title: Electronic Feedback for the Restitution and Valorization of Data on the Management of Acute Coronary Syndrome With ST Segment Elevation in Aquitaine to Emergency Teams

acronym: FERVEUR

summary:
ST+ Acute Coronary Syndrome (ACS) is a major cause of mortality, morbidity and healthcare costs in Europe and France. Emergency trans-luminal angioplasty (TLA), the gold standard treatment, is the major determinant of vital prognosis and functional recovery of patients with ST+ ACS.

However, data from surveys and French practice registers highlight frequent deviations from the recommendations at different stages of the procedure; in the pre-hospital phase these malfunctions result in longer delays. Improving the quality of care for patients with ST+ ACS, and in particular improving compliance with recommended delays in the acute phase, is a public health priority in France.

Feedback has been identified as one of the most effective interventions to improve practices and organisations in healthcare institutions. Feedbacks are defined as "any summary of a care performance over a given period of time that can be transmitted a posteriori to the health professional in any form, whether written, oral or by computer (in this case called e-feedbacks)". Feedbacks, by objectifying the level of individual and collective performance, encourage recipients to modify their practices and organisations to improve their performance. It also acts as a social pressure mechanism. While the minimum elements of feedback have been identified in the literature, there is a lack of information about the optimal operational modalities for their deployment, which limits the system's capacity to implement them. To overcome this lack of information, there is a consensus in the scientific community that research on feedback should focus not only on analysing its effectiveness, but above all on the determinants of its effectiveness. With regard to the quality of management of patients with ST+ ACS, only four trials were found in the literature that studied the effectiveness of feedbacks; none of them defined the optimal intervention for deploying feedbacks in the emergency department setting.

Practice registers, particularly in the cardiovascular field, have shown their effectiveness in improving practices, particularly through the implementation of feedback to practitioners, who produce data. In 2012, the ARS Aquitaine set up two regional cardiovascular registers constituting permanent, nominative, continuous and exhaustive records of the management of patients suffering from coronary pathologies: the Aquitaine Interventional Cardiology Register (ACIRA) and the Aquitaine Register of Initial Management of Myocardial Infarction (REANIM). The cross-referencing of the REANIM and ACIRA registers constitutes an exhaustive cohort of patients with ST+ ACS containing information on the management of the entire care pathway, from the onset of symptoms to the end of the hospitalization for the management of the acute episode. This cohort, which is unique in France in the field of coronary pathologies, makes it possible to produce unprecedented and highly accurate information, particularly concerning the time taken to provide care. Wishing to actively engage in a process of changing practices, the Aquitaine Cardiovascular Registries team has developed an e-feedback tool for emergency, EMS and cardiology teams. This tool alone cannot contribute to effectively improving patient care. It is necessary to build an intervention for the deployment of this tool that takes into account the scientific data and the organisational constraints of care. Secondly, the evaluation of the effectiveness and economic impact of this e-feedbacks tool deployment intervention will allow us to know its real added value on practices, organisations and health care expenditure.

location_facility:
Centre Hospitalier de Pau
Centre Hospitalier de la Cote Basque
Centre Hospitalier Agen Nérac
Centre Hospitalier Périgueux
Centre Hospitalier de Mont de Marsan
Hôpital de Libourne
Hôpital Pellegrin


type: Other Identifier

title: Prospective Multicentric Randomized Trial Comparing the Efficacy and Safety of Single-anastomosis Duodeno Ileal Bypass With Sleeve Gastrectomy (SADI-S) Versus Roux-en-Y Gastric Bypass (RYGB)

acronym: SADISLEEVE

summary:
Obesity is a major public health problem worldwide. Bariatric surgery has proved to be the most effective treatment of morbid obesity in terms of weight reduction and remission of co-morbid conditions during long-term follow-up. Nowadays, France is ranked 3rd in terms of bariatric surgeries performed per year.

Since the laparoscopic Roux-en-Y gastric bypass (RYGB) was described in 1977, this restrictive and malabsorptive procedure has become a gold standard for morbid obesity with an average Excess Weight Loss % (EWL%) of 72% at 2 years, and a strong metabolic effect, especially with regard to type 2 diabetes remission. Nevertheless, failures are observed (up to 20%), particularly in super obese patients, which are then difficult to manage. In this population, biliopancreatic diversion with duodenal switch (BPD-DS) is indicated due to its stronger weight loss and metabolic effect, but is still little performed worldwide because of its higher morbidity, surgical complexity and risk of malnutrition.

A novel technique combining the physiological advantages of pylorus preservation and the technical benefits of single-loop reconstruction was introduced in 2007 by Sanchez-Pernaute, who described the single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) as an evolution of the BPD-DS. With a 2.5-meter common channel, SADI-S seems to offer good results for the treatment of both morbid obesity and its metabolic complications, with an EWL% of up to 95% at 2 years and potentially less nutritional consequences.

To date, there is only one Spanish randomized trial comparing SADI-S to BPD-DS, whereas BPD-DS represents less than 1% of bariatric procedures in France and is only allowed in super obese patients. Thus only preliminary data of poor scientific value exists. Nevertheless, facing very encouraging short-term outcomes, there is a real need for a prospective trial comparing SADI-S to a standard bariatric procedure.

The aim of the investigator's study is to assess weight loss efficiency and the morbi-mortality of the SADI-S in comparison to a standard (RYGB), in order to validate this procedure among bariatric techniques

HYPOTHESIS SADI-S is superior to the standard RYGB for weight loss, increasing the EWL% by 10% (82% vs 72%, respectively) at 2 years.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Robert M, Poghosyan T, Delaunay D, Pelascini E, Iceta S, Sterkers A, Barsamian C, Khamphommala L, Bin Dorel S, Maucort-Boulch D, Czernichow S, Disse E. Prospective multicentre randomised trial comparing the efficacy and safety of single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) versus Roux-en-Y gastric bypass (RYGB): SADISLEEVE study protocol. BMJ Open. 2020 Sep 1;10(9):e037576. doi: 10.1136/bmjopen-2020-037576.

family: Robert

full_name: Maud Robert

given: Maud

sequence: first

family: Poghosyan

full_name: Tigran Poghosyan

given: Tigran

sequence: additional

family: Delaunay

full_name: Dominique Delaunay

given: Dominique

family: Pelascini

full_name: Elise Pelascini

given: Elise

family: Iceta

full_name: Sylvain Iceta

given: Sylvain

family: Sterkers

full_name: Adrien Sterkers

given: Adrien

family: Barsamian

full_name: Charles Barsamian

given: Charles

family: Khamphommala

full_name: Litavan Khamphommala

given: Litavan

family: Bin Dorel

full_name: Sylvie Bin Dorel

given: Sylvie

family: Maucort-Boulch

full_name: Delphine Maucort-Boulch

given: Delphine

family: Czernichow

full_name: Sebastien Czernichow

given: Sebastien

family: Disse

full_name: Emmanuel Disse

given: Emmanuel

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

license: cc-by

license_normalized: cc-by

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

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

title: Prospective multicentre randomised trial comparing the efficacy and safety of single-anastomosis duodeno–ileal bypass with sleeve gastrectomy (SADI-S) versus Roux-en-Y gastric bypass (RYGB): SADISLEEVE study protocol

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Chirurgie Digestive - Centre Hospitalier Intercommunal de Créteil

location_facility: Département de Chirurgie Digestive - CHU Grenoble

location_facility: Service de Chirurgie Digestive, Générale et Cancérologique - HEGP

location_facility: Département de Chirurgie Digestive et Hépatobiliaire - Centre Hospitalier Privé Saint Grégoire

location_facility: Service de Chirurgie Digestive et Endocrinienne - Groupe Hospitalier Pellegrin

location_facility: Département de Chirurgie Digestive et Hépatobiliaire - Hôpital Pitié Salpétrière

location_facility: Service de Chirurgie Générale, Digestive et Endocrinienne - Hôpital Nord

location_facility: Département de Chirurgie Digestive et Bariatrique, Clinique Mutualiste de l'Estuaire

location_facility: Service de Chirurgie Digestive et Métabolique - Hôpital Avicenne - APHP

location_facility: Service de Chirurgie Digestive et Transplantation - Hôpital Archet II

location_facility: Service de Chirurgie Digestive, Hôpital Rangueil

location_facility: Service de Chirurgie Digestive, Hépatobiliaire et Endocrinienne - Hôpital Brabois adultes

location_facility: Service d'Endocrinologie, Diabète et Nutrition - Centre Hospitalier Lyon Sud - HCL

location_facility: Département de Chirurgie Digestive et Viscérale, Centre Hospitalier Jean Marcel

location_facility: Département de Chirurgie Digestive et Viscérale - Clinique de l'Anjou

location_facility: Service de Chirurgie Digestive et Bariatrique - Hôpital Edouard Herriot - HCL

location_facility: Service de Chirurgie Digestive et Viscérale - Clinique La Parisière

location_facility: Département de Chirurgie Digestive - Institut Mutualiste Montsouris

location_facility: Service de Chirurgie Générale et Digestive - Hôpital Louis Mourier

location_facility: Service de Chirurgie Digestive et Endocrinienne - Hôtel Dieu

location_facility: Service de Chirurgie Digestive - Hôpital Bichat

location_facility: Département de Chirurgie Digestive et Thoracique, Hôpitaux Civils de Colmar

location_facility: Service de Chirurgie Générale et Endocrinienne - Hôpital Huriez

location_facility: Service de Chirurgie Générale et Digestive - Hôpital Purpan

location_facility: Département de Chirurgie Digestive, Centre Hospitalier René Dubos

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Ongoing


title: LAROTRACKING - A Retro-/Prospective, Non-interventional, Cohort Study in Adult Patients With Locally Advanced or Metastatic Tumors With a Neurotrophic Tyrosine Receptor Kinase (NTRK) Gene Fusion, Treated With Larotrectinib

acronym: LAROTRACKING

summary: Larotrectinib, a selective TRK inhibitor has showed marked and durable antitumor activity in patients with NTRK gene-fusion-positive tumors regardless of the tumor type, gene partner and patient's age. Because of this and the lack of alternative therapy in this rare but severe disease, the French National Agency for Medicines and Health Products Safety (ANSM) granted in April 2019, a "cohort" Temporary Authorization for Use (ATU) in the indication:"Larotrectinib is indicated as monotherapy for the treatment of adult and paediatric patients from one month, with locally advanced or metastatic solid tumours with a Neurotrophic Tyrosine Receptor Kinase (NTRK) fusion, refractory to standard treatments or in the absence of appropriate therapeutic alternative." Despite the potential benefit of identifying these fusions, the clinicopathologic features of NTRK fusion-positive tumors which are treated with Larotrectinib, are not well characterized. This study will provide information about the diagnosis and management of patients with locally advanced or metastatic NTRK fusion cancer treated with Larotrectinib under real-world treatment conditions in France, and describes the dosing patterns, safety and effectiveness of this agent.

study_type: Observational

time_perspective: Retrospective

lead_sponsor: Centre Leon Berard

location_facility:
Centre Leon Berard
Chi Elbeuf Louviers
CHU Amiens
Centre Georges Francois Leclerc


title: Post Marketing Observational Study Of Reformulated BeneFIX

summary: The primary objective of this observational study is to collect safety data on reformulated BeneFIX as prescribed in routine clinical practice conditions in France. The secondary objectives are to collect data on the clinical course of individuals treated with reformulated BeneFIX and on the ease of reformulated BeneFIX.

status: Completed

study_completion_date_type: Actual

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Pfizer

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Completed


title: Comparison of the Evolution of Memory Deficit in Patients With Sleep Apnea Obstructive Syndrome (SAOS) Before and After "Effective" Versus Sham Treatment by Positive Pression Continues (PPC)

summary:
The main objective of this study is to evaluate the evolution of memory deficit (verbal episodic memory, procedural memory, working memory, short-term memory) in Sleep Apnea Obstructive Syndrome (SAOS) patients after treatment by Continuous Positive Airway Pressure treatment (CPAP). For thus, we will compare memory tests in two separate groups of SAOS patients with "effective " versus "ineffective" ( or sham) CPAP, before and 6 weeks after the beginning of the treatment. Thus we will assess the evolution of memory deficit, the effectiveness of the treatment on the evolution of memory deficit before and 6 weeks after the beginning of the treatment by "effective " versus "ineffective" CPAP.

