title: Cemented Versus Uncemented Hemiarthroplasty for Displaced Femoral Neck Fracture in Elderly Patient : a Randomized Prospective Trial

acronym: PIH

summary:
The purpose of this study was to identify the clinical relevance of cementless hemiarthroplasties, compare Harris functional score.The hypothesis is the non-inferiority of cementless hemiarthroplasties compare cemented hemiarthroplasties in order to justify the relevance of cementless hemiarthroplasties in displaced femoral neck fractures.

150 patients will be included, 75 with cemented hemiarthroplasty and 75 with uncemented hemiarthroplasty. They will be followed during one year after the surgery, with a functionality assessment at 3 month and 12 month.

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: orthopedics department, University Hospital


type: Other Identifier

title: Feasibility of Microdialysis by Laparoscopy

acronym: MTM-COLON-I

summary: The aim of this pilot study is to evaluate the feasibility of microdialysis by laparoscopy in order to identify anastomotic leaks after rectal surgery.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Prevention

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Hogberg N, Carlsson PO, Hillered L, Meurling S, Stenback A. Intestinal ischemia measured by intraluminal microdialysis. Scand J Clin Lab Invest. 2012 Feb;72(1):59-66. doi: 10.3109/00365513.2011.629307. Epub 2011 Nov 21.

ReferenceCitation: Deeba S, Corcoles EP, Hanna GB, Pareskevas P, Aziz O, Boutelle MG, Darzi A. Use of rapid sampling microdialysis for intraoperative monitoring of bowel ischemia. Dis Colon Rectum. 2008 Sep;51(9):1408-13. doi: 10.1007/s10350-008-9375-4. Epub 2008 May 24. Erratum In: Dis Colon Rectum. 2008 Nov;51(11):1741. Hanna, B G [corrected to Hanna, G B].

ReferenceCitation: Verdant CL, Chierego M, De Moor V, Chamlou R, Creteur J, de Dieu Mutijima J, Loi P, Gelin M, Gullo A, Vincent JL, De Backer D. Prediction of postoperative complications after urgent laparotomy by intraperitoneal microdialysis: A pilot study. Ann Surg. 2006 Dec;244(6):994-1002. doi: 10.1097/01.sla.0000225092.45734.e6.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Device

lead_sponsor_type: academique

status_simplified: Completed


title: Measure of Ano-rectal Motility in Fecal Incontinence

summary: Traditionnal measurment of anorectal function is perfomed with manometric device using 2 to 3 pressure sensors. The investigators aim to evaluate the usefulness of high resolution manometry to measure anorectal motility

study_type: Observational

time_perspective: Prospective

lead_sponsor: University Hospital, Rouen


title: Prostate Cancer Evaluation of TaRgets in Genito Urinary Screening Program

acronym: PETRUS

summary: Toward personalised treatment in early metastatic prostate cancer based on the assessment of biomarkers in cancer tissue samples and circulating tumour cells.

primary_purpose: Diagnostic

ReferenceType: derived

ReferenceCitation: Lindsay CR, Le Moulec S, Billiot F, Loriot Y, Ngo-Camus M, Vielh P, Fizazi K, Massard C, Farace F. Vimentin and Ki67 expression in circulating tumour cells derived from castrate-resistant prostate cancer. BMC Cancer. 2016 Feb 29;16:168. doi: 10.1186/s12885-016-2192-6.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

intervention_type: Other


title: Interest of a Bi-truncal Nerve Block (Femoral + Sciatic) Extended, Systematically Associated With General Anesthesia, in the Femoropopliteal Bypass: Study of Post-operative Analgesia and Peripheral Circulation Downstream.

acronym: BLOC-FEMPOP

summary:
The aim of this study is to assess, in patients scheduled for femoropopliteal bypass, the benefit of a double peripheral nerve block (femoral + sciatic) with levobupivacaine and clonidine in a single dose, performed before induction of general anaesthesia, on analgesia postoperatively assessed by morphine consumption.

Applied to the patient at the beginning of general anesthesia, this technique could allow one hand, to reduce the need for opiates, on the other hand - due to anesthetized limb vasodilation - to improve tissue perfusion downstream.

study_start_date_type: Actual

design_allocation: Randomized

primary_purpose: Treatment

ReferenceCitation: Charvin M, Longeras F, Jouve P, Cherprenet AL, Futier E, Pereira B, Duale C. Effects of adding a combined femoral and sciatic nerve block with levobupivacaine and clonidine to general anaesthesia in femoropopliteal bypass surgery: A randomised, double-blind, controlled trial. Eur J Anaesthesiol. 2020 Sep;37(9):787-795. doi: 10.1097/EJA.0000000000001263.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: University Hospital, Clermont-Ferrand

sponsor_collaborators:
University Hospital, Clermont-Ferrand
ARAMU Association

intervention_type: Drug


title: Hemodynamic and Biological Evaluations During Reventilation Collapse in ICU

acronym: REVECOL

summary: Prospective, observational clinical multicentric study in ICU; during the period surrounding the orotracheal intubation.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

status_simplified: Unknown


title: Implementing Referral Guidelines for Imaging Exams Requested Via the Emergency Department: Impact on Exam Relevance and Associated Delays

acronym: RIU

summary: The main objective of this study is to evaluate the impact of the implementation of referral guidelines for imaging exams requested by the emergency department on exam relevance. The latter is assessed via the rate of suspected diagnoses that are confirmed by the requested exam.

design_allocation: Non-Randomized

primary_purpose: Health Services Research

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Renal Prognosis of Former Preterm Infants 3 to 10 Years After Neonatal Acute Renal Failure

acronym: IRENEO

summary: The aim of this study is to evaluate the signs of nephronic reduction in preterm infants who have presented neonatal acute renal failure. The investigators hypothesize that signs of nephronic reduction would appear earlier in former preterm with neonatal acute renal failure than in control preterm infants.

ReferenceCitation: Bruel A, Roze JC, Quere MP, Flamant C, Boivin M, Roussey-Kesler G, Allain-Launay E. Renal outcome in children born preterm with neonatal acute renal failure: IRENEO-a prospective controlled study. Pediatr Nephrol. 2016 Dec;31(12):2365-2373. doi: 10.1007/s00467-016-3444-z. Epub 2016 Jun 22.

lead_sponsor: Nantes University Hospital


title: HEPFER-Evaluation of a New Phenotypic Biological Marker in Genetic Type 1 Hemochromatosis

acronym: HEPFER

summary:
HFE(High iron FE)-related hereditary hemochromatosis has a highly variable penetrance. No phenotypic or genetic markers can predict the disease. The Iron Reabsorption Index (IRI), recently described by our group, correspond to the daily reabsorbed iron for a subject whose iron stock is stable and less than 50 µg / L.

The IRI is constant over time, reflecting the importance of the underlying functional deficit.

Hepcidin / ferritin (H / F) ratio may be an independent and constant over time marker of disease stage.No data are available on the validated values of this ratio.

The goal of this project is to determine the intra-individual variations of the H / F ratio over time during maintenance therapy and to assess the correlation with the IRI.

lead_sponsor: Rennes University Hospital


title: Treatment of Gastric Peritoneal Carcinomatosis by Association of Complete Surgical Resection of the Lesions and Intraperitoneal Immunotherapy Using Catumaxomab. A Randomized Phase II Trial.

acronym: IIPOP

summary: Treatment by association of complete surgical excision of the lesions and intraperitoneal immunotherapy using Catumaxomab for patients with gastric peritoneal carcinomatosis

status: Terminated

sponsor_collaborators: Gustave Roussy, Cancer Campus, Grand Paris


title: Evaluation of Evodial Hemodialyzer Selectivity Modifications (Evodial +) - A Prospective, Monocenter, Open and Non-randomized Pilot Study

summary:
Evodial +hemodialyzer consists of an evolution of the existing CE marked Evodial device, with respect to the hemodialyzer membrane removal characteristics. Different membrane prototypes configurations are proposed (3 versions in total), with the objective to modulate the hemodialyzer removal capacities (convective and adsorptive capacities).

Materials(including heparin grafted specifications) as well as the sterilization process are identical to the Evodial hemodialyzer. Based on available preclinical data , a clinical study is requested to document in vivo the different prototypes removal capacities with respect to middle Molecular Weight (MW) reference toxins such as b2 Microglobulin and collect data with regards to protein loss.

lead_sponsor: Baxter Healthcare Corporation

sponsor_collaborators:
Baxter Healthcare Corporation
Gambro Lundia AB

lead_sponsor_type: industriel


title: Effect of Deep Brain Stimulation on Gait of Patients With Parkinson's Disease Depending on Electrode Location in Subthalamic Area.

summary:
Deep brain stimulation of STN (subthalamic nucleus) at high frequencies generally improved gait in parkinsonian patients. However, sometimes the investigators observed a gait aggravation either with using high voltage and high frequencies, either because of suboptimal placement of electrode inside Forel H2 field. The most frequent hypothesise to explain this gait aggravation is a modulation of the activity of pedunculopontine nucleus due to a diffusion of the electric stimulation current to the fibbers going near STN area.

