title: REFIT Hearing: Remote Fitting of Hearing Aids

acronym: REFITHEARING

summary:
Currently, the fitting of hearing aids is using a computer interface that allows to adjust the gain and compression of acoustic amplification. This adjustment is made face to face, patient and audiologist being located in a soundproof space to test the effectiveness of the hearing aid.

However, advances in telemedicine in this context, let consider the possibility of addressing these hearing aids fitting via the same computer interface, but remotely controlled by the hearing care professional. The purpose of this study is to assess the ability to perform these tests no longer in front of the patient settings, but away from it, and without visual and sound contact other than through a computer interface.

At the end, this project wants to show that a remote fitting is an acceptable procedure that provides comparable results to-face fitting in terms of speech perception, speech in noise audiometry, hearing loss related quality of life in order to be able to offer this type of strategy.

ReferenceCitation: Venail F, Picot MC, Marin G, Falinower S, Samson J, Cizeron G, Balcon M, Blanc D, Bricaud J, Lorenzi A, Ceccato JC, Puel JL. Speech perception, real-ear measurements and self-perceived hearing impairment after remote and face-to-face programming of hearing aids: A randomized single-blind agreement study. J Telemed Telecare. 2021 Aug;27(7):409-423. doi: 10.1177/1357633X19883543. Epub 2019 Nov 6.

lead_sponsor: University Hospital, Montpellier


title: Comparison Between High-density Electroencephalography and Conventional Electroencephalography to Diagnose the Presence of Consciousness in Post-anoxic Comatose Patients

acronym: COMETIQUE

summary: The purpose of this study is to measure whether high-density electroencephalography can improve the detection of electrophysiological signs of awareness compared to conventional electroencephalography in post-anoxic comatose patients

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Actual

lead_sponsor: Centre Hospitalier Universitaire de Besancon

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Unknown


title: Effects of Exercise and Venous Compression on Upper Airway Resistance in Obese Teenagers With Obstructive Sleep Apnea Syndrome

acronym: OBESOMAC

summary: The purpose of this study is to assess the effects of physical exercise, associated or not with venous compression of the leg, on obstructive sleep apnea (OSA) severity and upper airway resistance in obese teenagers. Half of the participants will undergo physical exercise and compression socks program, and the other half of subjects will undergo physical exercise program without compression socks.

status: Completed

design_allocation: Randomized

primary_purpose: Supportive Care

ReferenceType: derived

ReferenceCitation: Roche J, Corgosinho FC, Dâmaso AR, Isacco L, Miguet M, Fillon A, Guyon A, Moreira GA, Pradella-Hallinan M, Tufik S, Túlio de Mello M, Gillet V, Pereira B, Duclos M, Boirie Y, Masurier J, Franco P, Thivel D, Mougin F. Sleep-disordered breathing in adolescents with obesity: When does it start to affect cardiometabolic health? Nutr Metab Cardiovasc Dis. 2020 Apr 12;30(4):683-693. doi: 10.1016/j.numecd.2019.12.003. Epub 2019 Dec 16.

ReferenceCitation: Roche J, Gillet V, Perret F, Mougin F. Obstructive Sleep Apnea and Sleep Architecture in Adolescents With Severe Obesity: Effects of a 9-Month Lifestyle Modification Program Based on Regular Exercise and a Balanced Diet. J Clin Sleep Med. 2018 Jun 15;14(6):967-976. doi: 10.5664/jcsm.7162.

ipd_sharing: No

location_facility: Centre de soins de suite et de réadaptation La Beline

intervention_type: Other

status_simplified: Completed


title: The Effect and Tolerance of a Ketamine Subcutaneous Bolus, During Painful Care of Refractory Bed Sores, Ulcers and Vascular Wounds in a Palliative Care Unit

acronym: KETAREF

summary:
Pain is one of the major symptoms in palliative care units and often is very difficult to treat, being considered as a refractory pain.

There are different causes of refractory pain: pain due to bed sores and ulcer bandages, carcinological or ischemic wounds or injuries, pain due to patients' reduced mobility, pain due to traumatological injuries, pain associated with a long-term bed confinement, etc.

The investigators propose a prospective study to estimate the effect and the tolerance to a subcutaneous bolus of ketamine administered for the treatment of refractory pain due to the care of bedsores, ulcers and vascular wounds in patients hospitalized in palliative care units.

primary_purpose: Treatment

lead_sponsor: Lille Catholic University

intervention_type: Drug


type: EudraCT Number

title: Pilot Phase II, Randomized , and Control in Double Blind Placebo Effectiveness a 3 Months on Bleeding Fibroids Treatment With ULIPRISTAL ACETATE 10 mg/Day in Patients Suffering From Symptomatic Endometriosis

acronym: FRA-IIT-UPA

summary: Evaluation of efficiency of selective progesterone receptor modulators (SPRM) (Ulipristal acetate) on bleeding control and pain for patients with adenomyosis and wish to keep fertility.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Study of the Bronchial Trans-epithelial Transport in Patients With Idiopathic Multiple Dilations of the Bronchi

acronym: EPITRANS

summary: The purpose of this study is to identify the abnormalities of bronchial trans-epithelial transport of chloride, sodium and bicarbonate in patients with idiopathic dilations of the bronchi.

design_allocation: Non-Randomized


title: A Chronological Study of the Formation of HIV Cellular Reservoirs Through the Expression of Surface Markers on CD4 + T Lymphocytes, Including CD32a

acronym: ANRS EP63

summary: To analyze the HIV viral sequences present in the CD32 + CD4a + T lymphocytes of the patients who have participated in the ANRS 139 TRIO trial, always followed and in virological success, and carrying multi-resistant viruses archived in the HIV cell reservoir, in order to reconstruct the chronology of the installation of this reservoir.

study_type: Observational

time_perspective: Other

lead_sponsor: ANRS, Emerging Infectious Diseases


title: Peak Tidal Inspiratory Flow in Infants With Moderate to Severe Acute Viral Bronchiolitis: a Physiologic Study

acronym: DEBIB

summary:
This aim of this study is to measure the peak tidal inspiratory flow (PTIF), using spirometry, in young infants with moderate to severe acute viral bronchiolitis (AVB).

PTIF is important to consider for the management of AVB with High Flow Nasal Cannulae (HFNC). Indeed, efficiency with HFNC is optimal provided that the settled flow is equal or higher than the patient's PTIF. However, PTIF values in infants with AVB have never been determined.

primary_purpose: Screening

ipd_sharing: Undecided

ipd_sharing_description: NC


title: A Multicentric Randomised Trial to Evaluate Efficacy, Morbidity and Functional Outcome of Endoscopic TranAnal Proctectomy Versus Standard Transabdominal Laparoscopic Proctectomy for Low Lying Rectal Cancer (ETAP-GRECCAR 11)

acronym: ETAP

summary:
Standard surgical treatment of mid and low rectal cancer is total mesorectal excision (TME). Originally performed by open surgery, TME demonstrated improved local control and reduced urogenital morbidity. Laparoscopic approach has been validated by several randomised controlled trials: laparoscopic approach offers to the patient a better post-operative recovery, a lower risk of wound hernia and comparable oncological results. However, the risk of conversion to open procedure remains significant.

Endoscopic Transanal Proctectomy allows retrograd mesorectal excision, performing the whole pelvic dissection via a specific-moderate cost device. The procedure is then completed by a briefer transabdominal laparoscopic step to mobilise the colon and perform inferior mesenteric vessels ligation, prior to low coloanal anastomosis. The originality of this approach is to perform a surgical dissection via an extra peritoneal route, without peritoneal and abdominal wound trauma. This focuses on new technical improvement in the area of mini-invasive pelviabdominal surgery using natural orifice as surgical access. This approach offer closer and better exposure of pelvic dissection plane and could improve oncological quality and pelvic nerve preservation. It could be profitable to postoperative patient outcome. However rates and type of cancer-recurrences as well as functional results have to be assessed in a controlled study. This technique has shown to be feasible and reproducible through early clinical series. Conversion rates appear to be lower than published rates of laparoscopic approach, markedly inferior to 10%. Compiled rates of morbidity (27.8%), R1 resection* (6%), mesorectum macroscopic integrity (100%) appear to be comparable to laparoscopic approach results. However functional results as well as urologic morbidity have to be evaluated in comparative studies. In a preliminary retrospective comparative (n=72) we founded comparable oncological quality criteria (R1 resection 5.9% vs 10.5% p 0.74, Grade 3 mesorectal integrity 57.5 vs 56.2 p 0.99), lower conversion rate to open procedure (2.9% vs 23.6% p 0.011), shorter in-hospital stay (8 vs 9 days p 0.038). Comparable morbidity rates (Dindo 1-4 27% vs 34% p 0.52) and functional results (Kirwan 1/2 80.3% vs 80.6% p 0.94) were also founded. These data need to be confirmed. To this date, Endoscopic Transanal Proctectomy has been evaluated through preliminary studies including several short series demonstrating the feasibility of the technique and showing low morbidity. For some authors the benefit of transanal approach is significant in difficult cases such as male patient and narrow pelvis. Very recently, two non randomised comparative studies were published with conclusions close to those in our study.

Investigators propose, with the support of the GRECCAR group, to conduct a national, multicenter, open-label randomized study based on oncological non-inferiority (R1 resection rate) for the main objective, comparing Endoscopic Transanal Proctectomy to Standard Transabdominal Laparoscopic Proctectomy, for low lying rectal cancer requiring manual colo-anal anastomosis. There is a clear expected benefit expected for the patients through the ETAP procedure in term of post operative short term outcome, risk of conversion to open procedure, risk of wound hernia.This trial could also show significant advantages in terms of quality of dissection, quality of the specimen, quality of nerve preservation.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Lelong B, de Chaisemartin C, Meillat H, Cournier S, Boher JM, Genre D, Karoui M, Tuech JJ, Delpero JR; French Research Group of Rectal Cancer Surgery (GRECCAR). A multicentre randomised controlled trial to evaluate the efficacy, morbidity and functional outcome of endoscopic transanal proctectomy versus laparoscopic proctectomy for low-lying rectal cancer (ETAP-GRECCAR 11 TRIAL): rationale and design. BMC Cancer. 2017 Apr 11;17(1):253. doi: 10.1186/s12885-017-3200-1.

lead_sponsor: Institut Paoli-Calmettes

intervention_type: Procedure

status_simplified: Ongoing


title: Endoscopic Submucosal Dissection for the Treatment of Early Barrett's Neoplasia

acronym: ESTEBAN

summary: This study assesses the quality of the resection of early neoplasia arinsing in Barrett's esophagus using endoscopic submucosal dissection. It is a multicenter prospective registry among 7 centers including all consecutive patients with early Barrett's neoplasia of 15 mm or more in size treated by endoscopic submucosal dissection.

status: Unknown status

time_perspective: Prospective

lead_sponsor: Hôpital Cochin


acronym: SCLERODERMIE

summary:
Systemic sclerosis (SSc) has heterogeneous symptoms and significant medical morbidity. Recently, itch was described as a symptom of SSc (prevalence of 42,6%). To the investigators knowledge, no study yet has examined the clinical features of itch neither had used a specific itch-related quality of life (QoL) scales in patients with SSc. The objectives were to evaluate the prevalence of pruritus, its characteristics and its impact on the QoL in those patients.

