title: Assessment of Cholangio-pancreatoscopy for the Diagnosis and the Treatment of Biliary and Pancreatic Diseases Trial " EASYSPY "

summary:
The biliary and pancreatic tumors are rare but the prognosis is pejorative. It was difficult to have histology of these tumors as the samples taken during ERCP were performed under " blind " radiology control. So the diagnostic accuracy was insufficient.

The arrival of A new optic fiber endoscope used by only one operator had improved the diagnostic of bilio-pancreatic diseases. However this technology with optic fiber quickly had proved outdated for several reasons: poor manoeuvrability, perfectible optical vision, optical fibers fragility and cost.

A new generation of endoscopes with digital vision appeared and would allow an increase in diagnostic accuracy related to better vision and manoeuvrability.

The purpose of the study is to assess the interest of the cholangio pancreatoscopy performed with digital vision.

ReferenceCitation: Nakeeb A, Pitt HA, Sohn TA, Coleman J, Abrams RA, Piantadosi S, Hruban RH, Lillemoe KD, Yeo CJ, Cameron JL. Cholangiocarcinoma. A spectrum of intrahepatic, perihilar, and distal tumors. Ann Surg. 1996 Oct;224(4):463-73; discussion 473-5.

ReferenceCitation: Bar-Meir S, Rotmensch S. A comparison between peroral choledochoscopy and endoscopic retrograde cholangiopancreatography. Gastrointest Endosc. 1987 Feb;33(1):13-4.

ReferenceCitation: Tringali A, Lemmers A, Meves V, Terheggen G, Pohl J, Manfredi G, Häfner M, Costamagna G, Devière J, Neuhaus H, Caillol F, Giovannini M, Hassan C, Dumonceau JM. Intraductal biliopancreatic imaging: European Society of Gastrointestinal Endoscopy (ESGE) technology review. Endoscopy. 2015 Aug;47(8):739-53. doi: 10.1055/s-0034-1392584. Epub 2015 Jul 6. Review.

name: Digestive Endoscopy Unit, Catholic University, Rome, Italy

family: Tringali

full_name: Andrea Tringali

given: Andrea

name: Department of Gastroenterology, Hepatopancreatology and Digestive Oncology, Erasme University Hospital, Brussels, Belgium

family: Lemmers

full_name: Arnaud Lemmers

given: Arnaud

name: Department of Gastroenterology and Interventional Endoscopy, Klinikum Friedrichshain, Berlin, Germany

family: Meves

full_name: Volker Meves

given: Volker

name: Department of Internal Medicine, Evangelisches Krankenhaus, Düsseldorf, Germany

family: Terheggen

full_name: Grischa Terheggen

given: Grischa

family: Pohl

full_name: Jürgen Pohl

given: Jürgen

name: Department of Gastroenterology, Maggiore Hospital, Crema, Italy

family: Manfredi

full_name: Guido Manfredi

given: Guido

name: Department of Internal Medicine, St. Elisabeth Hospital,Vienna, Austria

family: Häfner

full_name: Michael Häfner

given: Michael

family: Costamagna

full_name: Guido Costamagna

family: Devière

full_name: Jacques Devière

given: Jacques

family: Neuhaus

full_name: Horst Neuhaus

given: Horst

name: Endoscopy Unit, Paoli-Calmettes Institute, Marseille, France

family: Caillol

full_name: Fabrice Caillol

given: Fabrice

family: Giovannini

full_name: Marc Giovannini

given: Marc

name: Department of Gastroenterology, Nuovo Regina Margherita Hospital, Rome, Italy

family: Hassan

full_name: Cesare Hassan

given: Cesare

name: Gedyt Endoscopy Center, Buenos Aires, Argentina

family: Dumonceau

full_name: Jean-Marc Dumonceau

given: Jean-Marc

journal_name: Endoscopy

publisher: Georg Thieme Verlag KG

publisher_dissemination: Georg Thieme

publisher_group: Georg Thieme

publisher_normalized: Georg Thieme

ReferenceCitation: Urakami Y, Seifert E, Butke H. Peroral direct cholangioscopy (PDCS) using routine straight-view endoscope: first report. Endoscopy. 1977 Mar;9(1):27-30.

ReferenceCitation: Ramchandani M, Reddy DN, Gupta R, Lakhtakia S, Tandan M, Darisetty S, Sekaran A, Rao GV. Role of single-operator peroral cholangioscopy in the diagnosis of indeterminate biliary lesions: a single-center, prospective study. Gastrointest Endosc. 2011 Sep;74(3):511-9. doi: 10.1016/j.gie.2011.04.034. Epub 2011 Jul 7.

family: Ramchandani

full_name: Mohan Ramchandani

given: Mohan

family: Reddy

full_name: D. Nageshwar Reddy

given: D. Nageshwar

family: Gupta

full_name: Rajesh Gupta

given: Rajesh

family: Lakhtakia

full_name: Sandeep Lakhtakia

given: Sandeep

family: Tandan

full_name: Manu Tandan

given: Manu

ReferenceCitation: Draganov PV, Lin T, Chauhan S, Wagh MS, Hou W, Forsmark CE. Prospective evaluation of the clinical utility of ERCP-guided cholangiopancreatoscopy with a new direct visualization system. Gastrointest Endosc. 2011 May;73(5):971-9. doi: 10.1016/j.gie.2011.01.003. Epub 2011 Mar 17.

ReferenceCitation: Rey JW, Hansen T, Dümcke S, Tresch A, Kramer K, Galle PR, Goetz M, Schuchmann M, Kiesslich R, Hoffman A. Efficacy of SpyGlass(TM)-directed biopsy compared to brush cytology in obtaining adequate tissue for diagnosis in patients with biliary strictures. World J Gastrointest Endosc. 2014 Apr 16;6(4):137-43. doi: 10.4253/wjge.v6.i4.137.

journal_name: World Journal of Gastrointestinal Endoscopy

title: Efficacy of SpyGlassTM-directed biopsy compared to brush cytology in obtaining adequate tissue for diagnosis in patients with biliary strictures

ReferenceCitation: Navaneethan U, Hasan MK, Lourdusamy V, Njei B, Varadarajulu S, Hawes RH. Single-operator cholangioscopy and targeted biopsies in the diagnosis of indeterminate biliary strictures: a systematic review. Gastrointest Endosc. 2015 Oct;82(4):608-14.e2. doi: 10.1016/j.gie.2015.04.030. Epub 2015 Jun 10. Review.

ReferenceCitation: Boyer J. [Endoscopic sphincterotomy and lithiasis of the common bile duct. Reality and perspectives]. Gastroenterol Clin Biol. 1993;17(4):241-3. Review. French.

ReferenceCitation: Seelhoff A, Schumacher B, Neuhaus H. Single operator peroral cholangioscopic guided therapy of bile duct stones. J Hepatobiliary Pancreat Sci. 2011 May;18(3):346-9. doi: 10.1007/s00534-010-0360-7. Review.

name: Department of Internal Medicine; Evangelisches Krankenhaus; Düsseldorf Germany

name: Department of Gastroenterology and Hepatology; Evangelisches Krankenhaus Düsseldorf; Kirchfeldstr. 40 40217 Düsseldorf Germany

journal_name: Journal of Hepato-Biliary-Pancreatic Sciences

ReferenceCitation: Arnelo U, Siiki A, Swahn F, Segersvärd R, Enochsson L, del Chiaro M, Lundell L, Verbeke CS, Löhr JM. Single-operator pancreatoscopy is helpful in the evaluation of suspected intraductal papillary mucinous neoplasms (IPMN). Pancreatology. 2014 Nov-Dec;14(6):510-4. doi: 10.1016/j.pan.2014.08.007. Epub 2014 Sep 27.

ReferenceCitation: Laquière AE, Privat J, Fumex F, Grandval P, Lecomte L, Curel L, Belle A, Trottier-Tellier F, Urena-Campos R, Penaranda G, Boustière C, Napoléon B. Performance of digital single-operator cholangiopancreatoscope for biliopancreatic diseases in real life: results from a prospective multicenter study. Scand J Gastroenterol. 2020 Nov;55(11):1381-1388. doi: 10.1080/00365521.2020.1832143. Epub 2020 Oct 23.

name: Departments of Hepatogastroenterology and Clinical Research, Hôpital Saint Joseph, Marseille, France

name: Department of Hepatogastroenterology, Centre Hospitalier Vichy, Vichy, France

name: Department of Hepatogastroenterology, Hôpital Privé Jean Mermoz, Lyon, France

name: Digestive Endoscopy and Gastroenterology Department, AP-HM Hôpital de la Timone, Marseille, France

name: ALPHABIO – Laboratoire de biologie médicale, Marseille, France

journal_name: Scandinavian Journal of Gastroenterology

location_facility:
Hopital Mermoz
Centre Hospitalier Jacques Lacarin
Hopital Saint Joseph


title: Substrate Ablation Guided by Automatic High Density Mapping for the Treatment of Atrial Fibrillation

acronym: SUBSTRATE-HD

summary: To evaluate a new AF Substrate mapping method based on automatic high density CFAE detection with a multipolar catheter (Pentaray) and the " SCI 30-40 " setting of CARTO CFAE algorithm.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Seitz J, Bars C, Théodore G, Beurtheret S, Lellouche N, Bremondy M, Ferracci A, Faure J, Penaranda G, Yamazaki M, Avula UM, Curel L, Siame S, Berenfeld O, Pisapia A, Kalifa J. AF Ablation Guided by Spatiotemporal Electrogram Dispersion Without Pulmonary Vein Isolation: A Wholly Patient-Tailored Approach. J Am Coll Cardiol. 2017 Jan 24;69(3):303-321. doi: 10.1016/j.jacc.2016.10.065.

