title: Evaluation of the Written Information Delivered by the General Practitioner of the Patients Presenting to the Emergency Room for an Aggravation of Asthma

acronym: ASTHMAVILLE

summary:
Asthma is a common pathology (prevalence 6.4% in 2018, in France), currently managed by the general practitioner in general practice. It is a chronic disease at risk of exacerbation, which can lead to the use of care. The treatment of asthma is based on a basic treatment, to be taken every day, the purpose of which is to avoid acute exacerbations and lead a normal life. There is also an emergency treatment, to be taken in case of sudden worsening of the respiratory state. The asthmatic patient is the first actor in his care. He must be able to react in case of emergency. A good knowledge of the disease and its treatment as well as training in self-management of crises are thus fundamental and must be part of its medical care. The existence of an exacerbation represents a criterion of non-control of the disease, thus a failure of the long-term care of the patient. The optimization of this care includes individual issues aimed at improving the quality of life and collective by reducing the avoidable use of care and thus the expenses related to this disease. It relies on therapeutic education sessions as well as the provision of written information, clear and detailed by the doctor. This information consists of the writing of a detailed medication prescription as well as the dispensing of a written action plan.

The action plan must describe the actions to be taken by the patient in case of exacerbation of his asthma, to regain control. Regarding the format, it can be coupled to the prescription drug (action plan and prescription on the same prescription) or distinct from the prescription drug (a prescription for drugs and a prescription for the action plan). In some countries, "ready-to-use" action plans have been validated by learned societies, which is not the case today in France. In Canada, a study demonstrated in 2006 that 46% of asthmatic patients followed in hospital had an action plan, while the national average was estimated at about 10% in 2010. There is little data in France on the proportion of patients with asthma action plans.

Unlike the action plan, which is little distributed to the patient, the prescription drug for asthma is always given to the patient at the end of the consultation and specifies the procedures for taking treatments.

As part of this work, the investigators are interested in evaluating the written information given to the adult asthmatic patient by their general practitioner: the action plan but also the prescription medication.


type: Other Identifier

title: Study on the Association Between Vitamin C Deficiency and Diarrhea in Children

acronym: VITAL

summary:
Diarrheal disease is the second leading cause of death in children under five, althought it is both preventable and treatable. The causative factors of diarrheal diseases vary a lot from region to region (bacteria, viruses, parasites). Diarrhea is one of the main causes of malnutrition in children under five years of age. Inversely, nutritional deficiency, particularly vitamin C deficiency, can be a risk factor for diarrhea.

The main objective of this study is to assess the impact of vitamin C deficiency on diarrheal infection in children aged 2 to 5 years in countries with a high diarrheal rate. This pilot case-control study will be conducted in metropolitan France, Africa and South America. This question will be addressed by comparing vitamin C levels in children with diarrhea, regardless of the infectious agent, to levels in age- and sex-matched controls.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Institut Pasteur

location_country:
Central African Republic
France
New Caledonia

location_facility: Centre Hospitalier Territorial Gaston Bourret

intervention_type: Diagnostic Test

lead_sponsor_type: academique

status_simplified: Ongoing


title: Protists and Nematodes Fish Parasites: From Their Circulation in Ecosystems to Their Impact on Human Health - Prevalence of Fish Allergy in Occupational Settings.

summary:
Anisakidae frequently infect fish species that are commonly eaten by humans. Some of them are recognized as zoonotic agents, and have a high impact on human health.

Infestation results from the ingestion of living larvae from contaminated fishes. It can be asymptomatic or symptomatic, resulting in acute gastric, acute intestinal or chronic forms. Allergic manifestations are frequently encountered in gastric forms, but isolated allergic symptoms can occur after ingestion of Anisakidae antigens in raw or cooked fish. Cutaneous contact or Anisakis allergen inhalation have also been reported to induce allergy/anaphylactic reactions or sensitization in the occupational setting in Spain, Italy, Sicilia or South Africa. But no data is available in France.

In this context, the investigators propose to determine and compare the frequency and characteristics of fish allergy in fish workers (fishermen and fish-processing factory workers) and a control population of workers without occupational exposure to fish, in Boulogne-sur-Mer, which is an important fishing port in France, and the first European center for fish processing.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: University Hospital, Lille

location_facility:
Service de Santé des Gens de Mer
CHRU
Centre ASTIL

intervention_type: Other

status_simplified: Completed


title: Nutritional Intervention in Geriatric Oncology in Patients at Risk of Undernutrition

acronym: INOGAD

summary: Older patients with cancer are poorly treated or not treated at all. A previous study in the south west of France (364 patients) showed that patients receiving chemotherapy had short survival times which strongly depended on nutritional status. In this study, the researchers would like to evaluate if individual dietician follow-up at each cycle of chemotherapy increases survival of patients at risk of undernutrition.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

ReferenceType: derived

ReferenceCitation: Bourdel-Marchasson I, Blanc-Bisson C, Doussau A, Germain C, Blanc JF, Dauba J, Lahmar C, Terrebonne E, Lecaille C, Ceccaldi J, Cany L, Lavau-Denes S, Houede N, Chomy F, Durrieu J, Soubeyran P, Senesse P, Chene G, Fonck M. Nutritional advice in older patients at risk of malnutrition during treatment for chemotherapy: a two-year randomized controlled trial. PLoS One. 2014 Sep 29;9(9):e108687. doi: 10.1371/journal.pone.0108687. eCollection 2014.

lead_sponsor: University Hospital, Bordeaux

location_facility: Pôle de Gériatrie - CHU Bordeaux-Hôpital Xavier Arnozan - Avenue du Haut-Lévèque

location_facility: Institut Bergonié - 229 Cours de l'Argonne

intervention_type: Behavioral


title: Effect of Enzyme Replacement Therapy in Patients With Juvenile-Onset Pompe Disease: a Long-term Observational Study

summary:
Pompe disease is known as glycogen storage disease type II, an autosomal recessive disease that results from acid alpha-glucosidase (GAA) deficiency leading to lysosomal glycogen accumulation. Patients with classic infantile form have less than 1% of enzyme activity, which explains severe impairment before one year with rapid death without treatment, while later-onset form shows progressive symptoms later in childhood (juvenile form) or adulthood (adult form).

Enzyme replacement therapy (ERT) consists of periodic intravenous infusion of missing GAA produced by the recombinant method. ERT improves significantly the cardiac function and the children's survival in classic infantile form. This therapy has been approved for all patients with Pompe's disease in the United States and the European Union since 2006, but its efficacy was not clear for patients with later-onset form. Recent studies show motor improvement in adult patients, but there is little published data for the juvenile form disease. A separate analysis of juvenile form is justified as patients are still in a developmental stage and show clinical symptoms early in life, may have more severe disease and a different response to ERT. The recommendation is no treatment in the absence of clinical symptoms, but the consensus does not stratify patients into juvenile- or adult-onset form. ERT is an expensive long-term therapy, and its administration every 2 weeks in the hospital is a great limitation for patients. Therefore, an evaluation of the treatment effect in patients with the juvenile form is necessary.

time_perspective: Retrospective

lead_sponsor: Central Hospital, Nancy, France


title: Cohort Follow-up of Systemic Lupus Erythematosus Within the Framework of the Multidisciplinary Consultation at the CHRU of Brest

acronym: CO LUPUS

summary: Diagnosis and follow up of a lupus cohort in a multidisciplinary consultation in Brest ( France)

primary_purpose: Diagnostic

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient

acronym: REMAIN

summary: The purpose of this study is to describe common treatment pathways, to collect health care utilization data and to assess symptom load as well as impact of symptoms on daily life in GERD patients who are partial-responders to PPI treatment.

lead_sponsor: AstraZeneca

lead_sponsor_type: industriel


primary_purpose: Treatment

acronym: MEGA

intervention_type: Drug

title: MEGA (Met or EGFR Inhibition in Gastroesophageal Adenocarcinoma): FOLFOX Alone or in Combination With AMG 102 or Panitumumab as First-line Treatment in Patients With Advanced Gastroesophageal Adenocarcinoma FNCLCC-FFCD-AGEO PRODIGE 17-ACCORD 20 Randomized Phase II Trial

lead_sponsor: UNICANCER

type: EudraCT Number

source: euctr

summary: This multicentre, open-label, randomized phase II trial is ongoing in 30 centres in France. Main eligibility criteria include: histologically proven adenocarcinoma of the stomach, esophagus or gastroesophageal junction; locally advanced or metastatic disease; measurable disease (RECIST 1.1); no known HER2 overexpression; no prior palliative chemotherapy.


title: Psychological and Ethical Support for Hospital Professionals During the COVID-19 Pandemic: Suitability and Post-crisis Implications for the Experience of All Professionals

acronym: PsyCOVID All P

summary: SARS-COV-2 has created an unprecedented health crisis, resulting in unprecedented mobilization of all hospital professionals. The massive influx of patients overwhelmed the human, therapeutic and material resources available, and teams were confronted with an unusually heavy workload in a highly stressful emergency context. These professionals were thus exposed to a risk of over-investment in a context of acute and repetitive stress over an indefinite period of time, combining a heavy workload, emotional challenges and specific ethical issues. These factors simultaneously affected the professional sphere but also the personal and family spheres (lockdown, risk of contamination). In this context, the mental health of hospital staff is considered to be more important than ever, as emphasized on numerous occasions by the Director General of Health and the French Minister for Health and Solidarity. Mental health involves the way in which individuals respond specifically to work-related suffering by developing individual and collective defensive strategies. Thus, the question of the mental health of hospital professionals cannot be considered without taking into account the strategies implmented to combat stress, and the factors that contribute or not to the construction and stabilization of the work environment (collaboration, support).

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: RELATIONSHIP BETWEEN THORACIC AORTIC STRUCTURE ASSESSED BY PET/CT SCAN AND ARTERIAL STIFFNESS IN ELDERLY PATIENTS: FICTEP STUDY

acronym: FICTEP

summary:
The purpose of this study is to determine the relationship between thoracic aortic inflammation and arterial stiffness in elderly patients.

Vascular-aging is accompanied by a gradual remodeling affecting both cardiac and arterial walls. Arterial hypertension, an established cardiovascular risk factor, has been suggested to exert pro-inflammatory actions threw several biological mediators enhancing arterial stiffness. Both effects of aging and hypertension are associated with higher levels of arterial stiffness, but their respective role is not well established in the pathophysiology of arterial stiffening.

Few data are available neither on the real anatomic aortic impact of aging and hypertension on aortic compliance and ventricular function and its relationship to arterial stiffness assessed by carotid-femoral pulse wave velocity, nor on the reliability of cine phase contrast magnetic resonance imaging arterial stiffness measurements.

