title: Impact on Antibiotic Prescriptions of a Bundle Intervention Conducted by Medical Representatives in General Practitioner Facilities, Based on Operational Demonstration of an Internet Decision Support Tool: Antibioclic

acronym: ACTION

summary:
At the international level, several experiments have been conducted to modify antibiotic prescribing practices in GPs. The mere development of training or the mere provision of information on the internet do not seem to change the practices when these interventions are conducted in isolation. On the other hand, various approaches involving communication training, specific educational interventions working on ideas received from examples, interventions at the point of care, and the use of electronic decision support systems have demonstrated beneficial effects on prescription. The fact of sending feedback on their prescribing practices back to GPs also showed an impact

The Antibioclic website was created in 2011. It is an internet tool for prescribing help developed for general practitioners. Every day, it is consulted on average by 9000 health professionals. One question is how far the use of the site makes it possible to modify prescribing practices, which would justify, if need be, to actively promote it to general practitioners who do not use it. (The council of the order of doctors counted a little more than 88000 general practitioners in 2018.)

One challenge would be to implement a strategy:

combining different actions that have shown their impact: visit to the place of care, awareness of antibiotic resistance, work on preconceived ideas, feedback on practices, use of decision support tools,
and generalizable nationally.

The proposed study will thus experiment with an intervention modality based on the visit of a medical representative in general practitioner facilities, with:

antibiotic resistance sensitization,
work on preconceived ideas,
feedback on prescriptions,
use of an Internet tool to assist in the prescription of antibiotics: Antibioclic.

The generalizability of the intervention will be based on the collaboration with the medical representatives , which already intervene in an operational and regular way on this topic on the whole France. The medical representatives, distributed throughout the country, provide regular visits to the GPs and promote good practices. This type of visit to GPs is original internationally, demonstrating its impact on practices is decisive.

The purpose of the research is to compare the effect on antibiotic prescriptions made by general practitioners after 12 months of follow-up, i) an intervention led by the medical representatives in general practitioner facilities, the intervention involving usual visit (antibiotic resistance sensitization, work on preconceived ideas, feedback on practices) and demonstration of the use of Antibioclic, ii) an intervention conducted on the same terms by the the medical representatives but without Antibioclic demonstration, iii) compared to usual practice.

primary_purpose: Other

lead_sponsor: Nantes University Hospital


title: Evaluation of Ultrasound Biomicroscopy in the Local Staging of Cutaneous Melanoma

acronym: BMUMM

summary:
Cutaneous melanomas represent 4 to 11% of cutaneous cancers, but is responsible for 75% of the deaths reported for these pathologies. The incidence rate double every 10 years. Fourteen thousand cases and 1700 deaths were reported in France in 2015.

The local staging of the cancer is represented by the Breslow index, which is measured on histological analysis, corresponding to the maximum depth of the cancer. Breslow index is a good pronostic value, and is used to choose for the best treatment for the patient.

Having access to the Breslow index before the first resection of the tumor would allow dermatologists to make a complete resection with the best treatment, and the analysis of the sentinel lymph node, all during the same surgical time. Currently, patients need 2 surgeries : one before the Breslow index, and a second one after.

The depth of cutaneous melanoma was already evaluated with High-Frequency Ultrasound (HF-US), but gave disappointing results, with Breslow index not being accurately measured.

Only 50% of tumors less than 2mm depth were efficiently measured. Results were even worst for bigger tumors.

Ultrasound biomicroscopy (UBM) is a new approach, depending on the use of ultra high frequency and large-band transducer. Nice's CHU acquired the only ultrasound device capable of applying such ultra high frequency ultrasound (UHF-US) to human tissues. The device is a VEVO MD (Vevo MD, Toronto, Canada) and equip the Ultrasound Department since June 2018.

The images investigators can assess with this device have an axial resolution of 30µm, for a maximum emission frequency of 70MHz, which was not attainable until this day in human care.

Furthermore, when compared to some of the mono-frequency devices investigators experimented before, this device allow investigators to attain a maximum depth of analysis up to 8mm.

In consequence, this device seems to be able to realize an extremely precise analysis of the skin, and of the cutaneous melanomas, for a structural analysis, as well as a precise depth measurement, and should be evaluated in the measurement of the Breslow Index.

The objective of the study is to analyze the interest of ultrasound biomicroscopy in the pre-therapeutic evaluation of the Breslow index of cutaneous melanoma, compared to histological findings.

The study will include 60 patients with cutaneous melanomas, recently diagnosed in the Dermatology Department of the Nice University Hospital (Pr Bahadoran, Pr Passeron, Pr Lacour). Each patient will beneficiate from complete Ultrasound biomicroscopy analysis of the tumor The examination will be made blindly by 2 operator, both with experience in Ultra High frequency Ultrasound examinations (Dr Azulay, Dr Raffaelli).

The maximum depth of the melanoma (Breslow index) will be recorded in µm. After surgical resection, the histologic analysis (Dr Long, Pr Hofman, Clinical and Experimental AnatomoPathologic laboratory, Nice's University Hospital) will measure the gold-standard Breslow Index.

The comparison will analyze the capacity of Ultrasound biomicroscopy for a precise measurement of the Breslow Index, as well as the inter and intra-operator concordance.

If the results of this study are positives and suggest a modification of the therapeutic strategy, a larger multicentric study would be launched in the near future.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire de Nice

intervention_type: Diagnostic Test

lead_sponsor_type: academique

status_simplified: Ongoing


title: Impact of the Automated Administration of Intravenous Anesthesia Compared to Inhalatory Anesthesia on the Speed of Emergence and the Occurrence of Postoperative Delirium

acronym: AG-DPO

summary: The intravenous administration of anesthetic agents by a controller automatically-guided by an index of cerebral activity (i.e. the bispectral index) decreases the incidence of postoperative delirium, compared with an inhalational anesthesia.

status: Unknown status

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: background

ReferenceCitation: American Geriatrics Society Expert Panel on Postoperative Delirium in Older Adults. Postoperative delirium in older adults: best practice statement from the American Geriatrics Society. J Am Coll Surg. 2015 Feb;220(2):136-48.e1. doi: 10.1016/j.jamcollsurg.2014.10.019. Epub 2014 Nov 14.

ReferenceCitation: Robinson TN, Raeburn CD, Tran ZV, Angles EM, Brenner LA, Moss M. Postoperative delirium in the elderly: risk factors and outcomes. Ann Surg. 2009 Jan;249(1):173-8. doi: 10.1097/SLA.0b013e31818e4776.

ReferenceCitation: Saczynski JS, Marcantonio ER, Quach L, Fong TG, Gross A, Inouye SK, Jones RN. Cognitive trajectories after postoperative delirium. N Engl J Med. 2012 Jul 5;367(1):30-9. doi: 10.1056/NEJMoa1112923.

ReferenceCitation: Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62.

ReferenceCitation: Chan MT, Cheng BC, Lee TM, Gin T; CODA Trial Group. BIS-guided anesthesia decreases postoperative delirium and cognitive decline. J Neurosurg Anesthesiol. 2013 Jan;25(1):33-42. doi: 10.1097/ANA.0b013e3182712fba.

ReferenceCitation: Radtke FM, Franck M, Lendner J, Krüger S, Wernecke KD, Spies CD. Monitoring depth of anaesthesia in a randomized trial decreases the rate of postoperative delirium but not postoperative cognitive dysfunction. Br J Anaesth. 2013 Jun;110 Suppl 1:i98-105. doi: 10.1093/bja/aet055. Epub 2013 Mar 28.

ReferenceCitation: Fritz BA, Kalarickal PL, Maybrier HR, Muench MR, Dearth D, Chen Y, Escallier KE, Ben Abdallah A, Lin N, Avidan MS. Intraoperative Electroencephalogram Suppression Predicts Postoperative Delirium. Anesth Analg. 2016 Jan;122(1):234-42. doi: 10.1213/ANE.0000000000000989.

ReferenceCitation: Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.

family: Liu

full_name: Ngai Liu

given: Ngai

sequence: first

family: Chazot

full_name: Thierry Chazot

given: Thierry

sequence: additional

family: Hamada

full_name: Sophie Hamada

given: Sophie

family: Landais

full_name: Alain Landais

given: Alain

family: Boichut

full_name: Nathalie Boichut

given: Nathalie

family: Dussaussoy

full_name: Corinne Dussaussoy

given: Corinne

family: Trillat

full_name: Bernard Trillat

given: Bernard

family: Beydon

full_name: Laurent Beydon

given: Laurent

family: Samain

full_name: Emmanuel Samain

given: Emmanuel

family: Sessler

full_name: Daniel I. Sessler

given: Daniel I.

family: Fischler

full_name: Marc Fischler

given: Marc

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Anesthesia & Analgesia

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Closed-Loop Coadministration of Propofol and Remifentanil Guided by Bispectral Index

ReferenceCitation: Besch G, Liu N, Samain E, Pericard C, Boichut N, Mercier M, Chazot T, Pili-Floury S. Occurrence of and risk factors for electroencephalogram burst suppression during propofol-remifentanil anaesthesia. Br J Anaesth. 2011 Nov;107(5):749-56. doi: 10.1093/bja/aer235. Epub 2011 Aug 8.

ReferenceCitation: Liu N, Lory C, Assenzo V, Cocard V, Chazot T, Le Guen M, Sessler DI, Journois D, Fischler M. Feasibility of closed-loop co-administration of propofol and remifentanil guided by the bispectral index in obese patients: a prospective cohort comparison. Br J Anaesth. 2015 Apr;114(4):605-14. doi: 10.1093/bja/aeu401. Epub 2014 Dec 10.

full_name: N. Liu

given: N.

family: Lory

full_name: C. Lory

given: C.

family: Assenzo

full_name: V. Assenzo

given: V.

family: Cocard

full_name: V. Cocard

full_name: T. Chazot

given: T.

family: Le Guen

full_name: M. Le Guen

given: M.

full_name: D.I. Sessler

family: Journois

full_name: D. Journois

given: D.

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

repository_institution: The Pennsylvania State University - CiteSeer X

title: Feasibility of closed-loop co-administration of propofol and remifentanil guided by the bispectral index in obese patients: a prospective cohort comparison †

ReferenceCitation: Orliaguet GA, Benabbes Lambert F, Chazot T, Glasman P, Fischler M, Liu N. Feasibility of closed-loop titration of propofol and remifentanil guided by the bispectral monitor in pediatric and adolescent patients: a prospective randomized study. Anesthesiology. 2015 Apr;122(4):759-67. doi: 10.1097/ALN.0000000000000577.

