicine to quickly diagnose the infected patients, and offer them the best medical care.

lead_sponsor: Association pour la Formation l'Enseignement et la Recherche du Service de l'Accueil des Urgences

collaborators: Collège de Médecine d'Urgence de la Région PACA (COPACAMU)

location_facility: Centre Hospitalier Universitaire de Nice

intervention_type: Diagnostic Test


title: A Double Blind, Placebo-controlled, Randomized, 15-day Treatment, Pharmacodynamics, Safety, and Pharmacokinetics Study of THN201 Versus Donepezil Administered Orally to Healthy Male Volunteers Including a Scopolamine Challenge

summary: This study explores the safety, pharmacodynamics and pharmacokinetics of THN201 a combination of donepezil and mefloquine to improve cognitive function in healthy male volunteers after impairment by a scopolamine challenge.

lead_sponsor: Theranexus

location_facility:
Biotrial
CHU Grenoble
CHU Toulouse
CHU Lille
CHU Bordeaux
CHU Clermont Ferrand
CHU Marseille


title: External Validation of a Quantitative Computer Aided Diagnostic (QCAD) System for Prostate mpMRI

acronym: DIJON-CAD

summary:
Multiparametric magnetic resonance imaging (mpMRI) of the prostate combines T2-weighted imaging, diffusion-weighted imaging and dynamic contrast-enhanced imaging. Correlation with radical prostatectomy specimens has demonstrated that mpMRI has excellent sensitivity in detecting prostate cancers (PCa) with a Gleason score ≥7 and cancers with a Gleason 6 and a volume ≥0.5 cc. Nevertheless, its specificity is poor and there is large overlapping between the appearances of benign and malignant prostate lesions. As a result, the use of a 5-point subjective score has been widely encouraged to describe the level of suspicion of prostate lesions. This so-called 'Likert score' is a highly significant predictor of the malignant nature of prostate focal lesions. However, because there are no descriptions of specific criteria to be used in the scoring process, the Likert score relies heavily on the reader's experience.

In an attempt to standardize mpMRI interpretation, the European Society of Urogenital Radiology and the American College of Radiology recently endorsed the so-called Prostate Imaging-Reporting and Data System (PIRADS) score. The second version of this scoring system (PI-RADS v2 score) gave good results in characterizing prostate focal lesions. However, Inter-reader agreement remains moderate at best, even after training, and there is still a high-rate of false positives. These results have led some authors to suggest that there might be structural limits to the ability of any score based on MR imaging to allow detection of prostate cancer with high specificity.

Using quantitative magnetic resonance (MR) image features to characterize prostate lesions seen on mpMRI could improve interpretation standardization, and recently, several computer-aided diagnosis (CAD) systems combining various image features have shown promising results in characterizing prostate tissues. However, most CAD systems have been trained and evaluated on images from the same MR scanner. Unfortunately, quantification in MR imaging is limited by substantial inter-manufacturer variability in the calculation of quantitative image parameters. The quantitative thresholds defined for one manufacturer may therefore not be valid for another manufacturer. Of the many reported CAD systems, only few have shown robust results at cross-validation in datasets from different manufacturers.

We developed in Lyon a mpMRI CAD system for discriminating Gleason ≥7 cancers in the peripheral zone (PZ). That CAD system was trained using mpMRI from patients treated by radical prostatectomy. It combines the 10th percentile of the apparent diffusion coefficient (ADC_10th) and the time to the peak of enhancement (TTP) at dynamic contrast-enhanced (DCE) imaging. It provided good results when cross-validated in two datasets from two different manufacturers (General Electric and Philips). We then tested the CAD on a cohort of 130 patients who underwent mpMRI (General Electric or Philips MR unit) before prostate biopsy. Each MR lesion targeted at biopsy had prospectively received a Likert score of likelihood of malignancy at the time of the biopsy. Retrospective analysis of these MR lesions with the CAD showed that the stand-alone CAD outperformed the Likert score in predicting the presence of Gleason ≥7 cancer at biopsy (Area under the receiver operating characteristic curve (AUC): 0.94 (95% confidence interval (95CI): 0.90-0.98 versus 0.81 (95CI: 0.75-0.88), p<0.0002)). These good results encourage us to perform an external validation of the CAD testing its performance on mpMRI from another manufacturer (Siemens) and another institution.

The principal objective of the DIJON-CAD study is to evaluate the performances of the QCAD developed in Lyon (QCAD/Lyon) in a cohort of consecutive patients treated by prostatectomy and who underwent preoperative mpMRI on a Siemens 3 Tesla MR imager at the Dijon University Hospital center or at the Dijon Cancer Center (both institutions share the same MR unit). This study is the first step of the external validation of the QCAD/Lyon system. It is only aimed at verifying that the diagnostic performance of the system is not very poor on external mpMRI (which is a substantial risk). If the results are good, a proper multicentric prospective validation study will be planned.

lead_sponsor: Hospices Civils de Lyon

location_facility: Department of vascular and urinary imaging, hôpital Edouard Herriot, Hospices Civils de Lyon

location_facility: Department of biostatistics, Université Joseph Fourrier

location_facility: Department of radiology and nuclear medicine, Centre anti-cancéreux Georges-François Leclerc, Dijon


title: Dulaglutide and Insulin MicrosecretiON in Type 1 Diabetes : A Randomized Double-blind Placebo-controlled Trial

acronym: DIAMOND GLP1

summary:
Some patients with type 1 diabetes (T1D) can still have some remaining insulin-positive cells in the pancreas and secrete little amounts of insulin. Despite the presence of residual beta cells, the HbA1C levels remain at high levels due to functional defects of insulin secretion associated with glucotoxicity. Previous trials have indicated that treatment with a Glucagon-like peptide 1 (GLP-1 )receptor agonist in T1D with some residual beta-cell function might improve glycemic control, reduce dose of insulin and risk of hypoglycemia.