Recent studies using positron emission tomography imaging (PET) with 18 F fluorodeoxyglucose (FDG) has been advocated as a means of measuring arterial wall inflammation in various population referred for oncology staging. FDG uptake is correlated with the number of cardiovascular risk factors and even the risk of future cardiovascular events. This method, combined with X-ray computed tomography (CT), has also demonstrated that aortic calcifications quantified by CT and local signs of inflammation detected by FDG uptake contribute to arterial stiffness. A strong relationship between large vessels stiffening assessed by carotid-femoral pulse wave velocity measurement, aortic calcifications quantified by CT and inflammation evaluated by FDG uptake has been demonstrated.

Therefore, in the current study, we use FDG PET associated to CT to characterize aortic inflammation and aortic calcifications coupled to pulse wave velocity measurement and cardiac function in elderly individuals.

In fact, if vascular aging promoting a local inflammatory process is a risk factor for cardiovascular disease, then vascular changes assessed by non-invasive vascular imaging (MRI,FDG PET) could represent a potential target for treatment and prevention Thirty individuals ≥ 65 years of age were examined, 15 hypertensive subjects and 15 controls. Pulse wave velocity, a surrogate for aortic stiffness, was measured both by cine phase contrast magnetic resonance imaging and applanation tonometry. Brachial pulse pressure, carotid calculated pulse pressure and pulse pressure amplification (brachial to carotid ratio), predictors of cardiovascular mortality were also quantified. Thoracic aorta local inflammation and calcification were measured by 18 F-fluorodeoxyglucose positron emission tomography/computed tomography imaging. Moreover, biomarkers of low grade inflammation (high-sensitivity C-reactive protein, interleukin 6 were also determined).

ReferenceCitation: Joly L, Mandry D, Verger A, Labat C, Watfa G, Roux V, Karcher G, Marie PY, Benetos A. Influence of Thoracic Aortic Inflammation and Calcifications on Arterial Stiffness and Cardiac Function in Older Subjects. J Nutr Health Aging. 2016 Mar;20(3):347-54. doi: 10.1007/s12603-015-0574-0.

intervention_type: Radiation


title: Longitudinal Prospective Cohort Study to Describe the Clinical Characteristics of COVID-19, the Acquired Immune Response and the Biological and Clinical Parameters of Patients Followed in Oncology by the Saint-Joseph Hospital Group, Paris, France for a Period of 6 Months During the COVID-19 Pandemic in 2020

acronym: OBVIONCO

summary: This registry will allow to evaluate the correlation of the incidence and evolution of associated symptoms of infection of COVID-19 with the biological and clinical parameters in patients followed in Oncology during the COVID-19 pandemic.

primary_purpose: Other

ReferenceType: result

ReferenceCitation: Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.

ReferenceCitation: Gliklich RE, Dreyer NA, Leavy MB, Christian JB, editors. 21st Century Patient Registries: Registries for Evaluating Patient Outcomes: A User's Guide: 3rd Edition, Addendum [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2018 Mar. Available from http://www.ncbi.nlm.nih.gov/books/NBK493818/

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Relationship Between Chronic Renal Disease Gradation and Risk Stratification for Chronic Ulcer on the on the Diabetic Foot

acronym: NEPHROPOD

summary:
Context and hypothesis: The prevalence of diabetes mellitus keeps going to increase, due to the ageing of the population and the high prevalence of overweight and obesity. Thus about 5% of the French population is said to have diabetes according to the national health insurance reimbursement data estimations. 15 to 20% of diabetic patients will have a foot chronic ulcer in their lifetime. Nowadays, diabetes is still the leading cause of non-traumatic amputation in France, amputation being very often preceded by a trophic disorder. Thus, the person with diabetes has a 7-fold risk of amputation. For the year 2013, in France, incidence rates of hospitalizations for lower limb amputations and foot wounds in the diabetic population were 252/100000 and 668/100000 respectively. In an attempt to prevent the risk of foot wounds in people with diabetes, the International Working Group on the Diabetic Foot (IWGDF) has established foot grades associated with an increased risk of foot wounds. These grades are now used by health authorities to calibrate their care offer such as reimbursements for podiatry care. Chronic kidney disease is one of the major complications of diabetes. In 2013, according to data from the French registry (REIN), 4,856 diabetics started renal replacement therapy in 2016, representing 46% of the newly dialyzed population. This represents a relative risk 9.2 times higher than in the general population. The Investigators hypothesize that beyond the risk of wound, there is a link between the stage of chronic renal disease and the risk of foot ulcer grade as defined by the IWGDF. The link between chronic renal disease and this common marker of foot risk has never been studied to our knowledge. The long-term objective, beyond this study, is to improve patient pathways and thus improve the prevention of foot wounds in diabetics with renal insufficiency. This is all the more true since prevention actions in the dialysis population have already shown their effectiveness on a large scale on the risk of amputation.

Protocol : All patients with a diabetes mellitus who consult diabetology and nephrology services at the Montpellier University Hospital will be included in this study. The consultation wil be the same as usual. The Investigators will ask for the history of diabetes, the history of complications, the current treatments and the Investigators will make a standardized clinical examination of feet with a foot risk gradation according to the IWGDF.The investigators will report the standard biologicals values.

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Post-Covid Condition Monitoring Cohort: Evaluation of the Evolution of Symptomatology, Patient Profile and Associated Prognostic Factors

acronym: SYNPOCov

summary: The aim of our cohort is to collect prospectively, in a standardized and exhaustive manner, the health data of patients referred to the CAPCoV, our holistic referal post covid clinics for post-covid condition in order to be able to identify typical profiles of patients suffering from post covid syndrome and to follow the evolution of their disease over time.


title: Features of Microcrystalline Polyarthritis Treated by Biologics and Evolution - FUMBLE Study

acronym: FUMBLE

summary:
The study will involve adult patient who had received any biologic agent for microcrystalline disease in western France (Tours, Le Mans, Orléans, Angers, Rennes, Poitiers et Brest) between 01/01/2010 and 31/12/2018.

Investigators will answer retrospectively a questionnaire that covers patient and disease data, biologic agent use, efficacy and adverse events.


title: A Retrospective Analysis in Real World on Lymphocyte Reconstitution After Lymphopenia in Patients Treated by Tecfidera and Description of Management Strategies in France

acronym: Lympho-TEC

summary:
The primary objective of the study is to describe absolute lymphocyte count (ALC) reconstitution after Dimethyl fumarate (DMF) discontinuation because of lymphopenia, in Relapsing-Remitting Multiple Sclerosis (RRMS) participants.

The secondary objectives of the study are characterization of lymphopenia; characterization of lymphopenia having led to DMF discontinuation treatment; description of the evolution of ALC during DMF treatment; description of discontinuation of DMF treatment; exploration of clinical outcomes in participants with lymphopenia on DMF and/or after DMF discontinuation due to lymphopenia; description of vigilance and participant management overall and in participants with lymphopenia who continued DMF treatment; incidence's assessment of opportunistic or serious infections; investigation of the potential impact of baseline demographic and disease characteristics in risk of developing lymphopenia while on DMF; investigation of the potential impact of baseline demographics on the kinetics of ALC reconstitution upon discontinuation of DMF; investigation of the changes of lymphocyte subtypes in participants on DMF if available.

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

lead_sponsor: Biogen


title: Interest of DBM Fasciatherapy for Physiotherapy in the Care of Patients Suffering From Non-Specific Chronic Low Back Pain: a Cluster Randomized Multicenter Clinical Trial

summary:
Low back pain (LBP) is pain localized below the costal margin and above the inferior gluteal folds. It may be associated with radiculalgia. Non-specific LBP refers to LBP without specific problems such as infection, inflammation, vertebral fracture or cancer. Chronic LBP is a LBP lasting more than 3 months.

The causes of LBP remain unknown. While there are recommendations for physiotherapy, the protocol of care is not well defined. New therapeutic models centered on neurophysiology are replacing biomechanics-based models. New programs centered on patient education and a biopsychosocial approach are emerging.

Research has shown the possible involvement of fascia in LBP and the interest of manual fascia therapies in the treatment of LBP. To date, there are no studies that have shown the effects of fasciatherapy in the treatment of non-specific LBP.

In France, many physiotherapists use this type of treatment and more specifically fasciatherapy. French physiotherapists say that it may improve their management of LBP. Studies on fasciatherapy have highlighted the effects of fasciatherapy in the management of fibromyalgia pain, the treatment of anxiety, malaise and the improvement of body perception. They show the multidimensional actions of fasciatherapy and support its clinical, functional and psychosocial evaluation for LBP.

Fasciatherapy is part of the manual therapies that target their action on the fascial system. This "patient-centered" technique is a biopsychosocial and humanistic approach to health. The manual and gestural approaches of the fascia are part of the Non-Pharmaceutical Interventions field. Fasciatherapy involves manual and gestural interventions, with the objective of restoring the contractile, elastic and movement properties of the fascia in order to provide relief, improve function and quality of life for patients.

In France, fasciatherapy is not part of recommendations and is not recognized by the Conseil National de l'Ordre des Masseurs-Kinésithérapeutes.

This study aims to assess the effects of fasciatherapy on LBP and to evaluate how it could contribute to its management for physiotherapists. It is a cluster randomized trial conducted on 180 subjects. Intensity of pain (measured with VAS) is the primary outcome. The secondary outcomes are the impact of LBP on daily life (Dallas Pain Questionnaire), on quality of life (SF-12 questionnaire), on anxiety (STAI questionnaire), and the evolution of drug consumption.

The study will take place in France and the treatment structures will be the practitioners' practice.

ReferenceType: background

ReferenceCitation: Bruyère O, Demoulin M, Beaudart C, Hill JC, Maquet D, Genevay S, Mahieu G, Reginster JY, Crielaard JM, Demoulin C. Validity and reliability of the French version of the STarT Back screening tool for patients with low back pain. Spine (Phila Pa 1976). 2014 Jan 15;39(2):E123-8. doi: 10.1097/BRS.0000000000000062.

ReferenceCitation: Marty M, Blotman F, Avouac B, Rozenberg S, Valat JP. Validation of the French version of the Dallas Pain Questionnaire in chronic low back pain patients. Rev Rhum Engl Ed. 1998 Feb;65(2):126-34. Erratum in: Rev Rhum Engl Ed 1998 May;65(5):363.

ReferenceCitation: Leplège A, Ecosse E, Verdier A, Perneger TV. The French SF-36 Health Survey: translation, cultural adaptation and preliminary psychometric evaluation. J Clin Epidemiol. 1998 Nov;51(11):1013-23.

ReferenceCitation: Lawlis GF, Cuencas R, Selby D, McCoy CE. The development of the Dallas Pain Questionnaire. An assessment of the impact of spinal pain on behavior. Spine (Phila Pa 1976). 1989 May;14(5):511-6.

