title: Multicenter Randomized Prevention Trial of Recurrence of Suicide Attempt by Adolescent by Sending SMS (MEDIACONNEX)

acronym: MEDIACONNEX

summary:
MEDIACONNEX study propose a new way of connectedness for adolescents after a suicide attempt: it is based on the sending of SMS (or mail or other new media), over a period of 6 months after their suicide attempt (SA), in order to allow them to recourse to the care more easily and so to limit the risk of suicidal recurrence. The MEDIACONNEX study will be a multicenter controlled randomized trial (East of France) and there is a funding from the Hospital. The proposal trial will test the hypothesis that adolescent suicide attempters who are receiving SMS (or mail or other new media) from the unit of care in addition to the usual care will do less SA recurrence, than those who are receiving the usual care.

The primary objective is to determine whether the use of SMS (or mail or other new media) to keep in touch with adolescent suicide attempters in addition to the usual care, compare to usual care, will reduce the delay of recurrence of suicide attempt during 6 months after the SA.

ReferenceCitation: 1. World Health Organization WHO. (2011). http://www.who.int/maternal_child_adolescent/topics/adolescence/fr/ Accessed April 2016

ReferenceCitation: Hawton K, Rodham K, Evans E, Weatherall R. Deliberate self harm in adolescents: self report survey in schools in England. BMJ. 2002 Nov 23;325(7374):1207-11.

ReferenceCitation: Moran P, Coffey C, Romaniuk H, Olsson C, Borschmann R, Carlin JB, Patton GC. The natural history of self-harm from adolescence to young adulthood: a population-based cohort study. Lancet. 2012 Jan 21;379(9812):236-43. doi: 10.1016/S0140-6736(11)61141-0. Epub 2011 Nov 16.

ReferenceCitation: Wong JP, Stewart SM, Claassen C, Lee PW, Rao U, Lam TH. Repeat suicide attempts in Hong Kong community adolescents. Soc Sci Med. 2008 Jan;66(2):232-41. Epub 2007 Oct 4.

ReferenceCitation: Miranda R, Scott M, Hicks R, Wilcox HC, Harris Munfakh JL, Shaffer D. Suicide attempt characteristics, diagnoses, and future attempts: comparing multiple attempters to single attempters and ideators. J Am Acad Child Adolesc Psychiatry. 2008 Jan;47(1):32-40. doi: 10.1097/chi.0b013e31815a56cb.

ReferenceCitation: Thompson MP, Light LS. Examining gender differences in risk factors for suicide attempts made 1 and 7 years later in a nationally representative sample. J Adolesc Health. 2011 Apr;48(4):391-7. doi: 10.1016/j.jadohealth.2010.07.018. Epub 2010 Oct 8.

ReferenceCitation: MacDonald R, Taylor J, Clarke D. The relationship between early suicide behaviors and mental health: results from a nine-year panel study. J Adolesc. 2009 Oct;32(5):1159-72. doi: 10.1016/j.adolescence.2009.01.012. Epub 2009 Mar 9.

ReferenceCitation: Ligier F, Guillemin F, Angot C, Bourion S, Kabuth B. Recurrence of suicide attempt in adolescents lost to contact early by clinicians: The 10-year REPEATERS cohort of French adolescents. J Adolesc. 2015 Aug;43:111-8. doi: 10.1016/j.adolescence.2015.05.011. Epub 2015 Jun 12. Erratum in: J Adolesc. 2017 Jan;54:135-136.

ReferenceCitation: Vaiva G, Jardon V, Vaillant A, Ducrocq F. [What can we do to prevent the suicide re-attempts?]. Rev Prat. 2011 Feb;61(2):202-3, 206-7. French.

ReferenceCitation: Davidson K, Norrie J, Tyrer P, Gumley A, Tata P, Murray H, Palmer S. The effectiveness of cognitive behavior therapy for borderline personality disorder: results from the borderline personality disorder study of cognitive therapy (BOSCOT) trial. J Pers Disord. 2006 Oct;20(5):450-65.

ReferenceCitation: Linehan MM, Comtois KA, Murray AM, Brown MZ, Gallop RJ, Heard HL, Korslund KE, Tutek DA, Reynolds SK, Lindenboim N. Two-year randomized controlled trial and follow-up of dialectical behavior therapy vs therapy by experts for suicidal behaviors and borderline personality disorder. Arch Gen Psychiatry. 2006 Jul;63(7):757-66. Erratum in: Arch Gen Psychiatry. 2007 Dec;64(12):1401.

ReferenceCitation: Weinberg I, Gunderson JG, Hennen J, Cutter CJ Jr. Manual assisted cognitive treatment for deliberate self-harm in borderline personality disorder patients. J Pers Disord. 2006 Oct;20(5):482-92.

ReferenceCitation: Bateman A, Fonagy P. Effectiveness of partial hospitalization in the treatment of borderline personality disorder: a randomized controlled trial. Am J Psychiatry. 1999 Oct;156(10):1563-9.

ReferenceCitation: Evans K, Tyrer P, Catalan J, Schmidt U, Davidson K, Dent J, Tata P, Thornton S, Barber J, Thompson S. Manual-assisted cognitive-behaviour therapy (MACT): a randomized controlled trial of a brief intervention with bibliotherapy in the treatment of recurrent deliberate self-harm. Psychol Med. 1999 Jan;29(1):19-25.

ReferenceCitation: Motto JA, Bostrom AG. A randomized controlled trial of postcrisis suicide prevention. Psychiatr Serv. 2001 Jun;52(6):828-33.

ReferenceCitation: 16. Beautrais AL, Gibb SJ, Faulkner A, Mulder RT. A randomised controlled trial of a brief intervention to reduce repeat presentations to the emergency department for suicide attempt. Annals of Emergency Medicine. 2008;51:474

ReferenceCitation: Carter GL, Clover K, Whyte IM, Dawson AH, D'Este C. Postcards from the EDge project: randomised controlled trial of an intervention using postcards to reduce repetition of hospital treated deliberate self poisoning. BMJ. 2005 Oct 8;331(7520):805. Epub 2005 Sep 23.

ReferenceCitation: Vaiva G, Walter M, Al Arab AS, Courtet P, Bellivier F, Demarty AL, Duhem S, Ducrocq F, Goldstein P, Libersa C. ALGOS: the development of a randomized controlled trial testing a case management algorithm designed to reduce suicide risk among suicide attempters. BMC Psychiatry. 2011 Jan 2;11:1. doi: 10.1186/1471-244X-11-1.

ReferenceCitation: Czyz EK, Liu Z, King CA. Social connectedness and one-year trajectories among suicidal adolescents following psychiatric hospitalization. J Clin Child Adolesc Psychol. 2012;41(2):214-26. doi: 10.1080/15374416.2012.651998.

ReferenceCitation: Berrouiguet S, Alavi Z, Vaiva G, Courtet P, Baca-García E, Vidailhet P, Gravey M, Guillodo E, Brandt S, Walter M. SIAM (Suicide intervention assisted by messages): the development of a post-acute crisis text messaging outreach for suicide prevention. BMC Psychiatry. 2014 Nov 18;14:294. doi: 10.1186/s12888-014-0294-8.

ReferenceCitation: Milner AJ, Carter G, Pirkis J, Robinson J, Spittal MJ. Letters, green cards, telephone calls and postcards: systematic and meta-analytic review of brief contact interventions for reducing self-harm, suicide attempts and suicide. Br J Psychiatry. 2015 Mar;206(3):184-90. doi: 10.1192/bjp.bp.114.147819. Review.

ReferenceCitation: Brian RM, Ben-Zeev D. Mobile health (mHealth) for mental health in Asia: objectives, strategies, and limitations. Asian J Psychiatr. 2014 Aug;10:96-100. doi: 10.1016/j.ajp.2014.04.006. Epub 2014 Apr 27. Review.

ReferenceCitation: Collins JL, Champion JD. Assessment of mobile device and SMS Use for Diet and Exercise Information Among Rural Mexican-American adolescents. J Pediatr Nurs. 2014 Nov-Dec;29(6):493-502. doi: 10.1016/j.pedn.2014.03.020. Epub 2014 Mar 15.

ReferenceCitation: 24. Gibson K, Cartwright C. Young people's experiences of mobile phone text counseling: Balancing connection and control. Child Youth Ser Rev. 2014;73:96-104

ReferenceCitation: Hawton K, Fagg J, Platt S, Hawkins M. Factors associated with suicide after parasuicide in young people. BMJ. 1993 Jun 19;306(6893):1641-4.

ReferenceCitation: Hinman RS, McCrory P, Pirotta M, Relf I, Crossley KM, Reddy P, Forbes A, Harris A, Metcalf BR, Kyriakides M, Novy K, Bennell KL. Efficacy of acupuncture for chronic knee pain: protocol for a randomised controlled trial using a Zelen design. BMC Complement Altern Med. 2012 Sep 19;12:161. doi: 10.1186/1472-6882-12-161.

ReferenceCitation: Hatcher S, Sharon C, House A, Collins N, Collings S, Pillai A. The ACCESS study: Zelen randomised controlled trial of a package of care for people presenting to hospital after self-harm. Br J Psychiatry. 2015 Mar;206(3):229-36. doi: 10.1192/bjp.bp.113.135780. Epub 2015 Jan 22.

ReferenceCitation: Adamson J, Cockayne S, Puffer S, Torgerson DJ. Review of randomised trials using the post-randomised consent (Zelen's) design. Contemp Clin Trials. 2006 Aug;27(4):305-19. Epub 2006 Feb 7. Review.

ReferenceCitation: 29. Chou Kee-lee. Assessing Chinese adolescents' social support: the multidimensional scale of perceived social support. Pers Individ Dif. 2000;28: 299-307

ReferenceCitation: Osman A, Lamis DA, Freedenthal S, Gutierrez PM, McNaughton-Cassill M. The multidimensional scale of perceived social support: analyses of internal reliability, measurement invariance, and correlates across gender. J Pers Assess. 2014;96(1):103-12. doi: 10.1080/00223891.2013.838170. Epub 2013 Oct 3.

ReferenceCitation: Denis A, Callahan S, Bouvard M. Evaluation of the French version of the multidimensional scale of perceived social support during the postpartum period. Matern Child Health J. 2015 Jun;19(6):1245-51. doi: 10.1007/s10995-014-1630-9.

ReferenceCitation: 32. The KIDSCREEN Group Europe. The KIDSCREEN Questionnaires - Quality of life questionnaires for children and adolescents. Handbook. Lengerich: Pabst Science Publishers. 2006

ReferenceCitation: Sapin C, Simeoni MC, El Khammar M, Antoniotti S, Auquier P. Reliability and validity of the VSP-A, a health-related quality of life instrument for ill and healthy adolescents. J Adolesc Health. 2005 Apr;36(4):327-36.

ReferenceCitation: Chabrol H, Montovany A, Chouicha K, Duconge E. [Study of the CES-D on a sample of 1,953 adolescent students]. Encephale. 2002 Sep-Oct;28(5 Pt 1):429-32. French.

ReferenceCitation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2021 Mar 7;3:CD013667. doi: 10.1002/14651858.CD013667.pub2.

