title: Percentage of Oxygen Saturation of Haemoglobin in Tissues (StO2) Performance Measured on Admission to the Emergency Department in the Assessment of Drug Poisoning

acronym: IMACS

summary:
The primary purpose of the protocol is to evaluate the StO2 performance measured at the admission to the emergency department to identify hemodynamic failure at the admission or within the first three hours of monitoring patients with drug poisoning.

The study hypotheses are:

The early detection of hypoperfusion by StO2, essential to prevent the development of collapse.
To limit hemodynamic failure effects, reduce morbidity and mortality of drug poisoning, hospital stay and cost.

ReferenceCitation: Lambert H, Manel J, Bellou A, el Kouch S. [Morbidity and mortality from acute drug poisoning in France]. Rev Prat. 1997 Apr 1;47(7):716-20. French.

ReferenceCitation: F.Adnet, S.Atout, M. Galinski. Evolution des intoxications médicamenteuses volontaires en France, 2005, Société de réanimation de langue française

ReferenceCitation: Cohn SM, Nathens AB, Moore FA, Rhee P, Puyana JC, Moore EE, Beilman GJ; StO2 in Trauma Patients Trial Investigators. Tissue oxygen saturation predicts the development of organ dysfunction during traumatic shock resuscitation. J Trauma. 2007 Jan;62(1):44-54; discussion 54-5.

ReferenceCitation: Reducing the severity of road injuries through post impact care. European Transport Safety Council. Eur J Emerg Med. 1999 Sep;6(3):271-4.

ReferenceCitation: Cohn SM, Crookes BA, Proctor KG. Near-infrared spectroscopy in resuscitation. J Trauma. 2003 May;54(5 Suppl):S199-202. Review.

ReferenceCitation: Crookes BA, Cohn SM, Bloch S, Amortegui J, Manning R, Li P, Proctor MS, Hallal A, Blackbourne LH, Benjamin R, Soffer D, Habib F, Schulman CI, Duncan R, Proctor KG. Can near-infrared spectroscopy identify the severity of shock in trauma patients? J Trauma. 2005 Apr;58(4):806-13; discussion 813-6.

ReferenceCitation: Creteur J, Carollo T, Soldati G, Buchele G, De Backer D, Vincent JL. The prognostic value of muscle StO2 in septic patients. Intensive Care Med. 2007 Sep;33(9):1549-56. Epub 2007 Jun 16.


title: Appraisal of MDCO-157 and Plavix® Pharmacokinetics and Pharmacodynamics in Healthy Volunteers With an Open-label, Randomized, Cross-over Evaluation: The AMPHORE Study

acronym: AMPHORE

summary: Following a first, dose ascending study that enrolled 144 normal healthy volunteers (NHVs), this study, to be conducted in approximately 36 NHVs, will provide pertinent information in determining the dose-response of MDCO-157 for platelet aggregation inhibition and P2Y12 receptor inhibition effects and in selection of doses that match the antiplatelet effects of 300 mg PLAVIX® ®. The study will also provide additional data for pharmacokinetics (PK), safety and tolerability of single doses of MDCO-157.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Collet JP, Funck-Brentano C, Prats J, Salem JE, Hulot JS, Guilloux E, Hu MY, He K, Silvain J, Gallois V, Brugier D, Anzaha G, Galier S, Nicolas N, Montalescot G. Intravenous Clopidogrel (MDCO-157) Compared with Oral Clopidogrel: The Randomized Cross-Over AMPHORE Study. Am J Cardiovasc Drugs. 2016 Feb;16(1):43-53. doi: 10.1007/s40256-015-0145-0.

family: Collet

full_name: Jean-Philippe Collet

given: Jean-Philippe

sequence: first

family: Funck-Brentano

full_name: Christian Funck-Brentano

given: Christian

sequence: additional

family: Prats

full_name: Jayne Prats

given: Jayne

family: Salem

full_name: Joe-Elie Salem

given: Joe-Elie

family: Hulot

full_name: Jean-Sébastien Hulot

given: Jean-Sébastien

family: Guilloux

full_name: Edith Guilloux

given: Edith

family: Hu

full_name: Ming-yi Hu

given: Ming-yi

family: He

full_name: Kan He

given: Kan

family: Silvain

full_name: Johanne Silvain

given: Johanne

family: Gallois

full_name: Vanessa Gallois

given: Vanessa

family: Brugier

full_name: Delphine Brugier

given: Delphine

family: Anzaha

full_name: Ghalia Anzaha

given: Ghalia

family: Galier

full_name: Sophie Galier

given: Sophie

family: Nicolas

full_name: Nathalie Nicolas

given: Nathalie

family: Montalescot

full_name: Gilles Montalescot

given: Gilles

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: American Journal of Cardiovascular Drugs

