title: Multi-family Therapy and School Refusal: an Exploratory Study With Adolescents and Their Families

acronym: Multi-Fast

summary: The purpose of this study is to determine whether multi-family therapy is effective in the treatment of school refusal with anxiety in adolescence.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Maison de Solenn Maison des Adolescents, Cochin Hospital


title: Esophageal Stent With or Without Anti-migration Device for Tumors of the Gastroesophageal Junction: Multicenter Randomized Controlled Study. ANTIMIG Study

acronym: ANTIMIG

summary: The aim of this prospective, controlled, randomized, multicentre, single-blind study is to compare the rate of intragastric migration of 2 types of esophageal stents with and without an anti-migration device placed for locally advanced or metastatic malignant stenosis of the gastroesophageal junction.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Société Française d'Endoscopie Digestive

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Access to Parenthood and Gynecological Follow-up After Organ Transplantation

acronym: FerGyTransplan

summary: Solid organ transplants affect subjects of all ages, including young women of childbearing age. The improvement in the management of young female transplant patients makes it possible to consider pregnancies, about which the literature reports reassuring data on small series. The question of gynecological follow-up, access to parenthood, as well as the information and experience of patients regarding these issues after transplantation have thus become topical issues.

study_start_date_type: Actual

status: Recruiting

primary_purpose: Other

lead_sponsor: Hopital Foch

intervention_type: Other

lead_sponsor_type: academique


type: Other Identifier

title: Etude de l'activité cérébrale Sous-jacente Aux mécanismes prédictifs Lors de la Perception de scènes Visuelles

acronym: PREPER

summary: This study aims to clarify the mechanisms by which the predictions we have about our visual environment influence the processing of expected or unexpected visual stimuli at the cerebral level.

primary_purpose: Basic Science

lead_sponsor: University Hospital, Grenoble


title: Cardiac Resynchronization Under Electroanatomical Guidance After Failure of Primary Implantation: CRT3D Study

summary: The purpose of the study is to assess the feasibility of cardiac resynchronization under electroanatomic guidance in the event of primary implantation failure due to catheterization failure or instability in the coronary sinus ostium

ipd_sharing: No

lead_sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

intervention_type: Procedure


title: Evaluation of the Impact of Laterality on Cerebral Activation During a Motor Task of the Upper Limb Using fNIRS Technology in Healthy Subjects

acronym: Lateralinirs

summary: The aim of this study is to investigate the differences in brain activation in healthy subjects during motor tasks, depending on the laterality of the subject, the laterality of the task and the complexity of the task. It seems that the laterality of activation is less marked in left-handed people, when using the non-dominant hand and when performing a complex task. The objective of this study is to highlight profiles of subject and modality of use of the hand with a specific lateralization of cerebral activation.

ReferenceType: background

ReferenceCitation: Bartur G, Pratt H, Dickstein R, Frenkel-Toledo S, Geva A, Soroker N. Electrophysiological manifestations of mirror visual feedback during manual movement. Brain Res. 2015 May 5;1606:113-24. doi: 10.1016/j.brainres.2015.02.029. Epub 2015 Feb 23.

ReferenceCitation: Bondi D, Prete G, Malatesta G, Robazza C. Laterality in Children: Evidence for Task-Dependent Lateralization of Motor Functions. Int J Environ Res Public Health. 2020 Sep 15;17(18). pii: E6705. doi: 10.3390/ijerph17186705.

ReferenceCitation: Harris JE, Eng JJ. Individuals with the dominant hand affected following stroke demonstrate less impairment than those with the nondominant hand affected. Neurorehabil Neural Repair. 2006 Sep;20(3):380-9.

ReferenceCitation: Lüdemann-Podubecká J, Bösl K, Theilig S, Wiederer R, Nowak DA. The Effectiveness of 1 Hz rTMS Over the Primary Motor Area of the Unaffected Hemisphere to Improve Hand Function After Stroke Depends on Hemispheric Dominance. Brain Stimul. 2015 Jul-Aug;8(4):823-30. doi: 10.1016/j.brs.2015.02.004. Epub 2015 Mar 16.

ReferenceCitation: Duboc V, Dufourcq P, Blader P, Roussigné M. Asymmetry of the Brain: Development and Implications. Annu Rev Genet. 2015;49:647-72. doi: 10.1146/annurev-genet-112414-055322. Epub 2015 Oct 6. Review.

ReferenceCitation: Grabowska A, Gut M, Binder M, Forsberg L, Rymarczyk K, Urbanik A. Switching handedness: fMRI study of hand motor control in right-handers, left-handers and converted left-handers. Acta Neurobiol Exp (Wars). 2012;72(4):439-51.

ReferenceCitation: Jin SH, Lee SH, Yang ST, An J. Hemispheric asymmetry in hand preference of right-handers for passive vibrotactile perception: an fNIRS study. Sci Rep. 2020 Aug 7;10(1):13423. doi: 10.1038/s41598-020-70496-y.

ReferenceCitation: Kim SG, Ashe J, Hendrich K, Ellermann JM, Merkle H, Uğurbil K, Georgopoulos AP. Functional magnetic resonance imaging of motor cortex: hemispheric asymmetry and handedness. Science. 1993 Jul 30;261(5121):615-7.

ReferenceCitation: Lee SH, Jin SH, An J. The difference in cortical activation pattern for complex motor skills: A functional near- infrared spectroscopy study. Sci Rep. 2019 Oct 1;9(1):14066. doi: 10.1038/s41598-019-50644-9.

ReferenceCitation: Oldfield RC. The assessment and analysis of handedness: the Edinburgh inventory. Neuropsychologia. 1971 Mar;9(1):97-113.

ReferenceCitation: O'Regan L, Serrien DJ. Individual Differences and Hemispheric Asymmetries for Language and Spatial Attention. Front Hum Neurosci. 2018 Oct 4;12:380. doi: 10.3389/fnhum.2018.00380. eCollection 2018.

ReferenceCitation: Solodkin A, Hlustik P, Noll DC, Small SL. Lateralization of motor circuits and handedness during finger movements. Eur J Neurol. 2001 Sep;8(5):425-34.

ReferenceCitation: Vingerhoets G, Acke F, Alderweireldt AS, Nys J, Vandemaele P, Achten E. Cerebral lateralization of praxis in right- and left-handedness: same pattern, different strength. Hum Brain Mapp. 2012 Apr;33(4):763-77. doi: 10.1002/hbm.21247. Epub 2011 Apr 15.

lead_sponsor: Centre Hospitalier Régional d'Orléans

intervention_type: Behavioral


title: Physiological Study of the Critical Closing Airway Pressure in a Population of Didgeridoo Players

acronym: SASDICrit

summary: Obstructive sleep apnea is characterised by an abnormal upper airway collapsibility. Upper airway collapsibility can be evaluated through critical closure airway pressure (Pcrit). Didgeridoo is a traditional australian musical instrument involving circular respiration, a breathing technique involving mouth muscles. We hypothesize that didgeridoo players have a lower risk of airway collapsibility due to circular breathing technique

design_allocation: Non-Randomized

ipd_sharing: Undecided


title: Development of a Predictive Algorithm for a Hemoglobin Value of Less Than 10 g/dl Postoperatively in Scheduled Hip or Knee Arthroplasty

summary: Hip (THR) or knee (KT) prosthetic surgery is a bleeding surgery with an average blood spoliation of about 1 liter and an average decrease of about 3 g/dl in hemoglobinemia (Hb). Consequently, anemia is observed postoperatively in almost all patients (between 85% and 99% depending on the preoperative Hb value). In all cases, anemia-related events delay the patient's recovery, favor the occurrence of complications and prolong the length of stay. The immediate treatment of acute postoperative anemia is based on transfusion of red blood cells (RBCs). However, this presents several risks for the patient. The first is immediate and associated with the procedure: risk of error with ABO/Rhesus incompatibility, sepsis, pulmonary edema, etc. The second is a medium-term risk, with an increased risk of infection after prosthetic hip or knee surgery. In the long term, immediate postoperative blood transfusion is associated with higher mortality. In order to reduce the likelihood of a patient receiving RGCs, strategies have been developed within a "Patient Blood Management" (PBM), which could be translated as "Personalized Blood Transfusion Management". This strategy is based on 3 pillars: preoperatively, to ensure a patient's hemoglobin level of at least 13 g/dl; during the procedure, to limit blood loss; and postoperatively, to limit the indications for blood transfusion and the number of RGCs to the strict necessary. As the main determinant to trigger the prescription of a blood transfusion is the Hb value, the objective is that the lowest value of hemoglobinemia (Hb_nadir) postoperatively is as close as possible to 10 g/dl. The objective of this study is to describe, by means of the data available in the computerized patient record of patients undergoing scheduled THR or PTG operations at the Paris Saint Joseph Hospital, a prediction equation for Hb_nadir < 10 g/dl and, thus, to prescribe iron and ESAs only in patients who require them.

status: Active, not recruiting

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ReferenceCitation: Spahn DR. Anemia and patient blood management in hip and knee surgery: a systematic review of the literature. Anesthesiology. 2010 Aug;113(2):482-95. doi: 10.1097/ALN.0b013e3181e08e97. Review.

ReferenceCitation: Lasocki S, Krauspe R, von Heymann C, Mezzacasa A, Chainey S, Spahn DR. PREPARE: the prevalence of perioperative anaemia and need for patient blood management in elective orthopaedic surgery: a multicentre, observational study. Eur J Anaesthesiol. 2015 Mar;32(3):160-7. doi: 10.1097/EJA.0000000000000202.

ReferenceCitation: Kim JL, Park JH, Han SB, Cho IY, Jang KM. Allogeneic Blood Transfusion Is a Significant Risk Factor for Surgical-Site Infection Following Total Hip and Knee Arthroplasty: A Meta-Analysis. J Arthroplasty. 2017 Jan;32(1):320-325. doi: 10.1016/j.arth.2016.08.026. Epub 2016 Aug 31. Review.

ReferenceCitation: Smilowitz NR, Oberweis BS, Nukala S, Rosenberg A, Zhao S, Xu J, Stuchin S, Iorio R, Errico T, Radford MJ, Berger JS. Association Between Anemia, Bleeding, and Transfusion with Long-term Mortality Following Noncardiac Surgery. Am J Med. 2016 Mar;129(3):315-23.e2. doi: 10.1016/j.amjmed.2015.10.012. Epub 2015 Oct 30.

ReferenceCitation: Roque-Castellano C, Marchena-Gómez J, Fariña-Castro R, Acosta-Mérida MA, Armas-Ojeda MD, Sánchez-Guédez MI. Perioperative Blood Transfusion is Associated with an Increased Mortality in Older Surgical Patients. World J Surg. 2016 Aug;40(8):1795-801. doi: 10.1007/s00268-016-3521-2.

