title: Motivational Interviewing of Parents in Maternity Wards About Vaccination (Entretien Motivationnel Sur la Vaccination auprès Des Parents Dans Les maternités)

summary:
CONTEXT Vaccination has reduced mortality and morbidity by controlling many vaccine-preventable diseases. To prevent recurrence of these diseases, high vaccine coverages (VCs) (≥ 95%) are needed. But VCs for infants remain suboptimal, and four out of 10 parents doubt the safety and efficacy of vaccines in France. The Ministry of Health therefore decided in July 2017 to expand vaccination requirements to 11 valences now required to enter in young children collective structures. This measure, which went into effect in January 2018, has produced significant effects on VCs, but despite this, vaccine hesitancy (VH) persists in the general population at a prevalence level that fluctuates around 20% to 25%.

Motivational interviewing is a collaborative conversational style that reinforces a person's own motivation and commitment to behavior change. It has been successfully tested in multiple domains related to health behavior change. It has also been adapted in Quebec in the area of vaccination and tested in maternity wards with postpartum mothers (Promovac study). Having led to an increase in the VCs of infants by an average of 7 percentage points and a 40% decrease in vaccine hesitancy, this approach has been in the process of being generalized to all maternity units in Quebec since 2017 (EMMIE program). It is indeed proving to be one of the most effective at present in improving confidence in early childhood vaccines.

OBJECTIVES The main objective of this research is to provide proof of concept that, in the French context of mandatory vaccination for infants but also of high rates of VH, an educational strategy based on the principles and techniques of motivational interviewing and carried out with parents in the maternity ward in the days following delivery can reduce vaccine hesitancy (VH).

The secondary objectives are as follows:

to verify that this reduction in VH is associated with a change in knowledge, attitudes, and beliefs regarding vaccines;
to verify that this reduction is sustainable (at 12 months);
to evaluate the acceptability and satisfaction of the interview for the parents

METHODS This is a pragmatic randomized controlled multicenter study with individual randomization unit comparing the impact of motivational interviewing to a standard care with a leaflet on vaccination.

Motivational interviewing will be carried out by trained midwives from the two participating maternity units (one in Marseille (Bouches-du-Rhône) and the other in Toulon (Var)), as part of the routine care provided to parturients. The midwives will be trained by the founding specialist of motivational interviewing in Quebec, during a two and a half day training course. This training will include a presentation of the theoretical foundations of this approach, its adaptation to the field of vaccination, and interactive games to put it into practice. The trained midwives will then be able to put this approach into practice during a one-month pilot period with parturients, during which they will be able to benefit from support in the form of a debriefing. The actual survey will only start at the end of this pilot phase.

In each group, a questionnaire will be offered to the women (couples) who have agreed to participate, both before the motivational interview (or delivery of the leaflet) and after the interview (or delivery of the leaflet). The second questionnaire will be completed before discharge from the maternity hospital. A third evaluation time is planned at 12 months in both groups: it will be carried out by internet or telephone.

The primary endpoint will be the change in the vaccine hesitancy score, measured by an international scale validated in French (Opel scale).

Secondary endpoints will be changes in knowledge, attitudes and beliefs about vaccination between the two groups as well as satisfaction with the ME and the brochure.

Randomization will be performed in blocks of 8, prior to acceptance for participation in this research.

EXPECTED BENEFITS If the results of this research provide proof of concept that the educational strategy based on motivational interviewing adapted to the vaccination of infants after delivery, in maternity wards, makes it possible, in the French context, to reduce VH, this will be a major advance in public health in France. Indeed, even if the vaccination obligations introduced in January 2018 have had a positive impact on infant vaccination coverage, VH remains present in parents in a proportion that remains worrying (20 to 25% according to surveys). The results of this research will then allow us to study the conditions for generalizing motivational interviewing in order to reinforce confidence in vaccination, which is lacking in a significant part of the French population.

lead_sponsor: Observatoire Regional de la Sante Provence-Alpes-Côte d'Azur

collaborators: Institut de Recherche en Santé Publique, France

location_facility:
Hôpital Sainte-Musse
Hôpital Saint-Joseph


title: A Pilot, Prospective Study Assessing the Evolution of Cardiovascular Function and Quality of Life in Patients With Acute Coronary Syndrome, Included in the SCArabée Therapeutic Education Program

acronym: SCArabée

summary:
Coronary artery disease is defined as a disease of the arteries that vascularize the heart, resulting in myocardial ischemia, i.e. insufficient blood supply to the heart muscle. Eventually, it may be responsible for acute coronary syndrome that includes unstable angina (chest pain) and myocardial infarction (necrosis of the heart muscle).