We feel the results of the tests of memory will show greater memory disorders in patients with SAOS before beginning the treatment rather than six weeks afterwards. Thus we hypothesise that, after the treatment by "effective" CPAP, the patients with SAOS will have greater improvement of their memory disorders than those treated by "sham CPAP".

ReferenceType: background

ReferenceCitation: Beebe DW, Gozal D. Obstructive sleep apnea and the prefrontal cortex: towards a comprehensive model linking nocturnal upper airway obstruction to daytime cognitive and behavioral deficits. J Sleep Res. 2002 Mar;11(1):1-16. Review.

ReferenceCitation: Engleman HM, Douglas NJ. Sleep. 4: Sleepiness, cognitive function, and quality of life in obstructive sleep apnoea/hypopnoea syndrome. Thorax. 2004 Jul;59(7):618-22. Review.

ReferenceCitation: Farré R, Hernández L, Montserrat JM, Rotger M, Ballester E, Navajas D. Sham continuous positive airway pressure for placebo-controlled studies in sleep apnoea. Lancet. 1999 Apr 3;353(9159):1154.

ReferenceCitation: Naëgelé B, Launois SH, Mazza S, Feuerstein C, Pépin JL, Lévy P. Which memory processes are affected in patients with obstructive sleep apnea? An evaluation of 3 types of memory. Sleep. 2006 Apr;29(4):533-44.

ReferenceCitation: Joyeux-Faure M, Naegelé B, Pépin JL, Tamisier R, Lévy P, Launois SH. Continuous positive airway pressure treatment impact on memory processes in obstructive sleep apnea patients: a randomized sham-controlled trial. Sleep Med. 2016 Aug;24:44-50. doi: 10.1016/j.sleep.2016.06.023. Epub 2016 Aug 23.

family: Joyeux-Faure

full_name: Marie Joyeux-Faure

given: Marie

family: Naegelé

full_name: Bernadette Naegelé

given: Bernadette

family: Pépin

full_name: Jean-Louis Pépin

given: Jean-Louis

family: Tamisier

full_name: Renaud Tamisier

given: Renaud

family: Lévy

full_name: Patrick Lévy

given: Patrick

family: Launois

full_name: Sandrine H. Launois

given: Sandrine H.

journal_name: Sleep Medicine

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Jullian-Desayes I, Tamisier R, Zarski JP, Aron-Wisnewsky J, Launois-Rollinat SH, Trocme C, Levy P, Joyeux-Faure M, Pepin JL. Impact of effective versus sham continuous positive airway pressure on liver injury in obstructive sleep apnoea: Data from randomized trials. Respirology. 2016 Feb;21(2):378-85. doi: 10.1111/resp.12672. Epub 2015 Nov 16.

name: HP2; INSERM, U1042University Grenoble Alpes Grenoble France

family: Jullian‐Desayes

full_name: Ingrid Jullian‐Desayes

given: Ingrid

name: Hepato‐Gastro‐Enterology DepartmentCHU Grenoble Grenoble France

family: Zarski

full_name: Jean‐Pierre Zarski

given: Jean‐Pierre

name: Endocrinology and Nutrition DepartmentAP‐HP, La Pitié‐Salpétrière, Hospital Paris France

name: Nutriomic DepartmentINSERM, UMRS 872, University Pierre and Marie Curie‐Paris 6 Paris France

family: Aron‐Wisnewsky

full_name: Judith Aron‐Wisnewsky

given: Judith

family: Launois‐Rollinat

full_name: Sandrine H. Launois‐Rollinat

name: Biochemistry, Toxicology and Pharmacology DepartmentCHU Grenoble Grenoble France

family: Trocme

full_name: Candice Trocme

given: Candice

family: Levy

full_name: Patrick Levy

family: Joyeux‐Faure

full_name: Marie Joyeux‐Faure

family: Pepin

full_name: Jean‐Louis Pepin

given: Jean‐Louis

journal_name: Respirology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ipd_sharing: Yes

ipd_sharing_description: All individual patient data are anonymized

lead_sponsor: University Hospital, Grenoble

location_facility: Laboratoire EFCR-Functional Cardio-Respiratory Exploration Laboratory

intervention_type: Device


title: Evaluation of Mucogyne® Ovule in Vulvovaginal Dryness Management in Women Treated by Brachytherapy and/or Radiotherapy for Endometrial or Cervical Cancer.

acronym: HYDRAMUC

summary:
Randomized, open-label, national (France), multicenter, prospective clinical study, to evaluate the superiority of Mucogyne® ovules over the control group on vaginal health (including hydration) in women treated by brachytherapy and/or radiotherapy for endometrial or cervical cancer.

The study will be carried out in 2 phases: the first part will focus on 80 women with endometrial cancer, an interim analysis will determine the interest of continuing or not the study (second part) on the whole targeted population (endometrial or cervical cancer).

status: Active, not recruiting

lead_sponsor: Laboratoires IPRAD

location_facility: Institut de Cancerologie de Lorraine - Site 004


title: Usefulness of Sodium MRI in the Presurgical Assessment of Drug-resistant Partial Epilepsy

acronym: EPISODIUM

summary: Epilepsy is a common disease affecting 0.5 to 1% of the general population. Epilepsies refractory to drug treatment lead to increased morbidity, mortality and high costs for public health (representing 75% of the costs associated with epilepsy is among the most costly diseases in Neurology). The only curative therapy is surgical removal or disconnection of the epileptogenic network. To do this, a comprehensive presurgical evaluation is essential to accurately define the location of the epileptogenic zone (EZ) and its relationship with the functional areas that must be preserved. This approach requires in some cases intracerebral EEG recordings. This latter technique, expensive and invasive, remains at present, the standard method in the location of the ZE. In this context, the development of non-invasive and inexpensive methods is a priority in the field. Moreover, many fundamental studies have shown changes in ion homeostasis including sodium associated with hyperexcitability related to epilepsy. The investigators team at CEMEREM, CHU Timone, specialized in the development and validation of innovative methods in MRI, has developed an in vivo sodium MRI acquisition and processing of data unique in France, capable of quantifying the intracerebral sodium concentration in three dimensions in a completely non-invasive and non-irradiating manner

status: Unknown status

primary_purpose: Diagnostic

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique - Hopitaux de Marseille

status_simplified: Unknown


title: Stress Thallium-201/Rest Technetium-99m Sequential Dual Isotope High-Speed Myocardial Perfusion Imaging Validation Versus Invasive Coronary Angiography

acronym: CameraCZT

summary: The new cadmium-zinc-telluride (CZT) technology is a powerful tool for cardiac nuclear medicine. The increased photon counting sensitivity of camera can be used to explore novel protocols like dual isotope (rapid stress Tl-201/rest Tc-99m protocol for use with high-speed SPECT MPI). The use of dual isotope imaging is very interesting because this imaging combines the use of thallium-201 with technetium-99m agents permitting optimal image resolution and simultaneous assessment of viability, all with an exam duration of approximately 20 minutes. However, no study compares stress thallium-201/rest technetium-99m sequential dual isotope high-speed myocardial perfusion imaging versus invasive coronary angiography. The investigators report here the first validation of high-speed protocol with dual isotope for myocardial perfusion imaging using invasive coronary angiography as the standard of reference.

ReferenceCitation: Barone-Rochette G, Leclere M, Calizzano A, Vautrin E, Céline GC, Broisat A, Ghezzi C, Baguet JP, Machecourt J, Vanzetto G, Fagret D. Stress thallium-201/rest technetium-99m sequential dual-isotope high-speed myocardial perfusion imaging validation versus invasive coronary angiography. J Nucl Cardiol. 2015 Jun;22(3):513-22. doi: 10.1007/s12350-014-0016-0. Epub 2014 Nov 8.

family: Barone-Rochette

full_name: Gilles Barone-Rochette

given: Gilles

family: Leclere

full_name: Mélanie Leclere

given: Mélanie

family: Calizzano

full_name: Alex Calizzano

given: Alex

family: Vautrin

full_name: Estelle Vautrin

given: Estelle

family: Céline

full_name: Gallazzini-Crepin Céline

given: Gallazzini-Crepin

family: Broisat

full_name: Alexis Broisat

given: Alexis

family: Ghezzi

full_name: Catherine Ghezzi

given: Catherine

family: Baguet

full_name: Jean Philippe Baguet

given: Jean Philippe

family: Machecourt

full_name: Jacques Machecourt

given: Jacques

family: Vanzetto

full_name: Gérald Vanzetto

given: Gérald

family: Fagret

full_name: Daniel Fagret

given: Daniel

journal_name: Journal of Nuclear Cardiology

oa_host_type: repository

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

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: submittedVersion

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer


title: Human Papilloma Virus Vaccination and Chronic Inflammatory Rheumatic Disease. A Cross-sectional Study of Vaccinal Coverage, Barriers and Motivations.

acronym: HPV-CIR

summary:
Patients with chronic inflammatory rheumatic disease (CIR) are at increased risk for infections. Vaccination is a powerful tool to prevent infections, even in immunocompromised patients. Low-risk types of Human papilloma virus (HPV) cause anogenital warts, while high risk types are strongly related to pre-malignant cervical abnormalities and cervical cancer. HPV vaccines have been developed to prevent these conditions. Human papillomavirus (HPV) infections are more prevalent in systemic lupus erythematosus (SLE) patients or other auto-immune diseases when compared to the healthy population. In France, despite a vaccination available since 2007, rate of vaccination remain low. Although little is known about HPV vaccination in SLE, few studies in patients with autoimmune rheumatic diseases (AIRDs) have shown that HPV vaccines are safe, and capable to induce an immunogenic response in this group of patients. To date, available data suggest that HPV vaccines can be given safely to SLE patients. Given the increased incidence of cervical abnormalities due to HPV in SLE patients, this vaccination should be encouraged.

The aim of this study was to assess the vaccination coverage rate in chronically ill girls with SLE or idiopathic juvenile arthritis who require a close pediatric specialized follow-up vaccination and to understand barriers or motivations for it.

time_perspective: Cross-Sectional

location_facility: Service de médecine interne, Centre hospitalier Lyon Sud


title: Sleep Apnea, Obesity and Pregnancy

acronym: GOS

summary:
Main objective:

Determine the prevalence of obstructive sleep apnea syndrome (OSA) in late pregnancy in a population of obese patients .

Secondary objectives :

Identify risk factors for OSA during pregnancy (age, parity, high blood pressure, snoring , weight, neck circumference, scores on symptoms of sleep apnea, ... ) .
Compare perinatal morbidity among obese patients with OSA in late pregnancy with case-controls.
Evaluate the evolution of a moderate or severe OSA 6 months after pregnancy.

