title: Subjective Experience of Adolescents Suffering From Anorexia Nervosa With Antidepressants

summary: The purpose of this study is to explore the experience of adolescents suffering from anorexia nervosa confronted with the prescription of antidepressants

ReferenceCitation: Leblé N, Radon L, Rabot M, Godart N. [Depressive symptoms during anorexia nervosa: State of the art and consequences for an appropriate use of antidepressants]. Encephale. 2017 Feb;43(1):62-68. doi: 10.1016/j.encep.2016.02.017. Epub 2016 Jul 21. Review. French.

ReferenceCitation: Anderson C, Roy T. Patient experiences of taking antidepressants for depression: a secondary qualitative analysis. Res Social Adm Pharm. 2013 Nov-Dec;9(6):884-902. doi: 10.1016/j.sapharm.2012.11.002. Epub 2012 Dec 4.

ipd_sharing_description:
Use of a treatment database, named Actipidos
Interview recording on a Dictaphone [kept all over the study in a locked drawer in a medical office at the Maison de Solenn, and then destroyed].
Verbatim transcription, on a word-formatted file from a computer in a medical office at the Maison de Solenn; computer secured by a password.
Transcripts will be anonymized with an identical number as soon as they are created; no non-anonymized data records will be kept beyond the end of the study.


title: MECHANISMS OF NEURONAL RESILIENCE IN ALZHEIMER'S DISEASE AND ITS FOCAL VARIANTS: A PET/MR STUDY

acronym: PET-AL

summary: Patients with Alzheimer's disease and with early onset of symptoms (<65 years) (AD-Y) have a multi-domain cognitive deficit, whereas memory disorders (typical of the elderly patient's AD) are less often in the foreground. In addition, some MA-J have an atypical phenotype indicating focal brain damage, although they have the same pathological lesions: amyloid deposits and tau protein deposition (DNF). This is the case of posterior cortical atrophy (PCA) characterized by complex visual disturbances and atrophy affecting the more posterior regions of the brain. Based on the clinical profile of PCA patients, a more refined anatomo-clinical classification was proposed, distinguishing a rather "ventral" form and a rather "dorsal" form. The recent arrival of tau-specific PET tracers now makes it possible to evaluate in vivo fibrillary neurodegeneration (FND), which is well correlated with the severity of cognitive disorders. Advances in MRI have shown that each neurodegenerative syndrome targets a large-scale neural network, which in turn shows a vulnerability for a specific biological disease. In the case of AD, the reason for such a difference in cognitive and anatomical impairment between patients with diffuse involvement and others with more focal involvement is not known. One possible explanation is the existence, in focal forms, of neuronal mechanisms that oppose vulnerability. These mechanisms may correspond to the so-called "resilience" phenomenon, defined as resistance to a neuropathological process by the ability to optimize cognitive performance via the efficient recruitment of neural networks. The mechanisms underlying resilience in neurodegeneration are unknown. Their identification is very important for the management and treatment of AD.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Anticipated

ipd_sharing: Undecided

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

location_facility: Service de Médecine Nucléaire - Hopital La Pitié Salpetriere

location_facility: Service Hospitalier Frédéric Joliot SHFJ

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Ongoing


title: Evaluation of the Organization of Continuity of Care for Home Hospice Patients by Four Parisian Health Networks

acronym: DICODOM

summary:
In Paris, France, home hospice care for terminally ill patients is organized by four "palliative care networks". These networks are responsible for information sharing and coordination of all health care professionals working with the patient. Two different systems are in place to ensure continuity of care outside working hours, in such a setting. In the first system, palliative care specialists from the network are reachable over the phone 24/7 by the patient or its caregivers, whenever needed. In the second system, medical information about the patient, regularly updated by the network's medical team, is available to professionals via a secure website, so that in case the patient requires an urgent medical home visit outside working hours, the visiting physician has access to accurate information.

The study's goal is to compare patient's and caregiver's satisfaction between these two systems of continuity of care.

For that purpose, patients will be taken care of as usual by every palliative care network. In every instance where the patient or caregivers have reached out for medical help through the network's continuity of care system, the patient or caregiver will be called 5 days later by the investigation team to go through a satisfaction questionnaire (Likert scales)

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

location_facility:
Reseaux ROPE
Reseau QUIETUDE
Reseau ENSEMBLE
Reseaux ParisOuest

lead_sponsor_type: industriel

status_simplified: Completed


title: Metformin Use in Chronic Kidney Disease: The CKD-Met Study

acronym: CKD-Met

summary:
Metformin is the most widely prescribed oral treatment for diabetes, and the only one that showed a survival benefit.

Yet, there is no consensus on the optimal dose and withdrawal of metformin in chronic kidney disease (CKD) patients.

The aim of the study is to describe the use and side-effects of metformin in CKD patients in routine practice.

status: Unknown status

ReferenceType: derived

ReferenceCitation: Coliche V, Koppe L, Laville M, Nouvier M, Pelletier S, Trolliet P, Fouque D. Metformin misuse in chronic kidney disease. Diabetes Metab. 2020 Sep;46(4):337-339. doi: 10.1016/j.diabet.2018.07.005. Epub 2018 Jul 24.

lead_sponsor: Hospices Civils de Lyon

location_facility: Claude Bernard University, Lyon, France, Lyon Sud university hospital

intervention_type: Other

status_simplified: Unknown


type: Other Identifier

title: Evolution of Chronic Low Back Pain of Active Discopathy After Intradiscal Corticosteroid Infiltrations According to Modic 1 Distribution and Association With Degenerative Restructuring

acronym: MODISC

summary: The primary objective of the study is to demonstrate the difference in the reduction of pain at 1 month after intradiscal infiltration of corticosteroids depending on symmetrical or asymmetrical active discopathies with MRI examination. The difference should be judged significant if it ⩾ 2 points.

status: Recruiting

ReferenceType: background

ReferenceCitation: GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8. Erratum in: Lancet. 2019 Jun 22;393(10190):e44.

ReferenceCitation: Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9. Review.

ReferenceCitation: Dagenais S, Caro J, Haldeman S. A systematic review of low back pain cost of illness studies in the United States and internationally. Spine J. 2008 Jan-Feb;8(1):8-20. doi: 10.1016/j.spinee.2007.10.005. Review.

ReferenceCitation: Hueftle MG, Modic MT, Ross JS, Masaryk TJ, Carter JR, Wilber RG, Bohlman HH, Steinberg PM, Delamarter RB. Lumbar spine: postoperative MR imaging with Gd-DTPA. Radiology. 1988 Jun;167(3):817-24.

ReferenceCitation: Albert HB, Kjaer P, Jensen TS, Sorensen JS, Bendix T, Manniche C. Modic changes, possible causes and relation to low back pain. Med Hypotheses. 2008;70(2):361-8. Epub 2007 Jul 10.

ReferenceCitation: Toyone T, Takahashi K, Kitahara H, Yamagata M, Murakami M, Moriya H. Vertebral bone-marrow changes in degenerative lumbar disc disease. An MRI study of 74 patients with low back pain. J Bone Joint Surg Br. 1994 Sep;76(5):757-64.

ReferenceCitation: Nguyen C, Jousse M, Poiraudeau S, Feydy A, Rannou F. Intervertebral disc and vertebral endplate subchondral changes associated with Modic 1 changes of the lumbar spine: a cross-sectional study. BMC Musculoskelet Disord. 2017 Jan 23;18(1):34. doi: 10.1186/s12891-017-1407-6.

ReferenceCitation: Nguyen C, Poiraudeau S, Rannou F. From Modic 1 vertebral-endplate subchondral bone signal changes detected by MRI to the concept of 'active discopathy'. Ann Rheum Dis. 2015 Aug;74(8):1488-94. doi: 10.1136/annrheumdis-2015-207317. Epub 2015 May 14. Review.

ReferenceCitation: Nguyen C, Boutron I, Baron G, Sanchez K, Palazzo C, Benchimol R, Paris G, James-Belin É, Lefèvre-Colau MM, Beaudreuil J, Laredo JD, Béra-Louville A, Cotten A, Drapé JL, Feydy A, Ravaud P, Rannou F, Poiraudeau S. Intradiscal Glucocorticoid Injection for Patients With Chronic Low Back Pain Associated With Active Discopathy: A Randomized Trial. Ann Intern Med. 2017 Apr 18;166(8):547-556. doi: 10.7326/M16-1700. Epub 2017 Mar 21.

ReferenceCitation: Benyahya R, Lefevre-Colau MM, Fayad F, Rannou F, Demaille-Wlodyka S, Mayoux-Benhamou MA, Poiraudeau S, Revel M. [Intradiscal injection of acetate of prednisolone in severe low back pain: complications and patients' assessment of effectiveness]. Ann Readapt Med Phys. 2004 Nov;47(9):621-6. French.

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service d'imagerie médicale, Hôpital Raymond Poincaré, Garches, France


type: Registry Identifier

title: Effect of Combined Anodal tDCS and Peripheral Nerve Stimulation on Motor Recovery in Acute Stroke

summary:
Recent work showed that application of peripheral nerve and cortical stimulation independently can induce 10-15 % improvement in motor performance in patients with chronic stroke.

The purpose of this study was to compare in post-stroke hemiplegic patients the effect on motor recovery of one session of anodal transcranial direct current stimulation to the ipsilesional primary motor cortex (M1) combined with a peripheral radial nerve electrical stimulation (rEPNS) to the paretic hand repeated 5 successive days with the effect of the same peripheral nerve stimulation combined with sham tDCS.

Design: randomized, double-blind, parallel controlled clinical trial. Patients eligible for the study: Acute ischaemic stroke Primary outcome measure: Jebsen Taylor test Secondary outcome measures Nine peg hole test Hand tapping grip and wrist force Cortical excitability of Ipsilesional M1(TMS) Follow-up: 30 days

design_allocation: Randomized

primary_purpose: Treatment

ReferenceCitation: Loubinoux I, Dechaumont-Palacin S, Castel-Lacanal E, De Boissezon X, Marque P, Pariente J, Albucher JF, Berry I, Chollet F. Prognostic value of FMRI in recovery of hand function in subcortical stroke patients. Cereb Cortex. 2007 Dec;17(12):2980-7. Epub 2007 Mar 26.