The main cause of this disease is atheroma, and management involves reducing modifiable cardiovascular risk factors (sedentary lifestyle, smoking, obesity, high blood pressure, diabetes, dyslipidemia). Every year, this disease affects more than 120 000 people in France, aging 65 years on average.

In this real public health problem, there is a significant discrepancy between the excellence of the management of the acute incident and the inadequacy of the re-adaptive and educational management of the care suites. In fact, it is noted that hospitalization times are short given the progress of myocardial revascularization, associated with a low intra-hospital mortality rate, 3% but the places in rehabilitation programs ("Soins de Suite et de Réadaptation" or "SSR") are too limited (25% of the patients are included in these programs). Physical rehabilitation has proven effective for decades, with robust evidence of decreased recurrence and mortality (-20%).

At the Groupe Hospitalier Mutualiste of Grenoble, France, patients are offered two courses of treatment in post-myocardial infarction:

A therapeutic education program: SCarabée,
A rehabilitation program (SSR) The therapeutic education program aims to help the patient identify his needs, acquire knowledge, strengthen his resources and finally develop with him a project to improve his quality of life.

SSR offers physical rehabilitation as a treatment for infarction, which improves cardiovascular function, which is assessed by the cardiorespiratory test.

Is the Scarabée therapeutic education program is sufficient to help the patient improve his physical abilities? This study aims to answer this question, by setting up a reinforced monitoring of the evolution of the cardiovascular function of the patients included in the SCArabée program, via cardiorespiratory tests. The results of this first pilot study will potentially lead to a second randomized study comparing therapeutic education associated with Adapted Physical Education versus therapeutic education alone for the improvement of cardiorespiratory functions and the quality of life of these patients.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Other

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Puymirat E, Simon T, Cayla G, Cottin Y, Elbaz M, Coste P, Lemesle G, Motreff P, Popovic B, Khalife K, Labeque JN, Perret T, Le Ray C, Orion L, Jouve B, Blanchard D, Peycher P, Silvain J, Steg PG, Goldstein P, Gueret P, Belle L, Aissaoui N, Ferrieres J, Schiele F, Danchin N; USIK, USIC 2000, and FAST-MI investigators. Acute Myocardial Infarction: Changes in Patient Characteristics, Management, and 6-Month Outcomes Over a Period of 20 Years in the FAST-MI Program (French Registry of Acute ST-Elevation or Non-ST-Elevation Myocardial Infarction) 1995 to 2015. Circulation. 2017 Nov 14;136(20):1908-1919. doi: 10.1161/CIRCULATIONAHA.117.030798. Epub 2017 Aug 27.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Mines Nantes

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - uB

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

repositories_concat: HAL

unpaywall_oa_status: bronze

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Kotseva K, De Bacquer D, De Backer G, Ryden L, Jennings C, Gyberg V, Abreu A, Aguiar C, Conde AC, Davletov K, Dilic M, Dolzhenko M, Gaita D, Georgiev B, Gotcheva N, Lalic N, Laucevicius A, Lovic D, Mancas S, Milicic D, Oganov R, Pajak A, Pogosova N, Reiner Z, Vulic D, Wood D, On Behalf Of The Euroaspire Investigators. Lifestyle and risk factor management in people at high risk of cardiovascular disease. A report from the European Society of Cardiology European Action on Secondary and Primary Prevention by Intervention to Reduce Events (EUROASPIRE) IV cross-sectional survey in 14 European regions. Eur J Prev Cardiol. 2016 Dec;23(18):2007-2018. doi: 10.1177/2047487316667784. Epub 2016 Sep 27.

