title: Real Life Second-Line Nivolumab in Advanced Non-Small Cell Lung Cancer: a French Observational Multicenter Study of 259 Patients (ABCT-IMMUNOBZH)

acronym: IMMUNOBZH

summary: Data regarding nivolumab as second line treatment in advanced non-small cell lung cancer (NSCLC) are based on selected populations and might not reflect daily practice. Investigators aimed at assessing efficacy and safety of nivolumab in a real-life setting and determining a subtype of NSCLC patients that are more likely to benefit from immunotherapy.

time_perspective: Retrospective

ReferenceCitation: 1. Malhotra J, Jabbour SK, Aisner J. Current state of immunotherapy for non-small cell lung cancer. Transl Lung Cancer Res. 2017 Apr;6(2):196-211. 2. Kazandjian D, Suzman DL, Blumenthal G, Mushti S, He K, Libeg M et al. FDA Approval Summary: Nivolumab for the Treatment of Metastatic Non-Small Cell Lung Cancer With Progression On or After Platinum-Based Chemotherapy. The Oncologist. 2016 May;21(5):634-42. 3. Brahmer J, Reckamp KL, Baas P, Crinò L, Eberhardt WE, Poddubskaya E et al. Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Jul 9;373(2):123-35. 4. Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE et al. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627-39. 5. Herbst RS, Baas P, Kim D-W, Felip E, Pérez-Gracia JL, Han JY et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. The Lancet. 2016 Apr;387(10027):1540-50. 6. Rittmeyer A, Barlesi F, Waterkamp D, Park K, Ciardiello F, von Pawel J et al. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet Lond Engl. 2017 21;389(10066):255-65. 7. Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer Oxf Engl 1990. 2009 Jan;45(2):228-47. 8. Common Terminology Criteria for Adverse Events (CTCAE) - CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf

location_facility:
Centre Hospitalier de Bretagne Sud
Centre Hospitalier Yves Le Foll
CH DINAN
CH de VANNES
CHRU de Brest
Centre hospitalier de Saint Malo
CHU de Rennes


type: Other Identifier

title: Study of the Use of Hearing Protection Equipment in the Occurence of Acute Acoustic Trauma in the Army

acronym: QPROTEC

summary:
Each year, military epidemiological surveillance counts approximately 1,000 acute acoustic injuries. Most are caused by exposure to weapon noise during training sessions while military personnel are provided with hearing protection. Several hypotheses could explain the occurrence of acute acoustic trauma despite wearing protections:

A lack of practices or knowledge about the use of hearing protection equipment that could facilitate the occurrence of acute acoustic trauma (improper fitting, use of an inappropriate type of protection, dropping of protectors, inappropriate removal)
A failure to seal the external ear canal due to an inappropriate plug size. These hypotheses will be explored using a questionnaire distributed to a population of Army soldiers training to shoot.

The main objective is to determine the predictive factors corresponding to practices or knowledge related to the use of hearing protection equipment in the occurrence of acute acoustic trauma in a population of Army soldiers.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: 119e Antenne Médicale, 14e Centre Médical des Armées

location_facility: 76e Antenne Médicale, 7e Centre Médical des Armées

location_facility: 176e Antenne Médicale, 11e Centre Médical des Armées

location_facility: 101e Antenne Médicale, 13e Centre Médical des Armées

location_facility: 93e Antenne Médicale, 8e Centre Médical des Armées

location_facility: Institut de Recherche Biomédicale des Armées

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: AProtinin Versus Tranexamic Acid in Cardiac Surgery Patients With High-risk for Excessive Bleeding

acronym: APACHE

summary: In this before-after multicenter study the authors tested the hypothesis that the prophylactic use of aprotinin compared to tranexamic acid could reduce the proportion of patients presenting severe perioperative bleeding.

ipd_sharing: No

lead_sponsor: University Hospital, Bordeaux

location_facility: Georges Pompidou European University Hospital

location_facility: North Val de Seine Paris University Hospital


title: Impact of COVID-19 Pandemic and Social Distancing on Mental Health of Chronic Inflammatory Rheumatism Affected Patients

acronym: EMOPTION

summary: Recent studies have highlighted the consequences of COVID-19 pandemic and social distancing on mental health of individuals. The aim of this study is to evaluate those consequences within a sample of inflammatory chronic rheumatism affected patients, taking into account the well-known key role of stress in the set-up of such diseases.

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Other

location_facility: CHU de Saint-Etienne - service de rhumatologie

location_facility: CHU de Toulouse - service de rhumatologie

location_facility: AP-HP - Hopital Cochin - service de rhumatologie

location_facility: CHU de Montpellier - service de rhumatologie

location_facility: AP-HP - Hopital Henri Mondor - service de rhumatologie

location_facility: CHU de Bordeaux - service de rhumatologie

intervention_type: Behavioral


title: Human Recombinant Interferon Gamma-1b for the Prevention of Hospital-acquired Pneumonia in Critically Ill Patients: a Double-blind, International, Phase 2, Randomized, Placebo-controlled Trial - the PREV-HAP Study

acronym: PREV-HAP

summary:
PREV-HAP study is part of a larger project entitled 'Host-targeted Approaches for the Prevention and the treatment of Hospital-Acquired Pneumonia' (HAP2), funded by the European Union's H2020 research and innovation programme under grant agreement N°847782. HAP2 aims to develop stratified host-directed drugs and biomarkers to enhance the prevention and the treatment of HAP and develop precision medicine in infectious diseases. Its ambition is to revolutionize the management of HAP: capitalising on the novel concept of critical-illness related immunosuppression altering the host-pathogens interactions, the aim is to propose a complete reappraisal of the physiopathology of HAP based on the concept of respiratory dysbiosis.

The main hypothesis of the PREV-HAP study is that human recombinant Interferon gamma 1b (rHuIFN-γ, Imukin) treatment can restore immunity in critically ill patients and prevent Hospital-Acquired Pneumonia.

The hypothesesis is that the in vivo investigations of the host-pathogens interactions can be used for the stratification of patients into high/low risk and responders/non-responders to host-targeted prevention of hospital-acquired infections.

The involvement of a state of critical-illness related immunosuppression in the susceptibility to hospital-acquired pneumonia is widely accepted, and an emerging trend is that the development of drugs for the treatment of this acquired immunosuppression will prevent infection and enhance outcomes of hospitalized patients.

It has been demonstrated that the productions of IFN-γ by immune cells are decreased in critically ill patients, and that these defects are associated with the susceptibility to HAP. rHuIFN-γ has neither been tested nor is recommended as adjunctive treatment of patients with HAP. Based on these specific factors identified in the host response, it is proposed in this study to use rHuIFN-γ as novel preventive approach for HAP.

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Nantes University Hospital

location_country: Spain France Greece

location_facility: Koutlimbaneio & Triantafylleio General Hospital of Larissa

location_facility: Aghioi Anargyroi General Oncology Hospital

location_facility: General University Hospital of Heraklion

intervention_type: Drug


title: Open Versus Closed Treatment of Intra-articular Fractures of the Mandibular Condyle: a Multicentre Randomized Controlled Trial

acronym: FIAC

summary:
Intra-articular fractures of the mandibular condyle ((IAFC) are usually treated by means of physical therapy with or without transient maxillo-mandibular fixation (conservative or closed treatment). However, this can lead to incomplete manducatory function recovery due to limited mandibular mobility. During the last 15 years, a growing interest has emerged for open (surgical) treatment of these fractures. Although there is more and more evidence suggesting that the open treatment may be the treatment of choice for selected cases of subcondylar fractures, the best option remains controversial for high condylar fractures.

The primary objective of the trial is to compare mandibular mobility at 3 months post-treatment between open (surgical) and closed (conservative) treatment of intra-articular fracture (high fracture) of the mandibular condyle.

This study is an open multicenter randomized controlled trial with 2 parallel arms. Eligible patients will be randomized 1 :1 between open and closed-treatment group.

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing: Yes

ipd_sharing_description: Data are available upon reasonable request The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
CHU Dijon Bourgogne
APHM - Hôpital de la Conception
CHU de Nantes
Hôpital Annecy Genevois
Hôpitaux Universitaires de Strasbourg
CHU Purpan - Hôpital Pierre-Paul Riquet
Hôpital Pitié-Salpêtrière


title: Evaluation of the Feasability of a Care Pathway Integrating Collaborative Tele-expertise for the Prevention of Recurrent Hospitalisations for Patients With Diabetes

acronym: TELXCODIA

summary:
Telemedicine for diabetic patients is currently based simply on remotely monitoring capillary blood glucose levels. This experimental approach remains limited to insulin-treated diabetic patients with sufficient motivation and ability to use connected devices and only considers one aspect of the care required by diabetic patients. So far, telemedicine has not offered a more global approach to the therapeutic support of patients. This failing leads to recurrent hospitalizations for acute metabolic events.

This project aims to demonstrate the feasibility of an individualized care pathway based on a multidisciplinary tele-medical network on a territorial scale. This pathway will include a base program with follow-up that can be adapted and revised thanks to the regular use of collaborative tele-expertise.