The primary purpose of this study is to compare the effect of deep brain stimulation with high frequency versus low frequency on gait of patients whatever the electrodes placement (STN ou Forel fields) and whatever the medication condition (with or without treatment).

intervention_type: Behavioral


type: Registry Identifier

title: PREoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation

acronym: PREONIV

summary: Prospective, randomized clinical multicentric study, in ICU, during preoxygenation for the intubation of hypoxemic patients.

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Hopital Gabriel Montpied

intervention_type: Procedure


title: DAILY: Observational Description of Compliance for the Daily Ventavis® Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients

acronym: DAILY

summary: This prospective, non-interventional, multi-center study documents observational data on subjects under routine treatment of Pulmonary Arterial Hypertension, functional class III with inhaled Iloprost administered with I-Neb AAD (Adaptive Aerosol Delivery) device. The observation period for each subject covers a one year treatment period with inhaled Ventavis. For each subject, the investigator or a delegate collects data as defined in the case report form at an initial visit, routine follow-up visit at 6 months and final visit at 12 months.

lead_sponsor: Bayer


title: Role of Dopamine on Loss Aversion Behaviour: Study on Parkinsonian Patients.

summary:
Use lay language.

Many decisions involve the possibility of gaining or losing relative to the status quo. The loss aversion behaviour is a cognitive concept explaining that people are more sensitive to the possibility of losing objects or money than they are to the possibility of gaining the same objects or amounts of money.

We hypothesised that dopamine could be involved in the loss aversion behaviour. To highlight this, we have chosen a model of dopaminergic depletion : the Parkinson's disease The primary purpose of this protocol is to study the role of dopamine in the loss aversion phenomenon by comparing brain activity in parkinsonian patient with and without treatment with L Dopa, when they are exposed to mixed (gain/loss) gambles using money.

The second purpose is to highlight the role of a dopamine depletion by comparing patient without treatment vs healthy paired control.

2 groups :

20 parkinsonian patients (tested two times : with and without treatment by L dopa)
20 healthy paired control

Description of the protocol for patients :

J0 : Inclusion visit (duration : 4h):

motor assessment (UPDRS)
neuropsychological and psychiatric assessment (MMS, MATTIS, BREF, Stroop, Ardouin scale, UPPS, MADRS, Hamilton, LARS).

J0+1 day and J0 +2 days : 2 visits of MRI (magnetic resonance imaging) acquisition (with or without treatment) :

Each acquisition was composed by an orientation sequence+ an anatomic sequence + a functional sequence.

For healthy subjects, they have only one visit of 2 hours including a MMS, a MADRS and the MRI acquisitions.


title: Secondary Prevention of Osteoporosis in Women Over 50 Years Old After Low Intensity Fracture of the Upper Limb: Evaluation of an Intervention Focused on the Patient.

acronym: PREVOST

summary:
Osteoporosis is a disease characterized by reduced bone mass and increased skeletal fragility, predisposing to an increased fracture risk. The presence of a low trauma fracture is a powerful predictor of future fractures and about 50% of patients with a fragility fracture will suffer a subsequent fracture in the next 10 years (Center Jacqueline R, 2007). Osteoporotic fractures are associated with an increased morbidity and mortality but also high financial costs. However, less than 20% of patients presenting a low trauma fracture receive an appropriate post-fracture osteoporosis management (Little and Eccles, 2010). The hypothesis of a lack of information and an under assessment of consequences by both patients and physicians has been raised to explain this gap between recommended care and usual practices.

The aim of the PREVOST program is to assess the efficiency of patient-centered osteoporosis prevention program, after a fragility fracture of the upper limb, to improve post-fracture management of osteoporosis (ie BMD test and / or osteoporosis treatment) in women over 50 years old.

This open randomized controlled trial aims to compare the BMD or osteoporosis treatment prescription rate at 6 months after inclusion between two groups: "intervention" receiving information on fracture and osteoporosis (oral and written), phone call reminders and written information to give to their family physician, and "control" receiving usual care without information.

ReferenceCitation: Merle B, Chapurlat R, Vignot E, Thomas T, Haesebaert J, Schott AM. Post-fracture care: do we need to educate patients rather than doctors? The PREVOST randomized controlled trial. Osteoporos Int. 2017 May;28(5):1549-1558. doi: 10.1007/s00198-017-3953-z. Epub 2017 Feb 28.

lead_sponsor: Hospices Civils de Lyon


title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Crossover Study of Single Doses of LY2624803 in a 5-hour Phase Advance Model of Transient Insomnia in Healthy Subjects

summary: The aim of this study is to learn how different doses of LY2624803 affect sleep in healthy people. The study has four treatment periods. Participants will receive a single dose of LY2624803, another sleeping pill, or placebo in each treatment period. The study will last approximately 1 month for each participant.

lead_sponsor: Eli Lilly and Company

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: Conducting Airways in Lung Fibrosis

acronym: VACFI

summary: The purpose of this study is to determine whether extension of the conducting airways into the distal lung, or bronchiolization, occurs early in the course of Idiopathic Pulmonary Fibrosis, a disease wherein normal lung structures are destroyed and replaced by non-functional scar tissue.

time_perspective: Cross-Sectional

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Bicentric Prospective Study, Evaluating Bronchial THERMOPLASTY in a Patient Presenting Severe Uncontrolled Asthma

acronym: ASMATHERM

summary: To determine, from patients presenting severe asthma and an increase in bronchial smooth muscle mass, those who would be the best candidates for bronchial THERMOPLASTY. THERMOPLASTY should improve control of the asthma, reduce day-to-day symptoms and severe exacerbations, and improve respiratory function

ReferenceCitation: Debray MP, Dombret MC, Pretolani M, Thabut G, Alavoine L, Brillet PY, Taille C, Khalil A, Chanez P, Aubier M. Early computed tomography modifications following bronchial thermoplasty in patients with severe asthma. Eur Respir J. 2017 Mar 15;49(3):1601565. doi: 10.1183/13993003.01565-2016. Print 2017 Mar.

oa_host_type: publisher

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: European Respiratory Society

ipd_sharing: Undecided

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Boston Scientific Corporation


title: Detection and Characterization of Circulating Tumor Cells in Patients With Malignant Pleural Mesothelioma: Towards a New Phase in the Understanding of the Natural History of This Cancer?

summary:
Malignant pleural mesothelioma (MPM) has a growing incidence and in spite of early diagnostic, their outcome remains dismal. The evolution of MPM is often local with rare distant metastases. There is now a sizable body of evidence that metastases could develop from circulating tumor cells (CTC) spread in blood before or during surgery. Thus, sensitive and specific detection of CTC in blood is considered as a potentially relevant predictive biomarker for patients with carcinomas. In exchange, the prognostic value of CTC in MPM has not yet been evaluated.

Indeed, the main goal for preoperative detection of CTC is to identify patients with high risk of recurrence after surgery, in order to perform more adapted therapeutic strategy. Despite several studies reported about CTC detection, methodological aspects concerning sensitivity, specificity and reproducibility have prevented a clear appraisal of their clinical impact. Thus, the aim of our study is to evaluate the presence and the prognostic value of CTC in MPM by a double approach. In our setting, cytopathological analysis of circulating non hematological cells (CNHC), of epithelial origin, isolated according to their size (ISET, Isolation by Size of Epithelial Tumor cells) along with immunomagnetic selection, identification and enumeration of circulating epithelial cells in peripheral blood (CellSearch method) is considered a promising approach.

sponsor_collaborators: Centre Hospitalier Universitaire de Nice

location_facility: CHU de Nice - LPCE- Hôpital de Pasteur - 30 ave de la voie Romaine


title: The Role of Central and Systemic Inflammation and Aβ-specific Immune Responses in Early AD

summary: The main objective of this study is to investigate the central and peripheral inflammatory, as well as the spontaneous Aβ-specific, immune responses at the asymptomatic stage and early stages of AD by combining molecular imaging techniques with blood biomarker analyses. The early and preclinical stages of AD will be studied in the relatives of patients with PSEN1, PSEN2 or APP mutations that are at-risk (50%) to be mutation carriers. This study will evaluate the contribution of Inflammatory and immune anti-Aβ responses (I2ARs) in AD progression. Inclusion of sporadic and familial forms of AD will aid in studying the chronology of pathological events. Clinical follow-ups will be conducted annually for two years and will include an MRI and a blood draw on the last visit. We expect I2ARs to appear in the early stages of the disease and to constitute new prognostic factors. I2ARs could also become therapeutic markers for the assessment of novel anti-amyloid treatments and may offer new insights to the development of Aβ-specific immunotherapy strategies.