Material and methods

Characteristics of the study:

Interventional biomedical research
Prospective Multicenter nonrandomized study

Flow chart

Patients will be included between 30 and 36 weeks of amenorrhea (WA) .
Will rated from inclusion: age, parity, weight, height, BMI in early pregnancy, neck circumferrence, treated high blood pressure.
As recommended in France, the main test results during the pregnancy follow-up will be recorded.
At the inclusion visit will be conducted a Berlin Questionnaire and Epworth Score.
Screening for OSA by nocturnal polysomnography will be performed between 30 and 36WA. This screening can be performed as an outpatient.
In case of proven OSA patients will be offered an appropriate care by today's standards.
Whatever the outcome of pregnancy, a second polysomnography will be performed 6 months after childbirth in case of OSA during pregnancy.

lead_sponsor: University Hospital, Rouen

location_facility:
Angers University Hospital
Le Havre Hospital
Rouen University Hospital
Caen University Hospital


title: Feasibility of ARTUS MONO Artificial Urinary Sphincter Implant in Women

summary: The ARTUS MONO implant is an active implantable medical device (AIMD) that assist the urethral sphincter function of female patients suffering from moderate to severe urinary incontinence, by remotely opening and closing a cuff placed around the bladder neck. The purpose of this clinical investigation is to evaluate the feasibility of implantation of the device, its safety and its efficacy, when temporarily implanted in female patients scheduled for anterior pelvic exenteration for bladder cancer.

primary_purpose: Device Feasibility

ipd_sharing: Undecided

lead_sponsor: Myopowers Medical Technologies France SAS

location_country: France Czechia

location_facility:
Thomayer hospital
Cochin Hospital


title: Prospective, Multicenter, Randomized, Parallel Group Clinical Study Evaluating the Efficacy of a Biological Mesh (StratticeTM) for the Prevention of Parastomal Hernia After Colorectal Surgery With Colostomy

acronym: PROBIOCOL

summary:
In France around 5,000 colostomies are performed after elective or emergency surgery. These colostomies could be associated with major outcomes including parastomal hernia (4 - 53%) of cases.

To reduce the incidence of these outcomes, several methods have been proposed but the more pertinent consist in the use of a biological mesh during the stoma's conception.

Nevertheless there is no data on the use of a biological mesh (StratticeTM) for the prevention of parastomal hernia.

primary_purpose: Prevention

ReferenceCitation: Timmermans L, Deerenberg EB, Lamme B, Jeekel J, Lange JF. Parastomal hernia is an independent risk factor for incisional hernia in patients with end colostomy. Surgery. 2014 Jan;155(1):178-83. doi: 10.1016/j.surg.2013.06.014. Epub 2013 Nov 12.

ReferenceCitation: Lee L, Saleem A, Landry T, Latimer E, Chaudhury P, Feldman LS. Cost effectiveness of mesh prophylaxis to prevent parastomal hernia in patients undergoing permanent colostomy for rectal cancer. J Am Coll Surg. 2014 Jan;218(1):82-91. doi: 10.1016/j.jamcollsurg.2013.09.015. Epub 2013 Sep 29.

ReferenceCitation: Swann JM, Turek FW. Transfer from long to short days reduces the frequency of pulsatile luteinizing hormone release in intact but not in castrated male golden hamsters. Neuroendocrinology. 1988 Apr;47(4):343-9.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
Amiens university hospital
Lariboisiere Hospital
Claude Huriet Hospital
Caen hospital
Beauvais hospital
Charles Nicolle Hospital


title: Study on the Prevention of Cardiovascular Events by Antiplatelet Agents After Acute Coronary Syndrome

acronym: AReMIS

summary: Prevention of cardiovascular events by antiplatelet agents after acute coronary syndrome

lead_sponsor: AstraZeneca


title: Carbapenem-resistant Enterobacteriaceae: Prevalence, Risk Factors and Impact of the Use of the Phenotypic Algorithm for the Detection of Carbapenemases

acronym: E-CARB

summary: The non-susceptibility of enterobacteriaceae isolates to carbapenem (CARBA) is an emerging concern with a high impact on infectious disease therapy. carbapenemase (CARBase) production are one of the mechanisms of resistance to CARBA. When CARBase production is suspected or proved, specific hygiene measures have to be applied in any hospital. Detecting CARBase in the routine in any laboratory is difficult. it will be useful to standardize them detection to control the emergence.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Effects of an Endurance Training Program at Ventilatory Threshold on the Walking Distance of Ambulatory Patients With Multiple Sclerosis

acronym: AEROSEP

summary:
Multiple sclerosis (MS) is a disease affecting the white matter of the central nervous system. In France, it concerns approximately 80 000 patients and represents one of the most frequent neurological affections in young adults. Effort deconditioning of people affected by MS is already proven, but it is not just linked to the disease itself. The decrease of capacities to produce an effort is aggravated by neurovegetative and cardiovascular disorders. The limitation or the complete stop of physical activity is often linked to the fear of a handicap aggravation. Causes of stop are multiple, including fatigue and balance disorders, even if the handicap level is low (average EDSS = 2). Walking disorders generated by MS are frequent, represent the first symptom of the disease (10 to 20 % of cases) and alter significantly the quality of life.

Some reeducation programs were proposed in hospitalization with some efficiency on functional capacities. It is now admitted that physical exercise is not noxious, and allows the implementation of effort reeducation for MS. Randomized controlled studies have shown in MS patients an improvement of physical abilities, of O2max (aerobic capacity), of quality of life and a decrease of fatigue. For MS, only a few studies estimate the effect of effort reeducation on treadmill. Unfortunately, the efficiency of these programs on walking endurance are controversial.

During the maximal cardiorespiratory effort test, the ventilatory threshold 1 (VT1) corresponds to a greater increasing of CO2 compared to O2. The identification of VT1 allows the precise determination of the limit from which the body is incapable of producing the necessary energy to realize an effort using the aerobic metabolism. The VT1 is situated at a level of load with enough intensity for the subject to support the test without dyspnea. A VT1 lower than 40 % of the theoretical VO2 max is considered as a marker of maladjustment to effort due to dyspnea and excessive muscular fatigue. This indication is very informative about the quality of life of patients.

The goal of this study is to apply a personalized reeducation concerning the working load pre-hyperventilation to deconditioned subjects, easily worried by effort induced breathlessness and fatigue in order to get the optimization of the aerobic function. The hypothesis is that reeducation at this level improves the distance of walking and the quality of life of patients affected by MS.

primary_purpose: Supportive Care

ipd_sharing: No

lead_sponsor: Lille Catholic University

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: Groupement des Hôpitaux de l'Institut Catholique de Lille

location_facility: Centre Hospitalier Universitaire d'Amiens


title: Comparative Evaluation of Minimally Invasive "Tibial Tuberoplasty" Surgical Technique Versus Conventional Open Surgery for Tibial Plateau Fractures (TUBERIMPACT Study)

acronym: TUBERIMPACT

summary:
PMSI (French Medico-Administrative Database) data shows more than 10000 proximal tibial fractures diagnosed in 2014 and 4055 lateral tibial plateau fractures operated in 2013 in France. 50% of these surgical fractures is related to the lateral condyle and causes split/depression (Schatzker 2) or pure depression (Schatzker 3). This high rate results from the recent democratization of high-risk sports, as well as an aging population with increased risks of falling. Aside from the resulting reduced physical activity, the social and professional impact of these fractures is undeniable and represents significant costs for our health care system. A recently published prospective case series reports 28 job losses out of 41 patients treated.

The clinical outcome of these patients depends mainly on the primary stability provided by the surgical treatment, after the greatest anatomical reduction possible. Indeed, Giannoudis and al. have demonstrated that under simple X-rays, the smaller the detected step-off, the better the outcome.The aim is to allow for recovery of good joint mobility to promote rapid resumption of activity and to limit the onset of early osteoarthritis.

The classical technique used for reduction and osteosynthesis of tibial plateau fractures (open surgical technique using a bone tamp) has several pitfalls : devascularization of the bone and skin, risks of infection and functional rehabilitation difficulties with delayed recovery of weight bearing. Moreover, this technique does not allow for the simultaneous diagnosis and treatment of other possible lesions, such as meniscal injuries in particular.

Since 2011, Poitiers University Hospital is offering to its patients a new minimally invasive technique for the reduction and stabilization of tibial plateau fractures, baptized "Tibial Tuberoplasty". The concept derives from the divergent use of vertebral kyphoplasty, initially dedicated for spinal injuries and transposed here to the tibial plateau. This technique involves expansion of the tibial plateau through inflation of a kyphoplasty balloon, filling of the created cavity with cement (PMMA, calcium phosphate) and percutaneous screw fixation.

Orthopaedic surgeons of Poitiers University Hospital performed the first tibial tuberoplasties through a feasibility study on 36 cadaveric subjects and then transposed the technique to human. Surgeons identified major advantages such as minimal skin damage, possible treatment of posterior and multi-fragmented compressions (lifting in a single block by the balloon), reinforcement of the stability of the assembly using cement, possible use of combined arthroscopy (for concomitant meniscal injuries treatment).

This technique allows for optimization of the fracture reduction by elevating the posterior fragments with the inflatable bone tamp through an anterior approach. The reduction is made possible thanks to the specificity of the inflatable bone tamp which inflates and reduces the area of least resistance.

The aim of this innovative technique is focused on the anatomical reduction in order to restore the convexity of the tibial plateau which is similar to the balloon convexity.

The results from the first 40 patients operated since 2011 are promising and show a proportion of 70% presenting less than 5 mm step-off reduction. A larger scale multicenter randomized controlled trial is now requested to further demonstrate the superiority of the "Tibial Tuberoplasty" to the standard treatment.

The coordinator investigator designed this study to evaluate the quality of tibial fracture reduction offered by percutaneous "Tibial Tuberoplasty" versus conventional open surgery for tibial plateau fracture but also its impact on clinical outcome.

ReferenceCitation: Vendeuvre T, Monlezun O, Brandet C, Ingrand P, Durand-Zaleski I, Gayet LE, Germaneau A, Khiami F, Roulaud M, Herpe G, Rigoard P. Comparative evaluation of minimally invasive 'tibial tuberoplasty' surgical technique versus conventional open surgery for Schatzker II-III tibial plateau fractures: design of a multicentre, randomised, controlled and blinded trial (TUBERIMPACT study). BMJ Open. 2019 Sep 3;9(8):e026962. doi: 10.1136/bmjopen-2018-026962.

family: Vendeuvre

full_name: Tanguy Vendeuvre

given: Tanguy

family: Monlezun

full_name: Olivier Monlezun

given: Olivier

family: Brandet

full_name: Claire Brandet

given: Claire

family: Ingrand

full_name: Pierre Ingrand

given: Pierre

family: Durand-Zaleski

full_name: Isabelle Durand-Zaleski

given: Isabelle

family: Gayet

full_name: Louis-Etienne Gayet

given: Louis-Etienne

family: Germaneau

full_name: Arnaud Germaneau

given: Arnaud

family: Khiami

full_name: Frederic Khiami

given: Frederic

family: Roulaud

full_name: Manuel Roulaud

given: Manuel

family: Herpe

full_name: Guillaume Herpe

given: Guillaume

family: Rigoard

full_name: Philippe Rigoard

given: Philippe

repository_institution: PubMed Central - Europe PMC

title: Comparative evaluation of minimally invasive ‘tibial tuberoplasty’ surgical technique versus conventional open surgery for Schatzker II–III tibial plateau fractures: design of a multicentre, randomised, controlled and blinded trial (TUBERIMPACT study)

lead_sponsor: Poitiers University Hospital

location_country: Martinique France

location_facility:
CHU Angers
CHU de Nantes
AP/HP La Pitié Salpétrière
CHU d'Amiens
CHU Rouen
CHU de Poitiers
AP-HP / Hopital Ambroise Paré
CH Versailles
CHU Dijon
CHU de Martinique
CHU de Rennes
CHU de Brest
CHRU Tours


title: A Double-blind, Two-arm, Multicenter, Randomized Trial to Evaluate Efficacy of Cyclophosphamide Versus Methylprednisolone in Patients With Recent Secondary Progressive Multiple Sclerosis: P.R.OM.E.S.S Study

acronym: PROMESS

summary: Preliminary not-controlled clinical studies of the efficacy of monthly intravenous cyclophosphamide administration in secondary progressive multiple sclerosis reported encouraging results, but no randomized controlled trial has been conducted so far. The primary objective of this trial is to evaluate the efficacy of IV cyclophosphamide as compared to IV methylprednisolone administered every 4 weeks during 1 year and every 8 weeks during 1 year, on the delay to confirmed disability deterioration as assessed by the Expanded Disability Status Scale (EDSS) in patients with secondary progressive multiple sclerosis. The secondary objectives are to evaluate safety, tolerability and efficacy at 2 years on the Multiple Sclerosis Functional Composite (MSFC), the percentage of patients with disability deterioration (EDSS) and the number of relapses. An intention-to-treat statistical analysis will be carried out.