ReferenceCitation: Ligier F, Kabuth B, Guillemin F. MEDIACONNEX: a multicenter randomised trial based on short message service to reduce suicide attempt recurrence in adolescents. BMC Psychiatry. 2016 Jul 19;16:251. doi: 10.1186/s12888-016-0965-8.

ipd_sharing_description: Study results will be restituted to each participant if they ask for it.

location_facility: Hôpital de Mercy. CHR de Metz-Thionville


acronym: POLYTITAN

summary: The total hip replacement, with over 120,000 cases per year in France, provides short term, excellent functional results and a significant improvement in quality of life, in almost all cases. However, the observation has shown that the lifetime of the implants is limited due to aseptic loosening. One of the factors associated with these failures is a peri-prosthetic osteolysis wherein the polyethylene wear debris (PE) have been implicated. Several solutions have been proposed: change the friction torque (hard-hard pairs using ceramic or metal on the two components of the couple) or improving quality polyethylene. Improving the resistance of polyethylene wear is the primary objective evaluated in this study.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Diagnostic

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Rochcongar G, Remazeilles M, Bourroux E, Dunet J, Chapus V, Feron M, Praz C, Buia G, Hulet C. Reduced wear in vitamin E-infused highly cross-linked polyethylene cups: 5-year results of a randomized controlled trial. Acta Orthop. 2021 Apr;92(2):151-155. doi: 10.1080/17453674.2020.1852785. Epub 2020 Dec 2.

lead_sponsor: University Hospital, Caen

location_facility: Département d'orthopédie - traumatologie, CHU de Caen

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


title: Metabolic Consequences of Cross-sex Hormonal Treatment in Transgender Persons

acronym: DysGeMet

summary: Retrospective study in a single academic regional transgender referral center. Analyse VAT, body composition and metabolic parameters in non-obese transgender subjects one year after starting gender-affirming hormone therapy and in controls

study_type: Observational

time_perspective: Retrospective

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Central Hospital, Nancy, France


title: Impact of 18F-fluoroestradiol (FES) Positron Emission Tomography (PET) on the Therapeutic Treatment of Metastatic Breast Cancer Ipatients, Initially ER Positive and HER2 Negative, in Relapse After First-line Therapy Combining Hormone Therapy

acronym: ESTROTIMP

summary:
This is a multi-center study in France to evaluate the impact of ESTROTEP PET/CT results on the therapeutic management of patients with metastatic breast cancer (MBC).

Each patient will be screened to determine whether the patient meets all the inclusion criteria and none of the exclusion criteria.

After inclusion, a standardized pre ESTROTEP PET/CT questionnaire will be completed by the investigators to evaluate the initial management plan. Patient will perform the ESTROTEP PET/CT examination at visit 2. A standardized post ESTROTEP PET/CT questionnaire will then be completed by the investigators.

Patients will be followed for 12 months to evaluate their clinical status and standard of care investigations.

status: Recruiting

lead_sponsor: Zionexa

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Assessment of Dissociative Traumatic Disorders

acronym: TEDI

summary:
More than 70% of ambulatory patients with IDD have attempted suicide (APA, 2015). This disorder, as well as all the disorders on the dissociation spectrum, must therefore be clarified and better diagnosed.

The goal of this research is :

to assess the prevalence of dissociative disorders using specific tools in patients suffering from PTSD.
to validate the French version of the DDIS interview (Ross, 1997) that the investigators have translated.

primary_purpose: Other

lead_sponsor: Januel


type: Other Identifier

title: Endoscopic Gastric Tubulization

acronym: Endosleeve

summary:
Endoscopic gastric tubulization is currently proposed in the Digestive Surgery Department of the Nouvel Hôpital Civil, Strasbourg, France, to adult patients with morbid obesity. The procedure is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA). It is standard practice since October 2016.

The objective of this study is to prospectively collect data of patients who underwent an endoscopic gastric tubulization, from last visit before procedure to 2 years after procedure. These data are usually collected during medical consultations and will enable the evaluation of weight loss, quality of life and comorbidities improvement, reproducibility and durability of the technique.

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Lopez-Nava G, Galvão MP, da Bautista-Castaño I, Jimenez A, De Grado T, Fernandez-Corbelle JP. Endoscopic sleeve gastroplasty for the treatment of obesity. Endoscopy. 2015 May;47(5):449-52. doi: 10.1055/s-0034-1390766. Epub 2014 Nov 7.

ReferenceCitation: Lopez-Nava G, Galvão MP, Bautista-Castaño I, Jimenez-Baños A, Fernandez-Corbelle JP. Endoscopic Sleeve Gastroplasty: How I Do It? Obes Surg. 2015 Aug;25(8):1534-8. doi: 10.1007/s11695-015-1714-7.

ReferenceCitation: Lopez-Nava G, Galvao M, Bautista-Castaño I, Fernandez-Corbelle JP, Trell M. Endoscopic sleeve gastroplasty with 1-year follow-up: factors predictive of success. Endosc Int Open. 2016 Feb;4(2):E222-7. doi: 10.1055/s-0041-110771. Epub 2016 Jan 15.

ReferenceCitation: Sharaiha RZ, Kedia P, Kumta N, DeFilippis EM, Gaidhane M, Shukla A, Aronne LJ, Kahaleh M. Initial experience with endoscopic sleeve gastroplasty: technical success and reproducibility in the bariatric population. Endoscopy. 2015 Feb;47(2):164-6. doi: 10.1055/s-0034-1390773. Epub 2014 Nov 7.

ReferenceCitation: Abu Dayyeh BK, Rajan E, Gostout CJ. Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity. Gastrointest Endosc. 2013 Sep;78(3):530-5. doi: 10.1016/j.gie.2013.04.197. Epub 2013 May 24.

ipd_sharing: No

lead_sponsor: IHU Strasbourg

location_facility: Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil

intervention_type: Procedure


title: Study of Skin Parameters in the PROOF Cohort

acronym: PEAU PROOF

summary:
This study aims to evaluate skin aging of an homogeneous population of 77 years old patient selected among the PROOF cohort who has been continuously investigated by cardiological examination.

Skin aging will be explored by macroscopic and microscopic evaluation. In particular, skin aging will be measured by an index of clinical aging (SCINEXA) and other complementary measures such as facial photos, standard and High Definition dermoscopy, elastography, sebumetry, in vivo and ex vivo confocal microscopy, and classical histological examinations.

status: Completed

study_completion_date_type: Actual

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

status_simplified: Completed


title: Out of Hospital Cardiac Arrest: Cluster Randomized Trial Assessing the Survival Impact of Phone Advice Delivered by Medical Call Center

acronym: CONTAC

summary: Medical call center have no phone advice protocol within out of hospital cardiac arrest in France. The purpose of the present study is to compare a group of patients with protocol phone advice delivered by the dispatchers ("CONTARM" group) versus usual phone advice ( "CONTHAB" group). Comparison will be performed on survival to seven days. The hypothesis is that CONTARM group has an higher survival at seven days. A second goal is to measure the survival to 15 and 30 days. The trial is randomized, controlled and will include 2600 patients. The patients will be enrolled in 19 hospitals in France.

primary_purpose: Treatment

ReferenceCitation: Berg RA, Hemphill R, Abella BS, Aufderheide TP, Cave DM, Hazinski MF, Lerner EB, Rea TD, Sayre MR, Swor RA. Part 5: adult basic life support: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2010 Nov 2;122(18 Suppl 3):S685-705. doi: 10.1161/CIRCULATIONAHA.110.970939. Review. Erratum in: Circulation. 2011 Oct 11;124(15):e402.

ReferenceCitation: Nolan JP, Soar J, Zideman DA, Biarent D, Bossaert LL, Deakin C, Koster RW, Wyllie J, Böttiger B; ERC Guidelines Writing Group. European Resuscitation Council Guidelines for Resuscitation 2010 Section 1. Executive summary. Resuscitation. 2010 Oct;81(10):1219-76. doi: 10.1016/j.resuscitation.2010.08.021.

ReferenceCitation: Koster RW, Baubin MA, Bossaert LL, Caballero A, Cassan P, Castrén M, Granja C, Handley AJ, Monsieurs KG, Perkins GD, Raffay V, Sandroni C. European Resuscitation Council Guidelines for Resuscitation 2010 Section 2. Adult basic life support and use of automated external defibrillators. Resuscitation. 2010 Oct;81(10):1277-92. doi: 10.1016/j.resuscitation.2010.08.009.

ReferenceCitation: Desmettre T, Jenvrin J, Freysz M, Nace L, Puyraveau M, Berthier F, Dreyfus P, Philippe MH, Labourey JM, Capellier G. Drug prescription at the medical call center. Ann. Fr. Med. Urgence (2013) 3:14-19.

ReferenceCitation: Sigaux A, Jonquet S, Puyraveau M, Bretillot L, Labourey JM, Capellier G, Desmettre T. Evaluation of phone advice delivered by a medical call center in case of cardiac arrest. Ann. Fr. Med. Urgence (2014) 4:11-17.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
CHU Besançon
CHU Nantes
CHU Lyon
CH Orléans
CH Mulhouse
CHU Strasbourg
CH Lons Le Saunier
CHU Poitiers
CHU Angers
CHU Bordeaux
CH Châlon sur Saône
CHU Nancy
CH Troyes
CHU Nîmes
CH Montauban
CHU Metz
CHU Reims
CHU Dijon
CH Colmar


title: National Observatory of the Care of Young Sick Children in Community or Not, Indications and Cost-effectiveness of PCR-Sars-CoV-2 - VIGIL Study

acronym: VIGIL

summary:
In order to clarify the current management of young sick children in France, whether or not they are cared for in community settings (nursery, schools), paediatricians have proposed an algorithm whose objective is to help define the indications for PCR-Sars-CoV-2 (https://www.infovac.fr/actualites/bulletin-special-mai-2020).

This algorithm, in two parts, can be used, when symptoms are detected in children, to orient and guide :

first, parents and community personnel to recognize the signs of infection call signs that should involve medical consultation;
but also, the physicians who will carry out this medical evaluation and will have to decide whether or not PCR screening is necessary, in parallel with their diagnostic and therapeutic management, which should not be altered in this particular context

Our main objective is to describe, after the confinement phase, the management of young sick children in the community (crèches, nursery and elementary schools, etc.) or not in order to best define the indications for PCR-Sars-CoV-2

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility:
PARI network
ACTIV network


title: Surgical and Functional Outcomes of Rectourethral Fistulas Surgery With Gracilis Flap Interposition After Localized Prostatic Cancer Treatment.

acronym: GRA-FUR

summary:
Prostate cancer is the first cancer amongst men with more than 50000 cases per year in France. Surgical, radiation, frost, or ultrasound induced rectourethral fistula is a rare complication (<1%) of localized prostatic cancer treatment but hard to manage. Different types of treatment exist: conservatory, trans-sphinteric (York-Masson), transanal, perineal, with or without muscle flap interposition. Gracilis flap interposition for rectourethral fistula management is a promising technique but few cases are described and functional results are scarce.

The aim of this study is to present surgical and functional outcomes of rectourethral fistulas surgery with gracilis flap interposition after treatment of localized prostate cancer.

lead_sponsor: Hospices Civils de Lyon


title: Adherence to Opioids in Oncology Out Patients

summary: Cancer pain is undertreated despite a good access to opioids in France. Although many factors are involved, the barriers related to the patient (and his family) are often reported .the reluctance of the patient or the family to take the prescribed medication is linked to misconceptions about the opioids , cultural barriers; or the lack of explanations provided by the physician. Some patients can have undiagnosed slight cognitive impairment .The situation is now more complicated as appear on the market the new form of opioids for the cancer breakthrough pain drug, adding one more opioid formulation in the prescription. The goal of the study is to measure the adherence to opioids in cancer out patients and the associated factors.

time_perspective: Cross-Sectional


summary: A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of diarrhoea caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC diarrhoea tests . This lab has discovered over 200 new species of bacteria in humans, including vector bacteria and opened the field of large Deoxyribonucleic Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribonucleic Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens described in POC laboratory, this study proposes to expand the etiological diagnosis strategy of diarrhoea after POC tests.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Evaluation of Changes in Weight, Sleep, and Other Psycho-behavioural Parameters During Covid-19 Confinement in Subjects Monitored by the RNPC Network

acronym: CO-RNPC

summary:
During confinement, food intake can become compulsive, physical activity is significantly reduced, sleep is altered with exacerbated anxiety and stress levels and increased family violence. In some at-risk patients, mental health may even deteriorate. The temptation is great for all to take refuge in food or in front of screens. The main elements that can impact weight changes during this period of confinement are stress and anxiety, lack of physical activity, changes in eating habits, sleep disturbance and alcohol consumption.

