title: Validation of a French-language Version of Specific Quality of Life Questionnaires in Patients With Peripheral Facial Palsy

acronym: PFQDV

summary:
Facial palsy is a serious and disabling disease whose drudgery and sensation are probably underestimated. Psychological, social and economic issues have major impacts although vital prognosis is not engaged in this pathology. Facial palsy remains a personal drama for patient. Consequences may take the form of: aesthetic deformation, modification of body image, with socio-professional consequences. Beside unsightly facial aspects, weakness of facial muscles can cause troubles in eating, drinking, talking, communicating personal emotions and communication. Facial palsy impacts patients' quality of life (QOL) and affects mental health. This wide multidimensional concept usually includes self-measures of physical and mental health. QOL is evaluated with general and specific scales. General scales allow to compare QOL of different diseases, when specific scales focus on one disease and consider all aspects related to this disease and therefore are more appropriate and sensitive in dimensions related to patient disease and health.

"Facial disability Index" (FDi) and "Facial Clinimetric Evaluation" (FaCE) are the most used validated questionnaires to assess QOL of patients suffering from peripheral facial palsy (PFP). There is no existing validated questionnaire or scale in French version despite many French studies on PFP available. Using these questionnaires in French language requires translation and strict approval of the new language version. The aim of the study is to translate and validate French versions of specific scales of QOL in peripheral facial palsy patients: FDI and FaCE. Secondary objective is to evaluate QOL of patients depending on PFP etiology. Translation process will be done respecting internationally recognized rules. A pilot study will be performed on 5 physicians and 5 patients in order to validate the questionnaires translations. French versions obtained will be used for their validation on 80 patients suffering from PFP.

Cronbach's alpha will be estimated to check internal consistency of FDI and FaCE scales. Test re-test reliability will be calculated with inter-class correlation, reiterating questionnaires one week later. Scores of FDI and FaCE scales will be compared to other clinical evaluation scales, estimating correlation coefficient. Social function of FDI and FaCE scales will be compared with general scale SF-36 scores, estimating a correlation coefficient.


title: Addition of Azathioprine to the Switch of Anti-TNF Drug in IBD Patients in Clinical Relapse With Undectectable Anti-TNF Trough Levels and Anti-drug Antibodies : a Prospective Randomized Trial

acronym: Comboswitch

summary: Loss of response under anti-TNF is frequent. 20% of patients with clinical relapse present an immune mediated pharmacokinetic failure. In the last AGA recommendations, switch to another anti-TNF drug is suggested with no indication of immunosuppressive agent. In a recent study, 70% of patients with an immunogenic failure to a first anti-TNF agent developed a new immunogenic failure to the second anti-TNF drug using alone.

study_start_date_type: Anticipated

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Védrines, Philippe, M.D.

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: Prospective Multicentre Randomized Double-blind Study Comparing Caspofungin to Placebo for the Treatment of ICU Intra-abdominal Candidiasis

acronym: CASPER

summary: The incidence of intra-abdominal candidiasis is increasing, and it is now the leading indication for antifungal therapy, ahead of candidemia. Prospective randomized trials of antifungal therapy have almost exclusively concerned patients with candidemia and did not include patients with intra-abdominal infections. The aim of this study is to demonstrate that caspofungin antifungal therapy for intra-abdominal candidiasis in ICU patients is associated with lower failure rate compared to placebo.

study_start_date_type: Actual

status: Recruiting

lead_sponsor: Centre Hospitalier Universitaire, Amiens

lead_sponsor_type: academique

status_simplified: Ongoing

appel_a_projets: PHRCN

region: Hauts-de-France

nom_etablissement: CHU AMIENS PICARDIE

type_etablissement: CH

acronyme: CASPER

titre: Etude prospective randomisée multicentrique en double aveugle comparant la caspofongine à un placebo pour le traitement des infections intra-abdominales à levure en réanimation

discipline_principale: infectiologie / biologie des agents infectieux / hygiène

nom_porteur: Dupont

prenom_porteur: Hervé


title: Pulmonary Perfusion by Iodine Subtraction Mapping CT Angiography in Acute Pulmonary Embolism: a Diagnostic Accuracy Study Versus Pulmonary Perfusion SPECT.

acronym: PASEP

summary:
Pulmonary embolism (PE) is a diagnostic and therapeutic challenge. The risk of death of untreated PE is approximately 25%. On the other hand, anticoagulant treatment is associated with a haemorrhagic risk (2% of major haemorrhagic accidents per year, of which 10% are fatal). A diagnostic accuracy is therefore necessary.

Two approaches are available to diagnose PE:

A functional approach, represented by pulmonary ventilation / perfusion scintigraphy (V / P), which looks for the functional consequences of PE. The main disadvantage of this approach is that there is a high rate of non-diagnostic examinations. On the other hand, it allows a mapping of pulmonary perfusion at the microcapillary scale, and thus allows the quantification of the vascular obstruction index, which would be an independent risk factor of PE recurrence.
A morphological approach, represented by CT pulmonary angiography (CTPA), which allows the visualisation of the clot itself. This approach is currently the most used but has some limitations, including a risk of over-diagnosis of pulmonary embolism and the inability to reliably quantify the index of vascular obstruction.

Lung subtraction iodine mapping CT is a new technique allowing, during the realization of a CTPA, without additional irradiation, to provide a mapping of the iodine. This mapping of iodine could potentially be used to evaluate pulmonary perfusion.

It would then be possible to obtain, during a single examination, in addition to the anatomical information of the thoracic angioscan, information on the pulmonary perfusion and thus to assess the functional consequences of PE.

No study to date has evaluated the performance of the pulmonary subtraction CT for the evaluation of pulmonary perfusion in the context of acute pulmonary embolism suspicion.

status: Completed

study_completion_date_type: Actual

primary_purpose: Diagnostic

enrollment_type: Actual

lead_sponsor: University Hospital, Brest

intervention_type: Diagnostic Test

status_simplified: Completed


type: Other Identifier

title: Practical Application of Indocyanine Green Camera in Laparoscopic Liver Surgery

acronym: CAMVIC

summary:
"Indocyanine Green (ICG) is a dye used as an indicator of hepatic function considering its capacity to be eliminated only by the bile. Thus, ICG tend to remain in liver tumors.

The hypothesis of CAMVIC study is that the use of fluorescence imaging during laparoscopic hepatic surgery will allow to detect small subcapsular superficial lesions undetected by other diagnostic methods, which will improve the results of the oncologic treatment."

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
FLUOPTICS

location_facility: Centre Hépato Biliaire de l'hopital Paul Brousse

intervention_type: Device


title: Does the Performance of the Ductus Venosus Doppler at 16 Weeks Allow to Increase the Screening of the Twin-twin Transfusion Syndrome and to Reduce the Neonatal Mortality?

acronym: DVSTT

summary: Studies shows that the realization of the Ductus venosus Doppler may improve the screening of the twin-twin transfusion syndrome. In this study, we want to compare the outcome of monochorial pregnancy when this Doppler was performed during the ultrasound at16 weeks, and when it wasn't. In order to do that, we will compile past reports (January 2015/ January 2018) of all monochorial pregnancy handled in the hospital of Montpellier and Kremlin Bicêtre. We will establish if the Doppler was done or not, if the twin-twin transfusion syndrome appears and the neonatal outcome.

study_type: Observational

time_perspective: Retrospective

ipd_sharing: Undecided

ipd_sharing_description: NC

lead_sponsor: University Hospital, Montpellier

intervention_type: Other


title: Modeling of the Geriatric Multidisciplinary Meeting of the Angers University Hospital

acronym: GRIMM

summary:
The primary objective of this study is to develop a typology of patients referred to the Geriatric Multidisciplinary Meeting (GMM) according to their demographic and clinical profile.

The secondary objectives are:

To distinguish the different types of answers given by the GMM according to the demands and situations.
To study the factors associated with the orientation proposed by the GMM
To examine the adequacy between the orientation proposed by the GMM and the pathway actually taken
To compare the diagnoses made during the following year with the data collected during the GMM

lead_sponsor: University Hospital, Angers


title: Influence of Main Psychological and Social Factors on Primary Headaches

acronym: CEPHAPSY

summary: This study aims to describe the psychological and social characteristics of patients suffering from primary headache and monitored in Neurology department of Besançon University Hospital

time_perspective: Prospective

ReferenceType: derived

ReferenceCitation: Belot RA, Bouteloup M, Bonnet M, Parmentier AL, Magnin E, Mauny F, Vuillier F. Evaluation of Attachment Style and Social Support in Patients With Severe Migraine. Applications in Doctor-Patient Relationships and Treatment Adherence. Front Neurol. 2021 Jul 12;12:706639. doi: 10.3389/fneur.2021.706639. eCollection 2021.

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

repository_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Frontiers

ReferenceCitation: Bouteloup M, Belot RA, Noiret N, Sylvestre G, Bertoux M, Magnin E, Vuillier F. Social and emotional cognition in patients with severe migraine consulting in a tertiary headache center: A preliminary study. Rev Neurol (Paris). 2021 Oct;177(8):995-1000. doi: 10.1016/j.neurol.2020.09.013. Epub 2021 Jan 13.

oa_colors: green other

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

evidence: open (author manuscript)

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Francois Rabelais - Tours

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

repositories_concat: HAL

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: Impact of Appearance and Control of Emotions in Virtual Reality on Behaviour in Children and Young Adults: Link With Feeling of Presence

acronym: EPREV-EA

summary:
Recently, researchers in the field of cognitive psychology have shown a great interest in Virtual Reality (VR). Indeed, this technology is the most advanced to create immersion and sense of presence in a virtual environment (VE) and gives the opportunity to study cognitive mechanisms in more ecological way. However, little is known about the impact of VR on the cognition and emotional states of the VR users. According to the scientific literature, the sense of presence (the fact that the user experiences the sense of being in the VE) is strongly related to the emotional experience, but it is not clear what mechanisms underline this relation. Thus, more research is necessary to its better understanding. Moreover, a few studies have shown age related differences in sense of presence, with children having greater inclination for sense of presence than adults. This might be explained by the fact that frontal cortex (which is responsible for a control of the sense of presence) is still developing in childhood (the maturation last for the beginning of adulthood).