ReferenceCitation: Belle L, Cayla G, Cottin Y, Coste P, Khalife K, Labeque JN, Farah B, Perret T, Goldstein P, Gueugniaud PY, Braun F, Gauthier J, Gilard M, Le Heuzey JY, Naccache N, Drouet E, Bataille V, Ferrieres J, Puymirat E, Schiele F, Simon T, Danchin N; FAST-MI 2015 investigators. French Registry on Acute ST-elevation and non-ST-elevation Myocardial Infarction 2015 (FAST-MI 2015). Design and baseline data. Arch Cardiovasc Dis. 2017 Jun-Jul;110(6-7):366-378. doi: 10.1016/j.acvd.2017.05.001. Epub 2017 Jun 21.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Fox KA, Carruthers KF, Dunbar DR, Graham C, Manning JR, De Raedt H, Buysschaert I, Lambrechts D, Van de Werf F. Underestimated and under-recognized: the late consequences of acute coronary syndrome (GRACE UK-Belgian Study). Eur Heart J. 2010 Nov;31(22):2755-64. doi: 10.1093/eurheartj/ehq326. Epub 2010 Aug 30.

ReferenceCitation: Pavy B, Barbet R, Carre F, Champion C, Iliou MC, Jourdain P, Juilliere Y, Monpere C, Brion R; Working Group of Exercise Rehabilitation and Sport; Therapeutic Education Commission of the French Society of Cardiology. Therapeutic education in coronary heart disease: position paper from the Working Group of Exercise Rehabilitation and Sport (GERS) and the Therapeutic Education Commission of the French Society of Cardiology. Arch Cardiovasc Dis. 2013 Dec;106(12):680-9. doi: 10.1016/j.acvd.2013.10.002. Epub 2013 Nov 15.

ReferenceCitation: Nocon M, Hiemann T, Muller-Riemenschneider F, Thalau F, Roll S, Willich SN. Association of physical activity with all-cause and cardiovascular mortality: a systematic review and meta-analysis. Eur J Cardiovasc Prev Rehabil. 2008 Jun;15(3):239-46. doi: 10.1097/HJR.0b013e3282f55e09.

ReferenceCitation: Hambrecht R, Walther C, Mobius-Winkler S, Gielen S, Linke A, Conradi K, Erbs S, Kluge R, Kendziorra K, Sabri O, Sick P, Schuler G. Percutaneous coronary angioplasty compared with exercise training in patients with stable coronary artery disease: a randomized trial. Circulation. 2004 Mar 23;109(11):1371-8. doi: 10.1161/01.CIR.0000121360.31954.1F. Epub 2004 Mar 8.

ReferenceCitation: Anderson L, Thompson DR, Oldridge N, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2016 Jan 5;2016(1):CD001800. doi: 10.1002/14651858.CD001800.pub3.

ReferenceCitation: Wood DA, Kotseva K, Connolly S, Jennings C, Mead A, Jones J, Holden A, De Bacquer D, Collier T, De Backer G, Faergeman O; EUROACTION Study Group. Nurse-coordinated multidisciplinary, family-based cardiovascular disease prevention programme (EUROACTION) for patients with coronary heart disease and asymptomatic individuals at high risk of cardiovascular disease: a paired, cluster-randomised controlled trial. Lancet. 2008 Jun 14;371(9629):1999-2012. doi: 10.1016/S0140-6736(08)60868-5.

ReferenceCitation: Giannuzzi P, Temporelli PL, Marchioli R, Maggioni AP, Balestroni G, Ceci V, Chieffo C, Gattone M, Griffo R, Schweiger C, Tavazzi L, Urbinati S, Valagussa F, Vanuzzo D; GOSPEL Investigators. Global secondary prevention strategies to limit event recurrence after myocardial infarction: results of the GOSPEL study, a multicenter, randomized controlled trial from the Italian Cardiac Rehabilitation Network. Arch Intern Med. 2008 Nov 10;168(20):2194-204. doi: 10.1001/archinte.168.20.2194.

ReferenceCitation: Wasserman K, Hansen JE, Sue DY, Whipp BJ, Froelicher VF. Principles of Exercise Testing and Interpretation. Journal of Cardiopulmonary Rehabilitation and Prevention. avr 1987;7(4):189.

ReferenceCitation: Pavy B, Iliou MC, Meurin P, Tabet JY, Corone S; Functional Evaluation and Cardiac Rehabilitation Working Group of the French Society of Cardiology. Safety of exercise training for cardiac patients: results of the French registry of complications during cardiac rehabilitation. Arch Intern Med. 2006 Nov 27;166(21):2329-34. doi: 10.1001/archinte.166.21.2329.

