title: Efficacy of Oral Prednisolone Versus Partial Endodontic Treatment on Pain Reduction in Emergency Care of Acute Irreversible Pulpitis of Mandibular Molars: Non Inferiority Randomized Clinical Trial

acronym: PULPISOLONE

summary: Irreversible pulpitis is an inflammatory condition of the dental pulp, highly painful, representing one of the main reasons for consulting dental emergency. The recommended emergency care is a partial endodontic treatment under local and/or locoregional anesthesia. The purpose of the emergency partial endodontic treatment is to stop the pain of pulpitis by removing a portion of the pulp. The final endodontic treatment is ideally performed 72 hours after. The literature reports major difficulty in obtaining adequate anesthesia in the mandible to perform partial endodontic treatment, especially for the mandibular molars. This results in a very painful care for the patient. The management of this type of emergency is costly in terms of equipment and time for health facilities. Patient comfort, cost saving and rationalization of the care time justify the search for an alternative to emergency partial endodontic treatment. In current practice, the short course oral corticotherapy is used in the management of oral pain from inflammatory origin. Glucocorticoids, thanks to their anti-inflammatory action, can neutralize the inflammatory mediators and thus pain. The pulp inflammation can be treated with this molecule: the effectiveness of intraosseous local steroid injection for irreversible pulpitis of mandibular molars has already been shown but results in local comorbidities and requires specific device. Oral administration of short-course prednisolone is simple and safe but its effectiveness to manage pain caused by irreversible pulpitis has not yet been demonstrated. Per-os administration of prednisolone has a very high (90%) and rapid (≤ 4 hours) bioavailability. No difference in effectiveness between intravenous and oral administration of this molecule was reported. This oral treatment could limit comorbidities and technical difficulties related to intraosseous injection and could delay the endodontic treatment to 72 hours in optimal conditions of anesthesia for the patient. Despite the difficulties described for the partial endodontic treatment, it is very effective in pain reduction and can reach 100% of success. Therefore a non-inferiority design was chosen to compare the effect of a short-course oral corticotherapy to a partial endodontic treatment for the reduction of pain at the emergency care of the irreversible pulpitis in mandibular molars. The intervention arm will receive an oral dose of prednisolone (1 mg/kg) during the emergency visit followed-up by one morning dose by day during three days and the reference arm will have partial endodontic treatment. Both groups will have planned complete endodontic treatment 72 hours after enrolment.

ReferenceCitation: Kérourédan O, Jallon L, Perez P, Germain C, Péli JF, Oriez D, Fricain JC, Arrivé E, Devillard R. Efficacy of orally administered prednisolone versus partial endodontic treatment on pain reduction in emergency care of acute irreversible pulpitis of mandibular molars: study protocol for a randomized controlled trial. Trials. 2017 Mar 28;18(1):141. doi: 10.1186/s13063-017-1883-x.

family: Kérourédan

full_name: Olivia Kérourédan

given: Olivia

family: Jallon

full_name: Léonard Jallon

given: Léonard

family: Perez

full_name: Paul Perez

given: Paul

family: Germain

full_name: Christine Germain

given: Christine

family: Péli

full_name: Jean-François Péli

given: Jean-François

family: Oriez

full_name: Dominique Oriez

given: Dominique

family: Fricain

full_name: Jean-Christophe Fricain

given: Jean-Christophe

family: Arrivé

full_name: Elise Arrivé

given: Elise

family: Devillard

full_name: Raphaël Devillard

given: Raphaël

journal_name: Trials

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

endpoint_id: HAL

repository_institution: HAL


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.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Health Services Research

enrollment_type: Actual

ReferenceType: derived

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.

name: ENT and Audiology Department, University Hospital Gui de Chauliac, France

name: Auditory Disorders, Institute for Neurosciences of Montpellier, INSERM, France

family: Venail

full_name: Frederic Venail

given: Frederic

sequence: first

name: Biostatistics & Clinical Research Unit, University Montpellier, France

family: Picot

full_name: Marie C Picot

given: Marie C

sequence: additional

family: Marin

full_name: Gregory Marin

given: Gregory

family: Falinower

full_name: Sylvain Falinower

given: Sylvain

family: Samson

full_name: Jacques Samson

given: Jacques

family: Cizeron

full_name: Gilles Cizeron

given: Gilles

family: Balcon

full_name: Maxime Balcon

given: Maxime

family: Blanc

full_name: Denis Blanc

given: Denis

family: Bricaud

full_name: Jeremy Bricaud

given: Jeremy

family: Lorenzi

full_name: Antoine Lorenzi

given: Antoine

name: Audiology Department and Hearing Aid Dispenser Formation Center, CREFA, University of Montpellier, France

family: Ceccato

full_name: Jean-Charles Ceccato

given: Jean-Charles

family: Puel

full_name: Jean-Luc Puel

given: Jean-Luc

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Telemedicine and Telecare

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

ipd_sharing: No

lead_sponsor: University Hospital, Montpellier

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Completed


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

status: Unknown status

primary_purpose: Diagnostic

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire de Besancon

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.

study_start_date_type: Actual

primary_purpose: Supportive Care

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.

family: Roche

full_name: Johanna Roche

given: Johanna

family: Corgosinho

full_name: Flavia C. Corgosinho

given: Flavia C.

family: Dâmaso

full_name: Ana R. Dâmaso

given: Ana R.

family: Isacco

full_name: Laurie Isacco

given: Laurie

family: Miguet

full_name: Maud Miguet

given: Maud

family: Fillon

full_name: Alicia Fillon

given: Alicia

family: Guyon

full_name: Aurore Guyon

given: Aurore

family: Moreira

full_name: Gustavo A. Moreira

given: Gustavo A.

family: Pradella-Hallinan

full_name: Marcia Pradella-Hallinan

given: Marcia

family: Tufik

full_name: Sergio Tufik

given: Sergio

family: Túlio de Mello

full_name: Marco Túlio de Mello

given: Marco

family: Gillet

full_name: Valérie Gillet

given: Valérie

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Duclos

full_name: Martine Duclos

given: Martine

family: Boirie

full_name: Yves Boirie

given: Yves

family: Masurier

full_name: Julie Masurier

given: Julie

family: Franco

full_name: Patricia Franco

given: Patricia

family: Thivel

full_name: David Thivel

given: David

family: Mougin

full_name: Fabienne Mougin

given: Fabienne

journal_name: Nutrition, Metabolism and Cardiovascular Diseases

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

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.

name: Research Unit EA3920, University Bourgogne Franche-Comté, Besançon, France

name: Sports Science Faculty, University Bourgogne Franche-Comté, Besançon, France

name: Sleep Medicine Center, Ellipse, Franois, France

name: UGECAM Bourgogne Franche-Comté, Salins les Bains, France

publisher: American Academy of Sleep Medicine (AASM)

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


title: Cancer Patient Perceptions of the Osteopathy Treatment: a Qualitative Study

summary: For more than seven years an osteopath has been working in the palliative care unit (PCU) and in both palliative care mobile team (PCMT) as a member of the multidisciplinary team. The patients referred to the osteopath by the palliative care physicians present pains related to cancer, but also to the treatment, in particular to surgery or radiotherapy. The osteopath can help with other symptoms such as constipation or dyspnoea. As this approach is provided in complement of the medicinal approach, it is not considered as an alternative medicine but as a complementary medicine associated to a conventional care. It seemed relevant to the investigators to ask the cancer patients undergoing osteopathic sessions for pain how they saw this complementary therapy.

