title: Evaluation of a Digital Perioperative Support Solution for Colorectal Surgery: Compliance and Impact on Patients

summary:
The Institute of Image-Guided Surgery (IHU) of Strasbourg develops new minimally invasive therapies, the benefit of which is maximized by an integrated approach to the care pathway (pre, per and postoperative).

Encouraging patient engagement in the process responds to its growing demand for information and consideration, enhances its care experience and clinical outcomes.

Medtronic has designed an digital solution for patient engagement (current name: "Get Ready") for scheduled colorectal surgery. The IHU is a pilot experiment site for this solution. This research protocol, of which the IHU is the promoter, aims at evaluating the use and the impact of this solution made available to the patients of the Hepato-Digestive Pole (PHD) of the New Civil Hospital.

The solution deployed at the Strasbourg IHU aims to improve the patient's preparation for his colorectal surgery and follow his rehabilitation after surgery, by reinforcing his compliance with existing protocols and enriching it with complementary practices.

The solution is not a medical device. It is limited to advice, monitoring and restitution of data declared by the patient; it is not intended to prevent, diagnose or treat the pathology; it is independent of any other medical device.

This study aims to assess the pre-operative impact of the solution, in terms of patients' adherence to the pre-operative program and correlations with their physical and psychological condition until their admission to surgery. The secondary purpose of the study is to precise the acceptability of the solution.

ReferenceCitation: Santa Mina D, Clarke H, Ritvo P, Leung YW, Matthew AG, Katz J, Trachtenberg J, Alibhai SM. Effect of total-body prehabilitation on postoperative outcomes: a systematic review and meta-analysis. Physiotherapy. 2014 Sep;100(3):196-207. doi: 10.1016/j.physio.2013.08.008. Epub 2013 Nov 13.

ReferenceCitation: Wind J, Polle SW, Fung Kon Jin PH, Dejong CH, von Meyenfeldt MF, Ubbink DT, Gouma DJ, Bemelman WA; Laparoscopy and/or Fast Track Multimodal Management Versus Standard Care (LAFA) Study Group; Enhanced Recovery after Surgery (ERAS) Group. Systematic review of enhanced recovery programmes in colonic surgery. Br J Surg. 2006 Jul;93(7):800-9. doi: 10.1002/bjs.5384.

ReferenceCitation: Wang L, Lee M, Zhang Z, Moodie J, Cheng D, Martin J. Does preoperative rehabilitation for patients planning to undergo joint replacement surgery improve outcomes? A systematic review and meta-analysis of randomised controlled trials. BMJ Open. 2016 Feb 2;6(2):e009857. doi: 10.1136/bmjopen-2015-009857.

ReferenceCitation: Li C, Carli F, Lee L, Charlebois P, Stein B, Liberman AS, Kaneva P, Augustin B, Wongyingsinn M, Gamsa A, Kim DJ, Vassiliou MC, Feldman LS. Impact of a trimodal prehabilitation program on functional recovery after colorectal cancer surgery: a pilot study. Surg Endosc. 2013 Apr;27(4):1072-82. doi: 10.1007/s00464-012-2560-5. Epub 2012 Oct 9.

ReferenceCitation: van der Meij E, Anema JR, Leclercq WKG, Bongers MY, Consten ECJ, Schraffordt Koops SE, van de Ven PM, Terwee CB, van Dongen JM, Schaafsma FG, Meijerink WJHJ, Bonjer HJ, Huirne JAF. Personalised perioperative care by e-health after intermediate-grade abdominal surgery: a multicentre, single-blind, randomised, placebo-controlled trial. Lancet. 2018 Jul 7;392(10141):51-59. doi: 10.1016/S0140-6736(18)31113-9. Epub 2018 Jun 21.

ReferenceCitation: Mayo NE, Feldman L, Scott S, Zavorsky G, Kim DJ, Charlebois P, Stein B, Carli F. Impact of preoperative change in physical function on postoperative recovery: argument supporting prehabilitation for colorectal surgery. Surgery. 2011 Sep;150(3):505-14. doi: 10.1016/j.surg.2011.07.045.

ReferenceCitation: Snow R, Granata J, Ruhil AV, Vogel K, McShane M, Wasielewski R. Associations between preoperative physical therapy and post-acute care utilization patterns and cost in total joint replacement. J Bone Joint Surg Am. 2014 Oct 1;96(19):e165. doi: 10.2106/JBJS.M.01285.

ReferenceCitation: van Rooijen S, Carli F, Dalton S, Thomas G, Bojesen R, Le Guen M, Barizien N, Awasthi R, Minnella E, Beijer S, Martinez-Palli G, van Lieshout R, Gogenur I, Feo C, Johansen C, Scheede-Bergdahl C, Roumen R, Schep G, Slooter G. Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and reduce postoperative complications: the first international randomized controlled trial for multimodal prehabilitation. BMC Cancer. 2019 Jan 22;19(1):98. doi: 10.1186/s12885-018-5232-6.

ReferenceCitation: Lin LY, Wang RH. Abdominal surgery, pain and anxiety: preoperative nursing intervention. J Adv Nurs. 2005 Aug;51(3):252-60. doi: 10.1111/j.1365-2648.2005.03502.x.

ReferenceCitation: Adamina M, Kehlet H, Tomlinson GA, Senagore AJ, Delaney CP. Enhanced recovery pathways optimize health outcomes and resource utilization: a meta-analysis of randomized controlled trials in colorectal surgery. Surgery. 2011 Jun;149(6):830-40. doi: 10.1016/j.surg.2010.11.003. Epub 2011 Jan 14.

ReferenceCitation: Pecorelli N, Fiore JF Jr, Gillis C, Awasthi R, Mappin-Kasirer B, Niculiseanu P, Fried GM, Carli F, Feldman LS. The six-minute walk test as a measure of postoperative recovery after colorectal resection: further examination of its measurement properties. Surg Endosc. 2016 Jun;30(6):2199-206. doi: 10.1007/s00464-015-4478-1. Epub 2015 Aug 27.

ReferenceCitation: Hijazi Y, Gondal U, Aziz O. A systematic review of prehabilitation programs in abdominal cancer surgery. Int J Surg. 2017 Mar;39:156-162. doi: 10.1016/j.ijsu.2017.01.111. Epub 2017 Feb 2.

ReferenceCitation: Inoue T, Ito S, Kanda M, Niwa Y, Nagaya M, Nishida Y, Hasegawa Y, Koike M, Kodera Y. Preoperative six-minute walk distance as a predictor of postoperative complication in patients with esophageal cancer. Dis Esophagus. 2020 Mar 5;33(2):doz050. doi: 10.1093/dote/doz050.

ReferenceCitation: Chen YC, Chen KC, Lu LH, Wu YL, Lai TJ, Wang CH. Validating the 6-minute walk test as an indicator of recovery in patients undergoing cardiac surgery: A prospective cohort study. Medicine (Baltimore). 2018 Oct;97(42):e12925. doi: 10.1097/MD.0000000000012925.

ReferenceCitation: Marek W, Marek E, Vogel P, Muckenhoff K, Kotschy-Lang N. [A new procedure for the estimation of physical fitness of patients during clinical rehabilitation using the 6-minute-walk-test]. Pneumologie. 2008 Nov;62(11):643-54. doi: 10.1055/s-2008-1038204. Epub 2008 Aug 18. German.

ReferenceCitation: Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27.

ReferenceCitation: Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

lead_sponsor: IHU Strasbourg

location_facility: Service de Chirurgie Digestive et Endocrinienne, NHC


type: Other Identifier

title: Function of the Pigment Epithelium in Patients With Type 1 Neurofibromatosis

summary:
The objective of this study is to study the function of the pigment epithelium in patients with neurofibromatosis type 1 using electro-oculogram to confirm abnormally high values reported in previous studies, but also to correlate this hyperactivity of the pigment epithelium with the presence and size of choroidal hyperreflective areas observed in infra-red imaging of the fundus.

The hypothesis of the study is that the function of the pigment epithelium measured by the electro-oculogram correlates with the surface of choroidal hyperreflective areas. Finally, the potential consequences of a supra-normal function of the pigment epithelium on the global retinal function are not known. A full-field electroretinogram will evaluate the global neurosensory retinal function.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Lubinski W, Zajaczek S, Sych Z, Penkala K, Palacz O, Lubinski J. Electro-oculogram in patients with neurofibromatosis type 1. Doc Ophthalmol. 2001 Sep;103(2):91-103. doi: 10.1023/a:1012271206258.

ReferenceCitation: Viola F, Villani E, Natacci F, Selicorni A, Melloni G, Vezzola D, Barteselli G, Mapelli C, Pirondini C, Ratiglia R. Choroidal abnormalities detected by near-infrared reflectance imaging as a new diagnostic criterion for neurofibromatosis 1. Ophthalmology. 2012 Feb;119(2):369-75. doi: 10.1016/j.ophtha.2011.07.046. Epub 2011 Oct 2.

ReferenceType: result

ReferenceCitation: Touze R, Abitbol MM, Bremond-Gignac D, Robert MP. Function of the Retinal Pigment Epithelium in Patients With Neurofibromatosis Type 1. Invest Ophthalmol Vis Sci. 2022 Apr 1;63(4):6. doi: 10.1167/iovs.63.4.6.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

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

repository_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Association for Research in Vision and Ophthalmology (ARVO)

ipd_sharing: No

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: Effects of Cycling Workstation on Cardiometabolic Health for Workers With an Office-sitting Desk

acronym: REMOVE

summary:
The recent literature has highlighting the importance of the time of inactivity and the level of physical activity (PA) as predictors of metabolic cardio risks. Now, sedentary lifestyles are well recognized as one of the causes of mortality. As with physical activity, a dose-response relationship appears to exist: mortality would increase with time spent in sedentary behaviors. However, this relationship would not be linear: the more the daily sitting time increases, the more the consequences on mortality are important. It is now well demonstrated that time spent in sedentary adult behaviour finds primarily its origin in the work, characterized by prolonged and uninterrupted periods of sitting. Many strategies have been settled to break the prolonged sitting time. The most promising one seem to be the use of active workstations (treadmill, cycling, stepping) because they reduce sedentary time at work and increase physical activity with positive effects on the global health. If active workstations have demonstrated their effectiveness with overweight or obese people by increasing daily energy expenditure, their interest in prevention in normal weight people is less known. In addition, the long-term effectiveness of a program of reactivation by active workstation on biological parameters, quantitative and qualitative time of sedentary behaviour (duration, number of breaks) and physical fitness was not assessed.