ReferenceCitation: Brochet B, Deloire MS, Perez P, Loock T, Baschet L, Debouverie M, Pittion S, Ouallet JC, Clavelou P, de Sèze J, Collongues N, Vermersch P, Zéphir H, Castelnovo G, Labauge P, Lebrun C, Cohen M, Ruet A; PROMESS study investigators. Double-Blind Controlled Randomized Trial of Cyclophosphamide versus Methylprednisolone in Secondary Progressive Multiple Sclerosis. PLoS One. 2017 Jan 3;12(1):e0168834. doi: 10.1371/journal.pone.0168834. eCollection 2017.

family: Brochet

full_name: Bruno Brochet

given: Bruno

family: Deloire

full_name: Mathilde S. A. Deloire

given: Mathilde S. A.

family: Perez

full_name: Paul Perez

given: Paul

family: Loock

full_name: Timothé Loock

given: Timothé

family: Baschet

full_name: Louise Baschet

given: Louise

family: Debouverie

full_name: Marc Debouverie

given: Marc

family: Pittion

full_name: Sophie Pittion

given: Sophie

family: Ouallet

full_name: Jean-Christophe Ouallet

given: Jean-Christophe

family: Clavelou

full_name: Pierre Clavelou

family: de Sèze

full_name: Jérôme de Sèze

given: Jérôme

family: Collongues

full_name: Nicolas Collongues

given: Nicolas

family: Vermersch

full_name: Patrick Vermersch

given: Patrick

family: Zéphir

full_name: Hélène Zéphir

given: Hélène

family: Castelnovo

full_name: Giovanni Castelnovo

given: Giovanni

family: Labauge

full_name: Pierre Labauge

family: Lebrun

full_name: Christine Lebrun

given: Christine

family: Cohen

full_name: Mikael Cohen

given: Mikael

family: Ruet

full_name: Aurélie Ruet

given: Aurélie

currency_apc_doaj: USD

journal_name: PLOS ONE

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

repository_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

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

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org
univOAK

location_facility: (CHR Metz-Thionville) Hôpital Notre Dame de Bon Secours

location_facility: (CHU Montpellier), Hôpital de Gui de Chauliac

location_facility: Hôpital Pellegrin, Département de neurologie


title: Cognitive Remediation Therapy Effectiveness in Anorexia Nervosa: a Multicenter Randomized Clinical Study

acronym: TreCogAM

summary:
"Clinicians from the Maudsley (IoP, London, UK) have specifically tailored a cognitive remediation therapy (CRT) for treating Anorexia Nervosa (AN). It is an intensive manualised training cognitive therapy which addresses the difficulties in flexibility and holistic processing that have been incriminated in AN. CRT has been found to improve AN's neuropsychological functioning and short term outcome. To our knowledge, no French speaking country has tested its effectiveness. Moreover, the question whether it is efficient for both anorexic restrictive and anorexic binge-purging patients remains unanswered.

The aim of the present study is to determine if CRT in AN adolescents and young adults has a favourable impact on cognitive functioning and clinical status. We will also explore whether the impact of CRT is similar in both anorexic restrictive and binge-purging subtypes. There will also be an Historical Control Group of patients, sixty, who received traditional medical interventions in a specialized inpatient unit for eating disorders (i.e., EVHAN study)."

ReferenceCitation: Maria AS, Barry C, Ringuenet D, Falissard B, Group T, Berthoz S. Subjective cognitive rigidity and attention to detail: A cross-cultural validation of the Detail and Flexibility Questionnaire (DFlex) in a French clinical sample. J Clin Exp Neuropsychol. 2020 Dec;42(10):1059-1071. doi: 10.1080/13803395.2020.1842333. Epub 2020 Dec 4.

name: Université Paris-Saclay, Université Paris-Sud, UVSQ, CESP, INSERM, Villejuif, France

family: Maria

full_name: Anne-Solène Maria

given: Anne-Solène

family: Barry

full_name: Caroline Barry

given: Caroline

name: Unité de Traitement des Troubles des Conduites Alimentaires, Département de Psychiatrie et d’Addictologie, Hôpital Paul Brousse, Villejuif, France

family: Ringuenet

full_name: Damien Ringuenet

given: Damien

family: Falissard

full_name: Bruno Falissard

family: Group

full_name: Trecogam Group

given: Trecogam

name: Département de Psychiatrie de l’Adolescent et du Jeune Adulte, Institut Mutualiste Montsouris, Paris, France

name: Univ. Bordeaux, CNRS, EPHE, INCIA, UMR 5287, Bordeaux, France

family: Berthoz

full_name: Sylvie Berthoz

given: Sylvie

journal_name: Journal of Clinical and Experimental Neuropsychology

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Maria AS, Bourdier L, Duclos J, Ringuenet D, Berthoz S. Psychometric properties of the French version of a scale measuring perceived emotional intelligence : the Trait Meta-Mood Scale (TMMS). Can J Psychiatry. 2016 Oct;61(10):652-62. doi: 10.1177/0706743716639936. Epub 2016 Mar 28.

name: Unité de traitement des Troubles des Conduites Alimentaires, Département de Psychiatrie et d'Addictologie, Hôpital Universitaire Paul Brousse, Villejuif, France

name: Centre de recherche en épidémiologie et santé des populations (CESP), Institut National de la Santé et de la Recherche Médicale (INSERM), Villejuif, France

name: Institut Mutualiste Montsouris, Département de Psychiatrie de l'Adolescent et du Jeune Adulte, Paris, France

name: Université Paris Ouest Nanterre La Défense, Nanterre, France

family: Bourdier

full_name: Léna Bourdier

given: Léna

name: Université de Reims Champagne-Ardenne, Laboratoire Cognition, Santé, Socialisation, Reims, France

family: Duclos

full_name: Jeanne Duclos

given: Jeanne

journal_name: The Canadian Journal of Psychiatry

oa_colors: green hybrid

evidence: open (via free pdf)

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

location_facility: Assistance Publique - Hôpitaux de Paris, Hôpital Paul Brousse

intervention_type: Behavioral


title: Evaluation of a Screening Program for SARS-CoV-2 Infection in the General Population Based on the Use of New Detection Approaches or for Diagnostic Orientation on Saliva (COVID-19)

acronym: SALICOV

summary: The investigators hypothesize that detection of SARS-CoV2 on saliva samples will increase the performance of the screening program compared to the reference strategy (RT-PCR on a nasopharyngeal swab).

ReferenceCitation: To KK, Tsang OT, Leung WS, Tam AR, Wu TC, Lung DC, Yip CC, Cai JP, Chan JM, Chik TS, Lau DP, Choi CY, Chen LL, Chan WM, Chan KH, Ip JD, Ng AC, Poon RW, Luo CT, Cheng VC, Chan JF, Hung IF, Chen Z, Chen H, Yuen KY. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020 May;20(5):565-574. doi: 10.1016/S1473-3099(20)30196-1. Epub 2020 Mar 23.

ReferenceCitation: Lai CKC, Chen Z, Lui G, Ling L, Li T, Wong MCS, Ng RWY, Tso EYK, Ho T, Fung KSC, Ng ST, Wong BKC, Boon SS, Hui DSC, Chan PKS. Prospective Study Comparing Deep Throat Saliva With Other Respiratory Tract Specimens in the Diagnosis of Novel Coronavirus Disease 2019. J Infect Dis. 2020 Oct 13;222(10):1612-1619. doi: 10.1093/infdis/jiaa487.

ReferenceCitation: Chen JH, Yip CC, Poon RW, Chan KH, Cheng VC, Hung IF, Chan JF, Yuen KY, To KK. Evaluating the use of posterior oropharyngeal saliva in a point-of-care assay for the detection of SARS-CoV-2. Emerg Microbes Infect. 2020 Dec;9(1):1356-1359. doi: 10.1080/22221751.2020.1775133.

ReferenceCitation: Rao M, Rashid FA, Sabri FSAH, Jamil NN, Zain R, Hashim R, Amran F, Kok HT, Samad MAA, Ahmad N. Comparing Nasopharyngeal Swab and Early Morning Saliva for the Identification of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Clin Infect Dis. 2021 May 4;72(9):e352-e356. doi: 10.1093/cid/ciaa1156.

ReferenceCitation: Landry ML, Criscuolo J, Peaper DR. Challenges in use of saliva for detection of SARS CoV-2 RNA in symptomatic outpatients. J Clin Virol. 2020 Sep;130:104567. doi: 10.1016/j.jcv.2020.104567. Epub 2020 Jul 31.

ReferenceCitation: Migueres M, Mengelle C, Dimeglio C, Didier A, Alvarez M, Delobel P, Mansuy JM, Izopet J. Saliva sampling for diagnosing SARS-CoV-2 infections in symptomatic patients and asymptomatic carriers. J Clin Virol. 2020 Sep;130:104580. doi: 10.1016/j.jcv.2020.104580. Epub 2020 Aug 5.

ReferenceCitation: To KK, Tsang OT, Yip CC, Chan KH, Wu TC, Chan JM, Leung WS, Chik TS, Choi CY, Kandamby DH, Lung DC, Tam AR, Poon RW, Fung AY, Hung IF, Cheng VC, Chan JF, Yuen KY. Consistent Detection of 2019 Novel Coronavirus in Saliva. Clin Infect Dis. 2020 Jul 28;71(15):841-843. doi: 10.1093/cid/ciaa149.

ReferenceCitation: Williams E, Bond K, Zhang B, Putland M, Williamson DA. Saliva as a Noninvasive Specimen for Detection of SARS-CoV-2. J Clin Microbiol. 2020 Jul 23;58(8). pii: e00776-20. doi: 10.1128/JCM.00776-20. Print 2020 Jul 23.

ReferenceCitation: McCormick-Baw C, Morgan K, Gaffney D, Cazares Y, Jaworski K, Byrd A, Molberg K, Cavuoti D. Saliva as an Alternate Specimen Source for Detection of SARS-CoV-2 in Symptomatic Patients Using Cepheid Xpert Xpress SARS-CoV-2. J Clin Microbiol. 2020 Jul 23;58(8). pii: e01109-20. doi: 10.1128/JCM.01109-20. Print 2020 Jul 23.

ReferenceCitation: Jamal AJ, Mozafarihashjin M, Coomes E, Powis J, Li AX, Paterson A, Anceva-Sami S, Barati S, Crowl G, Faheem A, Farooqi L, Khan S, Prost K, Poutanen S, Taylor M, Yip L, Zhong XZ, McGeer AJ, Mubareka S; Toronto Invasive Bacterial Diseases Network COVID-19 Investigators. Sensitivity of Nasopharyngeal Swabs and Saliva for the Detection of Severe Acute Respiratory Syndrome Coronavirus 2. Clin Infect Dis. 2021 Mar 15;72(6):1064-1066. doi: 10.1093/cid/ciaa848.

ReferenceCitation: Lambert-Niclot S, Cuffel A, Le Pape S, Vauloup-Fellous C, Morand-Joubert L, Roque-Afonso AM, Le Goff J, Delaugerre C. Evaluation of a Rapid Diagnostic Assay for Detection of SARS-CoV-2 Antigen in Nasopharyngeal Swabs. J Clin Microbiol. 2020 Jul 23;58(8). pii: e00977-20. doi: 10.1128/JCM.00977-20. Print 2020 Jul 23.

ReferenceCitation: Azzi L, Baj A, Alberio T, Lualdi M, Veronesi G, Carcano G, Ageno W, Gambarini C, Maffioli L, Saverio SD, Gasperina DD, Genoni AP, Premi E, Donati S, Azzolini C, Grandi AM, Dentali F, Tangianu F, Sessa F, Maurino V, Tettamanti L, Siracusa C, Vigezzi A, Monti E, Iori V, Iovino D, Ietto G; ASST dei Sette Laghi Rapid Salivary Test Nurse staff Research Group, Grossi PA, Tagliabue A, Fasano M. Rapid Salivary Test suitable for a mass screening program to detect SARS-CoV-2: A diagnostic accuracy study. J Infect. 2020 Sep;81(3):e75-e78. doi: 10.1016/j.jinf.2020.06.042. Epub 2020 Jun 21.