The general hypothesis of DIAMOND-GLP1 is that GLP1-R agonists will improve blood glucose

After initial screening to select insulin microsecretors and a run-in period of one month, patients will be randomized into two arms and followed in parallel for 24 weeks :

Experimental group receiving 1.5 mg Dulaglutide s.c weekly in addition to their usual insulin regimen
Control group receiving placebo s.c weekly in addition to their usual insulin regimen.

The primary endpoint is HbA1c value at 24 weeks

location_facility: Service de Diabétologie, Maladies Métaboliques, Nutrition ; CHU Nancy ; Technopôle Nancy-Brabois ; Rue du Morvan,

location_facility: Département d''Endocrinologie, Diabétologie, Nutrition ; CHU Montpellier ; Hôpital Lapeyronie, Avenue du Doyen Giraud

location_facility: Service de Diabétologie et Maladies Métaboliques, Assistance Publique des Hôpitaux de Paris ;Hôpital Cochin, 27 rue du Faubourg Saint-Jacques

location_facility: Service de Diabétologie Maladies Métaboliques et Nutrition ; CHU Toulouse, Pôle cardiovasculaire et métabolique, Hôpital Rangueil ; 1, avenue du Professeur Jean Poulhès - TSA 50032

location_facility: Service d'Endocrinologie, Diabétologie, Maladies de la Nutrition, Hospices Civils de Lyon, Centre hospitalier Lyon-Sud

location_facility: Service d'Endocrinologie, Maladies Métaboliques et Nutrition, CHU Grenoble, Hopital de la Tronche

location_facility: Service d'Endocrinologie, Maladies Métaboliques et Nutrition,CHU Nantes,Hôpital Nord Laennec,Bd Jacques-Monod,Saint-Herblain

region: Auvergne-Rhône-Alpes

nom_etablissement: HOSPICES CIVILS DE LYON

acronyme: DIAMOND

titre: Microsécrétion d'insuline au cours du diabète de type 1: les agonistes du récepteur du GLP1 peuventils améliorer l'équilibre glycémique? Etude randomisée en doubleaveugle contre placebo, DIaMOND: Dulaglutide and Insulin MicrosecretiON in type 1 Diabetes

discipline_principale: endocrinologie / diabétologie / métabolisme et nutrition

nom_porteur: Thivolet

prenom_porteur: Charles


title: Follow-up of HBsAg Inactive Carriers Study

acronym: PIBAC

summary: The definition of HBs antigen (HBsAg) inactive carrier status has evolved during time. We spoke first from HBsAg" healthy carrier ", then from " asymptomatic carrier ", last from HBsAg" inactive carrier ". This definition continue to be not totally consensual. A very low viral load (< 2000 UI/ml) or undetectable, associated with repetitive normal transaminases and with detectable anti-HBe antibodies were necessary to affirm the inactive carrier status on 2009 EASL recommendations. The 2012 EASL recommendations confirm that the normality of alanine aminotransferase (ALT) with an upper limit of normal (ULN) approximately below 40 UI/ml, like low viral load (HBV-DNA), does necessary be verified every 3 or 4 months during a year to diagnose an inactive carrier. Nevertheless, they admit the possibility for some patients to be inactive carriers with HBV-DNA between 2000 and 20000 UI/ml with consistently normal transaminases This study will follow-up HBsAg inactive carriers during 5 years, in order to evaluate the incidence of unfavourable liver events: chronic hepatits B, liver cirrhosis, hepatocarcinoma (CHC) during this time, and to determine the independant prognosis criteria of unexpected arrival of such events. Secondary outcomes will evaluate HBsAg quantification for the prognosis of such events or, in contrary HBs seroconversion; will evaluate the influence of B genotype on HBsAg level; will evaluate the influence of comorbidities on unexpected arrival of such events.

lead_sponsor: Centre Hospitalier Régional d'Orléans

collaborators: INSERM U785-CNR Hôpital Paul Brousse 94800 VILLEJUIF

location_facility:
Medical Center Besancon
Ch General Du Pays D'Aix
Medical Center La Sauvegarde
CH CREIL
CHR d'ORLEANS
Ch de Caen
Hopital Saint Jean
CH MELUN
Medical Center Paris 7
Ch Du Mans
Ch de Pau
Ch de Creteil
Chd Vendee
Chi Villeneauve Saint Georges
Ch Montelimar
CH d'AVIGNON
Clinical Center Montpellier
Ch Saint Brieuc
Ch Sud Fracilien Jean Jaures
Ch D'Hyeres
Clinique de La Chataigneraie
Clinical Center Bourgoin Jallieu
Clinique Du Palais
Hopital Sainte Camille
Medical Center Nanterre
Ch de Lagny Marne La Valee
Ch de Montfermeil
Ch de Saint Denis
Ch de Meaux
Ch de Vannes
CH de GONESSE
Ch de La Region Annnecienne


title: Evaluation of the Clinical Utility and Cost Effectiveness Ratio of Generalized Neonatal Screening for Severe Combined Immunodeficiencies (SCID) by Quantification of TRECs on Guthrie Cards

acronym: DEPISTREC

summary:
Severe combined Immunodeficiencies ( SCID ) are a group of inherited diseases of the immune system by characterised profound abnormalities of T cell development . Infants with SCID require prompt clinical response to Prevent life -threatening infection and studies show significantly improved survival in babies Diagnosed at birth as a result of previous family history . SCID follows criteria for population -based newborn screening since it is asymptomatic at birth and fatal within the first year of life, the confirmation of the disease is easy, there is a curative treatment , and it is known that early stem cell transplantation improves survival . Quantification of TRECs (T- cell receptor excision circles ) in DNA extracted from Guthrie samples is a sensitive screening test for Specific and SCID .