ReferenceCitation: Ware J, Kolinski M, Keller S. How to score the SF-12 physical and mental health summaries: a user's manual. Boston: The Health Institute, New England Medical Centre, Boston, MA. 1995;

ReferenceCitation: Carlsson AM. Assessment of chronic pain. I. Aspects of the reliability and validity of the visual analogue scale. Pain. 1983 May;16(1):87-101. doi: 10.1016/0304-3959(83)90088-X.

ReferenceCitation: Boureau F. L'appréciation de la sévérité d'une douleur chronique. Médecine et hygiène. 1987;45(1703):1560-6.

ReferenceCitation: Wilke J, Schleip R, Klingler W, Stecco C. The Lumbodorsal Fascia as a Potential Source of Low Back Pain: A Narrative Review. Biomed Res Int. 2017;2017:5349620. doi: 10.1155/2017/5349620. Epub 2017 May 11. Review.

ReferenceCitation: Courraud C, Bois D, Lieutaud A. Apports de la pratique de la fasciathérapie à l'exercice de la physiothérapie: le point de vue des praticiens. Mains Libres. 2016;(3):49-58.

ipd_sharing_description: No IPD sharing

lead_sponsor: FasciaFrance

intervention_type: Procedure


title: A Retrospective, Observational Study to Collect Clinical Safety and Performance Data of POLYMAILLE® EXTRA THIN Vascular Prothesis

summary:
The purpose of this PMCF study is to evaluate a minimum of 125 subjects in 1 or 2 sites in France at least 1-year follow-up after surgery until a maximum of 5 years in the indication of abdominal and peripheral arterial surgery not crossing the knee flexion crease.

the objectives of the evaluation will describe safety and performance of POLYMAILLE® EXTRA THIN.

lead_sponsor: Perouse Medical

intervention_type: Device


title: Detection of Myocardial Inflammation in Cyclists After Strenuous Exercise: a Pilot Study Part 2

summary:
The study will evaluate myocardial inflammation in cyclists after high intense and sustained exercise. Our hypothesis is that strenuous exercise in recreational cyclists may be associated with myocardial inflammation. Myocardial fibrosis in asymptomatic athletes is associated with life-threatening arrhythmic events and sudden death. Although myocarditis seems to be the most likely underlying cause, it remains unclear if strenuous and sustained physical exercise can cause myocardial inflammation with development of myocyte necrosis and possibly myocardial fibrosis in athletes.

Nineteen recreational cyclists performing "L'ETAPE DU TOUR (EDT) de France" a cycling ride (175 km, 3600 m of positive altitude difference) on July 4 2021 will be included in this study. Each participant will complete a detailed questionnaire detailing their training history. All participants will have exercise testing approximately 1 week before the EDT stage to set aerobic and anaerobic gas exchange thresholds, as well as VO2max.

In part 2 of the study cardiac MRI will be performed at rest before the EDT cycling ride completion. An ECG registration using a RootiRx will be realized during and up to 6 hours after the cycling ride. An echocardiography and cardiac MRI will be repeated in each cyclist between 3 and 6 hours after EDT cycling ride completion. A blood sample will be obtained at that time after the ride. This time point is chosen based on the highest troponin release that 3 to 6 hours post-exercise would allow a sufficient amount of time for inflammation to develop and be detectable, corresponding with the time when cardiac Troponin T is typically detectable and representing the liberation of enzymes from damaged myocytes.

Finally, a third cardiac MRI will be repeated 24 hours after start of the cycling ride to verify the evolution of possible inflammation over this time period.

status: Active, not recruiting

lead_sponsor: Jessa Hospital

location_country: France Belgium

location_facility: Centre Hospitalier Universitaire de Nice


title: Structural and Functional Correlates of Clinical Response to Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Schizophrenia Patients With Resistant Auditory Hallucinations

acronym: TMSCCS

summary: The potential of non-invasive Transcranial Magnetic Stimulation (TMS) as a therapeutic tool for improving schizophrenic symptoms, in particular resistant hallucinations, has been increasingly studied over the past decades. Several studies have demonstrated that low-frequency patterns of repetitive TMS (rTMS) applied over the left Temporoparietal Junction (TPJ), which are known to decrease local activity, significantly reduced auditory verbal hallucinations in schizophrenic patients. In spite of highly promising results, a high level of inter-individual variability in the responses to non-invasive brain stimulation treatments, and the fact that rTMS may prove ineffective in some patients, keep spurring controversy about the efficacy of these approaches (as currently performed), as well as about how to increase its efficacy and consistency. Accordingly, the objectives of this project are to better understand the impact of rTMS on the brains of patients with resistant auditory hallucinations, and to use this information not only to better understand this condition but to develop more efficient and consistent therapies. Thus, in this study, the investigators focus more specifically on resistant auditory hallucinations in schizophrenia, which is a common symptom in schizophrenic patients, and can be treated by rTMS. The investigators hypothesize that there is a baseline difference in anatomical and/or functional connectivity between responder and non-responder patients who are treated with rTMS. Therefore, our project will aim to determine some anatomical and functional connectivity markers of response to rTMS treatment in patients with schizophrenia

status: Unknown status

ReferenceCitation: Thomas F, Bouaziz N, Gallea C, Schenin-King Andrianisaina P, Durand F, Bolloré O, Benadhira R, Isaac C, Braha-Zeitoun S, Moulier V, Valero-Cabré A, Januel D. Structural and functional brain biomarkers of clinical response to rTMS of medication-resistant auditory hallucinations in schizophrenia patients: study protocol for a randomized sham-controlled double-blind clinical trial. Trials. 2019 Apr 23;20(1):229. doi: 10.1186/s13063-019-3311-x.

lead_sponsor: Centre hospitalier de Ville-Evrard, France

location_facility: Unité de Recherche Clinique, EPS Ville Evrard

status_simplified: Unknown


title: Parathyroid Autofluorescence Visualization in Thyroid Surgery: Impact on Postoperative Hypocalcemia. A Randomized Controlled Trial

summary: This Multicenter, Randomized Controlled Trial evaluates the clinical impact of parathyroid autofluorescence visualization using near infrared light (NIR) during total thyroidectomy (TT). It compares patients who undergo TT associated or not with lymph node dissection (LND) with NIR vs without NIR use during surgery.

ReferenceCitation: Duclos A, Peix JL, Colin C, Kraimps JL, Menegaux F, Pattou F, Sebag F, Touzet S, Bourdy S, Voirin N, Lifante JC; CATHY Study Group. Influence of experience on performance of individual surgeons in thyroid surgery: prospective cross sectional multicentre study. BMJ. 2012 Jan 10;344:d8041. doi: 10.1136/bmj.d8041.

ReferenceCitation: McWade MA, Sanders ME, Broome JT, Solórzano CC, Mahadevan-Jansen A. Establishing the clinical utility of autofluorescence spectroscopy for parathyroid detection. Surgery. 2016 Jan;159(1):193-202. doi: 10.1016/j.surg.2015.06.047. Epub 2015 Oct 9.

ReferenceCitation: Benmiloud F, Godiris-Petit G, Gras R, Gillot JC, Turrin N, Penaranda G, Noullet S, Chéreau N, Gaudart J, Chiche L, Rebaudet S. Association of Autofluorescence-Based Detection of the Parathyroid Glands During Total Thyroidectomy With Postoperative Hypocalcemia Risk: Results of the PARAFLUO Multicenter Randomized Clinical Trial. JAMA Surg. 2020 Feb 1;155(2):106-112. doi: 10.1001/jamasurg.2019.4613.

lead_sponsor: Hôpital Européen Marseille

location_facility:
Hopital Europeen
Hopital La Pitie Salpetriere
Hôpital Saint Joseph Marseille


title: Research for Angiostrongylus Cantonensis and Costaricensis in French West Indies and French Guiana: a Clinical and Environmental Study

acronym: ACCRAG

summary:
Hospitals in the French West Indies (Fort-de-France (Martinique); Basse-Terre and Pointe-à-Pitre (Guadeloupe); and French Guiana (Cayenne, Saint-Laurent du Maroni)) have noted the emergence of eosinophilic meningitis cases in recent years. This finding is part os eosinophilic meningitis cases emergence and meningoencephalitis caused by the parasite Angiostrongylus cantonensis on the American continent and in the Greater Antilles.

In 2013, the investigation of an eosinophilic meningitis case by the Basse-Terre hospital team with a positive specific PCR in the CSF (CDC, Atlanta, USA) showed the first case of neuromeningeal angiostrongylosis in Guadeloupe. A similar case was diagnosed by serology at Pointe-à-Pitre University Hospital a few years earlier without having been published, and another serious case diagnosed also at Pointe-à-Pitre University Hospital Center in January 2017. The team at the Martinique University Hospital Center also reported several cases of eosinophilic meningitis with positive serologies for A. cantonensis carried out in laboratories outside Martinique (Laboratory of Parasitology, Gonesse, France; Thailand; and Tropical Institute and Public Health, Switzerland) in recent years.

The emergence of this parasitosis is related to the introduction of the intermediate host Achatina fulica on the American continent and the geographical evolution of the angiostrongylosis cases is intrinsically linked to that of the Achatins. To date, only two studies report the environmental presence of Angiostrongylus cantonensis in the Lesser Antilles. One proved the presence in rats (23.4%) on the island of Grenada, and the other in Guadeloupe, showing that 32.4% of Achatina fulica collected carried the parasite by specific PCR. In Martinique, where the number of cases is increasing, and in French Guiana, where there is an increase in the number of cases in neighboring countries, especially Brazil, no study has been conducted on this parasite.

In parallel with this finding, several serious digestive tables associated with strong hypereosinophilia were reported in Martinique and Guadeloupe in the 90s but also in recent years, the last case in December 2016. Etiological diagnoses were established by the discovery of Angiostrongylus costaricensis parasite in ileal pathological specimens. However, these cases could never be investigated by serology or specific PCR due to lack of diagnostic tools available in the French West Indies and Guiana region, and more broadly in metropolitan France.

lead_sponsor: University Hospital Center of Martinique

intervention_type: Biological


title: Effectiveness and Safety of Preoperative Magnetic Detection of Non-palpable Breast Lesions

acronym: MAGREES

summary:
Breast cancer is the most common cancer in women and also has the highest death rate. In 2018, 58,500 new cases were diagnosed in metropolitan France. It affects, in 8 out of 10 cases, women aged 50 and over. Nevertheless, thanks to early detection and improved therapeutic techniques, its mortality rate has continued to decrease each year (a decrease of 1.6% per year was recorded between 2010 and 2018), which allows it to maintain its status as a cancer with a good prognosis. Furthermore, net survival is 87% at 5 years and 76% at 10 years. The median age of death is 74 years. Organized screening was initiated in France in 1990 and generalized in 2004, while maintaining a specific management according to the personal risk of each patient. It consists of a mammogram, plus or minus an ultrasound, every two years from the age of 50. The mammogram is reviewed by two different radiologists. In case of abnormality, a biopsy is performed.

