title: ANDDI-PRENATOME - Feasibility Study for a " Fast " Pangenomic High Throughput Sequencing Analysis in Prenatal Diagnosis

acronym: AnddiPrenatome

summary:
Prenatal diagnosis of genetic diseases is a real medical challenge. The discovery of antenatal abnormalities on ultrasound is frequent (5 to 10% of pregnancies), and when an abnormalities is seen on ultrasound, it raises the possibility of an underlying developmental anomaly. Currently, in France, when abnormalities are discovered with an ultrasound scan, the etiological diagnosis is based on additional imaging tests (cerebral MRI, 3D bone tomography, fetal CT, fetal CT) or diagnostic tests such as invasive chorionic villus sampling, amniocentesis or fetal blood for infectious, metabolic, immunological and genetic investigations (standard karyotype, FISH (fluorescence in situ hybridization) for the rapid detection of aneuploidy, Chromosome Analysis on DNA Chip (ACPA or CGH-array) and possible sequencing of targeted genes when they are available within a time frame compatible with pregnancy). NIPT (Non-invasive prenatal testing) on cell free fetal DNA circulating in maternal blood has more limited indications, allowing, from an early stage of pregnancy, the determination of fetal sex and fetal rhesus factor and the search for aneuploidy.

However, establishing an etiological diagnosis during pregnancy has many benefits for the parents: clarifying the cause, obtaining a more precise prognosis to determine future management and outcome of the pregnancy, and establishing the risks of recurrence.

Over the past decade, medical genetics has undergone a real technological revolution, leading to the development of high throughput genome-wide, exome (ES) and genome (GS) sequencing. However, few countries have currently embarked on ES/GS in prenatal care, due to the constraints of time and the difficulty of interpreting genomic data when the clinical data is limited to antenatal imaging data.

In 2016, France launched the France Medicine Genomics 2025 Plan (PFMG2025) to deploy GS, particularly in the diagnosis of rare diseases. It is thus becoming essential to define the modalities of prescription of this testing, in particular during prenatal diagnosis. In parallel, from the first publications, the applications of genomic analysis on circulating fetal DNA seem to be able to extend to genome sequencing for research of SNVs responsible for developmental diseases.

The AnDDI-rares health network therefore proposes this ANDDI-PRENATOME pilot project to study the feasibility of a "rapid" analysis of ES in prenatal diagnosis from 61 fetuses with ultrasound abnormalities, as a first step before considering future cost-effectiveness (PRME) or care system performance (PREPS) studies in conjunction with the PFMG2025.


title: Equivalence of Monitoring by a Nurse Practitioner for Patients With Digestive Cancer, Requiring Intravenous Chemotherapy Versus a Medical Monitoring

acronym: INCISIVE

summary:
With 42,150 new cases per year, colorectal cancer is the third cause of cancer in France according to the latest report from the Institut national du Cancer (INCa). Second leading cause of cancer death in men, its management is a public health problem. According to projections by WHO, the prevalence of cancers expected to increase 50% by 2050 especially in digestive oncology. These projections can be concluded that the demand for care will continue to be growing.

Medical advances and societal leading to increased life expectancy, have operated a mutation of the cancer disease. Formerly fatal disease, it is now a chronic disease in some cases. These changes are causing new challenges for the health system.

To address this problem, it is asked health professionals to adapt the organization of health care delivery to improve efficiency, in a constrained economic environment. To this end, action 4.1 of the cancer plan includes the creation of clinical nursing profession, a proposal reiterated in article 120 of the French Health System Law. Nursing clinicians will be empowered to ensure, under certain conditions, prescription treatments protocolized of follow-up tests, further treatment and support, as well as the extension or adaptation of specific treatments.

This project is a first step, in France, in thinking around new organizations in the supply of care in oncology.

For patients, strengthening their monitoring during chemotherapy, will better know their tolerance regarding chemotherapy. This optimized management of chemotherapy-induced effects will help reduce the use of emergency care.

The establishment of such a practitioner will free medical time to handle the most complex patients and perform tasks related to research.

For hospital pharmacies this type of organization will optimize their productivity by anticipating orders for chemotherapy pockets.

This project represents an opportunity to demonstrate the added value of advanced practice nurses in France in the health system and particularly in oncology. It also adds value to clinical expertise nurse and register the profession in the research.

The hypothesis is that the quality and safety of care provided by a nurse practitioner are equivalent to those provided by a doctor at follow-up of patients with gastrointestinal cancer, treated with intravenous chemotherapy.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: University Hospital, Rouen

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


type: EudraCT Number

title: Study of the Impact of a Targeted Decolonization of S. Aureus Persistent Carriers on the Occurrence of S. Aureus Infections in Hemodialysis Patients

acronym: CIBERSTAPH

summary: S. aureus nasal carriage is a well-known risk factor for S. aureus infections in hemodialysis (HD) patients. Strains of carriage and infections are the same in >80% of cases We recently shown that persistent carriers of S. aureus, not intermittent ones are at increased risk of staphylococcal infections in HD. Thanks to a new algorithm developped based on one nasal sample the determination of carriage status (persistent, intermittent or non-carriers) among patients is easy. Mupirocin use in HD have been shown to reduce significantly S. aureus infections however, multiples schedules of decolonization have been proposed to all S. aureus carriers. To date, there is no national guideline for decolonization of S. aureus in HD. We showed that only 50% of HD centers in France propose screening and decolonization of S. aureus carriers. The aim of the study is therefore to evaluate the impact of a targeted decolonization of S. aureus persistent carriers using mupirocin nasal ointment and chlorhexidine baths during 5 days on the occurrence of S. aureus infections in HD patients compared to the absence of decolonization using a randomized open study methodology.

status: Recruiting

primary_purpose: Prevention

ipd_sharing: No

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Villefranche sur Saône: ATIRRA et Hôpital Nord Ouest

status_simplified: Ongoing


title: Infective Endocarditis in the Elderly: Description of the Geriatric Characteristics and Their Influence on Therapeutic Care and the Morbidity and Mortality at 3 Months (ELDERL-IE)

acronym: ELDERL-IE

summary:
ELDERL-IE is a multicenter national prospective observational study.

The main objective is to describe geriatric characteristics (comorbidities, cognitive status, autonomy, nutritional status, balance and walking) in patients aged 75 years or older with infective endocarditis (IE).

The secondary objectives are to assess the impact of geriatric features on the medico - surgical care and on morbidity and mortality at 3 months after the end of the hospitalization, and to describe the initial clinical presentation and diagnostic modalities in the IE elderly.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Forestier E, Fraisse T, Roubaud-Baudron C, Selton-Suty C, Pagani L. Managing infective endocarditis in the elderly: new issues for an old disease. Clin Interv Aging. 2016 Sep 2;11:1199-206. doi: 10.2147/CIA.S101902. eCollection 2016. Review.

ReferenceCitation: Forestier E, Roubaud-Baudron C, Fraisse T, Patry C, Gavazzi G, Hoen B, Carauz-Paz P, Moheb-Khosravi B, Delahaye F, Sost G, Paccalin M, Nazeyrollas P, Strady C, Alla F, Selton-Suty C; AEPEI and the GInGer Elderl-IE study group; AEPEI and the GInGer Elderl-IE study group. Comprehensive geriatric assessment in older patients suffering from infective endocarditis. A prospective multicentric cohort study. Clin Microbiol Infect. 2019 Oct;25(10):1246-1252. doi: 10.1016/j.cmi.2019.04.021. Epub 2019 May 2.

ReferenceCitation: Forestier E, Selton-Suty C, Roubaud-Baudron C. Managing infective endocarditis in older patients: do we need a geriatrician? Aging Clin Exp Res. 2021 Mar;33(3):719-722. doi: 10.1007/s40520-019-01400-6. Epub 2019 Nov 22.

lead_sponsor: Central Hospital, Nancy, France

status_simplified: Completed


title: EValuation of Cardiac Magnetic Resonance Imaging in Follow up assessmenT of Patients With Pulmonary Arterial Hypertension (EVITA)

acronym: EVITA

summary:
Pulmonary arterial hypertension (PAH) is characterized by a progressive increase in pulmonary vascular resistance leading to right ventricular failure and eventually to death. The therapeutic strategy has become complex and needs to perform recurring follow up evaluations including right heart catheterizations (RHC).

Cardiac magnetic resonance imaging (cMRI) has the advantage to accurately assess right ventricular volumes and important prognostic predictors such as cardiac index, stroke volume and right ventricular ejection fraction.

The main objective of EVITA is to assess the hemodynamic diagnosis performances at baseline and at follow up visits of cMRI in comparison with the results of the RHC (current guidelines) to detect an unfavorable hemodynamic status.

The primary endpoint is sensitivity and specificity of cMRI for the diagnosis of an unfavorable status defined by the current RHC criteria (with 95% confidence interval).

The secondary objectives are 1) to identify clinical and hemodynamic variables independently contributing to prognosis, 2) to describe complications due to cMRI and to RHC, 3) to compare acceptability and tolerability of cMRI over RHC for the patient and 4) to constitute biological collection of blood samples to determine diagnostic and prognostic PAH biomarkers.

PAH patients will be recruited in centers of the French network of severe pulmonary hypertension in a prospective cohort study.

180 subjects will be enrolled in the study: that size will give the study 90% power to find significant at the 5%-level.

If the primary endpoint were achieved, since first, strategies and procedures planed in this project are consistent with those currently used in routine and second, inclusion criteria are not limited to a sub-population of PAH patients, positive results could allow to broadly extend our findings.

Therefore, it will be possible to decrease the number of RHC, an invasive and cumbersome procedure without altering the prognosis. Moreover, all clinical procedures would be performed in outpatient clinics and thereby would reduce the cost to assess the severity of the disease. Current recommendations for evaluation of severity and follow-up being mainly derived from consensus of opinion of the experts, positive results will also improve the level evidence of severity assessment of PAH patients.

According to secondary objectives we expect to better predict morbimortality events with cMRI compared to RHC.

primary_purpose: Diagnostic

intervention_type: Procedure


title: Assessment of Perceptual and Postural Performances Following a Cochlear Implantation

acronym: ORIENTIMPLANT

summary:
The cochlear implant is an electrical hearing aid that restores the perception of surrounding sounds and speech intelligibility in profoundly deaf patients. During surgery, the labyrinthine break necessary for insertion into the cochlea of the implantable part may cause a malfunction of the vestibular system which can induce dizziness, balance and perception (of the gravitational vertical) disorders. Vestibular compensation and new sonic interactions could alter the balance control and the visual and postural spatial orientation perceptions.