family: Seitz

full_name: Julien Seitz

given: Julien

sequence: first

family: Bars

full_name: Clément Bars

given: Clément

sequence: additional

family: Théodore

full_name: Guillaume Théodore

given: Guillaume

family: Beurtheret

full_name: Sylvain Beurtheret

given: Sylvain

family: Lellouche

full_name: Nicolas Lellouche

given: Nicolas

family: Bremondy

full_name: Michel Bremondy

given: Michel

family: Ferracci

full_name: Ange Ferracci

given: Ange

family: Faure

full_name: Jacques Faure

family: Penaranda

full_name: Guillaume Penaranda

family: Yamazaki

full_name: Masatoshi Yamazaki

given: Masatoshi

family: Avula

full_name: Uma Mahesh R. Avula

given: Uma Mahesh R.

family: Curel

full_name: Laurence Curel

given: Laurence

family: Siame

full_name: Sabrina Siame

given: Sabrina

family: Berenfeld

full_name: Omer Berenfeld

given: Omer

family: Pisapia

full_name: André Pisapia

given: André

family: Kalifa

full_name: Jérôme Kalifa

given: Jérôme

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of the American College of Cardiology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Hospital St. Joseph, Marseille, France

location_facility:
Institut Mutualiste de Montsouris
CHU
Hopital Saint Joseph

intervention_type: Procedure

lead_sponsor_type: academique


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.

study_start_date_type: Actual

study_type: Interventional

primary_purpose: Other

ipd_sharing: Undecided

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

location_facility: Sanatorium du Petit Fontainebleau Centre Médical de Bligny

intervention_type: Drug

status_simplified: Completed


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.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: University Hospital, Strasbourg, France

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

status_simplified: Unknown


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.

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

intervention_type: Other

status_simplified: Ongoing


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.


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

status: Recruiting

primary_purpose: Diagnostic

intervention_type: Device


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.

primary_purpose: Screening


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

intervention_type: Behavioral


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.

ReferenceType: background

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.

ReferenceType: result

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

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. 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.

family: Philippi

full_name: N. Philippi

given: N.

family: Vinzio

full_name: S. Vinzio

given: S.

family: Collongues

full_name: N. Collongues

family: Vix

full_name: M. Vix

given: M.

family: Boehm

full_name: N. Boehm

family: Tranchant

full_name: C. Tranchant

given: C.

family: Echaniz-Laguna

full_name: A. Echaniz-Laguna

given: A.

journal_name: Revue Neurologique

title: Polyneuropathies après chirurgie bariatrique

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.

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.

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.

family: Devigili

full_name: G. Devigili

given: G.

family: Tugnoli

full_name: V. Tugnoli

given: V.

family: Penza

full_name: P. Penza

given: P.

family: Camozzi

full_name: F. Camozzi

given: F.

family: Lombardi

full_name: R. Lombardi

given: R.

family: Melli

full_name: G. Melli

family: Broglio

full_name: L. Broglio

given: L.

family: Granieri

full_name: E. Granieri

given: E.

family: Lauria

full_name: G. Lauria

journal_name: Brain

evidence: open (via page says Open Access)

license: implied-oa

license_normalized: implied-oa

repository_institution: University of Ferrara - Institutional Research Information System University of Ferrara

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.

name: Strelitz Diabetes Center for Endocrine and Metabolic Disorders and the Neuroendocrine Unit, Department of Medicine, Eastern Virginia Medical School.

title: Sudoscan, a Noninvasive Tool for Detecting Diabetic Small Fiber Neuropathy and Autonomic Dysfunction

location_facility: Groupe Hopitalier Paris Saint Joseph Service de neurologie


title: Initialization of Methadone in Primary Care; a Randomized Intervention Research for Preventing HCV Transmission Practices. ANRS Methaville

acronym: Methaville

summary:
The rapid scale up of opioid substitution treatment (OST) for drug users mainly achieved through the possibility of prescribing buprenorphine in primary care has been successful in reducing HIV prevalence among drug users but still inadequate for reducing the spread of HCV. To date, methadone in France can only be initialised in drug centres but GPs can prescribe methadone after stabilisation of dosages.

This study was born as an answer to a request from the French Minister of Health that supports the initialisation of methadone in primary care in order to improve coverage by OST (now 70%) in drug users.

design_allocation: Randomized

primary_purpose: Prevention

ReferenceCitation: Carrieri P, Vilotitch A, Nordmann S, Lions C, Michel L, Mora M, Morel A, Maradan G, Spire B, Roux P; Methaville Study Group. Decrease in self-reported offences and incarceration rates during methadone treatment: A comparison between patients switching from buprenorphine to methadone and maintenance treatment incident users (ANRS-Methaville trial). Int J Drug Policy. 2017 Jan;39:86-91. doi: 10.1016/j.drugpo.2016.08.005. Epub 2016 Oct 19.

family: Carrieri

full_name: Patrizia Carrieri

given: Patrizia

family: Vilotitch

full_name: Antoine Vilotitch

given: Antoine

family: Nordmann

full_name: Sandra Nordmann

given: Sandra

family: Lions

full_name: Caroline Lions

given: Caroline

family: Michel

full_name: Laurent Michel

given: Laurent

family: Mora

full_name: Marion Mora

given: Marion

family: Morel

full_name: Alain Morel

given: Alain

family: Maradan

full_name: Gwenaelle Maradan

given: Gwenaelle

family: Spire

full_name: Bruno Spire

given: Bruno

family: Roux

full_name: Perrine Roux

given: Perrine

journal_name: International Journal of Drug Policy

ReferenceCitation: Roux P, Lions C, Vilotitch A, Michel L, Mora M, Maradan G, Marcellin F, Spire B, Morel A, Carrieri PM; ANRS Methaville study group. Correlates of cocaine use during methadone treatment: implications for screening and clinical management (ANRS Methaville study). Harm Reduct J. 2016 Apr 5;13:12. doi: 10.1186/s12954-016-0100-7.

family: Marcellin

full_name: Fabienne Marcellin

given: Fabienne

full_name: Patrizia M. Carrieri

given: Patrizia M.

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

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

ReferenceCitation: Carrieri PM, Michel L, Lions C, Cohen J, Vray M, Mora M, Marcellin F, Spire B, Morel A, Roux P; Methaville Study Group. Methadone induction in primary care for opioid dependence: a pragmatic randomized trial (ANRS Methaville). PLoS One. 2014 Nov 13;9(11):e112328. doi: 10.1371/journal.pone.0112328. eCollection 2014.

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

title: Methadone Induction in Primary Care for Opioid Dependence: A Pragmatic Randomized Trial (ANRS Methaville)

ReferenceCitation: Roux P, Lions C, Michel L, Mora M, Daulouède JP, Marcellin F, Spire B, Morel A, Carrieri PM; ANRS Methaville study group. Factors associated with HCV risk practices in methadone-maintained patients: the importance of considering the couple in prevention interventions. Subst Abuse Treat Prev Policy. 2014 Sep 10;9:37. doi: 10.1186/1747-597X-9-37.

journal_name: Substance Abuse Treatment, Prevention, and Policy

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Audencia Business School

ReferenceCitation: Lions C, Carrieri MP, Michel L, Mora M, Marcellin F, Morel A, Spire B, Roux P; Methaville Study Group. Predictors of non-prescribed opioid use after one year of methadone treatment: an attributable-risk approach (ANRS-Methaville trial). Drug Alcohol Depend. 2014 Feb 1;135:1-8. doi: 10.1016/j.drugalcdep.2013.10.018. Epub 2013 Oct 31.

title: Predictors of non-prescribed opioid use after one year of methadone treatment: An attributable-risk approach (ANRS-Methaville trial)

ReferenceCitation: Roux P, Michel L, Cohen J, Mora M, Morel A, Aubertin JF, Desenclos JC, Spire B, Carrieri PM; ANRS Methaville Study Group. Methadone induction in primary care (ANRS-Methaville): a phase III randomized intervention trial. BMC Public Health. 2012 Jun 28;12:488. doi: 10.1186/1471-2458-12-488.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENS-LYON

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis


type: Other Identifier

title: Optimizing Drug Management of Patients Suffering From Rare Disease Through Medication Reconciliation: Proof of Concept in Pulmonary Hypertension

acronym: OPTICARE-HTP

summary: Pulmonary hypertension (PH) is a life threatening condition. In PH, pulmonary arterial hypertension (PAH) and chronic thrombo-embolic chronic pulmonary hypertension (CTEPH) are two rare diseases requiring specific and complex drug management. In France ,a part of these treatments ,only available in hospital pharmacies, are generally unknown from community health care professionals despite the high risk of drug-interactions and side effects. Anticipating medication errors at the begging of the disease is therefore important, and could be done through medication reconciliation.

ipd_sharing_description: No sharing

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Cryoablation of Venous Vascular Malformations Located in Soft Tissues

acronym: CRYOMAV

summary: To now, two alternatives for the management of venous vascular malformations are recognized, appropriate to the location, size and patients: sclerosis and surgery. However, sclerosis is effective on symptoms in 80% of cases and excision removes the malformation completely or partially, but it is aggressive and recurrences are common.

primary_purpose: Treatment

ReferenceCitation: Cornelis F, Neuville A, Labrèze C, Kind M, Bui B, Midy D, Palussière J, Grenier N. Percutaneous cryotherapy of vascular malformation: initial experience. Cardiovasc Intervent Radiol. 2013 Jun;36(3):853-6. doi: 10.1007/s00270-012-0434-9. Epub 2012 Jun 22.