ReferenceCitation: Cerretelli P. Traité de physiologie de l'exercice et du sport. Elsevier Masson; 2002. 504 p.

ReferenceCitation: Wilmore JH, Costill DL, Kenney L. Physiologie du sport et de l'exercice. De Boeck Superieur; 2017. 644 p.

ipd_sharing: Undecided

lead_sponsor: Groupe Hospitalier Mutualiste de Grenoble

intervention_type: Diagnostic Test

lead_sponsor_type: academique

status_simplified: Completed


title: Study of the Impact of Adjuvant Hormone Therapy on Bone and Cardiovascular Risk After Initial Treatment in Patients With Non-metastatic Breast Cancer

acronym: IMPACTTHKS

summary: Breast cancer is the most frequently observed cancer in women in France.The mortality rate is still decreasing with a decrease of 1.6% per year between 2010 and 2018, explained by the improvement in available treatments.For patients with breast cancer expressing hormone receptors, treatment with Tamoxifen or anti-aromatase can have the risk of the cancer coming back.However, these treatments have many side effects, including the risk of osteoporosis and metabolic disorders with anti-aromatases; and arterial and thromboembolic accidents with Tamoxifen.These effects have been well studied while taking hormone therapy.However, very few studies have analyzed the impact of these treatments after stopping them in women who have had non-metastatic hormone-sensitive breast cancer and uncertainties persist on the evolution of the health risk after initial treatment.

primary_purpose: Prevention

ipd_sharing: No

lead_sponsor: University Hospital, Toulouse

intervention_type: Other


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

acronym: ASTHMAVILLE

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

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

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

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

status: Terminated

study_type: Observational

time_perspective: Prospective

lead_sponsor: Fondation Hôpital Saint-Joseph

status_simplified: Unknown


title: Dataids Prospective Observational Cohort on Quality of Care of French HIV Infected Patients

summary:
The objective of the Dataids cohort is to continue a long-term, prospective collection of clinical, laboratory and therapeutic data on a large cohort of HIV infected patients seeking care in 15 HIV centers in France in order :

to provide and develop a surveillance system to describe clinical practice and temporal changes in the clinical course of HIV and HIV-related co-infections and co-morbidities in France.
to assess the factors associated with the clinical, immunological and virological course of HIV infection and HIV-related co-infections and co-morbidities

The specific objectives are as follows

To continue surveillance of HIV infection in France to describe temporal changes
To evaluate the efficacy of ART and factors associated with ART efficacy
To monitor the uptake and outcome of HCV therapy

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceType: result

ReferenceCitation: Pugliese P, Cuzin L, Cabie A, Poizot-Martin I, Allavena C, Duvivier C, El Guedj M, de la Tribonniere X, Valantin MA, Dellamonica P; Nadis Group. A large French prospective cohort of HIV-infected patients: the Nadis Cohort. HIV Med. 2009 Sep;10(8):504-11. doi: 10.1111/j.1468-1293.2009.00719.x. Epub 2009 May 19.

ReferenceType: derived

ReferenceCitation: Cuzin L, Allavena C, Cotte L, Delpierre C, Huleux T, Palich R, Delobel P, Raffi F, Cabie A; Dat'AIDS Study Group. No barrier to care, yet disparities in the HIV care continuum in France: a nationwide population study. J Antimicrob Chemother. 2021 May 12;76(6):1573-1579. doi: 10.1093/jac/dkab061.

publisher_dissemination: Oxford University Press

ReferenceCitation: Cotte L, Hocqueloux L, Lefebvre M, Pradat P, Bani-Sadr F, Huleux T, Poizot-Martin I, Pugliese P, Rey D, Cabie A; Dat'AIDS Study Group. Microelimination or Not? The Changing Epidemiology of Human Immunodeficiency Virus-Hepatitis C Virus Coinfection in France 2012-2018. Clin Infect Dis. 2021 Nov 2;73(9):e3266-e3274. doi: 10.1093/cid/ciaa1940.

ReferenceCitation: Ursenbach A, Max V, Maurel M, Bani-Sadr F, Gagneux-Brunon A, Garraffo R, Ravaux I, Robineau O, Makinson A, Rey D; Dat'AIDS Study Group. Incidence of diabetes in HIV-infected patients treated with first-line integrase strand transfer inhibitors: a French multicentre retrospective study. J Antimicrob Chemother. 2020 Nov 1;75(11):3344-3348. doi: 10.1093/jac/dkaa330.