The usual treatment includes the monitoring of the patient's quality of life, of the vestibular function and of hearing. This study adds an assessment of spatial orientation and of posture.

design_allocation: Non-Randomized

primary_purpose: Supportive Care


type: Other Identifier

title: Assessment of the Preoperative Vestibular Rehabilitation Effectiveness on Balance Control Compensation After Vestibular Schwannoma Surgery

acronym: ReveSTAN

summary:
Vestibular schwannoma (VS) is a benign tumour from Schwann cells surrounding the vestibular nerve, which slowly grows within the internal auditory canal and then into the cerebellopontine angle, leading to a gradual vestibular dysfunction. The slowly progressive alteration of vestibular function allows the gradual implementation of central adaptive mechanisms called vestibular compensation. The total unilateral vestibular deafferentation induced by the surgical tumour removal suddenly leads to a decompensation of this previously compensated situation, which explains why most patients report severe vertigo immediately after surgery and which is responsible for perturbations of the postural control (Parietti-Winkler et al., 2006, 2008, 2010, 2011). Recently, Gauchard et al. (2013) suggested that preoperative and regular physical activity would limit the adverse effects of surgical removal on balance control. Also, patients benefited faster and better from the postoperative vestibular rehabilitation.

Thus, preoperative vestibular rehabilitation, including physical and balance exercises, could help to limit postoperative balance disorders and promote postoperative balance compensation. This could lead to a decrease in the duration and cost of the postoperative management and faster improvement of quality of life.


title: Evaluation of the Influence of Psychological Factors on Balance Control Compensation After Vestibular Schwannoma Surgery

summary:
The surgery of a vestibular schwannoma induces balance disorders which have a an impact on the patient's daily life and disrupt their quality of life.

But the balance disorders don't seem to be the only ones factors that impaired the patient's quality of life. It has been alrealdy shown that emotional and psychological factors are also related to patient's quality of life.

This study evaluates the relationship between the balance control compensation and these factors (i.e. emotional and psychological) in the vestibular schwannoma resection process.

location_facility: Centre Hospitalier Universitaire de Nancy


title: Exploration de l'Odorat en Imagerie Par Résonance Magnétique Fonctionnelle Chez Les Patients Atteints de Polypose Nasosinusienne

summary:
Nasal polyposis (NP) is a disease affecting 4% of the population. This disease is frequently accompanied by olfactory disorders (41%-84% of patients) that affect patients' quality of life.

The aim of this study is to show brain activity differences in olfactory areas before and after surgery in each patient and between patient groups (normosmic, hyposmic and anosmic one) using functional Magnetic Resonance Imaging (fMRI). Brain activity will be measured by the intensity of brain signals and of the size of olfactory areas during olfactory stimulation before and after surgery. We suppose that fMRI could predict whether or not the patient will be able to recover smell after surgery.

primary_purpose: Other

intervention_type: Device


type: Registry Identifier

title: Determinants of Health Status and Quality of Life of Patients and Their Parents With Inherited Metabolic Diseases Diagnosed During Childhood and Requiring Restrictive and Specific Diet

acronym: MHMRSQol

summary: The general objective is study medical, socioeconomic, behavioral, health environmental, school and professional integration, and short- and medium- term quality of life determinants for all patients under 18 years old, residing in France for which the diagnosis of inherited metabolic diseases with specific regime (MHMRS) has been achieved during their childhood.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Hôpital de la Timone Assistance Publique Hôpitaux de Marseille

intervention_type: Behavioral


title: Benefits of an Oocyte Pickup Simulation Training Program Using a High-fidelity Simulator for Obstetrics and Gynecology Residents

summary: The primary objective of this study was to evaluate oocyte pick up simulation training program for teaching residents. The secondary objectives were to evaluate resident satisfaction and the overall current state of oocyte pick up training in France.

lead_sponsor: University Hospital, Angers


title: Effectiveness of VistaO2 Device in Screening of Sleep Apnea/Hypopnea Syndrome

summary:
The high prevalence (9% in men and 4% in women) of sleep apnea / hypopnea syndrome (SAHS) in adults is now well documented as well as its cardiovascular repercussions. Previous studies showed a conclusive link between SAHS and severe cardiovascular diseases such as hypertension, myocardial infarction, heart failure and stroke.Then, SAHS is a public health issue in adults.

In this context, early detection of such a disease is crucial if the management is tailored to the patient, the practitioner's choice of therapy moving towards continuous positive airway pressure (CPAP) or mandibular advancement device. The detection is based on full nocturnal polysomnography or polygraphic recordings. Polysomnography remains the gold standard but it is a time consuming and costly examination. Polygraphic recording is a test that allows simplified the diagnosis of severe patients, but may not be sufficient for mild form of SAHS. Thus, the SAHS is a pathology under-diagnosed and under-treated. The validation of a technique for identifying patients most at risk to either limit the number of polysomnographic examination is requested.

status: Terminated

location_facility:
Hopital Pitié Salpetrière - APHP
CHU de Saint-Etienne


title: French Hypertrophic Cardiomyopathy Observatory

acronym: REMY

summary:
Hypertrophic cardiomyopathy (Hypertrophic CardioMyopathy=HCM) remains a poorly understood disease with an assumption insufficiently codified. There is no data available in France on the profile of patients, diagnostic methods and assessment and therapeutic use.

The purpose of this study is to establish a monitoring of patients with HCM (sarcomere of origin or not) in France (diagnosis, treatment)

time_perspective: Other

ReferenceCitation: Mirabel M, Damy T, Donal E, Huttin O, Labombarda F, Eicher JC, Cervino C, Laurito M, Offredo L, Tafflet M, Jouven X, Giura G, Desnos M, Jeunemaître X, Empana JP, Charron P, Habib G, Réant P, Hagège A; REMY working group of the French Society of Cardiology. Influence of centre expertise on the diagnosis and management of hypertrophic cardiomyopathy: A study from the French register of hypertrophic cardiomyopathy (REMY). Int J Cardiol. 2019 Jan 15;275:107-113. doi: 10.1016/j.ijcard.2018.09.083. Epub 2018 Sep 28.

lead_sponsor: French Cardiology Society

lead_sponsor_type: industriel


title: Pain Associated With ICU Procedures: An International Study

acronym: Europain®

summary:
Pain associated with procedures performed on adult ICU patients is ubiquitous and the subject of research attention.While there is growing evidence about the prevalence, characteristics and measurement of procedural pain in ICUs, most of this evidence has been derived from English-speaking patients in the United States who were able to verbally report the intensity and distress of this pain. Frequently performed procedures include turning,chest tube removal,wound care/wound dressing change,endotracheal suctioning,central catheter insertion(arterial/venous, have been a focus for research. Other potentially painful procedures, including lumbar puncture and physiotherapy,are numerous and have not been systematically studied in adults.

Patients unable to verbally report their pain have not been able to participate in procedural pain studies, which has limited the generalizability of study results to a narrow population of ICU patients.

The Specific Aims of this proposed European-based, international study of ICU patients undergoing selected procedures are to:

Describe patient self-reports of pain intensity and distress
Describe the behaviors exhibited by patients during a procedure, comparing the behaviors exhibited by those able versus unable to self-report pain intensity and pain distress
Examine predictors of amount of pain intensity, behavioral responses, and analgesic use related to procedures such as gender, age, language spoken, country, and type of hospital.

Validated pain intensity, pain distress, and behavioral observation instruments will be methodically translated into the predominant languages spoken in our international study sites; research and training packets similar to those developed in a large, multisite study in the United States will be developed and provided to data collection sites; and data collection will occur over a 6-month period of time. Study data will be analyzed and disseminated at international meetings and in publications.

ReferenceType: derived

ReferenceCitation: Puntillo KA, Max A, Timsit JF, Vignoud L, Chanques G, Robleda G, Roche-Campo F, Mancebo J, Divatia JV, Soares M, Ionescu DC, Grintescu IM, Vasiliu IL, Maggiore SM, Rusinova K, Owczuk R, Egerod I, Papathanassoglou ED, Kyranou M, Joynt GM, Burghi G, Freebairn RC, Ho KM, Kaarlola A, Gerritsen RT, Kesecioglu J, Sulaj MM, Norrenberg M, Benoit DD, Seha MS, Hennein A, Periera FJ, Benbenishty JS, Abroug F, Aquilina A, Monte JR, An Y, Azoulay E. Determinants of procedural pain intensity in the intensive care unit. The Europain® study. Am J Respir Crit Care Med. 2014 Jan 1;189(1):39-47. doi: 10.1164/rccm.201306-1174OC.

lead_sponsor: Saint-Louis Hospital, Paris, France


title: Effect of Iodine Supplementation and During Pregnancy on Neuropsychological Development of Children Assessed at 2 Years Old

summary: The investigators have shown that Nice area, like most of France, remains an area of mild iodine deficiency. The investigators want to assess the potential benefit of early iodine supplementation during pregnancy in women with normal thyroid function on the neuropsychological development of their children assessed at the age of two with the Bayley test.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Endocrinology Department, Nice University Hospital


title: Predictive Value of Induced Sleep Endoscopy on Surgical Indication in Obstructive Sleep Apnea Syndromes

summary:
Obstructive sleep apnea syndrome (OSA) is a pathology that affects 2 to 15% of the French adult population and more than 30% of subjects over 65 years old. It consists of repeated collapses of the upper airways during sleep leading to interruptions in ventilation (apneas) or significant reductions in ventilation (hypopneas). Balagny et al. have demonstrated the occurrence of hypertension in patients screened positive for sleep apnea syndrome in a French general population cohort. It is also established that sleep apnea increases the risk of cardiovascular disorders, such as metabolic syndrome (combining abdominal obesity and metabolic disorders), hypertension, heart rhythm disorders, especially at night, atherosclerosis (deposits of atheromatous plaques on the artery walls) or type 2 diabetes. These different complications increase the risk of cardiovascular accidents such as cardiac arrest, myocardial infarction, stroke, and expose to a risk of premature death (Inserm). The treatment of choice is night-time positive pressure ventilation, made possible by the use of a breathing apparatus (Continuous Positive Airway Pressure or CPAP). Alternatives to CPAP are the use of a nocturnal Mandibular Advancement Orthosis (MAO) which advances the jaw and allows a pharyngeal opening, and surgery in selected patients. The phenomenon at the origin of apneas is due to a relaxation of the muscles of the pharyngeal wall located at different heights. This obstruction is favored by anatomical particularities specific to each individual. The clinical examination can detect certain anomalies (enlarged tonsils, obstructive soft palate, prominent tongue base, abnormal epiglottis) and propose surgery to remove the obstruction.