The main objective of this project is to study the effects of the use of a cycling workstation for 60 minutes per day (30 minutes twice a day) for 3 months among professionals with an office-sitting desk on overall quantity of physical activity time (work and non-work) and sedentary time.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Guirado T, Metz L, Pereira B, Brun C, Birat A, Boscaro A, Bergouignan A, Thivel D, Duclos M. A 12-Week Cycling Workstation Intervention Improves Cardiometabolic Risk Factors in Healthy Inactive Office Workers. J Occup Environ Med. 2022 Aug 1;64(8):e467-e474. doi: 10.1097/JOM.0000000000002583. Epub 2022 Jun 11.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Guirado T, Metz L, Pereira B, Bergouignan A, Thivel D, Duclos M. Effects of cycling workstation to get tertiary employee moving on their overall health: study protocol for a REMOVE trial. Trials. 2021 May 22;22(1):359. doi: 10.1186/s13063-021-05317-2.

license: cc-by

license_normalized: cc-by

repositories_concat: PubMed Central

publisher_dissemination: Springer-Nature

lead_sponsor: University Hospital, Clermont-Ferrand

collaborators: Laboratoire AME2P - Unversité Clermont Auvergne

intervention_type: Behavioral

status_simplified: Unknown


title: Characterization and Understanding of the Mechanisms of Balance Disorders in a Seated Position Following a Stroke

acronym: HEMISEAT

summary:
One of the causes of disability in stroke patients is postural disturbances that result in postural asymmetry in the standing position, characterized during an evaluation on a force platform by a greater displacement of the center of pressure towards the lesion side and thus by a greater percentage of weight on the lower limb (Weight -Bearing Asymmetry (WBA)). Today, the mechanisms of balance disorders in standing position are better understood. Indeed, in addition to sensory and motor deficits, spatial cognitive disorders also contribute to these postural disturbances, particularly in right brain damage stroke. This would be the reason why patients with right brain damage have a more precarious and time-consuming balance to re-educate than patients with lesions located in the left hemisphere.

Postural disturbances can also result in a disturbance of balance in the sitting position, which is a poor prognosis for the acquisition of transfers, standing and walking. To date, seated postural disturbances are not perfectly described with many differences in the explanatory mechanisms found in the literature. Thus, some people notice a more pronounced asymmetry on the medio-lateral plane while others find a more pronounced imbalance at the antero-posterior plane.

Sitting posture disorders benefit from few instrumental measurement tools outside clinical measurement scales. A very wide variety of evaluation methods by instrumental measurements are proposed and not validated. Sensor pad, which are usually used to adjust the bases of pressure ulcer patients, may be useful in quantifying the postural balance. But since the involvement of the head and trunk in the sitting posture is well documented in the literature, the addition of an evaluation of the position of the trunk and head seems essential. To our knowledge, no author has proposed to quantify sitting balance disorders by combining a measure of support asymmetry by taking into account the posture of the trunk with that of the head.

study_start_date_type: Anticipated

primary_purpose: Basic Science

ipd_sharing: Undecided

lead_sponsor: Rennes University Hospital

location_facility: Service de Médecine Physique et Réadaptation - Hôpital de Pontchaillou


title: Prevalence of Auditory Dysfunction and ICU-acquired Delirium Following Cardiac Surgery With Cardiopulmonary Bypass: a Prospective Observational Study

acronym: AUDICS-ICU

summary: AUDICS-ICU is a prospective observational aiming to evaluate the prevalence of auditive dysfunction following cardiac surgery. Participants will undergo audiometric testings before and 3 months after cardiac surgery with cardiopulmonary bypass. Furthermore, the study evaluates hearing loss-associated ICU-acquired delirium after cardiac surgery with cardiopulmonary bypass.

lead_sponsor: European Georges Pompidou Hospital


title: Developing a Multi-scale Account of Attentional Control as the Constraining Interface Between Vision and Action (MAC-Brain).

acronym: MACBRAIN

summary: The project is dedicated to understanding the integration within the brain of signals of different natures that contribute to attentional control. The investigator will make use of standardized experimental displays involving the discrimination of a target (tilted-bar) presented together with 3 distractor items, with one stimulus in each visual quadrant. Across three fMRI experiments in healthy participants, the investigator will manipulate different types of signals that will guide the subject's attention towards one of the four quadrants: Exp 1 - task instruction & item salience; Exp 2 - probabilistic target location; Exp 3 - probabilistic reward. The investigator expects that irrespective of the nature of the control signal, activity in dorsal parietal cortex will index the currently relevant/attended location. Moreover, The investigator expects that upon changes of the most relevant location, one will observe activation of the ventral parietal cortex, plus increased inter-regional connectivity between ventral and dorsal parietal regions - again irrespective of the nature of the attention guiding signals.

lead_sponsor: Hospices Civils de Lyon


title: Effect of a Fish Collagen Peptide Food Supplement on the Weight and Body Composition of Healthy Volunteers in Overweight

acronym: NATICOL

summary:
Fish collagen hydrolysates or peptides orally administered have been investigated in recent clinical trials in human health. These peptides have been evaluated in various biological and medical fields including skin aging, osteoarticular apparatus, muscle and more recently in energy metabolism in both animals and humans.

However, very few studies investigated the effect of fish collagen peptides on weight, body composition or glycemic response. Recently, it has been shown that the consumption of fish collagen peptides (Naticol®) limits weight gain and increase in fat mass in a mouse model made obese by a hyperlipidic diet. Since these results have never been observed in humans, this pilot study proposes to answer this question.

primary_purpose: Treatment

lead_sponsor: Institut Pasteur de Lille

intervention_type: Dietary Supplement


title: Study of Neuro-ophthalmology Disorders in Autoimmune Encephalitis (NODE)

acronym: NODE

summary: Autoimmune encephalitis represents a group of rare and heterogeneous neurological disorders. Pathophysiological mechanisms in these diseases are still unknown. Recently, oculomotor and neurovisual disorders have been described. Cerebral areas and neuronal networks associated with these abnormalities are well described. The investigator proposes to study and describe such neuro-ophthalmological disorders in a prospective cohort of patients with a autoimmune encephalitis, to better understand the pathophysiological basis of this neurological condition.

status: Recruiting

status_simplified: Ongoing


title: A 12-month Real Life Study of IBD Patients Under Stable Steroid Free Clinical and Biological Remission Switched From Adalimumab Originator Humira® to One of Its Biosimilar: Amgevita®,Hulio®,Hyrimoz® or Imraldi®.

acronym: Rhoneswitch

summary:
Biosimilars represent great potential in cost saving and reinvestment opportunities in healthcare. Biosimilars of adalimumab appear to be clinically equivalent to the reference product in patients with rheumatoid arthritis and psoriasis. No data are currently available in IBD patients. Real-life data are needed.

Minimizing the switch back is another clinical challenge in the current area of biosimilars. The primary objective of Rhoneswitch is to describe the magnitude of patient's switch back defined as a deterioration of symptoms without objective identification of disease activity, 12 months after the switch from ada originator Humira®.

The primary endpoint is to assess the percentage of patients who switch back to originator therapy Humira® 12 months after switching from ada Humira® to ada Bs: Amgevita® ,Hulio®, Hyrimoz® or Imraldi® in IBD patients without any objective markers of inflammation.

lead_sponsor: University Hospital, Grenoble


title: Retrospective Observational Study of Posterior Keratometry Measured by IOLMaster 700 in Patients With Keratoconus

summary:
Keratoconus is a progressive bilateral disease leading to an apical stromal thinning and an irregular astigmatism by a steepening of the cornea, causing visual impairment. The causes are not yet well known, but it seems to be linked to several comorbidities. Keratoconus is a rare and for a long-time asymptomatic condition and its diagnosis needs meticulous screening for the early stages. Detecting it as soon as possible is a goal as it could lead to earlier avoiding of contributing factors such as eye rubbing and earlier treatment if needed.

The gold standard for keratoconus screening and staging is computerized videotography. It gives information about anterior and posterior corneal bulging, steepening, and thinning. It can be completed by anterior segment optical coherence tomography, which can show corneal scarring. Since recently, some biometry devices can give some information about the posterior corneal keratometry trough swept source optical coherence tomography measures. The measurement of the total corneal power instead of an extrapolation lead to better precision in refractive results after cataract surgery in some cases. It also helped to increase our knowledge about posterior corneal astigmatism. In normal eyes, average posterior corneal astigmatism is 0.37 diopters and against the rule in 91 percent of eyes. There is a correlation between the magnitude of anterior and posterior astigmatism.

In keratoconus eyes, several studies have shown that there is an alignment between axes of the anterior and posterior corneal astigmatism. These studies have been performed on computerized videotopography devices.

The goal of this study was to confirm or deny previous observations about posterior astigmatism in keratoconus eyes, and to assess if the rotation of axis between anterior and posterior astigmatism measured by IOL Master 700® can be a good sign for detection of early stages and fruste keratoconus.

time_perspective: Retrospective

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: Evaluation of the Muscular FORCE in the Upper Limbs of Patients Presenting a Thoracic Outlet Syndrome : Monocentric Case-control Study

acronym: EFORD

summary:
The thoracic outlet syndrome is a rare but debilitating pathology, responsible for upper limb pain. Its frequency is probably underestimated because of diagnostic difficulties. This syndrome encompasses several entities including compressions of neurological, venous or arterial origin. In addition to pain, the majority of patients report fatigability and loss of strength in the upper limbs. However, the quantification of this loss of strength and fatigability has hardly been studied.

In addition, the rehabilitation treatment is the first-line treatment of this pathology. It most often includes a muscle building phase.

In this project, we would like to evaluate the proximal and distal force of patients presenting a thoracic outlet syndrome by comparing them to a population free from any pathology in the upper limbs. This evaluation would involve an isokinetic strength analysis of shoulder rotators at the proximal level, using an isokinetic dynamometer. At the distal level, the evaluation would be done using force clamps.

In a second step, we will also be able to evaluate the effects of the reeducation on the strength and the muscular fatigability of the patients presenting a thoracic outlet syndrome.

lead_sponsor: Nantes University Hospital


title: Cerebrospinal Fluid Movements Through Interventricular Foramina in Phase Contrast Magnetic Resonance Imaging (PC-MRI)

acronym: MLCSFIV

summary: Assess the reproductibility of PC-MRI for cerebrospinal fluid movements through the interventricular foramina on volunteer subjects.

primary_purpose: Other

lead_sponsor: Centre Hospitalier Universitaire de Besancon

intervention_type: Device


title: Evaluation of the Effectiveness of the TOVERTAFEL System on Behavioral Disorders of People With Cognitive Disorders Hospitalized in Long-Term Care Units and in Reinforced Hosting Unit

acronym: TOVERTAFEL

summary:
The prevalence of behavioral disorders is high in patients living in an institutional environment or hospitalized in a long-term care unit. The consequences of these symptoms are not negligible with a faster cognitive decline and a significant impact on the life of the institution and of other patients when the disorders are pervasive and too difficult to manage for the healthcare teams.