The possibility of monthly multidiciplinary meetings via Tele-expertise between the different diabetes centers of the hospital groups would help to define and implement an individualized care pathway for diabetic patients hospitalized on a recurring basis (≥2 hospitalizations/year), which would be defined collegially during the multidiciplinary meetings .

primary_purpose: Prevention

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: Centre Hospitalier Universitaire de Montpellier


title: A Randomised, Double Blind Study to Evaluate the Safety and Efficacy of the p38 Kinase Inhibitor, GW856553, in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

summary: This study will be a double-blind, placebo-controlled, parallel group study. After enrolment and initial assessments, subjects will receive 35 days of study medication. During this treatment period, they will be randomised to either oral GW856553 7.5mg BID or matching placebo in a 1:1 ratio. Sufficient numbers of subjects will be recruited to obtain 128 evaluable subjects.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country: Sweden France Norway Denmark Germany

lead_sponsor_type: industriel

status_simplified: Completed


title: A Single Arm, Multicenter Phase II Trial of RAD001 as Monotherapy in the Treatment of Advanced Papillary Renal Cell Cancer

summary: To evaluate the preliminary efficacy and safety of RAD001 as monotherapy for first-line treatment of patients with metastatic papillary carcinoma of the kidney.

ReferenceType: derived

ReferenceCitation: Escudier B, Molinie V, Bracarda S, Maroto P, Szczylik C, Nathan P, Negrier S, Weiss C, Porta C, Grünwald V, Albiges L. Open-label phase 2 trial of first-line everolimus monotherapy in patients with papillary metastatic renal cell carcinoma: RAPTOR final analysis. Eur J Cancer. 2016 Dec;69:226-235. doi: 10.1016/j.ejca.2016.08.004. Epub 2016 Sep 24.

family: Escudier

full_name: Bernard Escudier

given: Bernard

sequence: first

family: Molinie

full_name: Vincent Molinie

given: Vincent

sequence: additional

family: Bracarda

full_name: Sergio Bracarda

given: Sergio

family: Maroto

full_name: Pablo Maroto

given: Pablo

family: Szczylik

full_name: Cezary Szczylik

given: Cezary

family: Nathan

full_name: Paul Nathan

given: Paul

family: Negrier

full_name: Sylvie Negrier

given: Sylvie

family: Weiss

full_name: Claudia Weiss

given: Claudia

family: Porta

full_name: Camillo Porta

given: Camillo

family: Grünwald

full_name: Viktor Grünwald

given: Viktor

family: Albiges

full_name: Laurence Albiges

given: Laurence

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: European Journal of Cancer

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Novartis Pharmaceuticals

location_country: Italy France Poland Belgium Spain Germany


title: Restoration of Central Vision With the PRIMA System in Patients With Atrophic Age-Related Macular Degeneration

acronym: PRIMAvera

summary: The objective of this study is to evaluate the efficacy and safety of the PRIMA System in patients with atrophic AMD. Eligible subjects will be implanted with the PRIMA Implant. The subjects will be assessed with various visual function and functional vision tests at defined timepoints throughout the clinical investigation with the PRIMA System (Implant and Visual Processor).

ReferenceType: background

ReferenceCitation: Palanker D, Le Mer Y, Mohand-Said S, Muqit M, Sahel JA. Photovoltaic Restoration of Central Vision in Atrophic Age-Related Macular Degeneration. Ophthalmology. 2020 Aug;127(8):1097-1104. doi: 10.1016/j.ophtha.2020.02.024. Epub 2020 Feb 25.

family: Palanker

full_name: Daniel Palanker

given: Daniel

family: Le Mer

full_name: Yannick Le Mer

given: Yannick

family: Mohand-Said

full_name: Saddek Mohand-Said

given: Saddek

family: Muqit

full_name: Mahiul Muqit

given: Mahiul

family: Sahel

full_name: Jose A. Sahel

given: Jose A.

journal_name: Ophthalmology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

version: acceptedVersion

repositories:
PubMed Central
UCL Discovery

lead_sponsor: Pixium Vision SA

location_country:
Germany
United Kingdom
France
Spain

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: Instituto de Microcirugía Ocular de Barcelona

location_facility: Fondation Ophtalmologique A. De Rothschild

location_facility: Augenklinik der Ludwig-Maximilian Universität München

location_facility: Universitätsklinikum Hamburg-Eppendorf (UKE), Augenklinik

location_facility: Centre hospitalier intercommunal de Créteil - Service Ophtalmologie

location_facility: KNAPPSCHAFTSKLINIKUM SAAR GMBH Augenklinik Sulzbach

intervention_type: Device


title: ENT Barotrauma Epidemiology Among French Army Divers

acronym: BTORL PAF

summary:
Ear, nose and throat barotrauma are the most frequently encountered accidents during diving. One study related to recreational diving reports that ENT barotrauma concern 10% of dives with experimented divers and 30% with novice divers. Nevertheless, a low number of studies were realized on ENT barotrauma, particularly those involving middle ear and sinuses, maybe because most of them evolve favorably without sequelae.

Besides, it has been described that pathologies which may induce chronic or acute tubal dyspermeability can result in an increased middle ear or sinus barotrauma risk. But once again no study was realized which objective was to look for an association between these risk factors and for the association strength between risk factors and ENT barotrauma occurrence. Few data on military population exist either. However, operational constraints, stressing environment with necessity of realizing performances to validate diving certificate or other military diving specificities can lead one to think that military divers have an increased risk to be subjected to ENT barotrauma. Furthermore, therapeutic measures and more particularly physicians' attitude concerning a temporary incapacity period to avoid recurrence or clinical worsening of barotrauma differ depending on diving centers. But the question to resume diving or not is essential for military staff given that temporary incapacity may lead to training cessation or can be questioned because of operational constraints requiring anticipated diving resumption.

The purpose of this research is to study middle ear and sinus barotrauma thanks to questionnaires focused on those pathologies and their potential risk factors. The hypothesis is that it will allow identification of main risk factors in order to develop preventive measures as well as the characteristics and missions of concerned divers and the impact of those barotrauma on this population.

primary_purpose: Screening

ReferenceCitation: Taylor DM, O'Toole KS, Ryan CM. Experienced scuba divers in Australia and the United States suffer considerable injury and morbidity. Wilderness Environ Med. 2003 Summer;14(2):83-8.

ReferenceCitation: Fitzpatrick DT, Franck BA, Mason KT, Shannon SG. Risk factors for symptomatic otic and sinus barotrauma in a multiplace hyperbaric chamber. Undersea Hyperb Med. 1999 Winter;26(4):243-7.

location_facility: Service de médecine hyperbare et expertise de la plongée

location_facility: 1er Groupe Plongeurs Démineurs Cherbourg


title: Open-label, Uncontrolled, Long-term Surveillance Study of Iloprost Aerosol Inhalation Therapy in the Treatment of Patients With Primary or Secondary Pulmonary Hypertension. Follow-up Program for Patients Who Completed 12 Weeks in Study ME97218/300180.

summary: The aim of this study is to monitor long-term safety and tolerability of iloprost aerosol inhalation therapy in patients suffering from pulmonary hypertension.

lead_sponsor: Bayer

location_country: Italy Netherlands Spain Poland France Belgium Portugal


title: Retrospective, Observational Chart Review Study Evaluating Clinical Effectiveness and Disease/Treatment Management Among Patients Who Initiated Long-term Prophylaxis With Takhzyro® in a Real-world Setting

summary:
The main aims of this study are to learn how many people with HAE Type I or Type II are attack-free when treated with lanadelumab in real life. This includes the number of people that are attack-free when lanadelumab is given every 2 and every 4 weeks.

This study is about collecting existing data only; participants will not receive lanadelumab as part of this study. No new information will be collected during this study. Only data already available at the participant's doctor's office will be reviewed and collected for this study.

Participants do not need to visit their doctor in addition to their normal visits.

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Takeda

location_country: Austria Germany France Greece

location_facility: Klinikum rechts der Isa der Technischen Universitaet Muenchen

location_facility: Medizinische Universitat Wien (Medical University of Vienna)

location_facility: Centre Hospitalier Universitaire Hopitaux de Rouen

location_facility: Childrens' Hospital of Athens 'P. and A. Kyriakou'


title: Treatment of COVID-19 by Nebulization of Inteferon Beta 1b Efficiency and Safety Study

acronym: COV-NI

summary: COVID-19 is causing a serious viral pandemic in terms of health and social impact. To date, no treatment has yet demonstrated Strong efficacy in treating the infectious disease (COVID-19). Pulmonary administration of Interferon (IFN) type I is a therapeutic strategy with high potential,due to higher local concentrations and minimal adverse effects. Type I interferons (including IFN-α and IFN-β) are antiviral defence cytokines and also have the potential to negatively modulate IFN Type II and IL-6 dependent cytokine storm, the latter being induced in the late forms of COVID-19. In vitro, IFN-β were more effective on COVID-19 than IFN-α. In existing preliminary studies, only patients receiving IFN type I modulators have a decrease in viral carriage and a rapid reversal. The purpose of this project is to assess in hospitalized patients with oxygen for COVID 19, the clinical efficacy on oxygen requirements of the addition of inhaled Interferon type I compared to the control arm .