Nevertheless, it remains difficult to affirm that the detected anomaly is really at the origin of the obstruction and surgical failures are frequent. Endoscopy under induced sleep has been developed for about 10 years in France. This examination, widely used in the world, remains confidential in France. It consists, in the operating room, in inducing a medicated sleep (specific drugs delivered by an anesthetist) and performing a pharyngolaryngeal fibroscopy. The ENT physician can then visualize "live" the site and origin of the obstruction during an apnea.

The main objective is to evaluate the interest of endoscopy under sleep before making a surgical indication in a patient presenting a sleep apnea syndrome. The secondary objective is to evaluate the reliability of sleep endoscopy.

time_perspective: Retrospective

ReferenceType: background

ReferenceCitation: Chong KB, De Vito A, Vicini C. Drug-Induced Sleep Endoscopy in Treatment Options Selection. Sleep Med Clin. 2019 Mar;14(1):33-40. doi: 10.1016/j.jsmc.2018.11.001. Epub 2018 Dec 3. Review.

ReferenceCitation: De Vito A, Carrasco Llatas M, Ravesloot MJ, Kotecha B, De Vries N, Hamans E, Maurer J, Bosi M, Blumen M, Heiser C, Herzog M, Montevecchi F, Corso RM, Braghiroli A, Gobbi R, Vroegop A, Vonk PE, Hohenhorst W, Piccin O, Sorrenti G, Vanderveken OM, Vicini C. European position paper on drug-induced sleep endoscopy: 2017 Update. Clin Otolaryngol. 2018 Dec;43(6):1541-1552. doi: 10.1111/coa.13213. Epub 2018 Sep 30. Review.

ReferenceCitation: Aljassim A, Pang KP, Rotenberg BW. Does Drug-Induced Sleep Endoscopy Improve Sleep Surgery Outcomes? Laryngoscope. 2020 Nov;130(11):2518-2519. doi: 10.1002/lary.28668. Epub 2020 Apr 18. Review.

ReferenceCitation: Kezirian EJ, Hohenhorst W, de Vries N. Drug-induced sleep endoscopy: the VOTE classification. Eur Arch Otorhinolaryngol. 2011 Aug;268(8):1233-1236. doi: 10.1007/s00405-011-1633-8. Epub 2011 May 26.

ReferenceCitation: Kotecha B, De Vito A. Drug induced sleep endoscopy: its role in evaluation of the upper airway obstruction and patient selection for surgical and non-surgical treatment. J Thorac Dis. 2018 Jan;10(Suppl 1):S40-S47. doi: 10.21037/jtd.2017.10.32. Review.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: AN OBSERVATIONAL REAL-WORLD STUDY OF THE SYSTEMIC TREATMENT OF WELL-DIFFERENTIATED, UNRESECTABLE OR METASTATIC, PROGRESSIVE PANCREATIC NEUROENDOCRINE TUMOURS (PNET): A STUDY OF MORBIDITY AND MORTALITY AT 2 YEARS

acronym: OPALINE

summary: A descriptive, prospective (partly retrospective), multisite, observational study conducted in France in adult patients treated for a well differentiated, unresectable or metastatic, pancreatic neuroendocrine tumor with disease progression.

ReferenceCitation: Smith D, Lepage C, Vicaut E, Dominguez S, Coriat R, Dubreuil O, Lecomte T, Baudin E, Venat Bouvet L, Samalin E, Santos A, Borie O, Bisot-Locard S, Goichot B, Lombard-Bohas C. Observational Study in a Real-World Setting of Targeted Therapy in the Systemic Treatment of Progressive Unresectable or Metastatic Well-Differentiated Pancreatic Neuroendocrine Tumors (pNETs) in France: OPALINE Study. Adv Ther. 2022 Jun;39(6):2731-2748. doi: 10.1007/s12325-022-02103-7. Epub 2022 Apr 13.

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_facility: Hopital Edouard Herriot - Service d'Oncologie Digestive, Pavillon H

location_facility: Hopital Edouard Herriot - Pavillon H - Service d'oncologie digestive

location_facility: Hopital La Timone Service de Gastroenterologie et Oncologie Digestive

location_facility: Hopital Robert Debre, Service D'Hepato-gastro-enterolo

location_facility: Unite d'Oncologie Digestive, Departement d'HGE

location_facility: CHU de Strasbourg - Hopital de Hautepierre / Service de Medecine Interne et Nutrition

location_facility: Hopital Edouard Herriot, Pavillion O, Oncologie Medicale

location_facility: Hopital de LA Source, Centre Hospitalier Regional

intervention_type: Drug


title: MEOPA (Equimolar Mix of Oxygen and Nitrogen Monoxide) Versus Local Anesthesia for Analgesia During Chorionic Villus Sampling.

acronym: MELIBIO

summary: determine if efficiency of MEOPA anesthesia is at least equivalent to local anesthetics into the chorionic villus sampling in the first trimester of pregnancy

lead_sponsor: Hospital St. Joseph, Marseille, France


title: In Vivo Imaging Innovation : Optical Coherence Microscopy in Dermato-oncology

acronym: OCTAV

summary: OCTAV is a medical device class I, CE marked, based on a new technique for high-resolution imager (cell) internal microstructures of all types of biological tissues in vivo or ex vivo, to a depth of penetration 800 .mu.m. It allows to explore the epidermis, the dermo-epidermal junction and middle dermis in a totally non-invasive (direct contact with the tissue without sampling).


acronym: GALAXY

summary: OCTAV is a medical device class I, not CE marked, based on a new technique for high-resolution imager (cell) internal microstructures of all types of biological tissues in vivo or ex vivo, to a depth of penetration 800 .mu.m. It allows to explore the epidermis, the dermo-epidermal junction and middle dermis in a totally non-invasive (direct contact with the tissue without sampling).


title: Treatment of Aggressive Prostate Cancer in Real Life: Initiation, Schedule and Management of Triptorelin Treatment.

acronym: TALISMAN

summary: The purpose of the protocol is to describe the proportion of subjects treated continuously with triptorelin during 12 months following treatment initiation. This study will take place at 187 locations (approximately) in France.

status: Active, not recruiting

ipd_sharing: Yes

ipd_sharing_description:
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

lead_sponsor: Ipsen


title: Preoperative Treatment With Noninvasive Intra-auricular Vagus Nerve Stimulation Pending Bariatric Surgery. A Randomized, Controlled, Double-blind Trial

acronym: OBESITE

summary:
Faced with the current obesity epidemic, new avenues of research into effective weight loss must be developed.

Among the possible actions on obesity, vagus nerve stimulation has been shown in several studies to be effective in treating epilepsy or depression, at the same time inducing weight loss in those patients. Vagus nerve stimulation has also shown to be effective on weight loss in experimental animal studies. Vagus nerve stimulation has never been attempted in obese patients awaiting bariatric surgery.


title: Study of the Role of Socio-psychological Factors in the Hematopoietic Stem Cell Transplantation Process in People With Hemopathies

acronym: Psy-Greffe

summary: Identify the psychological factors (i.e. personality and transactional factors), beneficial and deleterious, at different phases of the transplant process, on the patient's mental health (quality of life, short and long-term post-transplant recovery) and physical health (e.g. infections, relapse, length of hospitalization or even death).

ReferenceCitation: Corman M, Rubio MT, Cabrespine A, Brindel I, Bay JO, De La Tour RP, Dambrun M. Retrospective and prospective measures of post-traumatic growth reflect different processes: longitudinal evidence of greater decline than growth following a hematopoietic stem-cell transplantation. BMC Psychiatry. 2021 Jan 11;21(1):27. doi: 10.1186/s12888-020-03007-y.


title: French Registry of Adult Patients With Immune Thrombocytopenia and Autoimmune Hemolytic Anemia

acronym: CARMEN

summary: CARMEN is a national, real-world clinical registry of all adult patients with incident diagnosis of Immune thrombocytopenia (ITP) or Autoimmune Hemolytic anemia (AIHA) patients in France. It is aimed at describing ITP and AIHA clinical features, assessing the real-world risk-benefit ratio of treatments and adherence to guidelines for ITP and AIHA management.

lead_sponsor: University Hospital, Toulouse


title: Influence of Factors Specific to Patient, Procedure or Surgeon on Thyroid Surgery Outcomes

acronym: CATHY

summary: In a large prospective cross-sectional study, the investigators aimed to identify the determinants of thyroid surgery outcomes and quantify the relative influence of preoperative and intraoperative factors. For this purpose, the investigators considered the interplay of several characteristics specific to surgeons, patients, and surgical procedures.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet


title: Impact of Sick Peer Relation on the Adaptation to Disease and on Treatment of Cancer-suffering Adolescents and Young Adults (PEERS-AYA)

acronym: PAIRS-AJA

summary:
Adolescents and young adults (AYA) with cancer have to deal with a relatively segmented organization of care between pediatric and adult medicine structures in France. However, the third french Plan Cancer 2014-2019 helped in the recognition of the specificities of the AYA affected by cancer and allowed the creation of specific structures in some care units in France, whose primary goal is the preservation of the social link.

Indeed, peer relations contribute to access to quality social support, which is an important variable in patient adjustment with cancer. The adolescents that perceive higher social support report less psychological distress and exhibit higher adaptation scores.

It nevertheless happens that AYA experience negative social support, often from friends because of contact reduction during the disease. Patients can then elect to turn towards non-intimate relations such as support groups. The main risk when a AYA with cancer defines a sick peer as one bringing him quality social support is the installation of a sense of guilt, for example, when a young person is confronted with disease negative progress or with peer death. The more an adolescent identifies with the deceased, the more he is able to consider his own mortality.

AYA units are developing in France, creating a community of sick adolescents. These communities are precious for AYA and allow information and experience sharing, a feeling of reduced isolation and a greater emotional closeness with peers suffering from the same disease.

How is social support from peers and close friends perceived by these young people in AYA units and through the social networks? What can the consequences of the evolution of peer disease be on AYA? What is the impact of the mourning of sick peers on these young people? What are the predictors?