ReferenceCitation: Jans Ø, Jørgensen C, Kehlet H, Johansson PI; Lundbeck Foundation Centre for Fast-track Hip and Knee Replacement Collaborative Group. Role of preoperative anemia for risk of transfusion and postoperative morbidity in fast-track hip and knee arthroplasty. Transfusion. 2014 Mar;54(3):717-26. doi: 10.1111/trf.12332. Epub 2013 Jul 5.

lead_sponsor: Groupe Hospitalier Paris Saint Joseph


title: Effectiveness of a One-day Psychoeducation Program on Internalized Stigmatization for Borderline Personality Disorder (BPD) Patients

acronym: EDUC-BPD

summary: Education day on borderline personality disorder (BPD), including a transmission of current scientific knowledge on the disease. A dimensional understanding of BPD is delivered as well as disidentification of oneself to the symptoms of borderline personality disorder (Ducasse 2020 Eur Arch Psychiatry Clin Neurosci). The main objective is to evaluate the impact of borderline education day on self-stigma.

status: Completed

study_completion_date_type: Actual

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

status_simplified: Completed


title: Cognitive, Emotional, Physiological, Chronobiological and Genetic Effects of a Time Underground Isolation

acronym: DEEPTIME

summary: The objectives of this scientific expedition are: a/ Evaluation of temporal cognitive perception and collective synchronization in a temporally anomalous universe (underground environment), b/ Influence of group living on the endogenous circadian rhythmicity of the central biological clock and peripheral clocks in a "free-running" situation (absence of light/natural darkness), c/Evaluation of cognitive and physiological performance in response to exposure to an extreme environment in a natural underground cavity (cave) without access to a time indicator for 40 days, d/Correlation of cognitive, behavioral, psychological, social, neurophysiological and physiological parameters, e/ Determination of adaptation or maladaptation criteria (biological, genetic, physiological, neurophysiological, psychological and cognitive) in an isolation environment (underground) f/ Study of the evolution of collective organization, decision making and leadership in an extreme isolation and management situation.

lead_sponsor: University Hospital, Caen


title: Acceptability of Advanced Chronic Liver Disease Screening by Transient Elstography (Fibroscan ®) in Patients Hospitalised in Psychiatric Unit: a Single Center Prospective Study

acronym: HEPSY

summary:
Scares data exists concerning the prevalence of chronic liver diseases in people with psychiatric disorders.

There are still many barriers to screening and linkage to care for patients having somatic illness.

Moreover follow-up of these patients may be difficult because of poor access to care, sometimes marginalization, and insufficient compliance with health programs.

The aim of this study is to asses acceptability of of advanced chronic liver disease screening by transient elstography (Fibroscan ®) in patients hospitalised in a psychiatric unit.

primary_purpose: Prevention

intervention_type: Diagnostic Test


title: Impact of the Experience of Anaesthetists in Changing Ventilation Strategies During Panendoscopy on the Incidence of Intraoperative Hypoxaemia

summary:
High Flow Nasal Oxygen Therapy (HFNO) is a new oxygenation tool that is becoming increasingly widespread in perioperative anaesthesia. The benefits of this oxygenation tool are based on different physiological principles. These include the reduction of dead space by "flushing" the nasopharyngeal cavities, positive airway pressure and the warming and humidification of inspired air. In addition, the high flow rates used ensure that the patient's inspiratory demand is covered, allowing for the delivery of oxygen-enriched and controlled air. It is simple to use, with the only parameters to be set being gas flow and FiO2. The use of HFNO appears to allow a prolongation of apnoea time without desaturation in apneic ventilation.

Mainly studied in ENT surgery because of the interest that this oxygenation strategy presents with the absence of recourse to oro-tracheal intubation (OTI), several authors will use it in the framework of micro-laryngoscopy surgery in suspension. However, its use as an oxygenation strategy during panendoscopy has been little explored. Panendoscopy is a common procedure that requires deep and short anesthesia. The main challenge is the sharing of the airway between the anesthesia team and the surgical team. Learning to use this new method or the impact of operator experience has never been explored.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire de Besançon


title: Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma, Part 2

summary:
Pilot, prospective, monocentric study aimed at evaluating the rate of patients with circulating "cancer cell/macrophage" hybrid cells in the peripheral blood and the evolution of this rate over time.

The study will be conducted on a population of patients with leiomyosarcoma and treated in the context of routine care. 20 patients will be included:

10 patients with localized disease.
10 patients with metastatic disease.

For each included patient, blood samples will be collected during baseline visit and up to 24 months after inclusion.

lead_sponsor: Institut Claudius Regaud

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole


title: Medical Assistance for Procreation Patient Library Targeting Patients With Idiopathic Infertility or Low Ovarian Reserve Before the Age of 35

acronym: FERTITHEQUE

summary:
Creation of a patient library in Medically Assisted Procreation to allow the implementation of further research with the following objectives:

To identify new relevant biomarkers in patients who will carry a pregnancy to term
To better specify or identify new infertility risk factors
To identify new relevant biomarkers in patients with reduced ovarian reserve

Four consultations are planned with biological et clinical collection.

time_perspective: Prospective

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: LDL Cholesterol: Friedewald, Always the Best Option to Evaluate LDL cholesteRol Concentration in norMal and Dyslipidemic sUbjects, in Fasting and Pot-prandiaL State?

acronym: LDL FORMULA

summary:
Purpose The LDL-C is a very important marker of the lipid panel which allows the introduction of a treatment and then the follow-up to prevent the cardiovascular risk. Friedewald et al have established the most widely used equation at the present time. However, it has many well-known limitations, as being false in postprandial period.

New equations have been developed recently. Our work consisted in the assessment of the accuracy of Friedewald, Sampson and Martin-Hopkins equations and evaluated the consequences in terms of misclassification. Given that European recommendations allow the realization of lipid profiles in postprandial period, we studied the accuracy of these equations in non-fasting state .

Method The LDL cholesterol concentrations will be calculated using at least three different equations (Friedewald, Sampson, Martin-Hopkins). Results will be compared between equations and between calculated and measured concentrations determined using an ultracentrifugation method. The study is conducted out according to The Code of Ethics of the World Medical Association (Declaration of Helsinki) and obtained the agreement of the Scientific and Ethics Committee of the Hospices Civils de Lyon (LDL EQUATION CNIL 21_488) Hypothesis

To evaluate the most accurate equation in different conditions:

Fasting and non-fasting state
In subjects with normal or dyslipidemic lipid profile To evaluate the clinical impact on risk re-classification and lipid treatment goals if LDL-c is calculated using the best equation instead of the Friedewald's.

lead_sponsor: Hospices Civils de Lyon

location_facility: Laboratoire de Biologie Médicale Multi Sites, Centre de Biologie et de Pathologie Est


title: Long-term Result of Placing Intracorneal Rings in Keratoconus Using Laser

acronym: STAK

summary:
Intracorneal rings are indicated in patients whose central cornea does not present opacity and whose visual acuity is not satisfied despite correction with lenses or linked to an intolerance to lenses.

Surgeries such as crosslinking and intracorneal rings placement are alternatives to corneal transplantation with the expected effects: stabilization of the disease for corneal collagen crosslinking and visual rehabilitation by the placement of intracorneal rings.

The main objective of this study is to evaluate visual benefit1 year after placement of intracorneal rings using laser in keratoconus

lead_sponsor: Elsan


title: Comparison of the Effects of Three Warm-up Interventions at the Workplace on Pain, Heart Rate, Work Performance and Physical Capacities Among Vineyard Workers - a Protocol Study

summary:
Background:

Physical activity programs at the workplace have shown positive results on physical capacities and pain for several years. Due to the duration of the training session, the need of instructor, and the need of a place to practice, these programs are commonly complex to implement. For this reason, many of companies, especially companies in manual sectors are turning to another solution, i.e warm-up intervention before work shift. These interventions present on paper numerous advantages such as short duration, no need to specifically allocate a place in companies and the possibility to perform exercises in working clothes… Surprisingly, while positive effects of warm-up interventions on pain, performance physical and psychological capacities, are expansively reported in sport context, effects of workplace warm-up intervention are lacking. Therefore, the aims of this study are (1) to implement such intervention among vineyard-workers, workers highly exposed to heavy physical workload and pain and (2) to assess their effects on physical (pain, strength, flexibility) and psychological (workload) functions and also on work-related outcomes (work performance, readiness to work)

Methods:

A cluster randomized study will be implemented among French vineyard workers. Four groups of 30 participants will be constituted; corresponding to four different conditions: (1) hybrid warm-up intervention (HWU); (2) dynamic warm-up intervention (DWU); (3) stretching warm-up intervention (SWU); (4) no warm-up intervention (NWU). A total of 120 vineyard-workers will be recruited to participate in the study.

Discussion:

The results will provide more evidence about the short-term effects of warm-up interventions at the workplace, and will provide more evidence on which warm-up modality is the most effective on pain, performance, physical and psychological capacities among vineyard workers.

lead_sponsor: Opti'Mouv


title: Comparison of the ENDOCUFF VISION® Endoscopy Cap Coupled With GI GENIUS™ Artificial Intelligence Compared to Each Device Alone in Improving Colonic Adenoma Detection Rate During Colonoscopy

summary:
Colorectal cancer is the 2nd most common cause of death by cancer. Screening is therefore essential, with a positive impact for prevention, and in the visualization and removal of colonic adenomas, pre-cancerous lesions of colorectal cancer.

The colonic adenoma detection rate (CADR), the gold standard for colonoscopy screening and screening studies, is the ratio of the number of colonoscopies with at least one histologically verified colonic adenoma to the total number of colonoscopies performed in a center. It varies between 25 and 45% depending on the center. There is a large inter-operator CADR variability, which has been linked to an increased incidence and excess mortality in colorectal cancers.

To improve this detection rate, several innovative techniques have been developed:

The endoscopic cap helps improve this detection rate: it is a 2cm tip with double row of plastic wings, fixed to the distal end of the colonoscope, which acts by unfolding the colonic haustrations allowing a better visualization of adenomas, and more particularly those of sessile morphology and sigmoidal location. Several multicenter studies have shown an improvement in the adenoma detection rate with this device compared to screening colonoscopy alone, with an adenoma detection rate optimization of 14%. Since then other devices, such as the Endocuff, have emerged with comparable efficacy. The Medtronic© GI GENIUS system integrates artificial intelligence (AI) to assist in the detection of polyps. It automatically identifies these precancerous lesions in real time.

The study investigators previously performed a retrospective pilot study (COLODETECT), comparing colonoscopy alone as a control group, against AI alone and against the combined cap + AI. This study showed encouraging results in terms of colonic adenoma detection rate (60% for the AI + cap group versus 37% for the AI alone group versus 33% for the colonoscopy alone group, p=0.037) However, it requires a higher level of evidence to be validated in practice. This prospective COLODETECT2 study estimated an a priori expected difference between A.I. - Cap and A.I. alone of about 15% CADR.

The GI GENIUS artificial intelligence system and the ENDOCUFF VISION endoscopic cap have separately proven their effectiveness in terms of colonic adenoma detection compared to colonoscopy alone. However, some limitations remain: existence of false positives (mucosal folds, residues), some morphological types still difficult to recognize (scalloped adenomas), non visualized colonic lesions.

This study therefore focuses on the possible complementarity of these 2 medical devices, in order to maximize the detection rate of colonic adenomas, and thus overcome the limitations of these two techniques by optimizing the visualization of these precancerous lesions, and consequently increasing the impact of colorectal cancer screening.

