title: Fibromyalgia and Specific Physical Activity

acronym: FibrAPSpé

summary:
Fibromyalgia is a common, expensive and controversial condition, one of whose origins would be central nervous system sensitization to pain.

Usual treatment consists of multimodal care including physical activity. This dosage should be adapted to the patient's health needs. Currently recommended physical exercise is aerobic work associated with muscle reinforcement, without evidence of superiority of the efficacy of one over the other. Recommended dosage for aerobic exercises is 20 minutes (or twice 10 minutes), two to three times a week (70 - 80% of Theoretical Maximum Heart Rate).

At the Vendee Departmental Hospital Center (CHD), adapted physical activity is proposed to fibromyalgia patientsby the associative group "Siel Bleu". This physical activity, performed with patients suffering from different pathologies, is non specific for fibromyalgia context.

In parallel, a preliminary study showed the interest of a lifestyle coaching for fibromyalgia patients, performed by physiotherapists, nurses and coaches specifically trainede.

Another possibility seems to be personalized coaching with a physical activity adapted to the physical and organizational constraints of the patient, and specific to pathology. This solution would make it possible to adapt to the patient's choice of physical activities, to ensure a better adaptation to their physical and organizational constraints as well as a better individualized follow-up.

ReferenceCitation: Rulleau T, Planche L, Etcheverrigaray F, Dorion A, Kacki N, Miot M, Liaigre A, Ganem Y, Schmidt A, Taddéi F, Acapo S, Nizard J, Pluchon YM. Comparison of patient-led, fibromyalgia-orientated physical activity and a non-specific, standardised 6-month physical activity program on quality of life in individuals with fibromyalgia: a protocol for a randomised controlled trial. Trials. 2020 Sep 17;21(1):800. doi: 10.1186/s13063-020-04730-3.

family: Rulleau

full_name: T. Rulleau

given: T.

family: Planche

full_name: L. Planche

given: L.

family: Etcheverrigaray

full_name: F. Etcheverrigaray

given: F.

family: Dorion

full_name: A. Dorion

given: A.

family: Kacki

full_name: N. Kacki

given: N.

family: Miot

full_name: M. Miot

given: M.

family: Liaigre

full_name: A. Liaigre

family: Ganem

full_name: Y. Ganem

given: Y.

family: Schmidt

full_name: A. Schmidt

family: Taddéi

full_name: F. Taddéi

family: Acapo

full_name: S. Acapo

given: S.

family: Nizard

full_name: J. Nizard

given: J.

family: Pluchon

full_name: Y. M. Pluchon

given: Y. M.

currency_apc_doaj: GBP

journal_name: Trials

license: cc-by

license_normalized: cc-by

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

location_facility:
Centre Hospitalier Universitaire
Centre Hospitalier Départemental Vendée


title: Effect of Depletive Lumbar Puncture and Cerebrospinal Fluid Shunt Surgery on Lower Urinary Tract Dysfunction in Normal Pressure Hydrocephalus

acronym: PLHPN

summary:
Lower urinary tract dysfunction in normal pressure hydrocephalus has received little attention from the scientific community. Urinary symptoms in normal pressure hydrocephalus are mainly represented by overactive bladder, which is a significant burden for the concerned patients. A harmonization of neuro-urological practices in the pre-therapeutic evaluation of patients suffering from normal pressure hydrocephalus is necessary.

The investigators conducted a bicentric prospective study aiming to evaluate the effect of depletive lumbar puncture on urinary symptoms in iNPH.

The secondary objective was to evaluate, in the same participants previously diagnosed, the effect of cerebrospinal fluid shunt surgery on urinary symptoms.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Anticipated

ReferenceType: result

ReferenceCitation: Mary P, Gallisa JM, Laroque S, Bedou G, Maillard A, Bousquet C, Negre C, Gaillard N, Dutray A, Fadat B, Jurici S, Olivier N, Cisse B, Sablot D. [Predictive value of postural and dynamic walking parameters after high-volume lumbar puncture in normal pressure hydrocephalus]. Rev Neurol (Paris). 2013 Apr;169(4):321-7. doi: 10.1016/j.neurol.2012.09.010. Epub 2013 Feb 12. French.

family: Mary

full_name: P. Mary

given: P.

sequence: first

family: Gallisa

full_name: J.-M. Gallisa

sequence: additional

family: Laroque

full_name: S. Laroque

family: Bedou

full_name: G. Bedou

given: G.

family: Maillard

full_name: A. Maillard

family: Bousquet

full_name: C. Bousquet

given: C.

family: Negre

full_name: C. Negre

family: Gaillard

full_name: N. Gaillard

family: Dutray

full_name: A. Dutray

family: Fadat

full_name: B. Fadat

given: B.

family: Jurici

full_name: S. Jurici

family: Olivier

full_name: N. Olivier

family: Cisse

full_name: B. Cisse

family: Sablot

full_name: D. Sablot

given: D.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Revue Neurologique

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Intérêt prédictif de l’évolution des facteurs posturaux et locomoteurs après ponction lombaire soustractive dans l’hydrocéphalie chronique de l’adulte

ReferenceCitation: Jonas S, Brown J. Neurogenic bladder in normal pressure hydrocephalus. Urology. 1975 Jan;5(1):44-50.

ReferenceCitation: Sakakibara R, Uchida Y, Ishii K, Kazui H, Hashimoto M, Ishikawa M, Yuasa T, Kishi M, Ogawa E, Tateno F, Uchiyama T, Yamamoto T, Yamanishi T, Terada H; SINPHONI (Study of Idiopathic Normal Pressure Hydrocephalus On Neurological Improvement). Correlation of right frontal hypoperfusion and urinary dysfunction in iNPH: a SPECT study. Neurourol Urodyn. 2012 Jan;31(1):50-5. doi: 10.1002/nau.21222. Epub 2011 Oct 28.

family: Sakakibara

full_name: Ryuji Sakakibara

given: Ryuji

family: Uchida

full_name: Yoshitaka Uchida

given: Yoshitaka

family: Ishii

full_name: Kazunari Ishii

given: Kazunari

family: Kazui

full_name: Hiromitsu Kazui

given: Hiromitsu

family: Hashimoto

full_name: Masaaki Hashimoto

given: Masaaki

family: Ishikawa

full_name: Masaaki Ishikawa

family: Yuasa

full_name: Tatsuhiko Yuasa

name: the members of SINPHONI (Study of Idiopathic Normal Pressure Hydrocephalus On Neurological Improvement)

title: Correlation of right frontal hypoperfusion and urinary dysfunction in iNPH: A SPECT study

ReferenceCitation: Sakakibara R, Kanda T, Sekido T, Uchiyama T, Awa Y, Ito T, Liu Z, Yamamoto T, Yamanishi T, Yuasa T, Shirai K, Hattori T. Mechanism of bladder dysfunction in idiopathic normal pressure hydrocephalus. Neurourol Urodyn. 2008;27(6):507-10.

ReferenceCitation: Sakakibara R, Uchiyama T, Kanda T, Uchida Y, Kishi M, Hattori T. [Urinary dysfunction in idiopathic normal pressure hydrocephalus]. Brain Nerve. 2008 Mar;60(3):233-9. Review. Japanese.

ReferenceCitation: Campos-Juanatey F, Gutiérrez-Baños JL, Portillo-Martín JA, Zubillaga-Guerrero S. Assessment of the urodynamic diagnosis in patients with urinary incontinence associated with normal pressure hydrocephalus. Neurourol Urodyn. 2015 Jun;34(5):465-8. doi: 10.1002/nau.22600. Epub 2014 Apr 12.

name: Urology Department; Marqués de Valdecilla University Hospital; Santander Cantabria Spain

name: School of Medicine; University of Cantabria; Santander Spain

ReferenceCitation: Kazui H, Mori E, Ohkawa S, Okada T, Kondo T, Sakakibara R, Ueki O, Nishio Y, Ishii K, Kawaguchi T, Ishikawa M, Takeda M. Predictors of the disappearance of triad symptoms in patients with idiopathic normal pressure hydrocephalus after shunt surgery. J Neurol Sci. 2013 May 15;328(1-2):64-9. doi: 10.1016/j.jns.2013.02.020. Epub 2013 Mar 16.

ReferenceCitation: Mouton Paradot G, Baledent O, Sallioux G, Lehmann P, Gondry-Jouet C, Le Gars D. [Contribution of phase-contrast MRI to the management of patients with normal pressure hydrocephalus: Can it predict response to shunting?]. Neurochirurgie. 2010 Feb;56(1):50-4. doi: 10.1016/j.neuchi.2009.12.007. Epub 2010 Jan 25. French.

title: Apport de l’IRM de flux dans les hydrocéphalies à pression normale de l’adulte : intérêt prédictif dans les indications chirurgicales

ReferenceCitation: Sakakibara R. Lower urinary tract dysfunction in patients with brain lesions. Handb Clin Neurol. 2015;130:269-87. doi: 10.1016/B978-0-444-63247-0.00015-8. Review.

ReferenceCitation: Griffiths D, Tadic SD. Bladder control, urgency, and urge incontinence: evidence from functional brain imaging. Neurourol Urodyn. 2008;27(6):466-74. Review.

ReferenceCitation: Sakakibara R, Panicker J, Fowler CJ, Tateno F, Kishi M, Tsuyusaki Y, Yamanishi T, Uchiyama T, Yamamoto T, Yano M. Is overactive bladder a brain disease? The pathophysiological role of cerebral white matter in the elderly. Int J Urol. 2014 Jan;21(1):33-8. doi: 10.1111/iju.12288. Epub 2013 Sep 30. Review.

name: Neurology Division; Department of Internal Medicine; Toho University; Sakura Japan

name: Department of Uro-Neurology; National Hospital for Neurology and Neurosurgery; London UK

name: Continence Center; Dokkyo Medical College; Tochigi Japan

name: Department of Neurology; Chiba University; Chiba Japan

name: Department of Urology; Sakura Medical Center; Toho University; Sakura Japan

ReferenceCitation: Sakakibara R, Uchida Y, Ishii K, Hashimoto M, Ishikawa M, Kazui H, Yamamoto T, Uchiyama T, Tateno F, Kishi M, Tsuyusaki Y, Aiba Y, Tateno H, Nagao T, Terada H, Inaoka T; Members of SINPHONI (Study of Idiopathic Normal Pressure Hydrocephalus On Neurological Improvement). Bladder recovery relates with increased mid-cingulate perfusion after shunt surgery in idiopathic normal-pressure hydrocephalus: a single-photon emission tomography study. Int Urol Nephrol. 2016 Feb;48(2):169-74. doi: 10.1007/s11255-015-1162-2. Epub 2015 Nov 17.

name: The Members of SINPHONI (Study of Idiopathic Normal Pressure Hydrocephalus On Neurological Improvement)

ReferenceCitation: Kang K, Hwang SK, Lee HW. Shunt-responsive idiopathic normal pressure hydrocephalus patient with delayed improvement after tap test. J Korean Neurosurg Soc. 2013 Nov;54(5):437-40. doi: 10.3340/jkns.2013.54.5.437. Epub 2013 Nov 30.

name: Department of Neurology, School of Medicine, Kyungpook National University, Daegu, Korea.

name: Department of Neurosurgery, School of Medicine, Kyungpook National University, Daegu, Korea.

name: Brain Science & Engineering Institute, Kyungpook National University, Daegu, Korea.

title: Shunt-Responsive Idiopathic Normal Pressure Hydrocephalus Patient with Delayed Improvement after Tap Test

ReferenceCitation: Wikkelsø C, Andersson H, Blomstrand C, Lindqvist G. The clinical effect of lumbar puncture in normal pressure hydrocephalus. J Neurol Neurosurg Psychiatry. 1982 Jan;45(1):64-9.