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: The Medicines Company

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Pharmacogenetic Study in Castration-resistant Prostate Cancer Patients Treated With Abiraterone Acetate

acronym: ABIGENE

summary:
Prostate cancer is the 2nd leading cause of mortality in men in developed countries. For metastatic prostate cancer patients, the 1st-line treatment relies on hormone therapy. However, the efficacy of androgen deprivation therapy remains limited in time and most patients eventually develop castration-resistant prostate cancer (CRPC), while remaining androgen-dependent.

Docetaxel is currently the standard of care for metastatic CPRC. It has been shown that testosterone levels within metastatic tumoral tissue from men receiving hormone therapy were significantly higher than those from primitive tumors of untreated prostate cancers. Among the mechanistic explanations for this observation, it has been shown that CYP17A1, a key enzyme in de novo steroid synthesis localized in testis and adrenal gland, is up-regulated in CRPC metastases. The existence of de novo CYP17A1-dependent androgen biosynthesis at the tumor level has supported the development of novel antiandrogens, including abiraterone acetate (AA), an irreversible CYP17A1 inhibitor. Based on a placebo-controlled phase III trial, demonstrating that abiraterone prolonged overall survival (14.8 vs 10.9 months) and increased PSA response rate (29% vs 6%) in patients with metastatic CRPC who previously received docetaxel, AA was recently approved by the FDA and French Health Authorities. AA is well-tolerated and main toxicities are urinary tract infections (2%) and a syndrome of secondary mineralocorticoid excess characterized by fluid overload, hypertension and hypokaliema (1% to 4% of grade 3-4).

Almost concomitantly, a novel taxane-class cytotoxic agent, cabazitaxel, has proven efficacy in CRPC treatment after failure to docetaxel, and has recently been approved by the FDA and French Health Authority. Although cabazitaxel exhibits a less favorable toxicity profile, this precise context creates a need to dispose of objective individual criteria so as to orientate patients to treatment towards AA or towards cabazitaxel. To this purpose, several approaches are of potential interest for identifying good candidates for a treatment by AA: tumor-specific TMPRSS2-ERG gene fusion measurement, circulating tumor cell analysis, tumoral CYP17A1 expression, analysis of splicing forms of the androgen receptor. However, the clinical relevance of these potential predictive factors remains to be established in this setting.

Pharmacogenetics examines germinal gene polymorphisms likely to influence the pharmacodynamics of anticancer agents. Encouraging results have recently been reported by our group for irinotecan pharmacogenetics with concrete possibilities of individual dose adaptations, and very recently by other investigators for sunitinib pharmacogenetics. Concerning AA, one can hypothesize that tumors with elevated CYP17A1 expression will be more likely to respond better to AA. This hypothesis is indirectly supported by the observation that in CPRC patients receiving AA, PSA-based response is higher in patients with elevated pre-treatment blood concentration of DHEA and androstenedione.

The CYP17A1 gene presents numerous single nucleotide polymorphisms (SNPs), whose frequencies of rare alleles are at least 12%. Their functional impact has been suggested for nine of them, which were linked either to the risk of developing prostate cancer or to survival of prostate cancer patients. So far, no study has examined the links between these polymorphisms and the efficacy of a CYP17A1 inhibitor. Also, relationships with the efficacy of androgen deprivation therapy have recently been reported for SNPs of genes involved in the membrane-transport testosterone and dehydroepiandrosterone, namely SLCO2B1 and SLCO1B3. One can make the hypothesis that gene polymorphisms of these transporters may play a role for the intratumoral concentration of testosterone locally-produced through the mediation of CYP17A1 activity.

To resume, two second-line treatments of metastatic CRPC cancers are currently available, thus is raising the question in practice of which treatment is more appropriate for a given patient. Herein, the present study proposes an original pharmacogenetic approach in order to highlight a relationship between AA activity and patient's genetic profile. Ultimately, this could reveal evidences of genetic predispositions for potentially good responders to AA treatment.

