title: Study of Metabolic Changes in the Transformation Malignant Precancerous Skin Lesions

acronym: MITOSKIN

summary: Skin carcinomas are the most frequent cancers in the world, including basal cell carcinomas and cutaneous squamous cell carcinoma (cSCCs), with more than 60.000 new annual cases in France. Their incidence increases mainly due to ultraviolet (UV) exposure and population ageing. Then from 1994 to 2006, the incidence of cSCC has increased by 300%. CSCCs typically manifests as a spectrum from a precursor actinic keratosis (AK) - possible spontaneous regression at this stage- to in situ cSCC invasive cSCC and finally metastatic cSCC.

ReferenceCitation: Obre E, Rossignol R. Emerging concepts in bioenergetics and cancer research: metabolic flexibility, coupling, symbiosis, switch, oxidative tumors, metabolic remodeling, signaling and bioenergetic therapy. Int J Biochem Cell Biol. 2015 Feb;59:167-81. doi: 10.1016/j.biocel.2014.12.008. Epub 2014 Dec 24.

ReferenceCitation: Hosseini M, Dousset L, Mahfouf W, Serrano-Sanchez M, Redonnet-Vernhet I, Mesli S, Kasraian Z, Obre E, Bonneu M, Claverol S, Vlaski M, Ivanovic Z, Rachidi W, Douki T, Taieb A, Bouzier-Sore AK, Rossignol R, Rezvani HR. Energy Metabolism Rewiring Precedes UVB-Induced Primary Skin Tumor Formation. Cell Rep. 2018 Jun 19;23(12):3621-3634. doi: 10.1016/j.celrep.2018.05.060.

ReferenceCitation: Hosseini M, Dousset L, Michon P, Mahfouf W, Muzotte E, Bergeron V, Bortolotto D, Rossignol R, Moisan F, Taieb A, Bouzier-Sore AK, Rezvani HR. UVB-induced DHODH upregulation, which is driven by STAT3, is a promising target for chemoprevention and combination therapy of photocarcinogenesis. Oncogenesis. 2019 Sep 24;8(10):52. doi: 10.1038/s41389-019-0161-z.

ReferenceCitation: Mahfouf W, Hosseini M, Muzotte E, Serrano-Sanchez M, Dousset L, Moisan F, Rachidi W, Taieb A, Rudolf J, Rezvani HR. Loss of Epidermal HIF-1alpha Blocks UVB-Induced Tumorigenesis by Affecting DNA Repair Capacity and Oxidative Stress. J Invest Dermatol. 2019 Sep;139(9):2016-2028.e7. doi: 10.1016/j.jid.2019.01.035. Epub 2019 Mar 13. Erratum In: J Invest Dermatol. 2022 May;142(5):1506-1507.

lead_sponsor: University Hospital, Bordeaux

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


type: EudraCT Number

title: Study of the Benefit of Lenvatinib Treatment in Waiting List of Liver Transplantation After TACE Failure in Patients With Hepatocellular Carcinoma (HCC)

acronym: Ta-Len-Tra

summary:
Currently in France, hepatocellular carcinoma (HCC) represents over 30% of indications of liver transplantation (LT) (# 500 cases/year). Chemoembolization (TACE) is the most commonly used bridge treatment in those patients (estimate 60%). These patients will present with a complete response in only 60 % of the cases (# 180 patients per year in France) and failure in 40 % of the cases (# 120 patients per year in France).

A systemic treatment using lenvatinib might provide a benefit in patients presenting with a non-resectable HCC in waiting list for LT and with a TACE failure (i.e. those with an active disease and a partial response or a stable disease or a progressive disease on imaging data, in particular when AFP remains significantly increased after 2 TACE) by decreasing dropout rate before LT and decreasing recurrence rate post-LT without new safety signal.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Laboratoire EISAI

location_facility:
Hospital Trousseau
Hospital Claude Huriez
Hospital Haut levêque
Hospital Henri Mondor
Paul Brousse Hospital
Pontchaillou Hospital

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Ongoing


study_start_date_type: Actual

acronym: CHOLINE

lead_sponsor: Merck KGaA, Darmstadt, Germany

summary: The aim of this multicentre, randomised, double-blind, placebo-controlled study is to evaluate the efficacy and safety of supplementary treatment with cholecalciferol (vitamin D3) in subjects with relapsing multiple sclerosis (R MS) treated with subcutaneous (s.c.) interferon beta-1a 44 microgram (mcg) [Rebif] 3 times weekly. The subjects will be divided into 2 groups, one receiving cholecalciferol 100,000 IU twice monthly along with Rebif treatment and the other group will be on placebo along with Rebif treatment. A total of 200 subjects will be recruited in 20-30 centres in France.

ReferenceType: derived

ReferenceCitation: Camu W, Lehert P, Pierrot-Deseilligny C, Hautecoeur P, Besserve A, Jean Deleglise AS, Payet M, Thouvenot E, Souberbielle JC. Cholecalciferol in relapsing-remitting MS: A randomized clinical trial (CHOLINE). Neurol Neuroimmunol Neuroinflamm. 2019 Aug 6;6(5):e597. doi: 10.1212/NXI.0000000000000597. Print 2019 Sep. Erratum In: Neurol Neuroimmunol Neuroinflamm. 2019 Nov 15;7(1):

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: HAL;PubMed Central;University of Melbourne - Minerva Access

unpaywall_oa_status: gold

publisher_dissemination: Wolters Kluwer Health

sponsor_collaborators:
Merck KGaA, Darmstadt, Germany
Merck Serono S.A.S, France

location_facility: CHU Hôpital Gui de Chauliac Service de Neurologie B

status: Completed

title: A Multicentre, Randomised, Double-blind, Placebo-controlled Study of the Efficacy of Supplementary Treatment With Cholecalciferol (Vitamin D3) in Patients With Relapsing- Multiple Sclerosis (RMS) Treated With Subcutaneous Interferon Beta-1a 44 µg 3 Times Weekly

primary_purpose: Supportive Care

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

lead_sponsor_type: industriel

status_simplified: Completed


title: Characterization of Intra-osseous Vascular Response With Ultrasound Imaging on Healthy Volunteers

summary: Blood circulation within bone is thought to have a key role in bone growth, in fracture healing and in the development of bone diseases like osteoporosis. Current medical imaging techniques such as conventional ultrasonography fail to detect blood circulation within bone. The investigators propose to develop a new type of ultrasonography called intraosseous functional ultrasonography that will enable the detection and the characterization of blood circulation in solid bone tissue, marrow and soft tissues surrounding bone (muscle for instance). Because most soft tissues are essentially made of water, the speed of sound in soft tissues is close to that in water and it varies only a little between different types of soft tissues. For this reason, clinical ultrasound scanners used for ultrasonography assume that the speed of sound in the human body is the same for all types of soft tissues. This assumption is reasonable in soft tissues, but it does not hold in bone because solid bone tissue is much stiffer than soft tissues. Seismologists have extensive experience in producing images of the structure of the Earth based on the analysis of elastic waves which follow the same laws of Physics as ultrasound waves. The subsurface of the Earth contains layers of solid materials and liquids, consequently it is very similar to a region of the human body containing bone and soft tissues. Therefore the investigators will first work on the adaption of time-tested seismic imaging methods to make ultrasonography of bone possible. Once a correct image of bone is obtained, the investigators will use an ultrasound scanner dedicated to research to repeat this image hundreds of times per second, very much like a slow motion video. Because blood is moving while bone is still, the intensity in the image is being slightly changed where blood is moving. Thus the analysis of these changes makes it possible to detect and characterize blood flow within bone. In this way the investigators expect to be able to detect blood flowing with a speed as low as a few millimeters per second. Finally the sensitivity of the technique to detect and characterize blood circulation in bone will be evaluated in patients at the hospital and in healthy volunteers. The success of this work will help gaining knowledge on the role of blood circulation within bone. In the long term, it may help in the diagnosis of bone diseases.

status: Active, not recruiting

primary_purpose: Basic Science

ipd_sharing: Undecided

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

location_facility: Service de Radiologie polyvalente et oncologique, hôpital La Pitié-Salpêtrière

intervention_type: Device


title: Time Prediction for Complete Recovery From Neuromuscular Blockade After Visual Recovery With Double Burst Stimulation

acronym: DBS PREDICTION

summary: The purpose is to calculate the time for an optimal recovery (T4/T1 > 0.9) from the moment when 2 responses to double burst stimulation are visually identical and this for 95% of patients.

status: Unknown status

study_type: Observational

time_perspective: Prospective

lead_sponsor: Central Hospital, Nancy, France

intervention_type: Procedure

status_simplified: Unknown


title: Covid-19 Vaccine Cohort in Specific Populations

acronym: COV-POPART

summary:
Multicentre national cohort study with prospective data collection and biological specimen collection.

Ancillary study in this cohort : pediatric cohort with participants from 5 to 17 years old.

Enrollment complete for adult cohort. Active recruting for ancillary pediatric cohort.

lead_sponsor: ANRS, Emerging Infectious Diseases

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

location_facility:
Nîmes CHU
Paris Cochin APHP
Cmg-Ec U1219

intervention_type: Biological


title: COrticosteroids in acUte uRticAria in emerGency dEpartment

acronym: COURAGE

summary: To demonstrate the non-inferiority of the efficacy of a single antihistamine in comparison with an association of antihistamine and corticosteroid in the treatment of acute urticaria in emergency departments

status: Recruiting

ReferenceCitation: Javaud N, Soria A, Maignan M, Martin L, Descamps V, Fain O, Bouillet L, Berard F, Tazarourte K, Roy PM, Fontaine JP, Bagot M, Khellaf M, Goulet H, Lapostolle F, Casalino E, Doutre MS, Gil-Jardine C, Caux F, Chosidow O, Pateron D, Vicaut E, Adnet F. Glucocorticoids for acute urticaria: study protocol for a double-blind non-inferiority randomised controlled trial. BMJ Open. 2019 Aug 21;9(8):e027431. doi: 10.1136/bmjopen-2018-027431.

license: cc-by-nc

license_normalized: cc-by-nc

repositories_concat: PubMed Central

publisher_dissemination: British Medical Journal

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: COURAGE

titre: Corticothérapie dans le traitement de l'urticaire aigue aux Urgences. Protocole COURAGE (COrticothérapie dans l'URticaire AiGuE)

discipline_principale: médecine d'urgence

nom_porteur: JAVAUD

prenom_porteur: Nicolas


title: Intervention Research for Suicide Prevention Among Adolescents and Young Adults in the General Population Using E-health Tools and a Promotion System Involving the Civilian Population

acronym: E-psYouth

summary:
"France's suicide rate is among the highest in Europe, with the young among the more at risk. Several European projects have demonstrated the effectiveness of using e-tools in suicide prevention particularly for hard-to-reach populations.

Lessons from StopBlues, an e-health tool (application/website) for suicide prevention in the general population developed in 2018 which was promoted by municipalities and general practitioners, show the necessity to adapt its content for young people.

The objective is to develop an e-health tool for suicide prevention targeting adolescents and young adults with psychological pain by adapting StopBlues and its promotional plan.

The detailed content of the e-health tool and its promotional plan will be determined via a literature review followed by individual and group interviews with experts and youth, with StopBlues as a starting part.

This adaptation of StopBlues will allow to reach a larger audience by offering a more suitable solution for this vulnerable population. A web-portal will serve as an entry point for both StopBlues and the new e-tool where users will be redirected to one of the tools/modules according to their profile and respective needs. "

design_allocation: Non-Randomized

primary_purpose: Prevention

location_facility: ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (URC Eco, Hôpital Hôtel-Dieu)

intervention_type: Other


title: Abatacept Versus Tocilizumab by Subcutaneous Administration for the Treatment of Rheumatoid Arthritis in TNF Alpha Inhibitor Inadequate Responder Patients: A Randomized, Open-labeled, Superiority Trial

acronym: SUNSTAR

summary:
Rheumatoid arthritis (RA) is the most common inflammatory rheumatoid disease in France, affecting 0.3% of the general population. Without effective treatment, the persistent inflammation causes invalidating pain and joint destruction, leading to major functional disability.