ReferenceCitation: Lim TS, Yong SW, Moon SY. Repetitive lumbar punctures as treatment for normal pressure hydrocephalus. Eur Neurol. 2009;62(5):293-7. doi: 10.1159/000235808. Epub 2009 Aug 27.

title: Repetitive Lumbar Punctures as Treatment for Normal Pressure Hydrocephalus

ReferenceCitation: Ahlberg J, Norlén L, Blomstrand C, Wikkelsö C. Outcome of shunt operation on urinary incontinence in normal pressure hydrocephalus predicted by lumbar puncture. J Neurol Neurosurg Psychiatry. 1988 Jan;51(1):105-8.

ReferenceCitation: Aruga S, Kuwana N, Shiroki Y, Takahashi S, Samejima N, Watanabe A, Seki Y, Igawa Y, Homma Y. Effect of cerebrospinal fluid shunt surgery on lower urinary tract dysfunction in idiopathic normal pressure hydrocephalus. Neurourol Urodyn. 2018 Mar;37(3):1053-1059. doi: 10.1002/nau.23399. Epub 2017 Sep 11.

name: Department of Urology; Tokyo Kyosai Hospital; Meguro-ku Japan

name: Department of Neurosurgery; Tokyo Kyosai Hospital; Meguro-ku Japan

name: Department of Continence Medicine; University of Tokyo Graduate school of Medicine; Bunkyo-ku Japan

name: Japanese Red Cross Medical Center; Shibuya-ku Tokyo

ReferenceCitation: Krzastek SC, Bruch WM, Robinson SP, Young HF, Klausner AP. Characterization of lower urinary tract symptoms in patients with idiopathic normal pressure hydrocephalus. Neurourol Urodyn. 2017 Apr;36(4):1167-1173. doi: 10.1002/nau.23084. Epub 2016 Aug 4.

name: Division of Urology; Department of Surgery; Virginia Commonwealth University School of Medicine; Richmond Virginia

name: Department of Neurosurgery; Virginia Commonwealth University School of Medicine; Richmond Virginia

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

location_facility:
University Hospital of Grenoble
University Hospital of Lyon


title: A Multicenter Phase 2 Single-arm Proof-of-concept Trial to Assess the Efficacy and Safety of Ustekinumab in Association With Prednisone for the Treatment of Non-infectious Severe Uveitis (NISU)

acronym: USTEKINISU

summary:
Uveitis is characterized by inflammation of the uvea, which is the middle portion of the eye. The greatest challenge for the treatment of uveitis is patients who have inflammation involving the posterior segment, either primarily in the vitreous (intermediate uveitis), the choroid or retina (posterior uveitis), or involving the entire eye (panuveitis). The term "uveitis" denotes a heterogeneous collection of diseases including infections, systemic immune-mediated diseases like sarcoidosis, and immune-mediated syndromes confined to the eye like sympathetic ophthalmia. Despite the progress in recent decades, uveitis and the related intraocular inflammation are comparable to diabetes or macular degeneration as a cause of lost quality-adjusted life years due to visual morbidity, and as such are a significant public health problem. The Standardization of Uveitis Nomenclature Working Group Guidelines recommend the use of corticosteroids as the first-line therapy for patients with active uveitis. However, long-term corticosteroid treatment can cause serious systemic and ocular side effects, such as hypertension, diabetes, osteoporosis, cataract, and glaucoma that limit its use in the treatment of uveitis. Alternatively, immunomodulatory therapy (IMT) drugs are given as steroid-sparing agents and have shown good clinical results for both systemic diseases and ocular inflammatory diseases. Given the side effects of chronic corticosteroid therapy and better understanding of the mechanisms of autoimmune-mediated uveitis, the aim of the treatment for patients with noninfectious uveitis is steroid-free remission with IMT. While uveitis is a heterogeneous disease with polygenic and environmental factors, most forms of immune-mediated uveitis are thought to be due to an imbalance between regulatory mechanisms that inhibit the immune system and inflammatory mechanisms, which have evolved to rid the body of infectious organisms, but which can result in immune-mediated, often chronic disease if they are activated outside the context of the immediate infection. The pathophysiology of non-infectious uveitis involves the rupture of peripheral tolerance, resulting in auto-aggressive Th1 or Th17 lymphocytes reaching the eye. L-12 and IL-23 are two key cytokines involved in Th1 and Th17 polarization in uveitis, respectively. Furthermore, these two cytokines share a common subunit (p40). Ustekinumab, a humanized anti-p40 monoclonal antibody, is able to target both IL-12 and IL-23 pathways, thus disrupting Th1 and Th17 immune responses.

Decreasing the dose as well as the duration of treatment with GC is of particular importance in uveitis, and ustekinumab, which selectively inhibits Th1 and Th17 pathways in the inflammatory cascade, could provide a ideal additional therapy for non-infectious severe uveitis (NISU) to reach this objective.

Therefore, in the present study, we propose to evaluate the efficacy and safety of ustekinumab for the treatment of NISU.

status: Recruiting

primary_purpose: Treatment

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
CHU Dijon Bourgogne
CH Avignon

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Could Decrease the Incidence of Oxygen Desaturation During Suspension Laryngoscopy: a Randomized Controlled Trial

acronym: optilaryngo

summary:
Suspension laryngoscopy is realised during apnea. In effect, surgeons are in the mouth of the patient and we can't have access at the aiways.

So investigators like to use a Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) to increase time of apnea and decrease the impact of oxygen desaturation.

design_allocation: Randomized

lead_sponsor: University Hospital, Caen

location_facility:
CaenUH
Centre François Baclesse

intervention_type: Device

status_simplified: Unknown


title: COLON-IM : Prospective Cohort Study About Colorectal Environment : Microbiota and Immune Infiltrate in Normal, Dysplastic and Neoplastic Colorectal Tissue

summary: The primary objective of COLON-IM is to describe colorectal tissue microenvironment (neutrophils infiltrate) of patients with benign or malignant colorectal lesion (from stage I to III according to Tumor Node Metastasis (TNM)/ Union for International Cancer Control (UICC) classification).

study_type: Observational

time_perspective: Prospective

lead_sponsor: Centre Leon Berard

location_facility:
GARBIT Vincent
Centre Leon Berard


title: Pharmaco-metabolomic Effects of Statins: METASTATINE

acronym: METASTATINE

summary: Statins are effective in cardio-vascular prevention by lowering LDL-Cholesterol levels but also through other mechanisms poorly understood. Our hypothesis is that some of these effects are mediated by microbiota alteration, leading to diminution of expression of microbiota derived pro-atherogenic metabolites.

ipd_sharing: No

lead_sponsor: French Cardiology Society

location_facility:
CIC La Sapétrière
CIC HEGP

intervention_type: Drug

lead_sponsor_type: industriel


title: Study of the Digestive Colonization of the Newborn Children by the Streptococcus of the Group B

acronym: Col-Strepto B

summary:
The main objective of this study : Demonstrate that GBS (group B streptococci) "ST-17" colonize and persist to 60 days twice in the digestive tract of newborns that strains of GBS non-ST-17.

Secondary objectives:Determine:

The frequency of colonization with GBS ST-17 and GBS non-ST-17 of at risk pregnant women.
The frequency of colonization of neonates by GBS ST-17 at birth.
The preferential site of colonization in the mother (rectum, vagina, breast milk).
The kinetics of colonization after birth in the newborn.
The sensitivity and specificity of different GBS detection methods (conventional phenotypic versus molecular) in the different types of samples from the mother and the newborn.

status: Completed

study_completion_date_type: Actual

primary_purpose: Screening

enrollment_type: Actual

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility:
Louis Mourier Hospital
Cochin Hospital

status_simplified: Completed


title: Pupillometry : Predictive Indicator in External Ventricular Drain Clamping ?

acronym: CLAMP

summary:
Pupillar diameter variation to predict success or failure of external ventricular derivation clamping.

Pupillometry utilisation as a diagnostic tool in external ventricular clamping test in neurological ICU should improve patients care in several ways :

earlier use of ventriculo-peritoneal or ventriculo-atrial shunts to shorten the external ventricular treatment duration and thus reduce risks of infection and hospital stay duration
limit the medical imagery prescription and radiation exposition
avoid neurological deterioration linked to the external ventricular drain clamping in case of the pupillometric parameters variation would be earlier than clinical signs

status: Active, not recruiting

lead_sponsor: Association Pro-arte

location_facility:
CHU Clermont Ferrand
Chu Grenoble Alpes

intervention_type: Diagnostic Test


title: Multicentric Prospective Study of Genetic and Physiopathology Concerning Dysregulation of Complement During Repeated Fetal Abortions

summary: The aim of the study is to assess the role of complement dysregulation and its impact on antiangiogenic factors (soluble Flt1 and endoglin) in patients with foetal losses.

lead_sponsor: Nantes University Hospital

location_facility:
Antoine Beclere Hospital (AP-HP)
CHU


title: Study of Subcutaneous Interstitial Pressure During Sepsis

acronym: PISEP

summary:
The pathophysiology of sepsis is characterized by the sudden onset of vasodilation and vascular permeability with capillary leakage. This leakage contributes to the development of generalized edema which is not clinically detectable below 4 litres but which becomes visible after a few days. The edema accumulates mainly at the subcutaneous level due to the high compliance of this tissue. Edema, and therefore hydrosodium overload, testifies to the severity of the inflammation. However, it could also be harmful in itself (affecting microcirculation and increasing mortality) as suggested by numerous clinical and experimental studies.