The study authors hypothesize that the combination of GI GENIUS™ AI coupled with the ENDOCUFF VISION® endoscopy cap provides a better colonic adenoma detection rate (CAD) during colonoscopy than either GI GENIUS™ AI alone or the ENDOCUFF VISION® cap alone.

primary_purpose: Diagnostic

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Analysis of Risk Factors of Neurodevelopmental Disorder in Deaf Infants Under Ten Months of Age.

acronym: EnTNDre

summary:
Among risk factors of neurodevelopmental disorder is congenital hearing loss. However, congenital deafness is neither necessary nor sufficient for the occurrence of warning signs of neurodevelopmental disorder. The investigative team hypothesizes that the co-occurrence of these two clinical entities results from a common origin, within a syndromic diagnosis including other medical issues. These situations would therefore be very different from those of babies suffering from isolated sensorineural deafness.

This study aims to identify which factors are statistically correlated with the association of congenital deafness and early symptoms of neurodevelopmental disorder, thanks to a partnership between a regional center for psychiatry of deaf children (Therapeutic Childhood and Deafness Unit of St Maurice Hospitals, UTES) and a pediatric audiophonology department (ENT department of the Necker-Enfants Malades hospital).

This work is based on a cohort of 26 children under ten months of age diagnosed with severe to profound congenital sensorineural hearing loss. As part of their pre-implantation cochlear assessment, a consultation was filmed to precisely analyze the interactional and sensorimotor skills of these children (clinical observations, administration of a specific evaluation grid called Olliac Grid), after reviewing the films. The investigative team will then be able to grade the neurodevelopmental risk.

In order to clarify what factors are linked with a neurodevelopmental risk, medical data concerning the child's family context, birth, and audiological profile will also be collected, and put in perspective with the assessed neurodevelopmental risk gradation.


title: Comparison of High-flow Nasal Oxygen Therapy and Face Mask Ventilation on Desaturations During Panendoscopy Under General Anesthesia

summary:
Panendoscopy is a common procedure that requires deep and short anesthesia. The main challenge is the sharing of the airway between the anesthesia team and the surgical team. There are several methods to ensure oxygenation during this type of procedure: oro-tracheal intubation, jet ventilation, spontaneous ventilation anesthesia, apneic ventilation with intermittent face mask ventilation. There is no consensus regarding the best airway management technique for this procedure. Regardless of the method chosen to ensure oxygenation during this procedure, the risk of hypoxemia during desaturation episodes is significant.

However, the use of HFNO seems to show a prolongation of apnea time without desaturations (< 90% SpO2) and seems to allow the performance of panendocoscopies.

In the Besançon University Hospital, since 2017, all panendoscopies are performed with HFNO. Before 2017, panendoscopies were performed under face mask ventilation. The main of the study hypothesis is that HFNO brought a gain in terms of safety, especially on the desaturation rate compared to face mask ventilation.

The investigators will carry out a quasi-experimental study comparing two periods. The first period concerns the years 2015-2016. It aims to study patients who had panendoscopies performed under FMV. The second period covers the years 2018-2019. It aims to study patients who had panendoscopies performed under HFNO.

The year 2017 is considered as the washout period necessary to avoid the learning effect of the HFNO introduced during that year.


title: Participation Rate (Response Rate) and Factors Associated With Non-response to "Online Surveys" in Perioperative Knee Anterior Cruciate Ligament (ACL) Reconstruction

acronym: ORTHENSE

summary: To monitor the quality of health care systems, patient-reported outcome measures (PROMs) should be collected and analyzed before and after medical interventions. The development of information technology and software along with an exponential increase in the use of the Internet now allows new modalities for collecting PROMs. Online survey has become one of the most popular methods of data collection. tHE hypothesis is that providing a "brace cold therapy" to patients undergoing knees surgeries will generate an increasing in Response Rate to Online surveys.

lead_sponsor: University Hospital, Toulouse


type: EudraCT Number

title: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase 2 Study to Assess the Efficacy and Safety of ATX01 (Topical Amitriptyline Hydrochloride 10% and 15% w/w) in Comparison to Placebo, in Cancer Survivor Adult Patients With Chemotherapy-induced Peripheral Neuropathy (CIPN)

acronym: ACT

summary: The purpose of this clinical trial is to compare the efficacy of twice daily applications of ATX01 (10% & 15%) versus placebo during a 12-week treatment period in treating chemotherapy-induced peripheral neuropathy (CIPN) in adult cancer survivor patients.

lead_sponsor: AlgoTherapeutix

intervention_type: Drug


title: Effectiveness of Medical Management in the Field of Rare Diseases. The Example of Fibrous Dysplasia of Bone.

acronym: Efficience

summary:
The objective of our study was to assess the effectiveness of our reference center since its constitution.

In a retrospective cohort study, we compared the activity of our center, including the time elapsed between diagnosis and access to the center and the diagnostic delay of patients with fibrous dysplasia between two periods, 1996-2006 (before certification of our center) and 2007-2019 (after certification of our center).

location_facility: rheumatology department, hopital Edouard Herriot


title: Feasibility of an Il-17a Assay and Impact on Therapeutic Response in Patients With Active Axial Spondyloarthritis

summary:
There are, to date, no validated biomarkers or head-to-head RCTs of biologics to guide choice of biologic agent in axSpA. While there are now two head-to-head studies of a TNF inhibitor (TNFi) vs an IL-17 inhibitor (IL-17i) in psoriatic arthritis. Recommendations refers to biological DMARDs (bDMARDs) including TNFi and IL-17i for patients with high disease activity despite the use (or intolerance/contraindication) of at least two non-steroidal anti-inflammatory drugs (NSAIDs) in axial SpA (axSpA) and in failure of a strategy including methotrexate for psoriatic arthritis. A tool to help us to decide which bDMARDs to use is necessary.

In SpA, the method of determination of IL17 seems to be questionable.

The determination of cytokines after stimulation of immune cells in patients with active SpA requiring a biological treatment could provide us with a tool to assist in the choice of therapy.

The aim of the study was to show the feasibility of cytokine assay following lymphocyte stimulation in active SpA requiring biological treatment. And secondly, to show the predictive character of this expression on the therapeutic response at three months after the implementation of a biological treatment.

ipd_sharing_description: not schedule

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Use of MiniMed 780G System in Children and Adolescents, a French Real Life Observational Study

summary:
Hybrid closed-loop technology have shown that it improves glycemic control parameters, but the investigators do not have sufficient data at more than 6 months of follow-up, allowing us to describe the effectiveness of these systems in the long term.

All MiniMed 780G system users from November 2020 to March 2022 were included (n=32) For every time points, there was a significant difference in Time In Range between the pre-AHCL and post-AHCL. Noted difference were +14.5% and, +10.8% at respectively 3 months and 1 year. No more hypoglycemia were identified.

This "real-life" analysis shows that the algorithm is effective in improvement of metabolic control for T1 diabetic children and adolescents, at one year of follow-up.

However, an effect of breathlessness is observed which underlined the need for a solid therapeutic education program.


title: Radiomics and Metabolomics in the Follow-up of CAR T-cells for Refractory or Relapsed Non-Hodgkin's Lymphoma: Pilot Study

acronym: CART-Omic

summary: This is an interventionnal pilot study to investigate whether 18FDG radiomics or serum metabolomic signatures could be predictive or prognostic factors in the follow-up of patients receiving CAR T-cell therapy for refractory non-Hodgkin's lymphoma or in relapse.


title: Evaluation of Interest of LUMEEN Virtual Reality Headset to Reduce Preoperative Anxiety in AMBulatory Surgery

acronym: AMBLUMEEN

summary: This study evaluate the interest of Virtual Reality to reduce the preoperative anxiety in patients who undergo to ambulatory surgery. Half of the patients will received the virtual reality program, and the other half will received de common treatment.


title: Evaluation of the Inter-center Variability of the Measurement of Thrombin Generation by the ST Genesia System

acronym: EVIGE

summary:
The thrombin generation test is a global test for the study of coagulation that allows the fine study of the balance between procoagulant and anticoagulant factors. For many years, it has been performed in laboratories by semi-automated techniques, sometimes using in-house reagents, which led to a high variability and did not allow multicenter studies. Recently, an automated device for the evaluation of thrombin generation has been placed on the market (ST-Genesia), allowing a better standardization of the technique. In order to allow multicenter studies, which are essential for the routine positioning of the thrombin generation test, the inter-center variability must be evaluated, as a priority, in the pathologies for which the test is routinely positioned.

Thrombin generation (TG) assays are long-established research tools in hemostasis. They are used for both fundamental and clinical research, but a multiplicity of test methodologies limits the large adoption of TG due to the variability of results despite the attempts to standardize practices.

Several publications already exist to evaluate its analytical performances, and thereby demonstrate that the test automation also allows its democratization to reach acceptable performances It also enables the evaluation of the device in various indications such as, for example, the evaluation of the effect of direct oral anticoagulants or the evaluation of the risk of breast cancer recurrence.

The confirmation of these anterior results allows further clinical investigations in larger cohorts. However, the absence of interchangeability between the two systems indicates that the results will need to be more rugged through multicenter studies on ST Genesia.

ReferenceCitation: Hemker HC. Recollections on thrombin generation. J Thromb Haemost. 2008 Feb;6(2):219-26. Epub 2007 Dec 10.

ReferenceCitation: Baglin T. The measurement and application of thrombin generation. Br J Haematol. 2005 Sep;130(5):653-61. Review.

ReferenceCitation: de Laat-Kremers RMW, Ninivaggi M, Devreese KMJ, de Laat B. Towards standardization of thrombin generation assays: Inventory of thrombin generation methods based on results of an International Society of Thrombosis and Haemostasis Scientific Standardization Committee survey. J Thromb Haemost. 2020 Aug;18(8):1893-1899. doi: 10.1111/jth.14863. Epub 2020 Jun 3.

ReferenceCitation: Dargaud Y, Wolberg AS, Luddington R, Regnault V, Spronk H, Baglin T, Lecompte T, Ten Cate H, Negrier C. Evaluation of a standardized protocol for thrombin generation measurement using the calibrated automated thrombogram: an international multicentre study. Thromb Res. 2012 Dec;130(6):929-34. doi: 10.1016/j.thromres.2012.07.017. Epub 2012 Aug 19.

ReferenceCitation: Perrin J, Depasse F, Lecompte T; French-speaking CAT group and under the aegis of GEHT; French-speaking CAT group (all in France unless otherwise stated):; French-speaking CAT group all in France unless otherwise stated. Large external quality assessment survey on thrombin generation with CAT: further evidence for the usefulness of normalisation with an external reference plasma. Thromb Res. 2015 Jul;136(1):125-30. doi: 10.1016/j.thromres.2014.12.015. Epub 2014 Dec 24.

ReferenceCitation: Calzavarini S, Brodard J, Quarroz C, Maire L, Nützi R, Jankovic J, Rotondo LC, Giabbani E, Fiedler GM, Nagler M, Angelillo-Scherrer A. Thrombin generation measurement using the ST Genesia Thrombin Generation System in a cohort of healthy adults: Normal values and variability. Res Pract Thromb Haemost. 2019 Jul 18;3(4):758-768. doi: 10.1002/rth2.12238. eCollection 2019 Oct.

ReferenceCitation: Douxfils J, Morimont L, Bouvy C, de Saint-Hubert M, Devalet B, Devroye C, Dincq AS, Dogné JM, Guldenpfennig M, Baudar J, Larock AS, Lessire S, Mullier F. Assessment of the analytical performances and sample stability on ST Genesia system using the STG-DrugScreen application. J Thromb Haemost. 2019 Aug;17(8):1273-1287. doi: 10.1111/jth.14470. Epub 2019 May 31.