ReferenceCitation: Le Guillou A, Pugliese P, Raffi F, Cabie A, Cuzin L, Katlama C, Allavena C, Drame M, Cotte L, Bani-Sadr F; Dat'AIDS Study Group. Reaching the Second and Third Joint United Nations Programme on HIV/AIDS 90-90-90 Targets Is Accompanied by a Dramatic Reduction in Primary Human Immunodeficiency Virus (HIV) Infection and in Recent HIV Infections in a Large French Nationwide HIV Cohort. Clin Infect Dis. 2020 Jul 11;71(2):293-300. doi: 10.1093/cid/ciz800.

ReferenceCitation: Gantner P, Cotte L, Allavena C, Bani-Sadr F, Huleux T, Duvivier C, Valantin MA, Jacomet C, Joly V, Cheret A, Pugliese P, Delobel P, Cabie A, Rey D; Dat'AIDS Study Group. Higher rates of HBsAg clearance with tenofovir-containing therapy in HBV/HIV co-infection. PLoS One. 2019 Apr 18;14(4):e0215464. doi: 10.1371/journal.pone.0215464. eCollection 2019.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

evidence: oa repository (via pmcid lookup)

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

unpaywall_oa_status: gold

publisher_dissemination: Public Library of Science

ReferenceCitation: Hentzien M, Drame M, Delpierre C, Allavena C, Cabie A, Cuzin L, Rey D, Pugliese P, Hedelin G, Bani-Sadr F; Dat'AIDS Study Group. HIV-related excess mortality and age-related comorbidities in patients with HIV aged >/=60: a relative survival analysis in the French Dat'AIDS cohort. BMJ Open. 2019 Jan 25;9(1):e024841. doi: 10.1136/bmjopen-2018-024841.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repositories:
HAL
PubMed Central

ReferenceCitation: Virlogeux V, Zoulim F, Pugliese P, Poizot-Martin I, Valantin MA, Cuzin L, Reynes J, Billaud E, Huleux T, Bani-Sadr F, Rey D, Fresard A, Jacomet C, Duvivier C, Cheret A, Hustache-Mathieu L, Hoen B, Cabie A, Cotte L; Dat'AIDS Study Group. Modeling HIV-HCV coinfection epidemiology in the direct-acting antiviral era: the road to elimination. BMC Med. 2017 Dec 18;15(1):217. doi: 10.1186/s12916-017-0979-1.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - TeLearn

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - hprints.org

location_facility: Hôpital Sainte Marguerite - Assistance Publique des Hôpitaux de Marseille

location_facility: Hôpital de la Croix-Rousse - Hospices Civils de Lyon

location_facility: Hôpital Bichat - Assistance Publique des Hôpitaux de Paris

location_facility: Hôpital Bicêtre - Assistance Publique des Hôpitaux de Paris

location_facility: Hôpital Necker-Pasteur - Assistance Publique des Hôpitaux de Paris

location_facility: CHU Clermont-Ferrand - Hôpital Gabriel-Montpied

location_facility: Groupe Hospitalier Pitié Salpêtrière - Assistance Publique des Hôpitaux de Paris

location_facility: Hôpital de la Conception - Assistance Publique des Hôpitaux de Marseille


title: A French Non-interventional Prospective Multicenter Study Evaluating Quality of Care Perception of Cancer Patients Treated by Immunotherapy at Home - SATISFACT-HOME

summary: The purpose of this observational study in France is to evaluate changes in satisfaction with care in participants with solid tumors who transitioned from receiving immunotherapy treatment in the hospital outpatient setting to receiving treatment at home

lead_sponsor: Bristol-Myers Squibb

location_facility:
CH Francois Quesnay
CH Metropole Savoie
CH de Pau

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


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.

design_allocation: Randomized

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Endocrinology Department, Nice University Hospital

intervention_type: Behavioral


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

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.

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.

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. No abstract available.

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.

sponsor_collaborators:
Fondation Hôpital Saint-Joseph
Institut Arthur Vernes


acronym: MEGA

lead_sponsor: UNICANCER

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

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

primary_purpose: Treatment

type: EudraCT Number

source: euctr


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.