ReferenceCitation: Liu N, Chazot T, Trillat B, Michel-Cherqui M, Marandon JY, Law-Koune JD, Rives B, Fischler M; Foch Lung Transplant Group. Closed-loop control of consciousness during lung transplantation: an observational study. J Cardiothorac Vasc Anesth. 2008 Aug;22(4):611-5. doi: 10.1053/j.jvca.2008.04.022. Epub 2008 Jun 25.


title: Photoprotection Habits in Patients With Vitiligo

acronym: VITISUN

summary:
Intro:

Patients with vitiligo have a reduced protection on depigmented areas. To date, however, little is known about photoprotection habits in patients with vitiligo even though these patients are thought to have a decreased ability to efficiently protect their skin against sun damage. Moreover, exposure to artificial UV is one of the major elements of the treatment of vitiligo even though certain phenotypes of vitiligo could be photoinduced.

Hypothesis The Primary objective is to describe patients behaviour with sun exposition

The Secondary objectives are:

to assess the link between sun exposition and vitiligo outbreaks
to assess photoprotection habits according to initial phototype and vitiligo severity (SA-VES)
To validate a short form of the VIPs questionnaire, a validated burden questionnaire.

Method We aim to conduct a prospective cross sectional study in patients with Vitiligo with the aim to evaluate sun protection habits in patients with vitiligo. For that purpose a semi-directed questionnaire to investigate the sun protection behavior of vitiligo patients (adults> 18 years of age) have been created by experts in the field. Vitiligo severity will be self-assessed by patients using a recently validated patient reported outcome, the SA-VES. Consecutive vitiligo patients consulting in the dermatology department of Henri Mondor Hospital (Créteil, France) will be proposed to participate the study after having given their oral consent. We are planning to enrol 500 patients.

In a first step, a descriptive analysis will be carried out in order to describe the characteristics of the sample. Basic summary statistics, such as proportions, means and standard deviations, will be used to characterize the population. In order to identify the factors associated with the severity of the disease on the one hand and the phototype on the other, comparisons between groups (severe versus non-severe and light phototype versus dark phototype) will be carried out by unconditional logistic regression. All potential predictors of severity will first be assessed individually, and Odds Ratio (OR), corresponding 95% CIs and P values will be calculated. The significance of the OR will be determined by the Wald test χ2, and the predictors with P <.20 will then be evaluated using a multivariate analysis with a pre-selection procedure. Possible interactions and multi-colinearity will be examined. Finally, the quality of fit of the final model will be evaluated using the logistic regression diagnostic procedure. P ≤ 0.05 will be considered as statistically significant. The Hosmer-Lemeshow test will be carried out to test the suitability of the model.

Conclusion This study will help to identify gaps in the knowledge of sun protection habits in patients with vitiligo.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Actual

ipd_sharing: No

ipd_sharing_description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR

intervention_type: Other

status_simplified: Completed


type: Other Identifier

title: NEUROFEEDSTIM : Therapeutic Use of Neurofeedback in Depression in Association With TMS

acronym: NEUROFEEDSTIM

summary:
Neurofeedback is an increasingly researched technique for the treatment of many psychological disorders, such as attention deficit / hyperactivity disorder (AD / HD), depression, or substance abuse. This technique would allow patients to regulate their cortical electroencephalographic activity while receiving a visual or auditory feedback on the cortical electroencephalographic activity. Changes in the electroencephalogram (EEG) would thus be correlated with changes in cortical activity and thus with symptoms.

On the electroencephalographic plane, the depression appears associated with relatively more alpha activity (in "resting state", 8-13 Hz) in left than in right frontal cortex. This difference in alpha activity between frontal regions is known as alpha asymmetry in depression. As a reminder, increased alpha activity indicates a decrease in cortical activation. This alpha asymmetry appears to be associated with a decrease in sensitivity to reward.

It is on these bases that the modification of the alpha asymmetry has become one of the most frequent objectives of the studies on the use of neurofeedback in depression.

Transcranial magnetic stimulation (TMS) also offers a non-invasive and painless method of effective cerebral stimulation in psychiatric disorders and especially depression. It received a favorable opinion from the Food & Drug Administration (FDA) in the United States for the treatment of this pathology. This treatment is still under evaluation in France. The results are promising but improvements must be done to increase its effectiveness.

TMS offers stimulation of brain tissue in a localized and non-invasive manner. The principle consists of a brief electric current passing through a coil which generates a transient magnetic field inducing an electric field through conductive fabrics. TMS modifies neuronal activity in target superficial brain structures, but also modulates neuronal circuit activity.

In recent years, the concept of "state dependency TMS" has been developed. It suggests that the activation state of neuronal circuits before and after stimulation alters the effect of stimulation. Thus, the efficacy of TMS could be amplified in depression by taking into account the cerebral activity during the stimulation sessions, in particular on the electroencephalographic plane.

However, TMS may also help patients increase their EEG response during Neurofeedback sessions.

The combination of stimulation techniques and brain-machine interfaces such as neurofeedback is still little studied at present.

A study on the combined use of TMS and Neurofeedback by EEG in depression would therefore be an innovative approach and in line with the latest data from the literature.

Design : Prospective, monocentric, non-randomized, non-comparative, unblinded study.

lead_sponsor: Rennes University Hospital

intervention_type: Device


title: A Study of Bioequivalence When Administering Biktarvy® (TAF/FTC/BIC) in the Form of a Solid/Crushed/Dissolved Tablet to Healthy Volunteers - SOLUBIC Study

acronym: SOLUBIC

summary:
Study context:

Some HIV-positive patients have difficulties with oral administration of antiretroviral drugs, such as children and adults suffering from ENT cancer. It is therefore necessary to offer these patients an alternative: administering the triple therapy in a liquid or well crushed form would be alternatives to a solid tablet, conditional on demonstrating their bioequivalence and that they are well tolerated (taste in particular).

Objectives:

The investigator's primary intention is to demonstrate the bioequivalence of each of the three active ingredients in Biktarvy® (single daily tablet made up of a set combination of tenofovir alafenamide/emtricitabine/bictegravir: TAF/FTC/BIC) by administering the drug in the forms of a complete and solid tablet (phase S), a tablet dissolved in water (phase D) or a tablet crushed and suspended in apple compote (phase C). The secondary objectives are to compare the safety, tolerance (taste in particular) and preference of healthy volunteers after administration of Biktarvy®, depending on the three methods of oral administration.

Equipment and methods:

This is a phase I, monocentric, open, three-period, randomised, cross-over trial that will be conducted with 18 healthy volunteers (9 men, 9 women) above the age of 18 in a French university hospital (Caen University Hospital - CHU de Caen). The healthy volunteers will be randomised to receive three different forms (solid, dissolved or crushed) in a varying order, according to the randomisation, at an interval of 14 to 28 days. After each of the three doses, the volunteers will be hospitalised for 24 hours and will then return three times to carry out the pharmacokinetic study with samples taken at the following times: 0 h (right before taking Biktarvy®); 0.5 h; 1 h; 1.5 h; 2 h; 2.5 h; 3 h; 4 h; 8 h; 12 h; 24 h; 36 h; 48 h and 72 h (after Biktarvy®).

The plasma concentration in antiretroviral drugs will be analysed by liquid chromatography-mass spectrometry (QTRAP 5500, Sciex, Les Ulis, France) at Orléans Regional Hospital (CHR d'Orléans). The bioequivalence between administration methods D or C will be demonstrated if the confidence interval at 90% (CI 90%) of the ratio parameters Cmax, AUC0-72h and AUC0-∞ is included in the 80%-125% range of those obtained for administration method S and for the three active ingredients.

Hypothesis tested:

Oral administration of Biktarvy® tablets dissolved in water (as a liquid solution) or crushed and administered in an apple compote is bioequivalent to the solid form (entire tablet swallowed with water) with regard to the three active ingredients that make up Biktarvy®. This means that these methods could be offered to patients who have difficulties with swallowing tablets. Preliminary data must be obtained using healthy volunteers.

lead_sponsor: University Hospital, Caen

intervention_type: Drug


title: Risk of GAstric Adenocarcinoma After Cephalic Duodenopancreatectomy : RAGAD Study

acronym: RAGAD

summary:
In view of the similarities of the surgical set-ups of partial gastrectomies and cephalic duodenopancreatectomies, and the increased risk of gastric cancer after early partial gastrectomy, it is possible that the former pancreatic cephalic duodenopancreatectomy pancreaticoduodenectomy (CPD) is also associated with the occurrence of stomach cancer.

The investigators expect a high rate of cancer and high grade dysplasia in these patients based on literature data and available data on gastric cancer after partial gastrectomy. Participants with lesions to be discovered will benefit from earlier medical management of less advanced tumor lesions, with improved prognosis.

The primary objective of this study is to evaluate the incidence of gastric cancer or high grade dysplasia in patients with old CPP CPD (10 years or older) and who performed the endoscopy protocol.

The cohort will consist of all eligible patients identified from pathology registries and PMSI data from participating centers (patients living 10 years after CPDP, with no previous history of gastric cancer before entering the cohort).

Entry into the cohort (beginning of exposure) will be 10 years after CPD. If a gastric cancer has been diagnosed previously at the beginning of the current study (2019) with histological documentation present in the medical file, no new endoscopy will be performed and the patient will be considered as a "new case" on the date of histological diagnosis of cancer.

Of the patients included in the cohort, some will be eligible to perform the endoscopy added for research. This group will be the sample in which the primary endpoint will be measured.

1. Recruitment of patients with cephalad cephalic duodenopancreatectomy 10 or more years ago 2.

Per patient (in the group with endoscopies):

Inclusion consultation with patient consent collection
Anesthesia consultation
Upper gastrointestinal endoscopy and biopsy

Follow-up consultation to report the results to the patient and possibly organize a support (announcement device complies with HAS recommendations). For patients in the cohort not included in the endoscopy study, the data collection will be retrospective only (no specific patient consultation for research and no endoscopy review added for this research).

3. Data analysis: primary endpoints (incidence rate of high grade dysplasia and gastric cancer) and secondary endpoints 700 to 800 patients will be included in the entire cohort and 164 patients in the group with endoscopy.