Despite the daily attention paid to these disorders and their causes, especially the environmental ones, the teams are sometimes helpless, the teams are sometimes helpless today to fight against these symptoms, and their management thus constitutes a real challenge.

Non-drug interventions targeting this problem often require additional training, architectural installations (Snoezelen space) and / or are moderately effective. In order to offer a solution that can be used by everyone, that is transportable and based on new technologies, the TOVERTAFEL device was created.

These are interactive games projected onto a table using a ceiling projector. The light animations invite people to "play with the light" using arm or hand movements. These games stimulate residents' physical activity and encourage interactions between residents and with caregivers.

In this study, it is a question of evaluating the effectiveness of the TOVERTAFEL device on the frequent behavioral symptoms in dementia (agitation, ambulation, apathy, anxiety), the quality of life of the patients, as well as on psychotropic treatments.

design_allocation: Non-Randomized

primary_purpose: Supportive Care


title: CATRIPCA - A Phase I Study of PD1 Monoclonal Antibody (Pembrolizumab) In Combination With a IAP Antagonist (Debio 1143) In (Exocrine) Pancreatic And Colorectal Non MSI-high Advanced/Metastatic Adenocarcinoma.

acronym: CATRIPCA

summary:
This trial is a Phase I study to be conducted in patients with non-MSI-high advanced/metastatic pancreatic ductal adenocarcinoma (PDAC) or colorectal cancer (CRC) and is divided in two Parts.

Dose escalation Part :To determine the Maximum Tolerated Dose (MTD) and the Recommended Dose for Phase 2 (RP2D) of Debio1143 when combined with a fixed dose of Pembrolizumab.
Extension Part: To evaluate preliminary efficacy data of the proposed combination.

ReferenceCitation: Crawford N, Stott KJ, Sessler T, McCann C, McDaid W, Lees A, Latimer C, Fox JP, Munck JM, Smyth T, Shah A, Martins V, Lawler M, Dunne PD, Kerr EM, McDade SS, Coyle VM, Longley DB. Clinical Positioning of the IAP Antagonist Tolinapant (ASTX660) in Colorectal Cancer. Mol Cancer Ther. 2021 Sep;20(9):1627-1639. doi: 10.1158/1535-7163.MCT-20-1050. Epub 2021 Aug 13.

oa_colors: green hybrid

evidence: open (via crossref license)

repository_institution: Queen's University Belfast - Research Portal

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

repository_institution: Cold Spring Harbor Laboratory - bioRxiv

repository_normalized: bioRxiv

version: submittedVersion

repositories:
PubMed Central
bioRxiv
pure.qub.ac.uk/portal

unpaywall_oa_status: hybrid

publisher_dissemination: American Association for Cancer Research

lead_sponsor: Centre Leon Berard

sponsor_collaborators:
Centre Leon Berard
Merck Sharp & Dohme LLC
Debiopharm International SA

intervention_type: Drug


title: COLchicine to Prevent Sympathetic Denervation After an Acute Myocardial Infarction

acronym: COLD-MI

summary: This study evaluates the benefit of colchicine on induced denervation after myocardial infarction. Patients who have suffered a documented De Novo myocardial infarction and completed a revascularization procedure will receive either colchicine on top of standard therapy, compared to standard therapy alone (1:1 allocation ratio). Colchicine 1mg (or 0.5mg) will be initiated within 48h after percutaneous revascularization and prescribed for one month.

status: Terminated


title: Evaluation of Stem and Immune Cells in the Early Stage Breast Cancer Without Genetic Risk

acronym: MACSSI

summary:
Monocentric, observational and prospective study in adult women having an early-stage breast cancer without genetic risk.

The main objective is to characterize quantitatively and qualitatively, after solitary confinement, the resident breast stem cells and the immune system cells infiltrated in the mammary gland in women:

With a moderate risk of breast cancer progression (women with an early "Luminal A" tumor) = Group A.
With a high risk of breast cancer progression (women with an early "Luminal B" or basal tumor) = Group B.


title: Assessment of a New Measurement Technique for Type C Fibre Nerve Conduction Velocity in Polyneuropathies.

acronym: FIBREC

summary: Peripheral nerve diseases can separately affect different kind of nerve fibres. Globally two kinds of fibres can be distinguished: large size and small size. The usual electromyogram only investigates large size fibres. Techniques to explore small size fibre function exist but are not used in common practice because of their very specialized aspect or their lack of diagnostic value. The purpose of this study is to develop a measurement technique of small size type C nerve fibre conduction velocity, to show that this velocity is reduced in patients suffering from polyneuropathies and to establish reference values in healthy patients.

primary_purpose: Diagnostic

ReferenceCitation: Arunodaya GR, Taly AB, Swamy HS. Sympathetic skin response in acute sensory ataxic neuropathy. J Neurol Sci. 1995 May;130(1):35-8. doi: 10.1016/0022-510x(94)00271-o.

ReferenceCitation: Vetrugno R, Liguori R, Cortelli P, Montagna P. Sympathetic skin response: basic mechanisms and clinical applications. Clin Auton Res. 2003 Aug;13(4):256-70. doi: 10.1007/s10286-003-0107-5.

ReferenceCitation: Fagius J, Wallin BG. Sympathetic reflex latencies and conduction velocities in normal man. J Neurol Sci. 1980 Sep;47(3):433-48. doi: 10.1016/0022-510x(80)90098-2.

ReferenceCitation: Fagius J, Wallin BG. Sympathetic reflex latencies and conduction velocities in patients with polyneuropathy. J Neurol Sci. 1980 Sep;47(3):449-61. doi: 10.1016/0022-510x(80)90099-4.

ReferenceCitation: Tzeng SS, Wu ZA, Chu FL. The latencies of sympathetic skin responses. Eur Neurol. 1993;33(1):65-8. doi: 10.1159/000116904.

ReferenceCitation: Soliven B, Maselli R, Jaspan J, Green A, Graziano H, Petersen M, Spire JP. Sympathetic skin response in diabetic neuropathy. Muscle Nerve. 1987 Oct;10(8):711-6. doi: 10.1002/mus.880100806.

ReferenceCitation: Valls-Sole J, Monforte R, Estruch R. Abnormal sympathetic skin response in alcoholic subjects. J Neurol Sci. 1991 Apr;102(2):233-7. doi: 10.1016/0022-510x(91)90074-h.

ReferenceCitation: Montagna P, Marchello L, Plasmati R, Ferlini A, Patrosso MC, Salvi F. Electromyographic findings in transthyretin (TTR)-related familial amyloid polyneuropathy (FAP). Electroencephalogr Clin Neurophysiol. 1996 Oct;101(5):423-30.

ReferenceCitation: Carmichael EA, Honeyman WM, Kolb LC, Stewart WK. Peripheral conduction rate in the sympathetic nervous system of man. J Physiol. 1941 Mar 25;99(3):338-43. doi: 10.1113/jphysiol.1941.sp003905. No abstract available.

ReferenceCitation: Sourek K. [Reflex skin potential reactions in cases of surgically tested discopathies]. Acta Univ Carol Med (Praha). 1965:Suppl 21:99+. No abstract available. Multiple languages.

ReferenceCitation: Uncini A, Pullman SL, Lovelace RE, Gambi D. The sympathetic skin response: normal values, elucidation of afferent components and application limits. J Neurol Sci. 1988 Nov;87(2-3):299-306. doi: 10.1016/0022-510x(88)90254-7.

ReferenceCitation: Knezevic W, Bajada S. Peripheral autonomic surface potential. A quantitative technique for recording sympathetic conduction in man. J Neurol Sci. 1985 Feb;67(2):239-51. doi: 10.1016/0022-510x(85)90120-0.

ReferenceCitation: Elie B, Guiheneuc P. Sympathetic skin response: normal results in different experimental conditions. Electroencephalogr Clin Neurophysiol. 1990 Sep;76(3):258-67. doi: 10.1016/0013-4694(90)90020-k.

ReferenceCitation: Sequeira H, Hot P, Silvert L, Delplanque S. Electrical autonomic correlates of emotion. Int J Psychophysiol. 2009 Jan;71(1):50-6. doi: 10.1016/j.ijpsycho.2008.07.009. Epub 2008 Jul 23.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Centre hospitalier intercommunal de Toulon La Seyne sur Mer

intervention_type: Diagnostic Test


title: Validation of a Semi-automatized Method to Detect Cyclic Hyperinflation on CT-scan in ARDS

summary:
This study aims to validate a semi-automatized method to quantify cyclic hyperinflation on CT-scan of ARDS patients.

The gold standard will be cyclic hyperinflation assessed on the same CT scan, using manual segmentation of the lung.


title: Evaluation of the Risk of Necrotizing Enterocolitis in Fetuses With Intrauterine Growth Restriction.

acronym: ECUN

summary: Necrotizing enterocolitis is the most common gastroenterological emergency in neonatology. Its mortality is high, ranging from 15 to 30%. Prematurity is the main risk factor for necrotizing enterocolitis, as well as the very low birth weight (<1500 g) associated with prematurity. Among the early neonatal complications of intrauterine growth restriction neonates, necrotizing enterocolitis is frequently reported in the literature. The situation of chronic hypoxia of these fetuses is at the origin of a vascular redistribution favoring the cerebral circulation to the detriment of the mesenteric vascularization, which could lead to the development of an necrotizing enterocolitis. However, data from the literature concerning this over-risk of necrotizing enterocolitis in the case of intrauterine growth restriction are discordant. The heterogeneity of the definitions used for the intrauterine growth restriction and diagnostic criteria for necrotizing enterocolitis from one study to another could explain these discrepancies. The investigator's hypothesis is that the risk of necrotizing enterocolitis is higher among newborns in intrauterine growth restriction compared to control children.


title: Evaluation of Virtual Surgical Planning Systems and Customized Devices in Fibula Free Flap Mandibular Recontruction

summary: The purpose of this study was to evaluate the accuracy of virtual planning using customized surgical devices (VP3D) in fibula free flap mandibular reconstruction. Virtual planning was compared to postoperative scans using cephalometric and three-dimensional (3D) measurements. Operative times of both VP3D and conventional surgery groups were compared.

