title: Four Weeks Withdrawal of Non-invasive Ventilation (NIV) in Patients With Myotonic Dystrophy: Cardiovascular, Metabolic and Daytime Vigilance Induced Changes

summary:
Background: Myotonic dystrophy lead to highly heterogeneous, multisystemic symptoms including myotonia, progressive muscle weakness, cardiac conduction defects, cataract, metabolic dysfunction, and excessive daytime somnolence. This last symptom is related to respiratory failure and/or to involvement of the central nervous system. However the metabolic disturbances could contribute to it. From the respiratory point of view this disease is characterised by the progressive appearance of respiratory failure of muscular origin but mainly associated with a defect in the central respiratory drive. The treatment for this hypoventilation is non-invasive ventilation (NIV).

It is not currently absolutely clear as to the best choice of criteria to judge long term effectiveness of NIV. The most usual criteria are normalisation of daytime blood gases, diminution of respiratory work, improvement in daytime symptoms and improvement in sleep structure. Other criteria are currently little studied, for instance the contribution of the interaction between alveolar hypoventilation and oxygen desaturation during the night and biological deficiencies such as systemic inflammation, glucose intolerance or insulin resistance. Likewise there is little information about the interaction between alveolar hypoventilation and endothelial dysfunction and arterial stiffness both being accurate predictive factors for cardiovascular risks.

Aim: to evaluate the impact of NIV on endothelial dysfunction in patients with myotonic dystrophy. The secondary objectives are to assess the impact of NIV on systemic inflammation, arterial stiffness, insulin-resistance, quality of sleep, and daytime vigilance in these patients.

Methods: Patients with chronic alveolar hypoventilation already treated by long term NIV will be included. They will have an initial check-up (Visit 1), then will interrupt NIV treatment for four weeks (Visit 2), and then return to NIV treatment. The last check-up will be done four weeks after NIV resumption (Visit3).

Expected results: It is expected that NIV withdrawal will results in a deterioration of cardio-vascular parameters (endothelial function and arterial stiffness), metabolic parameters (insulin-resistance and systemic inflammation), quality of sleep and daytime vigilance. Return to NIV treatment may show an improvement of these parameters with a basal state recovery.

ReferenceCitation: 1-Cho DH. Biochim Biophys Acta 2007;1772:195-204. 2-Harper PS. W.B. Saunders ed. London, 1989. 3-Machuca-Tzili L. Muscle Nerve 2005;32:1-18. 4-Lazarus A. J Am Coll Cardiol 2002;40:1645-52. 5-Johansson A. J Intern Med 1999;245:345-51. 6-Johansson A. Int J Obes Relat Metab Disord 2002;26:1386-92. 7-Carter JN. J Clin Endocrinol Metab 1985;60:611-4. 8-Kouki T. Diabet Med 2005;22:346-7. 9-Mammarella. J Neurol Sci 2002;201:59-64. 10-Laberge L. J Sleep Res 2004;13:95-100. 11-Begin P. Am J Respir Crit Care Med 1997;156:133-9. 12-DAngelo MG. Muscle Nerve 2006;34:16-33. 13-Veale D. Eur Respir J 1995;8:815-8. 14-Vgontzas A. Sleep Med Rev 2005;9:211-24. 15-Perrin C. Semin Respir Crit Care Med 2005;26:117-30. 16-Guilleminault C. J Neurol Neurosurg Psychiatry 1998;65:225-32. 17-Mehta S. Am J Respir Crit Care Med 2001;163:540-77. 18-Babu AR. Arch Intern Med 2005;165(4):447-52. 19-Talbot K. Neuromuscul Disord 2003;13(5):357-64.

lead_sponsor: University Hospital, Grenoble

location_facility: France.Functional Cardio-Respiratory Exploration Laboratory


title: Maggot Therapy for Wound Debridement: a Randomized Multicentric Double-blind Trial

acronym: MAGGOT

summary: The main objective of the trial was to study the efficacy of bagged larvae on wound debridement in comparison to classical treatments. The secondary outcome was to assess wound healing, treatment related pain, microbiological modifications, adverse events, comfort of the dressing and duration of wound care. We performed a randomized, double-blind, multicenter, controlled, prospective phase III trial in three referral institutional centers of hospitalized care in Caen, Lisieux and Lyon, France. A total of 120 patients with a non-healing fibrinous wound ≤ 40cm2, less than 2cm-deep, and an ankle-brachial pressure index (ABPI) ≥ 0.8 were included, from March 2005 to December 2008. During two weeks´ hospitalization, patients received either Maggot Debridement Therapy (MDT, changes of bagged larvae twice a week) or classical treatments (mechanical debridement and classical dressings performed three times a week). At discharge, classical dressings were applied and a follow-up visit performed at D30. Main outcome measure was the comparison of the reduction of fibrin percentage on wounds treated with MDT and classical treatments at D15. The percentages of fibrin were measured using a computerized planimetry software package, Canvas (ACD Systems, British Columbia, Canada), which enables the quantification of color surface variations in a wound after manual delimitation (using a mouse) on a series of photographic images.

status: Completed

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Opletalová K, Blaizot X, Mourgeon B, Chêne Y, Creveuil C, Combemale P, Laplaud AL, Sohyer-Lebreuilly I, Dompmartin A. Maggot therapy for wound debridement: a randomized multicenter trial. Arch Dermatol. 2012 Apr;148(4):432-8. doi: 10.1001/archdermatol.2011.1895. Epub 2011 Dec 19.

lead_sponsor: University Hospital, Caen

location_facility: Hospital of Caen, dermatology department

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Study on the Prevalence of Hepatitis C In a psychiatRic Population

acronym: SaPHIR

summary:
Viral hepatitis, especially hepatitis C, is a major public health issue. Nowadays, very few studies in France have evaluated the prevalence of hepatitis C in a psychiatric environment.

In 2019, at the time of new treatments for HCV, it therefore seems essential to update the available data by estimating the prevalence of chronic active hepatitis C in psychiatric population. In addition to an update of epidemiological data, it is of high importance to assess the effectiveness of the care pathway for patients in whom chronic active hepatitis C is diagnosed, including the cascade of care, currently too inefficient despite treatments that are themselves ultra-efficient. Indeed, it is essential that once hepatitis is detected, it is formally diagnosed, then that the patient actually starts care and is adherent to treatment (take his treatment according to the prescription and until the end: this implies that the patient accepts his or her illness and understands the value of the prescribed treatments), to hope to cure the infection.

In this context, the SaPHIR study will allow to test a systematic screening of patients in an adult psychiatric environment, through rapid diagnostic tests (RDT). The objective is to promote the adherence of patients, and to assess possible obstacles in order to optimize the screening (RDTs), diagnosis (confirmation of only positive RDTs by venous sampling) and care management circuits in routine practice. In addition, the study envisages a combined HCV-HBV-HIV screening, taking into account the cross-infection risk (same mode of contamination, same risk population, frequent co-infections, more severe liver pathology in case of co-infection, etc.), thus making it possible to take care of the patient as a whole. The results of the SaPHIR study can ultimately be sent to the French health authorities to improve screening and care circuits, and their coverage by social security.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

primary_purpose: Other

enrollment_type: Anticipated

lead_sponsor: Nantes University Hospital

location_facility:
CHU Nantes
CH Georges Daumézon
CHS de Blain

intervention_type: Diagnostic Test

status_simplified: Ongoing


title: Mesenchymal Stem Cell Administration in the Treatment of Coronary Graft Disease in Heart Transplant Patients

acronym: MESHT

summary:
MES-HT is a pilot multicenter prospective study conducted in transplant patients who developed severe coronary vasculopathy. A preparation of autologous mesenchymal cells of bone marrow is administered by endomyocardial injection, guided by the Noga® cardiac mapping system.

The main objective is to determine the effect of the administration of autologous mesenchymal cells of the bone marrow by intramyocardial injection on myocardial perfusion in cardiac transplant patients with severe coronary vasculopathy.

status: Suspended

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Département de cardiologie du Pr Michel KOMADJA

intervention_type: Biological

status_simplified: Unknown


title: Incidental Findings Produced by Diagnostic HTS: From the Needs of Patients to Organisational Considerations

acronym: FIND

summary:
High-throughput whole-genome sequencing (WGS) is bringing new opportunities in the diagnosis of rare diseases. It will more frequently lead to a primary diagnosis (aim of the genetic consultation), but it may also lead to the discovery of mutations not related to the patient's disease. These findings are called "incidental findings" (IF) and may give rise to preventive or curative interventions in a personalised medicine approach.

The question of proposing to patients access to all or part of these findings is a matter of debate in France and elsewhere. This question has given rise to new challenges and new needs that professionals must respond to by implementing appropriate management and new skills. It raises specific ethical issues, which require precise understanding of the expectations and experiences of patients. Patients' diagnostic trajectories must also meet criteria for efficacy and financial and organisational sustainability for the healthcare establishments and, for the healthcare system. Our project aims to assess the expectations of patients/parents with regard to this opportunity, and to determine how information should be provided to patients and how they should be accompanied to ensure efficient and appropriate management.

study_completion_date_type: Actual

design_allocation: Non-Randomized

primary_purpose: Diagnostic

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
CHU Dijon Bourgogne
Hospices Civils de Lyon
Groupe Hospitalier Pitié-Salpêtrière


title: Efficacy of Ozurdex® in the Treatment of Diabetic Macular Edema (DME)

acronym: Louvre 3

summary: This study will evaluate the efficacy of Ozurdex® as prescribed in clinical practice in France for the treatment of Diabetic Macular Edema (DME).

study_type: Observational

time_perspective: Prospective

lead_sponsor: Allergan

location_facility:
Hopital Saint Joseph
CHU Bordeaux
CH BLOIS
CHU Pasteur 2
Lariboisiere
Hopital Saint Germain en Laye
Clinique Monticelli
Centre Rétine Gallien à Bordeaux
Chno 1520
Hopital De La Croix Rousse
Centre OPHTA.Kervision
CH SCORFF - Lorient
CHI Créteil
Hôpital de La Milétrie Poitiers
Maison Rouge
Hopital de la Timone
Hopital Poissy
CH Avicennes Bobigny
Chu Toulouse
CHR Annecy
CHU Brest
COCHIN
Fondation Rothschild
Centre MGM
Ballanger

intervention_type: Drug

lead_sponsor_type: industriel


type: Registry Identifier

title: Randomized Cross Over Study Assessing the Effectiveness of Non-invasive Vagus Nerve Stimulation in Patients With Axial Spondyloarthritis Resistant to Biotherapies

acronym: ESNV-SPA II

summary:
The primary objective of the study is to study the change in SpA disease activity, according to ASAS20 definition (Anderson et al., 2001), after 8 weeks of VNS treatment versus placebo non-specific stimulation (control group).

