title: Patient-reported, Health Economic and Psychosocial Outcomes in Friedreich Ataxia

acronym: PROFA

summary: The PROFA study is an international, multi-centric observational and validation study to assess the patient-reported, psychosocial and economic outcomes of patients with Friedreich Ataxia (FA). Eligible patients will be recruited from six study centers in Germany, Austria and France. Patients will complete a baseline assessment via face-to-face interviews at the study centers and multiple momentary follow-up assessments via a mobile-health app at home daily to monthly for six months. Study results will gain essential and in-depth insights into the daily life of patients with FA.

lead_sponsor: German Center for Neurodegenerative Diseases (DZNE)

collaborators:
McMaster University
Sorbonne University

location_country: Germany Austria France

location_facility: Department of Neurology, RWTH Aachen University

location_facility: German Center for Neuro-degenerative Diseases (DZNE)

location_facility: Friedrich-Baur-Institut an der Neurologischen Klinik und Poliklinik

location_facility: Klinik für Neurologie, Medizinische Universität Innsbruck

location_facility: Neurologische Klinik und Hertie-Institut für Klinische Hirnforschung, Universitätsklinik Tübingen


title: Impact of Patient Involvement in Alerts Management of Telemonitoring CPAP

summary:
Adherence to CPAP determines the expected benefits of the treatment. A dose-benefit relationship has been demonstrated for both functional and cardiovascular benefits. The first few days' use of the device are decisive in determining long-term compliance. In this context, daily monitoring of the data teletransmitted means that we can be more responsive to problems of compliance during the first few days of use; the contribution of telemonitoring can be very positive in a context of poor compliance.

In France, compulsory health insurance coverage of CPAP treatment is authorised for patients aged over 16 with clinical symptoms and an AHI ≥15 events per hour and <30 events/h in patients with severe cardiovascular co-morbidity. These patients are often not very sleepy due to sympathetic hypertonia with a shorter sleep duration. They are at high risk of non-compliance.

The IPIAM study specifically targets a population at cardiovascular risk and at high risk of non-compliance with CPAP treatment. The IPIAM study aims to involve patients in the success of their treatment via remote monitoring and to show that this approach makes it possible to improve the handling of alerts and to participate in the therapeutic support of the patient. Finally, this population also shares the risk of heart rhythm disorders. As part of a cross-disciplinary inter-pathology telemonitoring approach, it also makes sense to screen for cardiac rhythm disorders by wearing a connected watch.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Asten Sante

collaborators:
Slb Pharma
Nouvéal
Withings

sponsor_collaborators:
Asten Sante
Slb Pharma
Nouvéal
Withings

location_facility: Polyclinique Saint-Laurent - Groupe médical de pneumologie

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Ongoing


title: BATTLE Trial: Bare Metal Stent Versus Paclitaxel Eluting Stent in the Setting of Primary Stenting of Intermediate Length Femoropopliteal Lesions

acronym: BATTLE

summary:
Over the past years, endovascular interventions have become an important part of treatment in patients with peripheral arterial disease.1 Indication for endovascular repair of femoropopliteal lesions has been considerably enlarged as shown in the TASC classification.1 Enlargement of endovascular therapy indication was based on patient choice for a less invasive technique and evidence based medicine. Consequently, TASC classification of lesions has been modified to reflect increased evidence for endovascular treatment of more extensive femoropopliteal lesions, and indication for endovascular repair has been enlarged to more severe TASC types. In summary, endovascular treatment is indicated for TASC A and B lesions which correspond to femoropopliteal lesions ≤15-cm. To treat these lesions, the interventionalists have at their disposal a huge tool box. Evaluation of these tools is crucial to determine the right treatment strategy to avoid further reinterventions and overcosts.

The objective of the BATTLE trial is to compare a bare metal self expandable nitinol stent (Misago RX) versus a paclitaxel eluting stent (Zilver PTX) in the treatment of above-the-knee intermediate length femoropopliteal lesions.

From hospitals in Europe (France, Switzerland) we will randomly assign patients with symptomatic atherosclerotic femoropopliteal lesions to be treated either by bare metal stent or paclitaxel eluting stent. In total, 186 patients will be randomized (93 per group).

status: Terminated

study_completion_date_type: Actual

primary_purpose: Health Services Research

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Goueffic Y, Kaladji A, Guyomarch B, Montagne C, Fairier D, Gestin S, Riche VP, Vent PA, Chaillou P, Costargent A, Patra P. Bare metal stent versus paclitaxel eluting stent for intermediate length femoropopliteal arterial lesions (BATTLE trial): study protocol for a randomized controlled trial. Trials. 2014 Oct 30;15:423. doi: 10.1186/1745-6215-15-423.

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 OAI-PMH doi match)

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer

lead_sponsor: Nantes University Hospital

location_facility: Centre Hospitalier Pierre Oudot Bourgoin Jallieu

lead_sponsor_type: academique

status_simplified: Unknown


acronym: DENIVOS

intervention_type: Drug

lead_sponsor: Centre Hospitalier Annecy Genevois

summary:
Bone metastases are common in Non-Small Cell Lung Cancer (NSCLC). They most often occur during disease progression. It is thought that more than half of the patients with bone metastases will have at least 1 skeletal-related event (SRE, i.e. pathological fractures, medullary compression, analgesic radiotherapy, preventive and/or analgesic surgery and hypercalcemia).

Expert and medical Society guidelines, notably European Society for Medical Oncology in 2014, then in 2016, recommended using anti-resorptive agents (bisphosphonates or denosumab) to prevent SREs, attenuate pain and improve the quality of life, and decrease the medical-economic impact of this major metastatic site. Denosumab was accorded marketing authorization in France in 2011 as an anti-resorptive agent for bone metastases to delay the occurrence of SREs in lung-cancer patients.

Immunotherapy, notably immune-checkpoint inhibitors, like nivolumab (anti-programed death-1), has recently become an integral part of the therapeutic arsenal against NSCLCs. Nivolumab was accorded marketing authorization based on the phase III CHECKMATE 017 (squamous cell NSCLCs) and CHECKMATE 057 (non-squamous cell NSCLCs) trials versus docetaxel, after the phase II CHECKMATE 063 trial.

The denosumab-nivolumab combination is commonly used in current practice but has not been evaluated prospectively. The aim of this trial is to evaluate the combination of denosumab and nivolumab in second line of NSCLC with bone metastases.

sponsor_collaborators:
Centre Hospitalier Annecy Genevois
French Lung Cancer Group

location_facility: CHU Morvan - Institut de Cancérologie et d'Hématologie

location_facility: Groupe Hospitalier Sud Réunion - CHU de la Réunion

location_facility: Hôpital d'Instruction des Armées Saint-Anne

location_facility: Ch Intercommunal Elbeuf Louvier Val de Reuil

location_facility: Hôpital André Mignot Centre Hospitalier de Versailles

status: Active, not recruiting

title: A Multicenter Phase II Study Evaluating Denosumab (XGEVA®) in Combination With Nivolumab (OPDIVO®) as Second-line Therapy for Patients With Stage IV Non-small-Cell Lung Cancer (Squamous and Non-squamous) With Bone Metastases: DENIVOS STUDY

type: EudraCT Number

source: euctr

ipd_sharing: Undecided


title: Epidemiology and Determinants of Outcomes of Hospital Acquired Blood Stream Infections in the Intensive Care: the Eurobact II Multinational Cohort Study

acronym: EurobactII

summary: Eurobact II will investigate the mortality and morbidity of hospital-acquired blood stream infections in patients treated in intensive care units (ICU). It will investigate the effects of the micro-organism and its characteristics, such as type and resistance to antibiotics on the infection and its consequences. It will also investigate the effects of the antibiotics and other treatments on survival of patients. Eurobact II will include patients from multiple ICUs in multiple countries.

status: Completed

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Tabah A, Koulenti D, Laupland K, Misset B, Valles J, Bruzzi de Carvalho F, Paiva JA, Cakar N, Ma X, Eggimann P, Antonelli M, Bonten MJ, Csomos A, Krueger WA, Mikstacki A, Lipman J, Depuydt P, Vesin A, Garrouste-Orgeas M, Zahar JR, Blot S, Carlet J, Brun-Buisson C, Martin C, Rello J, Dimopoulos G, Timsit JF. Characteristics and determinants of outcome of hospital-acquired bloodstream infections in intensive care units: the EUROBACT International Cohort Study. Intensive Care Med. 2012 Dec;38(12):1930-45. doi: 10.1007/s00134-012-2695-9. Epub 2012 Sep 26.