ReferenceCitation: Blanc J, Fuchsmann C, Nistiriuc-Muntean V, Jacquenot P, Philouze P, Ceruse P. Evaluation of virtual surgical planning systems and customized devices in fibula free flap mandibular reconstruction. Eur Arch Otorhinolaryngol. 2019 Dec;276(12):3477-3486. doi: 10.1007/s00405-019-05625-z. Epub 2019 Sep 9.

location_facility: Croix-Rousse Hospital - Hospices Civils de Lyon

intervention_type: Procedure


title: Incidence and Factors Associated With Double-J Urinary Stent Infection (IJJ)

acronym: IJJ

summary: The aim of the study was to determine the incidence and factors associated with double-J urinary stent infection.

sponsor_collaborators: Centre Hospitalier Universitaire de Besancon


title: Cone Beam Computed Tomography Following Thrombectomy : Identification of Hemorrhage and Distinction From Contrast Accumulation Due to Blood-Brain Barrier Disruption

acronym: Hemathromb

summary: Cerebral haemorrhages following reperfusion treatments involve not only rupture of the blood-brain barrier, but also direct damage to vessels related to the equipment used and secondary toxicity to thrombolytics. The rupture of the blood-brain barrier which results from ischemia / reperfusion is responsible for stagnation of the contrast product on the exams performed after thrombectomy. It is difficult to distinguish hyperdensities related to the stagnation of contrast product and Hemorrhage on a conventional scanner. The reference imaging is the double energy scanner performed at the thrombectomy outlet. But no study directly compared the results of the flat panel with the cone beam CT performed in immediate post-thrombectomy. The investigators propose a direct comparison of the cone beam CT with the dual energy CT performed at the exit of thrombectomy.

status: Active, not recruiting

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Evaluation of a Screening Strategy of Fabry Disease in Patient With Renal Biopsy: Histo-Fab Study

acronym: HISTOFAB

summary:
Fabry disease is genetic X linked disease, with annual incidence of 1 in 100,000 that is certainly underestimate the true prevalence of the disease.

Renal biopsy in some patients does not allow determining the etiology of nephropathy. It is why investigators would like to evaluate the screening of Fabry patients from renal biopsy in patient with idiopathic nephropathy.

Investigator hypothesize to detect one or more cases of patients with Fabry disease in local idiopathic nephropathy population with renal biopsy.

That would allow reviewing and optimizing the target screening for Fabry Disease. The purpose would be to detect Fabry disease systematically in patients presenting a nephropathy of undetermined etiology in spite of the renal biopsy or presenting nonspecific histological characteristics.

In Fabry disease with renal impairment, proteinuria is the first sign, usually occurring in the second decade. The evolution is progressively towards end-stage renal failure during the fourth decade. The presence of renal impairment is globally associated with a poor prognosis.

Renal histology can be used to diagnose Fabry disease by revealing sphingolipid deposits identified by optical microscopy in the form of vacuoles in podocytes, distal tubule epithelial cells or in the media of the distal tubules. vascular walls. Resin inclusion with Toluidine blue staining is the staining of choice for visualizing lipid inclusions. However, this staining is not used as a first intention in routine. On the paraffin-fixed tissues, the vacuoles are less visible because they dissolve.

Thus, the renal histological analysis sometimes reveals only non-specific damage to the various structures of the kidney and may not allow identification of very evocative inclusions. Under the effect of oxidative stress induced by sphingolipid deposits, lesions of tubulo-interstitial fibrosis settle quite early. At the level of the glomerulus, glycosphingolipids lead to the production of angiotensin II and TGF-β leading to an excess production of constituents of the glomerular basement membrane inducing its thickening and glomerulosclerosis. Arteries of all sizes are also the seat of intimal thickening and media accelerating the process of intrarenal ischemia. These lesions, which may appear isolated or synchronous, and nonspecific, are sometimes in the foreground and do not point in the first line to the etiological diagnosis of Fabry disease.

Also, among the patients presenting a nephropathy of undetermined etiology in spite of the renal biopsy or presenting nonspecific histological characteristics, investigator propose to systematically detect the Fabry disease. Screening will be done in a selected population of renal biopsy patients using the dried blood spot kits.

lead_sponsor: University Hospital, Angers


title: Septic Management and Outcome of Open Fracture : a 7 Years Retrospective Cohort Study

summary:
The aim is the study of the management and outcome of the open fractures.

Some open fractures will become pseudarthrosis. Thoses pseudarthrosis may be septic or not.

The management and evolution of all the open fractures will be described in order to identify the presence or not of a sepsis and then a development of a pseudarthrosis (septic or non septic).


title: Effects of Relaxing Breathing Combined With Biofeedback on the Performance and Stress of Residents During a High-fidelity Simulation Session.

acronym: RETROSIMU

summary:
The harmful effects of stress on health professionals are expressed both in terms of their health (physical or mental) and the quality of work (reduced memory capacity, deterioration in patient care). These adverse effects highlight the importance of implementing effective coping strategies and/or early learning of stress management methods in medical training programs.

Relaxation breathing techniques coupled with heart rate variability (HRV) biofeedback is one of the new techniques used to reduce the stress level.

No research has yet tested the effects of HRV induced by relaxation breathing technique before managing a simulated critical situation.

ReferenceCitation: Schlatter ST, Therond CC, Guillot A, Louisy SP, Duclos A, Lehot JJ, Rimmele T, Debarnot US, Lilot ME. Effects of relaxing breathing paired with cardiac biofeedback on performance and relaxation during critical simulated situations: a prospective randomized controlled trial. BMC Med Educ. 2022 Jun 2;22(1):422. doi: 10.1186/s12909-022-03420-9.

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

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

lead_sponsor: Claude Bernard University

collaborators: Schlatter, S., Claude Bernard University


title: Evaluation of the Archimedes ™ System for Transparenchymatous Access to Pulmonary Nodules.

acronym: SATAN

summary: The aim of this study protocol is to evaluate the feasibility of biopsies using the new system called Archimedes® in 12 patients with solitary pulmonary nodules (SPN) suspicious of malignancy not accessible through current bronchoscopy techniques.

lead_sponsor: University Hospital, Limoges


title: Level of Accelerometer-assessed Preoperative Physical Activity and Short Term Outcome After Elective Cardiac Surgery. A Monocentric Prospective Observational Cohort Study

acronym: ACTI-CARD

summary: Short term morbidity after elective cardiac surgery remains significant. Standard predictive models, considering simple patient demographics and clinical parameters, show limited efficiency in individual operative risk assessment. There is growing evidence about daily physical activity as a relevant indicator of preoperative "frailty". Although cardiopulmonary exercise testing remains a gold standard, we are looking for more simple tools in order to identify patients with poor physical condition. Accelerometry may be an objective and reproductible method to measure physical activity at patient's home.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Analysis of the Distribution of Adrenal Steroids in Blood and Urine Measured by Mass Spectrometry Coupled to Liquid Chromatography in a Control Population

acronym: STEROTEM

summary: This is a biomedical research study on the determination of adrenal steroids. It has been proposed in recent years as a tool for the diagnostic orientation of an adrenal pathology. The main objective is to analyze the distribution of blood and urinary adrenal steroid values in a population of 60 controls. The secondary objective is to establish reference values for each of these parameters, if their distribution permits, and to study the possible link between the blood pressure level, the orthostatism state, the potassium level and these adrenal steroids.

lead_sponsor: University Hospital, Lille

collaborators: AREM (Association Régionale Endocrinologie Métabolisme)


title: Accordance Between Transferrin Saturation Coefficient and Ferritinemia in Diagnosis of Iron Deficiency, in Patients Hospitalised in Internal Medicine Service and 65 Years Old and More

acronym: CarenceMartial

summary: Transferrin saturation coefficient and ferritinemia in diagnosis of iron deficiency

lead_sponsor: Lille Catholic University


title: Complications of Adenovirus Keratoconjunctivitis in Ophthalmologists and Orthoptists: Epidemiology and Risk Factor, a Retrospective Questionnaire Analysis

acronym: ADV-OPH

summary:
Adenovirus conjunctivitis is an epidemic disease registered as a common occupational disease for ophthalmologists and orthoptists. It can leave corneal sequelae even several years after infection.

The primary aim of the study is to investigate the prevalence of these sequelae in the at-risk population of ophthalmologists and orthoptist.

Secondary aim are to describe administrative procedures (occupational disease declaration and sick leave),infections characteristics; and risk factors.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Echocardiography in Critically-ill Patients With COVID-19 Pneumonia

acronym: ECHO-COVID

summary: Critical care echocardiography (CCE) has been widely used since the 10 last years. Covid outbreak leads that many patients with acute respiratory failure were admitted in the ICU. Many of these patients were ventilated and developed ARDS. Some of them developed deep vein thrombosis and pulmonary embolism. Nothing is already described about the cardiac function and the hemodynamics in these patients (how many RV failure, LV systolic dysfunction,...). The echo group of the cardiodynamix section of European society of intensive care medicien (ESICM) aims to promote CCE and evaluate its interest. The objective is to retrospectively enter in an international database all the echo studies done as usual care in these patients to evaluate (i) incidence of RV failure, (ii) incidence of LV systolic function, (iii) incidence of other patterns. Another objective will be to look for any association between some patterns and respiratory strategy, blood gas analysis, systemic hemodynamics. The echo studies were done and will be reported following one of the recent systematic review published by the same group (Huang S et al. AOIC 2020).

lead_sponsor: Hospital Ambroise Paré Paris


title: Contribution of Physical Activity to Self-esteem and Motivation in Older Adults With Minor to Major Cognitive Disorders Such as Alzheimer's Disease or Related Disorders

acronym: APAMA

summary:
Alzheimer's disease is the leading cause of dementia in people over 60 years of age. It is characterized by a decline in memory, learning ability and other cognitive domains (language, gnosis, praxis, attention), with a gradual progression of cognitive and behavioral symptoms. Because of the difficulties it causes in carrying out daily living activities, it has a very significant impact on the autonomy of patients suffering from it.

To date, there are various non-drug strategies available to manage these difficulties. Thus, in recent years, more and more studies have shown the benefits that can be gained by several patients care including physical activity, on cognitive function and general quality of life of the elderly people without cognitive impairment but also for patients suffering from Alzheimer's disease or a related pathology.

The objective of this study is to evaluate the effectiveness of adapted physical activity on self-esteem and motivation in patients with neurocognitive disorders. Stimulation groups are proposed within the Claude Pompidou Institute. Within these groups we offer an adapted physical activity program that we have developed in our department. More specifically, it is a study that aims to evaluate the impact of physical activity on the self-esteem and motivation of patients who perform these exercises for 12 weeks, at the rate of one hour per week.

The interest of this study lies in the validation of the effectiveness of such patient care, which would make it possible to promote its dissemination and strengthen the accessibility of this type of non-drug management to elderly people suffering from neurocognitive disorders.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Institut Claude Pompidou - Centre Mémoire de Ressources et de Recherche du CHU de Nice


title: Evaluation of the Recovery Rate and Postoperative Incontinence of Surgical Fistulas in a Cohort of a Reference Centre

acronym: PROFIL

summary:
Fistula is a pathology that can be complex and lead to treatment difficulties for the proctologist.

