title: Observatoire de l'ANTADIR - Database of Patients Registered as Treated With Respiratory Support in a Multicenter Homecare Federation for Patients Wirh Respiratory Problems

acronym: observatory

summary: An observatory of patients registered in 22 local homecare associations in France, for respiratory diseases, with annual data update. Demographic and clinical data are registered rendering possible extraction of clinical and prognostic data.

ReferenceCitation: Chambellan A, Chailleux E, Similowski T; ANTADIR Observatory Group. Prognostic value of the hematocrit in patients with severe COPD receiving long-term oxygen therapy. Chest. 2005 Sep;128(3):1201-8. Erratum in: Chest. 2006 Mar;129(3):831.

ReferenceCitation: Chailleux E, Laaban JP, Veale D. Prognostic value of nutritional depletion in patients with COPD treated by long-term oxygen therapy: data from the ANTADIR observatory. Chest. 2003 May;123(5):1460-6.

ReferenceCitation: Chailleux E, Boffa C. [Chronic respiratory insufficiency in France]. Rev Prat. 2001 May 31;51(10):1061-5. Review. French.

ReferenceCitation: Veale D, Chailleux E, Hoorelbeke-Ramon A, Reybet-Degas O, Humeau-Chapuis MP, Alluin-Aigouy F, Fleury B, Jonquet O, Michard P. Mortality of sleep apnoea patients treated by nasal continuous positive airway pressure registered in the ANTADIR observatory. Association Nationale pour le Traitement A Domicile de l'Insuffisance Respiratoire chronique. Eur Respir J. 2000 Feb;15(2):326-31.

ReferenceCitation: Veale D, Chailleux E, Taytard A, Cardinaud JP. Characteristics and survival of patients prescribed long-term oxygen therapy outside prescription guidelines. Eur Respir J. 1998 Oct;12(4):780-4.

ReferenceCitation: Voisin C. [Medico-social management of severe respiratory insufficiency. Role of Associations]. Bull Acad Natl Med. 1998;182(6):1159-71; discussion 1172. Review. French.

ReferenceCitation: Chailleux E, Fauroux B, Binet F, Dautzenberg B, Polu JM. Predictors of survival in patients receiving domiciliary oxygen therapy or mechanical ventilation. A 10-year analysis of ANTADIR Observatory. Chest. 1996 Mar;109(3):741-9.

lead_sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche


title: Study of Parental Stress and Care Consumption Until 24 Months Corrected Age of Infants at a High Risk of Developmental Delay, After Discharge From Neonatal Intensive Care

acronym: DeStreSs

summary:
Cerebral palsy (CP) is the leading cause of motor disability in children, affecting 125,000 people in France and with 1800 new cases per year. Prematurity remains a major risk factor, although children born at term represent 52% of children with cerebral palsy in France. Recent international and national (Haute Autorité de Santé, Troubles du neurodéveloppement - Repérage et orientation des enfants à risque, February 2020) recommendations emphasize the importance of continuous, early, and systematic management of infants at risk of cerebral palsy before 6 months of corrected age (CA), which is beneficial on the motor, cognitive, and social development of these children into preschool age. The principles of early identification and therapeutic intervention, which are at the core of multi-professional care, are becoming better known.

The priorities of this care are: the identification of high-risk infants, the continuity of follow-up from the neonatal period and after the return home in order to detect motor developmental disorders as early as possible, with a the global approach centered on the family. From the neonatal period, parents have traumatic experiences and are subjected to sources of stress. A framework of trust must be established during hospitalization, and preventive, multidisciplinary post-hospitalization follow-up is necessary. Informing families about the risks of motor developmental disorders that may affect their child and about the necessary follow-up in the first months is essential to obtain their adherence to an early course of action. This should take place even before parents have noticed abnormalities, and without waiting for a proven disability. However, it is necessary to support parents in these difficult situations by trying to reduce stress and to preserve the role of the parent.

Finally, the ESPaCe survey reveals several of the challenges faced by parents of children with CP: difficulty in finding trained therapists, low frequency of sessions, heterogeneity of rehabilitation techniques, and 75% of parents felt excluded from care and wish to be more involved. Fondation Motrice has therefore suggested developing recommendations for good clinical practice based on scientific evidence to address these difficulties.

In this context, the physiotherapists of the CHU Dijon Bourgogne have implemented the recommended early identification tools in the traditional perinatal follow-up pathway by collaborating with the neonatologists and rehabilitation physicians of the CHU Dijon Bourgogne. After the child goes home from the hospital, professionals can ensure continuity and adapt developmental support care by continuing to accompany the families. The follow-up pathway currently offered to these high-risk children includes a motor assessment at 4, 9 and 24 months of corrected age, with an additional consultation at 18 months of corrected age depending on the child's neurodevelopment. However, the psychological impact of this type of pathway on the parents, their satisfaction and their level of adherence to this care pathway are currently unknown.

Therefore, the objective of the DéStreSs study is to describe the level of parental stress and whether is varies over time, the consumption of care, parent satisfaction, and adherence to the follow-up program currently offered at the Dijon Bourgogne University Hospital.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire Dijon

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: eDiagEPU, a Computerized Help to Diagnosis for Early Pregnancy Unit : a Retrospective Study

acronym: eDiagEPU

summary: In a recently published study, a poor knowledge of guidelines in the field of early pregnancy was observed in France, Belgium and Switzerland. To improve the respect of the most recent criteria of diagnoses, a computerized tool was developped.

status: Completed

study_completion_date_type: Actual

time_perspective: Retrospective

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Blavier F, Cosyns S, Dony N, Faron G, Parra J, Gucciardo L. Perception and knowledge of early pregnancy assessment units among perinatal practitioners in Europe. Int J Gynaecol Obstet. 2018 Dec;143(3):289-299. doi: 10.1002/ijgo.12661. Epub 2018 Sep 21.

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

status_simplified: Completed


type: Other Identifier

title: Effectiveness of a Case Management Algorithm on Clinical Outcome After Consultations Requested in a Clinical Forensic Medicine Unit by Female Victims of Violence

acronym: VIGITRAUMA

summary:
A considerable body of research has demonstrated that women who are victims of interpersonal violence are at substantially elevated risk for the development of post-traumatic stress disorder (PTSD). In France, victims can request a medico-legal examination in a clinical forensic medicine unit. Although these units are also a place for initial psychological examination, women often don't attend future scheduled appointments. Decision-making algorithm using phone contact are effective in suicide prevention. Our aim is to assess the effectiveness of case management algorithm using early phone contact compared to a control group treated as usual on clinical outcome after consultation requested in a clinical forensic medicine unit by female victims of violence.

Method: Prospective, multicenter, open-label, randomized controlled clinical trial, for women victims of violence. Victims randomized in VIGITRAUMA group will be contacted by phone at 3 weeks after the consultation in a clinical forensic medicine unit, and a second phone call can be done. If the subject is not contacted after the second phone call, he will receive a postcard.

Control group will benefit from usual follow-up.

All the subjects included will be then evaluated at 3 months, 6 months and 1 year during a phone call.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: University Hospital, Lille

location_facility:
General Hospital, Saint-Quentin
University Hospital, Amiens
University Hospital, Caen
University Hospital, Lille
General Hospital, Creil
University Hospital, Rouen
General Hospital, Valenciennes
General Hospital, Boulogne sur Mer


title: Evaluation of a Back-to-home Support Program for Hospitalized Patients for Heart Failure

summary:
The prevalence of heart failure is very high worldwide is between 1 and 2% in developed countries.

The French Federation of Cardiology estimates that a million people are affected in France. Each year in France, there are nearly 70,000 deaths linked to heart failure, and more than 150,000 hospitalizations with an average cumulative duration per year of 12.7 days, figures which show the extent of the phenomenon. Heart failure is therefore a common pathology, which constitutes an important public health issue. It requires rigorous monitoring and early adaptation of treatments to avoid repeated hospitalizations. Studies show that following hospitalization for heart failure, all-cause re-hospitalization rates rise to 18% within 30 days. In 2019, the rate of re-hospitalization at 1 year is 30%, half of which in the following 3 months. The prognosis is grim with 20 to 30% of deaths within the year.

The European Society of Cardiology recommends that the patient be integrated into a care path coordinated by the general practitioner; and a consultation with his general practitioner in the week after hospitalization and his cardiologist within two weeks. The CPAM (Caisse Primaire d'Assurance Maladie) has set up since 2013 the PRADO-IC program (Program for Return to Home Hospital for Heart Failure). This program must be in place before discharge from hospital. A health insurance advisor comes to meet the patient, declared eligible for PRADO by the hospital medical team, to present the offer and collect his approval before discharge. He then contacts the attending physician and organizes his return home. A follow-up book is given to the patient to allow better transmission of information between town and hospital.

A specially trained nurse visits the patient's home every week. The duration of PRADO support varies according to the NYHA stage of severity. It provides therapeutic education with reinforcement of hygieno-dietetic rules, warning signs, checks compliance with treatments and the necessary biological monitoring and must alert the attending physician in the event of aggravation.

The objectives of this program are: to preserve the quality of life and the autonomy of patients, to support the reduction of the length of stay in hospital, to strengthen the quality of care in town around the attending physician, improve the efficiency of recourse to hospitalization by reserving the heaviest structures for the patients who need them most.

status: Active, not recruiting

ReferenceType: background

ReferenceCitation: Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, González-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. Erratum in: Eur Heart J. 2016 Dec 30;:.

ReferenceCitation: Gheorghiade M, Vaduganathan M, Fonarow GC, Bonow RO. Rehospitalization for heart failure: problems and perspectives. J Am Coll Cardiol. 2013 Jan 29;61(4):391-403. doi: 10.1016/j.jacc.2012.09.038. Epub 2012 Dec 5.