ReferenceCitation: Cornelis F, Havez M, Lippa N, Al-Ammari S, Verdier D, Carteret T, Amoretti N, Gangi A, Palussiere J, Hauger O, Grenier N. Radiologically guided percutaneous cryotherapy for soft tissue tumours: A promising treatment. Diagn Interv Imaging. 2013 Apr;94(4):364-70. doi: 10.1016/j.diii.2013.02.001. Epub 2013 Mar 11. Review.

ReferenceCitation: Barza M, Pavan PR, Doft BH, Wisniewski SR, Wilson LA, Han DP, Kelsey SF. Evaluation of microbiological diagnostic techniques in postoperative endophthalmitis in the Endophthalmitis Vitrectomy Study. Arch Ophthalmol. 1997 Sep;115(9):1142-50.

lead_sponsor: University Hospital, Bordeaux


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).


title: Identification of Genes and Pathogenesis Involved in Familial Thoracic Aortic Aneurysm (TAA)

acronym: TAA

summary:
The primary objectives of the study are

to assess the contribution of alteration of each known gene on non-syndromic TAA.
to map and identify unknown gene involved in the non-syndromic TAA.

location_facility: Département de Génétique, Hôpital Bichat


title: Efficacy of a Brief Alcohol Intervention for Non Dependant Alcohol-misusing Patients Undergoing a Scheduled Surgery: a Randomized Controlled Trial

acronym: ITBCHIR

summary:
Excessive alcohol consumption is a worldwide major public health problem. Brief interventions have shown to be an efficient treatment modality for problem drinkers, but have never been tested in scheduled surgery.

Patients will be recruited in various surgery units in 7 hospital in France. All patients attending a scheduled surgery will be screened during the visit with the anaesthesist by the Alcohol Use Disorders Identification Test (AUDIT). Patients aged 30-75 with an AUDIT between 7 and 12, corresponding to at risk or harmful use, will be proposed to enter a control study and randomized between a brief intervention by a trained nurse during the post-surgery hospitalisation and no intervention. Twelve months after the surgery, a research technician will interview by telephone patients and evaluate AUDIT and alcohol consumption of the last month.

primary_purpose: Supportive Care

lead_sponsor: Rennes University Hospital

location_facility: Unité d'Alcoologie et Hépatologie Générale, Département d'Anesthésie Réanimation- Hôpital de Pontchaillou


title: Efficiency and Satisfaction With Telephone Consultation in Neuro-urology: Experience of the COVID-19 Pandemic

summary:
The COVID-19 pandemic has necessitated drastic measures in order to limit the spread of SARS-CoV-2. The stay home policies for the whole population and especially for frail patients and the express instruction to deprogram non-urgent consultations and interventions limited the clinic visits in neuro-urology department. In this context, telemedicine was seen as a pragmatic solution to provide follow-up care for our neurologic patients. Due to the delay in deploying telemedicine and the cognitive impairment of some of our patients, telephone consultation has been prioritized.

The COVID-19 pandemic might be an opportunity to review and refine our practices in neuro-urology. For the follow-up of selected patients, telephone consultations may be efficient and cost effective.

The aim of the study is to assess the efficiency and the satisfaction with telephone consultation for the physician and the patient.

The study was conducted in a neuro-urology department of a university hospital in France.

During the stay-home policies for the COVID-19 pandemic, all the scheduled medical visits were converted into telephone consultation. New patients weren't included.

For each teleconsultation, the physician assess the duration of the consultation, the number of tries to join the patient, the efficiency of the consultation, the difficulty to obtain relevant information due to the phone way of the consultation and the lack of physical examination.

On the next days, the patient was contacted by phone and was asked a) if he was satisfied of being phoned by the physician, b) if the teleconsultation was embarrassing, c) if he had enough time of teleconsultation d) if he got all the answers to his queries, e) if he would preferred to had a physical consultation f) to assessed the global satisfaction of the teleconsultation and g) if in the future, they may considered converting some clinic visits to teleconsultations.

The physician and the patient assessed whether this teleconsultation has replaced a physical visit.

The usual transport mode of the patient for a clinic visit and the need to take a day off for worker patients were recorded.

The primary aim was to assess the efficiency and the satisfaction of the telephone consultation. The primary outcome was the evaluation of the efficiency of the telephone consultation by the physician on a numerical 10-points scale. The secondary outcome was the evaluation of the satisfaction of the telephone consultation by the patient on a numerical 10-points scale.

Four hundred teleconsultations are scheduled for five physicians.

lead_sponsor: Pierre and Marie Curie University

location_facility: Department of Neuro- Urology, Hôpital Tenon


title: Palliative Care Transfer Announcements: Qualitative Analysis of the Perspective of Physicians and Their Patients With Cancer

summary:
The course of care of a patient with a cancer whose evolution is pejorative, is marked by difficult announcements, called "bad news". In the palliative phase, prognostic announcements are at the forefront. Of these, the announcement of a transfer to the Palliative Care Unit has not been the subject of any specific studies to the best of our knowledge. It therefore seemed interesting to us to explore the stakes of this particular announcement, a source of upheaval for the doctor and the patient, by gathering the point of view of each one.

The objective of our study is to analyze the methods of announcing a transfer to the Palliative Care Unit and the perception of this announcement by the doctor and his patient with an incurable cancer.

time_perspective: Other

location_facility: Service : Unité de soins d'Accompagnement de soins de Support et de soins Palliatifs (UnASP)


title: Descriptive Pharmacoepidemiological Study of Patients Treated With Iressa

acronym: EPIDAURE

summary: The aim of the study is to describe the characteristics of patients treated with Iressa (particularly age, gender, phenotype, histology and stage of disease, line of treatment and previous treatments, smoking history, conditions of initiation of treatment (presence of an EGFR-activating mutation) and to evaluate the impact of treatment on the health of the population concerned in terms of morbidity and mortality (clinical benefit, safety,...) and quality of life

lead_sponsor: AstraZeneca

location_facility:
Research Site
Reseacrh Site

lead_sponsor_type: industriel


title: Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients After Acute Exacerbation With Monitoring the Quality of Support

summary: The hypothesis of this study is that any of 3 modalities of home non- invasive ventilation (NIV) compared to 'no NIV' (=hospital NIV) will reduce re-admission to hospital or death in COPD patients who remain persistently hypercapnic following an exacerbation requiring NIV.

ReferenceCitation: Rescue2-monitor group. Respiratory support in COPD patients after acute exacerbation with monitoring the quality of support (Rescue2-monitor): an open-label, prospective randomized, controlled, superiority clinical trial comparing hospital- versus home-based acute non-invasive ventilation for patients with hypercapnic chronic obstructive pulmonary disease. Trials. 2020 Oct 22;21(1):877. doi: 10.1186/s13063-020-04672-w. Erratum in: Trials. 2020 Nov 23;21(1):961.

currency_apc_doaj: GBP

journal_name: Trials

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Clinact

location_facility: Groupe Hospitalier Pitié Salpêtrière-Charles Foix


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:
Hôpitaux Universitaires de Strasbourg
CHU de Besançon


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: Study of Diagnostic Performances of Dual Energy Imaging With Flat Detectors and Tomosynthesis in Identification of Loosening of Painful Hip Prosthesis

acronym: PLIDET

summary:
The purpose is to determine diagnostic performances of flat panel dual energy arthrography and arthro-tomosynthesis in identification of loosening of painful hip prosthesis, taking as reference the results of surgery performed 6 months after arthrography.

Secondary purposes are:

To describe the level of concordance of each technique with the indication for surgery
To study inter-technique concordance with kappa coefficient
To study the relationship between density differential between 2 acquisitions and grey level on subtraction, i.e. subtraction quality according to metal

lead_sponsor: Central Hospital, Nancy, France

location_facility:
CHU de Nancy
SINCAL


title: PAthwAy of Dyspneic patIent in Emergency

acronym: PArADIsE

summary:
This is an observational retrospective single-center study (CHRU of Nancy) in patients cared for acute dyspnea by a medical team of the emergencies of the CHRU of Nancy.