Biological agents have been proposed for patients with RA who have the most severe form of the disease and that are inadequate responder patients to conventional synthetic Disease-modifying antirheumatic drugs (csDMARDs). TNF inhibitors (TNFi) are historically proposed as the first biological DAMRD for inadequate responder patients to csDMARDs. A diverse therapeutic arsenal has become available in recent years with the development of non-anti-TNFα drugs whose mechanisms of action are different from the classical TNFi. This new biotherapy class includes tocilizumab and abatacept, two drugs recently available for subcutaneous administration that enables ambulatory care for patients who would otherwise require repeated in-hospital care.

The role of these new treatments in the therapeutic strategy has been emphasized by studies that demonstrated their efficacy as first-line treatments. However, in clinical practice, TNFi remain the most common first-line treatment for the majority of patients, non-anti-TNFα biological agents being reserved for inadequate responder patients.

In second line, several studies have investigated therapeutic strategies for inadequate responder patients to TNFi. Current data suggest that it could be wise to change the therapeutic target after failure of a first-line treatment with TNFi.

Data about the comparative efficacy of different biologics proposed after failure of a first-line treatment with TNFi are in progress. Meta-analyses from registries and academic trials conducted in France and The Netherlands suggest that non-anti-TNFα agents would have equivalent or superior efficacy compared with a second TNFi. This finding suggests clinicians to switch for an alternate therapeutic target after failure of a first-line TNFi.

Data comparing different non-anti-TNFα biologics in inadequate responder patients to TNFi are scare. Industrial trials have demonstrated sustained biological efficacy of non-anti-TNFα biologics after failure of a TNFi. However, there is very little solid data on the direct comparison between them.

lead_sponsor: Lille Catholic University

location_facility:
Hôpital Avicenne
CHU de Poitiers
CHU Nice
Clinique Infirmerie Protestante de Lyon
CHU de Grenoble Hôpital Sud
CH René-Dubos
CHRU de Lille
CHU Bichat
CHU Saint-Etienne
CHU Rouen
Hôpital Bicêtre
CH de Boulogne-sur-Mer
CHU de Saint-Etienne
Hôpital Cochin
CHU de Reims
CH de Valenciennes
CHU de Tours
CHU de Montpellier
CHU de Bordeaux
Ch Cahors
CHU de Clermont-Ferrand
CHRU de Strasbourg
CHD Vendée
Hôpital Lariboisière
Hôpital Saint-Philibert
Hôpital de la Pitié-Salpêtrière

region: Hauts-de-France

nom_etablissement: GCS GHICL DES HOPITAUX DE L'ICL

type_etablissement: GCS

acronyme: Sunstar

titre: Etude de l'utilisation séquentielle des biomédicaments sous-cutanés pour le traitement de la polyarthrite rhumatoïde

discipline_principale: rhumatologie

nom_porteur: PASCART

prenom_porteur: Tristan


title: Interscalene Block on Ventilatory Function After Shoulder Surgery : Evaluation of Single or Continuous Injection

acronym: KTBIS

summary: Interscalene block with local anesthetic impairs ventilation (unilateral diaphragmatic dysfunction). Single injection of local anesthetic induced transitory dysfunction (< 24h). The investigators hypothesized that continuous interscalene block would prolonged ventilatory impairment

lead_sponsor: Pierre and Marie Curie University


title: Management of Diabetic Patients With Neuropathic Osteoarthropathy (Charcot Foot) : Descriptive Study in Diabetic-foot Centers.

acronym: EPiChar

summary: Despite the prominence of diabetes prevalence (more than 8% of the world population in 2012) and its expected increase in the next 15 years, Charcot foot remains a widely unknown diabetes complication. At this day, there is no national guidelines about diagnosis and treatment of this complication, which is known to alter life quality and to increase risk of foot ulceration and mortality in diabetics. Through this descriptive multicentric study, we will investigate the Charcot foot cares in diabetic-foot centers in France and Belgium.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi


title: Etude Comparative Monocentrique, randomisée, en Cross-over, en Double Aveugle, Contre Placebo, de l'Action du méthylphénidate Sur Les paramètres Cognitifs de la Motivation

summary: The purpose of this study is to evaluate the impact of methylphenidate, a mixed dopaminergic and noradrenergic agent, onto the different components of motivation: decision-making, effort allocation and instrumental learning.

location_facility: Centre d'investigation clinique, Institut du Cerveau et de la Moelle


title: Overall Patient Care in a Montpelier Sexual Health Center (CeGIDD). Response Rate to Ceftriaxone 1g IM in Gonorrhoea : a French Retrospective Monocentric Study

acronym: GONOCEF

summary:
Sexual health centers (CeGIDD, in France) manage the majority of STI in France, especially gonorrhea.

Patients wanting STI screening can consult either they are symptomatic or not.

If they are symptomatic, they can be treated immediately. If they are not symptomatic, they must come back seven days after in order to get their results and to be treated if necessary.

Before any treatment for gonorrhea, subjects should be sampled for bacterial culture in order to perform AMR surveillance.

After every treatment for gonorrhea, subjects should realized a test of cure (TOC) according to current recommandation.

Response rate to ceftriaxone 1g IM for treating gonorrhea has never been evaluated in France while being used widely over the past months.

Compliance to current recommandation at CeGIDD Montpellier has never been evaluated.

This study will assess the response rate to ceftriaxone 1g IM as gonorrhea treatment by realizing a test of cure 14 days after each treatment.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


type: Other Identifier

title: Study of SARS-CoV2 Virus (COVID-19) Seroprevalence in the Population of Creil Air Force Base (BA110)

acronym: EpiCovCreil

summary:
In mid-February 2020, within the Oise (France) cluster, a case of COVID-19 disease caused by a SARS-CoV2 infection was described among the personnel of the Creail Air Force Base (BA110). This resulted in the beginning of an epidemic controlled by epidemiological measures. One month later, containment measures were taken at the national level, measures that also applied to BA110 personnel. These personnel, exposed to both the initial phase of the epidemic and national protection measures, represent an extremely interesting population for understanding the epidemiological dynamics of the virus, particularly at a time when France is lifting the containment measures. It becomes extremely important to understand the levers of viral spread in order to adjust the health measures to be maintained as best as possible.

The main objective of this study is to determine the extent of virus diffusion in this highly circulating population, as evidenced by several identified cases of COVID-19.

lead_sponsor: Direction Centrale du Service de Santé des Armées

intervention_type: Diagnostic Test


title: Impact of a Front-of-pack Nutrition Label on the Nutritional Quality of Purchases in Campus Cafeteria

summary: This study evaluates the impact of the introduction of a front-of-pack nutrition label on foods and beverages sold in a campus cafeteria in France on the nutritional quality of purchases.

primary_purpose: Other

lead_sponsor: University of Paris 13

intervention_type: Behavioral


title: Real-life Observatory of Efficacy and Resistance to Anti CMV Molecules in Stem Cell Recipients

acronym: NAViRe

summary:
Cytomegalovirus (CMV) is a ubiquitous herpesvirus that represent a major cause of morbidity in haematopoietic stem cell transplants (HSCT) recipients, mostly through reactivation of the recipient's virus.

If left untreated, 40 to 80% of patients will develop CMV infection, leading to CMV disease in 30 to 35 % patients, and associated with considerable morbi-mortality. Interstitial pneumonia is the most severe and specific manifestation, although CMV replication by itself has also indirect effects such as triggering graft versus host disease and increasing immunosuppression. The current burden of CMV infection increases by 25 to 30% the cost of the graft in France. This also includes the burden for refractory - infections, that represent up to 13% of recipients with CMV infection, including 3% of cases with virological resistance in France (data from the Reference Center cohorts).

Ganciclovir, or valganciclovir preemptive treatment, guided by CMV viral load follow-up allowed significant reduction of CMV disease to 2-6% but did not prevent CMV indirect effects. In addition, hematotoxicity can compromise post-transplant haematological reconstitution, thus preventing its use as prophylaxis in France. Foscarnet, iv-administered and nephrotoxic, remains less used. There is thus a high expectation from less toxic molecules for prophylaxis The development letermovir recently available for prophylaxis of CMV infection in high risk patients will modify the patients care and follow-up. This new molecule targeting CMV terminases (developed by Merck) was recently marketed in France (Jan 2020). However, the analysis of the letermovir phase III study and further publications show that the risk of emergence of resistance is low, but may occur in case of breakthrough and thus post AMM monitoring is required.

A "real-life" evaluation of these new molecules in terms of efficacy, emergence of resistance, tolerance and morbimortality related to CMV infection, is useful, to propose recommendations on management strategies, in particular for the most at-risk patients i.e. CMV-seropositive recipients. To this purpose, the National Reference Center in collaboration with the French Society for marrow graft and cell therapy (SFGMTC) set up a cohort of surveillance of allografted patients, receiving, in prevention or treatment, old and new molecules.

ReferenceType: background

ReferenceCitation: Ljungman P, Boeckh M, Hirsch HH, Josephson F, Lundgren J, Nichols G, Pikis A, Razonable RR, Miller V, Griffiths PD; Disease Definitions Working Group of the Cytomegalovirus Drug Development Forum. Definitions of Cytomegalovirus Infection and Disease in Transplant Patients for Use in Clinical Trials. Clin Infect Dis. 2017 Jan 1;64(1):87-91. doi: 10.1093/cid/ciw668. Epub 2016 Sep 28.

ReferenceCitation: Chemaly RF, Chou S, Einsele H, Griffiths P, Avery R, Razonable RR, Mullane KM, Kotton C, Lundgren J, Komatsu TE, Lischka P, Josephson F, Douglas CM, Umeh O, Miller V, Ljungman P; Resistant Definitions Working Group of the Cytomegalovirus Drug Development Forum. Definitions of Resistant and Refractory Cytomegalovirus Infection and Disease in Transplant Recipients for Use in Clinical Trials. Clin Infect Dis. 2019 Apr 8;68(8):1420-1426. doi: 10.1093/cid/ciy696.

ReferenceCitation: Billat PA, Ossman T, Saint-Marcoux F, Essig M, Rerolle JP, Kamar N, Rostaing L, Kaminski H, Fabre G, Otyepka M, Woillard JB, Marquet P, Trouillas P, Picard N. Multidrug resistance-associated protein 4 (MRP4) controls ganciclovir intracellular accumulation and contributes to ganciclovir-induced neutropenia in renal transplant patients. Pharmacol Res. 2016 Sep;111:501-508. doi: 10.1016/j.phrs.2016.07.012. Epub 2016 Jul 9.

ReferenceCitation: Marty FM, Ljungman P, Chemaly RF, Maertens J, Dadwal SS, Duarte RF, Haider S, Ullmann AJ, Katayama Y, Brown J, Mullane KM, Boeckh M, Blumberg EA, Einsele H, Snydman DR, Kanda Y, DiNubile MJ, Teal VL, Wan H, Murata Y, Kartsonis NA, Leavitt RY, Badshah C. Letermovir Prophylaxis for Cytomegalovirus in Hematopoietic-Cell Transplantation. N Engl J Med. 2017 Dec 21;377(25):2433-2444. doi: 10.1056/NEJMoa1706640. Epub 2017 Dec 6.

ReferenceCitation: Robin C, Hemery F, Dindorf C, Thillard J, Cabanne L, Redjoul R, Beckerich F, Rodriguez C, Pautas C, Toma A, Maury S, Durand-Zaleski I, Cordonnier C. Economic burden of preemptive treatment of CMV infection after allogeneic stem cell transplantation: a retrospective study of 208 consecutive patients. BMC Infect Dis. 2017 Dec 5;17(1):747. doi: 10.1186/s12879-017-2854-2.

