title: Study of the Determinants of Pediatric Onset Inflammatory Diseases: Host-microbiota-environment Interactions

summary:
Two types of inflammatory and autoimmune diseases (excluding monogenic diseases) can be distinguished in children: those similar to adult diseases but with an early onset (type 1 diabetes, inflammatory diseases of the gastrointestinal tract, rheumatoid arthritis with anti-CCP antibodies) and those specific to children that are not described in adults (early-onset juvenile idiopathic arthritis with anti-nuclear and anterior uveitis).

The familial and nosological aggregations suggest that these diseases are probably polygenically determined, and result from interactions with the environment. In a singular way, the incidence of "adult" diseases is increasing while the age of onset is getting earlier; conversely, there is no increase in early-onset juvenile idiopathic arthritis.

On the other hand, the influence of early events that may alter the microbiotic environment is different for different diseases: whereas cesarean section (or early antibiotic therapy) has been shown to increase the risk of JIA and T1DM, it does not seem to change the risk of IBD. We hypothesize that environmental factors, particularly those related to diet and bacterial and fungal digestive microbiota - are different between these disease categories.

ReferenceCitation: Schwiertz A, Jacobi M, Frick JS, Richter M, Rusch K, Köhler H. Microbiota in pediatric inflammatory bowel disease. J Pediatr. 2010 Aug;157(2):240-244.e1. doi: 10.1016/j.jpeds.2010.02.046. Epub 2010 Apr 18.

ReferenceCitation: Rouxel O, Da Silva J, Beaudoin L, Nel I, Tard C, Cagninacci L, Kiaf B, Oshima M, Diedisheim M, Salou M, Corbett A, Rossjohn J, McCluskey J, Scharfmann R, Battaglia M, Polak M, Lantz O, Beltrand J, Lehuen A. Cytotoxic and regulatory roles of mucosal-associated invariant T cells in type 1 diabetes. Nat Immunol. 2017 Dec;18(12):1321-1331. doi: 10.1038/ni.3854. Epub 2017 Oct 9. Erratum in: Nat Immunol. 2018 Jun 7;:.

ReferenceCitation: Di Paola M, Cavalieri D, Albanese D, Sordo M, Pindo M, Donati C, Pagnini I, Giani T, Simonini G, Paladini A, Lionetti P, De Filippo C, Cimaz R. Alteration of Fecal Microbiota Profiles in Juvenile Idiopathic Arthritis. Associations with HLA-B27 Allele and Disease Status. Front Microbiol. 2016 Oct 26;7:1703. eCollection 2016.

ReferenceCitation: Defois C, Ratel J, Garrait G, Denis S, Le Goff O, Talvas J, Mosoni P, Engel E, Peyret P. Food Chemicals Disrupt Human Gut Microbiota Activity And Impact Intestinal Homeostasis As Revealed By In Vitro Systems. Sci Rep. 2018 Jul 20;8(1):11006. doi: 10.1038/s41598-018-29376-9.

lead_sponsor: University Hospital, Clermont-Ferrand


title: A Communication Tool's Evaluation on Intensive Care Patients Equipped With Ventilation Systems.

acronym: PICT'REA

summary:
PICTREA is a study evaluating the impact of a communication tool "PICT'REA" on patients in reanimation units, equipped with ventilation systems, preventing them from speaking.

The app consists of simple pictograms allowing simple communication between patients and the reanimation care team.

The study will assess the quality of communication before and after the introduction of the communication tool in the reanimation unit.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Supportive Care

enrollment_type: Anticipated

lead_sponsor: University Hospital, Toulouse

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Ongoing


title: Organizational Impact of Rapid Screening for COVID-19 by Delocalized Biology in the Birth Room

acronym: DELOCOVIDMATER

summary:
COVID-19 disease, caused by SARS-CoV-2 first appeared in China, and then spread worldwide. In December 2019, a group of patients with pneumonia of unknown origin were infected after exposure to the market in Wuhan, Hubei Province, China. Very quickly, a new coronavirus was isolated from a sample of a patient's lower respiratory tract and the complete genome of the virus was sequenced. This new coronavirus, named Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) for its genetic homology with SARS-CoV, showed a global extension. Thus, on January 30, 2020, the World Health Organization (WHO) announced the outbreak of COVID-19 as an international public health threat, and then in March 2020, the global situation escalated to a pandemic. Johns Hopkins University reported over 7,600,000 cases of infection and over 427,000 deaths as of June 13, 2020. Due to the rapid progression of the COVID-19 pandemic and the limited molecular testing capabilities at the laboratory level, the concept of molecular testing for off-site biology examination appears relevant. Indeed, the urgent need for increased testing for COVID-19 has been clearly identified as an essential element of the strategy to combat the coronavirus worldwide. Indeed, COVID-19 represents a major public health problem currently causing rapidly increasing numbers of infections and significant morbidity and mortality worldwide. As of September 3, 2021, more than 200 million people worldwide have been infected with SARS-CoV-2 and more than 4.5 million have died according to data collected by Johns Hopkins University. Early detection with a sensitive COVID-19 technique is essential to ensure rapid and appropriate patient management, contain the epidemic, and better understand the global epidemiology of the virus. To date, laboratory diagnostics have relied primarily on amplification and detection of viral gene sequences in upper respiratory tract specimens performed in a centralized laboratory. A new test (ID NOW COVID-19) is based on isothermal amplification at 56°C of the gene encoding the RdRp RNA polymerase. This molecular biology test can be performed as an off-site medical examination (EBMD), providing a result in less than 13 minutes directly in the clinical department. This rapidity could allow a more rapid management, isolation and "filiarization" of COVID-19 patients.

To our knowledge, there is no study available in the literature evaluating the impact of a rapid examination in delocalized biology on the organization of the management of pregnant women in the delivery room. The objective of this work is to evaluate the organizational impact of parturients who have received a rapid test for SARS-CoV-2.

The primary objective is to evaluate the impact of the use of the ID NOW COVID-19 test on the length of stay of parturients in the delivery room.

The secondary objectives are to evaluate the time to result, time to isolation and user satisfaction.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.

ReferenceCitation: Wu F, Zhao S, Yu B, Chen YM, Wang W, Song ZG, Hu Y, Tao ZW, Tian JH, Pei YY, Yuan ML, Zhang YL, Dai FH, Liu Y, Wang QM, Zheng JJ, Xu L, Holmes EC, Zhang YZ. A new coronavirus associated with human respiratory disease in China. Nature. 2020 Mar;579(7798):265-269. doi: 10.1038/s41586-020-2008-3. Epub 2020 Feb 3. Erratum in: Nature. 2020 Apr;580(7803):E7.

ReferenceCitation: Wu F, Zhao S, Yu B, Chen YM, Wang W, Song ZG, Hu Y, Tao ZW, Tian JH, Pei YY, Yuan ML, Zhang YL, Dai FH, Liu Y, Wang QM, Zheng JJ, Xu L, Holmes EC, Zhang YZ. Author Correction: A new coronavirus associated with human respiratory disease in China. Nature. 2020 Apr;580(7803):E7. doi: 10.1038/s41586-020-2202-3.

ReferenceCitation: Young BE, Ong SWX, Kalimuddin S, Low JG, Tan SY, Loh J, Ng OT, Marimuthu K, Ang LW, Mak TM, Lau SK, Anderson DE, Chan KS, Tan TY, Ng TY, Cui L, Said Z, Kurupatham L, Chen MI, Chan M, Vasoo S, Wang LF, Tan BH, Lin RTP, Lee VJM, Leo YS, Lye DC; Singapore 2019 Novel Coronavirus Outbreak Research Team. Epidemiologic Features and Clinical Course of Patients Infected With SARS-CoV-2 in Singapore. JAMA. 2020 Apr 21;323(15):1488-1494. doi: 10.1001/jama.2020.3204. Erratum in: JAMA. 2020 Apr 21;323(15):1510.

ReferenceCitation: Spiteri G, Fielding J, Diercke M, Campese C, Enouf V, Gaymard A, Bella A, Sognamiglio P, Sierra Moros MJ, Riutort AN, Demina YV, Mahieu R, Broas M, Bengnér M, Buda S, Schilling J, Filleul L, Lepoutre A, Saura C, Mailles A, Levy-Bruhl D, Coignard B, Bernard-Stoecklin S, Behillil S, van der Werf S, Valette M, Lina B, Riccardo F, Nicastri E, Casas I, Larrauri A, Salom Castell M, Pozo F, Maksyutov RA, Martin C, Van Ranst M, Bossuyt N, Siira L, Sane J, Tegmark-Wisell K, Palmérus M, Broberg EK, Beauté J, Jorgensen P, Bundle N, Pereyaslov D, Adlhoch C, Pukkila J, Pebody R, Olsen S, Ciancio BC. First cases of coronavirus disease 2019 (COVID-19) in the WHO European Region, 24 January to 21 February 2020. Euro Surveill. 2020 Mar;25(9). doi: 10.2807/1560-7917.ES.2020.25.9.2000178.

ReferenceCitation: Mousavi SH, Shah J, Giang HTN, Al-Ahdal TMA, Zahid SU, Temory F, Paikan FM, Karimzadeh S, Huy NT. The first COVID-19 case in Afghanistan acquired from Iran. Lancet Infect Dis. 2020 Jun;20(6):657-658. doi: 10.1016/S1473-3099(20)30231-0. Epub 2020 Mar 23.

ReferenceCitation: Silverstein WK, Stroud L, Cleghorn GE, Leis JA. First imported case of 2019 novel coronavirus in Canada, presenting as mild pneumonia. Lancet. 2020 Feb 29;395(10225):734. doi: 10.1016/S0140-6736(20)30370-6. Epub 2020 Feb 13. Erratum in: Lancet. 2020 Feb 29;395(10225):e41.

ReferenceCitation: Holshue ML, DeBolt C, Lindquist S, Lofy KH, Wiesman J, Bruce H, Spitters C, Ericson K, Wilkerson S, Tural A, Diaz G, Cohn A, Fox L, Patel A, Gerber SI, Kim L, Tong S, Lu X, Lindstrom S, Pallansch MA, Weldon WC, Biggs HM, Uyeki TM, Pillai SK; Washington State 2019-nCoV Case Investigation Team. First Case of 2019 Novel Coronavirus in the United States. N Engl J Med. 2020 Mar 5;382(10):929-936. doi: 10.1056/NEJMoa2001191. Epub 2020 Jan 31.

ReferenceCitation: Kim JY, Choe PG, Oh Y, Oh KJ, Kim J, Park SJ, Park JH, Na HK, Oh MD. The First Case of 2019 Novel Coronavirus Pneumonia Imported into Korea from Wuhan, China: Implication for Infection Prevention and Control Measures. J Korean Med Sci. 2020 Feb 10;35(5):e61. doi: 10.3346/jkms.2020.35.e61.

ReferenceCitation: Ghinai I, McPherson TD, Hunter JC, Kirking HL, Christiansen D, Joshi K, Rubin R, Morales-Estrada S, Black SR, Pacilli M, Fricchione MJ, Chugh RK, Walblay KA, Ahmed NS, Stoecker WC, Hasan NF, Burdsall DP, Reese HE, Wallace M, Wang C, Moeller D, Korpics J, Novosad SA, Benowitz I, Jacobs MW, Dasari VS, Patel MT, Kauerauf J, Charles EM, Ezike NO, Chu V, Midgley CM, Rolfes MA, Gerber SI, Lu X, Lindstrom S, Verani JR, Layden JE; Illinois COVID-19 Investigation Team. First known person-to-person transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the USA. Lancet. 2020 Apr 4;395(10230):1137-1144. doi: 10.1016/S0140-6736(20)30607-3. Epub 2020 Mar 13.