The secondary objectives of the Clinical Investigation are to show differences in disease evolution between the active and placebo periods of 8 weeks treatment with active VNS versus placebo VNS of the following items:

Change in disease activity according to "ASAS40" criteria
Obtaining a partial remission according to the ASAS definition
Change in BASFI
Change in C-reactive protein (CRP)serum level and erythrocytes sedimentation rate (ESR),
Change in ASDAS_CRP and ASDAS_ESR
Difference in levels of circulating cytokines, IL-6, IL-23, IL-17, IL-33 and of matrix metallopeptidases (MMP3-8-9).
Change in quality of life : assessment according to the following indexes: SF-36, AS Quality of Life (ASQOL)
Change in Health Index of patient with SpA (ASAS HI) and of the Productivity at Work Index (WPI)
Change in fatigue (BASDAI 1st question) and global pain
Change in Anxiety and Depression Assessment (HAD)
Change in BASMI
Change in non-steroidal anti-inflammatory drugs (NSAID) intake score.

study_start_date_type: Anticipated

status: Not yet recruiting

ReferenceCitation: Azabou E, Bao G, Costantino F, Jacota M, Lazizi C, Nkam L, Rottman M, Roux AL, Chevallier S, Grimaldi L, Breban M. Randomized Cross Over Study Assessing the Efficacy of Non-invasive Stimulation of the Vagus Nerve in Patients With Axial Spondyloarthritis Resistant to Biotherapies: The ESNV-SPA Study Protocol. Front Hum Neurosci. 2021 Jun 30;15:679775. doi: 10.3389/fnhum.2021.679775. eCollection 2021.

ipd_sharing: No

location_facility: Neurophysiology and Neuromodulation Unit, Department of Physiology, Raymond Poincaré Hospital, APHP

intervention_type: Device


type: EudraCT Number

title: Efficacy of Temocillin in Urinary Tract Infection Due to ESBL Producing and AmpC Hyperproducing Enterobacteriaceae

acronym: TEMO-ESBL

summary: The present study aims at demonstrating the efficacy of temocillin in the treatment of UTI requiring parenteral therapy due to a confirmed ESBL producing or AmpC hyperproducing Enterobacteriaceae, resistant to quinolones and Bactrim® in France. In addition, this study will describe and support the use of high dose (6g/day) of temocillin which could be of interest for the treatment urinary tract infection due to multi-resistant bacteria having high MIC (up to 32 mg/L). The investigators will also evaluate the tolerance of the drug by monitoring the adverse event and the incidence of eventual Clostridium difficile associated infection.

status: Unknown status

ReferenceType: background

ReferenceCitation: Laterre PF, Wittebole X, Van de Velde S, Muller AE, Mouton JW, Carryn S, Tulkens PM, Dugernier T. Temocillin (6 g daily) in critically ill patients: continuous infusion versus three times daily administration. J Antimicrob Chemother. 2015 Mar;70(3):891-8. doi: 10.1093/jac/dku465. Epub 2014 Nov 27.

ReferenceCitation: Balakrishnan I, Awad-El-Kariem FM, Aali A, Kumari P, Mulla R, Tan B, Brudney D, Ladenheim D, Ghazy A, Khan I, Virgincar N, Iyer S, Carryn S, Van de Velde S. Temocillin use in England: clinical and microbiological efficacies in infections caused by extended-spectrum and/or derepressed AmpC β-lactamase-producing Enterobacteriaceae. J Antimicrob Chemother. 2011 Nov;66(11):2628-31. doi: 10.1093/jac/dkr317. Epub 2011 Aug 2.

ReferenceCitation: Fournier D, Chirouze C, Leroy J, Cholley P, Talon D, Plésiat P, Bertrand X. Alternatives to carbapenems in ESBL-producing Escherichia coli infections. Med Mal Infect. 2013 Feb;43(2):62-6. doi: 10.1016/j.medmal.2013.01.006. Epub 2013 Feb 19.

ReferenceCitation: Schulze B, Heilmann HD. Treatment of severe infections with temocillin. Clinical and bacteriological evaluation. Drugs. 1985;29 Suppl 5:207-9.

ReferenceCitation: De Jongh R, Hens R, Basma V, Mouton JW, Tulkens PM, Carryn S. Continuous versus intermittent infusion of temocillin, a directed spectrum penicillin for intensive care patients with nosocomial pneumonia: stability, compatibility, population pharmacokinetic studies and breakpoint selection. J Antimicrob Chemother. 2008 Feb;61(2):382-8. Epub 2007 Dec 10.

location_facility:
CHU de Pointe à Pitre
CH de Perpignan
CHU de Nice
APHP - Avicenne Hospital
APHP - Bicêtre Hospital
CHU de Nantes
CHU de Rouen
CHU de Grenoble
CH Ajaccio
CH Annecy Genevois
CHU de Poitiers
CHU de Saint Etienne
APHP - Beaujon Hospital
CHU de Tours
APHP - St Louis
CHU de Lille
APHP - Cochin Hospital
APHP - Bichat Hospital
CHU de Martinique


type: Other Identifier

title: Comparison of Voice Results at 5 Years of Treatment of Glottic Squamous Cell Carcinoma T1 by Surgery Versus Radiotherapy

acronym: VO Qual

summary: Patients with early-stage squamous cell carcinomas of the vocal cord can be treated in an equivalent way in terms of carcinology by surgery or radiotherapy. The study will be to analyse the vocal outcome at 5 years of these two types of management in order to define whether one is superior to the other on this criterion of voice quality after treatment.

time_perspective: Retrospective

lead_sponsor: University Hospital, Lille

location_facility:
Centre Oscar Lambret
Hôpital Huriez, CHU


title: Interest of the Immunoscore® as a Post-operative Complementary Tool for the Detection of the Risk of Recurrence in Patients With Nonmetastatic Colorectal Cancer : Prospective Cohort Comparing the Recommandation for Patient Care According to the Immunoscore® With the Standard Care Decision.

summary: Evaluate the patient care recommandation induced by the IMMUNOSCORE® result

lead_sponsor: Hospital St. Joseph, Marseille, France

location_facility:
Hopital Saint Joseph
Hôpital Européen


title: A Phase III Prospective Randomized Comparison of Imatinib at a Dose of 400mg in Combination With Peg-Interferon-alpha2a (Peg-IFNa2a) or Cytarabine (Ara-C)Versus Imatinib at a Dose of 600mg Versus Imatinib a Dose of 400mg for Previously Untreated Chronic Myelogenous Leukemia (CML) in Chronic Phase

acronym: SPIRIT

summary:
To test whether increasing the dose of imatinib or combining it with IFNalpha or ara-C increases the rate of molecular response (as measured by the decrease in BCR-ABL transcripts after 12 months of treatment) in patients with previously untreated CML in chronic phase.

To compare overall survival in a selected arm according to molecular response at 1 year from randomization with the reference arm.

ReferenceCitation: Bruzzoni-Giovanelli H, González JR, Sigaux F, Villoutreix BO, Cayuela JM, Guilhot J, Preudhomme C, Guilhot F, Poyet JL, Rousselot P. Genetic polymorphisms associated with increased risk of developing chronic myelogenous leukemia. Oncotarget. 2015 Nov 3;6(34):36269-77. doi: 10.18632/oncotarget.5915.

ReferenceCitation: Delord M, Rousselot P, Cayuela JM, Sigaux F, Guilhot J, Preudhomme C, Guilhot F, Loiseau P, Raffoux E, Geromin D, Génin E, Calvo F, Bruzzoni-Giovanelli H. High imatinib dose overcomes insufficient response associated with ABCG2 haplotype in chronic myelogenous leukemia patients. Oncotarget. 2013 Oct;4(10):1582-91.

ReferenceCitation: Johnson-Ansah H, Guilhot J, Rousselot P, Rea D, Legros L, Rigal-Huguet F, Nicolini FE, Mahon FX, Preudhomme C, Guilhot F. Tolerability and efficacy of pegylated interferon-α-2a in combination with imatinib for patients with chronic-phase chronic myeloid leukemia. Cancer. 2013 Dec 15;119(24):4284-9. doi: 10.1002/cncr.28328. Epub 2013 Sep 16.

ReferenceCitation: Preudhomme C, Guilhot J, Nicolini FE, Guerci-Bresler A, Rigal-Huguet F, Maloisel F, Coiteux V, Gardembas M, Berthou C, Vekhoff A, Rea D, Jourdan E, Allard C, Delmer A, Rousselot P, Legros L, Berger M, Corm S, Etienne G, Roche-Lestienne C, Eclache V, Mahon FX, Guilhot F; SPIRIT Investigators; France Intergroupe des Leucémies Myéloïdes Chroniques (Fi-LMC). Imatinib plus peginterferon alfa-2a in chronic myeloid leukemia. N Engl J Med. 2010 Dec 23;363(26):2511-21. doi: 10.1056/NEJMoa1004095.

lead_sponsor: Poitiers University Hospital


title: Exploratory Study of the Relevance of a Blood Test in the Management of Patients in the Context of Colorectal Cancer Screening

acronym: PREDICT-IRFC

summary:
Colorectal cancer (CRC) is the third most common cancer in men and the second in women with an incidence of 43,350 new cases in 2018. This incidence is increasing every year.

Early detection is crucial in this pathology. In France, free screening is organized by health insurance for people aged 50 to 74 years. This screening is based on an immunological test (FIT: Fecal Immunological test), which aims to detect the presence of blood in the stool. In fact, some polyps or cancers cause bleeding that is often minimal and therefore difficult or even impossible to detect with the naked eye.

If this test is positive, a colonoscopy is done to check whether or not abnormalities are present in the colon or rectum. Performed under anesthesia, this examination can detect the possible presence of polyps or cancer.

Recently, with the covid-19 epidemic, the investigators were faced with an extension of the delays for colonoscopies which led to delays in patient care.

To prevent this, they propose to develop a blood test that would allow rapid identification of patients with colorectal cancer, requiring rapid management.

This blood test will permit to have a parameter for stratifying the therapeutic care in the event of epidemia or situation that constrains the organisation of the health system.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Intercommunal de Haute-Saône


summary: The aim of this study is to determine whether antibiotic treatment could reduce mechanical ventilation duration in patients with nosocomial tracheobronchitis acquired under mechanical ventilation.

ReferenceCitation: Nseir S, Favory R, Jozefowicz E, Decamps F, Dewavrin F, Brunin G, Di Pompeo C, Mathieu D, Durocher A; VAT Study Group. Antimicrobial treatment for ventilator-associated tracheobronchitis: a randomized, controlled, multicenter study. Crit Care. 2008;12(3):R62. doi: 10.1186/cc6890. Epub 2008 May 2.


title: Phase Ib/II Trial Evaluating the Safety, Tolerability and Immunological Activity of Durvalumab (MEDI4736) (Anti-PD-L1) Plus Tremelimumab (Anti-CTLA-4) Combined With FOLFOX in Patients With Metastatic Colorectal Cancer

acronym: MEDITREME

summary:
Colo-rectal cancer is still one of the leading causes of cancer death worldwide. In France, approximately 40 500 new cases are diagnosed each year. With more than 17 500 deaths in France in 2011, colo-rectal cancer is responsible for more than 12% of all cancer deaths, the overwhelming of deaths occurring in patients with metastatic disease.

Many studies highlight the fact that colo-rectal cancer has immunogenic properties and that host immune responses can influence survival. Recent data have provided a clearer understanding of the factors limiting the antitumor immune response in colo-rectal cancer. One of the most critical checkpoint pathways responsible for mediating tumor-induced immune suppression is the programmed death-1 (PD-1) and PD ligand 1 (PD-L1) pathway.