The main purpose of the study is to evaluate the outcome of patients cared for acute dyspnea by a medical team of emergencies of CHRU of Nancy.

time_perspective: Retrospective

ReferenceCitation: Chouihed T, Bassand A, Duarte K, Jaeger D, Roth Y, Giacomin G, Delaruelle A, Duchanois C, Bannay A, Kobayashi M, Rossignol P, Girerd N. Head-to-head comparison of diagnostic scores for acute heart failure in the emergency department: results from the PARADISE cohort. Intern Emerg Med. 2021 Nov 17. doi: 10.1007/s11739-021-02879-6. [Epub ahead of print]

ReferenceCitation: Chouihed T, Buessler A, Bassand A, Jaeger D, Virion JM, Nace L, Barbé F, Salignac S, Rossignol P, Zannad F, Girerd N. Hyponatraemia, hyperglycaemia and worsening renal function at first blood sample on emergency department admission as predictors of in-hospital death in patients with dyspnoea with suspected acute heart failure: retrospective observational analysis of the PARADISE cohort. BMJ Open. 2018 Mar 30;8(3):e019557. doi: 10.1136/bmjopen-2017-019557.

family: Chouihed

full_name: Tahar Chouihed

given: Tahar

family: Buessler

full_name: Aurélien Buessler

given: Aurélien

family: Bassand

full_name: Adrien Bassand

given: Adrien

family: Jaeger

full_name: Deborah Jaeger

given: Deborah

family: Virion

full_name: Jean Marc Virion

given: Jean Marc

family: Nace

full_name: Lionel Nace

given: Lionel

family: Barbé

full_name: Françoise Barbé

given: Françoise

family: Salignac

full_name: Sylvain Salignac

given: Sylvain

family: Rossignol

full_name: Patrick Rossignol

given: Patrick

family: Zannad

full_name: Faiez Zannad

given: Faiez

family: Girerd

full_name: Nicolas Girerd

given: Nicolas

journal_name: BMJ Open

license: cc-by-nc

license_normalized: cc-by-nc

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal


title: Comparing Epidemiological and Clinical Characteristics of Infantile Hemangioma With Minimal or Arrested Growth (IH-MAG) and Classic Infantile Hemangioma : a Retrospective Study

summary: Infantile hemangioma (IH) is the most common vascular tumor of infancy, characterized by its clinical history. Absent at birth or present under the form of a premonitory mark, they display a rapid proliferative phase starting in the first weeks of life. Then, after a plateau phase, they slowly involute. However, a subtype of IH named "abortive", "minimal or arrested growth", "reticular" or "telangiectatic" hemangioma differs from typical IH because it doesn't have a proliferative component, or only a minimal one. This subtype of hemangioma has been recently described and data are lacking regarding its proportion among infantile hemangioma and its differences with "classic" infantile hemangioma. The aim of this study is to estimate the proportion of abortive hemangioma among infantile hemangioma. Also, the investigators aim to compare the clinical characteristics of "classic" infantile hemangiomas and abortive hemangiomas. Lastly, investigators wished to study the evolution of abortive hemangioma.


title: Treatment of Low Back Pain in Pregnant Women ; Uses of Drugs and Other Therapies (Acupuncture, Manipulative Medicine, Physical Therapies, Homeopathy) : an Observational Study

summary:
Low back pain is a frequent clinical condition in pregnancy. Drugs treatments are limited. Other therapies are often used, associated or not with drugs (acupuncture, manipulative medicine, physical therapies, homeopathy). Clinical studies suggest a reduction of low back pain with these therapies.

The primary objective of this study is to determinate how many pregnant women use these alternative therapeutics.

In a second time, we want evaluate efficiency of these therapeutics, especially in pain modification and on quality of life.

Our study is a declarative study on pregnant women in Lorraine.

location_facility: Centre hospitalier régional universitaire de Nancy


title: Prognosis of Nutritional Status for Surgical Peri Hilar Cholangiocarcinoma

summary: Curative treatment of peri hilar cholangiocarcinomas is R0 surgery and require major hepatectomy with biliary tract resection. These complexe procedures can lead to high morbidity and mortality. A severe alteration of nutritional status before the surgery might be a poor prognosis for survival.

ReferenceCitation: Otsuji H, Yokoyama Y, Ebata T, Igami T, Sugawara G, Mizuno T, Nagino M. Preoperative sarcopenia negatively impacts postoperative outcomes following major hepatectomy with extrahepatic bile duct resection. World J Surg. 2015 Jun;39(6):1494-500. doi: 10.1007/s00268-015-2988-6.

ReferenceCitation: Golse N, Nunez J, Mazzotta A, Cano L, Bergeat D, Sulpice L, Jeddou H, Abdelrafee A, Sa Cunha A, Cherqui D, Adam R, Boudjema K, Vibert E. Personalized Preoperative Nomograms Predicting Postoperative Risks after Resection of Perihilar Cholangiocarcinoma. World J Surg. 2020 Oct;44(10):3449-3460. doi: 10.1007/s00268-020-05618-8.

ReferenceCitation: Yugawa K, Itoh S, Kurihara T, Yoshiya S, Mano Y, Takeishi K, Harada N, Ikegami T, Soejima Y, Mori M, Yoshizumi T. Skeletal muscle mass predicts the prognosis of patients with intrahepatic cholangiocarcinoma. Am J Surg. 2019 Nov;218(5):952-958. doi: 10.1016/j.amjsurg.2019.03.010. Epub 2019 Mar 14.

family: Yugawa

full_name: Kyohei Yugawa

given: Kyohei

family: Itoh

full_name: Shinji Itoh

given: Shinji

family: Kurihara

full_name: Takeshi Kurihara

given: Takeshi

family: Yoshiya

full_name: Shohei Yoshiya

given: Shohei

family: Mano

full_name: Yohei Mano

given: Yohei

family: Takeishi

full_name: Kazuki Takeishi

given: Kazuki

family: Harada

full_name: Noboru Harada

given: Noboru

family: Ikegami

full_name: Toru Ikegami

given: Toru

family: Soejima

full_name: Yuji Soejima

given: Yuji

family: Mori

full_name: Masaki Mori

given: Masaki

family: Yoshizumi

full_name: Tomoharu Yoshizumi

given: Tomoharu

journal_name: The American Journal of Surgery


title: Effect of Early Corticosteroid Therapy on Mortality in Patient With Acute Respiratory Distress Syndrome Secondary to Covid-19

acronym: CoCovSDRA

summary: Study conducted on hospitalized patient in critical ill units in Nancy and Metz to evaluate if early corticosteroid treatment in first seven days after admission improve patients outcome in Acute Respiratory Distress Syndrome secondary to Covid-19 compared to later corticosteroid therapy or no treatment. Also comparison of acquired infection with or without corticosteroid treatment during hospitalisation.

status: Active, not recruiting

location_facility: Hopital Central, Service de Reanimation Medicale


title: Impact of Smoking and Nicotine on the Risk of Being Infected With COVID-19

acronym: MAGIC

summary:
Several studies have shown that smokers have a higher risk of developing a severe form of COVID-19 once a person has been infected. This is explained by the damage caused by smoking at the bronchopulmonary level and an overexpression of some coronavirus receptors at the pulmonary level when exposed to tobacco. In contrast, recent data indicate that smokers are proportionally less infected with the COVID-19 virus since all available cohort data from around the world show a very low rate of smokers among COVID-19 infected subjects. The mechanisms at the origin of this protective effect are not known. All of these data lead us to question the real role of nicotine in the protective effect of tobacco observed in the general population against infection by the COVID-19 virus.

The objectives are :

To show that subjects taking nicotine substitutes as part of a smoking cessation program are less infected with COVID-19 than non-smokers.
To show that active smokers are less infected with COVID-19 than non-smokers.
To compare the percentage of positive serological tests in subjects taking nicotine substitutes to the percentage of positive serological tests in active smokers.

intervention_type: Diagnostic Test


title: Whole Blood Immune Cells Characterization in Critically Ill COVID-19 Patients: A Prospective Study

acronym: COVIDIMM

summary:
SARS-CoV-2 outbreak causes a spectrum of clinical patterns that varies from asymptomatic infection to mildly symptomatic manifestations and more-severe forms that need intensive care. Until now, the immune response to SARS-CoV-2 virus infection has been poorly reported to help decision for immune modulation therapies. As a consequence, trials have been designed to test both anti-inflammatory molecules as steroids or anti-bodies against IL-6, and others proposing to "boost" immunity with interferon beta based on similar inclusion criteria.

The immune response to infective agents including viruses may have a complex time evolution with early and late phases corresponding to different patterns, oscillating between pro-inflammation and immune-depression. The potential window to improve outcome in COVID-19 by therapeutic intervention aimed at a fine tuning between immune toxicity and immunodepression requires a longitudinal assessment during the course of illness, especially for the patients who develop acute respiratory failure. Immune monitoring of both innate and adaptive immunity would then be essential to appropriately design clinical trials.

The whole blood cells evaluation was recorded according to the time intervals between the onset of symptoms and the sampling after ICU admission. Patients' care was standardized, especially with regard to ventilation, sedation, and antimicrobial treatment.

In this study the investigators prospectively perform a longitudinal study of both innate and adaptive immunity on patients admitted to ICU for an COVID-19 related acute respiratory failure. The data will be analyzed in reference to the onset of initial symptoms and also to the admission in ICU.

The primary end point is the evolution of the characterization of monocytes and their subsets in term of number and expression of HLA-DR. A similar approach is used for lymphocytes and their subtypes with in addition, an ex vivo testing of their capabilities to be stimulated by SARS-CoV-2 viral proteins in term of TNFalpha, INFgamma, and IL1beta production.

The secondary end-point was to test the association with outcomes and other non-specific markers of inflammation as CRP (C reactive protein), PCT (procalcitonin), DDimers and ferritin.

ReferenceCitation: Tan L, Wang Q, Zhang D, Ding J, Huang Q, Tang YQ, Wang Q, Miao H. Lymphopenia predicts disease severity of COVID-19: a descriptive and predictive study. Signal Transduct Target Ther. 2020 Mar 27;5(1):33. doi: 10.1038/s41392-020-0148-4. Erratum in: Signal Transduct Target Ther. 2020 Apr 29;5(1):61.

ReferenceCitation: Payen D, Faivre V, Miatello J, Leentjens J, Brumpt C, Tissières P, Dupuis C, Pickkers P, Lukaszewicz AC. Multicentric experience with interferon gamma therapy in sepsis induced immunosuppression. A case series. BMC Infect Dis. 2019 Nov 5;19(1):931. doi: 10.1186/s12879-019-4526-x.

ReferenceCitation: Ziegler-Heitbrock L, Ancuta P, Crowe S, Dalod M, Grau V, Hart DN, Leenen PJ, Liu YJ, MacPherson G, Randolph GJ, Scherberich J, Schmitz J, Shortman K, Sozzani S, Strobl H, Zembala M, Austyn JM, Lutz MB. Nomenclature of monocytes and dendritic cells in blood. Blood. 2010 Oct 21;116(16):e74-80. doi: 10.1182/blood-2010-02-258558. Epub 2010 Jul 13.