The investigators wish to study the impact of confinement on pre-post confinement weight loss kinetics in adults included in weight reduction programs (RNPC).

lead_sponsor: University Hospital, Grenoble


title: Improving the Diagnosis of Pneumonia in Emergency Rooms

summary: A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of pneumonia caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC tests Pneumonia. This lab has discovered over 200 new species of bacteria in humans, including vector bacteria and opened the field of large Deoxyribo Nucleic Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribo Nucleic Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens described in POC laboratory, this study proposes to expand the etiological diagnosis strategy of pneumonia after POC tests.


title: Longitudinal Follow-up of a Population Cohort in a French City With High SARS-CoV-2 Circulation in Early 2020

acronym: COVID-OISE

summary:
An initial retrospective epidemiological investigation was conducted in a city north of France after the diagnosis of the first case of COVID-19 on February 2020. Sero-epidemiological studies were conducted in this town by the Institut Pasteur in early 2020 among families, teachers and non-teaching staff of the high and elementary schools.

The goal of this new project is to better characterize the specific immunity generated by the infection within this community. The specific immune response to the SARS-CoV-2 virus will be followed for a period of 2 years from the initial circulation of the virus, within a large cohort of participants covering all age groups from 5 years-old onwards. The study will focus on systemic humoral and cell responses, immunity of the nasopharyngeal mucosa and the humoral response present in saliva. Follow-up of participants in this cohort and monitoring of the virus circulation within this community would help to determine the protective character against re-infection of the natural immunity generated by SARS-CoV-2.

lead_sponsor: Institut Pasteur

location_facility:
Institut Pasteur
Hôpital de Crépy en Valois


acronym: STIMUPARK

summary:
Parkinson's disease affects between 100'000 and 150'000 people in France. Drug therapy (L-Dopa and other drugs) is effective to improve motor symptoms but after an initial 'honeymoon period' lasting a few years, motor symptoms reoccur in most patients, impairing gait and walking.

Spinal cord stimulation is currently an important therapeutic option in the treatment of neuropathic pain. Experimental and limited clinical data suggest that this technique might also be used to alleviate motor symptoms and improve walking in Parkinsons patients.

This exploratory study aims at measuring the benefits of spinal cord stimulation on the walking capacity of a small number of Parkinsons patients who are not adequately improved by drug therapy alone.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Fondation Ophtalmologique A. de Rothschild

intervention_type: Device


title: Kinetic of Humoral Immune Response of Asymptomatic Nursing Homes (EHPAD) Employees Infected With Severe Acute Respiratory Syndrome Coronavirus : a Case Control Study

acronym: SERASYMPTO

summary:
The investigators performed in April 2020, a screening campaign of asymptomatic staff working in elderly nursing homes in Paris France (EHPAD), where the virus had been circulating actively in March and April 2020. Among 241 employees tested in four nursing homes, 32 (13.2%) were asymptomatic carriers of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2).

Few data are available concerning the humoral immune response of asymptomatic carriers, the elicitation and duration of neutralizing antibodies and the duration of protection.

The purpose of the study is to determine whether these asymptomatic persons develop a humoral immune response, whether this immune response is durable and whether it is protective against the risk of reinfection

status: Withdrawn

primary_purpose: Screening

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Clinical Evaluation of Morbidity and Efficacy of Posterior IVS (Infracoccygeal Sacropexy), in Comparison to the Standard Sacrospinous Suspension in the Surgical Treatment of Vaginal Vault Prolapse by the Vaginal Route.

summary:
Hypothesis / aims of study The aim of this multicentre study is to evaluate anatomical and functional results of an innovative posterior tape in vaginal prolapse repair by vaginal route, in comparison to the sacrospinous suspension.

Study design, materials and methods This study involves 5 centres in French Public Hospital. Patients will be randomly allocated to be operated by a sacrospinous suspension or by an posterior IVSTM (Tyco Healthcare, France). Prolapse severity will be evaluated using the POP-Q system. In order to evaluate the patient's quality of life, the validated PFDI and the PFIQ questionnaires will be used preoperatively and during follow-up, as well as a validated questionnaire on sexual problems. The difference on early post-operative pain should be 30% (40% for the sacrospinous suspension and 10% for the posterior IVS). Then the estimated number of patient is 40 in each arm.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Living Conditions of Patients With Diffuse Large B-Cell Lymphoma or Follicular Lymphoma in the Côte d'Or Region

acronym: LymphoVi

summary: The development of new diagnostic tools and targeted therapy have significantly improved the management of non-Hodgkin's malignant lymphomas and thus their long-term prognosis. However, in the study of improved patient management, survival is not the only measurable indicator and preservation of quality of life is an essential component. In addition, there is little existing data regarding the determinants of quality of life in patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) in the general population in France.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Does the Intervention of an Advanced Practice Nurse for Nursing Home Residents Aged 75 and Over in the Grand Nancy Area Make it Possible to Reduce the Use of the Emergency Service for These Residents?

summary:
The rate of emergency room visits is high at the extremes of age, with patients aged 75 or over accounting for 12% of emergency room visits, and the time they spend there is significantly longer than that of younger patients.

Nursing Home residents represent 14% of these emergency room visits and only 5% of them on average are not hospitalised and return to their original Nursing Home.

A retrospective study of patients aged 75 and over referred to the emergency department of the Nancy Hospital by the Nursing Homes over a six-month period showed that nearly 30% of patients aged 75 and over referred by their Nursing Home were rehospitalized during the period studied, 1/3 for the same reason and 2/3 for other reasons.

The intervention of an Advanced Practice Nurse (IPA) attached to geriatric practice, among other things, as an interface between Nursing Home and the hospital therefore seems to have its place in improving the care pathway for the elderly.

The assessment by an Advanced geriatric Practice Nurse of residents of Nursing Home aged 75 and over in Grand Nancy area one week after a visit to the emergency room significantly reduces the number of new visits to the emergency room by these residents over a follow-up period of seven months, compared with residents of Nursing homes aged 75 and over (outside Grand Nancy area) who do not benefit from an assessment by an Advanced Practice Nurse.


title: Impact of Fatigue on Physical Performance During a Pulmonary Rehabilitation Program in Patients With COPD

acronym: PROMOD

summary: Patients with COPD benefit from pulmonary rehabilitation (PR), but a ceiling effect of performance (ie. absence of additional exercise tolerance increase) is observed in 80% of patients from only 20 sessions. An imbalance between intensity, duration and frequency of PR sessions, leading to fatigue development in the course of the PR, could explain this ceiling effect. However, previous studies having evaluated the impact of a PR program on fatigue scores reported either a decrease or no changing, but never an increase. To date, no study has evaluated intermediate variations of fatigue score during a PR program, but were limited to a pre-post PR assessment. Therefore, fatigue fluctuations during PR are unknown. Furthermore, most studies had only unidimensional fatigue assessment. Since fatigue is a multifactorial and a multidimensional process, it cannot be accurately estimated through a unique assessment. Given that most of COPD patients do not increase their exercise tolerance from 20 PR sessions, the investigators hypothesize a significant increase of multidimensional fatigue score between the 1st and the 20th PR session during an inpatient rehabilitation program lasting 4 weeks (40 sessions).

lead_sponsor: 5 Santé

location_facility:
Clinique du Souffle La Vallonie
Clinique du Souffle La Solane
Clinique du Souffle Les Clarines


title: Effects of Vagus Nerve Osteopathic Stimulations on Heart Rate Variability of Cancer Patients

summary:
In France, new cancer cases keep on increasing with around 150 000 deaths yearly. Cancer therapy research is constantly evolving. Indeed, several studies explore new treatments or their combination with conventional cancer treatments. But, at the same time, complementary and alternative medicines, as osteopathy, remain little explored upon their role in the combination with conventional therapy.

Several studies showed indirect interaction between vagus nerve and cancer. Firstly, vagus nerve regulates homeostasis and immunity by reducing systemic inflammation while maintaining local inflammation and antitumor effects. Secondly, vagus nerve stimulation increases Heart Rate Variability (HRV). Moreover, a higher HRV is associated with an improvement of vital prognosis in cancer patients. Vagus nerve could be stimulated by noninvasive osteopathic manipulations.

This prospective, monocentric and randomized study is a collaboration between the Centre Hospitalier d'Avignon and the Institut de Formation en Ostéopathie du Grand Avignon. It focuses on using noninvasive osteopathic mobilizations to stimulate vagus nerve. Indeed, this study aims to evaluate effects of vagus nerve osteopathic stimulations on HRV in patients with lung cancer, colorectal cancer, Non Hodgkin Lymphoma or Multiple Myeloma. More specifically, this study will tell us whether vagus nerve noninvasive osteopathic stimulations induce increase of HRV associated with a decrease of systemic inflammation and an improvement of patient's quality of life.

primary_purpose: Supportive Care

lead_sponsor: Centre Hospitalier Henri Duffaut - Avignon

intervention_type: Biological


title: Functional MRI Usage for Pyelo-ureteral Junction Syndrome : Results of Nancy Children Hospital Cohort

summary:
Pyelo-ureteral junction syndrome is the most common urological abnormality in children.

Functional MRI has been evaluated several times, and had shown good correlation with scintigraphy, but tends to over estimate results. Moreover, those studies included a small number of cases. Its sensitivity to detect crossing polar vessel is limited.

We aimed to evaluate, in patients between 0 and 1 year old, the correlation between MRI and scintigraphy differential renal function.

Our secondary objectives are : evaluation of MRI performances to detect polar vessel ; comparison of surgery times depending of MRI only realisation or MRI and scintigraphy realisation.

lead_sponsor: Central Hospital, Nancy, France

intervention_type: Diagnostic Test


title: Effect of Medical Hypnosis in Virtual Reality on Insomnia Disorders: a Monocentric, Randomized, Open-label, Comparative Study.

acronym: EMERITE

summary:
The prevalence of chronic insomnia is 13.3% in France in 2019 (8.9 million). The consequences for these people are multiple: drowsiness, memory problems, difficulty concentrating, anxiety.

Cognitive and Behavioral Therapy (CBT) is today the reference treatment recommended by the "Haute Autorité de Santé" and the American College of Physicians for chronic insomnia. Today, however, few patients use CBT treatment due to the lack of trained practitioners, the cost of non-reimbursed sessions and the time and involvement that these sessions require.