The transfer of fluids between vascular and interstitial compartments during sepsis therefore has a central role in the pathophysiology of the disease and associated mortality. These transfers are mainly controlled at the microvascular level (with constant permeability) by the difference between capillary (CP) and interstitial (IP) pressures. In healthy subjects, subcutaneous IP is discreetly negative (-1 mmHg) and varies very little. On the other hand, a sometimes drastic decrease in IP has been described in various localized and systemic inflammatory situations. These pressure variations may be explained by the collagen structure of the interstitial tissue and a change in the three-dimensional conformation of these macromolecules induced by inflammation mediators. In an animal model of sepsis, a study showed significantly lower pressure in a group of animals in endotoxic shock. IP has never been measured in humans during sepsis. The objective of this study is to analyze subcutaneous IP (SCIP) in patients with septic shock compared with controls in order to evaluate the direct role of interstitial tissue in the onset of edema during sepsis.

design_allocation: Non-Randomized

primary_purpose: Basic Science

location_facility:
HCL - Hôpital Edouard Herriot
CHU de DIJON

intervention_type: Procedure


type: Other Identifier

title: Involvement of SK3 Calcium Channel in Taxane Neuropathy

acronym: NEUROTAX

summary: Taxane neuropathy is a common and long-term side effect of long-term morbidity in patients surviving cancer. No preventive or symptomatic treatment has been shown to be effective. Its pathophysiology is poorly known and probably multifactorial. A possible mechanism would be mediated by the activation of the SK3 calcium channel: a retrospective study carried out at the University Hospital of Tours (Carina RUA) found a significant association between the number of CAG triplets in the KCNN3 gene coding for the SK3 channel and the appearance of a taxane neuropathy.

lead_sponsor: University Hospital, Tours

location_facility: Department of Oncology, Hospital, Chinon

location_facility: Department of Medical Oncology, University Hospital, Tours


title: Evaluation of Pain Sensitization in Rheumatoid Arthritis: Analysis on a Cohort of Tofacitinib Treated Patients

acronym: TOPRA

summary:
Persistent pain and chronic fatigue are very common complaints in rheumatoid arthritis (RA) patients, whatever the anti-inflammatory treatment response. Interestingly, pain remaining despite good clinical response was associated with high disability and low inflammation at baseline, suggesting a mechanism of pain independent of inflammation in these patients. Such patients, with discordantly high patient-reported DAS28 components, fatigue and mood disturbance might represent a subgroup of RA patients who have specific clinical needs, not resolved by classical conventional or biologic DMARDs. In this way, neuropathic pain and pain sensitization have been demonstrated in 20 to 30% of RA patients, neuropathic pain scores being associated with worsen disease activity scores. Thus, pain sensitization may contribute to amplification of pain in active RA, and should be responsible for persisting pain and fatigue even after inflammation has resolved.

Pain sensitization is associated with neuroplastic changes in sensory pathways at peripheral and central levels. Interestingly, major mediators responsible for this neuroplasticity operate via a JAK/STAT signaling pathway, which is specifically targeted by new RA treatments. New drug targeting JAK/STAT signalling pathway have been recently designed for RA treatment, based on the implication of this pathway on the signaling of various cytokines implicated in the pathophysiology of RA, such as IL-6, IL-12, IL-23 and IFNs. Two Jak-inhibitors have been put on the market: Tofacitinib and Baricitinib. In randomized clinical trials, Tofacitinib have shown a remarkable efficacy on pain and other patient reported outcomes, suggesting a specific effect or jak-inhibitors on pain control. Recent data suggest that Jak-inhibitors could have a direct effect on sensory neurons.

primary_purpose: Other

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Limoges - service de rhumatologie

location_facility: CHU de Bordeaux - Service de rhumatologie


title: Functional Implication of Corpus Callosum in Voluntary Strength in COPD Patients

summary: Patients with COPD have lower capability of activating their muscles. At the cortical level, force production is not only controlled by contralateral primary motor cortex but also by ipsilateral motor cortex. The aim of this study is to determine whether ipsilateral areas are functionally impaired in COPD.

lead_sponsor: 5 Santé


title: MYeloma Resistance And Clonal Evolution

acronym: MYRACLE

summary: Multiple Myeloma (MM) is often associated with progression, temporary response to therapy and a high relapse rate over time resulting in a poor long-term prognosis. Because MM is classified as an incurable disease, therapeutic resistance is of great interest. However, knowledge about the biological mechanisms underlying resistance associated with MM therapies and about associated predictors remains poor. The MYRACLE cohort, a multicenter prospective cohort of patients with MM, is set up to address this limitation.

ipd_sharing: Undecided

location_facility:
Nantes University Hospital
La Roche sur Yon Hospital Departmental


title: Evaluation of the Metrological Reliability of Connected Objects Available to the Public in the Measurement of Medical Physiological Parameters

acronym: EVALEXPLO

summary:
Many connected objects available over-the-counter to the general public claim to measure physical quantities that may have a medical application. Examples include heart rate, oxygen saturation, respiratory rate, blood pressure, body composition between body fat, lean mass and bone mass, and motion analysis. .

The continuous collection of these quantities by a cheap and easily accessible device opens important medical perspectives in the areas of home monitoring of chronic diseases or preventive medicine in general. Nevertheless, the medical decisions that could be made on the basis of the information provided by these objects require that the measurement be reliable, which is not always the case.

The evaluation of the accuracy of measurements made by these objects therefore seems to be a prerequisite for future use in a medical context. This study therefore proposes to test the adequacy between "gold-standard" measurements carried out in consultation in the department of functional explorations of the Bichat Claude-Bernard hospital and the measurements of the same parameters by connected objects, under the conditions of intended uses by their manufacturer.

time_perspective: Cross-Sectional

ReferenceType: derived

ReferenceCitation: Frija-Masson J, Mullaert J, Vidal-Petiot E, Pons-Kerjean N, Flamant M, d'Ortho MP. Accuracy of Smart Scales on Weight and Body Composition: Observational Study. JMIR Mhealth Uhealth. 2021 Apr 30;9(4):e22487. doi: 10.2196/22487.

family: Frija-Masson

full_name: Justine Frija-Masson

given: Justine

family: Mullaert

full_name: Jimmy Mullaert

given: Jimmy

family: Vidal-Petiot

full_name: Emmanuelle Vidal-Petiot

given: Emmanuelle

family: Pons-Kerjean

full_name: Nathalie Pons-Kerjean

given: Nathalie

family: Flamant

full_name: Martin Flamant

given: Martin

family: d'Ortho

full_name: Marie-Pia d'Ortho

given: Marie-Pia

currency_apc_doaj: USD

journal_name: JMIR mHealth and uHealth

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

version: publishedVersion

host_type: repository

license_normalized: no license

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

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

repository_normalized: HAL

version: submittedVersion

repositories:
HAL
PubMed Central

publisher: JMIR Publications Inc.

publisher_dissemination: JMIR Publications

publisher_group: JMIR Publications

publisher_normalized: JMIR Publications


title: Behavioral Exploration of Cognitive and Emotional Alterations in Adult Individuals Exposed to Alcohol During the Prenatal Period

acronym: ALTEMO

summary:
Hypothesis:

Individuals presenting with prenatal alcohol exposure (PEA) show emotional abilities deficits, and imbalance between the two systems involved in decision-making according to dual-process models, namely an under-activated reflective system (involved in deliberate behaviors) and an over-activated affective-automatic one (involved in impulsive behaviors).

Primary objective:

To explore performance (as a percentage of correct answers) in an emotional facial expression decoding task in PEA participants compared to controls without alcohol disorder.

lead_sponsor: University Hospital, Lille

location_facility:
CSAPA
CHRU Lille, Fontan2


title: Controlled Trial Testing the Effectiveness of Motivational Support on Physical Activity and Fatigue of Patients With Multiple Sclerosis

acronym: apsep

summary: The purpose of this study is to evaluate the effectiveness of an 8-week intervention based on implementation intention (motivation) in patients with multiple sclerosis on objectively measured physical activity.

study_start_date_type: Anticipated

primary_purpose: Supportive Care

lead_sponsor: University of Paris 5 - Rene Descartes

location_facility:
Hôpital Raymond-Poincaré
CHU Poissy Saint germain

intervention_type: Behavioral


type: Other Grant/Funding Number

title: Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012: Phase I Study

summary: This study is a phase I clinical trial aimed to determine the recommended dose of [131I]ICF01012 to administer for the treatment of patients with pigmented metastatic melanoma (binding [131I]ICF01012 ). The [131I]ICF01012 is a targeted radionuclide therapy with a high affinity for melanin.

lead_sponsor: Centre Jean Perrin

location_facility:
Centre Jean Perrin
CHU Clermont-Ferrand


title: Pharmacokinetics of Tranexamic Acid After Oral, Intramuscular or Intravenous Administration: a Prospective, Randomised, Cross-over Trial in Healthy Volunteers.

acronym: PharmacoTXA

summary: This is a Phase 1 study which aims to determine the pharmacokinetics and local and systemic tolerance of tranexamic acid in healthy volunteers using a population approach after oral, intramuscular or intravenous administration. It will also determine the feasibility of measuring tranexamic acid in spots of dry capillary blood.

lead_sponsor: London School of Hygiene and Tropical Medicine

location_facility: Unité de Recherche Clinique Paris Descartes Necker Cochin, Hôpital Necker-Enfants Malades

location_facility: UFR Sciences de la Santé Simone Veil Université Versailles Saint Quentin en Yvelines


acronym: ADSL

location_facility: Department of Pediatry. Reference centre of Hereditary diseases of the metabolism of child and adult. Necker - Enfants malades Hospital

type: EudraCT Number

source: euctr

title: Evaluation of a Treatment With Allopurinol on Autistic Disorders and Epilepsy in Adenylosuccinate Lyase Deficiency (ADSL)

summary:
The aim of this study is to evaluate the effectiveness of allopurinol treatment at 12 months on the adaptive and cognitive functioning of patients with adenylosuccinate lyase deficiency (ADSL). The psychiatric evaluation will involve the use of standardized tools prior to initiation of treatment, and will be repeated 6 months and 12 months after the start of treatment.

The decrease in the concentration of SAICAR and S-Ado metabolites, which are markers of adenylosuccinate lyase (ADSL) deficiency, will also be quantified.

Similarly, the efficacy of allopurinol on epileptic seizures for epileptic patients and on electrocardiogram abnormalities will be evaluated secondarily


title: Gastric Ultrasound Before Planned Caesarean Section or Operative Hysteroscopy : How Much Pregnancy Changes Surface of Antrum of the Stomach ? Comparative Observational Study

acronym: ECHOCESAR

summary: Realization of a gastric ultrasound just before surgery, to measure the surface of antrum of stomach and compare if divergence sizes can be observed between women with a operative hysteroscopy and women with a planned caesarean section. To know if anaesthesia need to be adapted to the population.

lead_sponsor: Hopital Foch

location_facility:
Hopital Foch
Hopital Béclère (APHP)


title: Influence of the Inspired Oxygen Fraction on the Noninvasive Measurement of Hemoglobin Using Two Different Devices (Namely Pronto 7 and NBM-200)

summary: This study examines the effect of oxygen supplementation on the non-invasive measurement of hemoglobin.

ReferenceType: background

ReferenceCitation: Gayat E, Aulagnier J, Matthieu E, Boisson M, Fischler M. Non-invasive measurement of hemoglobin: assessment of two different point-of-care technologies. PLoS One. 2012;7(1):e30065. doi: 10.1371/journal.pone.0030065. Epub 2012 Jan 6.

family: Gayat

full_name: Etienne Gayat

given: Etienne

family: Aulagnier

full_name: Jérôme Aulagnier

given: Jérôme

family: Matthieu

full_name: Emmanuel Matthieu

given: Emmanuel

family: Boisson

full_name: Mireille Boisson

given: Mireille

family: Fischler

full_name: Marc Fischler

given: Marc

journal_name: PLoS ONE

repository_institution: PubMed Central - Europe PMC

evidence: oa repository (semantic scholar lookup)

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

title: Non-Invasive Measurement of Hemoglobin: Assessment of Two Different Point-of-Care Technologies

ReferenceCitation: Gayat E, Bodin A, Fischler M. Instability in non-invasive haemoglobin measurement: a possible influence of oxygen administration. Acta Anaesthesiol Scand. 2011 Aug;55(7):902. doi: 10.1111/j.1399-6576.2011.02469.x. Epub 2011 Jun 9.