ReferenceCitation: Buetti N, Tabah A, Loiodice A, Ruckly S, Aslan AT, Montrucchio G, Cortegiani A, Saltoglu N, Kayaaslan B, Aksoy F, Murat A, Akdogan O, Saracoglu KT, Erdogan C, Leone M, Ferrer R, Paiva JA, Hayashi Y, Ramanan M, Conway Morris A, Barbier F, Timsit JF; Eurobact 2 study group. Different epidemiology of bloodstream infections in COVID-19 compared to non-COVID-19 critically ill patients: a descriptive analysis of the Eurobact II study. Crit Care. 2022 Oct 18;26(1):319. doi: 10.1186/s13054-022-04166-y.

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: New University of Lisbon - New University of Lisbon's Repository

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

repository_institution: University of Cambridge - Apollo

publisher_dissemination: Springer-Nature

lead_sponsor: Outcome Rea

collaborators: European Society of Intensive Care Medicine

collaborators: European Society of Clinical Microbiology and Infectious Diseases

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

location_country: Australia France

location_facility: Reanimation Medicale et Infectieuse-Hopital Bichat

status_simplified: Completed


type: Registry Identifier

title: Study of Change in Biological Markers of Bone Metabolism Following Consumption of Hydrolyzed Collagen for 3 Months in Healthy, Non-osteoporotic, Menopausal Women.

summary:
Preliminary scientific studies, in both animals and humans suggest that oral consumption of hydrolyzed collagen acts on the bone remodeling process by stimulating the activity of osteoblasts responsible for bone formation while improving the bone mineral density and biomechanical resistance of long bones.
The objective of this clinical research is to measure changes in biomarkers of bone turnover in postmenopausal healthy women, not osteoporotic, in response to consumption of hydrolyzed collagen for three months.
For this, we propose to measure blood and urinary markers of formation and bone resorption before consumption, then 45 and 90 days after daily consumption of 10 g of hydrolyzed collagen.

ReferenceCitation: Nomura Y, Oohashi K, Watanabe M, Kasugai S. Increase in bone mineral density through oral administration of shark gelatin to ovariectomized rats. Nutrition. 2005 Nov-Dec;21(11-12):1120-6. doi: 10.1016/j.nut.2005.03.007.

ReferenceCitation: Takeuchi Y, Nakayama K, Matsumoto T. Differentiation and cell surface expression of transforming growth factor-beta receptors are regulated by interaction with matrix collagen in murine osteoblastic cells. J Biol Chem. 1996 Feb 16;271(7):3938-44. doi: 10.1074/jbc.271.7.3938.

ReferenceCitation: Wu J, Fujioka M, Sugimoto K, Mu G, Ishimi Y. Assessment of effectiveness of oral administration of collagen peptide on bone metabolism in growing and mature rats. J Bone Miner Metab. 2004;22(6):547-53. doi: 10.1007/s00774-004-0522-2.

ReferenceCitation: Guillerminet F, Beaupied H, Fabien-Soule V, Tome D, Benhamou CL, Roux C, Blais A. Hydrolyzed collagen improves bone metabolism and biomechanical parameters in ovariectomized mice: an in vitro and in vivo study. Bone. 2010 Mar;46(3):827-34. doi: 10.1016/j.bone.2009.10.035. Epub 2009 Nov 4.

lead_sponsor: Nealth Sarl

sponsor_collaborators:
Nealth Sarl
ROUSSELOT SAS

location_facility: CRNH - Centre de Recherche sur Volontaires - Hôpital AVICENNE

intervention_type: Dietary Supplement


title: Subretinal Haematoma in AMD: Randomized Controlled Study of 2 Therapeutic Approaches in the Antiangiogenic Era

acronym: STAR

summary:
AMD is a disease of the central retina, a zone that enables fine detail activities (reading, detail…). This central zone of the retina can be affected by a haemorrhagic complication when small abnormal vessels suddenly start to bleed inside the retina. Several therapeutic approaches are currently available even though they have never been truly compared. The study will be proposed to patients who need to be treated for haemorrhage of the macula. A certain number of factors will be evaluated to compare the 2 principal approaches currently used in France: surgery followed by injections of an anti-angiogenic OR intravitreal injections of gas followed by injections of anti-angiogenics. This is a multicentre, randomized controlled trial to compare these 2 therapeutic approaches.

These diametrically opposed approaches have very different consequences for patients and in terms of cost for society. The consequences for patients will be immediately measurable so as to determine the best therapeutic approach in terms of functional recovery and the impact of the disease on quality of life, while taking into account the risks inherent to these 2 treatments. The impact on quality of life of these 2 approaches as well as their consequences - an important factor in this disease, which is a cause of sensory handicap - will provide the ophthalmological community with essential information making it possible to validate one or the other of these methods for the management of these haematomas.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility: Fondation Ophtalmologique A. de Rothschild

intervention_type: Procedure


type: Other Identifier

title: Late Versus Early Management of Gestational Diabetes Mellitus: a Non Inferiority Randomized Multicenter Trial

summary:
In 2010, the International Association of the Diabetes and Pregnancy Study Groups (IADPSG) panel published consensus-based recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Cognizant that milder degrees of hyperglycemia would also be detected by early pregnancy testing, the IADPSG recommended that fasting plasma glucose (FPG) in the range of 5.1-6.9 mmol/l should be considered diagnostic of early Gestational Diabetes Mellitus (GDM) even if the level of proof for this recommendation is very low regarding to prognosis. This threshold was extrapolated from the FPG value used between 24 and 28 weeks.

In France, a FPG is proposed at the first prenatal visit for women with risk factors of GDM. Early GDM is diagnosed if FPG is ≥ 5.1 mmol/l, leading to an intensive metabolic management. Data have shown that GDM prevalence increased rapidly from 5.9% in 2009 to 9.3% in 2014. 26.9% of women with hyperglycemia during their pregnancy but without known diabetes are treated before 22 weeks' gestation (WG). More recent data from Italy and China, where IADPSG diagnosis criteria were applied, have strongly challenged this recommendation, and showed that early FPG ≥ 5.1mmo/L is poorly predictive of later GDM. No prior studies have demonstrated benefits to early screening and management. In 2016, the IADPSG members have suggested that the use of the FPG threshold ≥5.1 mmol/l for the identification of GDM in early pregnancy is not justified by current evidence

primary_purpose: Other

lead_sponsor: University Hospital, Lille

location_facility: Hopital Saint Vincent - Saint Antoine - Lille

location_facility: Csapa / Hus / Hopital Civil - Strasbourg

location_facility: Hopital Estaing - Chu63 - Clermont Ferrand

intervention_type: Other

appel_a_projets: PHRCN

region: Hauts-de-France

nom_etablissement: CHR LILLE

type_etablissement: CH

acronyme: LEMA-GDM

titre: Prise en charge tardive versus précoce du diabète gestationnel: une étude multicentrique randomisée de non infériorité.

discipline_principale: endocrinologie / diabétologie / métabolisme et nutrition

nom_porteur: Vambergue

prenom_porteur: Anne


title: Finding Retinal Biomarkers in Alzheimer's Disease

acronym: FIREBALZ

summary:
CSF Alzheimer's disease (AD) biomarkers are the only one that reflect both Aβ and tau pathologies. There is increasing evidence for the presence of AD abnormalities in the retina of AD patients. Recent studies showed that they can be detected in living patients. Thus, retinal AD-linked abnormalities might be used as alternative diagnostic biomarkers for AD.

FIREBALZ study aims at identifying and validating retinal biomarkers for the diagnosis of Alzheimer's disease.

The study will include 160 patients in whom LP is indicated for assessment of CSF AD biomarkers according to French health authority (HAS) recommendations. Those patients will undergo a detailed neuro-ophtalmologic evaluation including retinal layers thickness evaluation (optical coherence tomography).

Univariate and multivariate analyses will be performed to test diagnostic properties of retinal parameters as compared to current diagnostic criteria including CSF biomarkers and logistic regression models will be used.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre Mémoire de Ressources et de Recherche Paris Nord


title: Evaluation of the Feasibility of the MACOCHA Score and Indication of Endotracheal Intubation in Prehospital and Emergency Room: a Prospective Observational Study

acronym: E-MAC

summary: A seven-item simplified score (the MACOCHA score) has been validated to predict difficult tracheal intubation in intensive care unit patients. In the prehospital or in the emergency department settings, no such validated predictive score is available yet. The aim of the present study is to assess the feasibility the quick calculation of the MACOCHA score before emergent intubation, in the prehospital and emergency department contexts.