In this descriptive study, patients followed for SSc in the departments of dermatology, rheumatology, internal medicine and pulmonology at the University Hospital of Brest were included. Participants received a questionnaire including questions about the clinical features of pruritus and 2 scores (5-D itch scale, ItchyQol).

lead_sponsor: University Hospital, Brest


title: Algorithm for the Early Diagnosis and Treatment of Patients With Eosinophilia

acronym: EOSINOPHILIM

summary:
Eosinophilia, defined by a blood eosinophil granulocytes rate greater than 500 / mm3, is frequently encountered in internal medicine.

Its causes are varied: atopy, drug allergies, parasitic infections, autoimmune diseases and solid neoplasias. Over 200 etiologies have been reported, some difficult to diagnose and can be life-threatening Eosinophilia can be a diagnostic dilemma, as the etiologies are extensive and varied.

The aim of this study is to assess the feasibility of a diagnostic approach based on a decision algorithm in a group of patients with eosinophilia.

We assume that a procedure with a hierarchy of additional tests would increase the frequency of diagnosed cases while decreasing the time to diagnosis.

This procedure defined by an algorithm would even reduce the number of tests necessary to reach a diagnosis.

lead_sponsor: University Hospital, Limoges


title: Multicenter Randomized Open-labelled Trial Which Aims to Show Non-inferiority of Adverse Events Risk During the Maintenance of Oral-anticoagulation in the Surgery of Benign Prostatic Hypertrophy by Laser Photovaporization

acronym: SOAP

summary:
Benign prostatic hyperplasia (BPH) is a very common pathology of the aging man with an incidence that rises from 40% in men aged 50 to 60 years to 90% in men over 80 years. Studies such as the MTOPS (the Medical Therapy of Prostatic Symptoms) study show that more than half of the patients recruited had an aggravation of their disease over time either by an increase in symptoms or by the appearance of complications such as acute retention of urine.

For benign symptomatic prostate hypertrophy, apart from any complication, first-line treatment is now a medical treatment. For patients who respond poorly to medical treatment or who have complications related to benign prostatic hypertrophy, the treatment becomes surgical. The reference treatment is endoscopic prostate resection (TURP). It is mainly to improve the safety of hemostasis in patients older and older and at significant surgical risk that new "minimally invasive" surgical techniques have emerged. Thus, lasers have been developed and are currently used as an alternative to the TURP. Used in clinical practice since 2000, prostatic photosensitive vaporization (PVP) relies on the absorption of a 532nm (green) wavelength laser beam by the oxyhemoglobin contained in richly vascularized prostate tissue.

Given the aging of the population, more and more patients are being treated with oral anticoagulants (Anti Vitamin K (AVK) or direct oral anticoagulants (DOACs)). Today there are about 1.4 million people on oral anticoagulants, 40% of whom are over 80 years of age. The peri-operative management of the AVK is currently based on the recommendations published by the FHA (French Health Authority) in 2008. Concerning the perioperative management of DOACs, the perioperative haemostasis interest group (GIHP) made proposals updated in September 2015.

Numerous studies published in the literature have concluded the feasibility of prostate removal surgery by PVP with greenlight laser without relay (or interruption) of AVK or DOACs because of the properties of hemostasis. But the levels of evidence for these studies remain low.

No study has focused on rigorously assessing the perioperative hemorrhagic risk associated with OAC therapy in patients eligible for PVP, and this is the originality of this study.

This study is a multicenter prospective randomized study whose objective is to show that the PVP performed in patients with OAC is not associated with an increase in perioperative hemorrhagic risk.

primary_purpose: Other

ReferenceType: background

ReferenceCitation: Kaplan SA, McConnell JD, Roehrborn CG, Meehan AG, Lee MW, Noble WR, Kusek JW, Nyberg LM Jr; Medical Therapy of Prostatic Symptoms (MTOPS) Research Group. Combination therapy with doxazosin and finasteride for benign prostatic hyperplasia in patients with lower urinary tract symptoms and a baseline total prostate volume of 25 ml or greater. J Urol. 2006 Jan;175(1):217-20; discussion 220-1.

ReferenceCitation: Rosen R, Altwein J, Boyle P, Kirby RS, Lukacs B, Meuleman E, O'Leary MP, Puppo P, Robertson C, Giuliano F. Lower urinary tract symptoms and male sexual dysfunction: the multinational survey of the aging male (MSAM-7). Eur Urol. 2003 Dec;44(6):637-49.

ReferenceCitation: Thomas JA, Tubaro A, Barber N, d'Ancona F, Muir G, Witzsch U, Grimm MO, Benejam J, Stolzenburg JU, Riddick A, Pahernik S, Roelink H, Ameye F, Saussine C, Bruyère F, Loidl W, Larner T, Gogoi NK, Hindley R, Muschter R, Thorpe A, Shrotri N, Graham S, Hamann M, Miller K, Schostak M, Capitán C, Knispel H, Bachmann A. A Multicenter Randomized Noninferiority Trial Comparing GreenLight-XPS Laser Vaporization of the Prostate and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: Two-yr Outcomes of the GOLIATH Study. Eur Urol. 2016 Jan;69(1):94-102. doi: 10.1016/j.eururo.2015.07.054. Epub 2015 Aug 15.

ReferenceCitation: Misraï V, Rouprêt M, Guillotreau J, Bordier B, Bruyère F. [Greenlight(®) photoselective vaporisation for benign prostatic hyperplasia: a systematic review]. Prog Urol. 2013 Feb;23(2):77-87. doi: 10.1016/j.purol.2012.10.013. Epub 2012 Nov 26. Review. French.

ReferenceCitation: Peyronnet B, Cornu JN, Rouprêt M, Bruyere F, Misrai V. Trends in the Use of the GreenLight Laser in the Surgical Management of Benign Prostatic Obstruction in France Over the Past 10 Years. Eur Urol. 2015 Jun;67(6):1193-1195. doi: 10.1016/j.eururo.2015.01.003. Epub 2015 Jan 17.

ReferenceCitation: Ruszat R, Wyler S, Forster T, Reich O, Stief CG, Gasser TC, Sulser T, Bachmann A. Safety and effectiveness of photoselective vaporization of the prostate (PVP) in patients on ongoing oral anticoagulation. Eur Urol. 2007 Apr;51(4):1031-8; discussion 1038-41. Epub 2006 Aug 18.

ReferenceCitation: Reich O, Bachmann A, Siebels M, Hofstetter A, Stief CG, Sulser T. High power (80 W) potassium-titanyl-phosphate laser vaporization of the prostate in 66 high risk patients. J Urol. 2005 Jan;173(1):158-60.

ReferenceCitation: Charbonneau H, Pathak A, Albenque JP, Misrai V. Greenlight™ photovaporization of the prostate in patients under rivaroxaban: Lesson learned after the first cases. Prog Urol. 2016 Apr;26(5):273-5. doi: 10.1016/j.purol.2016.02.002. Epub 2016 Mar 9.

ReferenceCitation: Douketis JD, Spyropoulos AC, Kaatz S, Becker RC, Caprini JA, Dunn AS, Garcia DA, Jacobson A, Jaffer AK, Kong DF, Schulman S, Turpie AG, Hasselblad V, Ortel TL; BRIDGE Investigators. Perioperative Bridging Anticoagulation in Patients with Atrial Fibrillation. N Engl J Med. 2015 Aug 27;373(9):823-33. doi: 10.1056/NEJMoa1501035. Epub 2015 Jun 22.

ReferenceCitation: Gratzke C, Bachmann A, Descazeaud A, Drake MJ, Madersbacher S, Mamoulakis C, Oelke M, Tikkinen KAO, Gravas S. EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction. Eur Urol. 2015 Jun;67(6):1099-1109. doi: 10.1016/j.eururo.2014.12.038. Epub 2015 Jan 19. Review.

ReferenceCitation: Malek RS, Kuntzman RS, Barrett DM. High power potassium-titanyl-phosphate laser vaporization prostatectomy. J Urol. 2000 Jun;163(6):1730-3.

ReferenceCitation: Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibañes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

ReferenceCitation: Bachmann A, Tubaro A, Barber N, d'Ancona F, Muir G, Witzsch U, Grimm MO, Benejam J, Stolzenburg JU, Riddick A, Pahernik S, Roelink H, Ameye F, Saussine C, Bruyère F, Loidl W, Larner T, Gogoi NK, Hindley R, Muschter R, Thorpe A, Shrotri N, Graham S, Hamann M, Miller K, Schostak M, Capitán C, Knispel H, Thomas JA. 180-W XPS GreenLight laser vaporisation versus transurethral resection of the prostate for the treatment of benign prostatic obstruction: 6-month safety and efficacy results of a European Multicentre Randomised Trial--the GOLIATH study. Eur Urol. 2014 May;65(5):931-42. doi: 10.1016/j.eururo.2013.10.040. Epub 2013 Nov 11.

ReferenceCitation: Peyronnet B, Pradere B, Brichart N, Bodin T, Bertrand P; Members of French Group of GreenLight Users, Bruyère F. Complications associated with photoselective vaporization of the prostate: categorization by a panel of GreenLight users according to Clavien score and report of a single-center experience. Urology. 2014 Sep;84(3):657-64. doi: 10.1016/j.urology.2014.05.028.

ReferenceCitation: Charbonneau H, Pasquié M, Peyronnet B, Descazeaud A, Barry-Delongchamps N, Della Negra E, Mathieu R, Karsenty G, Long JA, Ballereau C, Azzouzi AR, Pradère B, Bruyère F, Fournier G, Lebdai S, Calves J, Corbel L, Vincendeau S, Fiard G, Thuillier C, Descotes JL, Colin P, Culty T, Hesbois A, Fuzier V, Savy N, Pathak A, Albaladejo P, Samama CM, Guerrero F, Misraï V. Stopping or maintaining oral anticoagulation in patients undergoing photoselective vaporization of the prostate (SOAP) surgery for benign prostate obstruction: study protocol for a multicentre randomized controlled trial. Trials. 2018 Dec 27;19(1):705. doi: 10.1186/s13063-018-3066-9.

lead_sponsor: Dr Vincent Misrai

lead_sponsor_type: industriel


title: Pupillometry Guided Versus Standard Practice Remifentanil Administration and Total Opioid Consumption

summary: The aim of this prospective randomized study was to evaluate the impact of peroperative pupillometry monitoring on per and post-operative opioid consumption in major gynecological surgery. All patients were anesthetized with TCI of propofol and remifentanil. In the intervention group, peroperative remifentanil target was guided by pupillometry. In the other group, remifentanil was administered according to standard practice.

lead_sponsor: Pr Isabelle CONSTANT

location_facility: Departement d'anesthesie Hopital Armand Trousseau


type: Other Identifier

title: Mesh Reinforcement During Temporary Stoma Closure After Sphincter-Saving Rectal Cancer Surgery: A Randomized-controlled Trial

acronym: MEMBO

summary: This study aim to assess long-term results of an incisional hernia-prophylactic mesh placement during stoma reversal after total mesorectal excision (TME) for rectal cancer

primary_purpose: Prevention

location_facility: Service de Chirurgie Colorectale - Hôpital Beaujon


title: Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy

summary:
The primary objective of this monocentric and feasibility study is to review the efficacy of cryotherapy in the treatment of unifocal mammary carcinomas in post-menopausal patients, with lumpectomy indication.

