title: Evaluation of Professional Practices on the Management of Cardiogenic Pulmonary Edema (RENAU-OAP)

acronym: RENAU-OAP

summary:
The prevalence of heart failure is estimated to 2.3 percent of the adult population and strongly increases with age, according to french disability-health surveys. In France, more than 32,000 annual deaths are attributable to heart failure and the five-year survival rate is similar to those found in many cancers. A better therapeutic management (angiotensin converting enzyme inhibitor and beta-blockers) helped reduce mortality after an episode of heart failure requiring hospitalization, but, nevertheless it remains high.

The severity of cardiogenic pulmonary edema depends on several factors such as etiology, hemodynamic status, effect on hematosis, and fatigue.

It is important to note that cardiogenic pulmonary edema initial management is decisive. In addition, early and adapted management of cardiogenic pulmonary edema is associated with a shorter hospital stay and reduced hospital mortality.

The Coronary Emergency Network (RESURCOR) within the Northern French Alps Emergency Network (RENAU) is an emergency care system structured in the departments of Isère, Savoie and Haute Savoie. Its main goal is to help improve emergency management by using regional good practice guidelines (www.renau.org). In this context, projects aiming to evaluate professional practices are developed regularly. Since emergency management of cardiogenic pulmonary edema has not been evaluated, the Northern French Alps Emergency Network offers an approach to improve professional practices by defining and disseminating guidelines on cardiogenic pulmonary edema management which will then be assessed.

ReferenceCitation: Stewart S, MacIntyre K, Hole DJ, Capewell S, McMurray JJ. More 'malignant' than cancer? Five-year survival following a first admission for heart failure. Eur J Heart Fail. 2001 Jun;3(3):315-22. doi: 10.1016/s1388-9842(00)00141-0.

ReferenceCitation: Mebazaa A, Gheorghiade M, Pina IL, Harjola VP, Hollenberg SM, Follath F, Rhodes A, Plaisance P, Roland E, Nieminen M, Komajda M, Parkhomenko A, Masip J, Zannad F, Filippatos G. Practical recommendations for prehospital and early in-hospital management of patients presenting with acute heart failure syndromes. Crit Care Med. 2008 Jan;36(1 Suppl):S129-39. doi: 10.1097/01.CCM.0000296274.51933.4C.

ReferenceCitation: Heart Failure Society Of America. HFSA 2006 Comprehensive Heart Failure Practice Guideline. J Card Fail. 2006 Feb;12(1):e1-2. doi: 10.1016/j.cardfail.2005.11.005.

ReferenceCitation: McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; ESC Committee for Practice Guidelines. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2012 Jul;33(14):1787-847. doi: 10.1093/eurheartj/ehs104. Epub 2012 May 19. No abstract available. Erratum In: Eur Heart J. 2013 Jan;34(2):158.

ReferenceCitation: Emerman CL. Treatment of the acute decompensation of heart failure: efficacy and pharmacoeconomics of early initiation of therapy in the emergency department. Rev Cardiovasc Med. 2003;4 Suppl 7:S13-20.

ReferenceCitation: Peacock WF 4th, Emerman CL. Emergency department management of patients with acute decompensated heart failure. Heart Fail Rev. 2004 Jul;9(3):187-93. doi: 10.1007/s10741-005-6128-5.

ReferenceCitation: Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.

ReferenceCitation: Belle L, Fourny M, Reynaud T, Hammer L, Vanzetto G, Labarere J; RENAU-RESURCOR study investigators. Efficacy and safety of glycoprotein IIb/IIIa receptor antagonists for patients undergoing percutaneous coronary intervention within twelve hours of fibrinolysis. Catheter Cardiovasc Interv. 2011 Sep 1;78(3):376-84. doi: 10.1002/ccd.22825. Epub 2011 Mar 16.

ReferenceCitation: Chacornac M, Baronne-Rochette G, Schmidt MH, Savary D, Habold D, Bouvaist H, Marliere S, Belle L, Machecourt J, Vanzetto G; REseau des URgences CORonariennes (RESURCOR). Characteristics and management of acute ST-segment elevation myocardial infarctions occurring in ski resorts in the French Alps: Impact of an acute coronary care network. Arch Cardiovasc Dis. 2010 Aug-Sep;103(8-9):460-8. doi: 10.1016/j.acvd.2010.09.002. Epub 2010 Oct 30.

ReferenceCitation: Debaty G, Belle L, Labarere J, Fourny M, Torres JP, Savary D, Usseglio P, Menthonnex E, Guenot O, Vanzetto G. [Evolution of strategies of revascularisation in acute coronary syndromes with ST elevation. Analysis of the data of RESURCOR]. Arch Mal Coeur Vaiss. 2007 Feb;100(2):105-11. French.

ReferenceCitation: Ferrier C, Belle L, Labarere J, Fourny M, Vanzetto G, Guenot O, Debaty G, Savary D, Machecourt J, Francois P. [Comparison of mortality according to the revascularisation strategies and the symptom-to-management delay in ST-segment elevation myocardial infarction]. Arch Mal Coeur Vaiss. 2007 Jan;100(1):13-9. French.

ReferenceCitation: Fourny M, Belle L, Labarere J, Senee D, Savary D, Debaty G, Vanzetto G, Francois P. [Analysis of the accuracy of a coronary syndrome register]. Arch Mal Coeur Vaiss. 2006 Sep;99(9):798-803. French.

ReferenceCitation: Fourny M, Lucas AS, Belle L, Debaty G, Casez P, Bouvaist H, Francois P, Vanzetto G, Labarere J. Inappropriate dispatcher decision for emergency medical service users with acute myocardial infarction. Am J Emerg Med. 2011 Jan;29(1):37-42. doi: 10.1016/j.ajem.2009.07.008. Epub 2010 Mar 9.

ReferenceType: result

ReferenceCitation: Zannad F, Briancon S, Juilliere Y, Mertes PM, Villemot JP, Alla F, Virion JM. Incidence, clinical and etiologic features, and outcomes of advanced chronic heart failure: the EPICAL Study. Epidemiologie de l'Insuffisance Cardiaque Avancee en Lorraine. J Am Coll Cardiol. 1999 Mar;33(3):734-42. doi: 10.1016/s0735-1097(98)00634-2. Erratum In: J Am Coll Cardiol 1999 Oct;34(4):1363.

ReferenceCitation: Delahaye F, Roth O, Aupetit JF, de Gevigney G. [Epidemiology and prognosis of cardiac insufficiency]. Arch Mal Coeur Vaiss. 2001 Dec;94(12):1393-403. French.

ReferenceCitation: Schaufelberger M, Swedberg K, Koster M, Rosen M, Rosengren A. Decreasing one-year mortality and hospitalization rates for heart failure in Sweden; Data from the Swedish Hospital Discharge Registry 1988 to 2000. Eur Heart J. 2004 Feb;25(4):300-7. doi: 10.1016/j.ehj.2003.12.012.

ReferenceCitation: Logeart D, Isnard R, Resche-Rigon M, Seronde MF, de Groote P, Jondeau G, Galinier M, Mulak G, Donal E, Delahaye F, Juilliere Y, Damy T, Jourdain P, Bauer F, Eicher JC, Neuder Y, Trochu JN; Heart Failure of the French Society of Cardiology. Current aspects of the spectrum of acute heart failure syndromes in a real-life setting: the OFICA study. Eur J Heart Fail. 2013 Apr;15(4):465-76. doi: 10.1093/eurjhf/hfs189. Epub 2012 Nov 27.

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Wiley

ReferenceCitation: Logeart D. [The OFICA study of acute heart failure]. Soins. 2013 Apr;(774):35. No abstract available. French.

ReferenceCitation: Nguyen HB, Rivers EP, Havstad S, Knoblich B, Ressler JA, Muzzin AM, Tomlanovich MC. Critical care in the emergency department: A physiologic assessment and outcome evaluation. Acad Emerg Med. 2000 Dec;7(12):1354-61. doi: 10.1111/j.1553-2712.2000.tb00492.x.

ReferenceCitation: Sebat F, Johnson D, Musthafa AA, Watnik M, Moore S, Henry K, Saari M. A multidisciplinary community hospital program for early and rapid resuscitation of shock in nontrauma patients. Chest. 2005 May;127(5):1729-43. doi: 10.1378/chest.127.5.1729.

ReferenceCitation: Masip J, Roque M, Sanchez B, Fernandez R, Subirana M, Exposito JA. Noninvasive ventilation in acute cardiogenic pulmonary edema: systematic review and meta-analysis. JAMA. 2005 Dec 28;294(24):3124-30. doi: 10.1001/jama.294.24.3124.

ReferenceCitation: Peter JV, Moran JL, Phillips-Hughes J, Graham P, Bersten AD. Effect of non-invasive positive pressure ventilation (NIPPV) on mortality in patients with acute cardiogenic pulmonary oedema: a meta-analysis. Lancet. 2006 Apr 8;367(9517):1155-63. doi: 10.1016/S0140-6736(06)68506-1.

lead_sponsor: Centre Hospitalier Annecy Genevois


title: Long Term Effects and of a Pulmonary Rehabilitation Maintenance Program in Patients With a Chronic Respiratory Disease: Time Course and Determinants

acronym: LTAir+R

summary: Chronic respiratory diseases are characterized by a progressive and long term deline. Pulmonary rehabilitation (exercise training and therapeutic education) can improve several disease outcomes like dyspnea, exercise tolerance and health-related quality of life. After an inpatient PR program, maintenance program can stabilize the disease outcomes. However, maintenance program are heterogeneous and long term benefits (>36 month) have been observed in only one study, which is not feasible in France. A realistic maintenance program as proposed by the French Air+R network (http://airplusr.com/wordpress/) has only demonstrated benefits after 12 month. In addition, the time course of patients may be heterogeneous, with differens clusters that could be influenced by the clinical, functional and systemic determinants. In particular, the cellular muscle microenvironment could be deleterious for the muscle function in patients, caused by a "spill-over" of inflammatory pulmonary molecules in the systemic milieu.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: University Hospital, Montpellier

location_facility: Department of clinical Physiology - University Hospital

lead_sponsor_type: academique

status_simplified: Completed


title: Criteria Used by Health Professionals on the Selection of Allergen Immunotherapy in Real Clinical Practice: an International E-survey

acronym: CHOICE

summary:
Background : Allergen Immunotherapy (AIT) is the only etiological treatment for allergic respiratory diseases. In order to improve the competence on the use of AIT, it is important to extend the investigator's knowledge on its use in routine clinical practice, outside the experimental setting of clinical trials, in real life population of patients receiving AIT.