ReferenceCitation: Albert NM, Barnason S, Deswal A, Hernandez A, Kociol R, Lee E, Paul S, Ryan CJ, White-Williams C; American Heart Association Complex Cardiovascular Patient and Family Care Committee of the Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Transitions of care in heart failure: a scientific statement from the American Heart Association. Circ Heart Fail. 2015 Mar;8(2):384-409. doi: 10.1161/HHF.0000000000000006. Epub 2015 Jan 20.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Evaluation of the Program to Help Return Home Patients Hospitalized for Heart Failure, in a Cohort of Patients From the Hôpital Paris Saint-Joseph

ReferenceCitation: Tuppin P, Cuerq A, de Peretti C, Fagot-Campagna A, Danchin N, Juillière Y, Alla F, Allemand H, Bauters C, Drici MD, Hagège A, Jondeau G, Jourdain P, Leizorovicz A, Paccaud F. First hospitalization for heart failure in France in 2009: patient characteristics and 30-day follow-up. Arch Cardiovasc Dis. 2013 Nov;106(11):570-85. doi: 10.1016/j.acvd.2013.08.002. Epub 2013 Oct 18.

ReferenceCitation: Assyag P, Renaud T, Cohen-Solal A, Viaud M, Krys H, Bundalo A, Michel PL, Boukobza R, Bourgueil Y, Cohen A. RESICARD: East Paris network for the management of heart failure: absence of effect on mortality and rehospitalization in patients with severe heart failure admitted following severe decompensation. Arch Cardiovasc Dis. 2009 Jan;102(1):29-41. doi: 10.1016/j.acvd.2008.10.013. Epub 2009 Feb 10.

ReferenceCitation: Desai AS. The three-phase terrain of heart failure readmissions. Circ Heart Fail. 2012 Jul 1;5(4):398-400. doi: 10.1161/CIRCHEARTFAILURE.112.968735.

ReferenceCitation: Abassade P, Cohen L, Fels A, Chatellier G, Sacco E, Beaussier H, Fleury L, Komajda M, Cador R. [Impact of Home Return Assistance Service in Heart Failure (PRADO-IC) on the one year re-hospitalisation and mortality in a heart failure hospitalized population of patients]. Ann Cardiol Angeiol (Paris). 2022 Aug 5. pii: S0003-3928(22)00113-5. doi: 10.1016/j.ancard.2022.07.004. [Epub ahead of print] French.


intervention_type: Drug

acronym: PACS 11 - UNIRAD

title: Randomized, Double Blind, Multicentric Phase III Trial Evaluating the Safety and Benefit of Adding Everolimus to Adjuvant Hormone Therapy in Women With High Risk of Relapse, ER+ and HER2- Primary Breast Cancer Who Remain Free of Disease After Receiving at Least 1 Year of Adjuvant Hormone Therapy

lead_sponsor: UNICANCER

type: EudraCT Number

source: euctr

ReferenceType: derived

ReferenceCitation: Bachelot T, Cottu P, Chabaud S, Dalenc F, Allouache D, Delaloge S, Jacquin JP, Grenier J, Venat Bouvet L, Jegannathen A, Campone M, Del Piano F, Debled M, Hardy-Bessard AC, Giacchetti S, Mouret-Reynier MA, Barthelemy P, Kaluzinski L, Mailliez A, Legouffe E, Sephton M, Bliss J, Canon JL, Penault-Llorca F, Lemonnier J, Cameron D, Andre F. Everolimus Added to Adjuvant Endocrine Therapy in Patients With High-Risk Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Primary Breast Cancer. J Clin Oncol. 2022 Nov 10;40(32):3699-3708. doi: 10.1200/JCO.21.02179. Epub 2022 May 23.

location_facility:
Centre Leon Berard
Gustave Roussy

summary:
A significant number of patients relapse and eventually die, particularly if they were initially diagnosed with large nodes involvement and/or T3/4 diseases. When analyses focus on patients with ER+/Her2-negative breast cancer, with ≥4N+, 30% had relapsed at 5 years, emphasizing the need for new drugs in this setting (PACS01 data, UNICANCER internal data).

Strong evidence suggests that cross-talk between the phosphatidylinositol 3-kinase (PI3K)/AKT/mammalian target of rapamycin (mTOR) pathway and ER signaling is linked to hormone resistance in breast cancer patients.

In the present study, we plan to evaluate the benefit from adding everolimus to standard endocrine treatments after three years of treatment for patient ER+/HER2- at high risk of relapse due to high nodes involvement (≥4) and/or persistent node involvement after neo-adjuvant chemotherapy.

Genomic signatures have emerged during the last 10 years as a new and additive means to evaluate more precisely long term prognosis, and in some instances the amount of benefit from chemotherapy or endocrine therapy in the adjuvant setting. Therefore, the UNIRAD study can be proposed to patients with 1-3 positive lymph nodes at primary surgery and a high risk of relapse with the EndoPredict test.

This study is a unique opportunity to prove the efficacy of everolimus in adjuvant setting. The study could be practice changing in case of positive results and could allow improving outcome of breast cancer patients presenting high risk of metastatic relapse.

lead_sponsor_type: industriel


title: Randomized Phase III Trial Evaluating the Role of Autologous Stem Cell Transplantation in Previously Untreated Patients With Stage B and C Chronic Lymphocytic Leukemia

acronym: Auto-LLC 2001

summary:
Phase III trial evaluating the role of autologous stem cell transplantation in previously untreated patients under 65 years with stage B and C B-cell chronic lymphocytic leukemia.

Endpoints of the trial :

major : progression free survival at 3 years
secondary : overall survival, tolerance, prognostic factors according to baseline clinical stage and biological characteristics (IgHv mutational status, expression of ZAP70 and CD38, cytogenetics).

lead_sponsor: University Hospital, Caen

intervention_type: Procedure


title: Application of Guidelines for Medico-professional Supervision of Workers Exposed to Carcinogenic Action of Wood Dust: CERBois Cohort. Feasibility Evaluation

acronym: CERBois

summary:
The purpose is to evaluate feasibility of medical supervision of professionally active asymptomatic wood workers with questionnaires and nasofibroscopy.

Secondary purposes are:

Feasibility evaluation of identification of former and actual professional expositions to wood dust and to various naso-sinusal carcinogenics in case of co-expositions (formaldehyde, chrome, nickel, leather)
Description of abnormal symptoms identified by occupational doctor and needing an otorhinolaryngology test
Description of results and examinations induced by nasofibroscopy in symptomatic or asymptomatic individuals: counting of naso-sinusal adenocarcinoma cases
Evaluation of participation of workers retiring in 2 years after inclusion to medical supervision program
Evaluation of information flow among different players
Assessment of costs induced by this targeted screening: direct medical costs (screened pathologies, induced additional examinations…) and indirect costs for company (duration of worker absence for transfer, medical and additional examinations).

ipd_sharing: No

lead_sponsor: Central Hospital, Nancy, France

location_facility: Centres de Consultations de Pathologies Professionnelles


title: Study of the Impact of the COVID-19 Pandemic on the Management of Type 2 Diabetic Patients in a Sample in the Paris Region

acronym: DIABETOVID

summary:
The Covid-19 crisis is undoubtedly the most significant event of the early 21st century. The pandemic has profoundly changed our way of life, whether as human beings, but also as patients or caregivers. This pandemic of an incredible magnitude, after having been minimized, blew a wind of fear on the whole world because of the unknown that the SARS-CoV2 virus represented. The world scientific community being destabilized, a great majority of states decided to apply a containment. In France, a strict containment was applied between March 17, 2020 and May 11, 2020 (1 month and 23 days, about 8 weeks). Diabetic and obese patients were designated as "at risk" for infection by COVID 19. Type 2 diabetes is one of the most common chronic diseases in general practice. Its regular management, we know, is largely related to lifestyle, which is particularly important in controlling the disease and preventing complications. During the first months of the pandemic, we witnessed many emergency room visits of patients with chronic pathologies, in full decompensation, due to a lack of follow-up but also due to a lack of treatment. After the first containment, in the endocrinology department of the Paris Saint-Joseph hospital, we observed that many patients had a clear imbalance of their diabetes compared to their previous history.

The main objective of this study is to show that the COVID-19 pandemic, and more precisely the strict confinement applied in France from March 17, 2020 to May 11, 2020, had an impact on diabetes control in the study population. The secondary objectives are to study the explanatory covariates via the modification of the lifestyle of diabetic patients (decrease in physical activity, increase in poor dietary habits, psychological impact related to the situation, difficulties in accessing care, modification of work arrangements).

ReferenceCitation: Ghosal S, Sinha B, Majumder M, Misra A. Estimation of effects of nationwide lockdown for containing coronavirus infection on worsening of glycosylated haemoglobin and increase in diabetes-related complications: A simulation model using multivariate regression analysis. Diabetes Metab Syndr. 2020 Jul - Aug;14(4):319-323. doi: 10.1016/j.dsx.2020.03.014. Epub 2020 Apr 10.

ReferenceCitation: Fernández E, Cortazar A, Bellido V. Impact of COVID-19 lockdown on glycemic control in patients with type 1 diabetes. Diabetes Res Clin Pract. 2020 Aug;166:108348. doi: 10.1016/j.diabres.2020.108348. Epub 2020 Jul 22.

ReferenceCitation: Ruiz-Roso MB, Knott-Torcal C, Matilla-Escalante DC, Garcimartín A, Sampedro-Nuñez MA, Dávalos A, Marazuela M. COVID-19 Lockdown and Changes of the Dietary Pattern and Physical Activity Habits in a Cohort of Patients with Type 2 Diabetes Mellitus. Nutrients. 2020 Aug 4;12(8). pii: E2327. doi: 10.3390/nu12082327.

ReferenceCitation: Ruissen MM, Regeer H, Landstra CP, Schroijen M, Jazet I, Nijhoff MF, Pijl H, Ballieux BEPB, Dekkers O, Huisman SD, de Koning EJP. Increased stress, weight gain and less exercise in relation to glycemic control in people with type 1 and type 2 diabetes during the COVID-19 pandemic. BMJ Open Diabetes Res Care. 2021 Jan;9(1). pii: e002035. doi: 10.1136/bmjdrc-2020-002035.

ReferenceCitation: Karatas S, Yesim T, Beysel S. Impact of lockdown COVID-19 on metabolic control in type 2 diabetes mellitus and healthy people. Prim Care Diabetes. 2021 Jun;15(3):424-427. doi: 10.1016/j.pcd.2021.01.003. Epub 2021 Jan 9.