ReferenceCitation: Hotchkiss RS, Monneret G, Payen D. Sepsis-induced immunosuppression: from cellular dysfunctions to immunotherapy. Nat Rev Immunol. 2013 Dec;13(12):862-74. doi: 10.1038/nri3552. Epub 2013 Nov 15. Review.

ReferenceCitation: Alattar R, Ibrahim TBH, Shaar SH, Abdalla S, Shukri K, Daghfal JN, Khatib MY, Aboukamar M, Abukhattab M, Alsoub HA, Almaslamani MA, Omrani AS. Tocilizumab for the treatment of severe coronavirus disease 2019. J Med Virol. 2020 Oct;92(10):2042-2049. doi: 10.1002/jmv.25964. Epub 2020 May 10.

ReferenceCitation: Payen D, Cravat M, Maadadi H, Didelot C, Prosic L, Dupuis C, Losser MR, De Carvalho Bittencourt M. A Longitudinal Study of Immune Cells in Severe COVID-19 Patients. Front Immunol. 2020 Oct 23;11:580250. doi: 10.3389/fimmu.2020.580250. eCollection 2020.


title: Multicentric Retrospective Evaluation of the Vesico-vaginal Fistula Repair by Robot Assisted Laparoscopy

acronym: FFVLARO

summary: Robot-assisted Vesico-Vaginal fistula (VVF) repair was described a few years ago as an alternative to the open approach to minimize the morbidity of this surgery. Very little series have reported the results of robotic VVF repair. The objective of this work was to evaluate the results of robotic VVF repair.


title: Creation of a Database of PET Digital Brain Exams, Adapted to a Population Aged 50 Years and Over, to Help in the Interpretation of Fluoro Desoxy Glucose (FDG) Labelled With Fluor 18 (18F-FDG) PET/CT (Computer Tomography) Exam

acronym: BASITEP

summary: This study evaluate the interest to create a new database of PET digital brain exams in population of 50 years and over of patients. Half of patients with no abnormal brain metabolism while the other half patients with Alzheimer's disease.


title: Ventriculo-arterial Coupling Modification Evaluated by PRAM (Pressure Recording Analytical Method) in the Aortic Stenosis Treated by TAVI (Transcatheter Aortic Valve Implantation)

acronym: PRAM-TAVI

summary:
Calcified aortic stenosis is the most frequent valvulopathy in Europe and North America. Aortic stenosis is an obstacle to the ejection of blood from the left ventricle to the aorta and leads to morphological changes in the left ventricle and hemodynamic modifications.

Intrinsic ventricular performance can be characterized using three parameters:

Ventricular elastance (Ees for End Systolic Elastance) which represents the index of ventricular contractility independently of the load.
Arterial elastance (Ea for Arterial Elastance) which represents the post-load
The ventriculo-arterial coupling index (Ees / Ea) which represents energy efficiency.

For patients with high surgical risk (EuroSCORE II> 6), TAVI (Transcatheter Aortic Valve Implantation) is recommended for aortic valve replacement. Many complications may occur after TAVI (haemorrhagic, embolic, renal, myocardial ischemia). Post-TAVI complications may also be cardiac decompensation of the underlying cardiac disease to cardiogenic shock. However, literature on left ventricular performance after aortic valvular replacement is poor because of the difficulty and invasiveness of the analysis involved.

Cardiac energy analysis plays an additional role in understanding the clinical patients conditions. On this point, cardiac energy modifications, based on ventriculo-arterial coupling, could be indicators of cardiac function. Two methods (ultrasound and pulse contour) are used to understand and explore the ventriculo-arterial coupling, preload, postload, contractility and hemodynamic changes interactions.

Echocardiography allows the Ees / Ea and SW / PVA (Stoke work/ pressure-volume area) ratios mesurements. PRAM (Pressure Recording Analytical Method) through the MostCare® monitor, gives common hemodynamic parameters and more specific parameters such as arterial elastance (Ea) cardiac cycle efficiency (CCE), dP / dt. Cardiac cycle efficiency (CCE) is an exclusive variable that describes the hemodynamic performance in terms of energy expenditure in the patient being followed.

TAVI procedure is an acute model of ventriculo-arterial coupling modification by treatment of the ventricular ejection obstacle. The PRAM method evaluates the ventriculo-arterial coupling. The aim of our study is to evaluate by PRAM the changes in cardiac energy variables before and after aortic valve replacement by TAVI


title: Impact of Anesthesia Technique on Post-operative Delirium After Transcatheter Aortic Valve Implantation

acronym: DELIRIUMTAVI

summary: Aortic stenosis is a frequent valvulopathy in Europe and North America. It occurs mainly over 65 years (2-7% of the population over 65 years). Treatment of symptomatic stenosis is an indication of aortic valve replacement. For patients with high surgical risk (EuroSCORE II> 6), TAVI (Transcatheter Aortic Valve Implantation) is recommended. This type of procedure concerns elderly patients (75-80 years on average in the literature) therefore the anesthesia technique must be optimal. The postoperative complications are, on the one hand, well-described surgical complications (Cardiogenic shock, bleeding, rhythm disorders, renal insufficiency) and, on the other hand, those related to anesthesia which are less well characterized. There is no consensus on best anesthesia technique for TAVI procedure managment. Between teams practices are different. It may consist of general anesthesia (GA) or local anesthesia with sedation (LASed). Elderly anesthesia has specific complications, including acute cerebral disturbances (delirium) usually occurring within 24 to 48 hours postoperatively and up to 7 days. It is recommended to screen delirium for patients admitted in intensive care using the CAM-ICU scale. The aim of the study is to observe the impact of the anesthesia technique (GA versus LASed) on delirium in post-operative aortic valve replacement with TAVI procedure


title: Dissociated Optic Nerve Fiber Layer Appearance and Retinal Sensitivity After Macular Hole Surgery With Temporal Inverted Internal Limiting Membrane Flap Technique

acronym: MARTIAL

summary: Since 1991, idiopathic macular holes (MH) can benefit from an effective treatment initially involving pars plana vitrectomy, stripping of epiretinal membranes and intraocular gas tamponade followed by facedown positioning. The initial 58% success rate has further increased to 85-100% with internal limiting membrane (ILM) peeling. However, complete ILM removal has been shown to lead to anatomic changes causing the retina to have the appearance of a dissociated optic nerve fiber layer (DONFL). Moreover, it has been associated with decreased retinal sensitivity that may cause visual discomfort despite good visual acuity. Nawrocki et al. recently suggested to reduce the area of peeled ILM (temporal inverted ILM flap technique) in order to minimize iatrogenic trauma while maintaining satisfactory surgical outcomes. The aim of this study is to compare the incidence of DONFL appearance and retinal sensitivity after macular hole surgery in eyes that underwent temporal inverted ILM flap technique and eyes that had complete ILM peeling

ReferenceCitation: Michalewska Z, Michalewski J, Dulczewska-Cichecka K, Adelman RA, Nawrocki J. TEMPORAL INVERTED INTERNAL LIMITING MEMBRANE FLAP TECHNIQUE VERSUS CLASSIC INVERTED INTERNAL LIMITING MEMBRANE FLAP TECHNIQUE: A Comparative Study. Retina. 2015 Sep;35(9):1844-50. doi: 10.1097/IAE.0000000000000555.

ReferenceCitation: Michalewska Z, Michalewski J, Dulczewska-Cichecka K, Nawrocki J. Inverted internal limiting membrane flap technique for surgical repair of myopic macular holes. Retina. 2014 Apr;34(4):664-9. doi: 10.1097/IAE.0000000000000042.

ReferenceCitation: Tadayoni R, Svorenova I, Erginay A, Gaudric A, Massin P. Decreased retinal sensitivity after internal limiting membrane peeling for macular hole surgery. Br J Ophthalmol. 2012 Dec;96(12):1513-6. doi: 10.1136/bjophthalmol-2012-302035. Epub 2012 Oct 17.

ReferenceCitation: Michalewska Z, Michalewski J, Adelman RA, Nawrocki J. Inverted internal limiting membrane flap technique for large macular holes. Ophthalmology. 2010 Oct;117(10):2018-25. doi: 10.1016/j.ophtha.2010.02.011. Epub 2010 Jun 11.