ReferenceCitation: Wiersinga WJ, Rhodes A, Cheng AC, Peacock SJ, Prescott HC. Pathophysiology, Transmission, Diagnosis, and Treatment of Coronavirus Disease 2019 (COVID-19): A Review. JAMA. 2020 Aug 25;324(8):782-793. doi: 10.1001/jama.2020.12839. Review.

ReferenceType: result

ReferenceCitation: Organizational impact of an ID NOW™ COVID-19 point-of-care testing for SARS-CoV2 detection in a maternity ward Jean-Claude Nguyen Van, Benoît Pilmis, Amir Khaterchi, Olivier Billuart, Gauthier Péan De Ponfilly, Alban Le Monnier, Elie Azria, Assaf Mizrahi

lead_sponsor: Groupe Hospitalier Paris Saint Joseph

status_simplified: Completed


title: Interest of a Highly Cross-linked Polyethylene Acetabular Component Doped With Vitamin E in Total Hip Arthroplasty of the Young and Active Subject

acronym: ICARE

summary: Interest of a highly cross-linked polyethylene acetabular component doped with vitamin E in total hip arthroplasty of the young and active subject.

study_start_date_type: Anticipated

status: Not yet recruiting

design_allocation: Randomized

primary_purpose: Prevention

ipd_sharing: No

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

intervention_type: Device

lead_sponsor_type: industriel


title: Assessment of "Gut Feelings" Accuracy Regarding the Effect of Professional Experience in General Practitioners in Clinical Decision Making

acronym: EGFGP

summary:
Knowledge, experience and professional development limit the risk of diagnostic error for the clinician in daily practice. However, research has shown that other non-analytical factors are involved in clinical decision making. Intuition (or "gut feelings") is a subjective element involved in medical decision-making, and its place and relevance are being explored. The concept of "gut feelings" comes from General Practitioners (GPs) themselves and their description of their own practice. Several studies have shown its place in medical decision-making models, particularly in the face of diagnostic uncertainty.

A questionnaire used as a standardized measurement tool for gut feelings was created to address this issue. The Gut Feelings Questionnaire (GFQ) has been translated into French, German and Polish during a standardized linguistic validation procedure. It is currently validated and available in five languages. The QGF has been tested and validated in clinical practice by Belgian, French and Dutch physicians. Its feasibility has been evaluated in these three health systems.

The Gut Feelings Questionnaire was used in a prospective study to determine the accuracy of the sense of alarm in patients consulting their GP for chest pain and/or dyspnea. But the role of the practitioner's experience has not been studied: is the gut feeling more accurate in experienced GPs than in first semester interns in general practice?

time_perspective: Prospective

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Assessment of the Ionizing Radiation Received by the Patient and the Nursing Staff During Percutaneous or Conventional Surgery of Hallux Valgus

acronym: RADUS

summary: To assess the average whole body radiation dose received by the surgeon, the operating team and the patient during hallux valgus surgery, depending on whether the surgery is percutaneous or conventional.

intervention_type: Radiation


type: Other Identifier

title: Imaging Biomarkers in Spastic Paraplegia Type 5

acronym: SPIMA

summary: This is a research study aiming to identify imaging biomarkers in patients diagnosed with spastic paraplegia type 5 (SPG5)

ipd_sharing: Undecided

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Tracheal Intubation in Emergency Prehospital Setting. Impact of the Bougie on the Failure Rate of First Intubation Attempt.

summary:
Tracheal intubation in an out-of-hospital setting is a frequent and potentially difficult procedure. The risk of adverse events increases dramatically with the number of attempts. The failure rate of the first intubation attempt ranges from 5 to 32% and the risk factors are unclear.

In recent study, the prevalence of a failed first intubation attempt was 31.4% [95% CI = 30.2-32.6] among 1546 patients managed in an out-of-hospital setting. In this multicenter study, our center (N=462) had a rate of 36% of failure of the first attempt. Seven variables were independently associated with a failed first intubation attempt. Some of the associated factors can be improved (operator training and experience), but most cannot. Moreover some of them can not be anticipated in this context. A randomized control trial performed in an emergency department and a prospective, observational, pre-post study design showed that systematic use of a bougie during the first intubation attempt improved the success rate.

Our objective is to measure the impact of a modification of our intubation modalities introducing the incitation of the use of the bougie on the first intubation attempt in the prehospital setting.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de BORDEAUX - Hôpital Pellegrin - Pôle Urgences adultes - SAMU


title: Enhanced Recovery Program After a Robotic-assisted Surgery (RAAC) of Radical Prostatectomy. PROSTA-RAAC

acronym: PROSTA-RAAC

summary:
There are few published data on the benefit of Enhanced recovery program in radical prostatectomy in the management of localized prostate cancer. All the studies available on the subject are retrospective (1-3).

This randomized comparative study is proposed in order to compare in a homogeneous population (place and time) the interest of RAAC specifically in this surgery.

primary_purpose: Treatment

lead_sponsor: Elsan

intervention_type: Behavioral


title: A Dose-randomized, Double-blind, Placebo-controlled, Single- and Multiple-dose, Dose-escalation, Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic of JP-2266 in Healthy Subjects

summary: Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Characteristics of JP-2266 after Oral Administration in Healthy Male Caucasian Subjects

lead_sponsor: Jeil Pharmaceutical Co., Ltd.

intervention_type: Drug


title: Efficacy of Endocare Treatment at Home on Pain in Women With Chronic Pelvic-perineal Pain Related to Endometriosis. EndoHome.

summary:
Women with endometriosis experience recurrent pelvic-perineal pain impairing the quality of life, among other things. Endometriosis-related pain negatively impacts the sexual, family and work life.

Apart from the usual painkillers, the doctor's current therapeutic arsenal is limited to hormonal contraceptives and surgery. As endometriosis-related treatments do not currently address all of the patients' problems, developing a new, effective, non-pharmaceutical treatment would make it possible to relieve the pain of these women.

Endocare treatment consists of visual and auditory therapeutic procedures for pelvic-perineal pain in patients with endometriosis.

Moreover, as Endocare is not a pharmacological molecule but a digital therapy, it would not increase the consumption of pharmacological agents. An analgesic effect of Endocare lasting several hours on chronic pelvic-perineal pain associated with endometriosis is expected.

The effects of the treatment will be compare to a digital control also integrated in a virtual reality headset identical to the one distributing Endocare allowing to maintain the blindness to the patients and the investigator on the treatment received.

lead_sponsor: Lucine


type: Registry Identifier

title: Proof-of-concept Study to Assess Urinary PGE-MUM Concentration (PROSTAGLANDIN E-MAJOR URINARY METABOLITE) as a Potential Marker of Inflammation in Inflammatory Bowel Disease (IBD) - Comparison With Fecal Calprotectin Level (FC)

acronym: MICIMUM

summary: The inflammatory bowel diseases (IBD) are lifelong, relapsing-remitting diseases. As the timing of relapse is unpredictable, and current monitoring is symptoms-based, there remains a window between the initial upregulation of the inflammatory response and the onset of clinical symptoms at which point the inflammatory episode is well established. The use of endoscopy as means of predicting relapse is not suitable for regular use. The potential role of Fecal calprotectin (FC) in IBD in predicating the risk of relapse has been well investigated with key studies. Its fecal concentration is proportional to neutrophilic influx into the intestinal tract, which is a feature of active IBD. FC correlates well with the severity of endoscopic lesions. After excretion, FC remains stable in the feces for 1 week at room temperature. However, its considerable daily variation suggests interfering factors discrete from inflammatory disease. There is increasing research into novel markers with high correlation to the presence of mucosal healing constitute a cost-effective substitute to repeated endoscopies. Recent studies have reported that the prostaglandin E-major urinary metabolite (PGE-MUM) level was significantly higher in the active phase of patients with ulcerative disease (UC) than those in the remission phase. In the active UC phase, the stimulation of inflammatory cytokines, such as tumor necrosis factor-α, leads to the upregulation of cyclooxygenase-2 (COX-2) leading to PGE2 secretion in mucosal tissue. PGE2 plays an important role in the progression of inflammation. A precise measure of serum PGE2 is difficult due to the short half-life of PGE2 in the blood. Conversely, the urinary metabolite of prostaglandin E-major (PGE-MUM, 7-hydroxy-5,11-diketotetranor-prosta-1,16-dioic acid) is stable and may reflects the histological severity of inflammation. The aim of this concept study is to evaluate the PGE-MUM concentration in urine of patients with IBD in parallel with the standard investigation of Calprotectin in stool and to assess if urinary PGE-MUM should be able to serve as a simple and robust substitutive biomarker for the non-invasive evaluation of the inflammation of the mucous membrane tissues. The measurement of PGE-MUM in urine could give patients with IBD more comfort than the measurement of calprotectin in stool.

location_facility: Service de biochimie clinique - Hôpital Beaujon

intervention_type: Biological


title: Scleroderma: Description of Functional Disability Between the Dominant and Contralateral Hand, a Single-centre Descriptive Cohort.

acronym: SCLERO-HAND

summary: Systemic sclerosis is an autoimmune disease in which the hand is responsible for 75% of the overall disability. Management is based on systemic treatments combined with kinesitherapy aimed at maintaining joint amplitudes, improving muscle strength and preventing stiffness. The aim of this study is to describe and compare the average spontaneous and attempted reduction range of motion limitations between the dominant and contralateral hand.

lead_sponsor: University Hospital, Limoges

intervention_type: Diagnostic Test


title: A Prospective Cohort Survey of Foot and Leg Chronic Wounds Followed up to 20 Weeks After Initiation of CACIPLIQ20® add-on to Optimal Local Care

acronym: MATHCOW

summary:
CACIPLIQ20® is currently a class III CE marked medical device available in various European and non-European countries, and currently primarily used in managing hard-to-heal wounds.

This study is a prospective and standardized recording of patients' data followed in real-life conditions to appreciate the benefits of a therapeutic strategy including CACIPLIQ20® use. It also aims at collecting data to follow-up the device's efficacy and safety and estimate its cost-effectiveness.

lead_sponsor: Organ, Tissue, Regeneration, Repair and Replacement


title: Clariance Registry of ERISMA® and Idys® Devices

acronym: ErYs

summary:
International, prospective, single arm, multicenter and observational Post-Market Clinical Follow-up (PMCF).

The overall objective of this study is to collect preoperative, intraoperative and postoperative (at 9 weeks, 6 months, 1 year and 2 years) data on the clinical complications and functional outcomes of the study devices to demonstrate safety and performance in a real-world setting.

The primary objective is to demonstrate that the use of the study devices is safe.

The secondary objective is to demonstrate that the use of the study devices decreases the pain, and improves the quality of life and the daily activities of the subjects.

lead_sponsor: Clariance

intervention_type: Procedure


title: Cracking the Code of Crying Babies: How Familiarity Changes the Interpretation of Cries

acronym: BEBEDOL

summary: Understanding babies' signals is essential to meet their needs. Recent works suggest that crying provides useful information, not only allowing parents to recognize their baby among others (static information), but also to distinguish between mild discomfort and pain cries (dynamic information). The perception of this information by adults involves a "parental" brain network including brain areas involved in empathy, attention, emotional regulation, motor as well as regions of the limbic system or associated with the reward network.

primary_purpose: Basic Science

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Comparative Study of the Results of Trapeziometacarpal Prostheses According to the Preoperative Deformation

summary: Trapezometacarpal protheses are implanted for patients with trapezometacarpal arthritis. Having a pre-operative thumb adduction angle of less than 25 degrees with hyperextension, meaning a " Z-deformity " are somehow a reason to go for another surgical treatment: trapezectomy with ligament reconstruction. This study will aim at analyzing the results of another surgical treatment which is the trapezometacarpal arthroplasty in this type of deformities.

