title: Cardiovascular Risk and Chronic Obstructive Pulmonary Disease (COPD)

acronym: ECO-COPD

summary: The principal objective of the study is to measure parameters of inflammation, oxidative stress, and vascular, respiratory, and peripheral muscle function parameters, and identify parameters indicative of evolving cardiovascular risk (CVR) in COPD patients, using multivariate analysis.

ReferenceType: result

ReferenceCitation: Gan WQ, Man SF, Senthilselvan A, Sin DD. Association between chronic obstructive pulmonary disease and systemic inflammation: a systematic review and a meta-analysis. Thorax. 2004 Jul;59(7):574-80. doi: 10.1136/thx.2003.019588.

ReferenceCitation: Mallia P, Johnston SL. Mechanisms and experimental models of chronic obstructive pulmonary disease exacerbations. Proc Am Thorac Soc. 2005;2(4):361-6; discussion 371-2. doi: 10.1513/pats.200504-025SR.

ReferenceCitation: de Torres JP, Cordoba-Lanus E, Lopez-Aguilar C, Muros de Fuentes M, Montejo de Garcini A, Aguirre-Jaime A, Celli BR, Casanova C. C-reactive protein levels and clinically important predictive outcomes in stable COPD patients. Eur Respir J. 2006 May;27(5):902-7. doi: 10.1183/09031936.06.00109605. Epub 2006 Feb 2.

ReferenceCitation: Malo O, Sauleda J, Busquets X, Miralles C, Agusti AG, Noguera A. [Systemic inflammation during exacerbations of chronic obstructive pulmonary disease]. Arch Bronconeumol. 2002 Apr;38(4):172-6. Spanish.

ReferenceCitation: Dekhuijzen PN, Aben KK, Dekker I, Aarts LP, Wielders PL, van Herwaarden CL, Bast A. Increased exhalation of hydrogen peroxide in patients with stable and unstable chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1996 Sep;154(3 Pt 1):813-6. doi: 10.1164/ajrccm.154.3.8810624.

ReferenceCitation: Rahman I. The role of oxidative stress in the pathogenesis of COPD: implications for therapy. Treat Respir Med. 2005;4(3):175-200. doi: 10.2165/00151829-200504030-00003.

ReferenceCitation: Heunks LM, Vina J, van Herwaarden CL, Folgering HT, Gimeno A, Dekhuijzen PN. Xanthine oxidase is involved in exercise-induced oxidative stress in chronic obstructive pulmonary disease. Am J Physiol. 1999 Dec;277(6):R1697-704. doi: 10.1152/ajpregu.1999.277.6.R1697.

ReferenceCitation: Yende S, Waterer GW, Tolley EA, Newman AB, Bauer DC, Taaffe DR, Jensen R, Crapo R, Rubin S, Nevitt M, Simonsick EM, Satterfield S, Harris T, Kritchevsky SB. Inflammatory markers are associated with ventilatory limitation and muscle dysfunction in obstructive lung disease in well functioning elderly subjects. Thorax. 2006 Jan;61(1):10-6. doi: 10.1136/thx.2004.034181. Epub 2005 Nov 11.

ReferenceCitation: Carter R, Holiday DB, Nwasuruba C, Stocks J, Grothues C, Tiep B. 6-minute walk work for assessment of functional capacity in patients with COPD. Chest. 2003 May;123(5):1408-15. doi: 10.1378/chest.123.5.1408.

ReferenceCitation: Mador MJ, Kufel TJ, Pineda LA, Sharma GK. Diaphragmatic fatigue and high-intensity exercise in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2000 Jan;161(1):118-23. doi: 10.1164/ajrccm.161.1.9903010.

ReferenceCitation: Saey D, Debigare R, LeBlanc P, Mador MJ, Cote CH, Jobin J, Maltais F. Contractile leg fatigue after cycle exercise: a factor limiting exercise in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2003 Aug 15;168(4):425-30. doi: 10.1164/rccm.200208-856OC. Epub 2003 Apr 24.

ReferenceCitation: Engelen MP, Schols AM, Does JD, Wouters EF. Skeletal muscle weakness is associated with wasting of extremity fat-free mass but not with airflow obstruction in patients with chronic obstructive pulmonary disease. Am J Clin Nutr. 2000 Mar;71(3):733-8. doi: 10.1093/ajcn/71.3.733.

ReferenceCitation: Barreiro E, de la Puente B, Minguella J, Corominas JM, Serrano S, Hussain SN, Gea J. Oxidative stress and respiratory muscle dysfunction in severe chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2005 May 15;171(10):1116-24. doi: 10.1164/rccm.200407-887OC. Epub 2005 Feb 25.

ReferenceCitation: Debigare R, Cote CH, Maltais F. Peripheral muscle wasting in chronic obstructive pulmonary disease. Clinical relevance and mechanisms. Am J Respir Crit Care Med. 2001 Nov 1;164(9):1712-7. doi: 10.1164/ajrccm.164.9.2104035. No abstract available.

ReferenceCitation: Heunks LM, Dekhuijzen PN. Respiratory muscle function and free radicals: from cell to COPD. Thorax. 2000 Aug;55(8):704-16. doi: 10.1136/thorax.55.8.704. No abstract available.

ReferenceCitation: Hunninghake DB. Cardiovascular disease in chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2005;2(1):44-9. doi: 10.1513/pats.200410-050SF.

ReferenceCitation: Rennard SI. Clinical approach to patients with chronic obstructive pulmonary disease and cardiovascular disease. Proc Am Thorac Soc. 2005;2(1):94-100. doi: 10.1513/pats.200410-051SF.

ReferenceCitation: Gan WQ, Man SF, Sin DD. The interactions between cigarette smoking and reduced lung function on systemic inflammation. Chest. 2005 Feb;127(2):558-64. doi: 10.1378/chest.127.2.558.

ReferenceCitation: MacCallum PK. Markers of hemostasis and systemic inflammation in heart disease and atherosclerosis in smokers. Proc Am Thorac Soc. 2005;2(1):34-43. doi: 10.1513/pats.200406-036MS.

ReferenceCitation: Vassilakopoulos T, Karatza MH, Katsaounou P, Kollintza A, Zakynthinos S, Roussos C. Antioxidants attenuate the plasma cytokine response to exercise in humans. J Appl Physiol (1985). 2003 Mar;94(3):1025-32. doi: 10.1152/japplphysiol.00735.2002. Epub 2002 Nov 27.

ReferenceCitation: Lerman A, Zeiher AM. Endothelial function: cardiac events. Circulation. 2005 Jan 25;111(3):363-8. doi: 10.1161/01.CIR.0000153339.27064.14. No abstract available.

ReferenceCitation: Vivodtzev I, Minet C, Wuyam B, Borel JC, Vottero G, Monneret D, Baguet JP, Levy P, Pepin JL. Significant improvement in arterial stiffness after endurance training in patients with COPD. Chest. 2010 Mar;137(3):585-92. doi: 10.1378/chest.09-1437. Epub 2009 Oct 31.

ReferenceCitation: Minet C, Vivodtzev I, Tamisier R, Arbib F, Wuyam B, Timsit JF, Monneret D, Borel JC, Baguet JP, Levy P, Pepin JL. Reduced six-minute walking distance, high fat-free-mass index and hypercapnia are associated with endothelial dysfunction in COPD. Respir Physiol Neurobiol. 2012 Aug 15;183(2):128-34. doi: 10.1016/j.resp.2012.06.017. Epub 2012 Jun 18.

ReferenceCitation: Vivodtzev I, Tamisier R, Baguet JP, Borel JC, Levy P, Pepin JL. Arterial stiffness in COPD. Chest. 2014 Apr;145(4):861-875. doi: 10.1378/chest.13-1809.

ReferenceCitation: Weidemann F, Herrmann S, Stork S, Niemann M, Frantz S, Lange V, Beer M, Gattenlohner S, Voelker W, Ertl G, Strotmann JM. Impact of myocardial fibrosis in patients with symptomatic severe aortic stenosis. Circulation. 2009 Aug 18;120(7):577-84. doi: 10.1161/CIRCULATIONAHA.108.847772. Epub 2009 Aug 3.

ReferenceCitation: Marin JM, Soriano JB, Carrizo SJ, Boldova A, Celli BR. Outcomes in patients with chronic obstructive pulmonary disease and obstructive sleep apnea: the overlap syndrome. Am J Respir Crit Care Med. 2010 Aug 1;182(3):325-31. doi: 10.1164/rccm.200912-1869OC. Epub 2010 Apr 8.

ReferenceCitation: Vivodtzev I, Minet C, Tamisier R, Arbib F, Borel JC, Baguet JP, Levy P, Pepin JL. Arterial stiffness by pulse wave velocity in COPD: reliability and reproducibility. Eur Respir J. 2013 Oct;42(4):1140-2. doi: 10.1183/09031936.00014813. No abstract available.

evidence: open (via free pdf)

publisher_dissemination: European Respiratory Society

ReferenceCitation: Patel AR, Kowlessar BS, Donaldson GC, Mackay AJ, Singh R, George SN, Garcha DS, Wedzicha JA, Hurst JR. Cardiovascular risk, myocardial injury, and exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2013 Nov 1;188(9):1091-9. doi: 10.1164/rccm.201306-1170OC.

publisher_dissemination: American Thoracic Society

ReferenceCitation: Labarere J, Renaud B, Fine MJ. How to derive and validate clinical prediction models for use in intensive care medicine. Intensive Care Med. 2014 Apr;40(4):513-27. doi: 10.1007/s00134-014-3227-6. Epub 2014 Feb 26. Erratum In: Intensive Care Med. 2014 Jun;40(6):925. Bertrand, Renaud [corrected to Renaud, Bertrand].

publisher_dissemination: Springer

lead_sponsor: University Hospital, Grenoble


title: Prospective, Randomized Study Comparing Conventional, Burst And High Frequency (HF) Spinal Cord Stimulation (SCS) in Refractory Failed Back Surgery Syndrome (FBSS) Patients After a 32-contact Surgical Lead Implantation

acronym: MULTIWAVE

summary:
Chronic Back and/or Leg Pain (CBLP) after spinal surgical procedures, a condition commonly labelled Failed Back Surgery Syndrome (FBSS), affects between 15% and 40% of patients after a spine surgery. Treatment of this chronic condition by further operation or medical management has a heavy financial impact on health care systems.

Many studies have demonstrated the efficacy and economic value of Spinal Cord Stimulation (SCS) for chronic neuropathic pain, and randomized controlled trials (RCTs) have shown SCS to be a clinically effective adjunct to medical management. SCS has the advantages of being reversible and less invasive than surgery and may cause fewer issues over time than long-term pharmacological treatments.

Despite variable levels of success in the literature, approximately 30-55% of the patients treated with traditional SCS for neuropathic pain disorders will not receive adequate long term pain relief. Therefore, technical SCS system refinements, as well as new techniques have emerged.

Two new stimulation waveforms based on traditional SCS technology have appeared to further optimize the outcome for specific painful conditions;

Burst stimulation mode: which generates constant-current stimuli with 5 spikes at 500 Hz per burst and pulse width and interspike intervals of 1 ms.
High-frequency stimulation (from 1 to 10 kHz) mode.

Several studies have demonstrated the potential interest of these 2 new waveforms to treat FBSS patients compared to traditional SCS.

The Precision Spectra™ system allows MultiWave Technology by offering a broad spectrum of waveform options (from Tonic Conventional Stimulation (TCS), BURST stimulation to High Frequency stimulation (HF)).