The proctologist's objective is to treat the infection (anal fistula and abscess) with the minimum impact on anal continence. Drainage of the fistula pathway(s) and removal of infected tissue during initial surgery are essential. The treatment of upper trans-sphincterial fistulas, i. e. those that span more than half the height of the anal sphincter, poses risks to anal continence. It sometimes requires several times of surgical treatment.

The study aim to investigate the fate of all patients treated for anal fistula in an expert team, in terms of impact on healing and anal continence and according to the type of anal fistula, the co-morbidity, the surgical techniques used and the bacterial flora responsible.

lead_sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon


title: Vascular Complications and Bleeding After Transfemoral TAVI: a Comparison Between Surgical and Percutaneous Approaches

summary:
Since the first implantation by Cribier, transcatheter aortic valve implantation (TAVI) revolutionized the management of severe symptomatic aortic stenosis. Indeed, TAVI is indicated as an alternative to conventional surgery in patients at high surgical risk or contra-indicated to conventional surgery.

However, TAVI remains associated with specific complications related to the technics itself dominated by vascular complications and conductive disorders. Major vascular complications remain frequent after TAVI despite improvements in operators' experience, patient's selection and lower profile devices. Indeed, according to the Valve Academic Research Consortium 2 (VARC-2) criteria , major VC are still reported with an incidence of 1.5% to 15% of the procedures in registries and may be associated with unfavorable clinical outcomes. Currently, percutaneous approach (PC) in transfemoral TAVI is performed in routine, considered as a less invasive strategy than the traditional surgical cutdown (SC) performed in the first TAVI experience. Indeed, percutaneous approach may facilitate the local anesthesia and does not require the presence of the surgeon in the catheterization laboratory . However, surgical approach is still performed in many centers, allowing a better control of the puncture site with a low rate of vascular complications . Several non-randomized studies compared the two approaches with contradictory results]. No data are available comparing both approaches performed by the same team during the same period.

The aim of this study was to compare percutaneous and surgical approaches in terms of vascular complications and bleeding in patients undergoing transfemoral TAVI.


title: Cohort Study of Vasculitis Patients: Longitudinal Study for the Assessment of Presentation, Comorbidities, Management, Outcomes and Damage

acronym: VASCO

summary: VASCO is a prospective observational cohort study which aim to describe the presentation, comorbidities, management, outcomes and damage of vasculitis patients, from the analysis of the clinical, biological and immunological data.

ReferenceCitation: Leavitt RY, Fauci AS, Bloch DA, Michel BA, Hunder GG, Arend WP, Calabrese LH, Fries JF, Lie JT, Lightfoot RW Jr, et al. The American College of Rheumatology 1990 criteria for the classification of Wegener's granulomatosis. Arthritis Rheum. 1990 Aug;33(8):1101-7. doi: 10.1002/art.1780330807.

ReferenceCitation: Lightfoot RW Jr, Michel BA, Bloch DA, Hunder GG, Zvaifler NJ, McShane DJ, Arend WP, Calabrese LH, Leavitt RY, Lie JT, et al. The American College of Rheumatology 1990 criteria for the classification of polyarteritis nodosa. Arthritis Rheum. 1990 Aug;33(8):1088-93. doi: 10.1002/art.1780330805.

ReferenceCitation: Masi AT, Hunder GG, Lie JT, Michel BA, Bloch DA, Arend WP, Calabrese LH, Edworthy SM, Fauci AS, Leavitt RY, et al. The American College of Rheumatology 1990 criteria for the classification of Churg-Strauss syndrome (allergic granulomatosis and angiitis). Arthritis Rheum. 1990 Aug;33(8):1094-100. doi: 10.1002/art.1780330806.

ReferenceCitation: Jennette JC, Falk RJ, Andrassy K, Bacon PA, Churg J, Gross WL, Hagen EC, Hoffman GS, Hunder GG, Kallenberg CG, et al. Nomenclature of systemic vasculitides. Proposal of an international consensus conference. Arthritis Rheum. 1994 Feb;37(2):187-92. doi: 10.1002/art.1780370206.

ReferenceCitation: Jennette JC, Falk RJ, Bacon PA, Basu N, Cid MC, Ferrario F, Flores-Suarez LF, Gross WL, Guillevin L, Hagen EC, Hoffman GS, Jayne DR, Kallenberg CG, Lamprecht P, Langford CA, Luqmani RA, Mahr AD, Matteson EL, Merkel PA, Ozen S, Pusey CD, Rasmussen N, Rees AJ, Scott DG, Specks U, Stone JH, Takahashi K, Watts RA. 2012 revised International Chapel Hill Consensus Conference Nomenclature of Vasculitides. Arthritis Rheum. 2013 Jan;65(1):1-11. doi: 10.1002/art.37715. No abstract available.

ReferenceCitation: van der Woude FJ, Rasmussen N, Lobatto S, Wiik A, Permin H, van Es LA, van der Giessen M, van der Hem GK, The TH. Autoantibodies against neutrophils and monocytes: tool for diagnosis and marker of disease activity in Wegener's granulomatosis. Lancet. 1985 Feb 23;1(8426):425-9. doi: 10.1016/s0140-6736(85)91147-x.

ReferenceCitation: Sable-Fourtassou R, Cohen P, Mahr A, Pagnoux C, Mouthon L, Jayne D, Blockmans D, Cordier JF, Delaval P, Puechal X, Lauque D, Viallard JF, Zoulim A, Guillevin L; French Vasculitis Study Group. Antineutrophil cytoplasmic antibodies and the Churg-Strauss syndrome. Ann Intern Med. 2005 Nov 1;143(9):632-8. doi: 10.7326/0003-4819-143-9-200511010-00006.

ReferenceCitation: Bligny D, Mahr A, Toumelin PL, Mouthon L, Guillevin L. Predicting mortality in systemic Wegener's granulomatosis: a survival analysis based on 93 patients. Arthritis Rheum. 2004 Feb 15;51(1):83-91. doi: 10.1002/art.20082.

ipd_sharing: Yes

ipd_sharing_description: Undecided

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service de médecine interne, Hôpital Cochin, AP-HP


title: A Cross-over Study to Compare Two Different Tracheal Cuff Pressure Monitoring Devices in a Pediatric Intensive Care Unit

summary: Despite the expert recommendation about rigorous monitoring of tracheal cuff pressure using a continuous or intermittent technique, cuff underinflation and overinflation are common increasing the risk of microinhalation and tracheal ischemia. All these complications are associated with high morbidity and mortality in ICU.


title: Ability of Pupillometry to Reduce Sufentanil Consumption in Planned Cardiac Surgery: Randomized, Controlled, Single-center Clinical Superiority Trial

acronym: PUCCAR

summary:
The objective of general anesthesia is to obtain a loss of consciousness, stillness, and sufficient analgesia to allow surgery. Thus, general anesthesia has two components: hypnosis and analgesia. Combining these two components, with parallel use of a hypnotic agent and a morphine agent makes major surgery possible by limiting the stress on the body. In clinical practice, hypnosis can be assessed by a monitor of the depth of BIS®-type anesthesia, based on a simplified measurement of the patient's spontaneous cortical electroencephalographic activity. However, BIS® type monitors do not specifically judge analgesia.

Traditionally, analgesia is assessed on the basis of hemodynamic changes (blood pressure, heart rate) in relation to a nociceptive stimulus. There is an interaction between pain and cardiovascular control that is mediated by the baroreflex system. But not all hemodynamic changes during general anesthesia are necessarily secondary to nociceptive stimulation. For example, hypovolemia may be responsible for tachycardia without causing pain; opening the pericardium during cardiac surgery may increase blood pressure by increasing cardiac output.... On the other hand, a decrease in hemodynamic response can be observed in relation to the depressant effect of anesthetic agents, despite a lack of analgesia. Similarly, patients' disease-modifying treatments may mask hemodynamic responses (e.g. beta blocker). Thus, the appearance of tachycardia or high blood pressure during surgery does not necessarily reflect a nociceptive process. Currently, the available data do not allow the anaesthetist to differentiate between real hemodynamic changes related to nociception and sympathicotonia. This leads to typical management consisting of an increase in the dosage of morphine.

Pupillometry (monitoring the pupillary dilation reflex) is a simple and sensitive clinical approach that can be done during general anesthesia to specifically monitor the nociceptive component. The main objective of monitoring is to achieve a more rational use of opioids. This means optimizing opioid dosing, ensuring safety by monitoring the lowering of opioid dosages intraoperatively without the risk of waking up, and reducing postoperative hyperalgesia. In the context of cardiac surgery, the interpretation of hemodynamic changes could be facilitated by nociception monitoring coupled with anesthesia monitoring (BIS). Reducing opiod doses without changing other clinical parameters could ensure better hemodynamic stability in increasingly fragile patients.

ReferenceCitation: Berthoud V, Nguyen M, Appriou A, Ellouze O, Radhouani M, Constandache T, Grosjean S, Durand B, Gounot I, Bahr PA, Martin A, Nowobilski N, Bouhemad B, Guinot PG. Pupillometry pain index decreases intraoperative sufentanyl administration in cardiac surgery: a prospective randomized study. Sci Rep. 2020 Dec 3;10(1):21056. doi: 10.1038/s41598-020-78221-5.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: French Observational Study of Complications Associated With Anticoagulants and Antiplatelet Treatment in Retina/Vitreous Surgery (CLOT Study)

acronym: CLOT

summary: Anticoagulants and antiplatelet treatments are frequently prescribed treatments to prevent or treat thromboembolic complications and reduce morbidity and mortality related to cardiovascular risk factors. In retina/vitreous surgery, there are rare but potentially serious risks of hemmorrhagic complication resulting in irreversible loss of visual acuity. There is no clear consensus on how to proceed during the perioperative period with regard to the continuation or discontinuation of anticoagulant and antiplatelet treatments in these types of surgery. the purpose of the study is to identify complications at 1 month depending on the type of surgery with or without discontinuation of antithrombotic treatments. Practitioners are not asked to change their modus operandi. The hypothesis is that there is no excess risk of peri- or post-operative hemorrhage in retino-vitreous surgery in patients treated with antithrombotic compared to untreated patients and that therefore discontinuation of these treatments before surgery is not necessary.


title: Physical Activity Adapted at Home Supervised by Videoconferencing in Post-cancer for Children / AYA Treated for Leukemia: Reduction of Territorial and Social Inequalities Due to E-health - Feasibility Study (ONCOPED SAPATIC)

summary: Leukemia is the most common form of cancer (29%) in children, adolescents, and young adults (AYA) (CNIB Report, 2017). Current treatments for leukemia (conventional chemotherapy or hematopoietic stem cell transplantation) can lead to significant side effects, acute or chronic, which can lead to impaired physical abilities and reduced quality of life for patients in short, medium or long term. For children and AYA with cancer, adapted physical activity (APA) is now recommended even if the scientific evidence of its benefit is still insufficient.

lead_sponsor: University Hospital, Montpellier

sponsor_collaborators:
University Hospital, Montpellier
mooven society


title: Hand Dermatitis in the Care and Hospital Staff of the Brest CHRU: State of Play

acronym: MANUS-PRO

summary: Study of the prevalence and risk factors of occupational dermatitis in the hands of caregivers and hospital staff of the Brest CHRU.

lead_sponsor: University Hospital, Brest


title: Prospective and Retrospective Study Evaluating Epidemiological, Clinical, Molecular and Therapeutic Data of Prolymphocytic Leukemia T

acronym: T-PLL

summary:
Prolymphocytic leukemia T is a rare disease representing approximately 2% of mature lymphoid leukemias and 20% of prolymphocytic leukemias. It mainly affects the elderly with an aggressive clinical course. It is a hemopathy exhibiting a post thymic T phenotype (Tdt-, CD1a-, CD5 +, CD2 + and CD7 +), generally CD4 + / CD8-, but also CD4 + / CD8 + or CD8 + / CD4-.