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier


title: The Effectiveness of the Elastic Component of the Multilayer Bandage in the Treatment of Patients With Lymphedema at the University Hospital of Montpellier : a Randomised Clinical Study

summary:
The study is a cohort study of patients at the University Hospital during the first two days of intensive treatment. The patients are randomly divided into two groups (N=10).

Throughout the study, group A is treated with the multilayer elastic bandage while group B is bandaged with contention only. The bandages were applied on the first and second day and were maintained in place. The bandages were applied on the first and second day and were maintained for 24 hours. All patients performed 30 minutes of physical activity in the bandage on both days.

The evaluation is based on the volumetric difference, skin quality and quality of life of these patients


title: Apparent Characteristics of Genealogical Representations of Perpetrators of Sexual Violence.

acronym: CARG-AVS

summary:
Two French studies report that 25% of sexual abuse occurs in intrafamily sphere. To be victim of sexual abuse leads to cognitive troubles and redesign of psychological processes. Lot of studies report that offenders had been victims (30-97%). How psychological redesign is destroying genealogical representation and hinders the proper construction of family ties.

This study to study characteristics data about family, and how the patients see it, from medical records of a specific department for sexual offenders in University Hospital of Saint Etienne. Study is realized blind from criminal categories. Data are gathered with a standardized grid, to guarantee reproducibility of data collection.


title: Frequency, Consequences, and Determinants of Suboptimal Care in the Initial Care Pathway of Child Physical Abuse: a Confidential Prospective Population-based Study in the French Western Region

acronym: DIAPED

summary: Physical abuse is a significant cause of morbidity and mortality in the general child population. There are no data specific to the French child care and protection systems, and very few studies have examined the optimality of protective measures following a diagnosis of child physical abuse. the investigators propose to conduct a confidential, prospective, population-based study, in order to assess the frequency of suboptimal care, to describe the typology of suboptimal care, to assess the immediate consequences of suboptimal care on the health of the child, and to identify the determinants of suboptimal care.

lead_sponsor: Nantes University Hospital


title: Pilot Study of the Ambulatory Monitoring Evaluation of a Mindfulness Meditation Programme in Parkinsonian Tremor

acronym: MEDITAPARK

summary: Mindfulness meditation is an approach that has shown interest in treatment of anxiety in Parkinson's disease. This pilot study aims to assess a more specific effect on tremor using Essential Tremor Embarrassment Assessment and inertial sensors allowing monitoring during sessions and in daily life. This study will focus on 20 patients (10 with and without Mindfulness based intervention and will aim to develop the interface and demonstrate proof of concept before setting up a controlled study

primary_purpose: Other


title: Adherence Assesment for Diuretics in Patients Suffering From Precapillary Pulmonary Hypertension

acronym: PHARE

summary:
In this prospective study, the investigators will implement a systematic assessment of adherence to diuretics in a cohort of patients with precapillary pulmonary hypertension.

This study is designed to:

determine the overall adherence rates for diuretic regimen
determine the determinants of non-adherence to diuretics
assess the risk of PH worsening occurrence in the non-adhesion group

location_facility: Hospital Bicêtre - Pneumology department


title: Prospective Study to Investigate Changes in Both Brain and Behavior and Its Underlying Neural Correlates in Human Infants

acronym: MultiLongDev

summary: The unique importance of human brain development during the first years of life is unquestionable. During an infant's first year, the brain undergoes its most dramatic structural and functional changes, with factors such as early social experience having a significant effect on this development. This study proposes to investigate changes in both brain and behavior across the first 12 months of life. At three time points (~3, 6, and 12 month), anatomical and diffusion magnetic resonance imaging (MRI), resting state functional magnetic resonance imaging (fMRI), electroencephalography (EEG), eye tracking, and observational data will be obtained from the same sample of infants. These measures will be used to track the development of important sensorimotor, socio-emotional, and cognitive skills and their underlying neural correlates, as well as investigate the effects of early social experience on specific aspects of this development

lead_sponsor: Hospices Civils de Lyon

location_facility: Institut des Sciences Cognitives (ISC) Laboratoire CNRS UMR6229


title: Multicentric Evaluation of the Impact on Hypoxia Sensitivity of Patients With COVID-19

acronym: CORONALTITUDE

summary:
In this study, the investigators will examine the extent to which having suffered coronavirus disease 2019 (COVID19) impacts one's sensibility to hypoxia by means of the 'Richalet test'. The aim of the study is to formulate recommendations for advice in altitude mountain medicine for patients having suffered COVID19. To determine any eventual changes in response to hypoxia, performances by participants having suffered COVID-19 and participants having stayed free of COVID-19 will be both compared intra-individually with previous performances (pre-COVID-19 pandemic) and between both groups of subjects. The investigators hypothesize that patients having suffered COVID19 might perform differently on the cardiopulmonary exercise test compared to before the illness. Based on recent research on COVID19 pathophysiology and -patient follow-up, it might be expected that COVID19 alters the response to hypoxia, thus influencing one's acclimatization capabilities at high altitude, albeit reversibly and/or temporarily.

Different alterations of response to hypoxia could be observed. The virus causing COVID19, the "severe acute respiratory syndrome coronavirus 2" (SARS-CoV-2), has the potential to significantly damage the nervous system and to affect cardiorespiratory functions. If SARS-CoV-2 does, similarly to MERS and SARS, induce cardiorespiratory and neurological dysfunction, then COVID19 patients may have impaired hypoxia response after infection and perform worse on the 'Richalet test' in comparison to before the illness.

Conversely, reports of high prevalence of dyspnea in patients up to 3 months after SARS-CoV-2 infection, might indicate infection-induced degenerative changes in the carotid bodies, which might lead to sensibilization of the peripheral chemoreceptors to impaired oxygenation. Possibly similar to the impact of aging and smoking on the cardiorespiratory response to hypoxia, this phenomenon of sensibilization could entail an increased hypoxic response in patients having suffered COVID-19. Accordingly, patients might perform better on the 'Richalet test' post-COVID-19 than they did before.

primary_purpose: Screening

ReferenceCitation: Richalet JP, Pillard F, LE Moal D, Rivière D, Oriol P, Poussel M, Chenuel B, Doutreleau S, Vergès S, Demanez S, Vergnion M, Boulet JM, Douard H, Dupré M, Mesland O, Remetter R, Lonsdorfer-Wolf E, Frey A, Vilcoq L, Nedelec Jaffuel A, Debeaumont D, Duperrex G, Lecoq F, Hédon C, Hayot M, Giardini G, Lhuissier FJ. Validation of a Score for the Detection of Subjects with High Risk for Severe High-Altitude Illness. Med Sci Sports Exerc. 2021 Jun 1;53(6):1294-1302. doi: 10.1249/MSS.0000000000002586.

ReferenceCitation: Richalet JP, Canoui-Poitrine F. Pro: hypoxic cardiopulmonary exercise testing identifies subjects at risk for severe high altitude illnesses. High Alt Med Biol. 2014 Sep;15(3):315-7. doi: 10.1089/ham.2014.1032.

ReferenceCitation: Cao Y, Liu X, Xiong L, Cai K. Imaging and clinical features of patients with 2019 novel coronavirus SARS-CoV-2: A systematic review and meta-analysis. J Med Virol. 2020 Sep;92(9):1449-1459. doi: 10.1002/jmv.25822. Epub 2020 Apr 10.

ReferenceCitation: Huang C, Huang L, Wang Y, Li X, Ren L, Gu X, Kang L, Guo L, Liu M, Zhou X, Luo J, Huang Z, Tu S, Zhao Y, Chen L, Xu D, Li Y, Li C, Peng L, Li Y, Xie W, Cui D, Shang L, Fan G, Xu J, Wang G, Wang Y, Zhong J, Wang C, Wang J, Zhang D, Cao B. 6-month consequences of COVID-19 in patients discharged from hospital: a cohort study. Lancet. 2021 Jan 16;397(10270):220-232. doi: 10.1016/S0140-6736(20)32656-8. Epub 2021 Jan 8.

ReferenceCitation: Higgins V, Sohaei D, Diamandis EP, Prassas I. COVID-19: from an acute to chronic disease? Potential long-term health consequences. Crit Rev Clin Lab Sci. 2021 Aug;58(5):297-310. doi: 10.1080/10408363.2020.1860895. Epub 2020 Dec 21. Review.

ReferenceCitation: Luks AM, Grissom CK. Return to High Altitude After Recovery from Coronavirus Disease 2019. High Alt Med Biol. 2021 Jun;22(2):119-127. doi: 10.1089/ham.2021.0049. Epub 2021 May 11.

ReferenceCitation: Canouï-Poitrine F, Veerabudun K, Larmignat P, Letournel M, Bastuji-Garin S, Richalet JP. Risk prediction score for severe high altitude illness: a cohort study. PLoS One. 2014 Jul 28;9(7):e100642. doi: 10.1371/journal.pone.0100642. eCollection 2014.

ReferenceCitation: Coustet B, Lhuissier FJ, Vincent R, Richalet JP. Electrocardiographic changes during exercise in acute hypoxia and susceptibility to severe high-altitude illnesses. Circulation. 2015 Mar 3;131(9):786-94. doi: 10.1161/CIRCULATIONAHA.114.013144. Epub 2015 Jan 5.

ReferenceCitation: Richalet JP, Larmignat P, Poitrine E, Letournel M, Canouï-Poitrine F. Physiological risk factors for severe high-altitude illness: a prospective cohort study. Am J Respir Crit Care Med. 2012 Jan 15;185(2):192-8. doi: 10.1164/rccm.201108-1396OC. Epub 2011 Oct 27.

ReferenceCitation: Algahtani H, Subahi A, Shirah B. Neurological Complications of Middle East Respiratory Syndrome Coronavirus: A Report of Two Cases and Review of the Literature. Case Rep Neurol Med. 2016;2016:3502683. doi: 10.1155/2016/3502683. Epub 2016 Apr 28.

ReferenceCitation: Desforges M, Le Coupanec A, Dubeau P, Bourgouin A, Lajoie L, Dubé M, Talbot PJ. Human Coronaviruses and Other Respiratory Viruses: Underestimated Opportunistic Pathogens of the Central Nervous System? Viruses. 2019 Dec 20;12(1). pii: E14. doi: 10.3390/v12010014. Review.

ReferenceCitation: Li YC, Bai WZ, Hashikawa T. The neuroinvasive potential of SARS-CoV2 may play a role in the respiratory failure of COVID-19 patients. J Med Virol. 2020 Jun;92(6):552-555. doi: 10.1002/jmv.25728. Epub 2020 Mar 11. Review.

ReferenceCitation: Montalvan V, Lee J, Bueso T, De Toledo J, Rivas K. Neurological manifestations of COVID-19 and other coronavirus infections: A systematic review. Clin Neurol Neurosurg. 2020 Jul;194:105921. doi: 10.1016/j.clineuro.2020.105921. Epub 2020 May 15.

ReferenceCitation: Ellul MA, Benjamin L, Singh B, Lant S, Michael BD, Easton A, Kneen R, Defres S, Sejvar J, Solomon T. Neurological associations of COVID-19. Lancet Neurol. 2020 Sep;19(9):767-783. doi: 10.1016/S1474-4422(20)30221-0. Epub 2020 Jul 2. Review.