ReferenceType: result

ReferenceCitation: Steel A, Tricou C, Monsarrat T, Ruer M, Deslandes C, Sisoix C, Filbet M. The perceptions and experiences of osteopathic treatment among cancer patients in palliative care: a qualitative study. Support Care Cancer. 2018 Oct;26(10):3627-3633. doi: 10.1007/s00520-018-4233-y. Epub 2018 May 4.

family: Steel

full_name: Amie Steel

given: Amie

family: Tricou

full_name: Colombe Tricou

given: Colombe

family: Monsarrat

full_name: Thomas Monsarrat

given: Thomas

family: Ruer

full_name: Murielle Ruer

given: Murielle

family: Deslandes

full_name: Cécile Deslandes

given: Cécile

family: Sisoix

full_name: Corinne Sisoix

given: Corinne

family: Filbet

full_name: Marilène Filbet

given: Marilène

journal_name: Supportive Care in Cancer

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Hospices Civils de Lyon

location_facility: Médecine palliative - Groupement Hospitalier Lyon Sud- Hospices Civils de Lyon

intervention_type: Other


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

lead_sponsor: Assistance Publique - Hôpitaux de Paris


type: Other Identifier

title: Assessment of Renal Artery Fibromuscular Dysplasia: From Diagnosis to Treatment

acronym: DysArt

summary: This is a prospective multicenter study based on the validation of diagnostic criteria and predictive factors of treatment efficacy for renal artery stenosis in renal artery dysplasia. This is considered as a rare disease and patients are usually treated in specialized centers involved in a national network. Marseille is a center specialized in FMD and a member of the network that is very active across the country. In order to rapidly recruit patients the investigators propose a multicenter study. All patients included will benefit from an invasive angiography with trans stenotic gradient assessment at rest. In case of bilateral stenosis the investigators will randomly omit data from one side and consider the data from the contralateral artery for further analysis, to avoid statistical interdependency. Patients who require angioplasty and who have unilateral stenosis (unilateral FMD lesion or bilateral but with one non significant stenosis based on duplex ultrasound European recommendations for atherosclerotic renal artery stenosis) will be included in the second part of the study. These patients will in addition benefit from a trans stenotic pressure assessment under vasodilation and intravascular renal artery ultrasound. Patients with severe bilateral renal artery stenosis will not be included in the analysis to assess predictive criteria for treatment efficacy on hypertension, treatment of these patients will followed the current best clinical practice. These patients will be followed during 6 to 8 month to assess potential complication of the pressure assessment renal artery stenosis, but their data will be included to assess the value of FFR and IVUS to guide the procedure. Patients with unilateral stenosis will be followed up 6 month after angioplasty in order to assess hypertension and to look for potential complications.

study_completion_date_type: Anticipated

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Cluster Headache and SPINK-1 Gene

summary:
Cluster headache (CH) is a rare, excruciating primary headache disorder. A genetic basis has been suggested by family and twin studies, but the mode of transmission seems to vary and the amount of heritability is unclear.

The number of genetic association studies investigating variants implicated in the pathophysiology of CH is limited. The HCRTR2 1246G > A and the ADH4 925A > G polymorphisms have been associated with CH. The former has been confirmed and may affect the hypothalamic hypocretin system. The aim of the present study was to investigate the possible link between SPINK 1 gene and cluster headache.

primary_purpose: Screening

intervention_type: Genetic


title: Liver Perfusion MRI With Quantification of Tumoral Perfusion for Early Assessment of the Response of Antiangiogenics Treatments in Hepatocellular Carcinoma

acronym: ETAFIRM

summary:
Hepatocellular carcinoma (HCC) is the fifth most common cancer worldwide with an incidence of 500 000 cases per year. HCC most commonly appears in a context of liver chronic disease (patient with chronic viral hepatitis (hepatitis B or hepatitis C) or with cirrhosis). Surgical resection and liver transplantation concern patients with early stage and are the only curative treatments. Transcatheter arterial chemoembolization, Radiation Therapy and antiangiogenics treatments concern patients with inoperable lesions (palliative treatments).

Antiangiogenic treatments enable to inhibit the angiogenesis process and thus interrupt the blood supply to the tumor. In clinical practice, the efficacy of anti-angiogenic agents is usually assessed by methods based on morphological medical imaging. The measures of each target lesion are obtained by Response Evaluation Criteria In Solid Tumor (RECIST) criteria and WHO.

However, these morphological measures are not fully evaluated. An alternative to these is the functional medical imaging which assess changes before that a diminution of tumor size is detectable. Since these treatments induce generally necrosis without modification of initial tumor size, the new technologies of functional medical imaging are particularly adapted to an early evaluation of the response to treatments which may improve patient management.

In this context, liver Perfusion MRI needs to be assessed in its capacities to early predict the response of antiangiogenic treatments.

Positive results will enable to adapt therapy in order to improve overall survival of patients and avoid expensive treatments which may turn out to be inefficient and generating important side-effects.

status: Terminated

location_facility: Service d'Imagerie, MédicaleHôpital Croix-Rousse


title: Ambulatory Prolapse Surgery: Feasibility Study

acronym: PROLAMBU

summary:
Day surgery is performed in the same way as in full hospital admission, allowing same-day discharge without increased risk. It provides many grounds for patient satisfaction. Progress in surgical and anesthesia techniques now allows this form of management to be developed and prioritized.

Day-care surgery for prolapse has been little studied. The present study is intended to help extend its future implementation, the primary objective being to assess the feasibility of the day-care approach in prolapse surgery. The secondary objectives are to study criteria of non-eligibility for day-care prolapse surgery, reasons for patients' refusal, causes of failure, predictive factors for failure, patient satisfaction, postoperative complications, 2-year anatomic and functional results, pain, quality of life and sexuality, and postoperative onset of dyspareunia and urinary incontinence.