ReferenceType: result

ReferenceCitation: Corlier F, Rivals I, Lagarde J, Hamelin L, Corne H, Dauphinot L, Ando K, Cossec JC, Fontaine G, Dorothee G, Malaplate-Armand C, Olivier JL, Dubois B, Bottlaender M, Duyckaerts C, Sarazin M, Potier MC; Clinical ImaBio3 Team. Modifications of the endosomal compartment in peripheral blood mononuclear cells and fibroblasts from Alzheimer's disease patients. Transl Psychiatry. 2015 Jul 7;5(7):e595. doi: 10.1038/tp.2015.87.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Toulouse - Jean Jaurès

repository_normalized: HAL

version: submittedVersion

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

ReferenceCitation: Hamelin L, Bertoux M, Bottlaender M, Corne H, Lagarde J, Hahn V, Mangin JF, Dubois B, Chupin M, de Souza LC, Colliot O, Sarazin M. Sulcal morphology as a new imaging marker for the diagnosis of early onset Alzheimer's disease. Neurobiol Aging. 2015 Nov;36(11):2932-2939. doi: 10.1016/j.neurobiolaging.2015.04.019. Epub 2015 Jul 15.

publisher_dissemination: Elsevier

ReferenceCitation: Hamelin L, Lagarde J, Dorothee G, Leroy C, Labit M, Comley RA, de Souza LC, Corne H, Dauphinot L, Bertoux M, Dubois B, Gervais P, Colliot O, Potier MC, Bottlaender M, Sarazin M; Clinical IMABio3 team. Early and protective microglial activation in Alzheimer's disease: a prospective study using 18F-DPA-714 PET imaging. Brain. 2016 Apr;139(Pt 4):1252-64. doi: 10.1093/brain/aww017. Epub 2016 Mar 15.

oa_colors: green other

evidence: open (via free article)

repository_institution: CERN European Organization for Nuclear Research - Zenodo

repository_normalized: Zenodo

repositories_concat: Zenodo

publisher_dissemination: Oxford University Press


title: IgA Nephropathy, Lymphocyte Homing and IgA Class Switch

acronym: NIDOCIGA

summary:
IgA nephropathy (IgAN) is the most common primary glomerulonephritis in the world and it represents an important cause of end-stage kidney failure. This disease was described as a distinct entity in 1968 by J Berger and N Hinglais. The aetiology and the pathogenesis remain still obscure. Clinical observations and immunisation studies indicate that IgAN represents a dysregulation of the immune system, rather than an intrinsic renal abnormality. Twenty years ago, some authors proposed the mucosa-bone marrow axis to explain the pathogenesis of the disease. Mucosal IgA plasmocytes are displaced and take up residence in systemic sites. The unusual characteristics featured by the IgA produced by these cells (charge, size, glycosylation) drive their accumulation, deposition and mesangial activation characteristic of IgAN.

Evidence is emerging that altered lymphocyte homing may ultimately explain this aberrant localization.

lead_sponsor: University Hospital, Limoges


title: Prevention of Oxaliplatin-induced Neuropathic Pain by a Specific Diet

acronym: NEUROXAPOL

summary:
Use lay language. Oxaliplatin is a reference anticancer drug in the treatment of colorectal cancer. However, its use is hampered by a specific neurotoxicity, which is characterized by acute thermal hypersensitivity, notably to cold temperatures, and by chronic neuropathy appearing with the repetition of chemotherapy cycles.

To this date there is no effective therapy able to prevent and/or to treat these adverse drug reactions. So oncologists are sometimes strained to decrease anticancer doses or to stop chemotherapy; Previously, a polyamine deficient diet has been able to prevent acute oxaliplatin-induced hypersensitivity in animals.

So we hypothesizes that a specific nutritional therapy, a polyamine deprived diet, may prevent acute oxaliplatin-induced hypersensitivity in patients.

ReferenceCitation: Balayssac D, Ferrier J, Pereira B, Gillet B, Petorin C, Vein J, Libert F, Eschalier A, Pezet D. Prevention of oxaliplatin-induced peripheral neuropathy by a polyamine-reduced diet-NEUROXAPOL: protocol of a prospective, randomised, controlled, single-blind and monocentric trial. BMJ Open. 2015 Apr 1;5(4):e007479. doi: 10.1136/bmjopen-2014-007479.

license: cc-by-nc

license_normalized: cc-by-nc

publisher_dissemination: British Medical Journal

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Fondation Apicil
Ligue contre le cancer - Auvergne


title: Identification of Genetic and Cellular Markers Associated With Vascular Endothelial Modifications in Cutaneous Arteriovenous Malformations

summary: Cutaneous Arteriovenous malformations (AVM's) rare congenital high-flow vascular malformations in which arteries and veins are directly connected through a complex web of abnormal arteries and veins instead of a normal capillary network. Arterial feeders and enlarged draining veins directly connect through arteriovenous fistulas that create the "nidus". The natural history of AVMs is organized into a clinical staging system: during the first phase of quiescence, the arteriovenous malformation mimics a capillary malformation. After many years, the AVM may enlarge with loco-regional expansion and tissular destruction. At the ultimate stage, AVM may impact the heart function. They are considered non malignant but can expand and become a significant clinical risk when extensive. The management of these high flow AVM remains often problematic. Complete and large surgical excision of the nidus after hyperselective embolization is the only potential therapeutic solution but this, is often difficult if not impossible. There is no pathogenetic hypothesis for the development of these malformations. Histopathological examination (performed only on surgical resection specimen) is poor and does not provide sufficient evidence to assess the evolutivity or the severity of the MAV. Recent data hypothesize that these vascular malformations are associated with alterations of the vascular endothelium caused by genetic abnormalities involved in the control of angiogenesis and vascular homeostasis. The detection of these anomalies allows the search for cellular and genetic markers that might be useful to optimize the clinical classification, staging, predicting the evolution of these defects and some understanding of its pathophysiological mechanisms. To our knowledge, no studies to identify cellular markers / genetic and endothelial associated with the development of cutaneous AVMs have been published to date.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille

intervention_type: Genetic


title: Does the Sleeve Gastrectomy Improve the Kinematics of Obese Patients Perambulation ?

acronym: MARCHOBESE

summary: The aim of this study is to evaluate the consequences of sleeve gastrectomy on functional parameters of patients perambulation.

ReferenceCitation: Rebibo L, Fuks D, Verhaeghe P, Deguines JB, Dhahri A, Regimbeau JM. Repeat sleeve gastrectomy compared with primary sleeve gastrectomy: a single-center, matched case study. Obes Surg. 2012 Dec;22(12):1909-15. doi: 10.1007/s11695-012-0779-9.

ReferenceCitation: Rebibo L, Dhahri A, Verhaeghe P, Regimbeau JM. Early gastric fistula after laparoscopic sleeve gastrectomy: surgical management. J Visc Surg. 2012 Oct;149(5):e319-24. doi: 10.1016/j.jviscsurg.2012.07.004. Epub 2012 Aug 9. No abstract available.

ReferenceCitation: Pequignot A, Dhahri A, Verhaeghe P, Desailloud R, Lalau JD, Regimbeau JM. Efficiency of laparoscopic sleeve gastrectomy on metabolic syndrome disorders: two years results. J Visc Surg. 2012 Oct;149(5):e350-5. doi: 10.1016/j.jviscsurg.2012.06.005. Epub 2012 Jul 17.

ReferenceCitation: Rebibo L, Mensah E, Verhaeghe P, Dhahri A, Cosse C, Diouf M, Regimbeau JM. Simultaneous gastric band removal and sleeve gastrectomy: a comparison with front-line sleeve gastrectomy. Obes Surg. 2012 Sep;22(9):1420-6. doi: 10.1007/s11695-012-0689-x.

ReferenceCitation: Dhahri A, Verhaeghe P, Hajji H, Fuks D, Badaoui R, Deguines JB, Regimbeau JM. Sleeve gastrectomy: technique and results. J Visc Surg. 2010 Oct;147(5 Suppl):e39-46. doi: 10.1016/j.jviscsurg.2010.08.016. No abstract available.

sponsor_collaborators: Centre Hospitalier Universitaire, Amiens


title: Comparison Between Two Types of Semipermeable Dressings of New Generation in the Prevention of Intravascular Catheters Related Complications in Intensive Care.

acronym: ADVANCED

summary: Intravascular devices in intensive care units are often associated to complications. The investigators estimate that 23.5% of catheters placed and used in intensive care are subject to at least one complication; the investigators goal is to demonstrate the effectiveness of the new Tegaderm ™ IV Advanced dressings to achieve a decrease of 35% in the number of complications associated with intravascular catheters in intensive care.