ReferenceCitation: Phan J, Vander Haegen M, Karsenti L, Laurence V, Marec-Berard P, Cordero C, Thisse A, Riberon C, Flahault C. Psychological Adjustment, Adaptation, and Perception of Social Support in French Adolescents and Young Adults After the Diagnosis of Cancer. J Adolesc Young Adult Oncol. 2022 Sep 6. doi: 10.1089/jayao.2022.0034. [Epub ahead of print]

lead_sponsor: Institut Curie

location_facility:
Centre Leon Berard
INSTITUT CURIE - site Paris


title: Light Therapy in Parkinson's Disease : Effect on Motor Symptoms, Sleep, Circadian Rhythms, and Mood

summary: Parkinson's disease, a degenerative disorder of the dopaminergic system, combines motor symptoms but also non-motor, such as depression, sleep disorders and circadian rhythms and impaired cognitive functions. Difficulties in balancing the dopaminergic treatment of these patients emphasizes the need to find effective adjuvant therapies. Light therapy (LT) represents one such innovative therapeutic approach. Although light has an obvious to visual pathways within the brain, today it is known to additionally exert non-visual effects throughout the body. Recently our team has shown that non-visual, non-circadian light plays a major role in the regulation of sleep, as well as cognitive brain function in general. The retina, the primary conduit for the transmission of light information is weakened or thinned in Parkinson's patients. The dopamine system is known to enhance the processing of light information and intraocular injection of L-dopa in animal models of Parkinson's disease, can reverse associated motor symptoms. This allows for the possibility that LT would strengthen the dopaminergic tone in the central nervous system. However, to this date its effectiveness for alleviating Parkinson's symptoms has only been suggested by two studies, both poorly controlled. Thus, through the convergence of basic and clinical data, a study examining the effect of LT directly in people Parkinson's disease symptoms, whilst controlling for the effects on sleep, circadian system, mood, and cognitive functioning, is of extreme importance. With this information our hope is to determine if these polymorphisms allow for a predictive model of response to LT treatment.

lead_sponsor: University Hospital, Strasbourg, France

location_facility:
Hospices Civils de Lyon
University Hospital, Strasbourg, france


title: SARS-CoV-2 Seroprevalence Among Adults People Living in Jail

acronym: COVIDET

summary:
"Background France counted on January 1, 2020, 70,651 people detained, for 61,080 places. Overcrowding in detention is considered as risk factor for infectious diseases transmission, such as respiratory infections. The prison environment represents a confined environment, which could protect prisoners from possible external contamination. If one or more inmates were infected through visiting rooms, officers working in detention, or newly incarcerated people, an epidemic could spread more quickly in the prison community. Thus, few cases of COVID-19 were observed among the subjects in detention with a few weeks delay compared to the free world. However, detention conditions make it more difficult to detect suspicious cases. On the other hand, carrying out diagnostic tests is structurally more difficult to carry out there. Thus, given the plurality of clinical presentations, the non-optimal sensitivity of the SARS-CoV-2 RT-PCR, and the difficulty in carrying out diagnostic tests, it is today difficult to have a precise idea of the number of prisoners having encountered SARS-CoV-2. It is also a population that is not taken into account in the large seroprevalence studies currently conducted in the general population. In order to estimate the number of prisoners exposed to SARS-CoV-2 and in the absence of data currently available in the medical literature, a seroprevalence study in this at risk and little studied population would bring new data to the medical community.

Hypothesis In adult subjects living in penal establishments in Ile de France, the seroprevalence of SARS-CoV-2 would be lower compared to the general population.

Material and method Open multicenter cross-sectional study carried out in the 11 penal establishments of Ile de France. A sampling of 3,500 inmates stratified over the 16 detention areas concerned will be carried out. The inclusion criteria will be detained subjects who have expressed their consent to participate in the research, aged 18 to 80 years. Each selected detainee will be invited to the health unit to perform a venous blood test for anti-SARS-CoV-2 antibodies. The goal is to take 2,500 blood samples (30% expected refusal rate). Each sample will be analyzed in the virology laboratory at P. Brousse hospital.

Expected results Obtain an assessment of the seroprevalence of SARS-CoV-2 in prisons to determine the exposure of detained persons. This assessment will make it possible to undertake public health actions and to propose the implementation of group protection measures such as vaccination if this is soon available.

primary_purpose: Screening

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Biological


title: Assessment of the Satisfaction of Patient Undergoing Opioid Replacement Therapy Toward Their Management in Community Pharmacy - SATISFY: a Cross-sectional Study

acronym: SATISFY

summary:
The patient's compliance to his medication therapy, and therefore the success of the treatment, is particularly related to his pharmacy management. Thus, the satisfaction of an individual in their interview with the pharmacist is a very important element.

The pharmacist in his professional activity may have to manage patients with opioid related disorders. Pharmacist activity will result in the dispensing of opioid replacement therapy (ORT), single-use syringes, harm reduction kits and prevention advices for the reduction of toxicity and infection risks.

Since the 1990s, the consumption of ORT has been steadily increasing. According to the OFDT (French Observatory of Drugs and Drug Addiction), the number of patients undergoing ORT is about 150 000 patients. Since high-dose buprenorphine is prescribed for approximately two-thirds of patients, it remains the most frequently prescribed ORT in France.

Recently, a French association assisting drug users (ASUD - Auto-support des usagers de drogues) performed a study in Paris (20/07/2018 - 25/08/2018) to assess the delivery of opioid replacement therapies by community pharmacists. In this study, 71% of pharmacists refused to deliver opioid replacement therapies. The main reasons reported were security (56%) and activity saturation, meaning that pharmacists considered that they had too many patients using opioid drugs. In France, the refusal of a pharmacist to deliver drugs is a punishable offence. According to the Code of ethics of pharmacists, pharmacists must respect life and people without discrimination. Pharmacists have a low perception of patients suffering from opioid addiction. Another study performed by ASUD in 93 community pharmacies, showed that pharmacists used the term "toxicomaniacs" instead of "drug users". Most pharmacists had had a bad experience with drugs users, with physical and verbal aggressions. The conclusions of this study showed that pharmacists lacked knowledge of drug users and drug use. Pharmacists knew about harm reduction kits for opioid users (containing sterile syringes, needles, water, antiseptics, etc.) and had already opened them, but very few knew how to use them. More worryingly, some pharmacists did not understand the harm reduction strategies available It thus appears that community pharmacists have a difficult relationship with patient suffering of opioid related disorders, which can have an impact on patient's satisfaction.

The objective of this study will be to assess the satisfaction of patients undergoing ORT regarding their management by community pharmacists.

time_perspective: Cross-Sectional

lead_sponsor: University Hospital, Clermont-Ferrand


title: Generalized Training Program for Caregivers on the ESDM

acronym: PEGASE

summary:
The main objective of the study is to evaluate the effectiveness of a parent's training program (name PEGASE) of young children (aged 2 to 4 years) with Autism Spectrum Disorders.

This study is follow up by the Autism Resource Center PACA (CRA PACA), which is located in Marseille's university Department of Child Psychiatry.

This center is a regional expert center in diagnostic and research missions in the field of Autism. The center is promoting new advances in the field of Autism Spectrum Disorders (ASD) The center receives requests for diagnostic assessment from all the region. Autism is to date a major public health problem, current prevalence rates are 1 child / 88 in the United States. This prevalence continues to increase.

Autism is a severe neurodevelopment disorder with significant functional impact.

An essential axis in the field of health is to develop new treatment strategy including low costs and family impact particularly in quality of life.

In France, consensus guidelines (HAS 2012) on the diagnosis assessment for Autism Spectrum Disorders (ASD) people and interventions were edited.

Support for grade recommendations have been issued. In this research, the investigators focus on a global, early and coordinated management method: the Early Start Denver Model. This intervention obtained a grade B to the recommendations of the HAS in 2012. Early Start Denver Model (ESDM) is scientifically proven by a lots of studies.

Two management modalities are discuss in the ESDM model: the classical ESDM and the ESDM P (parents ESDM). Even if in both ways of care, the parent is put in a central position around the care of the child. In P ESDM, the parent is trained in the techniques of ESDM itself. This parental coaching program at ESDM (P-ESDM) was developed by Rogers et al at Sacramento Davis University.

P ESDM is not yet developed in France and has not been the subject of any French-language publication to date.

This program is dedicated to young parents of children with autism spectrum disorders aged between 2 and 4 years old.

This is a 7-month program (with a duration of inclusion of 3 year). The program is based on ESDM techniques, it meets both the need to include parents in care and the idea of reducing the cost of these care (need fewer hours of care by professionals).

This program is offered to all parents of autism spectrum disorders children between the ages of 2 and 4 who go to CRA PACA for an expert diagnostic evaluation.

The aim of this study is to objectify the effectiveness of this parental intervention in a French population.

primary_purpose: Health Services Research

location_facility: Service de pédopsychiatrie Sainte-Marguerite


title: Efficacy of Telenutrition (OBE-COACH) for the Treatment of Overweight Patients With Obesity and/or High Cardiometabolic Risk

acronym: TOOLBAR

summary:
The OBE-COACH program is an automated online nutritional coaching service that was evaluated in its first version (MXS-CARE program) in a clinical trial coordinated by our team, in type 2 diabetic patients with abdominal obesity. Results have confirmed the efficiency of the program to improve lifestyle habits, including the 4-month diet, and to reduce weight and HbA1c levels.

Based on our experience and the scientific literature, the investigators assume that adherence to the program may diminish in the long term to the point of calling into question its efficiency. So IRIADE compagny developed an enhanced program called OBE-COACH. The OBE-COACH program has been specifically designed to facilitate long-term user adherence. The OBE-COACH program, integrates a bidirectional interactive link between the patient and an automated support system (IRIADE-MED system) associated with an inexpensive remote human support.

In the TOOLBAR study, the investigators will evaluate the efficiency of the OBE-COACH solution in a population of obese patients or overweight persons with at least one cardiometabolic risk factor.

A group of patients will have access to the OBE-COACH program. It will be compared to a control group which will receive an e-learning program with free access to advice sheets via the web, to a menu generator, videos and a catalog of physical activity, (resources made available by the web site www.mangerbouger.fr (public health France, ministry in charge of health) . Indeed, the investigators judged that the loss of patients during follow-up would be greater if e-learning was not offered in the control group.

