title: Exploring the Use of the Cognitive Orientation to Daily Occupational Performance Approach (CO-OP) With Children, Teenagers and Young Adults With Executive Functions Deficits Following Severe Acquired Brain Injury

acronym: REFECO-OP

summary:
Acquired brain injury (ABI) in childhood are the cause of disabling motor, cognitive and behavioural disorders, with severe consequences on the later development of autonomy and learning, with long-term repercussions on independence for activities of daily living, and social and professional integration.

Among cognitive disorders, executive function (EF) deficits are among the most frequent and disabling, with major consequences on the development of autonomy and the course of schooling and learning.

The Cognitive Orientation to daily Occupational Performance (CO-OP) could be an interesting approach for the rehabilitation of these consequences. CO-OP is a performance-based treatment approach for children and adults who experience difficulties performing the skills they want to, need to or are expected to perform. CO-OP is a specifically tailored, active client-centered approach that engages the individual at the meta-cognitive level to solve performance problems. Focused on enabling success, the CO-OP approach employs collaborative goal setting, dynamic performance analysis, cognitive strategy use, guided discovery, and enabling principles.

It has been shown to be effective in a variety of populations, but has been little explored in children with ABI. The hypothesis that CO-OP is effective in improving the occupational performance and executive functioning of these children on a daily basis is emerging, but needs to be confirmed. This study falls within this framework.

Primary objective:

To measure the distance maintenance of the knowledge acquired through rehabilitation, as well as the generalization and transfer into everyday life.

Maintenance of acquired knowledge
Generalization and transfer
Impact of a consolidation session on generalization and transfer

Secondary objectives:

Gather the experience of family members/caregivers in accompanying their child in the CO-OP process outside of rehabilitation sessions.
Establish the parental educational style and identify whether there is a link between the parental educational style and the commitment of the family members/caregivers.

ReferenceCitation: Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15.

ReferenceCitation: Krasny-Pacini A, Hiebel J, Pauly F, Godon S, Chevignard M. Goal attainment scaling in rehabilitation: a literature-based update. Ann Phys Rehabil Med. 2013 Apr;56(3):212-30. doi: 10.1016/j.rehab.2013.02.002. Epub 2013 Feb 28.

ReferenceCitation: Scammell EM, Bates SV, Houldin A, Polatajko HJ. The Cognitive Orientation to daily Occupational Performance (CO-OP): A scoping review. Can J Occup Ther. 2016 Oct;83(4):216-225. doi: 10.1177/0008417416651277. Epub 2016 Jun 14.

ipd_sharing_description: We think it would be interesting to share the IPD with other researchers (especially Canadian researchers), but we have not yet defined the terms of this sharing.

lead_sponsor: Hopitaux de Saint-Maurice

location_facility: Centre Médical et Pédagogique pour Adolescents

nom_etablissement: LES HOPITAUX DE SAINT-MAURICE

type_etablissement: EPSM

acronyme: REFECO-OP

titre: Rééducation expérimentale des troubles des fonctions exécutives chez l'enfant cérébro-lésé avec l'approche CO-OP (Cognitive Orientation to daily Occupational Performance).

discipline_principale: médecine physique et réadaptation

nom_porteur: LEBRAULT

prenom_porteur: Hélène


title: Impact of Physical Activity Intervention on Myocardial Function in Patients With HER2 + Breast Cancer, During Treatment With Trastuzumab in Adjuvant

acronym: CARDAPAC

summary: Purpose of the study is to examine the effects of 3 months of physical activity intervention on myocardial function (Left ventricular ejection fraction) in patients with HER2+ breast cancer

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Jacquinot Q, Meneveau N, Falcoz A, Bouhaddi M, Roux P, Degano B, Chatot M, Curtit E, Mansi L, Paillard MJ, Bazan F, Chaigneau L, Dobi E, Meynard G, Vernerey D, Pivot X, Mougin F. Cardiotoxicity is mitigated after a supervised exercise program in HER2-positive breast cancer undergoing adjuvant trastuzumab. Front Cardiovasc Med. 2022 Sep 23;9:1000846. doi: 10.3389/fcvm.2022.1000846. eCollection 2022.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Frontiers

ReferenceCitation: Jacquinot Q, Meneveau N, Chatot M, Bonnetain F, Degano B, Bouhaddi M, Dumoulin G, Vernerey D, Pivot X, Mougin F. A phase 2 randomized trial to evaluate the impact of a supervised exercise program on cardiotoxicity at 3 months in patients with HER2 overexpressing breast cancer undergoing adjuvant treatment by trastuzumab: design of the CARDAPAC study. BMC Cancer. 2017 Jun 19;17(1):425. doi: 10.1186/s12885-017-3420-4.

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

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: Springer-Nature

lead_sponsor: University of Franche-Comté

collaborators: Centre Hospitalier Universitaire de Besancon

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Unknown


type: Other Identifier

title: The Needs and Burden of Family Caregivers of Older Adults With Cancer and Their Social Determinants

summary:
Elderly cancer patients need more help from their relatives and for longer than young adults.

Our hypothesis of research is that the needs and resources to help the couple " elderly patient/caregiver ", are at least in part socially determined and that the implementation of a personalized support plan to help the caregiver (PSP) taking into account needs, resources and expectations of the primary caregiver in addition to those of elderly patients with cancer may partly correct inequalities. The PSP should allow a better management of cancer, a lesser burden for the caregiver and a better quality of life for both the caregiver and the patient.

study_start_date_type: Actual

primary_purpose: Other

ipd_sharing: Undecided

lead_sponsor: University Hospital, Lille

sponsor_collaborators:
University Hospital, Lille
Centre Oscar Lambret
University of Lille Nord de France
National Cancer Institute, France

location_facility:
Centre Oscar Lambret
University hospital, Lille


title: EEG Analysis for the Objective Assessment of Secondary Hypersomnolence in Order to Limit the Accidental Risk

acronym: MEEGASAFE

summary: The objective of this clinical study is to develop solutions for the evaluation and management of drowsiness, based on 2 EEG sensors only, aiming at reducing the risk of accidents related to secondary hypersomnolence (sleepiness induced by sleep restriction or abnormal sleep/wake cycle). This project will allow a better understanding of the determinants of drowsiness and its impact on cognitive performance and the development of methods and models for the evaluation and prediction of cognitive performance deficit related to sleepiness. The secondary hypersomnolence will be objectified by continuous EEG recording and analysed by visual reading according to Objective Sleepiness Scale (OSS) criteria and automatically analyzed using the MEEGAWAKE algorithm (developed by PHYSIP). The level of secondary hypersomnolence will be modified by varying the duration and maintening of prior sleep or the sleep timing. The ability to stay awake will be measured by the maintenance of wakefulness test (MWT). Subjective sleepiness and mind wandering will be measured before and/or after all measurements. Simulated driving task, maintenance of wakefulness tests and several cognitive tasks to measure sustained attention, alertness, selective attention will be performed every 4 hours.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

primary_purpose: Basic Science

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Physip S.A

sponsor_collaborators:
Physip S.A
University of Bordeaux
National Research Agency, France

intervention_type: Behavioral

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A proSpective Randomized Controlled Trial comParing infliximAb-antimetabolites Combination Therapy to Anti-metabolites monotheRapy and Infliximab monothErapy in Crohn's Disease Patients in Sustained Steroid-free Remission on Combination Therapy

acronym: SPARE

summary:
Phase IV

Design : Prospective, open-label, randomized three-arms study

Main Inclusion criteria Luminal Crohn's disease patients with steroid free remission for at least 6 months and a combination therapy with infliximab and anti-metabolites for at least 8 months

Primary objective To demonstrate that Infliximab scheduled maintenance with or without antimetabolites is superior to antimetabolites alone to maintain sustained steroid-free remission over 2 years, while the latter is non inferior with regards to the mean time spent in remission over the same duration

Main co-primary end points Clinical relapse rate at 2 years Mean remission duration within 2 years Study treatment Infliximab, Mercaptopurine, azathioprine, methotrexate.

Number of subjects 225 randomized patients (75 per arm)

Study duration: 3 + 2 years Enrollment: 3 years Follow-up: 2 years

status: Completed

primary_purpose: Treatment

ReferenceCitation: Hirten RP, Lakatos PL, Halfvarson J, Colombel JF. Reply. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1301-1302. doi: 10.1016/j.cgh.2020.07.061. Epub 2020 Nov 26. No abstract available.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_country: Australia Belgium France

location_facility:
Chu Saint Etienne
Hopital Saint Joseph
Hopital Beaujon
Montsouris Mutualist Institute
Chu Nancy
Chu Rennes
St Vincent Hospital
Chu Nantes
CHU LYON
CHU LIEGE - Sart Tilman
Chu Clermont-Ferrand
CHU Bordeaux - Pessac
CHU NICE
Chu Amiens
Chu Lille
Chu Toulouse
Hopital Bicetre
Chr Valencienne
Gent University Hospital
Chu Besancon
Hopital Saint Louis
Chu Tours
Chu Reims
Chu Montpellier
Caen Unversity Hospital
Chu Kremlin Bicetre
Hopital St Antoine

intervention_type: Drug

status_simplified: Completed


title: A Phase I/II Study Evaluating M1774, an ATR Inhibitor, in Combination With Fulvestrant in Hormone Receptor-positive and HER2-negative, Advanced Breast Cancers, Resistant to CDK4/6 Inhibitor Plus Aromatase Inhibitor-based Endocrine Treatment

acronym: MATRIX

summary: CDK4/6 inhibitor in combination with endocrine treatment is the standard of care in advanced breast cancer (ABC) with expression of hormone receptors and without HER2 overexpression (ER+/HER2-). When patients experience disease progression under this strategy, options of second-line endocrine treatment in combination with other targeted therapies are limited and have failed to improve overall survival to date over endocrine treatment alone. A significant fraction of ER+/HER2- ABC display genetic alterations associated with homologous recombination deficiency (HRD) which may be associated with efficacy of therapeutic targeting DNA damage response (DDR) pathways. Moreover, other molecular alterations associated with replicative stress may be found in ER+/HER2- ABC patients which may also favor antitumor activity of DDR targeting therapeutics. M1774 is a novel orally administered inhibitor of ataxia telangiectasia and rad3-related (ATR), a protein kinase with key activity in DDR pathway. MATRIx is a phase I/II study aiming to determine the recommended phase II dose (RP2D, phase I) as well as efficacy and safety (phase II) of M1774 in combination with fulvestrant in ER+/HER2-ABC patients whose disease has become resistant to aromatase inhibitor plus CDK4/6 inhibitor, and whose tumor displays molecular alterations associated with HRD, oncogenic driver activation and/or replicative stress. Primary endpoints will include: maximum tolerated dose (MTD) of M1774 in combination with fulvestrant (phase I), the clinical benefit rate and toxicity of the combination at RP2D of M1774 in the molecularly selected population (phase II). Baseline, on-treatment and post-treatment blood and tumor tissue samples will be collected for pharmacokinetics and translational analyses including genomic characterization of tumor tissue and ctDNA as well as functional studies focusing on DDR pathways.

lead_sponsor: Institut Paoli-Calmettes

sponsor_collaborators:
Institut Paoli-Calmettes
Merck Sharp & Dohme LLC
National Cancer Institute, France


title: Lung Cancer Screening With Low-dose CT Scan in Women : Implementation Study

acronym: CASCADE

summary:
The purpose of this study is to determine whether reading of low-dose thoracic CT scans can be done by a single general radiologist who has been trained to lung cancer screening, and will evaluate the performance in comparison with double reading by experts.