ipd_sharing: No

lead_sponsor: University Hospital, Grenoble


title: Right Colon Cancer: Laparoscopic Surgery Versus Open Surgery, Costs, Mortality, Morbidity and Quality of Life

acronym: CHIRCOL

summary: The primary goal of this study is to compare in the long-term costs of laparoscopic or open right colectomy in patients sustaining a colon cancer controling for the carcinologic equivalence of the two surgical strategies. The secondary goals to compare long-term mortality, morbidity as well as quality of life of the two groups.The present study is an prospective multicentric observational trial taking into account the usual surgical strategy of every centers


title: Performance of Cone-beam Computed Tomography (CT) Compared to Multidetector CT for Arthrography of the Wrist, Ankle, Elbow and Knee

acronym: ARCOBE

summary: ConeBeam scanner (CBCT) is a widely technique used for dental and maxillofacial imaging. Patients can be set up in a sitting or a laying position in the, Newtom 5G CBCT allowing for an analysis of the limbs distal joints. Our hypothesis is that the cone-beam scanner could detect and characterize chondral lesions the cartilage similarly to a multidetector CT (MDCT). 100 patients over 18 years requiring arthroscanner of the wrist, ankle, elbow or knee will be enrolled The primary endpoint based on the ability of cone-beam scanner to detect cartilage lesions. Secondary endpoints will concern the depiction of the joint lesions, quality of the images, tolerability of the exams and inter- intra-operator reproducibility. After arthrography, patients will have a MDCT considered as the reference exam, and a CBCT on a randomized order. Exams will be anonymized and read twice by two trained radiologists with 3-6 week intervals. The inter-observer agreement for the diagnosis of cartilage lesion type between the two techniques will be evaluated by a kappa coefficient. The evaluation of diagnostic performance will be achieved by studying the sensitivity, specificity, negative predictive value and positive predictive value, and its likelihood ratio. Kappa test will be performed to evaluate the consistency of the depiction of the lesions. A Student t test will be performed for paired data if distributions are normal, a Wilcoxon test if not. To assess patient's tolerance, the percentages of (painful, not painful) will be calculated for each technique and will be compared using the Chi2 test (or Fisher's exact test if the chi can not apply).

location_facility: Hospices Civils de Lyon- hôpital Edouard Herriot- service de radiologie pavillon B


title: Evaluation of Synchrony in the Post-operative Patient (NAVA vs Pressure Support)

acronym: SYNCHRONY

summary:
Neurally adjusted ventilatory support improved synchronization in the medical patient. However no data are available in the postoperative patient.

This way the investigators designed a prospective randomized cross over trial to evaluate this issue in the abdominal post-operative patient.

primary_purpose: Basic Science

location_facility: Hospices Civils de Lyon- Centre Hospitalier Lyon Sud


title: Identification of Echocardiographic Criteria Predictive of the Inefficacy and/or the Unsafeness of Recruitment Maneuvers in Patients Suffering From Acute Respiratory Distress Syndrome

acronym: RV STAR

summary: The purpose of the study RVSTAR is to evaluate whether echocardiographic criteria exploring the right ventricle can predict the inefficacy and/or the unsafeness of recruitment maneuvers in patients suffering from acute respiratory distress syndrome

primary_purpose: Screening

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lead_sponsor: Centre Hospitalier Universitaire de Besancon


title: A Prospective, Observational, Open Label Study to Assess the 24-hour IOP Fluctuation Pattern Recorded With SENSIMED Triggerfish® in Patients With Primary Open-angle Glaucoma, Before and After Selective Laser Trabeculoplasty

summary:
Selective laser trabeculoplasty (SLT) is an increasingly popular treatment modality in early-to-moderate glaucoma patients. SLT has been suggested to reduce IOP more consistently during the nocturnal period than during the diurnal period in a group of medically-treated patients with primary open angle glaucoma (POAG). At present, there is scarce data on SLT effects on the 24-hour IOP pattern in patients with glaucoma and there is no data on the 24-hour effect of SLT in untreated glaucoma patients.

The purpose of this study is to assess the changes of IOP over a 24-hour period in patients with glaucoma undergoing SLT.

lead_sponsor: Sensimed AG

location_facility: Centre Hospitalier National d'Ophthalmologie des Quinze-Vingts


title: A Prospective, Open Label Study to Assess the 24-hour Intraocular Pressure Fluctuation Profile Recorded With SENSIMED Triggerfish® in Patients With Primary Open Angle Glaucoma Before and After Deep Sclerectomy

summary:
Primary open angle glaucoma (POAG) is associated with inadequate drainage of the aqueous humor via the trabecular meshwork through the Schlemm's canal towards the systemic circulation. This may lead to an increase in IOP and may damage the optic nerve. The purpose of glaucoma management is to lower IOP in order to prevent progression of the optic neuropathy and subsequent visual loss. Firstline treatment usually includes IOP-lowering drug therapy. However, if IOP remains uncontrolled and/or the optic nerve damage progresses despite controlled IOP, surgery may be indicated. Deep sclerectomy (DS) is a non-penetrating surgical procedure for the treatment of open angle glaucoma that allows the enhancement of the aqueous outflow by removing part of the inner wall of Schlemm's canal and trabecular meshwork. DS was shown to achieve a good control on IOP over the long term.

The purpose of this study is to assess the 24-hour IOP fluctuation profile recorded with Triggerfish in patients with POAG before and after DS.

status: Withdrawn

location_facility: Centre Hospitalier National d'Opthalmology des Quinze-Vingts


title: Study the Signs of Ocular Degeneration in a Population Cohort (Dijon 3C Montrachet Cohort): Seek Correlations Between Signs of Neurological and Vascular Degeneration and Signs of Ocular Aging

summary:
The aim of the study proposed in Dijon is above all to focus on the possible relationship between age-related ocular pathologies (AMD and glaucoma) and et les degenerative neurological and cardiac pathologies.

The principal objective is to seek in subjects who have undergone cerebral MRI and echocardiography, associations between the thickness of postganglionic fibers measured by Optical Coherence Tomography at the 7th year (n=1500) and signs of cerebral impairment (psycho-cognitive tests, circulation time, MRI signs). This association will be studied after taking into account the principal environmental (particularly dietary) and genetic risk factors.

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Evaluation of Nutritional Status in ICU : Interest for the Measurement of Body Composition by Body Bioelectrical Impedance and Comparison With Several Methods

acronym: IMPREA

summary: Prospective cohort, monocentric non-randomized and interventional clinical study in ICU assessing the evolution of body composition using bioelectrical impedance analysis.

collaborators: Center of study in Human Nutrition, INRA, Department of Clinical Nutrition


title: Treatment of Palmoplantar Psoriasis With Low Doses Interferential Current

summary:
Interferential current has shown promising results for treating psoriasis with a good tolerance. Prospective randomized studies versus placebo are required to confirm the interest of such an approach.

The Main objective is to assess the efficacy of interferential current for treating palmoplantar psoriasis.

Secondary objectives is to assess the subjective efficacy by the patients, the efficacy on the nails, to study the potential side effects.

lead_sponsor: Pr PASSERON

location_facility: ANPRED - Hôpital de l'archet - 151 route de sainte antoine de ginestière


title: Antalgic Treatment of Painful Bone Metastases by US-guided High Intensity Focused Ultrasound (HIFU).

summary: Antalgic treatment of painful bone metastases by US-guided High Intensity Focused Ultrasound (HIFU).

primary_purpose: Supportive Care

lead_sponsor: Theraclion


title: Contrast-harmonic Endoscopic Ultrasound (CH-EUS) for the Diagnosis of Pancreatic Adenocarcinoma: Results of the First Multicenter Prospective Study With Intra- and Interobserver Concordances Evaluation

summary:
Ductal adenocarcinoma is the most frequent pancreatic solid lesion and the most common tumor of the pancreas. Given its poor prognosis and the major therapeutic consequences, the discrimination between PA and other pancreatic solid lesions is mandatory. EUS is admitted as the most sensitive imaging procedure for the detection and characterization of pancreatic tumors [1-3]. Nevertheless it remains difficult to differentiate, on morphological features, PA from other solid masses. For 15 years, endoscopic ultrasound fine needle aspiration (EUS-FNA) has demonstrated its efficiency for tissue sampling and cyto-histologic diagnosis of PA. However, the negative predictive value (NPV) for the diagnosis of pancreatic adenocarcinoma (PA) remains low (30-70%) in the published prospective series [4]. So, in case of negative result, the choice between surgery and follow-up remains difficult. Additional criteria to get the decision are then warranted.

The assessment of pancreatic tumor enhancement using ultrasound contrast agents (UCAs) in real time with imaging specific methods seems useful to improve their characterization [4-8] either by contrast-enhanced EUS (CE-EUS) or, more recently, by contrast-enhanced harmonic EUS (CH-EUS).

The aims of this prospective multicenter study is:

to compare the NPV of contrast-enhanced endoscopic ultrasound (CH-EUS) and EUS-FNA for the diagnosis of PA;
to assess the intra- and inter-observer concordances of CH-EUS for the diagnosis of PA.

lead_sponsor: Société Française d'Endoscopie Digestive

location_facility: Société Française d'Endoscopie Digrestive


title: to Evaluate the Long-term Results of Endoscopic Papillectomy (EP)

summary:
Adenoma of the ampulla of Vater is rare but represents a large proportion of benign tumors occurring in the small intestine. The symptoms are usually non specific or due to pancreaticobiliary obstruction . The diagnosis can also be made in asymptomatic patients during an upper gastrointestinal endoscopy. Finally, the adenoma can be discovered during a screening procedure in patients with Familial Adenomatous Polyposis (FAP).