The goal of the present study is to examine which factors might be responsible of the interaction between the sense of presence, the immersion and the emotional experience in Virtual Reality, and the age-related difference. Thus, the investigator study 2 types of healthy participants (volunteers) in order to examine the age-related difference in this interaction: young adults between 18 and 25 years old and children between 8 to 14 years old. To study different factors potentially involved in the interaction four experiments will be conducted. In each experiment the investigator manipulate one type of factor to study its impact on emotions and the sense of presence in a VE: (1) the image quality, (2) the fact that participant had an avatar (body) in the VE, (3) the possibility to interact or not in VE and (4) the nature of elements with which it is possible to interact (objects or living being). In the end of this study the investigator hope to contribute to the knowledge of adapted use of VR for different type of users, such as children and young adults.

status: Terminated

design_allocation: Non-Randomized

primary_purpose: Other

lead_sponsor: Hospices Civils de Lyon

location_facility: EA3082 Laboratoire d'Etude des Mécanismes Cognitifs Institut de Psychologie Université Lyon 2

intervention_type: Behavioral


title: Medico-economic Evaluation of Anti-VEGF Treatments in the Treatment of naïve Age-related Macular Degeneration (AMD): a Model Adapted to the French Context

acronym: MEDIAL

summary: Age-related macular degeneration (AMD) is the leading cause of blindness after 50 years in industrialized countries, compromising daily activities and reducing quality of life. And whose treatment is one of the first health expenditures. Since September 2015, Bevacizumab, which does not have marketing authorization in AMD, has been given a temporary recommendation for use. Studies in other countries have shown that bevacizumab is cost-effective in the treatment of AMD compared to other anti-VEGF therapies used.

sponsor_collaborators: Centre Hospitalier Universitaire, Amiens

appel_a_projets: PRME

acronyme: MEDIAL

titre: Evaluation médico économique d'injection intra vitréenne de Bevacizumab par rapport au Ranibizumab dans le traitement de la dégénérescence maculaire liée à l'âge (DMLA) néovasculaire naive en milieu hospitalier.

discipline_principale: ophtalmologie

nom_porteur: Milazzo

prenom_porteur: Solange


title: Pyrophosphate Homeostasis and Hepatic Expression of ABCC6. Pilot Study in Liver Transplantation

acronym: Pyro-TH

summary:
In animals, normal hepatic expression of ABCC6 (ATP-binding transporter cassette, subfamily C, member 6) determines plasma pyrophosphate (PPi) concentration. PPi prevents the formation of hydroxyapatite crystals on tissues by precipitation of calcium and inorganic phosphate (Pi). It is an endogenous compound whose deficiency causes diffuse vascular calcifications in certain rare monogenic diseases, including the elastic pseudoxanthoma caused by the mutation of ABCC6. PPi is produced by enzymatic transformation of extracellular ATP and, in animals, the liver is the main supplier of ATP and PPi (more than 90%). In humans, liver transplantation offers the possibility of correlating the plasma concentration of PPi ([PPi]pl) with hepatic expression of ABCC6. Liver transplantation is performed in the treatment of chronic liver failure (Child B or C) or, in the absence of liver failure, in the treatment of hepatocellular carcinoma. By measuring[PPi]pl before transplantation and after liver function restoration and by measuring ABCC6 in the diseased liver and healthy liver, it is possible to determine whether liver failure is associated with decreased[PPi]pl and decreased liver expression of ABCC6, which is the objective of our pilot study. Its interest is to establish a physiopathological link between the frequent vascular calcifications in obese patients with hepatic steatosis and the production of PPi.

prupose: Look for a deficit in[PPi]pl in patients before the transplant compared to the phase of restoration of liver function

primary_purpose: Basic Science

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: A Phase III Randomized Trial of Post-operative Adjuvant Nivolumab and Concomitant Chemo-radiotherapy in High-risk Patients With Resected Squamous Cell Carcinoma of Head and Neck

acronym: NIVOPOSTOP

summary: The purpose of this study is to determine the efficacy of nivolumab + cisplatin-RT relative to standard of care (SOC) cisplatin-RT alone, using the disease-free survival (DFS by investigator imaging assessment) as primary endpoint )

lead_sponsor: Groupe Oncologie Radiotherapie Tete et Cou

collaborators:
For Drug Consulting
Eurofins


title: Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis

acronym: MICROLUPS

summary: Our study aims at defining the role of circulating microparticles in the physiopathology of two rare auto-immune diseases: systemic lupus erythematosus (SLE) and systemic scleroderma (SSc). Microparticles might have an prognostic and diagnostic interest as well as potential for the discovery of new therapeutic strategies.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Bordeaux - service de rhumatologie

intervention_type: Biological


title: Randomized, Double-blind, Placebo-controlled Clinical Study Evaluating the Effect of Oral Probiotic Yeast on the Composition of the Vaginal Microbiota in Healthy Women

summary: This study is designed to evaluate the impact of oral consumption of the probiotic yeast CNCM I-3856 on healthy vaginal microbiota

primary_purpose: Prevention

lead_sponsor: Lesaffre International

sponsor_collaborators:
Lesaffre International
Biofortis Mérieux Nutriscience

intervention_type: Dietary Supplement


title: Rectal Surgery Evaluation Trial (RESET): Laparotomy vs Laparoscopy vs Robotic vs TaTME Rectal Surgery Matched Parallel Cohort Trial for High Surgical Risk Cancer Patients, With Mid- to Low Rectal Cancer

acronym: RESET

summary: Total mesorectal excision (TME) is the standard of care for rectal cancer, which can be combined with low anterior resection (LAR) in patients with mid-to-low rectal cancer. The narrow pelvic space and difficulties in obtaining adequate exposure make surgeries technically challenging. Four techniques are used to perform the surgery: open laparotomy, laparoscopy, robot-assisted surgery, and transanal surgery. Comparative data for these techniques is required to provide clinical data on the surgical management of rectal cancers by surgery.

ReferenceType: background

ReferenceCitation: Hompes R, Guy R, Jones O, Lindsey I, Mortensen N, Cunningham C. Transanal total mesorectal excision with a side-to-end stapled anastomosis - a video vignette. Colorectal Dis. 2014 Jul;16(7):567. doi: 10.1111/codi.12660. No abstract available.

ReferenceCitation: MacFarlane JK, Ryall RD, Heald RJ. Mesorectal excision for rectal cancer. Lancet. 1993 Feb 20;341(8843):457-60. doi: 10.1016/0140-6736(93)90207-w.

ReferenceCitation: Buchs NC, Nicholson GA, Ris F, Mortensen NJ, Hompes R. Transanal total mesorectal excision: A valid option for rectal cancer? World J Gastroenterol. 2015 Nov 7;21(41):11700-8. doi: 10.3748/wjg.v21.i41.11700.

ReferenceCitation: Sun Z, Kim J, Adam MA, Nussbaum DP, Speicher PJ, Mantyh CR, Migaly J. Minimally Invasive Versus Open Low Anterior Resection: Equivalent Survival in a National Analysis of 14,033 Patients With Rectal Cancer. Ann Surg. 2016 Jun;263(6):1152-8. doi: 10.1097/SLA.0000000000001388.

ReferenceCitation: Vennix S, Pelzers L, Bouvy N, Beets GL, Pierie JP, Wiggers T, Breukink S. Laparoscopic versus open total mesorectal excision for rectal cancer. Cochrane Database Syst Rev. 2014 Apr 15;(4):CD005200. doi: 10.1002/14651858.CD005200.pub3.

ReferenceCitation: van der Pas MH, Haglind E, Cuesta MA, Furst A, Lacy AM, Hop WC, Bonjer HJ; COlorectal cancer Laparoscopic or Open Resection II (COLOR II) Study Group. Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial. Lancet Oncol. 2013 Mar;14(3):210-8. doi: 10.1016/S1470-2045(13)70016-0. Epub 2013 Feb 6.

ReferenceCitation: Lee SH, Lim S, Kim JH, Lee KY. Robotic versus conventional laparoscopic surgery for rectal cancer: systematic review and meta-analysis. Ann Surg Treat Res. 2015 Oct;89(4):190-201. doi: 10.4174/astr.2015.89.4.190. Epub 2015 Sep 25.

ReferenceCitation: Sun Y, Xu H, Li Z, Han J, Song W, Wang J, Xu Z. Robotic versus laparoscopic low anterior resection for rectal cancer: a meta-analysis. World J Surg Oncol. 2016 Mar 1;14:61. doi: 10.1186/s12957-016-0816-6.

ReferenceCitation: Trastulli S, Farinella E, Cirocchi R, Cavaliere D, Avenia N, Sciannameo F, Gulla N, Noya G, Boselli C. Robotic resection compared with laparoscopic rectal resection for cancer: systematic review and meta-analysis of short-term outcome. Colorectal Dis. 2012 Apr;14(4):e134-56. doi: 10.1111/j.1463-1318.2011.02907.x.

ReferenceCitation: Yang Y, Wang F, Zhang P, Shi C, Zou Y, Qin H, Ma Y. Robot-assisted versus conventional laparoscopic surgery for colorectal disease, focusing on rectal cancer: a meta-analysis. Ann Surg Oncol. 2012 Nov;19(12):3727-36. doi: 10.1245/s10434-012-2429-9. Epub 2012 Jul 3.

ReferenceCitation: Jayne D, Pigazzi A, Marshall H, Croft J, Corrigan N, Copeland J, Quirke P, West N, Rautio T, Thomassen N, Tilney H, Gudgeon M, Bianchi PP, Edlin R, Hulme C, Brown J. Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer: The ROLARR Randomized Clinical Trial. JAMA. 2017 Oct 24;318(16):1569-1580. doi: 10.1001/jama.2017.7219.

ReferenceCitation: Penna M, Hompes R, Arnold S, Wynn G, Austin R, Warusavitarne J, Moran B, Hanna GB, Mortensen NJ, Tekkis PP; TaTME Registry Collaborative. Transanal Total Mesorectal Excision: International Registry Results of the First 720 Cases. Ann Surg. 2017 Jul;266(1):111-117. doi: 10.1097/SLA.0000000000001948.

ReferenceCitation: Stevenson AR, Solomon MJ, Lumley JW, Hewett P, Clouston AD, Gebski VJ, Davies L, Wilson K, Hague W, Simes J; ALaCaRT Investigators. Effect of Laparoscopic-Assisted Resection vs Open Resection on Pathological Outcomes in Rectal Cancer: The ALaCaRT Randomized Clinical Trial. JAMA. 2015 Oct 6;314(13):1356-63. doi: 10.1001/jama.2015.12009.

ReferenceCitation: Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

ReferenceCitation: Baik SH, Kwon HY, Kim JS, Hur H, Sohn SK, Cho CH, Kim H. Robotic versus laparoscopic low anterior resection of rectal cancer: short-term outcome of a prospective comparative study. Ann Surg Oncol. 2009 Jun;16(6):1480-7. doi: 10.1245/s10434-009-0435-3. Epub 2009 Mar 17.

ReferenceCitation: Fleshman J, Branda M, Sargent DJ, Boller AM, George V, Abbas M, Peters WR Jr, Maun D, Chang G, Herline A, Fichera A, Mutch M, Wexner S, Whiteford M, Marks J, Birnbaum E, Margolin D, Larson D, Marcello P, Posner M, Read T, Monson J, Wren SM, Pisters PW, Nelson H. Effect of Laparoscopic-Assisted Resection vs Open Resection of Stage II or III Rectal Cancer on Pathologic Outcomes: The ACOSOG Z6051 Randomized Clinical Trial. JAMA. 2015 Oct 6;314(13):1346-55. doi: 10.1001/jama.2015.10529.

ReferenceCitation: Chessin DB, Enker W, Cohen AM, Paty PB, Weiser MR, Saltz L, Minsky BD, Wong WD, Guillem JG. Complications after preoperative combined modality therapy and radical resection of locally advanced rectal cancer: a 14-year experience from a specialty service. J Am Coll Surg. 2005 Jun;200(6):876-82; discussion 882-4. doi: 10.1016/j.jamcollsurg.2005.02.027.