The investigators propose in this study to perform a neonatal screening of SCID , in a population of 200,000 babies over a period of two years .

The investigators propose to study the clinical utility and cost effectiveness ratio, and SCID screening to demonstrate that could result in a broad benefit to Individuals detected , making screening relatively cost-effective in spite of the low incidence of the disease .

primary_purpose: Screening

ReferenceCitation: Thomas C, Durand-Zaleski I, Frenkiel J, Mirallie S, Leger A, Cheillan D, Picard C, Mahlaoui N, Riche VP, Roussey M, Sebille V, Rabetrano H, Dert C, Fischer A, Audrain M. Clinical and economic aspects of newborn screening for severe combined immunodeficiency: DEPISTREC study results. Clin Immunol. 2019 May;202:33-39. doi: 10.1016/j.clim.2019.03.012. Epub 2019 Apr 1.

ReferenceCitation: Audrain MAP, Leger AJC, Hemont CAF, Mirallie SM, Cheillan D, Rimbert MGM, Le Thuaut AM, Sebille-Rivain VA, Prat A, Pinel EMQ, Divry E, Dert CGL, Fournier MAG, Thomas CJC. Newborn Screening for Severe Combined Immunodeficiency: Analytic and Clinical Performance of the T Cell Receptor Excision Circle Assay in France (DEPISTREC Study). J Clin Immunol. 2018 Oct;38(7):778-786. doi: 10.1007/s10875-018-0550-7. Epub 2018 Sep 24.

lead_sponsor: Nantes University Hospital

location_facility: Toulouse Private Hospital Clinique Sarrus Teinturiers

location_facility: Bordeaux Maison de Santé Protestante Bordeaux Bagatelle

location_facility: Saint-Herblain Private Hospital Polyclinique de l'Atlantique

location_facility: Marseille University Hospital La Conception

location_facility: Nantes Private Hospital Clinique Jules Verne

location_facility: Corbeil Essonnes Hospital Sud Francilien

location_facility: Toulouse University Hospital P. DE VIGUIER

location_facility: Paris University Hospital Armand-Trousseau

location_facility: Strasbourg Private Hospital Clinique Adassa

location_facility: Poissy Hospital CHI Poissy-Saint-Germain

location_facility: Rennes Private Hospital Clinique Mutualiste La Sagesse

location_facility: Aulnay-sous-Bois Hospital CHI Robert Ballanger

location_facility: Saint-Martin-d'Hère Private Hospital Clinique Belledonne

location_facility: Angers Private Hospital Clinique de l'Anjou

location_facility: Bordeaux Private Hospital Polyclinique Bordeuax Nord Aquitaine

location_facility: Paris University Hospital La Pitié Salpétrière

appel_a_projets: PRME

region: Pays de la Loire

nom_etablissement: CHU DE NANTES

acronyme: DEPISTREC

titre: Evaluation de l'utilité clinique et médico-économique du dépistage néonatal généralisé des Déficits Immunitaires Combinés Sévères (DICS) par quantification des TRECs sur cartes de Guthrie

discipline_principale: biologie

nom_porteur: Audrain

prenom_porteur: Marie


title: Randomized, Multicenter, Phase II/III Study, Evaluating Fractionated Cisplatin Chemotherapy/Gemcitabine Versus Carboplatin/Gemcitabine in the Treatment of Advanced or Metastatic Urothelial Cancer With Impaired Renal Function.

acronym: VEFORA

summary:
This is a phase II/III, multicenter, randomized study which includes 420 patients on six years + 3 years follow up. 92 patients will be included during the phase II ; additional 328 patients will be included.

Patients with an advanced or metastatic urothelial cancer with impaired renal function will be randomized in one of the two following chemotherapy arm:

Fractionated Cisplatin + Gemcitabine.
Carboplatin + Gemcitabine.

The main objective of the part II study will be to evaluate the efficacy and the safety of a chemotherapy with a doublet platinum salt compound/Gemcitabine with fractionated Cisplatin or Carboplatin in this population.