ReferenceCitation: Gayat E, Imbert N, Roujansky A, Lemasle L, Fischler M. Influence of Fraction of Inspired Oxygen on Noninvasive Hemoglobin Measurement: Parallel Assessment of 2 Monitors. Anesth Analg. 2017 Jun;124(6):1820-1823. doi: 10.1213/ANE.0000000000001783.

family: Imbert

full_name: Nicolas Imbert

given: Nicolas

family: Roujansky

full_name: Ariane Roujansky

given: Ariane

family: Lemasle

full_name: Léa Lemasle

given: Léa

journal_name: Anesthesia & Analgesia

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

location_facility:
Hopital Foch
Hopital Lariboisière


title: Development of a Device for Evaluating Primary Hemostasis Under Whole Blood Flow Conditions

acronym: INDONESIA

summary:
Currently, the exploration of primary hemostasis (a physiological phenomenon used to stop bleeding) is imperfect because it is based on targeted tests for platelets or von Willebrand factor, without taking into account blood flow and other blood cells (red and white blood cells). Tests for whole blood and flow conditions exist, but there is currently no test that comes close to actual physiological conditions.

An exploration of whole blood haemostasis in a device that is similar to a blood vessel and at different flow conditions (venous and arterial) could help to better identify the risk of bleeding in predisposed patients (von Willebrand factor deficiency, antiplatelet therapy).

The objective of the study is to evaluate the performance of this new hemostasis test in whole blood and under flow conditions.

Participation in the study is ad hoc and is limited to adding a maximum of 4 citrated tubes (20 mL or the equivalent of 4 teaspoons) and 1 EDTA tube (5mL) to a routine blood sample (for patients) or during blood donation (for controls).

location_facility:
CHU Dijon Bourgogne
CHU de Besançon

intervention_type: Biological


title: TECHNICAL EVALUATION OF JEWELPUMP IN TYPE 1 DIABETIC PATIENTS TREATED WITH EXTERN INSULIN PUMP

acronym: DIABELOOP

summary:
The main objective of the study is to verify the reliability of the solutes volumes issued by the Debiotech JewelPUMPTM controlled by its remote.

Three clinical sites are participating in this study:

CHSF, Service of Endocrinology and Diabetology, CORBEIL-ESSONNES (91): Dr. Guillaume CHARPENTIER, Dr. Sylvia FRANC
Grenoble University Hospital, Department of Endocrinology, Diabetes Diseases, Nutrition, GRENOBLE (38): Pr Pierre-Yves BENHAMOU
CHU Jean Minjoz, Department of Endocrinology and Diabetology, BESANCON (25): Professor Alfred PENFORNIS, Dr. Annie CLERGEOT

The study will be conducted in 20 patients with type 1 diabetes treated by external insulin pump. Patients will be informed of the study during a screening visit. After signing the informed consent, they will return to the center where they will wear a JewelPUMPTM containing saline water, they will use their pumps in parallel. The investigator or nurse education will form the operation of the JewelPUMPTM and they will be instructed to replicate the same settings between their usual and JewelPUMPTM pump. The patient will be asked to complete visual analog scales of satisfaction with their usual treatment and the various elements of the devices (usual pump, and JewelPUMPTM) have been weighed using a precision balance to have a form of a base for comparison.

Patients will leave home for a period of about three days, but they will have to come back every days to the center. They will be asked to collect all events arising (programming problems to deliver a bolus, hardware failure ...) in a booklet.

At the end of study visit, patients will return to the center where the volumes will be assessed by the perfused weighed the various components and devices where they will complete the visual analog scales of satisfaction at endpoint.

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

location_facility:
CHU Jean Minjoz
University Hospital Grenoble


title: Second-Line Chemotherapy With Ramucirumab +/- Paclitaxel in Elderly Advanced Gastric or Gastroesophageal Junction Cancer Patients

acronym: SOCRATE

summary:
The primary objective is to evaluate six months survival rate and quality of life at 4 months of ramucirumab alone or in combination with paclitaxel in patients aged 70 years or more who have stomach or GEJ adenocarcinoma and whose first line of fluoropyrimidine- and platinumcontaining treatment has failed.

The co-primary endpoints are the following:

Six months survival rate
Quality of life at 4 months as assessed by the following three target dimensions of the EORTC QLQ-ELD14 questionnaire: mobility, illness burden and worries about the future

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility:
Hopitaux civils de Colmar
Clinique privée - CENTRE CARIO


title: Optimization of VIM Targeting in Essential Tremor Surgery

acronym: Opti-VIM

summary: Deep brain stimulation (DBS) for essential tremor is based on the intermedius ventralis nucleus of the thalamus (VIM) stimulation. This structure is however very difficult to target, as it remains invisible on imaging. The current procedure based on awake surgery with clinical and electrophysiological testings has several limitations that lead us to develop a probabilistic model to locate precisely the target. This study aims to show that asleep DBS surgery based on this new targeting method leads to at least the same clinical results than the classical procedure.

location_facility:
CHU de Bordeaux
Hospices Civils de Lyon


title: Health Care Access for Asylum Seekers in Brittany : Description, Associated Factors and Levers of Improvement

acronym: ACCEDAB

summary:
The main objective of this research is to study the logics and the associated factors with asylum seekers use of dedicated health structures.

This objective aims to address major concerns related to the entry and continued participation in the health care system of asylum seekers, including the medical and social dimensions.

It aims to produce, then analyze and disseminate data on the factors associated with seeking asylum seekers to optimize the care of migrants in the French health system

lead_sponsor: Rennes University Hospital

location_facility: COALLIA - Plateforme d'accueil des demandeurs d'asile


title: Intestinal Microbiota, Tryptophan and Autism

acronym: MTA

summary:
Autism Spectrum Disorder refers to complex neuro-developmental disorders that affect social communication and behavioral adaptation. Currently, the diagnosis of Autism Spectrum Disorder is based on a clinical examination that is performed classically during the first three years of life. The heterogeneity of the disorders occurring in autism make pathologies difficult to diagnose and manage.

The overall goal of this project is the identification of metabolic biomarkers based on clinical profile. The best characterization of physiopathological pathways will ultimately allow the identification of subgroups of subjects and facilitate the development of targeted therapeutics.

The proposed work aims to test the hypothesis of a disruption of tryptophan metabolism in Autism Spectrum Disorder via the gut microbiota.

location_facility: Child psychiatry department, University Hospital, Tours

location_facility: Clinical investigation center, University Hospital, Tours


title: Spatial Hearing Perception in Bilateral Cochlear Implant Children

summary:
Spatial hearing in cochlear implant (CI) users is a challenging investigation field since no studies have explored yet spatial auditory perception in three-dimensional space (3D). Moreover auditory rehabilitation after cochlear implantation is totally devoted to speech rehabilitation to date.

A novel methodology based on virtual reality and 3D motion capture protocol in an immersive reality system has recently been developed to evaluate and record spatial hearing abilities of norm-hearing (NH) listeners and CI adults in 3D. The results revealed worse sound localization in 3D for CI users compared to NH participants, and interestingly noted that head movements could improve sound localization performances, leading to a possible track for auditory rehabilitation.

The aim of this study is to explore spatial hearing in CI children with the protocol already tested in CI adults. This protocol will be adapted to children over eight years old. Children will have to perform a sound localization task in 3D without any feedback of performances. The knowledge improvement in pediatric sound localization will lead to develop a specific spatial rehabilitation in cochlear implant children.

primary_purpose: Health Services Research

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de Recherche en Neuroscience de Lyon (CRNL)


title: Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Thoracic Aortic Aneurysms and Chronic Dissections

acronym: MONA-LSA

summary: To ensure adequate seal of currently available stent grafts, a proximal 20 mm of healthy aorta is recommended. Extending the proximal landing zone into the arch by intentional covering of the left subclavian artery (LSA) without revascularization expose to serious neurologic complications. Serious risks are also known to accompany subclavian revascularization. The Valiant Mona LSA Thoracic Stent Graft System (Medtronic,Santa Rosa, Calif) consists of a main stent graft and a branch stent graft designed to maintain LSA patency. The purpose of this study is to characterize the safety and effectiveness of this device for the treatment of Aneurysms and chronic Type B dissections of the arch.

status: Withdrawn

primary_purpose: Device Feasibility

lead_sponsor: University Hospital, Toulouse

location_facility:
CHU Toulouse, Hôpital Rangueil
Hôpital Timone Adultes


title: Non-comparative Prospective Observational Cohort Study Describing the Safety and Efficacy of Aflibercept Administered in Combination With FOLFIRI After Failure Under Oxaliplatin + Anti-EGFR Therapy in the Treatment of Patients With Metastatic Colorectal Cancer in Practice Common

acronym: ZETA

summary:
Primary objective

- Evaluate the efficacy in terms of progression-free survival (PFS) of aflibercept in combination with FOLFIRI in patients treated routinely for metastatic colorectal cancer (mCRC) after failure of treatment with oxaliplatin + EGFR.

Secondary objective

Evaluate the efficacy of aflibercept in combination with FOLFIRI on the 2-year overall survival rate and the objective response rate.

Evaluate the tolerance profile of aflibercept in combination with FOLFIRI.

Observational study, national, multicenter, cohort, prospective without intervention on the therapeutic strategy.•

lead_sponsor: Dr.Laurent Mineur

location_facility:
Institut Sainte-Catherine
Institut Sainte Catherine

intervention_type: Combination Product


title: Contribution of the Study of Maternal Plasmatic Regulator T Cells and Th17 for the Diagnosis of Acute Chorioanmionitis Among Women Hospitalized for Premature Rupture of Fetal Membranes (PPROM) Between 24 and 34 Gestation Weeks

acronym: ICAR

summary: The purpose of this study is to evaluate if regulator T cells (Treg) and Th17 level modifications in maternal blood and placenta could be correlated to a chorioamnionitis, in women hospitalized for PPROM.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility:
Hôpital Hautepierre
Maternité du CHU de Dijon


title: Relation Between Safety Endpoints and Everolimus Trough Blood Level in Advanced Renal Cell Carcinoma

summary: The investigators hypothesize everolimus toxicities are linked to pharmacokinetic variabilities of everolimus. Thus, early detection of clinical or biological risk factors will lead to personalized dosage treatment and permit a better tolerance without altering efficacy.

status: Terminated

lead_sponsor: Centre Francois Baclesse

location_facility:
Institut Gustave Roussy
Centre François Baclesse


title: A Phase II Trial of Radiotherapy (RT)-Durvalumab Without Prophylactic Neck Irradiation in Squamous Cell Carcinoma of the Head and Neck (SCCHN)

acronym: REWRITe

summary: This study evaluate the regional (neck) nodal control of durvalumab in combination with RT restricted to the primary tumor and the immediately adjacent nodal level (i.e. without prophylactic neck irradiation) in N0 patients with SCCHN.

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou

location_facility:
Centre Eugene Marquis
Institut Sainte Catherine


title: Randomized, Multicenter, Open-label, Comparative Study of Efficacy and Safety of Treatment With a Calcineurin Inhibitor (CNI), Associating Myfortic ® and Neoral ® Compared to a CNI-free Treatment, Combining Myfortic ® and Certican ® , in Adult Patients With de Novo Renal Transplant

acronym: CIME

summary:
The main objective of this protocol is to compare the impact on renal function of two different immunosuppressive regimens in patients with de novo renal transplant.