ReferenceCitation: Tadayoni R, Paques M, Massin P, Mouki-Benani S, Mikol J, Gaudric A. Dissociated optic nerve fiber layer appearance of the fundus after idiopathic epiretinal membrane removal. Ophthalmology. 2001 Dec;108(12):2279-83.


title: Morphologic and Biomechanical Analysis of the Carpal Ligaments: a Kinematic Study on Dynamic Area Detector CT

acronym: EDLIS

summary: Compare various dynamic biomechanical markers (distances and angles) in the wrist during dynamic CT studies in three groups of patients: Normal subjects, with scapholunate instability and with other types of wrist instability.

design_allocation: Non-Randomized

ReferenceCitation: Gondim Teixeira PA, Gervaise A, Louis M, Lecocq S, Raymond A, Aptel S, Blum A. Musculoskeletal wide detector CT: principles, techniques and applications in clinical practice and research. Eur J Radiol. 2015 May;84(5):892-900. doi: 10.1016/j.ejrad.2014.12.033. Epub 2015 Jan 17. Review.

family: Gondim Teixeira

full_name: Pedro Augusto Gondim Teixeira

given: Pedro Augusto

family: Gervaise

full_name: Alban Gervaise

given: Alban

family: Louis

full_name: Matthias Louis

given: Matthias

family: Lecocq

full_name: Sophie Lecocq

given: Sophie

family: Raymond

full_name: Ariane Raymond

given: Ariane

family: Aptel

full_name: Sabine Aptel

given: Sabine

family: Blum

full_name: Alain Blum

given: Alain

journal_name: European Journal of Radiology

title: Musculoskeletal wide detector CT: Principles, techniques and applications in clinical practice and research

ReferenceCitation: Garcia-Elias M, Alomar Serrallach X, Monill Serra J. Dart-throwing motion in patients with scapholunate instability: a dynamic four-dimensional computed tomography study. J Hand Surg Eur Vol. 2014 May;39(4):346-52. doi: 10.1177/1753193413484630. Epub 2013 Apr 8.

name: Institut Kaplan, Hand and Upper Extremity Surgery, Barcelona, Spain

family: Garcia-Elias

full_name: M. Garcia-Elias

given: M.

name: Clínica Creu Blanca, Department of Radiology, Barcelona, Spain

family: Alomar Serrallach

full_name: X. Alomar Serrallach

given: X.

family: Monill Serra

full_name: J. Monill Serra

given: J.

journal_name: Journal of Hand Surgery (European Volume)

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

ReferenceCitation: Halpenny D, Courtney K, Torreggiani WC. Dynamic four-dimensional 320 section CT and carpal bone injury - a description of a novel technique to diagnose scapholunate instability. Clin Radiol. 2012 Feb;67(2):185-7. doi: 10.1016/j.crad.2011.10.002. Epub 2011 Dec 3.

family: Halpenny

full_name: D. Halpenny

given: D.

family: Courtney

full_name: K. Courtney

given: K.

family: Torreggiani

full_name: W.C. Torreggiani

journal_name: Clinical Radiology

title: Dynamic four-dimensional 320 section CT and carpal bone injury — A description of a novel technique to diagnose scapholunate instability

ReferenceCitation: Troupis JM, Amis B. Four-dimensional computed tomography and trigger lunate syndrome. J Comput Assist Tomogr. 2013 Jul-Aug;37(4):639-43. doi: 10.1097/RCT.0b013e31828b68ec.

family: Troupis

full_name: John M. Troupis

given: John M.

family: Amis

full_name: Benjamin Amis

given: Benjamin

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Four-dimensional Computed Tomography and Trigger Lunate Syndrome


title: Genotyping Infarct Patients to Adjust and Normalize Thienopyridine Treatment

acronym: GIANT

summary: The objective of GIANT Study is to evaluate the clinical impact of genetic resistance to thienopyridine profile determination (CYP2C19 gene) and the clinical impact of compliance to an adjusted thienopyridine treatment on STEMI patients treated by primary PCI within the 24 hours following the first chest pain.

ReferenceCitation: Hulot JS, Chevalier B, Belle L, Cayla G, Khalife K, Funck F, Berthier R, Piot C, Tafflet M, Montalescot G; GIANT Investigators. Routine CYP2C19 Genotyping to Adjust Thienopyridine Treatment After Primary PCI for STEMI: Results of the GIANT Study. JACC Cardiovasc Interv. 2020 Mar 9;13(5):621-630. doi: 10.1016/j.jcin.2020.01.219.

family: Hulot

full_name: Jean-Sébastien Hulot

given: Jean-Sébastien

family: Chevalier

full_name: Bernard Chevalier

given: Bernard

family: Belle

full_name: Loic Belle

given: Loic

family: Cayla

full_name: Guillaume Cayla

given: Guillaume

family: Khalife

full_name: Khalife Khalife

given: Khalife

family: Funck

full_name: François Funck

given: François

family: Berthier

full_name: Romain Berthier

given: Romain

family: Piot

full_name: Christophe Piot

given: Christophe

family: Tafflet

full_name: Muriel Tafflet

given: Muriel

family: Montalescot

full_name: Gilles Montalescot

given: Gilles

full_name: Loïc Belle

given: Loïc

family: Le Breton

full_name: Hervé Le Breton

given: Hervé

family: Teiger

full_name: Emmanuel Teiger

given: Emmanuel

family: Dambrin

full_name: Grégoire Dambrin

given: Grégoire

full_name: K. Khalife

family: Schmutz

full_name: L. Schmutz

given: L.

full_name: F. Funck

given: F.

full_name: R. Berthier

given: R.

full_name: C. Piot

given: C.

family: Hannebicque

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

location_facility: Centre Hospitalier de la Région Annecienne

location_facility: Centre Hospitalier Saint Joseph et Saint Luc

location_facility: Centre Hospitalier Universitaire Caremeau


title: Gender Dysphoria in Children and Adolescents : Parents' Perspectives

acronym: GeDyPar

summary:
Gender dysphoria is defined as a persistent incongruence between an experienced gender and the assigned sex at birth Transgender and gender nonconforming persons desire to modify their appearance to be consistent with their self-identified gender identities. In non-binary people, contrary to binary transgender persons, self-identified gender identities do not fit the classical pattern male/female.

During the last decennium, an increase in the number of young subjects, especially children and adolescents, referred to gender identity centres has been observed. A new nosological entity "rapid-onset gender dysphoria in adolescents and young adults" has recently been described in the literature, whose etiology has not been well understood.

This growing demand of adolescents and young adults observed in the recent years is not well understood.

ipd_sharing_description: Not planned


title: Observational Prospectif Monocentric Registry of Patients Suffering From VIE

acronym: REMOTEV

summary: Patients with an episode of VTE (DVT and / or PE) have a mortality rate of 16-21% at 1 year after diagnosis. Morbidity associated with VTE is marked by the risk of recurrence, estimated at 30% and estimated at 29% after 8 years of follow post-thrombotic syndrome. For a number of these patients, risk factors have been identified (congenital or acquired thrombophilia, cancer, postpartum, surgery, prolonged immobilization, etc..). In 25-50% of cases, the etiology remains unknown, justifying the need for well-conducted studies to determine other potential risk factors. In addition, the expansion of treatment options with the arrival on the market of new direct oral anticoagulants, allows comparative studies on the effectiveness and frequency of adverse events for each treatment.

location_facility: Service Des Maladies Vasculaires - Hta - Nhc


title: Effects of Diltiazem and/or N-Acétylcystéine Versus Placebo on hémodynamiques and Biological Repercussions of the Ischaemia-réperfusion During the Coronary Surgery With Beating Heart

summary: Less oxidative stress occurs during off-pump than on-pump coronary artery bypass graft (CABG) surgery but warm ischaemia-reperfusion injury may occur following transient coronary artery clamping. The aim of this study was to compare the preventive effects of diltiazem and N-acetylcysteine (NAC), alone or in combination, on biomarkers of myocardial damage and oxidative stress during off-pump CABG surgery.


title: Evaluation of Analgesic Efficacy of Transmucosal Fentanyl for Breakthrough Pain Caused by Interventional Gastrostomy

acronym: ANTALGIP

summary:
Patients with Head & Neck Squamous Cell Carcinoma often need a gastrostomy. It can be performed with a radiological approach. This procedure is usually not performed under general anesthesia, but local anesthesia is not sufficient to counteract pain due to gastric insufflation and incision of the abdominal wall. Standard analgesic treatments are usually not well-fitted due to onset of action or route of administration. An alternative solution could be fentanyl nasal spray, a treatment with a fast onset of action and with easy use allowing repetition if needed, during the procedure.

The purpose of this study is to compare analgesic efficacy of nasal instillation of PECFENT® to usually administered morphinic analgesic treatment with fast onset of action (ORAMORPH®), in radiologic percutaneous gastrostomy tube placement:

during the procedure
following the procedure (measured by Visual Analog Scale (VAS) for Pain at 15 min, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours and 12 hours after procedure).

Secondary purposes are to compare easiness of 2 treatments and their adverse effects.


title: Utero-placental Vascularisation in Normal and Preeclamptic and Intra-uterine Growth Restriction Pregnancies: Third Trimester Quantification Using 3D Power Doppler With Comparison to Placental Vascular Morphology

acronym: EVUPA

summary:
Introduction

Preeclampsia (PE) and intra-uterine growth restriction (IUGR) are two major pregnancy complications related to chronic utero-placental hypoperfusion. Three-dimensional power Doppler (3DPD) angiography has been used for the evaluation of utero-placental vascularisation and three vascular indices have been calculated: the vascularisation index (VI), flow index (FI) and vascularisation-FI (VFI). However, several technical endpoints hinder the clinical use of 3DPD as physical characteristics and machine settings may affect 3DPD indices, and so its clinical significance is not yet clear.

Objectives

The primary objective is to better understand the clinical significance of 3DPD indices by evaluating the relationship between these indices and placental morphometry. Secondary objectives are (i) to determine the impact of machine settings and physical characteristics on 3DPD indices, and (ii) to evaluate physio-pathological placental vascularisation patterns.

