title: Qualitative Assessment of the French Brief Contact Intervention "Stay in Contact" in Suicide Prevention

summary:
Background: For 40 years, brief contact interventions (BCIs) have been presented as promising approaches in suicide prevention but patient's experiences of BCIs are less investigated.

Aim: Understand mechanisms of BCIs after suicide attempt, through patient's experience of a French BCI "Stay in contact" and assess its impact on seeking care during suicidal crisis.

Method:This is a single-center, non-interventional, prospective qualitative study using phone call interview on a BCI, 6 months after suicide attempt behavior.

Statistical analysis

Data were analyzed using statistical software (Version 9.4, SAS Institute Inc., Cary, North Carolina, USA). Chi-squared test was used to assess qualitative variables and t-test to evaluate quantitative variables, with p<.05 considered significant.

ReferenceCitation: Cedereke M, Monti K, Ojehagen A. Telephone contact with patients in the year after a suicide attempt: does it affect treatment attendance and outcome? A randomised controlled study. Eur Psychiatry. 2002 Apr;17(2):82-91.

ReferenceCitation: Hawton K, Saunders K, Topiwala A, Haw C. Psychiatric disorders in patients presenting to hospital following self-harm: a systematic review. J Affect Disord. 2013 Dec;151(3):821-30. doi: 10.1016/j.jad.2013.08.020. Epub 2013 Sep 7. Review.

ReferenceCitation: Gruat G, Cottencin O, Ducrocq F, Duhem S, Vaiva G. [Patient satisfaction regarding further telephone contact following attempted suicide]. Encephale. 2010 Jun;36 Suppl 2:D7-D13. doi: 10.1016/j.encep.2009.10.009. Epub 2009 Dec 1. French.

ReferenceCitation: Milner A, Spittal MJ, Kapur N, Witt K, Pirkis J, Carter G. Mechanisms of brief contact interventions in clinical populations: a systematic review. BMC Psychiatry. 2016 Jun 8;16:194. doi: 10.1186/s12888-016-0896-4. Review.

ReferenceCitation: Castaigne E, Hardy P, Mouaffak F. [Follow-up interventions after suicide attempt. What tools, what effects and how to assess them?]. Encephale. 2017 Feb;43(1):75-80. doi: 10.1016/j.encep.2016.08.004. Epub 2016 Sep 28. Review. French.

ReferenceCitation: Kapur N, Cooper J, Bennewith O, Gunnell D, Hawton K. Postcards, green cards and telephone calls: therapeutic contact with individuals following self-harm. Br J Psychiatry. 2010 Jul;197(1):5-7. doi: 10.1192/bjp.bp.109.072496.

ReferenceCitation: Pirkis J, Burgess P, Meadows G, Dunt D. Self-reported needs for care among persons who have suicidal ideation or who have attempted suicide. Psychiatr Serv. 2001 Mar;52(3):381-3.

ReferenceCitation: Burgess P, Pirkis J, Morton J, Croke E. Lessons from a comprehensive clinical audit of users of psychiatric services who committed suicide. Psychiatr Serv. 2000 Dec;51(12):1555-60.

ReferenceCitation: Appleby L, Shaw J, Amos T, McDonnell R, Harris C, McCann K, Kiernan K, Davies S, Bickley H, Parsons R. Suicide within 12 months of contact with mental health services: national clinical survey. BMJ. 1999 May 8;318(7193):1235-9.

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

ReferenceCitation: Foster T, Gillespie K, McClelland R. Mental disorders and suicide in Northern Ireland. Br J Psychiatry. 1997 May;170:447-52.

ReferenceCitation: Hawton K et al. Attempted suicide : a practical Guide to its nature and management, 2nd ed. Oxford: Oxford University Press; 1987

ReferenceCitation: Kerkhof A al. Repetition of attempted suicide: results from the WHO/EU Multicentre Study on Parasuicide, repetition-prediction part. 7th European Symposium on Suicide and Suicidal Behaviour. Ghent: University Press; 1998

ReferenceCitation: Rygnestad T. [A 15-year follow-up study after deliberate self-poisoning]. Tidsskr Nor Laegeforen. 1997 Sep 10;117(21):3065-9. Norwegian.

ReferenceCitation: Schmidtke A, Bille-Brahe U, DeLeo D, Kerkhof A, Bjerke T, Crepet P, Haring C, Hawton K, Lönnqvist J, Michel K, Pommereau X, Querejeta I, Phillipe I, Salander-Renberg E, Temesváry B, Wasserman D, Fricke S, Weinacker B, Sampaio-Faria JG. Attempted suicide in Europe: rates, trends and sociodemographic characteristics of suicide attempters during the period 1989-1992. Results of the WHO/EURO Multicentre Study on Parasuicide. Acta Psychiatr Scand. 1996 May;93(5):327-38.

ReferenceCitation: Gilbody S, House A, Owens D. The early repetition of deliberate self harm. J R Coll Physicians Lond. 1997 Mar-Apr;31(2):171-2.

ReferenceCitation: Lönnqvist J et al.Suicide following the first suicide attempt: a five-year follow-up using a survival analysis. Psychiatr Fenn 1991;22:1719

ReferenceCitation: Van Heeringen K. The management of non-compliance with outpatient after-care in suicide attempters: a review. Ital J Suicidol 1992 ; 2 : 79-83

ReferenceCitation: Evans MO, Morgan HG, Hayward A, Gunnell DJ. Crisis telephone consultation for deliberate self-harm patients: effects on repetition. Br J Psychiatry. 1999 Jul;175:23-7.

ReferenceCitation: Vaiva G, Vaiva G, Ducrocq F, Meyer P, Mathieu D, Philippe A, Libersa C, Goudemand M. Effect of telephone contact on further suicide attempts in patients discharged from an emergency department: randomised controlled study. BMJ. 2006 May 27;332(7552):1241-5.

ReferenceCitation: Lebow JL. Client satisfaction with mental health treat- ment: Methodological considerations in assessment. Eval Rev 1983; 7:729-52

ReferenceCitation: Aoun S, Johnson L. A consumer's perspective of a suicide intervention programme. Aust N Z J Ment Health Nurs. 2001 Jun;10(2):97-104.

ReferenceCitation: Nguyen TD, Attkisson CC, Stegner BL. Assessment of patient satisfaction: development and refinement of a service evaluation questionnaire. Eval Program Plann. 1983;6(3-4):299-313.


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.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


type: Other Identifier

title: Assessment of the Technical Capabilities of the "SMART ANGEL" Intra-hospital System 's Connected Medical Device (CMD)

acronym: SMART-METRO

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.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Device Feasibility

enrollment_type: Anticipated

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Assistance Publique Hôpitaux de Paris - CHU Henri Mondor

intervention_type: Device

status_simplified: Ongoing


title: Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Naso- Pharyngeal Viral Load in Patients With SARS-CoV-2

acronym: KILLER

summary:
The SARS-CoV-2 coronavirus pandemic is responsible for more than 180,000 deaths worldwide and 20,000 deaths in France. To date, no treatment or vaccine has been successful. Povidone-iodine is an antiseptic suitable for use on the skin and mucosa with potent virucidal activity, particularly against coronaviruses. It is marketed for oro-nasopharyngeal decolonization.

24 patients with positive nasopharyngeal SARS-CoV-2 carriage will be randomized (1:1) in an experimental group (benefiting from povidone iodine decolonization) or a control group. Patients in the experimental group will be asked to gargle with a 1% povidone-iodine solution, spray their nose with the same antiseptic solution, and finally applied 10% povidone-iodine cream in each nostril, all four times a day for five days. Patients will be followed for 7 days to evaluate the efficacy and safety of povidone iodine decolonization.

study_start_date_type: Actual

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Guenezan J, Garcia M, Strasters D, Jousselin C, Lévêque N, Frasca D, Mimoz O. Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Nasopharyngeal Viral Load in Patients With COVID-19: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 Apr 1;147(4):400-401. doi: 10.1001/jamaoto.2020.5490.

name: Emergency Department, University Hospital of Poitiers, Poitiers, France

family: Guenezan

full_name: Jeremy Guenezan

given: Jeremy

sequence: first

name: Virology laboratory, University Hospital of Poitiers, Poitiers, France

family: Garcia

full_name: Magali Garcia

given: Magali

sequence: additional

family: Strasters

full_name: Deidre Strasters

given: Deidre

family: Jousselin

full_name: Clément Jousselin

given: Clément

family: Lévêque

full_name: Nicolas Lévêque

given: Nicolas

name: Department of Anesthesia, Intensive Care and Perioperative Medicine, University Hospital of Poitiers, Poitiers, France

family: Frasca

full_name: Denis Frasca

given: Denis

family: Mimoz

full_name: Olivier Mimoz

given: Olivier

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: JAMA Otolaryngology–Head & Neck Surgery

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

lead_sponsor: Poitiers University Hospital

intervention_type: Drug


title: CIRRAL: Hepatocellular Carcinoma in Patients With Uncomplicated Alcoholic Cirrhosis: Incidence and Predictive Factors. A Multicentric Prospective Cohort

acronym: CIRRAL

summary: Hepatocellular carcinoma (HCC) is a major public health problem, whose incidence is increasing in developed countries and is the leading cause of death in patients with cirrhosis. The diagnosis and the early management are key issues that could improve the prognosis. In France, alcoholic cirrhosis is the leading cause of HCC, while the aetiology of underlying chronic liver disease is mainly hepatitis C (HCV) in Southern Europe and Japan, and hepatitis B (HBV) in Asia and Africa. In the next years, due to the improved results of anti-viral therapies, this trend should be reinforced with a decreasing proportion of HCC related to viral cirrhosis and an increasing proportion of HCC related to alcoholic cirrhosis. However, natural history of alcoholic cirrhosis remains poorly understood, most studies being retrospective and including a small number of patients. This project is filed by the consortium CIRRAL including French Academic hospitals centers currently involved and referees in the field of alcoholic liver disease and HCC (8 at the moment, and more in the next months). It is a national multicenter prospective study that will include 1200 patients with alcoholic cirrhosis histologically proven over 3 years. The main goal of this cohort is to describe the natural history of a large number of patients with alcoholic cirrhosis prospectively followed, and to identify predictors of the occurrence of HCC.