The study will enroll women between 50 and 74 years old, at risk for lung cancer due to their smoking history.

status: Recruiting

primary_purpose: Diagnostic

lead_sponsor: Assistance Publique - Hôpitaux de Paris

collaborators: Ministère de la Santé et des Solidarités

intervention_type: Procedure


title: A Study of Biological, Pathological and Imagery Markers in the First-line Treatment of Metastatic Clear-cell Renal Cell Carcinoma With Sunitinib BEFORE and AFTER Nephrectomy

acronym: PREINSUT

summary: The aim of this study is to identify and/or validate biomarkers and imaging markers to predict and monitor the activity of a new class of therapeutic agents called antiangiogenics for the treatment of metastatic renal cell carcinoma (mRCC). Suntinib, approved for this indication, will be administred before and after nephrectomy and biomarkers sampling and imaging will be operated to monitor the activity and identify prognostic factors in mRCC.

design_allocation: Non-Randomized

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Pfizer
National Cancer Institute, France


title: Multicentre Clinical Study to Compare the Efficacy and the Tolerance of Cellularised LG002 With the Efficacy and Tolerance of Uncellularised LG002 in the Treatment of Severe Burn Injury

summary:
After severe burn injury, the full-thickness burn areas are excised (in the first week) and then temporarily covered with allograft (cryogenic preserved cadaver skin). This first covering is then replaced with thin skin meshed autograft.

In this study, either the dermal substrates cellularised LG002 or uncellularised LG002 will be grafted, after excision, in symmetrical areas, in replacement of the allografts. Fourteen to twenty one days after this first covering, the dermal substrate will be covered with thin skin meshed autograft.

ReferenceType: background

ReferenceCitation: Berthod F, Saintigny G, Chretien F, Hayek D, Collombel C, Damour O. Optimization of thickness, pore size and mechanical properties of a biomaterial designed for deep burn coverage. Clin Mater. 1994;15(4):259-65. doi: 10.1016/0267-6605(94)90055-8.

ReferenceCitation: Damour O, Gueugniaud PY, Berthin-Maghit M, Rousselle P, Berthod F, Sahuc F, Collombel C. A dermal substrate made of collagen--GAG--chitosan for deep burn coverage: first clinical uses. Clin Mater. 1994;15(4):273-6. doi: 10.1016/0267-6605(94)90057-4.

ReferenceCitation: Coulomb B, Lebreton C, Dubertret L. Influence of human dermal fibroblasts on epidermalization. J Invest Dermatol. 1989 Jan;92(1):122-5. doi: 10.1111/1523-1747.ep13071335.

ReferenceCitation: Berthod F, Hayek D, Damour O, Collombel C. Collagen synthesis by fibroblasts cultured within a collagen sponge. Biomaterials. 1993 Aug;14(10):749-54. doi: 10.1016/0142-9612(93)90039-5.

ReferenceCitation: Froget S, Barthelemy E, Guillot F, Soler C, Coudert MC, Benbunan M, Dosquet C. Wound healing mediator production by human dermal fibroblasts grown within a collagen-GAG matrix for skin repair in humans. Eur Cytokine Netw. 2003 Jan-Mar;14(1):60-4.

ReferenceCitation: Saintigny G, Bonnard M, Damour O, Collombel C. Reconstruction of epidermis on a chitosan cross-linked collagen-GAG lattice: effect of fibroblasts. Acta Derm Venereol. 1993 Jun;73(3):175-80. doi: 10.2340/0001555573175180.

ReferenceCitation: Sher SE, Hull BE, Rosen S, Church D, Friedman L, Bell E. Acceptance of allogeneic fibroblasts in skin equivalent transplants. Transplantation. 1983 Nov;36(5):552-7. doi: 10.1097/00007890-198311000-00015.

ReferenceCitation: Braye FM, Stefani A, Venet E, Pieptu D, Tissot E, Damour O. Grafting of large pieces of human reconstructed skin in a porcine model. Br J Plast Surg. 2001 Sep;54(6):532-8. doi: 10.1054/bjps.2001.3620.

ReferenceCitation: Coulomb B, Friteau L, Baruch J, Guilbaud J, Chretien-Marquet B, Glicenstein J, Lebreton-Decoster C, Bell E, Dubertret L. Advantage of the presence of living dermal fibroblasts within in vitro reconstructed skin for grafting in humans. Plast Reconstr Surg. 1998 Jun;101(7):1891-903. doi: 10.1097/00006534-199806000-00018.

lead_sponsor: Laboratoires Genévrier

collaborators: Hôpital d'Instruction des Armées de Percy

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

location_facility: Hôpital d' Instruction des Armées de Percy, Service des Brûlés


title: Interest of Sentinel Lymph Node Technique in Women With a Multifocal Breast Cancer - IGASSU-0502

summary: The scope of this trial is to assess the Sentinel Lymph Node Technique in Multifocal Breast Cancer

lead_sponsor: Centre Oscar Lambret

location_facility:
Centre Hospitalier Sud Léman Valsérine
Centre Leon Berard
Hôpital Georges PIANTA
Centre Rene Gauducheau
Centre Eugene Marquis
Centre Hospitalier
Centre Oscar Lambret
Institut Gustave Roussy
Clinique de Flandre
Centre Jean Perrin
Centre Georges-Francois LECLERCQ
Centre Claudius Regaud
Hopital Tenon
Centre Paul Papin
Institut Paoli Calmettes
CRLC Val d'Aurelle
Institut Bergonie
Hôpital Lariboisière
Centre Hospitalier Universitaire
Centre Henri Becquerel


type: EudraCT Number

title: Using Reconsolidation Blockade to Treat Trauma Related Disorders After Paris Attacks: an Effectiveness Study

acronym: PARIS-MEM

summary: The purpose of this study is: (1) to examine the effectiveness of reconsolidation blockade as a treatment for trauma-related disorders, (2) to evaluate the feasibility of implementing this new treatment on a large scale in a short delay. This clinical trial as been set up in response to the Paris attacks to increase treatment capacity of the AP-HP (Assistance Publique des Hopitaux de Paris) hospital network.. Reconsolidation blockade will be compared to treatment as usual (TAU), on symptoms reduction after 6 weeks of treatment. In order to measure effectiveness and cost-utility, socioeconomic measures, quality of life and social functioning outcomes will be measured pre- and post-treatment as well as 3 and 12 months after study enrollment.

ReferenceCitation: Mallet C, Chick CF, Maatoug R, Fossati P, Brunet A, Millet B. Memory reconsolidation impairment using the beta-adrenergic receptor blocker propranolol reduces nightmare severity in patients with posttraumatic stress disorder: a preliminary study. J Clin Sleep Med. 2022 Jul 1;18(7):1847-1855. doi: 10.5664/jcsm.10010.

oa_colors: green other

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: American Academy of Sleep Medicine (AASM)

ReferenceCitation: Brunet A, Ayrolles A, Gambotti L, Maatoug R, Estellat C, Descamps M, Girault N, Kalalou K, Abgrall G, Ducrocq F, Vaiva G, Jaafari N, Krebs MO, Castaigne E, Hanafy I, Benoit M, Mouchabac S, Cabie MC, Guillin O, Hodeib F, Durand-Zaleski I, Millet B. Paris MEM: a study protocol for an effectiveness and efficiency trial on the treatment of traumatic stress in France after the 2015-16 terrorist attacks. BMC Psychiatry. 2019 Nov 8;19(1):351. doi: 10.1186/s12888-019-2283-4.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Paris Observatory

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - IN2P3

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

ipd_sharing: Yes

ipd_sharing_description:
Data are available upon reasonable request :

The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
MSD France

location_country: Martinique France

location_facility: Grand Hôpital EST FRANCILIEN - site de Marne-la-Vallée

location_facility: Centre Hospitalier Universitaire de Martinique

location_facility: Grand Hôpital EST FRANCILIEN - site de Meaux


title: Screening for Biomarkers of Cardiovascular and/or Neurological Fragility: A Longitudinal Prospective Cohort Study Based on the Population Under General Anesthesia

acronym: CME

summary:
More accurate and earlier identification of people at risk of cardiovascular disease (CVD) and neurodegenerative diseases (memory, cognition, dementia) through the appropriate use of biomarkers could lead to earlier initiation of preventive therapies and potentially avoid sometimes fatal events and complications.

Biomarkers are useful for determining the risk of disease, but also for establishing a diagnosis.

High inter-individual variability hinders the establishment of general laws that can be- used in predictive medicine.

In addition to the lack of validation, other limitations are the low participation rate in screening campaigns (regardless of disease) and the relative difficulty, accuracy, cost and time taken to perform the measurements.

The perioperative period is a very good time to screen for cardiovascular and neurodegenerative pathologies for several reasons:

Patients come to their anesthesia consultation and to the operating room because they have a direct visible benefit.
the physiological data collected intraoperatively during systematic monitoring are very "rich" and of very good quality because they are not very noisy
The induction of general anesthesia or the onset of locoregional anesthesia and its maintenance represents a strong and reproducible physiological "test" for the cardiovascular and cerebral systems.
The patients are regularly re-examined postoperatively for the follow-up of their pathology and the possible complications are recorded in their file, allowing a short and medium term follow-up.

The project aims to validate a biomarker predictive of cardiovascular complications, the pulse wave velocity, and a biomarker predictive of cognitive disorders, the power of the Alpha wave on the electroencephalogram, from the data usually collected during each anesthesia and during the perioperative period. The objective is to build a predictive model of cardiovascular and neurodegenerative risks, possibly combined, on a survival analysis.

study_type: Observational

time_perspective: Prospective

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
INSERM UMR-942, Paris, France
M3DISIM

location_facility: AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive Care

intervention_type: Diagnostic Test


title: Cerebral Perfusion Variation During Blood Pressure Changes in ICU: Relationship Between Transcranial Doppler, Frontal EEG and Cerebral Oximetry: a Prospective Observational Study

acronym: DELTAPAMREA

summary:
The risk associated with arterial hypotension during anesthesia for intensive care sedation has been demonstrated, but the threshold at which consequences for perfusion of one or more organs appear varies according to the mechanism of hypotension, associated abnormalities (HR, cardiac output and oxygen transport) and the patient's terrain.

Currently, a mean arterial pressure greater than 60 mm Hg (1) and a reduction of less than 30-50% from the value measured before sedation are commonly used to ensure good perfusion of all organs. In intensive care, it is recommended to maintain a MAP between 60 and 70 mmHg and a Cerebral Perfusion Pressure (CPP) > 50 mmHg for neurocompromised patients with Intra Cranial pressure (ICP) measure. Normally, cerebral blood flow is self-regulated, allowing adaptation of cerebral blood flow to oxygen requirements at different levels of high and low blood pressure. However, this protective mechanism may fail for a degree of hypotension that depends on several factors such as the age or vascular status of the patient.

The aim of the study is to measure non-invasively, easily and reliably the variations of cerebral perfusion in patients with or without cardiovascular risk factors during controlled variations performed during routine care to set the blood pressure level within the recommended safety standards during sedation in intensive care unit.

What is the tolerable target BP level for a patient under continuous sedation in the ICU? Is there a simple and non-invasive way to measure the level of cerebral blood flow autoregulation and especially the adequacy of the brain's oxygen requirements?