The efficacy is defined by the rate of success of cryotherapy procedures. For each one of those evaluated process, an success will be defined on the tumor sample of lumpectomy by the absence of viable tumour cells.

On the basis of our expertise, it seems interesting to propose this experimental procedure to patients as described above.

lead_sponsor: Centre Leon Berard


acronym: VINTAGE VHC

summary: The study consists to Identify viral variants involved in the transmission of hepatitis C and characterize the antigenic and functional properties of their envelope glycoproteins at very early stage of infection (before seroconversion).

lead_sponsor: University Hospital, Tours


intervention_type: Biological

acronym: CYST-HD

title: Metabolomic Study in Huntington's Disease

lead_sponsor: University Hospital, Angers

source: euctr

summary: The purpose of this project is to study Huntington's disease by metabolomic approach.


title: Influence of Apelin Levels on Postoperative Cognitive Disorders After Orthopedic Surgery in Elderlies

acronym: APOCOGNIT

summary: No successful strategy is proposed to patients submitted to important surgery to reduce the incidence of postoperative cognitive disorders (POCD) onset. This project propose to measure plasma levels of apelin in wide population submitted to orthopedic surgery. Apelin could be involved in anti-inflammatory processes. Apelin levels before and after surgery correlated to postoperative cognitive disorders symptom measured by PET-Scan could be an important predictive or diagnostic marker to adapt therapeutic strategy to fight against postoperative cognitive disorders.

ReferenceCitation: Silverstein JH, Timberger M, Reich DL, Uysal S. Central nervous system dysfunction after noncardiac surgery and anesthesia in the elderly. Anesthesiology. 2007 Mar;106(3):622-8. Review.

ReferenceCitation: Deiner S, Silverstein JH. Postoperative delirium and cognitive dysfunction. Br J Anaesth. 2009 Dec;103 Suppl 1:i41-46. doi: 10.1093/bja/aep291. Review.

ReferenceCitation: Price CC, Garvan CW, Monk TG. Type and severity of cognitive decline in older adults after noncardiac surgery. Anesthesiology. 2008 Jan;108(1):8-17.

ReferenceCitation: Saczynski JS, Marcantonio ER, Quach L, Fong TG, Gross A, Inouye SK, Jones RN. Cognitive trajectories after postoperative delirium. N Engl J Med. 2012 Jul 5;367(1):30-9. doi: 10.1056/NEJMoa1112923.

ReferenceCitation: Cibelli M, Fidalgo AR, Terrando N, Ma D, Monaco C, Feldmann M, Takata M, Lever IJ, Nanchahal J, Fanselow MS, Maze M. Role of interleukin-1beta in postoperative cognitive dysfunction. Ann Neurol. 2010 Sep;68(3):360-8. doi: 10.1002/ana.22082.

lead_sponsor: University Hospital, Toulouse

location_facility: CHU Toulouse, service d'orthopédie et traumatologie


title: Continuous Monitoring of Right Ventricular Function, Based on the Correlation Between the C-X Segment of the Central Venous Pressure Curve, and the Echocardiographic Evaluation of Right Ventricular Systolic Function

acronym: CourbePVC

summary:
Close analysis of right ventricular function is still not done by all clinicians, even though it is indispensable; notably in cardiovascular ICUs.

Right ventricular dysfunction is responsible for increased morbidity and marks a turning point in the patient's prognosis.

It is difficult to analyse, and is principally assessed using echocardiography and by measuring the peak of the S' wave with pulsed Doppler and by measuring the tricuspid annular plane systolic excursion (TAPSE) in the TM mode. New studies have shown the interest of using 2D strain as a marker of systolic and diastolic function of the right ventricle. Finally, the use of 3D ultrasound seems to be more reliable than cardiac MRI for fine analysis of the right ventricle, even though it is rarely used in routine practice.

Study of the right ventricle using ultrasonography alone requires experienced and available operators for closely repeated evaluations making it possible to detect right ventricle dysfunction quickly.

US monitoring of left and right heart function is done systematically and repeatedly during post-operative care following heart surgery. This US evaluation could be optimized by finding a way to monitor the right ventricle continuously.

From a physiological point of view, we know about the tight relationship between the aspect of the central venous pressure curve and more precisely the C-X segment (tricuspid bulging into the atrium and start of contraction of the right ventricle) and right ventricular function. We wish to analyse this segment, combined with a US evaluation, and to look for a possible correlation so as to allow continuous, easy-to-interpret monitoring of right ventricular systolic function.

This will be facilitated by the systematic presence of a central venous catheter in every patient undergoing heart surgery, thus allowing central venous pressure to be monitored.

To this end, we wish to collect different data from patients in the cardiovascular ICU, especially the central venous pressure curve, the ventilatory pressure curve and settings of the respirator, and to carry out an echography evaluation of each patient.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Management of Giant Thoracic Disc Hernias by Thoracoscopy: Experience of 52 Cases

acronym: GHTT

summary: Introduction: Giant thoracic disc herniation is a rare condition for which surgical treatment is indicated when there are signs of spinal cord injury. To date, several surgical techniques have been described in the treatment of this condition on small patient series. The main objective is to evaluate the long-term results of a series of 53 patients treated with a minimally invasive endoscopic procedure. The secondary objective is to explain our pre-operative planning and the technical details of our procedure. METHOD: Retrospective monocentric study on a cohort of patients treated in our department. The following medical data from our database are analyzed: Morbidity of operative gesture (duration of procedure, bleeding, postoperative complications), clinical results at the last follow-up visit (thoracic Japanese Orthopedic Association (JOA) score, Frankel score, parietal pain , ability to walk, wish to carry out the same intervention again if necessary). On the radiological level, we evaluated the quality of the resection (total, subtotal, incomplete and impossible), the reappearance of a border of cerebrospinal fluid perimedullary and the presence of an intramedullary T2 hyperintense signal MRI post- operative. All these data are collected and analyzed anonymously. Expected Results: We believe we can demonstrate that thoracoscopy is a valid therapeutic option in the treatment of thoracic disc herniation responsible for spinal cord compression. This with a low morbidity given the minimally invasive nature of the approach.

time_perspective: Retrospective

lead_sponsor: Hopital Foch


type: Registry Identifier

title: Study of Alterations in Skeletal Muscle Energy Metabolism in Undernourished Patients With Gastrointestinal Cancer

acronym: METERMUCADIG

summary: Undernutrition associated with cancer, or cancer cachexia results from a deterioration of the energy balance that leads to a gradual mobilization of energy reserves in the body and to increasing deterioration of the nutritional status of patients. This will thus significantly reduce quality of life and survival of patients with a lower tolerance to cancer treatments. Despite undeniable progress in knowledge, many pathophysiological mechanisms remain few or not explored, which could explain that there is still no satisfactory therapeutic solution to halt the gradual deterioration of the nutritional status of patients. In this sense, apart from preclinical data obtained in animal models, there is currently no clinical study on the functioning of skeletal muscle energy metabolism in undernourished patients suffering of cancer.

primary_purpose: Health Services Research

ReferenceCitation: Dolly A, Lecomte T, Tabchouri N, Caulet M, Michot N, Anon B, Chautard R, Desvignes Y, Ouaissi M, Fromont-Hankard G, Dumas JF, Servais S. Pectoralis major muscle atrophy is associated with mitochondrial energy wasting in cachectic patients with gastrointestinal cancer. J Cachexia Sarcopenia Muscle. 2022 Jun;13(3):1837-1849. doi: 10.1002/jcsm.12984. Epub 2022 Mar 22.

location_facility: Service d'Hépato-gastroentérologie et de Cancérologie Digestive, CHRU de TOURS


title: Impact of Treatment of Periodontis on Endothelial Function in Patients With Obstructive Sleep Apnea

acronym: EndothSAS

summary: Evaluation of the add-on effect on endothelial dysfunction of treatment of periodontitis in patients with chronic periodontitis and severe obstructive sleep apnea treated by CPAP. Patients with and without chronic periodontitis will be treated by CPAP for 20 weeks. At V2 (10 weeks), endothelial dysfunction will be assessed by the Reactive Hyperemia- Peripheral Artery Tone index. The endothelial dysfunction of the patients will be also assessed at V3 (20 weeks) after periodontitis treatment for the group of patients with chronic periodontitis.


title: Study of Predictor of Mood Relapse in Bipolar Disorders : Prospective, Clinical, Neuropsychological, Biological and Genetic Study

acronym: RechuteBP

summary:
Study in 400 patients with bipolar disorder I or II, of relapse risk factors. The principal objective of this research is to test the predictive value of core vulnerability dimensions such as affective instability and emotional reactivity, measured by validated questionnaires (AIM and ALS) on recurrence of affective major episode (depressed, hypomanic or manic) during a 24 months prospective follow-up.

In addition, several arguments suggest that inter-individual variability in the risk of relapse is influenced by genetic factors. In particular, the implication of such factors have been demonstrated in rapid cycling or antidepressants induced mania. However, this has never been tested in cohorts followed prospectively. Finally, the existence of neuropsychological deficits in bipolar disorder is well documented and their role in the risk of relapse is suspected. Yet the nature of these deficits, their origin and evolutionary course remain poorly investigated. In summary, the secondary objectives of this research are the study of the influence of these other clinical, neuropsychological and genetic factors on the risk of relapse.

• Scientific rationale The dimensions of affective instability and emotional reactivity, are considered core psychological and temperamental vulnerability dimensions to bipolar disorder. Differences in levels of instability and reactivity may account for the inter-individual variability observed in bipolar disorder in terms of risk of relapse. These dimensions are measured using validated questionnaires (Affective Instability Measure (AIM) and Affective Lability Scale (ALS)). Relapsing is defined as the occurrence of a depressive episode, hypomanic, manic or mixed episode (DSMIV criteria).

Other factors that may influence the risk of relapse have been suggested in the literature but have not been formally tested in prospective studies:

cognitive deficits: the existence of neuropsychological deficits in bipolar disorder are well documented and their role in the risk of relapse is suspected. Yet the nature of these deficits, their origin and their course remain poorly investigated. Indeed, some appear to be related to the neurotoxicity of the episodes themselves, the other being related to the vulnerability to bipolar disorder
The involvement of genetic vulnerability factors in bipolar disorder is widely demonstrated. Several arguments suggest the implication of genetic factors in the risk of relapse. This is the case for some outcome patterns such as rapid cycling or antidepressants induced mania. Again, this has never been tested in cohorts followed prospectively.