Methods and analysis

This is a prospective controlled study. We expect to include 112 women: 84 with normal pregnancies and 28 with PE and/or IUGR (based on our former cohort study on 3DPD indices for PE and/or IUGR prediction (unpublished data)). Within 72 h before planned or semi-urgent caesarean section, utero-placental 3DPD images with five different machine settings will be acquired. Placentas will be collected and examined after surgery and stereological indices (volume density, surface density, length density) calculated. The 3DPD indices (VI, FI and VFI) of the placenta and adjacent myometrium will be calculated. Correlation between Doppler and morphological indices will be evaluated by Pearson or Spearman tests. Agreement between 3DPD indices and morphological indices will be assessed by Bland and Altman plots. The impact of Doppler settings and maternal characteristics on 3DPD indices will be evaluated with a multivariate linear regression model.

primary_purpose: Basic Science

ReferenceCitation: Duan J, Chabot-Lecoanet AC, Perdriolle-Galet E, Christov C, Hossu G, Cherifi A, Morel O. Utero-placental vascularisation in normal and preeclamptic and intra-uterine growth restriction pregnancies: third trimester quantification using 3D power Doppler with comparison to placental vascular morphology (EVUPA): a prospective controlled study. BMJ Open. 2016 Mar 31;6(3):e009909. doi: 10.1136/bmjopen-2015-009909.


title: Autonomic Nervous System Activity, Aging and Sleep Apnea/Hypopnea in a Prospective Cohort of Subjects Aged 67 Years

acronym: SYNAPSE

summary:
The regulatory effects of the autonomic nervous system (ANS) concern almost all organs which permanently feed information back to this global biological vigilance system controlling allostasis. Heart rate fluctuations are highly dependent on ANS control, making the heart one of the best indicators of ANS activity.

Low ANS activity level is associated with severe cardiac and cerebral events, as well as to death from any cause in the general population. It is even associated with sleep apnea/hypopnea.

ReferenceCitation: Tsuji H, Venditti FJ Jr, Manders ES, Evans JC, Larson MG, Feldman CL, Levy D. Reduced heart rate variability and mortality risk in an elderly cohort. The Framingham Heart Study. Circulation. 1994 Aug;90(2):878-83.

ReferenceCitation: Pitson DJ, Stradling JR. Autonomic markers of arousal during sleep in patients undergoing investigation for obstructive sleep apnoea, their relationship to EEG arousals, respiratory events and subjective sleepiness. J Sleep Res. 1998 Mar;7(1):53-9.

ReferenceCitation: Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53.

ReferenceCitation: Lavie P, Lavie L, Herer P. All-cause mortality in males with sleep apnoea syndrome: declining mortality rates with age. Eur Respir J. 2005 Mar;25(3):514-20.

ReferenceCitation: Barthélémy JC, Pichot V, Dauphinot V, Celle S, Laurent B, Garcin A, Maudoux D, Kerleroux J, Lacour JR, Kossovsky M, Gaspoz JM, Roche F. Autonomic nervous system activity and decline as prognostic indicators of cardiovascular and cerebrovascular events: the 'PROOF' Study. Study design and population sample. Associations with sleep-related breathing disorders: the 'SYNAPSE' Study. Neuroepidemiology. 2007;29(1-2):18-28.

ReferenceCitation: Celle S, Peyron R, Faillenot I, Pichot V, Alabdullah M, Gaspoz JM, Laurent B, Barthélémy JC, Roche F. Undiagnosed sleep-related breathing disorders are associated with focal brainstem atrophy in the elderly. Hum Brain Mapp. 2009 Jul;30(7):2090-7. doi: 10.1002/hbm.20650.

family: Celle

full_name: Sébastien Celle

given: Sébastien

family: Peyron

full_name: Roland Peyron

given: Roland

family: Faillenot

full_name: Isabelle Faillenot

given: Isabelle

family: Pichot

full_name: Vincent Pichot

given: Vincent

family: Alabdullah

full_name: Majed Alabdullah

given: Majed

family: Gaspoz

full_name: Jean-Michel Gaspoz

given: Jean-Michel

family: Laurent

full_name: Bernard Laurent

given: Bernard

family: Barthélémy

full_name: Jean-Claude Barthélémy

given: Jean-Claude

family: Roche

full_name: Frédéric Roche

given: Frédéric

journal_name: Human Brain Mapping

oa_host_type: repository

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Sforza E, Millasseau S, Hupin D, Barthélémy JC, Roche F. Arterial stiffness alteration and obstructive sleep apnea in an elderly cohort free of cardiovascular event history: the PROOF cohort study. Sleep Breath. 2019 Mar;23(1):201-208. doi: 10.1007/s11325-018-1683-x. Epub 2018 Jun 26.

family: Sforza

full_name: Emilia Sforza

given: Emilia

family: Millasseau

full_name: Sandrine Millasseau

given: Sandrine

family: Hupin

full_name: David Hupin

given: David

journal_name: Sleep and Breathing

ReferenceCitation: Monneret D, Barthélémy JC, Hupin D, Maudoux D, Celle S, Sforza E, Roche F. Serum lipid profile, sleep-disordered breathing and blood pressure in the elderly: a 10-year follow-up of the PROOF-SYNAPSE cohort. Sleep Med. 2017 Nov;39:14-22. doi: 10.1016/j.sleep.2017.07.028. Epub 2017 Sep 18.

ReferenceCitation: Saint Martin M, Labeix P, Garet M, Thomas T, Barthélémy JC, Collet P, Roche F, Sforza E. Does Subjective Sleep Affect Bone Mineral Density in Older People with Minimal Health Disorders? The PROOF Cohort. J Clin Sleep Med. 2016 Nov 15;12(11):1461-1469.

ReferenceCitation: Sforza E, Saint Martin M, Thomas T, Collet P, Garet M, Barthélémy JC, Roche F. Risk factors of osteoporosis in healthy elderly with unrecognized obstructive sleep apnea: role of physical activity. Sleep Med. 2016 Jun;22:25-32. doi: 10.1016/j.sleep.2016.04.010. Epub 2016 Jun 7.

ReferenceCitation: Sforza E, Saint Martin M, Barthélémy JC, Roche F. Mood disorders in healthy elderly with obstructive sleep apnea: a gender effect. Sleep Med. 2016 Mar;19:57-62. doi: 10.1016/j.sleep.2015.11.007. Epub 2015 Nov 25.

title: Mood disorders in healthy elderly with obstructive sleep apnea: a gender effect

ReferenceCitation: Boutet C, Vassal F, Celle S, Schneider FC, Barthélémy JC, Laurent B, Barral FG, Roche F. Incidental findings on brain magnetic resonance imaging in the elderly:the PROOF study. Brain Imaging Behav. 2017 Feb;11(1):293-299. doi: 10.1007/s11682-016-9519-4.

ReferenceCitation: Sforza E, Celle S, Saint-Martin M, Barthélémy JC, Roche F. Hippocampus volume and subjective sleepiness in older people with sleep-disordered breathing: a preliminary report. J Sleep Res. 2016 Apr;25(2):190-3. doi: 10.1111/jsr.12367. Epub 2015 Dec 14.

name: Service de Physiologie Clinique et de l'Exercice (Pôle Hospitalier NOL); Faculté de Médecine Jacques Lisfranc; CHU Nord; Université Jean Monnet; Saint-Etienne France

ReferenceCitation: Sforza E, Pichot V, Martin MS, Barthélémy JC, Roche F. Prevalence and determinants of subjective sleepiness in healthy elderly with unrecognized obstructive sleep apnea. Sleep Med. 2015 Aug;16(8):981-6. doi: 10.1016/j.sleep.2015.03.010. Epub 2015 Apr 15.

ReferenceCitation: Sforza E, Sabri M, DaCosta A, Isaaz K, Barthélémy JC, Roche F. Echocardiographic Findings in Healthy Elderly People with Unrecognized Sleep Disordered Breathing. J Clin Sleep Med. 2015 Sep 15;11(9):975-80. doi: 10.5664/jcsm.5006.

name: Service de Physiologie Clinique et de l'Exercice (Pole Hospitalier NOL), CHU Nord, Faculté de Médecine Jacques Lisfranc, Université Jean Monnet, Saint-Etienne, France

name: Service de Cardiologie CHU Nord, Faculté de Médecine Jacques Lisfranc, Université Jean Monnet, Saint-Etienne, France

publisher: American Academy of Sleep Medicine (AASM)

publisher_dissemination: American Academy of Sleep Medicine (AASM)

publisher_group: American Academy of Sleep Medicine (AASM)

publisher_normalized: American Academy of Sleep Medicine (AASM)

ReferenceCitation: Saint Martin M, Roche F, Thomas-Anterion C, Barthélémy JC, Sforza E; PROgnostic OF cardiovascular and cerebrovascular events study group. Eight-year parallel change in baroreflex sensitivity and memory function in a sample of healthy older adults. J Am Geriatr Soc. 2015 Feb;63(2):270-5. doi: 10.1111/jgs.13252. Epub 2015 Feb 2.

name: Département de Physiologie Clinique et de l'exercice; Pôle Neuro-Ostéo Locomoteur; Centre Hospitalo-Universitaire; Faculté de Mèdecine de Saint-Etienne; Université Jean Moulin; Saint-Etienne France

name: pôle de Recherche et d'Enseignement Supérieur; Université de Lyon; Lyon France

name: Laboratoire d'Etude des Mécanismes Cognitifs; University of Lyon 2; Lyon France

name: the PROgnostic OF cardiovascular and cerebrovascular events study group

journal_name: Journal of the American Geriatrics Society

title: Eight-Year Parallel Change in Baroreflex Sensitivity and Memory Function in a Sample of Healthy Older Adults

ReferenceCitation: Martin MS, Sforza E, Roche F, Barthélémy JC, Thomas-Anterion C; PROOF study group. Sleep breathing disorders and cognitive function in the elderly: an 8-year follow-up study. the proof-synapse cohort. Sleep. 2015 Feb 1;38(2):179-87. doi: 10.5665/sleep.4392.