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
INSERM UMR-942, Paris, France
LMS Polytechnique and M3DISIM, Inria


title: Non-invasive Measurement of Arterial Stiffness by Pulse Wave Velocity.

acronym: NIVOP

summary: Reducing the risk of perioperative cardiovascular complications is a major issue for anesthesiology practice and research. Carotid-Femoral Pulse Wave Velocity (PWVcf)is a predictive, early and independent biomarker of cardiovascular events. Despite the unanimous support for PWVcf, it has not been widely used in routine clinical practice because of the complexity of the measurement method. Our team has developed a method to estimate PWVcf continuously in the operating room from the data obtained by the usual monitoring: an electrocardiogram (ECG), a digital photoplethysmography (PPG) and an oscillometric brachial sphygmomanometer for non-invasive blood pressure measurement (NIP). The objective of this study is to validate, during anesthesia, the method of estimation of PWV (obtained using the usual monitoring tools including the parameters derived from the SpO2 signal, NIBP and ECG) by comparing it to the reference method by measuring the carotid-femoral transit time obtained by Doppler effect. The measurement of the carotid-femoral transit time obtained by Doppler effect is totally non-invasive.


title: Non Invasive Pressure -Volume Loop (PVLOOP) With 3D Echocardiography and Arterial Tonometry

acronym: LOOPING

summary: In patients under general anesthesia, the prevention of intraoperative hypotension to maintain blood pressure (BP) close to the initial blood pressure, i.e. before anesthesia, is essential to reduce the risk of death and improve surgical outcomes. Vasoactive agents are commonly used to correct this hypotension (Phenylephrine Ephedrine Noradrenaline). These three vasoconstrictors have specific effects on the afterload of the heart and can impair its function. The analysis of the left ventricular pressure-volume curve (PV Loop) allows continuous information on the post-charge state of the left ventricle and the changes induced by the vasoconstrictors to be observed. However, the investigators currently have no way of monitoring these effects. In clinical practice if these loops are obtained non-invasively they can be used in the evaluation of cardiac function of at-risk patients in perioperative and also in intensive care to allow therapeutic adaptation.

status: Unknown status

location_facility: Department of Anesthesiology and Intensive Care, Lariboisière Hospital


title: Multicenter, Randomized, Open Label Study Evaluating an Anti Insulin-like Growth Factor-1 Receptor (IGF-1R/CD221) Monoclonal Antibody, AVE1642, Administered Every 4 Weeks in Combination With Fulvestrant (Faslodex®) in Postmenopausal Patients With Advanced Hormono-dependent Breast Cancer

summary:
The purpose of this study is to evaluate the clinical activity of AVE1642 in combination with fulvestrant and of fulvestrant alone in terms of clinical benefit as the rate of "complete response", "partial response" and "stabilization of the disease".

The additional objectives are to evaluate the safety profile of AVE1642 in combination with fulvestrant and of fulvestrant alone, to assess the rate of patients without disease progression at 6 months and the overall progression-free survival time. An evaluation of the pharmacokinetics and pharmacodynamics interactions between AVE1642 and fulvestrant will also be performed.

The biological activity of treatment will be assessed on tumor biopsies, when possible The potential immunogenicity of AVE1642 will be studied

lead_sponsor: Sanofi

location_country: Italy Spain France


title: Efficacy and Safety of Dornase Alfa Aerosol in ARDS Secondary to SARS-CoV-2 Coronavirus Respiratory Infection - COVID-19

acronym: COVIDORNASE

summary:
This study plans to learn more about the effects of Dornase Alfa in COVID19 (coronavirus disease of 2019) patients, the medical condition caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Dornase Alfa is a FDA-approved drug for the treatment of cystic fibrosis, which facilitates mucus clearance by cutting apart neutrophil-derived extracellular double-stranded DNA. This study intends to define the impact of aerosolized intra-tracheal Dornase Alfa administration on the severity and progression of acute respiratory distress syndrome (ARDS) in COVID-19 patients. This drug might make lung mucus thinner and looser, promoting improved clearance of secretions and reduce extracellular double-stranded DNA-induced hyperinflammation in alveoli, preventing further damage to the lungs.

The study will recruit mechanically ventilated patients hospitalized in ICU who have been diagnosed with COVID-19 and meet ARDS criteria. It is a prospective, randomized, controlled, multicentric, open-label clinical trial.

The goal is to recruit 100 patients.

ReferenceCitation: Desilles JP, Gregoire C, Le Cossec C, Lambert J, Mophawe O, Losser MR, Lambiotte F, Le Tacon S, Cantier M, Engrand N, Trouiller P, Pottecher J. Efficacy and safety of aerosolized intra-tracheal dornase alfa administration in patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS): a structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Jun 19;21(1):548. doi: 10.1186/s13063-020-04488-8.

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild

collaborators: Centre Hospitalier Régional Metz-Thionville


title: Study of the Impact of Two Health Prevention Strategies on Students in the Auvergne-Rhône Alpes Region (I2S-Health Prevention)

summary: Alcohol is the psychoactive substance most experienced by young people. It benefits from positive representations that are reinforced by marketing strategies where advertisers integrate their products into TV series. Our project takes into account the reflexive and impulsive model developed by Strack & Deutsch (2004). We will compare the impulsive intervention to an educational module based on information and reflection that uses the individual's reflexive system with 30 classes in the Loire and Rhône departments. The intervention framework developed uses a modeling system that includes several concepts that work together. These concepts describe the influence of media messages on young people's opinions and behaviours. Given that the objective is to reduce the positive representations of alcohol among young people by means of an educational module based on information and reflection (reflexive model) and a module based on the impulsive system where the para-social connection is involved. The Alcohol Expectancies Scale will be proposed as a judgment criterion and will be administered before and after the intervention.

primary_purpose: Prevention

lead_sponsor: Institut de Cancérologie de la Loire

sponsor_collaborators:
Institut de Cancérologie de la Loire
National Cancer Institute, France

location_country:
United States
France

location_facility: Institut de Cancérologie Lucien Neuwirth


title: Surveillance Des données De l'Autosurveillance glycémique Via Internet Et Le réseau téléphonique GSM Chez Le diabétique De Type 1 Sous Traitement Insulinique Par Pompe Externe : Etude Prospective randomisée PumpNet.

summary: The purpose of this study is to determine if telecare using modern telecommunication devices can improve the metabolic control and the quality of life of type 1 diabetic patients.

lead_sponsor: University Hospital, Grenoble

location_facility: University Hospital, Department of Endocrinology

intervention_type: Device


title: Evaluation of Response to the Neoadjuvant Chemotherapy for Advanced Ovarian Cancer by Multimodal Functional Imaging (Fusion MRI and FDG-PET-CT)

acronym: IMOVA

summary: This study evaluates the therapeutic response by modern FMRI and PET techniques with the perspective to exploit multimodal data (fusion MRI/PET). The Sponsor would like to optimize the respective performances and to define the early assessment criteria, at the first detox, of the treatment efficacy, with and without antiangiogenic agent.

lead_sponsor: Institut Bergonié

sponsor_collaborators:
Institut Bergonié
Roche Pharma AG
Ligue contre le cancer, France


title: EMDR Psychotherapy of Anxious-depressive Symptoms for Women That Present an Invasive Breast Cancer : a Randomised Controlled Trial

acronym: PSYCANCER

summary: The study will consist in an evaluation of the EMDR (Eye Movement Desensitization and Reprocessing) psychotherapy in the context on invasive primitive breast cancer. EMDR could then allow the affected patients to readjust their point of view on the pathology and thus promote more adapted behaviors or additional resources to cope with the disease. 190 Patients are going to be randomized in two groups : one group with EMDR psychotherapists and one group with support psychotherapists. Patients will receive 8 sessions. We expect that patient in EMDR psychotherapists group will have an higher decrease of anxiety score, depressive score (CES-D) and PTSD score, and a higher increase in quality of life.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville

collaborators:
University of Lorraine
Central Hospital, Nancy, France


title: Molecular Genetics of Suicidal Behavior: Study of Association Between Aggressive Impulsiveness and Genes of the Serotoninergic System

summary:
Suicide is a major health problem that causes annually a million death worldwide. In the stress-vulnerability model, suicidal behavior (SB) results from the interaction between an individual's predisposition and stressful condition. According to this model, 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.

The four goals of this project are in the continuity of previous works team:

To determine whether combinations of the main serotonin-related genes may better contribute to the vulnerability to SB, than when they are considered independently.
To assess whether the associations between these genes and SB are modulated by childhood trauma, life events and stress response associated with these environmental factors.
To test the value of combined clinical, neuropsychological and genetic factor for suicide prevention, in a prospective study, in particularity impulsivity and gene gene interaction.
To investigate the association between events in real life (using ecological momentary assessment) and emotional response and suicidal ideation.

The investigators propose to use a multidisciplinary approach to answer these questions and, hence, be able to identify new prevention strategies for SB.

lead_sponsor: University Hospital, Montpellier

sponsor_collaborators:
University Hospital, Montpellier
Créteil Hospital
Central Hospital, Nancy, France


title: A Prospective, Multicenter, Randomized, Double Blind, Placebo-controlled, 2-parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib in Combination With FOLFIRI (Irinotecan, 5-fluorouracil and Folinic Acid) to Placebo in Combination With FOLFIRI in Second Line Treatment of Patients With Metastatic Colorectal Cancer

summary: The objective is to compare the efficacy and safety of masitinib in combination with FOLFIRI ( irinotecan, 5-fluorouracil and folinic acid) to placebo in combination with FOLFIRI in second line treatment of patients.

lead_sponsor: AB Science

location_country:
Singapore
United Kingdom
France

location_facility: National Cancer Center, 11 Hospital Drive

location_facility: Hopital Europeen George Pomipidou, Hepato-Gastro-enterologie, 20 rue Leblanc

location_facility: Hammersmith Hospital, Department of Cancer Medicine, Imperial College Healthcare Trust, Du Cane Road


title: RAPANK: Study of the Impact of Everolimus Treatment on the Development and Functions of Lymphocytes NK (Natural Killer), for Patients With a Metastatic Breast Cancer (HR+ / HER2/Neu Negative)

acronym: RAPANK

summary: NK (Natural Killer) cells are important in the fight against tumor, especially for the control of cancer metastasis. The purpose of this prospective study is to evaluate the impact on lymphocytes NK functions and development of an everolimus treatment in women treated for a metastatic breast cancer. In particular, the study of lymphocytes NK functions and development under everolimus treatment could permit to validate an early biomarker of the impact of everolimus on these NK cells.

lead_sponsor: Centre Leon Berard

collaborators: The Biostatistics and Therapy Evaluation Unit

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

location_facility:
Centre Leon Berard
Centre Hospitalier Lyon Sud


title: Evaluation of the Satisfaction of Patients Coming "on Foot" in the Operating Room (Standing, Dignified, Relaxed)

summary:
Ambulatory surgery is currently experiencing unprecedented growth and is becoming the standard of care compared to traditional hospitalization. Without mentioning the obvious financial gains, the benefits of ambulatory care essentially lie in optimised perioperative comfort. This comfort is due to a limited period of stay (< 12 hours) and to the proactive action of the care providers.

In this context, the optimization of the whole patient's journey during the perioperative period has been reviewed and adapted to personalized management within healthcare facilities. For more than a year now, multimodal approaches such as early rehabilitation have been undertaken, including

morning admission with an innovative principle of "3D" patient (standing, dignified, relaxed)
no premedication, wearing glasses and wigs,
Drinking on the morning of the intervention (2H before admission),
Walking to the block on foot (or in a wheelchair), return adapted to the wheelchair and no longer in a stretcher,
fast resumption of feeding.