The role of certain inflammatory and infectious factors in the etiology of bipolar disorder has been suggested but it is clear whether these biomarkers are "state" or "traits". Thus, the role of neurotoxic inflammatory or infectious factors in relapse mood has never been tested in a prospective follow up studies.

Main objective of the project To determine if the scores of AIM and ALS, assessed at baseline in euthymic bipolar patients is associated with relapse in patients during a 2 years follow-up period.
Secondary objectives of the project Determine if the neuropsychological performance at T0, measured in euthymic patients predict relapse during a 2 years follow-up period.

Determine whether the neuropsychological deficits observed in euthymic bipolar patients that contribute to functional impairment worsen with time.

DNA collection to test the involvement of candidate genes Serum collection to study the biological and infectious biomarkers

• Methodology Prospective follow up studies. Multicenter.


title: Pharmacokinetic Study of the Amoxicillin / Clavulanic Acid Association to Optimize Dosage Among Obese Adults (PHACO)

acronym: PHACO

summary:
Description of the pharmacokinetic parameters of the amoxicillin / clavulanic acid to healthy voluntary obese after oral and intra venous administration Determination of the pharmacokinetic parameters of amoxicillin / clavulanic acid obtained from plasmatic concentrations of intravenous injection (IV) and oral administrations. The criterion of evaluation allowing to answer our main objective corresponds to the parameters estimated by the pharmacokinetic model of the concentrations obtained from the data IV and by the pharmacokinetic model of the concentrations obtained from the oral data. The following pharmacokinetic parameters will be considered at every obese volunteer's for both molecules (amoxicillin and clavulanic acid) from the concentrations by pharmacokinetic analysis of population.

The main evaluation criteria are PK parameters of amoxicillin / clavulanic:

Cl, systematic plasmatic clearance
Vd, volume of distribution
ASC 0-oo, area under the curve time - concentration
T1/2, half-life time
F, bioavailability after oral administration
Ka, constant of speed of absorption

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


title: Virtual Reality and Relaxation for the Treatment of Generalized Anxiety Disorders: a Comparative Study With Standard Relaxation

acronym: Relax-TAG

summary:
The purpose is threefold: Assess the anxiety reduction, the mood positive effect and the rise of quality of life when using methods of relaxation combined with virtual reality with patients suffering from generalized anxiety disorder in comparison of the effect of traditional relaxation therapy. Observe and evaluate the effect of perceived presence in synthetic environments in the virtual experience of relaxation. Evaluate the therapeutic efficacy of stereoscopy during exposure to relaxing virtual environments for the treatment of generalized anxiety disorder.

It is a comparative, randomized, two groups study (29 in each group):

Relaxation optimized virtual reality
Classical relaxation (without Virtual Reality). The protocol comprised for each groups 7 relaxing sessions (with or without virtual reality epending on the group). Each session lasted for approximately 30 to 35 minutes, including a 5-minute pause between immersive trials, in order to avoid cyber sickness in the virtual reality group.

Expected results: a measurable therapeutic improvement produced by the combination of relaxation and virtual and its additional effect when compared to the traditional treatment.

Measurements of variables and therapeutic effects will be carried out with psychometric measures.

The creation process of the relaxing virtual environments has already been completed. The virtual environments are ready for use.

The apparatus needed and in our possession include:

A laptop for generating virtual environments
A stereoscopic display
Apparatus for physiological measurements

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hôpitaux de Marseille

intervention_type: Behavioral


title: Evaluation of Screening for Visual Disorders of the Old Subject in Consultation Memory

acronym: EVAM

summary: Visual disorders are often overlooked in the treatment of cognitive disorders of the elderly. Yet the visual deficit impacts the quality of life, the evolution of the autonomy and psycho-behavioral disorders in cognitive diseases. The main objective of the study is to evaluate the prevalence of visual disorders among elderly patients at consultant outpatient center of Nantes clinical gerontology as part of the consultation geriatric memory. Secondary objectives are to describe ophthalmological diseases detected and taken into the proposed ophthalmic load, to determine if there are associations between eye diseases and cognitive disorders, to estimate the proportion of patients who may have an ophthalmologic evaluation to determine the cognitive profiles and geriatric evaluation and ocular pathological, depending on the assessment of arterial stiffness. The results of this study will build a testing strategy to promote access of older patients with cognitive impairment to vision care.

lead_sponsor: Nantes University Hospital


title: A Bioequivalence Study of the Reference Clinical Fexinidazole Tablet vs Proposed Market Formulation in Healthy Male Volunteers of African Sub-Saharan Origin:an Open-label,Randomized,Two-treatment,Single Dose,Replicate Design,Fed Condition

summary:
Phase 1 bioequivalence (BE) study. This study is for regulatory purpose to determine BE of the tablet formulation used in the clinical trials and the final marketed tablet formulation under fed condition.

The study will be an open-label, 2-treatment, 2-sequence, 4-period, single-dose, replicate crossover study under fed condition. The 4-period sequences for the replicate design will be TRTR and RTRT, where R designates the reference formulation and T the test formulation. Subject will be allocated randomly to one of the two sequences of treatments according to the randomization list.

lead_sponsor: Drugs for Neglected Diseases


title: MELA Study - Hedonic Study on the Taste of Drugs Crushed in Food: Observational Study Involving 16 Healthy Volunteers

acronym: MELA

summary: Elderly people often suffer from chronic pathologies and they are given polypharmacy. In case of swallowing problems, the drugs are crushed and mixed in food, which alters the taste of food and is a cause of anorexia and malnutrition. Gustative side-effects of crushed drugs have nether been investigated. The MELA study is a one session hedonic test involving 16 healthy volunteers. They will score in a blind manner the taste of 10 drugs commonly prescribed in nursing homes, crushed in jelly or apple compote. These volunteers will be 8 food professionals and 8 geriatric care professionals. Thanks to the MELA protocol, they will have a unique opportunity to communicate and propose solutions to this neglected aspect of malnutrition in elderly populations.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Center for Clinical Research - Archet 1 Hospital Nice Hospital


title: Efficacy of Fluoxetine Against Seizure-induced Central Apneas : a Randomized Placebo-controled Double-blind Trial.

acronym: FLUOXETINE

summary:
Sudden unexpected death in epilepsy (SUDEP) is a tragic outcome of seizure disorders that primarily affect young adults suffering from refractory epilepsy. In this population, SUDEP incidence is estimated at 0.5%. While the mechanisms of SUDEP are not completely understood, it appears that the majority of such death occurs in the immediate aftermath of a general tonic-clonic seizure.

There is currently no validated preventive treatment for SUDEP. Some evidence suggest that modulation of the serotoninergic tone, and more specifically selective serotonin recapture inhibitor (SSRI) such as fluoxetine, might prevent SUDEP. Indeed, fluoxetine prevents seizure-induced lethal central apneas in DBA/2 and DBA/1 mice, one of the few animal models of SUDEP. Furthermore, serotoninergic bulbar nuclei are known to play a major role in the control of breathing, especially during sleep and in response to repeated hypoxia.

In patients with epilepsy undergoing in-hospital video-EEG monitoring, about one third of seizures are associated with decrease in SpO2 <90%, an abnormality suspected to represent a risk factor of SUDEP. In a retrospective uncontrolled study, patients treated with SSRIs displayed less frequent ictal/post-ictal hypoxemia than patients not taking SSRIs.

The investigators project aimed at testing whether fluoxetine can reduce the risk of ictal/post-ictal hypoxemia by performing a double-blind, randomized, placebo-controlled trial in patients undergoing video-EEG monitoring as part of the pre-surgical evaluation of their focal drug-resistant epilepsy.

lead_sponsor: Hospices Civils de Lyon

location_facility: Service de Neurologie Fonctionnelle et d'Epileptologie, Hôpital Neurologique


title: The Impact of Surgical Outcomes Monitoring Using Control Chart on Surgical Performance: A Cluster Randomized Trial

acronym: SHEWHART

summary: This two arms parallel cluster-randomized trial will evaluate the impact of monitoring surgical outcomes using Shewhart control chart (intervention) on the occurence of major adverse events, among a large sample of French surgical departments. Trends in surgical outcomes before and after the intervention will be compared between arms.

ReferenceCitation: Duclos A, Chollet F, Pascal L, Ormando H, Carty MJ, Polazzi S, Lifante JC; SHEWHART Trial Group. Effect of monitoring surgical outcomes using control charts to reduce major adverse events in patients: cluster randomised trial. BMJ. 2020 Nov 4;371:m3840. doi: 10.1136/bmj.m3840.


title: Effect of PEEP and Trendelenburg on Ultrasound Size of Internal Jugular and Subclavian Veins: A Cross-over Randomized Controlled Study

acronym: PEEPUS

summary:
There is no recommendation for the management of the positive end-expiratory pressure (PEEP) during setting of a central venous catheter (CVC) in a ventilated patient. Several non-randomized studies have investigated the cross-sectional area (AST) ultrasound minor axis for different pressure levels by evaluating a single vessel every time or by not displaying the right or left side in the evaluation. Another study showed that there could be unpredictable size differences between the 2 subclavian veins.

In ventilated patient, the PEEP, which is intrathoracic, will result in a decrease of venous return and thus possibly a superior vena cava dilation, located outside the pleura, depending on their capacitance. Different pressure levels showed an increase of AST with the increase of intra-thoracic pressure on certain veins, in a heterogeneous and not randomized manner.

The primary purpose of the study is to measure the effect of PEEP (0, 5, 10 or 15 cm H2O) and the patient's position (supine or Trendelenburg strict -15-20 °) on the cross-sectional area of the jugular and subclavian veins.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Evolution of the Metabolic, Cardiovascular, Bone Complications and of the Quality of Life in Cushing's Disease

acronym: COMPLICUSHING

summary: This study aims at investigating the complications of Cushing's disease in "de novo" patients. A series of investigations will assay before treatment and every year thereafter during a 3 years follow-up period the various complications of the disease. These investigations will determine the presence and severity of cardiovascular, metabolic, and bone complications as well as the Quality of Life. Outcome of these complications after treatment, especially after pituitary surgery will be monitored, as well as cortisol levels.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Epilepsy and Mood Regulation Disorders: a Prospective and Longitudinal Study in Children With Newly Diagnosed Epilepsy

acronym: EPILETRE

summary:
Epilepsy is a multifaceted disorder and a major public health problem. In addition to recurrent and unpredictable seizures, abnormalities in psychiatric status, cognition and social-adaptive behaviors are potential major sources of disability in children and adults with epilepsy disorders. Recent studies have unequivocally documented raised psychiatric comorbidities in children with epilepsy, particularly emotional regulation disorders such as depression and anxiety, as compared to both the general population and the children with other medical disorders, neurological and non-neurological. A prevalence of 12% to 35% has been reported, compared to 3-8% in the general population.