ReferenceCitation: Tanji Y, Sawada S, Watanabe T, Mita T, Kobayashi Y, Murakami T, Metoki H, Akai H. Impact of COVID-19 pandemic on glycemic control among outpatients with type 2 diabetes in Japan: A hospital-based survey from a country without lockdown. Diabetes Res Clin Pract. 2021 Jun;176:108840. doi: 10.1016/j.diabres.2021.108840. Epub 2021 Apr 30.


title: "Detection of Acute Rejection in Heart Transplant Patients by Mean of T2 Quantification With MRI" Open Transversal Clinical Trial With Repeated Measures

acronym: DRAGET

summary:
The investigators propose a simple and non-invasive method to monitor heart transplant patients with MRI. Its diagnostic and prognostic values have already been assessed in two monocentric studies. Other monocentric studies based on related methods have confirmed the investigators findings. These studies are insufficient to allow a large diffusion of the technique. Only a large multi-centric study will change medical practices. In addition, this project will spread the new method at a national level and will allow an assessment of its practical usefulness in centres not familiar with MRI T2 quantification.

Furthermore, MRI seems to detect rejections at earlier stage than biopsy. A confirmation of this observation could lead to a modification of diagnostic criteria of cardiac graft rejection. The ultimate aim of the DRAGET project is to replace a strategy based solely on biopsy with one based on a first-line MRI (with biopsy only when needed) for a more efficient and earlier detection of rejection. This would constitute a major advance in patients security and comfort as well as an economic improvement.

primary_purpose: Diagnostic

ReferenceCitation: Bonnemains L, Cherifi A, Girerd N, Odille F, Felblinger J. Design of the DRAGET Study: a multicentre controlled diagnostic study to assess the detection of acute rejection in patients with heart transplant by means of T2 quantification with MRI in comparison to myocardial biopsies. BMJ Open. 2015 Oct 29;5(10):e008963. doi: 10.1136/bmjopen-2015-008963.

location_facility:
CHU de Nantes
CHU Bordeaux
CHU de Tours
Hôpital Européen Georges Pompidou
CHU Grenoble
Groupe Hospitalier Pitié-Salpêtrière
CHU de Rennes
Hospices Civils de Lyon
Hopitaux Universitaires de Strasbourg
CHRU Nancy Brabois

intervention_type: Device


title: Causes of Fetal Death: Comparison of Diagnostic Accuracy Between Extensive and Selective Protocol Testing

acronym: EMIBICI

summary: Intrauterine fetal death (IUFD) is defined as the occurrence of fetal death at >20 weeks' gestation. IUFD affects about 1 in 160 pregnancies (6-7 per 1000 births). Optimal diagnostic evaluation for cases of IUFD is generally based on extensive protocol testing i.e. maternal and fetal blood tests, fetal bacteriology, cytogenetic analysis, autopsy, and placental examination. This extensive protocol testing may vary in clinical practice and interpretation of the results is rarely performed by multidisciplinary staff to establish cause of death. These findings are related to the fact that there are very few epidemiological studies to validate optimal protocol, no French recommendations on this subject, and a relative lack of pathologists with expertise in perinatal pathology. Only, one recent prospective study from the Netherlands has concluded that extensive protocol testing should be redefined and some diagnostics tests may only be performed with suggestive clinical circumstances. However these recommendations may not be applicable to all populations and countries. To date, there are no French published series on IUFD to evaluate causes of death in France and thereafter to better define optimal diagnostic evaluation tests. Improvement in prenatal diagnosis in France may contribute to detection of the vast majority of severe chromosomal abnormalities and malformed fetuses and particularly those at risk of death. Retrospective cohort unpublished data on IUFD from Lille and Caen have reported exceptional deaths attributable to chromosomal or malformation abnormalities. In fact in these two series, most deaths were related to placental diseases or fetal growth retardation. The hypothesis is that extensive protocol testing is not helpful in clinical practice and selective protocol testing focused on specific risk situations can be as efficient.

lead_sponsor: University Hospital, Rouen

intervention_type: Diagnostic Test


title: Sensitivity of Fecal Immunochemical Test (FIT) for Colorectal Cancer (CRC) Screening and Interval Cancer Risk : a Population Based Study

acronym: FITBACK

summary: Fecal immunochemical test (FIT) was introduced in France late 2015, FIT has better diagnostic accuracy for colorectal cancers (CRCs) than previous screening tests. Our primary objective was to evaluate the sensitivity of FIT and the proportion of interval cancer.

ReferenceCitation: Lee KJ, Inoue M, Otani T, Iwasaki M, Sasazuki S, Tsugane S; Japan Public Health Center-based Prospective Study. Colorectal cancer screening using fecal occult blood test and subsequent risk of colorectal cancer: a prospective cohort study in Japan. Cancer Detect Prev. 2007;31(1):3-11. doi: 10.1016/j.cdp.2006.11.002. Epub 2007 Feb 7.

ReferenceCitation: Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

ReferenceCitation: Drouillard A, Bouvier AM, Rollot F, Faivre J, Jooste V, Lepage C. Conditional net survival: Relevant prognostic information for colorectal cancer survivors. A French population-based study. Dig Liver Dis. 2015 Jul;47(7):597-601. doi: 10.1016/j.dld.2015.03.013. Epub 2015 Mar 27.

ReferenceCitation: Tinmouth J, Lansdorp-Vogelaar I, Allison JE. Faecal immunochemical tests versus guaiac faecal occult blood tests: what clinicians and colorectal cancer screening programme organisers need to know. Gut. 2015 Aug;64(8):1327-37. doi: 10.1136/gutjnl-2014-308074. Epub 2015 Jun 3.

ReferenceCitation: Brenner H, Tao S. Superior diagnostic performance of faecal immunochemical tests for haemoglobin in a head-to-head comparison with guaiac based faecal occult blood test among 2235 participants of screening colonoscopy. Eur J Cancer. 2013 Sep;49(14):3049-54. doi: 10.1016/j.ejca.2013.04.023. Epub 2013 May 22.

ReferenceCitation: European Colorectal Cancer Screening Guidelines Working Group, von Karsa L, Patnick J, Segnan N, Atkin W, Halloran S, Lansdorp-Vogelaar I, Malila N, Minozzi S, Moss S, Quirke P, Steele RJ, Vieth M, Aabakken L, Altenhofen L, Ancelle-Park R, Antoljak N, Anttila A, Armaroli P, Arrossi S, Austoker J, Banzi R, Bellisario C, Blom J, Brenner H, Bretthauer M, Camargo Cancela M, Costamagna G, Cuzick J, Dai M, Daniel J, Dekker E, Delicata N, Ducarroz S, Erfkamp H, Espinàs JA, Faivre J, Faulds Wood L, Flugelman A, Frkovic-Grazio S, Geller B, Giordano L, Grazzini G, Green J, Hamashima C, Herrmann C, Hewitson P, Hoff G, Holten I, Jover R, Kaminski MF, Kuipers EJ, Kurtinaitis J, Lambert R, Launoy G, Lee W, Leicester R, Leja M, Lieberman D, Lignini T, Lucas E, Lynge E, Mádai S, Marinho J, Maučec Zakotnik J, Minoli G, Monk C, Morais A, Muwonge R, Nadel M, Neamtiu L, Peris Tuser M, Pignone M, Pox C, Primic-Zakelj M, Psaila J, Rabeneck L, Ransohoff D, Rasmussen M, Regula J, Ren J, Rennert G, Rey J, Riddell RH, Risio M, Rodrigues V, Saito H, Sauvaget C, Scharpantgen A, Schmiegel W, Senore C, Siddiqi M, Sighoko D, Smith R, Smith S, Suchanek S, Suonio E, Tong W, Törnberg S, Van Cutsem E, Vignatelli L, Villain P, Voti L, Watanabe H, Watson J, Winawer S, Young G, Zaksas V, Zappa M, Valori R. European guidelines for quality assurance in colorectal cancer screening and diagnosis: overview and introduction to the full supplement publication. Endoscopy. 2013;45(1):51-9. doi: 10.1055/s-0032-1325997. Epub 2012 Dec 4.

ReferenceCitation: Ventura L, Mantellini P, Grazzini G, Castiglione G, Buzzoni C, Rubeca T, Sacchettini C, Paci E, Zappa M. The impact of immunochemical faecal occult blood testing on colorectal cancer incidence. Dig Liver Dis. 2014 Jan;46(1):82-6. doi: 10.1016/j.dld.2013.07.017. Epub 2013 Sep 4.

ReferenceCitation: Lee JK, Liles EG, Bent S, Levin TR, Corley DA. Accuracy of fecal immunochemical tests for colorectal cancer: systematic review and meta-analysis. Ann Intern Med. 2014 Feb 4;160(3):171. doi: 10.7326/M13-1484. Review.

ReferenceCitation: Parra-Blanco A, Gimeno-Garcia AZ, Quintero E, Nicolas D, Moreno SG, Jimenez A, Hernandez-Guerra M, Carrillo-Palau M, Eishi Y, Lopez-Bastida J. Diagnostic accuracy of immunochemical versus guaiac faecal occult blood tests for colorectal cancer screening. J Gastroenterol. 2010 Jul;45(7):703-12. doi: 10.1007/s00535-010-0214-8. Epub 2010 Feb 17.

ReferenceCitation: Chiu HM, Chen SL, Yen AM, Chiu SY, Fann JC, Lee YC, Pan SL, Wu MS, Liao CS, Chen HH, Koong SL, Chiou ST. Effectiveness of fecal immunochemical testing in reducing colorectal cancer mortality from the One Million Taiwanese Screening Program. Cancer. 2015 Sep 15;121(18):3221-9. doi: 10.1002/cncr.29462. Epub 2015 May 20.

ReferenceCitation: van der Vlugt M, Grobbee EJ, Bossuyt PMM, Bos A, Bongers E, Spijker W, Kuipers EJ, Lansdorp-Vogelaar I, Spaander MCW, Dekker E. Interval Colorectal Cancer Incidence Among Subjects Undergoing Multiple Rounds of Fecal Immunochemical Testing. Gastroenterology. 2017 Aug;153(2):439-447.e2. doi: 10.1053/j.gastro.2017.05.004. Epub 2017 May 5.