Objective: To evaluate the clinical criteria used by treating clinicians and by the patients themselves, when establishing AIT as treatment in a patient with respiratory disease caused by an IgE-dependent-hypersensitivity to aeroallergens Methods: In 6 country (Denmark, France, Germany, Norway, Spain & Sweden), the national coordinator will be directly responsible for selection of Survey Doctor's participants (Investigators).

During 12 months:

Firstly, each investigator will complete the Survey Doctor, online, on SurveyMonkey platform to explain what are the key drivers in Allergen Immunotherapy (AIT) selection (Doctors' Questionnaire, DQ).
On the other hand, at each AIT prescription to a patient, doctors will complete the Survey Patient, on the same platform, to explain how and why they have chosen this type of AIT (Patients' Questionnaire, PQ).

time_perspective: Retrospective

ipd_sharing: Undecided

ipd_sharing_description: NC


title: Fungal Contamination of a Hospital Water System With Fusarium App.: Prospective Environmental and Medical Surveillance During a Construction Period

summary:
Fusarium are microscopic filamentous fungi that live as saprobiontics in outside environments. They are found in the soil, the air, in water and on numerous plants. The frequency of fusariosis is currently increasing and Fusarium-related mycoses are the 3rd most frequent invasive mycoses. Most cases have been reported in the United States, in France, in Italy and in Brazil. A few epidemiological studies have shown the role of water in the appearance of mycoses in highly immunodepressed patients. Few studies have focused on the role of water in the transmission of mycoses in hospitals. The aim of this prospective study is to describe, in time and pace, the contamination by Fusarium sp. in the water of two different hospitals (Dijon, Nancy), by taking into account factors such as seasons and major works (reconstruction of a hospital). In each hospital, one reconstruction site will be compared with a site not under reconstruction (control).

Water samples will be taken from the rooms of hospitalized patients.

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Other


title: Immersive Virtual Reality Using a Head Mounted Display and Modelling Using Machine Learning Algorithms to Assess Risk of Falling in the Elderly and Patients With Parkinson's Disease.

acronym: PrévSim

summary:
The process of ageing affects at the same time the sensory, cognitive and driving functions. Furthermore, ageing is often accompanied by pathologies increasing the effects of the senescence. An ageing subject will have then more difficulties in maintaining balance control and will have a falling risk with sometimes critical consequences for the quality of life.

The risk of fall is estimated by tests at the same time of current life and with scores of sensitivity and specificity which must be improved. In a review including 25 studies (2 314 subjects), show a sensitivity of 32 % and a specificity of 73 % on the test "Timed Up and Go" (TUG) with a threshold at 13.5 seconds.

In addition, the fall occurs in a multifactorial context when a subject interacts with his environment. It therefore seems essential to test balance control or falling risk of individuals as close as possible to the situations of daily life. This research, based on the TUG, will aim to assess the neuro-psycho-motor behavior of subjects in situations close to daily life using a Virtual Reality (VR) and Human Metrology platform.

The results could ultimately lead to increased sensitivity and specificity in assessing the risk of falling with a TUG performed in VR, compared to the classic TUG, which is commonly used by healthcare professionals and thus allow for earlier or more appropriate management of the subject in preventing the risk of falling. This could allow healthcare professionals to better understand the risk of falling and thus guide medical recommendations and prescribing, particularly in terms of appropriate physical activity programs.

study_start_date_type: Anticipated

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Prevention

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Central Hospital, Nancy, France

collaborators: ONPA - Office Nancéien des Personnes Agées

status_simplified: Unknown


title: Fertility Preservation and Reproductive Needs of Transgender People: Desires, Attitude and Knowledge of Subjects With Gender Dysphoria

acronym: PaFer

summary:
Majority of transgender and gender nonconforming people seeking medical care are in pubertal and reproductive age. Cross-sex hormones may compromise fertility especially when preceded by puberty blocking regimen. Our current understanding on reproductive needs of transgender persons is insufficient.

The guidelines of Endocrine Society and the World Professional Association for Transgender Health prompt the health professionals to provide information on fertility risk and fertility preservation options before initiating hormonal treatment. Currently, no clear tools are available for healthcare professionals. Among several challenges for clinical care are a low clinical awareness, a lack of suitable psycho-educational instruments addressing fertility values that can be used to facilitate discussion between transgender persons and healthcare providers, a lack of established methods for fertility preservation in prepubertal youth, and a lack of long-term data regarding reproductive function, psychological and societal outcomes in this population. Likewise, current data are sparse regarding the experience of transgender and gender nonconforming people with fertility preservation.

Our aim is to describe desires, attitudes and knowledge of transgender and gender nonconforming people regarding fertility preservation wishes and reproductive needs.

ipd_sharing: Yes


title: Observance of Anticonvulsant Treatments and Quality of Life of Epileptic Children

acronym: ObEPI

summary: There is little epidemiological data in the literature on the therapeutic compliance of epileptic children. Yet it is a fundamental issue in the therapeutic education and balance of this pathology. To obtain more epidemiological precision on the observance of epileptic children and to propose, according to the factors involved, the improvement of practices (therapeutic education ..). Propose an evaluation of the quality of life of their children by a suitable self-questionnaire.


type: Other Identifier

title: Patient Acceptable Symptomatic State and Minimal Clinically Important Difference of the Fatigue in Multiple Sclerosis (SeDiF_SEP)

summary:
Fatigue is the most common symptom and the most disabling symptom of Multiple Sclerosis, and its inefficient management can be a source of multiple consultations (increase in health costs) and a reduction in productivity (work stoppages).

Hence the need to define the most effective therapeutic strategy to reduce fatigue in Multiple Sclerosis.

One of the aims of this project is to provide clinical indicators that can serve as evaluation criteria for determining the most effective fatigue management strategy in Multiple Sclerosis.

The primary objective of the study is to determine the Minimal Clinically Important Difference (MCID) and the Patient Acceptable Symptomatic State (PASS) for fatigue in Multiple Sclerosis.

The source population consists of all people with Multiple Sclerosis living in Lorraine and registered in the Lorraine Registry of Multiple Sclerosis (RelSEP).

location_facility: CIC 1433 Épidémiologie clinique, Inserm, CHRU de Nancy, Université de Lorraine


title: Comparison of PET Imaging With 68GA-PSMA-11 and 18F-Fluorocholine for the Identification of Site of Recurrence in Men With Prostate Cancer

acronym: TEPGALCHOL

summary: As choline transport and phosphorylation are upregulated in most cancers, including prostate cancer, positron emission tomography (PET) with choline tracers has found widespread use to detect recurrent disease. However, choline metabolism is not increased in a significant number of cases, probably explaining why this imaging method has been reported to be weakly sensitive and specific fro the detection of prostate cancer lesions, especially at low prostate-specific antigen (PSA) levels. By contrast, prostate-specific membrane antigen (PSMA) is overexpressed in most prostate cancer, suggesting that 68Ga-labelled PSMA ligands could be superior to choline tracers. A meta-analysis published in 2016 (Perera M. and al.), which included 18 studies, of which five reported histolopathologic correlation data for 68Ga-PSMA PET-positive lesions, indicated favourable sensitivity and specificity profiles of 68Ga-labelled PSMA ligands compared to choline-based PET imaging techniques.

design_allocation: Randomized

primary_purpose: Diagnostic

collaborators: Advanced Nuclear Medicine Ingredients (ANMI)

intervention_type: Drug


title: New Diagnosis or Prognosis Biomarkers for Alzheimer's Disease: Biobank of CSF Collected as Part of Differential Diagnosis of Dementia

acronym: BioAD

summary: Today, the Alzheimer's disease (AD) diagnosis is founded not only on clinical criteria but also on complementary examinations to confirm a physiopathological process of AD. In complex cases, lumbar punction could be necessary in order to measure Aβ peptides and Total and phosphorylated Tau but new biomarkers could be useful. The main objective of this project is to conserve these cerebrospinal fluids, collected in usual practice in order to validate new biomarkers for diagnosis, prognosis or therapeutic following of Alzheimer's disease and other dementia.

status: Recruiting

status_simplified: Ongoing


title: Prognostic Value of CD64 Marker for Patients in Intensive Care Unit

summary:
Among patients admitted to the intensive care unit (ICU), early recognition of those with the highest risk of death is of paramount importance. Since clinical judgment is sometimes uncertain biomarkers could provide additional information likely to guide critical illness management. We want to evaluate the prognostic value of leucocyte surface expression of CD64.

Blood samples for CD64 biomarker measurement will be obtained daily during the patient's hospitalization. The primary outcome was all-cause death at D28 after admission


title: Intestinal Dysbiosis and Immune Reconstitution After Allogeneic Hematopoietic Cell Transplantation

acronym: PARI-DYS

summary: Preliminary (proof of concept), monocentric, interventional, prospective, non-randomized and analytic trial designed to simultaneously explore intestinal microbiota changes and early post-transplant immune reconstitution, and to correlate biological data with clinical data (antibiotics use, stress level, GVHD).

primary_purpose: Basic Science

intervention_type: Biological


title: Predictive Role and HuR Mechanisms of Regulation in the Brain Tumours

acronym: HUR

summary:
The HuR protein binds to AU-rich elements in the untranslated 3' region of messenger RNA, thus allowing their stabilization. Its targets include multiple cell cycle regulating proteins, cytokines and growth factors. In some cancers, its overall expression level but especially its cytoplasmic expression are correlated to a higher grade and constitute a poor prognostic factor. To date, HuR's deregulation mechanisms remain poorly understood. A few experimental studies have shown the role of certain microARNS, or of post-translational modifications. In brain tumours, HuR expression, its prognostic value and its deregulation mechanisms have been little studied to date.