ReferenceCitation: De Jong A, Molinari N, Terzi N, Mongardon N, Arnal JM, Guitton C, Allaouchiche B, Paugam-Burtz C, Constantin JM, Lefrant JY, Leone M, Papazian L, Asehnoune K, Maziers N, Azoulay E, Pradel G, Jung B, Jaber S; AzuRea Network for the Frida-Rea Study Group. Early identification of patients at risk for difficult intubation in the intensive care unit: development and validation of the MACOCHA score in a multicenter cohort study. Am J Respir Crit Care Med. 2013 Apr 15;187(8):832-9. doi: 10.1164/rccm.201210-1851OC.

oa_host_type: repository

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

repository_normalized: HAL

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

repositories_concat: HAL

unpaywall_oa_status: green

publisher_dissemination: American Thoracic Society

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Assessment of Quality of Life and Its Determinants in Ventilator-dependent Patients With Slowly Progressive Neuromuscular Disease

acronym: EqualVENT

summary: This study aims at evaluating the quality of life of patients with slowly progressive neuromuscular disorders who are dependant on mechanical ventilation (daily usage ≥ 16h).

time_perspective: Cross-Sectional

lead_sponsor: Centre d'Investigation Clinique et Technologique 805

collaborators:
Fondation Garches
AFM Téléthon
FilNeMus


title: Prospective Follow-up Study for the Evaluation of the Safety and Efficacy of the Dermal Substitute NEVELIA® in the Treatment of Third-degree Burns and Reconstructive Surgery

acronym: NEVAL

summary:
The dermal substitute NEVELIA® has received CE marking in July 9, 2013. Its use in the NEVAL protocol will be in accordance with its leaflet, i.e. for the treatment of burns or in case of reconstructive plastic surgery.

The matric implantation will be followed by autologous skin grafting when the neodermis formation will be observed.

status: Unknown status

ReferenceCitation: Shevchenko RV, James SL, James SE. A review of tissue-engineered skin bioconstructs available for skin reconstruction. J R Soc Interface. 2010 Feb 6;7(43):229-58. doi: 10.1098/rsif.2009.0403. Epub 2009 Oct 28.

ReferenceCitation: Clark RA, Ghosh K, Tonnesen MG. Tissue engineering for cutaneous wounds. J Invest Dermatol. 2007 May;127(5):1018-29. doi: 10.1038/sj.jid.5700715.

ReferenceCitation: MacNeil S. Progress and opportunities for tissue-engineered skin. Nature. 2007 Feb 22;445(7130):874-80. doi: 10.1038/nature05664.

ReferenceCitation: Pham C, Greenwood J, Cleland H, Woodruff P, Maddern G. Bioengineered skin substitutes for the management of burns: a systematic review. Burns. 2007 Dec;33(8):946-57. doi: 10.1016/j.burns.2007.03.020. Epub 2007 Sep 7.

ReferenceCitation: Koenen W, Felcht M, Goerdt S, Faulhaber J. Skin substitutes in dermatosurgery. G Ital Dermatol Venereol. 2010 Oct;145(5):637-49.

ReferenceCitation: Chaouat M, Zakine G, Mimoun M. [Principles of the local treatment: Surgical processing]. Pathol Biol (Paris). 2011 Jun;59(3):e57-61. doi: 10.1016/j.patbio.2009.12.003. Epub 2010 Feb 8. French.

lead_sponsor: Symatese

location_facility: Centre François Xavier Michelet - CHU de Bordeaux


title: Reference Dose Levels During Fluoroscopically Guided Procedures Performed Using Mobile X-ray Systems in Operating Rooms

summary:
This study is conducted by a working group of the French Society of Medical Physics (SFPM). Its main aim is to establish reference dose levels for the most common procedures performed in operating rooms using mobile X-ray systems, hence helping medical physicists and surgeons to evaluate their practice and optimize patient radiation protection.

This is a multi-centric prospective study involving 73 medical institutions of different categories (public university hospitals, clinics, centers dedicated to cancer treatment, etc.). It consists on progressively collecting anonymous data for 15 to 30 procedures from a list of 62 types of procedures, belonging to 7 surgery specialties (neurosurgery, orthopedic surgery, digestive surgery, urology, cardiology, vascular surgery and multi-specialty). Collected data include patient BMI and information about the X-ray equipment, the medical procedure and the dosimetric parameters. Data collection doesn't require the access to the patient medical record and doesn't impact his medical care.

Proposed dose reference levels will be expressed in terms of KAP (Kerma-Area-Product), fluoroscopy time and air Kerma. Moreover, multiple statistical analyses will be done to investigate the impact of different variables on the procedure X-ray doses.

ipd_sharing_description:
Only the final results of this study will be shared with the medical physicist members of the French Society of Medical Physicist. These results are statistical data analysis based on the collected patient data.

Moreover, the study main results would be probably shared with the scientific community through a published paper in a scientific peer-reviewed journal.

lead_sponsor: Societe Francaise de Physique Medicale

collaborators: University hospital of Montpellier, FRANCE


title: A Phase 1, First-in-Human, Open-Label Study to Assess the Safety, Tolerability, and Pharmacokinetics of EVT801 in Patients With Advanced Solid Tumours

summary:
The main purpose of this study is to evaluate the safety and tolerability of EVT801 in subjects with advanced or metastatic solid tumours. The study also aims to determine the maximum tolerated dose (MTD) and / or a recommended Phase 2 dose (RP2D) of EVT801 when administered daily to subjects with advanced or metastatic solid tumours.

The study comprises two stages, each with distinct purposes, patient populations, and procedures:

Stage 1: a multiple ascending dose escalation of EVT801 to evaluate the safety and tolerability of EVT801 and to determine MTD / RP2D in subjects with advanced solid tumours.
Stage 2: a biomarker expansion cohort, in which all subjects will receive EVT801 at the MTD / RP2D, to explore pharmacodynamic outcomes and further elucidate tolerability, activity, and pharmacokinetics.

design_allocation: Non-Randomized

lead_sponsor: Kazia Therapeutics Limited

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole


title: Stress at Work and Infectious Risk in Patients and Caregivers

acronym: STRIPPS

summary:
In hospitals, the improvement of working conditions is often considered secondarily to patient satisfaction. Previous studies, showing statistically significant relationships, suggested the impact of hospital departments' organization (staff / patient ratio, bed distribution, caregiver's assignment), of the work environment, and the working conditions on the infectious risk at the hospital departments. In addition, organizational hospital constraints and the organization of care could equally have a major impact on the physical and psychological health of care workers (stress, fatigue, job satisfaction). To date, available data suggest that determinants of occupational stress and fatigue are multifactorial.

This research aims to develop an interdisciplinary approach to link two phenomena that are often studied independently while they are closely intertwined: working conditions and infectious risk in hospitals departments. Their main objective is to study the relationship between stress and caregiver fatigue at the work, organizational determinants and infectious risk for patients (healthcare-associated infections: HAIs) and for caregivers (blood exposure accidents: BEAs). The secondary objective is to analyze how the individual characteristics of the staff, the characteristics of their employment, and the overall organization in the hospital departments where they work interact to explain their physical and psychological state of health, on the one hand, and their behavior face to work (absenteeism, turnover and hand hygiene) on the other hand. The ultimate goal of this research is to be able to propose organizational strategies aimed at both reducing the probability of occurrence of healthcare-associated infections and preventing occupational risks for caregivers.

collaborators: National Conservatory of Arts and Crafts (Cnam) of Paris

appel_a_projets: PREPS

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: STRIPPS

titre: Stress au Travail et Risque Infectieux chez les Patients et le Personnel Soignant

discipline_principale: organisation des soins

nom_porteur: ASTAGNEAU

prenom_porteur: Pascal


title: Stoke Volume Measurements During Changes in Cardiac Preload: Are Pulse Contour Analysis (CLEARSIGHT) and Transthoracic Bioelectrical Impedance (NICCOMO) Equivalent?

acronym: ConBi-Car

summary:
Fluid therapy guided by stroke volume response to repeated fluid challenges is used for hemodynamic optimization during general anesthesia. Two types of devices that measure stroke volume non-invasively are primarily available for intermediate-risk surgery under general anesthesia. They are based on two different techniques, (1) pulse contour analysis, and (2) transthoracic bioimpedance. They have never been compared with each other. Therefore, it is not known (1) whether they are interchangeable for the measurement of stroke volume changes (usually assessed as the "concordance" of two techniques), and (2) whether one is better than the other.