ReferenceCitation: Castel-Lacanal E, Gerdelat-Mas A, Marque P, Loubinoux I, Simonetta-Moreau M. Induction of cortical plastic changes in wrist muscles by paired associative stimulation in healthy subjects and post-stroke patients. Exp Brain Res. 2007 Jun;180(1):113-22. Epub 2007 Jan 31.

ReferenceCitation: Castel-Lacanal E, Marque P, Tardy J, de Boissezon X, Guiraud V, Chollet F, Loubinoux I, Moreau MS. Induction of cortical plastic changes in wrist muscles by paired associative stimulation in the recovery phase of stroke patients. Neurorehabil Neural Repair. 2009 May;23(4):366-72. doi: 10.1177/1545968308322841. Epub 2008 Dec 5.

ReferenceCitation: Conchou F, Loubinoux I, Castel-Lacanal E, Le Tinnier A, Gerdelat-Mas A, Faure-Marie N, Gros H, Thalamas C, Calvas F, Berry I, Chollet F, Simonetta Moreau M. Neural substrates of low-frequency repetitive transcranial magnetic stimulation during movement in healthy subjects and acute stroke patients. A PET study. Hum Brain Mapp. 2009 Aug;30(8):2542-57. doi: 10.1002/hbm.20690.

ReferenceCitation: Celnik P, Paik NJ, Vandermeeren Y, Dimyan M, Cohen LG. Effects of combined peripheral nerve stimulation and brain polarization on performance of a motor sequence task after chronic stroke. Stroke. 2009 May;40(5):1764-71. doi: 10.1161/STROKEAHA.108.540500. Epub 2009 Mar 12.

ReferenceCitation: Uy J, Ridding MC. Increased cortical excitability induced by transcranial DC and peripheral nerve stimulation. J Neurosci Methods. 2003 Aug 15;127(2):193-7.

ReferenceCitation: Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11:CD009645. doi: 10.1002/14651858.CD009645.pub4.

location_facility: Centre d' Investigation Clinique de Toulouse et Hopitaux de Toulouse ( Purpan)


title: Prospective Study on the Prevalence on the Use of Prone Positioning in ARDS Patients

acronym: APRONET

summary:
Prone positioning has been shown to improve survival in patients with acute respiratory distress syndrome (ARDS). However, a recent large observational study found that prone positioning was used in only 7% of all ARDS patients, and 16% in the severe category. However, this study did not focus on the prone position per se. In present study, the investigators would like to explore the rate of use of prone positioning in ARDS patients and the reasons why this treatment was not applied. The present study is one-day prevalence study repeated four times over one year.

The hypothesis is that the rate of use of prone position is greater than 50% in the severe ARDS category.

location_facility: Réanimation médicale, Hôpital de la Croix Rousse, CHU de Lyon, France

intervention_type: Procedure


title: Multistate Relative Survival Modeling of Colorectal Cancer Progression and Mortality

acronym: MRS

summary:
Colorectal cancer (CRC) has high incidence and is associated with high case fatality. In France, the 5-year survival, pooled across all cancer stages at diagnosis, ranges from 57% in men to 60% in women. About one third of patients diagnosed with CRC will develop a metachronous recurrence during the following years. It is of paramount importance to accurately identify factors associated with the increased risk of progression and death, in order to develop effective follow-up and treatment strategies. However, to accurately assess the role of patients' specific characteristics in the progression of cancer several methodological challenges need to be overcome.

One difficulty, common to prognostic studies of cancer, concerns the need to separate the effects of prognostic factors on different clinical endpoints, such as disease recurrence vs recurrence-free death. Another difficulty, encountered in prognostic studies, is that the cause of death is not available or not accurately coded. Yet, some patients are likely to die of causes not related to the disease of primary interest, especially in cancers with longer survival and in those that affect older subjects. Until recently, the existing statistical methodology was not able to simultaneously, deal with both difficulties, i.e. to account for (i) possibly different effects of prognostic factors on death vs recurrence, and (ii) unknown causes of death. However, this challenge has been addressed by the recent development of the Markov relative survival model (MRS) , which extends the Markov multi-state model to incorporate relative survival modelling. Simulations demonstrate that MRS is able to accurately estimate different effects of prognostic factors on the risk of each of several events, including separate effects on disease-specific vs other causes of death. To date, the MRS had not been applied in clinical or epidemiological studies.

The aim of this study was to assess the potential advantages of the new multi-state relative survival model (MRS), proposed by Huszti et al. (2012), in a prognostic cancer study. To this end, we compared the MRS results with those obtained with two more conventional analyses, based on Cox's proportional hazards model, and the multi-state Markov model proposed by Alioum and Commenges (2001). The three models were applied to explore the impact of prognostic factors on cancer-specific mortality and recurrence, in a large population-based French registry of colorectal cancer, with up to 25 years of follow-up.

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Assessment of the Phenotype of the Type 2 Diabetic Responders to the First Insulinisation Using Lantus (Insulin Glargine) Plus Glucophage (Metformin) Combination After Failure in OADs Treatment

acronym: GALATEE

summary:
Primary objective:

Efficacy assessment of the percentage of positive responders patients receiving Lantus plus glucophage association. Positive responders patients are defined by a final value of HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final - HbA1c basal).

Secondary objectives:

Determination of the predictive criterion of HbA1c final,
Determination of the predictive criterion of weight variation,
Description of the glycemic and therapeutic criteria in the both groups of responders (positive and negative responders),
Assessment of the lipidic parameters according to the HbA1c and weight changes during the study (final value - basal value).

Safety:

Adverse Event (AE)/Serious Adverse Event (SAE) assessments

lead_sponsor: Sanofi

intervention_type: Drug


title: Evaluation of the Prognostic Value of Clinical, Imaging, Immunological and Virological Markers in the Neonatal Period for the Development of Neurosensorial Sequelae at 1 Year in Children Infected by Cytomegalovirus in Utero.

acronym: CYMEPEDIA

summary:
The main objective of this study is to validate , in the neonatal period, a prognostic score for the development of neurosensorineural sequelae at 1 year and at 2 years in neonates infected in utero by cytomegalovirus. This score will be based on clinical, imaging and biological criteria .

The second objective of the study is to estimate the prevalence of this infection in France and to describe its epidemiology through the screening of 12,000 consecutive neonates.

ReferenceType: result

ReferenceCitation: Leruez-Ville M, Magny JF, Couderc S, Pichon C, Parodi M, Bussières L, Guilleminot T, Ghout I, Ville Y. Risk Factors for Congenital Cytomegalovirus Infection Following Primary and Nonprimary Maternal Infection: A Prospective Neonatal Screening Study Using Polymerase Chain Reaction in Saliva. Clin Infect Dis. 2017 Aug 1;65(3):398-404. doi: 10.1093/cid/cix337.

ReferenceCitation: Leruez-Ville M, Ren S, Magny JF, Jacquemard F, Couderc S, Garcia P, Maillotte AM, Benard M, Pinquier D, Minodier P, Astruc D, Patural H, Ugolin M, Parat S, Guillois B, Garenne A, Parodi M, Bussières L, Stirnemann J, Sonigo P, Millischer AE, Ville Y. Accuracy of prenatal ultrasound screening to identify fetuses infected by cytomegalovirus which will develop severe long-term sequelae. Ultrasound Obstet Gynecol. 2021 Jan;57(1):97-104. doi: 10.1002/uog.22056.

ReferenceCitation: Faure-Bardon V, Magny JF, Parodi M, Couderc S, Garcia P, Maillotte AM, Benard M, Pinquier D, Astruc D, Patural H, Pladys P, Parat S, Guillois B, Garenne A, Bussières L, Guilleminot T, Stirnemann J, Ghout I, Ville Y, Leruez-Ville M. Sequelae of Congenital Cytomegalovirus Following Maternal Primary Infections Are Limited to Those Acquired in the First Trimester of Pregnancy. Clin Infect Dis. 2019 Oct 15;69(9):1526-1532. doi: 10.1093/cid/ciy1128.


title: From Movement Preparation to Gait Execution in ALS: : Combined Neurophysiological and Neuroimaging Approaches

acronym: GAITALS

summary:
This research program will focus on gait initiation and postural control in Amyotrophic Lateral Sclerosis (ALS) patients, by comparing patients with vs without postural instability (but also in comparison to controls), by using a multidisciplinary approach which combines neurophysiological and neuroimaging analyses.

After clinical evaluation, two groups of ALS patients, defined upon the feature of postural instability, and one group of healthy subjects (n=25 for each group of patients and 20 for healthy subjects) will be included in the study.

The neurophysiological evaluation will be performed through a gait initiation assessment, which will alow us to collect biomechanical and electromyographical data, such as the braking index.

The neuroradiological evaluation will include first an fMRI analysis, a study of specific circuits in networks will be performed which will provide the first description of neural network dynamics associated with the preparation and execution of movement in ALS patients.

The investigators major research hypothesis is:

By comparing patients with vs without postural instability, but also in comparison to controls, the investigators main research neurophysiological hypothesis is that patients with postural instability will display an impaired braking.
This impaired braking could be partly explained by a dysfunction and/or lesion of the basal ganglia and brain stem structures, corresponding to the investigators main neuroradiological hypothesis.

time_perspective: Other

location_facility: Hôpital Pitié-Salpétrière, Département des Maladies du Système Nerveux 47-83 Boulevard de l'Hôpital


title: A Cohort of Patients With Possible or Confirmed SARS-CoV-2 (COVID-19) Infection, From Diagnosis to Long-term Follow-up

acronym: COVIDothèque

summary:
SARV-CoV-2 infection was considered pandemic on March 11, 2020. The SARV-CoV-2 epidemic affected France from the beginning of March, spreading in particular from a 4-day large evangelical meeting of 2500 people on February 17 in the city of Mulhouse (North East of France). The Montpellier University Hospital has set up a clinical pathway for people suspected of being infected with SARV-CoV-2 because of signs compatible with pneumonia (screening criteria in France during the study period). This includes an emergency department, an infectious disease department dedicated to the surveillance of infected people requiring hospital treatment, and an intensive care unit for the most severe cases. The diagnosis of infection with SARV-CoV-2 was confirmed in approximately 20% of people initially referred in this special care system.