ReferenceCitation: Foulon-Pinto G, Jourdi G, Perrin J, Abdoul J, Paris G, Gouin-Thibault I, Curis E, Lecompte T, Siguret V. Study of thrombin generation with St Genesia to evaluate xaban pharmacodynamics: Analytical performances over 18 months. Int J Lab Hematol. 2021 Aug;43(4):821-830. doi: 10.1111/ijlh.13443. Epub 2020 Dec 28.

ReferenceCitation: Mori F, Genuardo C, Nannizzi S, Farina C. Intra- and interassay variations of two thrombin generation methods. Int J Lab Hematol. 2021 Aug;43(4):O218-O220. doi: 10.1111/ijlh.13524. Epub 2021 Mar 24.

ReferenceCitation: Metze M, Pfrepper C, Klöter T, Stöbe S, Siegemund R, Siegemund T, Edel E, Laufs U, Petros S. Inhibition of thrombin generation 12 hours after intake of direct oral anticoagulants. Res Pract Thromb Haemost. 2020 Apr 23;4(4):610-618. doi: 10.1002/rth2.12332. eCollection 2020 May.

ReferenceCitation: Gomez-Rosas P, Pesenti M, Verzeroli C, Giaccherini C, Russo L, Sarmiento R, Masci G, Celio L, Minelli M, Gamba S, Tartari CJ, Tondini C, Giuliani F, Petrelli F, D'Alessio A, Gasparini G, Labianca R, Santoro A, De Braud F, Marchetti M, Falanga A; HYPERCAN Investigators . Validation of the Role of Thrombin Generation Potential by a Fully Automated System in the Identification of Breast Cancer Patients at High Risk of Disease Recurrence. TH Open. 2021 Feb 10;5(1):e56-e65. doi: 10.1055/s-0040-1722609. eCollection 2021 Jan.

ReferenceCitation: Talon L, Sinegre T, Lecompte T, Pereira B, Massoulié S, Abergel A, Lebreton A. Hypercoagulability (thrombin generation) in patients with cirrhosis is detected with ST-Genesia. J Thromb Haemost. 2020 Sep;18(9):2177-2190. doi: 10.1111/jth.14963. Epub 2020 Jul 23.

lead_sponsor: University Hospital, Clermont-Ferrand


type: Registry Identifier

title: Transition From Paediatric Intensive Care to General Paediatrics and Pneumology Units : a Study of the Post-intensive Care Syndrome

acronym: Presage-SPSI

summary:
In developed countries, mortality rates in pediatric intensive care units (PICUs) are around 4% and most children admitted to these units survive. However, some pediatric survivors experience long-term morbidity (cognitive, psychological and/or physical impairment) associated with their PICU stay and there is increasing awareness of the onset of post-intensive care syndromes (PICS) like in adults. However comprehensive descriptive data are still lacking regarding PICS in pediatrics (PICS-p).

The aim of this study is to describe (in nature and frequency) the alterations in health defined by the WHO of children who have passed through the PICU and constitute a possible PICS-p.

In order to do this, we will perform a prospective cohort study in Robert-Debré University Hospital including the PICU. We will include children with an unplanned hospitalization for more than 72 hours for acute complication of sickle cell disease (such as acute chest syndrome or vaso-occlusive crisis), acute asthma or sepsis and aged from 3 to 17 years. We plan to include 40 patients admitted to the PICU as well as 40 controls admitted to the general pediatrics unit or the pneumology unit without PICU admission, matched on diagnosis, age range and period.

The primary endpoint will be the prevalence of children that had been admitted to PICU and reporting cognitive, psychological, physical and social impairments measured by questionnaire and medical record data collection on the day before discharge and at the routine post-hospitalization visit.

Secondary objectives will be to study the risk factors for PICS-p, to compare alterations in cognitive, psychological, physical and social domains in children with the same diagnosis and age not admitted to the PICU during their hospitalization.

In order to this, we will measure the association with the PICU stay characteristics, parental experience and social characteristics of families. We will also report the prevalence of children not admitted in intensive care and reporting cognitive, psychological, physical and social impairments measured by questionnaire and medical record data collection on the day before discharge and at the routine post-hospitalization visit.

Patients and their parents will be given questionnaires the day before discharge and during the first follow-up consultation between 2 and 4 months after hospital discharge.

Questionnaires will include the Pediatric Symptom Checklist long version (Assessment of cognitive, psychological and social domains - 35 items scored from 0 to 2) reported by parents for children under 8 years and by the patients for children older than 8 years. older), the physical items of Pediatric Quality of Life scale (8 items scored from 0 to 4) and a parent self-questionnaire (including relationship to child, annual income, household composition, understanding and use of the French language, highest diploma of mother and father, social support (""How many people can you really count on when you need help?"")) and a parental mental health self-assessment (PHQ-8).

The analyses will be descriptive (description of the nature and frequency of alterations) and comparative (between children who have or have not been in PICU). Univariate tests will be performed to identify possible risk factors for post intensive care syndrome. Statistics will be carried out on SAS 9.4 software.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Cardiometabolic Effects of Dapagliflozin in Heart Failure With Reduced Ejection Fraction: an Exploratory Study

acronym: ICARD

summary: Gliflozins have demonstrated a beneficial effect in terms of incident heart failure and related events in patients with or without diabetes. The clinical trial ICARD is an exploratory study that aims to evaluate the cardiometabolic mechanistic effects on the myocardium of dapagliflozin in heart failure with reduced ejection fraction. Deep phenotyping of cardiac and vascular function will be performed using MRI. Myocardial tissue characterization will be based on MRI and FDG-PET for glucose metabolism assessment. Liver steatosis and fibrosis will simultaneously be assessed.

ipd_sharing_description:
Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission Nationale de l'Informatique et des Libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.

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


title: Multicenter Study on Dialysis Modalities for End-stage Chronic Renal Failure Patients With Heparin-induced Thrombocytopenia

acronym: MODIATIH

summary:
This research is based on the hypothesis that the Hydrolink®-NV dialysis membrane could allow the realization of quality dialysis with a significant reduction in the doses of Orgaran®, or even a total cessation of the anticoagulant, in patients with chronic renal failure. with heparin-induced thrombocytopenia.

Thus, this study aims to show that the use of this dialysis membrane without prior anticoagulation does not increase the risk of coagulation of the circuit and allows the realization of quality dialysis sessions.

lead_sponsor: Ramsay Générale de Santé


title: Controlled Internal Convection in Low Flow Hemodialysis of Dialysate: Removal of Beta-2-microglobulin

acronym: CIMHBaDD

summary: Since 2013 daily home hemodialysis allows low volumes of convection. This study is a prospective cross-over trial testing the efficiency of internal convection on Beta2-microglobulin in daily home hemodialysis.

primary_purpose: Supportive Care


title: Development and Clinical Evaluation of an Innovative Medical Device to Predict Preterm Birth: From Basic Research to Obstetric Emergencies

acronym: PrediMAP

summary: The purpose of this study is to clinically validate the predictive performance (sensitivity and specificity) of the PrediMAP in-vitro diagnostic medical device to predict delivery within 7 days in the target population of women consulting obstetric emergencies for preterm labor (PTL).

intervention_type: Biological


title: Study of the Interest of the Combination of Stiripentol (Diacomit®) and Carbamazepine in the Treatment of Patients With Pharmacoresistant Focal Epilepsies

summary: This is a monocentric, open-label clinical study, presenting a retrospective part and a prospective part, studying the data of patients with drug-resistant focal epilepsies and treated with the combination of stiripentol (Diacomit®) and Carbamazepine.

lead_sponsor: Biocodex

location_facility: Centre de Référence Epilepsies Rares / Centre Investigation Clinique (CIC) - Hôpital Necker-Enfants Malades


title: Study Of Colchicine Resistance In Familial Mediterranean Fever

acronym: COLCHI-RESIST

summary:
Five to 10% of familial mediterranean patients are considered colchicine-resistant (i.e. patients with a persistent inflammatory syndrome, despite taking the maximum tolerated dose of colchicine daily). The recommended treatment in this case is a subcutaneous anti-interleukin 1 biotherapy (anakinra or canakinumab). These treatments are expensive (1,000 to 12,000 euros/month).

However, for a patient to be considered colchicine-resistant, compliance with the treatment must be verified. Furthermore specific activation of the pyrin inflammasome by Clostrioides difficile toxin and the overrepresentation of these bacteria in the stools of our patients led us to systematically search for them in our resistant patients. The demonstration of the involvement of C. difficile in the imbalance of the disease has not yet been published.

The colchiresist study aim to better characterize colchicine-resistance by confirming good compliance to treatment with colchicine hair measurement and by looking for clostrioides infection or intestinal dysbiosis.

location_facility: Service de Médecine Interne. Hôpital Tenon, 4 Rue de la Chine


title: Physical Activity Return After Popliteal Artery Entrapement Syndrome Surgery With Tegner Activity Scale

acronym: PAES

summary: evaluation of physical activity return after popliteal artery entrapement syndrome surgery with the tegner activity scale

lead_sponsor: University Hospital, Angers


title: Assessment of the Effects of a 24-hour Cold and Heat Exposure on the Factors Influencing Food Intake

acronym: TEMPCA

summary:
Military personnel and athletes have a very high energy expenditure which is increased during certain key periods (intense training, competition and mission). Compensating for this expenditure through food can be complicated by physiological ingestive limits and logistical and organizational constraints (number of meals, availability of food), which leads these populations to regularly experience energy deficit situations (intake below requirements), which could alter physical and cognitive performance and major physiological functions.

Among the many constraints to which military personnel and athletes are exposed to (stress, sleep deprivation, travel, etc.) that can increase the risk of energy deficits, the impact of thermal environmental constraints is not well known. The seasonal impact and travel to countries with very different thermal environments can lead these populations to experience cold and hot conditions for long periods.

Understanding how heat and cold exposure modifies appetite and energy intake therefore appears to be of great importance.

The hypothesis of this study is that a 24 h heat exposure would produce a rapid and long-lasting anorexigenic action impacting energy intake, while a cold exposure would produce the opposite effect (orexigenic action).

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Institut de Recherche Biomédicale des Armées


title: Comparison of Two Surgical Sequences "Cataract Surgery Then Vitrectomy" Versus "Vitrectomy Then Cataract Surgery" Under Local-regional Anesthesia. A Pilot, Exploratory, Monocentric, Prospective, Randomized Study

acronym: VICAR

summary: Cataracts and vitreo-retinal conditions are frequently associated and can lead to a combined surgery to treat both diseases at the same time. To date, in most cases cataract surgery is usually performed first, then followed by vitrectomy. However, there isn't any standard guidelines indicating what would be the best chronological order, or sequence, when performing those procedures. This randomised, double-arm, open-label study aims at investigating whether the sequence "cataract surgery then vitrectomy" or "vitrectomy then cataract surgery" can have an impact on iris hernia occurence.


title: Influence of Olfaction Essential Oils on the Consumption of Benzodiazepine Receptor Agonists & Z-Drugs (BZRAs) Prescribed as " if Needed " in Psychiatric Outpatients (HECBA-PSY).

acronym: HECBA-PSY

summary:
The goal of this interventional study is to test the use of olfactory Essential Oils through a nasal stick as one of the non-medicinal strategies to propose to the patient to reduce the consumption of medication in a population of stabilized patients with psychiatric disorder.