ReferenceType: result

ReferenceCitation: Billat PA, Woillard JB, Essig M, Sauvage FL, Picard N, Alain S, Neely M, Marquet P, Saint-Marcoux F. Plasma and intracellular exposure to ganciclovir in adult renal transplant recipients: is there an association with haematological toxicity? J Antimicrob Chemother. 2016 Feb;71(2):484-9. doi: 10.1093/jac/dkv342. Epub 2015 Nov 3.

oa_host_type: publisher

evidence: open (via free pdf)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Oxford University Press

ReferenceCitation: Kotton CN, Kumar D, Caliendo AM, Huprikar S, Chou S, Danziger-Isakov L, Humar A; The Transplantation Society International CMV Consensus Group. The Third International Consensus Guidelines on the Management of Cytomegalovirus in Solid-organ Transplantation. Transplantation. 2018 Jun;102(6):900-931. doi: 10.1097/TP.0000000000002191.

evidence: open (via free article)

lead_sponsor: University Hospital, Limoges


title: Medical Compression for Leg Chronic Wound in Patients With Arterial Peripheral Disease: A Practice Survey

summary: Real-life practice survey of vascular specialist in France caring for patients with chronic wound for which compression treatment would be indicated and arterial disease of the lower limbs

collaborators: Société Française de Médecine Vasculaire (SFMV)


title: Randomized Trial Evaluating Women's Behavior Not Participating in Cervical Cancer Screening Facing Three Strategies for Optimizing Home Sending by Post of Vaginal Self-sampling Kit

summary: Despite the existence of an effective screening test (pap smear), cervical cancer is, every year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in 10 women are not screened or not often enough (nearly 7 millions women). It is therefore necessary to develop new strategies to reach these women. The etiological factor of this cancer is persistent infection with High-Risk Human PapillomaVirus (HR-HPV). Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that sending vaginal self-sampling kit (with HPV test) to unscreened women's home is a powerful means to increase the participation rate of cervical cancer screening. It seems interesting to explore methods to increase the efficiency of this strategy by optimizing the ratio of the number of kits used compared to the number of kits sent. Two approaches will be tested: a system "available on request" of the kit and / or the addition of an SMS (Short Message Service) reminder.

primary_purpose: Screening

lead_sponsor: University Hospital, Tours

collaborators: Centre Régional de Coordination des Dépistages des Cancers - Centre-Val de Loire

collaborators: Centre d'Investigation Clinique-P1415, TOURS


title: Interstitial Pneumonia With Autoimmune Features: Evaluation of Connective Tissue Disease Incidence During Follow-up

acronym: EVOLIPAF

summary: Interstitial lung diseases (ILD) represent a frequent complication of connective tissue diseases (CTDs), especially systemic sclerosis, idiopathic inflammatory myopathies and rheumatoid arthritis. ILD can either occur during CTD course or be the first manifestation of CTDs. Therefore screening patients with ILD for CTD is crucial. In some cases, ILD are associated with clinical and/or serological autoimmune features but not classifiable for CTDs. Evolution of these forms to defined CTDs has never been study. Recently, the European Respiratory Society/American Thoracic Society experts proposed a new term, "interstitial pneumonia with autoimmune features" or IPAF, to describe these patients according to updated classification criteria. Aims of this study were to compare CTD occurence during follow-up between IPAF and non-IPAF patients in a idiopathic interstitial pneumonia cohort and to identify risk factors of CTD progression in IPAF patients at diagnosis.

time_perspective: Retrospective

ReferenceCitation: Steen VD, Medsger TA. Changes in causes of death in systemic sclerosis, 1972-2002. Ann Rheum Dis. 2007 Jul;66(7):940-4. doi: 10.1136/ard.2006.066068. Epub 2007 Feb 28.

ReferenceCitation: Fathi M, Dastmalchi M, Rasmussen E, Lundberg IE, Tornling G. Interstitial lung disease, a common manifestation of newly diagnosed polymyositis and dermatomyositis. Ann Rheum Dis. 2004 Mar;63(3):297-301. doi: 10.1136/ard.2003.006122.

ReferenceCitation: Tanaka N, Kim JS, Newell JD, Brown KK, Cool CD, Meehan R, Emoto T, Matsumoto T, Lynch DA. Rheumatoid arthritis-related lung diseases: CT findings. Radiology. 2004 Jul;232(1):81-91. doi: 10.1148/radiol.2321030174. Epub 2004 May 27.

ReferenceCitation: Keane MP, Lynch JP 3rd. Pleuropulmonary manifestations of systemic lupus erythematosus. Thorax. 2000 Feb;55(2):159-66. doi: 10.1136/thorax.55.2.159. No abstract available.

ReferenceCitation: Tillie-Leblond I, Wislez M, Valeyre D, Crestani B, Rabbat A, Israel-Biet D, Humbert M, Couderc LJ, Wallaert B, Cadranel J. Interstitial lung disease and anti-Jo-1 antibodies: difference between acute and gradual onset. Thorax. 2008 Jan;63(1):53-9. doi: 10.1136/thx.2006.069237. Epub 2007 Jun 8.

ReferenceCitation: Kinder BW, Collard HR, Koth L, Daikh DI, Wolters PJ, Elicker B, Jones KD, King TE Jr. Idiopathic nonspecific interstitial pneumonia: lung manifestation of undifferentiated connective tissue disease? Am J Respir Crit Care Med. 2007 Oct 1;176(7):691-7. doi: 10.1164/rccm.200702-220OC. Epub 2007 Jun 7.

ReferenceCitation: Vij R, Noth I, Strek ME. Autoimmune-featured interstitial lung disease: a distinct entity. Chest. 2011 Nov;140(5):1292-1299. doi: 10.1378/chest.10-2662. Epub 2011 May 12.

ReferenceCitation: Fischer A, West SG, Swigris JJ, Brown KK, du Bois RM. Connective tissue disease-associated interstitial lung disease: a call for clarification. Chest. 2010 Aug;138(2):251-6. doi: 10.1378/chest.10-0194.

ReferenceCitation: Fischer A, Antoniou KM, Brown KK, Cadranel J, Corte TJ, du Bois RM, Lee JS, Leslie KO, Lynch DA, Matteson EL, Mosca M, Noth I, Richeldi L, Strek ME, Swigris JJ, Wells AU, West SG, Collard HR, Cottin V; "ERS/ATS Task Force on Undifferentiated Forms of CTD-ILD". An official European Respiratory Society/American Thoracic Society research statement: interstitial pneumonia with autoimmune features. Eur Respir J. 2015 Oct;46(4):976-87. doi: 10.1183/13993003.00150-2015. Epub 2015 Jul 9.


title: French Cohort of HIV Associated Lymphomas

acronym: ANRS CO16

summary:
The incidence of lymphomas is increased among HIV infected patients. In 70 % of cases, those are Non Hodgkin's lymphomas (NHL) and Hodgkin lymphomas (HL) in 30% of cases. In France, their incidence is estimated to 100 cases per year (data from the "Base de données Hospitalière Française sur l'Infection à VIH" (FHDH)). The main mechanisms involved in lymphomagenesis are immune dysfunction, involvement of oncogenic viruses (Epstein-Barr (EBV) and HHV8) and molecular oncogenic events. A better understanding of these different pathways, give the possibility to design specific treatments. The treatment of these lymphomas is not standardized. A prospective study of patients with HIV associated lymphoid malignancies is an innovating tool to answer epidemiological, physiopathological and therapeutic questions. We propose a prospective multicentric study of these patients.

The main objectives of this prospective study are to:

evaluate the incidence, characterise clinically and histologically NHL and HL cases associated to HIV
perform an observational study of the treatment and outcome of these patients out of the context of clinical trials,
study the differentiation and activation of B-cell populations,
better understand the role of specific T cell responses in the control of EBV infection,
allow other biological studies from the ANRS group " Lymphome et VIH ".

The recruitment of 40 cases per year is expected. The length of inclusions is 7 years. The follow-up will be of 2 years. Clinical, pathological and biological data at diagnosis and during follow-up will be collected. This will allow characterizing the lymphoma, the HIV infection, the antitumoral treatments and the outcome of lymphoma. Biological samples will be centralized to collect cell, DNA, RNA, plasma, serum and tumour collections (Y.Taoufik, S Prevot* ). To better understand the EBV infection and lymphomagenesis in HIV infection, we propose to follow the viral load and the molecular characteristics of EBV in PBMC, plasma and tumour (P.Morand* , V.Boyer* ), to investigate the EBV-T cell responses (G.Carcelain) and the presence and reactivation of EBV in peripheral B cells (C.Amiel* , JC Nicolas) and in tumoral samples (M.Raphael* , I.Joab* ). The other mechanisms of lymphomagenesis in HIV infection will be studied by the analysis of the sub-populations of B-cells in terms of activation and differentiation (Y.Taoufik) and by the characterization of MSI tumours (A.Duval).

collaborators: Dr Yassine Taoufik Dr Houria Chavez Hôpital Bicêtre CIB Paris Sud France

collaborators: Dr Guislaine Garcelain Hôpital Pitié Slapétrière Paris France

collaborators: Dr Irène Joab Hôpital Paul Brousse Villejuif France

collaborators: Dr Alex Duval Fondation Jean Dausset CEPH


title: Diagnostic Value and Prognostic Value of the Blood Level Determination of S100 Protein in Minor or Mild Traumatic Brain Injury (GCS Glasgow Score 9 to 15).

summary:
Traumatic brain injury (TBI) is a Public Health problem, because of the numbers of events (more than 200,000 per year in France). Craniocerebral tomodensitometry (CCT) is widely used for the diagnosis of minor/mild TBI, but both the access to the CCT and the cost of this imagery are critical factors. We hypothesized that the blood level measurement of S100 protein (S100), a neurological biomarker of cerebral injury, would help to the clinical evaluation of minor/mild head injury events, and would be an economic alternative to CCT for the diagnosis of these pathologies. In addition, a part of the study will explore the prognostic value of such blood level S100 determination for the evaluation of medical/social consequences of minor/mild TBI.

Medical objective of the study:

to assess the contribution of early determination (to medical care) of S100 for the diagnosis of minor/moderate TBI (TCCMM - Glasgow sup or equal to 9),
to determine the usefulness of a second dosage three hours later for the medical decision.

In other words, to compare S100 biomarker and CCT considered as a reference ( "Gold Standard") for the diagnosis or exclusion of TCCMM, and to precise its terms of use.

Economic objective:

to conduct a cost-effectiveness study of blood level determination of S100 vs. CCT for the diagnosis of minor/moderate TBI and its medical/social consequences

time_perspective: Cross-Sectional

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France

location_facility: Groupe Hospitalier Pitié-Salpêtrière - Charles Foix


title: Antibiotic Prescribing Behavior Among French Intensivist: Construction and Validation of a Questionnaire

summary:
Antibiotic resistance is a major threat in modern medicine. Overuse of antibiotics is an important driver of antibiotic resistance. However, some authors have shown that up to 50% of antibiotic treatments in critically ill patients are inappropriate, mostly because they are used in patients with non-bacterial infections.

In order to improve antibiotic use, several antibiotic stewardship programs have been implemented worldwide. However, only few of them have taken into account the determinants of prescribing behaviors. Yet, these determinants have been shown to play a role among general practitioners of hospital doctors. Nevertheless, none of these factors have been studied among intensivists.

The current project represent phase 1 of the study : construction and validation of a questionnaire.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Study of Photographs of Interest in Training to Obtain Good Reproducibility of the Diagnosis of Perianal Lesions of Crohn's Disease Inspection in Internal Gastroenterology

acronym: PhotoCrohn

summary:
The diagnosis of LAP (lesions Ano-perineal) requires the inspection, palpation, anoscopy and possibly additional examinations including endoscopy and imaging; any of these steps of the diagnosis can only be replaced by another.