ReferenceCitation: Sebag-Montefiore D, Stephens RJ, Steele R, Monson J, Grieve R, Khanna S, Quirke P, Couture J, de Metz C, Myint AS, Bessell E, Griffiths G, Thompson LC, Parmar M. Preoperative radiotherapy versus selective postoperative chemoradiotherapy in patients with rectal cancer (MRC CR07 and NCIC-CTG C016): a multicentre, randomised trial. Lancet. 2009 Mar 7;373(9666):811-20. doi: 10.1016/S0140-6736(09)60484-0.

ReferenceCitation: Kang SB, Park JW, Jeong SY, Nam BH, Choi HS, Kim DW, Lim SB, Lee TG, Kim DY, Kim JS, Chang HJ, Lee HS, Kim SY, Jung KH, Hong YS, Kim JH, Sohn DK, Kim DH, Oh JH. Open versus laparoscopic surgery for mid or low rectal cancer after neoadjuvant chemoradiotherapy (COREAN trial): short-term outcomes of an open-label randomised controlled trial. Lancet Oncol. 2010 Jul;11(7):637-45. doi: 10.1016/S1470-2045(10)70131-5. Epub 2010 Jun 16.

ReferenceCitation: D'Agostino RB Jr. Propensity score methods for bias reduction in the comparison of a treatment to a non-randomized control group. Stat Med. 1998 Oct 15;17(19):2265-81. doi: 10.1002/(sici)1097-0258(19981015)17:193.0.co;2-b.

ReferenceCitation: Sgarbura O, Gourgou S, Tosi D, Bakrin N, Bouazza N, Delaine S, De Forges H, Pocard M, Quenet F. MESOTIP: Phase II multicenter randomized trial evaluating the association of PIPAC and systemic chemotherapy vs. systemic chemotherapy alone as 1st-line treatment of malignant peritoneal mesothelioma. Pleura Peritoneum. 2019 Jun 27;4(2):20190010. doi: 10.1515/pp-2019-0010. eCollection 2019 Jun 1.

oa_colors: green diamond

repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central

publisher_dissemination: De Gruyter

lead_sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

intervention_type: Procedure


title: Effect of Radical Prostatectomy on Involuntary Pelvic Floor Muscle Contraction

summary: This study evaluate the effect of radical prostatectomy on involuntary pelvic floor muscle contraction

lead_sponsor: Pierre and Marie Curie University

location_facility: Department of Neuro-urology, Tenon hospital


title: Presymptomatic Neuromuscular Junction Defects and Compensatory Mechanisms in Amyotrophic Lateral Sclerosis (ALS)

acronym: PRE-ALS

summary:
Denervation of neuromuscular junctions (NMJs) and initial compensatory reinnervation is the earliest pathological event in various motor neuron disease models, occurring far before motor symptom onset. In patients harboring genetic mutations responsible for Amyotrophic Lateral Sclerosis (ALS), identification of early, pre-symptomatic, NMJ pathological events and compensatory mechanisms could lead to the development of new treatments to prevent motor functional impairment.

The aims of our study are thus:

To investigate and characterize early, presymptomatic, defects of NMJ morphology in pre-manifest C9ORF72 or SOD1 mutation carriers;
To investigate and quantify reinnervation at the level of NMJs in these subjects;
To identify muscle molecular dysregulated pathways involved in the development of NMJ alterations and the development / maintenance of compensatory collateral reinnervation.

status: Active, not recruiting


title: Use of Titanium Plate in Rhinoplasty in Patients With Cleft Lip and Palate: Aesthetic and Functional Impact. TROPIC (Titanium RhinOPlasty ImpaCt)

acronym: PETROL/TROPHIC

summary:
The patients in this study are all born with a cleft lip and palate. They underwent several interventions in childhood to take care of it.

Professor Gleizal offered them a secondary rhinoplasty aimed at normalizing the appearance of their nose.

In this malformative and multioperated context, typical nasal deformities affect the tip of the nose, which appears to be sagging and asymmetrical. Scarred soft tissues exert an important retractile force against which conventional rhinoplasty techniques often remain insufficient.

The use of columellar struts makes it possible to give again projection to the tip of the nose but when this strut is made from cartilage or bone, it is absorbed with the time. Moreover, these interventions require a remote removal of the site of interest (costal cartilage, tibial crest, calvaria) which generates additional morbidity.

The investigators propose an alternative using a synthetic graft of titanium. This material has been used for many years for its excellent biocompatibility and trauma resistance.

28 patients were able to benefit from this technique between March 1, 2016 and March 1, 2018.

The investigators wish to evaluate the aesthetic and functional results from the patient's point of view by submitting them to one validated rhinoplasty questionnaire after the end of the patient's inclusion.

status: Withdrawn

location_facility: Service de chirurgie maxillo-faciale - Hôpital de la Croix Rousse - Groupement Hospitalier Nord - Hospices Civils de Lyon


title: Comparison of PVI and RPVI During a Tidal Volume Challenge Under General Anesthesia: A Prospective Validation Pilot Study

acronym: RPVI

summary: Pleth Variability Index (PVI) is a non-invasive and automated measure of the respiratory variations of plethysmography during mechanical ventilation. PVI is extracted via an algorithm implemented on Masimo Radical 7 device (Masimo, Irvine, CA). PVI is commonly used in anesthesiology and has been validated to predict fluid responsiveness and optimize fluid administration in the surgical setting. However, the signal/noise ratio of PVI makes acute changes in PVI somewhat difficult to interpret at the bedside. Subsequently, a new algorithm entitled RPVI (Rainbow Pleth Variability Index), has been developed in order to improve the signal/noise ratio of PVI and facilitate its clinical use by practitioners. The details of this new proprietary built-in algorithm are unknown and no data are available to date. Therefore, the main objective of the study was to compare RPVI and PVI during dynamic changes in venous return induced by a tidal volume (Vt) challenge during mechanical ventilation in anesthetized patients. The hypothesis was that the agreement between both dynamic indices would be good.

location_facility: Service d'Anesthésie Réanimation, Hôpital Cardiologique Louis Pradel, Hospices Civils de Lyon


title: Assessment of Rhythmic Risk in Patients With Type 1 Brugada Syndrome by Pulmonary Infundibulum Mapping

acronym: SB-CARTO

summary:
Brugada syndrome has been described as the association of a right bundle block with ST segment elevation on the V1 to V3 electrocardiogram in patients with a structurally normal heart. The rhythmic risk is thus difficult to evaluate in asymptomatic patients in whom the rate of events is estimated at 0.2 to 1.4% of events per year. In addition, the predictive value of ventricular pacing remains controversial; There is therefore currently no review to effectively assess rhythmic risk in patients with Brugada type I syndrome.

Investigators aimed to show a difference in pulmonary infundibulum voltage mapping in symptomatic and asymptomatic patients with Brugada type 1 syndrome with a comparable ECG.

The mapping of the pulmonary infundibulum will be performed during electrophysiological exploration. Only the catheter used differs from the usual procedure.


title: Perinatal and Long-term Outcome of Newborns With an Isolated Small Transverse Cerebellar Diameter

acronym: PECERI

summary:
The decreased cerebellar biometry during second and third trimester ultrasound examination is the main parameter to diagnoses cerebellar and pontocerebellar hypoplasia. Investigators already described that a transverse cerebellar diameter (TCD) below the 5th centile at second or third trimester scan is related to a high rate of fetal malformations, severe intrauterine restriction in growth, chromosomal anomalies and genetic disorders, therefore when facing a TCD below the 5th centile, patients should be referred for oriented sonogram, fetal MRI (Magnetic resonance imaging) and fetal karyotyping.

However, prenatal counseling in case of an isolated decreased cerebellar biometry remains challenging since there are no data in the literature regarding the neurodevelopmental outcome of these newborns. The aim of this work is to evaluate the neurodevelopmental outcome of newborns with a prenatal isolated decreased cerebellar biometry, in order to improve prenatal counseling.

location_facility: Service Obstétrique - Hôpital Femme Mère Enfant - Groupement Hospitalier Est


title: Functional Non Specific Immunity Monitoring After Kidney Transplantation Using an Interferon Gamma Test, QuantiFERON Monitor®

acronym: QuantiFERON

summary:
The best renal replacement therapy is kidney transplantation. It improves end-stage renal kidney disease (ESRD) patients quality of life and increases their survival, but still remains risky. Morbidity in kidney transplantation is dominated by two main complications : acute graft rejection and infections. To maintain an accurate balance between rejection and infection, immunosuppressive therapy must to be used with caution and kept into a tight spectrum.

The investigators dispose of a new test measuring interferon gamma production after T cells and Natural Killers (NK) in vitro stimulation : QuantiFERON Monitor® (QFM). They hypothesized QFM monitoring could improve management after kidney transplantation providing functional immune data to optimize balance between rejection and infection.

The investigators aim to assess whether QFM could be an objective biomarker to predict infection and rejection risks after kidney transplantation.

sponsor_collaborators: Centre Hospitalier Universitaire de Nice

location_facility: Nephrology Department, Nice University Hospital


title: Usefulness of Transcutaneous Capnography to Assess Residual Hypoventilation in Obesity-Hypoventilation Syndrom Treated by Non Invasive Ventilation at Home : a Prospective Study

summary: Transcutaneous capnography (PtcCo2) recently showed good agreement with blood gases to assess hypercapnia. There is no study that has evaluated the benefit to realise systematically a nocturnal PtcCo2 in the follow-up of home-ventilated patient with obesity hypoventilation syndrome (OHS). The investigators will evaluate the intake bring by nocturnal transcutaneous capnography, compared to nocturnal oximetry and blood gases, to diagnose nocturnal alveolar hypoventilation in a population of patient presenting an OHS, treated by non invasive ventilation (NIV) at home .

lead_sponsor: Nantes University Hospital


title: Prospective Descriptive Study of the Angiogenic T Cell Population in Subjects With Hereditary Hemorrhagic Telangiectasia (HHT)

acronym: TangRO

summary:
Hereditary hemorrhagic telangiectasia (HHT) results from genetic deregulation of angiogenesis. It is characterized by mucocutaneous telangiectasia responsible for recurrent epistaxis affecting quality of life (anaemia, iron deficiency, social distress). More rarely, HHT is complicated by the appearance of pulmonary, hepatic or cerebral arteriovenous malformations that can lead to serious complications: cerebrovascular accidents, cerebral abscesses, high output heart failure, and massive hemoptysis (1). The intensity of symptoms increases with age but with significant individual variability, even for the same mutation in the same family. Thus, while the mutations responsible for the disease have been identified, the pathophysiology is not fully understood because these mutations do not explain the great diversity of clinical presentations. Other factors not yet identified probably play an important role. Angiogenic T cells (TANG) are a newly individualized T cell population, defined by a CD4+CXCR4+CD31+ phenotype, which plays a key role in differentiating endothelial progenitors (2).

In an earlier study, the investigators showed that patients with HHT had a decrease in CD4+ and CD8+ LT compared to a cohort of healthy subjects (3).