The main objective of the part III study will be to compare the efficacy in terms of overall survival of a chemotherapy with a doublet platinum salt/Gemcitabine with fractionated Cisplatin or Carboplatin in this population.

lead_sponsor: Institut Claudius Regaud

location_facility: Institut de Cancerologie Lucien Neuwirth

location_facility: INSTITUT DE CANCEROLOGIE DE L'OUEST - Site René Gauducheau

location_facility: INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Paul Papin


title: Evaluation of the Efficacy and Safety of an Infant Formula Containing Synbiotics and Its Effects on the Incidence of Infectious Diseases in the Infant Gut : a Double-blind, Randomized, Controlled Interventional Study

acronym: GOLFIII

summary: The primary objective of this study is to demonstrate that a synbiotic formula, fed for the duration of the first year of life (infant and follow-on formula) reduces the incidence rate of episodes of infectious diarrhea in infants during the first year of life compared to a standard infant formula.

lead_sponsor: HiPP GmbH & Co. Vertrieb KG

sponsor_collaborators:
HiPP GmbH & Co. Vertrieb KG
Biofortis Mérieux NutriSciences

location_facility: C.I.C pédiatrique - C.H.U. de Nantes - Hôpital Mère-Enfant

location_facility: C.I.C Pédiatrique - C.H.U. de Grenoble - Hôpital Couple-Enfant

intervention_type: Dietary Supplement


acronym: MS-ON

lead_sponsor: MedDay Pharmaceuticals SA

summary: The purpose of this study is to demonstrate the superiority of MD1003 over placebo in the visual improvement of patients suffering from chronic visual loss resulting from multiple sclerosis related optic neuritis.

ReferenceCitation: Tourbah A, Gout O, Vighetto A, Deburghgraeve V, Pelletier J, Papeix C, Lebrun-Frenay C, Labauge P, Brassat D, Toosy A, Laplaud DA, Outteryck O, Moreau T, Debouverie M, Clavelou P, Heinzlef O, De Seze J, Defer G, Sedel F, Arndt C. MD1003 (High-Dose Pharmaceutical-Grade Biotin) for the Treatment of Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis: A Randomized, Double-Blind, Placebo-Controlled Study. CNS Drugs. 2018 Jul;32(7):661-672. doi: 10.1007/s40263-018-0528-2.

oa_colors: green hybrid

evidence: open (via page says license)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
HAL
PubMed Central
UCL Discovery

repositories_concat: HAL;PubMed Central;UCL Discovery

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

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

location_facility: Centre hospitalier Intercommunal Poissy/Saint-Germain-en-Laye

location_facility: Centre hospitalier national d'ophtalmologie des Quinze Vingts

title: Effect of MD1003 in Chronic Visual Loss Related to Optic Neuritis in Multiple Sclerosis: a Pivotal Randomized Double Masked Placebo Controlled Study

location_country:
United Kingdom
France


title: Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot Study

acronym: ITS-PILOT

summary:
Ectopic soft tissue calcifications or ossifications can complicate the course of numerous diseases; most of them are rare or very rare. Even if the clinical, radiological and pathological presentation of ectopic calcifications and ossifications are different, the same hypotheses are discussed considering their hypothetical pathophysiology. Indeed, high calcium phosphate product, local cellular lesions and abnormal transdifferentiation of mesenchymal cells are regularly evoked when pathophysiology of such calcifications or ossifications are discussed. Apart from several case reports that have not been confirmed so far, no medical treatments are available, leading to significant pain and impairment of quality of life for patients. Therefore, only surgical treatment can be proposed when the volume or the consequences of these calcifications/ossifications become too important.

Sodium thiosulfate (STS) is currently used as a cyanide poisoning antagonist and a chemoprotectant against adverse effects of several chemotherapies such as Cisplatin. Numerous case reports and several studies have revealed the potential interest of STS in the treatment of uremic induced vascular or soft tissues calcifications. Recently, our group has developed an expertise in the use of STS for the treatment of ectopic soft tissue calcifications or ossifications. Considering these promising preliminary data, and their limits, we developed a strategy to treat soft tissue calcifications or ossifications based on a local administration of STS. The first results of this therapeutic strategy are highly promising and the local or systemic safety is satisfactory so far. These preliminary data also reported by others deserve to be confirmed in a prospective study.

We propose in this project to conduct a prospective open controlled phase II trial in order to assess the efficacy and the safety of intralesional administration of STS for the treatment of calcifications secondary to dermatomyositis or systemic sclerosis and ectopic ossifications secondary to pseudo-hypoparathyroidism 1a type (PHP1A/iPPSD2) (inactivating parathyroid hormone / parathyroid-hormone-related peptid (PTH/PTHrP) signalling disorder).

location_facility:
Hospice Civil de Lyon
CHU de Toulouse
CHU de Limoges
CHU de ROUEN
CHU de BORDEAUX
ApHp - hôpital Lariboisière
ApHp - Hôpital Bicêtre

acronyme: ITS-Pilot

titre: Injections intralésionnelles de thiosulfate de sodium dans le traitement de calcifications ou d'ossifications ectopiques. Etude pilote.

nom_porteur: Guigonis

prenom_porteur: Vincent


title: Efficacy of Flash Continuous Glucose Monitoring (FREESTYLE LIBRE) on the Occurrence of Cardiac Arrhythmias Associated With Hypoglycemia in Patients With Type 2 Diabetes, High Risk of Hypoglycemia and Insulin Therapy : Open-label Randomized Controlled Trial

summary:
Hypoglycemia, frequently asymptomatic, may lead to cardiac arrythmias and induce an increased risk of cardiovascular morbidity and mortality in patients with type 2 diabetes (T2D). The study hypothesize is that the hypoglycemia reduction, achieved with the FREESTYLE LIBRE device, a Glucose Continuous Monitoring system, may decrease cardiac arrythmias associated with hypoglycemia. So the main objective is to evaluate the efficacy of the FREESTYLE LIBRE system, associated with a specific therapeutic education on the cardiac arrythmias reduction, compared to a capillary ASG system with standard therapeutic education, in patient with T2D with high risk of hypoglycemia.