Several clinical trials have shown beneficial effects of hypnotherapy on sleep disorders. The hypothesis of this work is that the use of hypnosis in virtual reality improves sleep time in patients suffering from insomnia disorders.

ipd_sharing: Yes

lead_sponsor: HypnoVR


title: Is There a Link Between Inflammation and Endocrinopathies in Turner Syndrome?

summary: Liver abnormalities are common in Turner syndrome. The physiopathology of these abnormalities is unknown for the moment but their potentially serious evolution requires additional explorations.


title: Attitudes of General Pracitioners in Lorraine Towards Prediabetes

acronym: PréDiabMedG

summary: Screening for the risk factors of type 2 diabetes is a part of the primary prevention approach. Pre-diabetes is one of the modifiable risk factors; however, it remains under-diagnosed. Our aim was to analyse the attitudes of general practitioners in Lorraine towards prediabetes


title: Pneumocystis Jirovecii Pneumonia in Non-HIV-infected Immunocompromised Patients : a Prognostic Observational Retrospective Monocentre Study

acronym: PnP-HIV-Free

summary: Pneumocystis jirovecii pneumonia (PjP) is a rare infectiouse disease with a high level of mortality. PjP is a classical opportunistic infection which concern HIV infected and immunocompromised patients. During the past decade, several therapeutic's progresses have been done in oncology, immunology and hematology. As a consequence, patients benefited of greater treatment efficacy but are exposed to a higher risk of opportunistic infections as PjP. The investigators hypothesis is that PjP incidence increase and its form is depending of underlying immune conditions. The investigators aim to describe its incidence, the PjP forms depending on comorbidities and to identifiy pronostics factors.

status: Active, not recruiting

location_facility: Université de Lorraine, CHRU Nancy and APEMAC


title: Sorbact TM: Effect of a Microbial Binding Dressing on Wound Healing After Pilonidal Sinus Excision

acronym: SORKYSA

summary:
Sinus pilonidal concern 26/100 000 young adults. It manifests after puberty, presenting as an acute abscess in approximately 50% of patients or as a discharging painful sinus. Patients may experience lengthy healing times resulting in considerable morbidity and disruption to a young adult's life. Eradication of pilonidal sinus is based on a wide surgical excision and at the end of the procedure, the wound is dressed with an alginate dressing (Algosteril®).

The objective is to show a better efficiency of Sorbact TM (trademark) dressings compared to Alginates that are standardized dressings after pilonidal sinus excision during a period of 75 days. The main objective is to show a difference of 20% of wounds completely healed in 75 days between the two types of dressing: 50% of wounds healed with Algosteril TM compared to 70% of wounds healed with Sorbact TM.

ReferenceCitation: Romain B, Mielcarek M, Delhorme JB, Meyer N, Brigand C, Rohr S; SORKYSA group. Dialkylcarbamoyl chloride-coated versus alginate dressings after pilonidal sinus excision: a randomized clinical trial (SORKYSA study). BJS Open. 2020 Apr;4(2):225-231. doi: 10.1002/bjs5.50259. Epub 2020 Feb 4.

lead_sponsor: University Hospital, Strasbourg, France

location_facility: Service de Chirurgie Générale Viscérale et Digestive-Centre Hospitalier de Saverne-19 Côte de Saverne

location_facility: Service de Chirurgie Digestive-Centre Hospitalier de Mulhouse- 20 av du Dr René Laennec

location_facility: Service de Chirurgie Digestive - Hôpital de Hautepierre- Hôpitaux Universitaires de Strasbourg - France

location_facility: Service de Chirurgie Digestive-Hôpital Pasteur-39 av de la Liberté


title: Skin Diseases: Which Heathcare Professionals do Pregnant Women in Vendee Use?

summary:
Pregnancy-induced physiological dermatological changes are common. In 2016, they represented between 23% (acne) and 75% (pigmentary changes) of pregnancies in France. Some dermatological changes require medical advice to identify a possible pathological rash.

These pathological rashes can be dangerous for the mother or the fetus.

The aim of this study is to assess the prevalence of skin diseases during pregnancy and to evaluate the care pathway in a healthcare sector (Vendee) for these pregnant women?

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Involvement of Myeloid Derived Suppressor Cells in Systemic Lupus Erythematosus

acronym: MDSC-SLE

summary:
Systemic Lupus Erythematosus (SLE) is a chronic invalidating chronic condition, with potential articular, cutaneous, renal, and neurologic involvement. Its pathophysiology is complex, and involves genetic, environmental and hormonal factors, leading to tolerance rupture. Among regulatory cells, Myeloid Derived Suppressor Cells (MDSCs) have been described as being increased during SLE, furthermore during flares. MDSCs are defined phenotypically as being HLA-DR-CD3-CD19-CD33+CD11b+, and either CD14+ (Monocytic MDSCs), CD15+ (Granulocytic MDSCs), or CD14-CD15- (Early-stage MDSCs). However, data regarding their immunosuppressive properties are conflicting, some studies identifying regulatory properties, while other have demonstrated a pro-inflammatory involvement through the induction of Th17 lymphocytes.

The objectives of this study is to assess the involvement of MDSC in SLE through accurate phenotypical and functional assessment, as well as characterizing their immunometabolic profile, and to identify innovative therapeutic strategies.


type: Registry Identifier

title: Prevalence of Abnormalities in Ultrasonography of Joint and Tendons in Patients With Gout

acronym: EchoGoutte

summary: Gout is the most frequent inflammatory arthritis in men after 40 years, with a prevalence of 0.9% in France. This disease is characterized by deposits of sodium urate crystals in joints, tendons and soft tissues, which can be detected by ultrasound examination. To date, there was no study assessing inflammatory, structural and deposit lesions due to gout in joints and tendons, since the standardization of ultrasound definitions of gout by the OMERACT (Outcome Measures in Rheumatology) in 2015. The objective of this study is t estimate the prevalence and severity of ultrasound inflammatory lesions (synovitis, tenosynovitis, soft tissues abnormalities), structural lesions (osteophytes, erosions) and abnormalities due to sodium urate deposits (double contour, aggregates, tophi) in patients with gout.

location_facility: Rhumatology department, Ambroise Paré hospital - APHP


title: Resilience Trajectories Following a Preoperative Lifestyle /Behavioral Modification Program and Bariatric Surgery

acronym: ECLAIRCIE

summary:
A high prevalence of psychological trauma on one hand and of psychiatric disorders, such as depression, anxiety, suicide attempts, addictions, and eating disorders on the other hand, has been reported in patients with severe obesity seeking bariatric surgery. Some studies reported an increased prevalence of these psychiatric disorders after bariatric surgery, potentially related to weight regain. In this context, psychological resilience is a concept that brings together internal and external factors of adaptation, and whose clinical use facilitates interdisciplinary collaborative work. This research focuses on the association between resilience and success or failure of bariatric surgery in patients followed in the Specialized Obesity Center (CSO) of the Nancy University Hospital. The hypothesis is that psychological resilience before surgery promotes successful surgical treatment. This retrospective study is based on existing data from patients with severe obesity who have undergone bariatric surgery at the Nancy CSO. The main objective is to study 1) the resilience of patients with severe obesity, candidates for bariatric surgery, at the first assessment (T0), at the end of lifestyle/behavioral modifications program (T1) and at 2 years after bariatric surgery (T2), 2) the relationship between internal and external factors explaining resilience and final weight outcomes.

The investigators are expected that non-resilient patients have more psychological vulnerabilities (psychopathology, negative life events, etc.), and have lower weight loss than resilient patients.

location_facility: Centre hospitalo-universitaire régional de Nancy


title: Relevance of Sensitization to Fenugreek in Children

summary: The prevalence of allergy to legumes is inscreasing, especially in children and for some of these legumes, little is known and there are not included in the list of priority allergen. The overall goal of this study is to improve knowledge about fenugreek allergy. The principal aim is to evaluate the prevalence of allergy to fenugreek confirmed by a positive oral food challenge in children sensitized to fenugreek. The secondary objectives are to describe the case of allergy to fenugreek (co-allergies, severity, age..), to evaluate diagnostic values of skin prick-tests and specific IgE and to compare the molecular profile of specific IgE to peanut between sensitization to fenugreek without allergy and sensitization with a confirmed allergy


title: Effect of Type 1 Diabetes on Sleep Fragmentation

summary: The main objective of this study is the objective evaluation of disease related sleep fragmentation in subjects with type 1 diabetes.

ReferenceCitation: Larcher S, Gauchez AS, Lablanche S, Pépin JL, Benhamou PY, Borel AL. Impact of sleep behavior on glycemic control in type 1 diabetes: the role of social jetlag. Eur J Endocrinol. 2016 Nov;175(5):411-9. doi: 10.1530/EJE-16-0188. Epub 2016 Aug 16.

ReferenceCitation: Larcher S, Benhamou PY, Pépin JL, Borel AL. Sleep habits and diabetes. Diabetes Metab. 2015 Sep;41(4):263-271. doi: 10.1016/j.diabet.2014.12.004. Epub 2015 Jan 23. Review.

ReferenceCitation: Borel AL, Pépin JL, Nasse L, Baguet JP, Netter S, Benhamou PY. Short sleep duration measured by wrist actimetry is associated with deteriorated glycemic control in type 1 diabetes. Diabetes Care. 2013 Oct;36(10):2902-8. doi: 10.2337/dc12-2038. Epub 2013 May 28.

ReferenceCitation: Borel AL, Benhamou PY, Baguet JP, Debaty I, Levy P, Pépin JL, Mallion JM. Short sleep duration is associated with a blood pressure nondipping pattern in type 1 diabetes: the DIAPASOM study. Diabetes Care. 2009 Sep;32(9):1713-5. doi: 10.2337/dc09-0422. Epub 2009 Jun 19.

ipd_sharing_description:
There is a plan to make IPD and related data dictionaries available to perform meta-analyses based on individual data.

The sharing of data will need the acceptation by the Principal Investigator.


title: Prognostic Value of Copeptin Level Before Cardiac Surgery and Involvement in Systemic Inflammatory Response Syndrome After Cardiopulmonary Bypass

acronym: MicorSIRS

summary: The purpose of this study is to find a preoperative biomarker before cardiac surgery with cardiopulmonary bypass related to severe postoperative inflammatory response and circulatory complications. The investigators hypothesize that an increase of the preoperative stimulation of vasopressinergic system (in response to acute or chronic conditions) could lead to a microcirculatory dysfunction and favor the occurrence of vasodilatation during and after CPB and increase the symptoms of an inflammatory response after CPB. By defining a high risk population, a targeted strategy of monitoring and early or preventive treatment could improve postoperative prognosis.

ReferenceType: result

ReferenceCitation: MacCallum NS, Finney SJ, Gordon SE, Quinlan GJ, Evans TW. Modified criteria for the systemic inflammatory response syndrome improves their utility following cardiac surgery. Chest. 2014 Jun;145(6):1197-1203. doi: 10.1378/chest.13-1023.

ReferenceCitation: Colson PH, Bernard C, Struck J, Morgenthaler NG, Albat B, Guillon G. Post cardiac surgery vasoplegia is associated with high preoperative copeptin plasma concentration. Crit Care. 2011;15(5):R255. doi: 10.1186/cc10516. Epub 2011 Oct 25.

lead_sponsor: University Hospital, Montpellier

location_facility: Department of critical care, Arnaud de Villeneuve Hospital


title: Patients Without Standard Modifiable Cardiovascular Risk Factors (SMuRF-less) and Their Prognosis After a ST-segment-Elevation Myocardial Infarction (STEMI)

summary: The purpose of this study is to asses the prognosis of STEMI patients without standard modifiable risk factors of cardiovascular disease (diabetes mellitus, hyperlipidemia, hypertension and cigarette smoking) compare to patients presenting at least one of these risk factors.

location_facility: Institut du Coeur et des Vaisseaux Louis Mathieu


title: Immune Responses to COVID-19 (SARS-CoV-2 Related Infection); Isolation of Human Neutralizing Monoclonal Antibodies for Therapeutics and Vaccine Design Approaches: a Prospective Monocentric Trial With Collaborative Sample Collection.

summary:
According to different projections, the COVID-19 outbreak currently happening in France and worldwide could result in millions of deaths in the absence of efficient therapies. The COVID-19 causative agent, the SARS-CoV-2, is a virus leading to respiratory system infections in human and for which there is currently no vaccine or treatment scientifically validated in clinical studies.