Breast lesions are separated into two nosological entities: palpable tumors, often diagnosed on clinical examination (or autopalpation) and confirmed on mammography, and non-palpable tumors detected during mammographic and/or ultrasound screening.

Thanks to the generalization of screening, the detection of subclinical lesions requiring surgery represents more than half of the breast surgeries and the challenge of their surgical management lies in a precise preoperative location to allow a complete removal, while limiting the sacrifice of healthy glandular tissue. The metallic location technique is currently the reference technique for the preoperative location of these lesions.

For all these reasons, new techniques of preoperative tracking have been developed.

Magnetic tracking (MR) appears to be a simple, non-radioactive and non-aggressive technique to use and organize. MR takes the form of a 1x5mm paramagnetic clip made of iron oxide visible on ultrasound and mammography and is detected by a SentiMag probe. The MR began to be used in France in 2017. It is placed in contact with the lesion under ultrasound guidance. It has the advantage that it can be placed up to 30 days before surgery and has less risk of complication. This MR contains iron particles and is 5mm long. It is pre-loaded in a sterile 18 G needle closed with a wax tip. It is deployed under mammographic and/or ultrasound guidance. The Sentimag probe is used to detect MR in a multidirectional way at 360°, with an audio and visual estimation of the distance. It generates an alternating magnetic field that magnetizes the iron in the MR.

All of these surgical procedures can be performed as outpatient surgery, which corresponds to a hospitalization of less than 12 hours without overnight accommodation, meaning that each patient is admitted and discharged on the same day as her procedure. Outpatient surgery represented 36% of all surgeries in France in 2018. The objective of the HAS is to achieve a majority ambulatory practice of 70% by 2022. This type of surgery has advantages for the patient, by making her journey safer: reduction in the risk of nosocomial infection, thromboembolic risk and anxiety linked to hospitalization for the patient and her family. It also has an important socio-economic advantage by reducing hospitalization costs and the number of hospital beds required. It improves the working conditions of the staff by reducing the workload and night shifts. It has also enabled a clear improvement in the optimization and efficiency of the organization of resources in the surgical technical platforms. The role of the MR is particularly well suited to this new organization.

ReferenceCitation: Broeders M, Moss S, Nyström L, Njor S, Jonsson H, Paap E, Massat N, Duffy S, Lynge E, Paci E; EUROSCREEN Working Group. The impact of mammographic screening on breast cancer mortality in Europe: a review of observational studies. J Med Screen. 2012;19 Suppl 1:14-25. Review.

ReferenceCitation: Shapiro S. Periodic screening for breast cancer: the HIP Randomized Controlled Trial. Health Insurance Plan. J Natl Cancer Inst Monogr. 1997;(22):27-30.

ReferenceCitation: Chagpar AB, Garcia-Cantu C, Howard-McNatt MM, Gass JS, Levine EA, Chiba A, Lum S, Martinez R, Brown E, Dupont E; SHAVE2 authors. Does Localization Technique Matter for Non-palpable Breast Cancers? Am Surg. 2022 Dec;88(12):2871-2876. doi: 10.1177/00031348211011135. Epub 2021 Apr 15.

ReferenceCitation: Hall FM, Frank HA. Preoperative localization of nonpalpable breast lesions. AJR Am J Roentgenol. 1979 Jan;132(1):101-5.

ReferenceCitation: Frank HA, Hall FM, Steer ML. Preoperative localization of nonpalpable breast lesions demonstrated by mammography. N Engl J Med. 1976 Jul 29;295(5):259-60.

ReferenceCitation: Norman C, Lafaurie G, Uhercik M, Kasem A, Sinha P. Novel wire-free techniques for localization of impalpable breast lesions-A review of current options. Breast J. 2021 Feb;27(2):141-148. doi: 10.1111/tbj.14146. Epub 2020 Dec 27. Review.

ReferenceCitation: Jeffries DO, Dossett LA, Jorns JM. Localization for Breast Surgery: The Next Generation. Arch Pathol Lab Med. 2017 Oct;141(10):1324-1329. doi: 10.5858/arpa.2017-0214-RA. Review.

ReferenceCitation: Pieszko K, Wichtowski M, Cieciorowski M, Jamont R, Murawa D. Evaluation of the nonradioactive inducible magnetic seed system Magseed for preoperative localization of nonpalpable breast lesions - initial clinical experience. Contemp Oncol (Pozn). 2020;24(1):51-54. doi: 10.5114/wo.2020.93677. Epub 2020 Mar 13.


title: Effectiveness of the Montpellier Falls Clinic in Preventing Injuries in Older High-risk Adults

acronym: EMPIRE

summary: A falls prevention clinic opened in Montpellier (France) in 2015. The objective of the project is to evaluate whether the tailored multifactorial programme delivered in this real practice setting by a geriatrician, a podiatrist, a physiotherapist, and a occupational therapist would help prevent injuries in high-risk older patients using a 6-month pre-post intervention analysis.


title: Very Severe Malaria Treated by Intravenous Artesunate: Epidemiology, Management, Outcome and Prognostic

acronym: Palustar

summary:
In endemic areas, Plasmodium falciparum malaria exacts a huge public health toll, causing close to half a million deaths each year. In non-endemic industrialized areas, imported malaria may develop. In France, around 5000 imported cases occured annually, including 10-15% of severe malaria.

The criteria for defining severe malaria in endemic areas are established by the World Health Organization (WHO), and have been adjusted for severe imported malaria. In France, in order to optimize management, severe imported malaria is separated into two groups: very severe malaria (VSM) and less severe malaria (LSM). Briefly VSM included coma and/or shock and/or respiratory failure and/or acidosis and/or hyperlactatemia and/or death during hospitalization.

In France, severe imported malaria is treated with intravenous artesunate. Little is known about the management of imported VSM in the ICU with intravenous artesunate.

In a French national multicentric retrospective frame, the main objective of the present study is to describe in detail: epidemiology, management, outcome and prognostic of very severe imported malaria treated with intravenous artesunate during the period 2011-2019. The second objective is to retrospectively compare two groups : VSM treated with intravenous artesunate in the ICU during 2011-2019 versus VSM treated with intravenous quinine in the ICU during 2000-2010.

lead_sponsor: Dr Fabrice BRUNEEL


title: Rate of Bronchopulmonary Dysplasia in Preterms Neonates Less Than 29 Weeks' Gestational Age and / or With Birth Weight Less Than 1000 g: a Double Blind Randomized Controlled Multicenter Trial Comparing SMOFlipid and Medialipide

acronym: SMOF

summary: SMOF is a large double blind placebo-controlled randomized clinical trial aiming to compare the rate of bronchopulmonary dysplasia (BPD) at 36 weeks corrected age in premature infants < 29 weeks and / or with birth weight < 1000 g receiving either SMOFlipid® or Medialipide® 20%. This study will offer new information for optimizing the management of preterms requiring parenteral nutrition. The investigators hypothesis is that the composition of SMOFlipid may decrease lipid peroxidation and oxidative stress in preterms, resulting in a lower incidence of BPD.

status: Withdrawn

lead_sponsor: Hospices Civils de Lyon

intervention_type: Dietary Supplement


title: Conditions for Prescribing Liraglutide in Medical Practice and Assessment of Maintenance Level, Tolerability, and Efficacy of Victoza® (Liraglutide) in Subjects With Type 2 Diabetes

acronym: EVIDENCE

summary: This observational study is conducted in Europe. The aim of this non-interventional (observational) study is to evaluate the efficacy of liraglutide (Victoza®) and to assess the conditions of use of Victoza® in daily medical practice in France.

ReferenceCitation: Gautier JF, Martinez L, Penfornis A, Eschwège E, Charpentier G, Huret B, Madani S, Gourdy P. Effectiveness and Persistence with Liraglutide Among Patients with Type 2 Diabetes in Routine Clinical Practice--EVIDENCE: A Prospective, 2-Year Follow-Up, Observational, Post-Marketing Study. Adv Ther. 2015 Sep;32(9):838-53. doi: 10.1007/s12325-015-0245-x. Epub 2015 Sep 30.

ReferenceCitation: Martinez L, Penfornis A, Gautier JF, Eschwège E, Charpentier G, Bouzidi A, Gourdy P. Effectiveness and Persistence of Liraglutide Treatment Among Patients with Type 2 Diabetes Treated in Primary Care and Specialist Settings: A Subgroup Analysis from the EVIDENCE Study, a Prospective, 2-Year Follow-up, Observational, Post-Marketing Study. Adv Ther. 2017 Mar;34(3):674-685. doi: 10.1007/s12325-017-0476-0. Epub 2017 Jan 30.

lead_sponsor: Novo Nordisk A/S


title: Valuation of the Long-term Tolerance of Proton Pump Inhibitor (PPI) Discontinuation in Geriatric Patients Treated With Long-term Therapy Without a Recognized Indication

acronym: EGERIPP 2

summary:
Proton pump inhibitors (PPIs) are widely prescribed in France as anti-ulcer drugs. The indications currently approved in France, with variations according to molecules, are as follows: eradication of Helicobacter pylori, active peptic ulcer disease, maintenance treatment of duodenal ulcer disease, treatment of gastroduodenal lesions induced by non-steroidal anti-inflammatory drugs (NSAIDs), prevention of NSAID-induced gastro-duodenal lesions in at-risk subjects, symptomatic treatment of gastroesophageal reflux disease (GERD), esophagitis by GERD, maintenance treatment of esophagitis by GERD and Zollinger-Ellison syndrome.

Several misuse situations had been identified by the High Authority of Health (HAS) in its reassessment in 2009.

Although these molecules are very well tolerated in the short term, studies show the occurrence of long-term adverse effects such as an increase in the number of lung infections, Clostridium difficile infections and an increased risk of fractures.


title: Inflatable Penile Prostheses : Predicting Factors of Pump Misuse and Unsatisfaction

summary:
Sexual health and satisfaction are well know as critical critera to assess quality of life, at any age. Among the multiple aspects of sexual health, erectile dysfunction (ED) is not anymore a fate, mainly thanks to the advent of phosphodiesterase type 5 (PDE5) inhibitors in 1998. Nevertheless, a significant part of patients are intolerant or does not respond to PDE5 inhibitors and thus are looking for other treatment options.

Since the first implantation of foreign material intracarvernosally in 1966 by Beheri, multiple modifications and enhancements were achieved in order to produce devices more reliable with a more natural appearance. First introduced in 1973 by Scott et al., inflatable prosthesis provides now high general satisfaction rates (69-94%), better than in malleable prostheses, except for few authors.