The main objective of this cohorte is the collection of clinical data and biological samples from care for non-interventional research on the patients with a possible or confirmed SARS-CoV -2 infection, from diagnosis to long-term follow-up.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Sleep Apnea in Type 1 Diabetes : Prevalence, Role of Glycemic Control and Autonomic Neuropathy

acronym: DIASOM

summary: Sleep apnea syndrome is strongly associated to type 2 diabet, partly and this is partly due to obesity. Treatment of sleep apnea may improve hypertension, cardiovascular risk and in some studies diabetes status. Few data are available for type 1 diabetes but suggest that the prevalence of sleep apnea syndrome may be high. We plan to compare the prevalence of sleep apnea syndrome assessed by polysomnography in a sample of type 1 diabetic patients and a control group matched by age, gender and body mass index. The secondary objective is to determine if the presence of an autonomic neuropathy or poorly controlled diabetes (assessed by glycosylated haemoglobin) may or not contribute to the presence of sleep apnea in the diabetic group.


title: Interest for a Relative of Seeing Himself Proposing to Witness Resuscitation of a Family Member Victim of a Cardiac Arrest

acronym: PRESENCE

summary: The bereavement generated by the loss of a family member can induce pathological situations: depressive state, anxiety, post-traumatic stress disorder and complicated grief. These morbid factors can be influenced by the death circumstances and in particular by the possibility given to the family to attend the medical management of the patient. This clinical trial aims to evaluate the psychological consequences of bereavement on the relatives according to the possibility of witnessing the cardiopulmonary resuscitation of a family member. This possibility lies within the scope of a strategy of global management of the relatives.

primary_purpose: Prevention

ReferenceCitation: Jabre P, Bougouin W, Dumas F, Carli P, Antoine C, Jacob L, Dahan B, Beganton F, Empana JP, Marijon E, Karam N, Loupy A, Lefaucheur C, Jost D, Cariou A, Adnet F, Rea TD, Jouven X. Early Identification of Patients With Out-of-Hospital Cardiac Arrest With No Chance of Survival and Consideration for Organ Donation. Ann Intern Med. 2016 Dec 6;165(11):770-778. doi: 10.7326/M16-0402. Epub 2016 Sep 13.

ReferenceCitation: Jabre P, Tazarourte K, Azoulay E, Borron SW, Belpomme V, Jacob L, Bertrand L, Lapostolle F, Combes X, Galinski M, Pinaud V, Destefano C, Normand D, Beltramini A, Assez N, Vivien B, Vicaut E, Adnet F. Offering the opportunity for family to be present during cardiopulmonary resuscitation: 1-year assessment. Intensive Care Med. 2014 Jul;40(7):981-7. doi: 10.1007/s00134-014-3337-1. Epub 2014 May 23.

ReferenceCitation: Jabre P, Belpomme V, Azoulay E, Jacob L, Bertrand L, Lapostolle F, Tazarourte K, Bouilleau G, Pinaud V, Broche C, Normand D, Baubet T, Ricard-Hibon A, Istria J, Beltramini A, Alheritiere A, Assez N, Nace L, Vivien B, Turi L, Launay S, Desmaizieres M, Borron SW, Vicaut E, Adnet F. Family presence during cardiopulmonary resuscitation. N Engl J Med. 2013 Mar 14;368(11):1008-18. doi: 10.1056/NEJMoa1203366.


title: Study of the Brain Energy Profile Evolution, Using 31Phosphorus-Nuclear Magnetic Resonance Spectroscopy, at Different Stages of Huntington Disease

summary: The purpose of this project is to study brain energy profile evolution at different stages of the Huntington disease.

primary_purpose: Basic Science

ReferenceCitation: Adanyeguh IM, Rinaldi D, Henry PG, Caillet S, Valabregue R, Durr A, Mochel F. Triheptanoin improves brain energy metabolism in patients with Huntington disease. Neurology. 2015 Feb 3;84(5):490-5. doi: 10.1212/WNL.0000000000001214. Epub 2015 Jan 7.


title: 31Phosphorus-Magnetic Resonance Spectroscopy and Huntington Disease

acronym: PRO-MH

summary: The purpose of this study is to identify and quantify a brain energy deficit in Huntington patients, using 31P-RMN spectroscopy.

ReferenceCitation: Mochel F, Haller RG. Energy deficit in Huntington disease: why it matters. J Clin Invest. 2011 Feb;121(2):493-9. doi: 10.1172/JCI45691. Epub 2011 Feb 1. Review.

ReferenceCitation: Mochel F, Charles P, Seguin F, Barritault J, Coussieu C, Perin L, Le Bouc Y, Gervais C, Carcelain G, Vassault A, Feingold J, Rabier D, Durr A. Early energy deficit in Huntington disease: identification of a plasma biomarker traceable during disease progression. PLoS One. 2007 Jul 25;2(7):e647.

ReferenceCitation: Mochel F, Benaich S, Rabier D, Durr A. Validation of plasma branched chain amino acids as biomarkers in Huntington disease. Arch Neurol. 2011 Feb;68(2):265-7. doi: 10.1001/archneurol.2010.358.


title: Effectiveness of a Managed Care Smoking Cessation Program in Patients With Acute Coronary Syndrome Based on Nicotine Replacement as a Treatment and a Cognitive-behavioral Approach

acronym: PATPAC

summary: The aim of the present study is to assess if a personal care program of smokers hospitalised for acute coronary syndrome can change the smoking habits as compared with similar patients in conventional care program at 6 months. The program includes a cognitive-behavioural approach associated with a nicotine replacement treatment presented as an obligatory non optional treatment. Patients are men and women of less than 70 years old hospitalised for acute coronary syndrome. Major exclusion criteria is the presence of another dependence. The program includes a cognitive-behavioural approach based on the specific technique of "exposure" and the prescription of nicotine patch considered as other usual cardiologic treatments for at least 6 months. The end point is the smoking habits at 6 months classified as: no smoking confirmed by CO measurement, smoking or doubtful (declaration of no smoking by the patient but a CO level > 10 ppm). 72 patients in each group will be included in 2 majors sites.

intervention_type: Behavioral


type: EudraCT Number

type: Other Grant/Funding Number

title: The Prevention of Post Operative Cognitive Dysfunction by Ketamine: a Prospective Multicenter Randomized Blinded Placebo-controlled Trial in Elderly Patients Undergoing Elective Orthopaedic Surgery

acronym: POCK

summary:
Over 30 million patients require a major surgery annually in the US alone and more than half of them are performed in patients over 60 years of age. Post-operative cognitive dysfunction (POCD) is a keystone complication of these surgeries and affects up to 40% of surgical patients aged over 60 years on discharge from the hospital. Despite controlled longitudinal studies have shown that POCD is transient, it is associated with delirium, higher mortality, earlier retirement, and greater utilization of social financial assistance The pathophysiology of persistent postoperative cognitive dysfunction and causal relationship between POCD and delirium remain incompletely understood. Identified clinical risk factors for both include advanced age, type of surgery, preexisting cognitive impairment, and drug addiction. We and others have provided evidence that the inflammatory response triggered by surgical trauma and pain may contribute to the development of delirium and cognitive impairment after surgery.

Ketamine, a N-methyl-D-aspartic acid receptor antagonist, is commonly used in anaesthesia and postoperative analgesia. By reducing both pain and glutamate excitotoxic effects on neuronal and microglial brain cells, it contributes to tone down the neuroinflammatory process associated with surgery. A recent body of evidence has shown that ketamine reduces the depressive-like behavior induced by inflammatory or stress-induced stimuli in mice. Ketamine was also found to reduce levels of inflammatory biomarkers in cardiac surgical patients.

Orthopaedic surgery is a high-risk situation for developing postoperative cognitive dysfunction. In patients undergoing non-cardiac surgery, the prevalence of POCD is 26% one week after surgery and decreased to 10% at 3 months postoperatively, and a similar prevalence is found 12 months after the operation. Postoperative delirium is associated with an increased risk of POCD. Hundred thousands of patients > 60 years undergo elective orthopaedic procedures per year around the world.

ReferenceCitation: Kurdi MS, Theerth KA, Deva RS. Ketamine: Current applications in anesthesia, pain, and critical care. Anesth Essays Res. 2014 Sep-Dec;8(3):283-90. doi: 10.4103/0259-1162.143110. Review.

ReferenceCitation: Jabre P, Combes X, Lapostolle F, Dhaouadi M, Ricard-Hibon A, Vivien B, Bertrand L, Beltramini A, Gamand P, Albizzati S, Perdrizet D, Lebail G, Chollet-Xemard C, Maxime V, Brun-Buisson C, Lefrant JY, Bollaert PE, Megarbane B, Ricard JD, Anguel N, Vicaut E, Adnet F; KETASED Collaborative Study Group. Etomidate versus ketamine for rapid sequence intubation in acutely ill patients: a multicentre randomised controlled trial. Lancet. 2009 Jul 25;374(9686):293-300. doi: 10.1016/S0140-6736(09)60949-1. Epub 2009 Jul 1.

ReferenceCitation: Riou B, Lecarpentier Y, Viars P. Inotropic effect of ketamine on rat cardiac papillary muscle. Anesthesiology. 1989 Jul;71(1):116-25.

ReferenceCitation: Riou B, Viars P, Lecarpentier Y. Effects of ketamine on the cardiac papillary muscle of normal hamsters and those with cardiomyopathy. Anesthesiology. 1990 Nov;73(5):910-8.

ReferenceCitation: Zanos P, Moaddel R, Morris PJ, Georgiou P, Fischell J, Elmer GI, Alkondon M, Yuan P, Pribut HJ, Singh NS, Dossou KS, Fang Y, Huang XP, Mayo CL, Wainer IW, Albuquerque EX, Thompson SM, Thomas CJ, Zarate CA Jr, Gould TD. NMDAR inhibition-independent antidepressant actions of ketamine metabolites. Nature. 2016 May 26;533(7604):481-6. doi: 10.1038/nature17998. Epub 2016 May 4.

ReferenceCitation: Harraz MM, Tyagi R, Cortés P, Snyder SH. Antidepressant action of ketamine via mTOR is mediated by inhibition of nitrergic Rheb degradation. Mol Psychiatry. 2016 Mar;21(3):313-9. doi: 10.1038/mp.2015.211. Epub 2016 Jan 19.