The first part of the project will be a monocentric retrospective study of human brain tumour samples collected during biopsies or surgical removal. We will first evaluate HuR expression in 140 brain tumors, including 40 meningiomas and 100 gliomas of increasing grade, and look for a correlation with histological grade and survival. We will then apprehend the consequences of its deregulation by analyzing different factors involved in the cell cycle and stress response markers. Finally, we will study the mechanisms of HuR deregulation by analyzing the expression level of several microRNAs (miR16, miR519) and the methylation state of HuR.

The second part of the project will focus on cell lines from human brain tumours. We will first attempt to confirm the interactions between HuR and markers involved in the cell cycle and stress response, then the regulation of HuR by its methylation and by microRNAs (miR16 and miR519). We would also like to study the consequences of HuR inhibition and overexpression on cell proliferation, under various conditions of induced stress (pharmacological agents, physical stress). Finally, we will study the consequences of an experimental vitamin B12 deficiency on HuR expression and tumor cell adaptation to stress.


title: Asymmetry of the Center of Pressure During Gait After Amputation of Lower Limbs

acronym: ASCOPALL

summary:
Retrospective, non-randomized, observational, single-center longitudinal study at the University Rehabilitation Hospital of Grau du Roi CHU of Nîmes, France. From January 2012 to Janvier 2023 patients hospitalized for lower limb amputation, were extracted from the computer database of the motion analysis laboratory (2 baropodometric platforms, Zebris, Germany). All patients with lower limb amputations, unilateral or bilateral, walking with or without technical aids, were included regardless of the level (trans-femoral or trans-tibial). Only patients hospitalized in the locomotor rehabilitation department were included in the study. Patients who were not autonomous for walking and required a third person (human assistance) were not included. Finally, deceased patients were also excluded from the study population. Prior to data collection, all participants received a note of non-objection. The study was reported on the Health Data Hub, and data collection and analysis were performed according to the MR004 reference methodologies.

Walking amputee patients hospitalized in the locomotor rehabilitation department benefited from a systematic gait assessment before discharge from hospital after rehabilitation and validation of the prosthesis. During the gait analysis, on baropodometric platforms, the software provides a number of parameters: spatiotemporal, pressure distribution, vertical component of the ground reaction force and trajectory of the center of pressure. All patients were recorded over a distance of ten meters including the two meters of acceleration and deceleration according to the validity of the TM-10 for a duration of two minutes.

The parameters from the CoP trajectory are calculated from the coordinates calculated in the platform reference frame. A processing of these data will be specially developed within the service. Three key parameters of the COP have been retained: Lateral symmetry (LS; the left/right offset of the intersection point, where the "zero position" is equivalent to perfect symmetry), lateral variability (LV; the standard deviation of the intersection point in the lateral direction, where "zero" equals constant steps in terms of width between the legs), and anteroposterior variability (APV; the standard deviation of the intersection point in the anteroposterior direction, where "zero" equals constant strides while walking on the treadmill). These parameters, which allow for the assessment of continuous COP trajectories with multiple strides, reflect the overall movements of individuals throughout the gait cycle.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Evaluation of Duration of Curarisation (Surgical Efficacy) and Pharmacokinetics of Neuromuscular Block After a Single Dose of Rocuronium in Geriatric Patients (Age ≥ 80 Years ) Compared to a Younger Population (Age < 50 Years).

acronym: NMB-old-age

summary:
Elderly people, especially geriatric patients, account for a growing share of patients receiving anesthesia.

In patients over 75 years of age the annual rate of anesthesia represents 16.8 / 100 inhabitants for women and 19.6 / 100 for men. It is a growing population, but also the most fragile population with a mortality amounting to 44.4 / 10000 anesthesia. After 85 years, one out of every two patients is ASA 3 or older.

The first cause of death related to anesthesia today remains respiratory complications, particularly infectious.

This is a major public health issue right now. The studies on the use of curare and particularly rocuronium are old and did not study a population of elderly people (with an average age of 70 years). Several studies show an increase in the duration of neuromuscular blockade in patients older than 70 years irrespective of any renal failure, with sometimes persistent curarizations more than 2h after a single dose. But no study to date has studied the duration of deep-intensity neuromuscular block (TOF).

ReferenceType: background

ReferenceCitation: Klopfenstein CE, Herrmann FR, Michel JP, Clergue F, Forster A. The influence of an aging surgical population on the anesthesia workload: a ten-year survey. Anesth Analg. 1998 Jun;86(6):1165-70. doi: 10.1097/00000539-199806000-00005.

ReferenceCitation: Auroy Y, Laxenaire MC, Clergue F, Pequignot F, Jougla E, Lienhart A. [Anesthetics according to characteristics of patients, establishments and indications]. Ann Fr Anesth Reanim. 1998;17(11):1311-6. doi: 10.1016/s0750-7658(99)80043-4. No abstract available. French.

ReferenceCitation: Forrest JB, Rehder K, Cahalan MK, Goldsmith CH. Multicenter study of general anesthesia. III. Predictors of severe perioperative adverse outcomes. Anesthesiology. 1992 Jan;76(1):3-15. doi: 10.1097/00000542-199201000-00002. Erratum In: Anesthesiology 1992 Jul;77(1):222.

ReferenceCitation: Pignaton W, Braz JRC, Kusano PS, Modolo MP, de Carvalho LR, Braz MG, Braz LG. Perioperative and Anesthesia-Related Mortality: An 8-Year Observational Survey From a Tertiary Teaching Hospital. Medicine (Baltimore). 2016 Jan;95(2):e2208. doi: 10.1097/MD.0000000000002208.

ReferenceCitation: Tiret L, Desmonts JM, Hatton F, Vourc'h G. Complications associated with anaesthesia--a prospective survey in France. Can Anaesth Soc J. 1986 May;33(3 Pt 1):336-44. doi: 10.1007/BF03010747.

ReferenceCitation: Yamamoto H, Uchida T, Yamamoto Y, Ito Y, Makita K. Retrospective analysis of spontaneous recovery from neuromuscular blockade produced by empirical use of rocuronium. J Anesth. 2011 Dec;25(6):845-9. doi: 10.1007/s00540-011-1229-x. Epub 2011 Sep 21.

ReferenceCitation: Comparison of Neuromuscular Blockade with Rocuronium in Young and Elderly Patients with or without Renal Failure. 1SK Gvalani, 2L Pradeep Research & Innovation in Anesthesia, July-December 2016;1(2):45-51

ReferenceCitation: Bevan DR, Fiset P, Balendran P, Law-Min JC, Ratcliffe A, Donati F. Pharmacodynamic behaviour of rocuronium in the elderly. Can J Anaesth. 1993 Feb;40(2):127-32. doi: 10.1007/BF03011309.

ReferenceCitation: Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Vender JS, Parikh KN, Patel SS, Patel A. Residual Neuromuscular Block in the Elderly: Incidence and Clinical Implications. Anesthesiology. 2015 Dec;123(6):1322-36. doi: 10.1097/ALN.0000000000000865. Erratum In: Anesthesiology. 2016 May;124(5):1201.

ReferenceCitation: Arain SR, Kern S, Ficke DJ, Ebert TJ. Variability of duration of action of neuromuscular-blocking drugs in elderly patients. Acta Anaesthesiol Scand. 2005 Mar;49(3):312-5. doi: 10.1111/j.1399-6576.2005.00634.x.

ReferenceCitation: Kocabas S, Yedicocuklu D, Askar FZ. The neuromuscular effects of 0.6 mg kg(-1) rocuronium in elderly and young adults with or without renal failure. Eur J Anaesthesiol. 2008 Nov;25(11):940-6. doi: 10.1017/S0265021508004717. Epub 2008 Jun 9.

ReferenceCitation: Neuromuskuläres Monitoring in Klinik und Forschung. T. Fuchs-Buder, Springer Medezin Verlag, 2008, ISBN 978-3-540-78569-9

ReferenceType: derived

ReferenceCitation: Schmartz D, Sghaier R, Bernard P, Fils JF, Fuchs-Buder T. Neuromuscular block in patients 80 years and older: a prospective, controlled study. BMC Anesthesiol. 2021 Sep 13;21(1):225. doi: 10.1186/s12871-021-01443-1.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature


title: Colonization of Bile Ducts and Postoperative Infectious Complications of Pancreaticoduodenectomies

summary:
The aim of the present prospective study was, first, to verify the correlation between biliary colonization and postoperative infectious complications, and secondarily to asses morbidity and mortality for patients who underwent pancreaticoduodenectomy.

The hypothesis is that a proportion of post-operative infections after pancreaticoduodenectomy is due to bacteria that colonize the bile ducts during the preoperative period.


title: Impact of Anxiety on the Decision-making Process of Anesthesiologists in the Choice of Drugs for Induction of General Anesthesia of Patients With Aspiration Risk Factors

acronym: DECIDINH

summary:
Except for exaggerated situations in which aspiration risk seems obvious (or absent), the choice of a rapid sequence induction protocol for general anesthesia is often made under uncertainty, according to the individual assessment of the balance between the aspiration risk on one hand and the anaphylaxis risk induced by short-acting curares on the other hand.

The impact of anxiety and impulsivity on the choice of induction protocols under uncertainty has never been studied before.

In order to investigate this issue, an online anonymous survey has been designed and will be sent to the anesthesiologists of the Bourgogne Franche-Comté and Grand Est regions in France.

The primary objective of this study is to assess the impact of trait-anxiety using the STAI-Y2 form on the decision-making process of anesthesiologists during the choice of an induction protocol for patients at risk of aspiration.