It has been demonstrated that ampullary adenomas have a malignant potential mimicking the "adenoma-adenocarcinoma" sequence already described in the colon. So, a complete removal is mandatory. The only exception is represented by subnormal ampulla with low grade dysplasia (LGD) adenoma discovered during screening follow-up of FAP patients. In these cases the situation can be stable during several years leading to simple, annual or biannual surveillance. Historically, the treatment was surgical, associated with a high mortality and morbidity rate for pancreaticoduodenectomy (PD) and a high recurrence rate for transduodenal resection (26 to 43%). Endoscopic papillectomy (EP) represents an alternative for patients with a benign or at least non-invasive ampullary tumor. Unlike thermal ablative methods by laser photoablation or argon plasma destruction, EP allows adequate histologic evaluation especially in case of en-bloc resection. This technique has been increasingly used in the last decade with very promising results. Nevertheless the long-term results have mainly been reported in retrospective monocentric series.

We intended to evaluate, in the first large multicenter prospective study, the long-term results of endoscopic papillectomy.

ReferenceCitation: Napoleon B, Gincul R, Ponchon T, Berthiller J, Escourrou J, Canard JM, Boyer J, Barthet M, Ponsot P, Laugier R, Helbert T, Coumaros D, Scoazec JY, Mion F, Saurin JC; Societe Francaise d'Endoscopie Digestive (SFED, French Society of Digestive Endoscopy). Endoscopic papillectomy for early ampullary tumors: long-term results from a large multicenter prospective study. Endoscopy. 2014 Feb;46(2):127-34. doi: 10.1055/s-0034-1364875. Epub 2014 Jan 29.

publisher_dissemination: Georg Thieme

sponsor_collaborators: Société Française d'Endoscopie Digestive


title: Impact of Fluid Resuscitation Therapy on Pulmonary Edema as Measured by Alveolar Fluid Clearance in Patients With Acute Respiratory Distress Syndrome (ARDS)

acronym: IROCA

summary:
The need for fluid resuscitation (FR) in ICU patients with acute respiratory distress syndrome (ARDS) is common. Indeed, relative or absolute hypovolemia is a common phenomenon that the intensivist must recognize early and treat promptly. Fluid challenge may have adverse side effects associated with fluid administration. The diffusion within the interstitial space may favor edema formation and cause cardiac dysfunction by volume overload. Edema formation is global and may specifically alter pulmonary alveolar epithelial integrity, leading to enhanced alveolar edema and impaired gas exchange.

Currently, two types of fluids are frequently used, crystalloids and colloids. Among colloids and compared to crystalloids, albumin has the theoretical advantage of causing greater volume expansion.

We hypothesized that a fluid resuscitation therapy with albumin generates less pulmonary edema than a fluid resuscitation therapy with crystalloids.

The aim of our study is to compare alveolar fluid clearance, as a marker of alveolar edema fluid resorption, in 2 groups of patients: those treated with albumin and those treated with crystalloid.

lead_sponsor: University Hospital, Clermont-Ferrand

collaborators: R2D2 Retinoids, Reproduction Developmental Diseases


title: Prospective, Single-blind, Randomized, Non-inferiority, and Controlled Study of Clinical and Health Economic Impact of Robot-assisted Surgery Versus Conventional Laparoscopy in Bariatric Surgery: the Case of Gastric Bypass

summary:
The purpose of this study is to gather clinical and economic evidence on the use of robotics for bariatric surgery (gastric bypass).

This monocentric, randomized, single blind, controlled study will evaluate post-operative pain, quality of life and appetite, post-operative complication incidence. It will also provide information on direct and indirect costs of surgery.

lead_sponsor: IHU Strasbourg

location_facility: Service de Chirurgie Digestive et Endocrinienne


title: Dysbetalipoproteinemia and Atheroma Risk : Assessment of Cardiovascular Risk in Dysbetalipoproteinemic Patients

acronym: DARK

summary:
Dysbetalipoproteinemia (type III, Fredrickson's classification) is a rare metabolic disorder. It results from a defect in the clearance of VLDL and chylomicron remnants due to homozygous APOE2 variants or heterozygous APOE mutations, and there is an elevated plasma cholesterol and triglycerides.

As a consequence of the derangements in lipoprotein metabolism, dysbetalipoproteinemia predispose to the premature development of atherosclerosis.

However among this population there is heterogeneity in development of cardiovascular complications and the determinants remain unclear actually.

The aim of the investigators study is to evaluate the intensity of clinical atherosclerosis, and identify its determinants.

location_facility: Hospices Civils de Lyon - Groupement Hospitalier Est


title: Long-term Anatomical and Functional Outcomes of Idiopathic Macular Hole Surgery. The Yield of Spectral-domain OCT Combined With Microperimetry.

summary: To evaluate the correlations between anatomical and functional changes studied with microperimetry (MPM) and spectral-domain OCT (SD-OCT) in patients after successful repair of idiopathic macular hole (MH).

time_perspective: Retrospective

ReferenceCitation: Bonnabel A, Bron AM, Isaico R, Dugas B, Nicot F, Creuzot-Garcher C. Long-term anatomical and functional outcomes of idiopathic macular hole surgery. The yield of spectral-domain OCT combined with microperimetry. Graefes Arch Clin Exp Ophthalmol. 2013 Nov;251(11):2505-11. doi: 10.1007/s00417-013-2339-y. Epub 2013 Apr 26.

publisher_dissemination: Springer


title: Evaluation of Galvus (Vildagliptin) Efficacy Versus Placebo in Patients With Type 2 Diabetes, Inadequately Controlled by Metformin and Basal Insulin, This One Having Been Properly Titrated.

summary:
The main objective is to show that the addition of Galvus versus placebo in patients with type 2 diabetes treated with metformin (at the maximum tolerated dose) and basal insulin properly titrated, allows a greater proportion of patients achieving an HbA1c below 7%.

The primary efficacy endpoint was the percentage of patients responding to treatment (HbA1c less than 7%) after 3 months of treatment with Galvus or placebo

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète


title: Detection of Right Ventricular Dysfunction by 2D Strain During Acute Respiratory Distress Syndrom (ARDS)

acronym: STRAIN

summary: Acute respiratory distress syndrome (ARDS) and mechanical ventilation can lead to right ventricular dysfunction and ultimately right ventricular failure by increasing pulmonary vascular resistances and pressure load. This can be prevented by modifying ventilator settings, using vasopressors or inotropes or even by prone positionning.But to do so, right ventricular dysfonction has to be detected. Echocardiography has emerged as a first line tool to diagnose right heart failure. Recently, strain analysis showed promising results to detect early right ventricle abnormalities in other settings such as pulmonary hypertension or scleroderma. We therefore decided to determine whether 2D strain could help detect early right ventricular dysfunction in ARDS.


title: Factors Impacting on Efficacy and Compliance to Cetuximab Treatment in First Line WT KRAS Metastatic Colorectal Cancer

summary: PREMIUM is an observational pharmaco-epidemiologic, transversal, multi-centric, prospective cohort study and with independent investigators. The purpose is to compare PFS in real life with PFS clinical trials and to determine factors impacting efficacy and compliance to cetuximab treatment in first line K-ras wild-type (wt) metastatic colorectal cancer.

ReferenceCitation: Mineur L, Francois E, Plassot C, Phelip JM, Miglianico L, Dourthe LM, Bonichon N, Moreau L, Guimbaud R, Smith D, Achille E, Herve R, Bons JM, Remy S, Faroux R, Villing AL, Mahamat A, Rabbia I, Soulie P, Baumgaertner I, Mathe N, Vazquez L, Boustany R. PREMIUM: A French prospective multicenter observational study of factors impacting on efficacy and compliance to cetuximab treatment in first-line KRAS wild-type metastatic colorectal cancer. PLoS One. 2020 Dec 21;15(12):e0243997. doi: 10.1371/journal.pone.0243997. eCollection 2020.

publisher_dissemination: Public Library of Science

lead_sponsor: Dr.Laurent Mineur

sponsor_collaborators:
Dr.Laurent Mineur
Merck Serono International SA
BESPIM, CHU Nîmes (data analysis)


title: Evolution Natriuretic Peptide Concentrations of B-type (BNP) During General Anesthesia Under Propofol and Sevoflurane Association in Patients Previously Sensitized to Anthracyclines. Pilot Study in Patients Operated on for Breast Cancer. Monocentric Study Feasibility.