The design is for a prospective non-randomized study conducted in 3 gynecologic surgery sites managed by the Lyon hospitals board (Hospices Civils de Lyon).

primary_purpose: Treatment

intervention_type: Procedure


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

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.

family: Lelong

full_name: Bernard Lelong

given: Bernard

name: the French Research Group of Rectal Cancer Surgery (GRECCAR)

family: de Chaisemartin

full_name: Cécile de Chaisemartin

family: Meillat

full_name: Helene Meillat

given: Helene

family: Cournier

full_name: Sandra Cournier

given: Sandra

family: Boher

full_name: Jean Marie Boher

given: Jean Marie

family: Genre

full_name: Dominique Genre

given: Dominique

family: Karoui

full_name: Mehdi Karoui

given: Mehdi

family: Tuech

full_name: Jean Jacques Tuech

given: Jean Jacques

family: Delpero

full_name: Jean Robert Delpero

given: Jean Robert

currency_apc_doaj: GBP

journal_name: BMC Cancer

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

license_normalized: no license

version: submittedVersion

repositories:
HAL
PubMed Central

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL


title: Ultrasound Assessment of Gastric Contents : the Way to Best Induce Children for Emergency Surgery

acronym: ECHOGASTRO

summary:
Anesthesia for emergency surgery is a situation at risk of pulmonary aspiration of gastric contents. It has been previously reported that bedside two-dimensional ultrasonography can be a useful tool for anesthesiologists to determine gastric contents and volume in adults and children.

In this prospective study, preoperative qualitative ultrasound assessment of gastric contents is performed for each children admitted for emergency surgery, in order to plane in case of empty stomach an intravenous or inhalation technique induction rather than an rapid sequence induction.


title: MRI Study of Ballooning and Ligamentisation Short Transplants ACL Hamstring According to Technical DT4

summary: MRI study of ballooning and ligamentisation short transplants of anterior cruciate ligament (ACL) according to DT4 technique in 60 patients with more than one year of follow up.

study_type: Observational

time_perspective: Prospective

lead_sponsor: University Hospital, Lille


title: Assessment of Magnetic Resonance Imaging Neurography and Tractography for Preoperative Mapping of Pelvic Nerves

acronym: Neuro-Tracto

summary: This project aims at assessing two MRI acquisition methods, neurography and tractography, for the visualization of pelvic nerves. The goal is to optimize both methods and to test them on a pool of volunteers to assess if nerves can be delineated, so as to provide an individualized mapping of nerves to surgeons before an intervention and avoid postoperative complications.

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Porter GA, Soskolne CL, Yakimets WW, Newman SC. Surgeon-related factors and outcome in rectal cancer. Ann Surg. 1998 Feb;227(2):157-67.

ReferenceCitation: Baader B, Herrmann M. Topography of the pelvic autonomic nervous system and its potential impact on surgical intervention in the pelvis. Clin Anat. 2003 Mar;16(2):119-30.

ReferenceCitation: Lange MM, Marijnen CA, Maas CP, Putter H, Rutten HJ, Stiggelbout AM, Meershoek-Klein Kranenbarg E, van de Velde CJ; Cooperative clinical investigators of the Dutch. Risk factors for sexual dysfunction after rectal cancer treatment. Eur J Cancer. 2009 Jun;45(9):1578-88. doi: 10.1016/j.ejca.2008.12.014. Epub 2009 Jan 13.

ReferenceCitation: Lim KS, Tan CH. Diffusion-weighted MRI of adult male pelvic cancers. Clin Radiol. 2012 Sep;67(9):899-908. doi: 10.1016/j.crad.2012.01.016. Epub 2012 Apr 11. Review.

ReferenceCitation: Shihab OC, Heald RJ, Rullier E, Brown G, Holm T, Quirke P, Moran BJ. Defining the surgical planes on MRI improves surgery for cancer of the low rectum. Lancet Oncol. 2009 Dec;10(12):1207-11. doi: 10.1016/S1470-2045(09)70084-1.

ReferenceCitation: Filler AG, Howe FA, Hayes CE, Kliot M, Winn HR, Bell BA, Griffiths JR, Tsuruda JS. Magnetic resonance neurography. Lancet. 1993 Mar 13;341(8846):659-61.

ReferenceCitation: Takahara T, Hendrikse J, Yamashita T, Mali WP, Kwee TC, Imai Y, Luijten PR. Diffusion-weighted MR neurography of the brachial plexus: feasibility study. Radiology. 2008 Nov;249(2):653-60. doi: 10.1148/radiol.2492071826. Epub 2008 Sep 16.

ReferenceCitation: van der Jagt PK, Dik P, Froeling M, Kwee TC, Nievelstein RA, ten Haken B, Leemans A. Architectural configuration and microstructural properties of the sacral plexus: a diffusion tensor MRI and fiber tractography study. Neuroimage. 2012 Sep;62(3):1792-9. doi: 10.1016/j.neuroimage.2012.06.001. Epub 2012 Jun 13.

ReferenceCitation: Bertrand MM, Macri F, Mazars R, Droupy S, Beregi JP, Prudhomme M. MRI-based 3D pelvic autonomous innervation: a first step towards image-guided pelvic surgery. Eur Radiol. 2014 Aug;24(8):1989-97. doi: 10.1007/s00330-014-3211-0. Epub 2014 May 17.

ReferenceCitation: Soler L, Nicolau S, Pessaux P, Mutter D, Marescaux J. Real-time 3D image reconstruction guidance in liver resection surgery. Hepatobiliary Surg Nutr. 2014 Apr;3(2):73-81. doi: 10.3978/j.issn.2304-3881.2014.02.03.

ReferenceCitation: Chang KJ, Kamel IR, Macura KJ, Bluemke DA. 3.0-T MR imaging of the abdomen: comparison with 1.5 T. Radiographics. 2008 Nov-Dec;28(7):1983-98. doi: 10.1148/rg.287075154. Review.

ReferenceCitation: Wijsmuller AR, Giraudeau C, Leroy J, Kleinrensink GJ, Rociu E, Romagnolo LG, Melani AGF, Agnus V, Diana M, Soler L, Dallemagne B, Marescaux J, Mutter D. A step towards stereotactic navigation during pelvic surgery: 3D nerve topography. Surg Endosc. 2018 Aug;32(8):3582-3591. doi: 10.1007/s00464-018-6086-3. Epub 2018 Feb 12.

family: Wijsmuller

full_name: A. R. Wijsmuller

given: A. R.

family: Giraudeau

full_name: C. Giraudeau

given: C.

family: Leroy

full_name: J. Leroy

given: J.

family: Kleinrensink

full_name: G. J. Kleinrensink

given: G. J.

family: Rociu

full_name: E. Rociu

given: E.

family: Romagnolo

full_name: L. G. Romagnolo

given: L. G.

family: Melani

full_name: A. G. F. Melani

given: A. G. F.

family: Agnus

full_name: V. Agnus

given: V.

family: Diana

full_name: M. Diana

given: M.

family: Soler

full_name: L. Soler

given: L.

family: Dallemagne

full_name: B. Dallemagne

given: B.

family: Marescaux

full_name: J. Marescaux

family: Mutter

full_name: D. Mutter

given: D.

journal_name: Surgical Endoscopy

oa_colors: green hybrid

evidence: open (via page says license)

repository_institution: Erasmus University, Rotterdam - RePub

repositories_institution:
Erasmus University, Rotterdam - RePub
PubMed Central - Europe PMC

location_facility: Institut de Physique Biologique - Laboratoire iCube UMR 7357 UdS/CNRS


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: A Prospective, Randomized, Double-blind, Placebo Controlled, Multi-national Study of Therapeutic Anticoagulation Strategy for Acute Chest Syndrome in Adults

acronym: TASC

summary:
Acute Chest Syndrome (ACS) is a pulmonary complication of sickle cell disease (SCD) representing the leading cause of death and the second cause of hospitalization among adult patients. Pulmonary vaso-occlusion is one of the main pathophysiologic hypotheses during ACS. Our hypothesis is that therapeutic anticoagulation may reduce the severity of ACS via the alleviation of pulmonary thrombosis. The main objective of this prospective, randomized, double-blind study is to test the efficacy and safety of a curative anticoagulation strategy during ACS. The main efficacy endpoint is time to ACS resolution. The main safety endpoint is number of major bleedings.