The main feature of T-PLL is the rearrangement of chromosome 14 involving genes encoding the T cell receptor complex (TCR) subunits, leading to overexpression of the proto-oncogene TCL1.

On the molecular level, the study of Prolymphocytic leukemia T shows a substantial mutational activation of the IL2RG-JAK1-JAK3-STAT5B axis.

Patients with Prolymphocytic leukemia T have a poor prognosis, due to a poor response to conventional chemotherapy. Treatment with the anti-CD52 monoclonal antibody: alemtuzumab has considerably improved the results, but the responses to treatment are transient; therefore, patients who obtain a response to alemtuzumab treatment are candidates for stem cell allograft (TSS) if they are eligible for this procedure. This combined approach extended the median survival to four years or more. However, new approaches using well-tolerated therapies that target signaling and survival pathways are necessary for most patients who are unable to receive intensive chemotherapy, such as JAK STAT axis inhibitors, anti-AKT, or anti BCL2 .

Main objective: Better manage prolymphocytic T leukemias.

Secondary objectives:

Molecular characterization of prolymphocytic leukemia T.
Study of the response to treatment, disease-free survival, overall survival.
Impact of prognostic factors on response to treatment, and survival.

lead_sponsor: French Innovative Leukemia Organisation

sponsor_collaborators:
French Innovative Leukemia Organisation
University Hospital, Lille

lead_sponsor_type: industriel


title: Fecal Incontinence Type Assessment Scale (FITAS): a New Tool to Distinguish Among Subgroups of Fecal Incontinence

summary:
Urge faecal incontinence (FI) and passive FI are the two subgroups of FI described by the International Continence Society. Urge FI is described as "the inability to defer defecation once the urge is perceived for long enough to reach a toilet" and passive FI as "the involuntary leakage of faeces without forewarning". If several validated questionnaires are available for FI, all of these questionnaires were developed to assess FI severity. In literature, there is only a small number of studies that investigated clinical and paraclinical characteristics of the different phenotype of FI. Moreover, there is an heterogenicity in the definitions used for both urge and passive FI among these studies. Lastly, patients with mixed FI were commonly excluded from these studies. It can be established that there is a lack of validate tools to distinguish patients between subgroups of FI.

The aim of the present study was to develop and to validate a new tool in order to investigate and classify patients among the different subgroups of FI (active, passive and mixed) defined by Rome IV criteria.

A monocentric prospective study was conducted in the Neuro-urology Department of a University Hospital. All consecutive patients presenting in the Department with FI between December 2019 and June 2020 were screened for inclusion in the present study. Criteria of inclusion were an age older than 18 years old and symptoms of FI according to Rome IV criteria. Exclusion criteria were anorectal fistula, active inflammatory bowel disease, anorectal malignant tumor not treated, rectal or hemorrhoidal prolapses and specific inability regarding the questionnaire (i.e. cognitive disorders, inability to read and to understand questions).

Phase 1: review of literature and qualitative interviews: To determine the dimensions of the different subgroups of faecal incontinence, a literature review was performed using Pubmed without date limitation until February 2020. The key words used were "active faecal incontinence", "active fecal incontinence", "passive faecal incontinence", "passive fecal incontinence", "urge faecal incontinence", "urge fecal incontinence", "questionnaire", "scale", "score" and "tool". In parallel to this literature review, semi-structured interviews were performed on 20 patients from December 2019 to February 2020. During this phase, a panel expert of 9 neuro-urologists and gastroenterologists was composed. At the term of all interviews, dimensions that were both the most used by patients and the most discriminative among subgroups of FI were included in the questionnaire. Redaction of questions was then performed by the panel expert.

Phase 2: feasibility study: The feasibility study was conducted from February to April 2020 on 30 patients. Each patient was asked to rate each version of the 2 questions with a four-point Likert scale (A: very good, B: good, C: difficult, D: very difficult) regarding acceptance and comprehension of the questions.

Phase 3: validation study: To investigate the psychometric properties of the questionnaire, a validation study was performed from April to June 2020 on 100 consecutive patients. In order to evaluate the FITAS' test reproducibility, patients were asked to answer a second time the questionnaire by mail with a second evaluation from 7 days to 10 days after the first one. The "intra-class correlation coefficient" (ICC) was used to determine if these evaluations could lead to similar results for each question. An ICC > 0.70 was necessary to define reproducibility.

lead_sponsor: Gérard Amarenco


title: Medico-economic and Quality of Life Evaluations in Obese Patients Followed by Medical Analysis Laboratories

acronym: BIOSAOS

summary: Obesity is a major risk factor for obstructive sleep apnea (OSA). However, OSA is still largely under diagnosed in patients with a high cardiovascular risk. In this population the STOP-BANG questionnaire facilitates OSA screening. Moreover, blood bicarbonate concentration is a simple tool to screen for chronic respiratory disease and if elevated, is a marker of cardiometabolic comorbidities in obese patients. A combination of blood bicarbonate concentration and STOP BANG score could provide a cost-effective method of screening for OSA in obese patients. Such screening could enable earlier management and might significantly reduce the costs of treatment and improve the quality of life of patients at 2 years.

status: Withdrawn

primary_purpose: Screening

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
University Hospital, Angers
Poitiers University Hospital
Union hospital, Toulouse
Hospital Alpes Leman, Annemasse
Hospital La Louvière, Lille
Oriade Laboratory, Vizille
Cerballiance laboratories, Lille
Oriade laboratory, Annemasse

appel_a_projets: PRME

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU GRENOBLE ALPES

type_etablissement: CH

acronyme: BIO-SAOS

titre: Evaluation médico-économique d'une stratégie de dépistage du syndrome d'apnées obstructives du sommeil (SAOS) chez l'obèse via les laboratoires de biologie médicale et les médecins traitants : Evaluation cout-utilité

discipline_principale: pneumologie

nom_porteur: Pépin

prenom_porteur: Jean-Louis


title: Insuffisance Gastro-intestinale Aiguë Translocation Microbienne Chez Les Patients en Choc Septique : Une étude Pilote

acronym: IGA-TM

summary:
The hypothesis of the investigators is that patients with septic shock in ICU have acute intestinal insufficiency favoring subclinical microbial translocation, which is the consequence of alterations of the epithelium, and is accompanied by qualitative and quantitative changes in the gut microbiota.

The primary objective is to determine the incidence of microbial translocation by measuring 16S rDNA and 18S rDNA plasma levels in a patient population with septic shock.

Secondary objectives are:

Describe the kinetics of markers of intestinal insufficiency (I-FABP / zonulin) over time (at admission, 12 hours after admission, one day, two day, three days and seven day after admission).
Study the correlation between the titer of I-FABP, zonulin, 16srDNA, 18srDNA and the stages of acute gastrointestinal insufficiency (AGF).
Establish correlations between the microorganisms of the intestinal microbiota and the bacteria involved in microbial translocation.
Study the possible correlations between the 16SrDNA levels and the other bacterial markers (sCD14, LBP).
Describe the evolution of the composition and the diversity of the gut microbiota in the first 7 days of septic shock

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Impact of the Combination of Pressure Support and Positive End Expiratory Pressure During Spontaneous Breathing Trial Versus T-piece on the Time to Successful Extubation

acronym: SBT-ICU

summary: The aim of this study is to assess if a bundle associating pressure support and positive end-expiratory pressure during spontaneous breathing trial and detection by T-piece of patients with high-risk of extubation failure can reduce the time to successful extubation in critically ill patients.

lead_sponsor: Hospices Civils de Lyon


title: Evolution of Food Orality in Children Aged Between 24 and 36 Months: Comparison of the Severity and Specificities of Disorders Between Two Populations of Children, Born Very Prematurely and Born at Term

acronym: EvOral

summary:
Oral disorders are currently widely described in the premature birth population, but few studies compare them to their prevalence in the full-term population.

In addition, new behaviours and eating habits are regularly emerging in our society.

The objective of this study is to compare the severity of signs of oral disorders between the group of preterm infants and the group of term infants born without organic pathologies that compromise oral development.

sponsor_collaborators: Centre Hospitalier Universitaire de Nice


title: Placental Insufficiency Microcirculation Quantification by Ultrafast Doppler: an Observational Prospective Study

summary:
To identify fetuses small for their gestational-age who have reached their appropriate growth potential from growth-restricted fetuses due to placental insufficiency is uneasy. Intra Uterine Growth Restriction (IUGR) increases the risk for indicated preterm delivery, neonatal mortality and morbidity. Therefore, improving the knowledge of the placental perfusion is essential to better identify and manage fetal chronic oxygen deprivation associated with placental insufficiency. Thus, the investigators propose to study placental microcirculation with a more efficient Doppler than conventional Doppler use in clinical practice. The Ultrafast Doppler is being able to map placental blood flow and could have potential impact in placental insufficiency diagnosis and prevention. Moreover, this Doppler could discriminate maternal and fetal vascularization.

The hypothesis is that Ultrafast Doppler could help clinician to diagnose and manage preeclampsia and IUGR during pregnancy.

lead_sponsor: Nantes University Hospital


title: Identification of New Candidate Genes in Patients With Mitochondrial Disease by High Resolution Chromosome Analysis on DNA Chip

acronym: ACPA HR

summary:
Mitochondrial diseases are complex diseases with great clinical and genetic heterogeneity and their diagnosis is difficult.

The Medical Genetics Department includes among its activities the diagnosis of these diseases. It has been a reference centre for mitochondrial diseases at the national level since 2006 and was recently approved under the call for projects "European Reference Network (ERN) for rare diseases", EURO-NMD, supported by the Nice University Hospital. The routine diagnostic strategy is based on high throughput mitochondrial DNA (mtDNA) sequencing analysis and a panel of 281 targeted "mitochondriopathies" genes. When these analyses are negative, an exome analysis (high throughput sequencing of all exons in the genome) can be performed in a research setting. To date, about 40% of the patients analysed remain without genetic diagnosis. Indeed, it does not allow to identify large variations of deletion, duplication or CNV (copy number variation) type. Moreover, targeting only exons, exome sequencing does not allow the detection of intronic or localized mutations in regulatory regions.