Renal function will be accurately evaluated by measuring the clearance of iohexol.

The protocol will also evaluate the efficacy and safety in a short term of these two different immunosuppressive regimens.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility: Nephrology department, Hospital University of Amiens

location_facility: Nephrology Department, University Hospital of Montpellier


type: Registry Identifier

title: Diagnosis Interest of Galectin 3 Dosage in Nodular and Multinodular Goiter Pretreatment

acronym: Galectins

summary: The investigators will dose galectin 3 in plasma and water rinse of the needle aspiration biopsy in patients with thyroid nodules. The investigators aim to show that preoperative dosage of the galectin 3 could provide good diagnosis of malignant versus benign thyroid cancer.

lead_sponsor: University Hospital, Rouen

location_facility:
Centre Henri Becquerel
CHRouen


title: Morphological, Biomechanical and Functional Properties of the Arterial Wall of Athletes: Impact and Consequences of Mechanical Stress on the Cardiovascular Adaptations of Peripheral Arterial Calcifications

acronym: MediaSport

summary: The main objective of this study is to obtain data for the integrated analysis of morphological, functional and biomechanical parameters pertaining to lower limb arteries in various categories of elite athletes (without cardiovascular risk and practicing high- or low-impact aerobic activities which preferentially implicate lower limb activity) as compared to (each other and to) sedentary controls.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau

location_facility: Université d'Avignon, Faculté des Sciences


title: Effects of Phlebotomy on Insulin Sensitivity in Insulin Resistance-associated Hepatic Iron Overload Patients

acronym: SAINPOS

summary: The purpose of this study is to evaluate efficacy of phlebotomy on insulin sensitivity as evaluated by euglycemic-hyperinsulinic clamp in insulin resistance-associated hepatic iron overload patients.


title: Circulating Expression Measurement of a Sirtuin Protein Isoform, Sirt6, as an Early Marker of Aging Quality

summary: This study follows the results of the COMPALICLAMP study (NCT00951392) where the investigators showed a differential expression of sirtuins protein isoforms, Sirt6, in muscle depending on the quality of aging. The investigators seek to confirm this difference in expression level of circulating leukocytes on a larger sample.

ReferenceCitation: Bétry C, Meugnier E, Pflieger M, Grenet G, Hercberg S, Galan P, Kesse-Guyot E, Vidal H, Laville M. High expression of CPT1b in skeletal muscle in metabolically healthy older subjects. Diabetes Metab. 2019 Apr;45(2):152-159. doi: 10.1016/j.diabet.2018.01.018. Epub 2018 Feb 12.

family: Bétry

full_name: C. Bétry

given: C.

family: Meugnier

full_name: E. Meugnier

given: E.

family: Pflieger

full_name: M. Pflieger

given: M.

family: Grenet

full_name: G. Grenet

given: G.

family: Hercberg

full_name: S. Hercberg

given: S.

family: Galan

full_name: P. Galan

given: P.

family: Kesse-Guyot

full_name: E. Kesse-Guyot

family: Vidal

full_name: H. Vidal

given: H.

family: Laville

full_name: M. Laville

journal_name: Diabetes & Metabolism

oa_host_type: repository

license: cc-by-nc

license_normalized: cc-by-nc

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

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

location_facility: Centre de Recherche en Nutrition Humaine

location_facility: Centre de recherche en nutrition humaine Rhone-Alpes


title: Performance of the Dosage of Plasma 1, 3-β-D-glucan (BDG) for the Diagnosis of Candidemia in Intensive Care Patients: A Prospective, Multicenter Study

acronym: BDG-REA

summary:
Systematic and repeated dosing (3 times weekly) of 1,3-β-D-glucan (BDG), associated with blood cultures and fungal mapping (twice a week) for the patients hospitalized in intensive care. The diagnosis of candidemia is defined as the 1st positive blood culture for Candida spp.

The dosage of BDG will be considered positive if the value is at least or equal to 80 pg/ml.

ReferenceCitation: Lortholary O, Renaudat C, Sitbon K, Madec Y, Denoeud-Ndam L, Wolff M, Fontanet A, Bretagne S, Dromer F; French Mycosis Study Group. Worrisome trends in incidence and mortality of candidemia in intensive care units (Paris area, 2002-2010). Intensive Care Med. 2014 Sep;40(9):1303-12. doi: 10.1007/s00134-014-3408-3. Epub 2014 Aug 6.

family: Lortholary

full_name: Olivier Lortholary

given: Olivier

family: Renaudat

full_name: Charlotte Renaudat

given: Charlotte

family: Sitbon

full_name: Karine Sitbon

given: Karine

family: Madec

full_name: Yoann Madec

given: Yoann

family: Denoeud-Ndam

full_name: Lise Denoeud-Ndam

given: Lise

family: Wolff

full_name: Michel Wolff

given: Michel

family: Fontanet

full_name: Arnaud Fontanet

given: Arnaud

family: Bretagne

full_name: Stéphane Bretagne

given: Stéphane

family: Dromer

full_name: Françoise Dromer

given: Françoise

journal_name: Intensive Care Medicine

oa_colors: green hybrid

evidence: open (via page says license)

license: implied-oa

license_normalized: implied-oa

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

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

publisher_dissemination: Springer

publisher_group: Springer

title: Worrisome trends in incidence and mortality of candidemia in intensive care units (Paris area, 2002–2010)

ReferenceCitation: Clancy CJ, Nguyen MH. Finding the "missing 50%" of invasive candidiasis: how nonculture diagnostics will improve understanding of disease spectrum and transform patient care. Clin Infect Dis. 2013 May;56(9):1284-92. doi: 10.1093/cid/cit006. Epub 2013 Jan 11. Review.

family: Clancy

full_name: Cornelius J. Clancy

given: Cornelius J.

family: Nguyen

full_name: M. Hong Nguyen

given: M. Hong

journal_name: Clinical Infectious Diseases

title: Finding the “Missing 50%” of Invasive Candidiasis: How Nonculture Diagnostics Will Improve Understanding of Disease Spectrum and Transform Patient Care

ReferenceCitation: Morrell M, Fraser VJ, Kollef MH. Delaying the empiric treatment of candida bloodstream infection until positive blood culture results are obtained: a potential risk factor for hospital mortality. Antimicrob Agents Chemother. 2005 Sep;49(9):3640-5.

ReferenceCitation: Posteraro B, De Pascale G, Tumbarello M, Torelli R, Pennisi MA, Bello G, Maviglia R, Fadda G, Sanguinetti M, Antonelli M. Early diagnosis of candidemia in intensive care unit patients with sepsis: a prospective comparison of (1→3)-β-D-glucan assay, Candida score, and colonization index. Crit Care. 2011;15(5):R249. doi: 10.1186/cc10507. Epub 2011 Oct 22.


title: Impact of Physical Rehabilitation on Sarcopenia Inolder and Chronic Kidney Patients

acronym: IMPREPA

summary: Older patients with chronic renal failure suffer from sarcopenia. Loss of muscle function is associated with increased morbidity and mortality. Currently few treatment are available. The aim of this study is to evaluate the impact of physical rehabilitation in this population on muscle performance and quality of life.

location_facility: Service de Médecine du vieillissement, soins de suite et de rééducation, Centre Hospitalier Lyon SUd

location_facility: Service de Néphrologie, Centre Hospitalier Lyon Sud


title: Pregnancy Loss Between 15 and 22 Weeks SA Within the Network of Perinatal Period of Western Brittany : Case Control Study

acronym: PEGREP

summary: The etiologies and some risk factors for pregnancy loss in the 2nd trimester are described in the literature. However, there are some risk factors that are not studied. The PEGREP study is a retrospective observational case-control study whose main objective is to identify risk factors for pregnancy loss between 15 and 22 weeks. The patients included cases are women who had a pregnancy loss between 15 and 22 SA between 2010 and 2015 and who were listed during the mortality reviews of the perinatal network of Western Brittany. The patient witnesses gave birth at the end of a healthy child in one of the maternity of Western Brittany. Matching 1 case for 1 controls was done on the woman's age, parity and number of fetuses.

time_perspective: Retrospective

lead_sponsor: University Hospital, Brest

location_facility:
SALAUN Anne -Laure
CHRU de Brest


title: What Are the Predictive Factors for Preeclampsia in Oocyte Recipients? - PREROVE

acronym: PREROVE

summary: The main goal is to determine which risk factors develop preeclampsia in this specific group of oocyte recipients.

location_facility:
CHU de Rennes
Clinique de la sagesse


title: Wide Awake Local Anesthesia No Tourniquet

acronym: WALANT

summary: The main objective is to assess patient's satisfaction regarding pure local anaesthesia and without use of a tourniquet (WALANT Technique) for trigger finger release surgery.

location_facility:
CHU de Rennes
Centre Hospitalier Privé de Plérin


title: A Prospective Cohort Study of Efficacy, Safety and Characterization of Immune Response to Vaccinations in Hematopoietic Stem Cell Transplant Recipients

acronym: VaccHemInf

summary: Hematopoietic stem cell transplantation (HSCT) is a cellular therapy aiming at curing some hematological diseases. Upon transplantation, recipients experience a phase of profound immune suppression with loss of protective immunity against most infectious agents. Revaccination of HSCT recipients against vaccine-preventable infections is an important post-transplant intervention for reducing morbi-mortality. The VaccHemInf project aims at assessing the efficacy of recommended vaccines in adult recipients of HSCT, through the antibody titers reference method and a panel of immune functional assays.

primary_purpose: Prevention

ReferenceCitation: Conrad A, Boccard M, Valour F, Alcazer V, Tovar Sanchez AT, Chidiac C, Laurent F, Vanhems P, Salles G, Brengel-Pesce K, Meunier B, Trouillet-Assant S, Ader F; Lyon HEMINF Study Group. VaccHemInf project: protocol for a prospective cohort study of efficacy, safety and characterisation of immune functional response to vaccinations in haematopoietic stem cell transplant recipients. BMJ Open. 2019 Feb 15;9(2):e026093. doi: 10.1136/bmjopen-2018-026093.

family: Conrad

full_name: Anne Conrad

given: Anne

family: Boccard

full_name: Mathilde Boccard

given: Mathilde

family: Valour

full_name: Florent Valour

given: Florent

family: Alcazer

full_name: Vincent Alcazer

given: Vincent

family: Tovar Sanchez

full_name: Aydee-Tamara Tovar Sanchez

given: Aydee-Tamara

family: Chidiac

full_name: Christian Chidiac

given: Christian

family: Laurent

full_name: Frédéric Laurent

given: Frédéric

family: Vanhems

full_name: Philippe Vanhems

given: Philippe

family: Salles

full_name: Gilles Salles

given: Gilles

family: Brengel-Pesce

full_name: Karen Brengel-Pesce

given: Karen

family: Meunier

full_name: Boris Meunier

given: Boris

family: Trouillet-Assant

full_name: Sophie Trouillet-Assant

given: Sophie

family: Ader

full_name: Florence Ader

given: Florence

journal_name: BMJ Open

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

location_facility:
Hôpital de la Croix Rousse
Centre Hospitalier Lyon Sud


title: Comparison of the Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis: a Prospective, Randomized Study

summary: The primary objective of this study is to demonstrate the superiority of the CGE physical therapy protocol versus a standard physical therapy protocol of the shoulder by measuring the following after 1 month of physical therapy: the FI2S score including validated measures of pain, glenohumeral joint range of motion in the three planes, the ability to perform certain everyday activities and the strength of forward elevation measured with a dynamometer.


title: Professional Life After Breast Cancer: Feasibility of a Coaching Program for an Adapted Return to Work

acronym: VISIBILITE

summary:
The diagnosis of breast cancer and the treatments implemented have a significant impact on the professional situation.