A thoracic CT scan will be performed to check for pulmonary artery thrombosis. If the CT scan is positive (thrombosis within a large elastic artery), the patient will not be randomized and will be treated with a curative anticoagulation. If the CT scan is negative, the patient will be randomized to receive subcutaneous anticoagulation with low molecular weight heparin (tinzaparin) either at a curative dose (175 Unit International (UI)/kg/day for 7 days) or at a prophylactic dose (4500 UI/day).

ReferenceCitation: Qari MH, Aljaouni SK, Alardawi MS, Fatani H, Alsayes FM, Zografos P, Alsaigh M, Alalfi A, Alamin M, Gadi A, Mousa SA. Reduction of painful vaso-occlusive crisis of sickle cell anaemia by tinzaparin in a double-blind randomized trial. Thromb Haemost. 2007 Aug;98(2):392-6.

ReferenceCitation: Mekontso Dessap A, Deux JF, Abidi N, Lavenu-Bombled C, Melica G, Renaud B, Godeau B, Adnot S, Brochard L, Brun-Buisson C, Galacteros F, Rahmouni A, Habibi A, Maitre B. Pulmonary artery thrombosis during acute chest syndrome in sickle cell disease. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1022-9. doi: 10.1164/rccm.201105-0783OC.

intervention_type: Drug


title: Circulating Silicone After Cosmetic Silicone Injection in Transgender Patients

acronym: TSBS

summary:
This cross-sectional monocentric study will describe transgender men transitioning into women and who had cosmetic silicone injection.

The principal objective is to estimate the prevalence of Transgender with circulating monocytes containing silicone vacuoles in blood smears among Male to Female Transgender population with a history of cosmetic silicon injections.

The secondary objectives are to describe the transgender population, to describe the quantity of silicone in vacuoles of circulating monocytes, and the association between dermatological complications (inflammatory and not inflammatory) and several clinical and biological characteristics (HIV status, level of immunosuppression, inflammatory syndrome, quantity of silicone which was injected , silicone quantity in blood smears).

time_perspective: Cross-Sectional

location_facility: Hôpitaux Universitaires Paris-Nord Val de Seine, site Bichat


title: Immune Modulation Study in Patients With Metastatic Melanoma Treated With Anti-PD1 Monoclonal Antibodies

acronym: PAIR

summary: This is an open mono-centric prospective non-randomized study in patients with metastatic melanoma treated with Anti-PD1 monoclonal antibodies (Nivolumab). The aim of the study is to identify the immune cells modulations differences between patients who present a complete, partial or stable response and patients who have non-response to the therapy in order to establish an improving response rate strategy.

primary_purpose: Other


title: Association Between Cerebral Arterial Vascular Flow and Sleep Apnea in Neurodegenerative Alterations

acronym: VAAPS

summary:
Obstructive sleep apnea syndrome (OSAS) is a sleep-disordered breathing characterized by the occurrence of repeated upper airway obstructions leading to airflow reduction (hypopnea) or cessation (apnea). The apnea-hypopnea index (AHI) is the number of apneas and hypopneas per hour of sleep. OSA patients often report cognitive complaints.

About 25% of the elderly population is affected by this syndrome with a drastic increase of this rate among dementia patients. OSAS is considered to be an important risk factor for the development of hypertension, heart disease and stroke.

lead_sponsor: Central Hospital Saint Quentin

status_simplified: Ongoing


acronym: ICA Langage

summary: Proceed to an analysis of sensitivity and specificity results of the fMRI language network obtained in two ways: by providing a conventional language test and independent component analysis. These two methods will be compared to the reference method what the cortical intraoperative mapping.

lead_sponsor: University Hospital, Angers


title: Hippocampal Sclerosis and Amnesia Not Due to Alzheimer's Disease

summary: Hippocampal Sclerosis (HS) leads to anterograde amnesia mimicking early Alzheimer's disease (AD) (so called HSA-nonAD). Recent studies showed that (a) the deficit of episodic memory as well as the level of hippocampal atrophy in bvFTD may be of similar severity to that observed in AD, even at initial presentation, leading to misdiagnosis in 22% of cases with post mortem diagnosis; (b) amnesia with HS due to microvascular lesion and microinfarcts can also cause impairment of episodic memory mimicking AD, without subcortical cognitive profile. Because these diseases involve distinct pathophysiological processes, they require different specific care and treatment. In consequence, it is very important to improve our knowledge about HS in order to identify its mechanism and improve the diagnosis.

primary_purpose: Basic Science

lead_sponsor: Centre Hospitalier St Anne

location_facility: Neurologie de la mémoire et du langage, Service de Neurologie, Centre Hospitalier Sainte-Anne


title: ELENA Cohort: A Long-term Longitudinal Study in a Pediatric Sample With Autism Spectrum Disorders

acronym: ELENA

summary:
The objective of the ELENA French Cohort is to study the developmental trajectories of children and adolescents with ASD and their risk or protective associated factors.

This is an open, prospective and multicenter cohort study, including children and adolescents under 16 years of age with ASD recruited from services specialized in the assessment of developmental disorders.

ReferenceCitation: Vernhet C, Michelon C, Dellapiazza F, Rattaz C, Geoffray MM, Roeyers H, Picot MC, Baghdadli A; ELENA study group. Perceptions of parents of the impact of autism spectrum disorder on their quality of life and correlates: comparison between mothers and fathers. Qual Life Res. 2021 Nov 25. doi: 10.1007/s11136-021-03045-3. [Epub ahead of print]