Currently, in the investigator's various institutions, several modes of transport to the operating theatres coexist. The purpose of this observational study is to evaluate this optimization of perioperative management "3D mode", in particular the mode of transport.

The main objective is to determine the level of patient satisfaction with this management using a standardized quality questionnaire: the "EVAN" questionnaire. This questionnaire contains 22 items allowing a global analysis of patient satisfaction. This questionnaire is already routinely conducted in many institutions. The EVAN questionnaire will be supplemented by questionnaires assessing the level of perioperative anxiety. They will be initiated into the anesthesia consultation, and finalized on the day of the surgery.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility:
Institut de cancerologie de Montpellier
Chu Montpellier - Saint-Eloi
CHU Nimes
Clinique Juge
Institut paoli Calmette


title: A Clinico-biological Database of Lung Cancers

acronym: Bio-lung

summary:
This prospective, single-center, interventional study is conducted in order to achieve a biological bank accompanied by clinical data. Blood samples, optional tumor tissue and fecal samples are collected, processed and banked for all the included subjects. Those samples are collected before the start of treatment, at the time of first tumor assessment, at the time of first and second disease progression. The subjects are treated according to standard of care.

Clinical data are collected at each sampling time. The primary objective of the study is to identify biological, clinical and tumoral factors associated with tumor response according SOC treatment.

lead_sponsor: University Hospital, Lille

sponsor_collaborators:
University Hospital, Lille
Institut Pasteur de Lille
University of Lille Nord de France


title: Crossed Assessment of the Burden Within the Dyad Patient/Caregiver: Analysis of Explanatory Factors and Consequences for Return at Home of the Life-ending Patient

acronym: RAPSODIE

summary:
This study is about the patients life ending and their caregiver, when a return to home is planned.

This is a behavioral sciences study (= interventional study for french law)

collaborators: Unité de REcherche en sciences Cognitives et Affectives URECA EA1059


title: Clinical Interest of Endovascular Cooling in the Management of Cardiac Arrest: Impact on Mortality in a Randomized Medico-economical Trial (the ICEREA Study)

summary: According to international guidelines, mild therapeutic hypothermia is recommended for resuscitated patients after cardiac arrest due to ventricular fibrillation. Whether external or internal cooling is superior in terms of prognosis or security remains unknown. The aim of this study is to evaluate in a randomized trial the clinical and economical interests of the endovascular cooling versus the conventional external cooling for the management of hypothermia after cardiac arrest.

ReferenceType: result

ReferenceCitation: Bernard SA, Gray TW, Buist MD, Jones BM, Silvester W, Gutteridge G, Smith K. Treatment of comatose survivors of out-of-hospital cardiac arrest with induced hypothermia. N Engl J Med. 2002 Feb 21;346(8):557-63. doi: 10.1056/NEJMoa003289.

ReferenceCitation: Hypothermia after Cardiac Arrest Study Group. Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest. N Engl J Med. 2002 Feb 21;346(8):549-56. doi: 10.1056/NEJMoa012689. Erratum In: N Engl J Med 2002 May 30;346(22):1756.

ReferenceCitation: Nolan JP, Morley PT, Vanden Hoek TL, Hickey RW, Kloeck WG, Billi J, Bottiger BW, Morley PT, Nolan JP, Okada K, Reyes C, Shuster M, Steen PA, Weil MH, Wenzel V, Hickey RW, Carli P, Vanden Hoek TL, Atkins D; International Liaison Committee on Resuscitation. Therapeutic hypothermia after cardiac arrest: an advisory statement by the advanced life support task force of the International Liaison Committee on Resuscitation. Circulation. 2003 Jul 8;108(1):118-21. doi: 10.1161/01.CIR.0000079019.02601.90. No abstract available.

ReferenceCitation: International Liaison Committee on Resuscitation. 2005 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Part 4: Advanced life support. Resuscitation. 2005 Nov-Dec;67(2-3):213-47. doi: 10.1016/j.resuscitation.2005.09.018. No abstract available.

ReferenceCitation: Steinberg GK, Ogilvy CS, Shuer LM, Connolly ES Jr, Solomon RA, Lam A, Kassell NF, Baker CJ, Giannotta SL, Cockroft KM, Bell-Stephens TE, Allgren RL. Comparison of endovascular and surface cooling during unruptured cerebral aneurysm repair. Neurosurgery. 2004 Aug;55(2):307-14; discussion 314-5. doi: 10.1227/01.neu.0000129683.99430.8c.

ReferenceCitation: Al-Senani FM, Graffagnino C, Grotta JC, Saiki R, Wood D, Chung W, Palmer G, Collins KA. A prospective, multicenter pilot study to evaluate the feasibility and safety of using the CoolGard System and Icy catheter following cardiac arrest. Resuscitation. 2004 Aug;62(2):143-50. doi: 10.1016/j.resuscitation.2004.02.016.

ReferenceCitation: Deye N, Cariou A, Girardie P, Pichon N, Megarbane B, Midez P, Tonnelier JM, Boulain T, Outin H, Delahaye A, Cravoisy A, Mercat A, Blanc P, Santre C, Quintard H, Brivet F, Charpentier J, Garrigue D, Francois B, Quenot JP, Vincent F, Gueugniaud PY, Mira JP, Carli P, Vicaut E, Baud FJ; Clinical and Economical Impact of Endovascular Cooling in the Management of Cardiac Arrest (ICEREA) Study Group. Endovascular Versus External Targeted Temperature Management for Patients With Out-of-Hospital Cardiac Arrest: A Randomized, Controlled Study. Circulation. 2015 Jul 21;132(3):182-93. doi: 10.1161/CIRCULATIONAHA.114.012805. Epub 2015 Jun 19. Erratum In: Circulation. 2016 Feb 23;133(8):e418.

oa_host_type: publisher

publisher_dissemination: Wolters Kluwer Health

collaborators: IST Cardiology (Le Fresne Camilly, France)


title: Assessment of Exercise Tolerance and Lower-limb Muscle Power in Patients With Chronic Respiratory Disease: a Multicenter Validity Study

acronym: VTEP

summary:
The aim of this study is to validate the six minute Stepper Test (6MST) and the 5-repetition chair lift test (5STS) as measures of exercise tolerance and muscle power, respectively, in patients with chronic respiratory disease.

As the reproducibility of the tests has been studied and validated in previous studies, the objective is to investigate the validity of the 6MST and 5STS in comparison with their respective gold standards.

lead_sponsor: Lille Catholic University

sponsor_collaborators:
Lille Catholic University
University of Lille Nord de France

location_country: Canada France

location_facility: Centre de Pneumologie Institut universitaire de cardiologie et de pneumologie de Québec


title: Phase 3, Vaccinal Activity Assessment of MenBVac Against Neisseria Meningitidis B:14,P1.7,16 Strain in Child

acronym: Exten Effivac

summary: The main objective of the study is to estimate the proportion of children, born between the 06/04/2004 and the 17/004/2008, living around Neufchatel en Bray, vaccinated by MenBVac, with a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (>= 4), before the fourth dose of MenBvac and after: 6 weeks and one year after the fourth dose.

lead_sponsor: University Hospital, Rouen

sponsor_collaborators:
University Hospital, Rouen
Direction Générale de la Santé, France
Institut Pasteur

intervention_type: Biological


title: Characterization of Rhythmic Markers Associated With the Response to Antidepressants

acronym: R&B

summary: The study aims to characterize the rhythmic parameters of unipolar depressed patients that are associated with the response to antidepressants after 6 weeks of treatment.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

collaborators:
Centre Hospitalier Universitaire Dijon
University Hospital, Strasbourg, France


title: Pilot Study to Assess Minimal Residual Disease on Cryopreserved Ovarian Fragments in Younger Patients Treated for Acute Myeloid Leukemia

acronym: FERTILAM

summary:
Cryopreservation of ovarian cortex represents an option for fertility preservation in patients diagnosed with acute myeloid leukemia and requiring allogeneic stem cell transplantation.

This pilot study aims to evaluate the minimal residual disease on ovarian fragments harvested before allogeneic stem cell transplantation at the time of complete remission.

time_perspective: Cross-Sectional

sponsor_collaborators:
University Hospital, Lille
Canceropôle Nord Ouest
Saint-Louis Hospital, Paris, France


title: Validation Study of the Feasibility of an Integrated Diagnostic System of Anatomo-pathological Lesions - Including Rejections - Appearing in Renal Grafts in the First Year of Transplant for Applicability in Routine Clinical Practice : KTD Innov-2 Study

acronym: KTD Innov-2

summary: The main objective of the present study (KTD Innov-2) is to validate the feasibility of SDI within a limited time frame to ensure its clinically relevant use, with a high level of evidence to consider its labelling as a medical device by health authorities prior to routine transfer and/or future marketing.

ipd_sharing_description:
eCRF

The collection of data on each person suitable for research is carried out through a coded database. This coded database will be extracted from the existing DIVAT database in each participating centre, and the variables specific to the KTD Innov study (patient identification number (centre number/patient number) for the study, inclusion/non-inclusion criteria, date of collection of the non-opposition, additional analyses, ...) will be added on specific tabs.

lead_sponsor: Nantes University Hospital

sponsor_collaborators:
Nantes University Hospital
Hôpital Necker-Enfants Malades
Saint-Louis Hospital, Paris, France


title: Exploration of Variations in Leukocyte Morphological Parameters (MDW and CPD) Using the Beckman Coulter DxH900, Based on the Infectious Condition, Inflammatory State and Response to Corticosteroid Therapy in Septic Patients

acronym: MOCORSEP

summary: Non-interventional, prospective, monocentric study on the exploration of leukocyte morphological parameters according to the infectious condition and response to corticosteroid therapy of septic patients.

ReferenceCitation: Annane D, Renault A, Brun-Buisson C, Megarbane B, Quenot JP, Siami S, Cariou A, Forceville X, Schwebel C, Martin C, Timsit JF, Misset B, Ali Benali M, Colin G, Souweine B, Asehnoune K, Mercier E, Chimot L, Charpentier C, Francois B, Boulain T, Petitpas F, Constantin JM, Dhonneur G, Baudin F, Combes A, Bohe J, Loriferne JF, Amathieu R, Cook F, Slama M, Leroy O, Capellier G, Dargent A, Hissem T, Maxime V, Bellissant E; CRICS-TRIGGERSEP Network. Hydrocortisone plus Fludrocortisone for Adults with Septic Shock. N Engl J Med. 2018 Mar 1;378(9):809-818. doi: 10.1056/NEJMoa1705716.

evidence: open (via free article)

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Annane D, Sebille V, Charpentier C, Bollaert PE, Francois B, Korach JM, Capellier G, Cohen Y, Azoulay E, Troche G, Chaumet-Riffaud P, Bellissant E. Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA. 2002 Aug 21;288(7):862-71. doi: 10.1001/jama.288.7.862. Erratum In: JAMA. 2008 Oct 8;300(14):1652. Chaumet-Riffaut, Philippe [corrected to Chaumet-Riffaud, Philippe].

ReferenceCitation: Crouser ED, Parrillo JE, Seymour C, Angus DC, Bicking K, Tejidor L, Magari R, Careaga D, Williams J, Closser DR, Samoszuk M, Herren L, Robart E, Chaves F. Improved Early Detection of Sepsis in the ED With a Novel Monocyte Distribution Width Biomarker. Chest. 2017 Sep;152(3):518-526. doi: 10.1016/j.chest.2017.05.039. Epub 2017 Jun 15.