ReferenceCitation: Zorumski CF, Nagele P, Mennerick S, Conway CR. Treatment-Resistant Major Depression: Rationale for NMDA Receptors as Targets and Nitrous Oxide as Therapy. Front Psychiatry. 2015 Dec 9;6:172. doi: 10.3389/fpsyt.2015.00172. eCollection 2015. Review.

ReferenceCitation: Hudetz JA, Patterson KM, Iqbal Z, Gandhi SD, Byrne AJ, Hudetz AG, Warltier DC, Pagel PS. Ketamine attenuates delirium after cardiac surgery with cardiopulmonary bypass. J Cardiothorac Vasc Anesth. 2009 Oct;23(5):651-7. doi: 10.1053/j.jvca.2008.12.021. Epub 2009 Feb 23.

ReferenceCitation: Arrowsmith JE, Harrison MJ, Newman SP, Stygall J, Timberlake N, Pugsley WB. Neuroprotection of the brain during cardiopulmonary bypass: a randomized trial of remacemide during coronary artery bypass in 171 patients. Stroke. 1998 Nov;29(11):2357-62.


title: Phrenic Nerve Conduction Study to Diagnose Unilateral Diaphragmatic Paralysis

acronym: ENMG-DIAPH

summary:
The study aims as the principal objective to compare two approaches to diagnosis unilateral diaphragmatic paralysis: transdiaphragmatic pressure (Pdi) measurement versus phrenic nerve conduction (NPC) study.

The secondary objective of the study is the strengths and weaknesses of different tests. Diagnostic threshold values.

location_facility: Service de Physiologie et Explorations Fonctionnelles, Hôpital Raymond Poincaré, APHP, France


title: Detection of Usability Errors of a Medical Device Zeneo®

summary: The research addresses the question of the number of participants needed to identify as many usability-induced errors as possible in the context of summative usability tests. The research addresses also the impact of the ecological validity of the test environment on the number of usability-induced errors uncovered.

primary_purpose: Other

lead_sponsor: University Hospital, Lille


title: Difficult Venous Access in Pediatric Anesthesia: Evaluation of a New Medical Device in Multicenter Trial.

summary: Our hypothesis is that a new medical device called Vein-Viewer Vision helps to see peripheral veins in children having forecasted difficult venous access and could facilitate the venous access.The main goal is to reduce the time necessary to get a venous access during the inhalation anesthesia induction.

ReferenceCitation: Gras S, Roy-Gash F, Bruneau B, Salvi N, Colas AE, Skhiri A, Orliaguet G, Dahmani S, Devys JM. Reducing the time to successful intravenous cannulation in anaesthetised children with poor vein visibility using a near-infrared device: A randomised multicentre trial. Eur J Anaesthesiol. 2021 Aug 1;38(8):888-894. doi: 10.1097/EJA.0000000000001467.

location_facility: Fondation ophtalmologique Adolphe de Rothschild


title: Impact of Ultrasound-guided Therapeutic Management of Ambulatory Patients With Heart Failure : An Open-label Randomized Clinical Trial

acronym: AMBUSH

summary:
AMBUSH study is a multicenter randomized, controlled, open-label clinical trial (PROBE (Prospective Randomized Open Blinded End-point) type).

The main objective of AMBUSH study is to assess the effect of therapeutic management guided by pulmonary ultrasound and the assessment of the inferior vena cava in patients with heart failure seen in an ambulatory (outpatient) setting on a mixed clinical-biological endpoint (including variations of natriuretic peptides - NtProBNP) at 30 days.

lead_sponsor: Central Hospital, Nancy, France

location_facility:
CH de Mulhouse
CHRU de Nancy
CHRU de Reims
CHR de Metz
CHU de Besançon


title: Comparison of Short and Mid-term Hemodynamic Performance Between Three Types of Stented Pericardial Aortic Valves

summary: This study suggests for the first time a comparison of the hemodynamic performance of the two most implanted aortic bioprosthesis in France with the new aortic bioprosthesis available since September 2010 at the University Hospital of Clermont Ferrand.

ReferenceCitation: Azarnoush K, Pereira B, Dualé C, Dorigo E, Farhat M, Innorta A, Dauphin N, Geoffroy E, Chabrot P, Camilleri L. Comparison between three types of stented pericardial aortic valves (Trivalve trial): study protocol for a randomized controlled trial. Trials. 2013 Dec 3;14:413. doi: 10.1186/1745-6215-14-413.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Study of the Genetic Factors Involved in Autism and Related Disorders

acronym: Gene&autism

summary: The main objective of the study is to define, for Autism Spectrum Disorder, the extent of genetic variation in synaptic pathways that may be targeted for therapeutic development. For this purpose the investigators will take advantage of large, well-characterized cohorts of patients with Autism Spectrum Disorder for genetic screenings. Targeted sequencing of selected synaptic genes, previously associated with Autism Spectrum Disorder, will be carried out in these cohorts with deep coverage of coding regions and a strong focus on previously untested regulatory regions. Genomic data from Copy Number Variant, whole genome sequencing and exome sequencing, available for some of these patients, will be integrated in the overall analysis. The investigators will strongly emphasize the establishment of comprehensive genotype/phenotype correlations.

ReferenceCitation: Delorme R, Ey E, Toro R, Leboyer M, Gillberg C, Bourgeron T. Progress toward treatments for synaptic defects in autism. Nat Med. 2013 Jun;19(6):685-94. doi: 10.1038/nm.3193. Epub 2013 Jun 6. Review.

location_facility: Centre de rehabilitation psychosociale, Hopital Saint Egreve

intervention_type: Genetic


title: Establishement of Normative Intra-epidermal Nerve Fiber Density Using Skin

summary: Intra-epidermal nerve fiber density can be assessed using skin biopsy. A decrease of this density is used to diagnose small fiber neuropathy, despite the absence of normative data in a selected normal population. To establish a normative set of data matched for age and sex is absolutely needed to evaluate the sensibility and specificity of this test.

lead_sponsor: University Hospital, Strasbourg, France

location_facility:
CHU de Nancy
Hôpitaux Universitaires de Strasbourg
CHU de Besançon


title: The Occlusive Dressing: a Comparative Randomized Trial on 2 Procedures of Treatment of Fingertips Traumatic Amputations

summary: Fingers amputations are very common injuries among the patients arriving at the Emergency Department. Fingertips amputations classified in 2nd and 3rd zones, in accordance with Rosenthal's classification (after the solum unguis), constitute a large proportion of them. The treatment aims at restoring a pulp with its sensitivity and a good subcutaneous fat tissue. The usual care of these amputations is a surgical treatment: it consists of pulp reconstruction by a flap (for example palmar V-Y advancement flaps of Atazoy). These technique involve hospital admission, brachial plexus anaesthesia, a surgical approach with cicatrix and donor site morbidities, postoperative cares, post-surgical pain management. And of course attention must be paid to the risks of postoperative complications related either to anaesthesia and/or to surgery, like necrosis, infection, and others. We have developed a nonoperative treatment for fingertips amputations: the occlusive dressing. It's a technique that has been known for about twenty years, and that is currently developed by the teams SOS main of Professor Liverneaux in Strasbourg and of Professor Obert in Besançon. It consists of the occlusive application of two Tegaderm®, a plastic dressing. Then the finger macerates in an anaerobic medium, and could develop an uncomfortable smell induced by maceration process. The first results described by the preclinical studies of these two groups look satisfying on both the functional aspect (sensibility) and the aesthetic component (preservation of the finger length and curve), as well as for healing that occurs without infection. Moreover, the length of the treatment is of about only three or four weeks, and its cost is very low by comparison with the cost of the surgery itself. Nevertheless this technique is still not very common, and it has been reported in only five references in the literature [Mennen & Al., Farrell & Al., Lee & Al., Allen & Al., Tago Hiroyuk & Al.]. On the other hand, the mechanism of action and/or the active components of this occlusive dressing have not yet been the objects of extended studies. An explanatory hypothesis is that some anaerobic germs and/or growth factors might play an active role in the process. However, they have not been identified yet. The aim of our study is to validate through clinical and biological criteria this non operative method and to compare with surgical treatment. The study will be held in the Hand Department of the University Hospital of Strasbourg, under the direction of the Pr Liverneaux. It will imply the collaboration of the laboratory of medical bacteriology directed by Pr Piemont, and the research department of INSERM (Parogène laboratory) will focus on the biochemistry. From a clinical point of view, a certain number of objective functional criteria will be measured: the pain will be evaluated by a visual analogic scale and the DN4 scale; the functional disability will be measured with the french version of the Disability Arm Shoulder Hand of Dubert; the pulpar 3D volume will be calculated from the numerical pictures with a computerized file, the cutaneous depth will be measured by 3D U.S; the tactile sensibility will be tested by standardized monofilaments and Weber's test and the dermatoglyphics of both handsides will be compared. In addition, the subjective feeling of the patients will be recorded through a visual and analogical scale of satisfaction. The purpose of the biological component of the study will be to put into light and to identify the components that are active in the process. This will be performed by the direct examination and by bacteriological cultures, and will look for the anaerobic, aerobic germs and the yeasts.The biochemical studies will first include a non specific search of growth factors, cytokines and interleukins. In a second step, specific researches will be undertaken if necessary in accordance with the results of the first investigations. By this study, the investigators would like to scientifically confirm the efficiency of this method with objective as well as subjective criteria, and to identify the underlying biomechanisms of the process.

status: Terminated


title: Study of a National Cohort of Adult Patients With Phenylketonuria

acronym: ECOPHEN

summary: Phenylketonuria (PKU) is a metabolic disease of genetic origin. This is a rare disease (incidence 1 / 16000 births) which is the subject of a systematic neonatal screening in France, because it is treatable by a diet low in phenylalanine. This plan is required upon confirmation of diagnosis and continued until the age of 8 years. The current trend is to continue the scheme at least until adolescence. Unlike other countries, in France there are no recommendations for a plan "for life". Knowledge about the natural history of PKU in adulthood, the effects of pediatric age, the frequency of complicated shapes, and prognostic factors are poorly documented. On the other hand, there is no consensus on the therapeutic management of this disease in adulthood and monitoring that could be directed towards the detection of neurological disorders and nutrition. Social integration and quality of life of adults PKU patients living in France have not been studied.