The main objective is to evaluate whether the olfaction of a mixture of essential oils can reduce the intake of BZRAs, prescribed if needed.

The investigators want to compare the number of medications prescribed on "if needed" basis before and after the introduction of Essential Oils.

A period prior to inclusion is used to assess the participant's frequency of BZRA use. Then, participants will received Essential Oils through a nasal stick during 4 weeks. During this period, the patient completes weekly anxiety and sleep scales and at the final visit, weekly and monthly anxiety and sleep scales.

lead_sponsor: Etablissement Public de Santé Barthélemy Durand


title: Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction

acronym: SOMNOSE

summary: The aim of the study is to evaluate the effect of nasal desobstruction surgery (septoplasty, septorhinoplasty or total ethmoidectomy) on sleep quality, assessed by the variation of the Wake after sleep onset (WASO), in patients presenting with sleep disorders and severe nasal obstruction.

lead_sponsor: University Hospital, Bordeaux


title: Multimodal Analysis of the Young Brain on Rhythm Perception: From Premature Neonates to Infants

acronym: Exposition

summary: Premature neonates are able to discriminate phonemes and voice from 28wGA at a time the neuronal network establish contact between the environment and the cortical neurones. In the present monocentric study the investigators will analyse the response of the cortical network in premature aged between 28 and 40 wGA in response to auditory stimuli using High Resolution Electroencephalography and High Density Near Infrared Spectroscopy

primary_purpose: Screening

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Assess the Performance of Metagenomic Sequencing in the Diagnosis of STI (NGS-IST)

acronym: NGS-IST

summary: The main objective of the study will be to assess the performance of the Next-Generation-Sequencing (NGS) diagnostics of Chlamydia trachomatis and Neisseria gonorrhoeae compared to reference techniques.

ReferenceCitation: Abdool Karim Q, Abdool Karim SS, Frohlich JA, Grobler AC, Baxter C, Mansoor LE, Kharsany AB, Sibeko S, Mlisana KP, Omar Z, Gengiah TN, Maarschalk S, Arulappan N, Mlotshwa M, Morris L, Taylor D; CAPRISA 004 Trial Group. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010 Sep 3;329(5996):1168-74. doi: 10.1126/science.1193748. Epub 2010 Jul 19. Erratum in: Science. 2011 Jul 29;333(6042):524.

ReferenceCitation: Chaix ML, Charreau I, Pintado C, Delaugerre C, Mahjoub N, Cotte L, Capitant C, Raffi F, Cua E, Pialoux G, Tremblay C, Meyer L, Molina JM; ANRS IPERGAY Study Group . Effect of On-Demand Oral Pre-exposure Prophylaxis With Tenofovir/Emtricitabine on Herpes Simplex Virus-1/2 Incidence Among Men Who Have Sex With Men: A Substudy of the ANRS IPERGAY Trial. Open Forum Infect Dis. 2018 Nov 8;5(11):ofy295. doi: 10.1093/ofid/ofy295. eCollection 2018 Nov.

ReferenceCitation: Deschamps O, Ortonne N, Hüe S, Rodriguez C, Deschodt C, Hirsch G, Colin A, Grégoire L, Delfau-Larue MH, Chosidow O, Wolkenstein P, Ingen-Housz-Oro S. Acute exanthemas: a prospective study of 98 adult patients with an emphasis on cytokinic and metagenomic investigation. Br J Dermatol. 2020 Feb;182(2):355-363. doi: 10.1111/bjd.18166. Epub 2019 Aug 9.

ReferenceCitation: Fourati S, Rodriguez C, Hézode C, Soulier A, Ruiz I, Poiteau L, Chevaliez S, Pawlotsky JM. Frequent Antiviral Treatment Failures in Patients Infected With Hepatitis C Virus Genotype 4, Subtype 4r. Hepatology. 2019 Feb;69(2):513-523. doi: 10.1002/hep.30225. Epub 2019 Jan 5.

ReferenceCitation: Hernando Rovirola C, Spiteri G, Sabidó M, Montoliu A, Gonzalez V, Casabona J, Cole MJ, Noori T, Unemo M. Antimicrobial resistance in Neisseria gonorrhoeae isolates from foreign-born population in the European Gonococcal Antimicrobial Surveillance Programme. Sex Transm Infect. 2020 May;96(3):204-210. doi: 10.1136/sextrans-2018-053912. Epub 2020 Feb 4.

ReferenceCitation: Hoornenborg E, Coyer L, Achterbergh RCA, Matser A, Schim van der Loeff MF, Boyd A, van Duijnhoven YTHP, Bruisten S, Oostvogel P, Davidovich U, Hogewoning A, Prins M, de Vries HJC; Amsterdam PrEP Project team in the HIV Transmission Elimination AMsterdam (H-TEAM) Initiative. Sexual behaviour and incidence of HIV and sexually transmitted infections among men who have sex with men using daily and event-driven pre-exposure prophylaxis in AMPrEP: 2 year results from a demonstration study. Lancet HIV. 2019 Jul;6(7):e447-e455. doi: 10.1016/S2352-3018(19)30136-5. Epub 2019 Jun 6.

ReferenceCitation: Looker KJ, Elmes JAR, Gottlieb SL, Schiffer JT, Vickerman P, Turner KME, Boily MC. Effect of HSV-2 infection on subsequent HIV acquisition: an updated systematic review and meta-analysis. Lancet Infect Dis. 2017 Dec;17(12):1303-1316. doi: 10.1016/S1473-3099(17)30405-X. Epub 2017 Aug 23. Review.

ReferenceCitation: Molina JM, Charreau I, Chidiac C, Pialoux G, Cua E, Delaugerre C, Capitant C, Rojas-Castro D, Fonsart J, Bercot B, Bébéar C, Cotte L, Robineau O, Raffi F, Charbonneau P, Aslan A, Chas J, Niedbalski L, Spire B, Sagaon-Teyssier L, Carette D, Mestre SL, Doré V, Meyer L; ANRS IPERGAY Study Group. Post-exposure prophylaxis with doxycycline to prevent sexually transmitted infections in men who have sex with men: an open-label randomised substudy of the ANRS IPERGAY trial. Lancet Infect Dis. 2018 Mar;18(3):308-317. doi: 10.1016/S1473-3099(17)30725-9. Epub 2017 Dec 8.

ReferenceCitation: Nieuwenhuis RF, Ossewaarde JM, Götz HM, Dees J, Thio HB, Thomeer MG, den Hollander JC, Neumann MH, van der Meijden WI. Resurgence of lymphogranuloma venereum in Western Europe: an outbreak of Chlamydia trachomatis serovar l2 proctitis in The Netherlands among men who have sex with men. Clin Infect Dis. 2004 Oct 1;39(7):996-1003. Epub 2004 Sep 8.

ReferenceCitation: Ong JJ, Baggaley RC, Wi TE, Tucker JD, Fu H, Smith MK, Rafael S, Anglade V, Falconer J, Ofori-Asenso R, Terris-Prestholt F, Hodges-Mameletzis I, Mayaud P. Global Epidemiologic Characteristics of Sexually Transmitted Infections Among Individuals Using Preexposure Prophylaxis for the Prevention of HIV Infection: A Systematic Review and Meta-analysis. JAMA Netw Open. 2019 Dec 2;2(12):e1917134. doi: 10.1001/jamanetworkopen.2019.17134.

ReferenceCitation: Rodriguez C, Jary A, Hua C, Woerther PL, Bosc R, Desroches M, Sitterlé E, Gricourt G, De Prost N, Pawlotsky JM, Chosidow O, Sbidian E, Decousser JW; Multidisciplinary Necrotizing Fasciitis Study Group. Pathogen identification by shotgun metagenomics of patients with necrotizing soft-tissue infections. Br J Dermatol. 2020 Jul;183(1):105-113. doi: 10.1111/bjd.18611. Epub 2019 Dec 2.

ReferenceCitation: Rodriguez C, Gricourt G, Ndebi M, Demontant V, Poiteau L, Burrel S, Boutolleau D, Woerther PL, Calvez V, Stroer S, Pawlotsky JM. Fatal Encephalitis Caused by Cristoli Virus, an Emerging Orthobunyavirus, France. Emerg Infect Dis. 2020 Jun;26(6):1287-1290. doi: 10.3201/eid2606.191431.

ReferenceCitation: Sitterlé E, Rodriguez C, Mounier R, Calderaro J, Foulet F, Develoux M, Pawlotsky JM, Botterel F. Contribution of Ultra Deep Sequencing in the Clinical Diagnosis of a New Fungal Pathogen Species: Basidiobolus meristosporus. Front Microbiol. 2017 Mar 7;8:334. doi: 10.3389/fmicb.2017.00334. eCollection 2017.

ReferenceCitation: Unemo M, Shafer WM. Antimicrobial resistance in Neisseria gonorrhoeae in the 21st century: past, evolution, and future. Clin Microbiol Rev. 2014 Jul;27(3):587-613. doi: 10.1128/CMR.00010-14. Review.

ReferenceCitation: Van Praet JT, Steyaert S, Vandecasteele S, Van Den Bergh B, Mahieu H, De Buyser S, Grootaert V, Descheemaeker P, Reynders M. Mycoplasma genitalium acquisition and macrolide resistance after initiation of HIV pre-exposure prophylaxis in men who have sex with men. Sex Transm Infect. 2020 Sep;96(6):396-398. doi: 10.1136/sextrans-2019-054335. Epub 2020 Jan 2.

ReferenceCitation: Wilson MR, Sample HA, Zorn KC, Arevalo S, Yu G, Neuhaus J, Federman S, Stryke D, Briggs B, Langelier C, Berger A, Douglas V, Josephson SA, Chow FC, Fulton BD, DeRisi JL, Gelfand JM, Naccache SN, Bender J, Dien Bard J, Murkey J, Carlson M, Vespa PM, Vijayan T, Allyn PR, Campeau S, Humphries RM, Klausner JD, Ganzon CD, Memar F, Ocampo NA, Zimmermann LL, Cohen SH, Polage CR, DeBiasi RL, Haller B, Dallas R, Maron G, Hayden R, Messacar K, Dominguez SR, Miller S, Chiu CY. Clinical Metagenomic Sequencing for Diagnosis of Meningitis and Encephalitis. N Engl J Med. 2019 Jun 13;380(24):2327-2340. doi: 10.1056/NEJMoa1803396.