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility: CH de l'Arrondissement de Montreuil-sur-mer


intervention_type: Biological

status: Active, not recruiting

lead_sponsor: Janssen Vaccines & Prevention B.V.

location_country:
Burkina Faso
France
Uganda
Tanzania
United States
United Kingdom
Kenya

type: EudraCT Number

source: euctr

title: A Multi-country, Prospective, Clinical Safety Study of Subjects Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo

summary: The purpose of the study is to assess the long-term safety profile of Ad26.ZEBOV and MVA-BN-Filo in participants previously exposed to these vaccines in Phase 1, 2, or 3 clinical studies.


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.

time_perspective: Other

ReferenceCitation: Falandry C, Malapert A, Roche M, Subtil F, Berthiller J, Boin C, Dubreuil J, Ravot C, Bitker L, Abraham P, Collange V, Balança B, Goutte S, Guichon C, Gadea E, Argaud L, Dayde D, Jallades L, Lepape A, Pialat JB, Friggeri A, Thiollière 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.

family: Falandry

full_name: Claire Falandry

given: Claire

family: Malapert

full_name: Amélie Malapert

given: Amélie

family: Roche

full_name: Mélanie Roche

given: Mélanie

family: Subtil

full_name: Fabien Subtil

given: Fabien

family: Berthiller

full_name: Julien Berthiller

given: Julien

family: Boin

full_name: Camille Boin

given: Camille

family: Dubreuil

full_name: Justine Dubreuil

given: Justine

family: Ravot

full_name: Christine Ravot

given: Christine

family: Bitker

full_name: Laurent Bitker

given: Laurent

family: Abraham

full_name: Paul Abraham

family: Collange

full_name: Vincent Collange

family: Balança

full_name: Baptiste Balança

given: Baptiste

family: Goutte

full_name: Sylvie Goutte

family: Guichon

full_name: Céline Guichon

given: Céline

family: Gadea

full_name: Emilie Gadea

given: Emilie

family: Argaud

full_name: Laurent Argaud

family: Dayde

full_name: David Dayde

given: David

family: Jallades

full_name: Laurent Jallades

family: Lepape

full_name: Alain Lepape

given: Alain

family: Pialat

full_name: Jean-Baptiste Pialat

given: Jean-Baptiste

family: Friggeri

full_name: Arnaud Friggeri

given: Arnaud

family: Thiollière

full_name: Fabrice Thiollière

given: Fabrice

currency_apc_doaj: GBP

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

location_facility: Resuscitation unit at Hospital Emile Roux

location_facility: Service de Réanimation de l'Hôpital Nord Ouest

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

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


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.

lead_sponsor: Centre Hospitalier Universitaire de Nice

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


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


title: Subcutaneous Injections of Autologous 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 autologous cultured adipose-derived stromal 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 autologous cultured adipose-derived stromal cell versus placebo for healing refractory active ischemic digital ulcers in patients with systemic sclerosis.

lead_sponsor: University Hospital, Toulouse

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

intervention_type: Procedure


ReferenceCitation: Gutzmer R, Rivoltini L, Levchenko E, Testori A, Utikal J, Ascierto PA, Demidov L, Grob JJ, Ridolfi R, Schadendorf D, Queirolo P, Santoro A, Loquai C, Dreno B, Hauschild A, Schultz E, Lesimple TP, Vanhoutte N, Salaun B, Gillet M, Jarnjak S, De Sousa Alves PM, Louahed J, Brichard VG, Lehmann FF. Safety and immunogenicity of the PRAME cancer immunotherapeutic in metastatic melanoma: results of a phase I dose escalation study. ESMO Open. 2016 Aug 8;1(4):e000068. eCollection 2016.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

location_country:
Italy
France
Czechia
Poland
Russian Federation
Germany

acronym: PRAME-AS15-MEL-001 (MET)

title: Study of GSK2302025A Antigen-Specific Cancer Immunotherapeutic in Patients With Metastatic Melanoma

summary: The purpose of this clinical study is to examine the safety, immunogenicity and clinical activity of the immunotherapeutic product GSK2302025A (also referred to as recPRAME + AS15 Antigen-Specific Cancer Immunotherapeutic [ASCI]) administered as a first line treatment in patients with unresectable and progressive metastatic cutaneous melanoma.


title: Randomised, Double-blind, Placebo-controlled, Phase II Study to Assess the Safety and Efficacy of Different Doses of Intravenous APD405 for the Prevention of Post-operative Nausea and Vomiting

summary: To assess the efficacy and safety of different doses of APD405 in the prevention of post-operative nausea and vomiting (PONV) in adult patients at moderate to high-risk of PONV. Patients must be undergoing elective surgery under general anaesthesia (hysterectomy (any surgical technique), cholecystectomy (any surgical technique) or "other" elective surgery scheduled to last at least one hour from induction of anaesthesia), requiring at least one overnight stay in hospital, and have at least 2 of the following risk factors for PONV: Past history of PONV and/or motion sickness; Non-smoking status; Female gender; Planned opiate use for post-operative analgesia.

ReferenceCitation: Kranke P, Röhm KD, Diemunsch P, Gan TJ, Apfel CC, Eberhart L, Minkowitz HS, Wallenborn J, Chassard D, Lebuffe G, Fox GM, Tramèr MR. Intravenous buspirone for the prevention of postoperative nausea and vomiting. Eur J Clin Pharmacol. 2012 Nov;68(11):1465-72. doi: 10.1007/s00228-012-1284-8. Epub 2012 May 1.

family: Kranke

full_name: Peter Kranke

given: Peter

family: Röhm

full_name: Kerstin D. Röhm

given: Kerstin D.

family: Diemunsch

full_name: Pierre Diemunsch

given: Pierre

family: Gan

full_name: Tong J. Gan

given: Tong J.

family: Apfel

full_name: Christian C. Apfel

given: Christian C.

family: Eberhart

full_name: Leopold Eberhart

given: Leopold

family: Minkowitz

full_name: Harold S. Minkowitz

given: Harold S.

family: Wallenborn

full_name: Jan Wallenborn

given: Jan

family: Chassard

full_name: Dominique Chassard

given: Dominique

family: Lebuffe

full_name: Gilles Lebuffe

given: Gilles

family: Fox

full_name: Gabriel M. Fox

given: Gabriel M.

family: Tramèr

full_name: Martin R. Tramèr

given: Martin R.

journal_name: European Journal of Clinical Pharmacology

oa_host_type: repository

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

repository_institution: University of Geneva - Archive ouverte UNIGE

repository_institution: reroDoc Digital Library

version: submittedVersion

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

lead_sponsor: Acacia Pharma Ltd

location_country:
Germany
United States
France
Switzerland

location_facility: Centre Hospitalier Universitaire Vaudois


lead_sponsor: Hoffmann-La Roche

location_country:
Italy
France
Poland
Thailand
Romania
Hungary
Belgium
Australia
Russian Federation
Spain
Germany
Ukraine

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadciśnienia Dzieci i Mlodziezy

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Nefrologia

location_facility: IRCCS G. Gaslini; U.O. Nefrologia, Dialisi e Trapianto

location_facility: KfH Nierenzentrum für Kinder und Jugendliche

location_facility: Semmelweis University; 1st Department of Pediatrics, Pediatric Nephrology Center

location_facility: Public Institution Zaporizhzhia City Multispecialty Children's Hospital #5; Allergologic

location_facility: St. Maria Emergency Clinical Hospital for Children

location_facility: DGCB St. Vladimir; Pediatric nephrologist

location_facility: Hospital Universitario La Paz: Nefrologia Pediatrica

location_facility: KfH-Nierenzentrum fur Kinder und Jugendliche

location_facility: Hopital Jeanne De Flandre; Cons Pediatrie

location_facility: Hopital Timone Enfants; Nephrologie Hemodialyse

location_facility: Hospital Universitario la Fe; Servicio de Nefrologia Pediatrica

location_facility: Wojewodzki Szpital Dzieciecy; Osrodek Chorob Nerek i Dializoterapii

location_facility: Ospedale Infantile Regina Margherita; U.O. Autonoma di Nefrologia, Dialisi e Trapianto

location_facility: Akademia Medyczna im. Piastow Slaskich; Katedra i Klinika Nefrologii Pediatrycznej

location_facility: Hopital Arnaud De Villeneuve; Pediatrie I

location_facility: Dzieciecy Szpital Kliniczny; Klinika Nefrologii Dzieciecej

location_facility: A.O. Di Padova; Dipartimento Di Pediatria U.O. Di Nefrologia Pediatrica, Dialisi e Trapianto

location_facility: Instytut "Centrum Zdrowia Matki Polki; Klinika Nefrologii i Dializoterapii