lead_sponsor: University Hospital, Tours

location_facility: CHU de Grenoble-Hôpital MICHALLON-Unité de Neurologie Générale

location_facility: CHU de St Etienne-Hôpital Nord-Service de Pédiatrie

location_facility: APHM-Hôpital de la Conception -Médecine Interne

location_facility: CHRU-Hôpital Bretonneau - Service de Médecine Interne-Nutrition

location_facility: CHU de Dijon--Hôpital des Enfants-Centre de Génétique

location_facility: CHU_Service de Médecine Interne Nutrition A2-Hôpital du Haut Levèque

location_facility: CHU de LILLE-Hôpital Claude HURIEZ-Service d'Endocrinologie

location_facility: CHU-Service de Réanimation Pédiatrique / Néonatalogie, Consultation spécialisée en Maladies Héréditaires du Métabolisme

location_facility: CHU-Toulouse-Hôpital PURPAN-Service de Médecine Interne

location_facility: CHU du Morvan-Département de Pédiatrie et génétique médicale,

location_facility: Hôpital Necker Enfants Malades, APHP-Maladies Métaboliques -Service de Pédiatrie

location_facility: Hôpital Femme-Mère-Enfant-Centre de Référence des Maladies Héréditaires du Métabolisme de Lyon

location_facility: CHU-RENNES-Hôpital Sud-Service de Génétique-Clinique


title: Multicentre, Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Investigate the Efficacy of Sodium Hyaluronate in Patients With Symptomatic Hip Osteoarthritis

summary:
To demonstrate the difference in terms of symptomatic efficacy between ADANT® sodium hyaluronate and placebo following an intra-articular injection in patients with symptomatic osteoarthritis of the hip.

Each patient will receive an injection of sodium hyaluronate or placebo in the symptomatic hip and will be followed up for three months.

At the third month, if the score for overall pain is still > 40 mm on the VAS, a second injection of ADANT® can be given irrespective of which treatment was received previously. The patient will be followed up for a further 3 months in an open-label fashion (monthly visits).

ReferenceCitation: Richette P, Ravaud P, Conrozier T, Euller-Ziegler L, Mazières B, Maugars Y, Mulleman D, Clerson P, Chevalier X. Effect of hyaluronic acid in symptomatic hip osteoarthritis: a multicenter, randomized, placebo-controlled trial. Arthritis Rheum. 2009 Mar;60(3):824-30. doi: 10.1002/art.24301.

lead_sponsor: Daiichi Sankyo, Inc.


title: Prognostic Impact of Neopterin on Resumption of Walking After a Fracture of the Upper Neck of the Femur in the Elderly

acronym: MAMI

summary: Society faces a major challenge with the management of the health and socio-economic burden caused by acute physical stress in the older population (>75 years). In particular, hip fracture (HF) represents a major health care preoccupation, affecting 1.6 M patients worldwide, resulting in a significant drop of life quality and autonomy. Nowadays, this trauma is still associated with a poor outcome of 20-30% one-year mortality in the elderly. This emphasizes the value of assessing biological factors that may predict clinical outcome after HF. The preliminary work pinpoints a central role of neopterin in loss of autonomy and death. Using HF as an acute stress model that accelerates the progressive course of aging, the aim is to validate neopterin as a predictive biomarker of pernicious clinical outcomes.

location_facility: GH Pitié-Salpêtrière / Service de gériatrie


title: Exploring the Potential of Novel Biomarkers Based on Plasma microRNAs for a Better Management of Pelvic Gynecologic Tumors

acronym: GYNO-MIR

summary:
This trial is a non-randomized, open label and multicenter study.

It aims to :

for endometrial cancer.:validate the 5-miR index assessed in plasma samples as a diagnostic marker to assess the risk of lymph node metastases for ovarian cancer : to validate the previous finding on the prognostic value of the pre-/post-treatment variation of miR200b plasma concentrations with regards to PFS (the investigators mean the primary treatment including up-front or post-chemotherapy debulking and adjuvant chemotherapy).

status: Active, not recruiting

location_facility: Service de chirurgie et oncologie gynécologique et mammaire


title: Dissection of Aorta: Descending Part, Imaging

acronym: DADI

summary: Patients with dissection of the descending aorta will be followed up according to a precise timeline.

location_facility: Pr Guillaume JONDEAU . Cardiologie. Hôpital Bichat

intervention_type: Radiation


title: PREMALDO : Aldosterone Resistance in Preterm Infants : Assessment by a Non Invasive Measurement of Urinary Aldosterone

acronym: PREMALDO

summary: In the neonatal period, the human kidney is characterized by a functional immaturity responsible for an impaired ability to regulate water and sodium homeostasis, which is exacerbated by prematurity. This altered sodium handling could be related to a partial renal aldosterone resistance. Renal sodium reabsorption and potassium excretion are mainly controlled by aldosterone, after binding to the mineralocorticoid receptor (MR). The investigators have analyzed MR expression throughout human and mouse renal development, and the investigators found a weak MR expression at birth. The investigators have conducted a pilot study in full-term newborns, which confirmed a partial neonatal aldosterone resistance. This study also highlighted that urinary aldosterone is the best index to accurately assess aldosterone sensitivity at birth.

ReferenceCitation: Martinerie L, Viengchareun S, Delezoide AL, Jaubert F, Sinico M, Prevot S, Boileau P, Meduri G, Lombès M. Low renal mineralocorticoid receptor expression at birth contributes to partial aldosterone resistance in neonates. Endocrinology. 2009 Sep;150(9):4414-24. doi: 10.1210/en.2008-1498. Epub 2009 May 28.

ReferenceCitation: Martinerie L, Pussard E, Yousef N, Cosson C, Lema I, Husseini K, Mur S, Lombès M, Boileau P. Aldosterone-Signaling Defect Exacerbates Sodium Wasting in Very Preterm Neonates: The Premaldo Study. J Clin Endocrinol Metab. 2015 Nov;100(11):4074-81. doi: 10.1210/jc.2015-2272. Epub 2015 Sep 8.

location_facility: Assistance Publique- Hôpitaux de Paris: Antoine Beclere Hospital


title: Comparison Between Myocardial Tomoscintigraphies Using a Semiconductor Camera or a Conventional Camera According to Conditions of Examination Execution: Assessment of Infarction or Ischemia, Injected Dye and Sequence of Injections

acronym: DSPECT

summary:
Myocardial perfusion tomoscintigraphy is a routine medicine procedure to check for the presence and severity of abnormalities of myocardial perfusion, as well as the extension of infarction residua. However, actual imagery devices (gamma cameras) have low resolution and detection sensitivity. A new semiconductor camera has 8 to 10 time higher detection sensitivity and could allow proportionally diminishing injected activities or recording times. Only one pilot study has been recently published on this type of camera, the D.SPECT camera.

This study will compare images recorded during 15 to 20 minutes by conventional cameras and 2 to 4 minutes by D.SPECT camera in patients doing tomoscintigraphy under usual conditions. The purpose is to demonstrate the equivalence of images recorded by two camera types for diagnostic information and the secondary purpose is to demonstrate the superiority of the D.SPECT camera in terms of image quality.

location_facility: Service de Médecine Nucléaire, Clinique Louis Pasteur

location_facility: Service de Médecine Nucléaire, Hôpital de Bichat, Assistance Publique des Hôpitaux de Paris

location_facility: Service de Médecine Nucléaire, Hôpital de Brabois, CHU de Nancy


title: Prospective Cohort With Clinic-biologic Database of Patients Treated by Immunotherapy

summary: ImmuCCo-1905 is a monocentric interventional study on patients treated by immunotherapy, which consist in establishment of a prospective clinic-biologic database over 5 years, associated with a biobank. This database will allow carrying out works aiming at assessing immunotherapy in real life situation.

lead_sponsor: Centre Oscar Lambret


title: Study of Sensory-motor Cortex Plasticity After Motor Cortex Stimulation in Healthy Subject and Chronic Pain Patients

summary:
The primary aim of this study is to evaluate the induction of sensory-motor cortex plasticity after motor cortex stimulation in healthy subjects, using laser-evoked nociceptive cortical potentials, and in chronic neuropathic pain patients using functional MRI. As a secondary goal, the project will analyse possible correlations between the magnitude of cortical plasticity and that of the pain-relieving effect.

In healthy subjects, cortical plasticity is evaluated by the comparison of somatosensory cortical maps before and after two isolated sessions of 20 Hz and theta-burst rTMS, in a cross-over randomized study.

Two sessions of 5 consecutive days of rTMS are proposed to the patients with a minimum of 4 weeks between the two sessions, defined by 20 Hz and theta-burst stimulation in a cross-over randomized order. Cortical plasticity of the motor cortex is evaluated via functional MRI (motor activation) performed before the first rTMS session and the last day of each session of rTMS.

location_facility: Service d'Exploration, Centre Hospitalier Lyon Est, Hospices civils de Lyon, Lyon, F-69495, France et NeuroPain lab - CRNL (Inserm U1028 - UCBL)


title: Crucial Areas on Atrial Fibrillation Termination by Substrate Ablation: Relevance to Anatomy

summary:
Recent data has demonstrated that focal sources are determinant in human atrial fibrillation (AF) perpetuation.