Major advances have begun to uncover the potential mediators of emotional regulation disorders and social comorbidities in epilepsy, but important gaps remain in the early detection, treatment and prevention of these disorders. A very small number of investigations have examined children with epilepsy at or near the time of diagnosis. This is a time during which the effects of chronic epilepsy, potential averse social effects of epilepsy, and other complicating aetiological effects are minimized.

Epilepsy syndromes provide a useful framework for considering the risk and type of emotional dysregulation comorbidities. But variability within and across syndromes needs to be taken into account thus requiring a strict phenotyping by specialists in the filed of pediatric epileptology. Retrospective studies, usually including patients with chronic epilepsies and suffering from a mixed spectrum of epilepsy syndromes introduce biases leading to rather disparate findings.

Are such disorders the result of common physiopathological mechanisms, which precede the development of the epilepsy? The link between an underlying brain disorder and psychiatric comorbidities has emerged in recent literature, with evidence based on studies in adults, suggesting bidirectional relations between epilepsy and neurobehavioural comorbidities. Emotional regulation disorders can follow the onset of epilepsy, but they can also precede it, thus serving as a possible risk factor. The clinical implication of such a bidirectional association is that neurobehavioural comorbidities might be present at diagnosis and even before epilepsy onset. There is a need for greater understanding of the causes of these conditions in younger people.

The degree to which specific epilepsy syndromes are associated with the relative risk of emotional dysregulation disorders in children with new- or recent-onset (within six months prior to enrolment) has rarely been comprehensively examined and represents the focus of the current investigation.

The investigators study will be based on a prospectively recruited cohort of 280 children/adolescents with recently diagnosed epilepsy. All participating centres dispose of the necessary competences for a precise diagnosis of the epilepsy syndromes and the tools for a per case appropriate aetiology screening. Following a first seizure children are usually first examined at hospital based emergency departments. Prompt referral to the epilepsy teams participating at the present study will significantly reduce the population biases and shortcuts encountered in studies that recruited patients with chronic epilepsy followed in tertiary care epilepsy units.

The investigators expect their results to provide a greater understanding of both the shared and the unique features of emotional regulation disorders, in relation to specific epilepsy categories defined on the basis of the underlying physiopathological mechanisms.

Such knowledge will also assist clinicians and families in the planning of both diagnosis and management resources.


title: Identification of Cognitive and Emotional Factors in Relation to Auditory Hallucinations in Non-psychotic Children

summary: The aim of this study is to show presence of cognitive and emotional factors on the beginning and persistence of auditory hallucinations in non-psychotic children. Investigators will describe a significant link between this factors and hallucinations in a sample of non-psychotic children. The results of this sample will be comparing to another group of children of the same age, sex and diagnosis, but without hallucination. Finally, investigators will control the persistence of hallucination on the first group after a six month period.

ReferenceCitation: Dumas LE, Bonnard-Couton V, Golse B, Askénazy F. [Identifying cognitive and emotional markers in relation to auditory-verbal hallucinations in pediatric population: Physalis study]. Encephale. 2022 Oct;48(5):546-554. doi: 10.1016/j.encep.2021.06.010. Epub 2021 Oct 5. French.

lead_sponsor: Fondation Lenval


title: Impact of Denosumab in the Prevention of Bone Loss in Non-menopausal Women With Anorexia Nervosa

acronym: DIBLAN

summary:
The drastic reduction of nutritional intake in anorexia nervosa(AN) alters many hormonal factors that regulate the activity of bone cells. This alteration of bone remodeling is characterized by increased bone resorption and decreased bone formation, leading to a marked reduction of bone mineral density, osteoporosis and an increased risk of fracture.

To date, there is a paucity of studies and no consensus on the management of bone loss in patients with AN. The few previous studies were performed with small samples and using short follow-up periods.

Denosumab is a fully human monoclonal antibody that binds with high specificity to human RANKL (6, 7), thereby reducing the number and activity of osteoclasts and therefore decreasing bone resorption that was found increased in patients AN.

Denosumab may transiently protect bone whilst psychonutritional management will induce a weight restoration

lead_sponsor: University Hospital, Montpellier


title: Biomechanical and Ultrasonic Assessment of the Achilles Tendon in Vivo (MEDUSAA)

acronym: MEDUSAA

summary:
Among Musculoskeletal disorders (MSD) the rupture of the Achilles tendon is the most common. Up today, the mechanical and elastic properties of the Achilles tendon are still unknown, and that both in healthy subjects in pathology. The viscoelastic properties or dynamic mechanical properties are directly related to the tendon of the health status and its elongation capacity.

The laboratory UMR Inserm U930 - CNRS ERL 3106 in Tours has developed a non-invasive ultrasonic device, named Achillus, which, via an ultrasonic probe, allowing to access the viscoelastic properties of the tendon during the contraction of the sural triceps.

This is what we want to do in this first protocol: in vivo observation of the normal values and variations, looking for changes related to hyper solicitation and finally trying to highlight a tendon fragility parameter for patients who have experienced of a Achilles tendon rupture.


title: Immunoregulation of Periodontal Diseases

summary: Periodontal diseases are a group of diseases that affect 15% of the population and in the absence of treatment causes tooth loss. Periodontal lesions are characterized mainly by strong inflammation and hyper-vascularization. Search in blood cells and inflammatory markers attempts to explain the etiological-pathogenetic mechanisms. Innate immunity can be assessed by qualitative and quantitative analysis of blood phagocytes, natural killer cells, complement, proteins of inflammation and cytokines. Current data from the literature on this subject give contradictory results and the comparison of studies are difficult because the diversity of the populations studied, evaluated cells and the methods used. The aim of the study was to evaluate the innate immunity of patients with periodontal disease and compare it with a group of patients without periodontal disease.

location_facility: Assistance Publique Hopitaux de Marseille


title: Ultrasound Guidance to Alleviate the Pain Associated With Intramuscular Injections of Botulinum Toxin in Spastic Patients

acronym: TOXINECHO

summary: Intramuscular injections of botulinum toxin are currently the best focal treatment of spasticity, with clearly defined indications and role. French and European recommendations focus on the toxin's mode of administration, which must be as precise as possible. The toxin's specific action on motor endplates (blocking the release of acetylcholine) shows the importance of targeted injections within the muscle belly. The pain caused by these injections is due partly the number of injections (up to 30 in a single session), and partly to the use of electrical stimulation guidance. Prevention and alleviation of the pain caused by these injections have become a regulatory obligation since the law of 4 March 2002 relating to the rights of patients and the quality of the health system (" Any person has the right to receive relief from pain, which must, under all circumstances, be prevented, evaluated, taken into account and treated … ").


title: Arthrodesis Gleno Humeral Under Arthroscopy in the Sequelae of Plexus Brachial Evaluation of the Technical Feasibility

acronym: DESEP

summary: Arthrodesis shoulder blade/humerus under arthroscopy. Implementation of an external fixative spray at the proximal level in the thorn of the scapula and distal in the diaphysis humerus.

lead_sponsor: University Hospital, Brest


title: Human Fine-motor-skills in Weightlessness: Comparison of a Laboratory and an Everyday-like Context

acronym: FINESKILL

summary:
The human performance during weightlessness was tested in a multiplicity of laboratory experiments during parabolic flights and in space. It is therefore known that human fine motor skills as grasping are affected by the impact of changing gravity levels. However, because everyday life movements differ in several aspects from those done in an experimental lab situation, investigators do not know until know if this kind of movements is altered in the same extend.

Fine motor skills seem to depend on the context in which they are made. Thus, the performance in weightlessness during everyday life could substantially differ from the results given by previous laboratory studies.

This assumption will be tested in the present project, with subjects executing one and the same grasping movement in two different contexts, both in normal gravity conditions and in weightlessness. To that end, the investigators developed a new method which allows comparing the same grasping movements under different conditions.

primary_purpose: Basic Science

lead_sponsor: University Hospital, Caen


title: French Registry of Acute ST-elevation or Non-ST-elevation Myocardial Infarction 2015

summary:
Over the last two decades, considerable progress has been made in the management of myocardial infarction, both in the acute phase and in monitoring beyond the hospital phase. However changing practices in the "real world" and their impact on prognosis in the medium and long term patients admitted to the intensive care unit for acute myocardial infarction are relatively little studied exhaustively.

The study of clinical, biological and genetic characteristics of patients and their conditions of care, help to identify patients at risk for increased morbidity and mortality after myocardial infarction and could be the basis for the subsequent realization of specific studies on the optimal therapeutic management of the disease according to the different risk profiles.

status: Active, not recruiting

ReferenceType: result

ReferenceCitation: Puymirat E, Simon T, Cayla G, Cottin Y, Elbaz M, Coste P, Lemesle G, Motreff P, Popovic B, Khalife K, Labèque JN, Perret T, Le Ray C, Orion L, Jouve B, Blanchard D, Peycher P, Silvain J, Steg PG, Goldstein P, Guéret P, Belle L, Aissaoui N, Ferrières J, Schiele F, Danchin N; USIK, USIC 2000, and FAST-MI investigators. Acute Myocardial Infarction: Changes in Patient Characteristics, Management, and 6-Month Outcomes Over a Period of 20 Years in the FAST-MI Program (French Registry of Acute ST-Elevation or Non-ST-Elevation Myocardial Infarction) 1995 to 2015. Circulation. 2017 Nov 14;136(20):1908-1919. doi: 10.1161/CIRCULATIONAHA.117.030798. Epub 2017 Aug 27.

ReferenceCitation: Belle L, Cayla G, Cottin Y, Coste P, Khalife K, Labèque JN, Farah B, Perret T, Goldstein P, Gueugniaud PY, Braun F, Gauthier J, Gilard M, Le Heuzey JY, Naccache N, Drouet E, Bataille V, Ferrières J, Puymirat E, Schiele F, Simon T, Danchin N; FAST-MI 2015 investigators. French Registry on Acute ST-elevation and non-ST-elevation Myocardial Infarction 2015 (FAST-MI 2015). Design and baseline data. Arch Cardiovasc Dis. 2017 Jun - Jul;110(6-7):366-378. doi: 10.1016/j.acvd.2017.05.001. Epub 2017 Jun 21.

ReferenceCitation: Puymirat E, Simon T, Danchin N; FAST-MI Investigators. Response by Puymirat et al to Letter Regarding Article, "Acute Myocardial Infarction Changes in Patient Characteristics, Management, and 6-Month Outcomes Over a Period of 20 Years in the FAST-MI Program (French Registry of Acute ST Elevation or Non-ST-Elevation Myocardial Infarction) 1995 to 2015". Circulation. 2018 May 22;137(21):2307-2308. doi: 10.1161/CIRCULATIONAHA.118.033969.