PD-1 is expressed on activated immune cells and can link to PD-L1 express on Antigen-Presenting-Cell. Usually, this pathway is involved in promoting T-cells tolerance and preventing tissue damage in settings of chronic inflammation. In pathological context, the PD-1/PD-L1 pathway contributes to immune suppression and evasion. Many human solid tumors including colo-rectal cancer express PD-L1, and this expression is associated with a worse prognosis. The interaction of PD-1 with the ligand PD-L1 inhibits T-cell proliferation, survival, and effectors functions; induces apoptosis of tumor-specific T cells; promotes the differentiation of CD4+ T cells into immunosuppressive regulatory T cells; and increases the resistance of tumor cells to cytotoxic T lymphocytes attack. Thus, the blockage of the PD-1/PD-L1 interactions represents a logical target for cancer immunotherapy and in particular colo rectal cancer immunotherapy strategy.

Preclinical studies have shown that PD-L1 blockade improves the immune response by restoring T-cell effectors functions. Recent work in two in vivo tumor models shows a strong interest in using an anti-PD-L1 in combination with standard treatment of colo-rectal cancer (FOLFOX). In these models, the survival of mice that are treated with the combination therapy reached 40% when no mice were alive with FOLFOX treatment alone. This result may be explained, in one hand by cytotoxicity of 5FU and in the other hand by the restoration of anti-tumor immune activity of anti-PD-L1. These results suggest that the combination of chemotherapy with immunotherapy would act synergistically in patients with colo-rectal cancer.

Research Hypothesis: Combination of chemotherapy (FOLFOX) with immunotherapy association (anti-PD-L1 + anti-CTLA-4) would act synergistically in patients with colo-rectal cancer.

ReferenceCitation: Fumet JD, Isambert N, Hervieu A, Zanetta S, Guion JF, Hennequin A, Rederstorff E, Bertaut A, Ghiringhelli F. Phase Ib/II trial evaluating the safety, tolerability and immunological activity of durvalumab (MEDI4736) (anti-PD-L1) plus tremelimumab (anti-CTLA-4) combined with FOLFOX in patients with metastatic colorectal cancer. ESMO Open. 2018 Jun 19;3(4):e000375. doi: 10.1136/esmoopen-2018-000375. eCollection 2018.

lead_sponsor: Centre Georges Francois Leclerc

location_facility:
CHU Nantes
Centre Georges François Leclerc
Hôpital Saint Antoine
Hôpital Europeen Georges Pompidou
CHRU Besançon


title: Prospective, Multicenter, Epidemiological Case-control Study, to Establish a Possible Correlation Between Persistent Chemical Contaminants (POPs) and Breast Cancer.

acronym: POPCASE

summary:
Exposure to certain classes of chemical contaminants, including certain persistent organic pollutants (POPs) with a character of endocrine disruptors, could be one of the factors that lead to increase incidence of breast cancer in the Western world .

However, the causal role of POPs in the onset of breast cancer remains nowadays unproven. Preliminary epidemiological studies on the impact of these environmental factors in breast cancer etiology have ignored the critical periods of exposure. Similarly, they have considered a limited number of pollutants (not including possible joint or synergistic effects between individual compounds) and did not distinguish the different breast cancer subtypes may have different etiologies or even of genetic susceptibility factors (POP polymorphism of detoxification enzymes).

Thus, POPCASE study examines the association between the presence of breast cancer and the levels and exposure profiles to a group of POPs measured in adipose tissue (AT) and blood, in particular using spectrometric methods developed by the team LABERCA (Nantes, France). These internal levels of POPs (organochlorine pesticides, dioxins, PCBs, brominated flame retardants) will be measured both quantitatively (tissue concentrations) and qualitative (relative proportions of different pollutants sought).

lead_sponsor: Institut Cancerologie de l'Ouest

location_facility:
ICO René Gauducheau
Gustave Roussy
Clinique Breteche

intervention_type: Procedure


title: Congenital Malformations and Intrauterine Pollutants Exposure (Alcohol, Solvents and Pesticides) in Brittany. Population Based Case-control Study Short Title : Malformations and Environment Acronym : PENEW for "Pregnancy Environment and Newborn Malformations"

acronym: PENEW

summary:
Congenital malformations rate is about 3% in France. There are already 5 registries in France, covering about 16% of French births: Paris Registry, (about 38 000 births /year), Alsace Registry, (about 23 000 births/year), Rhône-Alpes Registry, (about 56 000 births/year), Auvergne Registry, (about 14 000 births/year), and la Réunion Registry. The aim of malformation registries is to carry out epidemiologic surveillance of congenital anomalies. The objectives are mainly to provide essential epidemiologic information on congenital anomalies, to facilitate the early warning of teratogenic exposures, to act as an information and resource centre regarding clusters, to provide data for research related to the causes and prevention of congenital anomalies.

A previous study was carried out in Brittany in 2008-2009, by the perinatal network of Ille et Vilaine, in collaboration with two research teams (Inserm U1085 and Inserm U 936), to record all cases of 4 types of congenital anomalies: congenital heart disease, spina bifida, diaphragmatic hernia and hypospadia. The results showed prevalence rates similar to those observed by Eurocat for spina bifida and diaphragmatic hernia, but a higher prevalence regarding congenital heart diseases and hypospadia. In this study the investigators could not determine whether this was due to a real higher frequency or to a particular exhaustiveness in the recording methodology.

There are hypothesis about the role of intrauterine exposure to pesticides, known as endocrine disruptors, and the risk of congenital genital anomalies. Brittany is an intensive agricultural area, and it is thus worth studying the impact of pesticides exposure on congenital anomalies.

There are also hypothesis on the impact of occupational exposure to solvents on congenital anomalies (Garlantezec 2009), and on the role of alcohol exposure (which concerns about 8% pregnant women in France) on oro-facial clefts and congenital heart diseases.

The Registry of congenital anomalies in Brittany was set up in 2010. The main aim is to study the impact of intra-uterine exposure to solvents, pesticides and alcohol on the risk of congenital malformations diagnosed at births, by measuring the exposure both directly in meconium, and indirectly by questionnaires.

Secondary objectives are to study other risk factors such as medicine intake, pregnancy illness…

lead_sponsor: Rennes University Hospital

location_facility:
Polyclinique de Keraudren
Saint-Brieuc Hospital
Vannes Hospital
Ploermel Hospital
Brest University Hospital
Clinique Océane
Lannion Hospital
Saint-Grégoire Hospital
Rennes University Hospital
Quimper Hospital
Lorient Hospital


title: Parental Assessment of the Quality of Life of Infants Under 12 Months of Age With Moderate Bronchiolitis Referred for Ambulatory Respiratory Physiotherapy

summary:
Infant bronchiolitis is a frequent pathology that is the cause of a very large number of medical outpatient and physiotherapy treatments in France. Many international studies and recommendations have invalidated any drug treatment during its management during the first episode. In France, the consensus conference promoted by the National Agency for Accreditation and Health Evaluation (ANAES) in September 2000 was in the same vein.

Regarding the respiratory physiotherapy component, posture drainage, vibration and percussion are not considered effective. ANAES recommended the use of respiratory physiotherapy with passive exhalation techniques. This is a method of care that has developed mainly in French-speaking countries, making it difficult to compare with the habits of Anglo-Saxon countries, which, more generally, do not prescribe it. In France, the level of evidence of its effectiveness is considered low (grade C). To date, the vast majority of studies have focused exclusively on a population of infants hospitalized for severe bronchiolitis. For this type of population, the value of such treatment to shorten the healing time has not been demonstrated. So much so that the ANAES, in its time, recommended that studies be carried out "on an outpatient basis" to assess their degree. In this respect, several recent studies have provided new data. Despite the reservations inherent in their methodologies and/or staff, they raise the question of the interest of the respiratory physiotherapy on an outpatient basis. In terms of professional practice, the American recommendations state that clinicians should educate family members about evidence-based diagnosis, treatment and prevention in bronchiolitis. Finally, an opinion survey concludes that holders of parental authority are seeking information on bronchiolitis and that approximately 90% have read the brochure given out of the maternity ward explaining the modes of transmission, manifestations, care and hygiene measures in the event of bronchiolitis. Pending new French recommendations, it seems legitimate to evaluate the level of perception of the effect of pediatric respiratory physiotherapy with increase in expiratory flow (IEF) in urban practice on the respiratory comfort of infants directly with families confronted with this pathology.

lead_sponsor: Association des Réseaux Bronchiolite

location_facility:
RB 59 62
Rb Loiret
GAB
La Rochelle
Occirespi
Rb Grand Est
Rb Picard
Aquirespi
CHU Robert-Debré
ARBAM
RB 74


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

acronym: HPV-CIR

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

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

time_perspective: Cross-Sectional

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de médecine interne, Centre hospitalier Lyon Sud


title: Targeted Temperature Management With Therapeutic Hypothermia Using Esophageal COOLing After Cardiac Arrest: THE COOL STUDY

acronym: THE-COOL

summary:
To control patient's body temperature remains of major importance especially after cardiac arrest (CA). Therapeutic hypothermia (TH) targeted to 32-34°C is now recommended for most unconscious CA patients. However, available modalities for inducing TH have a number of technical (side effects), logistical (difficulties of placement), and financial (cost) barriers. The Esophageal Cooling Device (ECD) is a multi-chambered silicone heat exchanger placed in the esophagus providing highly efficient heat transfer to a patient. The ECD is a device that potentially improves the effectiveness of TH in minimizing the risks of existing methods (such as invasive cooling). Initial mathematical and animal studies have shown strong support for the efficacy and safety of the ECD. Placement of a naso-gastric probe is a systematic standard of care for all unconscious patients suffering from CA. The present study will replace the usual naso-gastric probe by the ECD that can be used for gastric suctioning as usually done in such patients.

The aim of this prospective, interventional study is to assess the feasibility and safety of the ECD in resuscitated CA-patients and treated with 32-34°C targeted TH. The primary outcome is the feasibility of inducing, maintaining, and rewarming patients from TH using the ECD (cooling rate, rewarming rate, and the percent of time within goal temperature during the goal-temperature maintenance period). Evaluation of adverse events (including cardiac arrhythmias, severe bradycardia, myocardial infarction/re-infarction, dysphagia, odynophagia, aspiration pneumonia, non-aspiration pneumonia, esophageal reflux and injury, and esophagitis) will be closely monitored during the whole period of the targeted temperature management (secondary endpoint).

lead_sponsor: IST cardiology


title: Evaluation of a Therapeutic Education Program for Pregnant Women With a First Child Diagnosed With an Autism Spectrum Disorder (ASD)

acronym: AUTMER

summary:
Autism Spectrum Disorder (ASD) is a heterogeneous set of severe developmental abnormalities of the nervous system characterized by deficits affecting social interactions and verbal and non-verbal communication, as well as the presence of restricted interests, repetitive behaviors, and atypical sensory manifestations . ASD affects approximately 1% of the general population (Elsabbagh et al., 2012). Studies of siblings of individuals with ASD show that ASD is present in 7-20% of the offspring in families where a child has had a diagnosis of ASD and this prevalence increases if there are two diagnosed children.

Several studies show the benefits of interventions targeting parents' interaction strategies in the early phases of development of infants at high risk for ASDs, in reducing the risk itself or its severity. Very early intervention, due to the presence of significant brain plasticity at these stages, may be particularly effective in changing these emerging trajectories, from a "preventive intervention" perspective that would aim to mitigate developmental risk and alter prodromal symptom trajectories, rather than eliminate a condition.