In the absence of data in the literature on the evaluation of specific LAP Crohn inspection, Clemence Horaist et al established definitions of these lesions inspection with the help of an expert group, then evaluated the diagnostic agreement LAP these definitions in the same group from a selection of photographs. Definitions ulceration, fistula, inflammatory external os, erythema and abscess had an acceptable agreement diagnosis (kappa> 0.70)

The LAP is a predictor of severe Crohn's disease, hepato any gastroenterologist it is appropriate that recognizes and adopts adequate care, this care has been a consensus in 2014. The interns Hepato gastroenterology must learn during their training to know the terminology of LAP Crohn inspection and to recognize so considered acceptable by experts.

lead_sponsor: Fondation Hôpital Saint-Joseph


title: Effects of Compression in Mixed Ulcers

acronym: ULCEREMIXTE

summary:
About 15% to 30% of patients with venous leg ulcers have a peripheral arterial disease (PAD) associated. The compression band is still a controversial issue in this context. It allows the reduction of venous hypertension and edema, but it could potentially degrade the arterial infusion of high levels of compression. The French High Authority for Health (HAS) defines mixed ulcers by IPS between 0.5 and 0.9. Investigators distinguish mixed ulcers blood predominance for IPS between 0.5 and 0.7; and mixed ulcers predominantly venous blood with moderate involvement for IPS values between 0.7 and 0.9.

Several studies have shown that IPS> 0.8 allowed a high compression, between 30 and 40 mmHg. In the case of mixed ulcers with IPS between 0.6 and 0.8, the HAS recommends using a lighter compression, bit by elastic bands (exercising low power compression at rest) under medical supervision, informing the patient to remove the bandage if pain or aggravation. It is therefore necessary to adapt the compression therapy in case of venous ulcers associated with arterial disease by providing a lower compression 30 mmHg short stretch. For HAS, IPS <0.6 against indicates compression.

A recent study showed that compression bit elastic bands could not only improve venous return, but it would also increase the distal arterial flow in a patient population with mixed ulcers. In this study, 25 patients had between IPS 0.5 and 0.8; or for certain patients below the threshold of 0.6 indicates that against a compression according to HAS. To our knowledge this is the only study that has examined the effect of compression on blood perfusion.


title: The Silent Cortical Infarcts in the Cerebral Amyloid Angiopathy: Is There a Link With Subarachnoid Hemorrhage?

acronym: CAA

summary: The Cerebral Amyloid angiopathy (CAA) is the leading cause of cortical hemorrhage after 65 years. The presence of cerebral infarction is also reported anatomically in the AAC. MRI studies of these infarcts are rare. They are described as punctate, cortical silent. Frequency and pathophysiology is poorly understood. The investigators put the question of a link with hemorrhagic lesions of the AAC.


title: Acquisition and Analysis of Medullary Trauma Patients Signs, With an Expert Model

acronym: SKY

summary: The aim of this study was to analyze using an artificial intelligence engine (IA) the influence of the pathophysiological environment (set parametric monitoring data, imaging, biology etc.) of acute spinal cord trauma on spinal pain. This project seeks to establish the principles of a new approach for studying spinal cord injury patients. It does not meet the usual criteria of clinical trials in so far as it does not test on patients the effect of a therapeutic

primary_purpose: Diagnostic


title: Prospective Study Evaluating the Interest of Long-term Cardiac Recording in Cerebral Infarction

acronym: SPIDERFLASH

summary:
Cerebral infarction (CI) can be linked to atherosclerosis of large vessels, occlusion of small vessels intracerebral (gaps), a cardioembolic disease or other rare causes. However, up to 40% of CI remains unexplained after a thorough diagnostic workup. They are called cryptogenic IC.

Atrial fibrillation (AF) is the cause of 25% of the CI but it is recognized that episodes of paroxysmal AF, asymptomatic and unnoticed, may be responsible for a portion of the IC cryptogenic pace. Recognition of these episodes is of great importance since they have the same risk embolic the FA continues [1, 2] and motivate anticoagulant therapy startup.

Several recording techniques heart rate were evaluated after the IC for detecting the AF. Their profitability increases with the duration of the recording: about 3% for a typical 24-hour Holter, the AF detection rate increases to 6% for a 7-day surveillance period, to 12-23% for 30 days and 17-26% with implantable recorders long.

Otherwise brief rhythmic heart abnormalities can be detected with the waning of an CI without the significance of these episodes is known.

Investigators decided to conduct this study because there is no prospective study of good quality with a sufficient number of patients that evaluated the interest of a non-invasive recording of long duration. The only randomized CRYSTAL AF is used for invasive subcutaneous implantable monitor (Reveal XT).

To clarify the significance of arrhythmias and because the presence of several causes is common after 65, investigators propose to record all patients hospitalized for HF.


title: Pilot Study of the Immediate Cardiovascular Effects of Electronic Cigarette in Subjects With Cardiovascular Disease

acronym: ECLOPE

summary:
Justification Smoking is a major factor for mortality and cardiovascular morbidity. The electronic cigarette, sometimes presented as smoking cessation "classic" is expanding but its safety has not been established to date. The smoke from the electronic cigarette is mainly composed of propylene glycol, some adverse effects were observed in animals.

Study Type interventional study assessing the effect of the electronic cigarette Inclusion criteria Topics under 35 years presenting to Rhythm of the consultation for a cardiovascular evaluation and already smoking the electronic cigarette and that for at least 1 month

Exclusion criteria

Consumption of traditional cigarettes, nicotine replacement or toxic
Presence of heart disease Primary objective To evaluate in a pilot study the immediate cardiovascular effects of electronic cigarette consumption Number of patients 20 Duration of Study Recruitment in 2015 for an unlimited period of inclusion. Exam time is about two hours.

Procedures performed during the study Physical examination, ECG, Holter-ECG 10 minutes and echocardiography were performed before and 15 minutes after the consumption of the usual electronic cigarette of the subject.

No additional follow-up visit is required

status: Terminated


title: Assessment of the Prevalence of Small Fiber Peripheral Neuropathy Among Non-diabetic Obese Patients

acronym: NEUROBISITE

summary:
Background / rational:

Obesity is associated with significant comorbidities including type 2 diabetes (insulin resistance), heart disease, stroke, hypertension, sleep apnea syndrome, dyslipidemia, cancer, hepatobiliary diseases, orthopedic complications and psychosocial impact 1 .

Peripheral neuropathy is a known complication in the type I and II diabetes and glucose intolerance and metabolic syndrome in 2. Outside of diabetes (type I and II) that are associated with cardiovascular risk high vascular, presence of metabolic syndrome constitutes in itself a well demonstrated vascular risk factor. Its definition requires the presence of three elements from the following 5: abdominal obesity (high waist circumference), high blood pressure, high fasting blood sugar, high triglycerides and / low HDL-cholesterol 3.

This peripheral neuropathy predominantly affects sensory fibers of small poorly myelinated diameter (Aδ fibers and C) and autonomous sensory fibers and is called small fiber neuropathy 4. The cardinal sign of NAION is the presence of neuropathic pain but abnormalities in physical examination are often absent and conventional electromyography is faulted to make the diagnosis. These small fibers are also constituent of the autonomic nervous system and causes damage autonomic dysfunction that can manifest the cardiovascular system (hypotension, cardiac conduction disorders), digestive, sweat, sphincter. neuropathy of the diagnosis of small fibers is suggested clinically by the presence of neuropathic pain often contrasting with a normal clinical examination. The confirmation is based on electrophysiology with various techniques and quantification of intra-epidermal nerve fibers.

Main objective / secondary:

Primary objective :

To determine the prevalence of a small fiber peripheral neuropathy in nondiabetic obese patients, by measuring skin conductance ion Chlorine (Sudoscan®) evaluating small fibers C autonomic

Secondary objectives:

Evaluation of the prevalence of occurrence of peripheral neuropathy by Sudoscan® during follow-up after treatment of obese patients with bariatric surgery (months) M1, 3, 6, 9, 12.
Correlation of results obtained Sudoscan® quantitative sensory testing (QST) Thermotest® evaluating small sensory fibers Aδ, among non-operated non-diabetic obese patients and in the postoperative follow-up (months) M1, 3, 6, 9, 12.
Characterization of electromyographic parameters (motor and sensory conduction) in patients with a skin conductance measured by lowered Sudoscan® and / or a threshold of sensitivity to pain increased Thermotest®.
Correlation between the presence of a small fiber neuropathy in non-diabetic obese subjects with clinical and biological parameters collected.

Methodology Design: prospective, single-center Study duration: 24 months (estimate: 3-5 patients included / week of 15 patients collected in central obesity / week) including 12 months of inclusion.

Number of topics to include: 100 over a period of one year to adjust to the rhythm of the inclusions.

As mentioned, patients will be a measure of impedance of the skin to products chlorine ions by the sweat glands via the Sudoscan®, marketed and used among diabetic patients or not for the detection of violations neuropathic (cf. references and CE certificate attached to the dossier).

The Thermotest® is also marketed and used in diabetic and non-diabetic patients (see references and CE certificate attached to the dossier).

Our center has gained experience of these techniques for the detection of peripheral neuropathy in several patient populations (diabetes and cancer in particular); manipulators (doctors and technicians) are trained in these techniques.

ReferenceCitation: Smith AG, Lessard M, Reyna S, Doudova M, Singleton JR. The diagnostic utility of Sudoscan for distal symmetric peripheral neuropathy. J Diabetes Complications. 2014 Jul-Aug;28(4):511-6. doi: 10.1016/j.jdiacomp.2014.02.013. Epub 2014 Mar 6.

ReferenceCitation: Kopelman PG. Obesity as a medical problem. Nature. 2000 Apr 6;404(6778):635-43. doi: 10.1038/35007508.

ReferenceCitation: Herman RM, Brower JB, Stoddard DG, Casano AR, Targovnik JH, Herman JH, Tearse P. Prevalence of somatic small fiber neuropathy in obesity. Int J Obes (Lond). 2007 Feb;31(2):226-35. doi: 10.1038/sj.ijo.0803418. Epub 2006 Jun 13.

ReferenceCitation: Philippi N, Vinzio S, Collongues N, Vix M, Boehm N, Tranchant C, Echaniz-Laguna A. [Peripheral neuropathies after bariatric surgery]. Rev Neurol (Paris). 2011 Aug-Sep;167(8-9):607-14. doi: 10.1016/j.neurol.2011.01.011. Epub 2011 Apr 22. French.

ReferenceCitation: Thaisetthawatkul P, Collazo-Clavell ML, Sarr MG, Norell JE, Dyck PJ. A controlled study of peripheral neuropathy after bariatric surgery. Neurology. 2004 Oct 26;63(8):1462-70. doi: 10.1212/01.wnl.0000142038.43946.06.

ReferenceCitation: Sumner CJ, Sheth S, Griffin JW, Cornblath DR, Polydefkis M. The spectrum of neuropathy in diabetes and impaired glucose tolerance. Neurology. 2003 Jan 14;60(1):108-11. doi: 10.1212/wnl.60.1.108.

ReferenceCitation: Devigili G, Tugnoli V, Penza P, Camozzi F, Lombardi R, Melli G, Broglio L, Granieri E, Lauria G. The diagnostic criteria for small fibre neuropathy: from symptoms to neuropathology. Brain. 2008 Jul;131(Pt 7):1912-25. doi: 10.1093/brain/awn093. Epub 2008 Jun 4.

ReferenceCitation: Casellini CM, Parson HK, Richardson MS, Nevoret ML, Vinik AI. Sudoscan, a noninvasive tool for detecting diabetic small fiber neuropathy and autonomic dysfunction. Diabetes Technol Ther. 2013 Nov;15(11):948-53. doi: 10.1089/dia.2013.0129. Epub 2013 Jul 27.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Mary Ann Liebert Inc

location_facility: Groupe Hopitalier Paris Saint Joseph Service de neurologie


title: Short and Medium Term Postoperative Complications After Hallux Valgus Surgery

acronym: HALLUXVALGUS

summary: The aim of this study is to make a precise inventory of the complications that may occur postoperatively in the more or less long term in a cohort of patients who should benefit from surgical management of Hallux Valgus.