Maintaining employment and/or reintegration into working life are therefore major issues for cancer patients.

This trial proposes to study the feasibility of a support/coaching program for a return to work in patients after breast cancer.

status: Not yet recruiting

ReferenceCitation: Arfi A, Baffert S, Soilly AL, Huchon C, Reyal F, Asselain B, Neffati S, Rouzier R, Héquet D. Determinants of return at work of breast cancer patients: results from the OPTISOINS01 French prospective study. BMJ Open. 2018 May 18;8(5):e020276. doi: 10.1136/bmjopen-2017-020276.

ReferenceCitation: Banning M. Employment and breast cancer: a meta-ethnography. Eur J Cancer Care (Engl). 2011 Nov;20(6):708-19. doi: 10.1111/j.1365-2354.2011.01291.x. Epub 2011 Sep 20. Review.

ReferenceCitation: Barnes AJ, Robert N, Bradley CJ. Job attributes, job satisfaction and the return to health after breast cancer diagnosis and treatment. Psychooncology. 2014 Feb;23(2):158-64. doi: 10.1002/pon.3385. Epub 2013 Sep 3.

ReferenceCitation: de Boer AG, Verbeek JH, Spelten ER, Uitterhoeve AL, Ansink AC, de Reijke TM, Kammeijer M, Sprangers MA, van Dijk FJ. Work ability and return-to-work in cancer patients. Br J Cancer. 2008 Apr 22;98(8):1342-7. doi: 10.1038/sj.bjc.6604302. Epub 2008 Mar 18.

ReferenceCitation: Ekbladh E, Thorell LH, Haglund L. Perceptions of the work environment among people with experience of long term sick leave. Work. 2010;35(2):125-36. doi: 10.3233/WOR-2010-0964.

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle


title: Effect of Prone Positioning on Mortality in Patients With Mild to Moderate Acute Respiratory Distress Syndrome.

acronym: PROMILD

summary:
Acute respiratory distress syndrome (ARDS) accounts for almost 10% of intensive care units (ICU) admissions. Three ARDS stages have been defined, based on the PaO2/FIO2 ratio measured with positive end-expiratory pressure (PEEP) ≥5 cmH2O: mild (201-300 mmHg), moderate (200-101 mmHg), and severe (≤100mmHg). They represent 30.0%, 46.6%, and 23.4% of ARDS, respectively.

Mechanical invasive ventilation (MV), the cornerstone of ARDS patient care, has a primary goal to protect the lung from ventilator-induced lung injury (VILI). Delivering MV in a prone position (PP) has been shown to improve oxygenation, protect the lung through a better homogenization of lung stress/strain, and stabilize hemodynamics.

A meta-analysis of four randomized controlled trials showed beneficial effect of PP vs. supine position (SP) in the most hypoxemic patients. A fifth randomized controlled trial further showed a significant reduction in mortality with PP in ARDS patients with PaO2/FIO2 <150 mmHg, when neuromuscular blockade and long proning sessions were used. Therefore, PP has since been strongly recommended for ARDS patients with PaO2/FIO2 <150 mmHg. Yet, there is limited evidence in patients with mild to moderate ARDS.

There are, however, strong arguments supporting the need for a new trial in ARDS patients with PaO2/FIO2 in the range 150-300 mmHg:

There is no trial that has specifically tested PP in this ARDS subset;
PP is safe and has become a standard of care in ICU;
Should VILI prevention be a mechanism through which PP improves survival, this should be involved in all ARDS patients;
The mortality at hospital discharge in this subset of ARDS remains significant, amounting to 34.9% (95% confidence intervals 31.4-38.5%) in mild and 40.3% (37.4-43.3) in moderate stages;
Among 580 patients with mild ARDS at admission to the ICU, in-hospital mortality was 10%, 30%, and 37% for those who improved, persisted, and worsened ARDS, respectively.
Finally, PP has been shown to be cost-effective under commonly accepted thresholds.

The hypothesis is that in patients within the 150-300mmHg PaO2/FIO2 range at the time of ARDS diagnosis, PP can reduce mortality as compared to a similar group left in the SP.

lead_sponsor: University Hospital, Grenoble


title: Nosocomial Outbreak of Monoclonal VIM Carbapenemase Producing Enterobacter Cloacae in an Intensive Care Unit During SARS-CoV-2 Pandemic

acronym: BHReICU

summary: Multidrug Resistant (MDR) bacteria have become a major worldwide public health challenge and hospitals are now increasingly faced with management of local outbreaks involving such pathogens. Especially, intensive care units (ICU) provide an ideal background for outbreaks caused by MDR bacteria among which carbapenemase-producing Enterobacteriaceae (CPE) can be found. Among CPE involved in ICU outbreaks, VIM producers have been reported worldwide, and described as especially difficult to control. The COVID-19 pandemic and all of the measures health workers have to implement to fight the spread of SARS-Cov-2 have also impacted the management of such outbreaks. In this retrospective study, the investigators aim to describe the management of an outbreak caused by a VIM-producing Enterobacter cloacae strain during the 2020 COVID-19 pandemic in an ICU, and show the importance of concerted measures and actions implemented at multiple levels to prevent the spread of this MDR strain.


title: Targeting ATR in Soft-tissue Sarcomas: a Randomized Phase II Study. TARSARC Study

acronym: TARSARC

summary: Multicenter, prospective, open-labeled, 2-arm, non-comparative randomized phase II trial to assess the antitumor activity of berzosertib in association with gemcitabine

lead_sponsor: Institut Bergonié


title: Attenuation of Tonal Tinnitus by Lateral Inhibition Therapy

acronym: TIL

summary: Lateral Inhibition Therapy (TIL) corrects the patient's hearing by notched amplification on the patient's listening soundtrack. This half-octave notch is targeted at tinnitus frequencies measured tonal. The device slightly increases the amplification around the notch, so that the cerebral cortex compensates for this "gap" in the sound spectrum, masking the crippling tinnitus at the same time. This research is based on a new algorithm developed by the SIEMENS Company which proposes an attenuation of tonal tinnitus by a TIL by notched amplification emitted by the hearing device, object of the study.

lead_sponsor: Ramsay Générale de Santé


title: Comparison Between Calculated Bioavailable Testosterone Level With Radio-immunoassay Result.

acronym: TESTOBIO

summary:
Currently, the gold standard to obtain bioavailable testosterone results is radioimmunoassay (RIA). However, this assay requires specific equipment.

Giton in 2006 proposed an optimized calculation of the Vermeulen equation, the results of which seem to be well correlated with those obtained by RIA.

The aim of this study is to determine if the bioavailable testosterone levels determined by both methods are similar in order to replace the usual RIA assay of bioavailable testosterone by this calculation.


title: Decompensation of Cirrhosis and Iron Metabolism

acronym: DeCiFer

summary:
Iron is a crucial metal whose metabolism is tightly regulated. Iron deficiency or iron overload are both deleterious at the cellular, organic and systemic levels. In line with the major role of the liver in iron homeostasis, links between iron metabolism and acute on chronic liver failure have been highlighted. Nevertheless, due to the difficulty of accurately assessing iron metabolism in this situation, therapeutic intervention on iron metabolism in this setting is currently not codified.

A better understanding of these mechanisms is therefore essential, in particular by characterizing the impact of exposure to non-transferrin-bound iron in acute on chronic liver failure on short-term mortality.

Overall, a better understanding of the physiopathological mechanisms of iron should allow to optimize the martial balance in this condition and also improve therapeutic approaches.


title: Short- and Medium-term Outcomes of New Generation Biological Aortic Valves in Aortic Valve Replacement Surgery

acronym: RVANG

summary: Over the past decade, aortic valve replacement surgery has undergone significant changes in terms of both the approaches and the prostheses used. In parallel with the historical biological prostheses for aortic valve surgery, a new generation of bioprostheses has been marketed since 2008, with the entry of these new prostheses in the armatorium of the Amiens-Picardy University Hospital since 2010. These are rapid deployment prostheses or prostheses without sutures. As a result, patients undergoing aortic valve replacement have been able to benefit from this type of bioprosthesis during their procedures. There are few publications reporting the 5-year follow-up of these bioprostheses. The investigators therefore decided to follow up patients operated on by a new generation bioprosthesis to study the 5-year survival and the functioning of their bioprostheses, in order to make a scientific contribution to the follow-up of these valves. These patients will be compared to patients who have benefited from the implantation of traditional bioprostheses.


title: Immunological Profile for Patients Treated With CAR-T Cells

acronym: SI-CART

summary:
In the frame of Si-CART study, blood will be collected from patients treated with CAR-T cells: before (at Day (D)-6 and D0 before cells injection), post infusion at D3, D5,D7, D9, D11, D14, D18, D 21, Month (M) 2 and M12 post injection.

A cerebrospinal fluid sample will also be collected if a Cerebrospinal Fluid Analysis Lumbar puncture is performed

lead_sponsor: Institut Paoli-Calmettes


title: Percutaneous Edge To Edge Repair for the Treatment of Severe Tricuspid Valve Regurgitation in High-surgical Risk Patients With Systemic Right Ventricle : a Multicentric French Cohort.

acronym: PETER-TRESRIV

summary:
Our study is about to follow adult congenital patients, known with systemic right ventricle (mostly correct transposition of the great arteries ou congenitally corrected transposition fo the great arteries) and systemic valve severe regurgitation which was treated with a Mitraclip device on this tricuspid valve.

It's an observationnal study with a 2 years follow up with clinical (symptoms, complications, VO2 exercice test) echographic and MRI outcomes

.

lead_sponsor: University of Bordeaux


title: A Prospective Observational Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response

acronym: OPALE

summary: The aim of the study is to describe the real-world profile of patients treated with adalimumab FK in gastroenterology, dermatology or rheumatology in order to evaluate in this population the predictive factors of therapeutic response (in particular nutritional status) and generate hypothesis between nutritional status and therapeutic response.

lead_sponsor: Fresenius Kabi


title: Evaluation of the Effect of Moderate and Controlled Hypercapnia on Ischemic Penumbra Vascular Collaterality During General Anesthesia for Anterior Circulation Acute Ischemic Stroke Mechanical Thrombectomy

acronym: COMET-AIS

summary: Acute ischemic stroke due to large vessel occlusion is responsible of cerebral blood flow impairment with a progressive and extensive ischemic process. Cerebral collateral circulation may preserve an ischemic penumbra that could recover providing timely reperfusion of the occluded vessel. Mechanical thrombectomy is the standard of care for anterior circulation large vessel reperfusion. Strategy to promote cerebral blood flow in collateral circulation before reperfusion is scarce and rely mainly on blood pressure maintenance. Carbon dioxide is a potent cerebral vasodilator that could enhance collateral circulation blood flow and cerebral protection before reperfusion. General anesthesia with endotracheal mechanical ventilation could be used for thrombectomy and give the opportunity to modulate and control carbon dioxide tension in the blood. This study will test the effect of moderate hypercapnia on penumbral collateral circulation before reperfusion during mechanical thrombectomy for anterior circulation acute ischemic stroke under general anesthesia.