7 centers in Ile de France participate.

duration of inclusion: 24 months
duration of participation (treatment + follow-up): schedule of the visit of anesthesia (5.5 months max), endoscopy programming (1 month max) + the day of the exam + 4 weeks for the results of the exam: 8 months maximum
total duration: 32 months

design_allocation: Non-Randomized

ipd_sharing: Undecided


title: Registry of Patient With Antithrombotic Agents Admitted to an Emergency

acronym: RATED Registry

summary:
Antithrombotics with antiplatelet agents, vitamin K antagonist (VKA), heparin and related substances, and new oral anticoagulants are prescribed for arterial diseases, especially in secondary prevention of embolic disease in carrier patients of heart valves and in patients with fibrillation atrial, and venous diseases, in prevention and treatment.

The prescription of these treatments is increasing especially in older patients associated with many comorbidities. Today, an estimated number of 900 000 patients under anti-vitamin K in France, and more than 1.5 million for patients on antiplatelet agents.

Venous thromboembolism (VTE) is common in the general population with an annual incidence of 10-18 cases per 10 000. The most severe form of VTE is represented by pulmonary embolism with a third of cases. Even if a large literature allows for high grade recommendations on many areas, there is still some gray areas regarding the long-term outcomes, the early evolution and tolerance of treatment, including long-term recurrence, the incidence of embolic sequelae with post-embolic pulmonary hypertension and association with other cardiovascular arterial accident (acute Coronary Syndrome, Stroke, arterial disease of the Lower Extremities ...).

The major risk of these antithrombotic is bleeding both in terms of morbidity mortality. Despite this risk, little study focuses on the exact epidemiology of bleeding associated with the use of antithrombotic. If the frequency of hemorrhagic stroke is low, some populations particularly at risk of bleeding represent the majority of serious bleeding events under VKA or anti-platelet. However, the VKA and antiplatelet agents are the first providers of hemorrhagic serious side effects drugs when looking at all national and international studies on the iatrogenic with in topped gastrointestinal bleeding and intracerebral hemorrhage (mortality of about 10 to 15%).

Moreover the recent arrival of new oral anticoagulants (Apixaban rivaroxaban, dabigatran ...) should profoundly change the management of venous thromboembolism and cardioembolic event. Because of their risk-benefit, simplicity and convenience of their prescription, the number of patients treated with these new anticoagulants were to rise rapidly. In addition, many patients deemed too "fragile" to be treated with VKA, should be treated with these treatments. These new anti-Xa and anti-IIa anticoagulants already marketed or about to be. They have the advantage over VKA: an oral way, their pharmacokinetic characteristics, absence of biological monitoring, chemical synthesis .... If it is not possible today to give the advantage to one or the other of these molecules, the choice will be directed by their pharmacokinetic characteristics, their half life, their method of disposal but also by patients co-morbidities. Although biological tests are currently available for the monitoring of these products, therapeutic solutions for severe bleeding does not exist: there is indeed no antidote for now, though the issue is finding a balance between increased therapeutic benefit and bleeding risk optimization. But hemorrhagic stroke is the most serious complications of oral anticoagulant therapy, with substantial documentation for these events occurring under VKA but little data on those occurring with the new oral anticoagulants (Apixaban rivaroxaban, dabigatran ...).

time_perspective: Prospective

ReferenceType: derived

ReferenceCitation: Moustafa F, Malhomme R, Pereira B, Barres A, Saint-Denis J, Dutheil F, Batisse M, Schmidt J. Assessment of the Impact of L-Thyroxine Therapy on Bleeding Risk in Patients Receiving Vitamin K Antagonists. Clin Drug Investig. 2017 Oct;37(10):929-936. doi: 10.1007/s40261-017-0545-9.

family: Moustafa

full_name: Farès Moustafa

given: Farès

family: Malhomme

full_name: Rémi Malhomme

given: Rémi

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Barres

full_name: Alain Barres

family: Saint-Denis

full_name: Jennifer Saint-Denis

given: Jennifer

family: Dutheil

full_name: Frederic Dutheil

given: Frederic

family: Batisse

full_name: Marie Batisse

given: Marie

family: Schmidt

full_name: Jeannot Schmidt

given: Jeannot

journal_name: Clinical Drug Investigation

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Assessment of the Impact of l-Thyroxine Therapy on Bleeding Risk in Patients Receiving Vitamin K Antagonists

lead_sponsor: University Hospital, Clermont-Ferrand


title: Observatory of Patients With Dyslipidemia Hospitalized in Endocrinology-Diabetology-Nutrition Unit: Observational Study

acronym: OBDYSLIP

summary:
Cardiovascular disease (CVD) due to atherosclerosis of the arterial vessel wall and to thrombosis is the foremost cause of premature mortality and of disability-adjusted life years in Europe, and is also increasingly common in developing countries. In the European Union, the economic cost of CVD represents annually €192 billion in direct and indirect healthcare costs. The main clinical entities are coronary artery disease (CAD), ischaemic stroke, and peripheral arterial disease (PAD). The causes of these CVDs are multifactorial. Some of these factors relate to lifestyles, such as tobacco smoking, lack of physical activity, and dietary habits, and are thus modifiable. Other risk factors are also modifiable, such as elevated blood pressure, type 2 diabetes, and dyslipidaemias, or non-modifiable, such as age and male gender. LDL-cholesterol (LDL-C) is one of the major risk factors for CVD, through its role in the development of atherosclerosis. The efficacy of statins has been demonstrated by a considerable amount of literature not only in lowering LDL cholesterol levels but also in reducing cardiovascular events, both in diabetes and non-diabetes patients. Guidelines for the management of dyslipidemia have emerged from different countries. Thereby, in 2016 the French Society of Endocrinology (SFE) and the New French Society of Atherosclerosis (NSFA) published a consensus statement on the management of dyslipidemias integrating features from European recommendations and in 2017 the Haute Autorité de Santé updated the French guidelines. However, LDL-C goal attainment has rarely been assessed specifically in diabetes population, in which CVD is of particular importance. This study aimed to assess the rate of dyslipidaemias in a population of patient hospitalized in Endocrinology-Diabetology-Nutrition unit.

This observational study was carried in the Diabetes-Nutrition unit of the University Hospital of Montpellier - France. All consecutive patients admitted to that unit during the study period were assessed for eligibility. Data on age, sex, tobacco smoking, body mass index, hypertension (treatment of previously diagnosed hypertension or blood values > 140/90 mmHg), presence and type of CVD (coronary artery disease, stroke and transient ischemic attack, peripheral arterial disease), were collected at admission. LDL-C, HDL-C and triglycerides levels calculated with the Friedewald formula, and glomerular filtration rate calculated according to the CKD-EPI formula were obtained from blood samples taken within 24 hours of hospitalization admission. Information on the name and daily dose of lipid lowering drugs (statins, fibrate, ezetimibe …) at admission was documented. Cardiovascular risk level and LDL-C target values were defined according to 2011 and 2016 ESC guidelines and 2017 French guidelines.

ReferenceCitation: Breuker C, Clement F, Mura T, Macioce V, Castet-Nicolas A, Audurier Y, Boegner C, Morcrette E, Jalabert A, Villiet M, Avignon A, Sultan A. Non-achievement of LDL-cholesterol targets in patients with diabetes at very-high cardiovascular risk receiving statin treatment: Incidence and risk factors. Int J Cardiol. 2018 Oct 1;268:195-199. doi: 10.1016/j.ijcard.2018.04.068.

family: Breuker

full_name: Cyril Breuker

given: Cyril

family: Clement

full_name: Florian Clement

given: Florian

family: Mura

full_name: Thibault Mura

given: Thibault

family: Macioce

full_name: Valérie Macioce

given: Valérie

family: Castet-Nicolas

full_name: Audrey Castet-Nicolas

given: Audrey

family: Audurier

full_name: Yohan Audurier

given: Yohan

family: Boegner

full_name: Catherine Boegner

given: Catherine

family: Morcrette

full_name: Emilie Morcrette

given: Emilie

family: Jalabert

full_name: Anne Jalabert

given: Anne

family: Villiet

full_name: Maxime Villiet

given: Maxime

family: Avignon

full_name: Antoine Avignon

given: Antoine

family: Sultan

full_name: Ariane Sultan

given: Ariane

journal_name: International Journal of Cardiology

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IRD - Institut de recherche pour le développement

repository_normalized: HAL

version: submittedVersion

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

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Evaluation of the Benefits of Percutaneous Posterior Tibial Nerve Stimulation in Post-operative Voiding Dysfunction After Deep Endometriosis Surgery

summary:
Symptomatic endometriosis can be responsible for urinary problems as well as symptoms of clinical bladder hyperactivity and/or symptoms of bladder pain before or during miction that can persist after bladder voiding. Whereas urinary problems can predate surgery due to the endometrial lesions themselves, the surgery can also have functional consequences for urinary function, specifically when there is trauma (incisions, per-operative coagulation) to the inferior hypogastric nerve fibers and/or to the hypogastric plexus.

The incidence of post-surgery urinary symptoms could be as high as 30%. The incidence of voiding problems and specifically of non-obstructive voiding dysfunction can be observed in 17,5% of cases of patients 1-month post-surgery for deep colorectal endometriosis, and persists in 4,8% of women after 12 months.

The gold standard for treatment of voiding problems consists of self-catheterization, as is the case for all non-obstructive voiding dysfunction symptoms. This procedure considerably impacts quality of life. The proper and complete voiding of the bladder remains essential in order to avoid recurring urinary tract infections and pelvic static disorder.

In the case of persistent dysuria, the use of self-catheterization is necessary in 21% of patients after surgery for deep endometriosis, for an average duration of 85 days. To date, few studies have explored the management of post-operative urinary complications after surgery for deep endometriosis. Pharmaceutical alternatives (alpha-blockers, anticholinergics, benzodiazepines) have not proven effective and sometimes cause side effects. However promising alternative treatments are being developed, specifically the neuromodulation of the sacral root. This procedure has been shown effective in the treatment of non-obstructive voiding dysfunction; however, it remains an invasive treatment that has its load of complications and undesirable side-effects. A recent study reports favorable results for the use of sacral neuromodulation in the case of persistent incomplete voiding following surgery for deep colorectal endometriosis. Some studies have also suggested that percutaneous posterior tibial nerve stimulation (PTN) could also be a treatment alternative. The advantage of this procedure is that it is non-invasive and less constraining. No study has yet evaluated whether PTN could also be used to treat patients with persistent voiding dysfunction following surgery for deep endometriosis.