ReferenceCitation: Puymirat E, Cayla G, Cottin Y, Elbaz M, Henry P, Gerbaud E, Lemesle G, Popovic B, Labèque JN, Roubille F, Andrieu S, Farah B, Schiele F, Ferrières J, Simon T, Danchin N. Twenty-year trends in profile, management and outcomes of patients with ST-segment elevation myocardial infarction according to use of reperfusion therapy: Data from the FAST-MI program 1995-2015. Am Heart J. 2019 Aug;214:97-106. doi: 10.1016/j.ahj.2019.05.007. Epub 2019 May 16.

ReferenceCitation: Puymirat E, Bonaca M, Iliou MC, Tea V, Ducrocq G, Douard H, Labrunee M, Plastaras P, Chevallereau P, Taldir G, Bataille V, Ferrières J, Schiele F, Simon T, Danchin N; FAST-MI investigators. Outcome associated with prescription of cardiac rehabilitation according to predicted risk after acute myocardial infarction: Insights from the FAST-MI registries. Arch Cardiovasc Dis. 2019 Aug - Sep;112(8-9):459-468. doi: 10.1016/j.acvd.2019.04.002. Epub 2019 May 22.

ReferenceCitation: Schiele F, Puymirat E, Ferrières J, Simon T, Fox KAA, Eikelboom J, Danchin N; FAST-MI investigators. The FAST-MI 2005-2010-2015 registries in the light of the COMPASS trial: The COMPASS criteria applied to a post-MI population. Int J Cardiol. 2019 Mar 1;278:7-13. doi: 10.1016/j.ijcard.2018.11.138. Epub 2018 Dec 3.

ReferenceCitation: Puymirat E, Bonaca M, Fumery M, Tea V, Aissaoui N, Lemesles G, Bonello L, Ducrocq G, Cayla G, Ferrières J, Schiele F, Simon T, Danchin N; FAST-MI investigators. Atherothrombotic risk stratification after acute myocardial infarction: The Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention in the light of the French Registry of Acute ST Elevation or non-ST Elevation Myocardial Infarction registries. Clin Cardiol. 2019 Feb;42(2):227-234. doi: 10.1002/clc.23131. Epub 2018 Dec 27.

ReferenceCitation: Garcia R, Marijon E, Karam N, Narayanan K, Anselme F, Cesari O, Champ-Rigot L, Manenti V, Martins R, Puymirat E, Ferrieres J, Schiele F, Simon T, Danchin N. Ventricular fibrillation in acute myocardial infarction: 20-year trends in the FAST-MI study. Eur Heart J. 2022 Oct 28:ehac579. doi: 10.1093/eurheartj/ehac579. Online ahead of print.

ReferenceCitation: Danchin N, Puymirat E, Cayla G, Cottin Y, Coste P, Gilard M, Goldstein P, Braun F, Belle L, Montalescot G, Ferrières J, Schiele F, Simon T; FAST-MI Investigators. One-Year Survival After ST-Segment-Elevation Myocardial Infarction in Relation With Prehospital Administration of Dual Antiplatelet Therapy. Circ Cardiovasc Interv. 2018 Sep;11(9):e007241. doi: 10.1161/CIRCINTERVENTIONS.118.007241.

lead_sponsor: French Cardiology Society


summary: This work also highlights the presence of an unknown virus double-stranded DNA. In this project we propose 1) incorporating a bank of 150 samples from patients with diabetic foot infection in grades 2-4; 2) to study the microbial flora of a selection of 50 diabetic feet previously untreated with antibiotics for bacterial metagenomics, viral metagenomics and a minimum of 10 per culturomique; 3) to evaluate the use of targeted quantitative PCR on the most frequent new species frequency in the disease and incidentally get a sense of their role in the evolution and prognosis of the disease, including failures of and targeted antibiotic therapy on all 150 samples.


title: Glucocorticoids Associated With Antihistamines Versus Antihistamines Randomized Double Blinded for the Management of Acute Urticaria in Emergency

acronym: CAHISU

summary: Acute urticaria is common and affected 12% of population. 400 patients come in department emergency of Toulouse each year and there aren't many studies in literature which evaluate the glucocorticoids treatment. The standard treatment of urticaria is antihistamines H1, but glucocorticoids treatment administered orally for short course would permit to increase quickly acute urticaria uncomplicated. Clinical trial, prospective randomized double blinded of adults with acute urticaria less 24 hours duration and no take treatment urticaria before.

ReferenceCitation: Barniol C, Dehours E, Mallet J, Houze-Cerfon CH, Lauque D, Charpentier S. Levocetirizine and Prednisone Are Not Superior to Levocetirizine Alone for the Treatment of Acute Urticaria: A Randomized Double-Blind Clinical Trial. Ann Emerg Med. 2018 Jan;71(1):125-131.e1. doi: 10.1016/j.annemergmed.2017.03.006. Epub 2017 May 3.


title: Exploration and Characterization of the Phenotypic and Genetic Profile of Patients With Early Onset Schizophrenia Associated With Autism Spectrum Disorder and Their First-degree Relatives (GenAuDiss).

acronym: GenAuDiss

summary:
Early onset schizophrenia "early dissociative disorder" is a rare disorder with a low incidence of approximately (1/5000 to 1/20000). Its link with autism spectrum disorders remains unknown although both are serious neurodevelopmental diseases. As part of the 2011-2013 Interregional hospital Clinical Research program, University Department of Child and Adolescent Psychiatry Pediatric Hospitals of CHU de Nice Lenval identified patients with a complex phenotype characterized by an early schizophrenia associated with autism spectrum disorders and developmental disabilities in mild to moderate. This phenotype could be a new syndrome.

The goal of our project is to define the genetic causes of this phenotype. The technique of high throughput sequencing will be used to obtain the sequence of exomes of these patients and their families. This study will therefore be important to give an accurate diagnosis for patients and their families. Moreover, we believe that this project will identify new genes involved allowing a better understanding of the pathophysiology. Recent studies show the involvement of mutations in several genes (eg NRXN1 and UPF3B) in these different clinical phenotypes. However, the genetic basis of the childhood and early onset schizophrenia are much less well known than those of autism spectrum disorder

ReferenceCitation: Fernandez A, Dor E, Maurin T, Laure G, Menard ML, Drozd M, Poinso F, Bardoni B, Askenazy F, Thümmler S. Exploration and characterisation of the phenotypic and genetic profiles of patients with early onset schizophrenia associated with autism spectrum disorder and their first-degree relatives: a French multicentre case series study protocol (GenAuDiss). BMJ Open. 2018 Jul 5;8(7):e023330. doi: 10.1136/bmjopen-2018-023330.


title: Prospective Assessment of Quality of Life in Patients Treated by Radiosurgery for Brain Metastases

summary: The aim of the study is to assess prospectively the impact of radiosurgery on the quality of life in patients with brain metastases.

lead_sponsor: Centre Oscar Lambret


title: Interaction of Otolith Stimulation and Carotid Baroreflex in Humans

acronym: OTOBAR

summary:
It is well documented that a few days stay in space induces a change in the vestibular-ocular reflex reflecting a reinterpretation of sensory inputs following the disappearance of gravity. If the change of eye reflexes actually the result of a reinterpretation of sensory input, the investigators should also expect to see an alteration of the vestibular-cardiovascular reflexes. The modification of these reflexes may modulate the carotid baroreflex and thus participate in the post-flight cardiovascular deconditioning.

The first objective of this project is to study the carotid baroreflex under different supine (dorsal, ventral and lateral) inducing different otolith stimulation in normal-gravity.


title: Secretion Induction of Neutrophil Extracellular Traps (NETs)in Inflammatory and Infectious Environment of Mucoviscidose

acronym: MucoNETs

summary:
The study is defined in 3 stages of in vitro assays :

Phase 1 : Secretion of NETs in response to lung disease and their secretion of factors.

This is a transversal study in which we compare :

Producing NETs (DNA and proteases ) by neutrophils purified from sputum and blood of patients
Producing NETs (DNA and proteases ) by purified neutrophils in the blood of patients and blood of control subjects

Phase 2: Mechanisms of activation of NETs secretory pathways . This phase will identify receptors (TLR ) involved in the secretion of NETs and analyze the involvement of dependent transduction pathways calcium and PKC . It will be performed on control blood neutrophils.

Phase 3: Analysis of cell death ( NETose )

This is a transversal study that will analyze :

the mode of cell death of neutrophils purified blood and sputum of patients and control blood neutrophils by flow cytometry and transmission electron microscopy .

lead_sponsor: University Hospital, Tours


title: Prospective, Randomized Study of the Impact of a Education Program for Patients Suffering From Low Back Pain

acronym: TENS

summary:
According to the WHO, therapeutic education is intended to help patients acquire or maintain the skills they need to optimally manage living with a chronic disease. Low back pain is frequent and therapeutic education could be a promising option.

The purpose of the study is to evaluate the impact of a therapeutic education program for patients suffering from low back pain.


title: Ultrasound Measurement of the Quadriceps Muscle Diameter for the Detection and the Follow-up of Malnutrition in Patients Receiving Mechanical Ventilation in Intensive Care Unit

acronym: MALICUS

summary:
Malnutrition is a major risk factor for morbidity and mortality of patients managed in intensive care unit. Early recognition and treatment of adult malnutrition are recommended in acute care settings especially for patients requiring mechanical ventilation. Biochemical indicators like serum concentrations of albumin and prealbumin (transthyretin) have a tradition of being used as markers of nutritional status but remains influenced by nonnutritional factors. A recent assessment of quadriceps muscle diameter with ultrasound method has gained interest for screening and follow-up of muscle weakness at the bedside in critically ill patients. In this light, the MALICUS project aims to investigate the validity of ultrasound as measurement tool for assessing malnutrition acquired in intensive care unit.

Skeletal muscle is central to cytokine regulation and it contributes 85% of total body glucose clearance. Some research findings suggest that muscle wasting is a smoldering inflammatory state partially driven by cytokines and oxidative stress but these conclusions need to be investigated in context of critically ill patients and perioperative settings.

The investigators search to determine impact of inflammatory biomarkers (IL-1, IL-6 and TNF-α) and oxidative stress (evaluated by quantifying the global anti-oxidative defenses in patient with an original method (Patrol® test) based on the use of excited molecular oxygen (singlet oxygen) as a source of ROS on erosion of lean body mass measure with quadriceps muscle ultrasound. Consequently, in an ancillary study of the MALICUS project, the investigators wish to investigate interaction between acute inflammation and muscle wasting.


title: Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Third Trimester Medical Termination of Pregnancy Analgesia : a Randomized Study.

acronym: PCEA-IMG

summary:
Background : Recently, delivery of local anaesthetics via Programmed Intermittent Epidural Bolus (PIEB) has been shown to improve labour epidural analgesia compared to delivery via Continuous Epidural Infusion (CEI).

Purpose : However, the superiority of PIEB compared to CEI has not been investigated for third trimester voluntary termination of pregnancy.