ReferenceCitation: Schönenberger S, Hendén PL, Simonsen CZ, Uhlmann L, Klose C, Pfaff JAR, Yoo AJ, Sørensen LH, Ringleb PA, Wick W, Kieser M, Möhlenbruch MA, Rasmussen M, Rentzos A, Bösel J. Association of General Anesthesia vs Procedural Sedation With Functional Outcome Among Patients With Acute Ischemic Stroke Undergoing Thrombectomy: A Systematic Review and Meta-analysis. JAMA. 2019 Oct 1;322(13):1283-1293. doi: 10.1001/jama.2019.11455. Erratum in: JAMA. 2019 Dec 24;322(24):2445.

ReferenceCitation: Slupe AM, Kirsch JR. Effects of anesthesia on cerebral blood flow, metabolism, and neuroprotection. J Cereb Blood Flow Metab. 2018 Dec;38(12):2192-2208. doi: 10.1177/0271678X18789273. Epub 2018 Jul 16. Review.

ReferenceCitation: Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL; American Heart Association Stroke Council. 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2018 Mar;49(3):e46-e110. doi: 10.1161/STR.0000000000000158. Epub 2018 Jan 24. Review. Erratum in: Stroke. 2018 Mar;49(3):e138. Stroke. 2018 Apr 18;:.

family: Powers

full_name: William J. Powers

given: William J.

family: Rabinstein

full_name: Alejandro A. Rabinstein

given: Alejandro A.

family: Ackerson

full_name: Teri Ackerson

given: Teri

family: Adeoye

full_name: Opeolu M. Adeoye

given: Opeolu M.

family: Bambakidis

full_name: Nicholas C. Bambakidis

given: Nicholas C.

family: Becker

full_name: Kyra Becker

given: Kyra

family: Biller

full_name: José Biller

given: José

family: Brown

full_name: Michael Brown

given: Michael

family: Demaerschalk

full_name: Bart M. Demaerschalk

given: Bart M.

family: Hoh

full_name: Brian Hoh

given: Brian

family: Jauch

full_name: Edward C. Jauch

given: Edward C.

family: Kidwell

full_name: Chelsea S. Kidwell

given: Chelsea S.

family: Leslie-Mazwi

full_name: Thabele M. Leslie-Mazwi

given: Thabele M.

family: Ovbiagele

full_name: Bruce Ovbiagele

given: Bruce

family: Scott

full_name: Phillip A. Scott

given: Phillip A.

family: Sheth

full_name: Kevin N. Sheth

given: Kevin N.

family: Southerland

full_name: Andrew M. Southerland

given: Andrew M.

family: Summers

full_name: Deborah V. Summers

given: Deborah V.

family: Tirschwell

full_name: David L. Tirschwell

given: David L.

journal_name: Stroke

evidence: open (via free pdf)

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

repository_institution: The Pennsylvania State University - CiteSeer X

ReferenceCitation: Willie CK, Macleod DB, Shaw AD, Smith KJ, Tzeng YC, Eves ND, Ikeda K, Graham J, Lewis NC, Day TA, Ainslie PN. Regional brain blood flow in man during acute changes in arterial blood gases. J Physiol. 2012 Jul 15;590(14):3261-75. doi: 10.1113/jphysiol.2012.228551. Epub 2012 Apr 10.

ReferenceCitation: Olsen TS, Larsen B, Herning M, Skriver EB, Lassen NA. Blood flow and vascular reactivity in collaterally perfused brain tissue. Evidence of an ischemic penumbra in patients with acute stroke. Stroke. 1983 May-Jun;14(3):332-41.


title: Using the Superb Microvascular Imaging Method in the Diagnosis of Intraocular Tumors (SMITIS)

acronym: SMITIS

summary:
The diagnosis and monitoring of intraocular tumors are based on multimodal imaging in addition to the clinical examination (ultra-widefield retinal imaging, echography, angiography). Nevertheless, it may be difficult in cases of retinal hemorrhage, small tumor size or atypical presentation. The study of microvascular flow (Superb Microvascular Imaging, SMI) of intraocular tumors could improve the confidence of differential diagnosis when evaluating these suspicious lesions, or even determine whether a lesion is benign or malignant by describing the vascularization of the lesion.

The investigators propose to study the microvascular flow patterns of intraocular tumors prior to proton therapy.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Analytical Validation of the abioSCOPE Device With a PSP Test: Point-of-Care Precision, Sample Type Comparison and Sample Stability

summary:
Abionic SA has developed a novel point-of-care (POC) platform, the abioSCOPE, and an in vitro diagnostic kit for the quantification of the pancreatic stone protein (PSP) to be analyzed specifically with the abioSCOPE® device. This test is intended to be used to aid in the early recognition of sepsis. The test is extremely easy to use and has a total turnaround time of approximately 8 minutes. This test uses only 30 microliters of K2/K3-EDTA anticoagulated whole blood or plasma. Results are quantitative (ng/ml). The product is for Investigational Use Only in the US and bears CE-marking. It is commercially available in selected European and non-European countries. The test has also been clinically validated in a multicentric, prospective, observational study performed (AB-PSP-001, clinicaltrials.gov identifier NCT03474809).

The main goals of this study are to evaluate certain analytical performances components of this product in a point-of-care environment, in particular the precision, sample type comparability and specimen stability of the product. Such data will support regulatory filing of a US FDA 510(k) premarket notification file and of a European IVD Regulation technical file to continue product commercialization in 2022, when this novel regulation will be effective.

lead_sponsor: University Hospital, Limoges


title: ONe Year Follow-up in Patients Admitted for Emergency Coronary Angiography After Rescuscited Cardiac Arrest

acronym: ONYRCA

summary:
While 80 % of all sudden cardiac death (SCD) result from coronary artery disease (CHD) approximatively 2/3 of SCD occur as a first manifestation of the CHD. VF (ventricular fibrillation) is the main cause of SCD in acute coronary syndrome (ACS), and the 2017 ESC Guidelines for the management of acute myocardial infarction, recommended direct admission to the catheterization laboratory in survivors of out of hospital cardiac arrest (OHCA) with criteria for STEMI on the post-resuscitation electrocardiogram (ECG) (Class I, grade B). However, During the past few years, the number of immediate coronary angiography (CA) for suspected ACS in patients presenting an OHCA increased, with a survival rate at discharge in this subgroup of patients better, about 60 to 80% (1). However, the survival rate remains poor in the global population of OHCA and some survivors patients may have neurological sequelles, related to global anoxia consequences or altered quality of life related to cardiac function impairement .

While the survival rate at hospital discharge is well known, the investigators have few data on long term outcomes , particularly regarding cardiac and neurological states.

Therefore the main objective of this study is to evaluate prospectively, in an observational study, the one-year prognosis of patients with rescuscited OHCA in whom a CA for suspected ACS was performed in the university hospital of Montpellier. Only patients alive at discharged are considered for the follow-up to eliminate the in-hospital mortality .

The investigators aim to assess year neurological status using medical questionnaires at one year follow-up(primary end point). The investigators hypothesize that 10% of patients will discharged alive from hospital with severe neurological sequelae at 1 year.Secondary end point will evaluate cardiac status, quality of life and pronostic factors of adverse outcome.

ReferenceCitation: Patel N, Patel NJ, Macon CJ, Thakkar B, Desai M, Rengifo-Moreno P, Alfonso CE, Myerburg RJ, Bhatt DL, Cohen MG. Trends and Outcomes of Coronary Angiography and Percutaneous Coronary Intervention After Out-of-Hospital Cardiac Arrest Associated With Ventricular Fibrillation or Pulseless Ventricular Tachycardia. JAMA Cardiol. 2016 Nov 1;1(8):890-899. doi: 10.1001/jamacardio.2016.2860.

name: Division of Cardiology, University of Miami Miller School of Medicine, Miami, Florida

family: Patel

full_name: Nish Patel

given: Nish

full_name: Nileshkumar J. Patel

given: Nileshkumar J.

family: Macon

full_name: Conrad J. Macon

given: Conrad J.

name: Cleveland Clinic Foundation, Cleveland, Ohio

family: Thakkar

full_name: Badal Thakkar

given: Badal

name: Department of Medicine, Emory University School of Medicine, Atlanta, Georgia

family: Desai

full_name: Maheshkumar Desai

given: Maheshkumar

family: Rengifo-Moreno

full_name: Pablo Rengifo-Moreno

given: Pablo

family: Alfonso

full_name: Carlos E. Alfonso

given: Carlos E.

family: Myerburg

full_name: Robert J. Myerburg

given: Robert J.

name: Brigham and Woman’s Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts

family: Bhatt

full_name: Deepak L. Bhatt

given: Deepak L.

family: Cohen

full_name: Mauricio G. Cohen

given: Mauricio G.

journal_name: JAMA Cardiology

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

ReferenceCitation: von Steinbüchel N, Wilson L, Gibbons H, Hawthorne G, Höfer S, Schmidt S, Bullinger M, Maas A, Neugebauer E, Powell J, von Wild K, Zitnay G, Bakx W, Christensen AL, Koskinen S, Formisano R, Saarajuri J, Sasse N, Truelle JL; QOLIBRI Task Force. Quality of Life after Brain Injury (QOLIBRI): scale validity and correlates of quality of life. J Neurotrauma. 2010 Jul;27(7):1157-65. doi: 10.1089/neu.2009.1077.

name: Department of Medical Psychology and Medical Sociology, Georg-August-University, Goettingen, Germany.

family: von Steinbüchel

full_name: Nicole von Steinbüchel

given: Nicole

name: Department of Psychology, University of Stirling, Stirling, United Kingdom.

family: Wilson

full_name: Lindsay Wilson

given: Lindsay

family: Gibbons

full_name: Henning Gibbons

given: Henning

name: Department of Psychiatry, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Victoria, Australia.

family: Hawthorne

full_name: Graeme Hawthorne

given: Graeme

name: Department of Medical Psychology, Medical University Innsbruck, Innsbruck, Austria.

family: Höfer

full_name: Stefan Höfer

given: Stefan

name: Department of Health and Prevention, Institute for Psychology, Ernst-Moritz-Arndt University of Greifswald, Greifswald, Germany.

family: Schmidt

full_name: Silke Schmidt

given: Silke

name: Department of Medical Psychology, University Hospital Eppendorf, Hamburg, Germany.

family: Bullinger

full_name: Monika Bullinger

given: Monika

name: Department of Neurosurgery, University Hospital Antwerp, Antwerp, Belgium.

family: Maas

full_name: Andrew Maas

given: Andrew

name: IFOM, Private University of Witten/Herdecke, Köln, Germany.

family: Neugebauer

full_name: Edmund Neugebauer

given: Edmund

name: Goldsmiths College, Department of Psychology, London, United Kingdom.

family: Powell

full_name: Jane Powell

given: Jane

name: Department of Neurosurgery and Early Neurotraumatological Rehabilitation, Clemens Hospital, Westfalian Wilhelms University of Münster, Münster, Germany.

family: von Wild

full_name: Klaus von Wild

name: Association Martha Jefferson Hospital, Charlottesville, Virginia.

name: Hoensbroeck Rehabilitation Centre, Hoensbroeck and Maastricht University, Maastricht, The Netherlands.

name: Centre for Rehabilitation of Brain Injury and Centre for Cognition and Memory, University of Kopenhagen, Kopenhagen, Denmark.

name: Käpylä Rehabilitation Centre, Helsinki, Finland.

name: IRCCS, Rehabilitation Hospital, Santa Lucia Foundation, Rome, Italy.

name: Service de Medicine physique et réadaption, C.H.U. Raymond-Poincaré, Garches, France.

title: Quality of Life after Brain Injury (QOLIBRI): Scale Validity and Correlates of Quality of Life


title: Observation of Platelets in Primary and Secondary Tumors of the Central Nervous System and Association With Survival: a Prospective Cohort Study

acronym: Platon

summary:
Platelets are primarily known for their central role in primary hemostasis. However, they are increasingly recognized for their participation in various non-hemostatic processes, such as cancer progression and clinical expression. Experimental and clinical data indicate that the involvement of platelets in the pathophysiology of cancer goes far beyond the realm of cancer-associated thrombosis.