Our hypothesis is that the implementation of a specific therapeutic education program during a new pregnancy in the mother of a child with a diagnosis of ASD (MER Program) could improve the mother's well-being, increase parenting communication skills, and thereby improve interaction with the newborn at high risk for ASD. If the infant is affected, it may also reduce the symptoms of the disorder. Indirectly, it could also improve the well-being of the other parent involved in the interaction.

primary_purpose: Prevention


title: Incidence and Risk Factors for Secondary Severe Postpartum Hemorrhage in the General Population

acronym: SPPH

summary: Postpartum hemorrhage (PPH) remains one of the leading causes of maternal mortality and morbidity worldwide, including in France, where it accounts for approximately 20% of maternal mortality. Although numerous studies have examined immediate PPH, very few have explored secondary (also called late) PPH. Moreover, there are no guidelines in France for the management of secondary PPH. Its frequency appears to vary from 0.2% to 3.0% of deliveries. It is, however, difficult to estimate because only severe secondary PPH will lead to hospitalization and the rare publications concern single-center studies. The cause of these secondary hemorrhages is often unknown, due to the lack of routine uterine aspiration. Nonetheless, this aspiration is not always medically justified. The principal objective of this study is thus to establish the incidence of severe late PPH in the general population.

ReferenceCitation: Dewhurst CJ. Secondary post-partum haemorrhage. J Obstet Gynaecol Br Commonw. 1966 Feb;73(1):53-8.

ReferenceCitation: King PA, Duthie SJ, Dong ZG, Ma HK. Secondary postpartum haemorrhage. Aust N Z J Obstet Gynaecol. 1989 Nov;29(4):394-8.

ReferenceCitation: Hoveyda F, MacKenzie IZ. Secondary postpartum haemorrhage: incidence, morbidity and current management. BJOG. 2001 Sep;108(9):927-30.

ReferenceCitation: Dossou M, Debost-Legrand A, Déchelotte P, Lémery D, Vendittelli F. Severe secondary postpartum hemorrhage: a historical cohort. Birth. 2015 Jun;42(2):149-55. doi: 10.1111/birt.12164. Epub 2015 Apr 13.

ReferenceCitation: Vendittelli F, Dossou M, Debost-Legrand A, Déchelotte P, Lémery D. Reply. Birth. 2016 Jun;43(2):185-6. doi: 10.1111/birt.12224.

ReferenceCitation: Vendittelli F, Savary D, Storme B, Rieu V, Chabrot P, Charpy C, Lémery D, Jacquetin B. Ovarian thrombosis and uterine synechiae after arterial embolization for a late postpartum haemorrhage. Case Rep Womens Health. 2014 Nov 22;5:1-4. doi: 10.1016/j.crwh.2014.10.001. eCollection 2015 Jan.

ReferenceCitation: Debost-Legrand A, Rivière O, Dossou M, Vendittelli F. Risk Factors for Severe Secondary Postpartum Hemorrhages: A Historical Cohort Study. Birth. 2015 Sep;42(3):235-41. doi: 10.1111/birt.12175. Epub 2015 May 29.

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
Ch Thiers
Ch Aurillac
CH Saint-Flour
Chu Clermont-Ferrand
CH PUY
CH VICHY
Ch Issoire
Ch Moulins
Clinique La Chataigneraie
Ch Montlucon


title: Thrombophilia Screening in Women After Severe IUGR

summary: This retrospective study aims to assess the input of thrombophilia screening in pregnant women with severe intra-uterine growth restricted babies.

ipd_sharing: Undecided

lead_sponsor: Central Hospital, Nancy, France


title: Feasibility Study of Robotic Trans-Abdominal Retromuscular Umbilical Prosthesis (r-TARUP) for the Treatment of Primary and Incisional Ventral Hernia

acronym: r-TARUP

summary:
Combining the advantage of minimally invasive surgery with laparoscopy to reduce postoperative complications and the placement of a retromuscular prosthesis with closure of the defect in order to reduce the risk of adhesion and restore normal anatomy in the treatment of primary and incisional ventral hernias, is made possible through robotic assistance.

The challenge of this study concerns the evaluation of quality of life, postoperative pain and recurrence at 6 months in the management of primary and incisional ventral hernias by robot-assisted laparoscopic approach.

location_facility: Centre Hospitalier Régional Universitaire (CHRU)


title: The ICCA Study (Early Identification of Candida in Intra-abdominal CAndidiasis)

acronym: ICCA

summary:
Intra-abdominal candidiasis remains the first origin of invasive candidiasis in critically ill patients with a mortality up to 60%. This high mortality is partly related to delay of anti-fungal treatment administration. According to experts in the field, new diagnostic methods to rapidly detect Candida in intra-abdominal infections is mandatory because the current strategies suffer from a lack of both sensitivity and specificity.

The calscreener (SYMCEL®) is a new diagnostic tool to rapidly identify the presence of pathogens in biological samples based on micrometabolic activity detection.

The ICCA project will test the feasibility, the accuracy and the diagnostic performance of the calscreener on an existing biological collection of peritoneal fluid. This collection came from a cohort of critically ill patients with intra-abdominal infection which required abdominal surgery. Intra-abdominal infections consist of bacterial peritonitis and intra-abdominal candidiasis. The presence of pathogens (bacteria and yeast) is already known, the peritoneal fluid being stored after routine analysis (bacteriology / mycology).

Only the detection / identification of yeast will be investigated in this project.


title: A Cross-sectional Study : Is There a Relationship Between Hyperventilation Syndrome and History of Acute SARS-CoV-2 Infection?

acronym: Hypercovid

summary: Following an acute COVID-19 infection, many patients suffer from long lasting physical symptoms that may greatly impair quality of life. Persisting dyspnea and other functional respiratory complaints could evoke Hyperventilation Syndrome (HVS) as a putative contributor of the long-COVID presentation in COVID-19 survivors. We aimed to assess the possible relationship between a HVS and previous acute SARS-CoV-2 infection.

location_facility: Centre Hospitalier Régional Universitaire de Nancy.


title: Positive End-expiratory Pressure Setting in COVID-19 Related ARDS : Comparison Between Electrical Impedance Tomography, PEEP/ Fraction of Inspired Oxygen Tables, and Transpulmonary Pressure.

summary: The best way to titrate positive end-expiratory pressure (PEEP) in patients suffering from acute respiratory distress syndrome is still matter of debate. Electrical impedance tomography (EIT) in a non-invasive technique that could guide PEEP setting based on an optimized ventilation homogeneity.

location_facility: Service de Réanimation Médicale, Hôpital Central


title: Relief of Pain in Patients With Cervical Dystonia Through the Use of Sensory Threshold TENS

acronym: TENDYS

summary:
Dystonia is a chronic neurological condition that impacts the quality of life due to decreased mobility, social repercussions caused by others's perception of abnormal involuntary movement and frequent pain. Botulinum toxin has been shown to be effective in reducing pain in dystonia. However, many patients remain painful despite the injections, especially when the decrease in the effect of the latter, performed every 3 months on average. Despite frequent use of TENS in pain relief, only a few small studies studying TENS in dystonia were published and none of them reported TENS effects on dystonic pain using sensory threshold.

This study aimed to quantify the efficacy and tolerance of TENS in the indication of pain related to dystonia, focusing on cervical dystonia which is the most common form of dystonia.


title: Neurosarcoidosis : Initial Presentation and Disease Course, a Multicenter Retrospective Study

acronym: NEUROSARC

summary:
Neurosarcoidosis represents up to 10% of sarcoidosis cases. Little is known about its long-term course, even if the disease remains mainly monophasic with/w.o. sequelae, or if bouts of new symptoms may arise over years (polyphasic).

Using retrospective data from patients diagnosed with neurosarcoidosis in three French referral centers for neuro-inflammation, the investigators aim to determine patterns of disease course, according to the initial presentation and the treatments used.


title: Comparison of the TOFscan and the TetraGraph During Recovery of Neuromuscular Function : a Pilot Study

acronym: DECURAR-EMG

summary:
Assess the values of train-of-four ratios with the TetraGraph and thoses obtained with the TOFscan during recovery of neuromusculat function in surgical patients who have been administred rocuronium.

Primary outcome : value of TOFratio with the TetraGraph when TOFratio of TOFscan is greater than or equal to 90% Pilot study : no hypothesis


title: Impact of Parathyroidectomy on Renal Function in Patients With Primary Hyperparathyroidism

acronym: PARA-REIN

summary: Primary hyperparathyroidism (PHPT) is a disorder of one or more of the parathyroid glands. The parathyroid gland(s) becomes overactive and secretes excess amounts of parathyroid hormone (PTH). As a result, the blood calcium rises to a level that is higher than normal. PHPT is associated with several other metabolic complications as osteoporosis, kidney stones, hypertension, insulin resistance, cardiac calcifications, cardiac arrhythmias, and kidney failure. Renal function deterioration over time has also been reported. However, the role of parathyroidectomy on renal function remains controversial in patients with PHPT. In some studies, surgical cure of PHPT has been shown to halt renal function deterioration in patients with coexisting renal disease. On the other hand, other studies showed no significant impact of parathyroidectomy on renal function. Consequently, the goal of this study was to evaluate renal function before and after parathyroidectomy in a large cohort of patients with pHPT.


title: Assessment of Physiological Parameters Measurements (Heart Rate, Respiratory Rate, and Oxygen Saturation) by Standard Acquisition System Compared Remote Photoplethysmography Imaging System

summary:
Introduced in 1930, photoplethysmography techniques presented the possibility of measuring SpO2 and HR using the absorption of light by the blood to define these signals In recent years, a new approach to photoplethysmography to measure physiological parameters without contact has been developed. This technique, called remote Photoplethysmography Imaging (rPPG), uses the different Red - Green - Blue color spectra at a skin captured by the camera video to determine a plethysmography signal.

Although these systems have been technically valid, they have not been clinically evaluated in a health setting. This clinical trial is to assess parameters measurements by rPPG compared standard acquisition system in real conditions

ReferenceCitation: Allado E, Poussel M, Moussu A, Saunier V, Bernard Y, Albuisson E, Chenuel B. Innovative measurement of routine physiological variables (heart rate, respiratory rate and oxygen saturation) using a remote photoplethysmography imaging system: a prospective comparative trial protocol. BMJ Open. 2021 Aug 13;11(8):e047896. doi: 10.1136/bmjopen-2020-047896.


title: Proximal Interphalangeal Joint Arthroplasty With the TACTYS® Prosthesis : Clinical and Radiographic Results at Medium Term.

summary: Study at middle term of the functional and radiographic results of proximal interphalangeal joint arthroplasty with the Tactys prothesis. The aim is to evaluate if the short term results are maintained in time.

location_facility: Centre Hospitalier Régional Universitaire


title: Proof of Concept for the Development of Clinical or Mixed Prognostic Score of Morbidity After Endoscopic Subcostal Dissection for Colorectal Lesions in Nancy's Hospital Since 2016 to Nowadays

summary:
The mains complications in colo-rectal dissection are the pain, the delayed bleeding and the perforation and represent around 10%.

Currently, the procedure is realized during a hospitalization with not real recommendation about the time of this.

There is currently no score established for the colo-rectal endoscopic submucosal dissection.