ReferenceCitation: Wilson MR, Naccache SN, Samayoa E, Biagtan M, Bashir H, Yu G, Salamat SM, Somasekar S, Federman S, Miller S, Sokolic R, Garabedian E, Candotti F, Buckley RH, Reed KD, Meyer TL, Seroogy CM, Galloway R, Henderson SL, Gern JE, DeRisi JL, Chiu CY. Actionable diagnosis of neuroleptospirosis by next-generation sequencing. N Engl J Med. 2014 Jun 19;370(25):2408-17. doi: 10.1056/NEJMoa1401268. Epub 2014 Jun 4.

ipd_sharing_description: Will be decided later by the scientific committee at the end of the study.

lead_sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

location_facility: Service des Maladies Infectieuses et Tropicales Hôpital Saint-Antoine


title: Effect of Injectable Anticoagulants on Research for a Circulating Lupus-type Anticoagulant

acronym: ANTICOLA

summary: The aim is to assess the effect of injectable anticoagulants (unfractionated heparin (UFH), low molecular weight heparins (LMWH), fondaparinux, danaparoid, argatroban) on lupus anticoagulant testing assays over broad anti-Xa activity ranges and to establish their potential for causing false-positive or false-negative results.


title: Medical Follow-up and Self-medication Among Medical Students

acronym: AutoMed-Int

summary:
As health actors, medical students educate patients to have regular medical follow-up and give them justified medical prescriptions. Regarding their own health, medical students do not seem to apply these same principles.

The medical follow-up of medical students seems insufficient, which can be explained by the lack of medical follow-up by occupational medicine, a consequent work time, but also the fear of judgment by colleagues Moreover, medical student have an easy access to all types of prescriptions and therefore the ease of self-prescription and self-medication. Medical students may also overestimate their medical knowledge and may not be objective about their symptomatology.

time_perspective: Cross-Sectional

lead_sponsor: Université de Reims Champagne-Ardenne


title: Association of a Digital Signature of Physical Activity and Sedentary Lifestyle With the Development of Multimorbidities Over 4 Years of Follow-up in Chronic Diseases (eMOB) : a Prospective Cohort

acronym: eMOB

summary:
Physical activity (PA) and sedentary lifestyle are determinants in the development of chronic diseases and associated quality of life alterations. PA levels are correlated with quality of life and morbidity in chronic lung disease (COPD), cardiovascular disease, diabetes, cancer, chronic inflammatory rheumatism, fibromyalgia and anxiety disorders. In these diseases, low-intensity PA often represents the main PA and the quantity of PA is correlated with health parameters.

This study aims to identify a typical profile (signature) in relation to the appearance of other chronic diseases, complications of your disease, from recording your physical activity and sedentary lifestyle by sensors evaluating very precisely the movements and taking into account the characteristics and disability related to your disease. The results of this study would therefore make it possible to identify this signature even before the appearance of complications or other diseases.


title: Augmented Bladder Tumor Detection Using the Bladder-Portable Artifact Detection System: A Multicentric Prospective Analytic Study Using Real Time Based Artificial Intelligence (IA).

acronym: Bladder-PAD

summary:
Today the standard for the diagnosis and monitoring of bladder tumors is bladder endoscopy. The performance of this exam is not perfect. With this work, based on artificial intelligence, the investigators wish to combine endoscopy with a complementary diagnostic tool in order to improve patient care. The main objective will be to reduce diagnostic errors / wanderings in patients treated or followed for bladder tumors, by imposing a new standard of diagnostic bladder mapping (high PPV and VPN, high precision)(primary purpose diagnostic). The secondary objective will be to homogenize and systematize the descriptive part of the lesions, and to use AI to better characterize tumor aggressiveness. The final objective being to validate a new precision tool (diagnostic companion) essential for developing and standardizing the therapeutic management of bladder tumors (correcting inter-observer heterogeneity).

In this project, video frame will be first extracted from our dataset of cystoscopy videos hosted in in the Next Cloud Recherche. Selected medical image will be segmented and analyzed using our pre-trained CNN model with a feature detection algorithm to obtain features.

Data will be analyzed on both patient and lesion levels. The study will assess the Bladder-PAD accuracy on the detection of bladder tumors, and its ability to predict tumor risk of recurrence and progression.


title: Impact of Implementing of Custom Surgical Tray (CST) in Anterior Cruciate Ligament Reconstruction Procedure on Sustainable Development.

summary:
In the Toulouse University Hospital, the Custom Surgical Tray (CST) were not referenced. The nurse had to prepare and open all the components of the procedure separately. This is a long and wasteful process.

CST brings together all the single-use medical devices necessary for an intervention, including draping and dressing elements, in the same single packaging.

Following the new local call for tenders on draping kits, and with the aim of standardizing and rationalizing practices, the implementation of CST within the requesting blocks whose orthopedic and traumatology block has been validated.

The hypothesis is that the CST would save time on preparing the trolley and on opening single-use equipment in the room while limiting the amount of waste.


title: Biomarkers of Inflammation and Autoimmunity: Diagnostic Contribution, Prognosis and Physiopathological Aspects in Arrhythmogenic Cardiomyopathy.

acronym: ACORE

summary: This study aims to identify novel inflammatory biomarkers in AC, whether in circulating blood, in situ or as imaging biomarkers to better understand the pathophysiology of the disease and then to determine contribution to the clinical management of patients.

location_facility: Institut de Cardiologie de la Pitié-Salpêtrière


title: Time-to-Detection in Culture of Mycobacterium Tuberculosis : Performance for Assessing Index Cases Infectivity

summary: determination if time-to-detection in cultures of M. tuberculosis samples is more discriminating than acid-fast staining in transmission


title: Ultrasound Evaluation of Alveolar Stress by Measurement of Ultrasound Pleural Strain in Healthy Subjects

acronym: LUNGSTRAIN

summary: In the critical patient, lung ultrasound is routinely performed for acute respiratory distress, adult respiratory distress syndrome and for hemodynamic evaluation. Its diagnostic performance is superior to that of chest radiography in the context of pleuropulmonary parenchymal pathologies. The search for lung sliding is performed to diagnose a pneumothorax or to search for the correct placement of the endotracheal intubation tube. However, this analysis is qualitative and is sometimes difficult to interpret. At present, there is no global evaluation technique at the patient's bed allowing to analyze simultaneously the alveolar recruitment, the pulmonary over-distension and the quality of the lung sliding, whereas the pulmonary damage is most often heterogeneous. The justification of our research project is based on the need to develop and validate a means of global and regional quantification of the mechanical and aeration properties of the lung parenchyma by the analysis of the acoustic markers of the pleura (pleural strain) by the ultrasound technique of speckle tracking. The aim is to establish the normal values of the pleural strain in healthy volunteers, in spontaneous ventilation and then in non-invasive mechanical ventilation, in order to vary the lung volume.

location_facility: CHU de Nîmes, Hôpital Universitaire Carémeau


title: Changes in the Quality of Life and Experience of Young Women With Utero-vaginal Aplasia (MRKHPSY)

acronym: MRKHPSY

summary: This study aims to evaluate the global evolution of the quality of life on patients diagnosed with MRKH syndrome (Mayer-Rokitansky-Kuster-Hauser), 8 to 10 years after the first research.


title: Monocentric Descriptive Study Regarding the Impact of Severe Dysmenorrhea on Teenagers, Their Parents and Caregivers Receiving Those Patients

acronym: DEMETER

summary: Teenagers experimenting severe dysmenorrhea also face age-specific challenges, particularly impacting their self-confidence, self-esteem, and relations. On one hand, the study team will conduct focus group interviews to better understand the experience of teenagers and their parents consulting pediatric services for severe dysmenorrhea. On the other hand, they will conduct focus group interviews with caregivers from services that usually encounter such patients (gastrologic, gynecologic and pain services). This, allowing to later propose specific tools and healthcare organization to evaluate and accompany teenagers suffering from severe dysmenorrhea.


title: Left Atrial Appendage Closure Registry of Henri Mondor Hospital

summary:
Intro: Patients with atrial fibrillation are at significant risk of thrombus formation in the left atrial appendage, which can lead to strokes or systemic embolisms. This risk justifies first-line prescribing of long-term oral anticoagulant therapy in these patients. Percutaneous left atrial appendage closure, is an interventional cardiology technique for patients at high risk of stroke related to atrial fibrillation in whom long term anticoagulation therapy cannot be conducted. This procedure involves implantation of an occlusion device into the left atrial appendage to close it and prevent migration of thrombotic material that could otherwise cause distant embolism. Closure of the left atrial appendage avoids long-term prescription of anticoagulants while protecting patients against the risk of systemic embolism and stroke.

Hypothesis/Objective: the main objective of this study is to assess the long term efficacy of left atrial closure, 5 years after the procedure Method: 150 patients will be included prospectively. We will also include restropectively100 other patients, previously treated by left atrial appendage closure at Henri Mondor hospital. Demographic, clinical, echocardiographic, and computed tomography data will be obtained by physical examination or medical records.

Conclusion: this study will allow to assess the long term efficacy of left atrial closure in atrial fibrillation patients.

ipd_sharing_description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

location_facility: Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR


title: Combined Study of ATrial Strain and Voltage by High Density Mapping in Young Patients With Atrial Fibrillation.

acronym: CATS-AF

summary:
Atrial The treatment of atrial fibrillation (AF) includes 2 axes: the prevention of the cardio-embolic risk and rhythm control. The possibilities for this control are antiarrhythmic drugs and, above all, catheter ablation, an interventional cardiology technique which consists in treating the areas responsible for the initiation and perpetuation of AF by applying radiofrequency energy or cryotherapy to the myocardial tissue.

Limited research has been done on the combination of different parameters to manage AF, especially during the initial stage of the disease. A translational and multimodal approach could make it possible to better characterize this pathology and thus, help to adjust the therapeutic management for the patients.

The combined analysis of regional electrophysiological, morphological, and functional parameters of the left atrium could make it possible to better detect early atrial cardiomyopathy and predict recurrences of atrial fibrillation.


title: Flapless Zygomatic Implants Robot-assisted Placement

acronym: ROSA-ZYGOMA

summary:
Zygomatic implants are indicated for the rehabilitation of the severely atrophic maxilla. Similar to standard implant placement, gaining an optimal position of the zygomatic implants is essential for a predictable prosthetic-driven treatment outcome.

However, there is no effective mechanism to physically control the drilling trajectory for the zygomatic implants. Therefore, deviation between the actual and planned implant position is inevitable.

This approach is technically difficult, and is performed by an experienced surgeon.

The development of a surgical technique that is both safer and less invasive is currently possible thanks to robotics. In this project, a robotic assisted new strategy for positioning zygomatic implants will be performed and its efficacy and accuracy will be assess.

Path planning will be carried out on a pre-operative scanner. The ROSA robot (Zimmer®) will guide the several drillings steps. Placement of the zygomatic implant will be performed manually.


title: Impact of a Self-Exclusion Procedure Optimized by an Extension of the Suspension of Commercial Solicitations

acronym: PASS

summary: Considering that self-exclusion from gambling on a particular website is an intervention for and by individuals who have developed a gambling disorder, it is currently exclusively a behavioural intervention in the sense that it prevents the behaviour Resumption of commercial solicitations only in the period when gambling is not accessible in the corresponding website , through voluntary self-exclusion (where the gambler prevents himself or herself from gambling), does not appear to be sufficient to prevent relapse. Early commercial solicitations, in the immediate intercourse after the end of the self-exlcusion period may precipitate relapse in gamblers whose behaviour change is by definition recent, and who have only received a behavioural measure. The investigators hypothesize an improved efficacy as measured by reduced gambling after a self-exclusion optimized by a period of suspension of commercial solicitations extended to 9 months, compared to self-exclusion with the standard procedure. Gamblers will be randomized according to an a priori randomization list.


title: Contribution of Lower Limb Venous Colour Doppler Ultrasound in the Diagnosis of Pulmonary Embolism Recurrence

acronym: RECHOPE

summary:
Venous thromboembolic disease is a clinical entity including pulmonary embolism (PE) and deep vein thrombosis (DVT). It is a chronic disease with 30% recurrence rate at 10 years. In patients with recurrent PE clinical suspicion, an objective and accurate diagnostic method/strategy is warranted to exclude or confirm a PE new episode diagnosis and to decide on treatment initiation.