ReferenceCitation: Crouser ED, Parrillo JE, Seymour CW, Angus DC, Bicking K, Esguerra VG, Peck-Palmer OM, Magari RT, Julian MW, Kleven JM, Raj PJ, Procopio G, Careaga D, Tejidor L. Monocyte Distribution Width: A Novel Indicator of Sepsis-2 and Sepsis-3 in High-Risk Emergency Department Patients. Crit Care Med. 2019 Aug;47(8):1018-1025. doi: 10.1097/CCM.0000000000003799.

lead_sponsor: Beckman Coulter, Inc.

sponsor_collaborators:
Beckman Coulter, Inc.
Hôpital Raymond Poincaré
Saint-Louis Hospital, Paris, France


title: Effect of the Inhibitors of the Way JAK-STAT on Regulatory B Cells in the Rheumatoid Arthritis

summary: This study will investigate whether inhibitors of the JAK / STAT signaling pathway can increase anti-inflammatory functions of B cells in patients with RA using in vitro and in vivo experiments.

collaborators: Centre National de la Recherche Scientifique, France


title: Prospective Randomized Multicenter Phase II Study of the Dose-Response Effects of Continuous Administration of Low-Dose VA2914 on Parameters of the Hypothalamic-Pituitary-Gonadal Axis and the Endometrium

summary: The purpose of the present study is to evaluate continuous administration of low doses of VA2914 for potential contraceptive activity and effects on the menstrual cycle and steroid hormone parameters.

ReferenceCitation: Chabbert-Buffet N, Pintiaux-Kairis A, Bouchard P; VA2914 Study Group. Effects of the progesterone receptor modulator VA2914 in a continuous low dose on the hypothalamic-pituitary-ovarian axis and endometrium in normal women: a prospective, randomized, placebo-controlled trial. J Clin Endocrinol Metab. 2007 Sep;92(9):3582-9. doi: 10.1210/jc.2006-2816. Epub 2007 Jun 19.

lead_sponsor: HRA Pharma

location_country: Belgium France

location_facility:
Saint Antoine Hospital
Liege University Hospital
Antoine Beclere Hospital
Sainte Rosalie Clinique


acronym: AcSé

lead_sponsor: UNICANCER

summary: This is a Phase 2, non-randomised, open-label, multicentric study to investigate the efficacy and safety of pembrolizumab monotherapy in 7 cohorts of patients with specific rare cancers who have unresectable locally advanced or metastatic disease, which is resistant or refractory to standard therapy, or for which standard therapy does not exist, or is not considered appropriate, and for which no other experimental treatment options are available, in order to identify subsets of patients that may benefit from treatment

sponsor_collaborators:
UNICANCER
National Cancer Institute, France
Ligue contre le cancer, France
Merck Sharp & Dohme LLC

status: Active, not recruiting

title: Secured Access to Pembrolizumab for Patients With Selected Rare Cancer Types

source: euctr


summary: This is a Phase 2, non-randomised, open-label, multicentric study to investigate the efficacy and safety of nivolumab monotherapy in 6 cohorts of patients with specific rare cancers who have unresectable locally advanced or metastatic disease, which is resistant or refractory to standard therapy, or for which standard therapy does not exist, or is not considered appropriate, and for which no other experimental treatment options are available.

sponsor_collaborators:
UNICANCER
National Cancer Institute, France
Ligue contre le cancer, France
Bristol-Myers Squibb

title: Secured Access to Nivolumab for Adult Patients With Selected Rare Cancer Types


title: Multicentric Randomized Phase III Trial Comparing Methotrexate and Cetuximab in First-line Treatment of Recurrent and/or Metastatic Squamous Cell Head and Neck Cancer in Elderly Unfit Patients According to Geriatric Evaluation

acronym: ELAN-UNFIT

summary: To test whether cetuximab improves efficacy/tolerance as compared to methotrexate in first line treatment of unfit patients ³ 70 years old with recurrent and /or metastatic HNSCC. Efficacy assessed by failure free survival

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

collaborators:
National Cancer Institute, France
Ligue contre le cancer, France
Merck Serono International SA


title: An Evaluator-blinded Multi-center Study of Combined Treatment With Azzalure/Dysport, Restylane/Emervel Filler and Restylane Skinbooster as Compared to Single Treatment With Either Azzalure/Dysport Alone or Restylane/Emervel Filler Alone

summary: The efficacy and safety, as well as subject satisfaction will be evaluated after single treatment with Azzalure/Dysport alone or Restylane/Emervel filler alone followed by repeated combined treatment with Azzalure/Dysport, Restylane/Emervel filler and Restylane Skinbooster. Subjects will be followed for up to 18 months after initial treatment.

ReferenceCitation: Heden P, Hexsel D, Cartier H, Bergentz P, Delmar H, Camozzato F, Siega C, Skoglund C, Edwartz C, Norberg M, Kestemont P. Effective and Safe Repeated Full-Face Treatments With AbobotulinumtoxinA, Hyaluronic Acid Filler, and Skin Boosting Hyaluronic Acid. J Drugs Dermatol. 2019 Jul 1;18(7):682-689.

lead_sponsor: Galderma R&D

location_country: Brazil Sweden France

location_facility: Brazilian Center for Studies in Dermatology


title: A Randomised, Double Blinded Cross-over Study Comparing the Efficacy of L-carnitine Versus Placebo in the Treatment of Fatigue in Multiple Sclerosis

acronym: FACTSEP

summary: The objective of this study is to evaluate the efficacy of L-carnitine versus placebo in the treatment of fatigue in multiple sclerosis patients. This study will randomize 60 patients in a cross-over design. This study is sponsored by academic French health institutions.

ReferenceCitation: Tejani AM, Wasdell M, Spiwak R, Rowell G, Nathwani S. Carnitine for fatigue in multiple sclerosis. Cochrane Database Syst Rev. 2010 Feb 17;(2):CD007280. doi: 10.1002/14651858.CD007280.pub2.

ReferenceCitation: Bakshi R. Fatigue associated with multiple sclerosis: diagnosis, impact and management. Mult Scler. 2003 Jun;9(3):219-27. doi: 10.1191/1352458503ms904oa.

ReferenceCitation: Filippi M, Rocca MA, Colombo B, Falini A, Codella M, Scotti G, Comi G. Functional magnetic resonance imaging correlates of fatigue in multiple sclerosis. Neuroimage. 2002 Mar;15(3):559-67. doi: 10.1006/nimg.2001.1011.

ReferenceCitation: Oken BS, Kishiyama S, Zajdel D, Bourdette D, Carlsen J, Haas M, Hugos C, Kraemer DF, Lawrence J, Mass M. Randomized controlled trial of yoga and exercise in multiple sclerosis. Neurology. 2004 Jun 8;62(11):2058-64. doi: 10.1212/01.wnl.0000129534.88602.5c.

ReferenceCitation: Pucci E, Branas P, D'Amico R, Giuliani G, Solari A, Taus C. Amantadine for fatigue in multiple sclerosis. Cochrane Database Syst Rev. 2007 Jan 24;2007(1):CD002818. doi: 10.1002/14651858.CD002818.pub2.

ReferenceCitation: Krupp LB, Coyle PK, Doscher C, Miller A, Cross AH, Jandorf L, Halper J, Johnson B, Morgante L, Grimson R. Fatigue therapy in multiple sclerosis: results of a double-blind, randomized, parallel trial of amantadine, pemoline, and placebo. Neurology. 1995 Nov;45(11):1956-61. doi: 10.1212/wnl.45.11.1956.

ReferenceCitation: van Diemen HA, Polman CH, van Dongen TM, van Loenen AC, Nauta JJ, Taphoorn MJ, van Walbeek HK, Koetsier JC. The effect of 4-aminopyridine on clinical signs in multiple sclerosis: a randomized, placebo-controlled, double-blind, cross-over study. Ann Neurol. 1992 Aug;32(2):123-30. doi: 10.1002/ana.410320203.

ReferenceCitation: Stankoff B, Waubant E, Confavreux C, Edan G, Debouverie M, Rumbach L, Moreau T, Pelletier J, Lubetzki C, Clanet M; French Modafinil Study Group. Modafinil for fatigue in MS: a randomized placebo-controlled double-blind study. Neurology. 2005 Apr 12;64(7):1139-43. doi: 10.1212/01.WNL.0000158272.27070.6A.

ReferenceCitation: Tomassini V, Pozzilli C, Onesti E, Pasqualetti P, Marinelli F, Pisani A, Fieschi C. Comparison of the effects of acetyl L-carnitine and amantadine for the treatment of fatigue in multiple sclerosis: results of a pilot, randomised, double-blind, crossover trial. J Neurol Sci. 2004 Mar 15;218(1-2):103-8. doi: 10.1016/j.jns.2003.11.005.

ReferenceCitation: Wingerchuk DM, Benarroch EE, O'Brien PC, Keegan BM, Lucchinetti CF, Noseworthy JH, Weinshenker BG, Rodriguez M. A randomized controlled crossover trial of aspirin for fatigue in multiple sclerosis. Neurology. 2005 Apr 12;64(7):1267-9. doi: 10.1212/01.WNL.0000156803.23698.9A.

ReferenceCitation: Lebrun C, Alchaar H, Candito M, Bourg V, Chatel M. Levocarnitine administration in multiple sclerosis patients with immunosuppressive therapy-induced fatigue. Mult Scler. 2006 Jun;12(3):321-4. doi: 10.1191/135248506ms1275oa.

ReferenceCitation: Pittion-Vouyovitch S, Debouverie M, Guillemin F, Vandenberghe N, Anxionnat R, Vespignani H. Fatigue in multiple sclerosis is related to disability, depression and quality of life. J Neurol Sci. 2006 Apr 15;243(1-2):39-45. doi: 10.1016/j.jns.2005.11.025. Epub 2006 Jan 24.

ReferenceCitation: Debouverie M, Pittion S. [Fatigue and episodic exhaustion as a feature of multiple sclerosis]. Rev Neurol (Paris). 2006 Mar;162(3):295-7. doi: 10.1016/s0035-3787(06)75015-9. No abstract available. French.

ReferenceCitation: Richardson BA, Flack VF. The analysis of incomplete data in the three-period two-treatment cross-over design for clinical trials. Stat Med. 1996 Jan 30;15(2):127-43. doi: 10.1002/(SICI)1097-0258(19960130)15:23.0.CO;2-D.

ReferenceCitation: GRIZZLE JE. THE TWO-PERIOD CHANGE-OVER DESIGN AN ITS USE IN CLINICAL TRIALS. Biometrics. 1965 Jun;21:467-80. No abstract available.

ReferenceCitation: Kieser M, Friede T. Re-calculating the sample size in internal pilot study designs with control of the type I error rate. Stat Med. 2000 Apr 15;19(7):901-11. doi: 10.1002/(sici)1097-0258(20000415)19:73.0.co;2-l.

ReferenceCitation: Graziano F, Bisonni R, Catalano V, Silva R, Rovidati S, Mencarini E, Ferraro B, Canestrari F, Baldelli AM, De Gaetano A, Giordani P, Testa E, Lai V. Potential role of levocarnitine supplementation for the treatment of chemotherapy-induced fatigue in non-anaemic cancer patients. Br J Cancer. 2002 Jun 17;86(12):1854-7. doi: 10.1038/sj.bjc.6600413.