To develop clinical or mixed prognostic score after endoscopic subcostal dissection for colorectal lesions in Nancy's hospital.
Allow to obtain an estimation of number of patients required for a larger study.


title: Evaluation of Two Methods of Olfactory Rehabilitation in Post-viral Loss of Smell: Classic and Intensive

acronym: Odorat-Covid

summary:
One of the most common causes of loss of smell is upper respiratory tract infection. These disorders can be quantitative (hyposmia or anosmia) or qualitative (parosmia or phantosmia). Loss of smell has been found as a major and frequent clinical sign of Sars Cov2 infection (more than 50% of patients screened at the CHU Nancy). Spontaneous recovery remains possible. It usually occurs in the first month . But when symptoms persist, the therapeutic management of post-viral anosmias is poorly codified in the literature. Olfactory rehabilitation could allow faster recovery and better quality, but the published protocols are numerous and could only be tested on small inhomogeneous series of patients (mixture of post-viral and post-traumatic hypo-ansomy). The significant increase in the population of patients suffering from post-viral anosmia following the current pandemic situation makes it possible to consider a prospective study aiming to compare two olfactory rehabilitation protocols: "classic" and "intensive" in a population of patients. suffering only from post-viral hypoanosmia.

Hypothesis: Intensive or classic olfactory rehabilitation allows better results than spontaneous recovery


title: Does PREVENA Vacuum-assisted Closure Reduce Lymphorrhoea Compared to Conventional Wound Closure After Axillary and Inguinal Lymph Node Dissection in the Management of Metastatic Cutaneous Skin Tumors ?

summary: In this study, we compared a negative pressure wound therapy, versus a conventional dressing in order to evaluate the most efficient wound therapy closure after axillary and inguinal lymph nodes dissections in the management of metastatic skin tumors. A vacuum assisted closure therapy should prevent these comorbidities.


title: Diagnostic Performance of Plasma Procalcitonin in Screening for Contamination When Detecting Potential Contaminants in Blood Cultures

summary:
In blood cultures, species considered as potentially contaminating (coagulase negative staphylococci (CNS), Bacillus spp., Corynebacterium spp., Cutibacterium acnes, Micrococcus spp., viridans group streptococci, and Clostridium perfringens) can, however, be responsable for true bacteremia.

Blood levels of the prohormone procalcitonin (PCT) markedly increase in the early stages of bacterial infections. The aim of our study is to determine the role of plasma PCT as a biomarker differentiating blood culture contaminations from true bacteremia.

ReferenceCitation: Lu B, Shi L, Zhu F, Zhao H. Clinical Utility of the Time-to-Positivity/Procalcitonin Ratio to Predict Bloodstream Infection Due to Coagulase-Negative Staphylococci. Lab Med. 1 nov 2013;44(4):313-8.

ReferenceCitation: Schuetz P, Mueller B, Trampuz A. Serum procalcitonin for discrimination of blood contamination from bloodstream infection due to coagulase-negative staphylococci. Infection. 2007 Oct;35(5):352-5. Epub 2007 Sep 19.

ReferenceCitation: Schuetz P, Albrich W, Mueller B. Procalcitonin for diagnosis of infection and guide to antibiotic decisions: past, present and future. BMC Med. 2011 Sep 22;9:107. doi: 10.1186/1741-7015-9-107. Review.

ReferenceCitation: Berthezène C, Aissa N, Manteaux AE, Guéant JL, Oussalah A, Lozniewski A. Accuracy of procalcitonin for diagnosing peripheral blood culture contamination among patients with positive blood culture for potential contaminants. Infection. 2021 Dec;49(6):1249-1255. doi: 10.1007/s15010-021-01697-4. Epub 2021 Sep 15.


title: Epidemiological Characteristics of the Population of Persons With Gender Dysphoria : Data From the Cohort Follow-up in CHRU de Nancy

acronym: DyGenEpi

summary: Retrospective study in a single academic regional transgender referral center. data from the cohort follow-up in CHRU de Nancy


title: Colonization of Bile Ducts and Post-operative Infectious Complications of Cephalic Duodenopancreatectomy : A Prospective Observational Study

summary:
Cephalic duodenopancreatectomy is part of the curative treatment for pancreatic cancer of the head and peri-ampullary area. The mortality of the procedure is around 5%, with a morbidity ranging from 30 to 50%. Infectious complications account for 35% of overall morbidity.

One of the risk factors for postoperative complications is the existence of preoperative retentional jaundice, due to tumoral obstruction of the main bile duct In these cases, it is proposed to perform preoperative bile duct drainage, preferably by endoscopic stenting (ERCP).

However, several studies have shown these procedures to cause biliary contamination which could be responsible for an increase in post-operative morbidity such as infectious complications and increased length of stay in hospital..

Thus, the biliary microbial flora is more often multi-microbial and may contain multidrug-resistant nosocomial germs,

The study carried out by Cortes et al., based on a control case study design, also showed that a correlation between biliary colonization and postoperative infectious complications existed in patients who benefited from a preoperative biliary drainage technique. In fact, the bacteria isolated during intraoperative bile sampling were similar, in 49% of cases, to those isolated during bacteriological samples collected postoperatively during infectious complications.

The work carried out by Krüger and al has shown that the spectrum of bacteria found in the preoperative bile samples from patients who have undergone bile duct dilation is potentially not covered by standard antibiotic therapy.

The aim of this observational prospective study is to investigate this correlation between biliary colonization and postoperative infectious complications, to evaluate the morbidity and postoperative mortality of cephalic duodenopancreatectomies performed at the CHRU of Nancy and to study a possible adaptation of perioperative antibiotic prophylaxis.

ReferenceCitation: Ho V, Heslin MJ. Effect of hospital volume and experience on in-hospital mortality for pancreaticoduodenectomy. Ann Surg. 2003 Apr;237(4):509-14.

ReferenceCitation: DeOliveira ML, Winter JM, Schafer M, Cunningham SC, Cameron JL, Yeo CJ, Clavien PA. Assessment of complications after pancreatic surgery: A novel grading system applied to 633 patients undergoing pancreaticoduodenectomy. Ann Surg. 2006 Dec;244(6):931-7; discussion 937-9.

ReferenceCitation: Okano K, Hirao T, Unno M, Fujii T, Yoshitomi H, Suzuki S, Satoi S, Takahashi S, Kainuma O, Suzuki Y. Postoperative infectious complications after pancreatic resection. Br J Surg. 2015 Nov;102(12):1551-60. doi: 10.1002/bjs.9919. Epub 2015 Sep 21.

ReferenceCitation: Yu L, Huang Q, Xie F, Lin X, Liu C. Risk factors of postoperative complications of pancreatoduodenectomy. Hepatogastroenterology. 2014 Oct;61(135):2091-5.

ReferenceCitation: Lermite E, Pessaux P, Teyssedou C, Etienne S, Brehant O, Arnaud JP. Effect of preoperative endoscopic biliary drainage on infectious morbidity after pancreatoduodenectomy: a case-control study. Am J Surg. 2008 Apr;195(4):442-6. doi: 10.1016/j.amjsurg.2007.03.016.

ReferenceCitation: Scheufele F, Aichinger L, Jäger C, Demir IE, Schorn S, Sargut M, Erkan M, Kleeff J, Friess H, Ceyhan GO. Effect of preoperative biliary drainage on bacterial flora in bile of patients with periampullary cancer. Br J Surg. 2017 Jan;104(2):e182-e188. doi: 10.1002/bjs.10450.

ReferenceCitation: Cortes A, Sauvanet A, Bert F, Janny S, Sockeel P, Kianmanesh R, Ponsot P, Ruszniewski P, Belghiti J. Effect of bile contamination on immediate outcomes after pancreaticoduodenectomy for tumor. J Am Coll Surg. 2006 Jan;202(1):93-9. Epub 2005 Nov 18.

ReferenceCitation: Krüger CM, Adam U, Adam T, Kramer A, Heidecke CD, Makowiec F, Riediger H. Bacterobilia in pancreatic surgery-conclusions for perioperative antibiotic prophylaxis. World J Gastroenterol. 2019 Nov 7;25(41):6238-6247. doi: 10.3748/wjg.v25.i41.6238.


title: Demographic Characteristics and Psychosocial Health of Transgender People

acronym: DyGeDem

summary: To study demographic characteristics of subjects referred to endocrine care for gender dysphoria and their psychosocial health


title: Infections and Colonization With the Third Group of Enterobacteriaceae in the Intensive Care Impact on the Mortality and Morbidity

summary: There is a lack of data whether colonization and infection with Enterobacteriaceae of the third group (EB3) affect the outcomes for ICU patients. This study evaluated the effects of EB3 colonization and infection on ICU mortality, ICU length of stay (LOS) and broad-spectrum antibiotic exposure. We focused on the sub type Enterobacter regarding its a priori higher risk of resistance.


title: Assessment of Diagnostic and Therapeutic Practices for Cardiac Implantable Electronic Devices Suspected Infections in Nancy University Hospital

summary:
The frequency of cardiac implantable electronic devices (CIED) is constantly increasing.

Devices infections are one of the most serious complications in terms of morbidity and mortality. Although the frequency of cardiac implantable devices infections is difficult to derminate due to divergent definitions, cohort studies report a trend of increasing.

The infection can be localized at the pocket of the implantation, at intravascular or intra-cardiac portion of leads. Infectious endocarditis defined by involvement of the intra-cardiac portion of leads is the most serious form. The diagnosis is based on clinical, biological and multimodal imagery data. Early diagnosis and specific management are necessary to reduce mortality and morbidity.

Since the last European recommendations on infectious endocarditis in 2015, the HeartRythm Society of patient described an algorithm to treat CIED infections and extraction indications.

However, in practice, management of CEID infections remains center-dependent and data from robust international studies are missing.

The main objective of our study is to evaluate the management of CEID suspected infections and the prognosis at 1 year in terms of survival according to the methods of treatment at the Nancy University Hospital and to compare the treatment with the latest recommendations in force

ReferenceCitation: Greenspon AJ, Patel JD, Lau E, Ochoa JA, Frisch DR, Ho RT, Pavri BB, Kurtz SM. 16-year trends in the infection burden for pacemakers and implantable cardioverter-defibrillators in the United States 1993 to 2008. J Am Coll Cardiol. 2011 Aug 30;58(10):1001-6. doi: 10.1016/j.jacc.2011.04.033.

ReferenceCitation: Joy PS, Kumar G, Poole JE, London B, Olshansky B. Cardiac implantable electronic device infections: Who is at greatest risk? Heart Rhythm. 2017 Jun;14(6):839-845. doi: 10.1016/j.hrthm.2017.03.019. Epub 2017 Mar 16.

ReferenceCitation: Habib G, Lancellotti P, Antunes MJ, Bongiorni MG, Casalta JP, Del Zotti F, Dulgheru R, El Khoury G, Erba PA, Iung B, Miro JM, Mulder BJ, Plonska-Gosciniak E, Price S, Roos-Hesselink J, Snygg-Martin U, Thuny F, Tornos Mas P, Vilacosta I, Zamorano JL; ESC Scientific Document Group . 2015 ESC Guidelines for the management of infective endocarditis: The Task Force for the Management of Infective Endocarditis of the European Society of Cardiology (ESC). Endorsed by: European Association for Cardio-Thoracic Surgery (EACTS), the European Association of Nuclear Medicine (EANM). Eur Heart J. 2015 Nov 21;36(44):3075-3128. doi: 10.1093/eurheartj/ehv319. Epub 2015 Aug 29.