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Nefrologia Pediatrica

location_facility: Chulalongkorn university Faculty of Medicine;Department of Pediatrics

location_facility: Hôpital Robert Debré; Nephrologie pediatrique

location_facility: KfH-Nierenzentrum für Kinder und Jugendliche

location_facility: Ospedale Pediatrico Bambino Gesu; U.O. Di Nefrologia E Dialisi

location_facility: Instytut Pomnik-Centrum Zdrowia Dziecka, Klinika Nefrologii, Transp. Nerek i Nadcisnienia Tetniczego

location_facility: Siriraj Hospital, Faculty of Medicine; Department of Pediatrics

location_facility: Hopital Femme Mere Enfant; Ped Nephrologie Rhumatologie

location_facility: SPSZOZ Zdroje Oddzial Pediatrii; Nefrologii i Toksykologii ze Stacja Dializ

location_facility: Kiev city childrens nephrological center of hospital #1; Nephrology and RRT

location_facility: Royal Children'S Hospital; Department of Nephrology

location_facility: SBIH Children City Hospital #1; Dialysis department

location_facility: Hopital Armand Trousseau; Pediatrie Nephrologie

title: An Open-Label Multi-center, Multiple Dose Study to Determine the Optimum Starting Dose of Intravenous MIRCERA for Maintenance Treatment of Anemia in Pediatric Participants With Chronic Kidney Disease on Hemodialysis

summary: This sequential study will assess the efficacy and safety of multiple doses of intravenous (IV) methoxy polyethylene glycol-epoetin beta (MIRCERA), and will determine the optimum starting dose for maintenance treatment of anemia in children with chronic kidney disease on hemodialysis. Pediatric participants will remain on epoetin alfa, epoetin beta or darbepoetin alfa during the screening period, after which they will receive IV MIRCERA monthly, at a starting dose related to the previous weekly epoetin or darbepoetin alfa dose. Depending on the response achieved, another group may be selected to receive a higher or a lower dose.


title: Evaluation of UCPVax Plus Nivolumab as Second Line Therapy in Advanced Non Small Cell Lung : a Randomized Non Comparative Phase II Trial

acronym: Optim-UCPVax

summary:
Lung cancer is the most commonly diagnosed malignancy and the leading cause of cancer-related mortality both in men and women worldwide.

The past few years have demonstrated great progress in the field of tumor immunotherapy through agents that address mechanisms of immune escape notably, so called immune checkpoint inhibitors (ICB). Indeed, ICB have emerged as a fatal weapon in the anticancer treatment arsenal. Anti-PD-1 and anti-PD-L1 antibodies have shown promising results in several cancers including Non-small Cell Lung Cancer (NSCLC) patients. Although such ICB extend patient's survival compared with conventional systemic therapies, they fail to control cancer progression in a significant proportion of patients which can reach up to 50-60% in NSCLC. Recent literature highlights a range of factors involved in the heterogeneous responses and failures to ICB therapies. The challenge is how can ICB treatment efficacy be extended to majority patients? To respond to this question, to increase the success of immunotherapy, immuno-oncology community develops combinations approaches.

The aim of these project is to evaluate the efficacy of Nivolumab plus a novel CD4Th1 inducer anti-cancer vaccine in NSCLC patients.

Nivolumab (NIVO), which is an anti-PD-1 antibody, has shown promising results in 2nd line treatment for advanced NSCLC.

UCPVax is a therapeutic anti-cancer vaccine based on the telomerase-derived helper peptides designed to induce strong TH1 CD4 T cell responses in cancer patients (NCT02818426).

ReferenceCitation: Adotévi O, Dosset M, Galaine J, Beziaud L, Godet Y, Borg C. Targeting antitumor CD4 helper T cells with universal tumor-reactive helper peptides derived from telomerase for cancer vaccine. Hum Vaccin Immunother. 2013 May;9(5):1073-7. doi: 10.4161/hv.23587. Epub 2013 Jan 28. Review.

ReferenceCitation: Godet Y, Dosset M, Borg C, Adotevi O. Is preexisting antitumor CD4 T cell response indispensable for the chemotherapy induced immune regression of cancer? Oncoimmunology. 2012 Dec 1;1(9):1617-1619.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
Institut de Cancérologie Privé CCGM
Institut de Cancérologie de l'Ouest
CHU of Besançon
Centre Georges François Leclerc
Institut Jean Godinot
CH Mulhouse
CHU Bordeaux


title: KDOG1 :Transcutaneous Breast Cancer Diagnosis by Canine Odorology

summary: Patient with an indication of interventional percutaneous procedure for characterization of a breast lesion, palpable or not, classified as category 4 or 5, according to the Breast Imaging (BI) Report and Data System of the American College of Radiology (RADS) classification detected at mammography and/or breast ultrasound examination.

primary_purpose: Diagnostic

lead_sponsor: Institut Curie

location_facility:
Institut de Cancérologie de l'Ouest
Groupe Hospitalier Paris Saint- Joseph
Centre République
Institut Curie
Centre Hospitalier Valenciennes
Centre Hospitalier Universitaire

intervention_type: Diagnostic Test


title: Usefulness of Hair Cortisol/Cortisone Concentrations for the Monitoring of Medical Treatment in Patients With Cushing's Disease

acronym: HAIRCUSH

summary: The biochemical tools usable to assess the control of hypercortisolism in patients with Cushing's disease receiving medical treatments are debatable. The aim of the study is to compare the results of the measurement of cortisol and cortisone using high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) in scalp hair (so called "Hair Cortisol") to that of 24h urinary free cortisol (UFC) and late night salivary cortisol (LNSC) for the monitoring of medical therapy in patients with Cushing's disease (CD).

lead_sponsor: University Hospital, Bordeaux

location_facility: CIC d'Endocrinologie, Maladies Métaboliques et Nutrition - CHU de Nantes

location_facility: Service d'endocirnologie, diabète, nutrition, Hôpital Haut Lévêque - CHU de Bordeaux

location_facility: Service d'Endocrinologie, Diabète et Maladies Métaboliques - APHM

location_facility: Service d'Endocrinologie et des Maladies de la Reproduction - APHP Bicêtre


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


title: A Randomized, Open-label Study Comparing the Anti-tumor Effect of Treatment With Tarceva Plus Avastin Versus Chemotherapy Plus Avastin in Patients With Advanced Non-small Cell Lung Cancer

summary: This 2 arm study will compare the efficacy and safety of Tarceva plus Avastin, and chemotherapy plus Avastin, in the first-line treatment of patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg p.o. daily plus Avastin 15mg/kg i.v. every 3 weeks, or standard platinum-based chemotherapy (4-6 cycles) plus Avastin. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

ReferenceCitation: Ciuleanu T, Tsai CM, Tsao CJ, Milanowski J, Amoroso D, Heo DS, Groen HJ, Szczesna A, Chung CY, Chao TY, Middleton G, Zeaiter A, Klingelschmitt G, Klughammer B, Thatcher N. A phase II study of erlotinib in combination with bevacizumab versus chemotherapy plus bevacizumab in the first-line treatment of advanced non-squamous non-small cell lung cancer. Lung Cancer. 2013 Nov;82(2):276-81. doi: 10.1016/j.lungcan.2013.08.002. Epub 2013 Aug 13.

family: Ciuleanu

full_name: T. Ciuleanu

given: T.

family: Tsai

full_name: C.-M. Tsai

family: Tsao

full_name: C.-J. Tsao

family: Milanowski

full_name: J. Milanowski

given: J.

family: Amoroso

full_name: D. Amoroso

given: D.

family: Heo

full_name: D.S. Heo

family: Groen

full_name: H.J.M. Groen

family: Szczesna

full_name: A. Szczesna

given: A.

family: Chung

full_name: C.-Y. Chung

family: Chao

full_name: T.-Y. Chao

family: Middleton

full_name: G. Middleton

given: G.

family: Zeaiter

full_name: A. Zeaiter

family: Klingelschmitt

full_name: G. Klingelschmitt

family: Klughammer

full_name: B. Klughammer

given: B.

family: Thatcher

full_name: N. Thatcher

given: N.

journal_name: Lung Cancer

oa_host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

location_country:
Italy
Netherlands
France
Poland
Lithuania
Romania
Singapore
Belgium
Australia
Spain
United Kingdom
Korea, Republic of
Taiwan


title: A Randomized, Controlled, Open-Label Study of the Long-Term Impact on Functioning Using Atomoxetine Hydrochloride Compared to Other Early Standard Care in the Treatment of Attention-Deficit/Hyperactivity Disorder in Treatment-Naïve Children and Adolescents

acronym: ADHD LIFE

summary: The purpose of this study is to demonstrate that atomoxetine is superior to other early standard therapy (any treatment that investigator considers is appropriate to initiate for the treatment of Attention-Deficit/Hyperactivity Disorder [ADHD]) on the long term functioning in approximately 400 children and adolescents with ADHD. Patients will be pharmacological naïve prior to entry into the study.

lead_sponsor: Eli Lilly and Company

location_country:
Italy
Mexico
France
Norway
Ireland
Belgium
Spain
Turkey
United Kingdom

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


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, Féasson 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.

family: Colas

full_name: Claire Colas

given: Claire

family: Jumel

full_name: Audrey Jumel

given: Audrey

family: Vericel

full_name: Marie-Pierre Vericel

given: Marie-Pierre

family: Barth

full_name: Nathalie Barth

given: Nathalie

family: Manzanares

full_name: Jessica Manzanares

given: Jessica

family: Goutte

full_name: Julie Goutte

given: Julie

family: Fontana

full_name: Luc Fontana

given: Luc

family: Féasson

full_name: Léonard Féasson

given: Léonard

family: Hupin

full_name: David Hupin

given: David

family: Guyot

full_name: Jessica Guyot

bso_classification: Biology (fond.)

currency_apc_doaj: USD

journal_name: Frontiers in Psychology

oa_colors: green gold

evidence: oa journal (via doaj)

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: 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, Féasson 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.

family: Creac'h

full_name: Christelle Creac'h

given: Christelle

family: Peuriere

full_name: Marie Peuriere

given: Marie

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

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

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility:
CH d'ANNONAY
CH du Gier
CH de Rive de Gier
Chu Saint Etienne
CH de Firminy
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 Pierre Paul Riquet, CHU Purpan
Hôpital Laennec
Centre Hospitalier Lyon Sud
Fondation Adolphe de Rothschild
Groupe Hospitalier Pellegrin
CHU de Rouen
CHU Rennes


title: Population Pharmacokinetics of Metronidazole in Neonates: Evaluation and Optimization of the Dose

acronym: METROPOP

summary:
The objective of NEOPOPI is to conduct a population pharmacokinetic study of metronidazole in neonates, in order to evaluate and optimize neonatal dose regimen.