To date, literature data comparing these 3 stimulation patterns is lacking but it is suggested the pain relief in some of non-responsive patients can be "recaptured" by increasing the SCS frequency to 500 Hz by BURST stimulation or beyond by HF stimulation. It seems important to conduct RCT in crossover, thanks to the new Precision SCS Stimulator, to compare the effects of these 3 different SCS modalities in FBSS patients and to determine which concept is the most effective in terms of pain reduction and energy consumption.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Billot M, Naiditch N, Brandet C, Lorgeoux B, Baron S, Ounajim A, Roulaud M, Roy-Moreau A, de Montgazon G, Charrier E, Misbert L, Maillard B, Vendeuvre T, Rigoard P. Comparison of conventional, burst and high-frequency spinal cord stimulation on pain relief in refractory failed back surgery syndrome patients: study protocol for a prospective randomized double-blinded cross-over trial (MULTIWAVE study). Trials. 2020 Aug 3;21(1):696. doi: 10.1186/s13063-020-04587-6.

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: Springer-Nature

lead_sponsor: Poitiers University Hospital

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Completed


title: Prospective Multicenter Registry of the Combination of Antiplatelet Agents and Anticoagulant in Atrial Fibrillation Patients With a CHA2DS2VASc Score >1 Undergoing Percutaneous Coronary Interventions

summary:
Patients undergoing percutaneous coronary intervention (PCI) with stent implantation and requiring chronic anticoagulation for atrial fibrillation (AF) with a CHA2DS2-VASc >1 are required to receive triple antithrombotic therapy . This triple therapy includes dual antiplatelet therapy with clopidogrel and aspirin in combination with an oral anticoagulant with either a vitamin K antagonist (VKA) or an oral anticoagulant (NOAC).

Recently NOAC, inhibiting the IIa (dabigatran) or Xa (rivaroxaban and apixaban) in the coagulation cascade have demonstrated non inferiority compared to VKA to prevent thrombo-embolic events in non-valvular AF for patients with a CHA2DS2-VASc >1 . Interestingly, NOAC are associated with a reduced fatal bleeding rate compared to VKA. Overall they seem to result in a lower bleeding rate compared to VKA in association with antiplatelet agents.

Recently European guidelines regarding patients requiring chronic anticoagulant therapy and undergoing coronary stent implantation have been updated. However they are based on an expert consensus because of the scarce data available.

These guidelines advocate the combination of dual antiplatelet therapy with clopidogrel and aspirin in combination with the lower dose of OAC or VKA with a target INR between 2 and 2.5 . The triple therapy should be prescribed for 1 to 6 months depending on the bleeding and thrombotic risk and the clinical setting. In patients with high bleeding risk the guidelines suggest that a sole antiplatelet agent could be used in addition to anticoagulation following the WOEST study . In the recently published ESC guidelines on the management of atrial fibrillation, despite the lack of new data, the expert advocate triple therapy followed by dual antiplatelet therapy in most patients for 12 months.

The recently published PIONEER study reinforced the possibility of the use of rivaroxaban in these patients. In this trial including ACS and not ACS patients undergoing PCI rivaroxaban 15 mg in addition to a P2Y12 ADP receptor antagonist was associated with less clinically relevant bleeding compared to triple therapy with VKA- aspirin and clopidogrel and similar efficacy .

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

intervention_type: Other

status_simplified: Unknown


title: Rapid Diagnostic of Hyperfibrinolysis in Liver Transplantation

acronym: FILYTHO

summary:
During liver transplantation (LT), hyperfibrinolysis is one of the most important modification of haemostasis. It is associated with t-PA and protein C increased activity. Hyperfibrinolysis is frequent, hardly predictable and associated with major bleeding. The diagnostic of hyperfibrinolysis with standard laboratory tests (euglobulin lysis test, t-PA, PAI-1 and D-dimers dosages) does not provide an answer in a delay compatible with the clinical practice in the operating room.

The "Lysis Timer" is a device developed by Hyphen-Sysmex in collaboration with SD Innovation and Charleroi University Hospital (Belgium). It allows the implementation of the "Global Fibrinolytic Capacity", or GFC test, in a complete system associating i) the reagents for in vitro triggering of the clot and its lysis (contact system activators, t-PA, thrombin and calcium), ii) the signal acquisition by the Lysis Timer (able to convert the analogic signal of the absorbance modifications related to clot formation into a numeric signal) and iii) a dedicated software treating the numeric signal to define clot lysis time.

The GFC test, using t-PA to shorten signal acquisition times, is particularly adapted to the diagnosis of hyperfibrinolysis with PAI-1 collapse, of which LT is an example.

lead_sponsor: University Hospital, Bordeaux

location_facility: BORDEAUX UNIVERSITY HOSPITAL Haut Lévêque


title: Comparison of Methods to Collect Healthcare Consumption Data of Patients in Clinical Trials With an Economic Evaluation

acronym: COMERE

summary:
Pragmatic study comparing historical data from usual collection tools to medical administrative databases (local / national PMSI and CRF / SNIIRAM). There are 3 phases to the data collection:

Collection of hospitalization data from the local PMSI and outpatient data from CRF
Collection of hospitalization data in the national PMSI with a probabilistic matching between local and national PMSI data
Collection of outpatient consumption data from SNIIRAM after matching of data from the national PMSI to the SNIIRAM.

time_perspective: Retrospective

ipd_sharing: Undecided

lead_sponsor: Assistance Publique - Hôpitaux de Paris

appel_a_projets: PREPS

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: COMERE

titre: COmparaison des MEthodes de REcueil des consommations de soins des patients inclus dans les projets de recherche clinique intégrant une évaluation médico-économique

discipline_principale: economie de la santé

nom_porteur: CHEVREUL

prenom_porteur: Karine


title: Chirurgie Eveillee du Cerveau Sous Realite Virtuelle Integree Aux Outils Bloc Operatoire : Etude de Tolerance

summary: Feasibility and tolerance study of virtual reality headset for brain mapping during brain awake surgery.

primary_purpose: Supportive Care

ReferenceCitation: Mazerand E, Le Renard M, Hue S, Lemee JM, Klinger E, Menei P. Intraoperative Subcortical Electrical Mapping of the Optic Tract in Awake Surgery Using a Virtual Reality Headset. World Neurosurg. 2017 Jan;97:424-430. doi: 10.1016/j.wneu.2016.10.031. Epub 2016 Oct 15.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Casanova M, Clavreul A, Soulard G, Delion M, Aubin G, Ter Minassian A, Seguier R, Menei P. Immersive Virtual Reality and Ocular Tracking for Brain Mapping During Awake Surgery: Prospective Evaluation Study. J Med Internet Res. 2021 Mar 24;23(3):e24373. doi: 10.2196/24373.

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

repository_institution: CCSD (Centre pour la Communication Scientifique Directe) - HAL - Nantes Université

repository_normalized: HAL

version: submittedVersion

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

publisher_dissemination: JMIR Publications

ReferenceCitation: Bernard F, Lemee JM, Aubin G, Ter Minassian A, Menei P. Using a Virtual Reality Social Network During Awake Craniotomy to Map Social Cognition: Prospective Trial. J Med Internet Res. 2018 Jun 26;20(6):e10332. doi: 10.2196/10332.

repository_institution: University of Geneva - Archive ouverte UNIGE

repository_institution: PubMed Central - Europe PMC

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

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

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


type: Other Identifier

title: Multicenter Phase II Study of Sentinel Node Detection in Squamous Cell Carcinoma T1-T2N0 of the Oropharynx Treated With Radiotherapy and Larynx Treated by Surgery, Laser or Robot

acronym: GS-OROPHARYNX

summary: Fifty patients with squamous cell carcinoma of the larynx T1 or T2N0 will therefore have a 99mTc lymphoscintigraphy per operative. The identified sentinel node will be removed along with the other lymph nodes of the selective group II and III recess. Sentinel lymph node staging alone and complete dissection with routine anatomical pathology will be compared If this technique is reliable it will make a therapeutic de-escalation in the treatment of small tumors of the larynx by limiting the ganglionic gesture in the patients whose sentinel node is free from metastasis and also to better choose the treatment in case of lymph node involvement

design_allocation: Non-Randomized

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

intervention_type: Procedure


title: Pressure Ulcer-associated Osteomyelitis: Retrospective Evaluation of a Two-stage Surgical Strategy (Debridement With Vacuum-assisted Closure Therapy and Reconstruction) With Prolonged Antimicrobial Therapy

summary: Pressure ulcer represents a frequent clinical condition in patient with spinal cord injury or after prolonged Intensive Care Unit (ICU) stay. Osteomyelitis constitutes a severe complication with a poorly known management, and is associated with a high rate of relapse, leading to a high-burden in hospital bed-days, financial cost, surgical intervention, antibiotic use, morbidity and mortality, and nursing care. In our reference center for bone and joint infection management, the medical and surgical strategies are systematically discussed during pluridisciplinary meetings. Most patients benefit from a two-stage surgical strategy (debridement with initiation of vacuum-assisted closure therapy until reconstruction using muscular flap) with prolonged antimicrobial therapy. In this context, our study aims to evaluate this complex approach and to determine risk factors of treatment failure in order to improve patient management, focusing on optimization of empirical antimicrobial therapy after each surgical stage, delay between the two surgical stage, and duration of antimicrobial therapy.

ReferenceCitation: Triffault-Fillit C, Valour F, Guillo R, Tod M, Goutelle S, Lustig S, Fessy MH, Chidiac C, Ferry T; Lyon BJI Study Group. Prospective Cohort Study of the Tolerability of Prosthetic Joint Infection Empirical Antimicrobial Therapy. Antimicrob Agents Chemother. 2018 Sep 24;62(10):e00163-18. doi: 10.1128/AAC.00163-18. Print 2018 Oct.

oa_colors: green other

unpaywall_oa_status: bronze

publisher_dissemination: American Society for Microbiology

ReferenceCitation: Andrianasolo J, Ferry T, Boucher F, Chateau J, Shipkov H, Daoud F, Braun E, Triffault-Fillit C, Perpoint T, Laurent F, Mojallal AA, Chidiac C, Valour F; Lyon BJI study group. Pressure ulcer-related pelvic osteomyelitis: evaluation of a two-stage surgical strategy (debridement, negative pressure therapy and flap coverage) with prolonged antimicrobial therapy. BMC Infect Dis. 2018 Apr 10;18(1):166. doi: 10.1186/s12879-018-3076-y.

repositories_concat: PubMed Central;ricerca.uniba.it

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de référence des Infections Ostéo-articulaires-Hôpital de la Croix Rousse


title: Prognostic and Predictive Biomarkers in Ovarian Cancers

acronym: OvBIOMark

summary: The investigators therefore propose to conduct a biological study of prospectively collected patient tumour samples, ascites, blood and other residual samples (feces, urine, cervical smear) throughout the disease course where markers (at diagnosis and their change with treatment) will be correlated to outcome in order to investigate how genetic diversity in OC prior to treatment and adaptation following treatment contribute to chemotherapy resistance. In addition freshly collected ascitic samples (and tumour samples) will be subjected to ex vivo DNA repair functional assays and isolated in primary culture (and established as xenografts) for target validation experiments.

primary_purpose: Basic Science

sponsor_collaborators: Gustave Roussy, Cancer Campus, Grand Paris


title: TrOma: A Cross-sectional Study Investigating Trauma Exposure, Emotion Regulation and Eating Pathology in Obese Patients

acronym: TrOma

summary: The purpose of this study is to investigate the associations between lifetime exposure to traumatic events, emotion regulation strategies, and eating pathology of patients with obesity.

time_perspective: Cross-Sectional

lead_sponsor: University of Paris 5 - Rene Descartes

sponsor_collaborators:
University of Paris 5 - Rene Descartes
European Georges Pompidou Hospital


title: Feasibility Study of Platelet Activation and Inflammatory Response of Platelets in Hematopoietic Stem Cell Allograft Patients Post-transplant: Spontaneously and After Stimulation by an CMV Antigen

acronym: FIPALLOC

summary:
Traditionally known for their role in haemostasis, platelets have also an immune role.