We hypothesized that PIEB administration would result in a better degree of satisfaction of the patients compared with CEI for third trimester legally induced abortion analgesia.

lead_sponsor: University Hospital, Limoges


title: Early Phase of Multi-disciplinary Prevention Program of Shoulder Pain Post-stroke

summary:
About 70% of hemiplegic patients suffer from hemiplegic shoulder pain after stroke. This common occurrence is a cause for concern in the rehabilitation setting as it leads to impairment of functional outcomes induced by discomfort and delays in rehabilitation, important psycho-emotional repercussions as there is a correlation between upper arm pain and depression, a longer hospital stay. Poor management of hemiplegic shoulder pain can ultimately give rise to type 1 "complex regional pain syndrome" (CRPS I). There is no consensus on treatment, care pathways or useful devices for positioning acute stroke patients in the literature. Our objective is to compare the effectiveness of a new positioning procedure of the hemiplegic arm with conventional positioning (pillow and "shoulder-immobilisation" sling) in acute stroke patients.

Patient's actions are focus in 4 points:

Positioning in bed, wheelchair and standing with specific materials (holds, sling in external rotation and abduction)
Be careful of shoulder's coaptation in care and functional activities (toilet, dressing, transfers)
A training of the patient and members of family on pathology, risk, use of material
Daily passive mobilisation of the upper member by a therapist.

lead_sponsor: University Hospital, Bordeaux


title: Feasibility of a Video-oculography in Patients With Huntington's Disease VOG-HD Study

acronym: VOG-HD

summary: The purpose of this study is to know the limits of feasibility of a reliable oculomotor record for patient with Huntington's disease.

lead_sponsor: University Hospital, Angers


title: The Operation of Control Devices During Parabolic Flights: Influence of Weightlessness, Stress and Motivation

acronym: Grafism

summary: The aim of this project is to investigate whether alterations in sensory-motor performances during weightlessness are only of theoretical relevance, or indeed restrict the capacity of the participants. To find out, volunteers will monitor a complex realistic process by operation of buttons and switches in weightlessness. The task will mimic the control of vehicles, research equipment and industrial processes. Effects of weightlessness will be separated from effects induced by stress and those of motivation through evaluation of cortisol and manipulation of motivation.


acronym: HYDRONAUT

summary: The scientific goal of this experiment is to evaluate the performances of our three-dimensional digital model by comparing its prediction computed from underwater data to posture observed during real weightlessness during parabolic flight.


summary: If investigators know that the anticipatory mechanisms involved in precision grip take into account the gravity, however it is unclear how they adapt to changes in the gravitational level. The objectives of this study are to study and model the movement control and the mechanisms underlying learning and adapting to the condition of weightlessness. Specifically, i) investigators will determine if a change in the level of gravity is taken into account when controlling grip force and ii) investigators will examine the effects of gravity change on hand-eye coordination.


title: Evaluation of 3D Selection Tasks in Parabolic Flight Conditions: Pointing Task in Augmented Reality User Interfaces

summary: During a space mission the crew has to perform a wide variety of tasks under different acceleration conditions. For handling of displays and control items during a mission, the astronaut's performance is strong depended on an intuitive usability. Currently investigators are exploring and developing different Augmented Reality interfaces for the International Standard Payload Rack (ISPR) Biolab that is installed in the International Space Station (ISS) module Columbus. Augmented reality (AR) is a live, direct or indirect, view of a physical, real-world environment whose elements are augmented by computer-generated sensory input such as sound, video, graphics or GPS data. Using AR technologies provides user-oriented support for working procedures in development, production, and operating of complex technical products and systems. It is conceivable that in future manned missions such interfaces will be applied to space operations, where the astronaut will handle virtual information that enriches the physical reality. To improve the support for the operational ground team and the space crew by performing service and maintenance tasks at the Columbus space laboratory Biolab, investigators explore innovative tridimensional (3D) interaction techniques that allow an intuitive way to interact with the virtual content. The developed AR interfaces for the ISPR Biolab ought to offer support while handling standardize service and maintenance procedures. This research is primarily focused on supporting the ground team during their work at the engineering model of Biolab that is located in Cologne at the Institute of Aerospace Medicine. Applying these interfaces subsequently to space operations requires previous exploration regarding the influence of different acceleration conditions that ought to be considered at the investigators' current stage of designing and development. Thereby one important aspect is focused on the correct placement of virtual user interfaces while interacting with it. To explore human adaption of handling and controlling virtual AR interfaces, this experiment denotes a usability study that will supply findings about human mental workload and sensorimotor coordination while performing the experimentation task under different accelerations of gravity. The proposed experiment will supply essential information about understanding the adequate quality characteristics concerning placement of virtual interfaces in physical reality and identify disturbing factors while applying in hyper-g and micro-g conditions.


title: The Effect of Gravity on the Muscular Control of Landing From a Jump

acronym: SLS-JUMP

summary:
In this project, investigators propose to study the jump in different reduced gravity fields obtained during parabolic flights profiles but also during increased gravity fields obtained during turns of the airplane or during the pull-up phase of the parabola. By means of a pneumatic device, an additional pull-down force will be added to the vertical force caused by the gravity field. By combining different levels of gravity to different levels of the added pull-down force it will be possible to dissociate the respective contribution of the otolithic and proprioceptive systems to the anticipatory landing response. To the investigators' knowledge, only one study has modified the gravity field during a jump. However, these authors did not add a pull-down force and only analyzed the vertical ground reaction force.

A better knowledge of the sensory-motor control of the landing phase of a jump will also increase the investigators' understanding of the physiopathology of joint instability. Indeed, similarities could be found between the evolution of the motor response due to the absence gravity during long-duration space flights and the pathological process of chronic ankle and knee instability. The knowledge generated by this study will thus provide invaluable information in the context of human performance and rehabilitation.


title: Interrupter Technique and Plethysmography Airway Resistance Measurement: Comparison of These Two Techniques for the Diagnosis of Airway Obstruction Diagnosis and Bronchodilation Response in Children 3 to 6 Years of Age

summary: In preschool aged children, the most suitable techniques to assess airway obstruction is debit interruption technic (Rint) and plethysmographic measure of specific airway resistance (sRaw). Even if Rint is easily and routinely performed, it also includes a component of lung tissue and chest wall resistance as well as respiratory tissue viscoelasticity. sRaw seems to be better for discriminating airway obstruction. These two techniques will be compared in terms of concordance in the diagnosis of pulmonary obstruction and bronchodilator response.

ReferenceCitation: Mauger-Hamel P, Du Boisbaudry C, Léon K, Alavi Z, Giroux-Metges MA. Relationship between baseline and post-bronchodilator interrupter resistance and specific airway resistance in preschool children. Ann Allergy Asthma Immunol. 2020 Apr;124(4):366-372. doi: 10.1016/j.anai.2020.01.003. Epub 2020 Jan 13.


title: Interest of the Ultrasound to Evaluate the Quadriceps Muscle Wasting in Critical Ill Patients.

acronym: ECHOSCAN

summary:
Intensive care unit acquired muscle weakness (ICUAW) is a common disease. After 7 days of mechanical ventilation, a quarter of patients develop an ICUAW responsible of a 15-20% of muscle loss. This is a serious pathology associated with high morbidity and mortality.

Clinical diagnosis of ICUAW is difficult and need a patient awoken. CT scan and Magnetic Resonance Imaging (MRI) are considered as "gold standards" to quantify and monitor changes in muscle mass. But these tools are not adapted to ICU patients.

Ultrasound (US) is an easy access tool at the bedside to assess muscle mass and does not expose the patient to additional radiation.

The objective of this study is to evaluate the correlation between US and CT scan to measure quadriceps muscle thickness of ICU patients.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Gastroenteric Anastomosis With Natural Orifice Translumenal Endoscopic Surgery (NOTES) Using the New Fashionned Tissue Apposing Stent Axios® for the Treatment of Antro-pyloric or Duodenal Obstructions : Prospective Evaluation of Feasibility, Efficacy and Tolerance.

summary:
Achieving gastro-jejunal or duodenal anastomosis (GJA ) by exclusive endoscopically is a real goal for many years in the development and research of the transluminal endoscopic surgery (N.O.T.E.S). Endoscopic treatment, including palliative antro duodenal stenosis by metallic stent, although minimally invasive, causes problems in long-term secondary obstruction and migration. Surgical treatment of these strictures is associated with significant morbidity and mortality . The complication rate and severity of post-operative surgery after gastric bypass Roux-en-Y anastomosis or gastroduodenal fistulas remain close to 5% with a mortality of 1%. After 3 years of experimental research on porcine model, our team has developed a procedure of gastro duodenal anastomosis using transgastric endoscopic minimally invasive surgical technique (or NOTES) - LBA UMRT24 CERC laboratory , Aix-Marseille University , Faculty of Medicine North, with the aim to offer a credible alternative to conventional surgery.

Thus the investigators propose to conduct a pilot prospective intervenionnal study. The investigators hypothetized that this technique would reduce morbidity and mortality clinical but also economic consequences of surgery while making it possible to obtain excellent results permeability and long-term functionality. This method uses a new concept of tissue apposition with a fully covered metallic stent to create the anastomosis under endoscopy exclusively. Ten patients with antro duodenal obstructions requiring surgical or endoscopic bypass will be included as part of an interventional biomedical research that will be conducted in one expert center. The duration of the inclusions will be 18 months. Then, the stent will be removed three months after insertion, at the end of the healing process, and each patient will be followed for one year. The primary endpoint will be the assessment of the feasibility of the procedure for gastro duodenal anastomosis using tissue apposition stenting and NOTES in human being. The secondary endpoints will be the clinical efficacy, the long term (1 year) patency of the anastomosis, the procedure duration, adverse events, morbidity and mortality, the quality of life and the length of stay.

In case of failure of the NOTES procedure, the patient will be treated either by surgery or by conventional endoscopy according to the usual techniques without loss of chance. The risk / benefit ratio appears positive and a safety report will be issued after the first 4 inclusions. There will be no supplementary examination in patient follow-up in this study for which a CT iconography and biology are enough. The material used in the context of this work is consistent with the legislation on medical devices and has received CE Mark (tissue apposition fully covered stent Axios ®).

lead_sponsor: Assistance Publique Hopitaux De Marseille


acronym: CAR-DIFF

summary:
An injury of haematosis in post ischemic chronic heart failure limits the clinic tolerance.

There is a correlation between injury of pulmonary diffusing, chronic heart failure intensity and aerobic physic ability evaluated by an heart-rate maximal exercise tolerance test (VO2 max). This injury is a new follow-up parameter of cardiac function for the adult.

The nature of damage (vascular or membrane) can be determined by the measure of double pulmonary diffusing capacity to carbon monoxide (CO) associated to nitric oxide (NO).

Today, in chronic heart failure consecutive to a congenital heart disease, there is no data on evolution of membrane and capillar factors.It is impossible to predict if membrane damage will be the best factor correlated to the VO2max in patients suffering from complex congenital heart disease.