ReferenceCitation: van de Veerdonk W, Hoeck S, Peeters M, Van Hal G, Francart J, De Brabander I. Occurrence and characteristics of faecal immunochemical screen-detected cancers vs non-screen-detected cancers: Results from a Flemish colorectal cancer screening programme. United European Gastroenterol J. 2020 Mar;8(2):185-194. doi: 10.1177/2050640619882157. Epub 2019 Oct 3.

ReferenceCitation: Portillo I, Arana-Arri E, Idigoras I, Bilbao I, Martinez-Indart L, Bujanda L, Gutierrez-Ibarluzea I. Colorectal and interval cancers of the Colorectal Cancer Screening Program in the Basque Country (Spain). World J Gastroenterol. 2017 Apr 21;23(15):2731-2742. doi: 10.3748/wjg.v23.i15.2731.

lead_sponsor: University Hospital, Brest


primary_purpose: Prevention

intervention_type: Biological

title: Randomized, Single-blinded, Multicenter Trial Comparing the Immune Response to a 2nd Booster Dose of COVID-19 mRNA Vaccine (Pfizer-BioNTech) or Sanofi /GSK B.1.351 Adjuvanted Vaccine in Adults Who Received 2 Doses of Pfizer-BioNTech mRNA Vaccine and a Booster Dose of Pfizer-BioNTech or Moderna mRNA Vaccine

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: GH Broca-Cochin-Hôtel-Dieu CIC 1417 Cochin-Pasteur

summary:
The effectiveness of COVID-19 vaccines in reducing the risk of severe COVID-19 is currently demonstrated. In France, since the beginning of the vaccination campaign, 54,266,859 people have received at least one injection (ie. 80.5% of the total population), 53,354,698 people now have a complete vaccination schedule (ie. 79.1% of the total population) and since the beginning of the booster campaign, 39,558,416 people have received a 1st booster dose.

However, the data currently available on the persistence of immunity on the one hand, and the appearance of viral variants with reduced sensitivity to vaccine immunity on the other, suggest the need to administer booster doses at variable intervals depending on age and comorbidities. Real-life efficacy data from France and around the World confirm that people who have received a booster dose are better protected than those who have only received a primary vaccination schedule (HAS).

In this context, the Ministry of Health, has pronounced on the possibility of administering a second booster dose for people aged 60 and over. Moreover, the recommendations for the Haute Autorité de Santé for the 2nd booster dose in general population should be available in June 2022.

Three vaccines, mRNA BNT162b2 vaccine, Sanofi/GSK monovalent D614 and B.1.351 formulations were administered as 1st booster in the CoviBOOST trial. All three vaccines boosted antibodies and neutralizing response after a BNT162b2 initial course. Heterologous boosting with the Sanofi/GSK SARS-CoV-2 recombinant adjuvanted protein vaccine B.1.351 (Beta formulation) provided higher rates of neutralizing antibodies against variants, including Omicron BA.1, compared with the mRNA BNT162b2 vaccine. Due to the start of the study after the beginning of booster vaccination campaign in elderly, the enrollment of participants over 65 years of age was difficult so, only 8 subjects aged 60 years and over were enrolled. As vaccine immunogenicity is lower in older populations and is waning more rapidly, it is important to evaluate the adjuvanted vaccine in this population.

The objective of this ancillary study is to compare, in participants aged of 60 years and older and previously vaccinated with 3 doses of mRNA vaccine (2 doses of Pfizer BioNTech) and a 3rd dose of Pfizer BioNTech or Moderna, the immunogenicity of a second booster dose of the B.1.351 strain recombinant protein- based subunit vaccine to BNT162b2 (mRNA Pfizer BioNTech Vaccine).These results will provide important information for booster vaccination recommendations in this age group.


title: Correlation Between the Incidence of COVID-19 in Nursing-homes and the Profile of Nursing Homes in the French Alps

acronym: PROCOPAD

summary: Since the beginning of the COVID-19 outbreak in France, nursing homes (NH) have been heavily affected. In this study, the investigators want to evaluate the factors associated with the occurrence of COVID-19 epidemic clusters within the nursing homes in the French Alps

lead_sponsor: Centre Hospitalier Annecy Genevois


title: Emerging Health Challenges for Children With Motor Disabilities and Their Parents Facing the COVID-19 Pandemic: Messages From Families Answering the ECHO French National Survey

acronym: ECHO

summary: During the COVID-19 pandemic, lockdown measures were established in France affecting the life course of children with disabilities. This study aimed at identifying the experiences, main difficulties and needs of these children and their parents during the lockdown period.

time_perspective: Cross-Sectional


title: Automatic Detection in MRI of Prostate Cancer: DAICAP

acronym: DAICAP

summary:
Prostate cancer is the most common cancer in France and the 3rd most common cancer death in humans. The introduction of pre-biopsy MRI has considerably improved the quality of prostate cancer (PCa) diagnosis by increasing the detection of clinically significant PCa , and by reducing the number of unnecessary biopsies.However the diagnostic performance of Prostate MRI is highly dependent on reader experience that limits the population based delivery of high quality multiparametricMRI (mpMRI) driven PCa diagnosis. The main objective of this study is the development and the test of diagnostic accuracy of an AI algorithm for the detection of cancerous prostatic lesions from mpMRI images.

The secondary objective is the development and the test of diagnostic accuracy of an AI algorithm to predict tumor aggressiveness from mpMRI images.

time_perspective: Other


title: Comparison of Mortality Impact of Coagulation Rotative Thromboelastometry Analysis Versus Standard Analysis (Prothrombin Ratio) for Patients With Digestive Hemorrage

acronym: HD-ROTEM

summary: Digestive hemorrhage is a common cause of acute hemorrhage in France, and its mortality remains high despite improvement of endoscopy technique and therapeutics. Hemostasis disorders are an important issue in the patient care both in severity diagnostic and therapeutic plan.

status: Terminated

lead_sponsor: Centre Hospitalier Régional Metz-Thionville

status_simplified: Unknown


title: Adolescent Dysmenorrhea : Prevalence, Severity, Experience and Management in the Use of Medication in High School Girls in Ille-et-Vilaine

acronym: DAPsvs

summary:
Dysmenorrhea or painful menstruation is a common symptom of menses. Dysmenorrhea is defined as a painful, cramping sensation in the lower abdomen or back associated with menstrual periods and is classified into primary and secondary types. Primary dysmenorrhea is painful menstrual periods not due to other diseases, and often occurs soon after menarche. Secondary dysmenorrhea is due to an underlying pelvic abnormality, such as endometriosis.

Dysmenorrhea is the most common gynecological complaint. In many studies, the prevalence of primary dysmenorrhea varies between 34 % in 2010 in Egypt, 86.6% in 2002 in Switzerland, and 21% in 1999 in France.

Nowadays, physiopathology is better understood, which suggests that we have treatments Although dysmenorrhea is a common concern, many women never seek medical advice, even though treatments are easily available and simple.

In fact, despite the high prevalence, dysmenorrhea is undertreated and even disregarded by health professionals, and the girls themselves, who may accept it as a normal part of the menstrual cycle.

The pain occurs just before and/or during menstruation ; it can be mild to severe and is frequently associated with many other symptoms, like nausea, vomiting, headache, diarrhea, tiredness and has many consequences in wellbeing and school. Dysmenorrhea is known to be the first cause of absenteism from school, and appears to have many consequences and a real impact on women's daily activities, which is why it's a public health problem.

Because of the lack of recent studies in France, the aim of this study is to evaluate the prevalence of adolescent dysmenorrhea. We also assessed its severity, how adolescent girls experienced their menses, and how they manage their pain (seeking medical consultation, use of medication).

We used a self-assessment questionnaire in a cohort of high school girls, aged 15 to 19 years old, during April and May of 2019, in 8 private and public high schools in Ille-et-Vilaine.

lead_sponsor: Rennes University Hospital


type: Registry Identifier

title: "What if we Talked About it…" Identification of Cancer Patients Taking up a Proposal for Discussions Dedicated to Anticipating Preferences of Care in the Event of Aggravation (DDA): Prospective Cohort Intervention Study Using a Mixed Methodology

acronym: ESOP

summary:
Context: In people concerned by serious illness, how to anticipate the aggravation of the disease according to the patient's preferences is a challenging clinical question and an ethical key-issue to improve end-of-life care and quality of dying in France. When end of life decision occurs, many patients can no longer express themselves and advance directives do not seem to be appropriate for many patients despite the current strong incentives to write them, reinforced by the 2016 Claeys Leonetti.

The "End-of-Life Discussions" and "Advance care planning" programs developed in the United States have shown a positive impact on the aggressiveness of end-of-life care. The implementation in France of these programs has not yet been consolidated despite a first recommendation for "Planification des soins futurs", published by the French Health Authority(HAS). Inspired by the definition given in the later document, investigators propose the acronym DDA, for the Discussions Dedicated to Anticipate wishes and preferences in the event of Aggravation, defined as the dynamic and evolving process of reflection and communication between the patient, his relatives and healthcare professionals, allowing him to address his preferences and wishes regarding his care and treatment

The objective of this observational study is to characterize, in a population of patients with advanced cancer, the profile of those who take up a proposal for Dedicated Discussions on Anticipating preferences of care in the event of Aggravation (DDA) and who engage in the discussion process. Secondary objectives are to

evaluate the aggressiveness of end-of-life care in the group of patients who died 1 year after their inclusion, depending on their engagement in DDA occurs and whether or not their preferences are formalized; and
evaluate the subjective effects of the DDA with the patient and the investigating professionals, through qualitative approach by a clinical psychologist.

Method: investigators designed a mixed, quantitative and qualitative prospective, monocenter methodology to evaluate how patients take up a proposal of DDA. This proposal consists in 2 interviews: the first one is dedicated to the assessment of the patient's wishes in terms of information and participation in decision-making (API questionnaire) and to the assessment of the degree of anxiety and depression (HADS questionnaire) (E1). The second one is conducted 1 to 4 weeks later and consists in offering and initiating DDA (E2).