ReferenceCitation: Monteagudo M, Martinez-de-Albornoz P. Management of Complications After Hallux Valgus Reconstruction. Foot Ankle Clin. 2020 Mar;25(1):151-167. doi: 10.1016/j.fcl.2019.10.011. Epub 2019 Nov 29.

ReferenceCitation: Barg A, Harmer JR, Presson AP, Zhang C, Lackey M, Saltzman CL. Unfavorable Outcomes Following Surgical Treatment of Hallux Valgus Deformity: A Systematic Literature Review. J Bone Joint Surg Am. 2018 Sep 19;100(18):1563-1573. doi: 10.2106/JBJS.17.00975.

ReferenceCitation: Raikin SM, Miller AG, Daniel J. Recurrence of hallux valgus: a review. Foot Ankle Clin. 2014 Jun;19(2):259-74. doi: 10.1016/j.fcl.2014.02.008. Epub 2014 Mar 29.

ReferenceCitation: Filippi J, Briceno J. Complications after Metatarsal Osteotomies for Hallux Valgus: Malunion, Nonunion, Avascular Necrosis, and Metatarsophalangeal Osteoarthritis. Foot Ankle Clin. 2020 Mar;25(1):169-182. doi: 10.1016/j.fcl.2019.10.008. Epub 2019 Nov 26.

ReferenceCitation: Lee KB, Kim MS, Park KS, Lee GW. Importance of postoperative sesamoid reduction on the outcomes of proximal chevron osteotomy for moderate to severe hallux valgus deformity. Foot Ankle Surg. 2019 Aug;25(4):434-440. doi: 10.1016/j.fas.2018.02.006. Epub 2018 Feb 16.

ReferenceCitation: Lee KT, Park YU, Jegal H, Lee TH. Deceptions in hallux valgus: what to look for to limit failures. Foot Ankle Clin. 2014 Sep;19(3):361-70. doi: 10.1016/j.fcl.2014.06.003. Epub 2014 Jul 2.

ReferenceCitation: Nix S, Smith M, Vicenzino B. Prevalence of hallux valgus in the general population: a systematic review and meta-analysis. J Foot Ankle Res. 2010 Sep 27;3:21. doi: 10.1186/1757-1146-3-21.

ReferenceCitation: Zambelli R, Baumfeld D. Intraoperative and Postoperative Evaluation of Hallux Valgus Correction: What Is Important? Foot Ankle Clin. 2020 Mar;25(1):127-139. doi: 10.1016/j.fcl.2019.10.007. Epub 2019 Dec 4.

ReferenceCitation: Bock P, Kluger R, Kristen KH, Mittlbock M, Schuh R, Trnka HJ. The Scarf Osteotomy with Minimally Invasive Lateral Release for Treatment of Hallux Valgus Deformity: Intermediate and Long-Term Results. J Bone Joint Surg Am. 2015 Aug 5;97(15):1238-45. doi: 10.2106/JBJS.N.00971.

ReferenceCitation: Jeuken RM, Schotanus MG, Kort NP, Deenik A, Jong B, Hendrickx RP. Long-term Follow-up of a Randomized Controlled Trial Comparing Scarf to Chevron Osteotomy in Hallux Valgus Correction. Foot Ankle Int. 2016 Jul;37(7):687-95. doi: 10.1177/1071100716639574. Epub 2016 Mar 23.

ReferenceCitation: Lee KB, Cho NY, Park HW, Seon JK, Lee SH. A comparison of proximal and distal Chevron osteotomy, both with lateral soft-tissue release, for moderate to severe hallux valgus in patients undergoing simultaneous bilateral correction: a prospective randomised controlled trial. Bone Joint J. 2015 Feb;97-B(2):202-7. doi: 10.1302/0301-620X.97B2.34449.

ReferenceCitation: Lai MC, Rikhraj IS, Woo YL, Yeo W, Ng YCS, Koo K. Clinical and Radiological Outcomes Comparing Percutaneous Chevron-Akin Osteotomies vs Open Scarf-Akin Osteotomies for Hallux Valgus. Foot Ankle Int. 2018 Mar;39(3):311-317. doi: 10.1177/1071100717745282. Epub 2017 Dec 14.

ReferenceCitation: Brogan K, Lindisfarne E, Akehurst H, Farook U, Shrier W, Palmer S. Minimally Invasive and Open Distal Chevron Osteotomy for Mild to Moderate Hallux Valgus. Foot Ankle Int. 2016 Nov;37(11):1197-1204. doi: 10.1177/1071100716656440. Epub 2016 Jul 4.

ReferenceCitation: Kaufmann G, Mortlbauer L, Hofer-Picout P, Dammerer D, Ban M, Liebensteiner M. Five-Year Follow-up of Minimally Invasive Distal Metatarsal Chevron Osteotomy in Comparison with the Open Technique: A Randomized Controlled Trial. J Bone Joint Surg Am. 2020 May 20;102(10):873-879. doi: 10.2106/JBJS.19.00981.

ReferenceCitation: Chong A, Nazarian N, Chandrananth J, Tacey M, Shepherd D, Tran P. Surgery for the correction of hallux valgus: minimum five-year results with a validated patient-reported outcome tool and regression analysis. Bone Joint J. 2015 Feb;97-B(2):208-14. doi: 10.1302/0301-620X.97B2.34891.

ReferenceCitation: Dawson J, Boller I, Doll H, Lavis G, Sharp R, Cooke P, Jenkinson C. Responsiveness of the Manchester-Oxford Foot Questionnaire (MOXFQ) compared with AOFAS, SF-36 and EQ-5D assessments following foot or ankle surgery. J Bone Joint Surg Br. 2012 Feb;94(2):215-21. doi: 10.1302/0301-620X.94B2.27634.

ReferenceCitation: Coughlin MJ, Freund E. Roger A. Mann Award . The reliability of angular measurements in hallux valgus deformities. Foot Ankle Int. 2001 May;22(5):369-79. doi: 10.1177/107110070102200503.

ReferenceCitation: Lee KM, Ahn S, Chung CY, Sung KH, Park MS. Reliability and relationship of radiographic measurements in hallux valgus. Clin Orthop Relat Res. 2012 Sep;470(9):2613-21. doi: 10.1007/s11999-012-2368-6. Epub 2012 Apr 28.

ReferenceCitation: Talbot KD, Saltzman CL. Assessing sesamoid subluxation: how good is the AP radiograph? Foot Ankle Int. 1998 Aug;19(8):547-54. doi: 10.1177/107110079801900808.

ReferenceCitation: Smith RW, Reynolds JC, Stewart MJ. Hallux valgus assessment: report of research committee of American Orthopaedic Foot and Ankle Society. Foot Ankle. 1984 Sep-Oct;5(2):92-103. doi: 10.1177/107110078400500208. No abstract available.

ReferenceCitation: Coughlin MJ. Hallux valgus. J Bone Joint Surg Am. 1996 Jun;78(6):932-66. No abstract available.

ReferenceCitation: Lewis TL, Ray R, Miller G, Gordon DJ. Third-Generation Minimally Invasive Chevron and Akin Osteotomies (MICA) in Hallux Valgus Surgery: Two-Year Follow-up of 292 Cases. J Bone Joint Surg Am. 2021 Jul 7;103(13):1203-1211. doi: 10.2106/JBJS.20.01178.

ReferenceCitation: Lehman DE. Salvage of complications of hallux valgus surgery. Foot Ankle Clin. 2003 Mar;8(1):15-35. doi: 10.1016/s1083-7515(02)00130-4.

ReferenceCitation: Costa MT, de Almeida Pinto RZ, Ferreira RC, Sakata MA, Frizzo GG, Santin RA. OSTEOTOMY OF THE FIRST METATARSAL BASE ON THE TREATMENT OF MODERATE TO SEVERE HALLUX VALGUS RESULTS AFTER MEAN FOLLOW-UP TIME OF EIGHT YEARS. Rev Bras Ortop. 2015 Nov 16;44(3):247-53. doi: 10.1016/S2255-4971(15)30075-6. eCollection 2009 Jan.

ReferenceCitation: Fuhrmann RA, Zollinger-Kies H, Kundert HP. Mid-term results of Scarf osteotomy in hallux valgus. Int Orthop. 2010 Oct;34(7):981-9. doi: 10.1007/s00264-010-0958-z. Epub 2010 Feb 16.

lead_sponsor: Clinique Saint Jean, France


title: Determination of Pharmacokinetic and Therapeutic Adaptation of Linezolid in the Treatment of Multi-Resistant Tuberculosis MDR-TB

acronym: LINEZOLIDE

summary:
Linezolid, primary treatment for MDR-TB combination therapy anti. Until it is the dose of 600 mg x1 / day, rather sensible for most patients is more, which was unanimous. It is true that if a dosage is consensus, it goes without saying, because of the interindividual variability, marked moreover to linezolid, a therapeutic monitoring assay of plasma levels is indispensable for most pharmacological treatments. This therapeutic drug monitoring (TDM) often gives rise, as known, to dosage changes. It turns out that at present no real STP on the basic objectives PK / PD is really made in France in the treatment of tuberculosis (TB) and the bibliography remains rather poor recommendations, and yet all the elements are there: indeed linezolid is an antibiotic whose activity is purely "time-dependent". So one should fulfill 2 PK / PD objectives whose precise boundaries are sometimes still to be determined:

-% T> MIC, or percentage of time spent with plasma concentrations above the minimum inhibitory concentration of linezolid (LNZ) for Mycobacterium tuberculosis. In practice, the residual concentration before the next shot must be> MIC (0.125 to 1 mg / l)

A fortiori it must also take into account the concentration preventing the appearance of resistant mutants, amounting to 1.2 mg / l
AUC / MIC> 80, or ratio of the area under the curve (AUC, Area under curve) of plasma concentration versus time and CMI LNZ Until then, and without real bibliographic support, and for the sake of kindness to patients coupled with an economic advantage, the STP consisted of 2 samples, a peak 1:30 after taking (Cmax) and a residual before taking (C min) , after all, to 600mg x1 / 24 correlates well with the AUC (55% peak and 75% for the residual).

Following an observation that 25 to 30% of patients had a C min <1.2 mg / L, and even frequently <0.2 mg / L to 600 mg x 1, with some low peaks and leaving presage an AUC may be insufficient well.

This study is therefore more imperative to be a pharmacological streamlining and ensuring adequate therapeutic monitoring involves both maximum and minimum toxicity efficiency. And in the light of what has already been practiced for other molecules such as mycophenolate for example which is carried AUC or miniAUC for example. It would therefore be in the achievement of AUC in all patients treated with LNZ for TB MDR / XDR for over a week. Achieving this requires AUC obtaining 7 blood samples given day instead of two samples taken at present. Indeed one must have in mind that the peak of rational / residual has become blurred in this context, and that one of the two goals PK / PD is now filled (Cmin> MIC / CMP) but it should not be that not at the expense of the second (AUC). The benefits, direct and indirect are multiple and obtaining them is ensured through this protocol. The study by analyzing individual data will confirm the accuracy of the dose fractionation 300mgx2 / day and at a time to highlight a potential new dosage adjustment that would need to achieve for further study, so a substantial gain in terms of efficacy and toxicity via a suitable therapeutic monitoring. Secondly, determine which collection points, in these patients, these doses will be most interesting to take later in the routine of STP in order to collect less points (eg miniAUC MPA) retaining same statistical power to estimate kinetic parameters, mainly the AUC (eg aminoglycoside also). Finally in a third phase construction on the basis of these individual kinetics of a population pharmacokinetic model with highlighting of population parameters and especially co-related variables explaining the high pharmacokinetic variability and allowing for following patients to determine the individually tailored dose immediately before the first shot and the first assays.

location_facility: Sanatorium du Petit Fontainebleau Centre Médical de Bligny


title: Alveolar Recruitment Maneuvers: Comparison of Supine to Prone Position During Major Spinal Surgery

acronym: MRA-RACHIS

summary:
During mechanical ventilation, the alveolar recruitment maneuver (ARM) is to apply a positive end-expiratory pressure (PEEP) (generally 30 cm H2O) for a period of at least 30 seconds. The realization of MRA is one of three main elements of mechanical ventilation called "protective". This ventilatory strategy, originally described for the ventilation of acute respiratory distress syndrome (ARDS), and pulmonary and during abdominal surgery is based on a decrease tidal volumes, optimization of PEEP and the realization of MRA. Protective ventilation limit the occurrence of atelectasis, the surdistentions and, ultimately, significantly decreases postoperative complications.