In that context, therapeutic human neutralizing antibodies targeting the SARS-CoV-2 envelop glycoproteins and which enable inhibition of the viral replication represent an innovative therapeutic alternative with great potential. These antibodies are also critical tools for vaccine development.

Simultaneously, CHUGA researchers coordinate with each other to set up a collective biological collection to achieve others objectives such as biomarkers identifications.

ReferenceCitation: Zhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y, Wang X, Yuan J, Li T, Li J, Qian S, Hong C, Wang F, Liu Y, Wang Z, He Q, Li Z, He B, Zhang T, Fu Y, Ge S, Liu L, Zhang J, Xia N, Zhang Z. Antibody Responses to SARS-CoV-2 in Patients With Novel Coronavirus Disease 2019. Clin Infect Dis. 2020 Nov 19;71(16):2027-2034. doi: 10.1093/cid/ciaa344.

ReferenceCitation: Haveri A, Smura T, Kuivanen S, Österlund P, Hepojoki J, Ikonen N, Pitkäpaasi M, Blomqvist S, Rönkkö E, Kantele A, Strandin T, Kallio-Kokko H, Mannonen L, Lappalainen M, Broas M, Jiang M, Siira L, Salminen M, Puumalainen T, Sane J, Melin M, Vapalahti O, Savolainen-Kopra C. Serological and molecular findings during SARS-CoV-2 infection: the first case study in Finland, January to February 2020. Euro Surveill. 2020 Mar;25(11). doi: 10.2807/1560-7917.ES.2020.25.11.2000266.

ReferenceCitation: Tai W, He L, Zhang X, Pu J, Voronin D, Jiang S, Zhou Y, Du L. Characterization of the receptor-binding domain (RBD) of 2019 novel coronavirus: implication for development of RBD protein as a viral attachment inhibitor and vaccine. Cell Mol Immunol. 2020 Jun;17(6):613-620. doi: 10.1038/s41423-020-0400-4. Epub 2020 Mar 19.

ReferenceCitation: Alshukairi AN, Khalid I, Ahmed WA, Dada AM, Bayumi DT, Malic LS, Althawadi S, Ignacio K, Alsalmi HS, Al-Abdely HM, Wali GY, Qushmaq IA, Alraddadi BM, Perlman S. Antibody Response and Disease Severity in Healthcare Worker MERS Survivors. Emerg Infect Dis. 2016 Jun;22(6). doi: 10.3201/eid2206.160010.

ReferenceCitation: Liu W, Fontanet A, Zhang PH, Zhan L, Xin ZT, Baril L, Tang F, Lv H, Cao WC. Two-year prospective study of the humoral immune response of patients with severe acute respiratory syndrome. J Infect Dis. 2006 Mar 15;193(6):792-5. Epub 2006 Feb 9.

ReferenceCitation: Tetro JA. Is COVID-19 receiving ADE from other coronaviruses? Microbes Infect. 2020 Mar;22(2):72-73. doi: 10.1016/j.micinf.2020.02.006. Epub 2020 Feb 22.

ReferenceCitation: Walker LM, Phogat SK, Chan-Hui PY, Wagner D, Phung P, Goss JL, Wrin T, Simek MD, Fling S, Mitcham JL, Lehrman JK, Priddy FH, Olsen OA, Frey SM, Hammond PW; Protocol G Principal Investigators, Kaminsky S, Zamb T, Moyle M, Koff WC, Poignard P, Burton DR. Broad and potent neutralizing antibodies from an African donor reveal a new HIV-1 vaccine target. Science. 2009 Oct 9;326(5950):285-9. doi: 10.1126/science.1178746. Epub 2009 Sep 3.

ReferenceCitation: Walker LM, Huber M, Doores KJ, Falkowska E, Pejchal R, Julien JP, Wang SK, Ramos A, Chan-Hui PY, Moyle M, Mitcham JL, Hammond PW, Olsen OA, Phung P, Fling S, Wong CH, Phogat S, Wrin T, Simek MD; Protocol G Principal Investigators, Koff WC, Wilson IA, Burton DR, Poignard P. Broad neutralization coverage of HIV by multiple highly potent antibodies. Nature. 2011 Sep 22;477(7365):466-70. doi: 10.1038/nature10373.

ReferenceCitation: MacLeod DT, Choi NM, Briney B, Garces F, Ver LS, Landais E, Murrell B, Wrin T, Kilembe W, Liang CH, Ramos A, Bian CB, Wickramasinghe L, Kong L, Eren K, Wu CY, Wong CH; IAVI Protocol C Investigators & The IAVI African HIV Research Network, Kosakovsky Pond SL, Wilson IA, Burton DR, Poignard P. Early Antibody Lineage Diversification and Independent Limb Maturation Lead to Broad HIV-1 Neutralization Targeting the Env High-Mannose Patch. Immunity. 2016 May 17;44(5):1215-26. doi: 10.1016/j.immuni.2016.04.016.

ReferenceCitation: Landais E, Murrell B, Briney B, Murrell S, Rantalainen K, Berndsen ZT, Ramos A, Wickramasinghe L, Smith ML, Eren K, de Val N, Wu M, Cappelletti A, Umotoy J, Lie Y, Wrin T, Algate P, Chan-Hui PY, Karita E; IAVI Protocol C Investigators; IAVI African HIV Research Network, Ward AB, Wilson IA, Burton DR, Smith D, Pond SLK, Poignard P. HIV Envelope Glycoform Heterogeneity and Localized Diversity Govern the Initiation and Maturation of a V2 Apex Broadly Neutralizing Antibody Lineage. Immunity. 2017 Nov 21;47(5):990-1003.e9. doi: 10.1016/j.immuni.2017.11.002.

ReferenceCitation: Zheng M, Gao Y, Wang G, Song G, Liu S, Sun D, Xu Y, Tian Z. Functional exhaustion of antiviral lymphocytes in COVID-19 patients. Cell Mol Immunol. 2020 May;17(5):533-535. doi: 10.1038/s41423-020-0402-2. Epub 2020 Mar 19.

ReferenceCitation: Gralinski LE, Sheahan TP, Morrison TE, Menachery VD, Jensen K, Leist SR, Whitmore A, Heise MT, Baric RS. Complement Activation Contributes to Severe Acute Respiratory Syndrome Coronavirus Pathogenesis. mBio. 2018 Oct 9;9(5). pii: e01753-18. doi: 10.1128/mBio.01753-18.

ReferenceCitation: Qin C, Zhou L, Hu Z, Zhang S, Yang S, Tao Y, Xie C, Ma K, Shang K, Wang W, Tian DS. Dysregulation of Immune Response in Patients With Coronavirus 2019 (COVID-19) in Wuhan, China. Clin Infect Dis. 2020 Jul 28;71(15):762-768. doi: 10.1093/cid/ciaa248.

ReferenceCitation: Lin L, Lu L, Cao W, Li T. Hypothesis for potential pathogenesis of SARS-CoV-2 infection-a review of immune changes in patients with viral pneumonia. Emerg Microbes Infect. 2020 Dec;9(1):727-732. doi: 10.1080/22221751.2020.1746199.

ReferenceCitation: Saylor C, Dadachova E, Casadevall A. Monoclonal antibody-based therapies for microbial diseases. Vaccine. 2009 Dec 30;27 Suppl 6:G38-46. doi: 10.1016/j.vaccine.2009.09.105. Review.

ReferenceCitation: Casadevall A. Antibody-based vaccine strategies against intracellular pathogens. Curr Opin Immunol. 2018 Aug;53:74-80. doi: 10.1016/j.coi.2018.04.011. Epub 2018 Apr 25. Review.

ReferenceCitation: Stadlbauer D, Amanat F, Chromikova V, Jiang K, Strohmeier S, Arunkumar GA, Tan J, Bhavsar D, Capuano C, Kirkpatrick E, Meade P, Brito RN, Teo C, McMahon M, Simon V, Krammer F. SARS-CoV-2 Seroconversion in Humans: A Detailed Protocol for a Serological Assay, Antigen Production, and Test Setup. Curr Protoc Microbiol. 2020 Jun;57(1):e100. doi: 10.1002/cpmc.100.

ipd_sharing_description:
All investigators should have submitted their first publication before study board deciding to share individual participant data.

Furthermore, sharing individual participant data require a contract according to RGPD law.


title: Study of the Response to Irradiation on Prostatic Explants ex Vivo, as a Predictive Factor of the Clinical Response to Irradiation of Prostate Cancers

acronym: EXPLANT

summary:
Of the 50,000 prostate cancers that occur each year in France, more than half will benefit from curative radiotherapy, alone or in combination with hormone therapy from 6 months to 3 years depending on the stage of the disease. At present, there are few ways to predict the response to this irradiation.

Evaluating the early response of tumor tissue to irradiation could predict the final response to treatment. It is difficult to offer biopsies during treatment for reasons of patient comfort. This is why this study consists in analysing transcriptomic and protein responses (immunohistochemistry) to irradiation on ex vivo prostate explants. These explants will be irradiated after culture and the transcriptional and immunohistochemical changes analysed before and after irradiation to determine an early tumor tissue response profile to irradiation.

lead_sponsor: Institut Cancerologie de l'Ouest


title: Evaluation of Methodological and Technical DEvelopmeNts to Improve the Quality and Comfort of Magnetic Resonance Imaging Exam on Voluntary Subjects

acronym: EDEN

summary: The EDEN study will make it possible to evaluate one or more development phases (from design to validation through optimization) of a method or a technique on voluntary subjects, in normal or pathological condition.


title: Study on the Benefit of the Intervention of Clowns in Pediatric Oncology in the Accompaniment of Painful Acts

acronym: ICOD

summary:
The diagnosis and treatment of childhood cancer involves frequent and repeated painful acts. The pediatric oncology-hematology service of Nancy's hospital innovates thanks to the involvement of clowns in the hospital. The effects of the clown's intervention corroborate the results of studies which demonstrate that when painful complaints are increased by an empathetic attitude, they are reduced by half when the child is distracted.

The main objective is to assess the impact of the presence or absence of clowns during the performance of a painful act, on pain, in children who have benefited from this act. no clowns during the performance of a painful act, on anxiety, in children who have benefited from this act.

The secondary objectives are:

Evaluate the impact of the presence or not of clowns during the performance of a painful act, on the anxiety of the parents of the child who benefited from this act.
Measure the perception and acceptance of the healthcare team of the presence of clowns 1 time every 3 months.
Measure the clowns' perception of their interaction with the child, the parents and the healthcare team once every 3 months.
Evaluate the overall impact of the clown intervention during the performance of a painful act in children on the course of the act by a "neutral" person (health manager) once every 3 months.


title: Efficacy and Safety of JAK Inhibitors in Patients With Systemic Sclerosis and Interstitial Lung Disease

acronym: SCLEROJAKI

summary:
Systemic sclerosis (SSc) is a heterogeneous systemic autoimmune disease with distinct prognosis according to patients. In patients with systemic sclerosis, interstitial lung disease (ILD) concerns almost 50 % of patients and represents the main cause of mortality.