ReferenceCitation: Kusumoto FM, Schoenfeld MH, Wilkoff BL, Berul CI, Birgersdotter-Green UM, Carrillo R, Cha YM, Clancy J, Deharo JC, Ellenbogen KA, Exner D, Hussein AA, Kennergren C, Krahn A, Lee R, Love CJ, Madden RA, Mazzetti HA, Moore JC, Parsonnet J, Patton KK, Rozner MA, Selzman KA, Shoda M, Srivathsan K, Strathmore NF, Swerdlow CD, Tompkins C, Wazni O. 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart Rhythm. 2017 Dec;14(12):e503-e551. doi: 10.1016/j.hrthm.2017.09.001. Epub 2017 Sep 15. Review. Erratum in: Heart Rhythm. 2021 Oct;18(10):1814.

ipd_sharing: Yes

ipd_sharing_description: Anonymous individual datas for baseline characteristcs and clinical outcomes would be available


title: Distribution and Prognostic Impact of Oncogenic Drivers in Metastatic Lung Adenocarcinoma : a Retrospective Monocentric Study in Nancy University Hospital Center

summary: The recent discovery of oncogenic drivers has revolutionized the management of advanced lung cancer by development of tyrosine kinase inhibitors targeted therapies. Prevalence of daily tobacco use is evaluated at 31,3 % in Grand-Est region, the only French region with a statistically significative difference for smoking habits. This region shows a higher incidence (+ 13 %) and mortality for lung cancer in comparison to the average for other French regions. The objectives of our studie were to estimate the distribution of oncogenic drivers and analyse their prognostic impacts in the Nancy University Hospital Center metastatic lung adenocarcinoma's population.


title: Optimization for Clinical Routine of a Dosimetry Protocol Using the Large Field of View VERITON-CT CZT Camera in Patients Treated With LUTATHERA® [177Lu- [DOTA0, Tyr3] -Octreotate

summary: The aim of this study is to assess the consistency between a dosimetry protocol using a large field of view CZT-camera and the dosimetry protocol used for recordings acquired with a conventional camera. Therefore, with the conventional camera, recordings are acquired on the "high energy" peak of lutetium 177 (208 keV) using a medium energy collimator. With the VERITON-CT™ CZT camera, recordings are acquired using the low energy peak of 113 keV. A second objective is to compare results between the dosimetry calculated using 3 measurement points (24h, 96h and 168h) and the dosimetry calculated using 2 measurement points (24h and 168h), obtained from the SYMBIA T conventional camera and the VERITON-CT™camera, respectively.

primary_purpose: Supportive Care


title: Nutritional Follow up After Hospital Discharge for Coronavirus Disease-19

acronym: NutriCoviDom

summary:
Coronavirus infection is responsible for muscle wasting (sarcopenia), especially during prolonged stays in intensive care. Sarcopenia, in its functional aspect also seems major in patients hospitalized for this infection, in non-ICU unit. Weight loss also appears to be significant, despite a prevalence of overweight and obesity in severe forms. Undernutrition in the obese patient is also possible (undernourished obese and sarcopenia obesity). Anosmia and dysgeusia participate in undernutrition by reducing energy intake. The rehabilitation of these patients requires nutritional support (increased protein intake) associated with progressive retraining to physical activity.

An early and proactive management procedure within Coronavirus disease-19 units has been implemented in conjunction with the Transversal Nutrition Unit (TNU). This nutritional care must be continued after discharge. Follow-up by teleconsultation or telephone consultation is put in place after the patient's discharge Primary Objective: Evaluation of nutritional status at the time of admission and discharge and home follow-up in outgoing patients from Coronavirus disease-19 Units Secondary objectives: Description of the evolution of food intake, diversity of food and coverage of needs Evaluation of the muscular strength of the wrist (by grip test in hospital) and on the arms and legs after return home (visual analog scale) Evolution of anosmia and dysgeusia (at the time of hospital admission, at the time of hospital discharge and at home) Level of physical training before infection (IPAQ) Description of the general state of health measured by the performance index - world health organization scale Description of nutritional prescriptions Description of the prevention measures and incidence of Inappropriate Refeeding Syndrome (IRS) Care needs assessments

ReferenceCitation: Quilliot D, Gérard M, Bonsack O, Malgras A, Vaillant MF, Di Patrizio P, Jaussaud R, Ziegler O, Nguyen-Thi PL. Impact of severe SARS-CoV-2 infection on nutritional status and subjective functional loss in a prospective cohort of COVID-19 survivors. BMJ Open. 2021 Jul 14;11(7):e048948. doi: 10.1136/bmjopen-2021-048948.


title: Long Term Outcomes of Cold Stored Venous Allografts in Vascular Access for Hemodialysis

acronym: RAVASC

summary:
Vascular access creation in patients with renal failure requiring long-term hemodialysis can be a challenge when there is no more autologous material or in case of infection, in a population undergoing long term dialysis with a longer life-expectancy. Many types of grafts have been used, with its advantages and drawbacks, such as prosthetic grafts (PTFE). Over the past decade, surgeons have used cold stored venous allografts as a biological conduit for hemodialysis, with the idea of avoiding most of major complications including a lower incidence of infection and steal syndrome, with patencies at least equivalent to PTFE. There is only a few data in the litterature, but many surgical teams use it when there is no autologous material or in case of infection.

The aim of the study is to give the primary patency of vascular access with this technique, and to assess its long term outcomes.

ReferenceCitation: Schmidli J, Widmer MK, Basile C, de Donato G, Gallieni M, Gibbons CP, Haage P, Hamilton G, Hedin U, Kamper L, Lazarides MK, Lindsey B, Mestres G, Pegoraro M, Roy J, Setacci C, Shemesh D, Tordoir JHM, van Loon M, Esvs Guidelines Committee, Kolh P, de Borst GJ, Chakfe N, Debus S, Hinchliffe R, Kakkos S, Koncar I, Lindholt J, Naylor R, Vega de Ceniga M, Vermassen F, Verzini F, Esvs Guidelines Reviewers, Mohaupt M, Ricco JB, Roca-Tey R. Editor's Choice - Vascular Access: 2018 Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2018 Jun;55(6):757-818. doi: 10.1016/j.ejvs.2018.02.001. Epub 2018 May 2.

ReferenceCitation: Heintjes RJ, Eikelboom BC, Steijling JJ, van Reedt Dortland RW, van der Heijden FH, Bastini M, van der Graaf Y, Blankestijn PJ, Vos J. The results of denatured homologous vein grafts as conduits for secondary haemodialysis access surgery. Eur J Vasc Endovasc Surg. 1995 Jan;9(1):58-63.

ReferenceCitation: Schneider M, Barrou B, Cluzel P, Hamani A, Bitker MO, Richard F. [Value of preserved saphenous vein graft for the creation of access ports in hemodialyzed patients: report of 309 cases]. Prog Urol. 2003 Sep;13(4):585-91. French.

ReferenceCitation: Berardinelli L. Grafts and graft materials as vascular substitutes for haemodialysis access construction. Eur J Vasc Endovasc Surg. 2006 Aug;32(2):203-11. Epub 2006 Feb 20. Review.

ReferenceCitation: Nedved K, Suchý T, Hálová J, Malický M, Gorun P, Vitvar P. Allogenous vein graft as vascular access for hemodialysis--lost battle? J Vasc Access. 2012 Jul-Sep;13(3):366-73. doi: 10.5301/jva.5000062.

location_facility: Departement of Vascular Surgery Nancy University Hospital


title: Monitoring of Sleepiness in Patients With Parkinson's Disease Before and During Treatment With Continuous Dopaminergic Delivery Device or Deep Brain Stimulation

summary: Sleepiness is frequent in parkinsonian patients, increasing with the duration of disease. By patients with motor fluctuations, continuous dopaminergic delivery devices or deep brain stimulation are justified to improve the motor prognosis. Antiparkinsonian treatments, especially dopaminergic agonists, may worsen the sleepiness and thus affect the quality of life. The investigators aimed to monitor sleepiness in parkinsonian patients before and during treatment with continous dopaminergic delivery device or deep brain stimulation.


title: Performance of CT Parameters (SBAC-L1, Fractal Analysis) Compared to BMD (Gold Standard) to Detect Vertebral Fractures in rheumatoïd Arthritis

summary: Objective: To evaluate the performance of CT parameters (SBAC-L1 and fractal analysis) compared to BMD (gold standard) to detect vertebral fractures in rheumatoid arthritis


title: Evaluation of the Prevalence of Critical Forms of CoVid-19 in Patients With Chronic Respiratory Disease Hospitalized for Severe Forms

acronym: CRITICoVid

summary:
A new Coronavirus (SARS-CoV-2) emerged in Wuhan Province, China in December 2019 and rapidly spread around the world. To date, the data in the literature regarding the clinical and epidemiological characteristics of severe forms of CoVid-19 in patients with chronic respiratory disease are not well known.

The hypothesis is that patients with chronic respiratory disease (COPD, asthma, bronchial dilatations, pulmonary hypertension, cystic fibrosis, obesity-hypoventilation syndrome, obstructive sleep apnea syndrome) infected with SARS-Cov-2 will have increased dyspnea and hypoxemia leading to hospitalization for severe forms more frequently than the general population. However, they do not appear to be more at risk of developing a critical form.

This study is carried out in order to propose to estimate the prevalence of critical forms of CoVid19 among patients with chronic respiratory diseases hospitalized for severe forms.

ReferenceType: result

ReferenceCitation: Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

ReferenceCitation: Fang L, Gao P, Bao H, Tang X, Wang B, Feng Y, Cong S, Juan J, Fan J, Lu K, Wang N, Hu Y, Wang L. Chronic obstructive pulmonary disease in China: a nationwide prevalence study. Lancet Respir Med. 2018 Jun;6(6):421-430. doi: 10.1016/S2213-2600(18)30103-6. Epub 2018 Apr 9.

ReferenceCitation: Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.

ReferenceCitation: Zhang JJ, Dong X, Cao YY, Yuan YD, Yang YB, Yan YQ, Akdis CA, Gao YD. Clinical characteristics of 140 patients infected with SARS-CoV-2 in Wuhan, China. Allergy. 2020 Jul;75(7):1730-1741. doi: 10.1111/all.14238. Epub 2020 Feb 27.


title: Novel Imaging Techniques for the Characterization of Musculoskeletal Tumors II: Texture Analysis and Artificial Intelligence

acronym: TUMOSTEO II

summary: This study aims at evaluating the value of various artificial intelligence based techniques to improve the characterization and image post-processing for patients with musculoskeletal tumors.


title: Comparative Study on the Relationship Between Fluid REsponsiveness and Arterial ELASTANCE in Patients With Septic Shock or in the Postoperative Course of Aortic Surgery

acronym: RELASTANCE

summary:
The MostCare system, thanks to the Pressure Recording Analytical Method (PRAM; Vygon, Padua, Italy), provides new hemodynamic parameters of the cardiovascular system. The PRAM method is a noncalibrated pulse contour method which requires only an arterial line (radial or femoral). This method has been validated in various clinical conditions. Among the collected parameters, some are well known and used daily care in Intensive Care Unit (ICU), i.e. cardiac output (CO), arterial pressure, heart rate, stroke volume (SV). Others such as arterial elastance (Ea) or dicrotic pressure are more recent and merit further investigation to determine their interest in clinical practice. To date, it is rarely used to adapt therapies, mostly because of a lack of knowledge regarding the evolution of these parameters.