The MRA is currently recommended in the "major" surgery. Most spine surgery (eg transpedicular fixation) used in this definition, the MRA are indicated and now commonly used. This type of surgery requires further positioning the patient in the prone position (DV). The DV modifies the compliance of the chest respiratory characteristics and changes (increase in insufflation pressure) and hemodynamic (decreased venous return) of the patient.

Respiratory and haemodynamic effects of MRA made VIS at major spine surgery are not known. The aim of this observational study, non-interventional, is to compare the hemodynamic and respiratory effects of MRA performed in DV to those of MRA performed in the prone position (DD).

The investigators hypothesis is that the respiratory and hemodynamic consequences of MRA performed in DV is different from those conducted in DD. A better understanding of hemodynamic and respiratory characteristics of MRA performed in DV would provide a more tailored to this type of surgery respiratory optimization strategy and reduce respiratory complications of this surgery.

lead_sponsor: University Hospital, Strasbourg, France

location_facility:
Service d'Anesthesiologie - NHC
Service D'Anesthesiologie - Nhc


title: Study of Feasibility and Diagnostic Profitability of Intra-cyst Fluid Molecular Biology Analysis in Pancreatic Cyst Tumors.

acronym: CYST-GEN

summary:
The main objective of the study is to compare the diagnostic accuracy of intra-cystic fluid DNA molecular analysis to standard diagnostics.

The secondary objective of the study is to evaluate the feasibility of intra-cystic fluid DNA molecular analysis.

ReferenceCitation: Lee KS, Sekhar A, Rofsky NM, Pedrosa I. Prevalence of incidental pancreatic cysts in the adult population on MR imaging. Am J Gastroenterol. 2010 Sep;105(9):2079-84. doi: 10.1038/ajg.2010.122. Epub 2010 Mar 30.

ReferenceCitation: Farrell JJ, Fernandez-del Castillo C. Pancreatic cystic neoplasms: management and unanswered questions. Gastroenterology. 2013 Jun;144(6):1303-15. doi: 10.1053/j.gastro.2013.01.073.

ReferenceCitation: Terris B, Ponsot P, Paye F, Hammel P, Sauvanet A, Molas G, Bernades P, Belghiti J, Ruszniewski P, Flejou JF. Intraductal papillary mucinous tumors of the pancreas confined to secondary ducts show less aggressive pathologic features as compared with those involving the main pancreatic duct. Am J Surg Pathol. 2000 Oct;24(10):1372-7. doi: 10.1097/00000478-200010000-00006.

ReferenceCitation: Crippa S, Fernandez-Del Castillo C, Salvia R, Finkelstein D, Bassi C, Dominguez I, Muzikansky A, Thayer SP, Falconi M, Mino-Kenudson M, Capelli P, Lauwers GY, Partelli S, Pederzoli P, Warshaw AL. Mucin-producing neoplasms of the pancreas: an analysis of distinguishing clinical and epidemiologic characteristics. Clin Gastroenterol Hepatol. 2010 Feb;8(2):213-9. doi: 10.1016/j.cgh.2009.10.001. Epub 2009 Oct 14.

ReferenceCitation: Marchegiani G, Mino-Kenudson M, Sahora K, Morales-Oyarvide V, Thayer S, Ferrone C, Warshaw AL, Lillemoe KD, Fernandez-Del Castillo C. IPMN involving the main pancreatic duct: biology, epidemiology, and long-term outcomes following resection. Ann Surg. 2015 May;261(5):976-83. doi: 10.1097/SLA.0000000000000813.

ReferenceCitation: Tanaka M, Fernandez-del Castillo C, Adsay V, Chari S, Falconi M, Jang JY, Kimura W, Levy P, Pitman MB, Schmidt CM, Shimizu M, Wolfgang CL, Yamaguchi K, Yamao K; International Association of Pancreatology. International consensus guidelines 2012 for the management of IPMN and MCN of the pancreas. Pancreatology. 2012 May-Jun;12(3):183-97. doi: 10.1016/j.pan.2012.04.004. Epub 2012 Apr 16.

ReferenceCitation: Brugge WR, Lewandrowski K, Lee-Lewandrowski E, Centeno BA, Szydlo T, Regan S, del Castillo CF, Warshaw AL. Diagnosis of pancreatic cystic neoplasms: a report of the cooperative pancreatic cyst study. Gastroenterology. 2004 May;126(5):1330-6. doi: 10.1053/j.gastro.2004.02.013.

ReferenceCitation: Serikawa M, Sasaki T, Fujimoto Y, Kuwahara K, Chayama K. Management of intraductal papillary-mucinous neoplasm of the pancreas: treatment strategy based on morphologic classification. J Clin Gastroenterol. 2006 Oct;40(9):856-62. doi: 10.1097/01.mcg.0000225609.63975.6f.

ReferenceCitation: Bournet B, Kirzin S, Carrere N, Portier G, Otal P, Selves J, Musso C, Suc B, Moreau J, Fourtanier G, Pradere B, Lazorthes F, Escourrou J, Buscail L. Clinical fate of branch duct and mixed forms of intraductal papillary mucinous neoplasia of the pancreas. J Gastroenterol Hepatol. 2009 Jul;24(7):1211-7. doi: 10.1111/j.1440-1746.2009.05826.x. Epub 2009 May 19.

ReferenceCitation: Sugiyama M, Izumisato Y, Abe N, Masaki T, Mori T, Atomi Y. Predictive factors for malignancy in intraductal papillary-mucinous tumours of the pancreas. Br J Surg. 2003 Oct;90(10):1244-9. doi: 10.1002/bjs.4265.

ReferenceCitation: Kanno A, Satoh K, Hirota M, Hamada S, Umino J, Itoh H, Masamune A, Asakura T, Shimosegawa T. Prediction of invasive carcinoma in branch type intraductal papillary mucinous neoplasms of the pancreas. J Gastroenterol. 2010 Sep;45(9):952-9. doi: 10.1007/s00535-010-0238-0. Epub 2010 Apr 10.

ReferenceCitation: Crippa S, Salvia R, Warshaw AL, Dominguez I, Bassi C, Falconi M, Thayer SP, Zamboni G, Lauwers GY, Mino-Kenudson M, Capelli P, Pederzoli P, Castillo CF. Mucinous cystic neoplasm of the pancreas is not an aggressive entity: lessons from 163 resected patients. Ann Surg. 2008 Apr;247(4):571-9. doi: 10.1097/SLA.0b013e31811f4449.

ReferenceCitation: Cizginer S, Turner BG, Bilge AR, Karaca C, Pitman MB, Brugge WR. Cyst fluid carcinoembryonic antigen is an accurate diagnostic marker of pancreatic mucinous cysts. Pancreas. 2011 Oct;40(7):1024-8. doi: 10.1097/MPA.0b013e31821bd62f. Erratum In: Pancreas. 2013 May;42(4):728. Turner, Brian [corrected to Turner, Brian G].

ReferenceCitation: Sahora K, Mino-Kenudson M, Brugge W, Thayer SP, Ferrone CR, Sahani D, Pitman MB, Warshaw AL, Lillemoe KD, Fernandez-del Castillo CF. Branch duct intraductal papillary mucinous neoplasms: does cyst size change the tip of the scale? A critical analysis of the revised international consensus guidelines in a large single-institutional series. Ann Surg. 2013 Sep;258(3):466-75. doi: 10.1097/SLA.0b013e3182a18f48.

ReferenceCitation: Wu BU, Sampath K, Berberian CE, Kwok KK, Lim BS, Kao KT, Giap AQ, Kosco AE, Akmal YM, Difronzo AL, Yu W, Ngor EW. Prediction of malignancy in cystic neoplasms of the pancreas: a population-based cohort study. Am J Gastroenterol. 2014 Jan;109(1):121-9; quiz 130. doi: 10.1038/ajg.2013.334. Epub 2013 Oct 1.

ReferenceCitation: Grobmyer SR, Cance WG, Copeland EM, Vogel SB, Hochwald SN. Is there an indication for initial conservative management of pancreatic cystic lesions? J Surg Oncol. 2009 Oct 1;100(5):372-4. doi: 10.1002/jso.21260.

ReferenceCitation: Huang ES, Turner BG, Fernandez-Del-Castillo C, Brugge WR, Hur C. Pancreatic cystic lesions: clinical predictors of malignancy in patients undergoing surgery. Aliment Pharmacol Ther. 2010 Jan 15;31(2):285-94. doi: 10.1111/j.1365-2036.2009.04173.x. Epub 2009 Oct 21.

ReferenceCitation: Crippa S, Bassi C, Salvia R, Malleo G, Marchegiani G, Rebours V, Levy P, Partelli S, Suleiman SL, Banks PA, Ahmed N, Chari ST, Fernandez-Del Castillo C, Falconi M. Low progression of intraductal papillary mucinous neoplasms with worrisome features and high-risk stigmata undergoing non-operative management: a mid-term follow-up analysis. Gut. 2017 Mar;66(3):495-506. doi: 10.1136/gutjnl-2015-310162. Epub 2016 Jan 7.

ReferenceCitation: Springer S, Wang Y, Dal Molin M, Masica DL, Jiao Y, Kinde I, Blackford A, Raman SP, Wolfgang CL, Tomita T, Niknafs N, Douville C, Ptak J, Dobbyn L, Allen PJ, Klimstra DS, Schattner MA, Schmidt CM, Yip-Schneider M, Cummings OW, Brand RE, Zeh HJ, Singhi AD, Scarpa A, Salvia R, Malleo G, Zamboni G, Falconi M, Jang JY, Kim SW, Kwon W, Hong SM, Song KB, Kim SC, Swan N, Murphy J, Geoghegan J, Brugge W, Fernandez-Del Castillo C, Mino-Kenudson M, Schulick R, Edil BH, Adsay V, Paulino J, van Hooft J, Yachida S, Nara S, Hiraoka N, Yamao K, Hijioka S, van der Merwe S, Goggins M, Canto MI, Ahuja N, Hirose K, Makary M, Weiss MJ, Cameron J, Pittman M, Eshleman JR, Diaz LA Jr, Papadopoulos N, Kinzler KW, Karchin R, Hruban RH, Vogelstein B, Lennon AM. A combination of molecular markers and clinical features improve the classification of pancreatic cysts. Gastroenterology. 2015 Nov;149(6):1501-10. doi: 10.1053/j.gastro.2015.07.041. Epub 2015 Aug 4.

ReferenceCitation: Al-Haddad MA, Kowalski T, Siddiqui A, Mertz HR, Mallat D, Haddad N, Malhotra N, Sadowski B, Lybik MJ, Patel SN, Okoh E, Rosenkranz L, Karasik M, Golioto M, Linder J, Catalano MF. Integrated molecular pathology accurately determines the malignant potential of pancreatic cysts. Endoscopy. 2015 Feb;47(2):136-42. doi: 10.1055/s-0034-1390742. Epub 2014 Oct 14.