The secondary objectives are to characterize decision-making profiles, to measure the implicit dimension of anxiety using an Implicit association test, to study the impact of impulsivity on decision-making processes under uncertainty using the short version of UPPS-P scale and to study the role of socio-demographic data and professional history in these decisions.

time_perspective: Cross-Sectional

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ReferenceCitation: Sajayan A, Wicker J, Ungureanu N, Mendonca C, Kimani PK. Current practice of rapid sequence induction of anaesthesia in the UK - a national survey. Br J Anaesth. 2016 Sep;117 Suppl 1:i69-i74. doi: 10.1093/bja/aew017. Epub 2016 Feb 24.

ReferenceCitation: Egloff B, Schmukle SC. Predictive validity of an Implicit Association Test for assessing anxiety. J Pers Soc Psychol. 2002 Dec;83(6):1441-55.

ReferenceCitation: Greenwald AG, Farnham SD. Using the implicit association test to measure self-esteem and self-concept. J Pers Soc Psychol. 2000 Dec;79(6):1022-38. doi: 10.1037//0022-3514.79.6.1022.

ReferenceCitation: Carpenter TP, Pogacar R, Pullig C, Kouril M, Aguilar S, LaBouff J, Isenberg N, Chakroff A. Survey-software implicit association tests: A methodological and empirical analysis. Behav Res Methods. 2019 Oct;51(5):2194-2208. doi: 10.3758/s13428-019-01293-3.

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ReferenceCitation: de Leeuw JR. jsPsych: a JavaScript library for creating behavioral experiments in a Web browser. Behav Res Methods. 2015 Mar;47(1):1-12. doi: 10.3758/s13428-014-0458-y.

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ReferenceCitation: Billieux J, Rochat L, Ceschi G, Carre A, Offerlin-Meyer I, Defeldre AC, Khazaal Y, Besche-Richard C, Van der Linden M. Validation of a short French version of the UPPS-P Impulsive Behavior Scale. Compr Psychiatry. 2012 Jul;53(5):609-15. doi: 10.1016/j.comppsych.2011.09.001. Epub 2011 Oct 27.

ReferenceCitation: Auroy Y, Benhamou D, Pequignot F, Jougla E, Lienhart A. [Survey of anaesthesia-related mortality in France: the role of aspiration of gastric contents]. Ann Fr Anesth Reanim. 2009 Mar;28(3):200-5. doi: 10.1016/j.annfar.2008.12.018. Epub 2009 Mar 10. French.

ReferenceCitation: Stiegler MP, Goldhaber-Fiebert SN. Cognitive Errors and Cognitive Aids in Anesthesiology. ASA Newsletter 2013; 77:10-12

ipd_sharing_description: The data will be strictly anonymous.

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Norepinephrine vs Norepinephrine and Dobutamine in Cardiogenic Shock : a Randomised, Opened, Cross-over Study. Heart SHOCK-NORDOB Study

acronym: SHOCK-NORDOB

summary:
Cardiogenic shock is a frequent cause of admission and death in the intensive care unit.

Mortality is about 50%. Once the etiologic treatment has been done, for instance coronary revascularization, management of the shock state is the cornerstone of the treatment. Norepinephrine is the first-line vasopressor therapy because of its minor effect on heart rhythm. Morever norepinephrine is a inotrope. In a previous study, we demonstrated that increasing the norepinephrine dose increases cardiac index, cardiac power index, SVO2 and tissue perfusion without acceleration of heart rate. Nevertheless, dobutamine remains the first-line inotropic treatment. Dobutamine has a positive chronotropic effect that might cause higher myocardial oxygen consumption. As a result, combination of vasopressor / inotrope is still controversial.

The aim of this study was to compare hemodynamics and metabolics effects of 2 treatments strategies (norepinephrine dose increasing or addition of dobutamine) in patients with cardiogenic shock and optimised blood pressure level (MAP≥65 mmHg) under norepinephrine treatment.

The secondary objectives were :

To evaluate the efficacy of the treatments on micro- and macrocirculation parameters
To evaluate the tolerance of the treatments
To evaluate the dose and the admistration's kinetics of the treatments

primary_purpose: Treatment


title: Efficacity of Hypnosis Versus Premedication for the Management of Perioperative Anxiety in Gynecological Surgery

acronym: HYPNOGYN

summary: The aim of this study is to evaluate the efficacy of an hypnosis session, performed on the eve of a laparoscopic gynecological surgery, on the level of immediate preoperative anxiety measured by State-Trait Anxiety Index (STAI-Y) self-administered questionnaire compared to premedication by alprazolam®.


title: COVID-19 Prevalence in UNIVI Group Nursing Homes and Geriatric Healthcare Institutions: Epidemiological Study of Immunological Status With Rapid Serological Tests for Diagnostic Guidance

summary:
To date, little information is available on the prevalence of Covid-19 and data are lacking on the proportion of patients, institutional residents and caregivers who have actually been exposed to SARS Cov-2.

With the NG Biotech rapid serological test, an individual's immunological status (presence of IgM and IgG antibodies) can be determined in 15 minutes on a finger-prick blood sample.

The proposed trial will be a noninterventional study of immunological status among the residents and caregivers of 26 nursing homes and 4 geriatric healthcare institutions belonging to the UNIVI Group who are representative of the institutional geriatric population in France. The NG Biotech rapid test will be carried out concomitantly with polymerase chain reaction (PCR) tests performed within the framework of a national screening campaign. Data on risk factors in staff members and on specific COVID 19 symptoms in residents will also be collected.

The study will terminate for residents and caregivers whose tests are both negative (absence of infection and no exposure to the virus). For residents and caregivers who have at least one positive test, follow-up visits will be scheduled in order to study the serology time course and the occurrence of reinfection (follow-up questionnaire).

lead_sponsor: Centre Médical Porte Verte

lead_sponsor_type: industriel


title: Reduction of Insulin Therapy Under Myo-inositol for the Treatment of Gestational Diabetes Mellitus: a Randomized Multicenter and Prospective Trial. MYO-GDM Study

acronym: MYO-GDM

summary:
Gestational diabetes mellitus (GDM) is defined as hyperglycemia first-diagnosed during pregnancy. Glycemic control reduces GDM-related complications. With the new diagnostic criteria of GDM, up to 25% of pregnant women have GDM, whereas it was previously 6-10% in France. Therefore caring for women with GDM is very time-consuming. Therapeutic strategy includes dietary and lifestyle measures and additional insulin therapy for 15 to 40% of the women with GDM if the glycemic targets are not achieved after a period of 1 to 2 weeks of diet. Insulin therapy is imperfect for the following main reasons: need for education (i.e. subcutaneous administration, dose titration), hypoglycemia and weight gain, limited acceptance and high cost. Psychosocial deprivation is associated with more cases of GDM and health accessibility may be unequal.

MYO-INOSITOL (MI) is an oral dietary supplement, which reduces insulin resistance. Women with GDM are deficient in MI. MI supplementation safely prevents GDM by 65 to 87% in high-risk women. A pilot study has shown a 75% reduction of the need for insulin during GDM not controlled by diet.

The coordinator investigator propose here, for the first time, a randomized controlled study evaluating MI versus placebo in women with newly diagnosed GDM.

ReferenceCitation: Croze ML, Soulage CO. Potential role and therapeutic interests of myo-inositol in metabolic diseases. Biochimie. 2013 Oct;95(10):1811-27. doi: 10.1016/j.biochi.2013.05.011. Epub 2013 Jun 10.

ReferenceCitation: Unfer V, Carlomagno G, Dante G, Facchinetti F. Effects of myo-inositol in women with PCOS: a systematic review of randomized controlled trials. Gynecol Endocrinol. 2012 Jul;28(7):509-15. doi: 10.3109/09513590.2011.650660. Epub 2012 Feb 1.

ReferenceCitation: Corrado F, D'Anna R, Di Vieste G, Giordano D, Pintaudi B, Santamaria A, Di Benedetto A. The effect of myoinositol supplementation on insulin resistance in patients with gestational diabetes. Diabet Med. 2011 Aug;28(8):972-5. doi: 10.1111/j.1464-5491.2011.03284.x.

ReferenceCitation: D'Anna R, Di Benedetto V, Rizzo P, Raffone E, Interdonato ML, Corrado F, Di Benedetto A. Myo-inositol may prevent gestational diabetes in PCOS women. Gynecol Endocrinol. 2012 Jun;28(6):440-2. doi: 10.3109/09513590.2011.633665. Epub 2011 Nov 28.

ReferenceCitation: Matarrelli B, Vitacolonna E, D'Angelo M, Pavone G, Mattei PA, Liberati M, Celentano C. Effect of dietary myo-inositol supplementation in pregnancy on the incidence of maternal gestational diabetes mellitus and fetal outcomes: a randomized controlled trial. J Matern Fetal Neonatal Med. 2013 Jul;26(10):967-72. doi: 10.3109/14767058.2013.766691. Epub 2013 Mar 1.

ReferenceCitation: D'Anna R, Scilipoti A, Giordano D, Caruso C, Cannata ML, Interdonato ML, Corrado F, Di Benedetto A. myo-Inositol supplementation and onset of gestational diabetes mellitus in pregnant women with a family history of type 2 diabetes: a prospective, randomized, placebo-controlled study. Diabetes Care. 2013 Apr;36(4):854-7. doi: 10.2337/dc12-1371. Epub 2013 Jan 22.

ReferenceCitation: D'Anna R, Di Benedetto A, Scilipoti A, Santamaria A, Interdonato ML, Petrella E, Neri I, Pintaudi B, Corrado F, Facchinetti F. Myo-inositol Supplementation for Prevention of Gestational Diabetes in Obese Pregnant Women: A Randomized Controlled Trial. Obstet Gynecol. 2015 Aug;126(2):310-315. doi: 10.1097/AOG.0000000000000958.