They hypothesize that the lymphopenia mainly involves TANG, whose quantification could make it possible to assess the individual level of angiogenesis during HHT. The evaluation of the TANG levels could thus make it possible to personalize HHT management.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Evaluation of the Potential Impact of HIV and Its Treatments on Ovarian Reserve: Prospective Study

acronym: VIHRO

summary:
Recent evidence suggests a decline in fertility of persons living with HIV (PLWH) (delayed pregnancies, sponteanous abortions, especially when patients receive an antiretroviral therapy, early menopause, amenorrhea and anovulatory cycles) with a possible decrease in ovarian reserve. However, indications of fertility preservation by freezing oocytes are nevertheless not clearly identified.

The objective of this study is to evaluate the ovarian reserve before and after the implementation of antiretroviral treatment in PLWH for whom the diagnosis of HIV has just been made.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Sleep Apnea : Diagnosis and Monitoring

acronym: ApneaBand

summary: This prospective study aims to evaluate a new medical screening method to detect and discriminate sleep apnea-hypopnea events. A new device called ApneaBand will be tested to propose a new screening method facilitating the diagnosis and monitoring of the sleep apnea syndrom, still underdiagnosed. This device will be tested in comparison with polysomnography (PSG), the gold standard reference method of sleep apnea diagnosis.

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
Commissariat A L'energie Atomique
AIRFAN
AGIR à Dom


title: Evaluation of a Promising New Combination of Protein Kinase Inhibitors on Organotypic Cultures of Human Renal Tumors

acronym: COMBOREIN

summary:
The investigators objective is to test the combination directly on organotypic cultures of tumors from patients after their excision in the Department of Urology and Renal Transplantation of the University Hospital of Grenoble and to compare their efficacy with that of currently selected treatments in the clinic.

The population targeted by the combination for use in clinical practice is patients with metastatic clear cell renal cell carcinoma.

Current treatments for these patients are Sunitinib, Pazopanib and Temsirolimus.


title: Can Diffusion Tensor Imaging (DTI) of the Optic Ways Contributes to Predict the 6 Months Prognosis of Optic Neuritis (ON)?

acronym: DTI et NOI

summary: Can diffusion tensor imaging (DTI) of the optic ways contributes to predict the 6 months prognosis of Optic Neuritis (ON)?

lead_sponsor: Rennes University Hospital


title: OPPORTOS : Fracture Prediction by Opportunistic Screening for Osteoporosis

acronym: OPPORTOS

summary: Fractures related to skeleton fragility (i.e. osteoporotic fractures) represent a growing health problem, as the life expectancy and thus the number of frail elderly subjects is increasing. These fractures are associated with individual and societal consequences. The fractures are responsible for increased disability, chronic pain, and loss of independency. The annual cost of either prevalent or incident osteoporotic-related fractures exceeds the same ratio calculation for many other serious chronic diseases. Mortality risk is increased following osteoporotic fractures. Several classes of osteoporosis therapies are proven to reduce fracture risk, based on placebo controlled trials of 3-5 years duration, including in elderly patients. These data are the rationale for screening of patients at risk of fracture, recognizing that the optimal approach is to identify subjects at risk for major fractures . Bone fragility is related to the decrease of both the quality and the quantity of bone. Bone mineral density (BMD) is a surrogate of bone fragility, with the advantage of being non-invasively measurable, at relevant sites, such as vertebrae and upper extremity of the femur. A low BMD, age, and prevalent fractures are the 3 main determinants of the risk of sustaining a fracture. A low BMD has also been reported as a determinant of all cause mortality risk in the general population. So far, screening of low BMD by QCT has not been recommended because of low availability of the devices, irradiation, and cost. However, a huge number of QCT are performed daily for various medical indications. These thoracic and abdominal QCT carry potential information about vertebral BMD. These data are already available, with no additional cost, patient time, nor radiation exposure. They can be retrospectively (in our study) or prospectively (in the future context of care) analyzed, and are the basis of an opportunistic screening for osteoporosis: this denotes the use of diagnostic QCT scans made for other medical indication to screen for patients at high fracture risk. There is no study of this QCT based measurement as an opportunistic screening for patients at short-term risk for fracture. Opportunistic screening of osteoporosis, by diagnosis of low BMD on abdominal QCT performed for various medical indications, is able to detect subjects at short-term (i.e. over 3 years) risk of fracture (necessitating an hospitalization).

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: OPPORTOS

titre: PREDICTION DES FRACTURES PAR DEPISTAGE OPPORTUNISTE DE L'OSTEOPOROSE

discipline_principale: rhumatologie

nom_porteur: ROUX

prenom_porteur: Christian


title: Stepwise Screening for Silent Atrial Fibrillation After Stroke

acronym: SAFAS

summary: The main hypothesis of this work is that an approach combining clinical parameters and biomarker assays could improve the understanding and prediction of the occurrence of silent atrial fibrillation (AF) in the acute phase after stroke. In this prospective work, the investigators will rely on the Dijon Stroke Registry, which collects extensive clinical data for each patient hospitalized for a stroke. As part of this registry, patients are seen 6 months after stroke to assess their clinical status. This clinical follow-up will allow us to judge the evolution of the AF diagnosed during the acute episode at a distance.

ReferenceCitation: Garnier L, Duloquin G, Meloux A, Benali K, Sagnard A, Graber M, Dogon G, Didier R, Pommier T, Vergely C, Bejot Y, Guenancia C. Multimodal Approach for the Prediction of Atrial Fibrillation Detected After Stroke: SAFAS Study. Front Cardiovasc Med. 2022 Jul 13;9:949213. doi: 10.3389/fcvm.2022.949213. eCollection 2022.

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

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


title: ESTIMation of the ABiLity of Prophylactic Central Compartment Neck Dissection to Modify Outcomes in Low-risk Differentiated Thyroid Cancer

summary:
Prospective randomized open phase III non-inferiority trial in cT1bT2N0 papillary thyroid carcinoma comparing: total thyroidectomy alone (experimental group) versus total thyroidectomy + Prophylactic Neck Dissection PND (reference group).

Pre-registered patients will be randomized before surgery for tumors with class-6 cytology (Bethesda) or in the operating room after confirmation of malignancy by frozen section analysis for tumors with class-5 cytology.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

appel_a_projets: PHRCK

nom_etablissement: INSTITUT GUSTAVE ROUSSY

type_etablissement: CLCC

titre: ESTIMABL 03 : ESTIMation of the ABiLity of prophylactic central compartment neck dissection to modify outcomes in low-risk differentiated thyroid cancer

discipline_principale: cancer

nom_porteur: HARTL

prenom_porteur: Dana


title: Identification of Gut Microbiome Biomarkers Associated to Acquisition of Enterobacteriae Highly Resistant to Third Generation Cephalosporines Following Ceftriaxone Treatment.

acronym: ARCMI

summary:
Patients receiving Ceftriaxone 1 gram or 2 grams per day during their presence in emergency unit of hospital whatever their medical condition, will be included.

Rectal swabs will be collected at inclusion and at days 5 and 30 to perform analysis.

Analysis will be performed to characterize gut microbiome in order to detect intestinal microbiome profiles significantly associated with protection against colonization by third generation cephalosporin resistant Enterobacteriae.


title: Markers of Pulmonary Dysbiosis Associated With Exacerbation in Patients Followed for Cystic Fibrosis

acronym: DYSBIOSE-CF

summary:
The aim objective is to identify markers of bacterial, viral and fungal pulmonary dysbiosis, associated with the occurrence of exacerbation in patients followed for cystic fibrosis.

The primary endpoint is the association between a modification of at least 10% of the relative abundance of a bacterial phylum (Proteobacteria, Firmicutes, Actinobacteria, Bacteroidetes, Fusobacteria) or fungal (ascomycetes / hemiascomycetes, basidiomycetes, zygomycetes), or viral, and the occurrence of exacerbations over a period of 12 months.

ReferenceCitation: Beaumier L, Chanoine S, Camara B, Pison C, Bedouch P. Alemtuzumab and de novo pulmonary arterial hypertension: A potential association? J Heart Lung Transplant. 2017 Mar;36(3):370-371. doi: 10.1016/j.healun.2016.10.013. Epub 2016 Oct 29. No abstract available.

ReferenceCitation: Wintenberger C, Maubon D, Charpentier E, Rendu J, Pavese P, Augier C, Malvezzi P, Camara B, Mallaret MR, Bouillet L, Epaulard O. Grouped Cases of Pulmonary Pneumocystosis After Solid Organ Transplantation: Advantages of Coordination by an Infectious Diseases Unit for Overall Management and Epidemiological Monitoring. Infect Control Hosp Epidemiol. 2017 Feb;38(2):179-185. doi: 10.1017/ice.2016.274. Epub 2016 Nov 28.

ReferenceCitation: Zhao Y, Garnaud C, Brenier-Pinchart MP, Thiebaut-Bertrand A, Saint-Raymond C, Camara B, Hamidfar R, Cognet O, Maubon D, Cornet M, Perlin DS. Direct Molecular Diagnosis of Aspergillosis and CYP51A Profiling from Respiratory Samples of French Patients. Front Microbiol. 2016 Jul 29;7:1164. doi: 10.3389/fmicb.2016.01164. eCollection 2016.

ReferenceCitation: Decorte N, Gruet M, Camara B, Quetant S, Mely L, Vallier JM, Verges S, Wuyam B. Absence of calf muscle metabolism alterations in active cystic fibrosis adults with mild to moderate lung disease. J Cyst Fibros. 2017 Jan;16(1):98-106. doi: 10.1016/j.jcf.2016.05.010. Epub 2016 Jun 15.

ReferenceCitation: Claustre J, Brion JP, Quetant S, Bedouch P, Pison C, Camara B. Favorable Evolution of Cryptococcal Meningitis in the Context of Flucytosine Resistance. Exp Clin Transplant. 2018 Feb;16(1):110-113. doi: 10.6002/ect.2015.0217. Epub 2016 Apr 26.

ReferenceCitation: Roca A, Oluwalana C, Bojang A, Camara B, Kampmann B, Bailey R, Demba A, Bottomley C, D'Alessandro U. Oral azithromycin given during labour decreases bacterial carriage in the mothers and their offspring: a double-blind randomized trial. Clin Microbiol Infect. 2016 Jun;22(6):565.e1-9. doi: 10.1016/j.cmi.2016.03.005. Epub 2016 Mar 26.

ReferenceCitation: Godet C, Laurent F, Bergeron A, Ingrand P, Beigelman-Aubry C, Camara B, Cottin V, Germaud P, Philippe B, Pison C, Toper C, Carette MF, Frat JP, Beraud G, Roblot F, Cadranel J; ACHROSCAN Study Group. CT Imaging Assessment of Response to Treatment in Chronic Pulmonary Aspergillosis. Chest. 2016 Jul;150(1):139-47. doi: 10.1016/j.chest.2016.02.640. Epub 2016 Feb 19.