status: Unknown status

ReferenceCitation: Ganne-Carrié N, Nahon P, Chaffaut C, N'Kontchou G, Layese R, Audureau E, Chevret S; CIRRAL group; ANRS CO12 CirVir group. Impact of cirrhosis aetiology on incidence and prognosis of hepatocellular carcinoma diagnosed during surveillance. JHEP Rep. 2021 Mar 26;3(3):100285. doi: 10.1016/j.jhepr.2021.100285. eCollection 2021 Jun.

family: Ganne-Carrié

full_name: Nathalie Ganne-Carrié

given: Nathalie

family: Nahon

full_name: Pierre Nahon

given: Pierre

family: Chaffaut

full_name: Cendrine Chaffaut

given: Cendrine

family: N’Kontchou

full_name: Gisèle N’Kontchou

given: Gisèle

family: Layese

full_name: Richard Layese

given: Richard

family: Audureau

full_name: Etienne Audureau

given: Etienne

family: Chevret

full_name: Sylvie Chevret

given: Sylvie

family: Archambeaud

full_name: Isabelle Archambeaud

given: Isabelle

family: d’Alteroche

full_name: Louis d’Alteroche

given: Louis

family: Oberti

full_name: Frédéric Oberti

given: Frédéric

family: Roulot

full_name: Dominique Roulot

given: Dominique

family: Moreno

full_name: Christophe Moreno

given: Christophe

family: Louvet

full_name: Alexandre Louvet

given: Alexandre

family: Dao

full_name: Thông Dao

given: Thông

family: Moirand

full_name: Romain Moirand

given: Romain

family: Goria

full_name: Odile Goria

given: Odile

family: Nguyen-Khac

full_name: Eric Nguyen-Khac

given: Eric

family: Carbonell

full_name: Nicolas Carbonell

family: Duclos-Vallée

full_name: Jean-Charles Duclos-Vallée

given: Jean-Charles

family: Pol

full_name: Stanislas Pol

given: Stanislas

family: de Ledinghen

full_name: Victor de Ledinghen

given: Victor

family: Ozenne


title: Quality of Life in Patients Having a Prosthetic Joint Infection

acronym: QuaVIPA

summary:
Bone and joint infections (BJI) are rare serious pathology which can lead to a very heavy handicap and sometimes to the life threatening. These are devastating diseases whose diagnosis is difficult. They are known to be associated with high mortality rates (5%) and significant morbidities responsible for functional sequelae (40% of patients) with an individual cost (prolonged hospitalization, altered quality of life) and societal (work stoppage, partial or total disability, temporary or permanent) extremely high.

These bone and joint infections have a significant impact on the quality of life of those affected who, in addition to their infection, are reduced in their autonomy and often need to be taken care of outside their home, sometimes away from home.

To the knowledge of investigators, there are few studies on the measurement of quality of life in patients with osteoarticular infection.

The aim of this study is to implement the EQ-5D-3L validated quality of life questionnaire and the EVA scale (created by EuroQol Group) for each patient with a prosthetic joint infection (IPA) on prosthesis during their medical care in the department of Infectious and Tropical Diseases.

status: Recruiting

ipd_sharing: No

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de reference des infections ostéo-articulaires de Lyon


title: Covid-19 and Prevention of Malnutrition After Confinement by Dentists: Prospective Study Among 100 Adults Received in Dental Consultation at Nice University Hospital and Sent to Their Physician for Assessment and Nutritional Care

summary: Background. The Covid-19 pandemic reached France in January 2020 and the French government decreed the confinement of the population for eight weeks, from March 17 to May 10, 2020. Dental surgeries were closed and only dental emergency services were provided. Dental surgeries reopened on May 11th, with a limited focus on urgent care, by applying new occupational hygiene standards to limit the circulation of SARS-Cov-2 coronavirus. Hypothesis. From May 11th, chronic patients and elderly patients who come to the hospital for dental consultations will have two risks of malnutrition:

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Continuous Pre-uterine Wound Infiltration Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Section. Controlled Comparative Study.

summary: The cesarean section is considered as a painful surgery during the post operative period. Mothers may need to move immediately after the surgery to take care of their babies. This may increase the risk of major pain and chronic pain. Thus, excellent postoperative analgesia is required so that mothers do not experience pain in caring for their baby. Currently, several techniques have been developed to manage postoperative pain related to c-section scar such as intrathecal morphine during spinal anesthesia or continuous pre-peritoneal wound infiltration. The comparison between anesthetic techniques has never been performed and it is still not know if the combination of intrathecal morphine plus continuous pre-peritoneal wound infiltration provide a synergistic or additional effect on pain relief.

lead_sponsor: Central Hospital, Nancy, France

status_simplified: Unknown


title: "Nintedanib for the Treatment of SARS-Cov-2 Induced Pulmonary Fibrosis"

acronym: NINTECOR

summary: Currently, there is no approved treatment for COVID-19 in France, either for the acute phase, nor for the late chronic phase. the investigator suggest that nintedanib has the potential to block the development of lung fibrosis when initiated early enough to inhibit the activation of mesenchymal cells and the progression of virus-induced pulmonary fibrosis. Computerized Tomography (CT) manifestations of fibrosis or fibrous stripes are described in COVID-19 (Ye, Eur Radiol 2020). Pan et al observed fibrous stripes in 17% patients in the early phase of the disease (Pan, Eur Radiol 2020). Ye et al observed bronchiectasis in 2 patients (15.4%) and evidence of pulmonary fibrosis in 3 patients (23.7%) at HRCT performed at 4 weeks (Ye, Eur Radiol 2020). Long term data are still lacking in patients with COVID-19 and the investigators do not know how many patients will have fibrotic sequelae from the acute illness.

ipd_sharing: Undecided


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.

primary_purpose: Basic Science

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


title: Quantified Analysis of the Movements of the Upper Limb of Children With Hemiparesis Participating in the Stress Induced Therapy Program

acronym: MouvsupTCIHemi

summary: In France, Cerebral Palsy (CP) affects 1 in 450 births. It results from lesions of the brain, before, during, or shortly after birth. These non-progressive lesions cause muscle impairments, responsible for activity limitations. These muscle impairments include muscle stiffness, and muscle weakness. Children with Unilateral CP (UCP) have these impairments on only one side of the body. To compensate for activity limitations with their impaired arm, these children over-use their non-impaired arm. The objective of constraint-induced therapy (CIT) is to minimize this asymmetry which deteriorates mobility on the impaired side, by forcing the child to only use its impaired arm several hours a day during several weeks of therapy. It is known using clinical tests that this therapy improves the overall motor function of the impaired arm. However, the underlying mechanisms are yet unknown. An understanding of these mechanisms would suggest ways to maximize the effectiveness of this therapy, which requires a significant commitment from the child and its family. The investigaors propose in this project a quantitative and objective evaluation of the effect of CIT on the movements of the impaired arm of children with UCP. The investogators focus their analysis on muscle activation, to assess which aspect of muscle impairments is modified by CIT. To this end, the investigators will use sensors identical to those already used in clinics for the Quantified Gait Analysis of children with CP, recognized since 2006 by the Haute Autorité de Santé as providing key supplementary data in the evaluation of complex gait disorders. Results from this study will provide leads to optimize CIT. Some children could for example benefit from CIT paired with treatments to reduce muscle stiffness or to strengthen muscles

primary_purpose: Other

lead_sponsor: Nantes University Hospital


title: Viewpoints on the Social Representations and Rationale Concerning the Choices of Patients, Doctors and Caregivers With Regard to the Management of Patients With Non-resectable Metastatic Cancer of the Colon, Stomach, Bile Ducts, Rectum, Pancreas or Lung, or Gastrointestinal Neuroendocrine Tumours

acronym: EOLE

summary: Reflexion on the therapeutic strategies to implement in patients at the end of life is advancing rapidly in France. However, beyond the choices presented to patients, sometimes even the decision to carry on, to limit or to stop treatments is also questioned. This decision is subjective; it is influenced by the patient's representation system (emotions, beliefs, values, practices, etc). In addition, even though he or she is the focus of the decision, the patient is not alone; other actors, accompanying the patient, play an important role in the final decision making. These actors, namely the doctors and close relatives, are also influenced in their decision making. This coexistence of representation systems may interfere with objective indicators that help in decision making (functional, clinical and biological) or with the knowledge acquired by doctors in their training and may complicate the decision-making process.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Observational Study of Cannabidiol Use in Patients Consulting in Addictology and/ or Algology Departments

acronym: ESCAPE

summary: Since its recent marketizing in France, the cannabidiol (CBD), a major component of cannabis, is used in many over-the-counter products in France. Some painful patients or patients suffering from addiction seem to use the CBD in search of therapeutic effects. Yet, there are no data available for patients in algology and addictology, particularly with regard to the prevalence of the use of CBD, the effects sought and felt. Faced with the emergence of the use of a substance with a therapeutic purpose but outside a medical framework and without monitoring of adverse effects, it becomes essential to characterize the use of CBD. The main objective of the study is therefore to assess the prevalence of CBD users in algology and addictology departments. Secondary objectives are to characterize the use of CBD as well as the users of CBD, and to evaluate the impact of the use of CBD on other psychoactive substances use or current drug treatments and the drug liking of CBD.