The identification of CNVs is made possible by chromosomal analysis on a DNA chip (CADC). This recognized technique is used routinely in the laboratory. The investigators use chips with a minimum resolution of approximately 13Kb for the genome-wide study of CNVs in patients with developmental disorders. However, this resolution is insufficient to detect rework events of the order of magnitude of an exon. There are high-resolution DNA chips, compatible with our platform, that would allow the investigators to more accurately visualize smaller rearrangements that could not be identified by exome analysis. The combined exome/CADC strategy has already proven its effectiveness in diagnosing various diseases by increasing yield.

In this context, the investigators aim to use this strategy in this non-interventional study on a series of 15 patients with mitochondrial disease who remain undiagnosed after analysis of mtDNA, gene panel and exome. They will test 2 types of patients:

In the first series, whose disease is supposed to be transmitted in an autosomal recessive mode, only one heterozygous variant was identified in a gene already described in a comparable clinical picture. It is therefore possible that these patients are carriers on the second allele of a CNV, which the exome sequencing could not identify.
In the second series, the exome analysis did not allow the identification of a single responsible gene (several candidate genes without any certainty on the pathogenicity of the gene(s) or variant(s))


title: Plantar Fasciitis Treatment: Double Blinded Randomized Control Study of the Efficacy of an Injection of Platelet Rich Plasma (PRP) Versus an Infiltration of Corticosteroids

acronym: APOPLANT

summary:
Plantar fasciitis is a common pathology among podiatry moreover the healing time takes several months.

The main aim of this study is to evaluate the efficacy of a injection of Platelet-Rich Plasma (PRP) versus corticosteroid injection.

ReferenceCitation: Breton A, Leplat C, Picot MC, Aouinti S, Taourel P, Laffont I, Julia M, Cyteval C. Prediction of clinical response to corticosteroid or platelet-rich plasma injection in plantar fasciitis with MRI: A prospective, randomized, double-blinded study. Diagn Interv Imaging. 2022 Apr;103(4):217-224. doi: 10.1016/j.diii.2021.10.008. Epub 2021 Nov 26.

oa_host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

publisher_dissemination: Elsevier


title: Descriptive Pilot Study of Brain MRI Imaging in Patients With SARS-Cov2 (COVID-19) Infection With or Without Anosmia

acronym: ANOSIRM

summary: To date there is no brain imaging and olfactory data available in COVID-19 positive patients with anosmia. By describing the pathophysiological characteristics underlying the olfactory symptoms and clinical characteristics of COVID-19 infection, the study investigators wish to compare the MRI aspects obtained in COVID-19 patients with and without anosmia, in the absence of other underlying neurological disorders.

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes


title: Surveillance fœtale assistée Par Ordinateur - Obstétrique

acronym: SURFAO-Obst

summary:
In the context of fetal heart monitoring, the SurFAO project offers an alternative to current clinical routines. The challenge is to extract, from few non-invasive sensors on the maternal abdomen, a fetal electrocardiogram (ECGf) of great quality allowing a clinical diagnosis (follow-up of the FHR (fetal heart rate)) and extraction of ECG waveforms).

The proposed approach proposes a technological breakthrough shared by a consortium of researchers and clinicians. The originality is driven by innovative methodological choices: the use of a multimodal system (ECG coupling with PCG (phonocardiographic)) for the signal acquisition in order to increase the robustness of information extraction, by taking into account clinical uses and the need for the monitoring process support, and by setting up a reference for this multimodal database.

The objective is to feed a database that will be used in the future to develop ECGf extraction methods estimating the FHR.

ReferenceCitation: Equy V, Buisson S, Heinen M, Schaal J-P, Hoffmann P, Sergent F. Confusion between maternal and fetal heart rate during delivery: risk factors and consequences British Journal of Midwifery, vol.20 (11), 2012

ReferenceCitation: Gobillot S, Fontecave-Jallon J, Equy V, Rivet B, Gumery PY, Hoffmann P. Non-invasive fetal monitoring using electrocardiography and phonocardiography: A preliminary study. J Gynecol Obstet Hum Reprod. 2018 Nov;47(9):455-459. doi: 10.1016/j.jogoh.2018.08.009. Epub 2018 Aug 23.

ReferenceCitation: Noorzadeh S, Rivet B, Gumery PY. An application of Gaussian processes on ocular artifact removal from EEG. Annu Int Conf IEEE Eng Med Biol Soc. 2015 Aug;2015:554-7. doi: 10.1109/EMBC.2015.7318422.

oa_host_type: repository

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

repositories_concat: HAL

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

unpaywall_oa_status: green

publisher_dissemination: IEEE

ReferenceCitation: Noorzadeh S, Niknazar M, Rivet B, Fontecave-Jallon J, Gumery PY, Jutten C. Modeling quasi-periodic signals by a non-parametric model: application on fetal ECG extraction. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:1889-92. doi: 10.1109/EMBC.2014.6943979.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

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

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

ReferenceCitation: Noorzadeh S, Rivet B, Guméry PY. A multi-modal approach using a non-parametric model to extract fetal ECG. Proc. IEEE Int. Conf. Acoustics, Speech, and Signal Processing (ICASSP), Brisbane, Australia, 2015, pp. 1856-60

collaborators: Clinical Investigation Centre for Innovative Technology Network


title: Benefits of Observing Point-light Displays in Postoperative Rehabilitation of the Total Knee Prosthesis.

acronym: LOARAL

summary: The LOARAL project concerns patients who have undergone total knee arthroplasty to treat symptomatic osteoarthritis. Patient will be divided into two groups: a control group where patients will do standard rehabilitation and an experimental group where patients will do standard rehabilitation associated with the judgement of point-light display. The aim of this study is to validate the use of point-light display for the Rehabilitation of patients with a totalarthroplasty of the knee.

lead_sponsor: Poitiers University Hospital


title: Monitoring Drug-induced Myocarditis

acronym: CardiTOX

summary: Several drugs and chemotherapies seem to induce myocarditis. This study investigates reports of myocarditis, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

time_perspective: Cross-Sectional

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM


title: Reorganization of the Healthcare System During COVID-19 Pandemic: Impact on Management of Patients With Exocrine Pancreatic Cancer

summary:
Pancreatic adenocarcinoma will be the 2nd cause of death by cancer in Europe in 2030. Pancreatic adenocarcinoma has poor prognosis with an all-stages combined 5-year survival rate below 8%.

Since December 2019, a new coronavirus (Severe Acute Respiratory Syndrome Corona Virus 2, SARS-CoV-2) is responsible of COVID-19 infection with potentially severe respiratory syndrome or even multi-organ failure. An increased risk of severe COVID-19 infection in cancer patients is suggested in several Chinese series. Cancer care structures quickly reorganized to limit high-risk situations (diagnostic procedure, major surgery, cytotoxic poly-chemotherapy) and use alternatives such as on-hold chemotherapy. These reorganizations could be associated with a loss of chance for pancreatic adenocarcinoma.

ReferenceCitation: Brugel M, Letrillart L, Evrard C, Thierry A, Tougeron D, El Amrani M, Piessen G, Truant S, Turpin A, d'Engremont C, Roth G, Hautefeuille V, Regimbeau JM, Williet N, Schwarz L, Di Fiore F, Borg C, Doussot A, Lambert A, Moulin V, Trelohan H, Bolliet M, Topolscki A, Ayav A, Lopez A, Botsen D, Piardi T, Carlier C, Bouche O. Impact of the COVID-19 pandemic on disease stage and treatment for patients with pancreatic adenocarcinoma: A French comprehensive multicentre ambispective observational cohort study (CAPANCOVID). Eur J Cancer. 2022 May;166:8-20. doi: 10.1016/j.ejca.2022.01.040. Epub 2022 Feb 10.

oa_colors: green other

evidence: open (via free pdf)

evidence: open (via crossref license, author manuscript)

version: acceptedVersion

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

repositories:
LillOA (Lille Open Archive)
PubMed Central

repositories_concat: LillOA (Lille Open Archive);PubMed Central

lead_sponsor: CHU de Reims


title: Psychological Impact of the Health Measures Generated by the SarsCov-2 Pandemic in Adolescents (COVADO)

acronym: COVADO

summary: The lockdown of the French population is a health measure put in place in response to the pandemic linked to a new coronavirus, SARS-CoV-2 (Covid-19). After a health campaign to recommend hygienic "barrier gestures" and social distancing, the decision to confine the population at the national level was decided by the executive from Monday 16 March to Monday 11 May 2020. The national confinement implies the restriction of movement to the strict necessary, outings near the home and the closure of schools and communities. These decisions have led to an unprecedented state of stress for the entire French population, the consequences of which are unknown in the short, medium or long term. The objectives of this study are to evaluate the psychological impact of the confinement on adolescents with or without chronic disease and also the difficulties and fears engendered by deconfinement .

lead_sponsor: Centre Hospitalier Intercommunal Creteil


title: Confinement Effect on Low Back Pain Intensity in Chronic Low Back Pain Patients

acronym: CONFI-LOMB

summary:
The current situation, linked to the pandemic of the new coronavirus SARS-CoV-2 generates health concerns, but is also accompanied by many other psychological, social, economic, professional, etc. consequences as well as numerous changes in behavior and lifestyles, notably due to confinement.

While the prevention of chronic low back pain and its management are primarily based on the practice of regular physical and sports activity, other psychological factors (stress, anxiety, depression), socioeconomic (low level of education, resources), professionals (physical workload, job dissatisfaction), etc. also have a major role in the onset and the persitence of low back pain.

Thus, it is to be supposed that the current context, and more particularly the confinement to which the population has been constrained for almost 2 months, have and will have notable consequences on the evolution of lumbar symptoms in chronic low back pain patients. However, the entanglement of different factors related to containment will potentially have different consequences depending on the individual. It therefore seems difficult to predict how the lumbar symptoms will develop in this population. Indeed, if it can imagined that the decrease in regular physical activity and the increase in anxiety in this context of insecurity could lead to an increase in pain, it could just as well consider that the decrease in stress work, strenuous physical work or travel time from work to home can, on the contrary, have a favorable effect.

The objective of this study is to assess the confinement effect on low back pain intensity in chronic low back pain patients.

This is an observational, descriptive, transversal and pluricentric study conducted by a single questionnaire.

lead_sponsor: University Hospital, Angers


title: Preliminary Study to Evaluate the Effect of an EEG-proprioceptive Neurofeedback on Cortical Excitability and Motor Function of the Upper Limb After Stroke

acronym: HANDS

summary: Interventional study with minimal risks and constraints, prospective, monocentric.