The investigators sought to identify crucial areas for AF perpetuation during our routine electrogram (EGM)-based substrate ablation.

lead_sponsor: Hospital St. Joseph, Marseille, France

location_country:
France
United Kingdom

location_facility:
Hopital Saint Joseph
Hôpital Privé Jacques Cartier;
Morphology Unit Royal Brompton Hospital
Institut Mutualiste Montsouris;


title: Diagnostic and Prognostic Value of p16INK4a Expression in Low Grade Squamous Intraepithelial Lesions of the Cervix. Immunohistochemical Study on Biopsies (Retrospective and Prospective Analysis) and on Liquid Based (SurePath) Cervical Cytology (Prospective Analysis). Correlation With HPV Typing and Clinical Outcome.

summary: P16INK4a has recently been described as a surrogate marker for HR-HPV associated squamous and glandular intraepithelial lesions of the cervix. The immunohistochemical staining pattern of p16INK4a in high grade intraepithelial neoplasia of the cervix (CIN 2 and 3) is diffuse, whereas in CIN 1 different staining patterns (diffuse, sporadic, focal or negative) can be seen. The aim of our study is to find out whether the p16INK4a staining pattern of CIN 1 is able to predict the outcome of the lesion. The retrospective part of the study includes cervical biopsies of 200 patients with CIN 1 and clinical follow-up for at least 5 years. p16INK4a staining and HPV detection by IHC will be correlated to clinical outcome.The prospective part of the study includes 300 patients with CIN 1 and LSIL on cytology. HPV detection by HCII and p16INK4a immunohistochemistry on liquid based cytology samples as well as p16INK4a staining and HPV detection by ISH on colposcopy guided biopsies will be correlated to clinical follow-up and colposcopy findings. Slides are analysed by 2 pathologists without knowledge of clinical data.

location_facility: Service de gynécologie-obtétrique - Centre Hospitalier Général

location_facility: Département de Gynécologie-Obstétrique - Hôpital de Hautepierre

location_facility: Service de Gynécologie-Obstétrique - Centre Hospitalier Général


title: Validity of Non-invasive Liver Fibrosis Assessment by Ultrasound-based Elastography at the Third Trimester of Pregnancy: a Prospective Study

summary: Non invasive methods are the only available methods to stage liver fibrosis during pregnancy. The safety of elastometry - ultrasound based - is obvious, as medical supervision of pregnancy is based on ultrasonography, both methods using same wavelengths. Therefore, this method is sometimes used in pregnant women with recent diagnosis of chronic viral hepatitis infection, whereas its validity in pregnant women has never been studied. This lack of data justifies our study.

status: Suspended

lead_sponsor: Hopital Lariboisière


title: Modification of the Expression of ADARs and PDE8A Editing in Suicidal Behavior

summary:
Suicidal behavior (SB) is a major public health problem in France, with more than 10,000 suicides and 220,000 suicide attempts per year.

According to the commonly accepted model for understanding suicidal behavior, individuals who carry a suicidal act when subjected to stress factors (environmental stress, depression, substance ...) are those which have a specific vulnerability.

These vulnerabilities can be considered as clinical parameters (propensity to despair, aggressive and/or impulsive traits), neurobiological parameters (dysfunction of the serotonergic system, ...) and cognitive parameters (taking disadvantageous decision ...). Suicidal vulnerability is partly underpinned by genetic factors. The interest of current researches is to identify biomarkers that will improve the opportunities for early identification of subject with a risk for SB. Numerous scientific studies, including post-mortem studies of the brains of suicide completers, have established a link between dysregulation of the ribonucleic acids editing (RNA) of certain genes, the enzymatic activity of Adenosine deaminases acting on RNA (ADARS) responsible for this edition and suicidal behavior. A prospective study is needed to quantify and qualify in the blood of depressed patients (with or without a history of suicide) and healthy controls, the editing changes and the expression and alteration of the activity of ADARS.


title: Baseline Characteristics, Processes of Care, System-related Factors, and Clinical Outcomes Associated With the Quality and Safety of Initial Management for ST-segment Elevation Myocardial Infarction: A Multicenter Cohort Study

acronym: STEMI-Qual

summary:
This is a multicenter multidisciplinary study designed to investigate patient, provider, and system-related factors that are associated with the quality and safety of initial management for suspected ST-segment elevation myocardial infarction (STEMI) evolving for less than 12 hours in daily practice. The primary hypotheses are that delayed reperfusion therapy for suspected STEMI independently relates to provider practice patterns and system barriers. It is further postulated that non-compliance with target delays in implementing percutaneous coronary intervention (PCI) or fibrinolytic therapy is associated with worse in-hospital clinical outcomes. The secondary hypotheses are that the delivery of acute reperfusion therapy within target delays is associated with increased rates of false-positive cardiac catheterization laboratory activation, inadvertent fibrinolytic therapy, and bleeding events.

The project will be conducted in three emergency medical services and 23 public and private (for-profit and non-for-profit) acute care hospitals in Northern Alps in France. Data over the index hospital stay period will be retrospectively collected for all the patients included in an ongoing prospective regional hospital-based clinical registry of suspected STEMI from October, 1st, 2002 to December, 31, 2014. Inclusion of 7435 patients is anticipated.

In this observational retrospective study, no specific intervention is assigned to participants. All diagnostic testing, procedures, and medication ordering are performed at the discretion of attending physicians. No enrollment or follow-up visits are planned.

The primary effectiveness outcome is timely acute reperfusion therapy. The secondary effectiveness outcomes include false-positive cardiac catheterization laboratory activation for catheterization candidates and inadvertent fibrinolytic therapy. The secondary medical outcomes include in-hospital all-cause mortality, major adverse cardiovascular events, and major bleeding events. Multivariable logistic regression model will be developed to identify baseline characteristics that are independently associated with timely acute reperfusion therapy. Propensity score analysis will be performed for comparing clinical outcomes between timely acute reperfusion therapy recipients and non-recipients.

ReferenceCitation: Belle L, Fourny M, Reynaud T, Hammer L, Vanzetto G, Labarère J; RENAU-RESURCOR study investigators. Efficacy and safety of glycoprotein IIb/IIIa receptor antagonists for patients undergoing percutaneous coronary intervention within twelve hours of fibrinolysis. Catheter Cardiovasc Interv. 2011 Sep 1;78(3):376-84. doi: 10.1002/ccd.22825. Epub 2011 Mar 16.

ReferenceCitation: Belle L, Labarère J, Fourny M, Drouet E, Mulak G, Dujardin JJ, Vilarem D, Bonnet P, Hanssen M, Simon T, Ferrières J, Danchin N; French registry of Acute ST elevation or non-ST-elevation Myocardial Infarction study investigators. Quality of care for myocardial infarction at academic and nonacademic hospitals. Am J Med. 2012 Apr;125(4):365-73. doi: 10.1016/j.amjmed.2011.11.015.

ReferenceCitation: Belle L, Motreff P, Mangin L, Rangé G, Marcaggi X, Marie A, Ferrier N, Dubreuil O, Zemour G, Souteyrand G, Caussin C, Amabile N, Isaaz K, Dauphin R, Koning R, Robin C, Faurie B, Bonello L, Champin S, Delhaye C, Cuilleret F, Mewton N, Genty C, Viallon M, Bosson JL, Croisille P; MIMI Investigators*. Comparison of Immediate With Delayed Stenting Using the Minimalist Immediate Mechanical Intervention Approach in Acute ST-Segment-Elevation Myocardial Infarction: The MIMI Study. Circ Cardiovasc Interv. 2016 Mar;9(3):e003388. doi: 10.1161/CIRCINTERVENTIONS.115.003388.

ReferenceCitation: Beygui F, Cayla G, Roule V, Roubille F, Delarche N, Silvain J, Van Belle E, Belle L, Galinier M, Motreff P, Cornillet L, Collet JP, Furber A, Goldstein P, Ecollan P, Legallois D, Lebon A, Rousseau H, Machecourt J, Zannad F, Vicaut E, Montalescot G; ALBATROSS Investigators. Early Aldosterone Blockade in Acute Myocardial Infarction: The ALBATROSS Randomized Clinical Trial. J Am Coll Cardiol. 2016 Apr 26;67(16):1917-27. doi: 10.1016/j.jacc.2016.02.033.

ReferenceCitation: Fourny M, Lucas AS, Belle L, Debaty G, Casez P, Bouvaist H, François P, Vanzetto G, Labarère J. Inappropriate dispatcher decision for emergency medical service users with acute myocardial infarction. Am J Emerg Med. 2011 Jan;29(1):37-42. doi: 10.1016/j.ajem.2009.07.008. Epub 2010 Mar 9.

ReferenceCitation: Labarère J, Belle L, Fourny M, Vanzetto G, Debaty G, Delgado D, Brallet J, Vallet B, Danchin N; USIC 2000; FAST-MI. Regional system of care for ST-segment elevation myocardial infarction in the Northern Alps: a controlled pre- and postintervention study. Arch Cardiovasc Dis. 2012 Aug-Sep;105(8-9):414-23. Epub 2012 Jul 17.

ReferenceCitation: Labarere J, Belle L, Fourny M, Genès N, Lablanche JM, Blanchard D, Cambou JP, Danchin N; Unité de Soins Intendifs Coronaires 2000 Inverstigators. Outcomes of myocardial infarction in hospitals with percutaneous coronary intervention facilities. Arch Intern Med. 2007 May 14;167(9):913-20.

ReferenceCitation: Raskovalova T, Twerenbold R, Collinson PO, Keller T, Bouvaist H, Folli C, Giavarina D, Lotze U, Eggers KM, Dupuy AM, Chenevier-Gobeaux C, Meune C, Maisel A, Mueller C, Labarère J. Diagnostic accuracy of combined cardiac troponin and copeptin assessment for early rule-out of myocardial infarction: a systematic review and meta-analysis. Eur Heart J Acute Cardiovasc Care. 2014 Mar;3(1):18-27. doi: 10.1177/2048872613514015. Epub 2013 Nov 20. Review.

ReferenceCitation: Yayehd K, Ricard C, Ageron FX, Buscaglia L, Savary D, Audema B, Lacroix D, Barthes M, Joubert P, Gheno G, Belle L; RENAU-RESURCOR study investigators. Role of primary care physicians in treating patients with ST-segment elevation myocardial infarction located in remote areas (from the REseau Nord-Alpin des Urgences [RENAU], Network). Eur Heart J Acute Cardiovasc Care. 2015 Feb;4(1):41-50. doi: 10.1177/2048872614544856. Epub 2014 Jul 29.

lead_sponsor: Centre Hospitalier Annecy Genevois


title: Membrane Shedding During Severe Sepsis and Septic Shock: Pathophysiological and Clinical Relevance

summary: Microparticles (MPs) result from plasma cell membrane remodeling and shedding after cell stimulation or apoptosis. MPs are know recognized as a pool of bioactive messengers with emerging role in pathophysiology of immune and cardiovascular diseases. MPs have been characterized during septic shock and may contribute to dissemination of pro-inflammatory and procoagulant mediators. This is a prospective observational study of circulating MPs and blood coagulation in 100 septic shock patients admitted in 3 tertiary hospitals medical ICU at baseline (D1), D2, D3, D4 and D7.

location_facility: Service Réanimation Médicale et Médecine Hyperbare, CHU

location_facility: Service de Réanimation Médicale, Nouvel Hôpital Civil, Hôpitaux Universitaires


title: Development of a Modified Pediatric Early Warning Score: a French Prospective Multicentre Regional Study.

summary: Children are admitted in intermediate units when the severity requires continuous monitoring. In France, Resources allocated to intermediate units are determined from lists of diagnoses and associated acts to additional budget. A score to assess the severity of illness may be associated with acts to develop an activity indicator easy to use. The investigators have chosen 2 scores to assess severity in intermediate cares : the Paediatric Advanced Warning Score (PAWS) and the Bedside Pediatric Early System Score (PEWS). In France, they have not been validated. The correlation between the severity of children and the associated diagnoses and acts has not been studied. The main objective of this study is to validate these 2 scores. The secondary objective is to determine a simplified activity indicator.

location_facility:
Centre Hospitalier général
Centre Hospitalier Général
Centre hospitalier général


title: Identification of Markers Associated With the Risk of COVID-19 Infection and Symptomatic COVID+ Versus Asymptomatic COVID+ Status Through the Establishment of a Biological Collection During Serological Screening in APHP Professionals

acronym: COVID-HOP

summary:
The objective of the COVID-HOP study is to identify biological and non-biological markers associated to: a positive or negative serology anti SRAS-Cov-2; a positive serology and having presented symptoms or, on the contrary, not having had symptoms; the persistence of immunity or the loss of this immunity over time; the protective nature of the presence of anti SRAS-Cov-2 antibodies.