This is a open, multicenter, controlled, randomized study in parallel group.

lead_sponsor: Poitiers University Hospital

location_facility:
Hospital, Pau
University Hospital, Limoges
University Hospital, Bordeaux
Hospital, Niort
University Hospital, Nantes
University Hospital, Poitiers
University Hospital, Toulouse


title: Randomized, Open-label, Multicenter Study of Azithromycin Compared With Doxycycline for Treating Anorectal Chlamydia Trachomatis Infection Concomitant to a Vaginal Infection

acronym: CHLAZIDOXY

summary:
Chlamydia trachomatis is the most commonly reported bacterial sexually transmitted infection (STI), especially among young women. Up to 75% of C. trachomatis infected women are asymptomatic. If untreated, C. trachomatis infection can cause sequelae such as pelvic inflammatory disease, ectopic pregnancy and tubal factor infertility. C. trachomatis can also cause anorectal infections, which are typically asymptomatic. Among women with urogenital chlamydial infection, around 36-91% also had concurrent anorectal chlamydial. Notably, there was no association with anal intercourse in the studies that reported it. However, guidelines do not recommend routine anorectal testing, but restricted testing in people who are in high-risk groups, report anal sexual behavior, or have anal symptoms, i.e., on selective indications. This is in contrast to urogenital testing, which is a routine procedure in STI care services.

The anal transmission of C. trachomatis in women may occur by autoinoculation from the vagina due to the close proximity of the vagina and the anus. C. trachomatis could lead to a persistent infection in the lower gastrointestinal tract, suggesting the potential role of autoinoculation of cervical chlamydial infection from the rectal site. Such (repeat) urogenital infections could lead to reproductive tract morbidity. Recommended treatments for C. trachomatis infections are a single 1g dose of azithromycin or 100mg of doxycycline 2 times a day for 7 days. Although these two regimens are equivalent for urogenital infection, no study has compared the effectiveness of these two treatments on anorectal infection. If rectal C. trachomatis is a hidden reservoir influencing transmission rates, and considering the potential complications of cervical infections, providing further evidence of the need for effective rectal treatments among women is highly relevant.

ReferenceType: result

ReferenceCitation: Rank RG, Yeruva L. Hidden in plain sight: chlamydial gastrointestinal infection and its relevance to persistence in human genital infection. Infect Immun. 2014 Apr;82(4):1362-71. doi: 10.1128/IAI.01244-13. Epub 2014 Jan 13.

oa_colors: green other

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: American Society for Microbiology

ReferenceCitation: Kong FY, Tabrizi SN, Fairley CK, Vodstrcil LA, Huston WM, Chen M, Bradshaw C, Hocking JS. The efficacy of azithromycin and doxycycline for the treatment of rectal chlamydia infection: a systematic review and meta-analysis. J Antimicrob Chemother. 2015 May;70(5):1290-7. doi: 10.1093/jac/dku574. Epub 2015 Jan 29.

publisher_dissemination: Oxford University Press

ReferenceCitation: Kong FY, Hocking JS. Treatment challenges for urogenital and anorectal Chlamydia trachomatis. BMC Infect Dis. 2015 Jul 29;15:293. doi: 10.1186/s12879-015-1030-9.

repositories_concat: PubMed Central;University of Melbourne - Minerva Access

ReferenceCitation: Peuchant O, Lhomme E, Martinet P, Grob A, Baita D, Bernier C, Gibaud SA, Le Hen I, Le Naour E, Trignol-Viguier N, Lanotte P, Lefebvre P, Vachee A, Girard T, Loubinoux J, Bebear C, Ghezzoul B, Roussillon C, Kret M, de Barbeyrac B; CHLAZIDOXY Study Group. Doxycycline versus azithromycin for the treatment of anorectal Chlamydia trachomatis infection in women concurrent with vaginal infection (CHLAZIDOXY study): a multicentre, open-label, randomised, controlled, superiority trial. Lancet Infect Dis. 2022 Aug;22(8):1221-1230. doi: 10.1016/S1473-3099(22)00148-7. Epub 2022 May 9.

evidence: open (via crossref license, author manuscript)

version: acceptedVersion

ReferenceCitation: Peuchant O, Lhomme E, Kret M, Ghezzoul B, Roussillon C, Bebear C, Perry F, de Barbeyrac B; and the Chlazidoxy study group. Randomized, open-label, multicenter study of azithromycin compared with doxycycline for treating anorectal Chlamydia trachomatis infection concomitant to a vaginal infection (CHLAZIDOXY study). Medicine (Baltimore). 2019 Feb;98(7):e14572. doi: 10.1097/MD.0000000000014572.

collaborators: USC EA 3671 Infections humaines à mycoplasmes et à chlamydiae

location_facility:
CeGGID - Bordeaux
Hôpital Hôtel Dieu
Hôpital de Roubaix
CHRU Tours
CHU de Nantes
CHU de Bordeaux
CeGIDD - Marseille

titre: Etude multicentrique randomisée en double aveugle comparant l'azithromycine à la doxycycline pour le traitement de l'infection anorectale à Chlamydia trachomatis concomittante à l'infection vaginale.


type: Other Grant/Funding Number

title: Analgesia of Acute Coronary Syndromes With ST-segment Elevation in a Pre-hospital Setting. Randomized Non-inferiority Trial of the Association MEOPA + Paracetamol Versus Morphine.

acronym: SCADOLII

summary: In the management of acute coronary syndromes with ST-segment elevation (STEMI), early analgesia reduces the effects of hyperadrenalism which increases the size of myocardial infarction. In order to reduce pain intensity, the recommendations advocate emergency use of morphine. In STEMI patients, other analgesic treatments could provide analgesia that is at least as effective as morphine. The equimolar oxygen/nitrous oxide mixture (MEOPA) is widely used in emergency medicine and has minor secondary effects that are very rapidly reversible when inhalation is discontinued. Used in association with paracetamol, it could be an at least equally effective alternative to the use of morphine.