Platelets play a key role in immune mediator secretion, and interact with innate and adaptive immune cells, contributing to the fight against pathogens, as viruses.

Cytomegalovirus (CMV) is responsible of allograft patients' serious infections, because of the induced immune depression. Platelets activation for patients is not determined during the post-graft period, and platelet induced inflammation following a CMV infection is not described.

primary_purpose: Other

lead_sponsor: Institut de Cancérologie de la Loire

collaborators: Groupe sur l'Immunité des Muqueuses et Agents Pathogènes, (GIMAP)

collaborators: Association Stéphanoise Pour la Recherche en Hématologie-Oncologie (ASPHRO)

location_facility: Institut de Cancérologie Lucien Neuwirth

lead_sponsor_type: industriel


title: Pulmonary Microbiota in COPD Patients Colonized With P. Aeruginosa OprD Mutant Resistant to Imipenem

acronym: MiPAD

summary: Pseudomonas aeruginosa (PA ) is associated with chronic lung infections in patients with chronic obstructive pulmonary disease (COPD). Commensal flora (microbiota) in lung was recently described using high-throughput sequencing techniques (NGS). PA strains isolated during lung infection episodes of severe COPD patients often show resistance to antibiotics including imipenem that is mainly due to mutation in oprD. In collaboration with Harvard Medical School, the investigators have recently demonstrated that PA OprD mutant shows increased survival (fitness) and its virulence. This bacterium could be more likely to colonize. Colonization by PA OprD mutant could influence the pulmonary microbiota and may worsen disease evolution, particularly in terms of frequency of exacerbations. Our objective is to describe modification of pulmonary microbiota associated with PA colonization, including OprD PA mutant, in severe COPD patients. The investigators will correlate the microbiota modification to medical history. Stable severe COPD patients will be included. Three groups of patients will be sampled: 1) not PA colonized, 2) PA colonized and 3) PA OprD mutant colonized. Medical history will be recorded by the physician as usual and three samples will be performed: 1) sputum, 2) oral wash and 3) water used for oral wash. Regular bacterial culture will be performed and NGS will be performed also to characterize the microbiota.

ReferenceType: background

ReferenceCitation: Audebert C, Even G, Cian A; Blastocystis Investigation Group; Loywick A, Merlin S, Viscogliosi E, Chabe M. Colonization with the enteric protozoa Blastocystis is associated with increased diversity of human gut bacterial microbiota. Sci Rep. 2016 May 5;6:25255. doi: 10.1038/srep25255.

ReferenceCitation: Wang Z, Bafadhel M, Haldar K, Spivak A, Mayhew D, Miller BE, Tal-Singer R, Johnston SL, Ramsheh MY, Barer MR, Brightling CE, Brown JR. Lung microbiome dynamics in COPD exacerbations. Eur Respir J. 2016 Apr;47(4):1082-92. doi: 10.1183/13993003.01406-2015. Epub 2016 Feb 25.

lead_sponsor: CHU de Reims


title: Descriptive Analysis of Morphological Aspects of Nerve by Ultra-high Frequency Ultrasound (30-50MHZ) in Demyelinating Neuropathies: Inflammatory Demyelinating Polyneuropathy Chronic (IPDC), Neuropathy Multifocal Motor Block of Conducting (NMMBC) and Neuropathy With Antibody A MAG

acronym: EchoNerf

summary:
The use of nerve ultrasound for the diagnosis and monitoring of neuromuscular diseases is a promising growing field (1). Non-invasive and painless, ultrasound provides additional data electroneuromyography (EMG), with a spatial resolution at least as good as MRI, while being easily accessible and inexpensive.The polyradiculoneuritis Inflammatory Demyelinating Chronicles (IPDC), Neuropathies Motrices in Multifocal Conduction Blocks (NMMBC) and neuropathy associated with anti-MAG antibodies are among the major chronic inflammatory neuropathies with an autoimmune etiology. The diagnosis of these pathologies is based on the clinic, diagnostic tests and EMG. The interest not only in the diagnosis, but also for monitoring these pathologies using ultrasound analysis nerves has been demonstrated recently in several studies. However the limited resolution of current ultrasound images do not allow detailed study of the internal structure of the nerves which could later help deepen knowledge in this innovative field and can better understand the pathophysiological mechanism of the evolution of these pathologies .

To do this, the investigators have available a UHF ultrasound in the ultrasound department of the Nice University Hospital Pasteur Hospital 2 The investigators realize a descriptive analysis study, pilot, mono-centric, multi and prospective on patients followed in the center with a diagnosis of IPDC, a NMMBC or neuropathy with anti-MAG antibodies and control subjects matched by age and sex. All the patients and controls in this study will receive a briefing and must sign an informed consent.

They realize an ultrasound study of the nerve, using an ultra high frequency ultrasound system that will allow the assessment of anatomical structures of nerve (size, structure, vascularisation and assessment booklets). Ultrasound data will, in a second stage, compared with the data obtained with the EMG and clinical scores obtained using clinical rating scales. 40 subjects will be included, divided into four subgroups: 10 subjects with a diagnosis of IPDC (1), 10 subjects with a diagnosis of NMMBC (2), 10 subjects with a diagnosis of neuropathy antibody-anti MAG (3) and 10 control subjects with no signs of neuropathy at the EMG examination.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Vitamin D and Its Metabolites Quantification in Adipose Tissues of Obese and Non-obese

acronym: VITADOSE

summary:
Vitamin D (VD) is a pleiotropic hormone, involved in many physiological processes including calcium and phosphorus absorption. The VD metabolism begin to be well-known and involves a hepatic hydroxylation (mediated by enzymes, which belong to the cytochrome P450 family) leading to the production of the 25(OH)D, which corresponds to the circulating form of the VD. After circulation in blood, the 25(OH)D is submitted to a second hydroxylation in the kidney resulting to the generation of 1,25(OH)2D, the active metabolite of VD. Numerous epidemiological studies reported an inverse relationship between obesity and circulation level of 25(OH)D. Several mechanisms could explain the low level of 25(OH)D observed in obese subjects, the more classical evoked being based on sequestration and/or dilution of VD in adipose tissue (AT), the main VD storage site. However, this mechanism has never been demonstrated. In order to confirm this hypothesis, the concentration of VD and its metabolites in adipose tissue need to be quantified.

The objective of this study is to determine the concentration of VD and its metabolites in adipose tissue as well as adipose tissue mass quantification and distribution (visceral or subcutaneous) to highlight putative difference of VD and its metabolites quantities between obese and non-obese patients. A quantification of VD metabolism, inflammation and lipid metabolism gene expression will be realized on biopsies. Correlations between gene expression and quantity of VD in tissue will be carrying out.

status: Recruiting

sponsor_collaborators: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille

intervention_type: Biological

status_simplified: Ongoing


title: Salivary Alpha Amylase Bronchial Measure for Early Aspiration Pneumonia Diagnosis in Patients Treated With Therapeutic Hypothermia After Out-of-hospital Cardiac Arrest.

summary:
Early Aspiration Pneumonia is a frequent and dreadful complication in survivors of cardiac arrest. Therapeutic Hypothermia widely used in Intensive Care Unit for its benefice on post cardiac arrest syndrome may otherwise hide signs of early pneumonia that may occur without use of a reliable screening biological marker. The goal is to assess the diagnostic accuracy of bronchial alpha amylase measure to predict a risk of early aspiration pneumonia in patients successfully resuscitated after out-of-hospital cardiac arrest.

In this prospective non interventional study we included patients resuscitated after cardiac arrest and treated with Targeted Temperature Management (TTM). A distal bronchoalveolar lavage using specific display (Combi-Cath) was executed immediately after admission for each patient with both biochemic and bacteriological analysis including dosage of bronchial salivary alpha amylase. Urea was used as a marker of dilution in the measure of bronchial and plasmatic alpha amylase. Aspiration pneumonia diagnosis was established with clinical and biological criteria. On this basis we intended to determine a threshold measure of alpha amylase predicting occurrence of aspiration pneumonia and allowing a guidance in antibiotherapy prescription. Sensibility and Specificity of this technique were determined.


acronym: STIMCOM

summary:
Limited treatments are available to improve consciousness in severely brain injured patients. Transcranial Direct Current stimulation (tDCS) is one of the few therapeutics that showed evidence of efficacy to increase level of consciousness and functional communication in some minimally conscious state (MCS) patients, and in some vegetative state (VS) patients. However the optimal intensity of electrical current stimulation remains unknown.

This study will test the effects of two intensities of tDCS stimulation (either 0.2mA or 2mA) applied on left dorso-lateral prefrontal cortex on both behavior, - assessed by the Coma Recovery Scale-Revised (CRS-R) scores -, as well as quantified EEG recorded during resting state (using algorithms previously designed and published by the investigators) and event-related potentials (using auditory paradigms we previously published) in severely brain damaged patients with disorders of consciousness (MCS, VS, and conscious but cognitively disabled patients) of various etiologies.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

sponsor_collaborators:
Groupe Hospitalier Pitie-Salpetriere
Hôpital Raymond Poincaré
Hospices Civils de Lyon


title: Evaluation de l'Intervention Des Services de Protection Maternelle et Infantile de 11 départements français Ayant bénéficié d'un référentiel Commun d'Intervention à Domicile (Projet Panjo : Promotion de la Santé et de l'Attachement Des Nouveau-nés et de Leurs Jeunes Parents : un Outil de Renforcement Des Services de PMI)

acronym: PANJO

summary: The PANJO study aims to evaluate, within the French public health services, the impact of a home visitors training on parent-child attachment, families outcomes, use of services and child maltreatment indicators.

primary_purpose: Prevention

ReferenceCitation: Saïas, T, Delawarde, C, Colson, S, Planche, M, Vallée, V, Du Roscoät, E, Bonnard, A, Bodard, J, Dugravier, R. De l'expérimentation scientifique à l'implantation dans les services publics : le projet Panjo. Revue Francophone Internationale de Recherche Infirmière, 2 : 232-241, 2016.

lead_sponsor: L'Agence des Nouvelles Interventions Sociales et de Santé

collaborators: Institut national de prevention et d'education pour la sante


title: Determination of Normal Range Values of Thrombin Generation Parameters in Pediatrics Population Using a New Standardized Thrombin Generation Assay

acronym: TGT

summary: The aim of this study is to establish normal values of thrombin generation assay parameters in pediatrics, according to different age groups. The standardized thrombin generation assay "Genesia™" will be used. Different age groups of healthy children will be recruited : neonates, 1-3 months, 3-6 months, 6-12 months, 1-2 years, 2-6 years, 6-12 years, and 12-15 years old. Adults values will be obtained (healthy adults > 18 years old).


title: Preterm Birth and Social Cognition: of the Executive Functions and Parental Anxiety's Stakes

acronym: TERM-COG

summary: The study aims at investigating social cognition outcomes of children born prematurely. Social cognition can be briefly defined as a process which underlines people's social and emotional behaviors. There are behavioral and cognitive evidences indicating that preterm children have executive dysfunctions. Executive functions refer to multiple cognitive processes that contribute to human higher order abilities, such as purposeful and future-orientated behavior. The literature regarding development of term born children indicates that executive functions are linked to the emergence of social cognition. Then, the investigators asked if children born prematurely, as they commonly present executive dysfunctions, would show an atypical development of social cognition. Additionally, as it has been shown that parental anxiety is a key factor of preterm children development, the investigators assumed that it should play a role in social cognition outcomes.

ReferenceCitation: Eutrope J, Novo A, Barbe C, Loron G, Rolland AC, Caillies S. Impact of Executive Functions and Parental Anxiety on the Development of Social Cognition in Premature Children: A Cross-Sectional Case-Control Protocol. Front Psychiatry. 2021 Sep 9;12:484571. doi: 10.3389/fpsyt.2021.484571. eCollection 2021.