Quantitative outcome evaluated will be:

the documentation by a physician in the medical record, of patient's care preferences/values
the documentation by the patient of his care preference/values, either by designation of surrogate or by writing advanced directives
the usefulness and necessity of this approach, and the anxiety it generated, as perceived by the patient The qualitative assessment will be based on data collected during E1 and E2, and for 20 patients, during a clinical interview with a psychologist dedicated to collecting the patient's impressions of previous interviews.

Thanks to this study investigators expect to gather some data on the desire and feelings of cancer patients to engage in a DDA process and possibly formalize their end-of-life preferences, the impact of DDAs on care pathway indicators and the psychological effect for the patient with severe disease to project himself in advance into aggravation.

These expected results will provide a better understanding of the process of anticipating end-of-life situations, which is needed to improve quality of care and end-of-life conditions.

ReferenceCitation: Sudore RL, Heyland DK, Lum HD, Rietjens JAC, Korfage IJ, Ritchie CS, Hanson LC, Meier DE, Pantilat SZ, Lorenz K, Howard M, Green MJ, Simon JE, Feuz MA, You JJ. Outcomes That Define Successful Advance Care Planning: A Delphi Panel Consensus. J Pain Symptom Manage. 2018 Feb;55(2):245-255.e8. doi: 10.1016/j.jpainsymman.2017.08.025. Epub 2017 Sep 1.

ReferenceCitation: Michael N, O'Callaghan C, Clayton J, Pollard A, Stepanov N, Spruyt O, Michael M, Ball D. Understanding how cancer patients actualise, relinquish, and reject advance care planning: implications for practice. Support Care Cancer. 2013 Aug;21(8):2195-205. doi: 10.1007/s00520-013-1779-6. Epub 2013 Mar 14.

ReferenceCitation: Wright AA, Zhang B, Ray A, Mack JW, Trice E, Balboni T, Mitchell SL, Jackson VA, Block SD, Maciejewski PK, Prigerson HG. Associations between end-of-life discussions, patient mental health, medical care near death, and caregiver bereavement adjustment. JAMA. 2008 Oct 8;300(14):1665-73. doi: 10.1001/jama.300.14.1665.

ReferenceCitation: Mack JW, Cronin A, Keating NL, Taback N, Huskamp HA, Malin JL, Earle CC, Weeks JC. Associations between end-of-life discussion characteristics and care received near death: a prospective cohort study. J Clin Oncol. 2012 Dec 10;30(35):4387-95. doi: 10.1200/JCO.2012.43.6055. Epub 2012 Nov 13.

ReferenceCitation: Dow LA, Matsuyama RK, Ramakrishnan V, Kuhn L, Lamont EB, Lyckholm L, Smith TJ. Paradoxes in advance care planning: the complex relationship of oncology patients, their physicians, and advance medical directives. J Clin Oncol. 2010 Jan 10;28(2):299-304. doi: 10.1200/JCO.2009.24.6397. Epub 2009 Nov 23.

ReferenceCitation: Maciejewski PK, Prigerson HG. Emotional numbness modifies the effect of end-of-life discussions on end-of-life care. J Pain Symptom Manage. 2013 May;45(5):841-7. doi: 10.1016/j.jpainsymman.2012.04.003. Epub 2012 Aug 25.

location_facility: Unité Fonctionnelle de Médecine palliative, Hôpitaux Universitaire Paris Centre - CHU Cochin


title: Assessing, Depending on Personalized Manner, a Predicted Time to Delivery in the Context of Cervical Ripening With Dinoprostone Vaginal Insert

summary:
Induction of labor is a common obstetric procedure that is routinely performed worldwide. However, when cervical conditions are not favorable (bishop <6), induction of labor is preceded by cervical ripening, usually with prostaglandins. The method of ripening most commonly used in France (89% of maternity wards) is the dinoprostone vaginal insert. In the majority of hospitals in France, dinoprostone vaginal inserts are usually placed in the morning, because of the higher availability of personnel (midwives and nurses). However, morning placement might increase the likelihood of the delivery occurring at night, since the mean interval between the insert placement and delivery is about 13 to 20 hours. Many studies have now shown that the risk of obstetrical complications, as well as neonatal morbidity and mortality is increased when deliveries occur at night. Several factors have been suggested behind the increased morbidity at night, including the lower number of personnel working, the fatigue associated with night work and the disruption of the circadian rhythm, and the insufficient supervision of residents.

Very few studies have evaluated the importance of the timing of placement of the intravaginal dinoprostone insert, and its influence on the occurrence of night deliveries. Some investigators have recently performed a retrospective study at Angers university hospital that assessed the time interval between placing the dinoprostone vaginal insert and delivery, as well as the factors impacting the time to delivery, and found that nulliparity, obesity, a closed cervix on initial examination, and intact membranes at the time of insertion increased the time to delivery. Moreover, the investigators proposed a regression equation that allows to calculate the mean time from insert placement to delivery for each patient, and have decided to incorporate it in the routine practice.

The investigators have decided to analyze the validity of the mathematical model. The consequence would be, thanks to a personalized timing for placement of dinoprostone vaginal insert based on every patient's characteristics (parity, BMI, cervical dilation and state of membranes), a decreased number of deliveries occurring between 12 p.m. and 6 a.m.

status: Unknown status

lead_sponsor: University Hospital, Angers


title: A Comparative Study Between a Pre-hospital and an In-hospital Circulatory Support Strategy (ECMO) in Refractory Cardiac Arrest

summary:
Cardiac arrest (CA) affects approximately 40,000 people in France. It is still a major cause of death in a young population. Management of CA is defined by international recommendations, detailed by learned societies in each country. It includes several links that are interconnected for its optimisation. Despite all these improvements, no progress, or little has been made in the survival of CA victims over the past few years in industrialised countries, and the survival rate in France is 3% to 5%.

Refractory cardiac arrest is defined as failure, after 30 minutes of specialised resuscitation. It used to be the standard to admit that there was no hope of spontaneous cardiac activity and satisfactory neurological recovery after this period, except in cases of CA with neuroprotection (intoxication, hypothermia).

External circulatory support such as "extracorporeal membrane oxygenation" (ECMO) makes it possible to replace the circulatory activity of the myocardium and the respiratory activity of the lungs.

In in-hospital cardiac arrest (CA) some teams use ECMO with an improvement in the survival rate of 20% in comparison to standard resuscitation. This use demonstrates the possibility of neurological recovery independent of the recovery of spontaneous cardiac activity which can be differed.

These results encouraged the use of ECMOs in cases of out-of-hospital refractory cardiac arrests. Patients who are victims of CA are resuscitated for 30 minutes on the spot where the CA occurs. They are then transferred to a specialised centre. The significant improvement in survival noted in in-hospital CAs was not observed in the French series of studies concerning out-of-hospital CAs. This survival is currently estimated at 4%. This difference can be partly explained by the difference in time between the beginning of cardiac massage and the implementation of circulatory support by ECMO ("low flow" period). This time period is directly correlated to survival.

To demonstrate the superiority of this strategy in terms of survival, investigators would like to conduct a randomised comparative study of two strategies: 1) installation of an ECMO between the 20th minute to the 30 minute of CA, directly at the site of the CA, by emergency physicians and/or specifically trained resuscitators 2) On-site resuscitation optimised with secondary transfer to the hospital for the implementation of support. The purpose is to increase by 5% to 20% the survival of victims of out-of-hospital refractory cardiac arrests with a good neurological prognosis.

Main objective:

The hypothesis is that pre-hospital ECMO will result in survival for 20% of the patients, considering that the percentage of survival with in-hospital ECMO is less than 5%.

Main judgement criterion:

Survival with good neurological outcome (CPC 1 or 2) on discharge from intensive care or at 6 months

Secondary judgement criteria:

Success rate of the implementation of ECMO ECMO implementation time Immediate complications: haemorrhage, infection Number of organ harvesting The quality of survivors' neurological status according to the CPC neurological classification at D 28, 2 months and 1 year Predictive indicators of the prognosis during cardiac arrest via cerebral and biological monitoring Methodology, type of study: This is a prospective randomised study of current care Sample size (SS, power, risk): A total number of 105 patients in each group will make it possible to demonstrate at the alpha risk of 5% and a power of 1-β=90%, a significant difference in favour of early pre-hospital ECMO compared to the current practice with in-hospital ECMO.


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

location_facility:
Hôpital Saint-Joseph
Hôpital Sainte-Musse


title: Practical Efficiency of Coupling Targeted Temperature Management to Brain Temperature Rather Than Systemic Temperature in Severe Brain Injury (BRAIN TTM)

acronym: BRAINTTM

summary:
In severe brain-injured patients, it is recommended to strictly control the fever in order to limit brain damage (objective of neuroprotection) via the targeted temperature management (TTM). In the guidelines, the target temperature is the systemic temperature, just for practical reasons (brain temperature not being monitored in most polyvalent ICU). However, in NICU, the brain temperature is monitored routinely via the Intra-Cerebral Pressure (ICP) sensor. Since in the febrile brain-injured patients the objective of the TTM is neuroprotection, it would be more appropriate to target temperature control over the cerebral temperature.

The objective of this study is to evaluate the efficacy of TTM directly coupled to the brain temperature.

Adult patients with brain injury requiring ICP monitoring (Pressio 2, Sophysa France) and fever requiring TTM (cerebral greater than or equal to 38.5 °C) will be enrolled. The TTM will be carried out according to the usual methods of the investigator's service: external cooling devices coupled with cerebral temperature (Artic Sun, Bard France), including two phases: the cooling phase (H0 to H3) and the maintenance phase (from H3 to the end of the cooling).

Two groups will be formed. In the interventional group, coupling of the TTM will be carried out to the cerebral temperature. In the control group, coupling of the TTM will be carried out to the systemic temperature measured at the bladder site.

The primary outcome will be the percentage of time during which the cerebral temperature will be measured within recommended target temperature range (i.e. 36 to 37 °C) during the maintenance phase (H3 to H12): comparison of averages. Cerebral hemodynamic parameters (ICP, transcranial doppler, and brain tissue oxygen partial pressure if available) will also be collected, in order to be correlated with the delta temperature (cerebral temperature minor systemic temperature).