ReferenceCitation: Danchin N, Puymirat E, Aissaoui N, Adavane S, Durand E. [Epidemiology of acute coronary syndromes in France and in Europe]. Ann Cardiol Angeiol (Paris). 2010 Dec;59 Suppl 2:S37-41. doi: 10.1016/S0003-3928(10)70008-1. French.

ReferenceCitation: Myocardial infarction redefined--a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. Eur Heart J. 2000 Sep;21(18):1502-13. doi: 10.1053/euhj.2000.2305.

ReferenceCitation: Task Force for Diagnosis and Treatment of Non-ST-Segment Elevation Acute Coronary Syndromes of European Society of Cardiology; Bassand JP, Hamm CW, Ardissino D, Boersma E, Budaj A, Fernandez-Aviles F, Fox KA, Hasdai D, Ohman EM, Wallentin L, Wijns W. Guidelines for the diagnosis and treatment of non-ST-segment elevation acute coronary syndromes. Eur Heart J. 2007 Jul;28(13):1598-660. doi: 10.1093/eurheartj/ehm161. Epub 2007 Jun 14. No abstract available.

ReferenceCitation: Van de Werf F, Bax J, Betriu A, Blomstrom-Lundqvist C, Crea F, Falk V, Filippatos G, Fox K, Huber K, Kastrati A, Rosengren A, Steg PG, Tubaro M, Verheugt F, Weidinger F, Weis M; ESC Committee for Practice Guidelines (CPG). Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation: the Task Force on the Management of ST-Segment Elevation Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J. 2008 Dec;29(23):2909-45. doi: 10.1093/eurheartj/ehn416. Epub 2008 Nov 12. No abstract available.

ReferenceCitation: Canadian Cardiovascular Society; American Academy of Family Physicians; American College of Cardiology; American Heart Association; Antman EM, Hand M, Armstrong PW, Bates ER, Green LA, Halasyamani LK, Hochman JS, Krumholz HM, Lamas GA, Mullany CJ, Pearle DL, Sloan MA, Smith SC Jr, Anbe DT, Kushner FG, Ornato JP, Pearle DL, Sloan MA, Jacobs AK, Adams CD, Anderson JL, Buller CE, Creager MA, Ettinger SM, Halperin JL, Hunt SA, Lytle BW, Nishimura R, Page RL, Riegel B, Tarkington LG, Yancy CW. 2007 focused update of the ACC/AHA 2004 guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2008 Jan 15;51(2):210-47. doi: 10.1016/j.jacc.2007.10.001. No abstract available. Erratum In: J Am Coll Cardiol. 2008 Mar 4;51(9):977.

ReferenceCitation: Charpentier S, Galinski M, Bounes V, Ricard-Hibon A, El-Khoury C, Elbaz M, Ageron FX, Manzo-Silberman S, Soulat L, Lapostolle F, Gerard A, Bregeaud D, Bongard V, Bonnefoy-Cudraz E; SCADOL II investigators. Nitrous oxide/oxygen plus acetaminophen versus morphine in ST elevation myocardial infarction: open-label, cluster-randomized, non-inferiority study. Scand J Trauma Resusc Emerg Med. 2020 May 12;28(1):36. doi: 10.1186/s13049-020-00731-y.

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

lead_sponsor: University Hospital, Toulouse

location_country: Réunion France

location_facility: Centre Hospitalier Départemental La Roche/Yon

location_facility: Groupe hospitamier Lariboisière-Fernand Widal-St-Louis

location_facility: Centre Hospitalier Poulon la Seyne-sur-mer

acronyme: SCADOL II

titre: Analgésie des syndromes coronaires aigus avec sus décalage du segment ST en pré hospitalier : essai randomisé de non infériorité de l'association MEOPA+paracétamol versus Morphine.Etude SCADOL II

discipline_principale: médecine d'urgence

nom_porteur: CHARPENTIER

prenom_porteur: Sandrine


title: A Phase II Trial of SGI-110 in Patients With IPSS High and Int 2 Myelodysplastic Syndrome, Acute Myeloid Leukemia With 20-30% Marrow Blasts or Chronic Myelomonocytic Leukemia Type 2 Not Responding to Azacitidine or Decitabine After at Least 6 Courses or Relapsing After a Response

summary: Treatment of patients with WHO defined IPSS int 2 and high risk MDS , AML with 20-30% marrow blasts and CMML type 2, after failure of azacitidine or decitabine exposure for at least 6 courses, or relapse after initial response.

lead_sponsor: Groupe Francophone des Myelodysplasies

sponsor_collaborators:
Groupe Francophone des Myelodysplasies
Astex Pharmaceuticals, Inc.

location_facility: Hopital Purpan Service d'Hématologie Clinique

location_facility: Centre Hospitalier de la région d'Annecy


title: Multicenter, Randomized Study, Evaluation of Adapted Physical Activity Program in Patients With Unresectable, Locally Advanced or Metastatic Pancreatic Cancer

summary:
Adapted Physical Activity (APA) program may provide an opportunity to improve symptoms for patients with unresectable pancreatic cancer.