To answer these questions, a biological collection (serum, plasma, DNA, RNA, mono-nucleated cells and urine) and a collection of detailed clinical data during the serological screening for SARS-CoV-2 of hospital agents (medical and non-medical staff) of the Assistance Publique Hôpitaux de Paris (Paris, France) will be carried out. 4000 professionals in 5 hospitals will be included. As part of the research, the anti SRAS-CoV-2 serology will be monitored 6 months and 12 months after the initial serology. Numerous studies will be carried out from this biological collection and from the database to answer the primary and secondary endpoints.

ipd_sharing: Yes


acronym: HTLP Necker

title: A Phase I/II Study Evaluating the Safety and the Efficacy of Human T Lymphoid Progenitor (HTLP) Injection to Accelerate Immune Reconstitution After Partially HLA Compatible Allogeneic Hematopoietic Stem Cell Transplantation in SCID Patients

source: euctr

location_facility: Unité d'Immunologie Hématologie Rhumatologie Pédiatrique (UIHR),

summary: The purpose of this study is to evaluate the safety and the efficacy of Human T Lymphoid Progenitor (HTLP) injection to accelerate immune reconstitution after partially HLA compatible allogeneic hematopoietic stem cell transplantation in SCID patients.


title: Thalamic LFPs and VIM DBS in Essential Tremor: Correlation, Evolution, and Therapeutic Perspectives

acronym: VIM-CLT

summary: The objective of this study is to characterize through spectral analysis intra-thalamic local field potentials (LFPs) recorded through implanted DBS leads during periods with and without tremor in patients suffering from severe essential tremor.

ReferenceCitation: Barbe MT, Liebhart L, Runge M, Pauls KA, Wojtecki L, Schnitzler A, Allert N, Fink GR, Sturm V, Maarouf M, Timmermann L. Deep brain stimulation in the nucleus ventralis intermedius in patients with essential tremor: habituation of tremor suppression. J Neurol. 2011 Mar;258(3):434-9. doi: 10.1007/s00415-010-5773-3. Epub 2010 Oct 8.

ReferenceCitation: Benabid AL, Pollak P, Louveau A, Henry S, de Rougemont J. Combined (thalamotomy and stimulation) stereotactic surgery of the VIM thalamic nucleus for bilateral Parkinson disease. Appl Neurophysiol. 1987;50(1-6):344-6.

ReferenceCitation: Blomstedt P, Hariz GM, Hariz MI, Koskinen LO. Thalamic deep brain stimulation in the treatment of essential tremor: a long-term follow-up. Br J Neurosurg. 2007 Oct;21(5):504-9.

ReferenceCitation: Brown P, Williams D. Basal ganglia local field potential activity: character and functional significance in the human. Clin Neurophysiol. 2005 Nov;116(11):2510-9. Epub 2005 Jul 18. Review.

ReferenceCitation: Garcia Ruiz P, Muñiz de Igneson J, Lopez Ferro O, Martin C, Magariños Ascone C. Deep brain stimulation holidays in essential tremor. J Neurol. 2001 Aug;248(8):725-6.

ReferenceCitation: Hariz MI, Shamsgovara P, Johansson F, Hariz G, Fodstad H. Tolerance and tremor rebound following long-term chronic thalamic stimulation for Parkinsonian and essential tremor. Stereotact Funct Neurosurg. 1999;72(2-4):208-18.

ReferenceCitation: Limousin P, Speelman JD, Gielen F, Janssens M. Multicentre European study of thalamic stimulation in parkinsonian and essential tremor. J Neurol Neurosurg Psychiatry. 1999 Mar;66(3):289-96.

ReferenceCitation: Schuurman PR, Bosch DA, Bossuyt PM, Bonsel GJ, van Someren EJ, de Bie RM, Merkus MP, Speelman JD. A comparison of continuous thalamic stimulation and thalamotomy for suppression of severe tremor. N Engl J Med. 2000 Feb 17;342(7):461-8.

ReferenceCitation: Stacy MA, Elble RJ, Ondo WG, Wu SC, Hulihan J; TRS study group. Assessment of interrater and intrarater reliability of the Fahn-Tolosa-Marin Tremor Rating Scale in essential tremor. Mov Disord. 2007 Apr 30;22(6):833-8.

ReferenceCitation: Yoshida F, Martinez-Torres I, Pogosyan A, Holl E, Petersen E, Chen CC, Foltynie T, Limousin P, Zrinzo LU, Hariz MI, Brown P. Value of subthalamic nucleus local field potentials recordings in predicting stimulation parameters for deep brain stimulation in Parkinson's disease. J Neurol Neurosurg Psychiatry. 2010 Aug;81(8):885-9. doi: 10.1136/jnnp.2009.190918. Epub 2010 May 12.

lead_sponsor: University Hospital, Bordeaux


summary:
The concept of early rehabilitation (ERAS: enhanced after-surgery recovery) was introduced by Kehlet et al. in 1995, as part of the colon surgery. This program is a support for patients combining laparoscopic surgery, epidural analgesia, early refeeding and rapid mobilization of patients. This strategy targets multiple elements (20 items) to support pre-, intra- and postoperative patients. This reduces the pain and the different organ dysfunction induced by surgical stress significantly decreasing length of hospital stay, postoperative morbidity and costs.

Furthermore, early mobilization of patients is fundamental to the ERAS method. Few studies have analyzed the influence of preoperative exercise on postoperative rehabilitation.

location_facility: Service de Chirurgie Digestive - Hôpital de Hautepierre


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: Critical Limb Ischemia Treatment by Local Intra-Muscular Injection of Autologous Mononuclear Cells

summary: The primary focus of the trial is safety and efficacy of the intra-muscular implantation of either bone-marrow, or peripheral blood mononuclear cells, in critical limb ischemia, as judged by the proportion of patients which are alive without major amputation 6 months after inclusion.

ReferenceCitation: Pignon B, Sevestre MA, Chatelain D, Albertini JN, Sevestre H. Histological changes after implantation of autologous bone marrow mononuclear cells for chronic critical limb ischemia. Bone Marrow Transplant. 2007 May;39(10):647-8. Epub 2007 Mar 26.

ReferenceCitation: Al-Rifai R, Nguyen P, Bouland N, Terryn C, Kanagaratnam L, Poitevin G, François C, Boisson-Vidal C, Sevestre MA, Tournois C. In vivo efficacy of endothelial growth medium stimulated mesenchymal stem cells derived from patients with critical limb ischemia. J Transl Med. 2019 Aug 9;17(1):261. doi: 10.1186/s12967-019-2003-3.

ReferenceCitation: Capiod JC, Tournois C, Vitry F, Sevestre MA, Daliphard S, Reix T, Nguyen P, Lefrère JJ, Pignon B. Characterization and comparison of bone marrow and peripheral blood mononuclear cells used for cellular therapy in critical leg ischaemia: towards a new cellular product. Vox Sang. 2009 Apr;96(3):256-65. doi: 10.1111/j.1423-0410.2008.01138.x. Epub 2008 Dec 15.

lead_sponsor: CHU de Reims


title: Acceptability of a Strategy Including Acupuncture in the Treatment of MusculoSkeletal Pain in Hospitalised Elderly

acronym: ACUPUNCTURE

summary: The aim is to investigate the feasibility and efficacy of an acupuncture intervention on persistent MusculoSkeletar pain in a long-term geriatric hospital care ward population. The main issue is the acceptability of this type of complementary and alternative medicine in older people, although the efficacy on pain is assessed too.

ReferenceCitation: Couilliot MF, Darees V, Delahaye G, Ercolano P, Carcaillé M, Vytopilova P, Tenenbaum B, Vicaut E. Acceptability of an acupuncture intervention for geriatric chronic pain: an open pilot study. J Integr Med. 2013 Jan;11(1):26-31. doi: 10.3736/jintegrmed2013005.

location_facility: HOPITAL RENE MURET BIGOTTINI - Dpt Interhosp. Santé Pub.


title: Superior Colliculus Activity in Parkinson Disease: a Potential Marker? fMRI Brain Activation in Response to Visual Stimuli.

acronym: AGIRPARK

summary:
The ultimate goal of this project is to evaluate a possible new strategy to diagnose earlier Parkinson's disease, using the superior colliculus as a biomarker.

Preliminary data from the investigator's group in a rat model of Parkinson's disease suggest that the superior colliculus, a sensory structure, show an early deficit in visual processing. The investigator's data also suggests that with the evolution of the disease, this structure presents a neuronal re-organisation leading which causes a sensory rebound after the introduction of the treatment. The light responses in the superior colliculus were faster, bigger in amplitude and lasted longer (Rolland et al., 2012). Those results raise an important question about the superior colliculus functional state in Parkinson's patients. If this structure have a similar neuroplasticity, the investigators could hypothesize that the superior colliculus may also present a sensory rebound when introducing the treatment. If this hypothesis is true, the accelerated and amplified light responses of this structure may explain the difficulties felt by the patients to inhibit reflexive saccades induced by the appearance of unexpected visual stimuli. Indeed, the superior colliculus is involved in the orientation of the head and eye toward any sudden changes in our environment (Wurtz and Albano, 1980) and the light responses of this structure are strongly correlated with the speed of the saccade (Marino et al., 2012).