family: Vernhet

full_name: Christelle Vernhet

given: Christelle

family: Michelon

full_name: Cécile Michelon

given: Cécile

family: Dellapiazza

full_name: Florine Dellapiazza

given: Florine

family: Rattaz

full_name: Cécile Rattaz

family: Geoffray

full_name: Marie-Maude Geoffray

given: Marie-Maude

family: Roeyers

full_name: Herbert Roeyers

given: Herbert

family: Picot

full_name: Marie-Christine Picot

given: Marie-Christine

family: Baghdadli

full_name: Amaria Baghdadli

given: Amaria

family: Chabaux

full_name: Catherine Chabaux

given: Catherine

family: Chatel

full_name: Clarisse Chatel

given: Clarisse

family: Cohen

full_name: David Cohen

given: David

family: Damville

full_name: Emmanuel Damville

given: Emmanuel

family: Gicquel

full_name: Ludovic Gicquel

given: Ludovic

family: Jardri

full_name: Renaud Jardri

given: Renaud

family: Maffre

full_name: Thierry Maffre

given: Thierry

family: Novo

full_name: Alexandre Novo

given: Alexandre

family: Roxane

full_name: Roxane Roxane

given: Roxane

family: Oreve

full_name: Marie-Joëlle Oreve

given: Marie-Joëlle

family: Périsse

full_name: Didier Périsse

given: Didier

family: Poinso

full_name: François Poinso

given: François

family: Pottelette

full_name: Julien Pottelette

given: Julien

family: Robel

ReferenceCitation: Miniarikova E, Vernhet C, Peries M, Loubersac J, Picot MC, Munir K, Baghdadli A. Anxiety and depression in parents of children with autism spectrum disorder during the first COVID-19 lockdown: Report from the ELENA cohort. J Psychiatr Res. 2021 Nov 8. pii: S0022-3956(21)00671-3. doi: 10.1016/j.jpsychires.2021.11.022. [Epub ahead of print]

ReferenceCitation: Berard M, Rattaz C, Peries M, Loubersac J, Munir K, Baghdadli A. Impact of containment and mitigation measures on children and youth with ASD during the COVID-19 pandemic: Report from the ELENA cohort. J Psychiatr Res. 2021 May;137:73-80. doi: 10.1016/j.jpsychires.2021.02.041. Epub 2021 Feb 22.

ReferenceCitation: Baghdadli A, Miot S, Rattaz C, Akbaraly T, Geoffray MM, Michelon C, Loubersac J, Traver S, Mortamais M, Sonié S, Pottelette J, Robel L, Speranza M, Vesperini S, Maffre T, Falissard B, Picot MC; ELENA Study Group. Investigating the natural history and prognostic factors of ASD in children: the multicEntric Longitudinal study of childrEN with ASD - the ELENA study protocol. BMJ Open. 2019 Jun 19;9(6):e026286. doi: 10.1136/bmjopen-2018-026286.

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


title: Prevention of HYPOthermia Before Admission in TRAUMa Patients - Hypotraum 2 Study

acronym: HYPOTRAUM 2

summary: The purpose of this study is to demonstrate that the specific management will increase the number of alive trauma patient arriving with a temperature > 35°C.

ReferenceCitation: Lapostolle F, Sebbah JL, Couvreur J, Koch FX, Savary D, Tazarourte K, Egman G, Mzabi L, Galinski M, Adnet F. Risk factors for onset of hypothermia in trauma victims: the HypoTraum study. Crit Care. 2012 Jul 31;16(4):R142. doi: 10.1186/cc11449.

location_facility: SAMU 93, AP-HP, Urgences - SAMU 93, Unité Recherche-Enseignement-Qualité, Hôpital Avicenne


title: Long Term Effects of Positive Airway Pressure Therapies on Vascular Function in Obstructive Sleep Apnea

summary:
Obstructive sleep apnea syndrome is responsible of endothelial dysfunction, which is a independent cardio-vascular risk factor.

Assessment of pulse wave velocity (PWV) and peripheral arterial tone (PAT) are study measurements of arterial stiffness, and are strong predictors of late cardiovascular events.

This study will compare long term evolution in arterial stiffness (PWV) and endothelial dysfunction (PAT) for patients treated by Positive Airway Pressure Therapies.

lead_sponsor: University Hospital, Grenoble


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: Walking, Brain and Functional Magnetic Resonance Imaging Study of Motor Representations in Healthy Subjects and Amnestic MCI

acronym: IRMARCHE

summary: Walking, Brain and Functional Magnetic Resonance Imaging Study of motor representations in healthy subjects and amnesic MCI.

ReferenceCitation: Dinomais M, Minassian AT, Tuilier T, Delion M, Wilke M, N'Guyen S, Richard I, Aubé C, Menei P. Functional MRI comparison of passive and active movement: possible inhibitory role of supplementary motor area. Neuroreport. 2009 Oct 7;20(15):1351-5. doi: 10.1097/WNR.0b013e328330cd43.

ReferenceCitation: Beauchet O, Allali G, Berrut G, Hommet C, Dubost V, Assal F. Gait analysis in demented subjects: Interests and perspectives. Neuropsychiatr Dis Treat. 2008 Feb;4(1):155-60.

ReferenceCitation: Rimmer E, Wojciechowska M, Stave C, Sganga A, O'Connell B. Implications of the Facing Dementia Survey for the general population, patients and caregivers across Europe. Int J Clin Pract Suppl. 2005 Mar;(146):17-24.

ReferenceCitation: Ogawa S, Lee TM, Nayak AS, Glynn P. Oxygenation-sensitive contrast in magnetic resonance image of rodent brain at high magnetic fields. Magn Reson Med. 1990 Apr;14(1):68-78.

ReferenceCitation: Beauchet O, Allali G, Launay C, Herrmann FR, Annweiler C. Gait variability at fast-pace walking speed: a biomarker of mild cognitive impairment? J Nutr Health Aging. 2013 Mar;17(3):235-9. doi: 10.1007/s12603-012-0394-4.

intervention_type: Radiation


title: MagnetoEncephaloGraphy Study of Cerebral Activations Induced by Psychomotor Tasks for Target Localisation in View of BCI Clinical Trial

acronym: TAPFINGER

summary: The study aims at mapping the magnetoencephalographic (MEG) activities induced in normal volunteers by tapping the finger .

intervention_type: Behavioral


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.

lead_sponsor: University Hospital, Tours

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.

lead_sponsor: Hopital Foch


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: Course and Follow up of Patients Affected by Facioscapulohumeral Dystrophy

acronym: FSHD

summary: On the basis of published data and our results indicating that oxidative stress may contribute to the peripheral skeletal muscle dysfunction in patients with FSHD, investigators conducted a pilot randomized double-blind placebo controlled trial to test whether oral administration of vitamins and mineral could improve the physical performance of patients with FSHD.The result of this clinical trial showed that antioxidants supplementation may improve skeletal muscle function of patients with FSHD and suggest that an antioxidant strategy adapted may be a relevant therapeutic approach for these patients. Since then, patients with FSHD who attend consultation at Montpellier hospital are systematically supplemented with antioxidants according their own blood tests.

location_facility: Montpellier University Hospital- Saint Eloi Hospital


title: Study of the Impact of Osteopathic Care, Complementary Therapy to Standard Care, on Pain in Patients With Breast Cancer Surgery

acronym: IPOD

summary:
Breast cancer can be painful following surgery or can develop later and remain persistent. Pain occurrence is frequent with 50% of women developing sequelae pain of varying intensity with an impact on the quality of life. One of the priorities of the 3rd French Cancer Plan is to preserve quality of life.

Osteopathy, complementary therapy, may help to reduce inconvenience caused by the disease, treatments and their side effects (asthenia, anxiety and pain).