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

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

publisher_dissemination: Frontiers

intervention_type: Behavioral


title: Effect of High-flow Nasal Cannula Therapy on Exposure to Nasal Continuous Positive Airway Pressure in Very Preterm Infants

acronym: HIFLO

summary: The HIFLO study evaluates the impact of HFNC oxygen therapy on duration of nCPAP therapy, oxygen therapy and hospitalization. The cost of use of CPAP and two HFNC devices are also evaluated.

lead_sponsor: Hôpital de la Croix-Rousse


title: An Open Prospective Randomized Controlled Study Comparing the Use of Remote Monitoring by Smartphone in the Care Management of Patients With Rheumatoid Arthritis Versus a Standard Outpatient Follow-up by Physical Consultation

acronym: SATIE-PR

summary:
Rheumatoid arthritis (RA) is the most common inflammatory rheumatism in adults, affecting nearly 0.4% of the general population. It is a real public health issue. International guidelines recommend strict control (remission or low disease activity) of the disease, to avoid joint destruction in order to reduce the functional impact of the disease in the long term and to improve the quality of life of the patients.

This care is based on a close follow-up requiring regular visits with the specialist which represents an additional cost (transport, visits). In this context, tele-medicine is often proposed as a complementary approach in the management of these chronic patients.

Thus, the investigators propose to study the interest of a connected device by comparing a group of patients using this Smartphone application, coupled with a hand dynamometer during the 6 months following initiation of a new DMARD.

status: Terminated

primary_purpose: Diagnostic

ReferenceCitation: Pers YM, Valsecchi V, Mura T, Aouinti S, Filippi N, Marouen S, Letaief H, Le Blay P, Autuori M, Fournet D, Mercier G, Ferreira R, Jorgensen C. A randomized prospective open-label controlled trial comparing the performance of a connected monitoring interface versus physical routine monitoring in patients with rheumatoid arthritis. Rheumatology (Oxford). 2021 Apr 6;60(4):1659-1668. doi: 10.1093/rheumatology/keaa462.

ReferenceCitation: Bernard L, Valsecchi V, Mura T, Aouinti S, Padern G, Ferreira R, Pastor J, Jorgensen C, Mercier G, Pers YM. Management of patients with rheumatoid arthritis by telemedicine: connected monitoring. A randomized controlled trial. Joint Bone Spine. 2022 Oct;89(5):105368. doi: 10.1016/j.jbspin.2022.105368. Epub 2022 Mar 4.

lead_sponsor: University Hospital, Montpellier

collaborators:
European Union
Occitanie Region

sponsor_collaborators:
University Hospital, Montpellier
European Union
Occitanie Region


title: Transition From Adolescents to Adulthood for Patients With Congenital Patients With Congenital Heart Diseases: Impact of a Therapeutic Education Program on Quality of Life

summary: The Investigators aim to measure the impact of a transition program in congenital cardiology in terms of health-related quality of life.

ReferenceCitation: Werner O, Bredy C, Lavastre K, Guillaumont S, De La Villeon G, Vincenti M, Gerl C, Dulac Y, Souletie N, Acar P, Pages L, Picot MC, Bourrel G, Oude Engberink A, Million E, Abassi H, Amedro P. Impact of a transition education program on health-related quality of life in pediatric patients with congenital heart disease: study design for a randomised controlled trial. Health Qual Life Outcomes. 2021 Jan 19;19(1):23. doi: 10.1186/s12955-021-01668-1.

evidence: oa repository (via page says license)

repository_normalized: Research Square

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: Research Square - Research Square

repositories:
HAL
PubMed Central
Research Square

repositories_concat: HAL;PubMed Central;Research Square

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

location_facility: Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital


title: Enhanced Lung Protective Ventilation for ARDS Patients With PrismaLung

acronym: PROVAP

summary:
Acute Respiratory Distress Syndrome (ARDS) still remains associated with a mortality rate of 30 - 45 % despite improvement in mechanical ventilation. Driving pressure, defined as the difference between the end-inspiratory and the end-expiratory airway pressure, appears as an important factor contributing to mortality in patients with the ARDS. In patients already receiving a conventional tidal volume of 6 ml/kg predicted body weight (PBW), a driving pressure ≥ 14 cmH2O increases the risk of death in the hospital. One mean to lower the driving pressure is to decrease the tidal volume such that from 6 to 4 ml/kg predicted body weight. However, this strategy promotes hypercarbia by reducing the alveolar ventilation, providing the respiratory rate is constant. In this setting, implementing an extracorporeal CO2 removal (ECCO2R) therapy may offset the associated hypercarbia. The investigators have previously demonstrated that combining a membrane oxygenator within an hemofiltration circuit provides efficacious low flow ECCO2R on a renal replacement therapy monitor. In this study, we thought to investigate the efficacy of the PrismaLung stand-alone therapy. Using a PrismaFlex monitor and a HP-X circuit, a neonatal membrane oxygenator (PrismaLung) is used to provide decarboxylation without renal replacement therapy. The study will consist in three periods:

The first period will address the efficacy of the PrismaLung device at tidal volume of 6 and 4 ml/kg PBW using an off-on-off design.
The second part of the study will investigate the effect of varying the sweep gas flow and the mixture of the sweep gas on the CO2 removal rate (random order).

The third part will compare three ventilatory strategies applied in a cross-over design :

Minimal distension: Tidal volume 4 ml/kg PBW and positive end-expiratory pressure (PEEP) based on the ARDSNet PEEP/FiO2 table (ARMA).
Maximal recruitment: 4 ml/kg PBW and PEEP adjusted to maintain a plateau pressure between 23 - 25 cmH2O.
Standard: Tidal volume 6 ml/kg and PEEP based on the ARDSNet PEEP/FiO2 table (ARMA).

Each strategies will be apply in a random order for a duration of 22 hours. Pulmonary inflammatory and fibrosis pathway will be assess before and after each period using bronchoalveolar lavage (BAL) samples. Systemic inflammatory cytokines will also be investigate. Main measurements will include respiratory mechanics, transpulmonary pressure, work of breathing, end-expiratory lung volume and tidal ventilation using electrical impedance tomography.

ReferenceCitation: Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291. Erratum In: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350.

repository_institution: Queen's University Belfast - Research Portal

publisher_dissemination: American Medical Association

ReferenceCitation: Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639.

oa_host_type: publisher

evidence: open (via free article)

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Allardet-Servent J, Castanier M, Signouret T, Soundaravelou R, Lepidi A, Seghboyan JM. Safety and Efficacy of Combined Extracorporeal CO2 Removal and Renal Replacement Therapy in Patients With Acute Respiratory Distress Syndrome and Acute Kidney Injury: The Pulmonary and Renal Support in Acute Respiratory Distress Syndrome Study. Crit Care Med. 2015 Dec;43(12):2570-81. doi: 10.1097/CCM.0000000000001296.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

unpaywall_oa_status: hybrid

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Hôpital Européen Marseille


title: Telemonitoring in Pulmonary Rehabilitation: Validity of a Remote Pulse Oxymetry System

acronym: TELE-REHAB

summary:
The purpose of this study is to assess the feasibility and the reliability of a telemonitoring system during pulmonary rehabilitation in patients with chronicle obstructive pulmonary disease.

The feasibility is assessed using the patient's satisfaction and it ease of use.

The reliability of the remote telemonitoring system is assessed comparing the local data (extracted from the monitoring device itself) and the data transmitted through the telemonitoring platform.

ReferenceCitation: Bonnevie T, Gravier FE, Elkins M, Dupuis J, Prieur G, Combret Y, Viacroze C, Debeaumont D, Robleda-Quesada A, Quieffin J, Lamia B, Patout M, Cuvelier A, Muir JF, Medrinal C, Tardif C. People undertaking pulmonary rehabilitation are willing and able to provide accurate data via a remote pulse oximetry system: a multicentre observational study. J Physiother. 2019 Jan;65(1):28-36. doi: 10.1016/j.jphys.2018.11.002. Epub 2018 Dec 17.

lead_sponsor: ADIR Association


title: Functioning of the Mirror Neurons System in Parkinson's Disease and Its Impact on the Social Cognition

summary: Parkinson's disease (PD) is usually responsible of cognitive and behavioral non-motor signs with a major impact on the quality of life. Social cognition is a complex system relying on emotion recognition (neurons mirror system, NMS), the theory of mind (with its two parts: emotional and cognitive), but also on the social and cultural environment and the personal history. The first step in this model is represented by the NMS, which seems to be altered in PD patients for both positive and negative emotions as shown in our preliminary study. The investigator purpose is to investigate the role of the treatment (levodopa and deep brain stimulation) on the functioning of the NMS.

location_facility: Service de Neurologie C Hôpital " Pierre Wertheimer "


title: Running Versus Interrupted Deep Plane Sutures in Massive Weight Loss Patients: a Randomized Double Blind Study

summary: The goal of this study is to assess whether running deep wound stiches will be superior to deep interrupted stiches in body contouring surgeries in massive weight loss patients. This is a split-wound study, thereby providing an internal control within each wound. Each side of the wound will be randomized to receive one of the two suturing techniques. Patients and raters will be blinded to the suture technique used in both wound-halfs.

lead_sponsor: St Joseph University, Beirut, Lebanon

sponsor_collaborators:
St Joseph University, Beirut, Lebanon
Fondation Hôpital Saint-Joseph


title: Correlation Study Between Heart Rate Variability and Anxiety in Anorexia Nervosa

acronym: VARIASTRESS

summary:
The heart rate variability (HRV) is a measure of the autonomic nervous system (ANS). In the model of anorexia nervosa, ANS is disturbed with mostly a predominance of activation of the parasympathetic nervous system and a decrease of the sympathetic system. Various explanations of this these dysfunctions are proposed in literature, mainly malnutrition, physical hyperactivity, anxiety, that are known characteristics of anorexia nervosa.

The primary aim of this study is to evaluate correlation between ANS dysfunction and anxiety in anorexia nervosa.

Other objectives of this study are firstly to evaluate correlation between ANS dysfunction and others parameters (weight, body mass index, depression, physical activity, purgative ou restrictive type, duration of disease, smoking) in anorexia nervosa and secondly to see if HRV is a predictive parameter of the evolution of anorexia nervosa.


title: Mastectomy in Ambulatory Breast Surgery

acronym: MASTAMBU

summary: This is a prospective observational study, involving 550 mastectomies in Lorraine Institute of Oncology, to assess care patients management of ambulatory surgical compared to standard surgery procedure.

ReferenceCitation: Hejl L, Raft J, Leufflen L, Rauch P, Buhler J, Abel-Decollogne F, Routiot T, Hotton J, Salleron J, Marchal F. Quality of life, anxiety, and postoperative complications of patients undergoing breast cancer surgery as ambulatory surgery compared to non-ambulatory surgery: A prospective non-randomized study. J Gynecol Obstet Hum Reprod. 2021 Feb;50(2):101779. doi: 10.1016/j.jogoh.2020.101779. Epub 2020 May 11.

lead_sponsor: Institut de Cancérologie de Lorraine


title: Auditory Rehabilitation With Hearing Aids and Cognition in Alzheimer Patients

acronym: RACO-MA

summary:
Alzheimer disease is a neurodegenerative disease. Recent studies suggest that subjects with hearing loss are more likely to develop Alzheimer's disease. Hearing loss can be consecutive to presbycusis and/or to central auditory dysfunction.

Standard audiometric measures with pure tone and speech intelligibility allow the diagnosis of presbycusis. However, to demonstrate central auditory dysfunction, specific audiometric tests as noisy and/or dichotic tests, are needed.