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing_description:
Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.


title: Prospective Cohort Study of Patients With Mutations in the Dystrophin Gene (X Linked Dilated Cardiomyopathy and Becker Muscular Dystrophy)

acronym: Becker-HS

summary: The purpose of this study is to determine whether electrocardiogram, echocardiography, cardiac MRI, sera biomarkers can improve early detection of myocardial involvement and clinical outcome.

lead_sponsor: Karim WAHBI


title: Seroprevalence of SARS-CoV-2 Infection in Patients With HIV Infection

acronym: COCOVIH

summary:
As of May 26, 2020, 5,508,904 confirmed cases (145,279 in France) of COVID-19 and 346,508 deaths (28,457 in France) have been reported since December 8, 2019 worldwide. The rapid increase in the number of cases in our territory caused France to pass to level 3 of the epidemic on March 14, 2020.

The natural history of this disease is still poorly understood, particularly in patients infected with HIV, patients considered to be at higher risk for severe forms.

Knowing the seroprevalence in the population of people living with HIV will make it possible to better understand the Covid infection in immunocompromised patients, know the percentage of immunization and the persistence or not of the antibodies over time, specify the protective nature or not of these antibodies detected.

lead_sponsor: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida


title: Study on the Phenotype of Language in Preterm Born Children at 5 Years of Age

summary:
In recent years, several studies confirm that some of preterm children have language developmental disabilities, in production, in comprehension, or in written language. These language impairments lead to learning disabilities. There are, however, contradictions concerning the origin and nature of language dysfunctions. Some studies find lexical disorders (number of words used by the child), others preferentially phonological disorders (sounds used in the language), others also disorders of the morphosyntaxe (organization of the sentences) and fragilities that affect pragmatics (understanding situations).

The computer-evaluation of the language is carried out at five and a half year coupled with the medical and neuropsychological examinations. The language assessment lasts 30 to 45 minutes per child. It is carried out using a laptop computer that allows the submission of stimuli and recording of the child's responses. The language evaluation scale is the battery CléA (Pasquet F et al, 2014), standardized reference tool for the realization of a language evaluation. The assessment includes three tests: comprehension of words and phrases, production of words and phrases, and judgment of sentences. Each time, the child sees images and hears words or phrases. Sometimes he has to say what he sees on the computer screen.

As usual, a speech-language assessment is not carried out, routinely, at the age of 5 years in the context of the follow-up of children born very preterm.

The evaluation proposed to the child in this research will be carried out at a significant period of development, before writing. This assessment will not only assess the structure of the child's language, but also determine if there are possible difficulties in learning to read and write.

The expected benefits for the health of the children included in the trial therefore concern the detection or characterization of any developmental fragilities affecting the language. These screenings or characterizations will make it possible to advocate a speech rehabilitation if necessary.

lead_sponsor: University Hospital, Rouen


title: Impact of Teledermatology Versus Usual Care on Delay Before Diagnosis and/or Treatment of Dermatologic Conditions in General Practice

acronym: TELEDERMATO

summary:
In France, there is usually a long delay (approximately 6 weeks) before a general practitioner can obtain a specialized advice by dermatologists for diagnosis of "unusual" dermatologic conditions of their patients.

Previous studies have shown that teledermatology is a reliable way for diagnosis in dermatology.

We hypothesize that a teledermatology advice could reduce delay before diagnosis and therefore treatment for patients.

ReferenceCitation: Piette E, Nougairède M, Vuong V, Crickx B, Tran VT. Impact of a store-and-forward teledermatology intervention versus usual care on delay before beginning treatment: A pragmatic cluster-randomized trial in ambulatory care. J Telemed Telecare. 2017 Sep;23(8):725-732. doi: 10.1177/1357633X16663328. Epub 2016 Aug 5.

lead_sponsor: University Paris 7 - Denis Diderot


title: Impact of Health Literacy Training for General Practitioners and a Consumer Facing Intervention to Improve Colorectal Cancer Screening in Underserved Areas: A Multicentric Cluster Randomized Controlled Trial

acronym: DECODE

summary: The aim of this project is to assess the impact of a health literacy (HL) intervention combining HL and CRC screening training for general practitioners with a short brochure and video targeting eligible patients to increase CRC screening and other secondary outcomes in four underserved geographic areas in France. The investigators will use a two-arm randomized controlled cluster trial at 8 clusters (2 per area) primarily serving underserved populations across 4 geographic areas in France with 32 primary care physicians and 1024 patients recruited.

ReferenceCitation: Durand MA, Lamouroux A, Redmond NM, Rotily M, Bourmaud A, Schott AM, Auger-Aubin I, Frachon A, Exbrayat C, Balamou C, Gimenez L, Grosclaude P, Moumjid N, Haesebaert J, Massy HD, Bardes J, Touzani R, Diant LBEF, Casanova C, Seitz JF, Mancini J, Delpierre C. Impact of a health literacy intervention combining general practitioner training and a consumer facing intervention to improve colorectal cancer screening in underserved areas: protocol for a multicentric cluster randomized controlled trial. BMC Public Health. 2021 Sep 16;21(1):1684. doi: 10.1186/s12889-021-11565-3.

lead_sponsor: University Paul Sabatier of Toulouse

location_facility: Service de recherche et épidémiologie cliniques


title: Efficacy of Mifepristone - Prostaglandin Analogue Combination in Medical Termination of Pregnancy Beyond 7 Weeks of Amenorrhea

summary:
This study is a non-interventional prospective, multicenter, longitudinal study conducted in France, among a representative sample of public and/or private birth control centers.

The aim of the study is to assess, in real-life settings, the success rate of the protocol Mifegyne / prostaglandin analogue in patients asking for medical abortion either prior or beyond 7 weeks of amenorrhea.

lead_sponsor: Nordic Pharma SAS


title: Physical Activity and Sedentary Lifestyle During Pregnancy: Feasibility and Impact Study on Sedentary Behavior

acronym: PregMouv

summary:
Background:

Physical activity (PA) has beneficial effects on health, physical condition, and the maintenance of autonomy and independence at all ages of life. It also has numerous benefits during pregnancy: maintenance or improvement of physical condition, prevention of excessive weight gain, aid in postpartum weight loss, prevention of gestational hypertension, reduction in number of macrosomic infants at birth, reduction in lower back and pelvic pain, and prevention and improvement of postpartum depressive symptoms. A recent systematic review of the literature concluded that interventions to increase PA levels among pregnant women have a positive effect on this level. The studies included in the review also showed that these interventions have a positive effect on these women's well-being and their mental and physical health. Nonetheless, no study has examined this subject in France. Moreover, to our knowledge, no study in the international literature has looked at online interactive video sessions of PA during pregnancy.

Overall, few studies allow an assessment of the effect of sedentary behavior and inadequate PA during pregnancy on maternal, neonatal, or infant outcomes. This is equally true for the health of adults whose mothers were physically active during pregnancy. Moreover, we do not know the actual level of PA of women in France. Finally, we do not know what types of intervention described in the literature would enable the best adherence by French women to their initiation or maintenance of an adequate PA level.

Study hypothesis:

Our hypothesis is that setting up a free program of physical and sports activity session for pregnant women will enable them to meet the guidelines for PA practice during this period and to reduce their sedentary behavior.

Objectives:

1.1. Principal objective To study the feasibility of setting up physical activity (PA) sessions for pregnant women during their prenatal care, by assessing its acceptability, the perceived difficulty of the sessions, and their satisfaction with these sessions.

1.2. Secondary objectives

To evaluate the effect of these sessions:

on the PA level and sedentary behavior of pregnant women,
on their quality of life (QoL).
The feasibility and impact of the sessions will be studied according to their PA level at inclusion: active or inactive.
To identify the facilitators of and obstacles to the acceptability of these sessions, other than those studied in the objectives above.
To measure the willingness to pay of pregnant women so that we can quantify how much they would be willing to pay for such a program, were it were not free. Willingness to pay (measured in €) makes it possible to measure indirectly the acceptability of the program to the participants and the monetary value they attribute to it.

ReferenceCitation: Haute Autorité de Santé. Guide de promotion, consultation et prescription médicale d'activité physique et sportive pour la santé chez les adultes [Internet]. 2019. Disponible sur: https://www.has-sante.fr/upload/docs/application/pdf/2018-10/guide_aps_vf.pdf

ReferenceCitation: Institut national de la santé et de la recherche médicale (France). Activité physique: prévention et traitement des maladies chroniques. 2019.

ReferenceCitation: Organisation mondiale de la santé. Recommandations mondiales sur l'activité physique pour la santé. Genève: OMS; 2010.

ReferenceCitation: Haute Autorité de Santé. Prescription d'activité physique et sportive Pendant la grossesse et en post-partum [Internet]. Saint-Denis: HAS; [cité 2 mars 2020] p. 14. Disponible sur: https://www.has-sante.fr/upload/docs/application/pdf/2019-07/app_329_ref_aps_grossesse_vf.pdf

ReferenceCitation: Agence nationale de sécurité sanitaire, de l'alimentation, de l'environnement, et du travail. Actualisation des repères du PNNS - Révisions des repères relatifs à l'activité physique et à la sédentarité [Internet]. Maison-Alfort; 2016 [cité 15 juill 2020]. Disponible sur: https://www.anses.fr/fr/system/files/NUT2012SA0155Ra.pdf

ReferenceCitation: Verdot C, Salanave B, Deschamps V. Activité physique et sédentarité dans la population française. Situation en 2014- 2016 et évolution depuis 2006-2007. Bull Epidémiol Hebd. 2020;15:296-304.

ReferenceCitation: Équipe de surveillance et d'épidémiologie nutritionnelle (Esen). Étude de santé sur l'environnement, la biosurveillance, l'activité physique et la nutrition (Esteban), 2014-2016. Volet Nutrition. Chapitre Activité physique et sédentarité. 2e édition [Internet]. Saint-Maurice: Santé publique France; 2020 p. 58. Disponible sur: www.santepubliquefrance.fr

ReferenceCitation: DIVISION OF MENTAL HEALTH AND PREVENTION OF SUBSTANCE ABUSE WORLD HEALTH ORGANIZATION. WHOQOL User Manual [Internet]. WHO; 2012 [cité 21 oct 2020] p. 106. Disponible sur: https://apps.who.int/iris/bitstream/handle/10665/77932/WHO_HIS_HSI_Rev.2012.03_eng.pdf?sequence=1&isAllowed=y

ReferenceCitation: Inserm (dir.). Activité physique : contextes et effets sur la santé. Rapport. [Internet]. Les éditions Inserm. Paris; 2008 [cité 23 juill 2020]. 811 p. Disponible sur: http://www.ipubli.inserm.fr/bitstream/handle/10608/97/expcol_2008_activite.pdf?sequence=1

ReferenceCitation: Ekelund U, Tarp J, Steene-Johannessen J, Hansen BH, Jefferis B, Fagerland MW, Whincup P, Diaz KM, Hooker SP, Chernofsky A, Larson MG, Spartano N, Vasan RS, Dohrn IM, Hagstromer M, Edwardson C, Yates T, Shiroma E, Anderssen SA, Lee IM. Dose-response associations between accelerometry measured physical activity and sedentary time and all cause mortality: systematic review and harmonised meta-analysis. BMJ. 2019 Aug 21;366:l4570. doi: 10.1136/bmj.l4570.