No medical device will be put in place specifically for the need of the study.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Development of a New Scale of Quality of Life, Specific of Neuro Muscular Diseases and More Specifically of Steinert Disease, by the Rasch Model Methods.

acronym: QoLNMD

summary: A Quality work was conducted to enable the future construction of a Quality of Life Questionnaire Related to Health (HRQoL) in patients with slowly progressive neuromuscular disease (NMD) as myopathies and muscular dystrophies. The discussion group training is an effective method to perform a thorough investigation of aspects of HRQoL potentially altered by NMD. Patients were recruited in France by 4 reference centers MNMs. All verbal interactions between participants focus groups were recorded. A qualitative analysis of the transcript was performed. The transcript provided 2424 CIF categories. The results helped to identify and quantify aspects of life that are altered by NMDs between patients. A pool of 64 items and a validated questionnaire (the WHOQOLBREF) were thern passed by 159 patients enrolled in eight reference centers MNMs. The investigators constructed a questionnaire called QoLNMD which is composed of two general items and 24 items classified into three areas: (1) \ Impact bodily symptoms, "(2) \ Self-perception" and (3) \ Activity participation. "Each area has good psychometric properties (Cronbach's alpha> 0.77, test-retest ICC> 0.81, H Loevinger> 0.41) and met the assumptions of IRT. the comparison with the WHOQOL-BREF was used to assess similarities and differences with a generic questionnaire. The next step was to validate the QoLNMD reassessing its psychometric properties in a new patient sample and calibrate the IRT measurement system. The purpose of these new part of study was to validate the French version of the QoL-NMD on a confirmatory sample of patients and to calibrate its measurement system. A prospective study in 8 NMD referral centers (France) was conducted. Both the QoL-NMD and a validated generic questionnaire (the WHOQOLBREF) were administered to patients. 156 patients were included for the confirmatory psychometric analysis. All three domains showed adequate psychometric properties and met IRT assumptions. The IRT model calibration was then performed successfully on 315 patients. The French version of the QoL-NMD showed adequate psychometric properties and can be used in rehabilitation services. A conversion table enables easy transformation of sum scores into IRT-calibrated measures. Minimum detectable change tables help interpreting score change.

lead_sponsor: CHU de Reims


title: Intraoperative Hypotension Predicted by Observation of Mean Arterial Pressure : a Retrospective Cohort Preliminary Study

acronym: HYPPOPOPAM

summary:
During general anesthesia, intraoperative hypotension (IOH) is associated with increased morbidity and mortality. Mean arterial pressure (MAP) < 65mmHg is the most common definition of hypotension. In order to reduce IOH, a complex method using machine learning called hypotensive prediction index (HPI) was shown to be superior to changes in MAP (ΔMAP) to predict hypotension (MAP between 65 and 75 excluded). Linear extrapolation of MAP (LepMAP) is also very simple and could be a better approach than ΔMAP. The main objective of the present study was to investigate whether LepMAP could predict IOH during anesthesia 1, 2 or 5 minutes before.

Hypothesis : the area under the ROC curves (ROC Area Under Curves) at 1, 2 and 5 minutes of LepMAP would be superior to ΔMAP

lead_sponsor: Hospices Civils de Lyon

location_facility: Department of Anesthesiology and Intensive Care, Louis Pradel University Hospital


title: Comparison of Maintenance Treatment by Ribavirin to a Placebo, After an Initial One-year Treatment With Pegylated Interferon-α2a - Ribavirin Association in Hepatitis C Viral Recurrence After Liver Transplantation

acronym: TRANSPEG

summary: In France, 50% of the hepatitis C virus carriers develop chronic clinical hepatitis, which may lead to cirrhosis and liver transplantation. Transplant infection by hepatitis C virus is constant after transplantation. This recurrence usually causes chronic liver disease, in 50 to 80% of the patients. The interest of a long-term treatment with ribavirin alone after transplantation has not been clearly demonstrated. The objective of our study is to evaluate the efficacy of ribavirin as a maintenance treatment after a one year interferon-α / ribavirin therapy on hepatitis C recurrence in the transplanted liver.

ReferenceCitation: Cattral MS, Hemming AW, Wanless IR, Al Ashgar H, Krajden M, Lilly L, Greig PD, Levy GA. Outcome of long-term ribavirin therapy for recurrent hepatitis C after liver transplantation. Transplantation. 1999 May 15;67(9):1277-80.

ReferenceCitation: Berenguer M, Prieto M, Córdoba J, Rayón JM, Carrasco D, Olaso V, San-Juan F, Gobernado M, Mir J, Berenguer J. Early development of chronic active hepatitis in recurrent hepatitis C virus infection after liver transplantation: association with treatment of rejection. J Hepatol. 1998 May;28(5):756-63.

location_facility: Service d'Hépaogastroentérologie - Hôpital Saint Eloi

location_facility: Service d'Hépatologie et Gastroentérologie - Hôpital Henri Mondor

location_facility: Service Hépato-gastroentérologie - Hôpital Saint Antoine

location_facility: Service des Maladies de l'Appareil Digestif - CHRU Claude Huriez

location_facility: Service de Chirurgie Digestive - Groupe Hospitalier Pellerin-Tripode

location_facility: Service d'Hépatogastroentérologie - Hôpital Beaujon

location_facility: Chirurgie Viscérale et Digestive -Hôpital de l'Archet

location_facility: Département de Chirurgie Viscérale- Hôpital Pontchaillou

location_facility: Chirurgie Générale - Hôpital de la Conception

location_facility: Centre Hépato-biliaire - Hôpital Paul Brousse

location_facility: Service d'Hépatologie - Hôpital Jean Minjoz

location_facility: Service de Chirurgie Générale - Hôpital Edouard Herriot

location_facility: Service de Chirurgie Générale et Transplantation Multi-organe - Hôpital de la Hautepierre

location_facility: Service de Chirurgie Générale et Digestive - Hôpital Cochin


title: Effect of Organizational Measures to Prevent and Control COVID-19 Infection in Nursing Homes on the Risk of Death of Residents During and After the Epidemic Period

summary: The COVID epidemic has shown very high mortality among older people, especially among polymorbid and dependent subjects. In addition to the classic risk factors of age, dependence and associated co-morbidities, community life exposes to specific increased risks in the event of this easily inter human transmissible viral epidemic. In France, according to the Drees data (Ehpa study, 2015) more than 600,000 elderly people currently live in nursing homes (NH). Since March 28, a national guidance for monitoring the COVID epidemic in NH has just been set up. In France, 14 178 of the 29 319 COVID deaths (48.35%) by June 10th 2020 occurred among NHs residents. Work to consolidate these data is underway, suggesting a much heavier balance sheet. Faced to this threat, in addition to practical recommendations (barrier protection gestures), strict instructions were also announced to all NH to keep their residents safe from COVID : restricting all visitors, all volunteers and nonessential personnel, and more recently, confining residents in their room in case of incident case of COVID in the NH. Organizational factors of NH such as the prevention strategies deployed before and during the epidemic (pneumococcal vaccination, restricting group activities), as well as NH internal resources (equipment, nursing staff) and health resources in the NH environment (hospital partnerships, support devices, telemedicine) lead to heterogeneous situations and could influence the death rates of residents. On the other hand, social isolation can also precipitate the decline of fragile residents. Beyond the immediate and directly risks linked to COVID-19, the present hypothesize that the organizational measures (guidance and recommendations) put in place can have, during and at a distance from the outbreak, beneficial effects but also deleterious effects depending on the severity of the outbreak of a geographic area. More precisely, the hypothesis is that strong and well-followed recommendations at the time of the epidemic were associated with a reduction in the risk of total death in particular of deaths related to COVID in the zones most affected by the epidemic but also that strong and well-followed recommendations were associated with an increased risk of total death, in particular of deaths unrelated to COVID in the areas least affected by the epidemic.

lead_sponsor: University Hospital, Toulouse

location_facility: University Hospital Toulouse - Gérontopôle


title: Impact of Containment on Primary Care Management and Clinical Adverse Events Non-related to COVID-19 in Older Patients and/or With Chronic Diseases During the Epidemic. The COVIMEGE French Retrospective Cohort Study.

acronym: COVIMEGE

summary:
In 2017, 10.7 million people affiliated to the general health insurance scheme benefited from the "Long-term condition" scheme, i.e. 17% of insured patients. Most of these patients suffer from chronic diseases requiring regular medical and paramedical follow-up. During the first containment period of the SARS-CoV-2 epidemic, the French government's messages were to call the Urgent Medical Assistance Service (15) and not to go directly to the general practitioner (GP), favouring teleconsultations. Other countries have adopted the same strategy. Mortality rates due to SARS-CoV-2 infection were higher in elderly patients and/or those with co-morbidities, particularly heart failure, hypertension, respiratory failure and diabetes. The elderly and patients with chronic cardiometabolic and respiratory diseases should therefore be particularly protected during the epidemic. However, these populations also need close monitoring to avoid acute decompensation of their chronic diseases or loss of autonomy. However, during the first containment, general practitioners and other medical and paramedical ambulatory health professionals perceived a notable decrease in their daily activity, including for their chronic and/or elderly patients who may not have called for a visit, consultation and/or access to telemedicine. "Public Health France" also reported a decrease in consultations with GPs at the beginning of the lockdown, a decrease in the number of emergency room visits and hospitalizations for cardio and neurovascular diseases. The investigators hypothesise that under-attendance of primary care services during the epidemic is associated with excess mortality and morbidity unrelated to COVID-19.

The main objective is to assess non-COVID-19 related overmortality during the containment period and 12 months after the start of containment, in a population of elderly and/or chronically ill patients in France. The overmortality will be assessed globally and according to individual and contextual characteristics such as gender, age, place of residence, pre-existing morbidity and socio-economic level.

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing_description: Datas are own by "Assistance Publique - Hôpitaux de Paris", please contact sponsor for further information.

location_facility: Assistance Publique Hôpitaux de Paris - CHU Henri Mondor


title: Contribution of High Throughput RNA Sequencing Combined With Sequencing of Whole Genomes in the Diagnosis of Intellectual Disability.

acronym: DI-WA

summary:
Intellectual disability (ID) is a clinically and genetically heterogeneous condition that often results in a diagnostic odyssey.