The aim of this study is to analyze the relationship between the evolution of Arterial Elastance and fluid responsiveness after a 250 mL fluid challenge of crystalloids in 5 minutes in patients with either septic shock or in the postoperative course of a major vascular surgery.

Patients will be considered fluid responders if an increase >10% of the stroke volume is observed .

ReferenceCitation: Romagnoli S, Franchi F, Ricci Z, Scolletta S, Payen D. The Pressure Recording Analytical Method (PRAM): Technical Concepts and Literature Review. J Cardiothorac Vasc Anesth. 2017 Aug;31(4):1460-1470. doi: 10.1053/j.jvca.2016.09.004. Epub 2016 Sep 14. Review.

ReferenceCitation: Romagnoli S, Ricci Z, Romano SM, Dimizio F, Bonicolini E, Quattrone D, De Gaudio R. FloTrac/Vigileo(TM) (third generation) and MostCare(®)/PRAM versus echocardiography for cardiac output estimation in vascular surgery. J Cardiothorac Vasc Anesth. 2013 Dec;27(6):1114-21. doi: 10.1053/j.jvca.2013.04.017. Epub 2013 Sep 19.

ReferenceCitation: Gopal S, Do T, Pooni JS, Martinelli G. Validation of cardiac output studies from the Mostcare compared to a pulmonary artery catheter in septic patients. Minerva Anestesiol. 2014 Mar;80(3):314-23. Epub 2014 Jan 8.

ReferenceCitation: Messina A, Romano SM, Bonicolini E, Colombo D, Cammarota G, Chiostri M, Della Corte F, Navalesi P, Payen D, Romagnoli S. Cardiac cycle efficiency and dicrotic pressure variations: new parameters for fluid therapy: An observational study. Eur J Anaesthesiol. 2017 Nov;34(11):755-763. doi: 10.1097/EJA.0000000000000661.

ReferenceCitation: Monge García MI, Guijo González P, Gracia Romero M, Gil Cano A, Oscier C, Rhodes A, Grounds RM, Cecconi M. Effects of fluid administration on arterial load in septic shock patients. Intensive Care Med. 2015 Jul;41(7):1247-55. doi: 10.1007/s00134-015-3898-7. Epub 2015 Jun 11.

ReferenceCitation: Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.

ReferenceCitation: Chantler PD, Lakatta EG, Najjar SS. Arterial-ventricular coupling: mechanistic insights into cardiovascular performance at rest and during exercise. J Appl Physiol (1985). 2008 Oct;105(4):1342-51. doi: 10.1152/japplphysiol.90600.2008. Epub 2008 Jul 10. Review. Erratum in: J Appl Physiol. 2009 Mar;106(3):1027.

ReferenceCitation: Sunagawa K, Maughan WL, Burkhoff D, Sagawa K. Left ventricular interaction with arterial load studied in isolated canine ventricle. Am J Physiol. 1983 Nov;245(5 Pt 1):H773-80.

ReferenceCitation: Guarracino F, Baldassarri R, Pinsky MR. Ventriculo-arterial decoupling in acutely altered hemodynamic states. Crit Care. 2013 Mar 19;17(2):213. doi: 10.1186/cc12522. Review.

ReferenceCitation: Suga H. Time course of left ventricular pressure-volume relationship under various enddiastolic volume. Jpn Heart J. 1969 Nov;10(6):509-15.

ReferenceCitation: Guarracino F, Ferro B, Morelli A, Bertini P, Baldassarri R, Pinsky MR. Ventriculoarterial decoupling in human septic shock. Crit Care. 2014 Apr 24;18(2):R80. doi: 10.1186/cc13842.

ReferenceCitation: Morelli A, Singer M, Ranieri VM, D'Egidio A, Mascia L, Orecchioni A, Piscioneri F, Guarracino F, Greco E, Peruzzi M, Biondi-Zoccai G, Frati G, Romano SM. Heart rate reduction with esmolol is associated with improved arterial elastance in patients with septic shock: a prospective observational study. Intensive Care Med. 2016 Oct;42(10):1528-1534. doi: 10.1007/s00134-016-4351-2. Epub 2016 Apr 21.

ReferenceCitation: Walley KR. Left ventricular function: time-varying elastance and left ventricular aortic coupling. Crit Care. 2016 Sep 10;20:270. doi: 10.1186/s13054-016-1439-6. Review.

ReferenceCitation: Guinot PG, Longrois D, Kamel S, Lorne E, Dupont H. Ventriculo-Arterial Coupling Analysis Predicts the Hemodynamic Response to Norepinephrine in Hypotensive Postoperative Patients: A Prospective Observational Study. Crit Care Med. 2018 Jan;46(1):e17-e25. doi: 10.1097/CCM.0000000000002772.


title: Evaluation of Airway Pressure Release Ventilation on Oxygenation in Acute Respiratory Distress Syndrome in Adult Patients With COVID-19 Pneumonia

summary:
The 2020 pandemic of the coronavirus (SARS-CoV2) has lead to an increase in ARDS cases requiring invasive mechanical ventilation in the ICU (Intensive Care Unit).

The investigators hypothesize that airway pressure release ventilation (APRV) could be beneficial in patients with ARDS secondary to SARS-COV2 viral pneumonia.

ReferenceCitation: Zhou Y, Jin X, Lv Y, Wang P, Yang Y, Liang G, Wang B, Kang Y. Early application of airway pressure release ventilation may reduce the duration of mechanical ventilation in acute respiratory distress syndrome. Intensive Care Med. 2017 Nov;43(11):1648-1659. doi: 10.1007/s00134-017-4912-z. Epub 2017 Sep 22.

ReferenceCitation: Nieman GF, Al-Khalisy H, Kollisch-Singule M, Satalin J, Blair S, Trikha G, Andrews P, Madden M, Gatto LA, Habashi NM. A Physiologically Informed Strategy to Effectively Open, Stabilize, and Protect the Acutely Injured Lung. Front Physiol. 2020 Mar 19;11:227. doi: 10.3389/fphys.2020.00227. eCollection 2020. Review.

location_facility: Centre Hospitalier Régional Universitaire de Nancy


title: Predictive Factors for the Results of Epiphysiodesis in Limb Length Discrepancy

summary:
Several techniques exist for epiphysiodesis in limb length discrepancy with different results. Most of the time the results are disappointing for this functional surgery.

The aim of this study is understanding the reasons of the failures by analyzing the different steps of the medical care.

The patients will be distributed in two groups : "fulfilled contract" and "failed contract" The differences between the two groups will be analyzed.


title: Analgesia Assessment of Conversational Hypnosis Script During Peripherical Veinous Catheter Set up Versus Standard Script in Operating Room

acronym: HYPNACESS

summary:
The peripherical veinous catheterization is required for anesthesia. However, it's a painful procedure and causes stress or even phobia.

Hypnosis can be seen as an interesting tool. Conversational hypnosis needs no training. It is used by script, which makes it easier.

The working hypothesis for study is that the conversational hypnosia script reduces pain during the set up of peripherical veinous access.

The main objective is the analgesia assessment of conversational hypnosis script for peripherical veinous catheter set up versus standard script in operating room. A nurse anesthetist is reading the conversational script or standard script during the procedure. The nurse anesthetist is untrained for hypnosis.

The secondary objective are the level of anxiety, patient satisfaction within the perioperative period (EVAN G questionnaire), the heart rate and the evaluation how nurse anesthetist feels about using the script after each use.

ReferenceCitation: Armstrong P, Young C, McKeown D. Ethyl chloride and venepuncture pain: a comparison with intradermal lidocaine. Can J Anaesth. 1990 Sep;37(6):656-8.

ReferenceCitation: Nir Y, Paz A, Sabo E, Potasman I. Fear of injections in young adults: prevalence and associations. Am J Trop Med Hyg. 2003 Mar;68(3):341-4.

ReferenceCitation: Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.

ReferenceCitation: Auquier P, Pernoud N, Bruder N, Simeoni MC, Auffray JP, Colavolpe C, François G, Gouin F, Manelli JC, Martin C, Sapin C, Blache JL. Development and validation of a perioperative satisfaction questionnaire. Anesthesiology. 2005 Jun;102(6):1116-23.


title: Hepatic Artery From Origin to Segmental Branching: a 500 Case CT Study

summary:
The origin of the hepatic artery is known to be highly variable, as reported by Michels in 1966 and other authors. This variability has an indisputable impact regarding hepatic, pancreatic and upper gastro-intestinal surgery.

As the investigators go deeper into the liver's parenchyma, full-liver and segment IV studies have also found high levels of variability. Only few cadaveric studies have analyzed the entire liver and with limited sample size.

The current CT technology allows for an accurate analysis of the arterial branching thanks to the 0.625mm voxel.

The aim of this CT study is to describe the anatomy of hepatic arterial segmental branching from the origin of the hepatic artery.


title: Clinical, Paraclinical, Functional Characteristics and Evolution of Juvenile Autoimmune Necrotizing Myopathies in a National Retrospective Cohort

acronym: MYONECPED

summary: Autoimmune necrotizing myopathies (AINM) in adult patients are characterized by severity of muscle damage, presence of necrosis with little inflammation on muscle biopsy and anti-HMGCR or anti-SRP auto-antibodies. Data on AINM in children are currently lacking. The purpose of this study is to specify the characteristics at AINM diagnosis, treatments and evolution of juvenile AINM with anti-HMGCR or anti-SRP antibodies.

ReferenceCitation: Benveniste O, Stenzel W, Allenbach Y. Advances in serological diagnostics of inflammatory myopathies. Curr Opin Neurol. 2016 Oct;29(5):662-73. doi: 10.1097/WCO.0000000000000376. Review.

ReferenceCitation: Mariampillai K, Granger B, Amelin D, Guiguet M, Hachulla E, Maurier F, Meyer A, Tohmé A, Charuel JL, Musset L, Allenbach Y, Benveniste O. Development of a New Classification System for Idiopathic Inflammatory Myopathies Based on Clinical Manifestations and Myositis-Specific Autoantibodies. JAMA Neurol. 2018 Dec 1;75(12):1528-1537. doi: 10.1001/jamaneurol.2018.2598.

ReferenceCitation: Watanabe Y, Uruha A, Suzuki S, Nakahara J, Hamanaka K, Takayama K, Suzuki N, Nishino I. Clinical features and prognosis in anti-SRP and anti-HMGCR necrotising myopathy. J Neurol Neurosurg Psychiatry. 2016 Oct;87(10):1038-44. doi: 10.1136/jnnp-2016-313166. Epub 2016 May 4.

ReferenceCitation: Allenbach Y, Drouot L, Rigolet A, Charuel JL, Jouen F, Romero NB, Maisonobe T, Dubourg O, Behin A, Laforet P, Stojkovic T, Eymard B, Costedoat-Chalumeau N, Campana-Salort E, Tournadre A, Musset L, Bader-Meunier B, Kone-Paut I, Sibilia J, Servais L, Fain O, Larroche C, Diot E, Terrier B, De Paz R, Dossier A, Menard D, Morati C, Roux M, Ferrer X, Martinet J, Besnard S, Bellance R, Cacoub P, Arnaud L, Grosbois B, Herson S, Boyer O, Benveniste O; French Myositis Network. Anti-HMGCR autoantibodies in European patients with autoimmune necrotizing myopathies: inconstant exposure to statin. Medicine (Baltimore). 2014 May;93(3):150-157. doi: 10.1097/MD.0000000000000028.