name: Department of Clinical Physiology and Exercise, Pole NOL, CHU and Faculty of Medicine of Saint-Etienne, UJM and PRES University of Lyon, Saint-Etienne, France

name: EMC Laboratory, EA 3880, University of Lyon 2, Lyon, France

title: Sleep Breathing Disorders and Cognitive Function in the Elderly: An 8-Year Follow-up Study. The Proof-Synapse Cohort

ReferenceCitation: Sforza E, Saint Martin M, Barthelemy JC, Roche F. Association of self-reported sleep and hypertension in non-insomniac elderly subjects. J Clin Sleep Med. 2014 Sep 15;10(9):965-71. doi: 10.5664/jcsm.4026.

name: Service de Physiologie Clinique et de l'Exercice, CHU Nord, Saint-Etienne, Faculté de Médecine Jacques Lisfranc, PRES de Lyon 42023, Université Jean Monnet, Saint-Etienne, France

title: Association of Self-Reported Sleep and Hypertension in Non-Insomniac Elderly Subjects

ReferenceCitation: Saint Martin M, Sforza E, Thomas-Anterion C, Barthélémy JC, Roche F; PROOF Study Group. Baroreflex sensitivity, vascular risk factors, and cognitive function in a healthy elderly population: the PROOF cohort. J Am Geriatr Soc. 2013 Dec;61(12):2096-2102. doi: 10.1111/jgs.12548. Epub 2013 Nov 26.

name: Département de Physiologie Clinique et de l'Exercice Pôle Neuro‐OstéoLocomoteur Centre Hospitalo‐UniversitaireSaint‐Étienne France

name: Faculté de Médicine de Saint‐Etienne Université Jean Moulin Saint‐Étienne France

name: Pôle de Recherche et d'Enseignement Supérieur Université de LyonLyon France

name: Laboratoire des Mécanismes Cognitifs Université de Lyon 2 Lyon France

title: Baroreflex Sensitivity, Vascular Risk Factors, and Cognitive Function in a Healthy Elderly Population: The PROOF Cohort

ReferenceCitation: Sforza E, Thomas T, Barthélémy JC, Collet P, Roche F. Obstructive sleep apnea is associated with preserved bone mineral density in healthy elderly subjects. Sleep. 2013 Oct 1;36(10):1509-15. doi: 10.5665/sleep.3046.

name: Service de Physiologie Clinique et de l'Exercice, CHU Nord, Saint-Etienne, Faculté de Médecine Jacques Lisfranc, PRES de Lyon 42023,Université Jean Monnet, Saint-Etienne, France

name: Service de Rhumatologie, CHU Saint-Etienne, Faculté de Médecine Jacques Lisfranc, Inserm U1059 LBTO, UJM, PRES de Lyon, Université Jean Monnet, Saint-Etienne, France

title: Obstructive Sleep Apnea is Associated with Preserved Bone Mineral Density in Healthy Elderly Subjects

ReferenceCitation: Martin MS, Sforza E, Barthélémy JC, Thomas-Anterion C, Roche F. Sleep perception in non-insomniac healthy elderly: a 3-year longitudinal study. Rejuvenation Res. 2014 Feb;17(1):11-8. doi: 10.1089/rej.2013.1457.

name: Department of Clinical Physiology and Exercise, Pole NOL, CHU, and Faculty of Medicine of Saint-Etienne, UJM and PRES University of Lyon, EA 4607 SNA-EPIS, Saint-Étienne, France.

name: EMC laboratory, EA 3880, University of Lyon 2, Lyon, France.

title: Sleep Perception in Non-Insomniac Healthy Elderly: A 3-Year Longitudinal Study

ReferenceCitation: Chouchou F, Pichot V, Pépin JL, Tamisier R, Celle S, Maudoux D, Garcin A, Lévy P, Barthélémy JC, Roche F; PROOF Study Group. Sympathetic overactivity due to sleep fragmentation is associated with elevated diurnal systolic blood pressure in healthy elderly subjects: the PROOF-SYNAPSE study. Eur Heart J. 2013 Jul;34(28):2122-31, 2131a. doi: 10.1093/eurheartj/eht208. Epub 2013 Jun 11.

ReferenceCitation: Degache F, Sforza E, Dauphinot V, Celle S, Garcin A, Collet P, Pichot V, Barthélémy JC, Roche F; PROOF Study Group. Relation of central fat mass to obstructive sleep apnea in the elderly. Sleep. 2013 Apr 1;36(4):501-7. doi: 10.5665/sleep.2532.

name: Health Research Unit, High School of Health, University of Applied Sciences Western Switzerland, Lausanne, Switzerland

name: Service de Physiologie Clinique et de l'Exercice, CHU Nord, Saint-Etienne, Faculté de Médecine Jacques Lisfranc, Université Jean Monnet, Saint-Etienne, France; PRES Université de Lyon, France

name: Neurology Unit D, Memory Research Center, Lyon University Hospital, France

name: DIRC, CHU de Saint-Etienne, Saint-Etienne, France

name: Service de Rhumatologie, CHU Saint-Etienne, Faculté de Médecine Jacques Lisfranc, Université Jean Monnet, Saint-Etienne, France

title: Relation of Central Fat Mass to Obstructive Sleep Apnea in the Elderly

ReferenceCitation: Sforza E, Gauthier M, Crawford-Achour E, Pichot V, Maudoux D, Barthélémy JC, Roche F. A 3-year longitudinal study of sleep disordered breathing in the elderly. Eur Respir J. 2012 Sep;40(3):665-72. doi: 10.1183/09031936.00133011. Epub 2012 Mar 9.

title: A 3-year longitudinal study of sleep disordered breathing in the elderly

ReferenceCitation: Tønnesen P, Lauri H, Perfekt R, Mann K, Batra A. Efficacy of a nicotine mouth spray in smoking cessation: a randomised, double-blind trial. Eur Respir J. 2012 Sep;40(3):548-54. doi: 10.1183/09031936.00155811. Epub 2012 Feb 9.

ReferenceCitation: Sforza E, Chouchou F, Pichot V, Barthélémy JC, Roche F. Heart rate increment in the diagnosis of obstructive sleep apnoea in an older population. Sleep Med. 2012 Jan;13(1):21-8. doi: 10.1016/j.sleep.2011.04.011. Epub 2011 Nov 21.

ReferenceCitation: Chouchou F, Sforza E, Celle S, Pichot V, Maudoux D, Garcin A, Barthélémy JC, Roche F; PROOF Study Group. Pulse transit time in screening sleep disordered breathing in an elderly population: the PROOF-SYNAPSE study. Sleep. 2011 Aug 1;34(8):1051-9. doi: 10.5665/SLEEP.1160.

name: INSERM, U1028; CNRS, UMR5292; Centre de Recherche en Neurosciences de Lyon, Integration centrale de la douleur chez l'Homme, Universite Claude Bernard, Lyon, F-69000, France

name: Service de Physiologie Clinique, Pole NOL, CHU Nord, EA 4607 SNA-EPIS, Universite Jean Monnet, PRES de Lyon, Saint-Etienne F-42023, France

title: Pulse Transit Time in Screening Sleep Disordered Breathing In An Elderly Population: The PROOF-SYNAPSE Study

ReferenceCitation: Sforza E, Chouchou F, Collet P, Pichot V, Barthélémy JC, Roche F. Sex differences in obstructive sleep apnoea in an elderly French population. Eur Respir J. 2011 May;37(5):1137-43. doi: 10.1183/09031936.00043210. Epub 2010 Sep 3.

title: Sex differences in obstructive sleep apnoea in an elderly French population

ReferenceCitation: Sforza E, Roche F, Thomas-Anterion C, Kerleroux J, Beauchet O, Celle S, Maudoux D, Pichot V, Laurent B, Barthélémy JC. Cognitive function and sleep related breathing disorders in a healthy elderly population: the SYNAPSE study. Sleep. 2010 Apr;33(4):515-21.

ReferenceCitation: Guillot M, Costes F, Sforza E, Maudoux D, Bertoletti L, Barthélémy JC, Roche F. Is tidal expiratory flow limitation predictive of sleep-related disorders in the elderly? Eur Respir J. 2010 Oct;36(4):842-8. doi: 10.1183/09031936.00078009. Epub 2010 Apr 8.


title: Prospective Evaluation of the Interest of a Systematic Biopsy for Hard-to-heal Leg Ulcers

acronym: ULCERE

summary: Primary aim of the study : to evaluate the prevalence of ulcerated cutaneous carcinoma or malignant degeneration, in leg ulcers, presumed of vascular origin and without evidence of healing despite 3 months of adequate treatmentSecondary aims of the study : to evaluate the interest of immunostainings for desmogleins 1-2 and p16 on biopsies to differentiate between pseudo epitheliomatous hyperplasia and squamous cell carcinoma ; and the prognosis of diagnosed carcinomas at 12 monthsStudy hypothesis : systematic biopsies of hard-to-heal leg ulcer may help to detect ulcerated carcinomas misdiagnosed as vascular ulcer or malignant degeneration of leg ulcer.

ReferenceCitation: Senet P, Combemale P, Debure C, Baudot N, Machet L, Aout M, Vicaut E, Lok C; Angio-Dermatology Group Of The French Society Of Dermatology. Malignancy and chronic leg ulcers: the value of systematic wound biopsies: a prospective, multicenter, cross-sectional study. Arch Dermatol. 2012 Jun;148(6):704-8. doi: 10.1001/archdermatol.2011.3362.

family: Combemale

full_name: Patrick Combemale

given: Patrick

journal_name: Archives of Dermatology

oa_host_type: publisher

evidence: open (via free pdf)

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Malignancy and Chronic Leg Ulcers