ReferenceCitation: Salehi S, Reddy S, Gholamrezanezhad A. Long-term Pulmonary Consequences of Coronavirus Disease 2019 (COVID-19): What We Know and What to Expect. J Thorac Imaging. 2020 Jul;35(4):W87-W89. doi: 10.1097/RTI.0000000000000534. Review.

ReferenceCitation: Huang Y, Tan C, Wu J, Chen M, Wang Z, Luo L, Zhou X, Liu X, Huang X, Yuan S, Chen C, Gao F, Huang J, Shan H, Liu J. Impact of coronavirus disease 2019 on pulmonary function in early convalescence phase. Respir Res. 2020 Jun 29;21(1):163. doi: 10.1186/s12931-020-01429-6.

ReferenceCitation: Zhao YM, Shang YM, Song WB, Li QQ, Xie H, Xu QF, Jia JL, Li LM, Mao HL, Zhou XM, Luo H, Gao YF, Xu AG. Follow-up study of the pulmonary function and related physiological characteristics of COVID-19 survivors three months after recovery. EClinicalMedicine. 2020 Aug;25:100463. doi: 10.1016/j.eclinm.2020.100463. Epub 2020 Jul 15.

ReferenceCitation: Zubieta-Calleja G, Zubieta-DeUrioste N. Pneumolysis and "Silent Hypoxemia" in COVID-19. Indian J Clin Biochem. 2021 Jan;36(1):112-116. doi: 10.1007/s12291-020-00935-0. Epub 2020 Nov 9.

ReferenceCitation: Zubieta-Calleja G, Zubieta-DeUrioste N, Venkatesh T, Das KK, Soliz J. COVID-19 and Pneumolysis Simulating Extreme High-altitude Exposure with Altered Oxygen Transport Physiology; Multiple Diseases, and Scarce Need of Ventilators: Andean Condor's-eye-view. Rev Recent Clin Trials. 2020;15(4):347-359. doi: 10.2174/1574887115666200925141108. Review.

ReferenceCitation: Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum in: JAMA. 2021 Mar 16;325(11):1113.

ReferenceCitation: Mao L, Jin H, Wang M, Hu Y, Chen S, He Q, Chang J, Hong C, Zhou Y, Wang D, Miao X, Li Y, Hu B. Neurologic Manifestations of Hospitalized Patients With Coronavirus Disease 2019 in Wuhan, China. JAMA Neurol. 2020 Jun 1;77(6):683-690. doi: 10.1001/jamaneurol.2020.1127.

ReferenceCitation: Nouri-Vaskeh M, Sharifi A, Khalili N, Zand R, Sharifi A. Dyspneic and non-dyspneic (silent) hypoxemia in COVID-19: Possible neurological mechanism. Clin Neurol Neurosurg. 2020 Nov;198:106217. doi: 10.1016/j.clineuro.2020.106217. Epub 2020 Sep 9. Review.

ReferenceCitation: Couzin-Frankel J. The mystery of the pandemic's 'happy hypoxia'. Science. 2020 May 1;368(6490):455-456. doi: 10.1126/science.368.6490.455.

ReferenceCitation: Carfì A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.

ReferenceCitation: Goertz YMJ, Van Herck M, Delbressine JM, Vaes AW, Meys R, Machado FVC, Houben-Wilke S, Burtin C, Posthuma R, Franssen FME, van Loon N, Hajian B, Spies Y, Vijlbrief H, van 't Hul AJ, Janssen DJA, Spruit MA. Persistent symptoms 3 months after a SARS-CoV-2 infection: the post-COVID-19 syndrome? ERJ Open Res. 2020 Oct 26;6(4):00542-2020. doi: 10.1183/23120541.00542-2020. eCollection 2020 Oct.

ReferenceCitation: Richalet JP, Lhuissier FJ. Aging, Tolerance to High Altitude, and Cardiorespiratory Response to Hypoxia. High Alt Med Biol. 2015 Jun;16(2):117-24. doi: 10.1089/ham.2015.0030. Epub 2015 May 6.

ReferenceCitation: Hackett PH, Roach RC. High-altitude illness. N Engl J Med. 2001 Jul 12;345(2):107-14. Review.

ReferenceCitation: Neubauer JA, Melton JE, Edelman NH. Modulation of respiration during brain hypoxia. J Appl Physiol (1985). 1990 Feb;68(2):441-51. Review.

ReferenceCitation: Bärtsch P, Swenson ER. Clinical practice: Acute high-altitude illnesses. N Engl J Med. 2013 Jun 13;368(24):2294-302. doi: 10.1056/NEJMcp1214870. Review.

ReferenceCitation: Lovis A, Gabus V, Daucourt C, De Riedmatten M, Sartori C. [Hypoxic tests and prediction of high altitude illnesses]. Rev Med Suisse. 2019 May 1;15(649):917-922. French.

ReferenceCitation: Hohenhaus E, Paul A, McCullough RE, Kücherer H, Bärtsch P. Ventilatory and pulmonary vascular response to hypoxia and susceptibility to high altitude pulmonary oedema. Eur Respir J. 1995 Nov;8(11):1825-33.

ReferenceCitation: Schoene RB, Roach RC, Hackett PH, Sutton JR, Cymerman A, Houston CS. Operation Everest II: ventilatory adaptation during gradual decompression to extreme altitude. Med Sci Sports Exerc. 1990 Dec;22(6):804-10.

ReferenceCitation: Hackett PH. The cerebral etiology of high-altitude cerebral edema and acute mountain sickness. Wilderness Environ Med. 1999 Summer;10(2):97-109. Review.

ReferenceCitation: Basnyat B, Cumbo TA, Edelman R. Infections at high altitude. Clin Infect Dis. 2001 Dec 1;33(11):1887-91. Epub 2001 Oct 19. Review.

ReferenceCitation: Song TT, Bi YH, Gao YQ, Huang R, Hao K, Xu G, Tang JW, Ma ZQ, Kong FP, Coote JH, Chen XQ, Du JZ. Systemic pro-inflammatory response facilitates the development of cerebral edema during short hypoxia. J Neuroinflammation. 2016 Mar 11;13(1):63. doi: 10.1186/s12974-016-0528-4.

location_facility: Institut de Formation et de Recherche en Médecine de Montagne (IFREMMONT)


title: Consequences of Eccentric Cycling on Exercise-related Neuromuscular Responses and Biomarkers in Breast Cancer Patients

summary:
This is a monocentric, prospective and interventional study aimed to investigating the physiological responses of eccentric compared to concentric cycling realized 1) at the same metabolic demand and 2) at the same mechanical power output. In order to compare the physiological responses between these two cycling modalities, 3 cycling sessions should be performed for each patient where concentric one will serve as reference / comparison to the eccentric one:

Session (a): eccentric cycling
Session (b): high intensity concentric cycling realized at the same mechanical power output than eccentric cycling
Session (c): low intensity concentric cycling realized at the same metabolic demand than eccentric cycling The 3 sessions will be performed for each patient and order will be randomized.

lead_sponsor: Institut de cancérologie Strasbourg Europe


title: Evaluation and Monitoring of the Protocol for the Management of Post Operative Atrial Fibrillation Based on Intravenous Beta-blockers in Cardiac Surgery

acronym: ETOFIB

summary:
Objectives The aims of this study is to evaluate the efficacy and tolerance of our post-operative AF management protocol after cardiac surgery, including beta-blockers, digoxin, amiodarone.

Methods This study concerns patients From brest university Hospital who underwent cardiac surgery between November 2019 and November 2021. Patients with a previous history of atrial arrhythmias were excluded. The primary endpoint is assess effectiveness of service protocol to maintain cardiac frequency below. 110 bpm. The secondary endpoints included hemodynamic tolerance and outcomes.

location_facility: CHRU de Brest - Service d'anesthésie-Réanimation


title: Local Undertaking of Resected Non-small Cell Lung Cancer by Generating a Residual Disease Outline Based on Circulating Cell-free DNA

acronym: LUNGDOC

summary: Prognosis of resectable early stages NSCLC might be improved by a better knowledge of post-operative minimal residual disease (MRD). This could be achieved by studying patient with stage I to IIIA completely resected-NSCLC, comparing qualitative and quantitative features of pre- and post-operative circulating cell-free DNA (cirDNA), using MiTest. We assume that the evolution of the parameters of MiTest and relapse rate after surgery are related and expect to prove that normalization of MiTest at one month after surgery is a prognostic factor of reduced relapse at one year.


title: Identification of Genetic Mutations Involved in Chiari Type I Malformations

acronym: ChiariGene

summary:
Although most cases of Chiari malformation type I (CM1) are sporadic, familial cases of CM1, with or without syringomyelia, suggest a genetic cause in the pathogenesis of these malformations.

The hypothesis is that there is one or more genes, in particular among those involved in the development of the axial skeleton and the cranium, which could lead to an abnormal morphology of the posterior fossa resulting in tonsillar herniation defining CM1.

The abnormal circulation of cerebrospinal fluid due to tonsillar herniation is believed to be responsible, in some patients whose predisposing factors remain to be determined, for the progressive onset of associated syringomyelia.

Since the determinants underlying the development of the posterior fossa of the skull are multigenic, the analysis of familial cases would make it possible to reduce genetic and phenotypic heterogeneity allowing to identify common pathogenic variants.

For this study the investigators will be taking a blood sample to perform whole exome sequencing, build a biological collection and record imaging and clinical data.

intervention_type: Genetic


title: Assessment of Cardiac Output by Transpulmonary Thermodilution and Pulse Contour Analysis in Patients With ARDS Implanted by Venous-venous ECMO

acronym: PiCCMO

summary:
In patients with severe acute respiratory distress syndrome, extracorporeal membrane oxygenation (ECMO), which also as known as extracorporeal life support, may be used. This technique helps the lungs by providing oxygenation to the blood via an external gas exchanger and thus participates partially or fully in gas exchange. The ECMO device includes a pump for draining and returning blood at a certain blood flow rate (ECMO blood flow). An ECMO rate that is adapted to the patient's cardiac output (CO) is essential for effective oxygenation for patients. The objective for clinicians is an ECMO blood flow to cardiac output ≥40%, which can go up to 100% as needed. In addition to the expected benefit in the management of the patient with ARDS, measuring CO is, therefore, all the more important in patients requiring ECMO.

Monitoring CO in a patient with ECMO is not only for determining the minimum ECMO blood flow rate but also for optimizing the functioning of the ECMO. However, the validity of techniques for measuring CO in patients with ECMO has been poorly studied. The reliability of the CO measurement by transpulmonary thermodilution is questioned since the extracorporeal circulation may influence the pathway of cold indicator injected into the patients' circulation and the thermodilution curve measured from the femoral arterial is thereby modified.

location_facility: Service de médecine intensive-réanimation de l'Hôpital Bicêtre


title: Didgeridoo Treatment to Improve Pharyngeal Compliance in Obstructive Sleep Apnea-hypopnea Syndrome in Children: Proof-of-concept Study

acronym: SASDICO

summary:
The therapeutic management of Obstructive Sleep Apnoea Syndrome in children remains a debated subject, only otorhinolaryngology surgery (adenoidectomy) has been studied on a large scale. Pathophysiologically, increased pharyngeal collapsibility is a major endotype of the disease and the investigators have shown that this surgery can improve pharyngeal compliance. The development of approaches to treat pharyngeal hypotonia by maxillofacial rehabilitation supports the treatment of this endotype. A study in adults showed a benefit from playing the didgeridoo, a wind instrument, for 3 months, without pathophysiological explanation. The investigators hypothesise that playing this instrument improves pharyngeal compliance (re-education effect) in a similar way to the effect observed after otorhinolaryngology surgery.