ReferenceCitation: Fazzi C, Saunders DH, Linton K, Norman JE, Reynolds RM. Sedentary behaviours during pregnancy: a systematic review. Int J Behav Nutr Phys Act. 2017 Mar 16;14(1):32. doi: 10.1186/s12966-017-0485-z. Review.

ReferenceCitation: Brekke I, Richardsen KR, Jenum AK. Sickness absence in pregnancy and sedentary behavior: a population-based cohort study from Norway. BMC Public Health. 2019 Jan 16;19(1):71. doi: 10.1186/s12889-018-6379-4.

ReferenceCitation: Barone Gibbs B, Paley JL, Jones MA, Whitaker KM, Connolly CP, Catov JM. Validity of self-reported and objectively measured sedentary behavior in pregnancy. BMC Pregnancy Childbirth. 2020 Feb 11;20(1):99. doi: 10.1186/s12884-020-2771-z.

ReferenceCitation: van der Waerden J, Nakamura A, Pryor L, Charles MA, El-Khoury F, Dargent-Molina P; EDEN Mother-Child Cohort Study Group. Domain-specific physical activity and sedentary behavior during pregnancy and postpartum depression risk in the French EDEN and ELFE cohorts. Prev Med. 2019 Apr;121:33-39. doi: 10.1016/j.ypmed.2019.02.012. Epub 2019 Feb 11.

ReferenceCitation: Poudevigne MS, O'Connor PJ. A review of physical activity patterns in pregnant women and their relationship to psychological health. Sports Med. 2006;36(1):19-38. Review.

ReferenceCitation: Chan CWH, Au Yeung E, Law BMH. Effectiveness of Physical Activity Interventions on Pregnancy-Related Outcomes among Pregnant Women: A Systematic Review. Int J Environ Res Public Health. 2019 May 23;16(10). pii: E1840. doi: 10.3390/ijerph16101840.

ReferenceCitation: Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017 Jan 26;17(1):88. doi: 10.1186/s12913-017-2031-8.

ReferenceCitation: Teychenne M, Abbott G, Stephens LD, Opie RS, Olander EK, Brennan L, van der Pligt P, Apostolopoulos M, Ball K. Mums on the Move: A pilot randomised controlled trial of a home-based physical activity intervention for mothers at risk of postnatal depression. Midwifery. 2021 Feb;93:102898. doi: 10.1016/j.midw.2020.102898. Epub 2020 Nov 27.

ReferenceCitation: Chandonnet N, Saey D, Alméras N, Marc I. French Pregnancy Physical Activity Questionnaire compared with an accelerometer cut point to classify physical activity among pregnant obese women. PLoS One. 2012;7(6):e38818. doi: 10.1371/journal.pone.0038818. Epub 2012 Jun 11.

ReferenceCitation: ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. Erratum in: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.

ReferenceCitation: Arcuri JF, Borghi-Silva A, Labadessa IG, Sentanin AC, Candolo C, Pires Di Lorenzo VA. Validity and Reliability of the 6-Minute Step Test in Healthy Individuals: A Cross-sectional Study. Clin J Sport Med. 2016 Jan;26(1):69-75. doi: 10.1097/JSM.0000000000000190.

ReferenceCitation: Baumann C, Erpelding ML, Régat S, Collin JF, Briançon S. The WHOQOL-BREF questionnaire: French adult population norms for the physical health, psychological health and social relationship dimensions. Rev Epidemiol Sante Publique. 2010 Feb;58(1):33-9. doi: 10.1016/j.respe.2009.10.009. Epub 2010 Jan 21.


title: "Sport on Prescription" in Primary Care for Patients With Long-term Illnesses: From General Practitioners' Prescriptions to the "Maison Sport Santé" System for Adapted Physical Activity

acronym: PRIMAPA-VAR

summary:
Adapted Physical Activity (APA) helps to prevent chronic diseases identified as major causes of mortality, particularly cardiovascular diseases and some cancers, according to the World Health Organization (WHO). However, in general population, physical activity levels are below recommendations for nearly 40% of french adults. In France, general practitioners are now authorised and encouraged to prescribe APA to long-term illness patients.

In Var department in France, the " Maison Sport-Santé 83 " has set up a program called "Cap Sport Santé 83" to support patients who received a prescription to practice APA on a regular basis. This program helps long-term illness patients to restart physical activity by considering their pathology.

The aim of this study is to evaluate " Maison Sport-Santé 83 " APA program effectiveness using a rigorous scientific methodology.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer


title: Clinical Evaluation of Beta-Lacta ™ Test in Urinary Infections

summary:
3rd generation cephalosporins (C3G) are the antibiotics recommended in probabilistic in most enteric infections in France including pyelonephritis and bacteraemia.

However, the prevalence of resistance of Enterobacteriaceae including E. coli to C3G is continuously increasing for several years. In 2012, in France, the proportion of E. resistant or intermediate coli categorized to C3G is 10 to 25% (EARSS data).

Antibiotics not adapted early in severe sepsis is responsible for worse prognosis for patients in terms of morbidity and mortality and unnecessary prolongation of the DMS.

At St. Joseph's Hospital on enterobacteria levels of resistance to C3G is 15.4%.

To avoid overuse of carbapenems for probabilistic antibiotic and to quickly prescribe antibiotics adapted to the resistance of the bacteria, it is interesting to use a rapid test for detection of resistance to C3G.

The Lacta ™ test could be used in this indication. This is a rapid test diagnostic orientation detecting hydrolysis of a substrate (chromogenic cephalosporin) by the enzymatic action of ESBL, cAMP-type cephalosporinases and carbapenemases. This test was initially marketed for rapid detection of resistance to C3G enterobacteria from isolated bacterial colonies in culture.

ReferenceCitation: Mizrahi A, Naouri D, Hobson C, Amzalag J, Pilmis B, Couzigou C, Ganansia O, Le Monnier A. Impact of the beta-lacta test on the management of urinary tract infections at the emergency department. Infect Dis (Lond). 2021 Jan;53(1):52-60. doi: 10.1080/23744235.2020.1822543. Epub 2020 Sep 22.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Mediterranean Visceral Leishmaniasis With Leishmania Infantum: Genetic Characterization of the Host Parasite in Relation to Asymptomatic Human Carriage

acronym: AsymptoGen

summary:
L. infantum leishmaniasis is endemic in the South of France. For several years, there has been an expansion of the territory of sandflies (vector of leishmaniasis), with the appearance of cases of canine leishmaniasis in new outbreaks: West of the Occitania region (South-West). The transition from asymptomatic to disease depends largely on the immune status of the carrier, but many other factors specific to the parasite and host remain poorly defined. Asymptomatic carriage is present in a large majority of infected subjects, however, to date, only parasite isolates causing the patent form have been characterized.

In this PHRC, the team wishes to study the genetics of parasite isolates present in asymptomatic carriers of the Alpes-Maritimes outbreak and the new Occitanie outbreak as well as the genetics of the host.

The primary objective is the genetic characterization of L. infantum isolates by the microsatellite method, present in asymptomatic carriers in southeast and southwestern France.

The secondary objectives are:

Comparison of the genetic profiles of L. infantum isolates, by microsatellite method, from asymptomatic carriers of the new Southwestern outbreak with isolates from asymptomatic carriers of the historical Southwestern outbreak.
Comparison of the genetic profiles of L. infantum isolates, by the microsatellite method, present in asymptomatic carriers in the Southeast with the profiles of isolates present in patients in the same outbreak, for whom a microsatellite study has already been obtained previously.
the team is also conducting a preliminary study of the host genetic factors that would be associated with asymptomatic carriage by studying the association between potential host-related genetic risk factors (HLA typing, NLRP3 gene study) and asymptomatic carriage. Indeed, a recent study showed that the NLRP3 gene prevents the development of the patent form of leishmaniasis in the mouse model. This preliminary genetic study will identify potential host-related factors associated with asymptomatic carriage.

To meet these objectives, leuco-platelet layer parasites (CLP) obtained via EFS from the 2 sources of interest will be isolated.

This project is a research not involving the human person. It is multicentric and non-randomized.

As a result of this research, isolates from asymptomatic carriers of the historical outbreak will be studied and compared to those present in new endemic outbreaks, as well as to those of patients already studied in a previous study. A better knowledge of parasites circulating in asymptomatic carriers will make it possible to study in a comprehensive way the risk factors associated with the parasite. In addition, the study of asymptomatic carrying in new endemic outbreaks such as Occitania is very original, since no human studies have yet been undertaken in this region. The results obtained in this PHRC will be used to understand the factors associated with the development of visceral leishmaniasis.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: When Asking the Indication of a Skin Biopsy From a Patient With a Leg Ulcer in Primary Care? Retrospective Study of 100 Consecutive Biopsies

acronym: BIOPULCER

summary:
Leg ulcers are frequent. There are no epidemiological studies available in France, but international studies estimate the prevalence between 0.045 and 0.63% of the total population, prevalence increases with age, reaching 5% of patients over 80 years. Extrapolating these prevalences in the French population between 28 000 and 395 000 people are affected in France a leg ulcer.

It is a costly disease. In 2001, a French study conducted among 800 physicians, including 85.7% of general practitioners, involving more than 1000 patients with venous ulcers, it was estimated that the total cost of treatment per patient average was 888 32 euros. This is truly a public health problem.

Leg ulcers are in 80% of cases of vascular causes (venous, arterial or arteriovenous mixed). However, there are rare causes of ulcers: skin carcinoma, infectious ulcers and vasculitis. These ulcers rare causes require specific treatments that can often heal. To diagnose, to perform a skin biopsy. Thus, the general practitioner must know when to put the indication for biopsy of a leg ulcer.


title: Evaluation of Pharmacy Students' Perception of Opioid / Opiate Dependence: Cross-sectional National Study

summary:
The pharmacist in his professional activity may have to manage opioid dependent patients. This professional activity will result in the provision of opioid substitution treatment (OST), single-use syringes, harm reduction kits and a prevention advice for the reduction of toxicity and infection risks.