ReferenceCitation: Dumollard C, Bailly S, Perriot S, Brenier-Pinchart MP, Saint-Raymond C, Camara B, Gangneux JP, Persat F, Valot S, Grenouillet F, Pelloux H, Pinel C, Cornet M. Prospective Evaluation of a New Aspergillus IgG Enzyme Immunoassay Kit for Diagnosis of Chronic and Allergic Pulmonary Aspergillosis. J Clin Microbiol. 2016 May;54(5):1236-42. doi: 10.1128/JCM.03261-15. Epub 2016 Feb 17.

ReferenceCitation: Godet C, Laurent F, Beraud G, Toper C, Camara B, Philippe B, Germaud P, Cottin V, Beigelman-Aubry C, Khalil A, Blouin P, Pouriel M, Roblot F, Bergeron A, Cadranel J; ACHROSCAN study group. Phenotyping chronic pulmonary aspergillosis by cluster analysis. Eur Respir J. 2015 Nov;46(5):1509-12. doi: 10.1183/13993003.00869-2015. Epub 2015 Sep 17. No abstract available.

ReferenceCitation: Gruet M, Decorte N, Mely L, Vallier JM, Camara B, Quetant S, Wuyam B, Verges S. Skeletal muscle contractility and fatigability in adults with cystic fibrosis. J Cyst Fibros. 2016 Jan;15(1):e1-8. doi: 10.1016/j.jcf.2015.05.004. Epub 2015 May 29.

ReferenceCitation: Bouvaist H, Thony F, Jondot M, Camara B, Jais X, Pison C. Balloon pulmonary angioplasty in a patient with chronic thromboembolic pulmonary hypertension. Eur Respir Rev. 2014 Sep;23(133):393-5. doi: 10.1183/09059180.00000514. No abstract available.

ReferenceCitation: Claustre J, Quetant S, Camara B, France M, Schummer G, Bedouch P, Pavese P, Saint Raymond C, Bardy B, Masson D, Roth H, Pison C; Grenoble Lung Transplantation group. Nonspecific immunoglobulin replacement in lung transplantation recipients with hypogammaglobulinemia: a cohort study taking into account propensity score and immortal time bias. Transplantation. 2015 Feb;99(2):444-50. doi: 10.1097/TP.0000000000000339.

ReferenceCitation: Bosc C, Clement M, Deroux A, Mammar A, Pison C, Camara B. [Severe pneumonia due to cytomegalovirus in chronic obstructive pulmonary disease]. Rev Mal Respir. 2014 May;31(5):435-8. doi: 10.1016/j.rmr.2013.09.013. Epub 2013 Dec 2. French.

ReferenceCitation: Camara B, Reymond E, Saint-Raymond C, Roth H, Brenier-Pinchart MP, Pinel C, Cadranel J, Ferretti G, Pelloux H, Pison C; Grenoble Aspergillus Committee. Characteristics and outcomes of chronic pulmonary aspergillosis: a retrospective analysis of a tertiary hospital registry. Clin Respir J. 2015 Jan;9(1):65-73. doi: 10.1111/crj.12105. Epub 2014 Feb 17.


title: Identification of Intestinal Microbiota Biomarkers Predictive of Diarrhea in Patients Treated by Ibrutinib.

acronym: COLMI

summary: Identify gut microbiome biomarkers associated with colitis in patients treated with targeted therapy in hematology

sponsor_collaborators:
Nantes University Hospital
Vendee Departmental hospital center


title: Validation of Pupillary Response to Nociceptive Stimulation in Cardiac Surgery During Extracorporeal Circulation Period

acronym: DOLOCEC

summary: The relationship between the target effect site concentration of remifentanil and the pupil diameter and reactivity in response to a standard noxious stimulus in cardiac surgery during extra corporeal circulation will be evaluated.

lead_sponsor: University Hospital, Tours

location_facility: Location Anesthesia-Resuscitation Department, University Hospital, Tours


title: Longitudinal Follow-up of High Viscosity Glassionomer IonoStar Plus Versus a Composite Bulk X-tra-Fil Combined With Futurabond U (Splith Mouth Study): Reunion Island, Circus of Mafate

acronym: CVB

summary: The main objective is the longitudinal follow-up and comparison of the maintenance of the dental filling materials up to 24 months using the HVGIC IonoStar Plus versus Bulk X-Tra -Fil composite (Futurabond U adhesive system). 150 patients will be recruited in the Mafate dental health center. Patients with minimum 2 carious lesions (or multiple of 2, maximum 6) class I or II moderate not including the cusps, and touching the outside part of the middle of dentin. Assignment period will be 4 years: Inclusion period 18 months with 2 years following (6-month, 1 year and 2 years checking) and 3 months for statistical analysis and publications process Estimation of the parameters associated with a failure of the restoration at 24 months will follow the FDI scores. The Secondary objectives are to evaluate the caries risk of isolated population thanks to Cambra application and estimate the concordance of the judgment of maintaining the restoration between the expert in-situ and experts based on the images remotely.

lead_sponsor: University Hospital, Montpellier


title: Application de l'oxymétrie Dynamique et Des Index de Pression Pour le Diagnostic Des Plicatures Iliaques du Sportif

acronym: SALTY-TURTLE

summary: Aim of the study is to test the feasibility of transcutaneous oxygen pressure (TcPO2) recording in the diagnosis of iliac kinking in 20 patients with suspected of endofibrosisoriliackinking and 40 asymptomatic control heathy subjects

lead_sponsor: University Hospital, Angers


title: Paraoptic Tumors : Study of the Radiological, Ophthalmological and Intraoperative Predictive Factors of Visual Recovery After Neurosurgical Removal

acronym: PRONOPTIC

summary: Paraoptic tumors - including mostly sellar meningiomas, pituitary gland adenomas and craniopharyngiomas - classically affect the visual function. Some preoperative factors, determined on retrospective studies, are known to constitute bad prognostic factors, such as duration of symptoms and retinal nerve fiber layer thinning on OCT. We propose to perform a single center prospective study in which detailed preoperative ophthalmological and radiological criteria will be collected before surgery. Intraoperative information will be noted as well. All these data will be statistically examined regarding the postoperative visual recovery at 3, 6 and 12 months

lead_sponsor: Fondation Ophtalmologique Adolphe de Rothschild


title: Body Schema Alterations in Patients Suffering From Musculoskeletal Disorders. Does Disorder Laterality Influence Recruitment of Cerebral Areas Involved in Voluntary Motricity?

acronym: Schem-TMS

summary: This study assess ocular movements in a hand laterality judgment task in a population of musculoskeletal disorders. Reaction time, error rate and visual strategy are compared between musculoskeletal disorders and healthy patients, and between the different locations of the disorder.


title: Pregnancy and Use of Psychoactive Substances: The Influence of Representations of Care on Care.

acronym: ADDGEST

summary:
It is observed that pregnant women using psychoactive substance (s) have a more random and more accidental pregnancy follow-up than women with no addictive problems.

The consumption approach can be either omitted during the pregnancy monitoring, or entrusted to the course or more often in late pregnancy or occurs more brutally during delivery at the time of complications (neonatal or obstetric). In this context, health professionals are looking for levers that allow women to take appropriate care quickly.

This difficulty of access to care questions us and all the more because the time of the pregnancy is a moment of important psychic reorganization conducive to modify its habits, to change its glance on its consumptions and thus to start a care concerning addiction.

Invesigators hypothesize that this population has less access to medical care during pregnancy for fear of stigmatization by the health care provider.

Invesigators propose a multicenter qualitative study based on individual clinical interviews to collect the testimony of women who used psychoactive substance (s) during their pregnancy.

The purpose of this work is to identify ways to improve the multidisciplinary medical management of these women by focusing on the representations they can make care of.

lead_sponsor: University Hospital, Caen


title: Etude Clinique, Monocentrique, Prospective, randomisée et contrôlés de l'Arthoplastie Totale de Genou Avec le système Robotique MAKO™ Par Rapport à l'Arthroplastie Totale de Genou Conventionnelle Par Ancillaire mécanique

acronym: TKA-MAKO

summary:
For the total knee arthrorplasty (TKA), the placement of a prosthesis is delicate and the correct positioning of the implants determines the result of the surgery.

Navigation has improved surgical accuracy but remains inadequate with nearly 20% malposition. In the early 2010s, robot-assisted surgery solutions were born. Amongst its offers, Stryker's MAKO™ system appears to be the most advanced and developed due to its precision and its flexibility of use during surgery.

In this study, the investigators evaluate the placement of the total knee prosthesis with the MAKO™ system compared to the placement of the total knee prosthesis with a conventional mechanical system for TKA

collaborators: Clinical Investigation Centre for Innovative Technology Network


title: Performance of a Non-invasive Test for the Detection of Helicobacter Pylori and Its Resistance to Clarithromycin in Stool by Real-Time PCR Amplidiag H. Pylori + ClariR (Mobidiag)

acronym: HEPYSTOOL

summary: Performance of a non-invasive test for the detection of Helicobacter pylori and its resistance to clarithromycin in stool by Real-Time PCR Amplidiag H. pylori + ClariR (Mobidiag).

lead_sponsor: Poitiers University Hospital


title: Assessment of Individual Follow-up by Reference Nurses (Telemedicine Coaching Program) for Type 1 Diabetes Children With Therapy Adjustment Difficulties

acronym: DIAB-HELP

summary:
The purpose of this project is to assess the introduction of an individual follow-up distance coaching (phone and messages on a secure line platform) in order to optimize the health care of type 1 diabetes children with therapy adjustment difficulties. It is a personalized, multi-disciplinary, medical et paramedical. It will consist of an individual coaching for the children and families with therapy adjustment difficulties.

The hypothesis is that the proposed coaching would allow to improve the patient glycemic control not only during this coaching, but also, to bring long lasting improvement following the coaching.

primary_purpose: Supportive Care

lead_sponsor: University Hospital, Lille


title: Functional Gastrointestinal Disorders in Children and Adolescents With Inflammatory Bowel Disease in Remission: Prevalence and Identification of Clinical and Psychosocial Risk Factors

acronym: TFI-MICI

summary:
Background: Persistent gastrointestinal symptoms have been described in patients who are considered in remission of their inflammatory bowel disease (IBD). These symptoms, attributed to Functional gastrointestinal disorders (FGID) in IBD, may have a significant impact of quality of life, and may be associated with fatigue, anxiety and depression. There is very little data regarding pediatric specificities of these FGID.

Aims: The aim of the study is to evaluate the prevalence of FGID in pediatric patients with IBD in remission. Secondary aims are to investigate a possible association of FGID with fatigue, anxiety, depression and impacted quality of life in the patients, as well as anxiety and depression in the parents.