ReferenceCitation: Lubin V, Shojai R, Darmon P, Cosson E. A pilot study of gestational diabetes mellitus not controlled by diet alone: First-line medical treatment with myoinositol may limit the need for insulin. Diabetes Metab. 2016 Jun;42(3):192-5. doi: 10.1016/j.diabet.2016.01.005.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: MYO GDM

titre: Réduction de l'insulino-requérance sous myo-inositol dans le diabète gestationnel: une étude multicentrique prospective randomisée contrôlée versus placebo. (Etude MYO-GDM)

discipline_principale: endocrinologie / diabétologie / métabolisme et nutrition

nom_porteur: COSSON

prenom_porteur: Emmanuel


title: Analysis of Core Temperature Afterdrop and Factors Associated With Afterdrop in Cold-water Swimming

acronym: THERMOCOLD

summary:
A significant risk associated with hypothermia during exercise in a cold environment is the core temperature (T°core) afterdrop, which corresponds to a continuous fall in T°core during rewarming after hypothermia. However, the rate and predictors of the afterdrop are unclear, particularly during prolonged cold water swimming.

The investigators propose to measure the changes in T°core during and after a cold water swim at 12.5-13°C qualifying for English Channel swim and to test the impact of anthropometric and swimming parameters on the duration of the T°core afterdrop. The hypotheses are that afterdrop is common during a prolonged cold water swimming event and that protective factors against T°core drop during cold water swimming (increased body fat and BMI) might, conversely, be associated with prolonged afterdrop.

lead_sponsor: University Hospital, Caen

collaborators: INSERM UMR U1075 Comète GIP Cyceron, unicaen, Caen Normandie


title: Prognostic Value of Tissue Factor (TF) in Blood t in Colorectal Cancer in Adults

acronym: TF

summary:
Severity of colorectal cancer (CRC) is evaluated by its local staging, locoregional and general ( presence of metastases , usually liver ). This is the most common cancer in France and, despite surgical treatment of the primary tumor, it is still subject to a high mortality rate due to metastatic evolution, mainly hepatic .

There is currently no specific marker for predicting cancer, the same hardly changed , which would modulate the aggressive therapeutic strategy . antigen (CEA) is used in the monitoring of JRC made.Tissue factor (TF) is the VII tissue factor receptor. it initiates the coagulation cascade. it was noted as a true cell marker tumorale1 aggressiveness. Corroborating evidence that the way the TF plays an important role in the invasive and metastatic potential of CRC. First, various human cancer cell lines express the FT colic. Furthermore, there is a relationship between the importance of monocyte TF expression and the evolutionary potential of human CRC.

The investigators hypothesize that these interest intra-platelet and plasma markers are a reflection of tumor angiogenic potential. And the investigators will verify the superiority of their preoperative levels in the CRC group compared with the control group, normalization of postoperative after surgical resection rates and their possible re-ascent in case of tumor recurrence in the CRC group.

The levy to one month in controls allow us to verify the absence of secondary modification to laparotomy, the colectomy and general anesthesia.

The investigators assume that the rate of soluble TF in peripheral blood of the holders of CRC patients may be a marker of invasion and aggression (i.e. prognosis).

lead_sponsor: University Hospital, Lille

location_facility: Service de Chirurgie Digestive et de transplantation Hôpital Claude HURIEZ


title: Parental Representations of the Impact of the Use of Screens on Their Preschool Children Health and Development. An Opinion Survey of Parents of 1096 2-6-years-old Children

acronym: ECRENFANT

summary:
The main objective of this study was to evaluate the distribution of parental representations concerning the use of screens by preschool children, expressed in qualitative surveys: perceptions of screens as a source of learning, a source of appeasement, a source of behavioral difficulties and a source of reduction in the social interactions of young children.

The hypothesis of this study was the representations expressed in the qualitative studies were the reflection of the opinion of a majority of parents of young children.

intervention_type: Behavioral


title: Study of the Effects of the Combination of Motor Imagery Exercises and Transcranial Magnetic Stimulation (TMS) Type PAS in Patients After Hemiplegic Stroke

acronym: MIPAS

summary:
Strokes represent, in industrialized countries the leading cause of acquired motor disability in adults older than 40. Stroke is responsible for France from 150 000 to 200 000 new cases of hemiplegia each year. These patients will see their deficit to improve during the first 6 months after stroke. This recovery is largely based on brain plasticity mechanisms and the rehabilitation has as main objective to optimize these mechanisms. However, only 20% of patients hospitalized in a rehabilitation sector recover a functional upper limb. This lack of functionality is not only due to overall strength gap but also to the predominance of this gap on the extension movements of the wrist and fingers.

Meanwhile, work on brain plasticity helped develop new techniques of non-invasive brain stimulation (Non-invasive Brain Stimulation, NIBS) as the model of coupled stimulations (Paired Associative Stimulation, PAS) for modulating way over effective brain plasticity. In previous studies, the investigators have shown over a 30 minutes session lasting facilitation (60mn) and specific motor evoked potential (MEP) of the Extensor Carpi Radialis (ECR). Several studies showed an adjuvant effect when GSIN were associated with learning of a motor task. For PAS, some studies have shown a greater facilitation when the latter is associated with muscle contraction.

The motor imagery (MI) is imagining a movement without realizing it, it is based on mechanisms similar to those of the real movement. This technique also showed its effects as an adjuvant therapy in hemiplegic patients, however, they remain lower than those obtained after a motor drive. Its use in patients with no motor makes its uniqueness and strength.

primary_purpose: Supportive Care

ReferenceCitation: Brihmat N, Tarri M, Gasq D, Marque P, Castel-Lacanal E, Loubinoux I. Cross-Modal Functional Connectivity of the Premotor Cortex Reflects Residual Motor Output After Stroke. Brain Connect. 2020 Jun;10(5):236-249. doi: 10.1089/brain.2020.0750. Epub 2020 Jun 11.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Mary Ann Liebert Inc

lead_sponsor: University Hospital, Toulouse

intervention_type: Procedure


title: Consequences of Temporomandibular Disorder on Balance Control

acronym: DAM

summary:
To evaluate the effects of the temporomandibular disorder (TMD) and its therapeutic care on postural control in somato-sensory and visual sensitization compared to control subjects matched on age, sex and lifestyle.

Parameters will be estimated by measures realized before the therapeutic care of the TMD (T0), then 2, 3 and 5 months after the starting care, both in TMD patients and control subjects. To evaluate also the effects of the TMD and its therapeutic care on balance control in various contexts of multi-sensory stimulation, orientation function, pain and tinnitus.

intervention_type: Diagnostic Test


title: Admission of Adult-onset Still Disease Patients in the ICU: a French Retrospective Multicentric Study

acronym: Still-ICU

summary: Since its first description in 1971, diagnosing adult-onset Still's disease (AOSD), a rare multisystemic disorder considered as a multigenic autoinflammatory syndrome, remains challenging. Rarely, AOSD may present severe systemic manifestations and require intensive care. The main purpose of the Stil ICU study is to make the first description of the epidemiology of critically ill AOSD patients. The investigators will use a retrospective cohort study design with dual recruitment strategies: (1) via the AOSD referral centres network and (2) via a French academic medical ICU network.


title: Multicentric Clinical Trials on the Prevalence of Entamoeba Gingivalis and Its Associated Bacterial Flora in Patients With Periodontitis

acronym: Paro-Proto

summary:
The buccal cavity is colonized by numerous microorganisms whose the number and composition could be modified with medical background (diseases and drugs) and the level of oral hygiene of the patients. Among all microorganisms identified in the periodontium, few of them are implicated in the etiopathogenesis of periodontal pathologies. To date, four major bacteria are identified for their ability to degrade periodontal tissues.

Although the periodontitis is established to be the consequence of bacterial virulence and immune dysfunction, these factors fail to explain the refractory periodontitis of some patients to etiologic treatment .

Others microorganisms such as protozoans could have an impact on this disease.

time_perspective: Other

ipd_sharing_description: non applicable

collaborators: Centre Hospitalier Universitaire de Nice


title: Life Quality of Children in Cancer Remission During School Reintegration

acronym: QdV leucémie

summary:
Few data about the evaluation of consequences of past life with cancer on life quality of children in school reintegration are available in literature. Nevertheless, some of these studies show that the reintegration impairs life quality of these children (school difficulties, conflictual relations with peers…). The hypothesis is that children with past life with cancer have more chances to have school integration difficulties with a consequent life quality degradation compared to healthy children.

The main objective of this project is to study the relation between the satisfaction of school reintegration of children in cancer remission and the evolution of life quality in the medium term (after getting back to school). More exactly, it is the question if the satisfaction of school reintegration influences life goals and priorities of these children.

The secondary objective is to study the role of psychological status of these children (anxiety, depressive symptoms) on satisfaction-life quality relation.

A group of children with cancer history sent to ordinary school is compared to a control group of children sent to school in the same conditions (sex and age matched). Data are collected with questionnaires some months to several years after school reintegration and same questionnaires 1 year later.

If the study hypothesis is confirmed, this study will show the necessity of a long term follow up of children in cancer remission and not only medical care, but also psychological and social care, in order to support a better school reintegration.

primary_purpose: Other


title: Measurements of Myocardial Relaxation Time by MRI During Respiration

acronym: ARTEMIS

summary:
Measurement of T2 transversal relaxation time by magnetic resonance has a major interest in cardiac imagery. It has been initially used for quantitative evaluation of heart viability and more recently for edema characterization. It allows to prematurely detect a cardiac transplant rejection. This technique needs successively around ten FSE sequences during apnea. Weak reproducibility of successive apneas and discomfort of patient limit the precision of this measurement and consequently its use in standard care. The ARTEMIS study method allows the examination during free respiration without prolonging the duration of examination compared to the examination during apnea. Moreover, image processing is simplified and correction of respiratory movements renders results more reliable.

This is a pilot study of evaluation of ARTEMIS technique of image reconstruction. ARTEMIS is a method of MRI image reconstruction for measurements of T2 transversal relaxation. It allows to obtain diagnostic images without movement artifacts.

The primary objective si to show the feasibility of ARTEMIS method for measurement of myocardial T2 relaxation time during free respiration in cardiac transplant patients.