There will be no change to the medication treatment received by participants. An opportunistic pharmacokinetic sampling approach will be followed: samples will be scavenged from blood or cerebrospinal fluid drawn for routine biochemical tests. In this way, no additional invasive tests will be needed.

lead_sponsor: Rennes University Hospital

location_facility:
CHU d'Angers
CH St Brieuc
CHU de Tours
CHU de Rennes
CHU de Brest
CH Vannes
Centre Robert Debré


title: Defining ENDOtypes in Perioperative Hypersensitivity by Extensive Cellular and Molecular PHENotyping and Assessment of Their Association to Severity

acronym: ENDOPHEN

summary:
Perioperative Acute Hypersensitivity (PAH) is a systemic reaction that occurs rapidly following injection of a drug during anesthesia. The main mechanism evoked is an immune response of immediate systemic hypersensitivity or anaphylaxis. Anaphylactic reactions are classically described as IgE-dependent and triggered by the injection of allergen which by bridging specific IgE present on the surface of mast cells, induces a massive release of histamine responsible for the observed symptoms. The diagnosis of this mechanism (IgE endotype) requires the determination of associated circulating mediators (histamine and mast cell tryptase) as well as skin tests performed during an allergologic evaluation. However, our previous work on patients with PAH (NASA study, ClinicalTrials.gov: NCT01637220) demonstrated that classical markers of IgE endotype are present in only 42% of patients. This finding has three consequences:

a diagnostic inaccuracy with deleterious consequences for the patient,
the existence of undocumented endotypes explaining the observed clinical manifestations,
a lack of formal identification of culprit drug, with uncertainty about the eviction recommendations leading to consequences for the safety of the patient.

The investigators hypothesize that symptoms associated with PAH are caused by several distinct endotypes involving different cellular effectors and molecular mediators. These endotypes may be related to the immune system but independent of IgE, or independent of the immune system.

To assess these endotypes, The investigators will be measuring the activation status of blood cells and a wide range of secreted mediators in blood drawn as soon as possible after PAH onset, and at steady state during a subsequent allergology visit. These data will be analyzed along with clinical data in multivariate analysis and clustering to define coherent profiles among patients.

Definition of previously unexplored endotypes will allow to explain more PAH reactions and to design new diagnostic and therapeutic strategies.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
La Pitié Salpêtrière Hospital
Ambroise Paré Hospital
Beaujon Hospital
Saint Louis Hospital
Louis Mourier Hospital
Bichat Hospital
Européen Georges Pompidou Hospital


location_country:
Italy
Netherlands
France
Spain
Denmark
Germany
United Kingdom
Korea, Republic of
Taiwan

acronym: Balise

title: A Randomized, Controlled Phase 2 Study Evaluating LY2875358 Plus Erlotinib Versus Erlotinib as First-Line Treatment in Metastatic Non-Small Cell Lung Cancer Patients With Activating EGFR Mutations Who Have Disease Control After an 8-Week Lead-In Treatment With Erlotinib

summary: The primary purpose of this study is to compare the efficacy of the study drug LY2875358, given together with erlotinib, against erlotinib, alone. Participants will have Non-Small Cell Lung Cancer (NSCLC) that has advanced to Stage IV. Participants should not have been treated with drugs for Stage IV NSCLC, previously. All participants will get erlotinib alone, for approximately 8 weeks. Participants with radiographic disease control at the end of the erlotinib lead-in study period will be randomly assigned to receive LY2875358 plus erlotinib or erlotinib alone. Participants, who were chosen to receive erlotinib, alone, may cross over to the combination treatment at the time of progression.


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.

status: Withdrawn

lead_sponsor: Sandoz

location_country: Germany France

status_simplified: Unknown


title: Phase III Randomized, Controlled, Open, Multicentre Medical-economic Study Evaluating the Efficacy of Adding ZOlédronique Acid to STERéotaxique Radiotherapy in the Treatment of Vertebral Metastases

acronym: ZOSTER

summary:
Hypo-fractured radiotherapy in stereotactic conditions (RSHF) of bone metastases allows high doses to be delivered to the affected bone segment while sparing adjacent healthy tissues as well as possible. In addition, it not only reduces pain and prevents spinal cord compression, but also improves long-term control of metastatic disease.

Zoledronic acid reduces bone complications. The economic literature shows that stereotactic radiotherapy, like zoledronic acid, are cost-effective strategies in these indications. The objective of this research project is to evaluate the efficiency of adding zoledronic acid to stereotactic radiotherapy in the treatment of vertebral metastases.

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
Centre Eugène Marquis
Hopital Lyon Sud
Centre Oscar Lambret
Institut de Cancérologie de l'OUEST
Institut de Cancérologie de Lorraine
Centre Henri Becquerel
Institut de Cancérologie de la Loire

intervention_type: Combination Product


ReferenceCitation: Christensen MC, Fagiolini A, Florea I, Loft H, Cuomo A, Goodwin GM. Validation of the Oxford Depression Questionnaire: Sensitivity to change, minimal clinically important difference, and response threshold for the assessment of emotional blunting. J Affect Disord. 2021 Nov 1;294:924-931. doi: 10.1016/j.jad.2021.07.099. Epub 2021 Jul 31.

family: Christensen

full_name: Michael Cronquist Christensen

given: Michael Cronquist

family: Fagiolini

full_name: Andrea Fagiolini

given: Andrea

family: Florea

full_name: Ioana Florea

given: Ioana

family: Loft

full_name: Henrik Loft

given: Henrik

family: Cuomo

full_name: Alessandro Cuomo

given: Alessandro

family: Goodwin

full_name: Guy M. Goodwin

given: Guy M.

journal_name: Journal of Affective Disorders

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

lead_sponsor: H. Lundbeck A/S

location_country: Italy Spain France Lithuania

acronym: COMPLETE

location_facility: Dr Karim Boutayeb MD, Office of (FR0009)

location_facility: Centro De Salud Mental De Foios (ES0002)

location_facility: PI Mental Health Center of Zirmunai (LT0004)

location_facility: Hospital Universitario Fundacion Alcorcon (ES0009)

location_facility: Dipartimento Salute Mentale ASL Lecce (IT0006)

location_facility: Antakalnis Psychiatric Consultation Centre (LT0003)

location_facility: Universita degli Studi di Roma La Sapienza - Azienda Ospedaliera Sant Andrea (IT0013)

location_facility: Private Practice Dr. Paule Khalifa (FR0010)

location_facility: Hospital Clínico Universiatrio de Salamanca (ES0001)

location_facility: Jsc Silutes Mental Health And Psychotherapy Center (LT0001)

location_facility: Instituto Internacional de Neurociencias Aplicadas (ES0004)

location_facility: Centro De Especialidades A Doblada (ES0006)

location_facility: Mental Health Centre Kaunas Outpatient Clinic (LT0005)

location_facility: DSM Giulianova c/o ospedale di Giulianova (IT0004)

title: Interventional, Open-label, Flexible-dose Study of Vortioxetine on Emotional Functioning in Patients With Major Depressive Disorder With Inadequate Response to SSRI/SNRI Treatment

summary: The study will evaluate effectiveness of flexible dose vortioxetine 10-20 mg/day on emotional functioning in patients with MDD with an inadequate response to SSRIs/SNRIs.


title: Exploratory Study Evaluating the Interest of PET to 18F-Fludarabine for the Initial Assessment and End-treatment Evaluation of Patients With Symptomatic Multiple Myeloma in the First Line of Treatment, Not Candidates for Marrow Autograft

acronym: Myelofludate

summary: The objective of this exploratory study is to evaluate, for the first time, the sensitivity of 18F-Fludarabine to the initial diagnosis of MM compared to FDG-PET and MRI. The interest of this molecule will also be investigated as part of the end-of-treatment therapeutic evaluation.