Our study, conducted in the gynecologic department of Croix ROUSSE Hospital, Lyon (France), evaluates PTN as a new treatment option for post-operative voiding dysfunction in women who suffer from deep endometriosis. Our aim is to prove that the use of PTN can reduce the duration of self-catheterization by 50% when compared to self-catheterization only.

lead_sponsor: Hospices Civils de Lyon


title: Evaluation of Pre-Exposure Prophylaxis Against HIV in Alpine Region

summary:
Despite the implementation of a national strategy to prevent the transmission of the human immunodeficiency virus (HIV) combining prevention campaigns, condom use, early detection of HIV infections and recommendations for treatment as soon as possible, the number of new HIV-infected patients per year in France does not decrease.

New HIV prevention strategies are therefore clearly needed. Since 2009, several studies have shown that tenofovir disoproxil fumarate and emtricitabine (TDF/FTC), an antiretroviral therapy combining two nucleoside reverse transcriptase inhibitors used for the treatment of patients seropositive for HIV, has preventive activity on HIV transmission. These results enabled the TDF/FTC to obtain in France an extension of the marketing authorization in March 2017 for preexposure prophylaxis (PrEP) of HIV transmission among patients at high risk of contamination.

Since the approval, many studies around the world investigate the use of PrEP in routine practice, highlighting its effectiveness in real life. These studies describe the population of patients who benefit from PrEP in order to adapt their multidisciplinary care but also track the transmission of other sexually transmitted infections to prevent their emergence, given the observed decline in condom use. However, these studies are limited to big cities while PrEP is accessible in all territories.

The Rhône-Alpes region is one of the three French regions that has been the most involved in the implementation of PrEP, one year after the FTC/TDF approval in France. Given the geographical position of the investigators, both in province and close to Switzerland, where the FTC/TDF is not authorized for PrEP, and the non-university nature of five of the six involved hospitals, the investigators would like to determine the profile of patients consulting in this region to benefit from PrEP. This analysis will also determine if the population at risk of the "Alpine Arc" region is similar to that observed in the other cohorts in order to adapt patient care.

lead_sponsor: Centre Hospitalier Annecy Genevois

location_facility:
CH de Sallanches
CH de Belley
CH Métropole Savoie
CHU Grenoble
CH Alpes Léman
Centre Hospitalier Annecy Genevois


title: Assessment of Analgesia Through Hypnosis With 3D Virtual Reality During Extra-corporeal Lithotripsy (LAHMA)

acronym: LAHMA

summary: The study is a randomised trial of hypnosis with 3D virtual reality headset (intervention group) versus control group with no hypnosis and no virtual reality headset to compare remifentanil consumption during shock wave lithotripsy.

study_start_date_type: Anticipated

status: Not yet recruiting

ReferenceCitation: Eijlers R, Utens EMWJ, Staals LM, de Nijs PFA, Berghmans JM, Wijnen RMH, Hillegers MHJ, Dierckx B, Legerstee JS. Systematic Review and Meta-analysis of Virtual Reality in Pediatrics: Effects on Pain and Anxiety. Anesth Analg. 2019 Nov;129(5):1344-1353. doi: 10.1213/ANE.0000000000004165.

ReferenceCitation: Scapin S, Echevarría-Guanilo ME, Boeira Fuculo Junior PR, Gonçalves N, Rocha PK, Coimbra R. Virtual Reality in the treatment of burn patients: A systematic review. Burns. 2018 Sep;44(6):1403-1416. doi: 10.1016/j.burns.2017.11.002. Epub 2018 Feb 1.

ReferenceCitation: Chan E, Foster S, Sambell R, Leong P. Clinical efficacy of virtual reality for acute procedural pain management: A systematic review and meta-analysis. PLoS One. 2018 Jul 27;13(7):e0200987. doi: 10.1371/journal.pone.0200987. eCollection 2018.

ipd_sharing: Yes

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

location_facility: Assistance Publique Hôpitaux de Paris, Hôpital Européen Georges Pompidou

location_facility: Assistance Publique Hôpitaux de Paris, Necker


acronym: HTLP-ONCO

location_facility: Hematology department / Necker Children's Hospital

location_facility: Service d'Hématologie et thérapie cellulaire / CHU of Bordeaux

type: EudraCT Number

source: euctr

title: A Phase I/II Study Evaluating the Safety and the Efficacy of Human T Lymphoid Progenitor (HTLP) Injection to Accelerate Immune Reconstitution After Umbilical Cord Blood (UCB) Transplantation in Adult Patients With Hematologic Malignancies

summary: This is an open-labelled and non-controlled Phase I/II clinical trial, evaluating the safety and the efficacy of Human T Lymphoid Progenitor (HTLP) injection to accelerate immune reconstitution after umbilical cord blood (UCB) transplantation in adult patients with hematologic malignancies. The dose limiting toxicity of HTLP injection will be evaluated using a model-based design.


title: REnAL denervatIon by ultraSound Transcatheter Emission

acronym: REALISE

summary: The REALISE trial is a single-arm, open-label, prospective, post market evaluation to be conducted on twenty (20) eligible patients with a twelve month follow-up period.

lead_sponsor: ReCor Medical, Inc.

location_facility:
Université de Toulouse et CHU
Hôpital Pitié-Salpêtrière

lead_sponsor_type: industriel


type: Registry Identifier

title: SeroCOVIDial Study: Assessment of SARS-COV2 Seroconversion in Patients on Chronic Hemodialysis and in Their Caregivers, a Cohort Study

acronym: SeroCOVIDial

summary:
Background: The preventive containment measures implemented in the COVID-19 pandemic are not feasible in chronic hemodialysis patients (HD) who need to attend their dialysis sessions 3 times a week. HD patients display frequent comorbidities (such as diabetes and cardiovascular disease), and immune deficiency, which expose them to an increased risk of severe forms of COVID-19. They can be infected in their dialysis center despite the measures taken to limit this risk. Their caregivers are also at risk of infection if patients carry the virus. Dialysis centers face major organizational challenges in terms of patient and caregiver safety. Knowing the viral serological status of HD patients and caregivers, the proportion of asymptomatic forms, and the persistence and effectiveness of immunization over time would be of major interest for patient management and the organization of dialysis care.

Research objectives: The primary objective of SeroCOVIDial is to assess the prevalence of SARS-COV2 seroconversion at inclusion (M0) in a cohort of HD patients, using the rapid serological test. Secondary Objectives : 1) assess the prevalence of SARS-COV2 seroconversion in dialysis caregivers at M0, using the same test; 2) assess the proportion of asymptomatic forms of COVID-19 in HD patients and in their caregivers; 3) compare the prevalence of seroconversion and the proportion of asymptomatic forms in HD patients according to their clinical characteristics and co-morbidities; 4) assess the prevalence of SARS-COV2 seroconversion in participants who had a documented COVID-19; 5) evaluate the spread of the epidemic and the kinetics of seroconversion in patients and caregivers by a second test performed at M3; 6) evaluate the predictive value of SARS-COV2 seroconversion at M0 on the risk of developing a symptomatic COVID-19 infection within 6 months, in patients and caregivers; 7) evaluate a posteriori the intrinsic diagnostic performances of the test in comparison with serological gold standards (ELISA and seroneutralization).

Methods: Multicenter cohort study, carried out in 4 dialysis facilities in Aix-Marseille.

Procedure: collection of clinical data and rapid serological tests carried out at M0 and M3, in patients and caregivers (a systematic screening for COVID-19 symptoms has been carried out in all HD patients in the 4 participating centers since the beginning of the pandemic in France).

Number of participants: 800 eligible persons (561 HD patients, and 239 caregivers). Material tested: rapid Biosynex serological test on 1 drop of blood, and 1 tube of frozen serum for patients at M0 and M3. Clinical data will also be collected.

Primary endpoint: prevalence of SARS-COV2 seroconversion in HD patients. Maximum duration of participation for each patient: 6 months. Duration of research: 6 months and 2 weeks (inclusions over 2 weeks).

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille

intervention_type: Biological


title: Glenohumeral Re-centering During Closed Kinetic Chain for Shoulder Physiotherapy. A Prospective and Randomized Study.

acronym: SCAPULEO

summary:
The rotator cuff tendinopathy is very common and associated with degenerative or traumatic changes of the rotator cuff and/or the sub-acromial bursa or the long head of the biceps. Lesions go of the simple tendinopathy without tear to the full-thickness tear of the cuff which means a loss of mobility or strength. The origin of this pathology remains controversial and many causes have been evoked (subacromial mechanical impingement, degenerative changes, muscle imbalance…). The clinical impairment is not always the same and varies from a painful shoulder with correct range of motion to a pseudoparalysis shoulder. The first treatment of the rotator cuff pathology is always non surgical and consists in relative resting, painkillers and/or non-steroidal anti-inflammatory drugs (NSAD) and physiotherapy. The aim of this management is to relieve pain and to restore the mobility and a good function of the shoulder.

There is no consensus about the physiotherapy protocol for the treatment of the rotator cuff tendinopathy. In France, the most used physiotherapy protocol uses the strengthening of the muscles which stabilize the scapula (rhomboide muscles, trapezius and serratus anterior) and which lower the humerus (pectoralis major, latissimus dorsi and teres major). The aim of this approach is to augment the subacromial space in order to decrease the inflammation of the rotator cuff tendons and the associated pain. A technique of Dynamic Humeral Centering (DHC) uses a new method of glenohumeral centering in closed kinetic chain has been described ("3C Concept" for Centering in a Closed Chain). Dynamic humeral centring (DHC) is a modality of physiotherapy that aims to prevent subacromial impingement of rotator cuff tendons. In order to simplify and to improve its reliability, a special device called Scapuleo® has been developed. The aim of this device is to help the physiotherapist to realize simultaneously a subacromial decompression, a specific strengthening of the rotator cuff muscles and an optimal activation of the lower trapezius and the anterior serratus.

Our hypothesis was that the DHC was not inferior to the conventional physiotherapy protocol for the medical treatment of the rotator cuff tendinopathy without full-thickness tear.

We proposed a prospective and randomized study. All the patients treated in our department for simple tendinopathy of the rotator cuff or partial thickness tear were included in this study after signed consent. The physiotherapy protocol consists in 20 sessions of either "Conventional program" (Control group) or "Dynamic Humeral Centering" (Study group). The clinical evaluation included the range of motion measurement, Constant Score, Quick-DASH and Oxford Shoulder Score at 3 months and 6 months. Patients were blinded to the study hypothesis. The assessor of all outcomes was blinded to the interventions.

status: Terminated

lead_sponsor: CHU de Reims

status_simplified: Unknown


title: A Phase I-II Trial Evaluating the Toxicity of Early Breast Partial Irradiation in Patients Aged at Least of 70 Years With Breast Cancer at Low Risk of Local Recurrence

acronym: SIFEBI

summary:
Irradiation and Accelerated Partial Breast (IPAS) to this day remains a therapeutic concept whose validity is being assessed on its non-inferiority in terms of local control compared to whole breast irradiation. At least eight phase III trials attempting to answer this question and thus provide a sufficient level of evidence to make this concept a new standard of care for sub-groups of patients well defined (1).