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

acronym: NEPHROPOD

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

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

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


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.


title: Pneumococcal Vaccination in Patients With Anti-TNF Alpha Therapy: Status Report on the NOVO Hospital - Pontoise Site

acronym: TNF-VAX

summary:
As the vaccination of immunosuppressed people is insufficiently performed in France, it seems interesting to carry out an evaluation of the situation on the site of the NOVO - Pontoise hospital.

The aim of this study is to assess the status of pneumococcal vaccination in patients at the NOVO hospital - Pontoise site, who have received anti-TNF alpha therapy.

lead_sponsor: Hôpital NOVO

location_facility: Internal Medicine Department - NOVO Hospital - Pontoise site


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

acronym: FUMBLE

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

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

lead_sponsor: University Hospital, Brest


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

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

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

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

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

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

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

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

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

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

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

ReferenceCitation: Leplege A, Ecosse E, Verdier A, Perneger TV. The French SF-36 Health Survey: translation, cultural adaptation and preliminary psychometric evaluation. J Clin Epidemiol. 1998 Nov;51(11):1013-23. doi: 10.1016/s0895-4356(98)00093-6.

ReferenceCitation: Lawlis GF, Cuencas R, Selby D, McCoy CE. The development of the Dallas Pain Questionnaire. An assessment of the impact of spinal pain on behavior. Spine (Phila Pa 1976). 1989 May;14(5):511-6. doi: 10.1097/00007632-198905000-00007.

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

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

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

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

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

ipd_sharing_description: No IPD sharing

lead_sponsor: FasciaFrance

sponsor_collaborators:
FasciaFrance
University Fernando Pessoa

intervention_type: Procedure


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

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

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

lead_sponsor: Perouse Medical

sponsor_collaborators:
Perouse Medical
Eclevar Medtech

intervention_type: Device


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

sponsor_collaborators:
University Hospital, Clermont-Ferrand
UFR de Pharmacie (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.

status: Unknown status

design_allocation: Non-Randomized

primary_purpose: Health Services Research

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Service de pédopsychiatrie Sainte-Marguerite


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.

primary_purpose: Diagnostic

ReferenceCitation: Mulleman D, Lauferon 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

collaborators: Institut National de la Santé Et de la Recherche Médicale, France

location_facility: University Hospital Jean MINJOZ -Besançon


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

acronym: MAGREES

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

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

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

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

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

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

ReferenceCitation: Broeders M, Moss S, Nystrom L, Njor S, Jonsson H, Paap E, Massat N, Duffy S, Lynge E, Paci E; EUROSCREEN Working Group. The impact of mammographic screening on breast cancer mortality in Europe: a review of observational studies. J Med Screen. 2012;19 Suppl 1:14-25. doi: 10.1258/jms.2012.012078.

ReferenceCitation: Shapiro S. Periodic screening for breast cancer: the HIP Randomized Controlled Trial. Health Insurance Plan. J Natl Cancer Inst Monogr. 1997;(22):27-30. doi: 10.1093/jncimono/1997.22.27.

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

ReferenceCitation: Hall FM, Frank HA. Preoperative localization of nonpalpable breast lesions. AJR Am J Roentgenol. 1979 Jan;132(1):101-5. doi: 10.2214/ajr.132.1.101.

ReferenceCitation: Frank HA, Hall FM, Steer ML. Preoperative localization of nonpalpable breast lesions demonstrated by mammography. N Engl J Med. 1976 Jul 29;295(5):259-60. doi: 10.1056/NEJM197607292950506. No abstract available.

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

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

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


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

acronym: EMPIRE

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


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

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

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

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
France Telecom R&D


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, Nougairede 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.

publisher_dissemination: SAGE Publications

lead_sponsor: University Paris 7 - Denis Diderot


type: Other Identifier

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

acronym: EVIDENCE

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

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

oa_colors: green hybrid

evidence: open (via page says license)

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

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

lead_sponsor: Novo Nordisk A/S


title: 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.

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: St George's University of London - St George's Online Research Archive

version: acceptedVersion

repositories:
PubMed Central
UCL Discovery
openaccess.sgul.ac.uk

publisher_dissemination: British Medical Journal

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.