The secondary objective is to collect quantitative data to compare ARTEMIS method of measurement of T2 during free respiration and standard clinical practice during apnea.

primary_purpose: Device Feasibility

intervention_type: Device


title: Physical Activity of Asthmatic School Children and Teenagers: Evaluation and Perspectives

acronym: Asthmeact

summary:
Physical activity is mandatory to the optimal development and health of children. The presence of asthmatic manifestations may influence the comportment of children and its family toward exercise and practice of sports. There no scientific argument to advice a reduction of physical activity in asthmatic children, but previous studies showed that physical activity is reduced in asthmatic children.

The aim of this observational study is to evaluate the existing factors leading to this reduction of physical activity in asthmatic children and their families.

sponsor_collaborators:
Central Hospital, Nancy, France
University of Lorraine


title: Interest of Doppler Ultrasound for the Assessment of Incidence of Deep Vein Thrombosis on Central Venous Catheters in the Post Operative Period of Carcinologic Surgery

acronym: THROMBOCAT

summary: The objective is to determine the incidence of thrombosis on central venous catheters in patients hospitalized in a surgical critical care unit, in the immediate postoperative period of urological or digestive carcinological surgery, and receiving parenteral nutrition.


title: Renal Function Evaluation in an Ultra Endurance Race: On the Interest of Monitoring Specific Biomarkers to Asses Renal Risk.

acronym: INFERNAL

summary:
During ultra endurance events, athletes experience extreme physical and mental demands, sometimes at the limits of the adaptive response to human physiology. This is particularly true for the renal function, and some evidence for acute renal failure has already been shown, sometimes leading to dialysis. However, the precise mechanisms involved in acute renal failure in such ultra endurance races are not clearly elucidated.

The aim of our study is to estimate glomerular filtration rate from serum and urinary creatinine and cystitin C at the beginning and at the end of a 110 km ultra endurance race. Our hypothesis is that during the ultra endurance race, renal function may be injured, with a risk for the athlete.

ReferenceCitation: Didier S, Vauthier JC, Gambier N, Renaud P, Chenuel B, Poussel M. Substance use and misuse in a mountain ultramarathon: new insight into ultrarunners population? Res Sports Med. 2017 Apr-Jun;25(2):244-251. doi: 10.1080/15438627.2017.1282356. Epub 2017 Jan 23.

ReferenceCitation: Poussel M, Vauthier JC, Renaud P, Gambier N, Chenuel B, Ladriere M. [Acute kidney injury following naproxene use in an ultraendurance female athlete]. Presse Med. 2013 Sep;42(9 Pt 1):1274-6. doi: 10.1016/j.lpm.2012.09.030. Epub 2013 Feb 27. No abstract available. French.

ReferenceCitation: Hoffman MD, Weiss RH. Does Acute Kidney Injury From an Ultramarathon Increase the Risk for Greater Subsequent Injury? Clin J Sport Med. 2016 Sep;26(5):417-22. doi: 10.1097/JSM.0000000000000277.

ReferenceCitation: Hoffman MD, Stuempfle KJ, Fogard K, Hew-Butler T, Winger J, Weiss RH. Urine dipstick analysis for identification of runners susceptible to acute kidney injury following an ultramarathon. J Sports Sci. 2013;31(1):20-31. doi: 10.1080/02640414.2012.720705. Epub 2012 Oct 4.


type: Registry Identifier

title: Study of Immunity at the Genital Mucosa of HIV-1 Infected and Healthy Women

acronym: MUCOVAC

summary:
Current knowledge on mucosa, especially genitals in women, however, remain inadequate, especially regarding defense mechanisms and possibilities for a vaccine to induce an active immune response at mucosal front door of the most pathogens. Induction of mucosal immune response has emerged as a research priority research prophylactic vaccine.The development of strategies to prevent sexual transmission of HIV-1 depends in part on an understanding of specific and innate immune mechanisms involved in this transmission.

MUCOVAC is a feasibility study of the immunological and transcriptomic analysis of cervicovaginal samples of women infected or not infected with HIV-1. We also assess tolerance samples taken by cytobrush and cervicovaginal washings, efficiency and reproducibility of the sample by cytobrush and cervicovaginal lavage for transcriptomic analysis, measurement of cytokines by Luminex technology, quantification of IgG and IgA. In blood we will determine the phenotype of B cells and Tfh cell frequency (T follicular helper) and quantification of serum immunoglobulins and will perform a transcriptomic analysis of blood cells. Finally we will make correlations with the observed responses at the genital mucosa.

This pathophysiological exploratory study will be performed in 20 women infected with HIV-1 and 20 healthy women recruited from two centers in France and will include a screening visit and two visits M0 and M1 during which mucous and blood samples will be performed.

The results of the study will capitalize skills in biology mucosa, using powerful tools to assess mucosal immunological parameters.

status: Terminated

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility: Centre d'investigation clinique Cochin Pasteur (CIC1417)

location_facility: Service des maladies infectieuses et tropicales


title: Creation of a Monocentric Cohort of Patients Treated for Acne at the Nantes University Hospital: the COPACNE Cohort.

acronym: COPACNE

summary:
With 24 million results associated with Google's searchon keywords "severe acne", Pr Dreno's team understand better thatthis disease, which affects many French people, is a real concern of Public Health and not a "forced evil" of the adolescent period, which will eventually resolve itself. Acne does not affect the vital prognosis, but its psychosocial impact is major and should not be underestimated. Paradoxically, despite the high prevalence of acne, few quality epidemiological studies have been published. Physicians are often helpless when faced with patients' questions. They often need a lot of explanations, especially on the factors aggravating this dermatosis, which greatly affects their quality of life.

This cohort, the first of its kind in France, will determine the predictive factors of therapeutic response, endogenous and environmental factors impacting on the severity of acne assess the quality of life and psychological impact of acne patients, determine the patient's course of care and the associated costs. Pr Dreno's team will also build up a bio collection (bacteriological samples).

lead_sponsor: Nantes University Hospital


title: Development and Qualification of Methods for Analyzing the Mucosal Immune Response to COVID-19

acronym: MUCOVID

summary:
The pandemic associated with the SARS-CoV-2 coronavirus has affected over 760 million individuals worldwide, resulting in more than 6.9 million deaths. France has also been heavily impacted, with over 39.8 million infections and 167,000 deaths.

SARS-CoV-2 primarily causes an upper respiratory tract infection transmitted through the air. When it reaches the lungs, it leads to a severe acute respiratory illness called COVID-19. The body's response to this viral assault primarily occurs at the level of the respiratory mucosa.

This mucosal response is complex, involving various levels of activity. Mucosal immunity is therefore essential for an adequate and long-term immune response against viral respiratory infections, including SARS-CoV-2 infection.

Infection with SARS-CoV-2 triggers a humoral immune response with the production of antibodies in the blood (serum antibodies) and antibodies in the upper respiratory tract (mucosal antibodies). It also induces a cellular immune response by activating specific blood T lymphocytes.

Tests used to measure the humoral blood response against SARS-CoV-2 and their neutralizing capacity are now well identified, as are tests for assessing the serum cellular T lymphocyte response. However, tests for measuring mucosal immune responses are not routinely used.

Our study aims to develop and qualify methods for analyzing mucosal immunity directed against SARS-CoV-2. These methods will be essential for a more precise analysis of the body's mucosal response to this virus.

Once these analytical methods are validated, they will enable the study of mucosal responses to infection, as well as mucosal responses induced by vaccination against SARS-CoV-2, particularly in the context of future nasal vaccine use.

status: Not yet recruiting

primary_purpose: Health Services Research

ReferenceCitation: Haute autorité de santé. Aspect immunologiques et virologiques de l'infection par le SARS-CoV-2 ; Rapport HAS 25 Novembre 2020

ReferenceCitation: Alu A, Chen L, Lei H, Wei Y, Tian X, Wei X. Intranasal COVID-19 vaccines: From bench to bed. EBioMedicine. 2022 Feb;76:103841. doi: 10.1016/j.ebiom.2022.103841. Epub 2022 Jan 24.

ReferenceCitation: Y. Jouan · M. Si-Tahar · A. Guillon. Immunité de la muqueuse respiratoire : physiologie et implications en réanimation. Méd. Intensive Réa 2017 ; 26 :11-20

ReferenceCitation: Smith N, Goncalves P, Charbit B, Grzelak L, Beretta M, Planchais C, Bruel T, Rouilly V, Bondet V, Hadjadj J, Yatim N, Pere H, Merkling SH, Ghozlane A, Kerneis S, Rieux-Laucat F, Terrier B, Schwartz O, Mouquet H, Duffy D, Di Santo JP. Distinct systemic and mucosal immune responses during acute SARS-CoV-2 infection. Nat Immunol. 2021 Nov;22(11):1428-1439. doi: 10.1038/s41590-021-01028-7. Epub 2021 Sep 1.

ReferenceCitation: Chavda VP, Vora LK, Pandya AK, Patravale VB. Intranasal vaccines for SARS-CoV-2: From challenges to potential in COVID-19 management. Drug Discov Today. 2021 Nov;26(11):2619-2636. doi: 10.1016/j.drudis.2021.07.021. Epub 2021 Jul 29.

ReferenceCitation: Denis F, Alain S, Hantz S, Lagrange P. [Antiviral vaccination and respiratory mucosal immunity: still disappointing results from a seductive idea]. Presse Med. 2005 Oct 8;34(17):1245-53. doi: 10.1016/s0755-4982(05)84165-x. French.

ReferenceCitation: Russell MW, Mestecky J. Mucosal immunity: The missing link in comprehending SARS-CoV-2 infection and transmission. Front Immunol. 2022 Aug 17;13:957107. doi: 10.3389/fimmu.2022.957107. eCollection 2022.

ReferenceCitation: Tang J, Zeng C, Cox TM, Li C, Son YM, Cheon IS, Wu Y, Behl S, Taylor JJ, Chakaraborty R, Johnson AJ, Shiavo DN, Utz JP, Reisenauer JS, Midthun DE, Mullon JJ, Edell ES, Alameh MG, Borish L, Teague WG, Kaplan MH, Weissman D, Kern R, Hu H, Vassallo R, Liu SL, Sun J. Respiratory mucosal immunity against SARS-CoV-2 after mRNA vaccination. Sci Immunol. 2022 Oct 28;7(76):eadd4853. doi: 10.1126/sciimmunol.add4853. Epub 2022 Oct 21.