In addition to changes in materials and construction, the two main manufacturers of IPP, Boston scientific AMS (Marlborough, MA, USA) and Coloplast (Minneapolis, MN, USA), modernized the pump mechanism of their devices. Since the introduction of AMS IPP, three main pump formats have been used : the standard pump has been replaced in 2004 by the " Tactile " pump and then the " Momentary Squeeze " (MS) pump in 2006, smaller and easier to deflate by not requiring the patient to hold the deflation button throughout deflation. Coloplast also replaced in 2008 their " Genesis " pump by a " One Touch Release " (OTR) pump, and finally in 2014 by the current " Touch " pump, smaller, and presenting a biconcave deflation button, easier to find.

Despite all technological advances, appropriate pre-operative counselling and careful post-operative teachning, a significant part of patients has still difficulties to handle the pump and thus, does not use their IPP, regardless of any material malfunction. That situation obviously leads to patient's dissatisfaction and highlights the operating risks of a useless surgical procedure.

The purposes of this study were:to identify the risks factors, modifiable and non-modifiable, for patients' difficulty to inflate and/or deflate their device after IPP implantation, then to show a correlation between easy handling and post-operative satisfaction. And last but not least, to show an association between pre-operative pump pattern viewing and handling and post-operative easy handling. That information could help the physicians to improve the pre-operative selection of patients and to adapt the peri-operative care in order to improve patients satisfaction.

ipd_sharing_description: No data sharing plan has been established.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Observational Study on Patients With Rasmussen Encephalitis Treated With Adalimumab: Efficacy and Tolerance in the Short and Long Term

summary: Since the initial study of cases reported between 2009 and 2015, adalimumab has become in France the immunomodulatory reference treatment used after failure of corticosteroids and immunoglobulins before a possible recourse to the hemispherotomy. This observational study is intended to document the long-term efficacy and safety of Adalimumab therapy in patients with Rasmussen encephalitis.

time_perspective: Other

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Total Physical Activity and Sedentary Behaviour Changes Associated With Regular Daily Life Utilitarian E-bike Use : VELONAPS Study

acronym: VELONAPS

summary:
Physical inactivity and sedentary are recognized as important risks factors for several diseases and total mortality. One of the main perceived barriers to physical activity is the lack of time and motivation. Active commuting during daily routine could overcome these barriers and e-bikes appears to be a promising and practical tool to meet physical activity guidelines.

E-bikes are a physically active transportation mode, with a riding intensity contributing to activities in the moderate-intensity range (3-6 METs) for any of the assistance mode. Electric assistance is provided only when a rider is pedaling. The study VELONAPS mainly aims at investigating if real-life usage of utilitarian e-bike is associated with significant changes on total physical activity and sedentary patterns. During up to 4 months of free use of an e-bike, our purpose is to quantify its usage along with total physical activity and sedentary levels. We hypothesize that using an e-bike for commuting increase the total physical activity of at least 7.5 MET-h/week, increasing as well adherence to physical activity guidelines.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Oral Feeding During Established Labor. Current Practices in the Obstetric Department of the Femme Mère Enfant Hospital (Lyon, France)

summary: Current French guidelines allow oral intake of clear fluid in women in established labor under epidural analgesia. To date, no study assessed how these guidelines are followed in clinical practice. This study aims to assess the current practices as to the fasting during the labor at our institution, while assessing the experience and the expectations of the parturients (level of comfort or discomfort related to fasting).


title: Evaluation of Vaccination Coverage in People Linving With Diabetes

acronym: VacDiab

summary:
For several years, the prevalence of people living with diabetes (pDT) has been steadily increasing. It was estimated by the health insurance in 2016 at 5 %, or more than 3.3 million people in France. By different physiological mechanisms, diabetes is associated with immunodeficiency. As a result, several vaccines are recommended in pDT.

The vaccination policy is drawn up in France by the French Minister of Health, who makes public the vaccination schedule after the opinion of the High Authority of Health.

Currently according to the 2019 immunization schedule, the dTP vaccine is the only mandatory in the general population with recalls in adults aged 25, 45, 65 and every 10 years. This vaccine is especially indicated for this segment of the population because diabetes is a risk factor for tetanus. In 2011, the Ministry of Health estimated that only 50.5% of the general population was up to date against dTP.

Two vaccines are recommended for pDT according to the current vaccine schedule: the flu vaccine and the pneumococcal vaccine. In fact, influenza and pneumococcal disease are more frequent and more serious for these patients compared to the general population. Influenza vaccine has to be done annually in the early winter period. The vaccine coverage for winter 2018/2019 was estimated at 46.8 % of the target population. The vaccination scheme for pneumococcal vaccine is more complex: it involves a primary vaccination with a vaccine with 13 valences followed by another with 23 valences at least eight weeks later. Thereafter, a recall is to be carried out every five years with the 23 valences vaccine. Vaccination coverage was estimated in France in 2011 at 8.1 % in the population at risk.

According to several studies, the shingles virus has a greater impact and is more aggressive in pDT than in the general population. Similarly, the virus would tend to unbalance diabetes. There is currently a vaccine against shingles that is recommended and reimbursed in the population aged 65 to 74 years.

In our practice, a pharmaceutical team has been carrying out medication reconciliation for several years at the hospital admission and discharge of the patient in the endocrinology-nutrition department of the university hospital of Montpellier.

During this medication reconciliation, a pharmaceutical interview on the management of drug treatments is carried out . Since May 2019, we added to this interview an assessment of the vaccination coverage and feelings of people regarding vaccination. Following this assessment, a report is made during an interview with the doctor responsible for the patient. During this interview, the update of mandatory and recommended vaccinations are discussed between the doctor and the pharmacist.

In this context, it seems interesting to us to make an assessment of our practices and the investigator make the following assumptions:

There is a defect in the mandatory and recommended process of vaccination for pDT
A synthesis of pDT vaccine status between the physician and the pharmacist at the time of hospitalization would allow optimization of vaccine management in accordance with current recommendations and practices.

The main objective of the study is to assess vaccine coverage for mandatory and recommended pDT vaccines at hospital admission.

The secondary objectives are:

Description of pDT experience with vaccination;
Description of the management of vaccination within the Department of Endocrinology-Nutrition-Diabetes during and after the patient's hospitalization in terms of (intra-hospital vaccination, hospital prescriptions of a vaccine after hospitalization and number of vaccination recommendations in the hospitalization report).
Description of transmission of vaccination status of patients to their treating physician


title: Relationship Between Adverse Drug Reactions and Unlicensed/ Off-label Drug Use in Hospitalized Children: an Observational Multicenter Prospective Study

acronym: EREMI

summary:
Medications are the most commonly used clinical intervention and complications associated with their use are one of the most common causes of adverse events in health care. Adverse Drug Reactions (ADR) are a major cause of morbidity and pose a substantial burden on limited health care resources.

Many drugs used to treat children in hospitals are either not licensed for use in children or are prescribed outside the terms of their product license (off-label prescribing). This is mainly due to the lack of clinical trials in this vulnerable population, and both practical difficulties and ethical considerations arising from involving children in clinical research.

Drugs used within the specifications of the product license might be less likely to cause ADR compared to drugs that are either unlicensed or off-label for use in children. Few studies have shown a significant association between pediatric off-label drug use and ADR.

To compare the probability of ADR after a licensed drug prescription versus the probability of ADR after prescribing a drug off-label in children, we are conducting a multi-center prospective observational study in different pediatric hospital wards in France.

The availability of electronic health records made this study feasible. An automatic data extraction from hospital information systems has been implemented. A computer algorithm for determining pediatric drug labelling (i.e. off-label or unlicensed use) using the French summaries of product characteristics available in Thériaque® database has been developed. Detection of ADRs is carried out by health care professionals and research groups using a trigger tool and patients' electronic health records. The causality between ADRs and suspected medications is evaluated using the Naranjo and the French methods by regional pharmacovigilance centers. An independent pharmacovigilance board validates ADR evaluations, assesses both of their severity and avoidability, and indicates therapeutic alternatives to suspected medications.

This is, to our knowledge, the first large multi-center and prospective study in France that evaluates the relationship between adverse drug reactions and unlicensed/ off-label drugs use in hospitalized children. The results of this study will provide more information on the prescription practice and the amplitude, nature and consequences of unlicensed/off-label drug use in hospitalized children. It will also help identify the risk factors of ADR that could be used to implement preventive actions, and guide future research in the field. An indirect benefit is represented by the increase of physicians' awareness in detecting and declaring ADRs and by communicating the results to the health professionals and to the public. This study is funded by ANSM (the French Medicine Agency).

location_facility: Pediatric Clinical Research and Investigation Centre CIC 1407 Inserm-UMR 5558 CNRS Lyon University & Hospices Civils de Lyon


title: A Randomized Non-Inferiority Clinical Trial of Doxycyline Vs BPG for Early Syphilis

acronym: SY-DOXY

summary:
According to European and US Centers for Disease Control and Prevention (CDC) guidelines, the recommended treatment for uncomplicated early syphilis in adults (i.e. primary, secondary and early latent) is a single intramuscular injection of 2.4 million units of benzathine benzylpenicillin G (BPG). Recent reviews have also recommended BPG as the first-line treatment of early syphilis, reporting a success rate of more than 90% over a large panel of studies. This form of the drug provides weeks of treponemicidal levels of penicillin in the blood, but does not efficiently cross the blood-brain barrier.

However, despite the use of BPG for almost 70 years and its status as the gold standard treatment for early syphilis, the need to administer this antibiotic parenterally has led to the use of second-line oral antibiotics, including firstgeneration macrolides, and then second-generation macrolides, such as azithromycin. Several African studies have shown 1 g azithromycin bid treatment for one day to be effective against early syphilis, but most authors agree that azithromycin should not generally be used as resistance to this macrolide is highly prevalent in Western countries. Moreover, a recent study by our group showed that more than 80% of the treponemal strains isolated in France harbor the mutation conferring resistance to azithromycin. The use of this alternative would, therefore, be highly unlikely to be effective in France. Tetracycline antibiotics have also been proposed as an alternative in patients with a contraindication for BPG or other forms of penicillin. Doxycycline, at a dose of 100 mg orally twice daily for 14 days, has been endorsed as a preferred alternative treatment, but few data are available concerning its efficacy. This issue is crucial, for two main reasons: there has been a recrudescence of early syphilis in most western countries over the last 20 years, increasing the need for BPG, and two periods of BPG shortage were experienced in 2013 and 2017, leading to the use of alternative treatments due to the temporary unavailability of BPG or its limitation to cases in which no other treatment was possible. Data for the manufacturing and distribution of antibiotics are not publicly available, but reports of limited availability, shortages, and price increases for old antibiotics suggest that the current system is too fragile to provide what should be a given in modern medicine: access to effective treatment for common and potentially severe bacterial infections. The recurrence of BPG shortages over the last five years has created an urgent need to demonstrate that doxycycline is safe, or at least as safe as BPG, for treating early syphilis. The investigators hypothesize that the recommended doxycycline regimen is not inferior to BPG and plan to test this hypothesis in a randomized clinical trial.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: REAL WORLD DATA IN LYMPHOMA AND SURVIVAL IN ADULTS

acronym: REALYSA

summary:
REALYSA cohort is a population-based epidemiological platform in real-life for lymphomas designed to enrich prognostic data, by integrating together epidemiological, clinical and biological data.