However, without waiting for the final results of these randomized trials (which will not be fully valid with a drop of at least ten years), the American societies (ASTRO) and European (ESTRO) radiotherapy have all two proposed classification (very similar) into 3 groups according to the risk to the patient in terms of local recurrence after IPAS. And are defined by the ESTRO:

The low-risk group ("suitable" for ASTRO)
The intermediate-risk group ("cautionary" in ASTRO)
The high-risk group ("not suitable" for ASTRO) (2.3). Therefore, it is possible to propose to a patient a randomized clinical tria IPAS, to subject it belongs to the group "low risk." The results of phase II trials as a long-term analysis of the matched team of William Beaumont Hospital (4) and the phase III trial using intra-operative radiation photons in low energy X whose results were recently published (5) confirm the value of this new therapeutic concept for post-operative breast cancer at low risk of local recurrence.

In France, the therapists were quickly directed to a sub-population for which the IPAS could represent a real improvement in the therapeutic management in significantly reducing the number of irradiation sessions of thirty in 6 weeks 5 days at 10 in a single view (6). Several French phase II trials were started specifically targeting the female population aged using a balloon catheter (MammoSite ®) (7) or by intra-operative radiation électronthérapie (8). The results of the test using the GERICO-03 brachytherapy with high dose rate (promoter: FNCLCC, National Federation of Anti Cancer Centres , recently merged into Group Health Cooperation entitled UNICANCER) are currently submitted to Journal Green Radiotherapy (Radiotherapy and Oncology from 09/11/11) (9).

On a technical level, two main approaches are used (10):

Irradiation intraoperative electron or low-energy photons,
Radiation after surgery The advantage of intraoperative irradiation is the optimal reduction of total processing time radio-surgery because the patient is irradiated during the lumpectomy. However, 15-20% of these patients receive partial breast irradiation, as histo-prognostic criteria provided in the histologically final report, confirm the non-adapted indication of IPAS (5).

In contrast, the post-operative IPAS can treat only patients meeting all criteria for IPAS but treatment-related travel are about 5 treatments for bi-fractionated (2 sessions per days separated by at least 6 hours).

ReferenceCitation: Hannoun-Lévi JM, Cham Kee DL, Gal J, Schiappa R, Hannoun A, Gautier M, Boulahssass R, Peyrottes I, Barranger E, Ferrero JM, Chand ME, Doyen J. Accelerated partial breast irradiation for suitable elderly women using a single fraction of multicatheter interstitial high-dose-rate brachytherapy: Early results of the Single-Fraction Elderly Breast Irradiation (SiFEBI) Phase I/II trial. Brachytherapy. 2018 Mar - Apr;17(2):407-414. doi: 10.1016/j.brachy.2017.11.008. Epub 2017 Dec 15.

family: Hannoun-Lévi

full_name: Jean-Michel Hannoun-Lévi

given: Jean-Michel

family: Cham Kee

full_name: Daniel Lam Cham Kee

given: Daniel Lam

family: Gal

full_name: Jocelyn Gal

given: Jocelyn

family: Schiappa

full_name: Renaud Schiappa

given: Renaud

family: Hannoun

full_name: Arthur Hannoun

given: Arthur

family: Gautier

full_name: Mathieu Gautier

given: Mathieu

family: Boulahssass

full_name: Rabia Boulahssass

given: Rabia

family: Peyrottes

full_name: Isabelle Peyrottes

given: Isabelle

family: Barranger

full_name: Emmanuel Barranger

given: Emmanuel

family: Ferrero

full_name: Jean-Marc Ferrero

given: Jean-Marc

family: Chand

full_name: Marie-Eve Chand

given: Marie-Eve

family: Doyen

full_name: Jérôme Doyen

given: Jérôme

journal_name: Brachytherapy

lead_sponsor: Centre Antoine Lacassagne

intervention_type: Radiation


title: Medico-pharmaceutical Collaboration in Optimizing Statin Tratment in People Living With Diabetes

acronym: MEDPHARM-RCV

summary:
Hypercholesterolemia is frequent (prevalence of 30% in general population) and constitue with diabetes, obesity and arterial hypertension a major risk factor of atherosclerosis that leads to cardiovascular diseases (CVD). Cardiovascular disease (CVD) due to atherosclerosis of the arterial vessel wall and to thrombosis is the foremost cause of premature mortality and of disability-adjusted life years in Europe, and is also increasingly common in developing countries. In the European Union, the economic cost of CVD represents annually €192 billion in direct and indirect healthcare costs. The main clinical entities are coronary artery disease (CAD), ischaemic stroke, and peripheral arterial disease (PAD). The causes of these CVDs are multifactorial. Some of these factors relate to lifestyles, such as tobacco smoking, lack of physical activity, and dietary habits, and are thus modifiable. Other risk factors are also modifiable, such as elevated blood pressure, type 2 diabetes, and dyslipidaemias, or non-modifiable, such as age and male gender. LDL-cholesterol (LDL-C) is one of the major risk factors for CVD, through its role in the development of atherosclerosis The efficacy of statins has been demonstrated by a considerable amount of literature not only in lowering LDL cholesterol levels but also in reducing cardiovascular events, both in diabetes and non-diabetes patients. Guidelines for the management of dyslipidemia have emerged from different countries. Thereby, in 2016 the French Society of Endocrinology (SFE) and the New French Society of Atherosclerosis (NSFA) published a consensus statement on the management of dyslipidemias integrating features from European recommendations. However, LDL-C goal attainment has rarely been assessed specifically in diabetes population, in which CVD is of particular importance.

This study aimed to assess the rate of patients which requiered an management in cardiovascular risk treatment according to european recommendations.

This observationnal study was carried in Diabetes-Nutrition unit of the University Hospital of Montpellier - France. Data of age, sex, tobacco smoking, body mass index, hypertension, presence and type of CVD (coronary artery disease, stroke, peripheral arterial disease), treatment by statins (intensity, molecule, dosage), diabetes complicaion (nephropathy, retinopathy) were collected at admission. Management of cardiovasculare risk treatment (initiation, modificiation of dosage, molecule or others …) were collected during hospitalization and at discharge of hospitalization. LDL-C, HDL-C and triglycerides levels calculated with the Friedewald formula, and glomerular filtration rate calculated according to the CKD-EPI formula were obtained from blood samples taken within 24 hours of hospitalization admission. Cardiovascular risk level and LDL-c target values were definied according to ESC guidelines.


title: Identification of Frailty Predictors of Adverse Health Outcomes in Community-dwelling Individuals Aged 50 and Over: the SUCCEED Prospective Cohort

acronym: SUCCEED

summary:
Introduction. Although ageing is a general phenomenon, a great inter individual variability on the quality of ageing can be observed. This substantial heterogeneity may be partly explained by extrinsic factors such as lifestyle, habits, physical activity, diet, which may play an important role in the age-associated declines. The concept of frailty was introduced to account for variability in the aging process. This clinical and biological syndrome reflects a decrease in the physiological reserve, and leads to an insidious, precarious equilibrium that can break down during a stressful life event. In older adults, frailty is known to be associated with an increased risk of adverse outcomes, such as falls, fractures, unplanned hospitalizations, and death. Several frailty domains may only be slightly altered, so that early-stage frailty is not necessarily clinically visible. The most commonly used operational definitions of frailty are based on two different conceptual frameworks. Fried's rules-based criteria correspond to a physical phenotype, whereas the "Rockwood accumulative model" defines frailty as the accumulation of multiple deficits. These tools were built for individuals aged 65 and over. However, frailty can also be found in younger adults. Although the early detection of frailty is potentially important (since the condition might be reversible in its early stages), frailty has not been extensively investigated among middle-aged individuals. Indeed, most of the literature studies have focused on older adults or on a small number of frailty parameters the investigators hypothesized that the factors determining the main ageing-related adverse events are already present in middle age.

The main objectives of the SUCCEED cohort are therefore to 1/investigate the prevalence of frailty parameters in community-dwelling individuals aged 50 and over, 2/ assess the parameters' prognostic value for future adverse health events, 3/ investigate frailty classifications in this population and assess the evolution of profiles over time Method. The SUCCEED survey is a French retrospective and prospective cohort that includes community-dwelling individuals aged 50 years or over consecutively attending an outpatient clinic ("successful ageing") in a geriatric teaching hospital in the Paris area, France. Baseline parameters are collected using a self-administered questionnaire followed by an interview, physical measurements, and performance tests conducted by trained nurses, and then a standardized clinical evaluation by a geriatrician. This clinical assessment includes evaluation of autonomy, cognition, mood, balance, mobility, muscle strength, nutrition, comorbidities, continence, sensory functions, bone density, sleeping disorders.

Patients who have attended the outpatient clinic from the 01/01/2010 to 14/01/2020 are retrospectively included in the cohort, the other ones are prospectively included.

time_perspective: Other


title: Lenvatinib in Neo-adjuvant and Adjuvant Therapy for Poor-prognosis BCLC A HepatoCellular Carcinoma Treated by Percutaneous Ablation Procedure in a Curative Intent: Multicentre Pilot Therapeutic Trial

acronym: LENVABLA

summary:
Percutaneous ablation (PA) is the only non-surgical curative treatment of hepatocellular carcinoma (HCC). Due to its excellent tolerance, particularly in patients with portal hypertension or bearing comorbidities, it now represents in France nearly 70% of the first-line curative treatment of "in Milan" tumours. For HCC less than 3 cm, ideal indication for percutaneous ablations, results of monopolar radiofrequency ablation (mRFA), are excellent with only 5% of reported non-tumoral control after a first procedure. In addition to mRFA the arsenal of ablations has grown considerably with the emergence of new techniques which allow the expansion of indications for PA, especially in patients with poor prognostic tumors or relatively advanced beyond the Milan criteria. In this setting, multibipolar mode using no touch technique (mbpRFAnt) increases the tumour volume than can be ablated, allowing the removal of large tumors> 5 cm. Inadequate tumour control is then de facto greater in these situations, around 20%. Difficult-to-access tumors can furthermore be treated by percutaneous irreversible electrotroporation (IRE).