acronym: PEPNATB

summary: The cardiotoxicity of anthracyclines chemotherapy remains a major problem, despite clinical and echocardiographic monitoring. In the case of treatment for breast cancer, surgery requiring general anesthesia may follow chemotherapy. Although a possible interaction between general anesthetics and anthracyclines on systolic function is only rarely mentioned, some cases of heart failure and / or conduction disturbances peranesthésique were observed in patients treated or previously treated with anthracyclines. The determination of concentration of BNP is a diagnostic tool used in the detection of heart failure and acute coronary syndromes. The question of a possible synergism between cardiotoxic anthracyclines and anesthetic agents arises. Given its minimally invasive nature and its diagnostic value, the BNP assay might thus allow to highlight a possible subclinical deficiency. To our knowledge, there is very little data regarding a possible synergism between cardiotoxic anthracyclines and anesthetic agents.

lead_sponsor: Institut Bergonié


title: VOLCAN: A Volumetric Coiling in Aneurysm Registry of the Penumbra Coil 400TM System

acronym: VOLCAN

summary: This study is a prospective, multi-center registry of patients with intracranial aneurysms who are treated by the PC 400 System. Data for each patient are collected up to 12 ± 3 months post-procedure for the study.

lead_sponsor: Penumbra Inc.


title: Levobupivacaine Continuous Wound Infiltration and Optimal Standard Analgesia Versus Optimal Standard Analgesia Alone After Cesarean Section.

acronym: KTcesar

summary: The purpose of this study is to determine wether wound infiltration brings additional analgesia effect after cesarean section with optimal standard postoperative analgesia

lead_sponsor: Poissy-Saint Germain Hospital


title: Endoscopic Resection of High Grade(TA, T1, Cis)Non-muscle Invasive Bladder Tumors: Modification of Usual Management of This Resection by Using the Blue Light and Evaluation of the Outcome: Should we Maintain the Dogma of Second Endoscopic Resection as a Principle?

summary: To confirm the benefit of endoscopic resection under fluorescence and blue light of high grade non-muscle invasive bladder tumor, and verifying if the second endoscopic resection recommended nowadays can be deleted.

ReferenceCitation: Neuzillet Y, Methorst C, Schneider M, Lebret T, Rouanne M, Radulescu C, Molinie V, Dreyfus JF, Pelcat V, Botto H. Assessment of diagnostic gain with hexaminolevulinate (HAL) in the setting of newly diagnosed non-muscle-invasive bladder cancer with positive results on urine cytology. Urol Oncol. 2014 Nov;32(8):1135-40. doi: 10.1016/j.urolonc.2014.04.005. Epub 2014 Jul 9.

lead_sponsor: Hopital Foch


title: Validation of the Measurement of a Systolic Pressure Index at the Toe (IPSO) After a Walking Test

acronym: IPSO FACTO

summary: The main objective of this study is to evaluate the concordance of the variation in systolic pressure indices measured at the toe and ankle after a walking test in healthy volunteers.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Correlation Between Clinical and Electrophysiological Phenotypes in a Population of Patients With Neuropathy Charcot-Marie-Tooth Disease Type 1A

summary: This exploratory cross-sectional study proposes, firstly, to objectify in a population of Charcot-Marie-Tooth disease type 1A (CMT 1A)if there is a correlation between the recording of electrical parameters and upper limb muscle strength of the thigh and in a second step, to seek a relationship between the measured parameters.

ReferenceCitation: Bihel L, Reynaud V, Givron P, Clavelou P, Cornut-Chauvinc C, Pereira B, Thomas E, Taithe F, Coudeyre E. Foot Function Index: A Promising Questionnaire for Individuals With Charcot-Marie-Tooth Disease Type 1A. Arch Phys Med Rehabil. 2019 Dec;100(12):2403-2406. doi: 10.1016/j.apmr.2019.06.003. Epub 2019 Jun 28.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

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

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

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

repositories_concat: HAL

unpaywall_oa_status: hybrid


title: Physiopathological Study of Autonomic Failure in Parkinson's Disease : a Monocentric Study

acronym: SYNAPark

summary: The aim of the study is to evaluate the autonomic failure in Parkinson's disease by clinical, electrophysiological and neuropathological examination.

lead_sponsor: Nantes University Hospital


title: Interest of the Measure of the StO2 to Estimate the Microcirculatory Disturbances Following Cardiac Surgery With Cardiopulmonary Bypass

summary: Microcirculatory disturbances following cardiac surgery with cardiopulmonary bypass (CPB) have been thought to be at the origin of organ dysfunction. Though, few studies correlated microvascular alterations with outcome. Investigators aimed at firstly describing microcirculation with near infra red spectroscopy (NIRS) and secondly correlating NIRS parameters with intensive care length of stay and organ dysfunction.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


type: EudraCT Number

title: Evaluation of Rituximab in Systemic Sclerosis Associated Polyarthritis

acronym: RECOVER

summary: The purpose of this study is to determine whether rituximab is effective in the treatment of articular symptoms that occur in systemic sclerosis related polyarthritis

ReferenceCitation: Bosello S, De Santis M, Lama G, Spano C, Angelucci C, Tolusso B, Sica G, Ferraccioli G. B cell depletion in diffuse progressive systemic sclerosis: safety, skin score modification and IL-6 modulation in an up to thirty-six months follow-up open-label trial. Arthritis Res Ther. 2010;12(2):R54. doi: 10.1186/ar2965. Epub 2010 Mar 25.

ReferenceCitation: Simms RW, Lafyatis R. Rituximab: a potential therapeutic advance in scleroderma: what is the evidence? Rheumatology (Oxford). 2010 Feb;49(2):201-2. doi: 10.1093/rheumatology/kep421. Epub 2009 Dec 23. No abstract available.

ReferenceCitation: Daoussis D, Liossis SN, Tsamandas AC, Kalogeropoulou C, Kazantzi A, Korfiatis P, Yiannopoulos G, Andonopoulos AP. Is there a role for B-cell depletion as therapy for scleroderma? A case report and review of the literature. Semin Arthritis Rheum. 2010 Oct;40(2):127-36. doi: 10.1016/j.semarthrit.2009.09.003. Epub 2009 Dec 11.

ReferenceCitation: Daoussis D, Liossis SN, Tsamandas AC, Kalogeropoulou C, Kazantzi A, Sirinian C, Karampetsou M, Yiannopoulos G, Andonopoulos AP. Experience with rituximab in scleroderma: results from a 1-year, proof-of-principle study. Rheumatology (Oxford). 2010 Feb;49(2):271-80. doi: 10.1093/rheumatology/kep093. Epub 2009 May 15.

ReferenceCitation: Lafyatis R, Kissin E, York M, Farina G, Viger K, Fritzler MJ, Merkel PA, Simms RW. B cell depletion with rituximab in patients with diffuse cutaneous systemic sclerosis. Arthritis Rheum. 2009 Feb;60(2):578-83. doi: 10.1002/art.24249.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Tamsulosin to Facilitate Early Catheter Removal After Urinary Retention in Older Women Hospitalized for an Acute Medical Condition

acronym: TAMSU

summary: Catheter-associated urinary infections are the most common hospital-acquired infections and can be prevented by early catheter removal. This study evaluates tamsulosin to reduce the failure of early catheter removal has been studied in elderly women hospitalized for an acute condition and experiencing acute urinary retention: 448 women 75-year old or more without an anatomical or neurological cause of urinary retention will be randomized to a 6 days course of tamsulosin 0.4 mg or placebo. Catheter removal will be attempted after the third dose of tamsulosin and the need to replace another catheter within 72 hours will define a failed attempt.

location_facility: Service de médecine interne, Hôpital Tenon


acronym: EPOP

summary:
The benefit of preoperative rehabilitation treatment combining physiotherapy and targeted education for patient undergoing Total Knee replacement (TKR) is now well known. Thus, there is lack of validated booklet containing evidence based informations.

Our aim is to assess the impact of an evidence based education pre-operative booklet on patient's knowledge and beliefs. The secondary objectives are to assess the impact of the booklet on patient's satisfaction on the information received, the length of stay in orthopedic surgery and the transfer rate to rehabilitation wards.

To show a difference of 2 points on the knowledge score (range 0-10) between the two groups, with a = 0.05 and a power of 90%, we considered that 44 patients are needed. The evaluations will take place at baseline, the day before surgery and 6 weeks post-surgery on knowledge and beliefs scores at each visit and on a satisfaction score on the last one. Quantitative data will be compared between groups by the Kruskal-Wallis and qualitative parameters via Fisher exact test.

The study protocol was approved by the local Ethic Committee.

ReferenceCitation: Eschalier B, Descamps S, Pereira B, Vaillant-Roussel H, Girard G, Boisgard S, Coudeyre E. Randomized blinded trial of standardized written patient information before total knee arthroplasty. PLoS One. 2017 Jul 5;12(7):e0178358. doi: 10.1371/journal.pone.0178358. eCollection 2017.

evidence: oa repository (semantic scholar lookup)

repositories:
HAL
PubMed Central
pdfs.semanticscholar.org

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

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

sponsor_collaborators:
University Hospital, Clermont-Ferrand
Sanofi


title: Can the Assessment of the Subhippocampal Region Contribute to the Detection of Early Diagnosis of Alzheimer's Disease?

summary:
Reliable diagnosis of Alzheimer's Disease (AD) at the predementia stage is currently considered to be a priority for research, as disease modifying therapies are being evaluated. Many studies focus on the functional and morphological assessment of the hippocampal formation. However, neurofibrillary tangles, associated with cognitive deficits, initially affect the anterior subhippocampal cortex (transentorhinal, entorhinal and perirhinal cortex) before reaching the hippocampus. Studies from our group have tried to investigate if the assessment of subhippocampal regions using cognitive tools and neuroimaging techniques could contribute to the diagnosis of AD at a very early stage.