Methods: This will be an observational, case-control study. All patients between 9 and 18 years old , with IBD in remission will be invited to participate. Questionnaires will be web-based and will evaluate: presence of FGID (Fr-qPGS), fatigue (FACIT-F), anxiety (SCARED-R), depression (CDI), quality of life (IMPACT-III). Parents will be invited to fill in web-based questionnaires on their symptoms of anxiety (STAI/Y-A and STAI/Y-B) and depression (BDI). Clinical parameters will be retrieved retrospectively from the chart. Level of remission will be confirmed by most recent blood tests and fecal calprotectin. Patients with FGID will be compared to patients without FGID in terms of clinical characteristics, disease phenotype and associated psychological comorbidities.

time_perspective: Cross-Sectional


title: Efficacy of a Long Term, High Intensity and Long Time Stretch Training Program on Viscoelasticity Plantarflexors Muscle in Children With Cerebral Palsy (CP).

acronym: LONGSTRETCH PC

summary: Children with cerebral palsy present early in the childhood altered muscular properties, as soon as structural or stiffness. In the gastrocnemius muscle, altered muscular properties are characterized by short muscle belly length and increased stiffness which contribute to contracture and limiting joint range of motion.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Consequences of At-risk Alcohol Consumption in ICU Patients : the Impact OH Study.

summary: At-risk drinking is known to cause a high incidence of alcohol withdrawal syndrome which has a high impact on morbidity and mortality.


type: Registry Identifier

title: Clinical and Molecular Aspects of Adult Onset Pompe Disease: a Natural History Study

acronym: POMPE

summary:
The project is a prospective study in which patients affected by adult-onset Pompe disease with c.-32-13T>G mutation in the GAA gene will be followed-up during two years to describe the natural history using clinical, imaging, histological and molecular parameters.

Secondary objectives are:

To identify biomarkers for assessing efficacy of future therapies based on correcting aberrant alternative splicing in Pompe patients with c.-32-13T>G mutations.
To determine effectiveness of antisense oligonucleotide chemistries to restore full length GAA transcripts, GAA protein and GAA enzyme activity in fibroblasts and myoblasts obtained from skin and muscle biopsies as well as leucocytes of Pompe patients with c.-32-13T>G mutations.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

appel_a_projets: PRTS

acronyme: POMPE

titre: Traitement de la maladie de Pompe par modulation d'épissage

discipline_principale: autre

nom_porteur: AMTHOR

prenom_porteur: Helge


title: Effects of Energy Conservation Technique During Stair Climbing in COPD Patients : a Randomized Controlled Trial

acronym: UpstAIR

summary: Chronic obstructive pulmonary disease (COPD) is characterised by non-reversible bronchial obstruction associated with systemic disorders and comorbid factors. Dynamic hyperinflation during an exercise increase dyspnea and can reduce exercise capacity. Stair climbing is associated with prolonged dynamic hyperinflation and severe dyspnea in COPD patients. The aim of this study is to carry out the effect of an energy conservation technique on dyspnea to facilitate stair climbing.

ReferenceCitation: Prieur G, Combret Y, Medrinal C, Arnol N, Bonnevie T, Gravier FE, Quieffin J, Lamia B, Reychler G, Borel JC. Energy conservation technique improves dyspnoea when patients with severe COPD climb stairs: a randomised crossover study. Thorax. 2020 Jun;75(6):510-512. doi: 10.1136/thoraxjnl-2019-214295. Epub 2020 Mar 26.

oa_host_type: publisher

evidence: open (via free pdf)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: British Medical Journal

ipd_sharing: Yes

ipd_sharing_description: Data will be available after publication. Please contact Guillaume Prieur at gprieur.kine@gmail.com

lead_sponsor: Groupe Hospitalier du Havre


title: STENTYS Xposition S in the Treatment of Chronic Total Artery Occlusion (SXS-CTO)

acronym: SXS-CTO

summary:
Intro: Chronic total occlusions (CTO) are the most severe coronary lesions. Negative distal vessel remodeling occurs in these lesions, leading to reduction of artery diameter. Treatment of CTO with percutaneous coronary intervention (PCI) is associated with good clinical outcomes. However, QCA and IVUS studies showed a notable lumen and vessel enlargement distal to recanalized CTO. In addition, optical tomography (OCT) studies showed high rates of stent strut malapposition and incomplete stent strut coverage after CTO PCI. The Stentys Xposition S is a self-apposing stent device which lowers stent strut malapposition rates. Its safety and effectiveness has been demonstrated in STEMI and stable coronary patients but never investigated in CTO lesions.

Hypothesis/Objective To investigate whether self-expanding stents are more effective than balloon-expandable stents for reducing stent malapposition at 6 months after implantation in patients with CTO undergoing percutaneous coronary intervention.

Method Pilot randomized study. Patients are randomized to receive either self-expandable stent or balloon expandable stent to perform CTO-PCI. Follow-up coronary angiography is performed at 6 months post-PCI. Stent malapposition is evaluated by OCT.

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

location_facility: Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR


title: Randomized Controlled Trial of Intermittent Hemodialysis With Regional Citrate Anticoagulation Versus Systemic Low Dose Heparin Anticoagulation in Patients at Risk of Bleeding in Nephrology Intensive Care Unit

acronym: ROBIN

summary: The study investigators hypothesize that intermittent hemodialysis with regional citrate anticoagulation (Prometheus system/Frésénius) is more efficient than reduced systemic heparin anticoagulation in patients at bleeding risk hospitalized in nephrology intensive care unit

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: VESTIBULAR EVOKED MYOGENIC POTENTIALS IN ALTERED GRAVITY

acronym: VEMP

summary:
Recently, new clinical testing of saccular and utricular function have been developed and validated, the so-called vestibular-evoked myogenic potentials - VEMP (Brantberg et al. 2009, Cornell et al. 2009, Curthoys 2010, Manzari et al. 2012). Among them, the cervical VEMP (cVEMP) are short-latency electromyographic (EMG) modulations of the contracted sternocleidomastoid muscles in responses to vibration applied on the forehead. The clinical literature suggests that cVEMP are almost entirely saccular in origin (Halmagyi et al 1995).

The aim of our research is to evaluate changes in the otolith function in microgravity and hypergravity using this clinical test. Cervical vestibular-evoked myogenic potentials (cVEMP) will be recorded by surface EMG electrodes in response to bone conducted vibration to specifically assess saccular function (Halmagyi et al 1995). The primary measures will include muscle activity response amplitudes and the stimulus intensity threshold at which the cVEMP is detected.

Given that there is an off-loading of the saccules in microgravity and an increased loading in hypergravity, we hypothesize that there will be a reduction in cVEMP amplitude in microgravity and an increase in cVEMP amplitude in hypregravity compared to normal gravity. These changes in amplitude will be accompanied by changes in the threshold of the stimulus level required to elicit a cVEMP.


acronym: REVE

summary: The purpose of this study is to evaluate if the treatment could maximize intestinal absorption, minimize the inconvenience of diarrhea, and avoid, reduce or eliminate the need for parenteral support (PS) to achieve normal growth, to avoid parenteral nutrition complications and to achieve the best possible quality of life for the patient

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Imagine Institute

title: A Monocentric Single-arm Study to Characterize the Long-term Safety, Efficacy, and Pharmacodynamic of GLP-2 Analog (Revestive®) in the Management of Short Bowel Syndrome Pediatric Patients on Home-parenteral Nutrition (HPN)

type: EudraCT Number

source: euctr


title: Observational Study on Perception of Information and Quality of Life in Neuroendocrine Tumor on Lanreotide Autogel

acronym: OPERA

summary: The purpose of the study is to evaluate, in standard practice, the change in information received and perceived by the patient, extension of the disease and its treatment. These parameters will be evaluated by means of validated self-administered questionnaires that can be used in standard practice.

lead_sponsor: Ipsen


title: Treatment of Refractory Systemic Lupus Erythematosus by Injection of Allogeneic Mesenchymal Stem Cells Derived From the Umbilical Cord

acronym: MSC-SLE

summary:
Systemic lupus erythematosus (SLE) is a rare (prevalence: 40- 50/100 000 persons) heterogeneous auto-immune and auto-inflammatory disease (AD), affecting both sexes and all races, with a peak incidence / prevalence among black people and a predilection for women in the 3rd-4th decade of life. SLE is characterized by successive periods of flares and remission, which may all vary in duration and quality. Prognosis of severe forms of SLE, which affect lung, heart or brain in addition to renal involvement, has improved, but still evolution remains pejorative in a subset of patients whose 10 years mortality remains 10-15%, even in tertiary referral centers. For 20 years, no new prospective clinical trial in the course of SLE has demonstrated its effectiveness. New biological therapies have not yet made the long awaited breakthrough in the treatment of severe SLE and only anti-Blys monoclonal antibody has gained indication in moderately active SLE. In addition, serious adverse side effects (progressive multifocal leukoencephalopathy) observed with several biologics in AD patients has dampened their expected benefits. For SLE subjects resistant to 1er or 2nd line conventional treatment, there is a need to develop more effective therapies with fewer long term side effects, based on new immunomodulatory and immunosuppressive strategies.

According to their in vitro immunomodulatory properties and ability to induce tissue repair mechanisms, mesenchymal stem cells (MSC) have been proposed as a new therapy for several AD, including SLE. The use of allogeneic umbilical cord-derived MSC is based on experimental and human clinical data, particularly produced by Nanjing team (Pr Sun) in China. It is also logical to select SLE patients with the same severity criteria as those used worldwide to validate the efficacy of anti-Blys therapies. Similarly, the analysis of the expected results should take into account criteria similar or comparable to those used for the pivotal clinical trials. This trial is a unique opportunity to set up collaboration between Saint-Louis APHP, clinical expert center for cell therapy in AD, and University College London for cell manufacturing.


title: PReventing EXtubation FAILure by Cough Assistance and NIV in a Population Selected on Cough Peak Flow

acronym: PREXFAIL

summary:
After the admission in ICU, most patients have to be intubated in order to control haematosis in case of acute respiratory failure, to reduce the metabolic crisis during severe haemodynamic shock, or to protect upper airways in case of impairment of consciousness. After the initial phase of etiological treatment, as soon as the patients no more required the intubation, weanibility has to be checked (thanks to a weaning trial with or without pressure support) before the separation attempt is decided on an evaluation of the overall extubability, based in particular on a subjective assessment of cough strength. The cases of re-intubation can be related to several factors such as: i) a ventilatory insufficiency indicating an imbalance between the muscular pomp function and the mechanical constraint of the chest; ii) an acute cardiogenic oedema; iii) an obstruction of the superior airways, possibly due to an imbalance between the bronchial overload and the cough efficacy.

Preventing extubation failure should avoid exposing such patients to an over-risk of morbidity and mortality due to the consequences of a prolonged invasive ventilation. This prevention can be implemented thanks to an early detection of the patients the most at risk and then a coherent intervention to manage of each risk factor involved. For example, the inspiratory insufficiency can be fixed by the use of Non-Invasive Ventilation (NIV), as proposed for patients developing a final hypercapnia at the end of the weanibility test.

Several studies have been conducted to improve the prediction of extubation failure. As this is notably influenced by the cough efficacy before extubation, it has been proposed to assess the peak flow expiratory during voluntary cough. The Cough Peak Flow could for example replaced some semi-quantitative measures of cough strength associated to a low reproducibility. The most validated threshold for a weak cough is < 60 L/min and it has recently been demonstrated that it remained valuable when directly assessed using the built-in ventilator flow-meter.

In the meantime, new devices of mechanical cough assistance have been developed and are frequently used for patients presenting a chronic neuro-muscular disease affecting their ability to spontaneously clear their airways from an inappropriate bronchial overload. However, the interest of such devices for a systematic use after extubation has not been validated with a sufficient level of evidence to be recommended, in particular because of the bias of the single randomised monocentric study.