ReferenceCitation: Plioplys AV, Plioplys S. Amantadine and L-carnitine treatment of Chronic Fatigue Syndrome. Neuropsychobiology. 1997;35(1):16-23. doi: 10.1159/000119325.

ReferenceCitation: Debouverie M, Pittion-Vouyovitch S, Louis S, Guillemin F. Validity of a French version of the fatigue impact scale in multiple sclerosis. Mult Scler. 2007 Sep;13(8):1026-32. doi: 10.1177/1352458507077942.

ReferenceCitation: Montel SR, Bungener C. Coping and quality of life in one hundred and thirty five subjects with multiple sclerosis. Mult Scler. 2007 Apr;13(3):393-401. doi: 10.1177/1352458506071170. Epub 2007 Jan 29.

ReferenceCitation: Cruciani RA, Dvorkin E, Homel P, Malamud S, Culliney B, Lapin J, Portenoy RK, Esteban-Cruciani N. Safety, tolerability and symptom outcomes associated with L-carnitine supplementation in patients with cancer, fatigue, and carnitine deficiency: a phase I/II study. J Pain Symptom Manage. 2006 Dec;32(6):551-9. doi: 10.1016/j.jpainsymman.2006.09.001.

ReferenceCitation: Gramignano G, Lusso MR, Madeddu C, Massa E, Serpe R, Deiana L, Lamonica G, Dessi M, Spiga C, Astara G, Maccio A, Mantovani G. Efficacy of l-carnitine administration on fatigue, nutritional status, oxidative stress, and related quality of life in 12 advanced cancer patients undergoing anticancer therapy. Nutrition. 2006 Feb;22(2):136-45. doi: 10.1016/j.nut.2005.06.003.

ReferenceCitation: Neri S, Pistone G, Saraceno B, Pennisi G, Luca S, Malaguarnera M. L-carnitine decreases severity and type of fatigue induced by interferon-alpha in the treatment of patients with hepatitis C. Neuropsychobiology. 2003;47(2):94-7. doi: 10.1159/000070016.

ReferenceCitation: Rebouche CJ. Kinetics, pharmacokinetics, and regulation of L-carnitine and acetyl-L-carnitine metabolism. Ann N Y Acad Sci. 2004 Nov;1033:30-41. doi: 10.1196/annals.1320.003.

ReferenceCitation: Plioplys AV, Plioplys S. Serum levels of carnitine in chronic fatigue syndrome: clinical correlates. Neuropsychobiology. 1995;32(3):132-8. doi: 10.1159/000119226.

ReferenceCitation: Cruciani RA, Dvorkin E, Homel P, Culliney B, Malamud S, Shaiova L, Fleishman S, Lapin J, Klein E, Lesage P, Portenoy R, Esteban-Cruciani N. L-carnitine supplementation for the treatment of fatigue and depressed mood in cancer patients with carnitine deficiency: a preliminary analysis. Ann N Y Acad Sci. 2004 Nov;1033:168-76. doi: 10.1196/annals.1320.016.

ReferenceCitation: Taglialatela G, Navarra D, Cruciani R, Ramacci MT, Alema GS, Angelucci L. Acetyl-L-carnitine treatment increases nerve growth factor levels and choline acetyltransferase activity in the central nervous system of aged rats. Exp Gerontol. 1994 Jan-Feb;29(1):55-66. doi: 10.1016/0531-5565(94)90062-0.

lead_sponsor: University Hospital, Bordeaux

location_facility:
University Hospital, Hospital Laënnec
University Hospital, Hospital Pasteur
University Hospital, Hospital Dupuytren
University Hospital, Hospital Central
University Hospital, Hospital Pellegrin
University Hospital


title: Contribution of 3D Printing in Anatomical Lung Segmentectomies: a Prospective Randomized Controlled Pilot Trial.

summary: The aim of the present work was to evaluate if the presence on the operating field of a 3D printed personalized model of the pulmonary anatomy of a patient operated by full thoracoscopy for an anatomical segmentectomy, makes it possible to reduce the mental workload and the fatigue of the surgeon.

lead_sponsor: Institut Mutualiste Montsouris

collaborators: Paris cite university, 75006 Paris, France

location_facility: Institut Mutualiste Montsouris (thoracic surgery department)


acronym: SONAR

summary: The aim of this study is to evaluate the efficacy of a new thickened formula on regurgitation.

lead_sponsor: United Pharmaceuticals

location_facility:
Universitair Ziekenhuis
Pediatricians

intervention_type: Dietary Supplement


title: Ill-health Related Jobloss

acronym: jobloss

summary: The current study aimed to estimate the one-year incidence of unfitness for the job in an occupational health service, and to describe their aetiology and the characteristics of the unfit employees

time_perspective: Retrospective

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

collaborators: Occupational Health Center, Montpellier, France


title: A Phase I/II Trial to Compare the Immunogenicity and Safety of 3 DNA C Prime Followed by 1 NYVAC C Boost to 2 DNA C Prime Followed by 2 NYVAC C Boost

summary: The purpose of the trial is to evaluate the effect upon immune system of two regimens of preventive HIV vaccination in healthy adult volunteers. Volunteers will be vaccinated by DNA-C and NYVAC-C vaccines, and the immune changes will be assessed, as well as safety of the vaccines. Volunteers will be followed during 72 weeks.

lead_sponsor: French National Agency for Research on AIDS and Viral Hepatitis

location_country: Switzerland France

location_facility: Centre Hospitalier Universitaire Vaudois CHUV


title: Regulation of the Energy Balance Following an Acute Exercise in Metabolic Chambers: Effect of the Exercise Intensity, Age and Weight Status

summary: Physical activity is mainly considered and use for its impact on energy expenditure in the treatment of obesity, and less is known concerning its indirect effects on energy intake. The aim of this work is to clarify the impact of an acute bout of exercise, depending on its intensity (high versus low), on the following energy intake and nutrient utilization, in obese and non-obese boys and men.

ReferenceCitation: Aucouturier J, Thivel D, Isacco L, Fellmann N, Chardigny JM, Duclos M, Duche P. Combined food intake and exercise unmask different hormonal responses in lean and obese children. Appl Physiol Nutr Metab. 2013 Jun;38(6):638-43. doi: 10.1139/apnm-2012-0246. Epub 2013 Jan 10.

publisher_dissemination: Canadian Science Publishing

ReferenceCitation: Thivel D, Isacco L, Montaurier C, Boirie Y, Duche P, Morio B. The 24-h energy intake of obese adolescents is spontaneously reduced after intensive exercise: a randomized controlled trial in calorimetric chambers. PLoS One. 2012;7(1):e29840. doi: 10.1371/journal.pone.0029840. Epub 2012 Jan 17.

ReferenceCitation: Thivel D, Isacco L, Taillardat M, Rousset S, Boirie Y, Morio B, Duche P. Gender effect on exercise-induced energy intake modification among obese adolescents. Appetite. 2011 Jun;56(3):658-61. doi: 10.1016/j.appet.2011.02.020. Epub 2011 Mar 2.

lead_sponsor: University Hospital, Clermont-Ferrand

collaborators: Regional Program for Clinical Research 2009 (PHRC 2009)

collaborators: Thermal Institution of Brides les Bains (FRANCE)


title: Comparison of Breathing Pattern During PSV and NAVA

summary: Comparison of Breathing pattern during mechanical ventilation. Two modes of mechanical ventilation are compared (Pressure Support Ventilation and Neurally Adjusted Ventilatory Assist)

ReferenceCitation: Meric H, Calabrese P, Pradon D, Lejaille M, Lofaso F, Terzi N. Physiological comparison of breathing patterns with neurally adjusted ventilatory assist (NAVA) and pressure-support ventilation to improve NAVA settings. Respir Physiol Neurobiol. 2014 May 1;195:11-8. doi: 10.1016/j.resp.2014.01.021. Epub 2014 Feb 5.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: EXPérimentation d'Envoi Postal DIrect à Domicile du kiT de dépistage du Cancer Colorectal Sans Commande préalable [Trial of Direct Home Delivery of Colorectal Cancer Screening Kit Without Pre-ordering]

acronym: EXPEDIT

summary:
The effect of mailing FIT with the invitation on participation and colonoscopy rates will be evaluated in a randomized controlled trial conducted in the Centre-Val de Loire (CVL) region, involving 64,000 people from the population eligible for colorectal cancer population-based organised screening program (CRC-PBOSP).

In the "C" control group, invitations, test delivery and reminders will be carried out in accordance with the CRC-PBOSP rules at the time of the study.

Intervention group "B" will evaluate two experimental modes of invitation with direct home mailing of the test:

Method "B1": invitation with test sent to home without prior information letter
Method "B2": information letter followed by invitation with test sent home, designed to optimize participation by first-time subjects (aged 50-51) invited to the CRC-PBOSP for the first time.

Ancillary studies will focus 1/ on acceptability of this intervention (qualitative study on a few general practitioners, gastroenterologists and invitees), 2/ on social and geographical inequalities of participation on a subsample of individuals included in EXPEDIT study using ecological indices (EDI, SCALE).

primary_purpose: Screening

lead_sponsor: University Hospital, Caen

collaborators: Centre Régional de Coordination des Dépistages des Cancers (CRCDC) Centre Val de Loire


title: Autologous Transplantation of Adipose Tissue Derived Mesenchymal Stroma/Stem Cells (ASC) in Patients With Critical Limb Ischemia.

summary:
Different types of stem cells have recently been studied in clinical trial on ischemic disease of the heart and muscular arteries. Adipose derived stem cell, have shown in vitro and in vivo models a stronger potential of success in recovering from ischemic disease and oxygenation of the tissues. The investigators already shown in a phase I study, that adipose derived mesenchymal cells injected in patients with critical limb ischemia and no option for revascularization, had a very good tolerance and interesting effects on skin oxygenation and healing.

The aim of the present clinical trial is to confirm the efficacy autologous transplantation of adipose tissue derived mesenchymal cells in patients with critical limb ischemia with poor options or no option for revascularization.

lead_sponsor: University Hospital, Toulouse

appel_a_projets: PHRCN

region: Occitanie

nom_etablissement: CHU TOULOUSE

type_etablissement: CH

titre: Transplantation autologue de cellules mesenchymateuses/cellules souches dérivées du tissu adipeux, chez des patients avec une ischémie critique des membres inférieurs: étude de phase II.

discipline_principale: médecine vasculaire

nom_porteur: BURA RIVIERE

prenom_porteur: Alessandra


title: Mechanism of DCs Dysfunction in Chronic HBV Infection

acronym: HepatoDC

summary: This research is to better understand the functional impairments of Dendritic cells (DCs) in chronic HBV infection. Aim is to determine if the virus is able to bind to the C-type lectin receptor (CLRs) of DCs to modulate their functions, also, to define the role of viral components and the molecular mechanisms of DCs modulation by HBV. This project should provide a better understanding of the mechanisms by which the immune response is altered by HBV and the immunological control of the infection, and thus propose new immunotherapeutic strategies based on the restoration of DC functions by releasing of virally-induced inhibitions, compromising the infection chronicity

lead_sponsor: University Hospital, Grenoble


title: Access to Care and Prognosis in Elderly Cancer Patients: Analysis of Determinants Using Data From Cancer Registries and Cohort Studies in Gironde, French Department

summary: The growing incidence of cancer associated to an aging population represents an epidemiologic reality that requires questioning access to care and prognosis in elderly with cancer, for which disparities have been highlighted. However, generally speaking, studies are limited in that they overlook geriatric-specific factors. The aim of this work was to study sociodemographic, socioeconomic and clinical determinants of access to care (cancer stage, cancer treatment) and prognosis (functional decline, survival) in elderly cancer patients.