primary_purpose: Other

lead_sponsor: Centre Antoine Lacassagne


title: Evaluation of Laryngeal Ultrasonography Performance in Predicting Major Post Extubation Laryngeal Edema in Intensive Care Patients

acronym: ECHOLPE

summary:
For patient in intensive care unit, extubation failure is defined as the necessity of early reintubation after scheduled extubation, with Increased morbidity and mortality, so it seems important to quickly identify patients with high risk of post-extubation acute respiratory failure.
Major post-extubation laryngeal edema is one of extubation failure causes, and its incidence vary in literature from 4 to 37%.
We can't currently predict arising of a major post-extubation laryngeal edema. However, a recent pilot study showed that laryngeal ultrasonography could help to identify patients with high risk of post-extubation stridor, measuring ultrasonic leak volume and cuff-deflated air-column width, of which we propose to assess diagnostic performance.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Ding LW, Wang HC, Wu HD, Chang CJ, Yang PC. Laryngeal ultrasound: a useful method in predicting post-extubation stridor. A pilot study. Eur Respir J. 2006 Feb;27(2):384-9.

ReferenceCitation: Wittekamp BH, van Mook WN, Tjan DH, Zwaveling JH, Bergmans DC. Clinical review: post-extubation laryngeal edema and extubation failure in critically ill adult patients. Crit Care. 2009;13(6):233. doi: 10.1186/cc8142. Epub 2009 Dec 1. Review.

ReferenceCitation: Sustić A. Role of ultrasound in the airway management of critically ill patients. Crit Care Med. 2007 May;35(5 Suppl):S173-7. Review.

ReferenceCitation: Frutos-Vivar F, Esteban A, Apezteguia C, González M, Arabi Y, Restrepo MI, Gordo F, Santos C, Alhashemi JA, Pérez F, Peñuelas O, Anzueto A. Outcome of reintubated patients after scheduled extubation. J Crit Care. 2011 Oct;26(5):502-509. doi: 10.1016/j.jcrc.2010.12.015. Epub 2011 Mar 3.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire Besançon

lead_sponsor_type: academique

status_simplified: Unknown


title: Characterization of Sitting Postures in Healthy Subjects

acronym: CaPAS

summary: The aim of this study is to assess the intra and inter-subjects variability of the pressure measurement cartography in healthy and well and able volunteers, sitting on a rigid base during two hours.

primary_purpose: Basic Science

lead_sponsor: University Hospital, Grenoble

intervention_type: Device


title: Detection and Localization of Prostate Cancer Local Recurrences After Radiation Therapy Using Histoscanning™ and Multiparametric MRI

acronym: HISTO-RAD

summary:
Inclusion criteria:

Patients with biochemical recurrence (Phoenix criteria: PSA nadir + 2 ng/ml) after radiation therapy for prostate cancer addressed for prostate biopsy OR
Patients referred to our institution for biopsy-proven local recurrence after radiation therapy for prostate cancer but needing a re-assessment with biopsy (insufficient number of biopsy and/or imprecise location of positive biopsy and/or questionable diagnostic of recurrence)

Study Design:

Included patients will undergo an endorectal US examination with a Histoscanning™ acquisition and a multiparametric (T2-weighted, diffusion-weighted and dynamic contrast-enhanced) MRI.
Two independent operators will separately define suspicious focal lesion on Histoscanning™ images and on MR images.
Random biopsies (at least 2 cores) will be performed in sextants negative at Histoscanning™ and at MRI ; In sextants positive at Histoscanning™ and/or at MRI, targeted biopsies will be performed in the suspicious part of the sextant (at least two cores per suspicious lesion).
Histoscanning™ and MRI results will be compared to biopsy results.

A total of 30 patients will be included

primary_purpose: Diagnostic

lead_sponsor: Hospices Civils de Lyon

intervention_type: Other


lead_sponsor: Fresenius Kabi

acronym: PropofolTE

location_facility: CHU de Bordeaux, Groupe Hospitalier Pellegrin

type: EudraCT Number

source: euctr

title: Therapeutic Equivalence Study of Propofol Using Target-Controlled Infusion of Propofol 2% (20 mg/mL) MCT Fresenius Compared With Diprivan® 20 mg/mL (AstraZeneca) in Patients Undergoing Elective Surgery

summary: The purpose of this study is to evaluate the therapeutic equivalence, based on pharmacodynamic parameters of Propofol 2% (20 mg/mL) MCT Fresenius and Diprivan® 20 mg/mL (AstraZeneca), administered by target controlled infusion (TCI).


title: Up Regulation of Alpha-1 Receptors Upon Septic Shock ?