The main objective is to assess the impact of osteopathic treatment on pain in patients following breast cancer surgery. The impact will be considered beneficial if the pain score (digital scale) in the intervention group is lower, by at least two points, than the pain score in the control group at the end of the study.

This is a monocentric, randomized, parallel group, single-blind and prospective clinical trial.


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

lead_sponsor_type: industriel


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.

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


title: ChEmo-Genomics Based Treatment of Acute Myeloid Leukemia- CeGAL-IPC 2014-012

acronym: CeGAL

summary: Adult acute myeloid leukemia (AML) is a heterogeneous hematologic malignancy associated with poor prognosis, especially after relapse. High-throughput genomic studies have highlighted the importance of molecular alteration in the pathophysiology, clinical evolution and treatment response of AML. In addition, identification of specific gene mutation can be targeted by specific inhibitors, opening the way to personalized treatments. However, only a limited number of gene mutations are druggable or actionable, highlighting the need for additional information to guide treatment choices. Among them, new Drug Screening Tests (DST) allow for the screening of library of hundreds of drugs to ex-vivo patient-derived AML cells. Combination of genomic and pharmacologic approaches might therefore improve prediction of drug effects. There is an urgent need to bring these approaches into the clinic but feasibility trials are necessary before incorporating them into treatments strategies.The proposed study is a prospective multicentre feasibility study of a combined "chemo-genomic" approach in patients with advanced AML.

ReferenceCitation: Collignon A, Hospital MA, Montersino C, Courtier F, Charbonnier A, Saillard C, D'Incan E, Mohty B, Guille A, Adelaïde J, Carbuccia N, Garnier S, Mozziconacci MJ, Zemmour C, Pakradouni J, Restouin A, Castellano R, Chaffanet M, Birnbaum D, Collette Y, Vey N. A chemogenomic approach to identify personalized therapy for patients with relapse or refractory acute myeloid leukemia: results of a prospective feasibility study. Blood Cancer J. 2020 Jun 3;10(6):64. doi: 10.1038/s41408-020-0330-5.

family: Collignon

full_name: A. Collignon

given: A.

family: Hospital

full_name: M. A. Hospital

given: M. A.

family: Montersino

full_name: C. Montersino

given: C.

family: Courtier

full_name: F. Courtier

given: F.

family: Charbonnier

full_name: A. Charbonnier

family: Saillard

full_name: C. Saillard

family: D’Incan

full_name: E. D’Incan

given: E.

family: Mohty

full_name: B. Mohty

given: B.

family: Guille

full_name: A. Guille

family: Adelaïde

full_name: J. Adelaïde

given: J.

family: Carbuccia

full_name: N. Carbuccia

given: N.

family: Garnier

full_name: S. Garnier

given: S.

family: Mozziconacci

full_name: M. J. Mozziconacci

given: M. J.

family: Zemmour

full_name: C. Zemmour

family: Pakradouni

full_name: J. Pakradouni

family: Restouin

full_name: A. Restouin

family: Castellano

full_name: R. Castellano

given: R.

family: Chaffanet

full_name: M. Chaffanet

given: M.

family: Birnbaum

full_name: D. Birnbaum

given: D.

family: Collette

full_name: Y. Collette

given: Y.

family: Vey

full_name: N. Vey

journal_name: Blood Cancer Journal

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


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. 2021 Oct 5. pii: S0013-7006(21)00182-2. doi: 10.1016/j.encep.2021.06.010. [Epub ahead of print] French.

family: Dumas

full_name: Louise-Emilie Dumas

given: Louise-Emilie

family: Bonnard-Couton

full_name: Valérie Bonnard-Couton

given: Valérie

family: Golse

full_name: Bernard Golse

given: Bernard

family: Askénazy

full_name: Florence Askénazy

given: Florence

journal_name: L'Encéphale

title: Identification de marqueurs sociaux et émotionnels associés à l’hallucination acoustico-verbale (HAV) en population pédiatrique : étude Physalis

lead_sponsor: Fondation Lenval


title: Value of Ultrasound for Evaluating Rheumatoid Arthritis in Remission: Longitudinal Study

acronym: SONORE

summary:
The objective of this study is to determine the longitudinal relation between clinical remission and ultrasound (US) remission in Rheumatoid arthritis (RA).

At a patient level, US-detected residual synovitis (evaluated both by US grey-scale signals and power Doppler signals) is frequent in patients with RA in clinical remission. Several longitudinal studies reveal an association of US-detected residual synovitis and risk of relapse and radiographic progression, in individual patients and joints, over 1-2 years.

However, the longitudinal relation between clinical remission and US remission is not so well-known and it is possible that clinical remission arrive before ultrasound remission. Thus arise the question as to whether the presence of US-detected residual synovitis require to adapt the treatment to ultrasound findings or to simply increase the patient care.

The investigator propose to conduct a prospective, bi-center, non randomized study.

lead_sponsor: University Hospital, Montpellier


title: Intravenous Versus Combined Oral and Intravenous Antimicrobial Prophylaxis for the Prevention of Surgical Site Infection in Elective Colorectal Surgery: A Double-blinded Multicenter Prospective Randomized Controlled Trial

acronym: COMBINE

summary: To assess the effects of a combined antimicrobial prophylaxis using oral ornidazole (the day before surgery) and intravenous cephalosporin (before surgical incision) with that of intravenous cephalosporin alone (standard of care) in combination with oral placebo on the incidence of SSI within 30 days after elective colorectal surgery.

ReferenceCitation: Vignaud M, Paugam-Burtz C, Garot M, Jaber S, Slim K, Panis Y, Lucet JC, Bourdier J, Morand D, Pereira B, Futier E; COMBINE trial management committee. Comparison of intravenous versus combined oral and intravenous antimicrobial prophylaxis (COMBINE) for the prevention of surgical site infection in elective colorectal surgery: study protocol for a multicentre, double-blind, randomised controlled clinical trial. BMJ Open. 2018 Apr 12;8(4):e020254. doi: 10.1136/bmjopen-2017-020254.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Evaluation of the Efficiency of Bronchial Thermoplasty on Dynamic Hyperinflation in Uncontrolled Severe Asthma

acronym: HEAT-SA

summary:
Bronchial thermoplasty is a treatment for severe asthma that consist in decreasing the thickness of bronchial muscle by heat using a catheter inserted into the bronchi under direct vision with the help of an endoscope This treatment has shown efficacy on symptoms, quality of life and the number of exacerbations related to severe asthma.

This clinical study evaluates the efficiency of this treatment on the dynamic hyperinflation phenomenon (worsening of bronchial obstruction during exercise in patients with asthma contributing to worsening shortness of breath).

ReferenceCitation: Moore WC, Bleecker ER, Curran-Everett D, Erzurum SC, Ameredes BT, Bacharier L, Calhoun WJ, Castro M, Chung KF, Clark MP, Dweik RA, Fitzpatrick AM, Gaston B, Hew M, Hussain I, Jarjour NN, Israel E, Levy BD, Murphy JR, Peters SP, Teague WG, Meyers DA, Busse WW, Wenzel SE; National Heart, Lung, Blood Institute's Severe Asthma Research Program. Characterization of the severe asthma phenotype by the National Heart, Lung, and Blood Institute's Severe Asthma Research Program. J Allergy Clin Immunol. 2007 Feb;119(2):405-13.