Assessing these parameters could be an comparative evaluation of heart-rate exercise tolerance test with VO2max and an early control of his damage without risks related to heart-rate maximal exercise and independently of age, sex, hemoglobin, type of heart disease.These results would have an early prognostic value that would permit to refine the follow-up and the treatment.

The main objective of this trial is to assess the statistic correlation between the membrane injury of alveolar-capillary diffusing at rest and aerobic physic ability restriction in children and adults suffering from complex congenital heart disease.


title: Toxicity of Perirenal Fat in Overweight or Obese Subjects: A Pathophysiological Link Between Uric Acid Stones and Renal Ammonium Formation

summary:
Patients who are overweight or obese, diabetic or not, share with those who are suffering from uric stones the same way to remove abnormal acidity of the body in urine, ie a kidney ammoniogenesis default. This results in an overly acidic urine pH which is directly pathogenic in people predisposed to develop uric stones because the precipitation of urate soluble uric acid is accelerated in acid medium.

Excess visceral fat, particularly perirenal, this defect may promote formation of renal ammonium. Indeed, the perirenal fat is adjacent to the renal cortex and shares with it a common arterial supply via the plexus Turner. Adipokines and fatty acids of the perirenal fat are predisposed to gain the renal cortex, seat of the ammoniogenesis. In humans the pathogenic role of the perirenal fat is demonstrated in chronic kidney disease and essential hypertension. However, the amount of fat and perirenal that of intra-abdominal fat are positively correlated.

Investigators hypothesis is that the perirenal fat also exert a pathogenic role in uric because of anatomical links between kidney stones and greasy environment and because excess fatty acids reaching the renal cortex decreases ammoniogenesis in an animal model metabolic syndrome.

For the test, the investigators will compare the amount of fat and perirenal renal ability to form ammonium in patients with uric or calcium lithiasis taking into account the amount of intra-abdominal fat.


title: Transcriptomes Breast, Ovarian and Leukocyte Hereditary Genes Predisposing to Breast and / or Ovarian Cancer

acronym: CASOHAR

summary:
This is a case-control study of molecular diagnostics.

This study requires two steps:

The first part of the study will be conducted on a population of 20 women without breast cancer and, or ovarian family (Healthy Volunteers controls)
The second part of the study will be conducted on a population of 50 patients predisposed to familial breast and, or ovarian cancer compared to 20 controls .

For analysis of leucocytes of the patients, a blood sample collected in a prior study (EXSAL study, ID-RCB 2009-A00833-54) will be used.

lead_sponsor: Centre Francois Baclesse


title: Cognitive Training in Children With Attention Deficit Hyperactivity Disorder (ADHD)

summary:
ADHD is associated with cognitive deficit. Therefore, cognitive training is often proposed as an intervention for ADHD that targets cognitive deficits, with specific exercises through intensive training sessions. This intervention is based on principles of brain plasticity and cerebral functional reorganizations.

Working memory deficits constitute a key impairment in ADHD. That is why, Cogmed working memory training is the most commonly used and studied cognitive training program in clinical practice and research. It is clear from most studies that Cogmed training program increases working memory in ADHD. However, transfer of learning is not demonstrated on: other cognitive functions that are not targeted by the program, on ADHD symptoms, nor on academic achievement.

In addition to this type of intervention multi-factorial program targeting different cognitive function as Presco also exist but have been less studied.

To address these challenges, this study will follow a randomized and controlled design.

The main objective of this study is to examine the impact of cognitive training in comparison with a control waiting-list group among children with ADHD on:

ADHD symptoms,
cognitive functioning,
attentional capacities
academic achievement.

The second objective is to compare two types of cognitive training a unifactorial program Cogmed targeting working memory and a multifactorial Presco focusing on different cognitive functions affected by ADHD.

Long-term effects are examined six months after training. Participants (n=90) will be randomly assigned to the two experimental group (Cogmed or Presco) or to the control group waiting list. Participants will be evaluated three time (time 1) just before the intervention, (time 2) six weeks after the first evaluation, immediately after the intervention and (time 3) six months after the intervention.


title: Identification and Quantification of a Mechanical Hyper-synchronicity State in Hypertrophic Cardiomyopathy (HCM) With Left Outflow-tract Obstruction and Description of Its Electrical and Electro-mechanical Characteristics Thanks to an Innovative Multi-imaging Approach to Predict a Positive Response to Dual Chamber Pacing. The Hsync Study.

acronym: HSYNC

summary:
Hypertrophic cardiomyopathy (HCM) is a common genetic cardiovascular disease. Outflow-tract gradient of 30 mmHg or more under resting conditions is an independent determinant of symptoms of progressive heart failure and death.

The investigators hypothesize that the electrical approach by dual chamber pacing could improve symptoms and reduce outflow-tract obstruction in a specific sub-group of selected patients with a mechanical hyper-synchronicity. The aim of the study is to identify and describe this phenomenon in HCM with (O-HCM) and without (NO-HCM) outflow-tract obstruction thanks to innovative multi-imaging approach.


title: Efficacy of Deep Transcranial Magnetic Stimulation (TMS) for Treatment-resistant Depression and Neuroanatomical Correlates: a Randomized Clinical Study Coupled With Positon Emission Tomography (PET)

summary:
Repetitive transcranial magnetic stimulation (TMS) is an emergent non-invasive treatment for treatment resistant depression (TRD). The exact neuro-functional mechanisms related to TMS efficiency remains however unknown; besides local effect on the target, TMS may induce interaction changes between remote cerebral regions. On the other hand, few studies have been performed in comparison to sham placebo stimulation. The investigators recently showed that non-responder depressive patients to TMS exhibited deeper and wider brain functional abnormalities hardly reachable by standard coils. The H1-Coil is a novel TMS (H-TMS) device capable of inducing a magnetic field with a deeper and wider distribution than standard coils.

The investigators design here a randomized controlled study in which the investigators will compare the clinical effects of H-coil TMS and standard TMS in patients with TRD, and their functional neuroanatomical correlates and changes in connectivity by Positron Emission Tomography (PET). The general objective is to better understand the mechanisms related to TMS efficiency in pharmacoresistant depression, in order to propose the best therapeutic approach for the patient.


title: Subcutaneous Injection of Autologous Adipose Tissue-derived Stromal Vascular Fraction Into the Fingers of Patients With Systemic Sclerosis : Controlled Clinical Trial With Efficacy Assessment

summary:
Systemic sclerosis (SSc) is an auto-immune orphan disease mainly characterized by an alteration of the microvascular network, and by cutaneous and visceral fibrosis. Hands are frequently affected, as a consequence of ischemic phenomena and cutaneous fibrosis.

. The injection of adipose autologous tissue is a common practice in plastic surgery, and has been known for over a century. Adipose tissue, originally used to increase volume, is also characterized by trophic properties associated to stromal vascular fraction (SVF), which contain multipotent stem cells, capable of tissue repair. Interestingly, some SVF cells can be angiogenic and anti-inflammatory, which could improve damage seen with SSc.

A prior study (the SCLERADEC protocol: ClinicalTrials.gov NCT01813279) has already allowed the safety and tolerance at 6 months of the subcutaneous injection of SVF in the fingers of twelve patients to be proven.

The encouraging results have encouraged us to propose a trial which would bear on a higher number of patients and include a control group.

ReferenceCitation: Daumas A, Magalon J, Jouve E, Casanova D, Philandrianos C, Abellan Lopez M, Mallet S, Veran J, Auquit-Auckbur I, Farge D, Levesque H, Benhamou Y, Arnaud L, Giraudo L, Dumoulin C, Giverne C, Boyer O, Giuliani A, Bourgarel V, Harlé JR, Schleinitz N, Brunet J, Pers YM, Ferreira R, Cras A, Boccara D, Larghero J, Château J, Hot A, Dignat-George F, Magalon G, Sabatier F, Granel B. Adipose tissue-derived stromal vascular fraction for treating hands of patients with systemic sclerosis: a multicentre randomized trial Autologous AD-SVF versus placebo in systemic sclerosis. Rheumatology (Oxford). 2022 May 5;61(5):1936-1947. doi: 10.1093/rheumatology/keab584.


title: Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment (Prednisone 5 Milligram Per Day) in Quiescent Systemic Lupus

acronym: CORTICOLUP

summary: Systemic Lupus (SLE) is a chronic disease for which long term treatments are warranted. The aim of this study was to study the possibility of corticosteroids interruption in patients with quiescent SLE treated since at least one year with 5 milligrams of predonisone per day.

ReferenceCitation: Mathian A, Pha M, Haroche J, Cohen-Aubart F, Hié M, Pineton de Chambrun M, Boutin THD, Miyara M, Gorochov G, Yssel H, Cherin P, Devilliers H, Amoura Z. Withdrawal of low-dose prednisone in SLE patients with a clinically quiescent disease for more than 1 year: a randomised clinical trial. Ann Rheum Dis. 2020 Mar;79(3):339-346. doi: 10.1136/annrheumdis-2019-216303. Epub 2019 Dec 18.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

location_facility: Groupe Hospitalier Pitié Salpêtrière, Service de médecine Interne 2, Institut e3m


title: Clinical and Medico-economic Evaluation of Radiofrequency Ablation Versus Oesophagectomy in the Treatment of High Grade Dysplasia in Barrett's Oesophagus

acronym: HARMONI

summary:
First intent treatment for superficial circular esophageal neoplasm is surgical resection. Endoscopic mucosal resection is not recommended due to the high rate of subsequent esophageal stenosis (higher than 80%).

Surgical limits are related to a high level of morbidity due, in particular, to respiratory complications or infections that require prolonged hospitalisations, and by significant rate of mortality (from 2 to 5 %). As an alternative to the surgical treatment, an innovative technique to remove esophageal circular preneoplastic and neoplastic lesions has been developed: it consists to ablate the mucosa by means of a balloon of a fixed diameter which incorporates approximately 100 electrodes on its surface that emit radiofrequency waves (HALO® Radiofrequency Ablation Technology System). By varying the strength and the duration of the electrical impulses, it is possible to obtain a homogenous and controlled destruction of the tissue of the whole mucosa, leaving no remaining pre-neoplastic or neoplastic elements underneath. The technique will be used for high grade glandular epithelial neoplasia, Vienna 4-1 or 4-2, developed on a mucosa at risk, i.e. the Barrett's oesophagus, occupying more than half of the circumference of the esophagus and that requires surgical treatment. The expected benefit for the patient is linked to the reduced invasiveness of the technique in comparison to the surgery

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon, Hépatogastroentérologie, Pavillon H, Hôpital Edouard Herriot


title: Quantification of Cerebral Blood Flow by Arterial Spin Labeling in the Screening and Monitoring of Vasospasm in Subarachnoid Haemorrhage

acronym: ASL-HSA

summary: A technique of MRI infusion -l'Arterial Spin Labeling-, non-invasive and non-irradiating, repeatable over time, appears promising in the field. This sequence allows for routine, generate perfusion maps relating to the entire brain volume