ReferenceCitation: Anti-HMGCR Autoantibodies in Juvenile Idiopathic Inflammatory Myopathies Identify a Rare but Clinically Important Subset of Patients. J Rheumatol. 2017 Sep;44(9):1417. doi: 10.3899/jrheum.160871.C1.

ReferenceCitation: Liang WC, Uruha A, Suzuki S, Murakami N, Takeshita E, Chen WZ, Jong YJ, Endo Y, Komaki H, Fujii T, Kawano Y, Mori-Yoshimura M, Oya Y, Xi J, Zhu W, Zhao C, Watanabe Y, Ikemoto K, Nishikawa A, Hamanaka K, Mitsuhashi S, Suzuki N, Nishino I. Pediatric necrotizing myopathy associated with anti-3-hydroxy-3-methylglutaryl-coenzyme A reductase antibodies. Rheumatology (Oxford). 2017 Feb;56(2):287-293. doi: 10.1093/rheumatology/kew386. Epub 2016 Nov 6.

ReferenceCitation: Tiniakou E, Pinal-Fernandez I, Lloyd TE, Albayda J, Paik J, Werner JL, Parks CA, Casciola-Rosen L, Christopher-Stine L, Mammen AL. More severe disease and slower recovery in younger patients with anti-3-hydroxy-3-methylglutaryl-coenzyme A reductase-associated autoimmune myopathy. Rheumatology (Oxford). 2017 May 1;56(5):787-794. doi: 10.1093/rheumatology/kew470.

ReferenceCitation: Binns EL, Moraitis E, Maillard S, Tansley S, McHugh N, Jacques TS, Wedderburn LR, Pilkington C, Yasin SA, Nistala K; UK Juvenile Dermatomyositis Research Group (UK and Ireland). Effective induction therapy for anti-SRP associated myositis in childhood: A small case series and review of the literature. Pediatr Rheumatol Online J. 2017 Oct 31;15(1):77. doi: 10.1186/s12969-017-0205-x. Review.


title: Interdependency Between Cognitive and Postural Activities in Prematurely Born Children

acronym: COGNIPOST

summary: Prematurely born children (PC) have academic difficulties related to poorer attention capabilities. Additionally, they often show excessive mobility, quoted as agitation. Some consider it could be related to poorer postural control and impaired perception of gravity vertical. But, this excessive mobility could also be an unconscious way for PC to improve their attention performance. The aim of this study is to evaluate the interdependence between postural and cognitive activities in school age PC versus term born children (TC). First, the performance of PC and TC at the Attention Network Test for Children will be analyzed with the use of a mobile versus a classic school chair. Secondly, participants will have to position a stick vertically to measure their perception of vertical gravity. Finally, the spontaneous postural activity of PC and TC (evaluated by the center of pressure displacement) will be studied during the execution of three different attention tasks at different levels of difficulty. Success rate and reaction time will be analyzed for all attention tasks. Moreover, center of pressure displacement calculation will allow evaluation of infants' spontaneous mobility, the precision of their postural control and the attention allocated to their posture.

location_facility: Maternite Regionale Universitaire CHRU NANCY

intervention_type: Behavioral


title: Bradycardia High Risk Patient Identification After Syncope With Loop Recorder an Observational Study in Nancy University Hospital

summary:
Syncope is a common symptom that may be related to a conductive disorder. If no bradycardia is authenticated, it is often necessary to implant an implantable loop recorder.

In somes cases, implantable loop recorder records cardiac conductive disorders. In this study, we want to try to identify a group of patients for whom we could immediately implant a pacemaker without prior implantation of an implantable loop recorder given the high probability of implantation of a pacemaker after interrogation of the implantable loop recorder. It would be interesting for the reduction of interventions for the patients and for the economic aspect of the healthcare system

ReferenceCitation: Brignole M, Moya A, de Lange FJ, Deharo JC, Elliott PM, Fanciulli A, Fedorowski A, Furlan R, Kenny RA, Martín A, Probst V, Reed MJ, Rice CP, Sutton R, Ungar A, van Dijk JG; ESC Scientific Document Group . 2018 ESC Guidelines for the diagnosis and management of syncope. Eur Heart J. 2018 Jun 1;39(21):1883-1948. doi: 10.1093/eurheartj/ehy037.

ReferenceCitation: Edvardsson N, Wolff C, Tsintzos S, Rieger G, Linker NJ. Costs of unstructured investigation of unexplained syncope: insights from a micro-costing analysis of the observational PICTURE registry. Europace. 2015 Jul;17(7):1141-8. doi: 10.1093/europace/euu412. Epub 2015 Mar 10.

ReferenceCitation: Padmanabhan D, Kancharla K, El-Harasis MA, Isath A, Makkar N, Noseworthy PA, Friedman PA, Cha YM, Kapa S. Diagnostic and therapeutic value of implantable loop recorder: A tertiary care center experience. Pacing Clin Electrophysiol. 2019 Jan;42(1):38-45. doi: 10.1111/pace.13533. Epub 2018 Dec 4.

ipd_sharing_description: anonymous individual datas for baseling pre implantatory caracteristcs and clinical outecome would be available


title: Morbidity of Abdominal Wall Hernia Reconstruction With Mesh: Study of Environmental Risk Factors in the Operating Room in the CHRU of Nancy- a Prospective Study

summary:
Mesh infection is the main complication in abdominal hernia repair. In case of infection, a conservative management of mesh is not always possible. The removal of the mesh (occurring in 5.1% to 8% of wall hernia repair) increases the risk of recurrence and surgical morbidity.

Within our digestive surgery department (CHRU de Nancy), an infection rate of 10.7% (32 cases out of 298 patients with wall hernia repair) was observed between January 2016 and December 2018. This rate is higher than those usually described in the literature.

Several studies have identified predictors of mesh infection and explantation after abdominal wall hernia repair. The influence of the operating environment (temperature, hygrometry, pressure, number of people present, etc.) has, to our knowledge, never been studied.

If the risk of prosthesis infection is influenced by one or more of these extrinsic characteristics, it is possible to act on these practices to reduce this risk.

The main purpose of this study is to identify the characteristics specific to the intervention and the operating environment associated with mesh infection after abdominal wall hernia reconstruction


title: Bone Fragility Evaluation by Dual X-Ray Absorptiometry (DXA) and CT-scan (Vertebral Fracture and Scanographic Bone Attenuation Coefficient of the First Lumbar Vertebra SBAC-L1) in Obese Patients

summary: This research will study the bone fragility in obese patients, on DXA and CT-scan, in a transversal study. The investigators want also to study the specific risk factors of bone fragility in these obese patients (relationship between body composition on whole body on DXA, fat mass and its location, lean mass, weight loss after surgery and SBAC-L1), to improve the bone screening.

ReferenceCitation: Murray TÉ, Williams D, Lee MJ. Osteoporosis, obesity, and sarcopenia on abdominal CT: a review of epidemiology, diagnostic criteria, and management strategies for the reporting radiologist. Abdom Radiol (NY). 2017 Sep;42(9):2376-2386. doi: 10.1007/s00261-017-1124-5. Review. Erratum in: Abdom Radiol (NY). 2017 Aug 5;:.

ReferenceCitation: Walsh JS, Vilaca T. Obesity, Type 2 Diabetes and Bone in Adults. Calcif Tissue Int. 2017 May;100(5):528-535. doi: 10.1007/s00223-016-0229-0. Epub 2017 Mar 9. Review.

ReferenceCitation: Hammoud E, Toumi H, Jacob C, Pinti A, Lespessailles E, El Hage R. Does the Severity of Obesity Influence Bone Mineral Density Values in Premenopausal Women? J Clin Densitom. 2021 Apr-Jun;24(2):225-232. doi: 10.1016/j.jocd.2019.04.006. Epub 2019 Apr 26.

ReferenceCitation: Bauer JM, Cruz-Jentoft AJ, Fielding RA, Kanis JA, Reginster JY, Bruyère O, Cesari M, Chapurlat R, Al-Daghri N, Dennison E, Kaufman JM, Landi F, Laslop A, Locquet M, Maggi S, McCloskey E, Perna S, Rizzoli R, Rolland Y, Rondanelli M, Szulc P, Vellas B, Vlaskovska M, Cooper C. Is There Enough Evidence for Osteosarcopenic Obesity as a Distinct Entity? A Critical Literature Review. Calcif Tissue Int. 2019 Aug;105(2):109-124. doi: 10.1007/s00223-019-00561-w. Epub 2019 May 16. Review. Erratum in: Calcif Tissue Int. 2019 Jul 23;:.

ReferenceCitation: Jammah AA. Endocrine and metabolic complications after bariatric surgery. Saudi J Gastroenterol. 2015 Sep-Oct;21(5):269-77. doi: 10.4103/1319-3767.164183. Review.

ReferenceCitation: Hong CS, Bergen MA, Watters TS. Transient osteoporosis of the hip after bariatric surgery. Arthroplast Today. 2018 Dec 7;5(1):32-37. doi: 10.1016/j.artd.2018.10.010. eCollection 2019 Mar.

ReferenceCitation: Lespessailles E, Hammoud E, Toumi H, Ibrahim-Nasser N. Consequences of bariatric surgery on outcomes in rheumatic diseases. Arthritis Res Ther. 2019 Mar 28;21(1):83. doi: 10.1186/s13075-019-1869-z. Review.

ReferenceCitation: Santos D, Lopes T, Jesus P, Cruz S, Cordeiro A, Pereira S, Saboya C, Ramalho A. Bone Metabolism in Adolescents and Adults Undergoing Roux-En-Y Gastric Bypass: a Comparative Study. Obes Surg. 2019 Jul;29(7):2144-2150. doi: 10.1007/s11695-019-03797-5.

ReferenceCitation: Geoffroy M, Charlot-Lambrecht I, Chrusciel J, Gaubil-Kaladjian I, Diaz-Cives A, Eschard JP, Salmon JH. Impact of Bariatric Surgery on Bone Mineral Density: Observational Study of 110 Patients Followed up in a Specialized Center for the Treatment of Obesity in France. Obes Surg. 2019 Jun;29(6):1765-1772. doi: 10.1007/s11695-019-03719-5.

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ReferenceCitation: Axelsson KF, Werling M, Eliasson B, Szabo E, Näslund I, Wedel H, Lundh D, Lorentzon M. Fracture Risk After Gastric Bypass Surgery: A Retrospective Cohort Study. J Bone Miner Res. 2018 Dec;33(12):2122-2131. doi: 10.1002/jbmr.3553. Epub 2018 Aug 13.

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title: Evaluation of the Effectiveness of a Closed-incision Negative-pressure Therapy (Prevena®) on Bilateral Groin Incision

acronym: PREVISION

summary: Closed-incision negative-pressure therapy are medical device that are suspected to reduce groin wound complication in vascular surgery. The aim of this study is to compareon on the same patient a Closed-incision negative-pressure therapy (Prevena®, KCI) versus a traditional gauze dressings after a bilateral vascular groin surgery. To do this, each device is applied on one groin incision and the side, left or right, is randomized.