ReferenceCitation: Angle C, Waggoner LP, Ferrando A, Haney P, Passler T. Canine Detection of the Volatilome: A Review of Implications for Pathogen and Disease Detection. Front Vet Sci. 2016 Jun 24;3:47. doi: 10.3389/fvets.2016.00047. eCollection 2016.

ReferenceCitation: Jendrny P, Schulz C, Twele F, Meller S, von Köckritz-Blickwede M, Osterhaus ADME, Ebbers J, Pilchová V, Pink I, Welte T, Manns MP, Fathi A, Ernst C, Addo MM, Schalke E, Volk HA. Scent dog identification of samples from COVID-19 patients - a pilot study. BMC Infect Dis. 2020 Jul 23;20(1):536. doi: 10.1186/s12879-020-05281-3.

ReferenceCitation: Grandjean D, Sarkis R, Lecoq-Julien C, Benard A, Roger V, Levesque E, Bernes-Luciani E, Maestracci B, Morvan P, Gully E, Berceau-Falancourt D, Haufstater P, Herin G, Cabrera J, Muzzin Q, Gallet C, Bacqué H, Broc JM, Thomas L, Lichaa A, Moujaes G, Saliba M, Kuhn A, Galey M, Berthail B, Lapeyre L, Capelli A, Renault S, Bachir K, Kovinger A, Comas E, Stainmesse A, Etienne E, Voeltzel S, Mansouri S, Berceau-Falancourt M, Dami A, Charlet L, Ruau E, Issa M, Grenet C, Billy C, Tourtier JP, Desquilbet L. Can the detection dog alert on COVID-19 positive persons by sniffing axillary sweat samples? A proof-of-concept study. PLoS One. 2020 Dec 10;15(12):e0243122. doi: 10.1371/journal.pone.0243122. eCollection 2020.

ReferenceCitation: LeGoff J, Kernéis S, Elie C, Mercier-Delarue S, Gastli N, Choupeaux L, Fourgeaud J, Alby ML, Quentin P, Pavie J, Brazille P, Néré ML, Minier M, Gabassi A, Leroy C, Parfait B, Tréluyer JM, Delaugerre C. Evaluation of a saliva molecular point of care for the detection of SARS-CoV-2 in ambulatory care. Sci Rep. 2021 Oct 26;11(1):21126. doi: 10.1038/s41598-021-00560-8.

family: LeGoff

full_name: Jérôme LeGoff

family: Kernéis

full_name: Solen Kernéis

given: Solen

family: Elie

full_name: Caroline Elie

family: Mercier-Delarue

full_name: Séverine Mercier-Delarue

given: Séverine

family: Gastli

full_name: Nabil Gastli

given: Nabil

family: Choupeaux

full_name: Laure Choupeaux

given: Laure

family: Fourgeaud

full_name: Jacques Fourgeaud

given: Jacques

family: Alby

full_name: Marie-Laure Alby

given: Marie-Laure

family: Quentin

full_name: Pierre Quentin

given: Pierre

family: Pavie

full_name: Juliette Pavie

given: Juliette

family: Brazille

full_name: Patricia Brazille

given: Patricia

family: Néré

full_name: Marie Laure Néré

given: Marie Laure

family: Minier

full_name: Marine Minier

given: Marine

family: Gabassi

full_name: Audrey Gabassi

given: Audrey

family: Leroy

full_name: Chrystel Leroy

given: Chrystel

family: Parfait

full_name: Béatrice Parfait

given: Béatrice

family: Tréluyer

full_name: Jean-Marc Tréluyer

given: Jean-Marc

family: Delaugerre

full_name: Constance Delaugerre

given: Constance

bso_classification: Biology (fond.)

repositories_institution:
Cold Spring Harbor Laboratory - medRxiv
Research Square - Research Square

ReferenceCitation: Kernéis S, Elie C, Fourgeaud J, Choupeaux L, Delarue SM, Alby ML, Quentin P, Pavie J, Brazille P, Néré ML, Minier M, Gabassi A, Gibaud A, Gauthier S, Leroy C, Voirin-Mathieu E, Poyart C, Vidaud M, Parfait B, Delaugerre C, Tréluyer JM, LeGoff J. Accuracy of saliva and nasopharyngeal sampling for detection of SARS-CoV-2 in community screening: a multicentric cohort study. Eur J Clin Microbiol Infect Dis. 2021 Nov;40(11):2379-2388. doi: 10.1007/s10096-021-04327-x. Epub 2021 Aug 3.

journal_name: European Journal of Clinical Microbiology & Infectious Diseases

location_facility: SARS-CoV-2 screening device of Assistance Publique des Hôpitaux de Paris (AP-HP)


title: Evaluation of a Therapeutic Education Programme for Harm Reduction in People With Alcohol Use Disorder

acronym: ETHER

summary:
Alcohol is the most harmful psychoactive substance in terms of overall damage. Although abstinence remains the objective of most pharmacological and non-pharmacological approaches addressing alcohol use disorder (AUD), new therapeutic objectives of reduced alcohol intake and controlled-drinking have emerged.

ETHER ("Education THEérapeutique pour la Réduction des dommages en alcoologie" or therapeutic education for the reduction of alcohol-related harms) is an ongoing, multicentre, community-based mixed-methods study, which aims to evaluate the innovative therapeutic patient education (TPE) programme named "Choizitaconso". This programme teaches psychosocial skills to people with alcohol use disorder (PWAUD), to help them (re)establish controlled drinking and reduce harms.

The evaluation of the programme will rely on a sequential explanatory design, where the qualitative study (16 semi-structured interviews) will assist in explaining and interpreting the findings of the controlled before-and-after quantitative study.

lead_sponsor: Institut National de la Santé Et de la Recherche Médicale, France

location_facility:
Clinique Saint Barnabé
CSAPA Convergence
ANPAA 04


type: Registry Identifier

title: Identification Des Bases moléculaires de l'éjaculation prématurée Primaire

summary: The main objective of our study is to identify the first genetic etiology of primary Premature Ejaculation (PE). We will test and evaluate the existence of genetic determinism conferring susceptibility to a life-long syndrome (primary premature ejaculation) in some patients. To this end, we plan to establish a collection of biological samples and a database of patients with this extreme syndrome, which we will analyze by Genome Wide analysis. This will lead to improvements in the biological understanding, the "knowledge" of physicians of the disease, and should improve the patients' quality of life. Not all PE cases have the same physiopathology and treatment efficiency, which depend on the specific mechanism involved in the clinical context. Our work will make it possible to develop new therapeutic approaches suitable for a large proportion of individuals presenting PE. This integrative approach combining researchers, patients and ethics committees will facilitate profound reflection, promoting the creation of suitable structures capable of receiving patients for appropriate consultations. This unique study of PE should also favor industrial partnerships.

primary_purpose: Basic Science

ReferenceCitation: Porto R, Giuliano F. [Premature ejaculation]. Prog Urol. 2013 Jul;23(9):647-56. doi: 10.1016/j.purol.2013.01.005. Epub 2013 Mar 1. Review. French.

location_facility:
Hôpital Necker
Hôpital Saint Joseph
Polyclinique de Blois


intervention_type: Biological

acronym: Transfluvac

location_facility: Hôpital E. Herriot , Service de néphrologie, transplantation et immunologie clinique

location_facility: Service d'urologie, GH Pitié Salpêtrière

location_facility: Centre hospitalier Lyon Sud, service de néphrologie transplantation

type: EudraCT Number

source: euctr

title: Etude de Phase II évaluant l'immunogénicité et la tolérance d'un Vaccin inactivé Non adjuvanté Contre la Grippe A (H1N1) après Transplantation rénale

summary: The study is aimed at assessing the safety and efficacy of an inactivated and non adjuvanted Influenza A (H1N1) vaccine in renal transplant recipients.


type: Other Grant/Funding Number

title: Cost-utility Analysis of the Outpatient Hospitalization Versus Conventional Hospitalization in Endovascular Treatment of Occlusive Arterial Disease

acronym: AMBUVASC

summary: The purpose of this study is to assess the efficiency of outpatient surgery compared to conventional hospitalization in endovascular treatment of occlusive arterial disease. A cost-utility analysis will be conducted from a societal perspective. Patients referred for peripheral arterial disease (PAD) will be randomized in two arms and a 3 months follow-up will be performed.

lead_sponsor: Nantes University Hospital

location_facility: Marseille University Hospital (La Timone)


intervention_type: Drug

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

acronym: XENON

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau

location_facility: CHU de Clermont Ferrand - Hôpital Estaing

title: Coming Out of Anesthesia After Bariatric Surgery : Desflurane Versus Xenon

summary: Obesity is increasing in France, resulting in an increased demand for bariatric surgery. However obesity also alters physiopathological pathways and the pharmacokinetics of anesthestic agents. The investigators objective is to compare, among morbidly obese patients, the immediate and intermediary emergence kinetics after balanced anesthesia using remifentanil associated either with desflurane (reference arm) or with xenon (experimental arm).


title: Efficacy and Tolerance of Liraglutide for Weight Loss in Obese Type 2 Diabetic Hemodialysis Patients

acronym: LIRADIAL

summary:
Diabetes is the second leading cause of end stage renal disease in France (22% in the 2016 REIN register). In hemodialysis, its prevalence is higher, between 30-40% depending on the study. Associated with type 2 diabetes, a large number of patients present with overweight (body mass index or BMI> 25 kg / m2) which can lead to a temporary contraindication to kidney transplant by the surgeon, or even definitive once BMI is over 30 kg / m2. Indeed, above this threshold, patients are exposed to an increased risk of surgical complications (wall infections, suture release), hospitalizations and potentially transplant failure. A recent study based on the Kidney Registry showed that patients with a BMI> 31 kg / m2 were more likely to stay on dialysis than to benefit from a transplant whereas for each decrease of 1 kg / m2 of BMI, there is a 9-11% increase in the likelihood of being transplanted. The management of obesity in dialysis patients is important for reducing cardiovascular risks but also because it increases the chances of access to transplantation. However, current weight loss programs are disappointing. The changes in hygiene and diet rules integrated into a specialized monitoring program only allow a weight loss of 2 to 8% in 24 months for half of the patients. Bariatric surgery is, of course, a more effective alternative, but with a 10% risk of postoperative complications.

Glucagon-Like Peptide 1 (aGLP1) analogues are a new class of antidiabetic drugs that have revolutionized the management of type 2 diabetes. In fact, they combine efficacy on glycemic control but also on weight loss. They are used in obese non-diabetic people in some countries, with a reduction in weight of up to 10 to 15% with certain molecules. In addition, they have shown an effect on reducing cardiovascular events in diabetics including with Chronic Kidney Disease CKD 3-4. AGPL1 are well tolerated with side effects mainly of digestive tropism such as nausea or vomiting. Exceptionally, these effects can occur from the first injection requiring permanent discontinuation of treatment. In 20% of cases, these side effects can appear in the first weeks. They gradually fade, spontaneously or after symptomatic treatment and allow titration of the drug.

AGLP1 is currently contraindicated in patients with reduced renal function, that is, when the glomerular filtration rate (GFR) is <15 ml / min (MRC stage 5-5D), because this population specific was excluded from the originator studies. However, aGLP1 are small peptides that are not eliminated by the kidneys. Their elimination takes place through the general catabolism of proteins. To date, 2 publications have evaluated the safety profile and efficacy of an aGLP1, liraglutide (Victoza®), in diabetic dialysis patients. These studies showed that the 24 hour plasma concentration of liraglutide increased by 50% over the long term. The safety profile was acceptable with, as expected, a predominance of gastrointestinal effects in the first weeks of treatment such as nausea, vomiting. The authors suggest an adjustment of the dosages and a longer titration period to limit side effects. However, treatment with aGPL1 is effective with better glycemic control and an average weight loss of 2.6 kg over a period of 3 months. Studies show that weight loss under liraglutide continues beyond 3 months with possible losses between 4 and 8 kg at 6 months and 12 months of treatment followed 12. Liraglutide (Victoza®) is the analogue of GPL1 for which we have a sufficiently long follow-up (> 10 years) on its effectiveness and its short and long-term side effects.