lead_sponsor: Nantes University Hospital

location_facility:
Centre Eugène Marquis
CHU de Caen
CHU de Nantes
CHU d'Angers
CHU de Tours
CHU de Rennes
CHU de Brest


title: A European, Multi-centre Phase II Trial of Atezolizumab and Bevacizumab in Patients With Recurrent or Metastatic Squamous-cell Carcinoma of the Head and Neck (HNSCC)

acronym: ATHENA

summary: This proof-of-concept study aims to assess the clinical and biological effects of Atezolizumab combined with Bevacizumab in advanced previously treated squamous-cell carcinoma of the head and neck (HNSCC).

lead_sponsor: Centre Leon Berard

location_facility:
Centre Antoine Lacassagne
Centre Léon Bérard
Clinique Mutualiste de l'Estuaire
Centre Paul Strauss
Institut Claudius Regaud
Institut Curie
Centre Henri Becquerel


title: A Phase II Study Of Su011248 In Patients With Recurrent And/Or Metastatic Squamous Head And Neck Carcinoma.

summary: Preclinical studies as well as phase I and II trials have demonstrated that SU11248 has antitumor activity in renal cell carcinoma, breast cancer, neuroendocrine tumor and GIST. So at the light of these pre-clinical and clinical data, it seems interesting and promising to test SU011248 in these poor prognosis patients.

status: Terminated

lead_sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

location_country: Belgium France

location_facility: Clinique universiataire de Mont Godinnes UCL


title: Validation du Diagnostic moléculaire Des Infections Virales Respiratoires Sur Les Expectorations Des Patients Atteints de Mucoviscidose Validation of the Molecular Diagnosis of Respiratory Viral Infections on the Sputum of Patients With Cystic Fibrosis

acronym: MUCOVIR

summary: The main objective of this project is to evaluate the agreement between nasopharyngeal and sputum specimens in terms of detection of viral infection in Cystic Fibrosis (CF) participants.This is a 12-month national, multicenter prospective study (7 centers). Inclusions concern CF participants (children or adults) with signs of acute respiratory infection seen in consultation or hospitalized in their CF Research Center. A molecular viral multiplex search is performed on both nasopharyngeal and expectoration collected samples for each included participant. Determination of viral detection agreement between the two CF respiratory samples is then performed.

status: Unknown status

lead_sponsor: University Hospital, Brest

location_facility:
CHU de NANTES
CHU de Tours
CHU d'ANGERS
AP-HP - Hôpital TROUSSEAU
Hôpital FOCH
Centre de PERHARIDY
CHU de CAEN


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

location_facility: Centre Hospitalier Universitaire de Nice


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


title: Evaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French Hospitals

acronym: AGAPO

summary: There is currently no consensus on the adequate concomitant treatment to apomorphine pump in Parkinson's disease (PD). In practice, some centers withdraw all dopaminergic agonists when initiating apomorphine pump therapy, whereas others combine the two. To date, there has been no study led to determine the best strategy for efficiently treating motor and nonmotor symptoms, as well as improving patients' quality of life (QoL). This preliminary study, entitled AGAPO, aims at identifying significant differences in patients' evolution (nonmotor symptoms and quality of life), over a course of 6 months, depending on the two strategies adopted in French centers (apomorphine pump with or without dopaminergic agonists), through the Non Motor Symptoms Scale (NMSS, Chaudhuri et al, 2017).

location_facility:
CHU La Pitié Salpêtrière
Hôpital Gui de Chauliac
CHU de Reims- hôpital Maison Blanche
CHU Charles Nicolle
CHU La Timone
CH Caremeau
CHU de Rennes


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 radiology and nuclear medicine, Centre anti-cancéreux Georges-François Leclerc, Dijon

location_facility: Department of biostatistics, Université Joseph Fourrier

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


title: Outcome of COVID-19 Patients After Extracorporeal Membrane Oxygenation for Acute Respiratory Distress Syndrome: A Multicenter European Study

summary: This study aims to investigate outcomes and predictors of outcome after extracorporeal membrane oxygenation (ECMO) therapy for severe acute respiratory syndrome (ARDS) in COVID-19 patients.

ReferenceCitation: Biancari F, Mariscalco G, Dalén M, Settembre N, Welp H, Perrotti A, Wiebe K, Leo E, Loforte A, Chocron S, Pacini D, Juvonen T, Broman LM, Perna DD, Yusuff H, Harvey C, Mongardon N, Maureira JP, Levy B, Falk L, Ruggieri VG, Zipfel S, Folliguet T, Fiore A. Six-Month Survival After Extracorporeal Membrane Oxygenation for Severe COVID-19. J Cardiothorac Vasc Anesth. 2021 Jul;35(7):1999-2006. doi: 10.1053/j.jvca.2021.01.027. Epub 2021 Jan 19.

family: Biancari

full_name: Fausto Biancari

given: Fausto

family: Mariscalco

full_name: Giovanni Mariscalco

given: Giovanni

family: Dalén

full_name: Magnus Dalén

given: Magnus

family: Settembre

full_name: Nicla Settembre

given: Nicla

family: Welp

full_name: Henryk Welp

given: Henryk

family: Perrotti

full_name: Andrea Perrotti

family: Wiebe

full_name: Karsten Wiebe

given: Karsten

family: Leo

full_name: Enrico Leo

given: Enrico

family: Loforte

full_name: Antonio Loforte

given: Antonio

family: Chocron

full_name: Sidney Chocron

given: Sidney

family: Pacini

full_name: Davide Pacini

given: Davide

family: Juvonen

full_name: Tatu Juvonen

given: Tatu

family: Broman

full_name: L. Mikael Broman

given: L. Mikael

family: Perna

full_name: Dario Di Perna

given: Dario Di

family: Yusuff

full_name: Hakeem Yusuff

given: Hakeem

family: Harvey

full_name: Chris Harvey

given: Chris

family: Mongardon

full_name: Nicolas Mongardon

given: Nicolas

family: Maureira

full_name: Juan P. Maureira

given: Juan P.

family: Levy

full_name: Bruno Levy

given: Bruno

family: Falk

full_name: Lars Falk

given: Lars

family: Ruggieri

full_name: Vito G. Ruggieri

given: Vito G.

family: Zipfel

full_name: Svante Zipfel

given: Svante

family: Folliguet

full_name: Thierry Folliguet

given: Thierry

family: Fiore

journal_name: Journal of Cardiothoracic and Vascular Anesthesia

repository_normalized: HELDA - Digital Repository of the University of Helsinki

repository_institution: University of Oulu - University of Oulu Repository - Jultika

location_country:
Italy
Sweden
Finland
France
Germany
United Kingdom

location_facility:
University Hospital Jean Minjoz
Hamburg University Heart Center
Robert Debré University Hospital
University Hospitals of Leicester
Münster University Hospital
Nancy University Hospital
Helsinki University Hospital
Lecco Hospital
Karolinska University Hospital
Henri Mondon Unoversity Hospital
S. Orsola Hospital


ReferenceCitation: Arslan C, Dizdar O, Altundag K. Chemotherapy and biological treatment options in breast cancer patients with brain metastasis: an update. Expert Opin Pharmacother. 2014 Aug;15(12):1643-58. doi: 10.1517/14656566.2014.929664. Review.

ReferenceCitation: Bart J, Nagengast WB, Coppes RP, Wegman TD, van der Graaf WT, Groen HJ, Vaalburg W, de Vries EG, Hendrikse NH. Irradiation of rat brain reduces P-glycoprotein expression and function. Br J Cancer. 2007 Aug 6;97(3):322-6. Epub 2007 Jul 3.

ReferenceCitation: Bartsch R, Fromm S, Rudas M, Wenzel C, Harbauer S, Roessler K, Kitz K, Steger GG, Weitmann HD, Poetter R, Zielinski CC, Dieckmann K. Intensified local treatment and systemic therapy significantly increase survival in patients with brain metastases from advanced breast cancer - a retrospective analysis. Radiother Oncol. 2006 Sep;80(3):313-7. Epub 2006 Sep 7.

ReferenceCitation: Chang AY, Ying XX. Brain Metastases from Breast Cancer and Response to Treatment with Eribulin: A Case Series. Breast Cancer (Auckl). 2015 May 24;9:19-24. doi: 10.4137/BCBCR.S21176. eCollection 2015.

ReferenceCitation: Cortes J, O'Shaughnessy J, Loesch D, Blum JL, Vahdat LT, Petrakova K, Chollet P, Manikas A, Diéras V, Delozier T, Vladimirov V, Cardoso F, Koh H, Bougnoux P, Dutcus CE, Seegobin S, Mir D, Meneses N, Wanders J, Twelves C; EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389) investigators. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011 Mar 12;377(9769):914-23. doi: 10.1016/S0140-6736(11)60070-6. Epub 2011 Mar 2.

family: Cortes

full_name: Javier Cortes

given: Javier

family: O'Shaughnessy

full_name: Joyce O'Shaughnessy

given: Joyce

family: Loesch

full_name: David Loesch

given: David

family: Blum

full_name: Joanne L Blum

given: Joanne L

family: Vahdat

full_name: Linda T Vahdat

given: Linda T

family: Petrakova

full_name: Katarina Petrakova

given: Katarina

family: Chollet

full_name: Philippe Chollet

given: Philippe

family: Manikas

full_name: Alexey Manikas

given: Alexey

family: Diéras

full_name: Veronique Diéras

given: Veronique

family: Delozier

full_name: Thierry Delozier

family: Vladimirov

full_name: Vladimir Vladimirov

given: Vladimir

family: Cardoso

full_name: Fatima Cardoso

given: Fatima

family: Koh

full_name: Han Koh

given: Han

family: Bougnoux

full_name: Philippe Bougnoux

family: Dutcus

full_name: Corina E Dutcus

given: Corina E

family: Seegobin

full_name: Seth Seegobin

given: Seth

family: Mir

full_name: Denis Mir

given: Denis

family: Meneses

full_name: Nicole Meneses

given: Nicole

family: Wanders

full_name: Jantien Wanders

given: Jantien

family: Twelves

full_name: Chris Twelves

journal_name: The Lancet

ReferenceCitation: Jimeno A. Eribulin: rediscovering tubulin as an anticancer target. Clin Cancer Res. 2009 Jun 15;15(12):3903-5. doi: 10.1158/1078-0432.CCR-09-1023. Epub 2009 Jun 9.