Therefore, the investigators want to test if a similar deficit could be observed in the superior colliculus of newly diagnosed PD patients. Data will be compared to matching controls.

ReferenceCitation: Marino RA, Levy R, Boehnke S, White BJ, Itti L, Munoz DP. Linking visual response properties in the superior colliculus to saccade behavior. Eur J Neurosci. 2012 Jun;35(11):1738-52. doi: 10.1111/j.1460-9568.2012.08079.x. Epub 2012 May 28.

ReferenceCitation: Wurtz RH, Albano JE. Visual-motor function of the primate superior colliculus. Annu Rev Neurosci. 1980;3:189-226. Review.

ReferenceCitation: Rolland M, Carcenac C, Overton PG, Savasta M, Coizet V. Enhanced visual responses in the superior colliculus and subthalamic nucleus in an animal model of Parkinson's disease. Neuroscience. 2013 Nov 12;252:277-88. doi: 10.1016/j.neuroscience.2013.07.047. Epub 2013 Jul 31.

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

location_facility:
IRMAGE
Grenoble Institute of Neurosciences
CHU de Grenoble


title: LUMIERE on the FETUS : A Study on the Added Value of Fetal MRI

acronym: FETUS

summary: Congenital anomalies are a major public health problem. They affect 2-3% of births, around 20,000 new cases per year in France, of which 15% are cared for in Ile de France. These congenital anomalies are a major cause of morbidity, infant mortality and disability. They are also a major cause of death during the infant period (22% of deaths during the first year of life: source CépiDC Inserm 2010). The detection, accurate diagnosis and accurate prognosis, particularly functional, of these congenital anomalies are still difficult in the current monitoring of pregnancy, which is based primarily on ultrasound. The use and development of modern imaging techniques is now essential to enable doctors to better see and better examine the fetus. Alongside ultrasound, Magnetic Resonance Imaging (MRI) is a technique that has undergone significant development in recent years. MRI must allow the effective anatomical and functional evaluation of the main fetal organs and could in particular be interesting in several situations in which it has not yet been sufficiently evaluated and is not yet performed in clinical routine.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


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.

lead_sponsor: Hospices Civils de Lyon

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


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.

ReferenceCitation: Viviand C, Pietretti E, Luc A, Herbain D, Baka N, Morel O, Feugeas J, Aron C, Bouaziz H, Guerci P, Vial F. Continuous wound infusion combined with intrathecal morphine for analgesia after Cesarean delivery compared with intrathecal morphine or continuous wound infusion alone. Can J Anaesth. 2022 Jun;69(6):788-789. doi: 10.1007/s12630-022-02223-2. Epub 2022 Mar 10.


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.

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.


title: Impact of Adrenoreceptor Expressions on Inflammatory Pattern in Refractory Cardiogenic Shock Patients Treated by Veno-arterial Extra-Corporeal Membrane Oxygenation

acronym: ADRECMO

summary: Refractory cardiogenic shock is characterized by a decreased in cardiac output with hypo-responsiveness to increasing doses of catecholamines resulting in a profound tissular ischemia. VAECMO, by restoring a circulatory flow, could be associated to a major reperfusion syndrome which may lead some patients to multiple organ failures and death. Pathophysiology of this syndrome includes 1/an hyper-adrenergic state secondary to the over activation of the sympathetic system and 2/ a major release of pro-inflammatory cytokines. As adrenoreceptors are also exhibited on immunes cells, the pro-inflammatory state might be enhanced by the over-activation of the sympathetic system.

intervention_type: Diagnostic Test


title: Generation of Clinical Grade Adenovirus Specific T Cells for Adoptive Immunotherapy After Allogeneic Stem Cell Transplantation : Clinical Trial

acronym: CTL-ADV

summary: Fourteen patients will be included for infusion of adenovirus-specific T-cells generated by a clinical grade IFN-γ based immunomagnetic isolation from a leukapheresis from their original donor or a haploidentical donor, in case of Umbilical cord blood transplantation, in the event of refractory ADV infection or disease.

ReferenceCitation: Aïssi-Rothé L, Decot V, Venard V, Jeulin H, Salmon A, Clement L, Kennel A, Mathieu C, Dalle JH, Rauser G, Cambouris C, de Carvalho M, Stoltz JF, Bordigoni P, Bensoussan D. Rapid generation of full clinical-grade human antiadenovirus cytotoxic T cells for adoptive immunotherapy. J Immunother. 2010 May;33(4):414-24. doi: 10.1097/CJI.0b013e3181cc263b.

ReferenceCitation: Feucht J, Opherk K, Lang P, Kayser S, Hartl L, Bethge W, Matthes-Martin S, Bader P, Albert MH, Maecker-Kolhoff B, Greil J, Einsele H, Schlegel PG, Schuster FR, Kremens B, Rossig C, Gruhn B, Handgretinger R, Feuchtinger T. Adoptive T-cell therapy with hexon-specific Th1 cells as a treatment of refractory adenovirus infection after HSCT. Blood. 2015 Mar 19;125(12):1986-94. doi: 10.1182/blood-2014-06-573725. Epub 2015 Jan 23.

ReferenceCitation: Feuchtinger T, Matthes-Martin S, Richard C, Lion T, Fuhrer M, Hamprecht K, Handgretinger R, Peters C, Schuster FR, Beck R, Schumm M, Lotfi R, Jahn G, Lang P. Safe adoptive transfer of virus-specific T-cell immunity for the treatment of systemic adenovirus infection after allogeneic stem cell transplantation. Br J Haematol. 2006 Jul;134(1):64-76.

ReferenceCitation: Qian C, Campidelli A, Wang Y, Cai H, Venard V, Jeulin H, Dalle JH, Pochon C, D'aveni M, Bruno B, Paillard C, Vigouroux S, Jubert C, Ceballos P, Marie-Cardine A, Galambrun C, Cholle C, Clerc Urmes I, Petitpain N, De Carvalho Bittencourt M, Decot V, Reppel L, Salmon A, Clement L, Bensoussan D. Curative or pre-emptive adenovirus-specific T cell transfer from matched unrelated or third party haploidentical donors after HSCT, including UCB transplantations: a successful phase I/II multicenter clinical trial. J Hematol Oncol. 2017 May 8;10(1):102. doi: 10.1186/s13045-017-0469-0.

location_facility: Centre Hospitalier Universitaire de Nancy


title: Study of Biomechanical Parameters of Unloading Braces Used in the Treatment of Knee Osteoarthritis (BIOoSE)

acronym: BIOoSE

summary:
Osteoarthritis is a chronic disease affecting millions of people worldwide, and knee is the second most affected site. Knee osteoarthritis is characterized by knee pain, loss of motion, disability, and muscle weakness, all factors contributing to gait alterations, and impacting greatly the patients quality of life. In the absence of curative treatment, pharmacological and non-pharmacological symptomatic treatments are prescribed to maintain this QoL, and therefore delay surgery to more appropriate window of opportunity later in life.

The aim of the study was to investigate the acute effects of three braces, using different unloading strategies, on gait kinematic and kinetic parameters, as well as pain in patients with medial knee ostoeoarthritis.

lead_sponsor: Thuasne


title: Research of Molecular Markers for Diagnosis and/or Prognosis in Lymph Node Metastasis of Resected Non-small Cell Lung Cancer

summary: This is a prospective study of surgically resected samples and lymph nodes of lung cancer patients. For histopathologically positive lymph nodes from a complete resection, the investigators would like to analyse tumor tissue by allelotyping and comparing these results with those observed in the primary lung tumor to establish a cartography of molecular alteration in resected lung cancer. For non histopathologically positive lymph nodes, the investigators would like to research the presence (or not) of micrometastasis by allele-specific PCR (polymerase chain reaction).

location_facility: Service d'Anatomie Pathologique, Hôpital de Hautepierre

location_facility: Service de Chirurgie Thoracique, Hôpital Civil

location_facility: Laboratoire de Biochimie et de Biologie Moléculaire, Hôpital de Hautepierre

location_facility: Service de Pneumologie, Hôpital de Hautepierre


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.

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: Chételat G, Lutz A, Klimecki O, Frison E, Asselineau J, Schlosser M, Arenaza-Urquijo EM, Mézenge F, Kuhn E, Moulinet I, Touron E, Dautricourt S, André C, Palix C, Ourry V, Felisatti F, Gonneaud J, Landeau B, Rauchs G, Chocat A, Quillard A, Devouge EF, Vuilleumier P, de La Sayette V, Vivien D, Collette F, Poisnel G, Marchant NL; Medit-Ageing Research Group. Effect of an 18-Month Meditation Training on Regional Brain Volume and Perfusion in Older Adults: The Age-Well Randomized Clinical Trial. JAMA Neurol. 2022 Oct 10. doi: 10.1001/jamaneurol.2022.3185. [Epub ahead of print]

ReferenceCitation: Demnitz-King H, Gonneaud J, Klimecki OM, Chocat A, Collette F, Dautricourt S, Jessen F, Krolak-Salmon P, Lutz A, Morse RM, Molinuevo JL, Poisnel G, Touron E, Wirth M, Walker Z, Chételat G, Marchant NL; Medit-Ageing Research Group. Association of Self-reflection With Cognition and Brain Health in Cognitively Unimpaired Older Adults. Neurology. 2022 Sep 27;99(13):e1422-e1431. doi: 10.1212/WNL.0000000000200951. Epub 2022 Jul 19.

ReferenceCitation: Felisatti F, Gonneaud J, Palix C, Garnier-Crussard A, Mézenge F, Landeau B, Chocat A, Quillard A, Ferrand-Devouge E, de La Sayette V, Vivien D, Chételat G, Poisnel G; Medit-Ageing Research Group. Role of Cardiovascular Risk Factors on the Association Between Physical Activity and Brain Integrity Markers in Older Adults. Neurology. 2022 May 17;98(20):e2023-e2035. doi: 10.1212/WNL.0000000000200270. Epub 2022 Apr 13.

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.

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.