The deployment of high throughput sequencing (HTS) and in particular exome sequencing (WES) has made it possible to identify many genes responsible for ID. However, the WES does not identify the cause of ID in about two-thirds of patients, due to, for example, the uneven depth and coverage of all exons, or the location of variants in non-exonic areas. It has thus been shown that genome sequencing (WGS), which is still rarely used because it is more complex and costly, would be more efficient, with an expected diagnostic rate of around 60%.

In response to the massive contribution of HTS in the diagnosis of patients suffering from rare diseases, France has launched the France Plan Médecine Genomique 2025 (PFMG2025) to deploy HTS platforms, which will be able to carry out WGS, WES and RNA sequencing (RNA-seq), and pilot studies to define the modalities for prescribing these examinations. Two cost-effectiveness evaluations of these technologies, in comparison with the current strategy for diagnosis of ID, are currently underway or planned in the short term in France: 1) PRME DISSEQ, comparing the large DI459 panel versus WES, 2) the DEFIDIAG pilot study of the PFMG2025 comparing WGS, in trio versus solo, versus current strategy. However, there are no studies examining the place of the RNA-seq in the ID diagnostic decision tree.

However, some pathogenic variations are likely to have an effect on transcription. WES/WGS can detect them but are not able to affirm their pathogenicity because it focuses on genomic DNA. Only the RNA-seq makes it possible to study the transcription of candidate genes on a large scale, providing an additional level of evidence on both known genes in human pathology (OMIM) and candidate genes.

The RNA-seq would increase the diagnostic rate from 10% to 35% in addition to the WGS in negative patients with first-line approaches (including WES) and thus optimize management by reducing diagnostic delays as part of a personalized care pathway.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Pravastatin in HIV-Infected Patients Treated With Highly Active Antiretroviral Therapy

summary: To assess the use of pravastatin in hypercholesterolemic HIV-infected patients treated with protease inhibitors in a randomised double blind study.

lead_sponsor: University Hospital, Bordeaux

location_facility: Hôpital Saint André, Service de médecine interne et maladies infectieuses


title: Assessment of Nutritional Consequences of Sleeve Gastrectomy

acronym: ERNEST

summary:
Bariatric surgery is now recognized as a procedure of choice for the treatment of morbid obesity, resulting in long-term effectiveness on weight loss and comorbidities. The two types of procedures, most often performed in Europe, are adjustable gastric banding (AGB), a purely restrictive reversible procedure, and gastric bypass (GBP), an irreversible procedure, which associates restriction and mild malabsorption. Longitudinal sleeve gastrectomy (LSG) is another bariatric procedure which tends to develop quickly. More recent, this technique is recognized in France by the High Authority of Health since 2008, consisting of fundus and greater curvature resection, removing 75 % the gastric volume, leaving a narrow gastric tube or "sleeve".

Although malabsorption does not occur in most bariatric procedures, micronutrient deficiencies are possible. GBP is known to induce nutritional and vitamin deficiencies concerning iron, calcium, vitamins B12, B9, D and proteins. Restrictive procedures have minor effects on normal physiological digestive processes but could lead to vitamin deficiency secondary to decreased nutrient intake and a tendency towards avoidance of certain types of food due to intolerance. Studies of nutritional complications of bariatric surgery concern essentially AGB, GBP and vertical banded gastroplasty (VBG) which is no longer performed in France. The nutritional impact of LSG remains to be evaluated. To date, data concerning evaluation of nutritional status from patients who underwent LSG are almost non-existent. Considering this type of surgical procedure, the investigators expect to observe essentially a deficiency in vitamin B12 and iron. Indeed, defined as a purely restrictive intervention, LSG consists of gastric fundus resection which is the site of intrinsic factor production, itself necessary for vitamin B12 absorption. Moreover, decrease of hydrochloric acid production and potential vomiting caused by gastric resection can alter iron absorption.

In view of the increasing popularity of this surgical technique, assessment of the nutritional consequences of longitudinal sleeve gastrectomy seems to be necessary.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Evaluation of Self-efficacy as a Predictor for CPAP-compliance in a OSAS-patients French Cohort

acronym: SAFES

summary:
Continuous positive airway pressure (CPAP) is the reference treatment for obstructive sleep apnea syndrome (OSAS) and is effective in improving symptoms of OSAS, reducing risk of accidents and improving quality of life. However, CPAP use is less than optimal. Recommended use is between 6-8 hour per night and a common clinical and empiric benchmark has been defined for CPAP use as an average of 4h per night for 70% of the night. Approximatively 30% of patients discontinue CPAP treatment during the first weeks. Thus, it is very important to identify the factors that influence CPAP adherence during the first weeks of treatment.

Biomedical factors, in particular nose respiratory abnormalities, somnolence complaints and insomnia complaints, have been widely studied but explain only 4 to 25 % of the variance in CPAP use. Interestingly, "self-efficacy" (the confidence to engage in a treatment), was found to explain more than 30 % of the variance in CPAP use.

The SEMSA (Self Efficacy in Sleep apnea) questionnaire is the instrument to investigate self-efficacy related to OSAS and CPAP that has received the most attention. Retrospective studies showed that the factor "self-efficacy" of the SEMSA was related to poor CPAP adherence. Prospective studies showed that the factor "self-efficacy" of the SEMSA at baseline was associated with future CPAP use when it was completed after education information.

A French version of the SEMSA has been validated by investigators in a retrospective study. They have confirmed in France that the factor "self-efficacy" of the SEMSA was related to poor CPAP adherence. No prospective study using the SEMSA has been conducted in French patients with OSAS treated with CPAP. Given the specificity of the French health care system and home care system, it is thus important to evaluate the predictive value of self-efficacy on CPAP adherence in France. The generation of predictive model would enable pretreatment prediction of those likely to have difficulty with CPAP adherence, and would serve as the basis for the development of maximally effective interventions in order to enhance CPAP adherence by patients with OSAS.


title: COVID-19 Infection at Samusocial in Paris: Descriptive and Serological Survey

summary: Study of COVID-19 seroprevalence in precarious population living in shelters of Samusocial de Paris and in staff working in these centers during COVID-19 epidemic.

ReferenceCitation: Bernard Stoecklin S, Rolland P, Silue Y, Mailles A, Campese C, Simondon A, Mechain M, Meurice L, Nguyen M, Bassi C, Yamani E, Behillil S, Ismael S, Nguyen D, Malvy D, Lescure FX, Georges S, Lazarus C, Tabaï A, Stempfelet M, Enouf V, Coignard B, Levy-Bruhl D; Investigation team. First cases of coronavirus disease 2019 (COVID-19) in France: surveillance, investigations and control measures, January 2020. Euro Surveill. 2020 Feb;25(6). doi: 10.2807/1560-7917.ES.2020.25.6.2000094.

ReferenceCitation: Lescure FX, Bouadma L, Nguyen D, Parisey M, Wicky PH, Behillil S, Gaymard A, Bouscambert-Duchamp M, Donati F, Le Hingrat Q, Enouf V, Houhou-Fidouh N, Valette M, Mailles A, Lucet JC, Mentre F, Duval X, Descamps D, Malvy D, Timsit JF, Lina B, van-der-Werf S, Yazdanpanah Y. Clinical and virological data of the first cases of COVID-19 in Europe: a case series. Lancet Infect Dis. 2020 Jun;20(6):697-706. doi: 10.1016/S1473-3099(20)30200-0. Epub 2020 Mar 27. Erratum in: Lancet Infect Dis. 2020 May 19;:. Erratum in: Lancet Infect Dis. 2020 Jun;20(6):e116.

ReferenceCitation: Deslandes A, Berti V, Tandjaoui-Lambotte Y, Alloui C, Carbonnelle E, Zahar JR, Brichler S, Cohen Y. SARS-CoV-2 was already spreading in France in late December 2019. Int J Antimicrob Agents. 2020 Jun;55(6):106006. doi: 10.1016/j.ijantimicag.2020.106006. Epub 2020 May 3.

ReferenceCitation: Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.

ReferenceCitation: Backer JA, Klinkenberg D, Wallinga J. Incubation period of 2019 novel coronavirus (2019-nCoV) infections among travellers from Wuhan, China, 20-28 January 2020. Euro Surveill. 2020 Feb;25(5). doi: 10.2807/1560-7917.ES.2020.25.5.2000062.

ReferenceCitation: Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.

ReferenceCitation: Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

ReferenceCitation: Baggett TP, Keyes H, Sporn N, Gaeta JM. Prevalence of SARS-CoV-2 Infection in Residents of a Large Homeless Shelter in Boston. JAMA. 2020 Jun 2;323(21):2191-2192. doi: 10.1001/jama.2020.6887.

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

location_facility:
LHSS Ridder-Plaisance
LHSS Saint-Michel
Haltes pour femmes


title: Impact of the Use of Allogeneic Hematopoietic Stem Cell Transplantation in Reunion Island Patients: Quality of Life, Determinants of Choices and Financial Repercussions

acronym: AlloRé

summary: This project aims to document and analyse - with a three-fold anthropological, psychosocial and economical approach - the consequences of the geographical distance from mainland France on the alloSCT on both patients, their caregivers and the healthcare system. It is organised in 3 working packages (WP).

lead_sponsor: Centre Hospitalier Universitaire de la Réunion


title: Impact of a Front-of-pack Nutrition Label on the Nutritional Quality of Purchases in Campus Cafeterias

acronym: 5-C CROUS

summary: This study evaluates the impact of the introduction of a front-of-pack nutrition label on fods and beverages sold in a campus cafeteria in France on the nutritional quality of purchases. The design involves one site with the intervention and one control site with the same consumer and product characteristics.

design_allocation: Non-Randomized

primary_purpose: Other

lead_sponsor: University of Paris 13

intervention_type: Behavioral


title: Medico-economic Evaluation of Different High-throughput Sequencing Strategies in the Diagnosis of Patients With Intellectual Deficiency

acronym: DISSEQ

summary:
Intellectual deficiency (ID) is a veritable public health issue because it affects 1 to 3% of the population at large. Currently, in France, the diagnosis is based on clinical expertise, the use of DNA microarray analysis, screening for fragile-X syndrome and, if necessary, a study of target genes depending on the clinical data. Although clinical expertise is not enough to target one gene in particular, these different tools currently lead to diagnosis in only 20% of patients on average (higher percentage in cases of syndromic intellectual deficiency), sometimes after numerous expensive biological examinations.