The aim is to study the concordance of these two non-invasive hemodynamic devices. it will use both of them in patients undergoing intermediate risk surgery. They will be tested during modifications of cardiac preload induced by Trendelenburg and anti-Trendelenburg positioning, as well as during intraoperative fluid challenges, vasopressor boluses and alveolar recruitment maneuvers.

primary_purpose: Diagnostic


title: Assessment of the Impact of Relay Timing and CPRmeter Guidance on the Quality of External Chest Compression: Compression Is Life In Cardiac Arrest - Human Study (CILICA-HS).

acronym: CILICA-HS

summary:
The management of out-of-hospital cardiac arrest is complex and multifactorial. With an incidence between 5 and 15 per 10,000 (46,000 patients per year in France) and a survival rate of only 5% to 15%, the room for improvement remains significant even today and is based on fast and optimal care. Thus French and international recommendations insist on the central element of external chest compression (ECC) and especially its quality (Monsieurs KG and Al. Resuscitation 2015; 95: 1-80). Improving the chest compression fraction (CCF) by limiting time without cardiac massage (No-Flow) is a second major point of the recommendations (Vaillancourt C and Al. Resuscitation 2011; 82: 1501-7). The survival of cardiac arrest victims is closely related on this No-Flow time. The principle of the chain of survival (early warning - ECC - defibrillation - resuscitation) implies that the deterioration of a single link threaten the whole of the care. To meet these qualitative needs, ECC guidance devices have been developed. They make possible to improve the quality of the ECC achieved (Hostler D and Al. BMJ 2011; 342d512). Their use is one of the areas of improvement mentioned in the recommendations. Our team studied in simulation the prolonged effects of guidance on the quality of the ECC during a prolonged resuscitation, with encouraging results (Buléon C and Al. Am J Emerg Med 2016; 34: 1754-60). The investigators propose a study evaluating the efficiency of the guidance of the ECC and the impact of the time of relay on the CCF. The investigators formulate two hypotheses that they wish to test simultaneously using a 2x2 factorial design, in a multicenter randomized trial. The first assumption is that a 4-minute relay rate improves the CCF (by reducing the No-Flow time) compared to the currently recommended 2-minute relay rate. The second hypothesis is that a guiding device improves the quality of the ECC.

This study should, over a period of 2 years, include 500 patients with cardiac arrest for whom specialized resuscitation is undertaken. The investigators hope by this study to improve the knowledge on the optimal rhythm of the ECC and to validate "in vivo" the interest for the guidance found on manikin. This study should make it possible to clarify the recommendations with a high level of evidence in this field and thus contribute to improving the prognosis of the victims of an out-of-hospital cardiac arrest.

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

ReferenceCitation: Nolan JP, Soar J, Zideman DA, Biarent D, Bossaert LL, Deakin C, Koster RW, Wyllie J, Bottiger B; ERC Guidelines Writing Group. European Resuscitation Council Guidelines for Resuscitation 2010 Section 1. Executive summary. Resuscitation. 2010 Oct;81(10):1219-76. doi: 10.1016/j.resuscitation.2010.08.021. No abstract available.

ReferenceCitation: Monsieurs KG, Nolan JP, Bossaert LL, Greif R, Maconochie IK, Nikolaou NI, Perkins GD, Soar J, Truhlar A, Wyllie J, Zideman DA; ERC Guidelines 2015 Writing Group. European Resuscitation Council Guidelines for Resuscitation 2015: Section 1. Executive summary. Resuscitation. 2015 Oct;95:1-80. doi: 10.1016/j.resuscitation.2015.07.038. Epub 2015 Oct 15. No abstract available.

ReferenceCitation: Christenson J, Andrusiek D, Everson-Stewart S, Kudenchuk P, Hostler D, Powell J, Callaway CW, Bishop D, Vaillancourt C, Davis D, Aufderheide TP, Idris A, Stouffer JA, Stiell I, Berg R; Resuscitation Outcomes Consortium Investigators. Chest compression fraction determines survival in patients with out-of-hospital ventricular fibrillation. Circulation. 2009 Sep 29;120(13):1241-7. doi: 10.1161/CIRCULATIONAHA.109.852202. Epub 2009 Sep 14.

ReferenceCitation: Wik L, Olsen JA, Persse D, Sterz F, Lozano M Jr, Brouwer MA, Westfall M, Souders CM, Travis DT, Herken UR, Lerner EB. Why do some studies find that CPR fraction is not a predictor of survival? Resuscitation. 2016 Jul;104:59-62. doi: 10.1016/j.resuscitation.2016.04.013. Epub 2016 May 4.

ReferenceCitation: Berg RA, Sanders AB, Kern KB, Hilwig RW, Heidenreich JW, Porter ME, Ewy GA. Adverse hemodynamic effects of interrupting chest compressions for rescue breathing during cardiopulmonary resuscitation for ventricular fibrillation cardiac arrest. Circulation. 2001 Nov 13;104(20):2465-70. doi: 10.1161/hc4501.098926.

ReferenceCitation: Cunningham LM, Mattu A, O'Connor RE, Brady WJ. Cardiopulmonary resuscitation for cardiac arrest: the importance of uninterrupted chest compressions in cardiac arrest resuscitation. Am J Emerg Med. 2012 Oct;30(8):1630-8. doi: 10.1016/j.ajem.2012.02.015. Epub 2012 May 23.

ReferenceCitation: Kleinman ME, Brennan EE, Goldberger ZD, Swor RA, Terry M, Bobrow BJ, Gazmuri RJ, Travers AH, Rea T. Part 5: Adult Basic Life Support and Cardiopulmonary Resuscitation Quality: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S414-35. doi: 10.1161/CIR.0000000000000259. No abstract available.

ReferenceCitation: Perkins GD, Jacobs IG, Nadkarni VM, Berg RA, Bhanji F, Biarent D, Bossaert LL, Brett SJ, Chamberlain D, de Caen AR, Deakin CD, Finn JC, Grasner JT, Hazinski MF, Iwami T, Koster RW, Lim SH, Ma MH, McNally BF, Morley PT, Morrison LJ, Monsieurs KG, Montgomery W, Nichol G, Okada K, Ong ME, Travers AH, Nolan JP; Utstein Collaborators. Cardiac Arrest and Cardiopulmonary Resuscitation Outcome Reports: Update of the Utstein Resuscitation Registry Templates for Out-of-Hospital Cardiac Arrest: A Statement for Healthcare Professionals From a Task Force of the International Liaison Committee on Resuscitation (American Heart Association, European Resuscitation Council, Australian and New Zealand Council on Resuscitation, Heart and Stroke Foundation of Canada, InterAmerican Heart Foundation, Resuscitation Council of Southern Africa, Resuscitation Council of Asia); and the American Heart Association Emergency Cardiovascular Care Committee and the Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation. Resuscitation. 2015 Nov;96:328-40. doi: 10.1016/j.resuscitation.2014.11.002. Epub 2014 Nov 11.

ReferenceCitation: Cheskes S, Schmicker RH, Rea T, Morrison LJ, Grunau B, Drennan IR, Leroux B, Vaillancourt C, Schmidt TA, Koller AC, Kudenchuk P, Aufderheide TP, Herren H, Flickinger KH, Charleston M, Straight R, Christenson J; ROC investigators. The association between AHA CPR quality guideline compliance and clinical outcomes from out-of-hospital cardiac arrest. Resuscitation. 2017 Jul;116:39-45. doi: 10.1016/j.resuscitation.2017.05.003. Epub 2017 May 2.

ReferenceCitation: Hostler D, Everson-Stewart S, Rea TD, Stiell IG, Callaway CW, Kudenchuk PJ, Sears GK, Emerson SS, Nichol G; Resuscitation Outcomes Consortium Investigators. Effect of real-time feedback during cardiopulmonary resuscitation outside hospital: prospective, cluster-randomised trial. BMJ. 2011 Feb 4;342:d512. doi: 10.1136/bmj.d512.

ReferenceCitation: Buleon C, Delaunay J, Parienti JJ, Halbout L, Arrot X, Gerard JL, Hanouz JL. Impact of a feedback device on chest compression quality during extended manikin CPR: a randomized crossover study. Am J Emerg Med. 2016 Sep;34(9):1754-60. doi: 10.1016/j.ajem.2016.05.077. Epub 2016 May 28.