Janus kinases (JAK) inhibitors are recent therapies in the field of systemic autoimmune diseases, already approved in patients with rheumatoid arthritis.

Use of JAK inhibitors in systemic sclerosis is based on their anti-inflammatory and anti-fibrotic properties. Several preclinical murine models of systemic sclerosis demonstrated the efficacy of ruxolitinib and tofacitinib on cutaneous and pulmonary fibrosis. Recently, tofacitinib was evaluated in SSc patients in two clinical studies and showed significant improvement on skin fibrosis.

The objective of this study is to evaluate efficacy and safety of JAK inhibitors in SSc patients with ILD.


title: Multicenter Randomized Controlled Trial Evaluating the Effectiveness and Cost-effectiveness of the Use of Short Message Service (SMS) in the Screening Invitation Strategy for Breast Cancer.

acronym: USIMaPI

summary:
Each year in France, breast cancer affects about 48,000 women and is the first cause of cancer death in women with 11,900 deaths estimated.

Since 2004, there is a national organized breast cancer screening (OBCS) programme for asymptomatic women aged 50-74 and with a medium-risk. Every two years, the local cancer screening department sends a personalized invitation mail to eligible women to perform a mammogram and a breast clinical examination. One to two reminder mails are sent to women who have not done the screening after an initial invitation. Despite this programme, almost 47% of women in France do not participate to organized breast cancer screening.

The Short Message Service (SMS) is an innovative communication tool in the field of health, immediate, reliable delivery, low cost and ecological. The use of SMS could be an innovative, low-cost, personalized and ecological way to support the OBCS invitation strategy.

The overall objective of this study is to preserve or even better increase participation in organized breast cancer screening while decreasing the associated costs by including SMS in our screening invitation procedure.

Two SMS interventions will be tested which will correspond to different phases of the OBCS invitation procedure. This sequence of interventions leads us to perform three interlinked trials: a trial of superiority for the first phase (intervention 1: sending an SMS a few days before the initial mail invitation), then two non-inferiority trials for the second phase ( two trials=one for each context of phase 1 _ intervention 2: sending an SMS in place of the first postal reminder).

lead_sponsor: University Hospital, Tours


title: Evaluation of the Benefit of the Training of the Manual Dexterity Post-stroke: Effect on the Function and Spontaneous Use of the Hand and the Cerebral Plasticity

acronym: DEXTRAIN

summary:
Stroke is the second leading cause of death and disability in France: more than half of stroke survivors have a disabling motor deficit, affecting mainly the upper limb. A lack of hand control makes everyday tasks more difficult and reduces the quality of life. The investigators lack approaches to specifically rehabilitate the hand after stroke.

Recently, a new tool has been developed to measure manual dexterity (the Finger Force Manipulandum or FFM). This tool, which records the forces applied by the fingers on pistons, allows to measure more finely the key components of manual dexterity during visuomotor tasks. The tool measures the ability to control and release the force applied by the fingers, to perform sequences, to track and maintain a frequency of tapping (temporality of movement) with the fingers, and to use the fingers independently one another.

lead_sponsor: Centre Hospitalier St Anne


title: Impact of Bloodletting on Iron Metabolism in Type 1 Hemochromatosis: Pathophysiological and Clinical Implications. Pilot Study.

acronym: SAIFER

summary:
Hemochromatosis type 1 is one of the most frequent genetic disease since the genetic predisposition (homozygosity for the C282Y mutation of the HFE gene) is encountered in about 3/1000 white subjects (5/1000 in Brittany, France).

For the half of these predisposed subjects, the phenotypic expression of the disease needs a treatment. This treatment is based upon repeated bloodletting which is generally considered as simple, safe and effective.

Nevertheless, it is still questioned as regard its physiopathological justification and its clinical implications. Indeed, bloodletting could cause an increase of non-transferrin bound iron (NTBI) particularly for its reactive form called labile plasma iron (LPI) This adverse physiopathological effect could have clinical consequences and could be linked with articular consequences which can be aggravated by the treatment.

lead_sponsor: Rennes University Hospital


title: Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility

summary:
Breast cancer affect around 52 000 women in France each year. Amongst them, 7% are less than 40 years old and 2% are in between 25 and 35 years old. Significant therapeutic advances have improved the prognostic of these patients. They will all most likely to received chemotherapy. Despite the fact that chemotherapy has many side effects, these women do question the impact of the treatment on their ability to procreate.

On 06/08/04 law basis, each patient is allowed to preserve gametes or germinal tissues when medical care potentially affect fertility.

Functional evaluation of ovarian reserve could help comprehend new chemotherapy protocols, provide fertility information, and help individualize fertility preservation supports.

Principal objective is to ensure the absence of ovarian stimulation's side effects and assess chemotherapy effects on child carrying potential.

status: Terminated

lead_sponsor: Centre Oscar Lambret


title: Study of Slow Prefrontal Cortex Oscillations During Social Exposure in Social Anxiety Disorder

acronym: POSAD

summary: Experimental fear in rodents is correlated with slow oscillations in electrical recordings of prefrontal cortex activities. The present study aims to test whether slow prefrontal oscillations is a biomarker of pathological anxiety in human subjects.

design_allocation: Non-Randomized

primary_purpose: Basic Science

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


title: Evaluation of the Use of Machine Learning Techniques to Classify Neurodegenerative PARKinsonian Syndromes (Artificial Intelligence)

acronym: PARKIA

summary:
The diagnosis of Parkinson's disease (PD) relies mainly on clinical observation of the patient, looking for the three characteristic symptoms and sometimes remains a real challenge. Machine Learning (ML) algorithms could help to diagnose PD early and differentiate idiopathic PD from atypical Parkinsonian syndromes.

In this context, the work of Castillo-Barnes' team provided a set of imaging features based on morphological characteristics extracted from DaTSCAN® or Ioflupane (iodine-123-labeled radiopharmaceutical) single-photon emission computed tomography (SPECT) scans to discern healthy participants from participants with Parkinson's disease in a balanced set of SPECTs from the "Parkinson's Progression Markers Initiative" (PPMI) data base.

The team of Shabii et al, evaluated the classification performance of Parkinson's patients and normal controls when semi-quantitative indicators and shape features obtained on the dopamine transporter (DAT) by Ioflupane (123I-IP) single-photon emission computed tomography (SPECT) are combined as a machine learning (ML) feature.

AI-based methods can improve diagnostic assessments. Several dopaminergic imaging studies using AI have reported accuracy of up to 90% for the diagnosis of PD.

These automated approaches use machine learning methods, based on textural analyses, to (i) differentiate PD and healthy subjects, (ii) differentiate PD and vascular parkinsonism, and (iii) distinguish between different forms of atypical parkinsonism.

A study conducted in 2 centers using a linear support vector machine (SVM) model discriminated patients with PD and healthy subjects with an accuracy of 82.5%.This performance is similar to visual assessment by nuclear physicians A linear SVM model based on voxel values of statistical parametric images was able to differentiate PD from vascular parkinsonism with an accuracy of 90.4%. The Nancy team has extensive experience in the detection of PD in SPECT and SPECT/CT scans with Ioflupane or DaTSCAN™

status: Suspended

location_facility: Nuclear medicine department CHRU de NANCY


title: Evaluation of the Targeted Screening of Type 2 Diabetes by Capillary Blood Glucose Compared to Current Screening in the Priority Health Area of Saint-Etienne and the Sainté Diabète Network.

acronym: Sainté Diabète

summary:
Type 2 diabetes is the chronic disease with the most important development in France, and particularly in the Saint-Etienne area due to his specific population.

Different studies showed the interest of screening targeted on high risk population to reduce cardiovascular risks and mortality.

The current screening recommandation is an opportunist targeted screening on population older than 45 years with risk factors by a fasting glucose every 3 years, and a communautaire screening targeted on population older than 45 years suffering precarity with or without risk factors by capillary blood glucose or fasting glucose.

The objective of the Sainté Diabete network is to optimize the screening of diabetics, their follow-up and their treatments. Using a self-administered questionnaire during a medical visit could be a simple, cheap and efficient tool to detect diabetics as soon as possible.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Evaluation of Professional Practices in the Management of Blunt Abdominal Trauma in Children in the Pediatric Emergency Department of the Nancy's University Hospital Between 2011 and 2020 : Indentify Children at Low Risk of Intra Abdominal Injuries

summary:
The aim of our study is primarily to evaluate the professional practices over the last years in the pediatric emergencies of the Nancy's Hospital for the BATiC.

This, in order to identify the traumatic mechanisms and the initial clinical elements which would make it possible to detect the patients at low risk of developing visceral lesions. Then, a management could be proposed which would rationalize the use of additional examinations and would favor the monitoring and the clinical reassessment after the initial management of a minor trauma.

The study of the data will then aim to establish a composite score (anamnestic and clinical) of initial evaluation, from which could result a uniform management protocol (clinical, biological and imaging) of the minor BATiC, of the intermediate BATiC and the major BATiC, applicable to pediatric emergencies at the Nancy's Hospital.


title: SaRS-Cov-2 Antibodies Following Exposure to COVID-19 and/or Vaccination in Nursing Homes

summary:
Presence of SaRS-Cov-2 antibodies following exposure to Coronavirus Disease 2019 (COVID-19) and/or vaccination is a major indicator of immunization. Few data exit about serology response in nursing homes (NHs), i.e. in the most vulnerable population for developing severe forms of the disease.

Residents and health professionals in 9 nursing homes (NHs) with SaRS-Cov-2 antibodies detection after exposure (either COVID-19 or vaccine) All biological tests were performed in the frame of the standard care of residents and health professionals and all participants did not express opposition for using anonymously their data for the purpose of this academic analysis. In addition all Directors and Physicians of these NHs accepted to participate in this study

ipd_sharing_description: The database can be used by other groups but only for academic purposes


title: Clinical Outcomes and Characteristics of Critically Ill Patients With Influenza and COVID-19 Induced ARDS: a Retrospective, Matched Cohort Study

summary: Since the beginning of the SARS CoV 2 pandemia, the SARS CoV 2 was frequently compared with the seasonal influenza virus. However, few studies compared patients presenting acute respiratory distress syndrome (ARDS) induced by these viruses, with results being discordant. Our study means to compare mortality and morbidity of patients hospitalized in an intensive care unit (ICU) with ARDS induced by SARS CoV-2 and seasonal influenza.


title: Impact on the Time to Diagnosis of Serious Post-operative Complications of Continuous, Individualised, Alert Monitoring of SpO2, Heart Rate and Respiratory Rate by a Controlled Connected Medical Device (SMART ANGEL Intra )

acronym: SMARTANGEL

summary:
Post-operative mortality in case of scheduled surgery is 3% in France (Lancet 2013) mainly due to cardiovascular or respiratory complications, by decompensation of pre-existing pathologies.

Complications due to the medical practice are the third cause of morbidity (BMJ, 2016). More than half are preventable and are mainly observed in surgical patients. In conventional hospitalization, excluding intensive care, monitoring is done discontinuously for most of the patients, which does not allow early diagnosis of a vital cardiovascular or respiratory failure.