This proof-of-concept study aims to demonstrate the effect of didgeridoo in children without syndromic pathology with a formal otorhinolaryngology surgical indication resulting from tonsillar hypertrophy (Brodsky grades III and IV) and symptomatology suggestive of Obstructive Sleep Apnoea Syndrome (Pediatric Sleep Questionnaire score ≥ 0.33). The investigators will take advantage of the long delay in performing the adenoidectomy (~6 months) in their university hospital to evaluate, before the scheduled surgery, the effect of the didgeridoo used for three months.

location_facility: Hôpital Robert Debré; service de Physiologie


title: Prevalence of Frailty Among People Aged 75 and Over Living at Home

acronym: FRAIL-DOM

summary:
The aging of population lead to study ways to prevent dependence. Frailty is a precursor to dependence which can be reversible. In the literature, estimate of prevalence of frailty is highly variable depending on the frailty definition, the population studied and the screan tool used. In fact, many scales to measure frailty have emerged without gold standard.

The SEGAm showed its usefulness in aged patients living at home.

time_perspective: Cross-Sectional

lead_sponsor: Université de Reims Champagne-Ardenne

location_facility: Maison de Santé Pluridisciplinaire de Bar sur Seine


title: Facial Infrared Thermal Imaging for Continuous Contact-less Respiratory Distress Monitoring in Mechanically Ventilated Patients

acronym: DYS-FEREA

summary:
Critically ill patients are exposed to many sources of discomfort and traumatic experiences, especially if they require invasive mechanical ventilation (IMV). Dyspnea, or sensation of "not getting enough air - suffocation" is the most common and distressing symptom experienced by IMV patients, far more unpleasant than pain. But, contrarily to pain, dyspnea has received only little attention and is still markedly under-recognized in IMV patients. Moreover, given the deleterious short- and long-terms consequences of letting IMV patients with dyspnea, its assessment and treatment figures among the main next great cause in critical healthcare.

However, dyspnea assessment in IMV patients is a challenge since many of them cannot express their suffering (e.g. sedative drugs, mouth tubes). Dyspnea observation scales (DOS) are promising alternatives that allow to strongly suspecting dyspnea. These scales encompass the dyspnea multidimensionality assessing the respiratory drive (respiratory rate, excessive use neck muscle, nasal flaring), neurovegetative signs (heart rate) and emotions (fearful face). DOS allows calculation of scores strongly correlated with dyspnea in IMV communicative patients and responsive to dyspnea treatment even in noncommunicative ones.

However these scales (1) require human resources, (2) still elicit caregivers' subjectivity (fearful face), and (3) are discontinuous, whereas dyspnea is unpredictable, and thus may lead to false appreciation of clinical deterioration. Thus there is an urgent unmet need for technology-enhanced clinical surveillance tools that reliably detect dyspnea in IMV patients and tailor its relief.

Infrared thermal imaging (IRTI) offers a unique opportunity to automatically and continuously compute DOS. Indeed, it has been demonstrated as reliable to measure heart and respiratory rate in patients and detect facial expressions even during surgical intervention.

The study goal is to prove the concept that IRTI camera device is feasible and reliable to strongly suspect dyspnea, based on the calculation of DOS including heart and respiratory rate, facial expression of fear, and activation of Alae nasi muscle, in IMV patients experiencing an asphyxial threat during a spontaneous breathing trial.

The second study goal is to assess the performance of of this multidimensional video taped monitoring to predict the outcome of the spontaneous breathing trial.

This project deals with the perspective that artificial intelligence and the development of autonomous patient-machine interfaces will give access to patients' emotions by the analysis of behaviors including facial expressions, in order to improve comfort and reduce traumatic memories of the ICU stay.

location_facility: Service de Médecine Intensive - Réanimation du département R3S, GHU APHP - Sorbonne Université, Site Pitié-Salpêtrière


title: Descriptive and Prospective Study of Sphincter Disorders in the Severe Traumatic Brain Injury Population

acronym: TCG

summary:
Severe traumatic brain injury (TCI), defined by an initial GCS of ≤ 8 and/or admitted to a neurosurgical intensive care unit, are responsible for diffuse brain lesions that can lead to multiple deficits, including impairment of sphincter functions: bladder, rectal and sexual.

Bladder-sphincter disorders are very common after a TBI. Urinary incontinence predominates, with a prevalence varying from 50 to 100% in the acute period following a TBI.

The variability of the clinical data is explained by the heterogeneity of the populations studied (severity of TBI, duration of coma, time to care) and the tools used to objectify sphincter disorders. The interest of this study is to make an evaluation and a prospective follow-up of sphincter disorders in this population during one year.

location_facility: Médecine Physique et Réadaptation , Pitié-Salpêtrière Hospital


title: Prevalence of the Victimization and the Perpetration of Intimate Partner Violence Among the Patients From Puy-de-Dôme and Paris Consulting or Being Hospitalized for Addiction Problems and Their Expectations From General Practitioners

acronym: VIA-MG

summary:
Intimate partner violence and addictions are two frequent problematics with many consequences on health. A link between intimate partner violence and addictions has been found in many studies. Being a drug user increases the risk to be a perpetrator and also a victim of intimate partner violence.

So, it is legitimate to question ourselves about the prevalence of the victims and perpetrators of intimate partner violence among the patients consulting or being hospitalized for an addiction problem. We believe that this prevalence will be high among these patients.

On the other hand, the general practitioners are in first line receiving victims and perpetrators of violence and patients with addiction problems. So it is important to know the profiles of these patients and their expectations from their general practitioners.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Impact of Oncogeriatric Consultation on Quality of Life of Patients Aged 75 and More With Cancer

acronym: ONCOGERIA-QDV

summary: Among patients with cancer, 6 in 10 are over 65 years of age. In order to improve quality of life of aged cancer patients, the oncogeriatric consultation has been created. Oncogeriatric consultation aim to help oncologists determine the best solutions to combine therapy and quality of life. Factors influencing quality of life of cancer patients have been studied previously. However, these studies always focus on one specific cancer.


title: Cardiac ResynchrOniSation Via Stimulation of the LEFT Bundle in AF Patients.

acronym: CROSS-LEFT-AF

summary:
Permanent ventricular pacing may be complicated with ventricular dyssynchrony and subsequent pacing-induced cardiomyopathy. We hypothesized that left bundle branch area pacing may prevent the development of pacing-induced cardiomyopathy in patients with permanent atrial fibrillation requiring permanent ventricular pacing.

Patients with permanent atrial arrhythmia with an indication of cardiac pacing and atrioventricular junction ablation will be prospectively enrolled.

They will undergo the implantation of a single-chamber pacemaker with left bundle branch area pacing, and then atrioventricular junction ablation.

They will be prospectively followed during 6 months.

lead_sponsor: Nicolas Clementy, MD, PhD


title: Characterization of the Impact of SARS-CoV-2 Variability on the Course of COVID-19 in Patients With Severe Disease Hospitalized in Intensive Care Units: Prospective Observational Multicentric Study

acronym: SEVARVIR

summary:
Background:The impact of the emergence of SARS-CoV-2 variants on the severity and clinical outcomes of COVID-19 is controversial. Whether virological characteristics including the mutational patterns of the different viral proteins (e.g., Spike, NSP proteins, ORF6) could be associated with a different immune response and subsequent severity of the disease is unknown. ln the next coming months, new variants carrying the same or new mutational patterns will continue to emerge. Monitoring their dynamics over time and their impact on disease severity is required for refining national and international disease control policies.

Main objective: To unravel the relationships between specific viral mutations/mutational patterns and the clinical outcomes of COVID-19 in patients hospitalized in intensive care units (ICUs) for acute respiratory failure following severe SARS-CoV-2 infection.

Design of the study Prospective multicentre observational cohort study

Schedule for the study: Inclusion period: 24 months; Participation period: 28 days ; Total duration : 24 months + 28 days;

ipd_sharing_description: AP-HP is the owner of the data. The data cannot be used or disclosed to a third party without its prior permission

location_facility: Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR


title: Bio Electrical Impedance Analysis to Monitor Fluid Status During Deresuscitation Strategy in Continuous Renal Replacement Therapy: a Proof of Concept Study

acronym: UF BIA

summary:
Fluid overload is a poor prognostic factor in patients undergoing continuous renal replacement therapy in critical care. A strategy of active fluid removal by net ultrafiltration (UFnet) is one of the means to correct it. However, fluid overload is difficult to quantify: weight variations or cumulative fluid balance are easy to use but imprecise and not concordant markers, while reference methods such as isotope dilution are not adapted to daily practice.

Bio electrical impedance analysis (BIA) is used to estimate body composition, including hydration. It is a non-invasive, rapid and painless measurement. It is commonly used in chronic intermittent haemodialysis to estimate dry weight and guide fluid removal, with a demonstrated impact on blood pressure control. This analysis is feasible in the ICU. Fluid overload as defined by BIA correlates with mortality, most notably in acute renal failure and during continuous renal replacement therapy.

We routinely perform multifrequency segmental BIA (InBody S10, Seoul, Korea) in patients with fluid overload in our intensive care department. Since February 2021, we have implemented a protocol to systematically correct fluid overload by inducing negative fluid balance with UFnet in a manner appropriate to tissue perfusion. In this context, we systematically perform a BIA analysis on the day of the beginning of the fluid balance negativation and then every 48 hours during the first five days.

We would like to evaluate the relevance of BIA monitoring in these patients by comparing it to other parameters of evaluation of the volume status usually used.

location_facility: Hôpital cardiologique Louis Pradel Groupe Hospitalier Est


title: Clinical Study on Healthy Volunteers for Validating the Stability of Different Diagnostic Biomarkers Studied at Firalis

summary: Stability studies on the peripheral biomarkers (lncRNAs, sncRNAs, mRNAs, proteins, lipids/metabolites) measured by Firalis IVD test candidates and effect of gender, age, nutrition on their expression level

primary_purpose: Diagnostic

lead_sponsor: Firalis SA


title: Analgesic Effect of Bilateral Erector Spinae Plane Block With Ropivacaine After Sternotomy in Cardiac Surgery

acronym: ESB-Sterno

summary: The sternotomy site is the most painful area after cardiac surgery. Erector spinae plane block is effective in thoracic and abdominal surgery, but literature is lacking in cardiac surgery. The bilateral erector spinae plane block could reduce pain at rest and during mobilization, reduce opioids consumption, decrease postoperative complications, improve respiratory outcomes and improve patient comfort and satisfaction. The research hypothesis is that a single shot bilateral erector spinae plane block could reduce pain during mobilization during the first 48 hours after cardiac surgery performed with sternotomy


title: Cannabidiol for Reducing Drinking in Alcohol Use Disorder and Modifying the Effects of Alcohol on the Brain and the Liver: a Phase 2 Clinical Trial.-The CARAMEL Study

acronym: CARAMEL

summary: The non-psychotomimetic cannabis compound cannabidiol (CBD) has been found effective for reducing alcohol drinking in mice. Moreover, other experimental studies have found that CBD reduced alcohol-induced steatosis in the liver, and reduced alcohol-related injury in the brain. Despite these promising results from animal data, no human study has been conducted yet in alcohol use disorder (AUD).

lead_sponsor: Hôpital le Vinatier


title: Genetic Modifying Factors and Pheochromocytomas in Multiple Endocrine Neoplasia Type 2

summary: Multiple endocrine neoplasia type 2A (MEN2A) is a rare syndrome associated with activating mutations in the RET proto-oncogene, combining medullary thyroid cancer in approximately 100% of cases and pheochromocytoma in 10-80% of cases. While it is accepted that the RET mutation causes variable penetrance of pheochromocytoma in the MEN2A patient population, there is no pathophysiological explanation for the phenotypic variability among patients with the same mutation, including within the same family. The aim of this study is to better characterise the genetic factors that may explain the variable penetrance of pheochromocytoma in MEN2. To this end, the investigatoes plan to perform a whole exome analysis in 2 families carrying the p. Cys634Arg mutation causing NEM2A, followed in Marseille by the principal investigator: the 1st family has 11 members all aged over 35 years, for which 8 are carriers of pheochromocytoma while 3 have not developed it (while their age is higher than the latest age of diagnosis of pheochromocytoma in this family); the 2nd family has 3 members (father and daughter with pheochromocytoma developed before 25 years; son without pheochromocytoma at an age of 42 years). The investigators believe that the analysis of these patients should allow the isolation of variants on genes potentially involved in the genesis of a pheochromocytoma in MEN2.