The main objective of the study consists in demonstrating in an open multicentre randomised study (focused on the patients with an objective low cough strength) the superiority of a systematic strategy combining mechanical cough assistance and non-invasive ventilation on standard care (manual post-extubation physiotherapy and NIV for restrictive indications) to reduce the re-intubation rate at 48h.

lead_sponsor: Hospices Civils de Lyon

appel_a_projets: PHRCI

region: Auvergne-Rhône-Alpes

nom_etablissement: HOSPICES CIVILS DE LYON

acronyme: PREXFAIL

titre: PReventing EXtubation FAILure by  Cough Assistance and NIV in a population selected on Cough Peak Flow

discipline_principale: hors cancer

nom_porteur: GOBERT

prenom_porteur: Florent


acronym: OLAGLI

summary: Recent data demonstrate that in IDH-mutant gliomas, 2 hydroxy-glutarate production induces a homologous recombination defect that renders tumor cells exquisitely sensitive to poly(adenosine 5'-diphosphate-ribose) polymerase (PARP) inhibitors, including olaparib (Lynparza; AstraZeneca). The aim of this open-label phase 2 study is to evaluate the efficacy of olaparib in in recurrent IDH-mutant high grade gliomas based on 6 months progression-free survival.

title: A Phase II Study of Olaparib in Recurrent IDH-mutant High Grade Gliomas OLAGLI

acronyme: OLAGLI

titre: Etude de phase II évaluant un traitement par olaparib dans les gliomes de haut grade avec mutation d'IDH sans codélétion 1p/19q en récidive

nom_porteur: DUCRAY

prenom_porteur: François


title: Composition of Triglyceride Rich Lipoproteins and Platelet Activation in Type 2 Diabetic Women

acronym: COMPLETE

summary:
To investigate in vitro the effect of triglyceride rich lipoproteins (TGRL) obtained in type 2 diabetic women in the fasting state and following a randomized isocaloric lipid rich breakfast on control human platelets

Randomized Comparison of butter versus chocolate spread in 2 groups of 15 patients

location_facility: Hôpital Louis Pradel - department of endocrinology


title: VISUALIZATION OF THE MICROCIRCULATION IN WEIGHTLESSNESS

acronym: µGµScan

summary:
During weightlessness, the cardiovascular system is subject to rapid changes which has been demonstrated in studies of short term (Space Shuttle) and long term missions to Skylab, MIR, and the International Space Station (Nicogossian et al., 1989; Blomquist, 1994; Platts et al., 2014). There is also evidence for changes in the blood vessel structure, the metabolism and the responses to vasodilator and constrictor substances that might have long-term health consequences resembling the effects of aging on the cardiovascular system (Hughson and Shoemaker, 2004). Cardiovascular adaptations cause an increased incidence of postflight orthostatic intolerance (fainting), decreased cardiac output and reduced exercise capacity. Besides these postflight effects, weightlessness could also have harmful consequences during the flight. For example, it has been shown that cardiac arrhythmia may occur during space missions, even in healthy individuals (Convertino, 2009).

To understand the cardiovascular reactions of the human body to changing conditions of gravity is thus an important aim of space science.

While non-invasive imaging of microcirculation is a very promising tool to evaluate cardiovascular condition, knowledge on the involvement of the microcirculation in cardiovascular alterations induced by weightlessness is very limited and further research in this field seems promising. Before using a non-invasive technique for imaging the microcirculation during space flights, it has to be evaluated on earth.

Different proven simulation models exist for investigating the effects of weightlessness on the human body under terrestrial conditions: head down bed rest, dry and wet immersion, and parabolic flights. Among these models, only parabolic flight recreates a real state of weightlessness (see the participant document of information for a description of parabolic flights). Cardiovascular studies have often been performed during parabolic flights. Within the limitations inherent to the method (short duration of weightlessness - about 21 s - following and followed by hypergravity 20 s periods at 1.8g), some remarkable results have been published over the years.

The aim of our research approach is to test feasibility of the in vivo evaluation of the microcirculation in parabolic flight in order to be able to better describe cardiovascular response mechanisms under these conditions. In this context, we expect alterations in the microcirculatory flow during the weightlessness period of parabolic flight.

Our approach might help develop a diagnostic tool to more easily identify weightlessness-induced cardiovascular diseases and improve strategies for adapting astronauts to weightlessness prior to the space mission.


title: Innovative Device for the Evaluation of the "Motor Functional Age": How Old is Your Muscle?

acronym: CHRONOS

summary: The CHRONOS project aims to provide a device to detect earlier the motor decline, by developing a precise quantitative device measuring "Motor Functional Age" (MFA) of young, middle-aged and old people, thus preventing future functional motor loss for healthy aging. The MFA might be different from the Chronological Age (CA), depending on lifestyle, physical activity, and medical condition. Thus, this device will permit monitoring, adaptation and new design of a variety of personalized therapies for healthy aging including physical exercise, medication and nutritional interventions to reduce the MFA toward or less than the CA. The device combines data processing software that estimates the MFA by assessing muscle aging using a non-invasive multichannel electromyographical technique coupled to accelerometry sensors for motion evaluation. These data will provide with a built-in clinical database of subjects from different age categories (25-75 years old).

ReferenceType: result

ReferenceCitation: Imrani L, Boudaoud S, Lahaye C, Moreau C, Ghezal M, Ben Manaa S, Doulazmi M, Laforet J, Marin F, Kinugawa K. High-density Surface Electromyography as Biomarker of Muscle Aging. J Gerontol A Biol Sci Med Sci. 2023 Jan 26;78(1):25-33. doi: 10.1093/gerona/glac143.

oa_host_type: closed

publisher_dissemination: Oxford University Press

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Université de Technologie de Compiegne
Sorbonne University


title: Evaluation of Global Coagulation Balance of 57 Patients With Congenital Disorder of Glycosylation Using the Thrombin Generation Assay

acronym: CDG-Coag

summary: The purpose of this study is to investigate the coagulation balance in a cohort of congenital disorder of glycosylation (CDG) patients using conventional tests combined with an integrated approach of their coagulation disorders in using TGA in the absence or presence of sTM. Thus, investigators aimed to define if the hemostatic balance in CDG patients, is preserved despite of combined deficiencies in both procoagulant and anticoagulant factors.


acronym: RITUXIVIG

summary:
Idiopathic Nephrotic Syndrome (INS) is the first glomerulopathy in children and 60% of the patients develop Steroid-Dependant Nephrotic Syndrome (SDNS). Recently, rituximab (RTX), a humanized anti-CD20 antibody depleting B cells demonstrated the ability to increase relapse free survival and to decrease the number of relapse and the need of other immunosuppressive drugs. However, the remission rate after 2 years is only 30 to 40%.

The aim of the study is to study the ability of intravenous Immunoglobulin to improve remission rate in SDNS when added associated with Rituximab compared to a treatment by Rituximab alone.

ReferenceCitation: Hogan J, Perez A, Sellier-Leclerc AL, Vrillon I, Broux F, Nobili F, Harambat J, Bessenay L, Audard V, Faudeux C, Morin D, Pietrement C, Tellier S, Djeddi D, Eckart P, Lahoche A, Roussey-Kesler G, Ulinski T, Boyer O, Plaisier E, Cloarec S, Jolivot A, Guigonis V, Guilmin-Crepon S, Baudouin V, Dossier C, Deschenes G. Efficacy and safety of intravenous immunoglobulin with rituximab versus rituximab alone in childhood-onset steroid-dependent and frequently relapsing nephrotic syndrome: protocol for a multicentre randomised controlled trial. BMJ Open. 2020 Sep 23;10(9):e037306. doi: 10.1136/bmjopen-2020-037306.

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

repositories:
HAL
PubMed Central
oskar-bordeaux.fr

repositories_concat: HAL;PubMed Central;oskar-bordeaux.fr

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

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

status: Suspended

title: Efficacy and Safety of Immunoglobulin Associated With Rituximab Versus Rituximab Alone in Childhood-Onset Steroid-dependent Nephrotic Syndrome

acronyme: RITUXIVIG

titre: Efficacité et tolérance de l'association des immunoglobulines polyvalentes au Rituximab comparé au Rituximab seul chez les enfants présentant un syndrome néphrotique corticodépendant

discipline_principale: néphrologie

nom_porteur: HOGAN

prenom_porteur: Julien


title: Analgesic Effect of Paracetamol in Neuropathic Pain Patients

acronym: PAeoNy

summary: The aim of this study is to evaluate the analgesic effect of paracetamol in patients suffering from pain with a peripheral neuropathic component in the presence of their usual treatment.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Profibrosing Role of B Lymphocytes in Patients With Systemic Sclerosis.

acronym: SCLERO-LB

summary: B Lymphocytes are thought to play an important role in the pathophysiology of systemic sclerosis. In this study, the profibrosing role of B lymphocytes of patients with systemic sclerosis will be evaluated.


title: Using Functional Near-infrared Spectroscopy (fNIRS) in the Evaluation of Cognitive-motor Interference in Post-stroke Patients

acronym: ICM-AVC

summary: This study evaluates cognitive-motor interference in stroke patients who is responsible an alteration of spatio-temporal gait parameters. It's proved in the literature but the underlying pathophysiological mechanisms remain poorly understood. fNIRS is a functional imaging technique that evaluates this interference under optimal conditions. The purpose of this study is to evaluate the hemodynamic activity of the CPF in walking post-stroke patients under different DT conditions.

lead_sponsor: University Hospital, Limoges


title: Metallic Taste Before, During and After Treatment of Head and Neck Cancer : Etiologies and Impact on Quality of Life

acronym: TORCAD

summary:
Metallic taste in head and neck cancer is widely under-estimated in the literature. Its causes are multiple and poorly defined. Though it has a strong impact on the nutritional status.

The main objective of the TORCAD project is to test the hypothesis that intraoral lipoperoxidation is associated to metallic taste onset before, during and after treatment of head and neck cancer (HNC).

The secondary goals are to evaluate the involvement of others physiopathological factors in metallic taste: (i) additional chemical modification in the saliva; (ii) release of inhibition of the facial nerve on the glossopharyngeal nerve; presence of an intraoral electric current; food pleasantness and acceptability; quality of life.

lead_sponsor: Centre Hospitalier de Valence


title: Preoperative Dry Lean Body Mass as a Prognostic Factor for Excess Weight Loss After Bariatric Surgery.

acronym: MMS-CB

summary:
Bariatric surgery is currently the only method that has proven long-term effectiveness in obesity. Although the benefit of physical activity on weight loss has been demonstrated, no correlation has ever been reported between preoperative lean body mass and postoperative weight loss. Dry lean mass is probably an essential prognostic factor for the effectiveness of bariatric surgery.

The main objective of this study is to define a preoperative dry lean body mass threshold as a worst prognostic factor for weight loss one year after bariatric surgery.