Several experimental studies have shown that platelets can promote the metastatic process by various mechanisms. However, while it has been shown in vitro that direct contact with platelets initiates tumor cells for metastasis, it remains unclear whether such contacts occur in solid tumors. In addition to their ability to promote metastasis, platelets have been shown to stimulate angiogenesis and play a crucial role in lymphangiogenesis.

Considering that blood vessels, lymphatics and immune cells are major components of the tumor ecosystem, our hypothesis is that platelets contribute to the development and / or regulation of the tumor microenvironment. This is because platelets stabilize tumor blood vessels by permanently repairing vascular damage caused by immune cells infiltrating tumors. Targeting platelets destabilizes tumor vessels, causing intra-tumor hemorrhage, which allows intra-tumor accumulation of intravenously administered anti-tumor drugs such as paclitaxel and improves their efficacy.

Studies have also reported the role of platelets in several pathogenic mechanisms of cancer: thrombocytosis is a paraneoplastic syndrome which suggests a poor prognosis in patients with solid tumors; a negative correlation between the platelet count and the response to chemotherapy has been reported in several types of cancer; histological analyzes of esophageal cancer suggested a possible association between the presence of platelets in the tumor stroma and the level of tumor lymphangiogenesis and lymphovascular invasion; finally, a recent study reported the expression of one of the main targets of immunotherapies, PD-L1, on the platelets of patients suffering from different types of solid cancers.

All of these data support our hypothesis that platelets are components and / or regulators of the tumor microenvironment and therefore potential targets for the improvement of anti-tumor therapies. In this context, the objectives of our project are to determine whether platelets are components of the microenvironment of tumors of the central nervous system, and to study the possible correlations between the intratumoral presence of platelets and the evolution of patients with central nervous system tumors

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: The Effectiveness of FRAME FR for ArterioVenous Fistula Repair in High-Flow Reduction, A Prospective, Monocenter Controlled Trial

acronym: FRAME

summary:
Patients with end-stage renal disease require permanent vascular access to enable safe and effective hemodialysis. An arteriovenous fistula (AVF), where a vein is mobilized and connected to an artery in the arm, is considered the gold standard and first choice for vascular access. After fistula creation, the vein is subjected to high pressure and flow, and undergoes remodeling. This includes the possibility of significant dilatation and intimal hyperplasia. Normal AVF flow required for effective dialysis is around 0.6 liters/min or 0.4-0.8 liters/min. However, in at least 20% of patients, excessive remodeling and dilatation of the fistula result in a high flow AVF with >2 liters/min.

High flow fistulas significantly increase the risk for the development of high output cardiac failure, skin breakdown, bleeding, hand ischemia, and other systemic complications. In cases of high flow AVF, venous reconstruction procedures, banding and/or plication, are often required to limit venous diameter and flow. The longevity of this procedure is limited as the reconstructed segment remodels and re-dilates due to ongoing arterial pressure. Banding and plication are both procedures that are designed to increase resistance to flow. Banding is performed by wrapping a segment of polytetrafluoroethylene (PTFE) around the outflow tract of the fistula, or by placing a suture around the fistula near the arterial anastomotic area to create a narrowing. Fistula plication involves narrowing of a short segment of the proximal venous outflow tract, usually accomplished by suturing or stapling the fistula for 2-6 cm. One of the notable systemic effects of a hemodialysis AVF is an acute decrease in systemic vascular resistance with a simultaneous increase in venous return to the heart, and thus an increase of the cardiac output. Cardiac failure occurs more frequently in patients with an access flow QA>2 l/min and CPR≥20%. Another adverse systemic effect of AV fistulas is pulmonary hypertension. The increased flow volume to the heart from an AV fistula yields an increase in pulmonary pressures. This can limit pulmonary vasodilation and result in pulmonary hypertension.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Observational Study of Basal Cell Carcinoma Operated at Montpellier University Hospital and Millau Hospital From February 2020 to February 2021 - Study of Correlation Between Localisation and Recurrence, and Other Criterias

summary:
.During one year all the resected basal cell carcinomas (BCC) analyzed in Montpellier University Hospital Anatomopathology unit were included in this study. Localisation and histological characteristics were collected. All the recurrences of BCC were searched from the medical records (or histopathology request form).

From 804 BCC, 48 were recurrent BCC with or without complete first resection. Patients with recurrent BCC were contacted to obtain agreement and more informations about the first resection and some clinical informations like sun exposure and phototype.

The statistical analysis focused on the localisation of recurrent BCC (with a complete first resection) compared to localisations of primary BCC in this population. The goal was to identified localisations with an increased risk of recurrences.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Characterization of Suicidal Depression Within a Large Cohort of Inpatients: a One-year Prospective Study.

summary:
Antidepressants are widely used to prevent suicidal risk. However, even though the use of antidepressants has been associated with a 40-60% decrease in suicidal risk, they do not seem to be sufficient and appropriate. Indeed recent studies have shown that patients with a history of suicide attempt and/or with current suicidal ideation (SI) respond less well to antidepressant treatments. This suggests that patients with depression with SI may be different from those with depression without SI, thus requiring specific treatments for both SI reduction and depressive remission. In other words, suicidal depression may be a specific subtype of depression.

The study aims to characterize the clinical phenotype of patients with suicidal depression vs. those without suicidal depression, and to assess the occurrence of suicidal events at one year in patients with suicidal depression vs. without suicidal depression.

All data having already been collected during the particpation of patients in various clinical research studies of the department


title: Hypnosis in Virtual Reality in Patients in Protector Isolation Room for Aplasia in Clinical Hematology. Monocentric, Comparative, Randomized, Open Study.

summary:
Hematology patients are frequently treated in hospital for aplasia. Patients are then placed in protective isolation room. This situation of protective isolation can represent a significant source of stress and anxiety for the patient. Hypnosis is already used to treat anxiety in patients with cancer.

The purpose of this study is to evaluate the impact of virtual reality medical hypnosis sessions on anxiety and chronic pain of patients hospitalized for aplasia in order to broaden the supportive care proposals in the clinical hematology service of Sévigné Private Hospital.

lead_sponsor: Hôpital Privé Sévigné


title: Management of Patients Suspected of COVID 19 With Ultra Low Dose Thoracic Scanner

acronym: COVID-19 ULD

summary:
The year 2020 was marked by the emergence of a new respiratory disease: COVID19 related to an infection with the coronavirus SARS-CoV-2 (name given by the WHO on February 11, 2020). Initially appearing in China, in the province of Hubei, this epidemic has rapidly spread to be declared a global pandemic on March 12, 2020 by the WHO.Given the current context of the COVID-19 epidemic, strict hygiene measures have been taken in scanning rooms with systematic bio-cleaning. Strategies have been modified as a matter of urgency, with changes in the practices of electro radiology manipulators who work in "isolation" to avoid contamination. The number of scanners has increased exponentially following the curve of the epidemic, making it more and more difficult to systematically check the images before the patient leaves the room. To ensure sufficient image quality for interpretation of all scans, a complementary acquisition in ULD, with very low exposure, was systematically added to the acquisition protocol. The standard acquisition in LD, associated with this acquisition in ULD remain well below the diagnostic reference thresholds dictated by the nuclear safety authority (NRD: 350 mGy.cm. In Nîmes: LD: 100 to 150 mGy.cm and ULD: < 15 mGy.cm). These two acquisitions allow us to avoid breathing and movement artifacts, etc., without having to have the patients return for a new scan in case of a bad acquisition. This avoids an overexposure of the staff to the risk of infection by the SARS-CoV-2 virus.

The main objective of this retrospective study is to evaluate the diagnostic performance of ULD vs. LD for the accurate diagnosis of COVID-19 pneumopathy which presents a particular ground glass pattern

Our study will demonstrate that the ULD scanner can be used in the search for COVID-19 pneumopathy and thus limit the exposure of patients to X-rays, especially since thoracic scans are often repeated.


title: Pathological Results After Downstaging of Agressive Hepatocellular Carcinoma Using 90Y-SIRT With Personalized Dosimetry

acronym: PAHCHS

summary:
The aim of our study is to analyze pathological analysis of surgically treated aggressive hepatocellular carcinomas after radio-embolization.

The investigators aim to demonstrate that a higher dose results in better tumor response while respecting safety conditions, that is, no radiologically induced liver disease.


title: Retro-prospective Evaluation of the Clinical Safety and Effectiveness of Hydrophilic Acrylic Intraocular Lens

summary: Evaluation of the clinical safety and effectiveness of hydrophilic acrylic intraocular lens

time_perspective: Other

lead_sponsor: Carl Zeiss Meditec AG


title: Investigation Clinique Observationnelle Des Performances de Diagnostic Electrocardiographique de l'Apple Watch (App ECG Version 2.0) augmentée d'un Algorithme d'Intelligence Artificielle

summary: This observational prospective clinical investigation will evaluate the performance on an Artificial Intelligence (AI) solution interpreting ECG (electrocardiogram) collected from an Apple Watch (AI-AW) in the detection of Atrial Fibrillation (AF)

lead_sponsor: Cardiologs Technologies

location_facility: Institut Cardiologique Paris Sud Hôpital Privé Jacques Cartier


title: Assessment of Peripheral Veins Doppler Ultrasound for Diagnosis of Acute Right Heart Failure in Suspicion or Follow-up of Pulmonary Hypertension

acronym: CODOVEIN

summary: Occurrence of acute right heart failure (ARHF) remains common during pulmonary hypertension (PH). Right atrial pressure (RAP) invasive measurement is the gold standard to diagnose ARHF in order to improve diuretic treatment management. Existence of indirect signs of ARHF on venous Doppler ultrasound waveform has long been described, but correlation with RAP has not been properly established yet. It is the aim of our study in order to obtain an additional tool to manage ARHF.

lead_sponsor: Poitiers University Hospital