Thereby, it is proposed to conduct an open trial to assess effects of the APA program in such population

primary_purpose: Basic Science

ReferenceCitation: Neuzillet C, Vergnault M, Bonnetain F, Hammel P. Rationale and design of the Adapted Physical Activity in advanced Pancreatic Cancer patients (APACaP) GERCOR (Groupe Cooperateur Multidisciplinaire en Oncologie) trial: study protocol for a randomized controlled trial. Trials. 2015 Oct 12;16:454. doi: 10.1186/s13063-015-0983-8.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
Hôpital FOCH
Centre Léon Bérard
Hôpital Henri Mondor
Hôpital Européen
Hôpital Cochin
Hôpital Saint Antoine
Centre Hospitalier de Belfort
CHD Vendée
Institut de cancérologie de Lorraine
CHU Morvan
CH Saint Joseph Saint Luc
Hôpital Beaujon
Institut Hospitalier Franco-Britannique
CHU Robert Debré
CH Mont de Marsan
Centre Georges François Leclerc
Polyclinique Bordeaux Nord Aquitaine


title: Evaluation of ONYX in ENDOVASCULAR Treatment of Cerebral AVMs. Prospective, Multi-center and Observational French Study

acronym: cAVM

summary: To assess safety and efficacy of ONYX treatment for cAVM:

ipd_sharing_description: No individual participant data will be available

lead_sponsor: Medtronic Neurovascular Clinical Affairs

location_facility:
CHU Nantes
CHRU Tours
CHU Strasbourg
Groupe Hospitalier Pitier Salpetrière
CHU Toulouse
CHU Gabriel Montpied
Hôpital GUI DE CHAULLAC
CHU Besançon
Chu Pellegrin
CHI Dijon
CHU Pontchaillou
Hôpital Beaujon
Fondation Ophtamoligique Rothschild
Hôpital Bicêtre
CHU Côte de Nacre
HIA Sainte Anne
CHP Clairval


title: Evaluation of the Serum Markers sFLt1 and PlGF for the Prediction of the Complications of the Placental Vascular Pathologies in the 3rd Quarter of the Pregnancy.

acronym: PRECOPE

summary:
The pre-eclampsia is a frequent pathology, concerning approximately 5 % of the pregnancies.The pre-eclampsia can evolve into severe maternal and\or foetal complications and is a major cause of mortality.

The purpose of the study will to estimate the relevance of the serum markers sFlt1 and PlGF to predict the arisen of severe complications at these patients, what would allow to decrease the materno-fœtale morbi-mortality due to the pathology.

lead_sponsor: Centre Hospitalier Metropole Savoie

location_facility:
Groupe Hospitalier du Havre
CHU de Limoges
CHU de Brest
Centre Hospitalier Alpes Léman
CHMetropoleSavoie
Centre Hospitalier Annecy Genevois
Hôpitaux du Léman


title: Phase II Study, Stratified, Non-randomized, Estimating SBRT Efficiency and Toxicity in Primary and Secondary Liver Tumors

acronym: STEREOLIVER

summary: Intervention research involving the human person, phase II, prospective, multicentric, non-randomized and multi-cohort study. The eligibility criteria are broad, on purpose, so every patient, able to be treated by SBRT and unable to participate in another trial (non eligible patient or non included centers), can be included in this national study, in a prospective way.

lead_sponsor: Centre Oscar Lambret

sponsor_collaborators:
Centre Oscar Lambret
Canceropôle Nord Ouest

location_facility: Institut Régional du Cancer de Montpellier

intervention_type: Radiation


title: Hepatic Arterial Infusion of Gemcitabine-oxaliplatin for Second-line Therapy in Non-metastatic Unresectable Intra-hepatic Cholangiocarcinoma: a Multicentric Single-arm Phase II Study

summary: We hypothesized that intra-arterial gemcitabine/oxaliplatin administered as second-line treatment could strongly improve objective response rate at 4 months after inclusion in patient with non-metastatic unresectable intra-hepatic cholangiocarcinoma.

lead_sponsor: University Hospital, Montpellier

collaborators: Federation Francophone de Cancerologie Digestive

location_facility:
Hôpital Européen Georges Pompidou
Angers University Hospital
Centre Georges François Leclerc
Uhmontpellier
Amiens University Hospital
Institut Gustave Roussy
Bordeaux University Hospital


title: Multicentric, Randomized, Phase III Trial Comparing 2 Strategies in Patients With Non-squamous Non-small Cell Lung Cancer With Asymptomatic Brain Metastases

summary:
The patients carrying a complicated primary lung cancer brain metastases die in less than 3 months of delay disease in the absence of treatment. The median survival of these patients is approximately six months when the treatment associated with radiotherapy chemotherapy based on cisplatin is now the standard treatment. In most studies the patients die of their brain disease in one case only two, so it is likely that some patients do not require brain irradiation (prognosis in this case is linked to extra-cerebral disease ). The benefits for patients in group B (without systematic irradiation) are not to suffer the side effects of this radiation. The risks are in the same group to see brain metastases become symptomatic.