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: VeDOlizumab PERsistence in IBD Patients After Switching From Intravenous to Subcutaneous Administration : a Real-life Multicenter Study

acronym: DOPER

summary:
Descriptive : A 12-months multicenter, observational, prospective cohort study. Population : IBD patients under stable clinical and biological remission will be proposed to switch from the IV vedolizumab to the SC vedolizumab as part of routine care. All consecutive IBD patients in IBD centers participating in the study will be proposed to participate in the study during their regular outpatients' visits.

Objectives : The primary objective of DOPER study is to describe SC vedolizumab persistence after switching from IV vedolizumab to SC vedolizumab at month 12.

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives


title: Advancing Tools for Human Early Lifecourse Exposome Research and Translation- Adolescence Follow-up of the HELIX Subcohort

acronym: ATHLETE

summary: ATHLETE will set up a prospective Europe-wide exposome cohort covering the first 2 decades of the life course, which will integrate data on the external, chemical, physical,behavioral, and social domains of the exposome, as well as on health outcomes and biological omics responses, from preconception until adolescence. As part of ATHLETE, the investigators will follow up a unique existing exposome cohort into adolescence (the HELIX Subcohort).

lead_sponsor: Poitiers University Hospital


title: Observational Study to Compare Two Prostate Laser Enucleation Techniques (Photo-vaporization of the Prostate (PLASMA) Versus HoLEP) in Terms of Overall Post-operative Urinary Incontinence

acronym: ENUPLASMHO

summary: Benign prostatic hypertrophy or prostatic adenoma is a benign tumour that develops in the central part of the prostate. Prostatic adenoma can result in the progressive appearance of a difficulty in evacuating the bladder or frequent urges to urinate and other complications (lithiasis, haematuria, urinary retention, etc.). Surgery is indicated when medical treatment is no longer effective and in the case of complications. The endoscopic techniques for treating prostate adenoma, PLASMA and HOLEP, are recognised and recommended by the French Association of Urology and the European Association of Urology (EAU) as Gold Standard techniques in view of the good results reported in the literature, the low rate of complications compared to the other techniques, and the reduced hospitalisation rate. For prostate volumes less than 80cc, there is no difference between HOLEP and Bipolar Plasma Enucleation of the Prostate (BTUEP) in terms of International Prostate Symptom Score (IPSS), Qmax, and reoperation rate at 12 months. The surgeon's experience is the most important factor influencing the risk of complications for HOLEP. Urinary incontinence after HOLEP according to Houssin et al. is 14.5% at 3 months and 4.2% at 6 months, the risk factors identified were surgeon experience and the existence of diabetes. Comparative evaluation of the two techniques is less frequent, hence the interest of our prospective and multicentre study. In this study, the investigators hope to demonstrate a better outcome of the PLASMA technique in terms of post-operative residual urinary incontinence.

ReferenceCitation: Professionals S-O. EAU Guidelines: Management of Non-neurogenic Male LUTS

ReferenceCitation: Varkarakis I, Kyriakakis Z, Delis A, Protogerou V, Deliveliotis C. Long-term results of open transvesical prostatectomy from a contemporary series of patients. Urology. 2004 Aug;64(2):306-10. Review.

ReferenceCitation: Kuntz RM, Lehrich K, Ahyai SA. Holmium laser enucleation of the prostate versus open prostatectomy for prostates greater than 100 grams: 5-year follow-up results of a randomised clinical trial. Eur Urol. 2008 Jan;53(1):160-6. Epub 2007 Aug 28.

ReferenceCitation: Gratzke C, Schlenker B, Seitz M, Karl A, Hermanek P, Lack N, Stief CG, Reich O. Complications and early postoperative outcome after open prostatectomy in patients with benign prostatic enlargement: results of a prospective multicenter study. J Urol. 2007 Apr;177(4):1419-22.

ReferenceCitation: Li M, Qiu J, Hou Q, Wang D, Huang W, Hu C, Li K, Gao X. Endoscopic enucleation versus open prostatectomy for treating large benign prostatic hyperplasia: a meta-analysis of randomized controlled trials. PLoS One. 2015 Mar 31;10(3):e0121265. doi: 10.1371/journal.pone.0121265. eCollection 2015.

ReferenceCitation: Skolarikos A, Papachristou C, Athanasiadis G, Chalikopoulos D, Deliveliotis C, Alivizatos G. Eighteen-month results of a randomized prospective study comparing transurethral photoselective vaporization with transvesical open enucleation for prostatic adenomas greater than 80 cc. J Endourol. 2008 Oct;22(10):2333-40. doi: 10.1089/end.2008.9709.

ReferenceCitation: Naspro R, Suardi N, Salonia A, Scattoni V, Guazzoni G, Colombo R, Cestari A, Briganti A, Mazzoccoli B, Rigatti P, Montorsi F. Holmium laser enucleation of the prostate versus open prostatectomy for prostates >70 g: 24-month follow-up. Eur Urol. 2006 Sep;50(3):563-8. Epub 2006 May 2.

ReferenceCitation: Tubaro A, Carter S, Hind A, Vicentini C, Miano L. A prospective study of the safety and efficacy of suprapubic transvesical prostatectomy in patients with benign prostatic hyperplasia. J Urol. 2001 Jul;166(1):172-6.

ReferenceCitation: Lin Y, Wu X, Xu A, Ren R, Zhou X, Wen Y, Zou Y, Gong M, Liu C, Su Z, Herrmann TR. Transurethral enucleation of the prostate versus transvesical open prostatectomy for large benign prostatic hyperplasia: a systematic review and meta-analysis of randomized controlled trials. World J Urol. 2016 Sep;34(9):1207-19. doi: 10.1007/s00345-015-1735-9. Epub 2015 Dec 23. Review.

ReferenceCitation: Neill MG, Gilling PJ, Kennett KM, Frampton CM, Westenberg AM, Fraundorfer MR, Wilson LC. Randomized trial comparing holmium laser enucleation of prostate with plasmakinetic enucleation of prostate for treatment of benign prostatic hyperplasia. Urology. 2006 Nov;68(5):1020-4. Epub 2006 Nov 7.

ReferenceCitation: Zhao Z, Zeng G, Zhong W, Mai Z, Zeng S, Tao X. A prospective, randomised trial comparing plasmakinetic enucleation to standard transurethral resection of the prostate for symptomatic benign prostatic hyperplasia: three-year follow-up results. Eur Urol. 2010 Nov;58(5):752-8. doi: 10.1016/j.eururo.2010.08.026. Epub 2010 Aug 20.

ReferenceCitation: Li K, Wang D, Hu C, Mao Y, Li M, Si-Tu J, Huang W, Qiu W, Qiu J. A Novel Modification of Transurethral Enucleation and Resection of the Prostate in Patients With Prostate Glands Larger than 80 mL: Surgical Procedures and Clinical Outcomes. Urology. 2018 Mar;113:153-159. doi: 10.1016/j.urology.2017.11.036. Epub 2018 Jan 3.

ReferenceCitation: Zhu L, Chen S, Yang S, Wu M, Ge R, Wu W, Liao L, Tan J. Electrosurgical enucleation versus bipolar transurethral resection for prostates larger than 70 ml: a prospective, randomized trial with 5-year followup. J Urol. 2013 Apr;189(4):1427-31. doi: 10.1016/j.juro.2012.10.117. Epub 2012 Oct 31. Erratum in: J Urol. 2013 Jun;189(6):2396.

ReferenceCitation: Zhang Y, Yuan P, Ma D, Gao X, Wei C, Liu Z, Li R, Wang S, Liu J, Liu X. Efficacy and safety of enucleation vs. resection of prostate for treatment of benign prostatic hyperplasia: a meta-analysis of randomized controlled trials. Prostate Cancer Prostatic Dis. 2019 Dec;22(4):493-508. doi: 10.1038/s41391-019-0135-4. Epub 2019 Feb 28.

ReferenceCitation: Tan A, Liao C, Mo Z, Cao Y. Meta-analysis of holmium laser enucleation versus transurethral resection of the prostate for symptomatic prostatic obstruction. Br J Surg. 2007 Oct;94(10):1201-8. Review.

ReferenceCitation: Qian X, Liu H, Xu D, Xu L, Huang F, He W, Qi J, Zhu Y, Xu D. Functional outcomes and complications following B-TURP versus HoLEP for the treatment of benign prostatic hyperplasia: a review of the literature and Meta-analysis. Aging Male. 2017 Sep;20(3):184-191. doi: 10.1080/13685538.2017.1295436. Epub 2017 Apr 3. Review.

ReferenceCitation: Gilling PJ, Wilson LC, King CJ, Westenberg AM, Frampton CM, Fraundorfer MR. Long-term results of a randomized trial comparing holmium laser enucleation of the prostate and transurethral resection of the prostate: results at 7 years. BJU Int. 2012 Feb;109(3):408-11. doi: 10.1111/j.1464-410X.2011.10359.x. Epub 2011 Aug 23.

ReferenceCitation: Zhang X, Shen P, He Q, Yin X, Chen Z, Gui H, Shu K, Tang Q, Yang Y, Pan X, Wang J, Chen N, Zeng H. Different lasers in the treatment of benign prostatic hyperplasia: a network meta-analysis. Sci Rep. 2016 Mar 24;6:23503. doi: 10.1038/srep23503.

ReferenceCitation: Yin L, Teng J, Huang CJ, Zhang X, Xu D. Holmium laser enucleation of the prostate versus transurethral resection of the prostate: a systematic review and meta-analysis of randomized controlled trials. J Endourol. 2013 May;27(5):604-11. doi: 10.1089/end.2012.0505. Epub 2013 Feb 1. Review.

ReferenceCitation: Lourenco T, Pickard R, Vale L, Grant A, Fraser C, MacLennan G, N'Dow J; Benign Prostatic Enlargement team. Alternative approaches to endoscopic ablation for benign enlargement of the prostate: systematic review of randomised controlled trials. BMJ. 2008 Jun 30;337:a449. doi: 10.1136/bmj.39575.517674.BE. Review.

ReferenceCitation: Cornu JN, Ahyai S, Bachmann A, de la Rosette J, Gilling P, Gratzke C, McVary K, Novara G, Woo H, Madersbacher S. A Systematic Review and Meta-analysis of Functional Outcomes and Complications Following Transurethral Procedures for Lower Urinary Tract Symptoms Resulting from Benign Prostatic Obstruction: An Update. Eur Urol. 2015 Jun;67(6):1066-1096. doi: 10.1016/j.eururo.2014.06.017. Epub 2014 Jun 25. Review.