ReferenceCitation: Yaugel-Novoa M, Bourlet T, Paul S. Role of the humoral immune response during COVID-19: guilty or not guilty? Mucosal Immunol. 2022 Jun;15(6):1170-1180. doi: 10.1038/s41385-022-00569-w. Epub 2022 Oct 4.

lead_sponsor: University Hospital, Tours


title: Osteoarticular Tumor Characterization by Advanced Imaging

acronym: TUMOSTEO

summary:
The purpose is to compare and evaluate multiple functional imaging methods (perfusion, diffusion, spectroscopy) for initial benign/malignant characterization of osteoarticular tumors and to determine which method or which association of methods could improve non invasive tissue characterization.

Secondary purposes are:

to determine a possible correlation between some parameters and the histological grade (FNCLCC)
to suggest a coherent diagnostic imaging approach for osteoarticular tumors.

The ancillary study will enroll patients needing radiological tumor follow-up. The purpose is to identify tools for evaluation of tumor activity and therapeutic response before modification of morpho-volumetric data.

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


title: MR Compatible Accelerometer for Respiratory MOTion Measurement

acronym: MARMOT

summary: A novel magnetic resonance (MR) compatible accelerometer for respiratory motion sensing (MARMOT) has been developed as a surrogate of the vendors' pneumatic belts. The aim is to model and correct respiratory motion for free-breathing thoracic-abdominal MR imaging and to simplify patient installation.

location_facility: Centre Hospitalier Régional Universitaire de Nancy Brabois


title: Wound Vitality Markers in Forensic Pathology

acronym: PLAIES VITALES

summary:
The purpose is to determine intrinsic properties of various immunohistochemical markers (FVIIIra, CD15, CD30, tryptase, TNFα, IL-1β, TGFα et TGFβ1) for diagnosis of vital wound, alone and in association (evaluation of sensibility with surgery wounds and evaluation of specificity with post-mortem wounds).

Secondary purposes are to measure the minimum time to obtain a positive labeling in vital wounds, and to evaluate inter-observer reproducibility of vitality diagnosis with different markers. Expression of microRNA miR 9, miR 21 et miR 198 will be also studied.


title: Targeted Next Generation Sequencing and Intellectual Disability

acronym: NGS-DI

summary:
The purpose is to determine the benefit of next generation sequencing (NGS) targeted on genes involved in intellectual disability for etiologic diagnosis of intellectual disabilities. In other words, it concerns the number of patients whose etiologic diagnosis will be established with NGS and could not with common techniques. Actually, the molecular etiology of intellectual disability is crucial to calculate the risk of recurrence and allows the perinatal diagnosis to these families.

Secondary purposes are:

To determine the place of NGS in the strategy of etiologic diagnosis of intellectual disability, to determine the order of analyses performed for a patient with intellectual disability without clinical signs.
To evaluate the number of variants with unknown significance and thus non-usable for genetic counselling without supplementary analysis.
To determine the number of samples that can be at most pooled keeping a good efficacy of capture and results with suitable read depth
To determine the possibility of detecting copy number variations (CNVs) in genes of interest with NGS
To establish genotype/phenotype correlations for each gene for which a mutation has been identified
To optimize the software pipelining for a rapid analysis for diagnosis.


title: First Episode of Anterior Glenohumeral Dislocation in Adult Patients Under 25 Years of Age: Anterior Capsulo-labral Reinsertion by Arthroscopic Approach Versus Immobilization "

acronym: BANKART

summary:
The risk of recurrence and chronic instability after an initial episode of anterior glenohumeral dislocation is high, the risk is higher the younger the patient is.

Most patients with recurrences develop this instability during the first 2 years.

Several studies have shown that an initial arthroscopic surgical treatment (Bankart intervention) decreased the risk of recurrence and therefore of chronic instability, but this attitude is not usual in France and none randomized study comparing intervention of arthroscopic Bankart and immobilization was published by a French team.

The primary objective was to evaluate at 2 years the efficacy on the rate of recurrent instability of the first-line arthroscopic repair of prior capsulo-labral lesions compared to conservative treatment by immobilization for patients under 25 years having an initial episode of anterior glenohumeral dislocation

Material and method : We conducted a randomized controlled, open-label, parallel-group study (conservative treatment group by immobilizing VS surgical treatment group) in patients aged 18 to 25 with anterior glenohumeral primo luxation. Patients were clinically reassessed at 2 years with functional scores (WOSI, DuplayWalch, DASH), mobility and instability recurrence.

Hypothesis: reduction of the recurrence rate in the surgically treated group

ReferenceCitation: Pouges C, Hardy A, Vervoort T, Amouyel T, Duriez P, Lalanne C, Szymanski C, Deken V, Chantelot C, Upex P, Maynou C. Arthroscopic Bankart Repair Versus Immobilization for First Episode of Anterior Shoulder Dislocation Before the Age of 25: A Randomized Controlled Trial. Am J Sports Med. 2021 Apr;49(5):1166-1174. doi: 10.1177/0363546521996381. Epub 2021 Mar 11.

publisher_dissemination: SAGE Publications


title: Evaluation of Dynamic Computed Tomography Anatomy of Ankle in Inversion / Eversion Mouvement in Subtalar Instability.

acronym: IDIS

summary: The purpose of this study is to describe normal dynamic computed tomography anatomy of hind foot in inversion/eversion movement, and to define diagnostic criteria for subtalar instability.


title: BIOtinidase Test In Optic-Neuropathy

acronym: BIOTIN

summary:
Biotinidase is an enzyme that recycles biotin, a water-soluble vitamin essential as a coenzyme for four carboxylases that are involved in gluconeogenesis, fatty acid synthesis, and in the catabolism of several branch-chain amino acids. Biotinidase deficiency (BD) is an autosomal recessively inherited disorder. Patients with profound BD (<10% of mean normal serum biotinidase activity) presents, usually during early childhood, with neurological (seizures, hypotonia, ataxia, developmental delay, vision problems, and/or hearing loss) and non-neurological findings (metabolic acidosis, respiratory difficulties, alopecia and/or skin rash) that may progress to coma or death if untreated.

Three cases of adult-onset biotinidase deficiency with reversible optic neuropathy have recently been described in France, where there is no neonatal screening of BP. Once treated with Biotin, patients' vision was fully restored.

This study aims to assess the prevalence of BP among a population of patients with idiopathic optic neuropathy, and to assess the efficacy of Biotin supplementation on visual impairment in these patients.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Predictive Score of PneumOThorax Secondary to CT-guided Transthoracic Lung Biopsy Made From a Large Retrospective Cohort and Validated on a Prospective Cohort

acronym: SPOT

summary: Transthoracic lung biopsy (TLB) provides a histological diagnosis of nodule or lung mass. Pneumothorax is the main complication of TLB with an average of 20%. Many risk factors, whether clinical, computed tomography or related to TLB, are described in the literature. The British Thoracic Society recommends monitoring for 2 hours after the procedure with a possible discharge if the chest X-ray is normal. There is no French or European recommendation for monitoring the occurrence of pneumothorax after TLB. In the university center of Besançon, France, a minimum supervision of 4 hours is recommended and approximately one in two patients is hospitalized until the following day to reach this minimum time of 4 hours. The objective of the SPOT study is to perform a predictive score of pneumothorax from a retrospective cohort of patients for whom a transthoracic lung biopsy was performed and to validate this score on a prospective cohort. The expected goal is to select patients who can benefit from outpatient care by shortening the post-procedure surveillance period and to monitor more long-term only high-risk patients.

sponsor_collaborators: Centre Hospitalier Universitaire de Besancon


title: French National Cohort of Patients With Melanoma (Any Stage). Network for Research and Clinical Investigation, the RIC-Mel Network.

acronym: RIC-Mel

summary:
With a high incidence, low survival rates and limiter availability of effective treatment, melanoma is one of the research priorities for health authorities. Optimizing the development of both academic and private research requires the availability information on the features of patients.

To meet this need, the French Multidisciplinary Melanoma Group (GMFMel) in collaboration with INCa (French National Cancer Institute), the CeNGEPS (National Centre for Healthcare Products Trial Management) and the CIC-BT0503 from Nantes University Hospital (Biotherapy Clinical Centre of Investigation) has set up in April 2011 a Clinical Investigation Network for melanoma, called the CeNGEPS-GMFMel network. Nowadays, the network is named :

RIC-Mel : network for Research and Clinical Investigation on Melanoma. Aims of the network are to promote translational and epidemiological projects as well as to optimize the achievements of clinical trials.

To achieve these goals, a database was launched in 2012 that gives a permanently updates mapping of melanoma treated in France with the key information needed for any research projects.

sponsor_collaborators:
Nantes University Hospital
CENGEPS
Bristol-Myers Squibb
Hoffmann-La Roche
GlaxoSmithKline
Amgen


title: Lili Smart Study - Connected Solution of Assistance Dedicated to Caregivers and People With Alzheimer's Disease or Related Diseases

acronym: Lili smart

summary:
Alzheimer's disease and related diseases (ADRD) are a major public health issue. In France, nearly 900,000 people have ADRD, which represents about 70% of dementia cases, and the expected prevalence for 2020 is 1.2 million.

Patients with ADRD have cognitive, behavioral and functional impairments that lead to progressive impairment of quality of life and autonomy. Maintaining them at home depends predominantly on their caregivers, mainly family, spouse or child. By definition, the caregiver is "the person who provides partial or total support to an elderly dependent person or a person with a disability in the vicinity of the victim for the activities of daily life".

The investment of caregivers is therefore both human and financial, representing a greater or lesser burden. This burden can significantly affect their quality of life. Indeed, studies have shown that caregivers suffer from depletion, anxiety, depression and sleep disorders resulting in a deterioration of their health, leading them to greater care consumption. They would be more prone to cardiovascular diseases and cancer.