ReferenceCitation: Goodloe JM, Idris AH. Metrics save lives: value and hurdles faced. Curr Opin Crit Care. 2017 Jun;23(3):204-208. doi: 10.1097/MCC.0000000000000408.

ReferenceCitation: Lin S, Scales DC. Cardiopulmonary resuscitation quality and beyond: the need to improve real-time feedback and physiologic monitoring. Crit Care. 2016 Jun 28;20(1):182. doi: 10.1186/s13054-016-1371-9.

ReferenceCitation: Cheskes S, Byers A, Zhan C, Verbeek PR, Ko D, Drennan IR, Buick JE, Brooks SC, Lin S, Taher A, Morrison LJ; Rescu Epistry Investigators. CPR quality during out-of-hospital cardiac arrest transport. Resuscitation. 2017 May;114:34-39. doi: 10.1016/j.resuscitation.2017.02.016. Epub 2017 Feb 24.

ReferenceCitation: Wallace SK, Abella BS, Becker LB. Quantifying the effect of cardiopulmonary resuscitation quality on cardiac arrest outcome: a systematic review and meta-analysis. Circ Cardiovasc Qual Outcomes. 2013 Mar 1;6(2):148-56. doi: 10.1161/CIRCOUTCOMES.111.000041. Epub 2013 Mar 12.

ReferenceCitation: Buleon C, Parienti JJ, Morilland-Lecoq E, Halbout L, Cesareo E, Dubien PY, Jardel B, Boyer C, Husson K, Andriamirado F, Benet X, Morel-Marechal E, Aubrion A, Muntean C, Dupire E, Roupie E, Hubert H, Vilhelm C, Gueugniaud PY; CILICA-HS study group. Impacts of chest compression cycle length and real-time feedback with a CPRmeter(R) on chest compression quality in out-of-hospital cardiac arrest: study protocol for a multicenter randomized controlled factorial plan trial. Trials. 2020 Jul 8;21(1):627. doi: 10.1186/s13063-020-04536-3.

lead_sponsor: University Hospital, Caen

location_facility: Hospital of Elbeuf Louviers Val de Reuil

appel_a_projets: PHRCI

region: Normandie

nom_etablissement: CHU DE CAEN NORMANDIE

acronyme: CILICA HS

titre: Evaluation de l'impact du rythme de relais et du guidage par le CPRmeter sur la qualité du massage cardiaque externe : Compression Is Life In Cardiac Arrest - Human Study

discipline_principale: arret cardiaquemassage cardiaque externeguidageno-flowpréhospitalier

nom_porteur: BULEON

prenom_porteur: Clément


title: Comparison of the Efficacy of Micro-holes vs. Laser-assisted Dermabrasion, for Repigmenting in Vitiligo Skin

acronym: Dermabrasion

summary:
Principal objective: To compare the efficacy of laser-assisted dermabrasion + autologous epidermal cells suspension grafting versus dermabrasion using micro-needling technique + autologous epidermal cells suspension grafting and dermabrasion using micro-needling technique + placebo suspension grafting in stable vitiligo.

A total of 10 patients with stable non-segmental vitiligo will be included in the ITT population.

In each patient, three separate test areas will be selected in the same part of the body.

One area will be pre-treated with dermaroller and receive the hyaluronic acid suspension alone and the two others will receive the epidermal cell suspension in hyaluronic acid after pre-treatment either with dermaroller or laser-assisted dermabrasion, each patient being his own control.

Targeted phototherapy with excimer lamp (308 nMm) will be applied on all test areas 1 week after cell grafting.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
CH Creteil
CHU de Nice
CHU de Bordeaux


title: Evaluation of RDS MultiSense® in Desaturation Analysis and Effects of Hypoxia on Circulating Oxidative Stress and Mitochondrial Respiration in Healthy Volunteers

acronym: HYPO

summary: In this clinical study, the investigators will compare vital parameters measurements obtained using continuous data from reference monitors and continuous wireless MultiSense® monitoring patch in 30 healthy volunteers under induced and controlled hypoxia.

lead_sponsor: IHU Strasbourg

sponsor_collaborators:
IHU Strasbourg
Rhythm Diagnostic Systems

location_facility: Clinical Investigation Center & Physiology and Functional Explorations unit at NHC


title: Enregistrement Des Bruits Vasculaires de l'artère Iliaque Externe Par STETHOscope électronique en Post - Effort Chez le SPORTif

acronym: Stethosport

summary: Define responses to exercise on both arterial bruits and oxymetry in patients referred for suspected endofibrosis.

lead_sponsor: University Hospital, Angers


title: Descriptive Study of Mental Activity in the Emergency Department of the Centre Hospitalier de Mayotte

acronym: URGPSYMAY

summary: Provide a description of patients admitted in the psychaitric department of the Mayotte Hospital

primary_purpose: Prevention

lead_sponsor: University Hospital, Montpellier


title: Multi-center Non-randomized Clinical Investigation of the Reverse Medical Barrel™ Vascular Reconstruction Device (VRD) for Adjunctive Treatment to Embolic Coils for Wide Neck Intracranial Bifurcation and Branch Aneurysms

acronym: Barrel

summary: The purpose of this clinical investigation is to evaluate the safety and effectiveness of the Barrel™ VRD when used to facilitate endovascular coiling of wide-neck bifurcating or branch intracranial aneurysms with any approved embolic coils.

ReferenceCitation: Gory B, Blanc R, Turjman F, Berge J, Piotin M. The Barrel vascular reconstruction device for endovascular coiling of wide-necked intracranial aneurysms: a multicenter, prospective, post-marketing study. J Neurointerv Surg. 2018 Oct;10(10):969-974. doi: 10.1136/neurintsurg-2017-013602. Epub 2018 Feb 2.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

unpaywall_oa_status: hybrid

publisher_dissemination: British Medical Journal

lead_sponsor: Medtronic Neurovascular Clinical Affairs

location_facility: Fondation Ophtalmologique Adolphe de Rothschild


title: Effect of Repeated Administration of Eslicarbazepine Acetate on the Pharmacokinetics of Simvastatin in Healthy Subjects

summary: The primary objective was to investigate whether multiple-dose administration of ESL 800 mg once daily affects the pharmacokinetics of simvastatin, a substrate of CYP34A.

lead_sponsor: Bial - Portela C S.A.


title: French Database of Occipital Nerves Stimulation in the Treatment of Refractory Chronic Headache Disorders

acronym: NGO

summary:
The purpose of this non interventional research is to set up a French database, initially for 3 years, of patients suffering from refractory chronic headache disorders (chronic migraine, cluster headache, chronic paroxysmal hemicranias, SUNCT syndrome, hemicrania continua, cervicogenic headache disorders), and treated by occipital nerves stimulation.

Every team using this neuromodulation approach in France is likely to participate in the network.

Fifty patients a year are expected. They will be informed about data which are collected and why they are collected.

The data will come from medical files and questionnaires filling out by the patients. The data will be collected on a case report form adapted to each refractory chronic headache disorder. The case report form pages will be faxed to the coordinating team who will enter the data in the database and analyse the data in a descriptive manner.

These data are social and demographic data, medical data (headache features, headache functional and emotional impact, medications, and concomitant medical conditions), technical data (kind of electrodes and implantable pulse generator used, stimulation parameters chosen), and safety data.

This research should provide an update on practices, an evaluation of the efficacy and long term safety of occipital nerves stimulation, and perhaps help in identifying response predictive factors to this neuromodulation approach.