Thanks to high-throughput sequencing (HTS), medical genetics is experiencing a major technological upheaval, originating from the development of sequencing panels of target genes, such as, for example, the DI459 panel, composed of 459 genes implicated in or likely to be implicated in ID, developed by the team in Strasbourg and whole-exome sequencing (WES). The deployment of HTS in diagnosis has occurred at different speeds depending on the country, some of which have been using it in routine diagnosis for several years. The type of strategy to adopt in development anomalies is still a matter of debate in France, in the absence of results from cost-effectiveness analyses; this absence has hampered the implementation of these technologies.

In the diagnosis of ID, the DI459 panel has a diagnostic yield of 25%. Data in the literature also show a high efficacy of WES in patients with ID: approximately 32% of genetic diagnoses (progressively increasing thanks to possible reanalysis as knowledge of genomics advances) and 10% of additional diagnoses through the identification of chromosomal micro-rearrangements, making an expected total of 42% of diagnoses. WES could thus replace array-CGH. The cost is higher than that for the DI44 and DI459 panels, but it means that examinations don't have to be repeated sequentially over time if the investigations are negative.

The question of medico-economic value is thus central so as to determine which strategy is the most effective. A few medico-economic studies, comparing classical investigations with WES, have already been carried out concerning the use of HTS for diagnostic purposes, but none have concerned ID, or compared panel sequencing with WES. In this context, a medico-economic study is essential in France, because ultimately the choice of the most appropriate HTS strategy in the diagnosis of ID will have major repercussions not only clinical and economic, but also for society at large, on the one hand because of the benefits 1) for the management and prognosis of patients, and 2) for families as they will have improved access to genetic counselling. It is important to note that the Genetic community has never experienced such a huge technological innovation, which will lead to a massive increase in diagnostic yield, thus justifying the interest that the community must give to this innovation.


title: The Reporting of Domestic Violence by Patients in the Emergency Department of the Reims University Hospital Center

summary:
Domestic violence is defined as violence carried out by one of the partners in a relationship of domination. This can be verbal, psychological, physical or sexual.

Domestic violence is a real public health problem for which emergencies are at the forefront.

In this context, the emergency department of the Reims University Hospital Center, the Public Prosecutor and the association LE MARS France Victim 51 decided to set up a report on July 01, 2020.

The report consists of retrieving the identity and information relating to the violence suffered through a survey, or report card . The report card, as well as an initial certificate without the total incapacity for work written by the doctor during the consultation, will be sent immediately by secure email to the public prosecutor and the police. The emails will be processed in real time by the prosecutor on duty. The contact details with the family name, first name and telephone number will be sent to the association LE MARS France Victime 51. Reporting therefore allows the prosecutor to decide whether or not to open a criminal investigation., At the same time, this will allow us to provide support through the association providing assistance to victims of domestic violence.

The objective of this study is to describe the proportion of patients accepting to report to the public prosecutor among the patients consulting the emergency department of the Reims University Hospital Center and for whom domestic violence is known or suspected. The secondary objectives will be to describe the number of patients who are victims of proven or suspected domestic violence consulting the emergency department, as well as to describe the factors associated with the acceptance of the report.

Participation in the study will consist of completing a questionnaire specific to the study. The estimated time to complete this questionnaire is 5 minutes.

This study will allow us to know the prevalence of acceptance of the report card in the emergency department of the Reims University Hospital Center. This information will tell us if this new procedure could be beneficial for the management of domestic violence and if the majority of patients are in favor of it.


acronym: SPLENEVAC

title: Multicenter Pilot Study Evaluating the Immunogenicity of an Innovative Pneumococcal Vaccination Strategy in Splenectomized Adults

location_facility: Service des Maladies Infectieuses et Tropicales - Centre d'Infectiologie Necker-Pasteur, IHU Imagine - Hôpital Necker-Enfants

summary:
Evaluate the immunogenicity of an innovative pneumococcal vaccination strategy in splenectomized adults comprising 1 dose of Prevenar13® conjugate vaccine (PCV) at M0 followed by 1 dose of Pneumo23® or Pneumovax® polysaccharide vaccine (PPSV) at M2. Duration of follow-up of 36 months.

The main endpoint will be the proportion of subjects responsive to 9 of the 13 serotypes common to the PCV and PPSV vaccines, selected because of their frequency in invasive infections in adults in France and their potentially reduced susceptibility to penicillin (serotypes 1, 3, 6A, 7F, 9V, 14, 19A, 19F, 23F).


title: Contribution of Multimodal Imaging in Early Neonatal Coarctation of Aorta: CT-COARCT-PED

acronym: CT-COARCT-PED

summary: The CT-Coarct-PED study is a multicentred observational study aiming to describe the population of early coarctation during the last 10 years in South of France. The secondary objective is to assess the importance of cross-sectional imaging in the surgical management of aortic coarctation in the first year of life

lead_sponsor: University Hospital, Montpellier


title: "Au Labo Sans Ordo ": A 12 Month Local Experimentation of Free HIV Testing Without Prescription in Private Medical and Biological Laboratories in Paris and in the Alpes-Maritimes

acronym: ALSO

summary: The program " Au labo sans ordo " aims to increase HIV testing coverage, in order to improve the first stage of the HIV care cascade in Paris and the Alpes-Maritimes, areas facing a much higher HIV epidemic than the other regions in metropolitan France. Both departments are engaged in the Fast Track Cities Initiative.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Evaluation of a New Strategy for the Diagnosis of Peroxisomal Diseases

summary: The principal aim of the study is to avoid the diagnostic wanderings of patients suffering from a peroxisomal disorder. For this purpose, a new diagnostic strategy is proposed. It rests on functional metabolic explorations and gene studies directly connected to a first-line enlarged physico-chemical detection of metabolites from peroxisomal origin in clinically suspect patients.

lead_sponsor: University Hospital, Lille

location_facility: Pédiatrie, Pavillon Mère et Enfant, CHU Ch. Nicolle de Rouen

location_facility: Département de Pédiatrie, Unité de Génétique Clinique, CHU d'Amiens


type: Other Grant/Funding Number

title: Effects of Technology-based Physical Activity Interventions for Women After Bariatric Surgery: a Three-arm Randomized Control Study

acronym: OCAPAS

summary:
Regular physical activity (PA) is essential throughout bariatric surgery (BS) management, especially for the long-term maintenance of weight loss. To optimize physical activity counseling and monitoring, the use of technology seems appropriate and effective. A recent meta-analysis provided proof of efficacy for mobile technology to increase physical activity or weight loss in the short term. Videoconferencing may also be effective, especially as it reduces the barriers related to face-to-face physical activity interventions. Both technologies (mobile and videoconferencing) seem particularly interesting for bariatric surgery management, but their long-term effects on physical activity maintenance are unknown. Moreover, the mechanisms underlying their effectiveness, such as technology acceptability and motivational processes, have not been examined.

The purpose of this study is to determine the effects of two technology-based (mobile technology and videoconferencing) PA programs after BS compared to standard care and to assess the contribution of acceptability and motivational mechanisms in explaining these effects on behavioral measure of PA, physical measures, and health indicators.

One hundred and twenty young women who have undergone BS in the last 3 to 6 months will be included. The volunteers will be randomly assigned to one of three arms: standard care (CONTROL), access to an internet-based physical activity program delivered by an eHealth platform associated with an activity bracelet (ACTI-MOBIL), or access to a physical activity program delivered via videoconferencing (ACTI-VISIO). The primary outcome is the distance traveled during a 6-minute walk test relativized according to Capadaglio's theoretical distance. Secondary outcomes are behavioral measures of physical activity, physical measures, health indicators, technology acceptability, and motivational concepts. Data will be collected baseline (T0), 3 months (T3) and 6 months later (T6). The technology groups will receive a PA program for 12 weeks (between T0 and T3). A mixed model approach will be used to analyze the change in outcomes over time for each group.

This study will provide information on the effects of two technology-based physical activity programs (mobile technology and videoconferencing) after bariatric surgery. Based on the results, recommendations for implementing these programs will be made.

primary_purpose: Supportive Care

ReferenceCitation: Hayotte M, Iannelli A, Nègre V, Pradier C, Thérouanne P, Fuch A, Diagana O, Garbarino JM, Vuillemin A, Colson SS, Chevalier N, d'Arripe-Longueville F. Effects of technology-based physical activity interventions for women after bariatric surgery: study protocol for a three-arm randomised controlled trial. BMJ Open. 2021 Jul 30;11(7):e046184. doi: 10.1136/bmjopen-2020-046184.

lead_sponsor: Pr Fabienne d'Arripe-Longueville


title: Adapted Physical Activity in the Treatment of Anorexia: a Randomised Control Trial

acronym: EfAPA

summary:
People with anorexia nervosa are known to engage in significant physical activity or sports. This practice is problematic because of the state of malnutrition, its interference with re-nutrition and the somatic and nutritional complications that the effect of physical activity can cause in these people. This significant physical activity is also called hyperactivity in the literature, it is in fact a problematic use of physical activity, it is a symptom commonly observed in people suffering from anorexia nervosa (in 31 to 80% cases).

In this context, Ms. Kern lecturer in Sciences and Techniques of Physical and Sports Activities (STAPS) at the University of Paris Nanterre has developed in collaboration with the clinical team (Pre Godart) an adapted physical activity program (APA) , for patients suffering from anorexia nervosa. The APA program includes 8 sessions of 1h30 including an important part of psychoeducation. The effectiveness of this program will be evaluated in terms of both restoration of body mass index and improvement in overall health.

The project's hypothesis is that adding a standardized 8-week Adapted Physical Activity program to the usual care, including psychoeducation on both problematic physical activity and the consequences in terms of good practice of physical activity leads to a better outcome of overall care in people with anorexia nervosa.

lead_sponsor: Fondation Santé des Étudiants de France

location_facility: CHU Nantes - service d'addictologie et Psychiatrie de Liaison