REALYSA is a platform perfectly set up to

Study prognostic factors using integrated epidemiological and biological data (genetics), to better characterize the determinants of refractoriness and relapse in patients with lymphoma, to follow the growing number of survivors and describe median to long-term sequela, second cancer, quality of life (QoL)…
Document treatment effectiveness in real life and observance
Address socio-economical questions

ReferenceCitation: Ghesquières H, Rossi C, Cherblanc F, Le Guyader-Peyrou S, Bijou F, Sujobert P, Fabbro-Peray P, Bernier A, Belot A, Chartier L, Fornecker LM, Baldi I, Bouabdallah K, Laurent C, Oberic L, Morineau N, Le Gouill S, Morschhauser F, Haioun C, Damaj G, Guidez S, Labouré G, Fitoussi O, Lebras L, Gressin R, Salles G, Ysebaert L, Monnereau A. A French multicentric prospective prognostic cohort with epidemiological, clinical, biological and treatment information to improve knowledge on lymphoma patients: study protocol of the "REal world dAta in LYmphoma and survival in adults" (REALYSA) cohort. BMC Public Health. 2021 Mar 2;21(1):432. doi: 10.1186/s12889-021-10433-4.

location_facility: Unité Hémopathies Lymphoïdes, Hôpital Henri Mondor

location_facility: Service Hématologie, Centre Hospitalier de Roubaix - Hôpital Victor Provo

location_facility: Service des maladies du sang, Hôpital Claude Huriez, CHRU de Lille

location_facility: Département d'Hématologie et Oncologie, Centre Léon Bérard

location_facility: METROPOLE SAVOIE - SITE CHAMBERY, place Lucien Biset,

location_facility: Service Oncologie médicale, HOPITAL SAINT VINCENT-DE-PAUL

location_facility: Service d'Hématologie et Thérapie Cellulaire, Centre Hospitalier Universitaire de Poitiers

location_facility: Service Hématologie Clinique et Thérapie Cellulaire, CHU DE LIMOGES - HOPITAL DUPUYTREN,

location_facility: Service d'Hématologie Clinique, Centre Hospitalier Universitaire Michallon

location_facility: Service d'Hématologie clinique, Centre Hospitalier Universitaire de Nantes

location_facility: Département d'Hématologie Clinique, Hôpital Saint-Eloi,

location_facility: Unité d'Hématologie Clinique, CH D'ARRAS

location_facility: Service d'Onco-radiolothérapie, Polyclinique Bordeaux Nord Aquitaine

location_facility: Service Hématologie, Institut Curie - Hôpital René HUGUENIN

location_facility: Hématologie Clinique, CH DE BRETAGNE ATLANTIQUE

location_facility: Service d'Hématologie Clinique et de Thérapie Cellulaire, Hôpital Estaing, CHU de Clermont-Ferrand

location_facility: Service Hématologie, UNIVERSITE DE ROUEN, CENTRE HENRI BECQUEREL

location_facility: Service d'Hématologie, Institut d'Hématologie de Basse Normandie

location_facility: Département d'Hématologie Clinique et Thérapie Cellulaire, Institut de Cancérologie Lucien Neuwirth

location_facility: Service Hématologie, Centre Hospitalier de Dunkerque

location_facility: Service Hématologie, GH REGION MULHOUSE ET SUD ALSACE - HOPITAL EMILE MULLER,

location_facility: Service Oncologie médicale, Groupe Hospitalier Mutualiste de Grenoble, Institut Daniel Hollard,


title: coHOrte fraNcaise Des dEfibrillateurs Sous cuTanés

acronym: HONEST

summary: Implantable cardioverter-defibrillators have been proven to be effective in the prevention of sudden cardiac death in high-risk patients. However, it is well acknowledged that such a strategy could be optimised, especially through new technologies/devices. Data on the entirely sub-cutaneous implantable cardioverter defibrillator (S-ICD) published so far come from high-volume centers and/or selected populations. The HONEST Cohort -taking the opportunity of a unique scenario with a single manufacturer and remote monitoring system available- aims to collect retrospectively baseline information as well as follow-up of all patients implanted with an S-ICD in France since the first implant in October 13, 2012 until December 31, 2019. An extended prospective yearly follow-up will be carried out since January 1, 2020 until December 31, 2024.

lead_sponsor: Paris Sudden Death Expertise Center

location_facility: Paris Cardiovascular Research Center (HONEST Investigators)


title: The Drug Eluting Devices French Safety Survey

acronym: DETECT

summary: This study aims to assess the all-cause mortality at 2 years of patients treated by a paclitaxel drug-eluting devices or non-drug-eluting devices after an endovascular femoropopliteal artery revascularization based on the French National Healthcare Data System (SNDS).

lead_sponsor: Nantes University Hospital


title: Alex Storm: Acute Stress Manifestations' Description in French Pediatric Population

acronym: ALEX

summary: Alex storm hits France, especially the French Riviera, from September 30, 2020 to October 3, 2020. A lot of people have been impacted by this event. Among these people, 116 children have been taking care by the medico-psychological emergency unit and have been assessed by child psychiatrists or by psychologists.

ReferenceCitation: Richez A, Gindt M, Battista M, Nachon O, Menard ML, Askenazy F, Fernandez A, Thümmler S. Storm Alex: acute stress responses in the pediatric population. Eur J Psychotraumatol. 2022 May 11;13(1):2067297. doi: 10.1080/20008198.2022.2067297. eCollection 2022.

lead_sponsor: Fondation Lenval

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval


title: Evaluation of the Quality of Life in the Elderly With Dementia : Validation of a Specific Instrument

summary: With nearly one million cases of dementia in France in 2010, Alzheimer's disease (AD) and related syndromes are a major public health issue. The lake of drug for treatment or preventing AD, health related quality of life (HRQoL) became an essential criterion of evaluation to assess the treatment strategies of patients. Generic HRQoL tools are generally less sensitive for a given disease. That is why other specific tools for AD have been developed. None of them was validated in French. The aim of this study was therefore, after a review of the literature, to achieve a cross-cultural adaptation and psychometric validation of the "Quality of Life in Alzheimer's Disease" (QoL-AD) and "Dementia Quality of Life" (DQoL). These two questionnaires were selected because they were the most popular in English- language literature for this disease.This study concerned a total of 155 patient-caregiver pairs recruited from six French hospitals and a Francophone Swiss center. Patients had a confirmed diagnosis of AD (mild stage to moderate: Mini Mental State Examination ≥ 10). QoL-AD and DQoL were administered by an interviewer. The caregiver sheet of QoL-AD was self-administered. Cross-cultural adaptation and psychometric validation have been carried out for these two questionnaires.

ReferenceCitation: Wolak A, Novella JA, Drame M, Morrone I, Boyer F, Blanchard F, Jolly D. Is the screening test of the French version of the dementia quality of life questionnaire indispensable? Dement Geriatr Cogn Dis Extra. 2011 Jan;1:84-92. doi: 10.1159/000326782. Epub 2011 Apr 6.

ReferenceCitation: Wolak A, Novella JL, Drame M, Guillemin F, Di Pollina L, Ankri J, Aquino JP, Morrone I, Blanchard F, Jolly D. Transcultural adaptation and psychometric validation of a French-language version of the QoL-AD. Aging Ment Health. 2009 Jul;13(4):593-600. doi: 10.1080/13607860902774386.

ReferenceCitation: Barbe C, Morrone I, Wolak-Thierry A, Dramé M, Jolly D, Novella JL, Mahmoudi R. Impact of functional alterations on quality of life in patients with Alzheimer's disease. Aging Ment Health. 2017 May;21(5):571-576. doi: 10.1080/13607863.2015.1132674. Epub 2016 Jan 8.

ReferenceCitation: Barbe C, Jolly D, Morrone I, Wolak-Thierry A, Dramé M, Novella JL, Mahmoudi R. Factors associated with quality of life in patients with Alzheimer's disease. BMC Geriatr. 2018 Jul 9;18(1):159. doi: 10.1186/s12877-018-0855-7.

lead_sponsor: CHU de Reims


title: Comparison of the Non-invasive Approach and Fetal Exome Sequencing in Prenatal Diagnosis When Fetal Ultrasound Signs Are Discovered

acronym: DPNI-Exome

summary:
The discovery of congenital malformations and/or non-specific signs by ultrasound (5% of pregnancies) represents a real medical challenge. Their prognosis is variable depending on the underlying etiology, ranging from acquired fetopathies to rare genetic diseases. In France, the diagnostic approach is currently based on imaging examinations (ultrasound, brain MRI, 3D bone scans, etc.) and/or biological examinations, generally on invasive sampling (trophoblast biopsy, amniocentesis or fetal blood puncture) with infectious (CMV, toxoplasmosis, parvovirus B19, etc.), metabolic (enzymes in the bloodstream, etc.), and genetic (standard karyotype, FISH, array CGH and targeted gene sequencing) investigations. The yield of this strategy is about 30%, leaving 70% of couples without a possible prognosis.

Over the last decade, medical genetics has undergone a technological revolution with the development of high-throughput DNA sequencing (HTS) allowing the analysis of targeted genes (panel) or the exome (ES). International studies published on the use of ES in prenatal diagnosis (PND) have become more common, with variable inclusion criteria, resulting in diagnostic rates between 15 and 36%, higher than those of array CGH (8-15%). In France, FHU TRANSLAD coordinates the national pilot study AnDDI-PRENATOME, which has made it possible to remove the technological barriers for PND ES and to obtain a diagnostic yield of 39% in 33 days on average.

In parallel, the recent development of NIPD (Non-invasive prenatal screening) on free fetal DNA circulating in maternal blood has made it possible to propose a non-invasive strategy. However, this technique is currently used in prenatal care only in a few indications: determination of the fetal sex, search for aneuploidies, analysis of the fetal rhesus status or, more rarely, the targeted diagnosis of monogenic diseases. The team in Strasbourg has recently conducted a pilot study using an NIPD-panel in couples with a history of neomutation in a gene responsible for intellectual disability, which has demonstrated the feasibility of capturing and then sequencing a panel of 500 genes on free fetal DNA circulating in maternal blood.

As high-depth exome sequencing from small amounts of DNA is now affordable and feasible, the investigators wish to compare invasive and non-invasive approaches for the discovery of fetal malformations on ultrasound: a trio exome analysis will be performed in parallel to circulating fetal DNA and fetal DNA extracted after an invasive puncture in order to compare the diagnostic performance of these two approaches.