ReferenceCitation: Brown RH, Wizeman W, Danek C, Mitzner W. Effect of bronchial thermoplasty on airway distensibility. Eur Respir J. 2005 Aug;26(2):277-82.

ReferenceCitation: Cox G, Thomson NC, Rubin AS, Niven RM, Corris PA, Siersted HC, Olivenstein R, Pavord ID, McCormack D, Chaudhuri R, Miller JD, Laviolette M; AIR Trial Study Group. Asthma control during the year after bronchial thermoplasty. N Engl J Med. 2007 Mar 29;356(13):1327-37.

ReferenceCitation: Pavord ID, Cox G, Thomson NC, Rubin AS, Corris PA, Niven RM, Chung KF, Laviolette M; RISA Trial Study Group. Safety and efficacy of bronchial thermoplasty in symptomatic, severe asthma. Am J Respir Crit Care Med. 2007 Dec 15;176(12):1185-91. Epub 2007 Sep 27.

ReferenceCitation: Castro M, Rubin AS, Laviolette M, Fiterman J, De Andrade Lima M, Shah PL, Fiss E, Olivenstein R, Thomson NC, Niven RM, Pavord ID, Simoff M, Duhamel DR, McEvoy C, Barbers R, Ten Hacken NH, Wechsler ME, Holmes M, Phillips MJ, Erzurum S, Lunn W, Israel E, Jarjour N, Kraft M, Shargill NS, Quiring J, Berry SM, Cox G; AIR2 Trial Study Group. Effectiveness and safety of bronchial thermoplasty in the treatment of severe asthma: a multicenter, randomized, double-blind, sham-controlled clinical trial. Am J Respir Crit Care Med. 2010 Jan 15;181(2):116-24. doi: 10.1164/rccm.200903-0354OC. Epub 2009 Oct 8.

ReferenceCitation: Wechsler ME, Laviolette M, Rubin AS, Fiterman J, Lapa e Silva JR, Shah PL, Fiss E, Olivenstein R, Thomson NC, Niven RM, Pavord ID, Simoff M, Hales JB, McEvoy C, Slebos DJ, Holmes M, Phillips MJ, Erzurum SC, Hanania NA, Sumino K, Kraft M, Cox G, Sterman DH, Hogarth K, Kline JN, Mansur AH, Louie BE, Leeds WM, Barbers RG, Austin JH, Shargill NS, Quiring J, Armstrong B, Castro M; Asthma Intervention Research 2 Trial Study Group. Bronchial thermoplasty: Long-term safety and effectiveness in patients with severe persistent asthma. J Allergy Clin Immunol. 2013 Dec;132(6):1295-302. doi: 10.1016/j.jaci.2013.08.009. Epub 2013 Aug 30.

ReferenceCitation: Guibert N, Guilleminault L, Lepage B, Heluain V, Fumat R, Dupuis M, Faviez G, Plat G, Hermant C, Didier A. Bronchial thermoplasty in patients with dynamic hyperinflation: results from the proof-of-concept HEAT trial. Eur Respir J. 2021 Jan 28;57(1). pii: 2001616. doi: 10.1183/13993003.01616-2020. Print 2021 Jan.

family: Guibert

full_name: Nicolas Guibert

given: Nicolas

family: Guilleminault

full_name: Laurent Guilleminault

given: Laurent

family: Lepage

full_name: Benoit Lepage

given: Benoit

family: Heluain

full_name: Valentin Heluain

given: Valentin

family: Fumat

full_name: Romane Fumat

given: Romane

family: Dupuis

full_name: Marion Dupuis

given: Marion

family: Faviez

full_name: Guillaume Faviez

given: Guillaume

family: Plat

full_name: Gavin Plat

given: Gavin

family: Hermant

full_name: Christophe Hermant

given: Christophe

family: Didier

full_name: Alain Didier

given: Alain

journal_name: European Respiratory Journal

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society


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

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.

name: Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Européen Georges Pompidou, Department of Cardiology; Université Paris-Descartes, Paris, France; INSERM U-970, France (E.P., N.A., N.D.).

family: Puymirat

full_name: Etienne Puymirat

given: Etienne

name: AP-HP, Hôpital Saint Antoine, Department of Clinical Pharmacology and Unité de Recherche Clinique (URCEST), Paris, France; Université Pierre et Marie Curie (UPMC-Paris 06); INSERM U-698, France (T.S.).

family: Simon

full_name: Tabassome Simon

given: Tabassome

name: Centre Hospitalier Universitaire de Nîmes, France (G.C.).

family: Cayla

full_name: Guillaume Cayla

name: Centre Hospitalier Universitaire du Bocage, Dijon, France (Y.C.).

family: Cottin

full_name: Yves Cottin

given: Yves

name: Toulouse University Hospital, Department of Cardiology, France (M.E.).

family: Elbaz

full_name: Meyer Elbaz

given: Meyer

name: Hôpital Cardiologique Haut Levêque, CHU de Bordeaux, Pessac, France (P.C.).

family: Coste

full_name: Pierre Coste

given: Pierre

name: Lille Regional University Hospital, Department of Cardiology, France (G.L.).

family: Lemesle

full_name: Gilles Lemesle

given: Gilles

name: Department of Cardiology, University Hospital of Clermont-Ferrand, UMR 6284 Auvergne University, France (P.M.).

family: Motreff

full_name: Pascal Motreff

given: Pascal

name: Département de cardiologie, CHU de Nancy, Vandoeuvre-lès-Nancy, France (B.P.).

family: Popovic

full_name: Batric Popovic

given: Batric

name: Centre Hospitalier Régional de Metz-Thionville, Mets, France (K.K.).

family: Khalife

full_name: Khalife Khalife

given: Khalife

name: Centre Hospitalier de la Côte Basque, Bayonne, France (J.-N.L.).

family: Labèque

full_name: Jean-Noel Labèque

given: Jean-Noel

name: Department of cardiology, Centre Hospitalier St Joseph et St Luc, Lyon, France (T.P.).

family: Perret

full_name: Thibaut Perret

given: Thibaut

name: Centre Hospitalier Bretagne Atlantique, Vannes, France (C.L.R.).

family: Le Ray

full_name: Christophe Le Ray

name: Department of Cardiology, Centre Hospitalier de Vendée, La Roche-sur-Yon, France (L.O.).

family: Orion

full_name: Laurent Orion

name: Hospital of Aix en Provence, Department of Cardiology, France (B.J.).

family: Jouve

full_name: Bernard Jouve

name: Clinique St Gatien, Tours, France (D.B.).

family: Blanchard

full_name: Didier Blanchard

given: Didier

name: Clinique Axium Aix en Provence, France (P.P.);

family: Peycher

full_name: Patrick Peycher

given: Patrick

name: Institut de Cardiologie, Centre Hospitalier Pitié-Salpêtrière, Paris, France (J.S.).