ReferenceCitation: Balossier A, Donnet A, Regis J, Leplus A, Lanteri-Minet M, Fontaine D. Occipital Nerve Stimulation for Recurrent Trigeminal Neuralgia Without Occipital Pain. Neuromodulation. 2023 Dec;26(8):1795-1801. doi: 10.1016/j.neurom.2022.03.012. Epub 2022 Jun 7.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Fontaine D, Blond S, Lucas C, Regis J, Donnet A, Derrey S, Guegan-Massardier E, Jarraya B, Dang-Vu B, Bourdain F, Valade D, Roos C, Creach C, Chabardes S, Giraud P, Voirin J, Bloch J, Rocca A, Colnat-Coulbois S, Caire F, Roger C, Romettino S, Lanteri-Minet M. Occipital nerve stimulation improves the quality of life in medically-intractable chronic cluster headache: Results of an observational prospective study. Cephalalgia. 2017 Oct;37(12):1173-1179. doi: 10.1177/0333102416673206. Epub 2016 Oct 3.

publisher_dissemination: SAGE Publications

sponsor_collaborators: Centre Hospitalier Universitaire de Nice

location_facility: Département d'Evaluation et Traitement de la Douleur


title: Evaluation gériatrique Avant Transplantation rénale

summary: Geriatric assessment is now widely used to decide whether older patients with chronic kidney disease should be put on the kidney transplantation waiting list. This study aims to evaluate the association between Geriatric assessment and inscription on kidney transplantation.

ipd_sharing_description: Data would be available on reasonable request


title: Central Neuromodulation of Pain Through Music in Healthy Subjects (DOUMU1)

summary: The present research aims to study the neuromodulatory effect of music on the sensory component of pain. The activation of pain control systems, through music, would pave the way for rehabilitation prospects for patients with a deficit of these controls.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Arterial Wall Calcium Load and Preferential Sites in Pseudoxanthoma Elasticum Versus Type 2 Diabetes and Chronic Kidney Disease.

summary: Quantification and preferential sites of arterial wall calcification within the coronary and lower legs arteries will be comared between Pseudo-Xanthoma elasticum(PXE) atients and type 2 diabetics and Chronic Kidney disease.


title: Functional and Structural Characterization of the Peripheral Arteriopathy in Pseudoxanthoma Elasticum (PXE)

acronym: Ca-Art-PXE

summary: To determine the specific structural and functional features of the peripheral arteriopathy in the Pseudoxanthoma Elasticum (PXE), an inherited autosomal disease.

ReferenceCitation: Naouri M, Boisseau C, Bonicel P, Daudon P, Bonneau D, Chassaing N, Martin L. Manifestations of pseudoxanthoma elasticum in childhood. Br J Dermatol. 2009 Sep;161(3):635-9. doi: 10.1111/j.1365-2133.2009.09298.x. Epub 2009 Jun 9.

ReferenceCitation: Martin L, Maitre F, Bonicel P, Daudon P, Verny C, Bonneau D, Le Saux O, Chassaing N. Heterozygosity for a single mutation in the ABCC6 gene may closely mimic PXE: consequences of this phenotype overlap for the definition of PXE. Arch Dermatol. 2008 Mar;144(3):301-6. doi: 10.1001/archderm.144.3.301.

ReferenceCitation: Martin L, Hoppe E, Kauffenstein G, Omarjee L, Navasiolava N, Henni S, Willoteaux S, Leftheriotis G. Early arterial calcification does not correlate with bone loss in pseudoxanthoma elasticum. Bone. 2017 Oct;103:88-92. doi: 10.1016/j.bone.2017.06.017. Epub 2017 Jun 27.


title: Pessary to Prevent Prematurity in Twins in Case of Short Cervix

acronym: PESSAR'ONE

summary: For 25 years, the twin pregnancy rate has regularly increased in the majority of European countries and in the United States, by 35% between 1981 and 2006. Increased use of medically assisted procreation and older maternal age are the two main causes. At the present time twin pregnancies represent nearly 20% of premature deliveries. The rate of very premature births (< 32-34 weeks) is 7 times higher in twin pregnancies than in singleton pregnancies. As prematurity accounts for 75% of neonatal morbidity and mortality, and extreme prematurity is the principal cause of neonatal mortality and of brain sequelae in twins, the search for a preventive treatment appears as a priority in perinatal medicine. The investigators recently showed in a prospective multicenter study that cervical ultrasound at 22 and 27 wks was a better predictive investigation of premature delivery < 34 wks than digital examination. Recently in a randomized trial in a population of short-cervix singleton pregnancies, the premature delivery rate decreased by 40% in the pessary group compared with the usual management group. No other trial of pessary use in short-cervix twin pregnancies was published today. Recently, in a historical comparison of twins with twin-to-twin transfusion syndrome treated with laser, Carreras et al. have showed a decreased rate of preterm delivery with the use of pessary in case of short cervix. The investigators wish to set up a randomized multicenter study in France in the population of short-cervix twin pregnancies to show a potential benefit of the pessary compared with simple surveillance.

lead_sponsor: University Hospital, Toulouse

location_facility:
Hôpital Antoine Béclère
CHU Nantes
CHU Toulouse
Hôpital Marseille AP-HM
CHU Tours
Hôpital Saint-Joseph
CHRU Lille
GH Pitié Salpétriêre
CHU Saint-Etienne
CHU Bordeaux
CHU Caen
CHI Poissy
Hôpital Universitaire de Strasbourg
Hôpital Bicêtre
Maternité Port-Royal Cochin
CHU Angers
Hôpital Robert Debré
Hôpital Necker

region: Occitanie

nom_etablissement: CHU TOULOUSE

acronyme: PESSARONE

titre: Le pessaire : une solution pour diminuer la prématurité des grossesses gémellaires ?

discipline_principale: obstétrique

nom_porteur: VAYSSIERE

prenom_porteur: Christophe


title: Comparison of Melphalan-Prednisone(MP),MP-THALIDOMIDE,and Autologous Stem Cell Transplantation in the Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma.

summary: In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been used since the 1960s and is regarded as the standard of care in elderly patients. We assess whether the addition of thalidomide to this combination or adapted high-dose chemotherapy, using a melphalan 100 mg/m2 -based regimen, would improve survival.

ReferenceCitation: Facon T, Mary JY, Hulin C, Benboubker L, Attal M, Pegourie B, Renaud M, Harousseau JL, Guillerm G, Chaleteix C, Dib M, Voillat L, Maisonneuve H, Troncy J, Dorvaux V, Monconduit M, Martin C, Casassus P, Jaubert J, Jardel H, Doyen C, Kolb B, Anglaret B, Grosbois B, Yakoub-Agha I, Mathiot C, Avet-Loiseau H; Intergroupe Francophone du Myelome. Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): a randomised trial. Lancet. 2007 Oct 6;370(9594):1209-18. doi: 10.1016/S0140-6736(07)61537-2.


acronym: TRANS-South

lead_sponsor: Olympus Biotech Corporation

summary:
Trafermin is a recombinant human basic fibroblast growth factor (bFGF; original development code, KCB-1), which is manufactured by genetic engineering using Escherichia coli by Kaken Pharmaceutical Co., Ltd. (Tokyo, Japan). Trafermin 0.01% cutaneous spray product kit consisting of a glass bottle containing lyophilized trafermin, a glass bottle with solvent for solution and a spray part to fit the glass bottle after reconstitution of the final product.

The investigators conduct a multinational, randomized, double-blind, placebo controlled, parallel-group, multicentre study consisting of a placebo run-in phase (2w), a treatment phase (max. 12w) and a follow-up phase (3mo+6mo). The primary objective of the study is to demonstrate a superior wound closure rate of diabetic foot ulcers (DFUs) of neuropathic origin after 12 weeks topical daily application of trafermin 0.01% spray compared with placebo, in addition to best local care (off-loading, dressings). Approximately 210 patients will be randomized and it is planned that this study will be conducted at approximately 30 investigational sites in an estimated 4 countries in Europe (Czech Republic,France,Hungary,Italy,).

title: A Phase III, Double-Blind, Placebo Controlled, Parallel Group, International, Multicenter Study of 12 Weeks Treatment With Trafermin 0.01% Spray in Patients With Diabetic Foot Ulcer of Neuropathic Origin

location_country:
France
Hungary
Italy
Czech Republic


title: Pharmacokinetic/Pharmacodynamic Parameters Associated With the Emergence of Resistance to Ciprofloxacin in Human Commensal Flora

summary: Bacterial resistance to antibiotics has been a growing therapeutic problem since the late 1980s. Resistant strains of pathogenic bacteria can arise through initial selection of resistant strains in the commensal flora. The emergence of fluoroquinolone resistance in the commensal flora will be assessed in 48 healthy volunteers receiving variable doses of ciprofloxacin during 14 days. Emergence of resistance will be correlated to pharmacokinetic characteristics of ciprofloxacin.

ReferenceCitation: de Lastours V, Maugy E, Mathy V, Chau F, Rossi B, Guerin F, Cattoir V, Fantin B; CIPHARES Study Group. Ecological impact of ciprofloxacin on commensal enterococci in healthy volunteers. J Antimicrob Chemother. 2017 Jun 1;72(6):1574-1580. doi: 10.1093/jac/dkx043.

oa_host_type: publisher

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: Oxford University Press

ReferenceCitation: de Lastours V, Cambau E, Guillard T, Marcade G, Chau F, Fantin B. Diversity of individual dynamic patterns of emergence of resistance to quinolones in Escherichia coli from the fecal flora of healthy volunteers exposed to ciprofloxacin. J Infect Dis. 2012 Nov;206(9):1399-406. doi: 10.1093/infdis/jis511. Epub 2012 Aug 28.