The management of patients included in this study was modelled on the management usually offered to patients followed for the same pathology in the diabeto-endocrinology department. There are no study-specific examinations that are not part of current practice.

lead_sponsor: Centre Hospitalier Departemental Vendee


title: Exome Analysis on Hearing Impaired Patients

acronym: NGS-NSHL

summary:
Hearing impairment is the most frequent sensory deficit in humans and affects one newborn out of 500. The prevalence rises to 3,5/1000 in teenagers due to retarded forms. Most of hearing impairments (about two thirds) have a genetic origin, with recessive, dominant or X-linked mode of inheritance. Some rare forms can be linked to mitochondrial DNA. Molecular diagnosis (i.e. defining the molecular basis of the disease, genes and precise DNA variants) is essential for the follow-up of patients and families.

The project intends to perform exome sequencing on 30 samples of families presenting with hearing impairment. Families have been included based on the genetic origin of the hearing impairment (familial cases) and the exclusion of the involvement of 74 known deafness genes. Exome sequencing (sequencing of the coding regions of all known genes, about 22,000) in these cases may underly new gene/disease relationships.

intervention_type: Genetic


title: Artificial Intelligence vs Physicians for Breast Cancer Patients' Information : a Blind, Randomized, Controlled Study

summary:
Chatbots (contraction of "chat" and "robot") are a computer software program that use statistical learning and aim to simulate a conversation by text or voice message. The use of these chatbots was evaluated as part of the increase in therapeutic adherence and information on well-being and mental health.

In clinical studies, chatbots are useful in gathering information through questionnaires directly submitted during conversations or through keyword analyzes. There is no longer any delay between the moment the patient notices a side effect, for example, and the moment when the patient announces it during a consultation. The responses given by the chatbot do not constitute medical advice and only provide information on the treatments envisaged or in progress in the context of the management of breast cancer.

The main objective of the study is to show that the chatbot Vik's answers to the common questions asked by breast cancer patients about their therapeutic management are at least as satisfactory as answers given by a committee of multidisciplinary doctors

ReferenceCitation: Bibault JE, Chaix B, Guillemasse A, Cousin S, Escande A, Perrin M, Pienkowski A, Delamon G, Nectoux P, Brouard B. A Chatbot Versus Physicians to Provide Information for Patients With Breast Cancer: Blind, Randomized Controlled Noninferiority Trial. J Med Internet Res. 2019 Nov 27;21(11):e15787. doi: 10.2196/15787.

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

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

publisher_dissemination: JMIR Publications

lead_sponsor: Wefight


title: Impact on Sensitivity and Motor Block Duration of an Intravenous Dexamethasone Injected 90 Min After Making an Axillary Block With Mepivacaine. A Prospective, Randomized, Placebo-controlled Study

acronym: DEXA-rescue

summary:
Intravenous dexamethasone is used to increase the duration of analgesia of interscalene bloc for shoulder surgery: it extends from 11h to 23h the sensitivity block in shoulder area. However, the time of dexamethasone intravenous injection has not been studied. In all studies, dexamethasone was injected right after the achievement of loco regional anesthesia.

The main objective is to demonstrate that intravenous injection of dexamethasone delayed at 90 minutes in patients who received an axillary block with mepivacaine prolongs the duration of the motor block by 40 minutes.


title: Peripheral Intravenous Cannulation With Support of Infrared Laser Vein Viewing System in Obese Patients

acronym: AccuV

summary: Peripheral venous access is a prerequisite for anesthesiological for surgical patients.It is often difficult to establish and potentially painful in obese patients (Body mass Index > 35). AV300 uses near infrared laser light to improve visibility of peripheral veins and could help cannulating them. The aim of this study was to examine if use of Accuvein(®) AV300 vein viewer could facilitate venous cannulation in obese patients (surgical and obstetric).

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes


title: Cerebral Bases of Tool Use and Tool Evolution

acronym: TOOLBOX

summary:
Tool use is considered to be the hallmark of complex cognitive adaptations that humans have achieved trough evolution, that provides an adaptive advantage to the human species. Even if nonhuman species do use tools too, human tool use is much more complex and sophisticated. Besides, only humans can make their tools evolve by improving them. If Man has special abilities for tool use, it has to be grounded in a specific neuroanatomical substrate. Humans and nonhumans share a similar prehension system located within the superior parietal lobe and the intraparietal sulcus. However, there is a human specificity : the surpramarginal gyrus within the left inferior parietal lobe is unique to Man, and could play a central role in tool use and tool evolution.

This project aims to study the neural correlates of human tool use with functional Magnetic Resonance Imaging (fMRI), to precise the cognitive mechanisms through which humans are able to use tools. We also wish to study what are the cognitive abilities that allow us to make our tools evolve by improving them, and the neural correlates associated.

location_facility: Laboratoire d'Etude des Mécanismes Cognitifs (EMC) -Université Lumière Lyon 2


title: Tele-ultrasound Experimentation: Cooperation Protocol Between Electro-radiology Assistant and Remote Radiologist for the Realization of Some Exploration Indications by Ultrasound

acronym: TELECHO

summary: This study tries to evaluate the non-inferiority quality and safety of ultrasound examinations realise by electro-radiology assistant with a remote radiologist compared to those realize by electro-radiology assistant with a referent radiologist on site.

lead_sponsor: Centre Hospitalier Régional Metz-Thionville


title: Agitation and Aggressivity in Alzheimer's Disease Patients: A Cohort Study

summary:
General Hypothesis: hypothesize that A / A symptoms of AD follow a particular course, influenced by associated factors, and a prospective longitudinal observational study specifically evaluating A / A symptoms in patients with MA, living in an institution and at home, would provide useful data for both clinical practice and research.

Specific Hypothesis: hypothesize that in patients with AD with clinically significant A / A there is a correlation between assessment of A / A severity based on specific scales of A / A and overall impression assessment of clinical improvement or worsening of these symptoms by the clinician.

ReferenceCitation: De Mauleon A, Delrieu J, Cantet C, Vellas B, Andrieu S, Rosenberg PB, Lyketsos CG, Soto Martin M. Longitudinal Course of Agitation and Aggression in Patients with Alzheimer's Disease in a Cohort Study: Methods, Baseline and Longitudinal Results of the A3C Study. J Prev Alzheimers Dis. 2021;8(2):199-209. doi: 10.14283/jpad.2020.66.

evidence: open (via page says license)

publisher_dissemination: SERDI

lead_sponsor: University Hospital, Toulouse

sponsor_collaborators:
University Hospital, Toulouse
Ethypharm

location_facility: Toulouse University Hospital (CHU de Toulouse)


title: Study of the Variations of Albumin Level for Patients With Unresecable Stage IIIc or Stage IV Melanoma Treated by Anti BRAF and Anti MEK

acronym: SVALMEL

summary:
The therapeutic arsenal of metastatic melanoma has changed considerably over the past 10 years. The treatment of metastatic melanoma is now based on immunotherapy and targeted therapies, while the place of conventional chemotherapy becomes more restricted. Targeted therapies are indicated for BRAF mutated melanomas.

The mutation BRAF leads activation of MAP Kinases pathway and the proliferation of melanoma cell in the body . About 50% of metastatic melanoma is BRAF mutated. The most frequent mutation is the V600E. The targeted therapy by anti BRAF and anti MEK allows the double bloking of the MAP Kinases pathway. This treatment is more efficient than that of the anti BRAF alone. The association of anti BRAF and anti MEK have a global survival global rate of 41% at the 1 year, against 9% for the anti BRAF .

In 2014, a program of extended access to the association of anti BRAF and anti MEK (dabrafenib and trametinib) started in many french hospitals (Protocol Mekinist, Novartis laboratory). Patients who were included in this program and followed in Poitiers Hospital, had frequent abnormalities of albumin level without any sign of undernutrition.

Hypoabuminemia is a poor prognosis factor described in many cancers, including metastatic melanoma.

The only prognostic factor in metastatic melanoma is the rate of LDH . The level of albumin and its prognostic impact have not been studied for patients with a metastatic melanoma and treated by anti BRAF and anti MEK.

The objective of this studie was to analyze the variations of albumin level in patients with unresecable stage IIIc or stage IV melanoma treated in our Center by dabrafenib and trametinib


title: Evaluation of the SARC-F Score as a Screening Tool for Undernutrition in a Geriatric Population

acronym: GERIASARC

summary:
To study the relationship between sarcopenia and undernutrition in adult patients over 70 years of age, and at the same time to define a threshold value for the predictive SARC-F score of undernutrition.

Hypothesis : the SARC-F score is correlated with malnutrition defined according to the following HAS criteria :

Moderate denutrition Severe denutrition

primary_purpose: Screening

ReferenceCitation: Cederholm T, Bosaeus I, Barazzoni R, Bauer J, Van Gossum A, Klek S, Muscaritoli M, Nyulasi I, Ockenga J, Schneider SM, de van der Schueren MA, Singer P. Diagnostic criteria for malnutrition - An ESPEN Consensus Statement. Clin Nutr. 2015 Jun;34(3):335-40. doi: 10.1016/j.clnu.2015.03.001. Epub 2015 Mar 9.

ReferenceCitation: Delliere S, Cynober L. Is transthyretin a good marker of nutritional status? Clin Nutr. 2017 Apr;36(2):364-370. doi: 10.1016/j.clnu.2016.06.004. Epub 2016 Jun 20.

ReferenceCitation: Zamboni M, Mazzali G, Fantin F, Rossi A, Di Francesco V. Sarcopenic obesity: a new category of obesity in the elderly. Nutr Metab Cardiovasc Dis. 2008 Jun;18(5):388-95. doi: 10.1016/j.numecd.2007.10.002. Epub 2008 Apr 18.

ReferenceCitation: Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.

ReferenceCitation: Beaudart C, Zaaria M, Pasleau F, Reginster JY, Bruyere O. Health Outcomes of Sarcopenia: A Systematic Review and Meta-Analysis. PLoS One. 2017 Jan 17;12(1):e0169548. doi: 10.1371/journal.pone.0169548. eCollection 2017.

repository_institution: University of Liège - Open Repository and Bibliography

evidence: oa repository (semantic scholar lookup)

publisher_dissemination: Public Library of Science

ReferenceCitation: Deren ME, Babu J, Cohen EM, Machan J, Born CT, Hayda R. Increased Mortality in Elderly Patients with Sarcopenia and Acetabular Fractures. J Bone Joint Surg Am. 2017 Feb 1;99(3):200-206. doi: 10.2106/JBJS.16.00734.

ReferenceCitation: Ethgen O, Beaudart C, Buckinx F, Bruyere O, Reginster JY. The Future Prevalence of Sarcopenia in Europe: A Claim for Public Health Action. Calcif Tissue Int. 2017 Mar;100(3):229-234. doi: 10.1007/s00223-016-0220-9. Epub 2016 Dec 24.

ReferenceCitation: Malmstrom TK, Miller DK, Simonsick EM, Ferrucci L, Morley JE. SARC-F: a symptom score to predict persons with sarcopenia at risk for poor functional outcomes. J Cachexia Sarcopenia Muscle. 2016 Mar;7(1):28-36. doi: 10.1002/jcsm.12048. Epub 2015 Jul 7.

ReferenceCitation: Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.