time_perspective: Cross-Sectional


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.

family: Chouaid

full_name: Christos Chouaid

given: Christos

family: Salaün

full_name: Mathieu Salaün

given: Mathieu

family: Gounant

full_name: Valérie Gounant

given: Valérie

family: Febvre

full_name: Michel Febvre

given: Michel

family: Vergnon

full_name: Jean-Michel Vergnon

given: Jean-Michel

family: Jouniaux

full_name: Vincent Jouniaux

given: Vincent

family: Fournier

full_name: Clément Fournier

given: Clément

family: Lachkar

full_name: Samy Lachkar

given: Samy

family: Hermant

full_name: Christophe Hermant

family: Raspaud

full_name: Christophe Raspaud

family: Quantin

full_name: Xavier Quantin

given: Xavier

family: Quiot

full_name: Jean-Jacques Quiot

given: Jean-Jacques

family: Molard

full_name: Anita Molard

given: Anita

family: Dayen

full_name: Charles Dayen

given: Charles

family: Marquette

full_name: Charles-Hugo Marquette

given: Charles-Hugo

family: Lena

full_name: Hervé Lena

given: Hervé

family: Zalcman

full_name: Gérard Zalcman

given: Gérard

family: Thiberville

full_name: Luc Thiberville

given: Luc

currency_apc_doaj: USD

journal_name: PLOS ONE

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

title: 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)


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

time_perspective: Retrospective

lead_sponsor: University Hospital, Brest


title: Prevalence and Diagnosis of Hidden Lesions of the Posterior Horn of the Medial Meniscus in Pediatric Anterior Cruciate Ligament (ACL) Lesions : Interest of Arthroscopic Intercondylar and Posteromedial Portals

summary:
Peroperatively observative study in pediatric orthopedic center in Lyon, France.

50 pediatric patients included in this study, to improve the diagnosis of hidden lesions of the medial meniscus associated with lesions of the anterior cruciate ligament.

All the patients need a reconstruction of the ACL because of chronic knee instability.

All the patients underwent a multi portal arthroscopy during the ACL reconstruction : anteromedial and anterolateral and after intercondylar and posteromedial.

The study consists in a peroperatively arthroscopic look, in order to diagnose lesions of the posterior horn of the medial meniscus which could be missed in MRI and anteromedial and anterolateral arthroscopy.

Statistics of this lesions are used to study prevalence and diagnosis capacity of this procedures.

First, the surgeon did a classic knee arthroscopy. Secondarily, he did an intercondylar portal and after a posteromedial portal.

primary_purpose: Diagnostic

intervention_type: Procedure


summary:
A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of tonsillitis caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC tonsillitis 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 tonsillitis after POC tests.

The objective of this study is to implement a new diagnosis strategy relying on the hypothesis that a second pharyngeal swab would improve the etiological diagnosis of tonsillitis of at least 5%.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Effect of Information Promoting Textured Food Introduction on Parental Practices and Children Acceptance of Textured Foods

acronym: PATATE

summary: The purpose of this study is to conduct an intervention with 60 parents of 8 months old children to test the effect of recommendations, compared to usual care, promoting the introduction of textured foods between 8 and 15 months on parental practices of use of textured foods and the effect of such practices on children acceptance for a variety of textured foods.

ReferenceType: background

ReferenceCitation: Demonteil L, Ksiazek E, Marduel A, Dusoulier M, Weenen H, Tournier C, Nicklaus S. Patterns and predictors of food texture introduction in French children aged 4-36 months. Br J Nutr. 2018 Nov;120(9):1065-1077. doi: 10.1017/S0007114518002386. Epub 2018 Sep 11.

ReferenceCitation: Tournier C, Demonteil L, Canon F, Marduel A, Feron G, Nicklaus S. A new masticatory performance assessment method for infants: A feasibility study. J Texture Stud. 2019 Jun;50(3):237-247. doi: 10.1111/jtxs.12388. Epub 2019 Feb 3.

ReferenceCitation: Demonteil, L., et al. (2019).Longitudinal study on acceptance of food textures between 6 and 18 months. Food Quality and Preference 71: 54-65.

ReferenceCitation: Wardle J, Guthrie CA, Sanderson S, Rapoport L. Development of the Children's Eating Behaviour Questionnaire. J Child Psychol Psychiatry. 2001 Oct;42(7):963-70.

lead_sponsor: Centre des Sciences du Goût et de l'Alimentation

intervention_type: Behavioral

lead_sponsor_type: industriel


type: Registry Identifier

title: Interventional Study in Cognitively Intact Seniors Aiming to Assess the Effects of Meditation Training and Foreign Language Learning on Behavioral, Biological and Neuroimaging Measures

acronym: Age-Well

summary: As the number of older people in Europe grows, increasing healthy life years is a priority. As people live longer, ensuring good mental as well as physical health into later years is becoming ever more important. Cognitive decline, dementia (e.g. Alzheimer's Disease, AD), sleep disturbances and depression, all related to psychological distress and anxiety, are significant drivers of reduced quality of life in older adults. This project builds on evidence that meditation practice have the potential to downregulate these adverse factors and positively impact mental and neurological conditions including AD.

status: Active, not recruiting

primary_purpose: Prevention

ReferenceCitation: Poisnel G, Arenaza-Urquijo E, Collette F, Klimecki OM, Marchant NL, Wirth M, de La Sayette V, Rauchs G, Salmon E, Vuilleumier P, Frison E, Maillard A, Vivien D, Lutz A, Chételat G; Medit-Ageing Research Group. The Age-Well randomized controlled trial of the Medit-Ageing European project: Effect of meditation or foreign language training on brain and mental health in older adults. Alzheimers Dement (N Y). 2018 Dec 14;4:714-723. doi: 10.1016/j.trci.2018.10.011. eCollection 2018.

ReferenceCitation: André C, Rehel S, Kuhn E, Landeau B, Moulinet I, Touron E, Ourry V, Le Du G, Mézenge F, Tomadesso C, de Flores R, Bejanin A, Sherif S, Delcroix N, Manrique A, Abbas A, Marchant NL, Lutz A, Klimecki OM, Collette F, Arenaza-Urquijo EM, Poisnel G, Vivien D, Bertran F, de la Sayette V, Chételat G, Rauchs G; Medit-Ageing Research Group. Association of Sleep-Disordered Breathing With Alzheimer Disease Biomarkers in Community-Dwelling Older Adults: A Secondary Analysis of a Randomized Clinical Trial. JAMA Neurol. 2020 Jun 1;77(6):716-724. doi: 10.1001/jamaneurol.2020.0311.

name: Normandie Université, Université de Caen, Institut National de la Santé et de la Recherche Médicale, Unité 1237 "Physiopathology and Imaging of Neurological Disorders,” Institut Blood and Brain @ Caen-Normandie, GIP Cyceron, Caen, France

name: Normandie Université, Université de Caen, Paris Sciences & Lettres Université, École Pratique des Hautes Études, Institut National de la Santé et de la Recherche Médicale, Unité 1077 "Neuropsychologie et Imagerie de la Mémoire Humaine," Centre Hospitalier Universitaire de Caen, GIP Cyceron, Caen, France

family: André

full_name: Claire André

given: Claire

family: Rehel

full_name: Stéphane Rehel

given: Stéphane

family: Kuhn

full_name: Elizabeth Kuhn

given: Elizabeth

family: Landeau

full_name: Brigitte Landeau

given: Brigitte

family: Moulinet

full_name: Inès Moulinet

given: Inès

family: Touron

full_name: Edelweiss Touron

given: Edelweiss

family: Ourry

full_name: Valentin Ourry

given: Valentin

family: Le Du

full_name: Gwendoline Le Du

given: Gwendoline

family: Mézenge

full_name: Florence Mézenge

given: Florence

family: Tomadesso

full_name: Clémence Tomadesso

given: Clémence

family: de Flores

full_name: Robin de Flores

given: Robin

family: Bejanin

full_name: Alexandre Bejanin

given: Alexandre

family: Sherif

full_name: Siya Sherif

given: Siya

name: Centre National de la Recherche Scientifique, Unité Mixte de Service 3048, GIP Cyceron, Caen, France

family: Delcroix

full_name: Nicolas Delcroix

given: Nicolas

name: Normandie Université, Université de Caen, EA 4650 "Signalisation, Électrophysiologie et Imagerie des Lésions d'Ischémie-Reperfusion Myocardique", GIP Cyceron, Caen, France

family: Manrique

full_name: Alain Manrique

given: Alain

family: Abbas

full_name: Ahmed Abbas

given: Ahmed

name: Division of Psychiatry, University College London, London, United Kingdom

family: Marchant

full_name: Natalie L. Marchant

given: Natalie L.

name: Lyon Neuroscience Research Center, Institut National de la Santé et de la Recherche Médicale Unité 1028, Centre National de la Recherche Scientifique Unité Mixte de Recherche 5292, Lyon University, Lyon, France

family: Lutz

full_name: Antoine Lutz

given: Antoine

name: Swiss Center for Affective Sciences, Department of Medicine, University of Geneva, Geneva, Switzerland

family: Klimecki

full_name: Olga M. Klimecki

given: Olga M.

name: GIGA–Cyclotron Research Centre, In Vivo Imaging and Psychology and Cognitive Neuroscience Unit, Liège University, Liège, Belgium

family: Collette

full_name: Fabienne Collette

given: Fabienne

family: Arenaza-Urquijo

full_name: Eider M. Arenaza-Urquijo

given: Eider M.

family: Poisnel

full_name: Géraldine Poisnel

given: Géraldine

name: Département de Recherche Clinique, Centre Hospitalier Universitaire de Caen-Normandie, Caen, France

family: Vivien

name: Unité d’Exploration et de Traitement des Troubles du Sommeil, Centre Hospitalier Universitaire de Caen, Caen, France

name: Service de Neurologie, Centre Hospitalier Universitaire de Caen, Caen, France

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

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

ipd_sharing_description:
Data access of AGE-WELL and SCD-WELL studies of the MEDIT-AGEING project for which Institut national de la santé et de la recherche médicale (Inserm) is the sponsor. The Material can be mobilized, under the conditions and modalities defined in the Charter, by any research team belonging to an Academic signatory to the Consortium Agreement concluded for the needs of the Project or by any research team belonging to an Academic outside the Consortium Agreement, French or foreign, for carrying out SRP relating to the scientific theme of mental health and wellbeing in older people.