Recurrent PE diagnosis raises several issues related to the limitations of clinical scores, D-dimer testing, and diagnostic imaging used for a first episode diagnosis. Most importantly, residual obstruction on chest imaging reported in more than 50% of cases at 6 months can make it difficult to distinguish between an old and a new thrombosis in the absence of possible comparison with a previous imaging carried out under the same modalities.

There are currently few recommendations about the diagnostic strategy for patients with a recurrent PE clinical suspicion and these recommendations are not very consistent due to the lack of a validated strategy. None of current guidelines have included imaging-detectable lower-limb DVT within the strategies despite a reported high prevalence of PE-associated DVT. In one study using venography, 82% (95% CI 76.5 - 86.9) of angiographically-proven PE patients had an associated proximal or distal deep vein thrombosis, of which 42% were asymptomatic. In another study using lower-limb venous ultrasound, a proximal or distal DVT was detected in 93% (95% CI 85-97) of patients with PE.

time_perspective: Other

ReferenceCitation: Heit JA, Spencer FA, White RH. The epidemiology of venous thromboembolism. J Thromb Thrombolysis. 2016 Jan;41(1):3-14. doi: 10.1007/s11239-015-1311-6. Review.

ReferenceCitation: Patel P, Patel P, Bhatt M, Braun C, Begum H, Wiercioch W, Varghese J, Wooldridge D, Alturkmani H, Thomas M, Baig M, Bahaj W, Khatib R, Kehar R, Ponnapureddy R, Sethi A, Mustafa A, Lim W, Le Gal G, Bates SM, Haramati LB, Kline J, Lang E, Righini M, Kalot MA, Husainat NM, Jabiri YNA, Schünemann HJ, Mustafa RA. Systematic review and meta-analysis of test accuracy for the diagnosis of suspected pulmonary embolism. Blood Adv. 2020 Sep 22;4(18):4296-4311. doi: 10.1182/bloodadvances.2019001052.

ReferenceCitation: Nijkeuter M, Hovens MM, Davidson BL, Huisman MV. Resolution of thromboemboli in patients with acute pulmonary embolism: a systematic review. Chest. 2006 Jan;129(1):192-7. Review.

ReferenceCitation: Meysman M, Everaert H, Vincken W. Factors determining altered perfusion after acute pulmonary embolism assessed by quantified single-photon emission computed tomography-perfusion scan. Ann Thorac Med. 2017 Jan-Mar;12(1):30-35. doi: 10.4103/1817-1737.197772.

ReferenceCitation: Sanchez O, Benhamou Y, Bertoletti L, Constans J, Couturaud F, Delluc A, Elias A, Fischer AM, Frappé P, Gendron N, Girard P, Godier A, Gut-Gobert C, Laporte S, Mahé I, Mauge L, Meneveau N, Meyer G, Mismetti P, Parent F, Pernod G, Quéré I, Revel MP, Roy PM, Salaün PY, Smadja DM, Sevestre MA. [Recommendations for best practice in the management of venous thromboembolic disease in adults. Long version]. Rev Mal Respir. 2021 Apr;38 Suppl 1:e1-e6. doi: 10.1016/j.rmr.2019.05.038. Epub 2019 Jul 4. French.

ReferenceCitation: Lim W, Le Gal G, Bates SM, Righini M, Haramati LB, Lang E, Kline JA, Chasteen S, Snyder M, Patel P, Bhatt M, Patel P, Braun C, Begum H, Wiercioch W, Schünemann HJ, Mustafa RA. American Society of Hematology 2018 guidelines for management of venous thromboembolism: diagnosis of venous thromboembolism. Blood Adv. 2018 Nov 27;2(22):3226-3256. doi: 10.1182/bloodadvances.2018024828.

ReferenceCitation: Ageno W, Squizzato A, Wells PS, Büller HR, Johnson G. The diagnosis of symptomatic recurrent pulmonary embolism and deep vein thrombosis: guidance from the SSC of the ISTH. J Thromb Haemost. 2013 Aug;11(8):1597-602. doi: 10.1111/jth.12301.

ReferenceCitation: Girard P, Musset D, Parent F, Maitre S, Phlippoteau C, Simonneau G. High prevalence of detectable deep venous thrombosis in patients with acute pulmonary embolism. Chest. 1999 Oct;116(4):903-8.

ReferenceCitation: Elias A, Colombier D, Victor G, Elias M, Arnaud C, Juchet H, Ducassé JL, Didier A, Colin C, Rousseau H, Nguyen F, Joffre F. Diagnostic performance of complete lower limb venous ultrasound in patients with clinically suspected acute pulmonary embolism. Thromb Haemost. 2004 Jan;91(1):187-95. Erratum in: Thromb Haemost. 2004 Mar;91(3):635.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer


title: Contribution of Hypnosis in Guided Hepatic Biopsy

acronym: Ap-Hy-PBH

summary:
The purpose of this study is to evaluate the contribution of hypnosis on the level of pain felt by the patient during ultrasound-guided hepatic biopsy, by comparing an intervention group (hypnosis) to a control group (routine and benevolent care).

Single-center randomized controlled trial.

ReferenceCitation: Eisenberg E, Konopniki M, Veitsman E, Kramskay R, Gaitini D, Baruch Y. Prevalence and characteristics of pain induced by percutaneous liver biopsy. Anesth Analg. 2003 May;96(5):1392-1396. doi: 10.1213/01.ANE.0000060453.74744.17.

ReferenceCitation: Bertrand AS, Iannessi A, Buteau S, Jiang XY, Beaumont H, Grondin B, Baudin G. Effects of relaxing therapies on patient's pain during percutaneous interventional radiology procedures. Ann Palliat Med. 2018 Oct;7(4):455-462. doi: 10.21037/apm.2018.07.02. Epub 2018 Jul 20.

ReferenceCitation: Adams PC, Stenn PG. Liver biopsy under hypnosis. J Clin Gastroenterol. 1992 Sep;15(2):122-4.

ReferenceCitation: Kendrick C, Sliwinski J, Yu Y, Johnson A, Fisher W, Kekecs Z, Elkins G. Hypnosis for Acute Procedural Pain: A Critical Review. Int J Clin Exp Hypn. 2016;64(1):75-115. doi: 10.1080/00207144.2015.1099405. Review.

ReferenceCitation: Häuser W, Hagl M, Schmierer A, Hansen E. The Efficacy, Safety and Applications of Medical Hypnosis. Dtsch Arztebl Int. 2016 Apr 29;113(17):289-96. doi: 10.3238/arztebl.2016.0289. Review.

ReferenceCitation: Lindor KD, Bru C, Jorgensen RA, Rakela J, Bordas JM, Gross JB, Rodes J, McGill DB, Reading CC, James EM, Charboneau JW, Ludwig J, Batts KP, Zinsmeister AR. The role of ultrasonography and automatic-needle biopsy in outpatient percutaneous liver biopsy. Hepatology. 1996 May;23(5):1079-83.

ReferenceCitation: Cadranel JF, Rufat P, Degos F. [Practices of transcutaneous liver biopsies in France. Results of a retrospective nationwide study]. Gastroenterol Clin Biol. 2001 Jan;25(1):77-80. French.

ReferenceCitation: Alexander JA, Smith BJ. Midazolam sedation for percutaneous liver biopsy. Dig Dis Sci. 1993 Dec;38(12):2209-11.

ReferenceCitation: Castéra L, Nègre I, Samii K, Buffet C. Patient-administered nitrous oxide/oxygen inhalation provides safe and effective analgesia for percutaneous liver biopsy: a randomized placebo-controlled trial. Am J Gastroenterol. 2001 May;96(5):1553-7.

ReferenceCitation: Froehlich F, Lamy O, Fried M, Gonvers JJ. Practice and complications of liver biopsy. Results of a nationwide survey in Switzerland. Dig Dis Sci. 1993 Aug;38(8):1480-4.

ReferenceCitation: Faymonville ME, Laureys S, Degueldre C, DelFiore G, Luxen A, Franck G, Lamy M, Maquet P. Neural mechanisms of antinociceptive effects of hypnosis. Anesthesiology. 2000 May;92(5):1257-67.


title: Artificial Intelligence to Search for Abnormalities in Ambulatory Cancer Patients

acronym: IASAAC

summary:
During treatment, cancer patients may experience side effects related to their disease but also to the different treatments they receive.

Currently, adverse effects and toxicities are well codified in the oncology community, notably via the NCI CTCAE criteria.

Unlike objective data such as a blood sample or a CTscan, a major bias in patient assessment is the subjective assessment of the physician or its team at a given time, which may not reflect the overall situation (for better or worse). Several studies had already highlighted the discrepancies between medical and patient data collection.

Self-assessment of symptoms is one way to overcome this bias. Moreover, there are now a large number of solutions that allow to perform these self-assessments at home.

Thanks to these tools, there are now two situations, the scheduled evaluation (before a chemotherapy treatment, or after a surgical procedure for instance) and the unscheduled situations, where it is the patient himself who can trigger an evaluation form.

These new evaluation methods also allow to take a quality of life approach. Patient-reported outcomes (PROs) is now a valid evidence-based assay to detect patient's symptoms and therefore provide helpful clinical information to healthcare providers.

The goal of this study is to go one step further than the previous PROs studies and evaluate the ability to train a machine learning algorithm to detect at-risk situations and lay the foundation for a viable solution for future prospective and randomized trials.

lead_sponsor: Institut de Cancérologie de Lorraine


title: Vaso-inotropic Score and ECMO-VA Support in Post-cardiotomy Cardiogenic Shock.

acronym: ECMOVIS

summary:
Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is a well-established lifesaving treatment for refractory cardiogenic shock, with or without concomitant respiratory failure. VA-ECMO is usually started in presence of refractory low cardiac output syndrome following CPB weaning. Currently, there is no consensus about the best timing for implantation and initiation of VA-ECMO in this setting. Some publications have suggested that VIS score could be used to determine the necessity of VA-ECMO in cardiologic area. It was demonstrated that a VIS score between 20 and 40 may be a cut-off value to discuss the implantation of VA-ECMO. Post cardiotomy shock is a very interesting setting because the timing of cardiogenic shock is known and several bias are more controlled than in medical area.

Based on the well-established ability of VIS Score in predicting mortality, we will investigate the role of the VIS Score as a determinant for early VA-ECMO implantation in patients suffering of post-cardiotomy cardiogenic shock.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Prospective Evaluation of Complications of MidLine Catheters in the ICU

acronym: COMIDREA

summary:
Midline catheters (MCs) are peripheral catheters inserted into a vein in the arm above the elbow crease, with the tip in the axillary vein. As such, they do not enter the central venous circulation and are therefore not considered central venous catheters.

The main complications associated with CM are accidental removal, leakage, subcutaneous diffusion and occlusion. Severe complications include deep vein thrombosis (DVT) and catheter-related bacteremia (CRB). There is very little data on the use of CMs in intensive care units (ICU).