Actually, no consensus exists to investigate hearing loss in people with Alzheimer's disease; therefore hearing loss may be an early manifestation of Alzheimer's disease. Until now, investigations and clinical procedure related to the diagnosis of Alzheimer's disease ignored the hearing ability of the patient. However, the major part of care management and investigations implies the patient's communication ability with caregivers. Hearing loss may be one of the most unrecognized deficit in subjects with Alzheimer's disease. Auditory rehabilitation with hearing aids could benefit to the patient to decrease cognitive decline but this management must be investigate during longitudinal studies in order to demonstrate their efficiency and need to be compared with a placebo.

lead_sponsor: University Hospital, Tours

appel_a_projets: PHRCI

region: Centre-Val de Loire

nom_etablissement: CHU DE TOURS

acronyme: RACO-MA

titre: Réhabilitation auditive et cognition chez les patients atteints d'une maladie d'Alzheimer ou d'un déclin cognitif léger

discipline_principale: autre

nom_porteur: BAKHOS

prenom_porteur: David


acronym: PSYEDUC

summary:
The involvement of family members is crucial and improves the prognosis of psychiatric patients and reinforces therapeutic adherence and reduces the frequency of relapses. For schizophrenia, the scientific literature clearly shows that it's in the interest of the patient to offer to his family a psychoeducational program.

Therapeutic education programs are now part of the recommendations of good clinical practice and in the French health through the law n ° 2009-879 of July 21, 2009 on the reform of the hospital and relating to patients, health and territories.

ReferenceCitation: Misdrahi D, Petit M, Blanc O, Bayle F, Llorca PM. The influence of therapeutic alliance and insight on medication adherence in schizophrenia. Nord J Psychiatry. 2012 Feb;66(1):49-54. doi: 10.3109/08039488.2011.598556. Epub 2011 Aug 10.

lead_sponsor: Centre Hospitalier Charles Perrens, Bordeaux

appel_a_projets: PHRIP

region: Nouvelle-Aquitaine

nom_etablissement: CH CHARLES PERRENS

type_etablissement: EPSM

acronyme: PsyEduc

titre: Évaluation d'un programme psychoéducatif destiné aux aidants de patients souffrants de schizophrénie : étude observationnelle .

discipline_principale: psychiatrie / addictologie

nom_porteur: ROGER


title: Study of RNA and Heat Shock Protein (HSP) Derived Biomarkers in Radiation-induced Fibrosis in Patients Treated for Breast Cancer.

acronym: SPLICI-Rad

summary: The purpose of this study is to seeking a molecular signature of pathological radiation induced fibrosis based on the response of skin fibroblasts after irradiation, comparing two groups of patients distinguished by their individual radiosensitivity. The signature will integrate recent insights in terms of alternative splicing of mRNAs and level of expression of non-coding RNAs, particularly long non-coding RNAs, snRNAs, snoRNAs and microRNAs. In each group each expression patterns of candidate HSP proteins potentially predictive of pathological radiation induced fibrosis (HSP27, HSP70, αβ crystalline) in the serum and on cell culture will be characterized.


title: A Phase III Randomized Trial of Avelumab-cetuximab-Radiotherapy Versus Standards of Care in Locally Advanced Squamous Cell Carcinoma of the Head and Neck

acronym: REACH

summary: The purpose of this study is to demonstrate that treatment with avelumab in combination with RT-cetuximab is superior to standard of care (SOC) cisplatin-RT and/or to SOC RT-cetuximab alone in terms of progression-free survival (PFS) in front-line patients with locally advanced SCCHN.

status: Active, not recruiting

ReferenceCitation: Tao Y, Auperin A, Sun X, Sire C, Martin L, Coutte A, Lafond C, Miroir J, Liem X, Rolland F, Even C, Nguyen F, Saada E, Maillard A, Colin-Batailhou N, Thariat J, Guigay J, Bourhis J. Avelumab-cetuximab-radiotherapy versus standards of care in locally advanced squamous-cell carcinoma of the head and neck: The safety phase of a randomised phase III trial GORTEC 2017-01 (REACH). Eur J Cancer. 2020 Dec;141:21-29. doi: 10.1016/j.ejca.2020.09.008. Epub 2020 Oct 24.

evidence: open (via crossref license)

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou

intervention_type: Drug


title: Pupillary Diameter Without Stimulation Under Different Concentrations of Propofol Alone

summary: Resting pupillary diameter was measured at a randomized Effect-site target concentration of propofol used as a sole anesthetic.

ReferenceCitation: Sabourdin N, Meniolle F, Chemam S, Rigouzzo A, Hamza J, Louvet N, Constant I. Effect of Different Concentrations of Propofol Used as a Sole Anesthetic on Pupillary Diameter: A Randomized Trial. Anesth Analg. 2020 Aug;131(2):510-517. doi: 10.1213/ANE.0000000000004362.

lead_sponsor: Hôpital Armand Trousseau

location_facility: Departement d'anesthesie Hopital Armand Trousseau


title: Population Pharmacokinetics Approaches for the Optimization of Anti-infective Concentrations Among Hospitalized Patients

acronym: OptiPOP

summary:
In case of sepsis, the therapeutic success is strongly influenced by the choice of anti-infectives (AI) in terms of spectrum, dosage and administration schedule. It is therefore critical to achieve adequate AI concentration as quickly as possible.

This protocol aims to define a common framework to studies conducted jointly by the Antimicrobial Stewardship Tea, the Pharmacology department of Cochin hospital and within the APHP Centre hospital group for various AI in a range of specific study populations (intensive care unit patients, neutropenic patients…).

These studies will use mathematical modeling methodologies to investigate the pharmacokinetics (PK) and pharmacodynamics (PD) of different AI including PK/PD targets or any other biological compartment. The effects of covariates on PK and PD parameters will be investigated to better explain the between-subject variability (BSV) and to ultimately suggest individualized dosage regimens.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Evaluation of the Switch From the Original Infliximab ( REMICADE®) to Its Biosimilar (INFLECTRA®) in Daily Practice at Cochin Hospital

acronym: SIC

summary: The purpose of this study is to evaluate the effectiveness of the switch from the original infliximab ( REMICADE®) to its biosimilar (INFLECTRA®) in all the patients at Cochin hospital receiving REMICADE® for either a rheumatic, gastro-enterologic or ophthalmic condition


title: Effect of Infant Formula Consumption on Infant Growth From 0 to 6 Months

acronym: BABYMILK

summary:
From birth to 5 months, milk is the essential and unique food of the newborn. The French National Nutrition Program (PNNS) recommends exclusive breastfeeding "up to 6 months and at least 4 months for a healthy benefit". However, only 36% of infants 0-6 months of age are exclusively breastfed worldwide. Some mothers choose to give infant formula to their baby in the first few months of life. This decision may be a personal choice or be imposed by pathophysiological situations.

The nutritional requirements of the infant are specific, which implies adequate nutrition. Infant formulas and follow-up formulas are therefore complex products, specially developed for a group of vulnerable consumers. In fact, the compositional and information requirements for infant formula are highly regulated.

Even clinical studies are not required to market an infant formula, it is important to obtain objective date on infant growth. Therefore, this study proposes to evaluate the effect of the consumption of an infant formula on the growth of infants from 0 to 6 months in comparison with the growth curves of the World Health Organization (WHO).

lead_sponsor: Institut Pasteur de Lille


title: Reliability of Indocyanine Green Use in Sentinel Lymph Node Identification in Cancer Surgery

acronym: GASVERT

summary:
This is a single-center prospective clinical trial to evaluate non-inferiority of indocyanine green guided sentinel lymph node biopsy compared with the gold standard Technecium99 guided sentinel lymph node biopsy in patients with cancers and subjected to surgery.

The diagnostic performance and the tolerance of indocyanine green (ICG) to the radio-isotope (Techniciun99) in the detection of sentinel lymph nodes will be assess using an "Optonuclear" probe (EURORAD S.A.) and QUEST camera


title: Asa Test ; un Nouvel Outil Dans le dépistage du Traitement Par Aspirine ? (This Official Titre is in French and Contains no Spelling Error. English Translation for it Would be : "ASA-test. A New Tool for the Screening of Aspirin Treatment")

acronym: FirstAMOS

summary: prospective interventional study. The aim is to analyse the effect of usual ongoing treatments over the microvascular cutaneous response to galvanic current application (Current induced vasodilation ; CIV) on the forearm of subjects referred for ultrasound investigations due to suspicion of peripheral artery disease. Hypothesis is that the use of aspirin (even at low dose) abolishes the response .

lead_sponsor: University Hospital, Angers


title: Feasibility of Breast Cancer Risk Evaluation in Women From the General Population

acronym: RIVIERA

summary: This study aims to evaluate the feasibility (acceptability) of a consultation dedicated to informing women about their risk of breast cancer and the screening methods recommended for them according to the recommendations in force during a routine consultation at a general practitioner, a gynecologist or a radiologist.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Randomised Phase III Multicentric Study Comparing Efficacy of Doxorubicin With Trabectedin Followed by Trabectedin in Non-progressive Patients Versus Doxorubicine Alone as First-line Therapy in Patients With Metastatic or Unresectable Leiomyosarcoma (Uterine or Soft Tissue)

summary:
The objective of LMS04 study is to better define the treatment strategy for patients with metastatic leiomyosarcoma (uterine or soft tissue), as well as identifying the best first line therapeutic option for these patients. LMS04 will test a new strategy for first line therapy LMS sarcoma compare to the reference therapy (6 cycles of doxorubicin alone): the interest of the association of trabectedin to doxorubicin in first line treatment followed by trabectedin alone for non-progressive patients after 6 cycles of the association of trabectedin and doxorubicin (the LMS02 design).

LMS04 will be the first phase III randomized study specifically dedicated to soft tissue leiomyosarcoma in first line metastatic disease.

It is planned to compare a new doxorubicin combination (including trabectedin) with very encouraging results followed by trabectedin maintenance therapy for non-progressive patients to doxorubicin alone. Prospective ancillary translational studies will attempt to define profiles of patients who could benefit from this new chemotherapy in an exploratory way.

The validation of a new first line option specific for LMS, identifying clinical factors that characterize aggressiveness and responsiveness to treatment aims to have an important in the spirit of personalized medicine in this rare and deadly disease.

ReferenceCitation: Pautier P, Italiano A, Piperno-Neumann S, Chevreau C, Penel N, Firmin N, Boudou-Rouquette P, Bertucci F, Balleyguier C, Lebrun-Ly V, Ray-Coquard I, Kalbacher E, Bardet A, Bompas E, Collard O, Isambert N, Guillemet C, Rios M, Archambaud B, Duffaud F; French Sarcoma Group. Doxorubicin alone versus doxorubicin with trabectedin followed by trabectedin alone as first-line therapy for metastatic or unresectable leiomyosarcoma (LMS-04): a randomised, multicentre, open-label phase 3 trial. Lancet Oncol. 2022 Aug;23(8):1044-1054. doi: 10.1016/S1470-2045(22)00380-1. Epub 2022 Jul 11.

ReferenceCitation: Hanvic B, Ray-Coquard I. Gynecological sarcomas: literature review of 2020. Curr Opin Oncol. 2021 Jul 1;33(4):345-350. doi: 10.1097/CCO.0000000000000753.


title: Prevalence of Chronic Pain After Scoliosis and Thoracic Surgery in Children

acronym: PEDIACHROII

summary:
The aim of this epidemiologic prospective study is to determine the prevalence of CPSP defined as pain occurring 4 months after scoliosis and thoracic surgery and rated > 3 on a 10 point visual analogue scale or FLACC scale, in children aged from 6 to 18 years.

The main objective : prevalence of chronic post surgical pain 4 months after scoliosis ant thoracic surgery in children aged 6 to 18 years.