The Material may also be mobilized, by non-academic third parties for the realization of SRP relating to the scientific theme of mental health and wellbeing in older people, under conditions, in particular financial, which will be established by separate agreement between Inserm and by the said third party.


title: Strategies for Management of Knee Osteoarthritis : Innovation and Medico-economic Study

summary:
Osteoarthritis is an evolving joint disease caused by degeneration of bones and cartilage, with significant personal and social impact. Osteoarthritis of the knee is the most common type of osteoarthritis, affecting up to 19% of adults (aged 45 and over) according to recent studies.

The costs associated with the management of osteoarthritis involve not only direct treatment strategies (clinical evaluations, drugs, prostheses, surgery), but also significant indirect costs (loss of productivity) The severity of knee osteoarthriris symptoms and the types of interventions are highly variable. There are surgical and nonsurgical treatment strategies. The replacement of the knee joint by a total prosthesis is a surgical choice for severe knee osteoarthritis which currently represents the basic treatment. However, a large proportion of patients with knee osteoarthritis can not or do not wish to have surgery, either because of the unavailability of the choice of surgery, or the disability and post-operative pain that can be caused by surgery.

Since surgery is not always the preferred or available treatment for people with knee osteoarthritis, it has been shown that acting on modifiable risk factors (severe obesity) can significantly reduce the pain and disability but it is not always sufficient.

Other effective therapeutic osteoarthritis strategies include biomechanical interventions, intra-articular injections like corticosteroids ; anti-inflammatory and analgesic drugs, exercise, patient education and bodybuilding. There is also an innovative strategy that is under development and consists of the use of nanostructured and functionalized implants for bone and cartilage regeneration.

The objective of this study is to carry out a medico-economic study centered on knee osteoarthritis management strategies. At a time when the decisions of management of pathologies must be based on the efficiency of the possible therapies, and given the high prevalence of knee osteoarthritis, it appears crucial to carry out this type of study in order to 'bring elements to public health decision makers. In addition, there is a demand for medico-economic assessment of osteoarthritis management strategies emerging in the literature. To carry out this study, we plan to carry out an extensive review of the literature on relevant non-surgical strategies for patients with moderate and severe knee osteoarthritis and for whom total knee replacement was feasible. This will aim to extract data to develop a modeling (Markov models) of knee osteoarthritis management by different therapeutic strategies. At this stage, the cost and quality of life data for the models will be searched in order to be linked to the strategy cost within a medico-economic evaluation.

If the literature proves to be insufficient, the use of the data of the University Hospitals of Strasbourg (retrospective study), the realization of an epidemiological study (prospective study) will be a possible in order to make the model.

lead_sponsor: University Hospital, Strasbourg, France


title: Influence of Emotion and Motivation on Behaviour and Neural Activity in Patients With Psychosis

summary: Anhedonia and avolition reflect emotional and motivational disorders, respectively. However, if these disorders play a major role in the symptomatology of schizophrenia, their mechanisms remain poorly understood, and existing treatments are inefficient on these symptoms. The literature suggests that the impairment does not concern emotion or motivation per se, but rather their influence on cognition. This project aims at using recent advances in the fundamental domain to better understand the cognitive and neuronal mechanisms of the patients' alterations, and especially how emotion and motivation influence cognition in schizophrenia.


title: Parent-implemented Intervention for Very Preterm Children With Language Delay

acronym: EPILANG

summary:
In studies of children born at term, language delay at the age of 2 years exhibits a spontaneously favourable course in 30 to 50% by the age of 3 years. In France, there is no recommendation for speech therapy before the age of 3 years. However, for term-born children, parent-implemented language interventions conducted during the third year of life have already shown a positive short-term effect on language skills. In these interventions, a skilled interventionist, generally a speech therapist, teaches parents how to use specific language strategies with their child.

The investigators' hypothesis is that such parent-implemented interventions would be particularly appropriate at short and medium term for the improvement of linguistic performances in very preterm children, a population with a high prevalence of early language delay. Currently, there is an opportunity to partly nest an intervention trial in a national prospective population-based cohort of very preterm children, the EPIPAGE (Etude EPIdémiologique sur les Petits Ages GEstationnels) 2 cohort, which has included 5 000 babies born alive in France in 2011. This situation provides considerable methodological advantages.

status: Terminated

lead_sponsor: Lille Catholic University

location_facility:
Hôpital femme mère enfant
Centre hospitalier Universitaire
Hôpital Necker
HôpitalCochin - Port Royal
Hôpital Saint Vincent de Paul (GHICL)
Centre Hospitalier
AP-HP Hôpital Antoine Béclère
Centre Hospitalier Universitaire


title: Inhibition by the Antibody, First Event of Infection by HIV-1 of Uterine Vaginal Tissue

summary: This non-interventional study aims to characterize the cells infected with HIV over time in different types of vagino-uterine tissue.

location_facility: INSERM U1109 - Institut de Virologie 3, rue Koeberlé - 67000 Strasbourg


title: Use of a Smartphone© Application to Study Autism Spectrum Disorders (ASD)

acronym: SMARTAUTISM

summary: This is a prospective, longitudinal, exploratory, open study with a 6-month follow-up period to explore via a specific Smartphone© application the evolution of a child's behavior over 6 months and the (psychological and social) effects of these changes on the family.

ReferenceCitation: Bonnot O, Bonneau D, Doudard A, Duverger P. Rationale and protocol for using a smartphone application to study autism spectrum disorders: SMARTAUTISM. BMJ Open. 2016 Nov 22;6(11):e012135. doi: 10.1136/bmjopen-2016-012135.

location_facility:
Nantes CHU
Angers CHU


title: Phase II Randomized Study Comparing the Association of Intraarterial Perfusion of Raltitrexed and Oxaliplatin Versus Standard Chemotherapy Using Intravenous Perfusion for Colorectal Cancer Patient With Metastases Localized to Liver After Failure of Conventional Treatments.

acronym: HEARTO

summary: Standard treatment of metastatic colorectal cancers relies on fluoropyrimidines, irinotecan alone or in association with fluoropyrimidines, oxaliplatin in association with fluoropyrimidines, bevacizumab and anti EGFR antibodies. After failure of classical regimen the national reference frame on the basis of phase II study proposes an association of fluoropyrimidine and mitomycin. These treatments give response rates of 10-20% with progression free survivals from 2 to 3 months. Hepatic intra-arterial chemotherapy is logical in the case of isolated hepatic metastases nonaccessible to curative resection: 1) hepatic metastases are vascularized by hepatic arterial system in contrast to nontumoral hepatic parenchyma; 2) arterial perfusion of oxaliplatin leads to a strong extraction by the liver during the first passage, a high intra-tumoral concentration and a low systemic concentration. So oxaliplatin is a drug of choice for arterial treatment but combination with fluoropyrimidines is impossible because of need for prolonged perfusion. Floxuridin is not available in France. Raltitrexed, a definitive inhibitor of the thymidylate synthase, does not require a prolonged perfusion and could be a good substitute.In a previous pilot study we demonstrated the feasibility, safety and efficacy of combination of raltitrexed and oxaliplatin arterial perfusion. Now we propose a phase II randomized clinical trial to evaluate the efficacy of hepatic arterial infusion of raltitrexed and oxaliplatin association versus standard chemotherapy for patients with metastases of colorectal origin restricted to the liver after failure of conventional chemotherapy.

lead_sponsor: Centre Georges Francois Leclerc


title: Biological Dating of Cerebral Ischemia With Glutathion S-Transferase-π (GST-π) and Peroxyredoxin 1 (PRDX1) to Detect Patients With Stroke of Unknown Onset Within the Therapeutic Window of Thrombolysis

summary: The FLAG1 study will assess the diagnostic performance of biomarkers Glutathion S-Transferase-π (GST-π) and Peroxyredoxin 1 (PRDX1) to identify cerebral infarction of less than 4,5 hours in a population of patients with neurological deficiency of less than 12 hours.