ReferenceCitation: Al-Haddad M, Wallace MB, Woodward TA, Gross SA, Hodgens CM, Toton RD, Raimondo M. The safety of fine-needle aspiration guided by endoscopic ultrasound: a prospective study. Endoscopy. 2008 Mar;40(3):204-8. doi: 10.1055/s-2007-995336. Epub 2007 Dec 4.

ReferenceCitation: Boustiere C, Veitch A, Vanbiervliet G, Bulois P, Deprez P, Laquiere A, Laugier R, Lesur G, Mosler P, Nalet B, Napoleon B, Rembacken B, Ajzenberg N, Collet JP, Baron T, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Endoscopy and antiplatelet agents. European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2011 May;43(5):445-61. doi: 10.1055/s-0030-1256317. Epub 2011 May 4.

ReferenceCitation: Dumonceau JM, Polkowski M, Larghi A, Vilmann P, Giovannini M, Frossard JL, Heresbach D, Pujol B, Fernandez-Esparrach G, Vazquez-Sequeiros E, Gines A; European Society of Gastrointestinal Endoscopy. Indications, results, and clinical impact of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2011 Oct;43(10):897-912. doi: 10.1055/s-0030-1256754. Epub 2011 Aug 12.

lead_sponsor: Hospital St. Joseph, Marseille, France

sponsor_collaborators:
Hospital St. Joseph, Marseille, France
Ramsay Générale de Santé

location_facility: CHU NANTES Institut des Maladies de l'Appareil Digestif

location_facility: Centre Hospitalier Universitaire Dupuytren

intervention_type: Genetic


title: Clinical Pathways and Patients' Attitudes in Acute Low Back Pain

acronym: AcuteLBP

summary:
In France the prevalence of low back pain is 70 to 80 %. It's the leading cause of health expenditure in Europe and costs 900 million euros per year to health insurance in France. This is the second reason to consult a general practitioner. Acute low back pain is defined as low back pain lasts less than 6 weeks. It represents 60 to 70 % of low back pain but only 20% of the costs induced by low back pain in general. In fact, acute low back pain often heals spontaneously.

Risk factors for acute low back pain and risk factors for chronic low back pain have been the subject of many publications. They remain very difficult to prevent in practice because of their multiplicity. Preventing acute low back pain is part of the prevention of chronic low back pain. Patient care management of low back pain is well codified and consensual in the various international recommendations. However, their application is sometimes very disparate and bad habits on both patients and professionals persist. Advices recommended in the case of low back pain are widely disseminated but their applications are little studied. In 2017, in France, health insurance started a "back pain" prevention campaign with the objective of raising awareness of good attitudes in the event of back pain. It made an initial assessment of the different knowledges concerning spinal pain in the general population but also in the medical population with the aim of improving them. It appears that number of patients would not consult physician in this case. The many proposals of care and the diversity of medical professionals, paramedics and other stakeholders, proposing to cure low back pain form as many different clinical pathways. Use of alternative or unconventional medicines is poorly assessed. In this context, it seems relevant to evaluate patient clinical pathways and patients' attitudes.

lead_sponsor: CHU de Reims


title: Research of Infra Clinical Liver Injuries in Adult Patients Presented With Alpha-1 AT Deficiency

summary: This cohort study will evaluate the prevalence of the infra clinical liver injuries among a group of adult patients presenting with Alpha-1 AT deficiency followed up in a large university hospital in Lyon, France.

ReferenceCitation: Guillaud O, Dumortier J, Traclet J, Restier L, Joly P, Chapuis-Cellier C, Lachaux A, Mornex JF. Assessment of liver fibrosis by transient elastography (Fibroscan(R)) in patients with A1AT deficiency. Clin Res Hepatol Gastroenterol. 2019 Feb;43(1):77-81. doi: 10.1016/j.clinre.2018.08.016. Epub 2019 Jan 3.

oa_colors: green other

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

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

repositories_concat: HAL

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

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

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Femme Mère Enfant - Hospices Civils de Lyon


title: Rubinstein-Taybi Syndrome: Functional Imaging and Therapeutic Trial

acronym: RUBIVAL

summary:
An exploratory phase 2 therapeutic trial in children from 6 to 21, RTS carriers, randomized to be treated either with sodium valproate with the usual pediatric dosage (30 mg/kg/j), or by placebo for one year.

The investigator would like to include children because they could best profit from it due to their neuronal plasticity as CBP and EP300 take effect through neuronal and synaptic plasticity.

The therapeutic effect of sodium valproate in RTS patients will be assessed thanks to a clinical approach (learning and memory neuropsychological evaluation, fine motor skills assessment by pointing), to a biological approach (histone acetylation functional tests), and to imaging (morphological and functional MRI).

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
Fondation Syndrome de Rubinstein-Taybi


title: Treatment of Chronic Active Antibody Mediated Rejection After Kidney Transplantation by Double-Filtration PlasmaPheresis (DFPP) or Plasma Exchange (PE).

acronym: DFPP

summary:
In France around 90,000 cases of end-stage chronic kidney disease patients treated either by dialysis (60%) or renal transplantation (just over 40%).

In terms of patient survival and quality of life and also economic reasons, the goal in France is to increase renal transplantation instead of patients on dialysis.

After renal transplant, two main causes of the graft loss after the first years are death of patient with functioning graft, and chronic AntiBody Mediated Rejection (ABMR).

Double Filtration PlasmaPheresis (DFPP) has never been evaluated for this indication.

DFPP makes it possible to treat larger volumes of plasma than plasma exchange, and essentially eliminates higher molecular weights molecules including immunoglobulins comprising DSA (donor-specific alloantibody) but also the C1q involved in the lesions of(ABMR). It is postulated that it will be more effective in treating ABMR than usual plasma exchanges.

A chronic ABMR is the result of the appearance de novo production of anti-Human Leucocyte Antigen antibodies (HLA) against one or more graft antigens (DSA: donor-specific alloantibody).These DSAs will lead to accelerated arteriosclerosis in the graft vessels, which will result in rapidly progressive renal failure, usually associated with a high rate of proteinuria.

Numerous studies have shown that up to 20% of renal transplant patients develop DSA within 5 years of renal transplantation.

Today, no treatment has been shown to be effective in the case of chronic ABMR: the basis of treatment is the reduction/elimination of DSA ( by apheresis for example) and the prevention of its re-synthesis B lymphocytes/plasma cells of the patient (with rituximab for example).

The investigators of this study propose in the context of the active ABMR demonstrated by renal biopsy to evaluate in combination with rituximab, a new apheresis technique double Plasma filtration (DFPP) instead of plasma Exchange.

ReferenceCitation: Eskandary F, Bond G, Kozakowski N, Regele H, Marinova L, Wahrmann M, Kikic Z, Haslacher H, Rasoul-Rockenschaub S, Kaltenecker CC, Konig F, Hidalgo LG, Oberbauer R, Halloran PF, Bohmig GA. Diagnostic Contribution of Donor-Specific Antibody Characteristics to Uncover Late Silent Antibody-Mediated Rejection-Results of a Cross-Sectional Screening Study. Transplantation. 2017 Mar;101(3):631-641. doi: 10.1097/TP.0000000000001195.

oa_host_type: closed

ReferenceCitation: Eskandary F, Wahrmann M, Muhlbacher J, Bohmig GA. Complement inhibition as potential new therapy for antibody-mediated rejection. Transpl Int. 2016 Apr;29(4):392-402. doi: 10.1111/tri.12706. Epub 2015 Nov 10.

publisher_dissemination: Frontiers

ReferenceCitation: Gatault P, Kamar N, Buchler M, Colosio C, Bertrand D, Durrbach A, Albano L, Rivalan J, Le Meur Y, Essig M, Bouvier N, Legendre C, Moulin B, Heng AE, Weestel PF, Sayegh J, Charpentier B, Rostaing L, Thervet E, Lebranchu Y. Reduction of Extended-Release Tacrolimus Dose in Low-Immunological-Risk Kidney Transplant Recipients Increases Risk of Rejection and Appearance of Donor-Specific Antibodies: A Randomized Study. Am J Transplant. 2017 May;17(5):1370-1379. doi: 10.1111/ajt.14109. Epub 2017 Jan 3.

evidence: open (via crossref license)

ReferenceCitation: Loupy A, Haas M, Solez K, Racusen L, Glotz D, Seron D, Nankivell BJ, Colvin RB, Afrouzian M, Akalin E, Alachkar N, Bagnasco S, Becker JU, Cornell L, Drachenberg C, Dragun D, de Kort H, Gibson IW, Kraus ES, Lefaucheur C, Legendre C, Liapis H, Muthukumar T, Nickeleit V, Orandi B, Park W, Rabant M, Randhawa P, Reed EF, Roufosse C, Seshan SV, Sis B, Singh HK, Schinstock C, Tambur A, Zeevi A, Mengel M. The Banff 2015 Kidney Meeting Report: Current Challenges in Rejection Classification and Prospects for Adopting Molecular Pathology. Am J Transplant. 2017 Jan;17(1):28-41. doi: 10.1111/ajt.14107.

oa_colors: green hybrid

license: cc-by

license_normalized: cc-by

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

repository_institution: Imperial College London - Spiral

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

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

repository_institution: California Digital Library - eScholarship

ReferenceCitation: Hanafusa N, Kondo Y, Suzuki M, Nakao A, Noiri E, Fujita T. Double filtration plasmapheresis can decrease factor XIII Activity. Ther Apher Dial. 2007 Jun;11(3):165-70. doi: 10.1111/j.1744-9987.2007.00433.x.

lead_sponsor: University Hospital, Grenoble


acronym: AcSé

lead_sponsor: UNICANCER

summary:
This is a biology driven, trans-tumoral, multicentric phase II trial assessing the efficacy and the safety of the targeted agent crizotinib as a monotherapy in 23 cohorts of patients with identified activating molecular alterations in the crizotinib target genes. A cohort is defined by a pathology and a crizotinib-target alteration (eg gastric cancer with MET amplification).

For each cohort a two-stage design will be implemented. In the situation where expected accrual allows for a sufficient number of patients to be accrued, the alpha and beta errors will be fixed at 10%. However, in very rare diseases, such as inflammatory myofibroblastic tumor (IMT), neuroblastoma, glioblastoma, and rhabdomyosarcoma (RMS), it is anticipated that the target number may not be achievable in a reasonable timeframe; for these cohorts, the alpha and beta errors will be fixed at 15%. Consequently three different statistical designs will be a priori considered according to the expected response rate and incidence.

ReferenceCitation: Aparicio T, Cozic N, de la Fouchardiere C, Meriaux E, Plaza J, Mineur L, Guimbaud R, Samalin E, Mary F, Lecomte T, Gomez-Roca C, Haineaux PA, Gratet A, Selves J, Menu Y, Colignon N, Johnson L, Legrand F, Vassal G. The Activity of Crizotinib in Chemo-Refractory MET-Amplified Esophageal and Gastric Adenocarcinomas: Results from the AcSe-Crizotinib Program. Target Oncol. 2021 May;16(3):381-388. doi: 10.1007/s11523-021-00811-8. Epub 2021 Apr 13.

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

publisher_dissemination: Springer-Nature

ReferenceCitation: Moro-Sibilot D, Cozic N, Perol M, Mazieres J, Otto J, Souquet PJ, Bahleda R, Wislez M, Zalcman G, Guibert SD, Barlesi F, Mennecier B, Monnet I, Sabatier R, Bota S, Dubos C, Verriele V, Haddad V, Ferretti G, Cortot A, De Fraipont F, Jimenez M, Hoog-Labouret N, Vassal G. Crizotinib in c-MET- or ROS1-positive NSCLC: results of the AcSe phase II trial. Ann Oncol. 2019 Dec 1;30(12):1985-1991. doi: 10.1093/annonc/mdz407.

sponsor_collaborators:
UNICANCER
National Cancer Institute, France
Fondation ARC
Pfizer

title: AcSé CRIZOTINIB : Secured Access to Crizotinib for Patients With Tumors Harboring a Genomic Alteration on One of the Biological Targets of the Drug.


title: Self-confidence in Midwife Students

acronym: ESF-conf

summary:
Self-confidence is essential during the training of students but in professional practice. Therefore, the training of students must allow its acquisition.