Resuscitation patients are more likely to develop severe catheter-related complications such as deep vein thrombosis and catheter-related infections. While the use of CMs in patients appears to be associated with a low risk of complications, this may not be the case in resuscitation patients.

Investigator therefore proposes to conduct a prospective observational study to determine the frequency and type of complications associated with CMs when they are implanted and used in ICU. In addition, investigator will attempt to determine whether risk factors predictive of complications can be identified. In addition, this study will evaluate whether the use of CMs can reduce the duration of central venous catheter maintenance in the ICU and the risk of central venous catheter-related infections.

lead_sponsor: Centre Hospitalier le Mans


title: Evaluation of the Prognostic Value of Preoperative Quadriceps and Respiratory Muscle Thickness by Ultrasound Measurement in Cardiac and Thoracic Surgery Patients: a Prospective Observational Study

acronym: MUSCA

summary:
Cardiac and thoracic surgery are major procedures. In order to estimate the operative risk, many scores have been developed, including the Euroscore 2 in cardiac surgery. However, the Euroscore has limitations since it does not assess all the parameters that may influence postoperative complications, such as the patient's general condition or the status of his or her functional reserves.

However, it has been shown that the preoperative functional reserves have a significant impact on the patient's risk of developing postoperative complications following major surgery. In addition, there is a strong association between cardiac failure and a well-described decrease in peripheral muscle lean mass (sarcopenia) in patients older than 65 years.

Usually, a nutritional assessment is performed during the pre-anesthesia consultation. This assessment is based on clinical and biological criteria that are not totally predictive of the patient's functional reserve status.

Lean body mass (muscle) is a well-validated marker for the assessment of patients' functional reserves. However, the techniques used to date are complex and require radiation.

This study aims to use ultrasound of muscle groups (respiratory muscles - Quadriceps muscle - Diaphragm) to study the relationship between preoperative muscle mass and postoperative complications in patients over 65 years of age undergoing cardiac or thoracic surgery.

This is a prospective observational study to be conducted at the Dijon University Hospital by the cardiovascular anesthesia-intensive care department. A total of 300 patients will participate in this study, and we have planned to complete the project over a 2-year period. The participating patients (if they do not present any exclusion criteria and are not opposed to inclusion) will be included and undergo a muscle ultrasound in the cardiovascular surgery department or the thoracic and pulmonary surgery department the day before their intervention.


acronym: FLUO

title: Multicenter, Randomized, Open, Phase III, Trial Assessing the Immunogenicity and Safety of Two Influenza Vaccine Strategies Among Severe Obese Adult Patients

source: euctr

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

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

summary:
Obesity has been considered as a risk factor for mortality and development of complications during infection with the influenza virus. Several case studies of severe and fatal infections have identified possible effects of obesity on disease progression; these effects include extensive viral replication in the deep lung, progression to viral pneumonia, and prolonged and increased viral shedding. These points may be linked to obesity which causes a chronic state of meta-inflammation with systemic implications for immunity: obese patients exhibit delayed and blunted innate and adaptive immune responses to influenza virus infection, and they experience poor recovery from the disease leading to an increased susceptibility to secondary bacterial infections and poor healing of the lung epithelium. Furthermore, in obese people, influenza virus may exploit the lack of antiviral pressure, generate a more virulent population and increase disease severity Due to the growing prevalence of obesity worldwide (500 million subjects in 2017), it is important to be able to offer vaccines that provide the highest protection for this at-risk population. The quadrivalent recombinant high-dose influenza vaccine has been shown to have greater immunogenicity and efficacy than standard influenza vaccine in non-obese adults older than 50 years. However, this vaccine has never been evaluated in obese subjects.

Investigators thus planned this trial to assess whether the use of the new quadrivalent recombinant high-dose influenza vaccine (RIV4) will induce a better immunological answer than current quadrivalent standard vaccine (SD) in patients with severe obesity, with an acceptable safety profile, thus leading to a better protection against influenza in this population at high risk of influenza complications.


title: Feasibility of End-tidal Oxygen Concentration Monitoring During Preoxygenation for Intubation in the Intensive Care Unit. First Part, Preliminary Study of the IMPROVE Global Project

acronym: IMPROVE-Pre

summary:
Intubation is a common procedure in the intensive care unit. Hypoxemia is the most frequent complication of this procedure.

Monitoring the end-tidal of oxygen is recommended in operating room (OR). End-tidal of oxygen (EtO2) >90% is an indication of a correct preoxygenation.

This monitoring is not used in routine in intensive care unit (ICU). There is no recommendation on the monitoring of end-tidal of oxygen in intensive care unit. In practice, clinicians use pulsed oxygen saturation (SpO2) to determine whether the patient is sufficiently preoxygenated. However, this parameter is not a good indicator of a correct preoxygenation.

In the OR, patients are compliant during the preoxygenation period and the measure of EtO2 with the face mask monitor is considered reliable because i) mask leakage is minimal and ii) the patient can breathe slowly and regularly.

Theses conditions are not available in critical ill patients requiring emergency intubation. EtO2 measured on the facemask may not reflect true EtO2.

This concern about the reliability of EtO2 measurement via the facemask justifies that we conduct a study to compare EtO2 measured on a facemask (facemask EtO2) to EtO2 measured in pharynx (via e nasopharyngeal catheter).

The aim of this study is to determine whether the measurement of EtO2 on facemask is reliable in patients in ICU.

ReferenceCitation: Carrillo A, Gonzalez-Diaz G, Ferrer M, Martinez-Quintana ME, Lopez-Martinez A, Llamas N, Alcazar M, Torres A. Non-invasive ventilation in community-acquired pneumonia and severe acute respiratory failure. Intensive Care Med. 2012 Mar;38(3):458-66. doi: 10.1007/s00134-012-2475-6. Epub 2012 Feb 9.

ReferenceCitation: Thille AW, Frat JP, Brun-Buisson C. Trends in use and benefits of non-invasive ventilation as first-line therapy in acute respiratory failure. Intensive Care Med. 2014 Aug;40(8):1179-80. doi: 10.1007/s00134-014-3370-0. Epub 2014 Jun 25.

ReferenceCitation: Ozsancak Ugurlu A, Sidhom SS, Khodabandeh A, Ieong M, Mohr C, Lin DY, Buchwald I, Bahhady I, Wengryn J, Maheshwari V, Hill NS. Use and outcomes of noninvasive positive pressure ventilation in acute care hospitals in Massachusetts. Chest. 2014 May;145(5):964-971. doi: 10.1378/chest.13-1707.

ReferenceCitation: Frat JP, Ricard JD, Quenot JP, Pichon N, Demoule A, Forel JM, Mira JP, Coudroy R, Berquier G, Voisin B, Colin G, Pons B, Danin PE, Devaquet J, Prat G, Clere-Jehl R, Petitpas F, Vivier E, Razazi K, Nay MA, Souday V, Dellamonica J, Argaud L, Ehrmann S, Gibelin A, Girault C, Andreu P, Vignon P, Dangers L, Ragot S, Thille AW; FLORALI-2 study group; REVA network. Non-invasive ventilation versus high-flow nasal cannula oxygen therapy with apnoeic oxygenation for preoxygenation before intubation of patients with acute hypoxaemic respiratory failure: a randomised, multicentre, open-label trial. Lancet Respir Med. 2019 Apr;7(4):303-312. doi: 10.1016/S2213-2600(19)30048-7. Epub 2019 Mar 18.

ReferenceCitation: Jaber S, Amraoui J, Lefrant JY, Arich C, Cohendy R, Landreau L, Calvet Y, Capdevila X, Mahamat A, Eledjam JJ. Clinical practice and risk factors for immediate complications of endotracheal intubation in the intensive care unit: a prospective, multiple-center study. Crit Care Med. 2006 Sep;34(9):2355-61.

lead_sponsor: Centre Hospitalier Régional d'Orléans


title: Pilot Study Evaluating Outpatient Management of Tubo-ovarian Abscesses

acronym: AmbATO

summary:
Pelvic inflammatory diseases (PID) require antibiotic treatment. Among PID, the investigators distinguish: pelvi-peritonitis and pelvic collections such as Douglas abscess and/or tubo-ovarian abscess (TOA).

Recent recommendations published in December 2018 by the National College of French Gynecologists and Obstetricians (CNGOF) suggest that it is preferable to drain TOA when their size is greater than 3-4 cm. Ultrasound-guided transvaginal drainage is recommended as first-line treatment because of its ease of performance and its effectiveness. In the literature, many authors have demonstrated the feasibility and efficacy of transvaginal drainage associated with antibiotics in the treatment of TOA. Since ultrasound-guided transvaginal drainage is a less invasive alternative therapeutic procedure than laparoscopy for the drainage of TOA, it would be compatible with outpatient management. This mode of management can be carried out in a dedicated outpatient or functional exploration room with the help of a nurse but without an anesthetic team present. This gesture is simple and short-lived. In addition, the antibiotics used have pharmacological properties allowing oral intake from their initiation.

The investigators have proposed a new service protocol to treat TOA in this outpatient mode. The investigators therefore wish to analyze this new protocol from these three angles: 1/ the feasibility of this care, 2/ the quality of life of the patients through questionnaires given throughout the care and 3/ an evaluation of the 'efficiency.

lead_sponsor: Nantes University Hospital


title: "ASsociation of Proteinuria and Progression of KidneY DysfunctioN in Sickle Cell Disease"

summary: To describe change in ACR and eGFR during study follow-up, and assesss the association of baseline and change in ACR and eGFR, with progression of kidney failure and/or all-cause mortality.

lead_sponsor: Soutien aux Actions contre les Maladies du Globule Rouge


title: Therapeutic Recommendations for Children Registered in the RFAOP Register and With a Hodgkin Lymphoma

summary:
The GFAOP propose a simple and reproducible staging according to clinical, biological and radiological data.

Develop standardized but different therapeutic recommendations based on the availability or lack of radiation therapy in the pilot unites who will adapt these recommendations.

lead_sponsor: French Africa Pediatric Oncology Group


title: Prevalence of Cannabidiol (CBD) Consumption and Cancer Patients' Expectations in One Oncology Day-Hospital: A Cross-sectional Study and Questionnaire Validation

acronym: CANPADIOL

summary: Alternative and complementary medicines (MAC) are commonly used by cancer patients to help them to face with anticancer treatment, reduce oncology symptoms and/or anticancer treatment adverse effects, detoxifying the body. In consistence with guidelines from the French Society for Oncology Pharmacy (SFPO), the pharmaceutical consultation includes a discussion and collection of herbs, botanical and other natural products consumed by cancer patients. This aim to prevent and manage herb-drug interaction as well as other drug-related problems (DRP). The recent French experimentation dedicated to cannabidiol for medical use could enhance interest of cancer patients in the field of MAC. However, cannabidiol have shown inhibitory effect on different cytochromes with a risk of HDI as other MAC. While the prevalence of MAC consumption is already known in some type of cancer, the consumption of CBD is less known and should be explored. Through this study we wish to know the prevalence of cannabidiol consumption in cancer patients and to establish a typical profile as well as to know the modalities of use. We also want to validate a questionnaire through a literacy scale.

lead_sponsor: CHU de Reims