ReferenceCitation: Karakus A, Girerd N, Sanchez JC, Sabben C, Wietrich A, Lavandier K, Marchal S, Aubertin A, Humbertjean L, Mione G, Bouali S, Duarte K, Reymond S, Gory B, Richard S. Identifying patients with cerebral infarction within the time window compatible with reperfusion therapy, diagnostic performance of glutathione S-transferase-π (GST-π) and peroxiredoxin 1 (PRDX1): exploratory prospective multicentre study FLAG-1 protocol. BMJ Open. 2021 Aug 20;11(8):e046167. doi: 10.1136/bmjopen-2020-046167.

family: Karakus

full_name: Arif Karakus

given: Arif

family: Girerd

full_name: Nicolas Girerd

family: Sanchez

full_name: Jean-Charles Sanchez

given: Jean-Charles

family: Sabben

full_name: Candice Sabben

given: Candice

family: Wietrich

full_name: Anthony Wietrich

given: Anthony

family: Lavandier

full_name: Karine Lavandier

given: Karine

family: Marchal

full_name: Sophie Marchal

given: Sophie

family: Aubertin

full_name: Anne Aubertin

given: Anne

family: Humbertjean

full_name: Lisa Humbertjean

given: Lisa

family: Mione

full_name: Gioia Mione

given: Gioia

family: Bouali

full_name: Sanae Bouali

given: Sanae

family: Duarte

full_name: Kevin Duarte

given: Kevin

family: Reymond

full_name: Sandrine Reymond

given: Sandrine

family: Gory

full_name: Benjamin Gory

given: Benjamin

family: Richard

full_name: Sébastien Richard

given: Sébastien

currency_apc_doaj: GBP

journal_name: BMJ Open

license: cc-by-nc

license_normalized: cc-by-nc

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

location_facility:
Centre Hospitalier de Troyes
Hôpital Central
Fondation Adolphe de Rothschild
Centre Hospitalier de Bar-Le-Duc
Centre Hospitalier de Verdun


title: MEMORA-Caregiver : Risk Factors of Caregiver Burden Among Patients With Neurocognitive Disorders or Subjective Cognitive Complaint

acronym: MEMORA

summary:
The investigators will investigate which patients' characteristics are associated with caregivers burden and its evolution for outpatients visiting a memory clinic, in particular how functional autonomy, behavioral and psychological symptoms as well as patients comorbidities can influence caregiver burden.

The study will be conducted among outpatients with progressive cognitive complaint followed in a Memory Clinic and their primary caregiver. The investigators hypothesis that caregivers experience a higher burden due to disease symptoms such as impairment of functional autonomy, behavioral and cognitive impairment, whatever the aetiology of the cognitive decline.

ReferenceCitation: Dauphinot V, Ravier A, Novais T, Delphin-Combe F, Mouchoux C, Krolak-Salmon P. Risk Factors of Caregiver Burden Evolution, for Patients With Subjective Cognitive Decline or Neurocognitive Disorders: A Longitudinal Analysis. J Am Med Dir Assoc. 2016 Nov 1;17(11):1037-1043. doi: 10.1016/j.jamda.2016.07.003. Epub 2016 Aug 26.

family: Dauphinot

full_name: Virginie Dauphinot

given: Virginie

family: Ravier

full_name: Alix Ravier

given: Alix

family: Novais

full_name: Teddy Novais

given: Teddy

family: Delphin-Combe

full_name: Floriane Delphin-Combe

given: Floriane

family: Mouchoux

full_name: Christelle Mouchoux

given: Christelle

family: Krolak-Salmon

full_name: Pierre Krolak-Salmon

given: Pierre

journal_name: Journal of the American Medical Directors Association

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

location_facility: Clinical and Research Memory Centre of Lyon (CMRR); Geriatrics Unit, Charpennes Hospital, University Hospital of Lyon, Villeurbanne, France - Clinical Research Centre (CRC) - VCF (Aging - Brain - Frailty), Charpennes Hospital, University Hospital of Lyon


title: "Psychological Burden in ICU Survivors of Severe COVID-19 Pneumonia, Their Relatives and Their Healthcare Providers" "Impact Psychologique de l'épidémie COVID-19 Chez Les Patients, Familles et Soignants de Reanimation" "BURDENCOV"

acronym: BURDENCOV

summary:
Coronavirus disease 2019 (COVID-19) is an infectious disease responsible for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The infection is highly contagious requiring restrictive and stressful measures for patients, family members and ICU healthcare providers. To avoid contagion, patient isolation has become the rule. For patients, these measures add stress to the ICU environment and deprive them of unrestricted family visits. Family members are not only left with fear but also many unanswered questions. In end-of-life situations, many family members are unable to say good-bye and unable to provide support to their loved-one throughout the process. The impact of exclusion or limited inclusion certainly needs to be explored. Moreover, ICU caregivers are having to face new challenges and to work in a unknown situation, juggling with both professional issues such as increased workload, working longer hours and safety issues, and personal issues such as child care and transport as well as family transmission of the virus.

The main objective of this study is to demonstrate that the COVID-19 pandemic, as compared to seasonal flu and community acquired pneumonia, significantly increases post-traumatic stress disorder (PTSD) in family members of critically ill patients.

PTSD-related symptoms will be assessed in family members using the IES-R (impact of event scale revised) during a telephone interview 90 days after ICU discharge. The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events. It will be compared across the three groups (COVID-19, FLU and CAP).

location_facility:
Pitié Salpetrière
Saint-Louis Hospital
Cochin


title: A Randomized Crossover Clinical Trial Regarding the Blockage of the Mineralocorticoid Receptor Using Eplerenone on the Evolution of Arterial Stiffness in Kidney Patients One Year After Transplant

acronym: EVATRAN

summary:
Cardiovascular (CV) pathologies are the leading cause of death in kidney transplant patients.Arterial stiffness is a prognostic factor for CV mortality in kidney transplantation. Despite a reduced CV risk in transplant kidney patients in comparison to patients in dialysis, CV mortality among kidney transplant patients is much higher than the general population.

After renal transplantation, the cardiac and vascular anomalies observed in chronic end-stage renal disease are partially improved because of restored normal kidney function and withdrawal from dialysis.

However, patients are exposed to immunosuppressive drugs, in particular calcineurin inhibitors, which can be associated with vascular toxicity, either directly or by promoting the appearance of hypertension, diabetes, or dyslipidemia.The pathophysiology of arterial stiffness in kidney transplantation is complex and multifactorial.

Calcineurin inhibitors are likely to play an important role in the persistence of increased arterial stiffness in transplant patients in whom renal function has been restored. Indeed, the discontinuation of anti-calcineurins in favour of other molecules .is associated with a decrease of arterial stiffness.

Preclinical work has shown that the vascular toxicity of cyclosporine is mediated by activation of the mineralocorticoid receptor in smooth muscle cells. The involvement of the mineralocorticoid receptor in the onset of arterial stiffness is also well demonstrated in non-transplanted subjects.

Blocking the mineralocorticoid receptor in patients under cyclosporine may reduce their arterial stiffness and in and consequently improve their CV prognosis.

Studies have show a good safety in kidney transplant patients. This pilot study proposes to examine, for the first time, the impact of treatment with a mineralocorticoid receptor antagonist on the evolution of arterial stiffness in renal transplant patients on calcineurin inhibitors.

lead_sponsor: Pr. Nicolas GIRERD


title: Interest of Dosage of Anti-PB230, Anti-PB180 and Cytokines for Monitoring of Patients Suffering From Bullous Pemphigoid

acronym: Cyto-PB

summary:
Bullous pemphigoid is the most common subepidermal autoimmune blistering disease of the skin in European countries, including France.

Immunologically, BP is characterized by the production of autoantibodies directed against two major components of the hemidesmosome, BP180 and BP230.

The anti-BP180 autoantibody is detected in 79-93% of cases of bullous pemphigoid and its serum level at diagnosis have been correlated with disease activity. The anti-BP230 autoantibody is detected in 57%-63% of bullous pemphigoid cases and its score at diagnosis did not correlate with disease activity.

Up to now, no clinical or immunologic factors have been identified to predict outcome of patients with good or poor prognosis bullous pemphigoid as defined by long complete remission off therapy and recurrent disease requiring maintenance therapy for years. The usefulness of BP180 or BP230 ELISA scores for monitoring BP patients during treatment also remains unclear.

ReferenceCitation: Plée J, Le Jan S, Giustiniani J, Barbe C, Joly P, Bedane C, Vabres P, Truchetet F, Aubin F, Antonicelli F, Bernard P. Integrating longitudinal serum IL-17 and IL-23 follow-up, along with autoantibodies variation, contributes to predict bullous pemphigoid outcome. Sci Rep. 2015 Dec 14;5:18001. doi: 10.1038/srep18001.

lead_sponsor: CHU de Reims


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

lead_sponsor: University Hospital, Lille


title: SERENDEM Study: MD1003 in Patients Suffering From Demyelinating Neuropathies, an Open Label Pilot Study

summary: The single-center, open-label Phase II study has the objective of assess the effect of MD1003 on motor and sensory conduction in patients suffering from demyelinating polyneuropathies in 15 subjects.

lead_sponsor: MedDay Pharmaceuticals SA


title: Evaluation of the Clinical Benefit of ToFAcitinib Treatment in Patients With Moderate to Severe Ulcerative Colitis Under Real-life Conditions of Use: TOFAst Study

acronym: TOFAST

summary: This is an observational prospective study with two years of follow-up, designed to evaluate the effectiveness of tofacitinib in patients with moderate to severe ulcerative colitis in French clinical practice