In a previous project, the investigators included 40 patients with single domain amnestic MCI (Mild Cognitive Impairment), known to be at high risk for AD and demonstrated that aMCI patients with a profile of subhippocampal dysfunction (impaired performance on a visual recognition memory task) display other clinical as well as imaging profiles of patients with early AD using MRI and SPECT. Longitudinal follow-up data in these patients is currently under way. Preliminary data indicates that evaluating the subhippocampal region using visual recognition tasks is highly predictive of AD over 6 years.

The aim of this project is to obtain additional diagnostic data using a PET amyloid tracer (Florbetapir F18 AV45 F18), an in-vivo marker of one of the neuropathological lesions that define AD, of in order to enhance diagnostic accuracy AD in these patients. This approach will validate the hypothesis as to whether the assessment of subhippocampal dysfunction can contribute to the early diagnosis of AD.

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: Evaluation of the Mobility of Elderly Patients (> 65 Years) When Using the "l'Ergonome" Mobility Device: a Randomized, Monocentric Study

acronym: L'ERGONOME

summary:
The main objective of this study is to compare the percentage of patients that successfully pass from a laying position to a sitting position in less than 10 seconds between study arms:

experimental arm: these patients will use the ERGONOME device to help them sit up
standard arm: these patients will use traditional hanging triangle bar to help them sit up

sponsor_collaborators: Centre Hospitalier Universitaire de Nīmes


title: Impact of the Contamination Mode on the Clinical Evolution During Pseudomonas Aeruginosa Ventilator Acquired Pneumonia

acronym: PYO GEN

summary:
Pseudomonas aeruginosa is the main pathogen of nosocomial respiratory infections. Its increasing resistance to antibiotics requires the development of new strategies for prevention and control, demanding a better understanding of the modes of transmission and evolutionary dynamics of this bacteria. In patients under invasive mechanical ventilation, the main mode of contamination by Pseudomonas remains debated, with 3 modes of contamination (endogenous, crossed transmission between patients, or environmental origin) of varying importance, mainly depending on the endemic situation of the place of study.

The emergence of new genotyping technologies (DiversiLab) can now facilitate studies of molecular epidemiology. Thanks to the multidisciplinary collaboration and innovative techniques, the investigators wish to study the impact of the mode of contamination on the outcome of ICU patients, intubated and ventilated for more than 72 hours.

lead_sponsor: University Hospital, Grenoble

location_facility: Medical ICU of Universitary Hospital of Grenoble


title: Monocentric, Randomized, Single Blinded Study Designed to Evaluate the Effect of Low Level Laser Therapy on Pain Occurring After Insertion of an Orthodontic Device : the "Quadhelix"

acronym: Ortholaser

summary:
Thus study consists of evaluating the effect of low level therapy on pain induced by insertion of an orthodontic device (the "quadhelix"). Each day during the first seven days post procedure, the level of pain will be reported on an analogic visual scale.

As secondary objectives, intake of antalgics and type of swallowed food (soft or tough) will also be daily registered.


summary:
Different treatment trials have been published in acquired nystagmus in the last decade; gabapentin and memantine have been found to be efficient in treating pendular nystagmus in Multiple Sclerosis. The effects of treatments are measured on nystagmus velocity, amplitude, frequency and on visual acuity. None of the trials measured a functional visual score or oscillopsia score.

The aim of our study is to evaluate the effect of gabapentin and memantine on the mean velocity, amplitude and frequency of pendular nystagmus, as well as on oscillopsia, visual acuity and vision-specific health-related quality of life score, in 10 patients with multiple sclerosis. The primary object is to find out the best variable to evaluate the efficiency of nystagmus treatment and the secondary, to compare the efficiency of both gabapentin and memantine in a common population of patients.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Neurologique Unité de Neuro-Ophtalmologie


title: Efficacy of Continuous Wound Infusion in Major Lumbar and Thoracic Spine Surgery : A Randomised, Double-blinded, Placebo-controlled Study

summary:
Introduction : Spine surgery is responsible for intense postoperative pain that can be treated by an analgesia multimodal approach (IV analgesic infusion and local anesthesia). Continuous wound infiltration is an efficient and simple technique with few adverse effects yet very few studies have investigated its potential use in spine surgery. Our randomised, controlled, double-blinded trial aims to evaluate efficacy of continuous wound infiltration after major spine surgery.

Methods : After written consent is obtained, the surgeon inserts, at the end of surgery, a multiholes catheter under muscular layers. Patients are randomised in two groups : The "treated group" receives ropivacaine 0.2% infusion (bolus of 10 milliliters (mL) followed by 8 mL/h continuous infusion during 48 hours) and the "control group" receives saline solution (0.9%). In addition, all patients receive patient-controlled intra-venous morphine analgesia. The investigators hypothesize that the "treated group" will consume morphine less than the "control group".

ReferenceCitation: Greze J, Vighetti A, Incagnoli P, Quesada JL, Albaladejo P, Palombi O, Tonetti J, Bosson JL, Payen JF. Does continuous wound infiltration enhance baseline intravenous multimodal analgesia after posterior spinal fusion surgery? A randomized, double-blinded, placebo-controlled study. Eur Spine J. 2017 Mar;26(3):832-839. doi: 10.1007/s00586-016-4428-1. Epub 2016 Feb 10.

location_facility: University Hospital, Departement of Anesthesia and Intensive Care


title: Utility of Whole-body MRI (STIR and Diffusion Weighted) in the Detection of Traumatic Injuries of Undetermined Origin in Children

acronym: PEDIMA

summary: The diagnosis of abuse in children relies heavily on the presence of skeletal and extraskeletal injuries. However, some lesions are not seen by initial skeletal survey. And the investigators have to complete the skeletal survey with either bone-scan or CT scan or whole-body MRI. whole-body MRI has proved its worth in the pediatric population for the evaluation of skeletal and extraskeletal lesions in children with cancer or infectious diseases. Thus, whole-body MRI would allowed to have total picture of children without ionising radiation exposure.

ReferenceCitation: Proisy M, Vivier PH, Morel B, Bruneau B, Sembely-Taveau C, Vacheresse S, Devillers A, Lecloirec J, Bodet-Milin C, Dubois M, Hamonic S, Bajeux E, Ganivet A, Adamsbaum C, Treguier C; PEDIMA study research group. Whole-body MR imaging in suspected physical child abuse: comparison with skeletal survey and bone scintigraphy findings from the PEDIMA prospective multicentre study. Eur Radiol. 2021 Nov;31(11):8069-8080. doi: 10.1007/s00330-021-07896-9. Epub 2021 Apr 29.

lead_sponsor: Rennes University Hospital


title: Protocole ULTRAFAST - ECHOTRACKING : Remodelage pariétal et rigidité artérielle Chez l'Hypertendu : Nouvelle étude de Leur Relation Utilisant l'élastographie Par Ultrafast-écho et la séparation Intima/média Par écho-tracking

summary: The aim is to compare a new technique for assessing mechanical properties of large arteries: the Ultrafast echo with the reference technique, the echotracking. This will be done by studying in parallel hypertensive patients and controls with both techniques and this will revisit old concepts of increased stiffness in hypertensive arteries.

lead_sponsor: French Cardiology Society

location_facility: Hopital Européen Georges Pompidou / Service de Pharmacologie


title: Reproductibility of Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in the Emergency Room

acronym: EDDRA-Repro

summary: The main objective of this study is to evaluate the inter-rater reproducibility of diaphragmatic excursion measures via time-motion-mode ultrasound (evaluation performed on the first measure) in patients experiencing acute respiratory distress emergencies.

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Nutritional Status of Patients Victims of Haemorragic Accidents With Antivitamins K

summary: Bleeding under vitamin K antagonists are a major iatrogenic causes of hospitalization, subject to a fatal outcome in more than one third of cases, mortality is particularly high in cases of serious bleeding, including intracerebral hemorrhage. If the INR measured in these patients are often away from the higher value of the target range, a significant proportion of bleeding were observed for INR between 2 and 3. The study captures the components of the nutritional status of patients on oral anticoagulants, including any micronutrient deficiencies, to determine whether nutritional status is an independent risk factor for bleeding

ReferenceCitation: Moustafa F, Dopeux L, Mulliez A, Boirie Y, Morand C, Gentes E, Farigon N, Richard D, Lebreton A, Teissandier D, Dutheil F, Schmidt J. Severe undernutrition increases bleeding risk on vitamin-K antagonists. Clin Nutr. 2021 Apr;40(4):2237-2243. doi: 10.1016/j.clnu.2020.10.002. Epub 2020 Oct 9.

oa_host_type: repository

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

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

unpaywall_oa_status: green

lead_sponsor: University Hospital, Clermont-Ferrand


title: Ultrasound-guided Intermediate Cervical Block Versus Superficial Cervical Block for Carotid : a Randomised Controlled Trial

acronym: CERVECHO

summary:
The aim of this prospective, randomised, controlled study is to compare the efficacy of ultrasound-guided intermediate cervical block to superficial block for carotid endarterectomy.