family: Silvain

full_name: Johanne Silvain

given: Johanne

name: AP-HP, Hôpital Bichat, Paris, France; Université Paris-Diderot, Sorbonne Paris-Cité, France; INSERM U-698, 75018 Paris, France (P.G.S.).

family: Steg

full_name: Philippe Gabriel Steg

given: Philippe Gabriel

name: Lille Regional University Hospital, Emergency Department, France (P. Goldstein).

family: Goldstein

full_name: Patrick Goldstein

name: University Hospital Henri Mondor, Department of Cardiology, Créteil, France (P. Guéret).

family: Guéret

full_name: Pascal Guéret

name: Department of Cardiology, Centre hospitalier Annecy Genevois, Epagny Metz-Tessy, France (L.B.).

family: Belle

full_name: Loic Belle

given: Loic

family: Aissaoui

full_name: Nadia Aissaoui

given: Nadia

name: Toulouse Rangueil University Hospital, Department of Cardiology; UMR1027, INSERM, France (J.F.).

family: Ferrières

name: University Hospital Jean Minjoz, Department of Cardiology, Besançon, France (F.S.).

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

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

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Acute Myocardial Infarction

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.

title: French Registry on Acute ST-elevation and non−ST-elevation Myocardial Infarction 2015 (FAST-MI 2015). Design and baseline data

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.

name: Department of Cardiology, Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, France (E.P., N.D.).

name: Université Paris-Descartes, France (E.P., N.D.).

name: Department of Clinical Pharmacology and Unité de Recherche Clinique, Assistance Publique-Hôpitaux de Paris, Hôpital Saint Antoine, France (T.S.).

name: Université Pierre et Marie Curie, France (T.S.).

title: 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”

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.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENSM-SE

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENSM-SE

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.

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

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.

name: Department of CardiologyAssistance Publique‐Hôpitaux de Paris (AP‐HP), Hôpital Européen Georges Pompidou (HEGP) Paris France

name: TIMI Study Group, Division of Cardiovascular MedicineBrigham and Women's Hospital, and Harvard Medical School Boston Massachusetts

name: Department of Intensive CareAP‐HP, HEGP Paris France

name: Department of cardiologyLille regional university hospital Lille France

name: Department of cardiologyhôpital Nord, AP‐HM, 13015 Marseille, France; Mediterranean Academic Association for Research and Studies in Cardiology (MARS Cardio), Marseille, France; Inserm UMRS 1076, Aix‐Marseille university Marseille France

name: Department of cardiologyAP‐HP, Hôpital Bichat Paris France

name: Department of cardiologyCHU Nîmes Nîmes France

name: Department of CardiologyRangueil Hospital Toulouse France

name: Department of CardiologyUniversity Hospital Jean Minjoz Besançon France

name: AP‐HP, Hôpital Saint Antoine, Department of Clinical Pharmacology and Unité de Recherche Clinique (URCEST)Paris, France ; Université Pierre et Marie Curie (UPMC‐Paris 06) France

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UFC - Université de Franche-Comté

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

title: Atherothrombotic risk stratification after acute myocardial infarction: the TIMI Risk Score for Secondary Prevention (TRS‐2P) in the light of the FAST‐MI registries

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.

name: Department of Cardiology, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Européen Georges Pompidou, France (N.D., E.P.).

name: Université Paris-Descartes, France (N.D., E.P.).

name: INSERM U-970, Paris, France (N.D., E.P.).

name: Department of Cardiology, Centre Hospitalier Universitaire de Nîmes, Université de Montpellier, France (G.C.).

name: Department of Cardiology, Centre Hospitalier Universitaire du Bocage, Dijon, France (Y.C.).

name: Department of Cardiology, Hôpital Cardiologique du Haut-Lévêque, CHU de Bordeaux, Pessac, France (P.C.).

name: Département de Cardiologie CHU La Cavale Blanche, Brest, France (M.G.).

name: Société Française de Cardiologie, Paris, France (M.G.).

name: Emergency Department, Lille Regional University Hospital, France (P.G.).

name: Emergency Department, Centre Hospitalier Régional, Hôpital Mercy, Metz, France (F.B.).

name: Department of Cardiology, Centre Hospitalier Annecy Genevois, Epagny Metz-Tessy, France (L.B.).

name: Collège National des Cardiologues des Hôpitaux, Paris, France (L.B.).

name: Institut de Cardiologie, Centre Hospitalier Pitié-Salpêtrière, Paris, France (G.M.).

name: Department of Cardiology, Toulouse Rangueil University Hospital, France (J.F.).

name: UMR1027, INSERM, Toulouse, France (J.F.).

name: Department of Cardiology, University Hospital Jean Minjoz, Besançon, France (F.S.).

name: Department of Clinical Pharmacology and Unité de Recherche Clinique (URCEST), AP-HP, Hôpital Saint Antoine, Paris, France (T.S.).

name: Université Pierre et Marie Curie (UPMC-Paris 06), France (T.S.).

title: One-Year Survival After ST-Segment–Elevation Myocardial Infarction in Relation With Prehospital Administration of Dual Antiplatelet Therapy


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.

family: Barniol

full_name: Caroline Barniol

given: Caroline

family: Dehours

full_name: Emilie Dehours

given: Emilie

family: Mallet

full_name: Jean Mallet

given: Jean

family: Houze-Cerfon

full_name: Charles-Henri Houze-Cerfon

given: Charles-Henri

family: Lauque

full_name: Dominique Lauque

given: Dominique

family: Charpentier

full_name: Sandrine Charpentier

given: Sandrine

journal_name: Annals of Emergency Medicine

oa_host_type: publisher

evidence: open (via free pdf)


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: 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.

lead_sponsor: University Hospital, Caen


title: Developing a Program for Transition to Adult Care for Youth With Chronic Conditions : a Mixed Method Study

acronym: TRANSAD

summary: Investigation in 3 steps the transition of young people with chronic diseases. FIRST STEP: qualitative survey. Interviews with carers, young people and parents. Chronic Diseases studied: epilepsy, HIV, sickle cell disease, obesity. SECOND STEP: Delphi consensus survey. Vote on internet : carers, patients' associations, young people and family. Chronic Diseases studied: all. THIRD STEP: validation survey. Vote on internet : young people. Chronic Diseases studied: all.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


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.

lead_sponsor: Nantes University Hospital


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.


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: Multicenter Trial Treatment of Philadelphia Chromosome Negative (Ph-) B-lineage Acute Lymphoblastic Leukemia (ALL) of Young Adults (18-59 Years).

summary: The purpose of this study is to prospectively validate the new risk model, based on minimal residual disease (MRD) response level and oncogenetic status by comparing historical results of GRAALL-2005 with those of GRAALL-2014 in an identical population of patients (Philadelphia chromosome negative, B lineage ALL, aged 18 to 59 years old).

location_facility: Hématologie Adulte, Saint Louis hospital


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.