ReferenceCitation: Joly F, Lange M, Rigal O, Correia H, Giffard B, Beaumont JL, Clisant S, Wagner L. French version of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) version 3. Support Care Cancer. 2012 Dec;20(12):3297-305. doi: 10.1007/s00520-012-1439-2. Epub 2012 May 2.

ReferenceCitation: Jordan MA, Kamath K, Manna T, Okouneva T, Miller HP, Davis C, Littlefield BA, Wilson L. The primary antimitotic mechanism of action of the synthetic halichondrin E7389 is suppression of microtubule growth. Mol Cancer Ther. 2005 Jul;4(7):1086-95.

ReferenceCitation: Kaufman PA, Awada A, Twelves C, Yelle L, Perez EA, Velikova G, Olivo MS, He Y, Dutcus CE, Cortes J. Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol. 2015 Feb 20;33(6):594-601. doi: 10.1200/JCO.2013.52.4892. Epub 2015 Jan 20.

name: Peter A. Kaufman, Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Martin S. Olivo, Yi He, and Corina E. Dutcus, Eisai, Woodcliff Lake, NJ; Ahmad Awada, Medical Oncology Clinic, Jules Bordet Institute, Université Libre de Bruxelles, Brussels, Belgium; Chris Twelves and Galina Velikova, Leeds Institute of Cancer and Pathology, and St James's Institute of Oncology, Leeds, United Kingdom; Louise Yelle, University of Montreal,...

family: Kaufman

full_name: Peter A. Kaufman

publisher: American Society of Clinical Oncology (ASCO)

title: Phase III Open-Label Randomized Study of Eribulin Mesylate Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With an Anthracycline and a Taxane

ReferenceCitation: Lin NU, Lee EQ, Aoyama H, Barani IJ, Barboriak DP, Baumert BG, Bendszus M, Brown PD, Camidge DR, Chang SM, Dancey J, de Vries EG, Gaspar LE, Harris GJ, Hodi FS, Kalkanis SN, Linskey ME, Macdonald DR, Margolin K, Mehta MP, Schiff D, Soffietti R, Suh JH, van den Bent MJ, Vogelbaum MA, Wen PY; Response Assessment in Neuro-Oncology (RANO) group. Response assessment criteria for brain metastases: proposal from the RANO group. Lancet Oncol. 2015 Jun;16(6):e270-8. doi: 10.1016/S1470-2045(15)70057-4. Epub 2015 May 27. Review.

ReferenceCitation: Lu J, Steeg PS, Price JE, Krishnamurthy S, Mani SA, Reuben J, Cristofanilli M, Dontu G, Bidaut L, Valero V, Hortobagyi GN, Yu D. Breast cancer metastasis: challenges and opportunities. Cancer Res. 2009 Jun 15;69(12):4951-3. doi: 10.1158/0008-5472.CAN-09-0099. Epub 2009 May 26.

ReferenceCitation: Matsuoka H, Tsurutani J, Tanizaki J, Iwasa T, Komoike Y, Koyama A, Nakagawa K. Regression of brain metastases from breast cancer with eribulin: a case report. BMC Res Notes. 2013 Dec 18;6:541. doi: 10.1186/1756-0500-6-541.

ReferenceCitation: Narayan S, Carlson EM, Cheng H, Condon K, Du H, Eckley S, Hu Y, Jiang Y, Kumar V, Lewis BM, Saxton P, Schuck E, Seletsky BM, Tendyke K, Zhang H, Zheng W, Littlefield BA, Towle MJ, Yu MJ. Novel second generation analogs of eribulin. Part III: Blood-brain barrier permeability and in vivo activity in a brain tumor model. Bioorg Med Chem Lett. 2011 Mar 15;21(6):1639-43. doi: 10.1016/j.bmcl.2011.01.096. Epub 2011 Jan 26.

ReferenceCitation: Pivot X, Marmé F, Koenigsberg R, Guo M, Berrak E, Wolfer A. Pooled analyses of eribulin in metastatic breast cancer patients with at least one prior chemotherapy. Ann Oncol. 2016 Aug;27(8):1525-31. doi: 10.1093/annonc/mdw203. Epub 2016 May 13.

ReferenceCitation: Qin DX, Zheng R, Tang J, Li JX, Hu YH. Influence of radiation on the blood-brain barrier and optimum time of chemotherapy. Int J Radiat Oncol Biol Phys. 1990 Dec;19(6):1507-10.

ReferenceCitation: Schwartz LH, Litière S, de Vries E, Ford R, Gwyther S, Mandrekar S, Shankar L, Bogaerts J, Chen A, Dancey J, Hayes W, Hodi FS, Hoekstra OS, Huang EP, Lin N, Liu Y, Therasse P, Wolchok JD, Seymour L. RECIST 1.1-Update and clarification: From the RECIST committee. Eur J Cancer. 2016 Jul;62:132-7. doi: 10.1016/j.ejca.2016.03.081. Epub 2016 May 14.

ReferenceCitation: Thavarajah N, Bedard G, Zhang L, Cella D, Beaumont JL, Tsao M, Barnes E, Danjoux C, Sahgal A, Soliman H, Chow E. Psychometric validation of the functional assessment of cancer therapy--brain (FACT-Br) for assessing quality of life in patients with brain metastases. Support Care Cancer. 2014 Apr;22(4):1017-28. doi: 10.1007/s00520-013-2060-8. Epub 2013 Nov 28.

ReferenceCitation: Tóth K, Vaughan MM, Peress NS, Slocum HK, Rustum YM. MDR1 P-glycoprotein is expressed by endothelial cells of newly formed capillaries in human gliomas but is not expressed in the neovasculature of other primary tumors. Am J Pathol. 1996 Sep;149(3):853-8.

ReferenceCitation: Zhang RD, Price JE, Fujimaki T, Bucana CD, Fidler IJ. Differential permeability of the blood-brain barrier in experimental brain metastases produced by human neoplasms implanted into nude mice. Am J Pathol. 1992 Nov;141(5):1115-24.

location_facility: Institut de Cancerologie de L'Ouest - Paul Papin

location_facility: Institut de Cancerologie de Lorraine Alexis Vautrin

title: A Phase II Study of Eribulin in Brain Metastases From HER2-negative Breast Cancer Pre-treated With Anthracyclines and Taxanes

summary: To evaluate the efficacy of eribulin for treatment of HER2-negative breast cancer brain metastases (BCBM)


title: Diagnostic Yield of Post PRandial Esophageal High Resolution Impedance Manometry in Patients With Gastro-Esophageal Reflux Disease Symptoms Resistant to Proton Pump Inhibitor Therapy

acronym: PRIMER

summary:
Gastro-esophageal reflux disease (GERD) is defined as the reflux of gastric content into the esophagus that causes troublesome symptoms or complications. Nine to 30% of the population suffers from GERD-suggestive symptoms (heartburn, regurgitation, chest pain, chronic couch, sore throat). In the absence of warning signs, proton pump inhibitors (PPI) are prescribed as first-line treatment. However, 20 to 60% of patients are unsatisfied because of persistent symptoms when taking PPI. Causes of persistent symptoms are: erroneous diagnosis of GERD (up to 50% of PPI non-responders), rumination syndrome, excessive weakly acid reflux on PPI due to defective esophago-gastric junction or an excessive number of transient lower esophageal sphincter relaxations (main mechanism of GERD), poor acid secretion inhibition on PPI, and non-compliance to therapy. Complementary examinations are indicated to explain persistent GERD symptoms. Upper gastro-intestinal endoscopy is performed first to rule out an esophageal tumor and to identify erosive esophagitis, a specific sign of GERD. However, it is normal in up to 70% of symptomatic GERD patients. Direct detection of reflux episodes is then requested to confirm GERD. The gold standard for reflux detection is the ambulatory measurement of esophageal pH for 24 to 96 hours using a catheter (catheter-based pH-monitoring) or a capsule clipped into the esophagus (wireless pH-monitoring). Reflux episodes are defined as an esophageal pH < 4. Another method of reflux detection is based on liquid and gas detection in the esophagus using pH-impedance monitoring. Recently the combination of impedance and esophageal pressure monitoring, called esophageal high resolution impedance manometry (HRIM) was introduced to simultaneously identify reflux episodes and their mechanisms. It has several advantages over esophageal pH measurement: shorter recording duration (1 or 2 hours post prandial) and identification of reflux mechanisms that might guide the choice of the best therapeutic option.