Patients scheduled for carotide endarterectomy under regional anaesthesia (ropivacaine 4.75 mg/ml) are randomised into 2 groups according to the technique of anaesthesia performed: superficial cervical block (Control group) or, ultrasound guided intermediate cervical block (Echo group). Main outcome is cervical block success, defined by surgery performed under regional anaesthesia without supplemental topical lidocaine. Secondary outcomes are rate of conversion to general anaesthesia, total dose of supplemental topical lidocaine and block-related complications.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier universitaire de Besançon


title: Prevalence of Psychocognitive Impairments in Adolescents Surviving Childhood Leukemia : LEA-PsyCog

acronym: LEA-PsyCog

summary:
The objective of the LEA-PsyCog project is to assess the prevalence of psychiatric disorders and psychocognitive impairments in adolescents surviving childhood leukemia .

The second objective is to explore the complex relationships between psycocognitive development and soiciodemodemographics data, main characteristics of leukemia, treatments, side-effects, quality of life and characteristics of proxyies environment.

3. Materials and Methods The LEA study is based on the constitution of a multi-centric prospective cohort in 11 university hospitals: Bordeaux, Clermont-Ferrand, Grenoble, Lyon, Paris (Trousseau, Robert Debré, St Louis), Marseille, Montpellier, Nancy, Nice, Rennes. Are inclued in LEA all the children diagnosed and treated for acute leukemia since January 1980 (incident and prevalent cases), surviving at month 24 for the AML and ALL grafted in complete remission and at month 48 for the ALL not grafted in first complete remission.

The LEA Psy-Cog study rests on a sample of the LEA cohort. Are included the patients 12-17-years-old from the PACA-Corse sub-cohort (administrative district of 4 million of people which corresponds to the Marseille and Nice centers). Patients from this two centers are the patients with the more important length of survey, allowing us to produce a not biaised estimation of prevalence rate. Finally, the choice of this subsample is supported by the proximity of the Mediterranean Center for Adolescent in Marseilles, specifically dedicated to the psychological follow-up of children suffering from cancer.

sponsor_collaborators: Assistance Publique Hopitaux De Marseille


summary: The purpose of this study is to evaluate the benefit of addition of droperidol to prophylaxis with ondansetron and dexamethasone in children with high risk of postoperative vomiting (POV). In adults some authors showed that the effectiveness of prophylaxis is correlated to the number of molecules or specific procedures used.

ReferenceCitation: Gunter JB, McAuliffe JJ, Beckman EC, Wittkugel EP, Spaeth JP, Varughese AM. A factorial study of ondansetron, metoclopramide, and dexamethasone for emesis prophylaxis after adenotonsillectomy in children. Paediatr Anaesth. 2006 Nov;16(11):1153-65. doi: 10.1111/j.1460-9592.2006.01952.x.

ReferenceCitation: Apfel CC, Korttila K, Abdalla M, Kerger H, Turan A, Vedder I, Zernak C, Danner K, Jokela R, Pocock SJ, Trenkler S, Kredel M, Biedler A, Sessler DI, Roewer N; IMPACT Investigators. A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. N Engl J Med. 2004 Jun 10;350(24):2441-51. doi: 10.1056/NEJMoa032196.

ReferenceCitation: Bourdaud N, Francois C, Jacqmarcq O, Guye ML, Jean J, Studer C, Engrand-Donal C, Devys JM, Boutin F, Guyot E, Bouazza N, Treluyer JM, Orliaguet GA; VPOP2 group. Addition of droperidol to prophylactic ondansetron and dexamethasone in children at high risk for postoperative vomiting. A randomized, controlled, double-blind study. Br J Anaesth. 2017 Jun 1;118(6):918-923. doi: 10.1093/bja/aex099.

evidence: open (via crossref license)

title: Postoperative Vomiting in Children: Evaluation of the Addition of Droperidol to Conventional Bi-prophylaxis

source: euctr


title: Screening and Understanding of the Pre-diabetes: DECODIAB

acronym: DECODIAB

summary: The main objective of the study is to understand the pathophysiological mechanisms involved in switching from pre-diabetes to type 2 diabetes and to identify new biomarkers of type 2 diabetes risk in the population of patients with pre-diabetes.


title: Evaluation of Endoscopic Treatment of Zenker's Diverticulum Using the LigaSure Thermal Vessel Sealing System

acronym: ZENKER LS

summary: The primary objective of this study is to evaluation the success of endoscopic treatment of Zenker's diverticulum using a LigaSure device (thermal fusion of vessels) via a measure of swallowing function at 12 months post-surgery.


title: Comparative Ultrasonic Study of Post Operative Diaphragmatic Dysfunction in Abdominal and Head and Neck Surgery

acronym: Under the Dome

summary: Diaphragmatic dysfunction (DD) is one of the main risk factors for post operative respiratory distress syndrome. Ultrasonography is a diagnosis tool for DD but few studies have been published. The aim of this prospective study is to compare the achievement of diaphragmatic function depending on the type of surgery (abdominal and head and neck surgery).

location_facility: Département d'Anesthésie Hôpital de la Croix Rousse


title: Ultrasonic Explorations of Cerebral Tissue Motions - Influence of Aging

acronym: COSTUM

summary: The new technical of ultrasonic exploration of this project purpose to validate the measurement of cerebral pulsatility by a new way called "Fast Cerebral Pulsatility Imaging" (FCPI).This will somehow determine the natural history of cerebral pulsatility during development adult to old age

lead_sponsor: University Hospital, Tours


title: Comparative Study of Plasma Free DNA and Nucleosome Concentrations: Pathological Versus Normal Pregnancies

summary:
The primary objective of this study is to demonstrate that plasma concentrations of nucleosomes and free DNA differ between three groups:

pregnant patients with complications typical of placental insufficiency or venous thrombosis (group P),
healthy women (Group T1) and
healthy pregnant women (Group T2).

ReferenceCitation: Bouvier S, Traboulsi W, Blois SM, Demattei C, Joshkon A, Mousty E, Nollet M, Paulmyer-Lacroix O, Foucault-Bertaud A, Fortier M, Leroyer AS, Bachelier R, Letouzey V, Alfaidy N, Dignat-George F, Blot-Chabaud M, Gris JC, Bardin N. Soluble CD146 is increased in preeclampsia and interacts with galectin-1 to regulate trophoblast migration through VEGFR2 receptor. F S Sci. 2022 Feb;3(1):84-94. doi: 10.1016/j.xfss.2021.11.002. Epub 2021 Nov 19.

evidence: oa journal (via observed oa rate)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

ReferenceCitation: Bouvier S, Mousty E, Fortier M, Demattei C, Mercier E, Nouvellon E, Chea M, Grosjean F, Letouzey V, Gris JC. Placenta-mediated complications: Nucleosomes and free DNA concentrations differ depending on subtypes. J Thromb Haemost. 2020 Dec;18(12):3371-3380. doi: 10.1111/jth.15105. Epub 2020 Oct 18.

intervention_type: Biological


title: Contribution of Multimodal Imaging (MRI, PET, MEG) in Pre-surgical Evaluation of Drug-resistant Focal Epilepsy

acronym: EPIMAGE

summary:
Epilepsy is the most common chronic neurological disorder in the world, affecting more than 50 million people worldwide. Approximately 35% of patients with epilepsy are refractory to all available antiepileptic drugs. Drug-resistant epilepsies are often partial or focal. Patients with drug-resistant focal epilepsy suffer from an increased risk of death, primarily due to seizure-related fatalities, in comparison with the general population. The only therapeutic option for this form of epilepsy is the surgical removal of the region of the brain responsible for seizures, called the epileptogenic zone (EZ). This requires the precise localization of the EZ based on a comprehensive pre-surgical evaluation of patients.

Today the gold standard for localizing the EZ and validating a non-invasive technique for localization of the EZ remains intracerebral stereo-EEG (stereo-electroencephalography or SEEG) recordings of spontaneous seizures. The implementation strategy of the intracerebral depth electrodes is guided by clinical and neuroimaging data, including anatomical Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET) with FDG (fluoro-Deoxy-Glucose) and MagnetoEncephaloGraphy (MEG). Although the contribution of each technique in the pre-surgical localization of the EZ has already been shown, no wide-scale study has examined the cumulative contribution of these three techniques.