The role of cerebral radiotherapy in the patients treated with chemotherapy is unclear: should all patients be irradiated systematically (since the "reference" treatment is involved and with the aim of obtaining better control of the brain lesions and maintaining a better neurological status) or should only the patients showing cerebral progression be irradiated (avoidance of possibly useless brain radiotherapy and its side effects). The aim of this study is to better determine the position of cerebral radiotherapy in this context.

Main objective:

determine whether there is a difference in terms of progression-free survival between a therapeutic strategy with initial systematic brain radiotherapy followed by chemotherapy cis-platine/alimta + / - Bevacizumab and strategy with an initial chemotherapy cis-platine/alimta + / - Bevacizumab associated with brain radiotherapy only in cases of cerebral progression in patients with NSCLC with asymptomatic brain metastases

ReferenceCitation: Monnet I, Vergnenegre A, Robinet G, Berard H, Lamy R, Falchero L, Vieillot S, Schott R, Ricordel C, Chouabe S, Thomas P, Gervais R, Madroszyk A, Abdiche S, Chiappa AM, Greillier L, Decroisette C, Auliac JB, Chouaid C; GFPC 02-13 (METAL2) investigators. Phase III randomized study of carboplatin pemetrexed with or without bevacizumab with initial versus "at progression" cerebral radiotherapy in advanced non squamous non-small cell lung cancer with asymptomatic brain metastasis. Ther Adv Med Oncol. 2021 Apr 16;13:17588359211006983. doi: 10.1177/17588359211006983. eCollection 2021.

publisher_dissemination: SAGE Publications

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Intercommunal de Cornouaille

location_facility: Institut de Cancérologie de la Loire (I.C.L)

location_facility: Centre Hospitalier de la Région d'Annecy (CHRA)

location_facility: Centre d'Oncologie et de Radiothérapie du Pays Basque

location_facility: Hopital d'Instruction des Armées Sainte Anne


title: Pharmaco-epidemiological Study on the Effect of Retacrit® on Chemotherapy Induced Anaemia in Standard Oncology and Haematology Practice: Impact of Concomitant Iron Supplementation

acronym: SYNERGY

summary: The aim of this study is to describe, in a real-life context, the impact of an epoetin alpha biosimilar, Retacrit®, on anaemia in patients receiving chemotherapy, according to concomitant iron supplementation.

lead_sponsor: Hospira, now a wholly owned subsidiary of Pfizer

location_facility:
CHG Cahors
Clinique St Faron
TENON
Clinique CONVERT
Hopital Louis Pasteur
MEDIPOLE
CHG William MOREY
Clinique de l'Ormeau
Hopital Mignot
Chu Rennes
IPC
Pole Sante Republique
Chu Hopital Civil
Clinique Belvédère
Clinique Ste Marie
Chi Frejus - St Raphael
CH Boulogne-sur-Mer
Ch Le Mans
Fondation Saint Joseph
Hopital Des Courses
Chp St Greg
CAC Paul Strauss
Chu Gabriel Montpied
HARTMANN
Hopital St Quentin
Clinique des Dentellieres
Ico Angers
Saint Louis
Centre Oscar Lambret
CHU Caremeau
Ch Duffaut
Hopital A.Pare
Hopital Troyes
Saint Antoine
Hpt Rene Dubos
CH Emile Muller
Ch Chambery
H.I.A Saint Anne
BEAUJON
CHU du BOCAGE
Clinique Pasteur
CHG
Clinique Rambot
Inst. Claudius Regaud
Chu St Eloi
Cac Jean Godinot
Ch Du Pays D'Aix
Clinique Vitalia Desertines
Chu Estaing
CHG St Gaudens
CHU SUD
CHU Purpan
CHRA
Chu Grenoble
Chu Timone
Icl St Etienne
Victor Hugo
Clinique St Laurent
CH Sainte Musse
CH Jacques Monod
Victor Dubos
CHR
Hopital Franco Britannique
Ch Valence
Ch St Malo
Clinique des Bonnettes
Hopital Foch


title: Clinical Evaluation of Integrative Practices Units Infant and Child Care for Unit Children With Typical or Atypical Autism (AUTISM)

acronym: AUTISM

summary: The research project is part of the evaluation of the therapeutic approaches in mental health. Its framework infant and juvenile units that have developed "integrative devices," taking into account recent advances in knowledge and providing care, education and pedagogical approach. The evolution of autistic children receiving these integrative devices is studied to determine the validity of the devices mentioned. The methodology is based on case studies in a natural situation. Clinicians are committed to network among themselves and with researchers in a multicenter study.

ReferenceCitation: Bettencourt C, Garret-Gloanec N, Pellerin H, Pere M, Squillante M, Roos-Weil F, Ferrand L, Pernel AS, Apter G, Cohen D. Migration is associated with baseline severity and progress over time in autism spectrum disorder: Evidence from a French prospective longitudinal study. PLoS One. 2022 Oct 6;17(10):e0272693. doi: 10.1371/journal.pone.0272693. eCollection 2022.

publisher_dissemination: Public Library of Science

location_facility: Unité de soins précoces HJ René Diatkine ASM13

intervention_type: Behavioral

appel_a_projets: PREPS

acronyme: AUTISME

titre: Evaluation clinique des pratiques intégratives en unités de soins infanto-juvéniles pour des enfants présentant un autisme typique ou atypique.

discipline_principale: psychiatrie / addictologie

nom_porteur: GARRET

prenom_porteur: Nicole