Hypothesis: The 1-hour post prandial esophageal HRIM might be useful to diagnose GERD.

location_facility: Service d'Hepato-Gastroenterologie - Hôpital Pontchaillou- CHU de Rennes

location_facility: Service d'Hepato-Gastroenterologie - Hôpital Louis Mourier - APHP

location_facility: Service d'Hepato-Gastroenterologie - Hôpital Haut Lévêque - CHU de Bordeaux

location_facility: Service de Physiologie Digestive, Respiratoire, Urinaire et Sportive - CHU de Rouen

location_facility: Service d'Explorations Fonctionnelles Digestives - Hôpital Edouard Herriot - HCL

location_facility: Service d'Hepato-Gastroenterologie - Hôtel Dieu - CHU de Nantes

location_facility: Service d'Hepato-Gastroenterologie - Hôpital Trousseau - CHU de Tours


title: A GCO Trial Exploring the Efficacy and Safety of Nivolumab Monotherapy or Nivolumab Plus Ipilimumab in Pre-treated Patients With Advanced, Refractory Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Tumors (NECs)

acronym: NIPINEC

summary:
Neuroendocrine tumors of the lung include the small cell carcinoma (SCLC), and large cell neuroendocrine carcinoma (LCNEC) and represent 20% of lung cancer. One of the only studies reported to date is reporting on a progression-free survival (PFS) and overall survival (OS) of 5.2 months and 7.7 months, respectively.

Poorly differentiated gastroentero-pancreatic neuroendocrine carcinomas (GEP-NEC) represent a small sub-group of digestive NENs, according to the studies, 7 to 21% of patients. However, their prognosis is more negative, with the 5-year survival at less than 20%.

Many Phase III trials showed superiority in terms of efficacy and tolerance of nivolumab+/-ipilimumab versus standard chemotherapy in second-line treatment in metastatic solid tumors. Neuroendocrine tumors are considered as rare disease without therapeutic guidelines in this setting. The French academic oncology groups (IFCT, FFCD and GERCOR) have the opportunity to recruit a sufficient number of patients, in a reasonable period of time, to provide a proof-of-concept of the safety and efficacy of nivolumab+/-ipilimumab in this population.

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility:
Centre Hospitalier du Pays d'Aix
CHU d'Angers
Auxerre - CH
Avignon - CH
CHU d'Amiens-Picardie
Lyon - Hôpital Edouard Herriot
Paris - Curie


title: A Phase 1b/2 Study to Evaluate the Safety and Efficacy of APR-246 in Combination With Azacitidine for the Treatment of Mutation TP53 (TP53) Mutant Myeloid Neoplasms

summary: The main purpose of this study is to determine the safe and efficacy of APR-246 in combination with azacitidine as well as to see complete remission of this patients

ReferenceCitation: Cluzeau T, Sebert M, Rahmé R, Cuzzubbo S, Lehmann-Che J, Madelaine I, Peterlin P, Bève B, Attalah H, Chermat F, Miekoutima E, Rauzy OB, Recher C, Stamatoullas A, Willems L, Raffoux E, Berthon C, Quesnel B, Loschi M, Carpentier AF, Sallman DA, Komrokji R, Walter-Petrich A, Chevret S, Ades L, Fenaux P. Eprenetapopt Plus Azacitidine in TP53-Mutated Myelodysplastic Syndromes and Acute Myeloid Leukemia: A Phase II Study by the Groupe Francophone des Myélodysplasies (GFM). J Clin Oncol. 2021 May 10;39(14):1575-1583. doi: 10.1200/JCO.20.02342. Epub 2021 Feb 18.

name: Cote d'Azur University, Hematology Department, Centre Hospitalier Universitaire of Nice, Nice, France

name: Cote d'Azur University, Mediterranean Center of Molecular Medicine, INSERM U1065, Nice, France

family: Cluzeau

full_name: Thomas Cluzeau

given: Thomas

name: Hematology Department, Hospital Saint Louis, Assistance Publique des Hopitaux de Paris (APHP), and Paris University, Paris, France

family: Sebert

full_name: Marie Sebert

given: Marie

family: Rahmé

full_name: Ramy Rahmé

given: Ramy

name: Neurology Department, Hospital Saint Louis, APHP, Paris, France

family: Cuzzubbo

full_name: Stefania Cuzzubbo

given: Stefania

name: Pharmacy Department, Hospital Saint Louis, APHP, Paris, France

family: Lehmann-Che

full_name: Jacqueline Lehmann-Che

given: Jacqueline

family: Madelaine

full_name: Isabelle Madelaine

given: Isabelle

name: Hematology Department, CHU of Nantes, Nantes, France

family: Peterlin

full_name: Pierre Peterlin

given: Pierre

family: Bève

full_name: Blandine Bève

given: Blandine

family: Attalah

full_name: Habiba Attalah

given: Habiba

family: Chermat

full_name: Fatiha Chermat

given: Fatiha

family: Miekoutima

full_name: Elsa Miekoutima

given: Elsa

name: Hematology Department, IUCT Oncopôle, Toulouse, France

family: Rauzy

full_name: Odile Beyne Rauzy

given: Odile Beyne

family: Recher

full_name: Christian Recher

given: Christian

name: Hematology Department, Centre Henri Becquerel, Rouen, France

family: Stamatoullas

full_name: Aspasia Stamatoullas

given: Aspasia

name: Hematology Department, Hospital Cochin, APHP, Paris, France

family: Willems

full_name: Lise Willems

given: Lise

family: Raffoux

full_name: Emmanuel Raffoux

given: Emmanuel

name: Hematology Department, CHU of Lille, Lille, France

family: Berthon

full_name: Céline Berthon

given: Céline

family: Quesnel

full_name: Bruno Quesnel

given: Bruno

family: Loschi

full_name: Michael Loschi

given: Michael

family: Carpentier

full_name: Antoine F. Carpentier

given: Antoine F.

name: Hematology Unit, Moffitt Cancer Center and Research Institute, Tampa, FL

family: Sallman

full_name: David A. Sallman

given: David A.

family: Komrokji

full_name: Rami Komrokji

given: Rami

name: SBIM, Hospital Saint Louis, APHP, and Paris University, Paris, France

family: Walter-Petrich

full_name: Anouk Walter-Petrich

given: Anouk

family: Chevret

publisher_dissemination: American Society of Clinical Oncology (ASCO)

location_facility: Hôpital Saint Louis - Hématologie Séniors

location_facility: Dr Pierre Peterlin and Pr Patrice Chevalier


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


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. Review.

family: Rank

full_name: Roger G. Rank

given: Roger G.

family: Yeruva

full_name: Laxmi Yeruva

given: Laxmi

journal_name: Infection and Immunity

evidence: open (via free pdf)

repository_institution: PubMed Central - Europe PMC

publisher: American Society for Microbiology

publisher_dissemination: American Society for Microbiology

publisher_group: American Society for Microbiology

publisher_normalized: American Society for Microbiology

title: Hidden in Plain Sight: Chlamydial Gastrointestinal Infection and Its Relevance to Persistence in Human Genital Infection

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. Review.

family: Kong

full_name: Fabian Yuh Shiong Kong

given: Fabian Yuh Shiong

family: Tabrizi

full_name: Sepehr N. Tabrizi

given: Sepehr N.

family: Fairley

full_name: Christopher Kincaid Fairley

given: Christopher Kincaid

family: Vodstrcil

full_name: Lenka A. Vodstrcil

given: Lenka A.

family: Huston

full_name: Wilhelmina M. Huston

given: Wilhelmina M.

family: Chen

full_name: Marcus Chen

given: Marcus

family: Bradshaw

full_name: Catriona Bradshaw

given: Catriona

family: Hocking

full_name: Jane S. Hocking

given: Jane S.

journal_name: Journal of Antimicrobial Chemotherapy

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: 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. Review.

full_name: Jane Simone Hocking

given: Jane Simone

repository_institution: University of Melbourne - Minerva Access

ReferenceCitation: Peuchant O, Lhomme E, Krêt M, Ghezzoul B, Roussillon C, Bébéar 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.

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

publisher: Ovid Technologies (Wolters Kluwer Health)

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


title: Value of the Combination Ultrasonography With Ti-RADS Score / Dual Tracer Scintigraphy MIBI-Tc99m/Iodine-123 in the Detection of Malignancy of Thyroid Nodules (Sup or Egal to 15 mm) Classified Bethesda III or IV on Cytology

acronym: MIBI-THYR

summary: The main objective of the study is to show that the addition of ultrasonography to the dual tracer scintigraphy MIBI-Tc99m/Iodine-123 will increase (at least +5%) the negative predictive value compared to the dual tracer scintigraphy alone in detection of malignancy in thyroid nodules ≥15 mm classified as Bethesda III-IV on cytology.

location_facility: Centre Hospitalier et Universitaire (chu)

location_facility: Assistance publique des Hôpitaux de Paris