The secondary objectives: the intensity of chronic post surgical pain, the prevalence of neuropathic syndrome and the predictive risk factors.

ReferenceCitation: Batoz H, Semjen F, Bordes-Demolis M, Benard A, Nouette-Gaulain K. Chronic postsurgical pain in children: prevalence and risk factors. A prospective observational study. Br J Anaesth. 2016 Oct;117(4):489-496. doi: 10.1093/bja/aew260. Epub 2016 Oct 17.

license: publisher-specific-oa

license_normalized: publisher-specific

lead_sponsor: University Hospital, Bordeaux

location_facility: Centre hospitalier Universitaire de Bordeaux


title: Analysis of the Capacity to Regulate Physical Efforts and to Estimate Its Intensity as an Endophenotype of Anorexia Nervosa, Because of a Specific Impact of the Physical Effort at the Emotional, Cognitive, Pain, Genetic and Biological Level

acronym: CAPANOX

summary:
The purpose of this study is to check if patients, but also relatives (as they share familial and genetic risk factors), are having more difficulties in regulating a spontaneous, pleasant physical effort (doing "too much") compared to healthy controls, and if physical efforts are participating to core symptoms of anorexia nervosa, such as more appetite (instead of less), less pain, more abnormal body image, and less cognitive flexibility.

Such a result could help to further understand the role of difficulties with physical exercise as part of the phenotype of anorexia nervosa.

lead_sponsor: Centre Hospitalier St Anne


acronym: POOL-BM

summary: The investigators compared a pooled mother's expressed breastmilk for 24 hours with individual pump session collection of milk to provide a more consistent caloric product without increasing bacterial contamination.

lead_sponsor: University Hospital, Brest


title: Elastometry of the Salivary Glands in Sicca Syndrome

acronym: ELSA

summary: Ultrasonography in salivary gland has demonstrated its usefulness to diagnose and follow patients with Sjögren syndrome (pSS). More recently, a new imaging technique allows to study the parenchymal elasticity in salivary glands and could be a new tool to evaluate patients with sicca syndrome and pSS.


title: Interest of Plasma Copeptin Levels in Management of Children With Diabetic Ketoacidosis

acronym: COPACD

summary:
Children with diabetic ketoacidosis risk neurological complications such as cerebral edema with high morbidity. To prevent cerebral edema, it is essential to control correction of hypovolemia, hyperglycemia and natremia. Markers usually used in management of diabetic ketoacidosis don't always permit an optimal care.

Plasma copeptin levels reflect vasopressin secretion which is high in diabetic ketoacidosis.

Therefore, monitoring of plasma copeptin levels could be of interest in children with diabetic ketoacidosis and risk of sévère neurological complications.


title: Axillary Reverse Mapping Using Near-infrared Imaging in Invasive Breast Cancer: Predictors of Nodal Positivity

acronym: ARMONIC

summary:
The initial standard treatment of breast cancer is surgery. Tumor involvement of lymph nodes is of paramount importance in the subsequent management of this cancer and surgery of invasive breast cancer (BC) involves axillary lymph node dissection (ALND). To preserve arm lymphatic drainage during ALND and avoid the risk of arm lymphedema, mapping the lymphatic drainage by axillary reverse mapping (ARM) has been developed. But oncological safety is uncertain.

The ARM procedure presented here uses indocyanine green (ICG) and fluorescence detection of draining lymphatics. The project aims to train surgeons to the technique and to identify predictive factors for metastatic ARM nodes in invasive BC using tumor and axillary pathological parameters to better select patients who would not require removal of the ARM node in the future

ReferenceCitation: Conversano A, Abbaci M, Karimi M, Mathieu MC, de Leeuw F, Michiels S, Laplace-Builhe C, Mazouni C. Axillary reverse mapping using near-infrared fluorescence imaging in invasive breast cancer (ARMONIC study). Eur J Surg Oncol. 2022 Dec;48(12):2393-2400. doi: 10.1016/j.ejso.2022.07.004. Epub 2022 Jul 8.

ReferenceCitation: Abbaci M, Conversano A, Karimi M, Mathieu MC, Rouffiac V, De Leeuw F, Michiels S, Laplace-Builhe C, Mazouni C. Near-Infrared Fluorescence Axillary Reverse Mapping (ARM) Procedure in Invasive Breast Cancer: Relationship between Fluorescence Signal in ARM Lymph Nodes and Clinical Outcomes. Cancers (Basel). 2022 May 25;14(11):2614. doi: 10.3390/cancers14112614.

repositories:
PubMed Central
Research Square

repositories_concat: PubMed Central;Research Square

publisher_dissemination: MDPI


title: Prognostic Value of Functional Exercise Test (EFX) in Cystic Fibrosis

acronym: EFX

summary: The objective of study is to prospectively determine if CPET with blood gas analysis should have a prognostic value in CF. The study plans to include 300 cystic fibrosis patients. Inclusion criteria will be: age >15 years, cystic fibrosis confirmed by chloride sweat test or genetic analysis, clinical and functional stability in the 2 month before CPET. Patients will perform a maximal exercise test on a cycloergometer during the inclusion visit, with pulmonary function testing and a six-minute walk test. The study will also include a visit every 6 months with: body mass index calculation, pulmonary function testing with DLCO (diffusing lung capacity for carbon monoxide), a six minute walk test, and antibacteriological study of sputum. The results of this study could help identify earlier the patients for referral to a lung transplantation centre, by using the usual criteria and the CPET abnormalities.

lead_sponsor: University Hospital, Lille


title: A Phase II Study to Assess the Efficacy of the Anti-PD-L1 Antibody Atezolizumab (MPDL3280A) Administered With Stereotactic Ablative Radiotherapy (SABR) in Patients With Metastatic Tumours

summary:
Although it is usually described as an immunosuppressive modality and not thought of as immunotherapy, there are new preclinical evidences suggesting that high-dose ionizing irradiation (IR) results in direct tumour cell death and augments tumour-specific immunity, which enhances tumour control both locally and distantly. Importantly, IR effects exceed the classical cytocidal properties by also causing phenotypic changes in the fraction of surviving cells, markedly enhancing their susceptibility to T cell-mediated elimination. However, not all IR-induced modifications of the tumour and its microenvironment favor immune rejection. The tumour microenvironment is populated by various types of inhibitory immune cells including Tregs, alternatively activated macrophages, and myeloid-derived suppression cells (MDSCs), which suppress T cell activation and promote tumour outgrowth. Chiang et al. showed the accumulation of pro-tumourigenic M2 macrophages in areas of hypoxia present in irradiated tumours. IR then may also induced responses that are inadequate to maintain antitumuor immunity.

Close interaction between IR, T cells, and the PD-L1/PD-1 axis exsit and provide a basis for the rational design of combination therapy with immune modulators and radiotherapy. Deng et al. demonstrate that PD-L1 was upregulated in the tumour microenvironment after IR. Moreover, administration of anti-PD-L1 enhanced the efficacy of IR through a cytotoxic T cell-dependent mechanism. Concomitant with IR-mediated tumour regression, IR and anti-PD-L1 synergistically reduced the local accumulation of tumour-infiltrating MDSCs, which suppress T cells and alter the tumour immune microenvironment. Finally, activation of cytotoxic T cells with combination therapy mediated the reduction of MDSCs in tumours through the cytotoxic actions of TNF. Sagiv-Barfi et al, also demonstrated in 5 patients receiving atezolizumab and radiation therapy, at least stabilization of systemic progression in all patients and a RECIST partial response at systemic sites in 1 patient. Transient, grade 1-2 inflammatory adverse events (fevers, flu-like symptoms) occurred with no serious immune-related toxicities. Abscopal out-field effects of irradiation has also been described in addition to a reduction in circulating MDSCs in a melanoma patient treated with the anti CTLA-4 ipilimumab and radiotherapy.

Lastly, recent evidence demonstrates that loco-regional curative treatment with stereotactic ablative radiotherapy (SABR) is a good alternative as compared with conventional 3D RT for patients with solid tumour, with durable remissions and a low toxicity profile. Many non-randomised studies have shown that SBRT for oligometastases is safe and effective, with local control rates of about 80%. Importantly, these studies also suggest that the natural history of the disease is changing, with 2-5 year progression-free survival of about 20%. For colorectal, non-small cell, and renal cell cancers, 1-year metastasis control rates ranged from 67 to 91%. Moreover, abscopal reponses in the setting of immune checkpoints inhibitors and radiotherapy combinations have been made in the setting of metastatic disease event in patients with extensive tumor burden. The goal of SABR is to deliver appropriate metastasis directed radiotherapy while minimizing exposure of surrounding normal tissues. Interestingly, the dose and fractionation employed modulate RT ability to synergize with immunotherapy. Vanpouille-Box et al, showed that immune response genes were differentially expressed in irradiated tumours by 8Gyx3 but not 20Gyx1. This highlight the interest of hypofractionated SABR acting as a "in situ tumour vaccine".

As hypofractionated SABR may, in addition to its good local control, increase the effectiveness of anti PD-L1, investigators aimed to investigate the efficacy and the tolerability of the combination of anti-PD-L1 antibody with SABR.


acronym: HONEY

summary: The aim of the study is to evaluate the effect of the consumption of a food supplement (live saccharomyces cerevisiae) on lipidic profile in moderate hypercholesterolemic subjects.

lead_sponsor: Lesaffre International

intervention_type: Dietary Supplement


title: Impact of Subcutaneous Electric Lumbar Stimulation on Treatment of Refractory Chronic and Disabling Lumbago

acronym: IMESCUT

summary: The aim of the study is to show that subcutaneous electric lumbar stimulation reduces pain in chronic lumbago after 12 months of treatment.

lead_sponsor: Hopital Foch


title: Concussion in Rugby Players: a Pilot Study of Neural Recovery Using Functional Magnetic Resonance Imaging (fMRI)

acronym: RugbyCom

summary: This study assess the putative persistence of neural damage using resting state fMRI after concussion in rugby player once they have clinically recovered. The hypothesis is that despite a clinical recovery (absence of symptoms; neurological and neuropsychological examination returned to normal) connectivity map obtained using resting state fMRI are significantly different from a group of control subjects.

ReferenceCitation: Smits M, Houston GC, Dippel DW, Wielopolski PA, Vernooij MW, Koudstaal PJ, Hunink MG, van der Lugt A. Microstructural brain injury in post-concussion syndrome after minor head injury. Neuroradiology. 2011 Aug;53(8):553-63. doi: 10.1007/s00234-010-0774-6. Epub 2010 Oct 6.

lead_sponsor: University Hospital, Toulouse


title: Evaluation of the Effect of an Inclined Plane on the Walking of Children With Cerebral Palsy: What Are the Paths for Rehabilitation?

summary: The adaptations in kinematics and muscle activity, investigated by 3D gait analysis and dynamic electromyography recordings, will be studied in children with bilateral spastic cerebral palsy during level walking, and before and after a training on a treadmill with a sloped surface (7°). Data will be compared with those obtained in a sample of typically developing (TD) children (controls)

lead_sponsor: Nantes University Hospital


title: Artificial Shrinkage of Fresh Blastocyst: Impact on Success Rates in Assisted Reproductive Technology

acronym: BlastoCollapse

summary:
The aim of the study is to determine if collapsing an embryo (or making it fold compactly by taking away its fluid) before the transfer in the uterine cavity improves pregnancy rates in assisted reproductive technology (ART).

Women coming to our ART center will be randomized in two groups : the collapsing group and a control group.