Despite a tumor burden accessible for curative ablation, a phenotype of "aggressive" HCC characterized by high rates of local recurrences is yet to be defined. Up to now, several characteristics might define this subtype with a poor-prognosis and include 1) high serum alpha-foetoprotein (AFP) levels, 2) radiological infiltrative form, and 3) histological macrotrabecular subtype. Based on these characteristics, median recurrence-free survival of these patients is usually below 10 months.

High serum AFP level is a well-known predictor of HCC recurrence following curative procedure. In patients treated by percutaneous ablation, regardless of the technique used and irrespective of tumor burden, high baseline serum AFP level has tenaciously been reported as an independent predictor or recurrence..

More recently, the radiological description of infiltrative HCC (as opposed to mass-forming) has been identified as an aggressive from of HCC with a poor prognosis even when eligible for ablation. This aspect is often associated with infra-clinical invasion of the portal veins (PV), leading to poor prognosis. Finally, a "massive macrotrabecular" (MTM) histological subtype of HCC associated with specific molecular features has recently been described. This MTM-HCC subtype, reliably observed in 12% of patients eligible for curative treatment, represents an aggressive form of HCC is an independent predictor of early and overall recurrence following PA, which is retained even after patient stratification according to common clinical, biological, and pathological features of aggressiveness.

The idea of optimizing HCC curative treatments using adjuvant biotherapy, particularly in patients with poor-prognosis tumors in curative intent, is particularly attractive. One trial in adjuvant setting was conducted, the STORM trial, that tested the benefit of sorafenib in curative intent of in Milan HCC. This negative trial included patients within Milan HCC, with an expected low rate of recurrence with only few patients treated by PA.

Lenvatinib is a multikinase inhibitor which has been recently approved as firs-line therapy for advanced HCC. The investigators assume that lenvatinib could have also a synergistic local action with PA in two ways. First, given as neoadjuvant regimen, lenvatinib by reducing tumor and liver perfusion could decrease the global heat sink effect associated with loco-regional blood microcirculation during PA. Second, by carrying on in adjuvant treatment, lenvatinib could decrease the magnitude of non-specific inflammatory angiogenesis around the treatment zone, therefore reducing the risk of locoregional (intrasegmental) cells tumor spreading or promotion.

Given the dismall prognosis of the aforementioned poor-prognosis HCC eligible for PA with an overall median recurrence-free survival below 10 months, the investigators hypothesis is that addition of Lenvatinib as neo- and adjuvant therapy might increase tumour control in these difficult-to-treat patients. Patients combining either high serum AFP levels, infiltrative form or MTM-HCC histological subtype represent 30% of BCLC A stage HCC patients in expert centers, and are the ideal candidates for such trials.

Therefore, the first aim of this proposal is to assess the benefit of lenvatinib in neo- and adjuvant setting combined with curative percutaneous ablation for BCLC A HCC patients considered at high risk of local recurrence (high AFP or infiltrative form or macrotrabecular massive subtype).

ReferenceCitation: Nault JC, Sutter O, Nahon P, Ganne-Carrié N, Séror O. Percutaneous treatment of hepatocellular carcinoma: State of the art and innovations. J Hepatol. 2018 Apr;68(4):783-797. doi: 10.1016/j.jhep.2017.10.004. Epub 2017 Oct 13. Review.

ReferenceCitation: N'Kontchou G, Nault JC, Sutter O, Bourcier V, Coderc E, Grando V, Nahon P, Ganne-Carrié N, Diallo A, Sellier N, Seror O. Multibipolar Radiofrequency Ablation for the Treatment of Mass-Forming and Infiltrative Hepatocellular Carcinomas > 5 cm: Long-Term Results. Liver Cancer. 2019 May;8(3):172-185. doi: 10.1159/000489319. Epub 2018 Jun 28.

ReferenceCitation: Sutter O, Calvo J, N'Kontchou G, Nault JC, Ourabia R, Nahon P, Ganne-Carrié N, Bourcier V, Zentar N, Bouhafs F, Sellier N, Diallo A, Seror O. Safety and Efficacy of Irreversible Electroporation for the Treatment of Hepatocellular Carcinoma Not Amenable to Thermal Ablation Techniques: A Retrospective Single-Center Case Series. Radiology. 2017 Sep;284(3):877-886. doi: 10.1148/radiol.2017161413. Epub 2017 Apr 28.

ReferenceCitation: Ziol M, Poté N, Amaddeo G, Laurent A, Nault JC, Oberti F, Costentin C, Michalak S, Bouattour M, Francoz C, Pageaux GP, Ramos J, Decaens T, Luciani A, Guiu B, Vilgrain V, Aubé C, Derman J, Charpy C, Zucman-Rossi J, Barget N, Seror O, Ganne-Carrié N, Paradis V, Calderaro J. Macrotrabecular-massive hepatocellular carcinoma: A distinctive histological subtype with clinical relevance. Hepatology. 2018 Jul;68(1):103-112. doi: 10.1002/hep.29762. Epub 2018 May 9.

ReferenceCitation: Bruix J, Takayama T, Mazzaferro V, Chau GY, Yang J, Kudo M, Cai J, Poon RT, Han KH, Tak WY, Lee HC, Song T, Roayaie S, Bolondi L, Lee KS, Makuuchi M, Souza F, Berre MA, Meinhardt G, Llovet JM; STORM investigators. Adjuvant sorafenib for hepatocellular carcinoma after resection or ablation (STORM): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2015 Oct;16(13):1344-54. doi: 10.1016/S1470-2045(15)00198-9. Epub 2015 Sep 8.

family: Bruix

full_name: Jordi Bruix

given: Jordi

family: Takayama

full_name: Tadatoshi Takayama

given: Tadatoshi

family: Mazzaferro

full_name: Vincenzo Mazzaferro

given: Vincenzo

family: Chau

full_name: Gar-Yang Chau

given: Gar-Yang

family: Yang

full_name: Jiamei Yang

given: Jiamei

family: Kudo

full_name: Masatoshi Kudo

given: Masatoshi

family: Cai

full_name: Jianqiang Cai

given: Jianqiang

family: Poon

full_name: Ronnie T Poon

given: Ronnie T

family: Han

full_name: Kwang-Hyub Han

given: Kwang-Hyub

family: Tak

full_name: Won Young Tak

given: Won Young

family: Lee

full_name: Han Chu Lee

given: Han Chu

family: Song

full_name: Tianqiang Song

given: Tianqiang

family: Roayaie

full_name: Sasan Roayaie

given: Sasan

family: Bolondi

full_name: Luigi Bolondi

given: Luigi

full_name: Kwan Sik Lee

given: Kwan Sik

family: Makuuchi

full_name: Masatoshi Makuuchi

family: Souza

full_name: Fabricio Souza

given: Fabricio

family: Berre

full_name: Marie-Aude Le Berre

given: Marie-Aude Le

family: Meinhardt

full_name: Gerold Meinhardt

given: Gerold

family: Llovet

full_name: Josep M Llovet

given: Josep M

journal_name: The Lancet Oncology

ReferenceCitation: Kudo M, Finn RS, Qin S, Han KH, Ikeda K, Piscaglia F, Baron A, Park JW, Han G, Jassem J, Blanc JF, Vogel A, Komov D, Evans TRJ, Lopez C, Dutcus C, Guo M, Saito K, Kraljevic S, Tamai T, Ren M, Cheng AL. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet. 2018 Mar 24;391(10126):1163-1173. doi: 10.1016/S0140-6736(18)30207-1.

repository_institution: The University of Glasgow - Enlighten: Publications

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna


title: Clinical Evaluation of Early Onset Neonatal Infection

acronym: CLEEONI

summary:
Early bacterial neonatal infection (INBP) defined as occurring in the first 3 days and by extension in the first week of life, remains to this day the leading cause of neonatal morbidity and mortality in developed countries. The germs most frequently found are Streptococcus B (SB) for term newborns (> 37 Weeks of Amenorrhea SA) and Escherichia coli (E. coli) in premature newborns. Although in France, its incidence of 0.4 / 1000 is lower than in other developed countries (0.8 / 1000 general incidence), it remains a major public health concern.

The infection criteria were defined by the National Agency for Health Accreditation and Assessment (ANAES) in 2002, allowing to differentiate between proven infections and highly probable cases of infection. Infection is considered to be proven when SB or E. coli is detected in blood culture or in cerebrospinal fluid. An infection is considered to be highly probable in the event of association of clinical signs (fever, polypnea, desaturation, tachycardia, etc.) evoking a beginning sepsis associating with a disturbance of the biological balance sheet (elevation of CRP, hyperleukocytosis, evidence of colonization on peripheral samples). These criteria remain valid to this day to define the infection.

In order to define the newborns to be monitored, risk factors were established after a review of the literature in 2002. They make it possible to decide on diagnostic management and / or the setting up of a treatment.

Since the recommendations of the ANAES of 2002, the rule, from the presence of a major criterion, was to carry out bacteriological samples peripheral to the birth (gastric liquid, swab of ear and anus) and to systematically collect a CRP of the child between H12 and H48. In the presence of an isolated minor risk factor, simple clinical monitoring (routine) was recommended for 48 hours without deciding firmly on the need for a biological sample. However, it is important to note that these two categories of signs are defined and classified in descending order of risk. This classification does not prejudge a systematic therapeutic attitude. In many situations, the choice is actually left to the practitioner depending on the context.

In 2017, new recommendations were implemented by the French Society of Pediatrics (SFP) and the French Society of Neonatology (SFN) regarding the prevention of INBP. These take up the risk factors of the 2002 ANAES by adding PCR SB at the same level as the traditional PV. They define 3 categories of children according to the risk of INBP and the associated care.

In most cases, these new practices make it possible to dispense with costly blood and bacteriological samples, which cause discomfort and pain for children. In addition, the use of gastric fluid is not internationally validated, its use in the management case remains very controversial. In case of delayed CRP or positive peripheral samples to the germs generated, and even in the absence of clinical signs, antibiotic therapy was almost systematically initiated. Unnecessary exposure to antibiotics promotes the development of bacteriological resistance and unbalances the neonatal flora.