The main objective of this project, in type 2 diabetic patients on dialysis, as a temporary contraindication for transplant due to overweight, is on the one hand to study the effect of liraglutide on weight loss and control of diabetes, and on the other hand to assess its tolerance in this population. The expected benefit is to be able to facilitate registration on the waiting list and access to renal transplantation of these overweight patients, without having to resort to more invasive methods such as bariatric surgery.

ReferenceType: result

ReferenceCitation: Nicoletto BB, Fonseca NK, Manfro RC, Gonçalves LF, Leitão CB, Souza GC. Effects of obesity on kidney transplantation outcomes: a systematic review and meta-analysis. Transplantation. 2014 Jul 27;98(2):167-76. doi: 10.1097/TP.0000000000000028. Review.

family: Nicoletto

full_name: Bruna B. Nicoletto

given: Bruna B.

family: Fonseca

full_name: Natasha K. O. Fonseca

given: Natasha K. O.

family: Manfro

full_name: Roberto C. Manfro

given: Roberto C.

family: Gonçalves

full_name: Luiz Felipe S. Gonçalves

given: Luiz Felipe S.

family: Leitão

full_name: Cristiane Bauermann Leitão

given: Cristiane Bauermann

family: Souza

full_name: Gabriela C. Souza

given: Gabriela C.

journal_name: Transplantation

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Effects of Obesity on Kidney Transplantation Outcomes

ReferenceCitation: Gill JS, Hendren E, Dong J, Johnston O, Gill J. Differential association of body mass index with access to kidney transplantation in men and women. Clin J Am Soc Nephrol. 2014 May;9(5):951-9. doi: 10.2215/CJN.08310813. Epub 2014 Apr 17.

family: Gill

full_name: John S. Gill

given: John S.

family: Hendren

full_name: Elizabeth Hendren

given: Elizabeth

family: Dong

full_name: Jianghu Dong

given: Jianghu

family: Johnston

full_name: Olwyn Johnston

given: Olwyn

full_name: Jagbir Gill

given: Jagbir

journal_name: Clinical Journal of the American Society of Nephrology

oa_colors: green other

publisher: American Society of Nephrology (ASN)

publisher_dissemination: American Society of Nephrology

publisher_group: American Society of Nephrology

publisher_normalized: American Society of Nephrology

title: Differential Association of Body Mass Index with Access to Kidney Transplantation in Men and Women

ReferenceCitation: Lassalle M, Fezeu LK, Couchoud C, Hannedouche T, Massy ZA, Czernichow S. Obesity and access to kidney transplantation in patients starting dialysis: A prospective cohort study. PLoS One. 2017 May 11;12(5):e0176616. doi: 10.1371/journal.pone.0176616. eCollection 2017.

family: Lassalle

full_name: Mathilde Lassalle

given: Mathilde

family: Fezeu

full_name: Léopold K. Fezeu

given: Léopold K.

family: Couchoud

full_name: Cécile Couchoud

given: Cécile

family: Hannedouche

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

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

ReferenceCitation: MacLaughlin HL, Cook SA, Kariyawasam D, Roseke M, van Niekerk M, Macdougall IC. Nonrandomized trial of weight loss with orlistat, nutrition education, diet, and exercise in obese patients with CKD: 2-year follow-up. Am J Kidney Dis. 2010 Jan;55(1):69-76. doi: 10.1053/j.ajkd.2009.09.011. Epub 2009 Nov 17.

title: Nonrandomized Trial of Weight Loss With Orlistat, Nutrition Education, Diet, and Exercise in Obese Patients With CKD: 2-Year Follow-up

ReferenceCitation: Turgeon NA, Perez S, Mondestin M, Davis SS, Lin E, Tata S, Kirk AD, Larsen CP, Pearson TC, Sweeney JF. The impact of renal function on outcomes of bariatric surgery. J Am Soc Nephrol. 2012 May;23(5):885-94. doi: 10.1681/ASN.2011050476. Epub 2012 Mar 1.

title: The Impact of Renal Function on Outcomes of Bariatric Surgery

ReferenceCitation: Nauck M, Frid A, Hermansen K, Shah NS, Tankova T, Mitha IH, Zdravkovic M, Düring M, Matthews DR; LEAD-2 Study Group. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care. 2009 Jan;32(1):84-90. doi: 10.2337/dc08-1355. Epub 2008 Oct 17.

title: Efficacy and Safety Comparison of Liraglutide, Glimepiride, and Placebo, All in Combination With Metformin, in Type 2 Diabetes: The LEAD (Liraglutide Effect and Action in Diabetes)-2 study

ReferenceCitation: O'Neil PM, Birkenfeld AL, McGowan B, Mosenzon O, Pedersen SD, Wharton S, Carson CG, Jepsen CH, Kabisch M, Wilding JPH. Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active controlled, dose-ranging, phase 2 trial. Lancet. 2018 Aug 25;392(10148):637-649. doi: 10.1016/S0140-6736(18)31773-2. Epub 2018 Aug 16.

ReferenceCitation: Astrup A, Rössner S, Van Gaal L, Rissanen A, Niskanen L, Al Hakim M, Madsen J, Rasmussen MF, Lean ME; NN8022-1807 Study Group. Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study. Lancet. 2009 Nov 7;374(9701):1606-16. doi: 10.1016/S0140-6736(09)61375-1. Epub 2009 Oct 23. Erratum in: Lancet. 2010 Mar 20;375(9719):984.

ReferenceCitation: Mann JFE, Ørsted DD, Brown-Frandsen K, Marso SP, Poulter NR, Rasmussen S, Tornøe K, Zinman B, Buse JB; LEADER Steering Committee and Investigators. Liraglutide and Renal Outcomes in Type 2 Diabetes. N Engl J Med. 2017 Aug 31;377(9):839-848. doi: 10.1056/NEJMoa1616011.

repository_institution: James Cook University - ResearchOnline at James Cook University

ReferenceCitation: Idorn T, Knop FK, Jørgensen MB, Jensen T, Resuli M, Hansen PM, Christensen KB, Holst JJ, Hornum M, Feldt-Rasmussen B. Safety and Efficacy of Liraglutide in Patients With Type 2 Diabetes and End-Stage Renal Disease: An Investigator-Initiated, Placebo-Controlled, Double-Blind, Parallel-Group, Randomized Trial. Diabetes Care. 2016 Feb;39(2):206-13. doi: 10.2337/dc15-1025. Epub 2015 Aug 17.

title: Safety and Efficacy of Liraglutide in Patients With Type 2 Diabetes and End-Stage Renal Disease: An Investigator-Initiated, Placebo-Controlled, Double-Blinded, Parallel Group, Randomized Trial

ReferenceCitation: Osonoi T, Saito M, Tamasawa A, Ishida H, Tsujino D, Nishimura R, Utsunomiya K. Effect of hemodialysis on plasma glucose profile and plasma level of liraglutide in patients with type 2 diabetes mellitus and end-stage renal disease: a pilot study. PLoS One. 2014 Dec 19;9(12):e113468. doi: 10.1371/journal.pone.0113468. eCollection 2014.

repository_institution: University of Pittsburgh - D-Scholarship@Pitt

repository_institution: University of Illinois at Chicago - INDIGO

title: Effect of Hemodialysis on Plasma Glucose Profile and Plasma Level of Liraglutide in Patients with Type 2 Diabetes Mellitus and End-Stage Renal Disease: A Pilot Study

ReferenceCitation: Overbeek JA, Heintjes EM, Huisman EL, Tikkanen CK, van Diermen AW, Penning-van Beest FJA, Herings RMC. Clinical effectiveness of liraglutide vs basal insulin in a real-world setting: Evidence of improved glycaemic and weight control in obese people with type 2 diabetes. Diabetes Obes Metab. 2018 Sep;20(9):2093-2102. doi: 10.1111/dom.13335. Epub 2018 May 29.

name: PHARMO Institute for Drug Outcomes Research; Utrecht the Netherlands

name: Department of General Practice and Elderly Care Medicine, Amsterdam Public Health Research Institute; VU University Medical Centre; Amsterdam the Netherlands

name: Novo Nordisk Farma BV, Alphen aan den Rijn; the Netherlands

name: Novo Nordisk Region Europe Pharmaceuticals AS; Copenhagen Denmark

name: Department of Epidemiology and Biostatistics; VU University Medical Center; Amsterdam the Netherlands

location_facility:
AURA Paris Plaisance
Hôpital Bichat
AURA Paris Site de Saint Ouen
Groupe Hospitalier Paris Saint-Joseph


title: Tumor and Treatments Impact on Neurocognitive Functions and Quality of Life of Patients With OMS Grade II Glioma: Multicentric Prospective Study

summary:
This is a multicenter prospective study:2 independant cohorts of patients with OMS grade II glioma will be followed during 5 years.

cohort A: patients in first-line treatment (surgery, radiotherapy or chemotherapy)
cohort B: patients with disease simple monitoring.

The primary endpoint is to evaluate the impact of tumor and treatments on neurocognitive functions and quality of life, using validate and standard tests.

status: Terminated

location_facility: Hôpital d'instruction des armées Desgenettes


title: Accuracy of Pulse Oximetry to Detect Sleep Apnea in Frail Hospitalized Patients

acronym: SAFE

summary:
Sleep apnea syndrome is common and increases with age. In the elderly, symptoms might be different than in the youngest people, and its consequences might be severe and atypical (falls, functional and cognitive decline).

Today, there is no specific tool to detect sleep apnea in the elderly. The goal of this study is to evaluate the accuracy of oximetry for detection of respiratory disturbances in sleep apnea in the hospitalized elderly.

lead_sponsor: AGIR à Dom


title: Phase II Study of Cetuximab as Monotherapy and First Line Treatment in Patients With Locally Advanced or Metastatic Squamous Cell Carcinoma of the Skin Expressing EGFR.

acronym: CTXSCC

summary: The purpose of this study is to determine whether cetuximab is effective in the treatment of locally advanced or metastatic squamous cell carcinoma of the skin expressing EGFR.

ReferenceCitation: Maubec E, Duvillard P, Velasco V, Crickx B, Avril MF. Immunohistochemical analysis of EGFR and HER-2 in patients with metastatic squamous cell carcinoma of the skin. Anticancer Res. 2005 Mar-Apr;25(2B):1205-10.

ReferenceCitation: Alam M, Ratner D. Cutaneous squamous-cell carcinoma. N Engl J Med. 2001 Mar 29;344(13):975-83. Review.

ReferenceCitation: Shimizu T, Izumi H, Oga A, Furumoto H, Murakami T, Ofuji R, Muto M, Sasaki K. Epidermal growth factor receptor overexpression and genetic aberrations in metastatic squamous-cell carcinoma of the skin. Dermatology. 2001;202(3):203-6.

ReferenceCitation: Huang SM, Bock JM, Harari PM. Epidermal growth factor receptor blockade with C225 modulates proliferation, apoptosis, and radiosensitivity in squamous cell carcinomas of the head and neck. Cancer Res. 1999 Apr 15;59(8):1935-40.

ReferenceCitation: Barbara A Burtness, Yi Li, William Flood, Bassam I Mattar, Arlene A Forastiere. Phase III trial comparing cisplatin (C) + placebo (P) to C + anti-epidermal growth factor antibody (EGF-R) C225 in patients (pts) with metastatic/recurrent head & neck cancer (HNC). Journal of Clinical Oncology,2002 ASCO Annual Meeting Proceedings. Abstract 901.