Diagnosis and late treatment do not allow good recovery. The early identification of a vital failure by the continuous monitoring of three simple physiological parameters (SpO2, heart rate and respiratory rate) would allow faster management by the hospital staff and a reduction in immediate and possibly delayed postoperative mortality.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Assistance Publique Hôpitaux de Paris - CHU Henri Mondor


title: Molecular Characterization and Cellular Infection Capacity of Urinary Viral Particles Isolated From SARS-CoV-2 and Association With Proximal Tubular Dysfunction, in Hospitalized Patients With COVID-19

acronym: CovUrinePTD

summary: The primary goal is to detect Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV2) urine viral particles in patients in intensive care units, hospitalized for coronavirus Coronavirus Disease-19 (COVID-19) infection, and correlate the presence of the virus in the urine with proximal tubular dysfunction (defined by the association of at least 2 abnormalities: tubular proteinuria, renal phosphate leak, uricosuria, normoglycemic glycosuria, amino aciduria)

ReferenceCitation: Kormann R, Jacquot A, Alla A, Corbel A, Koszutski M, Voirin P, Garcia Parrilla M, Bevilacqua S, Schvoerer E, Gueant JL, Namour F, Levy B, Frimat L, Oussalah A. Coronavirus disease 2019: acute Fanconi syndrome precedes acute kidney injury. Clin Kidney J. 2020 Jun 8;13(3):362-370. doi: 10.1093/ckj/sfaa109. eCollection 2020 Jun.


title: Benefit/Risk in Real Life of New Oral Anticoagulants and Vitamin K Antagonists in the Treatment of Non Valvular Atrial Fibrillation in Patients Aged 80 Years and Over, Living at Home or in Nursing Home. A Prospective Cohort Study

acronym: PRESAGE-ACO

summary:
The aim of the study is to compare, in real life, the risk benefit (including both major bleeding and thrombotic events (TE) and death from any cause) associated with direct oral anticoagulants (DOA) and with anti vitamin K (VKA) in older adults (≥ 80 years) suffering from non valvular atrial fibrillation and living in community or nursing home settings.

An observational multicenter prospective inception cohort will be conducted within the PRESAGE-Network, an ongoing active network on drug safety in older adults in France involving a sample of general practitioners (GPs) and pharmacists, for an active surveillance of drug safety in older adults. GPs and pharmacists will prospectively include all octo+ patients they care for, newly treated with an oral anticoagulant (VKA or DOA) for nv AF and will follow them during 2 years at least.


title: Site of Implantation of Continent Catheterizable Channel : Native Bladder or Enterocystoplasty ? Comparison in 106 Patients

acronym: ICODE

summary:
PURPOSE. To compare the results between two sites of implantation of the continent catheterizable channel (CCC): native bladder or enterocystoplasty.

METHODS. Retrospective monocentric study of pediatrics and adult patients who underwent a continent cystostomy between 1991 and 2020 with a continent catheterizable channel implanted in the native bladder's detrusor (D group) or the enterocystoplasty (EC group).


title: Follow up of Patients After a Visit to Tourcoing Emergency Department for an Ankle Sprain

acronym: CHEVILLE

summary: Ankle sprain is very common. In France, its daily incidence is estimated at 6000. It often causes pain, a temporary period of disability and can results in recurrence and chronic ankle instability. Therefore, an early management and follow up treatment is necessary. Now, functional treatment is clinically the treatment strategy of choice for ankle sprain. It is based on rest, ice, compression, elevation and can use a functional support (like an ankle brace). To evaluate gravity and improve management, a clinical assessment delayed between 4 and 5 days post injury is necessary.

lead_sponsor: University Hospital, Lille


title: Sensitivity and Specificity Study of Risk Factors for Intraductal Papillary Mucinous Neoplasms Degeneration at the Nancy CHRU (IPMN)

acronym: IPMN

summary:
Cystic lesions of the pancreas are frequent with a risk of degeneration into adenocarcinoma with pejorative prognosis.

IPMNs require characterization to clarify their potential for degeneration. Clinical and morphological risk factors for degeneration determine the monitoring rate and the indication for pancreatic surgery.

Pancreatic surgery remains invasive with high morbidity and mortality rates.

intervention_type: Behavioral


title: Analysis of Chilblains Profile During COVID-19 Epidemic

acronym: ACROVID

summary: Cases of chilblains have been reported with an unusual frequency in France in the context of the COronaVirus Infectious Disease 2019 (COVID-19) epidemic. Some of these cases have been linked to a virological status in favour of a recent Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) infection. Chilblains are acral inflammatory lesion typically reactive to cold (primary form). There are secondary forms acquired during autoimmune connectivitis such as lupus chilblain or hereditary forms related to type I Interferonopathy. An interferon type I signature has been described in these secondary forms of frostbite but also during the cytokine storm of severe forms of CoV-2 SARS infection. If cases of frostbite are indeed secondary to an SARS-CoV-2 infection, comparative analysis of their immunopathological profiles could provide a better understanding of the inflammatory mechanisms during COVID-19.

lead_sponsor: Poitiers University Hospital


title: Structural Cartography of the Insula in Temporal Epilepsy Patients

acronym: CON-INSULA

summary: The purpose of this study is to investigate insula structural connectivity in temporal epilepsy patients. Insula being at the interface of frontal, parietal, occipital and temporal lobes, its structural organization reflects the brain function. We hypothetize that insular structural organization will be different according to the different subtypes of temporal epilepsy.


title: Dynamic Evaluation of Myocardial Fibrosis and Structural Determinants of Ventricular Arrhythmia in Mitral Valve Prolapse (STAMP-2 : STretch and Myocardial Characterization in Arrythmogenic Mitral Valve Prolapse-2)

summary:
Mitral valve prolapse (MVP) is a frequent affection of the mitral valve with a prevalence of 2-3% in the general population. This valvular disease is generally considered as benign, but may at term evolve toward mitral valve regurgitation of various severity and/or arrhythmia.

Mitral valve prolapse is routinely diagnosed using transthoracic echocardiography. Subsequent examinations (24-hour external loop recording, exercise electrocardiogram, cardiac Magnetic Resonance Imaging) and a close follow-up can be proposed to the patient depending on its condition.

More recently, detection of myocardial fibrosis and a mitral ring disjunction among patients with MVP were associated with the occurrence of severe ventricular arrhythmia.

The investigators hypothesize that ventricular remodeling over time is mediated by the progression of mitral insufficiency severity from myocardial fibrosis secondary to MVP and possibly promoted by other mitral valve abnormalities. This remodeling, characterized by circulating biomarkers and imaging (MRI and echocardiography), could allow the identification of patients with a higher risk of severe ventricular arrhythmia.

The main objective of this study is to identify prognostic factors for unfavorable evolution (ventricular remodeling or a rhythm disorder event) at 3 years from initial assessments in MVP patients.


title: SMART Identification of Ventricular Tachycardia Isthmus

acronym: SMARTIS

summary:
Context :

Ventricular tachycardia (VT) are serious heart rhythm disorders which can lead to sudden death. A curative treatment for these abnormalities in the cardiac electrical conduction system is possible through an interventional electrophysiology procedure. A catheter is inserted, generally via a femoral access, and is introduced in the heart ventricles in order to collect various 3D electro-anatomical maps.

The pace-mapping technique developed in Nancy (de Chillou et al, Heart Rhythm 2014) allows the reentrant circuit underlying the VT to be identified, as well as a definition of the target zones to be ablated, using radiofrequency energy with the catheter. The pace-mapping technique consists of stimulating the ventricle from various sites within its internal surface, in order to generate different activation pathways of the myocardium. When an activation pathway is similar to the VT pathway, this means that the stimulation site is located near the pathologic zone to be ablated. The surface electrocardiogram (ECG) is used to compare activation pathways. A 3D correlation ma is then generated: the zones with high correlation (>90%) indicated the exit of the reentrant circuit, while rapid transition zones (several %/mm) indicate the entrance of the VT circuit. The pace-mapping technique has several limitations: (i) it requires an ECG recording of the clinical VT of the patient (spontaneous or induced at the beginning of the procedure), however it is not always possible to induce it; (ii) sometimes several VT circuits may be present, rendering the procedure of identification and ablation non-exhaustive.

The aim of this study is to analyze retrospectively electroanatomical data collected during the intervention, in order to develop a new method for identifying target zones to be ablated, and to compare the results with the conventionally used method.

Hypothesis :

The investigators hypothesize that alternative methods to analyze electroanatomical data (surface ECG and spatial coordinates of the pacing sites) could provide information equivalent to conventional methods (e.g. VT correlation map, VT activation maps etc…) without the need for a reference recording of the clinical VT of the patient.


title: Medico-economic Evaluation of a Preoperative Algorithm Including EBUS for NSCLC Initial Staging

acronym: EVIEPEB

summary: This study aims to assess both the role and cost-effectiveness of EBUS in preoperative Non small cell lung cancer staging. This controlled multicentric study will be conducted in 22 centers in France. The study design includes two prospective phases. In phase 1, one investigator in each center will prospectively be evaluated for its ability to perform EBUS, with a required goal of 9 informative samplings out of 10 consecutive patients. The phase 2 will include the medico-economic assessment of the technique in the preoperative setting. A maximum of 420 patients for each phase is forecasted.

ReferenceCitation: Chouaid C, Salaün M, Gounant V, Febvre M, Vergnon JM, Jouniaux V, Fournier C, Lachkar S, Hermant C, Raspaud C, Quantin X, Quiot JJ, Molard A, Dayen C, Marquette CH, Lena H, Zalcman G, Thiberville L. Clinical efficacy and cost-effectiveness of endobronchial ultrasound-guided transbronchial needle aspiration for preoperative staging of non-small-cell lung cancer: Results of a French prospective multicenter trial (EVIEPEB). PLoS One. 2019 Jan 7;14(1):e0208992. doi: 10.1371/journal.pone.0208992. eCollection 2019.

lead_sponsor: University Hospital, Rouen


title: Continuous Enteral Rehydration by Nasogastric Tube With ORS in Children With Acute Gastroenteritis: Evaluation of Professional Practices Before and After Protocol Change

acronym: GEA

summary: When oral rehydration is impossible, enteral rehydration via the nasogastric route has been the recommended method of rehydration since 2008 by ESPGHAN ( European Society for Paediatric Gastroenterology Hepatology and Nutrition ), for children with acute gastroenteritis. However, these recommendations are rarely followed in France. These recommendations were not applied in the Children's Emergency Department of BREST University Hospital. The investigators changed the protocol and shared it with the caregivers of the emergency unit. The investigators studied the impact of this change of protocol

lead_sponsor: University Hospital, Brest


title: Predictive Value of D-dimers Trends and Levels for Thrombosis in Patients With COVID-19

acronym: TRENDS

summary:
A high incidence of venous thromboembolic events (VTE) has been demonstrated in COVID-19. This incidence correlates with disease severity. Activation of coagulation secondary to sepsis combined with classical thrombotic risk factors may contribute to this prothrombotic state. Since the beginning of March 2020, the issue of venous thrombosis during SARS-CoV-2 infection has rapidly emerged as a major medical challenge since a significant rate of patients were thrombosing, some of them in spite of a well conducted preventive anticoagulation. Although D-dimers have been shown to be useful in identifying patients at risk of severe COVID-19 and even mortality, they cannot be used for diagnostic exclusion of pulmonary embolism. Indeed, since D-dimer levels rise non-specifically during infectious states, the exclusion threshold of 500 ng/ml cannot be used.

It would therefore be useful to study the predictive value of D-dimers for thrombosis in COVID-19 patients.

lead_sponsor: Central Hospital, Nancy, France


title: Sequential Treatment of Hepatocellular Carcinoma by Transarterial Chemoembolization and Local Ablation or External Radiation

acronym: CELPerCutCHC

summary:
Hepatocellular carcinoma (HCC) can present itself in many forms (size, number of lesions) for the treatment of which a therapeutic panel can be elaborated and layered. If a curative treatment cannot be considered in case of an HCC classified in an intermediate stage, a Transcatheter Arterial Chemoembolization (TACE) can be proposed. In case of a partial response or the treatment of some lesions of a multifocal HCC, a combined treatment by stereotaxic radiotherapy (CK), radiofrequency ablation (RFA) or microwave ablation (MWA) may be initiated in accordance with a decision of the multidisciplinary consultation meeting.