ReferenceCitation: Elzayat EA, Elhilali MM. Holmium laser enucleation of the prostate (HoLEP): long-term results, reoperation rate, and possible impact of the learning curve. Eur Urol. 2007 Nov;52(5):1465-71. Epub 2007 May 4.

ReferenceCitation: Du C, Jin X, Bai F, Qiu Y. Holmium laser enucleation of the prostate: the safety, efficacy, and learning experience in China. J Endourol. 2008 May;22(5):1031-6. doi: 10.1089/end.2007.0262.

ReferenceCitation: Houssin V, Olivier J, Brenier M, Pierache A, Laniado M, Mouton M, Theveniaud PE, Baumert H, Mallet R, Marquette T, Villers A, Robert G, Rizk J. Predictive factors of urinary incontinence after holmium laser enucleation of the prostate: a multicentric evaluation. World J Urol. 2021 Jan;39(1):143-148. doi: 10.1007/s00345-020-03169-0. Epub 2020 Mar 26.

ReferenceCitation: Patard P, Roumiguié M, Beauval JB, Sanson S, Roulette P, Teillac L, et al. Énucléation endoscopique pour hbp obstructive : comparaison holep vs plasma. Étude prospective monocentrique des résultats périopératoires et à 1 an chez 200 patients. Progrès en Urologie. 1 nov 2018;28(13):652

ReferenceCitation: Fallara G, Capogrosso P, Schifano N, Costa A, Candela L, Cazzaniga W, Boeri L, Belladelli F, Scattoni V, Salonia A, Montorsi F. Ten-year Follow-up Results After Holmium Laser Enucleation of the Prostate. Eur Urol Focus. 2021 May;7(3):612-617. doi: 10.1016/j.euf.2020.05.012. Epub 2020 Jun 21.

lead_sponsor: Elsan


title: Oral Exploration of Objects and Food Diversification

acronym: OPENING

summary:
Eating difficulties in infants and young children are defined as all the difficulties in feeding oneself in an appropriate and satisfactory manner. These disorders affect approximately 20 to 25% of infants and young children, and thus constitute one of the most frequent reasons for consultation in these age groups. Many of these children continue to be received in consultation.

Studies show that the lack of intraoral exploration in children could be associated with later difficulties in accepting different textures or new foods. Our clinical examination of sensorimotor functions shows signs of sensory hyper reactivity that are very common in children who always wipe their hands when in contact with food or sticky objects and for those who experience difficulty in brushing or grooming themselves.

In all of the publications available which includes pubmed, there is no mention of the lack of exploration of objects and the stigma of sensory hyper-responsiveness even if this latter was not entirely detailed in the descriptions made.

The trial hypothesis is that this exploration defect corresponds to early sensory hyperreactivity which also plays a deleterious role in the acceptance of new textures and new foods.

In this trial we propose a comparison study with a controlled population of children without eating difficulties as defined by the Montreal MCH score to validate a statistical link between the difficulties in food diversification beyond 18 months and the lack of exploration of the environment with 'mouthing' between 6 and 10 months.

Investigators will analyse consultation questionnaires dedicated to eating difficulties retrospectively (patients) and will compare them with questionnaires of children from daycares without eating difficulties (controls).

time_perspective: Other

lead_sponsor: Centre Hospitalier Intercommunal Creteil


title: Pilot Study of hPG80 (Circulating Progastrin) as a Blood Biomarker for High-grade Glial Tumors

acronym: PROGLIO

summary: PROGLIO is a French mono-centric study with longitudinal follow-up, in which patients with high grade brain tumors will be included. Blood samples will be taken during their therapeutic follow-up to evaluate plasma concentrations of hPG80 (circulating progastrin).

lead_sponsor: Centre Jean Perrin


title: Quality of Life in Patients After Pharyngolaryngectomy

acronym: LARYNG-QDV

summary: Laryngeal cancer is an indication for a laryngectomy (separation of the airways and digestive tract). Laryngectomy causes a permanent disruption of self-perception. Communication, social interactions, diet andaesthetic appearance are altered. Its modifications disrupt the quality of life of patients and must be taken into account as soon as possible in patient cares.


title: In-hospital Mortality of Patients With Veno Arterial ECMO: a Prospective Observational Study

acronym: ECMOCARD

summary: veno arterial (VA) extra corporeal membrane oxygenation (ECMO) is a rescue therapy with various indications including refractory cardiac arrest and refractory cardiogenic shock. Amiens hospital university has an ECMO program and is a regional center to address patients requiring VA ECMO. In spite of the application of international guidelines, the mortality of patients with VA remains high with an admitted survival rate at hospital discharge at 40%.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Identifying Risk Factors for Falls in Patients With a High Risk of Fracture Using Connected Insoles (FeetMe Monitor® Device)

acronym: FAIR

summary:
The objective of this study is to determine which gait parameters measured at home using e FeetMe® Insoles are associated with a risk for falls in a patient population suffering from osteoporosis and a higher with high risk of fractures and falls.

Each patient will be asked to go to 3 visits at the Cochin hospital, and to wear the soles after each of these visits during 3 days, at home, to record the data, so that it reflects walking patterns of the patient in his/her daily life and activities.

At the eachvisit, clinical tests to assess fall risk will be performed (Timed Up and Go test, one foot stance, Short Physical Performance Battery and 6 minutes walking test ).

The patients will be supplied with a pair of FeetMe® Monitor Insoles, return home and walking parameters will be recorded for 3 to 10 consecutive days.

lead_sponsor: FeetMe

location_facility: Service de Rhumatologie, Hôpital Cochin, Assistance Publique - Hôpitaux de


title: Endoscopic Ultrasound Evaluation of the Common Bile Duct in Patients With Obstructive Jaundice Due to Bilio-pancreatic Malignancies: a Multicenter Prospective Study (ECCO Trial)

acronym: ECCO

summary: To assess the size of the common bile duct in a large cohort of patients with jaundice following a malignant tumor of the head of the pancreas or the distal bile duct receiving a diagnostic EA for biopsy and / or for evaluation of tissue resectability.

lead_sponsor: Ramsay Générale de Santé


title: Analysis of the Different Strategies for Revascularization of the Lower Limbs by Peripheral Angioplasty

summary: Peripheral arterial disease (PAD) caused by atherosclerosis causes damage to the arteries originating in the aorta (descending) from the iliacs to the extremities of the lower limbs. It causes significant morbidity and mortality. Percutaneous revascularization plays a key role in the management of these patients. Many percutaneous treatment options have been developed: arteriectomy, naked stents, active balloons and active stents. Of these, only paclitaxel-active stents were successful in reducing the rates of restenosis and reoperation in patients with superficial femoral artery injury.The main objective is to study symptomatic improvement at 1 year of patients treated with revascularization of the lower limbs.


title: Real-time Monitoring of Concentration and Size Variations of Circulating Plasma Free DNA to Predict Early Response to Immunotherapies in Patients With Different Types of Cancer.

acronym: SCHISM

summary:
Immunotherapy, which can be represented by the immune checkpoint blockade, is a milestone in the progress of the ongoing struggle against cancer. However, the emergence of unexpected tumor response patterns, such as pseudo-progression or hyper-progression, might complicate the management of patients receiving these immune checkpoint inhibitors. A reliable standardized biomarker that can be used in clinical practice for predicting response to treatment, monitoring tumor evolution and evaluating treatment efficacy has not yet been established.

The general aim of this study is to assess the interest of the plasmatic free circulating DNA (cfDNA) on the clinical response for patients with different types of cancer treated with immunotherapies. The primary objective is to assess the performance of the plasmatic free circulating DNA using the estimation of the receiver operating characteristic (ROC) curve and calculation of the area under the curve (AUC) on the response rate.


title: Evaluation of Modification in VO2 Max After Performing the PAPS 53 Program

summary:
Physical inactivity is the leading cause of preventable death in developed countries, ahead of smoking. It is responsible for 5.3 million (9%) of the 57 million deaths worldwide in 2008 and 10% of deaths in Europe.

Encouraging regular physical activity in the general population is a public health priority.

Cardiorespiratory capacity, measured during an exercise test, expressed as maximal oxygen consumption (VO2 max) or Metabolic Equivalent Task (MET) = oxygen consumption at rest [3.5 ml/kg/min], is an excellent indicator of individual exercise capacity and is increased by regular physical activity (PA).

Any gain in cardiorespiratory capacity of 1 MET is accompanied by a 12% reduction in mortality whether the subjects are free of any cardiovascular pathology or have a chronic pathology, regardless of their age.

As physical activity is an integral part of the management of many diseases, it seems essential to evaluate specific protocols oriented towards the maintenance or development of strength or endurance, or even mixed protocols.

The PAPS 53 (Physical Activity and Health Pathway), set up in Mayenne, responds to the demand for prescription of adapted physical activity. It is a 3-month program with 2 one-hour sports sessions per week (30 minutes of endurance and 30 minutes of muscle strengthening).

The National Sport and Health Strategy 2019-2024 expert group recommends better defining the characteristics of physical activity (intensity, frequency, etc.) to determine the effect (dose-response) on different at-risk populations and according to the type of pathology.

Investigators proposed to study by comparison the VO2 max values obtained during the two exercise tests (at inclusion and after 3 months of physical activity program). The hypothesis is that, after completion of the PAPS program, the VO2 max value of a patient will be significantly increased.

The control group is represented by the patients who have not yet followed the adapted physical activity program. The intervention group is therefore composed of the same patients. The aim is to compare the same group of eligible patients, before and after having followed the "PAPS 53" protocol

lead_sponsor: University Hospital, Angers


title: Impact of Multi-tasking Situations on the Dismounted Soldier's Cognitive Load

acronym: SiMuCCoDé

summary:
The increased complexity of the dismounted combatant's equipment can result in a strain on the various senses (e.g., visual, auditory) that can exceed an individual's limited information processing abilities. The combatant may thus be cognitively overloaded in multi-tasking operational situations.

There has been a great deal of research conducted on cognitive load. A battery of multitasking tests has been developed in the field of aeronautics, but, to our knowledge, no measurement of cognitive load specifically dedicated to combatants has been conducted yet.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Institut de Recherche Biomédicale des Armées


title: Effect of Oral Water in Healthy Volunteers on Cardiac Output, Regional Flow and Microcirculation in Healthy Volunteers

acronym: WATERNAL

summary: Human digestive system physiologically ensures the absorption of oral water and hydration of the human body. Water is quickly absorbed by the digestive tract with a peak between 15 and 20 minutes. It has demonstrated that oral water remains the best hydration solution that have an effect on plasma volume expansion and cardiovascular system during exercise. While the cardiovascular effect of fluid expansion by saline serum is well known (venous return, preload and cardiac output), effect of oral water varies in the literature depending on the physiological state of the patient and the clinical state. Thus, the investigators aim to investigate oral water effects on fluid responsiveness, regional blood flow and microcirculatory changes.


title: A Pilot Study: Retrospective Evaluation of 3 Colonic Adenoma Detection Strategies During a Colonoscopy: Endoscopy Cap Associated With the Artificial Intelligence GI GENIUS ™ System, the Artificial Intelligence GI GENIUS ™ Alone and Colonoscopy Alone

acronym: COLODETECT

summary:
Retrospective study, single blind (patient), allowing a posteriori clinical data collection of 90 patients during their passage to the ambulatory endoscopy circuit, to consider 3 groups and thus to deduce a colonic adenoma detection rate for each arm :

Colonoscopy Only Group
Artificial intelligence only group (IA GI GENIUS ™ alone)
Endoscopic Cap and Artificial Intelligence Group (endoscopy cap associated with the GI GENIUS ™ IA System)

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Retro-prospective and Observational Study of 120 Patients for the Assessment of the Safety and the Performance of the SAGITTA EVL R Stems in Hip Arthroplasties

summary:
Total hip arthroplasty is the preferred treatment for hip disease (primary or secondary osteoarthritis, osteonecrosis, for example) and femoral neck fractures. Revision risk factors reported when considering the main surgical approaches. Studied from the Dutch arthroplasty registry found a revision rate in hemiarthroplasty (HA) of 1.6% at 1 year and 2.5% at 5 years postoperatively. For total hip replacement (THA), the rate was 2.4% at 1 and 4.3% at 5 years postoperatively. Analyze shows that the risk factors for hemiarthroplasty were male sex, age under 80 (regardless of gender), posterolateral approach and uncemented fixation. The risk factors for HAT were exactly the same, but they found that smoking also played a role. It should be noted that age as a risk factor for revision is not a risk during the first year after the fracture, but becomes one in the years that follow.