A review of the literature from 2009 examined 66 studies evaluating the contribution of various technologies targeting demented patients and their caregivers. Of these, only 10 dealt with independence at home and the well-being of the patient and his / her caregiver. The main limitations of these studies are the small samples (ranging from 1 to 6 patients), the degree of cognitive degradation (mainly moderately severe) and the lack of standardized assessment.

Although new technologies promise powerful home-based solutions, studies evaluating their efficacy for patients with ADRD and their caregivers remain scarce and fragile at the level of evidence due to methodological biases.

lead_sponsor: Hospices Civils de Lyon

sponsor_collaborators:
Hospices Civils de Lyon
Lili smart


title: Lyon Uveitis Study

acronym: LYS

summary:
Uveitis or inflammation of the uveal tract results from a heterogeneous collection of disorders of varying etiologies and pathogenic mechanisms. Uveitis is relatively frequent in industrial countries with an estimation of 115 cases for 100 000 persons and is associated with a blindness risk of 10%. Causes of uveitis can be related to different etiologies (infectious, inflammatory or general inflammatory diseases). Therapeutic care is based on ophthalmologic and systemic diagnosis and treatment strategy depends on the severity of inflammation.

The main objective of the Lyon uveitis study is to analyze the uveitis ophthalmologic etiology and diagnostic and therapeutic care of the patients. This study is proposed to all patients diagnosed for uveitis and referred to the Department of Internal Medicine of the Croix Rousse hospital, Lyon, france for etiologic diagnosis or treatment.

Analysis of i) patients' characteristics, ii) the relevance of complementary exams to determine the uveitis etiology, iii) treatment used.

This study will allow a better characterization of the disease on diagnosis practices and therapeutic care.

location_facility: Department of Internal Medicine, Croix-Rousse Hospital, Hospices Civils de Lyon


title: Hydroxyzine and Risk of Prolongation of QT Interval

acronym: HYDROXYZINE-QT

summary:
On 04/30/2015, ANSM (the National Security Agency of Medicines and Health Products) shared an information for general practicioners, pediatricians, anesthesiologists, dermatologists, geriatricians, psychiatrists, community pharmacists and hospital about using hydroxyzine and the associated risk of QT prolongation on the electrocardiogram.

Drugs containing hydroxyzine (the best known and most used is the Atarax®) are used in France in various indications including the treatment of minor manifestations of anxiety, premedication with general anesthesia and the symptomatic treatment of urticaria.

A prolonged QT interval is a known risk factor for occurrence of torsades de pointes which can cause sudden death. We distinguish congenital and acquired long QT interval. The main cause of acquired long QT interval is a drug inhibition of the HERG potassium channel 1. Many drugs have been reported to cause sudden death by prolongation of QT interval and occurrence of torsades de pointes (macrolides, anti -arythmics, some psychotropic ...) The molecules based on hydroxyzine are known to be at risk of prolongation of QT interval in an experimental point of view but is not clearly identified in daily clinical practice. Pharmacology unit of Caen was the first to publish a case of QT prolongation under hydroxyzine . Through this publication, associated with other clinical data, hydroxyzine has been added to the list of drugs that can induce QT prolongation .

Despite these recent recommendations, it does not seem that hydroxyzine prescriptions were changed daily and therefore the risk of QT prolongation persists. We therefore propose the study of the impact of hydroxyzine on the QT interval measured on the electrocardiogram in patients hospitalized at the University Hospital of Caen.


title: The Mortality and Its Associated Factors in Schizophrenia Patients Older Than 60 Years

acronym: CSA

summary: As in the general population, there is a gradual and steady increase in life expectancy of patients with schizophrenia. But this increase is at a smaller scale, with a rate of premature death that is still 2 to 3 times higher than that found in the general population. This excessive early mortality is explained by an overrepresentation of suicide deaths, but also a higher prevalence of somatic diseases, mainly cardiovascular. But today there are only very few epidemiological data on the mortality of patients with schizophrenia, including those aged over 60 years. What are the sociodemographic and clinical characteristics (psychiatric and somatic) of these schizophrenic elderly patients? Do they benefit from a somatic follow-up adequate and systematic? What are their levels of social independence and of quality of life? the answers these questions and the description of the offer of geriatric care and of psychiatric care currently provided by different sectors of psychiatry in France is an indispensable prerequisite for any project to improve the quality of life, state of health and mortality of older patients with schizophrenia.

ReferenceCitation: Raucher-Chene D, Hoertel N, Bera-Potelle C, Terrien S, Barriere S, Da Rin D, Tran E, Cuervo-Lombard C, Portefaix C, Limosin F. Mental healthcare in older adults with schizophrenia: results from 118 French public psychiatric departments. Int Psychogeriatr. 2015 Oct;27(10):1749-50. doi: 10.1017/S1041610215001064. Epub 2015 Jul 6. No abstract available.

lead_sponsor: CHU de Reims


title: Socio-professional Categories and Return to Work After Hip or Knee Replacement Surgery

acronym: ARRET-Pro

summary:
A significant proportion of patients (15 to 45%) who have benefited from a total hip or knee replacement surgery (THKA), are put on sick leave (SL). This SL allows these patients who had a professional activity at the time of the intervention (age <65 years) to enhance the healing, improve the quality of life and ensure a functional return to work. The number of patients returning to work and the time taken to return to work after the intervention are d depending on the intervention (hip or knee) and are linked to socio-demographic factors, to the patient's general condition (comorbidity, presence of other arthritis joints…) and the type of professional activity.

Studies evaluating the impact of the type of professional activity on the return to work after THKA are nonexistent in France, rare in the literature, mostly retrospective and methodologically weak. In addition, the individual and socioeconomic impact of the cessation of work after an THKA, the absence of national data assessing the predictive nature of socio-professional categories on the return to work using a multivariate analysis motivated us to set up this study.

ReferenceCitation: Tilbury C, Schaasberg W, Plevier JW, Fiocco M, Nelissen RG, Vliet Vlieland TP. Return to work after total hip and knee arthroplasty: a systematic review. Rheumatology (Oxford). 2014 Mar;53(3):512-25. doi: 10.1093/rheumatology/ket389. Epub 2013 Nov 23.

ReferenceCitation: Tilbury C, Leichtenberg CS, Tordoir RL, Holtslag MJ, Verdegaal SH, Kroon HM, Nelissen RG, Vliet Vlieland TP. Return to work after total hip and knee arthroplasty: results from a clinical study. Rheumatol Int. 2015 Dec;35(12):2059-67. doi: 10.1007/s00296-015-3311-4. Epub 2015 Jun 29.

lead_sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: Groupe Hospitalier Diaconesses Croix saint Simon


title: Evaluation of the Effectiveness of an Accelerated Rehabilitation Protocol Based on Multimodal Analgesia Optimization for Uni-compartmental Knee Prosthesis Surgery: Observational, Prospective, Monocentric "Before-after"

acronym: APUC

summary:
Today, prosthetic replacement for osteoarthritis of the knee is a frequent surgery. In France, nearly 100,000 knee arthroplasties are performed each year . Over the last two decades, there has been growing interest in performing single compartment knee replacement (SKR) surgery in patients with isolated single compartment osteoarthritis. The explanation lies in faster recovery, less postoperative pain and less morbidity compared to total knee arthroplasty (TKR) . Pain control is one of the major elements of outpatient management of CKD . Prosthetic knee surgery is very painful, the median pain is rated at 5 out of 10 and on average we use 32 milligrams of morphine . The efficiency of the adductor canal block is effective in this context, it avoids the motor block obtained by the femoral block, therefore interesting for ambulatory management in view of a resumption of the fast walking foreseen for the patient. The IPACK (interspace between popliteal artery and the capsule posterior knee) is designed to block the small sensory branches of the sciatic nerve that pass through this space without affecting the motor components. The IPACK block provides analgesia only for the posterior knee and would probably be ineffective alone for postoperative analgesia It is therefore often performed with an adductor canal block for multimodal analgesia. This block is performed in several facilities, and data are increasingly emerging on its effectiveness .

Thus, based on the recommendations of the French Society of Anesthesia and Resuscitation, on improved rehabilitation after heavy orthopedic surgery on the lower limb published in 2019 the objective of this study is to evaluate the relevance of a protocol concerning prosthetic knee replacement (PUC) in ambulatory care, based on optimized pain control.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Effectiveness of Various Environmental Measures to Eliminate the Risks of Lead Exposure in Infant Lead Poisoning

summary:
Infant lead poisoning is the clinical expression of lead poisoning. This environmental disease, still present in France, is the only notifiable non-infectious disease.

Its complications include, in the foreground, disorders of psychomotor development but also include in adults the attack of other systems.

The fight against lead poisoning mainly involves the removal of lead sources. Several methods of eviction exist: a modification of the practices, a palliative rehabilitation, a definitive rehabilitation and a relocation. The effectiveness of each method is not documented. This study therefore aims to compare the effectiveness of these various measures to eliminate the risk of exposure to lead on blood lead.

This study uses the methodology of a multicenter historical cohort. It will begin in the second quarter of 2017. The research centers will be child-environment consultations and mother-child PASS in Avignon, Manosque, Marseille, Nice and Toulon.

The study will be offered to all children monitored in these centers since 2011. The inclusion criteria will include: age <18 years, at least one blood lead ≥ 50μg.L-1, residence declared in PACA and absence opposition. The retrospective data will be incorporated into the prospective monitoring. The necessary number is at least 165 cases of infantile lead poisoning (of which 33 per type of intervention). The primary endpoint will be the kinetics of quarterly venous blood lead. The smallest clinically significant difference in blood lead levels will be 50μg.L-1 between the different groups.

Statistical analysis will use intra- and inter-individual variability analysis by compartmental modeling of the pharmacokinetics of blood lead. An interim analysis will be conducted in 2017 on the retrospective data to confirm the necessary staffing.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publiquye Des Hopitaux de Marseille