Following the implementation of these new recommendations at the Notre Dame de Bon Secours maternity hospital, which is the case in few centers today and no national survey has yet been carried out on their application, it therefore seems necessary to us evaluate the application of these new recommendations and verify that they allow the detection of all probable or proven infections.

time_perspective: Retrospective

ReferenceType: result

ReferenceCitation: Weston EJ, Pondo T, Lewis MM, Martell-Cleary P, Morin C, Jewell B, Daily P, Apostol M, Petit S, Farley M, Lynfield R, Reingold A, Hansen NI, Stoll BJ, Shane AL, Zell E, Schrag SJ. The burden of invasive early-onset neonatal sepsis in the United States, 2005-2008. Pediatr Infect Dis J. 2011 Nov;30(11):937-41. doi: 10.1097/INF.0b013e318223bad2.

family: Weston

full_name: Emily J. Weston

given: Emily J.

family: Pondo

full_name: Tracy Pondo

given: Tracy

family: Lewis

full_name: Melissa M. Lewis

given: Melissa M.

family: Martell-Cleary

full_name: Pat Martell-Cleary

given: Pat

family: Morin

full_name: Craig Morin

given: Craig

family: Jewell

full_name: Brenda Jewell

given: Brenda

family: Daily

full_name: Pam Daily

given: Pam

family: Apostol

full_name: Mirasol Apostol

given: Mirasol

family: Petit

full_name: Sue Petit

given: Sue

family: Farley

full_name: Monica Farley

given: Monica

family: Lynfield

full_name: Ruth Lynfield

given: Ruth

family: Reingold

full_name: Art Reingold

given: Art

family: Hansen

full_name: Nellie I. Hansen

given: Nellie I.

family: Stoll

full_name: Barbara J. Stoll

given: Barbara J.

family: Shane

full_name: Andi L. Shane

given: Andi L.

family: Zell

full_name: Elizabeth Zell

given: Elizabeth

family: Schrag

full_name: Stephanie J. Schrag

given: Stephanie J.

journal_name: Pediatric Infectious Disease Journal

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

title: The Burden of Invasive Early-onset Neonatal Sepsis in the United States, 2005–2008

ReferenceCitation: Stoll BJ, Hansen NI, Sánchez PJ, Faix RG, Poindexter BB, Van Meurs KP, Bizzarro MJ, Goldberg RN, Frantz ID 3rd, Hale EC, Shankaran S, Kennedy K, Carlo WA, Watterberg KL, Bell EF, Walsh MC, Schibler K, Laptook AR, Shane AL, Schrag SJ, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Early onset neonatal sepsis: the burden of group B Streptococcal and E. coli disease continues. Pediatrics. 2011 May;127(5):817-26. doi: 10.1542/peds.2010-2217. Epub 2011 Apr 25. Erratum in: Pediatrics. 2011 Aug;128(2):390.

full_name: B. J. Stoll

given: B. J.

name: for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network

repositories_institution: The Pennsylvania State University - CiteSeer X

title: Early Onset Neonatal Sepsis: The Burden of Group B Streptococcal and E. coli Disease Continues

ReferenceCitation: El Helali N, Nguyen JC, Ly A, Giovangrandi Y, Trinquart L. Diagnostic accuracy of a rapid real-time polymerase chain reaction assay for universal intrapartum group B streptococcus screening. Clin Infect Dis. 2009 Aug 1;49(3):417-23. doi: 10.1086/600303.

title: Diagnostic Accuracy of a Rapid Real‐Time Polymerase Chain Reaction Assay for Universal Intrapartum Group B Streptococcus Screening


title: Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication

acronym: BIOMEDE

summary:
Diffuse Intrinsic Pontine Gliomas (DIPG) appear almost exclusively in children and adolescents, representing 15 to 20% of posterior fossa tumours. Even if it is one of the most common malignant brain tumours, there are only 30 to 40 new cases per year in France. Their clinical presentation is stereotyped with a short clinical history and a unique MRI appearance that was usually considered as sufficient to establish the diagnosis. The prognosis of DIPG is always unfavourable; median overall survival is 9 to 10 months in general and most patients will die within two years after diagnosis (Kaplan 1996,Hargrave 2006). Malignant gliomas infiltrating the brainstem represent the greatest challenge of paediatric oncology; despite numerous collaborative studies performed, patients' survival has not significantly increased in thirty years (Hargrave 2009). There is no validated prognostic factor. There is currently no validated treatment except radiotherapy.

Several targeted agents have been tested in DIPG (Pollack 2007 Haas-Kogan 2008, Geoerger, 2011), without knowing whether the target was present in the tumour. A critical review of the paradigms of these trials tells us that there are long term survivors in these studies that is to say patients who may have benefited from the tested therapy, but they are few. So far, the new therapies that have been tried were evaluated one after the other in search of a treatment that would be effective for all patients, measuring the treatment effect on median survival. They were all rejected as ineffective. However the investigators can challenge the endpoint to evaluate efficacy in these trials as the existence of long term survivors (> 18 months, for example) and their number should not been ignored, especially if targeted therapies are considered. The investigators propose a paradigm shift in the choice of treatment; the issue raised would be to give to each patient the treatment associated with the highest likelihood of efficacy based on the specific biological tumour profile.

The development of targeted therapies for malignant gliomas infiltrating the brainstem has been hampered by the absence of biological data. It is therefore crucial to better understand the biology of these tumours. Despite the safety of the biopsy in brainstem tumours, most teams of paediatric neurosurgery limit the use of stereotactic biopsy only for clinically or radiologically unusual forms. Until recently, there has been no systematic genetic study at diagnosis to date and the few available data were confounded by the inclusion of autopsies or clinically and radiologically unusual cases (Louis, 1993; Gilbertson 2003; Okada, 2008; Zarghooni 2010; Broniscer, 2010; Wu, 2012 and Schwartzentruber, 2012).

French teams gathered in the French Society of Paediatric Oncology and the European consortium "Innovative Therapies in Children with Cancer (ITCC)" decided a few years ago to perform biopsies of these tumours for diagnostic confirmation and to ensure the presence of certain therapeutic targets prior to a possible inclusion in a trial evaluating a targeted therapy (Geoerger, 2009; Geoerger, 2010). Part of this experiment was reported by the team of the Necker Hospital in Paris, confirming the low rate of complications of stereotactic biopsy procedure (Roujeau, 2007). The biopsy specimen analysis allowed practicing immunohistochemical, genomic (CGHarray), gene expression (transcriptome) and direct sequencing of candidate genes studies.

In this study, the majority of patients will receive a treatment assumed to specifically target a biological abnormality identified on the biopsy. More importantly, patients will not receive a drug for which the identified target is absent.

In this first step of the protocol, the patients will thus be allocated to one of the three treatment groups as follows:

If the tumor overexpresses EGFR without PTEN loss of expression, patients may receive erlotinib or dasatinib allocated by randomization (R1 randomisation).
If the tumor shows loss of PTEN expression without EGFR overexpression, patients may receive everolimus or dasatinib allocated by randomisation (R2 randomisation).
If the tumor shows both EGFR overexpression and loss of PTEN expression, patients may receive erlotinib, everolimus or dasatinib by randomisation (R3 randomisation).
If the tumor shows neither EGFR overexpression nor loss of PTEN expression (a very rare situation in our experience), patients will receive dasatinib (no randomisation).
If the biopsy assessment is not contributive, the treatment will be allocated by randomisation between erlotinib, everolimus and dasatinib (R3 randomisation).

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Acceptability and Clinical, Cognitive and Brain Efficacy of the Pilot of a Computerized Psychotherapy Program Based on Behavioural and Cognitive Techniques in the Depressed Patient

acronym: STOP DEPRESS

summary:
Depression is a common disease with a high rate of recurrence. It is a major public health problem with significant health costs. World Health Organization estimates that 34 million people worldwide are affected by depression but not treated. Common barriers to accessing care in depression would be: the high cost of therapy, long waiting times, low presence of therapists in some communities, travel difficulties, fear of being "stigmatized", not to mention the presence of negative biases towards psychotherapy. Behavioural and Cognitive Therapies are standardized psychotherapies using operationalized methodologies and offering a pedagogical approach to learning specific change techniques and skills. They are the treatment of choice for many of the mental disorders, including depression, which has been proven effective through numerous scientific studies. They are now recognized by the French Authority for Health as the most scientifically validated psychotherapies and are recommended in particular for the treatment of depression.

In a context of constant development of information technology and the Internet, computer programs and websites concerning health, and in particular mental health, have emerged. Among the mental health programs, Computer Based Cognitive Behavior Therapy programs in English-speaking countries now offer patients remote Internet-based behavioural and cognitive therapies.

These programs, which are not available in France, have been the subject of numerous meta-analyses demonstrating their therapeutic effectiveness. Some of these Computer Based Cognitive Behavior Therapy programs such as Beating The Blues® are recommended by health organizations such as the National Institute of Health and Clinical Excellence in the treatment of depression.

This advent of computerized therapies is part of a movement to raise awareness of the epidemiological extent of mood disorders and the inadequacy of management methods. These "therapist-free" programs are, via an interactive and multimedia interface, an alternative means of care, making it possible to overcome the usual obstacles to accessing care. In our opinion, they represent an important area of research in an increasingly computerized health system.

We propose to study the acceptability and effectiveness of the pilot of a Computer Based Cognitive Behavior Therapy targeting depression developed at the University of Nice Sophia Antipolis; in three dimensions:

Clinical: via scales for measuring depressive symptomatology and depression characteristics;
Cognitive: via specific scales of cognitive-behavioural dimensions and validated in depression.
Neurophysiological: via electroencephalographic markers linked to cognitive processes; The research framework would be that of a prospective trial. This work bridges the gap between neurosciences, neuropsychology and the psychiatric clinic, while at the same time being part of a commitment to research in the field of "e-health".

primary_purpose: Prevention

location_facility: Hôpital Pasteur - Service de Psychiatrie


title: Efficacy of a Web Tutorial Based on Case Vignettes for Teaching Literature Critical Assessment to Nursing Students: a Randomized Controlled Trial

summary:
Objective: The aim of this study is to assess the efficacy of a web tutorial based on case vignettes as a complementary tool for teaching literature critical assessment to nursing students, in terms of: 1) knowledge, 2) tutorial quality and acceptability and 3) students' point of view on research participation.

Participants: Nursing second-year students from 3 universities in Paris (Paris Descartes University, Paris Diderot University and Paris 13 Nord).

Design: A randomized controlled trial will assess the teaching efficacy of a case vignettes based tutorial compared to no tutorial. In order to preserve a minimal blinding of participants, the comparator will be a basic passive teaching presentation on internet. The students will be randomized in two parallel groups. They will be evaluated on a final case vignette, and will be invited to follow the other intervention after evaluation. The allocation of participants will be done by a computerized randomization list, the sequence will be created by an independent statistician with a ratio 1: 1: 1. Since the students follow courses in different nursing institutes for each university which may have different teaching content and organization, the randomization will be stratified by nursing institute. Allocation concealment will be provided because only the statistician will have access to the randomization list. All the participants will receive an individual mail linking them to his group dedicated website. In order to preserve a minimal blinding of participants, the comparator will be a passive presentation and the participants will not be informed of the intervention evaluated and will have the opportunity to follow the other intervention after the evaluation. In parallel, both groups will follow normally their university courses.