In order to maintain compliance with the directive on medical devices (93/42 / EEC [M5]) and the future regulation (EU) (2017/745) relating to medical devices, SERF has set up post-market clinical follow-ups ( PMCF). This PMCF study aims to improve knowledge related to the performance, safety and benefit / risk ratio of the Sagitta EVL-R stem and to monitor patient care strategy through this clinical evaluation. Significant clinical results as well as safety must be confirmed with this patient cohort. It is important to note that this cohort reflects the specific care strategy of the University Hospital of Poitiers. Therefore, the strategy could be different between hospitals and countries.

ReferenceCitation: Delaunay C, Epinette JA, Dawson J, Murray D, Jolles BM. Cross-cultural adaptations of the Oxford-12 HIP score to the French speaking population. Orthop Traumatol Surg Res. 2009 Apr;95(2):89-99. doi: 10.1016/j.otsr.2009.01.003. Epub 2009 Apr 3.

ReferenceCitation: Girard J, Roche O, Wavreille G, Canovas F, Le Béguec P. Stem subsidence after total hip revision: 183 cases at 5.9 years follow-up. Orthop Traumatol Surg Res. 2011 Apr;97(2):121-6. doi: 10.1016/j.otsr.2010.10.006. Epub 2011 Mar 23.

ReferenceCitation: Maradit Kremers H, Larson DR, Crowson CS, Kremers WK, Washington RE, Steiner CA, Jiranek WA, Berry DJ. Prevalence of Total Hip and Knee Replacement in the United States. J Bone Joint Surg Am. 2015 Sep 2;97(17):1386-97. doi: 10.2106/JBJS.N.01141.

ReferenceCitation: Moerman S, Mathijssen NMC, Tuinebreijer WE, Vochteloo AJH, Nelissen RGHH. Hemiarthroplasty and total hip arthroplasty in 30,830 patients with hip fractures: data from the Dutch Arthroplasty Register on revision and risk factors for revision. Acta Orthop. 2018 Oct;89(5):509-514. doi: 10.1080/17453674.2018.1499069. Epub 2018 Aug 6.

ReferenceCitation: Tangsataporn S, Safir OA, Vincent AD, Abdelbary H, Gross AE, Kuzyk PR. Risk Factors for Subsidence of a Modular Tapered Femoral Stem Used for Revision Total Hip Arthroplasty. J Arthroplasty. 2015 Jun;30(6):1030-4. doi: 10.1016/j.arth.2015.01.009. Epub 2015 Jan 21.

lead_sponsor: Societe dEtude, de Recherche et de Fabrication


title: Clinical Evaluation of the All'InCath CBC 035M When Used for Peripheral Vasculature Percutaneous Transluminal Angioplasty.

summary: The purpose of this study is to evaluate the clinical safety, performance and benefits (e.g. decrease of procedure time, decrease of radiation time, decrease of the amount of injected contrast, delivery and ease of use) of a novel balloon catheter that combines angiography and angioplasty capabilities.

lead_sponsor: NexStep Medical


title: Musset's Surgical Technique: Evaluation of Long-term Results (LONGOMUSSET)

acronym: LONGOMUSSET

summary:
The surgical technique of Musset has shown its effectiveness for the cure of recto-vaginal fistulas. Recto-vaginal fistulas are mostly post-obstetric (88%).

The objective of this study is to investigate the outcome of patients who underwent a Musset surgical technique, as well as their postoperative functional and anatomical results at a distance from the procedure.

location_facility: Centre Hospitalier Intercommunal de Créteil


title: Effects of Blood Pulsatility on Von Willebrand Factor During Extracorporeal CO2 Removal (ECCO2R)

summary:
The primary objective of the study is to demonstrate that the ECCO2R pulsatile configuration prevents the Willebrand factor high molecular weight multimers decrease observed under continuous blood flow configurations.

The secondary objectives are to quantify the CO2 extracorporeal removal in the pulsatile configuration, to describe complications (hemorrhagic, thrombotic and hemolytic), to describe patients' gas exchanges under ECCO2R, to describe the clinical course of the patients under ECCO2R as well as during the whole stay in the Intensive Care Unit (ICU).

ReferenceCitation: Kalbhenn J, Neuffer N, Zieger B, Schmutz A. Is Extracorporeal CO2 Removal Really "Safe" and "Less" Invasive? Observation of Blood Injury and Coagulation Impairment during ECCO2R. ASAIO J. 2017 Sep/Oct;63(5):666-671. doi: 10.1097/MAT.0000000000000544.

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Virtual Reality in Awake Surgery : Pilot Study VIRAS

acronym: VIRAS

summary:
The virtual reality mask is a tool likely to improve the conditions for performing awake surgery:

by improving tolerance for the patient,
by improving ergonomics in the operating room.

In order to control the risks as well as possible, the investigators propose to test the equipment on patients who will undergo orthopedic surgery under local anesthesia at the hospital of Brest: the patients operated in orthopedics under local anesthesia are immobile during the procedure. This target population will allow an immersion of the equipment in the operating room, with an awake patient, during a short time (on average 1 hour of intervention) and for a technically light interventional procedure.

lead_sponsor: University Hospital, Brest


title: Evaluation Clinique et Cyto-histologique du Traitement Laser CO2 fractionné Sur Les Syndromes Génito-Urinaires de la Ménopause liés à l'Atrophie Vaginale

acronym: ATROVENANS

summary:
Estrogen deficiency can occur naturally during menopause or as a secondary effect of various treatments for breast or pelvic cancer and can lead to very disabling vulvovaginal symptoms, since it is associated with an anatomical and functional cellular modification of the urogenital sphere. These changes result in urogenital atrophy responsible for vaginal dryness, painful intercourse (dyspareunia), discomfort, itching and burning sensations, dysuria, urgency and incontinence. These symptoms, which significantly affect quality of life, are found in more than 40% of menopausal women and are grouped under the term Genitourinary Syndrome of Menopause (GSM). General or local estrogen-based treatments improve patients' symptoms, but remain contraindicated in women who have had breast cancer. Non-estrogenic local treatments are less effective, remain restrictive and are therefore often abandoned.

The CO2 laser is currently part of the therapeutic arsenal for the management of patients with GSM. This device prevents and eliminates the effects of low estrogen levels on vaginal tissue by restoring the characteristic conditions of the vaginal mucosa of a woman of childbearing age. This simple treatment, which lasts only a few minutes, is safe and painless and has no serious side effects. It restores the tone and elasticity of the tissues, with positive effects on the quality of life and the couple's relationship. The investigators wish to evaluate the possible changes of the genital sphere in a longitudinal way (before, during and after the treatment), including the induced cytohistological changes, in patients with GSM who can benefit of this therapy.

lead_sponsor: Hopital Nord Franche-Comte


title: Evaluation of a Urine Analysis Combining VisioCyt® Automated Cytology and FGFR3 Mutations for the Detection of Bladder Cancer

summary:
This study is a case-control, propsective and muticentric clinical trial, which aim to compare the specificity and sensibility of VisioCyt urinary cytological test combined with FGFR3 mutation detection test to VisioCyt urinary cyological test on its own to detect bladder cancer.

The case are patient in whom newly diagnosed, or recurring /progressing bladder cancer is strongly suspected after initial fibroscopy.

The control are patient attending or hospitalized for urolithiasis, urinary infections, urinary superior excretory stones or with non suspect urinary symptomatology.

lead_sponsor: Institut de Cancérologie de Lorraine


title: Evaluation of a Hysteroscopic Method With Vaporization in the Hysteroscopic Treatment of Submucosal Uterine Fibroids

acronym: VAPOHYSTERO

summary:
Operative hysteroscopy (OH) is an endoscopic technique for the treatment of benign intrauterine lesions and in particular uterine fibroids. The limit of this technique is the duration of the operation which is correlated with the operative risks. Thus, when there is a large fibroid or several fibroids, this technique can sometimes not be used or require several sessions. Today there is a new technique of HO that theoretically allows a gain in operative time. There are few comparative studies showing a clinically interesting gain in operating time. The aim of this study is to compare the operative time between the classical HO technique by resection and the vaporization technique.

This is a randomized, single-center study. The study population corresponded to women aged over 18 years requiring operative hysteroscopy for fibroids. After obtaining informed consent, patients will be randomized into two groups: a vaporization hysteroscopy group and a resection hysteroscopy group. The primary endpoint will be operative time. The secondary endpoints will be intraoperative characteristics and complications (amount of distension fluid used, cervical injury, uterine perforation), immediate postoperative data (pain) and medium-term data (postoperative synechiae). The starting hypothesis is that the technique of hysteroscopy by vaporization would reduce the operative time by 30%. The number of subjects required per group will be 27 patients, or 54 patients in total over 24 months.

The expected results are a significant decrease in operative time with the vaporization hysteroscopy technique. This would be important because the reduction in operative time is associated with a reduction in complications of operative hysteroscopy and the possibility of treating larger fibroids with this technique.

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Influence of the Dominance of the Shoulder Stabilized by the Open Latarjet Procedure on the Functional Recovery of the Shoulder at 4.5 Months Postoperatively: Patients Operated on the Dominant Side vs. Patients Operated on the Non-dominant Side vs. Healthy Controls

acronym: Dom Lat

summary: The aim of this study is to quantify the functional deficits as a function of the dominance of the shoulder stabilized by the open procedure of Latarjet at 4.5 months postoperatively compared to healthy controls.


title: Impact of Percutaneous Closure of the Left Atrial on the Maximum Proto-diastolic Speed of the Mitral Ring Measured by Tissue Doppler

acronym: ACTIFER

summary: The main objective is to demonstrate the equivalence, before and after the percutaneous closure of the left atrial procedure, of the maximum proto-diastolic velocity of the lateral mitral annulus (e 'lat) measured by tissue Doppler. Patients with AF at high embolic risk and presenting a formal and definitive contraindication to anticoagulants having been operated on for percutaneous closure of the left atrial by St Jude AMULET device, considering an equivalence margin of 1 cm / sec.


title: Detection of Amyloid Deposits in the Wrist by MRI With Mapping and High Resolution Sequences in Systemic Amyloidosis

acronym: AMYLOCARP

summary: This study is based on the hypothesis that MRI could make it possible to non-invasively detect these amyloid deposits at the level of the wrist using parametric sequences known as T1 mapping, in the form of an extension of T1 in the wrists. areas where amyloid deposits are found in the wrist.