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

lead_sponsor: Pfizer

location_facility:
Hopital Sud
Hopital Claude Huriez
CH Le Mans
Ch Valenciennes
Hopital Saint Eloi
Hopital Nord
Chu Nantes
Chu de Bordeaux - Hopital Haut Leveque
Hopital Trousseau
Clinique Pasteur
Hopital de L'Archet
CHU LYON
Hopital Albert Michallon
Ch Saint Joseph Saint Luc
Ch Annecy Genevois
Ch Montfermeil
Ch Valence
Hopital Jean Minjoz
Hopital Caremeau
Ch Dunkerque
Ch Emile Roux
Infirmerie Protestante de Lyon
Aphp - Hopital Beaujon


title: Language and Music, Speech and the Human Beatbox: Theoretical Issues for Research in General and Applied Linguistics; Monocentric Exploratory Study

acronym: HBB

summary: Beatboxing is a form of vocal percussion primarily involving the art of mimicking drum machines, using one's mouth, lips, tongue, and voice. It may also involve vocal imitation of turntablism, and other musical instruments. To produces the different sounds, the Beatboxers use their vocal apparatus in a much wider and more complex way than its use in speech. This allows them to acquire a panel of rich and varied sounds. The Human Beatbox (HBB) is a very recent subject of study in phonetics. This study offers an exploratory study of pharyngolaryngeal articulatory behaviors using nasofibroscopy and electroglottography and an aerodynamic study in order to better understand the articulatory capacities and limits of the vocal tract.

lead_sponsor: Hopital Foch


title: Randomized, Open-label, Phase III Trial Comparing a Dual Nucleoside Analogues Strategy Preceded by a Triple Therapy Induction Period to an Immediate Strategy With Dolutegravir Plus Lamivudine in Antiretriviral naïve People Living With HIV With Viral Load < 50000 cp/mL and CD4 Cells >300/mm3

acronym: ALTAR

summary: The purpose of this trial is to demonstrate at W48 the non-inferiority of a dual nucleoside analogues strategy with tenofovir (TDF) or tenofovir alafenamide (TAF) plus emtricitabine (FTC) or lamivudine (3TC) preceded by a 16 week induction period with TDF or TAF plus FTC or 3TC plus an integrase inhibitor (INI) relative to an immediate 2-DR strategy with dolutegravir plus 3TC in HIV-infected antiretroviral therapy (ARV) naïve participants with CD4 cells count greater than 300/mm3 and a low viral load defined as plasma HIV RNA strictly lower than 50 000 cp/mL

lead_sponsor: ANRS, Emerging Infectious Diseases


title: Sustained Attention Abilities, Attentional Resources and Cognitive Control Mechanisms in Schizophrenia

acronym: ACCRAS

summary: Schizophrenia is a psychiatric pathology, which concerns around 1% of adult population. It is characterized by clinical symptoms combining positive and negative symptoms and thinking disorganization. Schizophrenia is also characterized by cognitive deficits, likely to play an important part in adaptation of these patients in their every-day life, and to affect their clinical symptomatology. Among them, there are deficits in sustained attention which are associated with a difficulty for these patients to maintain efficiently their cognitive activity on a source of stimulation or task. This basic attentional process is fundamental for the efficiency of the overall of cognitive processes, and so for all behaviors directed on an aim. The question of whether or not patients with schizophrenia have difficulty sustaining attention is of high relevance, in the sense that it could undermine performance on nearly any task and so provide a compelling causal explanation of many other impairments observed in these patients. Yet it has not been conclusively answered in over four decades of research. Consequently, the main objective of the protocol is to evaluate sustained attention abilities in schizophrenic patients and to better understand the specific functioning of cognitive and neural mechanisms underlying these abilities (attentional resources and cognitive control mechanisms).


title: Comparison of the Impact on Digestive Portage of Broad Spectrum Beta-Lactamase-Producing Enterobacteriaceae (E-ESBLs) of Proposed Treatments in Outbreaks of Childhood Urinary Tract Infection

acronym: MIKA

summary:
The emergence of extended-spectrum beta-lactamase-producing Enterobacteriaceae (E-ESBL) is a major public health problem. It leads more frequent prescription of penems with the risk of emergence and spread of strains producing carbapenemases, which may be resistant to all known antibiotics. A policy of savings of penems is desirable. Among the alternatives to penems, amikacin is in the foreground. It remains active on the majority of E-ESBL strains. Some risk factors for E-ESBL emergence are known: recent antibiotic therapy (particularly quinolones and cephalosporins third generation), previous hospitalization or residence in a high endemic country.

In pediatrics, E-ESBLs are primarily responsible for urinary tract infection. In France, E-ESBLs represent about 10% of the strains responsible for urinary tract infections. The Pathology Group Pediatric Infectious (GPIP) of the French Society of Pediatrics (SFP) and the Society of Infectious Pathology French Language (SPILF) have proposed different therapeutic options to treat febrile UTIs in children: amikacin intravenous; intravenous (IV) ceftriaxone or intramuscular (IM); or cefixime per-os (PO).

The objective of this study is to compare the emergence of E-ESBLs in stools of children after febrile UTIs treatment with amikacin IV versus ceftriaxone or cefixime.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility:
Antoine Beclère Hospital
Cabinet du Dr Wollner
157 Avenue du Général Leclerc
Cabinet du Dr Turberg-Romain
Cabinet du Dr Benali
Centre Hospitalier de Meaux
Cabinet du Dr Michot
Cabinet du Dr Romain
Hospital Robert-Debré
Cabinet du Dr Werner
Cabinet du Dr Corrard
Cabinet du Dr Cohen
CHI Villeneuve-Saint-Georges
Jean Verdier Hospital
André Mignot Hospital
Cabinet du Dr Deberdt
Cabinet du Dr Coicadan
13 Villa Beauséjour
CHU Le Kremlin-Bicêtre
Cabinet du Dr Thollot


title: Effectiveness of an Early Intervention Aiming at Promoting Healthy Diet and Growth of Children Living in Situation of Social Disadvantage : the prEgnanCy and eArly Childhood nutrItion triaL (ECAIL)

acronym: ECAIL

summary: The purpose of this study is to conduct a randomized controlled trial among 800 socially disadvantaged pregnant women and their families to test the effectiveness of a multi-component home visitation nutrition program, compared to usual care, in promoting healthy feeding practices and growth in young children.

lead_sponsor: French Red Cross

location_facility: Valenciennes Hospital, Monaco Hospital maternity


title: Evaluation of Glycemic Profiles in Diabetic Patients on Dialysis Under Insulin Balsal-bolus Protocol, Using Freestyle Libre. Observational Prospective Study Without Modification of Management.

summary:
In France, chronic end-stage renal disease affects more than 11,000 new patients each year who will require dialysis or renal transplantation, of whom approximately 22.6% of new cases are related to diabetes. Among them, about 94% are managed by hemodialysis (HD), the others by peritoneal dialysis (PD). In addition, nearly 42% of dialysis patients have diabetes. There are issues related to glycemic control during dialysis and specific to each dialysis technique. Thus, hypoglycemic risk is the main risk observed during hemodialysis sessions, linked in particular to the use of a 1g/L glucose free dialysate, a decrease in renal neoglucogenesis and alterations in metabolic pathways. In addition, long-term glycemic control is difficult to assess in dialysis patients, because of the limitations of HbA1c witch is frequently underestimated.

This can be explained by 2 mechanisms:

EPO treatment is associated with an increase in the proportion of young érythrocytes
reduction in the lifetime of red blood cells reducing the duration of interaction between glucose and hemoglobin.

The results of studies conducted using continuous glucose measurements over a short period of time (48 hours to 5 days) suggest a benefit in using continuous glucose measurement to detect glycemic fluctuations during dialysis. To our knowledge, no studies have been conducted to evaluate longer-term glycemic control with this technology. In addition, the investigators now have the Freestyle, which allows us to record the continuous measurement of interstitial glucose over a longer period of time and is reimbursed for people on insulin basal-bolus protocol.

Thus, the investigators propose an observational study to evaluate glycemic control during dialysis sessions, but also to analyze the correlation between parameters measured with Freestyle and HbA1c measured routinely, according to the follow-up recommendations in diabetics.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: SCREENING OF ADOLESCENT MENTAL SUFFERING CONSULTANT TO EMERGENCIES, MANAGEMENT AND Later MONITORING

acronym: DESPERADOS

summary:
The primary purpose is to estimate the prevalence of depression and subsyndromal states among adolescents 13 to 17 years consulting to hospital emergency rooms for any reason, for they are another way of tracking this suffering, as they host many troubled teens at once for health problems and accidents sometimes iterative, reflecting their risk behaviour.

Secondary purposes are to assess the feasibility and desirability of a post-emergency medical consultation for adolescents who scored high on a self-administered questionnaire, and to assess the impact of this approach by later monitoring.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Department of paediatric emergencies, Ambroise Paré universitary hospital


title: Personalized Medicine: Pharmacogenetics Anomaly Research in Children and Adolescents With Pharmacological Resistance to Psychotropic Drugs

summary:
Psychotropic drugs are frequently used in children and adolescents in France with a prescription rate of 2.5%. Antipsychotics (PA) and antidepressants (AD), each concern 0.3% of the pediatric population (Kovess et al., 2015). Despite appropriate pharmacological treatment, some patients are drug-resistant and have persisting symptoms and ineffective psychotropic treatments. These children and adolescents are generally exposed to many psychotropic molecules and often to poly-therapy.

Most psychotropic treatments, especially AP and AD, are metabolised at the hepatic level by cytochrome P450 and in particular by CYP2D6. Duplication / multiplication of the CYP2D6 gene induces too rapid metabolism of drugs.