ReferenceCitation: Nemunaitis JJ, Eiseman I, Cunningham C et al. A phase I trial of CI-1033, a pan-erbB tyrosine kinase inhibitor, given daily for 14 days every 3 weeks, in patients with advanced solid tumors. Proc Am Soc Clin Oncol 22: page 243, 2003 (abstr 974).

ReferenceCitation: Maubec E, Petrow P, Scheer-Senyarich I, Duvillard P, Lacroix L, Gelly J, Certain A, Duval X, Crickx B, Buffard V, Basset-Seguin N, Saez P, Duval-Modeste AB, Adamski H, Mansard S, Grange F, Dompmartin A, Faivre S, Mentré F, Avril MF. Phase II study of cetuximab as first-line single-drug therapy in patients with unresectable squamous cell carcinoma of the skin. J Clin Oncol. 2011 Sep 1;29(25):3419-26. doi: 10.1200/JCO.2010.34.1735. Epub 2011 Aug 1.

name: Eve Maubec, Isabelle Scheer-Senyarich, Julien Gelly, Agnès Certain, Xavier Duval, Béatrice Crickx, and France Mentré, Assistance Publique-Hopitaux de Paris (APHP), Université Paris Diderot, Hôpital Bichat; Nicole Basset-Seguin, APHP, Université Paris Diderot, Hôpital Saint Louis; Peter Petrow, Institut Curie; Marie-Françoise Avril, APHP, Université Paris Descartes, Hôpital Cochin, Paris; Peter Petrow, Association des Centres Radiologie et de l'Imagerie Medicale, Compiègne; Pierre Duvillard and Ludovic...

family: Maubec

full_name: Eve Maubec

given: Eve

family: Petrow

full_name: Peter Petrow

given: Peter

family: Scheer-Senyarich

full_name: Isabelle Scheer-Senyarich

given: Isabelle

family: Duvillard

full_name: Pierre Duvillard

given: Pierre

family: Lacroix

full_name: Ludovic Lacroix

given: Ludovic

family: Gelly

full_name: Julien Gelly

given: Julien

family: Certain

full_name: Agnès Certain

given: Agnès

family: Duval

full_name: Xavier Duval

given: Xavier

family: Crickx

full_name: Béatrice Crickx

given: Béatrice

family: Buffard

full_name: Valérie Buffard

given: Valérie

family: Basset-Seguin

full_name: Nicole Basset-Seguin

given: Nicole

family: Saez

full_name: Pierre Saez

family: Duval-Modeste

full_name: Anne-Bénédicte Duval-Modeste

given: Anne-Bénédicte

family: Adamski

full_name: Henri Adamski

given: Henri

family: Mansard

full_name: Sandrine Mansard

given: Sandrine

family: Grange

full_name: Florent Grange

given: Florent

family: Dompmartin

full_name: Anne Dompmartin

given: Anne

family: Faivre

full_name: Sandrine Faivre

family: Mentré

full_name: France Mentré

given: France

family: Avril

full_name: Marie-Françoise Avril

given: Marie-Françoise

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Phase II Study of Cetuximab As First-Line Single-Drug Therapy in Patients With Unresectable Squamous Cell Carcinoma of the Skin

lead_sponsor: Centre Hospitalier of Chartres

location_facility: Hospital Saint Louis, Department of P. Morel

location_facility: Hospital Saint-Louis, department of L. Dubertret


title: Microcirculatory Effects of Methylene Blue in Vasoplegic Shock After Cardiopulmonary Bypass: a Pilot Study

acronym: MAGIC BLUE

summary:
International guidelines recommend Methylene Blue (MB) as a second-line drug in the treatment of norepinephrine refractory vasoplegic shock (VS) after Cardiopulmonary Bypass CPB. Macrocirculatory effects of MB in this setting are now well established but microcirculatory effects of MB remain unknown.

The purpose of this study is to assess the micro vascular effects of a single administration of methylene blue (1.5 mg/kg over 30 minutes) for norepinephrine-refractory VS post CPB.

Microcirculatory effect will be monitored before and one hour after MB infusion through cutaneous refill time, video microscopy measurements of the sublingual microcirculation and tissue oxygen saturation combined with vascular occlusion test (VOT).

ReferenceCitation: Maurin C, Portran P, Schweizer R, Allaouchiche B, Junot S, Jacquet-Lagrèze M, Fellahi JL. Effects of methylene blue on microcirculatory alterations following cardiac surgery: A prospective cohort study. Eur J Anaesthesiol. 2021 Oct 4. doi: 10.1097/EJA.0000000000001611. [Epub ahead of print]

family: Maurin

full_name: Carole Maurin

given: Carole

family: Portran

full_name: Philippe Portran

given: Philippe

family: Schweizer

full_name: Remi Schweizer

given: Remi

family: Allaouchiche

full_name: Bernard Allaouchiche

given: Bernard

family: Junot

full_name: Stéphane Junot

given: Stéphane

family: Jacquet-Lagrèze

full_name: Matthias Jacquet-Lagrèze

given: Matthias

family: Fellahi

full_name: Jean-Luc Fellahi

given: Jean-Luc

journal_name: European Journal of Anaesthesiology

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'anesthesie reanimation, Hôpital cardiologique Louis Pradel


title: A Randomized, Open, Parallel-group Study to Evaluate the Efficacy of Three Different Patient Management Strategies During a 12 Weeks Maintenance Phase Following an Initial 4-weeks Acute Treatment Phase in Subjects With Symptoms Thought to be GERD Related

acronym: MAESTRO

summary: To compare the efficacy of three different long-term treatment strategies of reflux disease in primary care setting.


title: A Patient Consensus for the Research in Supportive Care in French Cancer Care Centers: the CyPRES Project

acronym: CyPRES

summary: In oncology a number of supportive care therapies are proposed to patients. This study will identify the different therapies and prioritize these therapies from the patients' perspectives. This study will provide a framework for optimizing supportive care strategies and identifying those therapies that need to be validated by clinical trials.

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: Ligue Nationale Contre le Cancer - Comité du Val d'Oise

location_facility: Ligue Nationale Contre le Cancer - Comité des Vosges

location_facility: Ligue Nationale Contre le Cancer - Comité de Paris

location_facility: Ligue Nationale Contre le Cancer - Comité de la Haute-Vienne

location_facility: Centre Hospitalier Universitaire de Martinique

location_facility: Ligue Nationale Contre le Cancer - Comité de Seine-Saint-Deniss

location_facility: Ligue Nationale Contre le Cancer - Comité du Finistère

location_facility: Ligue Nationale Contre le Cancer - Comité de Charente

location_facility: Ligue Nationale Contre le Cancer - Comité de l'Aube

location_facility: Ligue Nationale Contre le Cancer - Comité des Landes

location_facility: Ligue Nationale Contre le Cancer - Comité de la Somme

location_facility: Ligue Nationale Contre le Cancer - Comité de Seine-Maritime

location_facility: Ligue Nationale Contre le Cancer - Comité des Yvelines

location_facility: Ligue Nationale Contre le Cancer - Comité de Moselle

location_facility: Pôle Régional de Cancérologie - CHU Poitiers

location_facility: Ligue Nationale Contre le Cancer - Comité des Pyrénées Atlantiques

location_facility: Ligue Nationale Contre le Cancer - Comité du Maine-et-Loire

location_facility: Ligue Nationale Contre le Cancer - Comité de l'Essonne

location_facility: Ligue Nationale Contre le Cancer - Comité de l'Ardèche

location_facility: Ligue Nationale Contre le Cancer - Comité des Côtes-d'Armor

location_facility: Ligue Nationale Contre le Cancer - Comité de l'Oise

location_facility: Ligue Nationale Contre le Cancer - Comité du Puy-de-Dôme

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

location_facility: Ligue Nationale Contre le Cancer - Comité du Lot

location_facility: Ligue Nationale Contre le Cancer - Comité du Gard

location_facility: ERI Territorial du Gard - Institut de Cancérologie du Gard

location_facility: Ligue Nationale Contre le Cancer - Comité du Rhône

location_facility: Ligue Nationale Contre le Cancer - Comité de la Marne

location_facility: Ligue Nationale Contre le Cancer - Comité de la Côte-d'Or

location_facility: Ligue Nationale Contre le Cancer - Comité du Val-de-Marne

location_facility: Ligue Nationale Contre le Cancer - Comité de la Vendée

location_facility: Ligue Nationale Contre le Cancer - Comité des Hautes-Pyrénées

location_facility: Ligue Nationale Contre le Cancer - Comité de la Loire

location_facility: Ligue Nationale Contre le Cancer - Comité de la martinique

location_facility: Institut de Cancérologie de la Loire - Lucien Neuwirth

location_facility: Ligue Nationale Contre le Cancer - Comité des Alpes de Haute-Provence

location_facility: Ligue Nationale Contre le Cancer - Comité de l'Hérault


title: Multicenter, Prospective, Randomised, Open-label Study, Evaluating the Effect of Two Levels of Haemoglobin on Quality of Life and Speed of Progression of Renal Insufficiency on Renal Transplanted Patients With Chronic Graft Dysfunction (CGD)

summary:
The purpose of this study is to evaluate, on renal transplanted patients with CGD, the effect of two levels of haemoglobin on quality of life at 6 months and the speed of progression of renal function degradation at 24 months.

This study will recruit 140 patients in 21 centers in France.

location_facility: CHU Clermont Ferrand - Hôpital Gabriel Monpied


title: Urinary and Prostate Microbiotes and Prostate Cancer

acronym: MICROPROSTK

summary:
In recent decades, the cancer process has been linked to microbial infections, particularly in gastric and Helicobacter pylori cancers, but also in cervical cancers promoted by exposure to Human papilloma virus (HPV). More recently, it has been shown that bacteria in the intestinal microbiota could promote the development of colorectal cancer by modulating the inflammatory response within the intestinal mucosa. Among male cancers, prostate cancer is the leading cause in France with 54,000 new cases per year. In addition, the dogma that urine is sterile has been broken and the notion of the presence of a "urinary microbiota" in asymptomatic patients is now accepted.

While the risk factors associated with this cancer have not yet been clearly elucidated, recent evidence in the literature agrees that chronic inflammation associated with prostate infection plays a key role as a factor that may promote the development and/or progression of prostate cancer. Most recently, a study shows for the first time that a group of 6 bacteria is found significantly higher in the urine of patients with prostate cancer than in patients with prostate adenoma. Interestingly, clinical microbiology studies conducted at the bacteriology laboratory of the University Hospital of Nice on A. schaalii have shown that this species is also isolated in the urine of patients with bladder and prostate cancers.

The investigators wish to study the association of the 6 bacterial species mentioned above with prostate cancer by directly analyzing the prostate tissue of patients with this condition.

the staff will carry out a multicenter case-control study by recruiting a total of 260 patients in 4 centres (Nice coordinating centre, Marseille, Tours and Nîmes): 130 in the prostate cancer group and 130 in the prostate adenoma control group. This project is a research involving the human person of category 2.

The innovative aspect of the work consists in detecting and quantifying in situ in the prostate tissue the presence of these 6 bacterial species per culture and per PCR in real time, comparing the prostate microbiota in terms of richness and diversity between cancer patients and those without cancer. Ultimately, this study opens up exciting prospects with the possibility of determining a microbial origin of prostate cancer and considering antibiotic therapy for anti-cancer purposes such as H. pylori and gastric cancer.

design_allocation: Non-Randomized

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
nice Hospital
Cannes hospital
Tours hospital
marseille Hospital


title: A Phase 2, Open Label, Multicenter, Single-stage Study to Evaluate the Efficacy of Isatuximab Plus Pomalidomide and Dexamethasone (IPd), in Patients With AL Amyloidosis Not in VGPR or Better After Any Previous Therapy

acronym: IsAMYP

summary: This phase 2 study ain to evaluate the efficacy of Isatuximab plus Pomalidomide and Dexamethasone (IPd), in patients with AL amyloidosis not in VGPR or better after any previous therapy. It will enrolled 46 patients (34 in France and 12 in Australia) through 15 sites (11 in France and 4 in Australia).