Since the 1990s, the consumption of OST has been steadily increasing. According to the OFDT (French Observatory of Drugs and Drug Addiction), the number of patients under OST is about 150 000 patients. Since high-dose buprenorphine is prescribed for approximately two-thirds of patients, it remains the most frequently prescribed OST in France.

Recently, a French association assisting drug users (ASUD - Auto-support des usagers de drogues) performed a study in Paris (20/07/2018 - 25/08/2018) to assess the delivery of opioid replacement therapies by community pharmacists. In this study, 71% of pharmacists refused to deliver opioid replacement therapies. The main reasons reported were security (56%) and activity saturation, meaning that pharmacists considered that they had too many patients using opioid drugs. In France, the refusal of a pharmacist to deliver drugs is a punishable offence. According to the Code of ethics of pharmacists, pharmacists must respect life and people without discrimination. Pharmacists have a low perception of patients suffering from opioid addiction. Another study performed by ASUD in 93 community pharmacies, showed that pharmacists used the term "toxicomaniacs" instead of "drug users". Most pharmacists had had a bad experience with drugs users, with physical and verbal aggressions. The conclusions of this study showed that pharmacists lacked knowledge of drug users and drug use. Pharmacists knew about harm reduction kits for opioid users (containing sterile syringes, needles, water, antiseptics, etc.) and had already opened them, but very few knew how to use them. More worryingly, some pharmacists did not understand the harm reduction strategies available It thus appears that community pharmacists have a difficult relationship with opioid-dependent patients, even though these pharmacists have received education in the management of addictions during their studies. Indeed, it can consider that these courses should help to better understand the addictive disease both in its nosological / semiological and therapeutic components. Thus, it would be interesting to evaluate the impact of addiction education on pharmacists' perception of opioid dependence. In this perspective, it would be interesting to focus on pharmacy students.

The objective of this study will be to evaluate the perception by pharmacy students of opioid dependent patients. Investigator would like to know if pharmacy students consider opioid addiction to be an illness and whether having taken education on drug use and addictions changes this perception.


title: Effect of Methotrexate on the Relation Dose-effect of Infliximab in Ankylosing Spondylitis

acronym: SPAXIM

summary:
There is a great individual variability of pharmacokinetic of infliximab in patients treated for ankylosing spondylitis (AS). Moreover, some patients have a treatment with methotrexate (MTX), others have not.

Thus, the aim of this study is to assess the effect of MTX on the pharmacokinetic properties of infliximab in 30 patients treated for AS, 15 with MTX, 15 without.

ReferenceCitation: Mulleman D, Lauféron F, Wendling D, Ternant D, Ducourau E, Paintaud G, Goupille P. Infliximab in ankylosing spondylitis: alone or in combination with methotrexate? A pharmacokinetic comparative study. Arthritis Res Ther. 2011 Jun 3;13(3):R82. doi: 10.1186/ar3350.

lead_sponsor: University Hospital, Tours

location_facility: University Hospital Jean MINJOZ -Besançon


title: Implementation and Assessment of a Multifaceted Risk Management Program in French Multiprofessional Offices in Primary Care : the PRisM Study

acronym: PRisM

summary:
Avoidable care associated incidents are relatively frequent in primary care. In France for example, avoidable incidents rate is estimated to 22/1000 medical acts from general practitioners. Patient safety is now a growing issue in primary care. One tool to increase patient safety is incident reporting and analysis. It could reduce some important consequences for patients and could allow implementing substantial corrective actions.

The aim of the PRisM study is to assess and compare the efficiency of a multifaceted risk management program implemented in the french pluridisciplinary offices in primary care in association with a centralized incident reporting system, versus a centralized incident reporting system only.


title: Dose-dependent Drug-drug Interaction Between Paracetamol and Warfarin in Adults Receiving Long-term Oral Anticoagulants: A Randomized Controlled Trial

summary: The objective of this study is to investigate whether paracetamol, given at therapeutic doses (2g/day and 3 g/day), may potentiate the anticoagulant effect of warfarin.

lead_sponsor: Hopital Lariboisière

location_facility: Therapeutic Research Unit, Department of Internal Medicine, Hospital Lariboière


title: Prospective Epidemiological Study of Injuries Encountered in the Practice of CrossFit in Grand Nancy Clubs Over a Period of 8 Months.

acronym: CROSSFIT

summary:
CrossFit is a recent sport that has been democratized since the beginning of the 2000's in France. The 3 major studies of CrossFit injuries were conducted in the United States in 2014, Brazil in 2016 and the United States in 2017. They show a discrepancy in terms of injuries average, from 19.4% to 31% in relation to an upsurge in the number of CrossFit practitioners, the specific training or not of the coaches framing this activity, the practice or not in competition. The main locations of these wounds are highlighted at the shoulders, lumbar region and knees. In France, to date, no epidemiological studies have been conducted on this subject.

Hypothesis: High incidence of injuries related to a lack of framing, or bad practice and ignorance of CrossFit practitioners.

Objectives : Estimate the injuries incident due to the CrossFit practice over a 8-month period in an adult population who practice in clubs .

Research, among the anthropometric, sociodemographic, environmental, and the nature and frequency of practice and training sessions, those which are associated with the occurrence of injury in this cohort.

lead_sponsor: Central Hospital, Nancy, France


title: Assessment of Transcultural Psychotherapy to Treat Major Depressive Disorder in Children and Adolescents From Migrant Families: a Bayesian Randomized Controlled Trial

acronym: EDPT-ADOS

summary:
The symptomatic and clinical expression of psychiatric disorders in children and adolescents is strongly influenced by the cultural setting they are growing up in. These cultural variations complicate psychiatric care, especially for migrant children, for whom appropriate care must be designed.

Transcultural psychotherapy is an original psychotherapeutic technique developed to meet these specific requirements in France and in different European and American countries. Its theoretical and methodological foundations rest on the works of George Devereux in ethnopsychiatry (1970). A psychotherapeutic technique intended for first-generation migrants was developed by Tobie Nathan and coll (1986). Marie-Rose Moro and colleagues (1990) have adapted this technique to second-generation migrants.

Indicated as a second-line treatment after the failure of standard management, this technique is fully formalized today. It comprises group consultations for the child and the family as a one-hour session each month, directed by a principal therapist, assisted by a group of co-therapists (of diverse cultural origins and occupations) and an interpreter in the family's mother tongue. The concept of culture is used to establish the therapeutic alliance, decode the symptoms, and propose treatment.

The children and adolescents receiving this treatment have varied psychopathological profiles, mostly involving depressive and/or anxiety disorders. Specifically, migrants' children are especially vulnerable to depression, their psychiatric care is generally longer and less effective than in the general population, and their rate of treatment failure higher.

Transcultural psychotherapy has demonstrated its value in these situations in numerous qualitative studies, but its efficacy has not yet been assessed by a method providing a high level of evidence, such as randomized controlled trials.

location_facility: Service de psychiatrie de l'enfant et de l'adolescent, CHRU Gabriel Montpied

location_facility: Secteur 75G23, Centre Médico-psychologique (CMP), GHU PARIS, Maison blanche

location_facility: Centre Médico-psychologique, Service Universitaire de Psychiatrie de l'Enfant et de l'Adolescent, Hôpital La Grave, CHU Toulouse

location_facility: Service de Psychopathologie de l'enfant, de l'adolescent, CHU Avicenne

location_facility: Service de médecine interne, unité de consultation transculturelle, CHRU Saint-André (CHU Bordeaux)


title: Post-approval Study of Percutaneous Left Atrial Appendage Closure

summary:
Patients with atrial fibrillation are at significant risk of thrombus formation in the left atrial appendage, which can lead to a stroke or systemic embolism. This risk justifies first-line prescribing of long-term oral anticoagulant therapy in these patients. Percutaneous left atrial appendage closure, is a new interventional cardiology technique for patients at high risk of stroke related to atrial fibrillation in whom long term anticoagulation therapy cannot be conducted. This procedure involves implantation of an occlusion device into the left atrial appendage to close it and prevent migration of thrombotic material that can cause distant embolism. Closure of the left atrial appendage avoids long term prescription of anticoagulants while protecting patients against the risk of systemic embolism and stroke. In 2016, two devices developed for transcutaneous closure of the left atrial appendage (WATCHMAN, Boston Scientific, AMPLATZER CARDIAC PLUG, S. Jude Medical and its evolution AMPLATZER AMULET) were included in the list of products reimbursable in France. The French national authorities have requested the realization of a register whose objectives will be to evaluate:

The efficiency and safety of implanting devices in France
The type and duration of antithrombotic treatment prescribed after left atrial appendage closure

ReferenceCitation: Menke J, Lüthje L, Kastrup A, Larsen J. Thromboembolism in atrial fibrillation. Am J Cardiol. 2010 Feb 15;105(4):502-10. doi: 10.1016/j.amjcard.2009.10.018. Review.

ReferenceCitation: Feinberg WM, Blackshear JL, Laupacis A, Kronmal R, Hart RG. Prevalence, age distribution, and gender of patients with atrial fibrillation. Analysis and implications. Arch Intern Med. 1995 Mar 13;155(5):469-73.

ReferenceCitation: Heeringa J, van der Kuip DA, Hofman A, Kors JA, van Herpen G, Stricker BH, Stijnen T, Lip GY, Witteman JC. Prevalence, incidence and lifetime risk of atrial fibrillation: the Rotterdam study. Eur Heart J. 2006 Apr;27(8):949-53. Epub 2006 Mar 9.

ReferenceCitation: Knecht S, Wilton SB, Haïssaguerre M. The 2010 update of the ESC guidelines for the management of atrial fibrillation. Circ J. 2010 Nov;74(12):2534-7. Epub 2010 Nov 2. Review.

ReferenceCitation: Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg. 1996 Feb;61(2):755-9. Review.

ReferenceCitation: Lam YY, Yip GW, Yu CM, Chan WW, Cheng BC, Yan BP, Clugston R, Yong G, Gattorna T, Paul V. Left atrial appendage closure with AMPLATZER cardiac plug for stroke prevention in atrial fibrillation: initial Asia-Pacific experience. Catheter Cardiovasc Interv. 2012 Apr 1;79(5):794-800. doi: 10.1002/ccd.23136. Epub 2011 Nov 30.

ReferenceCitation: Dawson AG, Asopa S, Dunning J. Should patients undergoing cardiac surgery with atrial fibrillation have left atrial appendage exclusion? Interact Cardiovasc Thorac Surg. 2010 Feb;10(2):306-11. doi: 10.1510/icvts.2009.227991. Epub 2009 Nov 26. Review.