Demonstration of a CYP2D6 abnormality has a direct impact on the management of the patient and on the clinical decisions of the clinician. Thus, knowledge of individual metabolism will decrease the failure of treatment, improve quality of life and therapeutic compliance.

lead_sponsor: Fondation Lenval

location_facility: Fondation Lenval Hôpitaux Pédiatriques de Nice CHU-LENVAL


title: Prevalence of Anxiety/Depression, Sleep Disturbances and Alcohol Use Disorder in Elderly With Cognitive Complaints

acronym: MEM-ASA

summary:
The goal of MEM-ASA is to investigate the prevalence of anxiety/depression, sleep disturbances and alcohol use disorder in elderly with cognitive complaints.

In memory clinics of Normandy (France), all patients aged over 50 year-old are systematically questioned about anxiety, depression, sleep quality and alcohol use disorder. They also perform a neuropsychological assessment. Questionnaires are given to the patient and his/her caregiver to be filled in at home.

Levels of anxiety/depression, sleep quality and alcohol consumption are related to neuropsychological performance, diagnosis and responses to the questionaires.

lead_sponsor: University Hospital, Caen


title: Use of Targeted Quantitative Proteomics and Metabolic Labelling With Stable Isotopes for the Diagnosis and the Investigation of Neurological Disorders and in Particular Alzheimer Disease

acronym: PROMARA

summary: In France, an estimated 860 000 patients are affected by Alzheimer Disease (AD) which represents, as in other developed countries, a major public health issue. In many cases, AD diagnosis is uncertain and its clinical evolution unpredictable. The exactitude of the diagnosis is however particularly important in the perspective of the validation and use of new therapeutic strategies in AD. Detection of cerebrospinal fluid (CSF) diagnosis biomarkers fell short in the detection, of atypical/mixed cases, of some differential diagnosis, and in differentiating rapid or slow clinical evolutions. Hence, CSF analysis gives a unique opportunity to detect and validate biomarkers in many neurological disorders. Nevertheless, in medical practice, CSF biological analysis is currently limited to a small number of analytes.Quantitative and targeted mass spectrometry, especially operated in the Multiple reaction monitoring mode (MRM), represents an alternative to immunodetection and could be used to detect specific biomarkers in complex matrices such as plasma by specifically discriminating the proteotypic peptides corresponding to each proteins. Mass spectrometry has also the ability to distinguish and quantify isotopically labelled and unlabeled selected targets. This ability was used in a publication by the group of R. Bateman (Washington University, St Louis, USA) who could, after administering stable isotope-labelled leucine, evaluate Ab synthesis and clearance in humans. This approach has an enormous potential to study the metabolism of proteins within the human CNS and consequently help in the understanding and diagnosis of neurological disorders.The main objective of this program is set up a targeted quantitative mass spectrometry method for existing and stable isotope-labelled CSF biomarkers in the neurological field; exploit this approach for diagnostic purpurses and to gain knowledge in the pathophysiology of diseases.

location_facility: Laboratoire de Biochimie et Protéomique Clinique, CHU Montpellier


title: Quantitative Evaluation of Motor Function Before and After Surgery for Degenerative Lumbar Spinal Stenosis

acronym: SPEED

summary: Low back pain is a leading cause of medical consultations in France and in other industrialized countries. Although spinal surgery is a recognized treatment, to date, its impact has only been assessed using subjective or declarative criteria. Yet, in many orthopaedic diseases, it has been shown that the evaluation of functional capacities, including walking speed, is particularly useful to study the impact of these diseases and their treatment. To date, no study has attempted to assess the impact of spinal surgery by evaluating 1) the functional capacities of patients and 2) spatio-temporal parameters of locomotion and joint dynamics. The investigators hypothesize that spinal surgery in patients with symptomatic lumbar spinal stenosis should lead to an improvement in quantifiable locomotion parameters, and in particular walking speed. Walking speed is a quantitative measurement, which could reflect the degree of functional impairment of the patient before and after surgery.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Estimation of Economic Consequences Linked With Different Care Management Pathways of Differentiated Thyroid Cancers : Involvement of Overtreatment

acronym: ECO-THYR

summary:
The incidence of Thyroid Cancer (TC) has increased over the last thirty years, in France and worldwide. This increase is mainly due to good prognosis microPapillary TC (mPTC). Sixty percent of diagnosed cancers are considered as over-diagnosed, leading to an over-treatment of these cases. The increase of diagnosis of mPTC and its treatment inevitably leads to an increase of medical resources consumption and corresponding costs.

The primary aim of this study is to estimate the cost related to different care management pathway of TC patient during a lifetime period using a multi-state Markov model.

This is a retrospective, observational population based cohort study, using data from a cohort study of TC patients implemented by the ONCOMIP network which initially aimed to perform an audit of clinical practices for the management of TC, and from database of the French social health insurance of Midi-Pyrenees region to calculate observed costs of TC management during 24 months.

lead_sponsor: University Hospital, Toulouse


title: Endothelial Dysfunction Leads to Bleeding Diathesis

summary: Inherited bleeding disorders (IBD) consist of a heterogeneous group of diseases including coagulation and/or platelets defects and more rarely vascular dysfunctions. A family of four patients suffering from unexplained excessive bleeding has been followed clinically in France for many years. Recently, whole exome sequencing (WES) of DNA allowed the identification of a heterozygous genetic variant which segregated to family members with bleeding diathesis. The aim of the study was to better characterize the phenotype by studying VWF and platelets in affected family members ultimately contributing to the pathogenesis of a bleeding diathesis.

time_perspective: Other


title: Prospective Evaluation of 1.3-ß-D-glucan in the Peritoneal Fluid for the Diagnosis of Fungal Peritonitis in Critically Ill Patients

summary: New rapid diagnostic strategies are warranted in intra-abdominal candidiasis (IAC). A previous retrospective study showed that one measure, the day of the surgery, of peritoneal 1.3-Beta-D-Glucan ≤ 310pg/ml could rule out an IAC. This strategy was independent of the patient underlying conditions and Candida risk factors. This study aimed to confirm these results with a multicenter prospective study

ReferenceCitation: Novy E, Laithier FX, Machouart MC, Albuisson E, Guerci P, Losser MR. Determination of 1,3-β-D-glucan in the peritoneal fluid for the diagnosis of intra-abdominal candidiasis in critically ill patients: a pilot study. Minerva Anestesiol. 2018 Dec;84(12):1369-1376. doi: 10.23736/S0375-9393.18.12619-8. Epub 2018 Jul 9.

ipd_sharing: Yes

ipd_sharing_description: all IPD that underlie results in a publication

lead_sponsor: Central Hospital, Nancy, France

location_facility:
PILI-FLOURY Sebastien
POTTECHER Julien
BOUHEMAD Belaid
CHR Mercy

intervention_type: Diagnostic Test


title: Contraception and Bariatric Surgery: Evaluation of Contraception and Contraceptive Knowledge of Women Undergoing Bariatric Surgery at the University Hospital of Reims

summary:
Obesity is a public health phenomenon affecting more than 17% of women in France, and more than 20% of men and women in Champagne-Ardenne.

Obese women are more likely to have an unplanned pregnancy, whereas these pregnancies are more at risk than women of normal weight and should be planned or considered after weight loss. These women are also often less well followed in terms of gynecology and especially on contraception.

More and more patients are opting for bariatric surgery. However, bariatric surgery is not trivial. Indeed, the important loss of weight expected is at risk of nutritional deficiencies. In addition, a large number of patients are still obese during the months following surgery. This is why pregnancy is theoretically contraindicated within 12 or 18 months postoperatively.

Women with bariatric surgery must have been properly informed of these risks so that they can choose a contraceptive method, and that can be adapted to both their risk factors and the surgical technique performed.


title: Evaluation d'un Dispositif de Suivi téléphonique Sur la Qualité de Vie Dans Les Crises Psychogènes Non Epileptiques.

acronym: EDUQ-CPNE

summary: The goal of this study is to evaluate effectiveness of the phone follow-up method compared to the conventional filler taken one.

primary_purpose: Supportive Care

ReferenceCitation: LaFrance WC Jr, Alosco ML, Davis JD, Tremont G, Ryan CE, Keitner GI, Miller IW, Blum AS. Impact of family functioning on quality of life in patients with psychogenic nonepileptic seizures versus epilepsy. Epilepsia. 2011 Feb;52(2):292-300. doi: 10.1111/j.1528-1167.2010.02765.x. Epub 2011 Feb 7.

ReferenceCitation: Duncan R, Razvi S, Mulhern S. Newly presenting psychogenic nonepileptic seizures: incidence, population characteristics, and early outcome from a prospective audit of a first seizure clinic. Epilepsy Behav. 2011 Feb;20(2):308-11. doi: 10.1016/j.yebeh.2010.10.022. Epub 2010 Dec 30.

ReferenceCitation: Goldstein LH, Chalder T, Chigwedere C, Khondoker MR, Moriarty J, Toone BK, Mellers JD. Cognitive-behavioral therapy for psychogenic nonepileptic seizures: a pilot RCT. Neurology. 2010 Jun 15;74(24):1986-94. doi: 10.1212/WNL.0b013e3181e39658.

ReferenceCitation: Hingray C, Maillard L, Hubsch C, Vignal JP, Bourgognon F, Laprevote V, Lerond J, Vespignani H, Schwan R. Psychogenic nonepileptic seizures: characterization of two distinct patient profiles on the basis of trauma history. Epilepsy Behav. 2011 Nov;22(3):532-6. doi: 10.1016/j.yebeh.2011.08.015. Epub 2011 Oct 1.