ReferenceCitation: Fantin B, Duval X, Massias L, Alavoine L, Chau F, Retout S, Andremont A, Mentre F. Ciprofloxacin dosage and emergence of resistance in human commensal bacteria. J Infect Dis. 2009 Aug 1;200(3):390-8. doi: 10.1086/600122.

location_facility: Hôpital Bichat Claude Bernard, 46 rue Henri Huchard


title: Oral and Dental Health Status in Patients Suffering From Chronic Kidney Disease

acronym: NEPHRODENT

summary:
A large panel of oral and dental diseases exist in patients suffering from chronic kidney disease (CKD) in end-stage renal disease: it concerns teeth, peridontium, alveolar bone and saliva and it has been already described in the literature. The consequences of oral diseases in systemic health are substantial, including increase of inflammatory parameters, alteration of nutrition and increase of cardiovascular risk factors. It has been shown before that several oral diseases can be considered as cardiovascular risk factor in the general population and in diabetic patients through the chronic inflammatory pathway. In CKD patients, the influence of oral diseases on the progression of the chronic kidney disease is not yet established, as most of the studies are focused on stage 5 CKD or dialysis patients. That's why the interactions between dental health and CKD will be evaluated in this population of patients, at different stages of the disease (stages 2 to 5).

The main objective will be to describe the oral diseases at each stage of CKD. Secondary objectives will be: (1) To evaluate the link between the oral health and the chronic kidney disease stage, the nutritional and inflammatory status; (2) Among patients needing dental treatments, to evaluate after 6 months and 12 months whether dental cares have an influence on nutrition parameters, inflammatory status and CKD; (3) to evaluate the completion of dental treatments after the dental consultation including advises on dental health.

lead_sponsor: University Hospital, Bordeaux

location_facility: Service de néphrologie, transplantation et dialyse - Hôpital Pellegrin


title: Tolerance of Nasal High Frequency Percussive Ventilation Versus Nasal CPAP in Neonatal Respiratory Distress in Term and Preterm (> 33 Weeks of Gestation) Neonates

acronym: TONIPEP

summary:
Respiratory distress is the main cause of morbimortality in preterm and term neonates. In most of the case, these babies required the use of positive end expiratory pressure (PEEP) delivered by a non invasive device. Nasal continuous airway positive pressure (nCPAP) is widely used in neonatal intensive care unit. Nasal high frequency percussive ventilation (nHFPV) can be used as non invasive device to deliver PEEP, and improved lung clearance.

We hypothesized that nHFPV can be used to deliver PEEP in preterm and term newborn with respiratory distress with the same tolerance as nCPAP. To compare the tolerance of these devices we used cerebral tissue oxygenation (rSO2c) measured by near infrared spectroscopy (NIRS).

location_facility: Service de Néonatalogie - Maternité - Hôpital Pellegrin


title: Sub-thalamic Nucleus Stimulation in Parkinson Disease: Comparison of a Two-steps Electrophysiological Approach Under Local and General Anesthesia and a One-step Approach Under General Anesthesia

acronym: PARKEO

summary:
Deep brain stimulation (DBS) is an established procedure for the symptomatic treatment of Parkinson's disease. This procedure performed in two steps using electrophysiology. This study is a prospective, randomized and monocentric study to compare two DBS procedures with or without electrophysiology.

A better control of targeting and trajectory is necessary before not using electrophysiology, which is the reference procedure. A new definition of sub thalamic nuclei with new MRI stereotactic landmarks, the use of surgical robot (Neuromata Renishaw) and the use of operative imaging (O-arm) could allow the implantation of electrode in sub-thalamic nuclei without the need of electrophysiology.

Two groups of patients will be followed: a first group of patients with a procedure under general anesthesia alone without electrophysiological stimulation and a second smaller group of patients with a first step of electrode implantation under awake surgery with electrophysiological stimulation followed by a second step under general anesthesia for the implantation of stimulator.

Clinical results will be assessed at 6 months after implantation.

ReferenceCitation: Bronstein JM, Tagliati M, Alterman RL, Lozano AM, Volkmann J, Stefani A, Horak FB, Okun MS, Foote KD, Krack P, Pahwa R, Henderson JM, Hariz MI, Bakay RA, Rezai A, Marks WJ Jr, Moro E, Vitek JL, Weaver FM, Gross RE, DeLong MR. Deep brain stimulation for Parkinson disease: an expert consensus and review of key issues. Arch Neurol. 2011 Feb;68(2):165. doi: 10.1001/archneurol.2010.260. Epub 2010 Oct 11.

ReferenceCitation: Cuny E, Guehl D, Burbaud P, Gross C, Dousset V, Rougier A. Lack of agreement between direct magnetic resonance imaging and statistical determination of a subthalamic target: the role of electrophysiological guidance. J Neurosurg. 2002 Sep;97(3):591-7. doi: 10.3171/jns.2002.97.3.0591.

ReferenceCitation: Ferrara J, Diamond A, Hunter C, Davidson A, Almaguer M, Jankovic J. Impact of STN-DBS on life and health satisfaction in patients with Parkinson's disease. J Neurol Neurosurg Psychiatry. 2010 Mar;81(3):315-9. doi: 10.1136/jnnp.2009.184127. Epub 2009 Sep 1.

ReferenceCitation: Kenney C, Simpson R, Hunter C, Ondo W, Almaguer M, Davidson A, Jankovic J. Short-term and long-term safety of deep brain stimulation in the treatment of movement disorders. J Neurosurg. 2007 Apr;106(4):621-5. doi: 10.3171/jns.2007.106.4.621.

ReferenceCitation: Kleiner-Fisman G, Herzog J, Fisman DN, Tamma F, Lyons KE, Pahwa R, Lang AE, Deuschl G. Subthalamic nucleus deep brain stimulation: summary and meta-analysis of outcomes. Mov Disord. 2006 Jun;21 Suppl 14:S290-304. doi: 10.1002/mds.20962.

ReferenceCitation: Limousin P, Krack P, Pollak P, Benazzouz A, Ardouin C, Hoffmann D, Benabid AL. Electrical stimulation of the subthalamic nucleus in advanced Parkinson's disease. N Engl J Med. 1998 Oct 15;339(16):1105-11. doi: 10.1056/NEJM199810153391603.

ReferenceCitation: Maltete D, Navarro S, Welter ML, Roche S, Bonnet AM, Houeto JL, Mesnage V, Pidoux B, Dormont D, Cornu P, Agid Y. Subthalamic stimulation in Parkinson disease: with or without anesthesia? Arch Neurol. 2004 Mar;61(3):390-2. doi: 10.1001/archneur.61.3.390.

ReferenceCitation: Engelhardt J, Caire F, Damon-Perriere N, Guehl D, Branchard O, Auzou N, Tison F, Meissner WG, Krim E, Bannier S, Benard A, Sitta R, Fontaine D, Hoarau X, Burbaud P, Cuny E. A Phase 2 Randomized Trial of Asleep versus Awake Subthalamic Nucleus Deep Brain Stimulation for Parkinson's Disease. Stereotact Funct Neurosurg. 2021;99(3):230-240. doi: 10.1159/000511424. Epub 2020 Nov 30.

publisher_dissemination: S. Karger AG


title: Obtaining Vascular Access (Venous or Intraosseous) During Cardiac Arrest in Out-of-hospital Care: Delays and Failure Risk Factors

acronym: ACCIO

summary: the international recommendations don't explain the place of the intraosseous infusion in the reanimation of adult cardiac arrest; the goal of this preliminary study is to inform the delay for obtaining a vascular access by evaluation of a current strategy (using intraosseous infusion after one peripheral venous access failure) and to determine the potential failure risk factors of venous access.


title: Non Comparative, Monocentric, Prospective, Phase II, Study of Calcium Phosphate Cement MCPC Efficacy and Safety for Bone Filling in Vertebral Site

acronym: VERTEBRO-MCPC

summary:
The macroporous calcium phosphate cement, MCPC, which composition is close to bone, is malleable and biocompatible, and has intrinsic radio opacity and good ability to undergo mechanical constraints. After the filling of the bone cavity, the cement hardens. Interestingly, this calcium phosphate cement has no exothermic hardening (on the contrary, the ordinary cements used nowadays cause necrotic lesions in tissues around during this phase) and favours vascularisation, cellular colonisation and bone healing. Thanks to its resorbability, the MCPC cement is replaced little by little by a physiologic bone. This last property is very important for young people needing a vertebroplasty after a traumatism.