ReferenceCitation: Sievert H, Lesh MD, Trepels T, Omran H, Bartorelli A, Della Bella P, Nakai T, Reisman M, DiMario C, Block P, Kramer P, Fleschenberg D, Krumsdorf U, Scherer D. Percutaneous left atrial appendage transcatheter occlusion to prevent stroke in high-risk patients with atrial fibrillation: early clinical experience. Circulation. 2002 Apr 23;105(16):1887-9.

ReferenceCitation: Klug D, Commeau P, Defaye P, Thambo JB, Gras D, Aubry P, Pasquie JL, Guerin P, Teiger E, Koning R, Piot O; Heart Rhythm, Pacing Group, the Atheroma, Interventional Cardiology Group of the French Society of Cardiology. Percutaneous occlusion of the left atrial appendage: An expert consensus statement. Arch Cardiovasc Dis. 2015 Aug-Sep;108(8-9):460-7. Review.

ReferenceCitation: Park JW, Bethencourt A, Sievert H, Santoro G, Meier B, Walsh K, Lopez-Minguez JR, Meerkin D, Valdés M, Ormerod O, Leithäuser B. Left atrial appendage closure with Amplatzer cardiac plug in atrial fibrillation: initial European experience. Catheter Cardiovasc Interv. 2011 Apr 1;77(5):700-6. doi: 10.1002/ccd.22764. Epub 2011 Mar 8. Erratum in: Catheter Cardiovasc Interv. 2014 Nov 15;84(6):1028. Lopez-Minquez, Jose Ramon [corrected to Lopez-Minguez, Jose Ramon].

ReferenceCitation: Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov 19;312(19):1988-98. doi: 10.1001/jama.2014.15192. Erratum in: JAMA. 2015 Mar 10;313(10):1061.

ReferenceCitation: Belgaid DR, Khan Z, Zaidi M, Hobbs A. Prospective randomized evaluation of the watchman left atrial appendage closure device in patients with atrial fibrillation versus long-term warfarin therapy: The PREVAIL trial. Int J Cardiol. 2016 Sep 15;219:177-9. doi: 10.1016/j.ijcard.2016.06.041. Epub 2016 Jun 15. Review.

ReferenceCitation: Boersma LV, Schmidt B, Betts TR, Sievert H, Tamburino C, Teiger E, Pokushalov E, Kische S, Schmitz T, Stein KM, Bergmann MW; EWOLUTION investigators. Implant success and safety of left atrial appendage closure with the WATCHMAN device: peri-procedural outcomes from the EWOLUTION registry. Eur Heart J. 2016 Aug;37(31):2465-74. doi: 10.1093/eurheartj/ehv730. Epub 2016 Jan 27.

ReferenceCitation: Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbinder M, Mullin CM, Sick P; PROTECT AF Investigators. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet. 2009 Aug 15;374(9689):534-42. doi: 10.1016/S0140-6736(09)61343-X. Erratum in: Lancet. 2009 Nov 7;374(9701):1596.

ReferenceCitation: Reddy VY, Möbius-Winkler S, Miller MA, Neuzil P, Schuler G, Wiebe J, Sick P, Sievert H. Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology). J Am Coll Cardiol. 2013 Jun 25;61(25):2551-6. doi: 10.1016/j.jacc.2013.03.035. Epub 2013 Apr 10.

ReferenceCitation: Reddy VY, Holmes D, Doshi SK, Neuzil P, Kar S. Safety of percutaneous left atrial appendage closure: results from the Watchman Left Atrial Appendage System for Embolic Protection in Patients with AF (PROTECT AF) clinical trial and the Continued Access Registry. Circulation. 2011 Feb 1;123(4):417-24. doi: 10.1161/CIRCULATIONAHA.110.976449. Epub 2011 Jan 17.

ReferenceCitation: Sick PB, Schuler G, Hauptmann KE, Grube E, Yakubov S, Turi ZG, Mishkel G, Almany S, Holmes DR. Initial worldwide experience with the WATCHMAN left atrial appendage system for stroke prevention in atrial fibrillation. J Am Coll Cardiol. 2007 Apr 3;49(13):1490-5. Epub 2007 Mar 21.

ReferenceCitation: Kappetein AP, Head SJ, Généreux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodés-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium (VARC)-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document (VARC-2). Eur J Cardiothorac Surg. 2012 Nov;42(5):S45-60. doi: 10.1093/ejcts/ezs533. Epub 2012 Oct 1.

ReferenceCitation: Kefer J, Vermeersch P, Budts W, Depotter T, Aminian A, Benit E, Stammen F. Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac plug: the Belgian Registry. Acta Cardiol. 2013 Dec;68(6):551-8.

ReferenceCitation: Friberg L, Rosenqvist M, Lip GY. Evaluation of risk stratification schemes for ischaemic stroke and bleeding in 182 678 patients with atrial fibrillation: the Swedish Atrial Fibrillation cohort study. Eur Heart J. 2012 Jun;33(12):1500-10. doi: 10.1093/eurheartj/ehr488. Epub 2012 Jan 13.

lead_sponsor: French Cardiology Society


title: Therapeutic Strategy in Rheumatology When Faced With a Patient Treated With Methotrexate (MTX) for Rheumatoid Arthritis (RA).

acronym: STRATEGE

summary:
This is a longitudinal, observational, prospective, multicentre study conducted in metropolitan France, among a representative sample of office-based or mixed practice rheumatology doctors.

The aim of this study is to describe in real life, the therapy strategy when faced with a patient treated with methotrexate as a monotherapy consulting for rheumatoid arthritis and the impact on the progression of the disease at 6 months.

ReferenceCitation: Gaujoux-Viala C, Hudry C, Zinovieva E, Herman-Demars H, Flipo RM. MTX optimization or adding bDMARD equally improve disease activity in rheumatoid arthritis: results from the prospective study STRATEGE. Rheumatology (Oxford). 2021 Dec 24;61(1):270-280. doi: 10.1093/rheumatology/keab274.


title: Scaling-up Packages of Interventions for Cardiovascular Disease Prevention in Selected Sites in Europe and Sub-Saharan Africa. SPICES Study Implementation Phase

summary:
Cardiovascular disease (CVD) is the leading cause of death in the world. 17.5 million people died in 2012 due to CVD (31% of all causes of death). In Europe more than 50% of deaths are due to CVD. The CVD mortality rate is higher in the lower socio-economic levels. Three quarters of CVD deaths occur in developing countries (LDCs). According to estimates in 2030, CVD will be responsible for more deaths than the sum of infectious, nutritional, maternal and perinatal diseases in developing countries. The lack of an adequate primary care network in developing countries limits the screening and treatment of people with CVRF. As a result, these people do not benefit from appropriate prevention, are diagnosed late and remain disabled or die at a young age, resulting in significant additional costs for families but also at the macroeconomic level.

Cardiovascular risk factor prevention measures (CVRF) have been shown to be effective. Interventions are possible on a large scale (policies against smoking and unfavorable eating habits, promoting physical activity, etc.). Actions are possible at the individual level, both in primary prevention (fight against the FDRCV) and secondary, where many treatments have proven their effectiveness. These interventions are effective and profitable from a macroeconomic point of view. It has been estimated that the cost for such interventions would not exceed 4% of health expenditure in developing countries and 1-2% in rich countries.

The World Health Organization (WHO) stresses the importance of the triad composed by the patient and his family, the community and health professionals. Results are possible only when these three components work together for the same purpose. Many studies show the benefit of people's involvement in care in rich and developing countries.

SPICES project builds on progress in HIV / AIDS treatment in sub-Saharan Africa (SSA) and chronic disease management through the Innovative Care for Chronic Conditions (ICCC Framework), WHO plan. With regard to HIV treatment, these interventions have proven to be effective and cost-effective in many SSA countries, both in terms of disease control and adherence. These data on communicable and infectious diseases seem to be transferable to non-communicable diseases.

These projects were born from the observation that the model of care of the rich countries (individual approach of the patient, centered on the hospital and the specialist with a regular clinical and paraclinical follow-up) could not be transposed to the developing countries, because the limitation of human, technical and financial resources. But also that this model was becoming more and more difficult to maintain in developed countries or resources become limited. New approaches need to be developed to increase the effectiveness of health systems.

A paradigm shift is needed to improve the control of CVD with greater cost-effectiveness.

The SPICES project incorporates the most up-to-date knowledge to improve the prevention and control of CVD in high-, middle- and low-income countries.

Rich countries and developing countries are therefore involved in the study. The selected sites are France, United Kingdom, Belgium, South Africa and Uganda.

Some main axes of the ICCC Framework will be developed in SPICES:

improve the efficiency of health professionals through the delegation of skills and appropriate training,
center care around the patient and his family and more generally his caregivers,
simplify the monitoring and treatment protocols,
support patients in their community and emphasize prevention, information and patient education.

A first step of observation in the various countries made it possible to make an inventory of fixtures and to target the most adapted interventions.

The following steps are the implementation of these interventions (delegation of skills, information campaign and screening, improve the availability of treatments, measure of strengthening of compliance, etc. ..) and their evaluation.

This study, carried out in France and integrated into the SPICES project, will test the best non-pharmacological interventions selected in the community and by the community.

ReferenceCitation: Le Goff D, Barais M, Perraud G, Derriennic J, Aujoulat P, Guillou-Landreat M, Le Reste JY. Innovative cardiovascular primary prevention population-based strategies: a 2-year hybrid type 1 implementation randomised control trial (RCT) which evaluates behavioural change conducted by community champions compared with brief advice only from the SPICES project (scaling-up packages of interventions for cardiovascular disease prevention in selected sites in Europe and sub-Saharan Africa). BMC Public Health. 2021 Jul 19;21(1):1422. doi: 10.1186/s12889-021-11443-y.

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_facility:
LE GOFF
LE RESTE


title: Pulse Oximetry in Healthy SubjEcts ImmergeD in OceaN.

acronym: POSEIDON

summary: Drowning is the 3rd leading cause of accidental death in the world. One of the tools used by lifeguards to help ER assess gravity, is pulse oximetry. Its measure is variable even in optimal condition and its accuracy can be altered by factors specific to the patient and by environmental factors. The conditions gathered during a drowning rescue are thus propitious to a misleading evaluation. Assessing its reliability and looking for influencing factors of the measure of pulse oximetry could help for pre-hospital care management.

lead_sponsor: University Hospital, Bordeaux