The investigators propose a pilot study in order to prepare an organizational evaluation including an evaluation of the stakes for coordination and interactions between professionals, the relevance of the system (acceptability, expectations, satisfaction of couples and professionals...), its effectiveness and efficiency. The aim of this pilot project will be to observe the organizational impact on the Plurldisciplinary Centers for Prenatal Disagnostics and the genetic laboratories, and to refine the indicators necessary for monitoring the system; it will also involve conducting exploratory interviews with professionals and couples in order to prepare the qualitative study that will subsequently make it possible to evaluate the relevance of the organization.

design_allocation: Non-Randomized

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Robot-based Tele-echography II - A Comparative Study Using Two Echographic Modalities for Diagnosis of Thoracoabdominal Injuries at the Trauma Center of the Grenoble University Hospital.

summary: The aim of this clinical trial is to evaluate the concordance of diagnosis of injuries in thoracoabdominal trauma using two different echographic methods. The first method is a robot-based tele-echography performed by radiologists in a remote location. The second is bedside echography performed by emergency physicians according to the FAST (Focussed Assessment by Sonography of Trauma) examination.

status: Terminated

ReferenceCitation: Vilchis A, Masuda K, Troccaz J, Cinquin P. Robot-based tele-echography: the TER system. Stud Health Technol Inform. 2003;95:212-7.

lead_sponsor: University Hospital, Grenoble


title: Post-reimbursement Study to Follow Spinal Neurostimulator Devices for Pain Therapy

acronym: SME

summary:
Observational study to evaluate the long term efficacy of Spinal Cord Stimulation (SCS) over 2 years following SCS implant.

This study is requested by French Health Authorities for reimbursement renewal, to maintain reimbursement for SCS in approved indication in France.

lead_sponsor: MedtronicNeuro


title: Epidemiology of High-risk HPV Infection in Women Participating in a Pilot Screening Program Entitled START-HPV (STudy of Primary Screening in the ARdennes Department by Testing for HPV Infection)

acronym: Epi-START

summary: Cervical cancer is due to a persistent infection with a group of viruses known as high-risk Human Papillomaviruses (hrHPV). Viral DNA can be easily detected in a cervical sample by a procedure called 'HPV testing', which can be used as a relevant screening test. A pilot screening program called START-HPV has been set up in the Ardennes, a French administrative area localized in the North of France, with HPV testing as a primary screening test.This observational study aimed to evaluate hrHPV genotypes repartition in the population who participate in the START-HPV screening program. This study will allow a better knowledge of hrHPV infection epidemiology in a screened population.


title: Multicenter Prospective Observational Study Assessing Outcomes, Adverse Events, Treatment Patterns and Related Costs in Patients Diagnosed With Bullous Pemphigoid

acronym: EDP-PB

summary: The study is an observational, multi-center, prospective, non-interventional and open-label data collection study assessing outcomes, treatment patterns, adverse events and costs in patients diagnosed with bullous pemphigoid. The patient enrollment period will be 1 year with a follow-up (observation period) of 1 year for each patient. Four dermatology centres in France will participate. The hypothesis to be answered by the study is that superpotent topical corticosteroid therapy is properly used to treat bullous pemphigoid in real-world life as recommended by French guidelines and whether this treatment influences the medical costs by comparison with systemic therapies (e.g. methotrexate or prednisone).


title: Identification by Transcriptomic Approach of New Prognostic and Predictive Markers in a Cohort of Atypical Meningiomas and Immunohistochemical Applications

acronym: TransMenAtyp

summary:
Determine by a transcriptomic approach new prognostic and predictive markers in atypical meningiomas (WHO grade II).

Retrospective observational study, on a cohort of 85 atypical meningiomas. Transcriptomic study first, on cryopreserved tumor samples. Then identify, thanks to the transcriptomic study, prognostic and predictive factors (study of the link between the quantity of certain RNA transcripts and progression-free survival). Finally, set up immunohistochemical applications, which can be used routinely by the pathologist.

study_start_date_type: Anticipated

lead_sponsor: Central Hospital, Nancy, France


title: Randomised Study Comparing Discharge 3 Days After Surgery to Home Within 24 Hours After Laparoscopic Hysterectomy.

summary:
Hysterectomy is one of the most performed surgery in gynecologic surgery. Actually, 70 000 hysterectomies are performed each year in France. Laparoscopic surgery is in progression. The percentage of hysterectomies performed laparoscopically is increasing. The advantage of laparoscopy include fewer infections, less operative pain, faster recovery time and shorter hospital stay. In France, the average of hospital stay after laparoscopic hysterectomy reduced to 3-4 days.

The study hypothesis is that a shorter postoperative stay does not decrease the quality of life of the patients.

This study will compare the evolution of quality of life (with a questionnaire concerning measuring health related quality of life the Euroqol EQ-5D) of patients discharged after 3 days hospital stay to patients discharged the first day after a laparoscopic hysterectomy.

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Hôptaux Universitaires de Strasbourg, Département de Gynécologie-Obstétrique


title: Pain Management in Neonatal Intensive Care Units by Studying the Autonomic Balance : Interest of the Co-evaluation of NIPE and Hetero-assessment Scale : the NIPE-DOL Study

acronym: NIPE-DOL

summary:
Fight against the pain caused by the disease or by the diagnostic and therapeutic procedures is a daily and essential concern for the caregiver neonatologist. The quantification of pain is needed to effectively adjust analgesic therapy and by the way, to limit side effects. Several pain scales are now validated for newborns but they are based on one-off measures and hetero assessments often dependent on many factors including the operator.

Recent developments in the real time analysis of the cardiac signal under the influence of autonomic control, have led to the development of a new painful stress index. A monitor has recently been developed by Mdoloris® company and provides an Analgesia and Nociception Index (ANI index in children and adults and NIPE index - for Newborn Infant Parasympathetic Evaluation - in newborns). It is based on the study of the heart rate variability and the variations of the sympathetic and parasympathetic indices to stimuli. The validation of this nociception index has not been validated in a neonatal unit where special attention is paid to pain control.

The main purpose of our study is to show the consistency of this NIPE index (adapted to newborns) from 2 validated pain scales routinely used in neonatology in non-sedated children, hospitalized in intensive unit and neonatal intensive care unit from the University Hospital of Saint-Etienne (France).

The study will involve 40 preterm or term newborn (i.e. with a gestational age between 26 and 42 weeks and less than 3 months of life), hospitalized in neonatal intensive care units of our university hospital (Saint-Etienne - France), who have to acute painful stimuli related to their care.

ReferenceCitation: Cremillieux C, Makhlouf A, Pichot V, Trombert B, Patural H. Objective assessment of induced acute pain in neonatology with the Newborn Infant Parasympathetic Evaluation index. Eur J Pain. 2018 Jul;22(6):1071-1079. doi: 10.1002/ejp.1191. Epub 2018 Mar 24.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Impact of Osteoporotic Fractures on Work: Data From a Fracture Liaisons Service

acronym: OPTIWORK

summary:
Osteoporosis is a bone disease characterized by a decrease in bone density with deterioration of the micro-architecture and the appearance of bone fragility, responsible for an increased risk of fractures. The most common osteoporotic fractures are spinal, wrist and femoral neck fractures. Osteoporosis affects 22.7% of women and 6.9% of men in France. Each year, around 8.9 million fragility fractures are identified worldwide, with an incidence in France in 2017 of 382,000 patients in France in 2017.

The economic impact, the functional consequences and the quality of life of patients with osteoporosis, fracture or not, have been widely described in the literature in recent years. There is indeed a great alteration in the mobility, functional capacities and overall quality of life of these patients, measured by composite scores such as Short Form-36 (SF-36), EuroQol 5 Dimensions (EQ-5D) , the Health-related quality of life (HRQoL), or more specifically for osteoporosis, osteoporososis quality of life questionnaire (OQLQ) or its shortened version OLQ, the osteoporosis assessment questionnaire (OPAQ), the Quality of life questionnaire of the European Foundation for Osteoporosis (QUALEFFO) (specific for vertebral fractures), etc.

However, few studies have focused on the repercussions of osteoporotic fractures at work, because this pathology affects more elderly subjects (> 65 years old) and therefore retirees.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Care Courses for Mild Head Injury Patients

summary:
Background / Rationale at. The mild head injury.

In France, the incidence of head injuries is estimated at 100,000 per year in France. 80% of mild head trauma. This is a pattern of frequent use of the health system. The reason for consultation, benign appearance, present a significant risk of complication. In 15 to 25% of the evolution of head injury is unfavorable. Disorders of attention, memory disorders, psychiatric events and mood changes may occur. These symptoms are grouped into a syndrome, post-concussion syndrome.

The post-concussion syndrome:

It affects approximately 20,000 people per year in France. This is a common disease and most undervalued in the general population. diagnostic criteria post-concussional disorder according to DSM-IV (Diagnostic and Statistical Manual). Symptoms may persist for more than 3 months after head injury. This syndrome is responsible for suffering, personal and professional sound and quality of life of patients. It is particularly debilitating in everyday life, and can have disastrous consequences on their family, social, cultural and professional. It gives rise to many financial implications with compensation requirements and expertise consultations.

Intention of work In a recent study by a team of neuropsychologists Kremlin Bicetre, it has been shown that screening and early treatment of post-concussion syndrome from the slight head injury prevents chronicity of symptoms.


title: Management of Diabetic Patients With Telemedicine in the Context of the Covid-19 Epidemic: Prospective Observational Study

acronym: TeleCoviDiab

summary:
Since the end of February 2020, Covid-19 infection has spread widely in France, particularly in the East region, with on March 25th, 2020, 5,479 infected patients and 407 deceased patients, including 256 in Alsace. Among the hospitalized patients reported in the initial Chinese studies, 48% had co-morbidity, particularly diabetes or cardiovascular disease. Covid-19 infection does not appear to be more common in diabetic patients, but infected diabetics have more severe forms.

The prevalence of diabetes is high in Alsace affecting 6.5% of the population against 4.6% in France. Du to health containment measures, asymptomatic diabetic patients can no longer come to the clinic in Hospital for their consultation. However, in the current epidemiological context, maintaining optimal glycemic control is fundamental since some of diabetic patients will have Covid-19 infections. Furthermore, the sedentary lifestyle and snacking linked to the confinement period will contribute to a glycemic imbalance in some patients. Telemedicine, and in particular teleconsultation, which until now has been very uncommon in the management of diabetic patients, represents a very interesting alternative for monitoring these patients and maintaining satisfactory metabolic control during the current period of confinement and Covid-19 epidemic.


title: Screening for Excessive Gambling Behaviors on the Internet (EDEIN Study). Study of the Database of French Online Gambling Sites.

acronym: EDEIN

summary:
The Internet medium is particularly vector for gambling problems. Since the opening of the online gambling sector in France, no screening for excessive gambling behaviours is provided for by the law, although it is known that preventive actions are more effective if they are implemented early in the gambler's career.