ReferenceCitation: Howlett S, Grünewald RA, Khan A, Reuber M. Engagement in psychological treatment for functional neurological symptoms--Barriers and solutions. Psychotherapy (Chic). 2007 Sep;44(3):354-60. doi: 10.1037/0033-3204.44.3.354.

ReferenceCitation: Hubsch C, Baumann C, Hingray C, Gospodaru N, Vignal JP, Vespignani H, Maillard L. Clinical classification of psychogenic non-epileptic seizures based on video-EEG analysis and automatic clustering. J Neurol Neurosurg Psychiatry. 2011 Sep;82(9):955-60. doi: 10.1136/jnnp.2010.235424. Epub 2011 May 10.

ReferenceCitation: Jirsch JD, Ahmed SN, Maximova K, Gross DW. Recognition of psychogenic nonepileptic seizures diminishes acute care utilization. Epilepsy Behav. 2011 Oct;22(2):304-7. doi: 10.1016/j.yebeh.2011.06.031. Epub 2011 Aug 2.

ReferenceCitation: Josien E. Crises non épileptiques. EMC neurologie. 2005 ;1-9.

ReferenceCitation: LaFrance WC Jr, Keitner GI, Papandonatos GD, Blum AS, Machan JT, Ryan CE, Miller IW. Pilot pharmacologic randomized controlled trial for psychogenic nonepileptic seizures. Neurology. 2010 Sep 28;75(13):1166-73. doi: 10.1212/WNL.0b013e3181f4d5a9. Epub 2010 Aug 25.

ReferenceCitation: Lesser RP. Psychogenic seizures. Neurology. 1996 Jun;46(6):1499-507. Review.

ReferenceCitation: Martin RC, Gilliam FG, Kilgore M, Faught E, Kuzniecky R. Improved health care resource utilization following video-EEG-confirmed diagnosis of nonepileptic psychogenic seizures. Seizure. 1998 Oct;7(5):385-90.

ReferenceCitation: Mayor R, Howlett S, Grünewald R, Reuber M. Long-term outcome of brief augmented psychodynamic interpersonal therapy for psychogenic nonepileptic seizures: seizure control and health care utilization. Epilepsia. 2010 Jul;51(7):1169-76. doi: 10.1111/j.1528-1167.2010.02656.x. Epub 2010 Jun 18.

ReferenceCitation: Strutt AM, Hill SW, Scott BM, Uber-Zak L, Fogel TG. Motivation, psychopathology, locus of control, and quality of life in women with epileptic and nonepileptic seizures. Epilepsy Behav. 2011 Oct;22(2):279-84. doi: 10.1016/j.yebeh.2011.06.020. Epub 2011 Jul 23.

ReferenceCitation: Worsley C, Whitehead K, Kandler R, Reuber M. Illness perceptions of health care workers in relation to epileptic and psychogenic nonepileptic seizures. Epilepsy Behav. 2011 Apr;20(4):668-73. doi: 10.1016/j.yebeh.2011.01.029. Epub 2011 Mar 25. Erratum in: Epilepsy Behav. 2011 Aug;21(4):495. Worsely, Caroline [corrected to Worsley, Caroline].

ReferenceType: result

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ReferenceCitation: Bodde NM, Brooks JL, Baker GA, Boon PA, Hendriksen JG, Aldenkamp AP. Psychogenic non-epileptic seizures--diagnostic issues: a critical review. Clin Neurol Neurosurg. 2009 Jan;111(1):1-9. doi: 10.1016/j.clineuro.2008.09.028. Epub 2008 Nov 18. Review.

family: Bodde

full_name: N.M.G. Bodde

family: Brooks

full_name: J.L. Brooks

family: Baker

full_name: G.A. Baker

family: Boon

full_name: P.A.J.M. Boon

family: Hendriksen

full_name: J.G.M. Hendriksen

family: Aldenkamp

full_name: A.P. Aldenkamp

journal_name: Clinical Neurology and Neurosurgery

title: Psychogenic non-epileptic seizures—Diagnostic issues: A critical review

ReferenceCitation: Bodde NM, Brooks JL, Baker GA, Boon PA, Hendriksen JG, Mulder OG, Aldenkamp AP. Psychogenic non-epileptic seizures--definition, etiology, treatment and prognostic issues: a critical review. Seizure. 2009 Oct;18(8):543-53. doi: 10.1016/j.seizure.2009.06.006. Epub 2009 Aug 13. Review.

family: Mulder

full_name: O.G. Mulder

journal_name: Seizure

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

title: Psychogenic non-epileptic seizures—Definition, etiology, treatment and prognostic issues: A critical review

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family: Hall-Patch

full_name: Lindsey Hall-Patch

given: Lindsey

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title: Cognitive behavioral therapy for psychogenic nonepileptic seizures

ReferenceCitation: LaFrance WC Jr, Alper K, Babcock D, Barry JJ, Benbadis S, Caplan R, Gates J, Jacobs M, Kanner A, Martin R, Rundhaugen L, Stewart R, Vert C; NES Treatment Workshop participants. Nonepileptic seizures treatment workshop summary. Epilepsy Behav. 2006 May;8(3):451-61. Epub 2006 Mar 15.

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publisher: Ovid Technologies (Wolters Kluwer Health)

title: Depression and symptoms affect quality of life in psychogenic nonepileptic seizures

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title: Psychogenic nonepileptic seizures and health-related quality of life: The relationship with psychological distress and other physical symptoms

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journal_name: Archives of Pediatrics & Adolescent Medicine

title: Effect of Telephone Calls From Primary Care Practices on Follow-up Visits After Pediatric Emergency Department Visits

ReferenceCitation: Ramachandran K, Husain N, Maikhuri R, Seth S, Vij A, Kumar M, Srivastava N, Prabhakaran D, Airan B, Reddy KS. Impact of a comprehensive telephone-based disease management programme on quality-of-life in patients with heart failure. Natl Med J India. 2007 Mar-Apr;20(2):67-73.

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ReferenceCitation: Reuber M. Psychogenic nonepileptic seizures: answers and questions. Epilepsy Behav. 2008 May;12(4):622-35. doi: 10.1016/j.yebeh.2007.11.006. Epub 2007 Dec 27. Review.

title: Psychogenic nonepileptic seizures: Answers and questions

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title: Telephone Intervention and Quality of Life in Patients With Breast Cancer

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location_facility:
Chu Dijon
Chu Nancy
Chu Strasbourg
Chu Reims


title: Multiple Sclerosis and Voiding Symptoms: How to Assess?

summary:
In multiple Sclerosis (MS), storage and voiding symptoms are well described. Urodynamic patterns underlying storage symptoms are clearly defined, but the assessment of voiding phase in neurological diseases is a sensitive topic. The international continence society (ICS) recommended performing pressure flow studies to assess voiding phase. Assessments of sphincter relaxation and detrusor contractility during voiding phase are tough aims to achieve. Indeed, there is no consensus for the detrusor contractility assessment on women or on patients with neurogenic bladder. Similarly, assessment of sphincter during bladder filling and during the voiding phase is not included in ICS recommendations. In the end, it is the physicians who conclude from the non-formalized urodynamic data if there is a DSD or detrusor underactivity. In MS patients undergoing urodynamics, studies reported 43% DSD and 12% impaired contractility. These data should be interpreted with caution due to the variability of the assessment methods.

This study aims to describe the voiding phase of MS patients with standardized urodynamic evaluation and parameters.

This prospective observational study was conducted in a neuro-urology department of a French university hospital.

All the MS patients consulting for a first urodynamic evaluation without urinary treatment were included. Standardized urodynamic evaluation included an uroflowmetry, urethral pressure profile, two pressure-flow studies. If no detrusor contractility was observed during the pressure flow studies, cystometries with 100ml/min filling rate and ice water test were performed. Anal sphincter activity was recorded using surface electromyography electrodes.

Demographic data (age, sex), disease course of the MS, treatments, Expanded Disability Status Scale, urinary symptoms using the Urinary Symptom Profile and the Neurogenic Bladder Symptom Score were collected.

For assessment of detrusor contractility, the following parameters are reported: the bladder voiding efficiency; the projected isovolumetric pressure (PIP) or bladder contractility index (BCI); the Watts factor. For women, the investigators presented 3 more parameters the PIP1; the Valentini-besson-Nelson parameter k and an urodynamic cut-off proposed by Gammie et al. for DUA. Presence of Detrusor-sphincter dyssynergia was reported if there were a detrusor contraction concurrent with an involuntary contraction of the periurethral striated muscle.

lead_sponsor: Pierre and Marie Curie University

location_facility: Department of Neuro- Urology, Hôpital Tenon


title: Cimex Lectularius or Bed Bugs : Vector of Infectious Agents and Pathogenic Role

summary: During the last years, the investigators were the witness to the increase of a old emerging pest due to bed bugs (Cimex lectularius) in the world. Insecticides resistances apparitions and internationals transports increases seem to be the reasons of the pest. Cimex lectularius as vector of parasites, bacteria or virus was often suggested although not much observation are recently investigated in France. This study intends to examine the vectorial ability and the direct pathogenicity of Cimex lectularius.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Collection of the bedbugs and dermatological follow-up of the stings


title: Translating Molecular Classifications and Genetic Alterations of Hepatocellular Carcinoma in Clinical Care (MUTHEC Project)

acronym: MUTHEC

summary: The MUTHEC project aims to describe the mutational and transcriptomic landscape of HCC treated by curative treatments (resection, radio frequency ablation, transplantation) as well as advanced HCC together with the analysis of circulating tumor DNA.

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