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repositories_concat: PubMed Central;pure.ed.ac.uk

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.

repository_institution: University of Oslo - Duo Research Archive

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.

evidence: open (via crossref license, author manuscript)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Toulouse - Jean Jaurès

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

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. doi: 10.2165/00007256-200636010-00003.

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):1840. 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.

repository_institution: Kingston University London - Research Repository

repository_institution: City University London - City Research Online

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;eprints.kingston.ac.uk;kclpure.kcl.ac.uk;openaccess.city.ac.uk;openaccess.sgul.ac.uk

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, Almeras 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. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. 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, Regat S, Collin JF, Briancon 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: Evaluation of Vaccination Coverage in People Linving With Diabetes

acronym: VacDiab

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

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

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

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

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

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

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

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

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

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

The secondary objectives are:

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


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

acronym: EREMI

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

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

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

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

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

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

lead_sponsor: Hospices Civils de Lyon

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


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

acronym: SY-DOXY

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

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

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: SY-DOXY

titre: Essai randomisé de non infériorité de la doxycycline à la BPG dans le traitement de la syphilis précoce

discipline_principale: dermatology

nom_porteur: DUPIN

prenom_porteur: Nicolas


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.

sponsor_collaborators:
University Hospital, Clermont-Ferrand
UFR Pharmacie (Clermont-Ferrand)


title: coHOrte fraNcaise Des dEfibrillateurs Sous cuTanés

acronym: HONEST

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

lead_sponsor: Paris Sudden Death Expertise Center

collaborators: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

collaborators: Centre Hospitalier William Morey - Chalon sur Saône

collaborators: Centre Hospitalier Antibes - Juan Les Pins

collaborators: Centre Hospitalier Henri Duffaut - Avignon

collaborators: Centre Hospitalier de Haguenau (Est France)

collaborators: Centre hospitalier de la Polynésie française - Papeete

collaborators: Centre Hospitalier Henri Mondor - Aurillac

collaborators: Centre Hospitalier Intercommunal Castres-Mazamet

collaborators: Centre Hospitalier Jacques Cœur - Bourges

collaborators: Centre Hospitalier Saint Joseph Saint Luc de Lyon

collaborators: Centre Hospitalier Universitaire de Saint Etienne

collaborators: Centre Hospitalier Universitaire de Besancon

collaborators: Centre Hospitalier Universitaire de la Réunion

collaborators: Centre Hospitalier Régional et Universitaire de Brest

collaborators: Centre Hospitalier Universitaire de Nice

collaborators: Clinique du Parc - Castelnau le Lez - Montpellier

collaborators: Centre Hospitalier Universitaire de Nīmes

collaborators: Hôpital Marie Lannelongue - Le Plessis Robinson

collaborators: Hôpital Privé Arnault Tzanck - Mougins - Sophia Antipolis

collaborators: Hôpital privé Claude Galien - Quincy-sous-Sénart

collaborators: Hôpital Privé de la Loire- Saint Etienne

collaborators: Hôpital privé Le Bois - Lille MetropoleHôpital Privé Les Franciscaines - Nîmes

location_facility: Paris Cardiovascular Research Center (HONEST Investigators)


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.

study_start_date_type: Anticipated

primary_purpose: Supportive Care

collaborators: Institut National de la Santé Et de la Recherche Médicale, France

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

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

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

acronyme: EDPT-ADOS

titre: Evaluation de la technique de psychothérapie transculturelle dans la prise en charge des enfants et adolescents issus de familles migrantes et souffrant de dépression caractérisée : un essai contrôlé randomisé à design bayésien

discipline_principale: psychiatry

nom_porteur: LACHAL

prenom_porteur: Jonathan


title: Study of Klotho Gene Polymorphisms in the Regulation of Serum Phosphate Levels in Hemodialysis Patients

summary: Patients with chronic kidney disease (CKD) and those with end-stage renal disease (ESRD) undergoing renal replacement therapies show elevated serum phosphate levels which predispose them to cardiovascular calcifications and high risks of death from cardiovascular diseases. However, in certain patients hyperphosphatemia is not related to dialysis insufficiency, excessive daily dietary phosphorus intake or high serum parathyroid hormone (PTH) levels, suggesting that other mechanisms could be involved. Transgenic mice lacking the klotho gene showed a phenotype which resembles that of dialyzed ESRD patients, in the sense that they have hyperphosphatemia, vascular calcifications, and a short lifespan. This study will analyze whether functional polymorphisms or variants in the human klotho gene are associated with hyperphosphatemia in these patients.