The investigators propose to develop a model for screening excessive gambling practices based on the gambling behaviours observed on French gambling websites, coupled to a clinical validation. The objective is to lead to early preventive measures directed towards the more vulnerable gamblers and adapted for each type of gambling.

This study will therefore contribute to setting up an innovative measure of prevention, to inform and protect gamblers as early as possible.

ReferenceCitation: Balem M, Perrot B, Hardouin JB, Thiabaud E, Saillard A, Grall-Bronnec M, Challet-Bouju G. Impact of wagering inducements on the gambling behaviors of on-line gamblers: A longitudinal study based on gambling tracking data. Addiction. 2022 Apr;117(4):1020-1034. doi: 10.1111/add.15665. Epub 2021 Sep 23.

ReferenceCitation: Perrot B, Hardouin JB, Costes JM, Caillon J, Grall-Bronnec M, Challet-Bouju G. Study protocol for a transversal study to develop a screening model for excessive gambling behaviours on a representative sample of users of French authorised gambling websites. BMJ Open. 2017 May 17;7(5):e014600. doi: 10.1136/bmjopen-2016-014600.


title: Evaluation de la Formation Des infirmières à la Stimulation de l'oralité Des Nouveau-nés Dans Une unité de Réanimation néonatale et Néonatologie : Impact Sur Les Connaissances, Les Pratiques et Sur la qualité Des Soins

acronym: TOP

summary:
Poor oral motor development in preterm neonates is common. Feeding problems lead to longer hospital stay and higher hospital cost. Different interventions have shown their efficacy to accelerate transition and move faster to full oral feeding autonomy. Our study aimed to evaluate the impact of a 2-year education nurse program on feeding pattern and hospital stay of preterm neonates.

This is an interrupted time series study placed in Intensive Care and Neonatal unit of an university hospital located in Lyon, France. All preterm neonates are included in the study, from April 2013 to January 2016.

ReferenceCitation: Touzet S, Beissel A, Denis A, Pillet F, Gauthier-Moulinier H, Hommey S, Claris O; TOP Study Group. Effectiveness of a nurse educational oral feeding programme on feeding outcomes in neonates: protocol for an interrupted time series design. BMJ Open. 2016 Apr 15;6(4):e010699. doi: 10.1136/bmjopen-2015-010699.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Femme-Mère-Enfant des Hospices Civils de Lyon


title: Detailed Clinical and MRI Characteristics in Primary Non-traumatic Convexity Subarachnoid Haemorrhage Elderly Patients.

acronym: cSAH

summary:
Transient focal neurological episode (TFNE) is the most frequent presenting symptom of convexity subarachnoid haemorrhage (cSAH) in elderly patients with non-traumatic cSAH with suspected, possible or probable cerebral amyloid angiopathy (CAA). The aim of our study was to analyse in detail clinical and MRI characteristics in these patients.

Methods: We performed a retrospective study analysing baseline, acute clinical symptom (TFNE and headache), and MRI characteristics (acute cSAH and chronic CAA features) of consecutive elderly (≥55 years) patients, recruited and registered in the stroke database, between june 2008 and october 2020 of two centres (Nîmes and Montpellier University Hospital, France), presenting with cSAH with suspected, possible, or probable CAA.

ReferenceCitation: Autieri V, Gaillard N, Mourand I, Laurent-Chabalier S, Mura T, Trandafir C, Wacongne A, de Champfleur NM, Thouvenot E, Pereira F, Renard D. Primary acute convexity subarachnoid hemorrhage in older patients: analysis of baseline, clinical and MRI characteristics including quantitative surface study and topographical probabilistic mapping of convexity subarachnoid hemorrhage. Acta Neurol Belg. 2022 Oct 14. doi: 10.1007/s13760-022-02115-8. [Epub ahead of print]

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Budget Impact Analysis of Discontinuing Tyrosin Kinase Inhibitors in Patients With Chronic Myeloid Leukemia Achieving a Complete Molecular Response by Using Probabilistic Markov Approach

acronym: ECOSTIM

summary:
Chronic myeloid leukemia (CML) is a model of targeted therapy for human malignancies. Over the past decade, a broad array of drugs designed to selectively inhibit protein tyrosine kinases (PTK) [i.e., tyrosine kinase inhibitors, (TKI)] have emerged as novel therapies for cancer patients. Hence, CML is an hematopoietic stem cell disorder in which a t(9;22) (q34;q11) reciprocal chromosomal translocation gives rise to Philadelphia chromosome (Ph) and generates the BCR-ABL1 fusion gene encoding a constitutively activated PTK. TKIs, such as imatinib by blocking BCR-ABL1 kinase activity, selectively eradicate CML cells and induce durable responses and prolong survival. CML patients treated with TKI are monitored by quantitative RT-PCR to detect leukemic BCR-ABL1 transcript performed from peripheral blood samples (1).

Since TKI treated CML patients have a near-normal life expectancy two important issues must be considered in the future:

the quality of life and ethical aspects of a lifetime treatment,
the budget impact for healthcare providers of treating patients during lifetime.

One of the best ways to consider these two points is to ask the question about stopping TKI in good responder patients. We first reported a pilot study where imatinib was withdrawn in 12 CML patients treated and maintained in complete molecular remission (CMR), defined by undetectable residual disease (with sensitivity of 4.5 log) on quantitative RT-PCR, for at least two years. Then, we demonstrated in a multicenter study entitled STIM trial that imatinib could be safely discontinued in patients with CMR for at least 2 years (2). All molecular relapsing patients were sensitive when imatinib was re-challenged (3). Around 40% of these patients remain in a prolonged treatment-free remission (TFR) after treatment cessation (4). Taking into account the cost of imatinib and the number of months without treatment in STIM trial, the savings in France were estimated to be 9 million €. However, since only 40 % of patients are in treatment free remission, a study, assessing the real budget impact of stopping TKI in the eligible population seems necessary as no published study has ever addressed this question in France.

Our aim is to assess the budget impact of discontinuing TKI treatment in patients with CML in deep molecular response since at least two years, compared with treatment during lifetime, from the French healthcare system point of view. This budget impact will be expressed as a "net benefit" and will be based on the difference between total costs incurred by this strategy and total costs avoided also.

One of the originality of our study is to raise the issue of treatment cessation in the context of a chronic disease from an economic point of view.

The other originality of this study is to use a decision model to perform this French budget impact analysis of TKI discontinuation, without setting up another trial. Besides the literature review and meta-analysis; the proposed probabilistic Markov model will use direct costs (including treatment costs and all health care related costs as well as costs related to relapse) extracted mainly from the French Health Insurance Databases.

lead_sponsor: University Hospital, Bordeaux


type: Other Grant/Funding Number

title: FLOW Evaluation to Guide Revascularization in Multi-vessel ST-elevation Myocardial Infarction

acronym: FLOWER-MI

summary:
Although current guidelines recommend fractional flow reserve (FFR) to identify haemodynamically relevant coronary lesion(s) in stable patients when evidence of ischaemia is not available (Class I, Level of Evidence: A), no published study has assessed the usefulness of FFR to guide percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI) patients with multi-vessel disease (MVD).

The main objective of this study is to determine whether, in STEMI patients with MVD amenable to PCI, the use of FFR in addition to angiography will improve cardiovascular outcomes, compared with the current practice of angiography- guided PCI, by improving the appropriateness of revascularisations by assessing the relevance of non-culprit lesions in the context of STEMI with multivessel coronary artery disease.

The secondary objective is to assess the safety and the cost-effectiveness of the FFR-guided strategy compared to the angiography-guided strategy.

ReferenceCitation: Authors/Task Force members, Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Jüni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29.

ReferenceCitation: Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrøm T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.

ReferenceCitation: Ntalianis A, Sels JW, Davidavicius G, Tanaka N, Muller O, Trana C, Barbato E, Hamilos M, Mangiacapra F, Heyndrickx GR, Wijns W, Pijls NH, De Bruyne B. Fractional flow reserve for the assessment of nonculprit coronary artery stenoses in patients with acute myocardial infarction. JACC Cardiovasc Interv. 2010 Dec;3(12):1274-81. doi: 10.1016/j.jcin.2010.08.025.

ReferenceCitation: Engstrøm T, Kelbæk H, Helqvist S, Høfsten DE, Kløvgaard L, Holmvang L, Jørgensen E, Pedersen F, Saunamäki K, Clemmensen P, De Backer O, Ravkilde J, Tilsted HH, Villadsen AB, Aarøe J, Jensen SE, Raungaard B, Køber L; DANAMI-3-PRIMULTI Investigators. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3-PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015 Aug 15;386(9994):665-71.

ReferenceCitation: Denormandie P, Simon T, Cayla G, Steg PG, Montalescot G, Durand-Zaleski I, le Bras A, le Breton H, Valy Y, Schiele F, Cuisset T, Vanzetto G, Levesque S, Goube P, Nallet O, Angoulvant D, Roubille F, Charles Nelson A, Chatellier G, Danchin N, Puymirat E. Compared Outcomes of ST-Segment-Elevation Myocardial Infarction Patients With Multivessel Disease Treated With Primary Percutaneous Coronary Intervention and Preserved Fractional Flow Reserve of Nonculprit Lesions Treated Conservatively and of Those With Low Fractional Flow Reserve Managed Invasively: Insights From the FLOWER-MI Trial. Circ Cardiovasc Interv. 2021 Nov;14(11):e011314. doi: 10.1161/CIRCINTERVENTIONS.121.011314. Epub 2021 Aug 23.

ReferenceCitation: Puymirat E, Cayla G, Simon T, Steg PG, Montalescot G, Durand-Zaleski I, le Bras A, Gallet R, Khalife K, Morelle JF, Motreff P, Lemesle G, Dillinger JG, Lhermusier T, Silvain J, Roule V, Labèque JN, Rangé G, Ducrocq G, Cottin Y, Blanchard D, Charles Nelson A, De Bruyne B, Chatellier G, Danchin N; FLOWER-MI Study Investigators. Multivessel PCI Guided by FFR or Angiography for Myocardial Infarction. N Engl J Med. 2021 Jul 22;385(4):297-308. doi: 10.1056/NEJMoa2104650. Epub 2021 May 16.

ReferenceCitation: Puymirat E, Simon T, de Bruyne B, Montalescot G, Steg G, Cayla G, Durand-Zaleski I, Blanchard D, Danchin N, Chatellier G; FLOWER-MI study investigators. Rationale and design of the Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction (FLOWER-MI) trial. Am Heart J. 2020 Apr;222:1-7. doi: 10.1016/j.ahj.2019.12.015. Epub 2019 Dec 27.