ReferenceCitation: Galvin A, Helmer C, Coureau G, Amadeo B, Joly P, Sabathe C, Monnereau A, Baldi I, Rainfray M, Soubeyran P, Delva F, Mathoulin-Pelissier S. Determinants of cancer treatment and mortality in older cancer patients using a multi-state model: Results from a population-based study (the INCAPAC study). Cancer Epidemiol. 2018 Aug;55:39-44. doi: 10.1016/j.canep.2018.04.013. Epub 2018 May 25.

ReferenceCitation: Galvin A, Delva F, Helmer C, Rainfray M, Bellera C, Rondeau V, Soubeyran P, Coureau G, Mathoulin-Pelissier S. Sociodemographic, socioeconomic, and clinical determinants of survival in patients with cancer: A systematic review of the literature focused on the elderly. J Geriatr Oncol. 2018 Jan;9(1):6-14. doi: 10.1016/j.jgo.2017.07.007. Epub 2017 Oct 10.

lead_sponsor: Institut Bergonié


title: A Study of Identity Building in Children With Attention Deficit Hyperactivity Disorder (ADHD)

acronym: SID-ADHD

summary:
Context: Attention Deficit Hyperactivity Disorder (ADHD), a major public health issue, is a neurodevelopmental disorder characterized by disturbance of attention, pathological impulsivity and a variable level of psychomotor hyperactivity. In addition to medium-term repercussions such as school failure or family dysfunction, these children have difficulties in dealing with emotions, metacognition and self-awareness that have serious consequences for self-regulation and identity construction.

Objective: To investigate identity building in children with ADHD and explore its links with the severity of the disorder and associated neuropsychological disturbances.

Material and method: 20 childrens with ADHD and 20 controls will be recruited over a 24-month period. They will be administered the Damon and Hart's Self-Understanding Interview, exploring 7 identity domains: Physical, Active, Social, Psychological, Continuity, Agentivity, Distinction Self/Other. The severity of ADHD, neuropsychological functioning (attention, working memory, executive functions, long-term memory), self-esteem and internal/external attributive style (locus of control) will be assessed by validated scales. The overall level of identity development and in each dimension will be compared between patients and controls. Within patients, the correlations between level of identity development and the severity of ADHD will be explored, as well as with neuropsychological functioning, with statistical control of age.

Assumptions: The investigators hypothesize that children with ADHD will exhibit a significantly lower level of identity development than controls, which will be positively correlated with neuropsychological functioning, and negatively correlated with the severity of ADHD.


title: Characterization of Tumoral Circulating Cells According to Stage of Progression of Colorectal Cancers

summary: Prospective research of circulating tumor cells as markers of progression risk in colorectal cancer.

ReferenceCitation: Sotelo MJ, Sastre J, Maestro ML, Veganzones S, Vieitez JM, Alonso V, Gravalos C, Escudero P, Vera R, Aranda E, Garcia-Alfonso P, Gallego-Plazas J, Lopez C, Pericay C, Arrivi A, Vicente P, Ballesteros P, Elez E, Lopez-Ladron A, Diaz-Rubio E. Role of circulating tumor cells as prognostic marker in resected stage III colorectal cancer. Ann Oncol. 2015 Mar;26(3):535-41. doi: 10.1093/annonc/mdu568. Epub 2014 Dec 15.

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

ReferenceCitation: Hodgkinson CL, Morrow CJ, Li Y, Metcalf RL, Rothwell DG, Trapani F, Polanski R, Burt DJ, Simpson KL, Morris K, Pepper SD, Nonaka D, Greystoke A, Kelly P, Bola B, Krebs MG, Antonello J, Ayub M, Faulkner S, Priest L, Carter L, Tate C, Miller CJ, Blackhall F, Brady G, Dive C. Tumorigenicity and genetic profiling of circulating tumor cells in small-cell lung cancer. Nat Med. 2014 Aug;20(8):897-903. doi: 10.1038/nm.3600. Epub 2014 Jun 1.

publisher_dissemination: Springer

ReferenceCitation: Yu M, Bardia A, Aceto N, Bersani F, Madden MW, Donaldson MC, Desai R, Zhu H, Comaills V, Zheng Z, Wittner BS, Stojanov P, Brachtel E, Sgroi D, Kapur R, Shioda T, Ting DT, Ramaswamy S, Getz G, Iafrate AJ, Benes C, Toner M, Maheswaran S, Haber DA. Cancer therapy. Ex vivo culture of circulating breast tumor cells for individualized testing of drug susceptibility. Science. 2014 Jul 11;345(6193):216-20. doi: 10.1126/science.1253533.

oa_host_type: repository

version: acceptedVersion

repository_institution: University of Turin - Institutional Research Information System University of Turin

version: submittedVersion

repositories_concat: PubMed Central;iris.unito.it

unpaywall_oa_status: green

publisher_dissemination: American Association for the Advancement of Science

ReferenceCitation: Khoo BL, Lee SC, Kumar P, Tan TZ, Warkiani ME, Ow SG, Nandi S, Lim CT, Thiery JP. Short-term expansion of breast circulating cancer cells predicts response to anti-cancer therapy. Oncotarget. 2015 Jun 20;6(17):15578-93. doi: 10.18632/oncotarget.3903.

evidence: open (via page says license)

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Impact Journals, LLC

lead_sponsor: Institut Paoli-Calmettes


title: Evaluation of the Free α-hemoglobin Pool in the Red Blood Cells : Prognostic Marker and Severity Index in Thalassemic Syndromes

acronym: ALPHAPOOL

summary: Our project aims to assess and validate an innovative prognostic and diagnostic test in order to i) define a severity index of the β-thalassemia according to the free α-Hb pool for a better management of the patient; ii) differentiate the α-thalassemia and β-thalassemia and iii) follow the evolution of this pool in response to treatment of patients. In the future, this prognostic test based on the measurement of free α-Hb pool may be suitable for routine laboratory practice. To carry out this project, cohort of 85 thalassemic patients and a group of 50 healthy volunteers have been recruited.

ReferenceCitation: Vasseur C, Pissard S, Domingues-Hamdi E, Marden MC, Galacteros F, Baudin-Creuza V. Evaluation of the free alpha-hemoglobin pool in red blood cells: a new test providing a scale of beta-thalassemia severity. Am J Hematol. 2011 Feb;86(2):199-202. doi: 10.1002/ajh.21918.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Research and Analysis of the Mechanisms Involved in the Emergence of Breast Cancer Stem Cells

summary:
From a cellular perspective, breast cancers appear to develop hierarchically from a small contingent of cancer stem cells (CSCs). The presence of CSCs in tumor tissue is associated with an increased risk of recurrence and metastasis, as well as a worse prognosis. Thus, these CSCs exhibit resistance to conventional anti-tumor treatments such as radiotherapy and chemotherapy. Moreover, these treatments would favor the emergence of these CSCs and the reprogramming of non-CSCs in CSCs. It has been demonstrated in neoadjuvant that the proportion of CSCs before any treatment is correlated with chemoresistance and that a resurgence of CSCs after chemotherapy is correlated with a poor prognosis. However, the mechanisms involved in the emergence of CSCs by reprogramming of non-CSCs are not yet known.

The Oscar Lambret Center proposes a monocentric prospective interventional study based on the cellular and molecular analysis of the tumor, serum and circulating cells, before, during and at the end of the treatment for each patient receiving a neoadjuvant chemotherapy for breast cancer. The identification of the mechanisms contributing to the enrichment of CSCs resistant to chemotherapy could lead to therapeutic solutions.

lead_sponsor: Centre Oscar Lambret

collaborators: Institut pour la Recherche sur le Cancer de Lille


title: Impact of Speed Of Rewarming After CaRdiac Arrest and ThErapeutic Hypothermia. A Randomized Controlled Pilot Study

acronym: ISOCRATE

summary: Comparing the production of interleukin 6 (inflammatory cytokine) in two heating speed (slow rewarming rate: 0.25 ° C / h or fast rewarming rate 0.50 ° C / h) at the completion of a period of targeted temperature at 33°C after cardiac arrest supported by shockable rhythm and successfully resuscitated.

ReferenceCitation: Lascarrou JB, Guichard E, Reignier J, Le Gouge A, Pouplet C, Martin S, Lacherade JC, Colin G; AfterROSC network. Impact of rewarming rate on interleukin-6 levels in patients with shockable cardiac arrest receiving targeted temperature management at 33 degrees C: the ISOCRATE pilot randomized controlled trial. Crit Care. 2021 Dec 17;25(1):434. doi: 10.1186/s13054-021-03842-9.

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Neutrophil Extracellular Traps and Thrombolysis in the Acute Stroke

acronym: NETs

summary: The purpose of the study was to investigate the correlation between the nucleosome concentration and the rate of recanalization after thrombolysis. All patients were admitted to the Stroke Unit at the University Hospital Sainte-Anne where they received standard stroke care. The investigators included all patients treated or not by intravenous thrombolysis for anterior circulation stroke with or without vessel occlusion. Exclusion criteria were neoplasms, chronic inflammatory diseases and cytostatic therapy at the time of stroke and stroke-specifics symptoms that had started earlier than 4.5 hours before admission.

ReferenceCitation: Holdenrieder S, Stieber P, Bodenmuller H, Fertig G, Furst H, Schmeller N, Untch M, Seidel D. Nucleosomes in serum as a marker for cell death. Clin Chem Lab Med. 2001 Jul;39(7):596-605. doi: 10.1515/CCLM.2001.095.

ReferenceCitation: Holdenrieder S, Stieber P, Chan LY, Geiger S, Kremer A, Nagel D, Lo YM. Cell-free DNA in serum and plasma: comparison of ELISA and quantitative PCR. Clin Chem. 2005 Aug;51(8):1544-6. doi: 10.1373/clinchem.2005.049320. No abstract available.

ReferenceCitation: Naggara O, Raymond J, Domingo Ayllon M, Al-Shareef F, Touze E, Chenoufi M, Gerber S, Mellerio C, Zuber M, Meder JF, Mas JL, Oppenheim C. T2* "susceptibility vessel sign" demonstrates clot location and length in acute ischemic stroke. PLoS One. 2013 Oct 11;8(10):e76727. doi: 10.1371/journal.pone.0076727. eCollection 2013.

lead_sponsor: Centre Hospitalier St Anne


title: Decrease of Exposure to Hypnosedative Drugs in the Elderly Through the Discontinuation of Hospital-initiated Prescription: Impact on the Quality of Sleep and Fall Frequency

acronym: HYPAGE

summary:
Brief Summary

Context. Sleep disorders complaints are common in elderly and hypnosedative drugs are widely prescribed in community-dwelling elderly. Furthermore, acute hospitalisation may induce sleep disorders and hypnosedative initiation occurs in 14 to 29% of elderly during a hospital stay. These hospital-induced sleep disorders should spontaneously disappear after discharge and, because of their potential impact on falls, hip fractures, psychiatric side effects and induced dependence, hypnosedative drugs should therefore be discontinued at discharge in these naïve-treated patients. Adhesion to this recommendation is poor. Recent and on-going research on this topic mostly concerns adverse effects although these are already substantially documented and evidence-based, while there is a poor interest on developing research on potential strategies susceptible to practically improve the current adhesion to recommendations.