Thus, it will be tested in a low-invasive surgery, a non-percutaneous vertebroplasty, consisting in filling with the MCPC the body of the broken vertebra, after its stabilization thanks to 4 interpedicular screws. This protocol will be proposed to patients 1 to 3 weeks after the trauma having caused the fracture.

The follow up will last 12 months with 5 visits (2 days, and 3, 4, 6 and 12 months after vertebroplasty), 2 CT scanners before inclusion and at 12 months, 2 EOS (ultra low dose imager replacing classical radiography) at 5 and 12 months, questionnaires (visual analogic scale for pain, and quality of life with OSWESTRY and SF36 scales) before inclusion and at 2 days, and 3, 4, 6 and 12 months, and biological exams (CRP/VS, for inflammation) at each visit except 2 days after surgery. An osteodensitometry will be performed at 3 months.

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location_facility: Service d'orthopédie-traumatolologie (C), Hôpital Pellegrin


title: Comparison of 2 Surgical Approaches in the Treatment of Degenerative Spondylolysthesis: Posterolateral Fusion With Instrumentation (GPLI) Plus or Minus Transforaminal Lumbar Interbody Fusion (TLIF)

acronym: SPONGIT

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location_facility: Service de chirurgie orthopédique, Hôpital Pellegrin Tripode


title: Proteomic Approach Using Matrix-assisted Laser Desorption/Ionization Tandem Time-of-flight (MALDI-TOF/TOF) of Tumor Response in Rectal Carcinoma After Radiochemotherapy

acronym: PROTEORECTUM

summary: Treatment for locally-advanced rectal adenocarcinoma includes preoperative radiochemotherapy before surgery with total mesorectal excision in order to reduce tumor infiltration, facilitate oncologic surgery and improve survival. About fifty percent of these patients are good responders i.e. their tumor infiltration reduces in the rectal wall and regional lymph nodes in order to be graded ypT0 to T2 N0 after pathologic assessment (so called downstaging). At the opposite, bad responders (ypT3-4 and/or N+) are not sensitive to standard preoperative radiochemotherapy, and their survival is poor than good responders. Until now, response to preoperative radiochemotherapy cannot be anticipated before pathological assessment of surgical specimen. Proteomic analysis of sera from good and bad responders to preoperative radiochemotherapy could allow identification of early biomarkers of tumor response, and subsequently adaptation of treatment to increase preoperative treatment efficiency and survival in most patients.

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location_facility: Laboratoire d'anatomie pathologique, University Hospital, Bordeaux


title: Evaluation of a New Diagnostic Approach to Familial Amyloid Neuropathy by Mutation of the TTR Gene in a Population of Idiopathic Chronic Neuropathies

acronym: TTR-FAP

summary: TTR-FAP is a rare disabling inherited disorder that predominantly affects the peripheral nervous system and the heart. Due to an important phenotypic and genetic heterogeneity, the diagnosis is often delayed, preventing therefore early onset treatment. Our project is to evaluate the prevalence of TTR-FAP in a series of 130 patients with from chronic neuropathy of undetermined aetiology through a systematic screening of TTR mutations.

sponsor_collaborators:
University Hospital, Bordeaux
University of Bordeaux

location_facility: Reference center for neuromuscular diseases

intervention_type: Genetic


title: Effect of the Infant Behavioral Assessment and Intervention Program (IBAIP) in Preterm Infants on Neurodevelopment at 2 Years Corrected Age

acronym: IBAIP

summary:
Mortality in very preterm infants has decreased significantly over the past twenty years. However, neuromotor, behavioral and cognitive development disorders are more common in these children born before 33 weeks of gestation as compared to term born infants.

These neurodevelopmental disorders include difficulties with self-regulation, tone, posture or poor quality movements as well as inadequate responses to sensory simulation.

Post-hospital discharge follow-up and interventionsof children born very preterm ares very heterogeneous in France. They are mainly carried out in a rehabilitation center, based on caregivers whereas IBAIP is carried out at home and family centered.

Early interventions during hospitalization or after discharge appear potentially of great interest in improving the neurodevelopemental outcome of the very preterm infants. Several early interventions have been developed and evaluated in other countries. These interventions are designed to be used early in life, mainly during the first 3 years of life, and are based on brain plasticity and intense synaptogenesis during this period of life.

The IBAIP (Infant Behavior Assessment and Intervention Program) was developed on the same theoretical foundations as the NIDCAP (Neonatal Individualized Development Care and Assessment Program). IBAIP consists of providing the child and his family with an intervention, at home, starting just before hospital discharge up to a 6 months corrected age. .The aim of IBAIP is to support developmental functions including infant's self-regulation and focus on improving the responsiveness of parents' infant interactions.

location_facility:
CHU Nantes
CHU Besançon
CHU Rennes
CHRU Strasbourg
CHU Brest
CHU Caen
CHU Tours
CHU Angers

region: Bretagne

nom_etablissement: CHRU BREST

acronyme: IBAIP

titre: Impact d'un programme d'intervention précoce post-hospitalière (IBAIP) sur le développement psycho-moteur à deux ans d'enfants nés prématurément

discipline_principale: autre

nom_porteur: DUIGOU

prenom_porteur: Anne Laure


title: Immunological Repertoire in Patients With Lymphoma and Chronic Lymphocytic Leukemia, Biomedical Research on Medical Devices Human ImmunTracker and Human Immun'IgH

acronym: RIPAL

summary: RIPAL is a prospective cohort study, which main goal is to define T and B immune repertoire diversity and magnitude in patients with non-Hodgkin lymphoma of high and low grade and chronic lymphocytic leukemia before and after treatment, and to evaluate the association of these parameters with clinical patient data and outcomes.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud

intervention_type: Biological


title: Impairment of Central Coherence in Restrictive Anorexia Nervosa: Single-center and Case-control Study

acronym: CoCA

summary:
The current etiological pathological model of anorexia nervosa is poly-factorial involving individual genetic and psychological factors, in close interaction with environmental, family and socio-cultural factors.

Among these factors, this study focuses on the central coherence process (cognitive ability to integrate complex information into a comprehensive meaning), in the active phase of the disease. Therefore, patients followed in the addiction service of the Nantes University Hospital will perform neuropsychological tests assessing executive functions involved in the process of central coherence.

Impairment of central coherence process could act as a maintenance factor of the disease, particularly in connection with body dysmorphic disorder. The therapeutic perspectives acting on the central coherence process like cognitive remediation deserve to deepen knowledge on the cognitive profile of patients with anorexia nervosa.

lead_sponsor: Nantes University Hospital

intervention_type: Behavioral


title: A Prospective and Multicentric Investigation Evaluating the Clinical Safety of FASY F and FASY P Hyaluronic Acid Gel for the Treatment of Pathological Facial Lipoatrophy

acronym: HAtrophy

summary:
Facial lipoatrophy (FLA) refers to the loss of adipose tissue and is manifested by flattening or indentation of convex contours of the face. Most frequently, the subcutaneous layer is affected and most common locations of adipose tissue loss are the cheeks, temples, preauricular, orbital or perioral and oral areas. Most common etiology for FLA is related to HIV. In 1998, first FLA was described in Subjects under highly active antiretroviral therapy (HAART). Currently, no specific treatment for FLA is known. For HIV-associated FLA, the European AIDS Clinical Society (EACS) recommends in prevention, the avoidance of some ART (Active Antiretroviral therapy) such as stavudine and zidovudine. In corrective purpose, the switch of ART is advisable as well as surgical intervention involving dermal fillers.

Different filling treatment options are available to treat volume defect on FLA Subjects including PolyLactic Acid (PLLA) (i.e.; Sculptra®), Calcium hydroxyapatite ( CaHa - i.e.: Radiesse®), autologous fat graft and hyaluronic acid (HA). Several studies shown promising results for the use of HA in this indication with good reconstructive and aesthetic outcomes, excellent safety profile and comparable to the autologous fat transfer treatment. HA fillers are described as voluming agents for treatment of FLA associated with fat wasting disorders, lasting at least 6 months but the persistent volumetric effect depends on HA crosslinking level and concentration.

sponsor_collaborators: Symatese EVAMED

location_facility:
Palais de Flore
THINKIN
Dermatology practice