However, the university environment is particularly stressful for students. This stress can lead to depression. Perceived stress refers to the feeling of inability to pass an exam even if the person has the abilities to do so.

lead_sponsor: Université de Reims Champagne-Ardenne


title: Study of the Specific Seroprevalence of SARS-CoV-2 in a Sample of Patients and Salaried Staff From a French Anti-cancer Center at the End of the Containment Period of the SARS-CoV-2 Pandemic

acronym: canSEROcov

summary:
Since March 2020, France has been confronted with the SARS-COV-2 pandemic. Analysis of the data of its spread would indicate that close contact between individuals is necessary and containment would be the best way to contain this virus. France has therefore been contained since March 17, 2020 until 11 May 2020.

In order to assess the impact of the measures taken (containment) to protect patients and salaried staff of a french anti-cancer center on the spread of the virus, this observational study assesses the specific seroprevalence of SARS-COV-2 in all caregivers and non-carers of this hospital and in patients treated in consultation, day hospitalization, full hospitalization at the end of the containment period.

The objective for the staff cohort is to describe the seroprevalence and the link between the seroprevalence and sociological / demographic factors relating to the category of profession, to the contacts with the patients, to the presence in the hospital during the period of containment, to the conditions of home containment.

The objective for the patient cohort is to describe the seroprevalence and the link between the seroprevalence and factors relating to the type of cancer treated, the type of treatment and their possible modification during the period of containment, to the conditions of home containment.

lead_sponsor: Centre Georges Francois Leclerc


title: Gynaecological Emergencies: Validation of Indicators of Activity and Quality of Care for Creation of a Network Sentinel

acronym: URGO

summary:
There is no large-scale data in France or internationally, on the quality of care in gynecological emergencies, or the consequences of delay or misdiagnosis of women's health or on determinants of these delays or misdiagnosis. The creation of a sentinel network for gynecological emergencies could help quantify these links and test strategies to avoid the worst effects by implementing simple diagnostic tools from clinical research.

The network will be designed to promote research in women's health and the emergency reception by focusing on:

(i) Assessment of the quality and organization of care and professional practice for the management of gynecological emergencies.

(ii) The study of severe morbidity and its determinants (iii) comparison of organizational practices and health outcomes of women over time within the same department or between services having substantially the same recruitment (iv) Comparison of organization systems gynecological emergencies departement between different high resource francophone countries (France, Switzerland, Belgium).

(v) The assessment of new diagnostic strategies (sorting or diagnostic aid) or therapeutic derived from clinical research.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Visual Exploration and Attention : Studies in Patients With Schizophrenia and Autism Spectrum Disorders

summary: The aim of the protocol is to better understand the impairments in visual processing, as such impairments may induce social interaction difficulties in subjects with autism spectrum disorders (adults and children) and schizophrenia, like face exploration.The same protocol will be used for the three populations, each population being compared with matched controls. The explorations are designed to test two different hypotheses regarding the mechanisms of the visual perception difficulties of the two populations. Even though difficulties to extract the global form of objects have been described in both subjects with autism and schizophrenia, we will test two different hypotheses for the two populations. We will test the hypothesis that subjects with autism display an advantage for the processing of local information arising at an early level of processing, whereas disorders observed in patients with schizophrenia originate from attention disorders. The protocol includes three consecutive studies, each one being applied in each of the three populations.

location_facility: INSERM U666 ; Pôle de Psychiatrie - Service de Psychiatrie Adulte- HUS

location_facility: Pôle régional du Centre de Ressources Autisme pour enfants et adolescents - Unité d'évaluation des troubles du développement Hôpital de l'Elsau - Pôle de Psychiatrie - Unité d'évaluation des troubles du développement Hôpital de l'Elsau - HUS

location_facility: Pôle départemental du Centre de Ressources Autisme pour adultes (67) - Etablissement public de santé Alsace-Nord (site de Brumath)

location_facility: Centre de Ressources Autisme Pôle adultes (68) - Espace Autisme 68


title: Impact of a Front-of-pack Nutrition Labelling on the Nutritional Quality of Purchases of Customers in Contract Catering - a Controlled Trial

summary: This controlled trial investigates the impact of the implementation of a front-of-pack nutrition label, namely Nutri-Score, on foods and beverages sold in a contract catering in France on the nutritional quality of purchases.

sponsor_collaborators:
University of Paris 13
ELIOR GESTION

location_facility: Equipe de Recherche en Epidémiologie Nutritionnelle


title: Analgesic Effect of Beta 2-mimetics in the Treatment of Neuropathic Pain

acronym: Bêtapain

summary: Neuropathic pain is due to a lesion or disease affecting the nervous system. Antidepressants (ADs) are recommended as the first line treatment. In a murine model, the investigators evidenced that antidepressants antiallodynic action is mediated through β2-adrenergic receptor stimulation and that β-mimetics display the same effect. These data support the idea that β-mimetics could offer a therapeutic alternative to ADs for neuropathic pain treatment. This study will aim at assessing the effects of terbutaline on neuropathic pain symptoms.

location_facility:
CHU de Besançon
Hôpitaux Universitaires de Strasbourg


title: Interest of New Dosages of Inflammatory Markers for the Early Diagnosis of Nosocomial Bacterial Infections of the Newborn

acronym: NOSODIAG

summary: This study aims to evaluate new dosage of inflammatory markers or new inflammatory markers for the diagnosis of nosocomial bacterial infection. We made the hypothesis that these new dosages or new inflammatory markers could be more useful than dosage of inflammatory markers already used in clinical practice (especially the use of a combination of interleukins (6 or 8) and C-reactive protein for the management of newborns with a clinical suspicion of nosocomial bacterial infection and especially could allow to avoid excessive treatment with antibiotics

location_facility: Service de Pédiatrie 2 - Hôpital de Hautepierre; 1 - Avenue Molière

location_facility: Service de Pédiatrie 2 - Hôpital d'Enfants CHU de Dijon; 10 - bld Maréchal de Lattre de Tassigny


title: Efficacy Study on Quality of Life Criteria of a Digital Application on Any Cellphone (OnKO-Tips&Tricks) Allowing Daily Follow-ups, Implementation of an ETP Program and a Direct Link With the Nurse Coordinator of Units Specifically Dealing With Adolescents and Young Adults Diagnosed With Cancer

acronym: OnKO T&T 2 0

summary:
Approximately 2,200 cancers per year in France are diagnosed within the adolescents and young adults population (15-25 years old, AYA). The cancer plans and the INCA recommend support during and after cancer treatment, taking into account both medical and psycho-social specificities related to age (support care, school learning/training and professional integration, fertility preservation, therapeutic education, addictology, sexology...). In this context, AJA teams have been developed in which the Nurse Coordinators (IDEC) play a fundamental role. These Nurse Coordinators are available to young patients, their families and the professionals who accompany follow them in their therapeutic journey. Their main missions are to assess the specific needs of these young people and their loved ones, to inform, orient and participate in the coordination of their care by providing psychosocial and paramedical solutions to these young patients. The circular of 30/05/2016 on the coordinated regional organization of care for AJAs supports the development of connected health tools for AJAs. This population is adept to new technologies, social networks allowing them to continue to be informed and remain integrated to the outside world while helping them prepare for life after cancer.

In this context, our team initiated the development of a digital application compatible for any cellphone OnKO-Tips&Tricks meeting these criteria of necessity with the company CAPCOD. We would want to move on to a validation stage by carrying out a national multicenter efficacy study in AJA mobile units by comparing two groups of patients: users/non-users of this digital tool on a main criterion of quality of life after using it for 6 months. As it should promote autonomy and integration into the care pathway as well as active participation in therapeutic education programs (TPE), these different items will be evaluated as secondary endpoints of our study

location_facility: Assistance Publique - Hôpitaux de Marseille

location_facility: Institut d'Hématologie et d'Oncologie Pédiatrique

location_facility: Institut de Cancerologie Strasbourg Europe


title: Assessment and Improvement of Regional Information and Coordination Tools to Promote Access to Fertility Preservation

acronym: EVAPREF

summary: The EVAPREF project aims to increase access to fertility preservation by developing an approach to improve and evaluate existing information and coordination tools developed by the Pays-de-la-Loire and Occitanie Regional Cancer networks. First, the investigators will use a qualitative, iterative, user-centered and participatory approach to improve the current tools and create training content for the physicians who will use these tools. Second, the investigators will conduct a randomized stepped wedge trial of women under 40 newly treated with chemotherapy for breast cancer. The investigators will evaluate the rate of fertility preservation consultation before and after implementation of the improved tools, over a 30-month period from mid-2023 to the end of 2025. Finally, in a third step, the investigators will study their approach (context-sensitive implementation analysis) and provide key elements for its transferability to other contexts and in particular to other Regional Cancer networks in France.

lead_sponsor: University Paul Sabatier of Toulouse

sponsor_collaborators:
University Paul Sabatier of Toulouse
National Cancer Institute, France
Institut Claudius Regaud
Réseau Onco-Occitanie
Réseau ONCOPL

location_facility:
Institut Claudius Regaud (IUCT-O)
CHU Nantes


title: Determination of the Aneurysm Vulnerability Index by Stimulation and Medical Imaging

acronym: ANEUVISM

summary:
Stroke is the leading cause of disability in France with 130,000 cases per year, 20% of strokes being hemorrhagic, with a majority of intracranial aneurysm rupture (80%). Each year, 6000 meningeal hemorrhages (MHA) caused by cerebral aneurysm rupture are reported in France: 40% of patients die within the first month and 30% are left with severe and permanent disability. Intracranial aneurysms are present in 2 to 6% of the population and only about 0.5% of them will rupture. Given the human and economic costs associated with this disease, systematic medical screening for intracranial aneurysms could be useful. However, the operative risk of endovascular treatment remains non-zero (around 1%) and could be proposed only to a selected population of aneurysms at risk of rupture. The absence of diagnostic criteria for aneurysmal vulnerability does not allow for the moment to consider screening for this disease, which continues to strike without warning a young and active population.

Nevertheless, access to brain imaging allows the detection of an increasing number of intracranial aneurysms. The question of preventive treatment then arises and is still a difficult point discussed by neurosurgeons / neurointerventionists based on general epidemiological data difficult to apply to an individual.

lead_sponsor: University Hospital, Montpellier


title: Multicentric Study for the Validation and Improvement of a Structured Report Tool for the Imaging Characterization of Bone Tumors - Bone Tumor Imaging Report and Data System (BTI-RADS)

acronym: BTI-RADS M

summary: In this study a previously described structured multimodality image report system for the characterization of focal bone lesions is evaluated in a larger patient population. The objective of this study is to evaluate the performance of this tool stratifying the malignancy risk of bone tumors.

ReferenceCitation: Ribeiro GJ, Gillet R, Hossu G, Trinh JM, Euxibie E, Sirveaux F, Blum A, Teixeira PAG. Solitary bone tumor imaging reporting and data system (BTI-RADS): initial assessment of a systematic imaging evaluation and comprehensive reporting method. Eur Radiol. 2021 Oct;31(10):7637-7652. doi: 10.1007/s00330-021-07745-9. Epub 2021 Mar 25.

lead_sponsor: Central Hospital, Nancy, France

collaborators: Groupement des Hopitaux de l'institut catholique de Lille

collaborators: Hopital Jules Courmont - Centre Hospitalier Lyon Sud

collaborators: Centre Hospitalier Universitaire de Besancon

location_facility: Hôpital Universitaire Paris Centre site Cochin APHP

location_facility: Université Lyon 1 - Centre Hospitalier Lyon-Sud