Design and objectives. This project proposes multi-component intervention and is directed towards hospital prescribers, patients, and their general practitioner. It aims at discontinuing, at hospital discharge, the hypnosedative treatment that was initiated during hospitalization in naïve-treated elderly (age≥65) patients. The value of the intervention, as compared to usual care management, will be estimated in a multicentre (6 hospitals gathering 8 centres: 5 internal medicine departments, 3 cardiology departments) randomised, cross-over, two-period trial. Two hospitals will gather 2 centres (2x2 centres) and 4 hospitals will gather only 1 centre (4x1 centres). An equilibrated randomization will be applied to the 8 centres, making sure that, in hospitals gathering 2 centres, these 2 centres will apply the same strategy in a given period and that the 2 hospitals will apply alternative strategies. This randomisation is set up to avoid the risk of a potential contamination between the 2 strategies from one centre to the other within the same hospital. As a result, 3 hospitals (including 4 medical departments) will apply the intervention during the first 11-month period, while the 3 others (including 4 medical departments) will apply usual care during this period, as a result of an equilibrated hospitals randomization. During the second 11-month period, each hospital will apply the alternative management. The two periods will be separated by a 1-month wash-out period.

In all 240 patients (15 patients / centre) will be enrolled (120 in the intervention group and 120 in the usual care group).

Patient follow-up duration will be 12 months after discharge. Patient status in regards with quality of sleep (study primary objective), hypnosedative consumption and frequency of falls (secondary objectives) will be collected by telephone interviews 1, 3, 6 12 months after discharge.

Expected results. The results of the study should contribute to guide research and public decisions to practically decrease hypnosedative prescription and consumption, and associated adverse events.

primary_purpose: Health Services Research

location_facility: Assistance Publique Hopitaux de Paris - Hopital Saint Antoine


title: Associative Memory in ASD Without Mental Retardation : Study in EEG and Neuropsychology

acronym: MEM-TA

summary: The aim of this study is to investigate the neural substrates of associative memory in Autism Spectrum Disorder using both behavioural and EEG assessments.

appel_a_projets: PHRCI

region: Normandie

nom_etablissement: CHU DE CAEN NORMANDIE

acronyme: MEMTA

titre: La mémoire associative dans les troubles austiques sans déficit intellectuel : Etude en Electroencéphalographie et en Neuropsychologie

discipline_principale: trouble du spectre autistique , autisme , pedopsychiatrie

nom_porteur: BALEYTE

prenom_porteur: Jean-Marc


title: Sentinel Patients : Value of an Information System Collecting Patient's Own Report on His Healthcare Management. Application to the Detection of Adverse Events After Hospital Discharge.

acronym: SENTIPAT

summary:
"Evolution of patient's health after hospital discharge is poorly documented. The investigators hypothesize that information of good quality on this concern might be accessible at a relatively low cost from patients, further referred to as sentinel patients, who would voluntary report their health evolution on a dedicated web site.

The SENTIPAT study presents as a proof of concept study. It will collect patient's health evolution during a post-hospital discharge period of 45 days. The study presents as a randomized trial comparing patients' reports issued from two different methods in a patient population returning home after hospital discharge and having at disposal an internet access at home:

in the " internet " arm, sentinel patients will be solicited to directly report their post-discharge health evolution on a website especially devoted for collecting these data while in the " telephone " arm, the same items will be collected through a telephone interview 45 days after hospital discharge. Investigations will focus on post-discharge adverse events and will include appearance/worsening of symptoms, healthcare resources utilization, quality of life, and patients' satisfaction."

ReferenceCitation: Acma A, Carrat F, Hejblum G. Comparing SF-36 Scores Collected Through Web-Based Questionnaire Self-completions and Telephone Interviews: An Ancillary Study of the SENTIPAT Multicenter Randomized Controlled Trial. J Med Internet Res. 2022 Mar 10;24(3):e29009. doi: 10.2196/29009.

evidence: oa repository (via page says license)

repository_normalized: medRxiv

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

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

repositories:
HAL
PubMed Central
medRxiv

repositories_concat: HAL;PubMed Central;medRxiv

publisher_dissemination: JMIR Publications

ReferenceCitation: Feldman SF, Lapidus N, Cosnes J, Tiret E, Fonquernie L, Cabane J, Chazouilleres O, Surgers L, Beaussier M, Valleron AJ, Carrat F, Hejblum G. Comparing Inpatient Satisfaction Collected via a Web-Based Questionnaire Self-Completion and Through a Telephone Interview: An Ancillary Study of the SENTIPAT Randomized Controlled Trial. J Med Internet Res. 2017 Aug 23;19(8):e293. doi: 10.2196/jmir.7061.

endpoint_id: HAL

repository_institution: HAL

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

ReferenceCitation: Couturier B, Carrat F, Hejblum G; SENTIPAT Study Group. Comparing Patients' Opinions on the Hospital Discharge Process Collected With a Self-Reported Questionnaire Completed Via the Internet or Through a Telephone Survey: An Ancillary Study of the SENTIPAT Randomized Controlled Trial. J Med Internet Res. 2015 Jun 24;17(6):e158. doi: 10.2196/jmir.4379.


title: Immune Biomarkers of Residual Beta-cell Mass in Type 1 Diabetes

acronym: IMMADIAB

summary:
There is currently no imaging technique allowing to directly visualize and measure pancreatic beta-cell mass. Consequently, the best parameter to estimate this mass is the insulin (and its C-peptide byproduct) that residual beta cells are able to produce. This insulin secretion is measured during a meal test, before and at different times after drinking a standardized quantity of nutrients. However, this test is cumbersome (lasting 3 h, with blood samples taken every 30 minutes) and it holds poor sensitivity, probably insufficient to detect very few residual beta cells. Nevertheless, these few residual cells can improve glycemic control and can be instrumental for the clinical efficacy of immune and/or regenerative therapies.

We hypothesize that residual beta cells may not only represent the remaining insulin secretory capacity, but also the antigenic load capable of stimulating beta-cell-reactive T lymphocytes. The disappearance of these T lymphocytes from circulating blood over time may thus be correlated with beta-cell loss. Measuring beta-cell-reactive T-cell responses may therefore provide simple and sensitive immune surrogate markers of residual insulin secretion. Other surrogate markers may be obtained by measuring urinary C peptide or residual secretion of the counter-regulatory hormone glucagon.

The main objectives of this study are:

To evaluate the correlation between beta-cell-reactive T-cell responses and residual insulin secretion.
To evaluate the correlation between the residual insulin secretion measured by serum C peptide and by urinary C peptide.
To evaluate the correlation between the residual insulin and glucagon secretion.

ReferenceCitation: Scotto M, Afonso G, Osterbye T, Larger E, Luce S, Raverdy C, Novelli G, Bruno G, Gonfroy-Leymarie C, Launay O, Lemonnier FA, Buus S, Carel JC, Boitard C, Mallone R. HLA-B7-restricted islet epitopes are differentially recognized in type 1 diabetic children and adults and form weak peptide-HLA complexes. Diabetes. 2012 Oct;61(10):2546-55. doi: 10.2337/db12-0136.

ReferenceCitation: Culina S, Mallone R. Immune biomarkers in immunotherapeutic trials for type 1 diabetes: cui prodest? Diabetes Metab. 2012 Nov;38(5):379-85. doi: 10.1016/j.diabet.2012.05.005. Epub 2012 Jul 31.

ReferenceCitation: Scotto M, Afonso G, Larger E, Raverdy C, Lemonnier FA, Carel JC, Dubois-Laforgue D, Baz B, Levy D, Gautier JF, Launay O, Bruno G, Boitard C, Sechi LA, Hutton JC, Davidson HW, Mallone R. Zinc transporter (ZnT)8(186-194) is an immunodominant CD8+ T cell epitope in HLA-A2+ type 1 diabetic patients. Diabetologia. 2012 Jul;55(7):2026-31. doi: 10.1007/s00125-012-2543-z. Epub 2012 Apr 20.

ReferenceCitation: Martinuzzi E, Afonso G, Gagnerault MC, Naselli G, Mittag D, Combadiere B, Boitard C, Chaput N, Zitvogel L, Harrison LC, Mallone R. acDCs enhance human antigen-specific T-cell responses. Blood. 2011 Aug 25;118(8):2128-37. doi: 10.1182/blood-2010-12-326231. Epub 2011 Jun 28.

ReferenceCitation: Brezar V, Carel JC, Boitard C, Mallone R. Beyond the hormone: insulin as an autoimmune target in type 1 diabetes. Endocr Rev. 2011 Oct;32(5):623-69. doi: 10.1210/er.2011-0010. Epub 2011 Jun 23.

collaborators: Recherche Clinique Paris Descartes Necker Cochin Sainte Anne

location_facility: INSERM U1016 - DeAR Lab Avenir, Hôpital Cochin


title: Evaluation of an Educational Program Associated With Exercises (EDEX) Before Total Knee Arthroplasty

acronym: EDEX

summary: The purpose of this study is to determine whether a standardized education and exercise program proposed before a total knee replacement for knee osteoarthritis is effective in functional recovery after surgery.

ReferenceCitation: Nguyen C, Boutron I, Roren A, Anract P, Beaudreuil J, Biau D, Boisgard S, Daste C, Durand-Zaleski I, Eschalier B, Gil C, Lefevre-Colau MM, Nizard R, Perrodeau E, Rabetrano H, Richette P, Sanchez K, Zalc J, Coudeyre E, Rannou F. Effect of Prehabilitation Before Total Knee Replacement for Knee Osteoarthritis on Functional Outcomes: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e221462. doi: 10.1001/jamanetworkopen.2022.1462.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

publisher_dissemination: American Medical Association


title: Implication of the Antiapoptotic Protein BCL-B in the Pathogenesis of Multiple Myeloma

summary: MM accounts for 10% of hematopoietic malignancies. Despite the use of various drug combinations in chemotherapy, life expectancy of MM patients does not exceed 7 years. Until now, lack of specific markers of the disease has not allowed efficient specific molecular targeting. In view of our preliminary results, the antiapoptotic protein Bcl-B could be a novel diagnostic and pronostic marker of MM. Therefore, our main objective will be to confirm that Bcl-B is indeed a novel diagnostic and pronostic marker and a new potential therapeutic target of MM. Targeting Bcl-2 family member's is a promising strategy for the treatment of hematopoietic malignancies. In this context, specific targeting of Bcl-B could improve the treatment of patients suffering MM. Of note, this could be achieved by converting the antiapoptotic function of Bcl-B to a proapoptotic one thanks to the use of small mimetic peptides derived from Nur77 one of its interactors.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Service de Médecine interne et cancérologie - Hôpital de l'Archet


title: Comparison of 3 Learning Methods and Their Underlying Mechanisms to Improve Independent Living in the Activities of Daily Living in Alzheimer's Dementia: a Randomized Controlled Trial

summary:
This study is a comparison of 3 learning techniques, Errorless learning, modelling and trial and error, in the relearning of IADL of Alzheimer patients from mild to moderately severe dementia.

Tailored IADL will be chosen for each patient (n=300) and trained in individualized sessions for 6 weeks.

This study focuses on the relationship between learning techniques, IADL and memory processes, in a threefold way:

it will determine which of the of the three learning techniques (EL, MR, TE) will improve most the (re)learning of instrumental skills in different dementia stages using a randomized controlled trial;
it will explain the role of implicit and explicit memory mechanisms in the (re)learning of IADL tasks; and
as a secondary objective, it will explore the possible drug treatment by behavioral intervention interaction effects of the three learning techniques.

lead_sponsor: Department of Clinical Research and Innovation