Pregnancy rates will be compared in the two groups. A biomarker (cell free DNA) will also be determined in each group and correlated to pregnancy occurrence.

lead_sponsor: University Hospital, Montpellier


title: Evaluation of a Cognitive Remediation Program on Patients With Bipolar Disorders, With Memory Complaints

acronym: COGMED

summary:
Bipolar disorder is a major health concern. Intercritical periods are marked with residual symptoms, both thymic and cognitive, which affects quality of life of patients, but also the quality of observance. The implementation of cognitive remediation programs could be interesting. The aim of this study is to evaluate the overall performance on euthymic bipolar patients with memory complaints included in the program named "COGMED", targeting the working memory.

The impact of this program on compliance, quality of life, and memory complaints will be evaluated.

The investigator will measure whether there is a correlation between working memory and overall performances.

Finally, the investigator will try to achieve a profile of bipolar patients in whom the Cogmed program is particularly effective on a plan of overall performance.


title: Comparison of Topography Guided LASIK With WaveLight® EX500 to SMILE With Zeiss VisuMax

summary: The purpose of this study is to compare Topography Guided Laser In Situ Keratomileusis (LASIK) corneal surgery to Small Incision Lenticule Extraction (SMILE) corneal surgery for the treatment of myopia with astigmatism.

lead_sponsor: Alcon, a Novartis Company


type: EudraCT Number

title: A Dose-response, Randomized, Double-blind Study to Evaluate the Effect of Type-A Botulinum Toxin in the Post-radiosurgical Neck Contractures

summary:
The main objective of the study is to estimate the efficiency and to determine the optimal dose of Botulinum toxin A, administered by intramuscular way in cervical spasms after radiotherapy, as well as the optimal sites for these injections.

The concerned muscular groups are the sternocleidomastoid (SCM), the trapezius muscle and the splenius capitis.


title: Prediction of Response to Cardiac Resynchronization Therapy by New Echocardiographic Methods

acronym: Echo-CRT

summary: The present observational prospective study aims at identifying echocardiographic parameters (based on the Left Bundle Branch Block (LBBB)-like contraction of the left ventricle (LV) ascertained using new methods of echocardiography including speckle tracking strain) that are linked to Cardiac Resynchronization Therapy (CRT) response and a better outcome following CRT

ReferenceCitation: Appert L, Menet A, Altes A, Ennezat PV, Bardet-Bouchery H, Binda C, Guyomar Y, Delelis F, Castel AL, Le Goffic C, Guerbaai RA, Graux P, Tribouilloy C, Marechaux S. Clinical Significance of Electromechanical Dyssynchrony and QRS Narrowing in Patients With Heart Failure Receiving Cardiac Resynchronization Therapy. Can J Cardiol. 2019 Jan;35(1):27-34. doi: 10.1016/j.cjca.2018.10.019. Epub 2018 Nov 14.

lead_sponsor: Lille Catholic University

location_facility: Hospitals of Lille Catholic University (GHICL)


title: Influence of Magnesium Variations (Serum and Intra-erythrocyte) on Markers of Cardiometabolic Risk in Long-term Prescription of Antipsychotic Drugs: a Prospective Cohort Study

summary:
Background: Antipsychotics can induce metabolic disorders such as obesity, hyperglycemia, dyslipidemia or metabolic syndrome. It has been observed that treatment with antipsychotic could be accompanied by a decrease in the concentration of serum magnesium. Low serum concentrations of magnesium are potentially a risk factor of cardiac sudden death (Peacock, 2010). Hypotheses linking magnesium and pathogenesis of cardiovacuscular diseases are multiple. Also, it seems to exist a close relationship between magnesium and carbohydrate metabolism. Most studies on the subject have generally studied plasmatic magnesium.

Objective : Describe the relationship between changes in serum and intra-erythrocyte magnesium and cardiometabolic risk in patients innitiating an antipsychotic treatment. A secondary objective is to specify the frequency, magnitude and time to onset of changes in plasma of magnesium levels under antipsychotic treatment.

Methods : This is a pilot single-center prospective cohort. After inclusion, patients status (including magnesium levels) will be evaluated (1 and 3 months of treatment) and that status will define the exposure criterion. Included patients will be followed for 1 year during which cardiometabolic markers will be measured.

Population : patients who are more than 18 years old with schizophrenia schizoaffective disorder or bipolar disorder, naive to antipsychotic treatment or off for more than 3 months and requiring the introduction of antipsychotic drug therapy. Patients will be recruited during consultations and stays in care units of Adult Psychiatry Unit of Montpellier University Hospital.

Factor studied: serum and intra-erythrocytic magnesium levels at beginning and during the antipsychotic treatment measured by a unique analyzer center. Changes in levels of hypomagnesemia expected during the treatment will determine exposure groups.

Outcome: cardiometabolic risk markers measured at the beginning and during the treatment will be fasting blood glucose, fasting plasma insulin, HOMA-IR [Ins (uU / mL) x Gly (mmol / L) / 22.5], lipid profile (total cholesterol, LDL, HDL), BMI, waist circumference and ECG (QTc).

Cofactors: age, sex, personal and family medical history, blood pressure, smoking, diet, physical activity, psychiatric disease, Global Impressions, anti-psychotic treatment and comedications.

Perspectives : to show that decreased in magnesium levels observed among patients starting antipsychotic treatment is associated with deterioration of cardiometabolic risk markers. The demonstration of this association could explain at least part the increased cardiovascular risk observed in this population. In the longer term, the results of this study would argue the implementation of an intervention research project studying magnesium supplementation to minimize the metabolic effects of antipsychotic medications.


title: Comparative Study, Randomized in Parallel Groups, Evaluating the Consequences of the Management of Diabetic Foot Ulcers by Telemedicine Versus Conventional Monitoring on the Number of Hospital Days in Diabetic Patients

acronym: TELEPIED

summary:
The TELEPIED project aims to show that it is possible to reduce the number of hospitalization days of a patient with ulcers of the foot thanks to a new organization of care, based on the intervention of a coordinating nurse interacting with the nurse in charge of the patient thanks to a telemedicine tool allowing the transfer of photos and ensuring itself a regular follow-up of the evolution of the wound and adapting the support nurse to the home if necessary.

It is a monocenter, randomized, in parallel study, in 180 diabetic patients with ulcers of the foot.

Patients included in the conventional group will be followed according to the usual practice Patients included in the "telepied" group will benefit from a personalized accompaniment by a nurse referring to diabetic foot ulcers who will guide and advise the nurse at home by acting by delegating tasks of the investigator.

The patient will be visited by the referring nurse every 15 days. During these visits, the referring nurse will have the objective to evaluate the evolution of the ulcer as well as the care performed. This visit also allows a close personalized accompaniment for the patient, who will benefit from an education adapted to the characteristics of ulcer (discharge modalities for example ..) and its way of life.

Every patients will be followed for one year (12 months).

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète


title: Is Fixation of Percutaneous Akin Osteotomy Enhanced First Ray Post-operative Mobility? A Prospective Randomized Study.

acronym: AKIN

summary: The study is a prospective randomized study about hallux valgus surgery. The investigator try to assess if the fixation of percutaneous Akin osteotomy with a cannulated screw have an incidence in the first ray mobility since the two technics ( fixation and no-fixation) are described and practiced, and since the stiffness of the first metatarso-phalangeal joint is determinant in the result of this functional surgery.

location_facility: University Hospital of Bordeaux - Hospital Pellegrin


title: Array-CGH in Plasma Cell Post-transplantation Lymphoproliferative Disorders

summary: Plasma-cell post-transplantation lymphoproliferative disorders (PC-PTLD) are rare monomorphic PTLD divided into plasma cell myeloma (PCM) and plasmacytoma-like lesion (PLL) PTLD. To date, there is no exhaustive published cytogenetic data on PC-PTLD. The investigators report array-based comparative genomic hybridization (aCGH) of 10 cases of PCM and PLL-PTLD.

lead_sponsor: Hospices Civils de Lyon


title: Acute Bronchiolitis and Severity Markers: Interest in Protein CC16

summary:
Acute bronchiolitis is a common viral infection in infants mainly due to RSV and rhinovirus.

Biomarkers can be useful for predicting its severity. The serum CC16 is a marker of epithelial aggression. Its rate increase during RSV bronchiolitis in infants less than 7 months. It could be an early predictive biomarker of the severity of acute bronchiolitis, and secondarily for the development of asthma.

Two other markers of airway aggression seem to increase during acute bronchiolitis: serum SP-D protein and serum soluble receptor sRAGE.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Monocentric Study of Validation of the Method "CaptHPV" for the Diagnosis of Human Papillomavirus Associated Infiltrating Carcinomas From a Biological Specimen.

acronym: CaptHPV

summary: The current project is based on the assumption that a diagnosis of human papillomavirus associated Infiltrating Carcinomas can be made from a blood sample for patient with Cervical Cancer, Vulvar Cancer, Anal Cancer, Oropharynx Cancer, Oral Cavity Cancer or Penis Cancer at any stage of the disease and including surgical treatment for the small tumors.

ReferenceCitation: Sastre-Garau X, Diop M, Martin F, Dolivet G, Marchal F, Charra-Brunaud C, Peiffert D, Leufflen L, Dembele B, Demange J, Tosti P, Thomas J, Leroux A, Merlin JL, Diop-Ndiaye H, Costa JM, Salleron J, Harle A. A NGS-based Blood Test For the Diagnosis of Invasive HPV-associated Carcinomas with Extensive Viral Genomic Characterization. Clin Cancer Res. 2021 Oct 1;27(19):5307-5316. doi: 10.1158/1078-0432.CCR-21-0293.

publisher_dissemination: American Association for Cancer Research

lead_sponsor: Institut de Cancérologie de Lorraine


title: Overall Survival With Ponatinib Versus Allogeneic Stem Cell Transplant in Philadelphia-positive Leukemias With the T315I Mutation

summary: Effective treatment options for chronic myeloid leukemia (CML) or Philadelphia-positive (Ph+) acute lymphoblastic leukemia (ALL) patients with the T315I mutation are few. This study compared overall survival (OS) between CML and Ph+ ALL patients treated with ponatinib versus allogeneic stem cell transplantation (allo-SCT).


title: Descriptive Study of a Phytotherapy Strategy for Sleep Disorders Related to Anxiety With Phytostandard® Eschscholtzia and Valerian, a Dietary Supplement Based on Eschscholtzia and Valerian Extracts

summary: The aim of the study is to evaluate the effect of a one-month supplementation with Phytostandard® Eschscholtzia and valerian on the Insomnia Severity Index (ISI), in insomniac so-called adjustment subjects (occasional or short-term insomnia)

lead_sponsor: PiLeJe


title: Descriptive Study of a Phytotherapy Management Strategy for Mild to Moderate Major Depression With Phytostandard® Rhodiola-Saffron : a Combination of Rhodiola and Saffron Extracts.

summary: The purpose of the study is to describe, over 6 weeks, the evolution of depressive symptoms in patients with mild to moderate major depression in a strategy with Phytostandard® Rhodiola-Saffron supplementation


title: BEAM: Prospective Open Label Study to Evaluate the Effectiveness of Juvéderm® VOLIFT®™ With Lidocaine for Treatment of Dynamic Radial Cheek Line Skin Depressions

acronym: BEAM

summary: This study will evaluate the effectiveness of Juvéderm® VOLIFT®™ with Lidocaine for dynamic radial cheek line skin depressions.

lead_sponsor: Allergan


title: Cardiac 4D MR Velocity Mapping in Repaired Tetralogy of Fallot Patients: Evaluation of Pulmonary Regurgitant Fraction and Ventricular Volume

acronym: CARDIOFLUX

summary: MRI with 4D flow permits to assess the hemodynamic parameters in a parent vessel and its branches inside the same sequence.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Development of the Tool " iPSC " (Induced Pluripotent Stem Cells) for the Functional Study of Mutations Responsible for Mental Retardation - Application to Familial Study of MYT1L Gene Mutations

acronym: Rementips

summary:
According to the World Health Organization (WHO), mental retardation (MR) is defined by an intelligence quotient (IQ) < 70 and touches between 1 to 3 % of the general population. Profound mental retardation (QI <25), severe (IQ: 25-40) and moderate (QI : 40-50) have a prevalence of 0,3-0,5% while the prevalence of mild MR, defined by an IQ between 50 and 70 is evaluated to about 1,5 %.