ReferenceCitation: Prie D, Beck L, Urena P, Friedlander G. Recent findings in phosphate homeostasis. Curr Opin Nephrol Hypertens. 2005 Jul;14(4):318-24. doi: 10.1097/01.mnh.0000172716.41853.1e.

sponsor_collaborators: Institut National de la Santé Et de la Recherche Médicale, France

location_facility: Clinique de l'Orangerie - Service de Néphrologie et Dialyse


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


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

acronym: ALEX

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

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

publisher_dissemination: Informa

lead_sponsor: Fondation Lenval

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval


title: Impact of Attention Deficit/Hyperactivity Disorder on the Post-detoxification Alcohol Relapse Rate

acronym: AGADIR

summary:
Some recent studies have found that adult attention deficit - hyperactivity disorder (ADHD) was frequent among patients with alcohol-dependence. However, no investigation has ever addressed whether ADHD may impact the drinking outcome.

Moreover, most of the different aforementioned studies assessed ADHD using the ADHD self-report scale (ASRS). The ASRS is a screening questionnaire that is of limited diagnostic value, and the overrepresentation of high-score ASRS among patients with alcohol-dependence could be in part due to differential diagnoses such as antisocial or borderline personality disorders, executive function impairments, or isolated impulsiveness.

The study aims to evaluate "ADHD: Gaps between patients with Alcohol Dependence and Impact on early Relapse" (AGADIR). In AGADIR, subjects with alcohol-dependence are recruited at the end of a residential detoxification program. They are assessed for ADHD using the ASRS, but also with a standardized diagnostic tool, i.e., the Diagnostic Interview for ADHD in adults (DIVA 2.0). Potential differential diagnoses are screened during the baseline visit. The patients are followed-up during the 12 first post-detox weeks, through a standardized psychosocial treatment. ASRS is re-performed at the end of the follow-up.

lead_sponsor: University Hospital, Lille

collaborators: Institute for Scientific Research on Beverages (France)


title: Metabolic Effects of an 8 Week Niaspan Treatment in Patients With Abdominal Obesity and Mixed Dyslipidemia

summary: Nicotinic acid (Niacin) has been used for many years for the treatment of dyslipidemia. Indeed Niacin decreases triglycerides (TG) and low density lipoprotein cholesterol (LDL-c) but more importantly increases high density lipoprotein cholesterol (HDL-c). Although the drug has been used for so long, its precise mechanism of action remains elusive. The aim of this study was to characterise the metabolic changes induced by 8 week treatment with Niacin in dyslipidemic, overweight patients. The importance of the inhibition of lipolysis on the overall lipid effects of niacin will be studied. In order to get a very comprehensive view of all metabolic activities of niacin, this study will investigate the potential effects of niacin on Glucose metabolism, lipid and lipoprotein turnover, quantitative changes in lipoproteins and key enzymes involved in lipid metabolism.

primary_purpose: Basic Science

ReferenceCitation: Blanchard V, Ramin-Mangata S, Billon-Crossouard S, Aguesse A, Durand M, Chemello K, Nativel B, Flet L, Chetiveaux M, Jacobi D, Bard JM, Ouguerram K, Lambert G, Krempf M, Croyal M. Kinetics of plasma apolipoprotein E isoforms by LC-MS/MS: a pilot study. J Lipid Res. 2018 May;59(5):892-900. doi: 10.1194/jlr.P083576. Epub 2018 Mar 14.

evidence: open (via crossref license)

repository_institution: PubMed Central - Europe PMC

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut | Nicod

repositories_concat: HAL;PubMed Central

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

ReferenceCitation: Ferchaud-Roucher V, Croyal M, Moyon T, Zair Y, Krempf M, Ouguerram K. Plasma Lipidome Analysis by Liquid Chromatography-High Resolution Mass Spectrometry and Ion Mobility of Hypertriglyceridemic Patients on Extended-Release Nicotinic Acid: a Pilot Study. Cardiovasc Drugs Ther. 2017 Jun;31(3):269-279. doi: 10.1007/s10557-017-6737-y.

lead_sponsor: Centre de Recherche en Nutrition Humaine Rhone-Alpe