Intervention: A case vignette is a clinical scenario based on clinical practice. It will ask a clinical problem the student will have to answer by reading a research article on a randomized clinical trial. Then he will have to answer questions about this article which are related to the major methodological points of a randomized trial. All these steps are available on a secure website.

Outcomes: The primary endpoint will be the student's knowledge of critical assessment of randomized controlled trials. It will be measured by students' score on an evaluation case vignette with multiple choice questionnaires. The secondary endpoints will be the quality perception and acceptance of the tutorial and if the tutorial has modified their perception of research participation. Responses will be ranged by a 5-point Likert scale.

Potential interests: This study takes place in the field of nursing universitary teaching. Nursing students have entered recently the universitary education system which enhances the nursing research, an emerging field in France.

The investigators hope that this complementary teaching tool will enhance the knowledge and participation of nurses in research.

Sample size expected: 506 participants.

primary_purpose: Health Services Research

location_facility: Centre d'Epidémiologie Clinique, hôpital Hôtel Dieu, Assistance Publique-Hôpitaux de Paris


title: Exploring Caregiver Representations That Could be Obstacles or Elements Favouring the Implementation of a Therapeutic Education Programme for Mental Health Patients: a Multicentre Qualitative Study.

acronym: ETPsy

summary:
Therapeutic patient education (TPE) is one of the approaches used to manage chronic diseases. It aims to make the patient an active participant in his or her own care and to establish an effective partnership with the carer, thereby also responding to the need to control health expenditures.

However, the contribution of TPE has revolutionised healthcare professions, in particular by profoundly changing the carer-patient relationship and certain aspects of their professional culture.

a recent action-research study conducted in partnership with Crf-Cnam in Paris showed that although the training of professionals appears to be a major issue, the integration of TPE forces the involved parties to question their practices. TPE imposes a change in the understanding that carers have of their usefulness in accompanying patients and in their perception of education and care. It also changes their relationship to the involvement of patients in maintaining their health.

The implementation of educational approaches in Mental Health is also at the origin of many questions.

In a study of patients suffering from schizophrenia, discrepancies appeared amongst the carers, whose outlooks seemed to be correlated with their experience in TPE. The carer-caregiver relationship was evoked with a feeling of lack of exchange, and a feeling of infantilization for certain carers. This study highlights the misconception that some psychiatric caregivers have of TPE in somatic care, and the idea that TPE is limited to drug treatments.

Therapeutic education is of particular importance as it is a determinant of the schizophrenic patient's adherence to therapeutic principles. However, it must be based on an appropriate strategy that facilitates communication and the exchange of knowledge with patients suffering from severe and persistent psychological disorders.

During the implementation of two ongoing TPE programs initiated with schizophrenic patients, we were able to observe that despite the knowledge of the TPE caregivers, there were still difficulties in its implementation: lack of recruitment, organizational difficulties, loss of motivation...

In the same prism as the development of new care strategies by the Ministère des solidarités et de la santé, we asked ourselves questions about strengthening the training of paramedical staff, such as: how can health literacy be enriched in mental health training programs? But the trainig of individuals in the field seems to be only one of the components. This care project raises questions about values systems and the mechanisms for legitimizing power, and requires consent and commitment from the various actors.

The hypothesis formulated is that one of the keys to better patient adherence and better appropriation of a TPE programme in mental health would be to take into account the representations of the carers dispensing these programmes. This investigation will be based on TPE programs dispensed to schizophrenic patients at La Chartreuse Psychiatric Hospital in Dijon, France.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Efficacy of Ondansetron on Vomiting Due to Acute Gastroenteritis in Pediatric During Winter

acronym: Ondangapi

summary:
Acute gastroenteritis is a common disease especially in children. With bronchiolitis and influenza, she participated widely in weight of winter epidemics that causes problems every year our health care system, particularly in the pediatric emergency and inpatient since they are the second leading cause of hospitalization in children. The main symptoms of viral acute gastroenteritis are diarrhea and vomiting which exposes children to the risk of sometimes severe dehydration, the most common cause of hospitalization. There is no specific treatment for these infections. At most, there is a vaccine against severe rotavirus diarrhea (Rotarix ® and RotaTeq ®), but does not yet official recommendations to use in France. The treatment of acute gastroenteritis virus is symptomatic and is generally based on the use of oral rehydration solutions (ORS) whose administration is limited by the frequent presence of vomiting. Until now, no treatment has demonstrated its effectiveness on vomiting due to acute gastroenteritis virus in children. Conventional anti-emetics, widely prescribed, are ineffective in practice, very few studies in this indication and encumbered side effects. Several drugs have long been used in children to fight against severe vomiting associated with the administration of anti-cancer chemotherapy, such as granisetron (Kytril ®) and ondansetron (Zofren ®). The mechanism of action of these molecules is well known. They act both on the enteric nervous system by blocking serotonin receptors. Several placebo-controlled trials suggest that ondansetron is effective in reducing the number of vomiting in children emergency consultant for acute gastroenteritis. However, the method used in these tests and the number of children enrolled has not yet demonstrated the efficacy of ondansetron on the number of admissions, the number of emergency and return the cost / benefit ratio of this treatment. In addition, several studies reported the occurrence of watery stools more frequently in children treated with the placebo group.

Evidence that ondansetron is well tolerated and effective for reducing the severity of vomiting during acute gastroenteritis pediatrics winter could support the use of this treatment in routine pediatric emergencies.

This study is a clinical trial, multicenter, controlled versus placebo whose main objective is to evaluate the efficacy of ondansetron to decrease the intensity of vomiting in children with acute gastroenteritis during winter emergencies Upon arrival to the emergency room after signing. Consent, an ECG is performed in eligible patients. Children meet all the criteria for inclusion and non-inclusion receive, at random, one of two treatments: ondansetron (active) or placebo. The study does not alter the usual care of the child to the emergency room. After passing emergency, patients will be followed in the study for 8 days, through a phone call home to J3 and J7. The total duration of patient participation in the study is 8 days, including 4 hours emergencies (usual transit time to emergencies).


title: Determinants of Lower Limb Muscle Atrophy Induced During an Hospitalization for Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

acronym: AMI-EX-BPCO

summary:
Chronic Obstructive Pulmonary Disease (COPD) is characterized by persistent airway obstruction and inflammatory response of the lungs and bronchi. Episodes of exacerbations contribute to increase the severity and prognosis of the disease. Muscle dysfunction (loss of strength and muscle mass) is one of comorbidities affecting 30% to 60% of patients and playing a key role in their prognosis. Indeed, several studies have shown muscle weakness during hospitalization for exacerbation of COPD by measure of maximal voluntary contraction of quadriceps (MVCQ), but the results are variable from one patient to another. Moreover, no study was interested in the change of muscle mass in patients hospitalized for an exacerbation of COPD. Several mechanisms have been mentioned but not demonstrated: systemics factors (initial amyotrophy, inflammation, oxidative stress, corticotherapy, hypoxia…) but also physical inactivity. In this context, identifying factors associated with the onset of muscle weakness during hospitalization for exacerbation of COPD is a necessary step to better understand the mechanisms and consider a personalized therapeutic approach that can improve the functional and clinical prognosis of disease.

The primary outcome is to identify the clinical and biological determinants associated with the onset of amyotrophy (Measure by ultrasound of sectional area of the Rectus Femoris, CSARF), during hospitalization for exacerbation of COPD. The secondary outcome is to identify the clinical and biological determinants associated with the onset of MVCQ decrease, during hospitalization for exacerbation of COPD.

120 patients hospitalized for exacerbation of COPD will be recruited in two hospitals (CHU Montpellier - CHU Grenoble, FRANCE). The measures of CSARF and MVCQ are carried out on the second, fifth, eighth day of hospitalization, on discharge and on the sixtieth day after hospitalization. A blood test will be performed on the second day of hospitalization to explore different markers of inflammation and oxydative stress. Moreover, to quantify the level of physical activity (number of steps), each patient will carry a pedometer throughout the duration of hospitalization.

At the end of protocol, two groups will be made from the median of CSARF : patients with a small reduction in CSARF compared to patients with a greater reduction in SSRF between the second and eighth days of hospitalization (or between the second day of hospitalization and discharge). Then clinical (comorbidities, severity disease, initial weakness, initial amyotrophy, usual physical activity before hospitalization, treatment, exacerbation number in the previous year…) and biological (markers of inflammation and oxydative stress) determinants were compared between the two groups.

Thus, the identification of the determinants associated with the onset of amyotrophy induced during exacerbation of COPD will guide research for exploration of physiopathological mechanisms of this muscular dysfunction in the exacerbation of COPD as well as to identify a personalized support.

status: Active, not recruiting

primary_purpose: Basic Science

location_facility: Montpellier University Hospital Arnaud de Villeneuve Hospital


title: A Randomized Controlled Study Evaluating the Effect of MUCIPLIQ Versus Placebo on the Incidence of Radio-chemotherapy-induced Mucositis in Patients Suffering of Upper Aerodigestive Tract Carcinomas

acronym: MUCIPLIQ

summary:
MUCIPLIQ is a nanopolymer engineered to mimic glycosaminoglycans such as heparan sulfates. Glycosaminoglycans are involved 1) in the stabilization of cells micro-environment, known as extracellular matrix, by binding to structural proteins, and 2) in cells communication process by protecting growth factors. At the site of a lesion, glycosaminoglycans are degraded, thereby the extracellular matrix is disorganized and the tissue is destroyed. By replacing damaged glycosaminoglycans, MUCIPLIQ provides a protection, and restores the matrix scaffold and cells communication, a process known as Matrix Therapy.

The purpose of this new controlled study is to determine whether MUCIPLIQ can decrease the incidence and the severity of radio-chemotherapy-induced mucositis in patients suffering of upper aerodigestive tract cancers, when used as a preventive agent.

The study's main hypothesis is that MUCIPLIQ mouthwash applications before radiotherapy would protect the healthy oral tissue against cytotoxic effect of chemotherapy and radiations.

lead_sponsor: Organ, Tissue, Regeneration, Repair and Replacement

location_facility: CHRU de Besançon, Site du CH Belfort-Montbéliard

location_facility: Centre Hospitalier Intercommunal de Créteil