The origin of MR can be infectious, toxic, traumatic, genetic or environmental. genetic causes of MR gather the number and structure anomalies of the chromosomes, the genomic microreorganization, monogenic diseases and more rarely other non Mendelian-inherited anomalies like print or epigenetic anomalies, mutations of the mitochondrial genome etc... Genetic causes represents 50% of moderate to severe, whereas environmental factors (malnutrition, cultural deprivation,...) plays an important role in mild MR.

The main goal of this study is to get an innovative tool (neuronal distinction of iPSC) that wil allow to study the functionnal impact of mutations uppon genes probably involved in MR like MYT1L. The main criteria associated to characterisation of the tool by the trial is the study of the pluripotency of iPSC obtained and to highlight the mutation of the gene MYT1L in the iPSC.

Neurons from the iPSC of the patient and his father du patient wille also be morphologically characterised, but also thanks to the expression of specifically neurals genes.

Characteristics of iPSC and neurons from d'iPSC with MYT1L mutation will be compared among the patient and his father, in relation with the same cells coming from the two witnesses.

ReferenceCitation: Bonnet C, Leheup B, Beri M, Philippe C, Gregoire MJ, Jonveaux P. Aberrant GRIA3 transcripts with multi-exon duplications in a family with X-linked mental retardation. Am J Med Genet A. 2009 Jun;149A(6):1280-9. doi: 10.1002/ajmg.a.32858.

ReferenceCitation: Brosco JP, Mattingly M, Sanders LM. Impact of specific medical interventions on reducing the prevalence of mental retardation. Arch Pediatr Adolesc Med. 2006 Mar;160(3):302-9. doi: 10.1001/archpedi.160.3.302.

ReferenceCitation: Chambers SM, Fasano CA, Papapetrou EP, Tomishima M, Sadelain M, Studer L. Highly efficient neural conversion of human ES and iPS cells by dual inhibition of SMAD signaling. Nat Biotechnol. 2009 Mar;27(3):275-80. doi: 10.1038/nbt.1529. Epub 2009 Mar 1. Erratum In: Nat Biotechnol. 2009 May;27(5):485.

ReferenceCitation: Chanda S, Marro S, Wernig M, Sudhof TC. Neurons generated by direct conversion of fibroblasts reproduce synaptic phenotype caused by autism-associated neuroligin-3 mutation. Proc Natl Acad Sci U S A. 2013 Oct 8;110(41):16622-7. doi: 10.1073/pnas.1316240110. Epub 2013 Sep 17.

ReferenceCitation: Chiurazzi P, Schwartz CE, Gecz J, Neri G. XLMR genes: update 2007. Eur J Hum Genet. 2008 Apr;16(4):422-34. doi: 10.1038/sj.ejhg.5201994. Epub 2008 Jan 16.

ReferenceCitation: Chiyonobu T, Hayashi S, Kobayashi K, Morimoto M, Miyanomae Y, Nishimura A, Nishimoto A, Ito C, Imoto I, Sugimoto T, Jia Z, Inazawa J, Toda T. Partial tandem duplication of GRIA3 in a male with mental retardation. Am J Med Genet A. 2007 Jul 1;143A(13):1448-55. doi: 10.1002/ajmg.a.31798.

ReferenceCitation: Cohn DM, Pagon RA, Hudgins L, Schwartz CE, Stevenson RE, Friez MJ. Partial ATRX gene duplication causes ATR-X syndrome. Am J Med Genet A. 2009 Oct;149A(10):2317-20. doi: 10.1002/ajmg.a.33006. No abstract available.

ReferenceCitation: Doco-Fenzy M, Leroy C, Schneider A, Petit F, Delrue MA, Andrieux J, Perrin-Sabourin L, Landais E, Aboura A, Puechberty J, Girard M, Tournaire M, Sanchez E, Rooryck C, Ameil A, Goossens M, Jonveaux P, Lefort G, Taine L, Cailley D, Gaillard D, Leheup B, Sarda P, Genevieve D. Early-onset obesity and paternal 2pter deletion encompassing the ACP1, TMEM18, and MYT1L genes. Eur J Hum Genet. 2014 Apr;22(4):471-9. doi: 10.1038/ejhg.2013.189. Epub 2013 Oct 16.

ReferenceCitation: Froyen G, Belet S, Martinez F, Santos-Reboucas CB, Declercq M, Verbeeck J, Donckers L, Berland S, Mayo S, Rosello M, Pimentel MM, Fintelman-Rodrigues N, Hovland R, Rodrigues dos Santos S, Raymond FL, Bose T, Corbett MA, Sheffield L, van Ravenswaaij-Arts CM, Dijkhuizen T, Coutton C, Satre V, Siu V, Marynen P. Copy-number gains of HUWE1 due to replication- and recombination-based rearrangements. Am J Hum Genet. 2012 Aug 10;91(2):252-64. doi: 10.1016/j.ajhg.2012.06.010. Epub 2012 Jul 26.

ReferenceCitation: Kearney HM, Thorland EC, Brown KK, Quintero-Rivera F, South ST; Working Group of the American College of Medical Genetics Laboratory Quality Assurance Committee. American College of Medical Genetics standards and guidelines for interpretation and reporting of postnatal constitutional copy number variants. Genet Med. 2011 Jul;13(7):680-5. doi: 10.1097/GIM.0b013e3182217a3a.

ReferenceCitation: Kleinjan DA, van Heyningen V. Long-range control of gene expression: emerging mechanisms and disruption in disease. Am J Hum Genet. 2005 Jan;76(1):8-32. doi: 10.1086/426833. Epub 2004 Nov 17.

ReferenceCitation: Larson SA, Lakin KC, Anderson L, Kwak N, Lee JH, Anderson D. Prevalence of mental retardation and developmental disabilities: estimates from the 1994/1995 National Health Interview Survey Disability Supplements. Am J Ment Retard. 2001 May;106(3):231-52.

ReferenceCitation: Lee C, Iafrate AJ, Brothman AR. Copy number variations and clinical cytogenetic diagnosis of constitutional disorders. Nat Genet. 2007 Jul;39(7 Suppl):S48-54. doi: 10.1038/ng2092.

ReferenceCitation: Lujan E, Chanda S, Ahlenius H, Sudhof TC, Wernig M. Direct conversion of mouse fibroblasts to self-renewing, tripotent neural precursor cells. Proc Natl Acad Sci U S A. 2012 Feb 14;109(7):2527-32. doi: 10.1073/pnas.1121003109. Epub 2012 Jan 30.

ReferenceCitation: McLaren J, Bryson SE. Review of recent epidemiological studies of mental retardation: prevalence, associated disorders, and etiology. Am J Ment Retard. 1987 Nov;92(3):243-54.

ReferenceCitation: Raff ML, Craigen WJ, Smith LT, Keene DR, Byers PH. Partial COL1A2 gene duplication produces features of osteogenesis imperfecta and Ehlers-Danlos syndrome type VII. Hum Genet. 2000 Jan;106(1):19-28. doi: 10.1007/s004390051004.

ReferenceCitation: Pang ZP, Yang N, Vierbuchen T, Ostermeier A, Fuentes DR, Yang TQ, Citri A, Sebastiano V, Marro S, Sudhof TC, Wernig M. Induction of human neuronal cells by defined transcription factors. Nature. 2011 May 26;476(7359):220-3. doi: 10.1038/nature10202.

ReferenceCitation: Rodriguez-Revenga L, Mila M, Rosenberg C, Lamb A, Lee C. Structural variation in the human genome: the impact of copy number variants on clinical diagnosis. Genet Med. 2007 Sep;9(9):600-6. doi: 10.1097/gim.0b013e318149e1e3.

ReferenceCitation: Rooryck Thambo C. Analyse de réarrangements génomiques chez des patients atteints d'anomalies du développement embryonnaire. Retard mental et malformations multiples congénitales ; Spectre oculo-auriculo-vertébral. 2009. Thèse de science n°1675. Ecole doctorale des sciences de la vie et de la santé, université Bordeaux 2.

ReferenceCitation: Shimojima K, Inoue T, Imai Y, Arai Y, Komoike Y, Sugawara M, Fujita T, Ideguchi H, Yasumoto S, Kanno H, Hirose S, Yamamoto T. Reduced PLP1 expression in induced pluripotent stem cells derived from a Pelizaeus-Merzbacher disease patient with a partial PLP1 duplication. J Hum Genet. 2012 Sep;57(9):580-6. doi: 10.1038/jhg.2012.71. Epub 2012 Jun 14.

ReferenceCitation: Stankiewicz P, Beaudet AL. Use of array CGH in the evaluation of dysmorphology, malformations, developmental delay, and idiopathic mental retardation. Curr Opin Genet Dev. 2007 Jun;17(3):182-92. doi: 10.1016/j.gde.2007.04.009. Epub 2007 Apr 30.

ReferenceCitation: Stasia MJ, Mollin M, Martel C, Satre V, Coutton C, Amblard F, Vieville G, van Montfrans JM, Boelens JJ, Veenstra-Knol HE, van Leeuwen K, de Boer M, Brion JP, Roos D. Functional and genetic characterization of two extremely rare cases of Williams-Beuren syndrome associated with chronic granulomatous disease. Eur J Hum Genet. 2013 Oct;21(10):1079-84. doi: 10.1038/ejhg.2012.310. Epub 2013 Jan 23.

ReferenceCitation: Stevenson, R. E., Schwartz, C. E. & Schroer, R. J. X-Linked Mental Retardation. 2000. Oxford Univ. Press

ReferenceCitation: Takahashi K, Yamanaka S. Induction of pluripotent stem cells from mouse embryonic and adult fibroblast cultures by defined factors. Cell. 2006 Aug 25;126(4):663-76. doi: 10.1016/j.cell.2006.07.024. Epub 2006 Aug 10.

ReferenceCitation: Thienpont B, de Ravel T, Van Esch H, Van Schoubroeck D, Moerman P, Vermeesch JR, Fryns JP, Froyen G, Lacoste C, Badens C, Devriendt K. Partial duplications of the ATRX gene cause the ATR-X syndrome. Eur J Hum Genet. 2007 Oct;15(10):1094-7. doi: 10.1038/sj.ejhg.5201878. Epub 2007 Jun 20.

ReferenceCitation: Wapinski OL, Vierbuchen T, Qu K, Lee QY, Chanda S, Fuentes DR, Giresi PG, Ng YH, Marro S, Neff NF, Drechsel D, Martynoga B, Castro DS, Webb AE, Sudhof TC, Brunet A, Guillemot F, Chang HY, Wernig M. Hierarchical mechanisms for direct reprogramming of fibroblasts to neurons. Cell. 2013 Oct 24;155(3):621-35. doi: 10.1016/j.cell.2013.09.028. Epub 2013 Oct 24.

ReferenceCitation: Yanaba K, Nakagawa H, Takeda Y, Koyama N, Sugano K. Muir-Torre syndrome caused by partial duplication of MSH2 gene by Alu-mediated nonhomologous recombination. Br J Dermatol. 2008 Jan;158(1):150-6. doi: 10.1111/j.1365-2133.2007.08233.x. Epub 2007 Oct 17.

ReferenceCitation: Yang N, Ng YH, Pang ZP, Sudhof TC, Wernig M. Induced neuronal cells: how to make and define a neuron. Cell Stem Cell. 2011 Dec 2;9(6):517-25. doi: 10.1016/j.stem.2011.11.015.

lead_sponsor: University Hospital, Grenoble