The aim of this study was to evaluate the clinical outcome of HCC receiving MWA, RFA or CK after downstaging with TACE.


title: Predicting the Risk of Readmission in Patients With Chronic Heart Failure

acronym: PREDIC

summary:
Heart failure (HF) is a frequent, serious, and costly chronic disease: it leads to 150,000 hospitalizations each year in France at a cost of 525 million Euros.

It is estimated that 20-40% of these hospitalizations are preventable by known interventions: home telemonitoring, care coordination, therapeutic intensification and therapeutic education. But these interventions only work if patients at high risk of rehospitalization are targeted to individualize management. In these patients, the risk of rehospitalization depends on clinical, biological, socioeconomic, care pathway, and location-related data. Existing predictive tools perform poorly due to three important limitations: non-use of unstructured clinical data, lack of integration of multimodal data, and weakness of the algorithmic approach.

The objective is to design and validate a predictive algorithm for the risk of rehospitalization in heart failure patients, using multiple data sources

ipd_sharing_description: NC


title: Osseointegration of Hydroxyapatite-coated Femoral Stems in Femoral Neck Fractures Over 80 Years

summary:
This study aimes to prove that osseointegration of hydroxyapatite coated stem is possible for patients over 80 years with femoral neck fracture, without the risks of cemented stems.

The hydroxyapatite has a local effect which can improve cortical index.


title: Predictive Criteria of Acute Heart Failure (AHF) in Patients Admitted to Emergency Department for Dyspnea.

acronym: PREDICA

summary: No studies have analyzed the predictive value of different anamnestic and clinical signs for the diagnosis of acute heart failure (AHF) in patients admitted to emergency department. That's why the expert group of the AHF of South West of France mobilizes to conduct this study to evaluate the diagnostic predictive value of different anamnestic and clinical signs for the diagnosis of AHF to emergencies.

ReferenceCitation: Roncalli J, Picard F, Delarche N, Faure I, Pradeau C, Thicoipe M, Galinier M, Charpentier S. Predictive criteria for acute heart failure in emergency department patients with acute dyspnoea: the PREDICA study. Eur J Emerg Med. 2019 Dec;26(6):400-404. doi: 10.1097/MEJ.0000000000000622.

lead_sponsor: University Hospital, Toulouse

location_facility:
Hospital
University Hospital Toulouse
University Hospital


title: Evaluation of Cognitive Function in a Suicidal Crisis and Interest to Achieve a MoCA Test in Acute Situations

acronym: CocaCS

summary:
The aftermath of suicide is devastating, being the cause of 800 000 deaths every year worldwide. In France, suicide still causes about 10 000 deaths per year and the number of suicide attempts (SA) is estimated between 170 000 and 200 000 per year (InVS).

It is often thought that a suicidal crisis is only related to depression, as it actually is a far more complex phenomenon. A suicidal crisis can occur on various grounds like psychiatric disorders but also contextual events or somatic diseases and it has been hypothesized that suicidal ideas or inclinations could have a common and independent cognitive origin


title: Characterization in 18F-FDG PET-CT of Brain and Lung Lesions in Young Subjects With Sequelae Psycho-cognitive Disorders in the Aftermath of Severe Covid-19

acronym: TEP-COV

summary:
Patients with Covid-19 (Coronavirus disease 19) may experience multiple neurological symptoms .

18F-FDG PET-CT ( Positons EmissionTomography coupled with a Computer Tomography with flurodesoxyglucose labelled with fluor 18), which reflects neuronal glycolytic metabolism, shows early variations in neuronal function.

Moreover the tropism of Covid-19 is essentially pulmonary and the hypothesis of this study is with 18F-FDG PET-CT it's possible to study the relationship between cerebral metabolism and the metabolism of pulmonary lesions following Covid-19 infection.

location_facility: CHRU NANCY Brabois, nuclear medicine department


title: Study of Metformin Overdose in Adult Patients Treated at the University Hospital of Nancy: Single-center Descriptive Retrospective Observational Study

acronym: METINFO

summary: The objective of the METINFO study is an observational single-center retrospective and descriptive study. The main objective is to estimate the real mortality rate associated to a Metformin overdose. Second objectives are to estimate the real hospitalization rate related to metformin overdose and to identify the risk factors of a metformin overdose and especially the potential correlation between metformin blood concentration and overdose severity.

ReferenceCitation: Goonoo MS, Morris R, Raithatha A, Creagh F. Metformin-associated lactic acidosis: reinforcing learning points. BMJ Case Rep. 2020 Sep 2;13(9). pii: e235608. doi: 10.1136/bcr-2020-235608. Corrected and republished in: Drug Ther Bull. 2021 Aug;59(8):124-127.

ReferenceCitation: Walz L, Jönsson AK, Ahlner J, Östgren CJ, Druid H. Metformin - Postmortem fatal and non-fatal reference concentrations in femoral blood and risk factors associated with fatal intoxications. Forensic Sci Int. 2019 Oct;303:109935. doi: 10.1016/j.forsciint.2019.109935. Epub 2019 Aug 28.

ReferenceCitation: Taub ES, Hoffman RS, Manini AF. Incidence and risk factors for hyperlactatemia in ED patients with acute metformin overdose. Am J Emerg Med. 2019 Dec;37(12):2205-2208. doi: 10.1016/j.ajem.2019.03.033. Epub 2019 Mar 23.


title: Prognostic Impact of the Inflammatory Microenvironment in Atypical Meningiomas

summary:
Atypical meningiomas represent 15% of meningiomas. They present a high rate of recurrence, and therapeutic strategies are limited. There is a need for novel treatment strategies, such as immuotherapy.

This is a retrospective study including 84 patients with primary diagnosis of atypical meningiomas. The presence of T cells (CD4, CD8, Treg and memory T cells) and mature dendritic cells will be quantified on whole tissue sections stained by immunohistochemistry (CD4, CD8, FOXP3, CD45RO and CD208).

This could allow us to identify novel biomarkers for survival, and facilitate the selection of patients who may benefit from immunotherapeutic modalities.


title: Multimodal IMAgery (Echocardiography and Cardiac MRI) Characterization of Cardiac Damage and Severity After COVID-19 Infection

acronym: IMACovid

summary:
Coronavirus Disease 2019 (COVID-19) is an infection caused by Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2), which affects multiple organ system particularly the lung and heart. Indeed, SARS CoV-2 has various cardiac manifestations which are associated with higher mortality and morbidity. Cardiac involvement, based on elevated levels of myocardial enzymes, have been described in 20 to 30% of COVID-19 infection. However, the physiopathological mechanisms of myocardial injury remains unclear. Main hypothesis include inflammation and cytokine storm, hypercoagulability and vascular thrombosis, inflammation or stress leading to coronary plaque rupture (type I myocardial infarction), supply-demand mismatch and hypoxemia resulting in myocardial damage (type II myocardial infarction) ...

Two patterns can be identified : ischemic or non-ischemic pattern including myocarditis, stress induced cardiomyopathy, thrombo-embolic disease. However, the consequences of myocardial damage after confirmed COVID-19 infection are unknown at medium to long term prognosis.

Data are needed to identify myocardial damage and to guide effective therapies and follow-up (use of ACE inhibitor, beta-blockers, steroids...? ) In this study, the investigators proposed to collect multimodal cardiac imaging including MRI (Magnetic Resonance Imaging) and TTE (Transthoracic echocardiogram) in order to identify and characterize cardiac injury as ischemic or non-ischemic pattern, to better assess risk stratification and to guide effective therapies if necessary.

ReferenceCitation: Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum in: JAMA. 2021 Mar 16;325(11):1113.

ReferenceCitation: Bavishi C, Bonow RO, Trivedi V, Abbott JD, Messerli FH, Bhatt DL. Special Article - Acute myocardial injury in patients hospitalized with COVID-19 infection: A review. Prog Cardiovasc Dis. 2020 Sep-Oct;63(5):682-689. doi: 10.1016/j.pcad.2020.05.013. Epub 2020 Jun 6.

ReferenceCitation: Driggin E, Madhavan MV, Bikdeli B, Chuich T, Laracy J, Biondi-Zoccai G, Brown TS, Der Nigoghossian C, Zidar DA, Haythe J, Brodie D, Beckman JA, Kirtane AJ, Stone GW, Krumholz HM, Parikh SA. Cardiovascular Considerations for Patients, Health Care Workers, and Health Systems During the COVID-19 Pandemic. J Am Coll Cardiol. 2020 May 12;75(18):2352-2371. doi: 10.1016/j.jacc.2020.03.031. Epub 2020 Mar 19. Review.

ReferenceCitation: Inciardi RM, Lupi L, Zaccone G, Italia L, Raffo M, Tomasoni D, Cani DS, Cerini M, Farina D, Gavazzi E, Maroldi R, Adamo M, Ammirati E, Sinagra G, Lombardi CM, Metra M. Cardiac Involvement in a Patient With Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Jul 1;5(7):819-824. doi: 10.1001/jamacardio.2020.1096.

ReferenceCitation: Babapoor-Farrokhran S, Gill D, Walker J, Rasekhi RT, Bozorgnia B, Amanullah A. Myocardial injury and COVID-19: Possible mechanisms. Life Sci. 2020 Jul 15;253:117723. doi: 10.1016/j.lfs.2020.117723. Epub 2020 Apr 28.

ReferenceCitation: Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. Erratum in: Lancet Respir Med. 2020 Feb 25;:.

ReferenceCitation: Barton LM, Duval EJ, Stroberg E, Ghosh S, Mukhopadhyay S. COVID-19 Autopsies, Oklahoma, USA. Am J Clin Pathol. 2020 May 5;153(6):725-733. doi: 10.1093/ajcp/aqaa062. Erratum In: Am J Clin Pathol. 2020 May 5;153(6):852.

ReferenceCitation: Agewall S, Beltrame JF, Reynolds HR, Niessner A, Rosano G, Caforio AL, De Caterina R, Zimarino M, Roffi M, Kjeldsen K, Atar D, Kaski JC, Sechtem U, Tornvall P; WG on Cardiovascular Pharmacotherapy. ESC working group position paper on myocardial infarction with non-obstructive coronary arteries. Eur Heart J. 2017 Jan 14;38(3):143-153. doi: 10.1093/eurheartj/ehw149.

ReferenceCitation: Imazio M, Klingel K, Kindermann I, Brucato A, De Rosa FG, Adler Y, De Ferrari GM. COVID-19 pandemic and troponin: indirect myocardial injury, myocardial inflammation or myocarditis? Heart. 2020 Aug;106(15):1127-1131. doi: 10.1136/heartjnl-2020-317186. Epub 2020 Jun 4.

ReferenceCitation: Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648.

ReferenceCitation: Filippetti L, Pace N, Louis JS, Mandry D, Goehringer F, Rocher MS, Jay N, Selton-Suty C, Hossu G, Huttin O, Marie PY. Long-Lasting Myocardial and Skeletal Muscle Damage Evidenced by Serial CMR During the First Year in COVID-19 Patients From the First Wave. Front Cardiovasc Med. 2022 Mar 9;9:831580. doi: 10.3389/fcvm.2022.831580. eCollection 2022.