ReferenceCitation: Le Franc S, Bonan I, Fleury M, Butet S, Barillot C, Lecuyer A, Cogne M. Visual feedback improves movement illusions induced by tendon vibration after chronic stroke. J Neuroeng Rehabil. 2021 Oct 30;18(1):156. doi: 10.1186/s12984-021-00948-7.

repository_institution: PubMed Central - Europe PMC

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

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

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

lead_sponsor: Rennes University Hospital


title: Assessment of Thrombus Stiffness Using Ultrasound Elastography in Venous Thrombo-embolism.

acronym: TEVTE

summary:
Venous Thrombo-Embolic Disease (VTED) is a serious and common ailment, defined by the growth of a clot - or thrombus - in a vein, and/or as the migration of this thrombus to a pulmonary artery. It represents the third cause of death after cardio-vascular disease and cancer, and encompass superficial, muscular and Deep Venous Thrombosis (DVT), and Pulmonary Embolisms (PE), which can be isolated or associated.

Ultrasound is today the most frequently used exam to diagnose DVT. However, it's unable to provide information on thrombus age or cause.

Elastography is an imaging technic which aims to analyse elastic properties of a tissue, by applying a mechanical impulse on it, and could be an interesting tool in thrombus exploration, and provide additional information.

ipd_sharing_description: All collected data that underlie results in a publication


title: Assessment of the Relations Between Endothelial and Venous Dysfunctions and Left Ventricular Obstruction in Genetic Hypertrophic Cardiomyopathies

acronym: HCM-Vein

summary:
Left ventricular obstruction is an invalidating complication of hypertrophic cardiomyopathies (HCM), and endothelial dysfunction has also been observed in these pathologies. However, the relation between obstruction and endothelial and venous dysfunctions has not been previously studied.

The main objective is to investigate the relations between endothelial and venous dysfunctions and symptomatic left ventricular outflow-tract obstruction in HCM patients.

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
Fédération Française de Cardiologie
Fondation Bordeaux Université
Amicus Therapeutics


type: EudraCT Number

title: Hydrocortisone and Fludrocortisone for Critical Illness-related Corticosteroid Insufficiency

acronym: HORNbILL

summary: The study aims at assessing the efficacy and the safety of hydrocortisone combined with fludrocortisone compared to placebo in ICU adults with critical illness related corticosteroid insufficiency.

ReferenceCitation: Annane D, Pastores SM, Rochwerg B, Arlt W, Balk RA, Beishuizen A, Briegel J, Carcillo J, Christ-Crain M, Cooper MS, Marik PE, Umberto Meduri G, Olsen KM, Rodgers S, Russell JA, Van den Berghe G. Guidelines for the diagnosis and management of critical illness-related corticosteroid insufficiency (CIRCI) in critically ill patients (Part I): Society of Critical Care Medicine (SCCM) and European Society of Intensive Care Medicine (ESICM) 2017. Intensive Care Med. 2017 Dec;43(12):1751-1763. doi: 10.1007/s00134-017-4919-5. Epub 2017 Sep 21. Erratum In: Intensive Care Med. 2018 Feb 23;:

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

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: General Intensive care Unit, Raymond Poincaré Hospital, APHP

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: HORNbILL

titre: Association de l'hydrocortisone et de la fludrocortisone dans le traitement de l'insuffisance corticosteroïdienne associée aux états critiques, à l'exclusion des chocs septiques.

discipline_principale: anesthésiologie / réanimation

nom_porteur: HEMING

prenom_porteur: Nicholas


title: Localizing in the Brain the Areas of Time to Contact Perception During an Awake Surgery

acronym: BRAIN-TIME

summary: During a brain surgery targeted to remove a brain tumor, the neurosurgeon wakes up the patient to delimit the tumor area exactly, and identify the surrounding areas, to limit the surgery damages. The present project aims at testing the patient in this awake phase to determine the brain areas implied in time to contact (TTC) perception, a function that allows determining the arrival time of moving objects and used in many tasks of our daily life.

lead_sponsor: University Hospital, Toulouse


title: Evaluation of Efficacy and Tolerance of Fludrocortisone (Flucortac) in the Treatment of Orthostatic Neurogenic Hypotension

summary: To evaluate the efficacy of a 4-week fludrocortisone (FLU) treatment on systolic blood pressure depression after 5 minutes of active orthostatism in patients with neurogenic orthostatic hypotension (HON) symptomatic, despite treatment with non-drug measures with or without midodrine.

lead_sponsor: H.A.C. PHARMA


title: "STUDY OF THE EFFICIENCY OF NORMAL HUMAN IMMUNOGLOBULINS (IVIG) IN PATIENTS AGED 75 YEARS AND OVER COVID-19 WITH SEVERE ACUTE RESPIRATORY FAILURE" GERONIMO 19

acronym: GERONIMO 19

summary:
According to recent data, death rate is more than 20% for 75 years old hospitalized patients and older.

In case of aggravation, according to the latest observations, if they are refused for mechanical ventilation in intensive care, their death rate could reach 60% even for patients without comorbidity.

Apart from an increase in oxygen therapy, no specific treatment is currently proposed.

The control of the inflammatory component seems to be a key element to be able to influence the patients' health evolution.

Polyvalent intravenous immunoglobilins have immunomodulatory and anti-inflammatory properties with a favorable safety profile for these elderly patients and several clinical cases lead to positive impact in the caring for Covid patients.

This study objective is evaluation of the efficacy of polyvalent IVIg in combination with the standard management of patients aged 75 and over with SARSCov2 infection with acute respiratory failure (saturation ≤ 95%) requiring oxygen therapy> 5 L / min (i.e. patients considered as moderate to severe ARDS according to the Berlin definition, Pa02 / Fi02≤200) and disqualified from a care in the ICU.

lead_sponsor: Versailles Hospital


title: Bi-daily Injection of Subcutaneous Teriparatide in Children With Hypoparathyroidism: Single-center Experience

acronym: FOR-HYPO

summary:
Pediatric hypoparathyroidism is an orphan disease. Conventional management combines native and active vitamin D, calcium supplementation and sometimes phosphate binders, with the risk of long term hypercalciuria, nephrocalcinosis and further renal impairment. The use of teriparatide has been reported in adults (daily or bi-daily subcutaneous infusions) and in children (rather continuous subcutaneous infusion) as second-line therapy.

The objective of this study is to obtain efficacy and safety data on the use of teriparatide in children with hypoparathyroidism to improve our knowledge of their management.

location_facility: Service de Néphrologie, Rhumatologie et Dermatologie Pédiatriques - Hôpital Femme Mère Enfant


title: Observational Study in Diagnosed Patients Covid-19, Supported on an Outpatient Basis.

acronym: COVID-PSL

summary:
COVID-19 is an infection linked to a new coronavirus: SARS-CoV-2, which appeared in Wuhan in China at the end of 2019, and which has since spread around the world, responsible for a new major pandemic, which is upsetting the whole world.

If severe respiratory disease is the form that constitutes the extreme gravity of the disease (mortality, with more than 170,000 deaths worldwide to date).

However, there is a great heterogeneity of clinical forms with asymptomatic or symptomatic pauci forms, moderate forms, up to severe forms.

Different symptoms may appear: fever, cough, asthenia, dyspnea, gastrointestinal forms, anosmia and / or ageusia, skin involvement, etc.

Given the novelty of this infection, several questions remain:

What are all the symptoms that can be contracted by a COVID-19 patient?
Are there clinical forms not described?
What is the evolutionary profile, the healing time of this disease in patients treated on an outpatient basis?
What are the factors associated with a prolonged form of COVID-19 disease, including on an outpatient basis?

lead_sponsor: Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida


title: Pulmonary Vascular Impairment in Chronic Obstructive Pulmonary Disease (COPD) Assessed by MRI

acronym: PulmoVasc

summary:
Chronic Obstructive Pulmonary Disease (COPD) is a highly prevalent pulmonary disease providing major morbidity and mortality. Bronchial obstruction is the cornerstone in assessment of the disease whereas associated pulmonary vascular disease remains poorly known.

Improving knowledge on pulmonary vascular adaptive skills in COPD patients could allow for better understanding disease exacerbations, evolution towards chronic pulmonary hypertension (PH) and therapeutics to be offered to the patients.

Magnetic resonance imaging (MRI) is an innovative and non-invasive tool capable of pulmonary vascular evaluation. This work aims at identifying pulmonary vascular impairment in COPD patients using functional MRI.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille


title: Survey of Cannabis Use in Patients With Chronic Inflammatory Arthritis

acronym: CannabisRIC

summary:
Patients with inflammatory rheumatism very often have residual pain that is not easily relieved by conventional treatments. They can then use non-drug methods, such as physiotherapy, hypnosis or even cannabis.

The aim of this study is to assess the percentage of patients who use cannabis to better relieve their pain or anxiety in chronic inflammatory rheumatism.

time_perspective: Other

lead_sponsor: University Hospital, Clermont-Ferrand


title: Evaluation of the Impact of Transit Troubles in Patients Undergoing Peritoneal

acronym: TransDiPe

summary:
Patients with Terminal Chronic Kidney Disease undergoing Peritoneal Dialysis (PD) often have pathophysiological factors that promote chronic constipation. It affects the quality of life of Patients undergoing PD in a much greater way than for hemodialysis patients because it causes complications, mechanical and infectious associated with the transmural migration of enteral bacteria, with an impact on patient morbidity and survival of the technique. In addition, it should be noted that PD patients often take potentially constipants treatments such as phosphorus chelators, calcium inhibitors, opiates, iron preparation and antidepressants. Taking these drugs decreases gastric acidity, which is associated with an increased prevalence of peritonitis.

In this context, a significant lack of literature, specifically studying the risk factors for constipation in Terminal Chronic Kidney Disease patients treated with DP and the correlation with mechanical and infectious complications, is improvable.

ipd_sharing_description:
Source documents defined as any original document or object to prove the existence or accuracy of a data or fact recorded during the clinical study will be kept for 15 years by the Hospital Center; this is the hospital medical record, original results of the patient's biological examinations.

The protocol data that will be collected in the observation book and which will be considered source data can be found in the attached observation book.

Source data will be collected by the service's investigators and nurses; It will be collected in the CRF by investigators.

The data will then be entered into the Excel database by the clinical research officer and a team member (investigator, intern or IDE) for a double entry.

During or after the research, data collected on the appropriate individuals and transmitted to the sponsor by investigators will be anonymized.

lead_sponsor: Centre Hospitalier de Vichy

sponsor_collaborators:
Centre Hospitalier de Vichy
University Hospital, Clermont-Ferrand