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Intergroupe Francophone du Myelome

location_facility: CHU Poitiers - Pôle régional de Cancérologie

location_facility: Centre Hospitalier Universitaire (CHU) de Limoges


title: BeAT1D: Benign Autoimmunity and Type 1 Diabetes

summary: National multi-center non-interventional case-control cohort study with collection of biological samples to characterize the autoimmune T and B lymphocytes involved in the development of type 1 diabetes.

location_facility: APHP Hôpital Pitié-Salpêtrière - Service de Chirurgie

location_facility: Hôpital Mignot - Services de Diabétologie/Endocrinologie Adultes

location_facility: Hôpital Pitié-Salpêtrière - Service de Diabétologie

location_facility: APHP Hôpital Cochin - Service de Chirurgie

location_facility: APHP Hôpital Cochin - Service de Diabétologie et Immunologie Clinique


title: Evaluation of the Efficacy of Radiofrequency Ablation in the Treatment of Renal Tumors: Prospective Observational Study

acronym: RF-REIN

summary: Multi-institutional registry on a cohort of 310 patients with biopsy-proven renal cell carcinoma treated by Radiofrequency ablation. All patients will be included consecutively and retrospectively in all centers to obtain the required number of patient followed during 5 years.

lead_sponsor: University Hospital, Bordeaux

location_facility: Assistance Publique - Hôpitaux de Paris (AP-HP) - Hopital Necker

location_facility: Assistance Publique - Hôpitaux de Marseille


title: Evaluation of the Effects of Conditioning of Insufflated Gas on the Core Temperature and the Post-operative Pain During Laparoscopic Surgery

summary:
During laparoscopy, administration of cold and dry carbon dioxide (CO2) leads to hypothermia. Different types of gas conditioning have been studied in order to prevent this specific hypothermia. Intra-abdominal administration of local anesthetics has also been studied in order to prevent post-operative pain. In both cases, some results have been described.

The investigators propose to evaluate in a prospective, randomized, double blind trial, the impact of 4 different types of conditioning of insufflated gas during laparoscopy for womb surgery on hypothermia prevention and post-operative pain. These 4 types of gas conditioning are:

CO2 wet and cold with nebulized Nacl and direct intra-abdominal administration of Nacl
CO2 wet and cold with nebulized ropivacaïne 0.75% and direct intra-abdominal administration of Nacl
CO2 dry and cold with direct intra-abdominal administration of ropivacaïne 0.2%
CO2 dry and cold with direct intra-abdominal administration of Nacl

The investigators use a new device (Aeroneb® Pro [Aerogen® Company]) which can wet (by nebulization) the insufflated gas and therefore permits intraperitoneal medicament administration (local anesthetics).

lead_sponsor: University Hospital, Strasbourg, France

location_country: Italy France

location_facility: Department of Perioperative Medicine and Intensive Care - SAN GERARDO HOSPITAL


title: Incidence and Risk Factors for Infections in Patient Treated With Corticosteroids, Immunosuppressive Drugs or Biotherapy for Immunologic and Inflammatory Diseases

acronym: INFIM

summary:
Infections represent the first cause of death and of morbidity in people treated for immunologic and inflammatory diseases with corticosteroids, immunosuppressive drugs or biotherapy. Epidemiological, clinical, biological and therapeutic determinants of these infections are poorly understood. There is no recommendation for the prevention and treatment of infections in this particular field.

Purpose : Recent therapeutic trials evaluating immunosuppressive and biotherapy (cyclophosphamide, mycophenolate mofetil, rituximab, belimumab) in the field of immunologic and inflammatory diseases have found a risk of severe infection of 7 to 18% during the first year after the beginning of the treatment. Thus, the main objective of the study is to describe the incidence and risk-factors for infections in people treated with such agents for immunologic and inflammatory diseases.

location_facility: service Médecine Interne - CHU de Toulouse - Hôpital Purpan (5)

location_facility: service Médecine Interne - CHU de Toulouse - Hôpital Purpan (7)

location_facility: Service de Médecine Interne - CHU de Limoges

location_facility: Service de Médecine Interne et maladies Infectieuses - Hôpital Saint-André

location_facility: service de médecine interne - CH de Libourne


title: A Randomised Controlled Trial of High-Flow Nasal Oxygen Versus Standard Oxygen Therapy in Critically Ill Immunocompromised Patients

acronym: HIGH

summary:
Acute respiratory failure (ARF) is the leading reason for ICU admission in immunocompromised patients. Usual oxygen therapy involves administering low-to-medium oxygen flows through a nasal cannula or mask [with or without a bag and with or without the Venturi system] to achieve SpO2≥95%.

Oxygen therapy may be combined with non-invasive ventilation [NIV] providing both end-expiratory positive pressure and pressure support. However, in a recent trial by our group, non-invasive ventialtion [NIV] was not superior over oxygen without NIV.

High-flow nasal oxygen [HFNO] therapy is a focus of growing attention as an alternative to standard oxygen therapy. By providing warmed and humidified gas, HFNO allows the delivery of higher flow rates [of up to 60 L/min] via nasal cannula devices, with Fraction of inspired oxygen (FiO2) values of nearly 100%. Physiological benefits of HFNO consist of higher and constant FiO2 values, decreased work of breathing, nasopharyngeal washout leading to improved breathing-effort efficiency, and higher positive airway pressures associated with better lung recruitment.

Clinical consequences of these physiological benefits include alleviation of dyspnoea and discomfort, decreases in tachypnoea and signs of respiratory distress, a diminished need for intubation in patients with severe hypoxemia, and decreased mortality in unselected patients with acute hypoxemic respiratory failure However, although preliminary data establish the feasibility and safety of this technique, HFNO has never been properly evaluated in immunocompromised patients.

Thus, this project aims at demonstrating that HFNO is superior to low/medium-flow (standard) oxygen, minimising day-28 mortality

ReferenceCitation: Azoulay E, Lemiale V, Mokart D, Nseir S, Argaud L, Pène F, Kontar L, Bruneel F, Klouche K, Barbier F, Reignier J, Berrahil-Meksen L, Louis G, Constantin JM, Mayaux J, Wallet F, Kouatchet A, Peigne V, Théodose I, Perez P, Girault C, Jaber S, Oziel J, Nyunga M, Terzi N, Bouadma L, Lebert C, Lautrette A, Bigé N, Raphalen JH, Papazian L, Darmon M, Chevret S, Demoule A. Effect of High-Flow Nasal Oxygen vs Standard Oxygen on 28-Day Mortality in Immunocompromised Patients With Acute Respiratory Failure: The HIGH Randomized Clinical Trial. JAMA. 2018 Nov 27;320(20):2099-2107. doi: 10.1001/jama.2018.14282.

name: Medical Intensive Care Unit and Department of Biostatistics, APHP, Hôpital St-Louis, Paris, France.

family: Azoulay

full_name: Elie Azoulay

given: Elie

family: Lemiale

full_name: Virginie Lemiale

given: Virginie

name: Intensive Care Unit, Paoli Calmettes Institut, Marseille, France

family: Mokart

full_name: Djamel Mokart

given: Djamel

name: Critical Care Center, CHU de Lille, Lille, France

family: Nseir

full_name: Saad Nseir

given: Saad

name: Medical Intensive Care Unit, Hospices Civils de Lyon, Hôpital Edouard Herriot, Lyon, France

family: Argaud

full_name: Laurent Argaud

given: Laurent

name: Medical Intensive Care Unit, Hôpital Cochin, APHP, Université Paris Descartes, Paris, France

family: Pène

full_name: Frédéric Pène

given: Frédéric

name: Medical Intensive Care Unit, INSERM U1088, Amiens University Hospital, Amiens, France

family: Kontar

full_name: Loay Kontar

given: Loay

name: Medical Intensive Care Unit, André Mignot Hospital, Versailles, France

family: Bruneel

full_name: Fabrice Bruneel

given: Fabrice

name: Medical Intensive Care Unit, CHU de Montpellier, Montpellier, France

family: Klouche

full_name: Kada Klouche

given: Kada

name: Medical Intensive Care Unit, La Source Hospital, CHR Orléans, Orléans, France

family: Barbier

full_name: François Barbier

given: François

name: Medical Intensive Care Unit, Hotel Dieu, CHU de Nantes, Nantes, France

family: Reignier

full_name: Jean Reignier

given: Jean

name: Intensive Care Unit, Institut Gustave Roussy, Villejuif, France

family: Berrahil-Meksen

full_name: Lilia Berrahil-Meksen

given: Lilia

name: Intensive Care Unit, CHR de Metz-Thionville, Metz, France

family: Louis

full_name: Guillaume Louis

given: Guillaume

name: Department of Perioperative Medicine, CHU Clermont-Ferrand, Clermont-Ferrand, France

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

name: Medical Intensive Care Unit and Respiratory Division, APHP, Hôpital Pitié-Salpêtrière, Sorbonne University, Paris, France

family: Mayaux

full_name: Julien Mayaux

given: Julien

name: Intensive Care Unit, Lyon Sud Medical Center, Lyon, France

family: Wallet

full_name: Florent Wallet

name: Medical Intensive Care Unit, CHRU, Angers, France

family: Kouatchet

full_name: Achille Kouatchet

given: Achille

name: Intensive Care Unit, Centre Hospitalier Métropole-Savoie, Chambery, France

family: Peigne

full_name: Vincent Peigne

given: Vincent

family: Théodose

full_name: Igor Théodose

given: Igor

name: Medical Intensive Care Unit, Hôpital Brabois, Vandoeuvre Les Nancy, France

family: Perez

full_name: Pierre Perez

given: Pierre

name: Medical Intensive Care Unit, Hôpital Charles Nicolle, Rouen, France

family: Girault

full_name: Christophe Girault

given: Christophe

name: Montpellier University Hospital, PhyMedExp, INSERM U-1046, CNRS 34295 Montpellier, France

family: Jaber

full_name: Samir Jaber

given: Samir

name: Medical Intensive Care Unit, Avicenne University Hospital, Bobigny, France

family: Oziel

full_name: Johanna Oziel

given: Johanna

name: Intensive Care Unit, Roubaix hospital, Roubaix, France

name: Medical Intensive Care Unit, CHU de Grenoble Alpes, Grenoble, France

name: Medical Intensive Care Unit, CHU Bichat, Paris, France

name: Intensive Care Unit, Centre Hospitalier Départemental Les Oudairies, La Roche Sur Yon, France

name: Medical Intensive Care Unit, Gabriel-Montpied University Hospital, Clermont-Ferrand, France

name: Medical Intensive Care Unit, CHU St-Antoine, Paris, France

name: Department of Anesthesia and Critical Care, Necker Hospital, Paris, France

name: Réanimation des Détresses Respiratoires et Infections Sévères, Assistance Publique–Hôpitaux de Marseille, Hôpital Nord, Aix-Marseille Université, Faculté de Médecine, Marseille, France

name: Respiratory Intensive Care Unit, Hôpital Cochin, Paris, France

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

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

ReferenceCitation: Azoulay E, Lemiale V, Mokart D, Nseir S, Argaud L, Pène F, Kontar L, Bruneel F, Klouche K, Barbier F, Reignier J, Stoclin A, Louis G, Constantin JM, Mayaux J, Wallet F, Kouatchet A, Peigne V, Perez P, Girault C, Jaber S, Oziel J, Nyunga M, Terzi N, Bouadma L, Lebert C, Lautrette A, Bigé N, Raphalen JH, Papazian L, Rabbat A, Darmon M, Chevret S, Demoule A. High-flow nasal oxygen vs. standard oxygen therapy in immunocompromised patients with acute respiratory failure: study protocol for a randomized controlled trial. Trials. 2018 Mar 5;19(1):157. doi: 10.1186/s13063-018-2492-z.

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

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