acronym: CATACHOC

summary: The hallmarks of septic shock are hypovolemia and reduced pressor response to endogenous noradrenaline. The working hypothesis is that the higher the plasma concentration of endogenous noradrenaline will be, the lower the pressor response to exogenous noradrenaline will be. This will be tested in patients presenting with septic shock, following state of the art management (including repeated assessment of vena cava diameter and compliance, and response to dynamic indices of loading) following placebo vs clonidine administration (1 mcg.kg-1.h-1 over 24 h without bolus) and administration of increasing doses of noradrenaline (1 mcg, 2 mcg, etc. up to a delta systolic blood pressure circa 25-30 mm Hg).

status: Terminated

lead_sponsor: Direction Centrale du Service de Santé des Armées


title: ROPI Study: Evaluation of the Interest of Ropivacaine Streaming in Postoperative Pain After Mastectomy.

acronym: ROPI

summary:
After surgery for breast cancer, the prevalence of chronic pain is estimated between 20 and 68%. They begin after surgery and may persist until more than 6 months. They respond poorly to opioid analgesics impair the quality of life.

Among the different postoperative analgesic techniques used, the use of a local anesthetic infiltration continues catheter has advantages including improving the quality of analgesia, with a significant decrease in average of VAS (scale visual Analogue), a decrease in morphine consumption, improving the quality of life of patients.

Our study aims to evaluate the effectiveness of a continuous local anesthetic infiltration in the control of postoperative pain after mastectomy.

lead_sponsor: Centre Jean Perrin


title: Benefit of Pharyngeal and Oesophageal pH-impedance of Patients With High Suspicion of Laryngopharyngeal Reflux

acronym: PHARO

summary:
Laryngopharyngeal reflux (LPR) is the retrograde movement of gastric contents into the larynx, pharynx and upper aerodigestive tract. The symptoms and manifestations are very changeable and non specific. Pharyngeal and Oesophageal pH-impedance may help to detect these reflux and to identify patients with abnormal LPR.

To compare and describe the results of pharyngeal and oesophageal pH-impedance of patients with high suspicion of laryngopharyngeal reflux, with the results of healthy patients.

lead_sponsor: University Hospital, Bordeaux


type: Other Identifier

title: Betamethasone and Severity of Hyaline Membrane Disease in the Newborn Premature

acronym: b-Mhyalines

summary: Primary purpose: to study the relationship between betamethasone placental transfer and the occurrence and severity of the Hyaline Membrane Disease.

study_start_date_type: Actual

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Ibuprofen and Ketoprofen Concentrations in Human Mature Milk. PK Study in Breastmilk AOR-10127 "Antalait" Study

acronym: ANTALAIT

summary: The purpose of this study is to determine whether ibuprofen and ketoprofen do not enter into mature breastmilk that could allowed breastfeeding during a long time


title: Phase I of Infusion of Selected Donor NK Cells After HLA Identical Allogeneic Stem Cell Transplantation Prepared With Reduced Intensity Conditioning - DLI-NK/IPC 2012-003

acronym: DLI-NK

summary: The goal of our study will be to determine the clinical and biological safety of infusing immuno-selected NK (Natural Killer) CD3-/CD56+ cells, early after allogeneic transplantation with colony stimulating factor (G-CSF) mobilized peripheral blood stem cells and Reduced Intensity Conditioning (RIC), as a potential substitute to usual "Donor Lymphocyte Infusion" (DLI), that contain the whole range of immune effectors. The trial will include several progressive steps: dose escalation up to a level compatible with the cost-effectiveness potential of the device and clinical situation and recombinant interleukin-2 (r-IL2) activation of selected NK cells in vitro prior to re-infusion.

ReferenceCitation: Mfarrej B, Gaude J, Couquiaud J, Calmels B, Chabannon C, Lemarie C. Validation of a flow cytometry-based method to quantify viable lymphocyte subtypes in fresh and cryopreserved hematopoietic cellular products. Cytotherapy. 2021 Jan;23(1):77-87. doi: 10.1016/j.jcyt.2020.06.005. Epub 2020 Jul 25.

family: Mfarrej

full_name: Bechara Mfarrej

given: Bechara

family: Gaude

full_name: Julie Gaude

given: Julie

family: Couquiaud

full_name: Jerome Couquiaud

given: Jerome

family: Calmels

full_name: Boris Calmels

given: Boris

family: Chabannon

full_name: Christian Chabannon

family: Lemarie

full_name: Claude Lemarie

given: Claude

journal_name: Cytotherapy

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Institut Paoli-Calmettes

intervention_type: Biological


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.

design_allocation: Non-Randomized

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.

ReferenceCitation: Péquignot 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.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

intervention_type: Procedure


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.

primary_purpose: Prevention

ipd_sharing: No


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: Bundle Evaluation in Extra Renal Epuration, Incidence of Thrombosis

acronym: BEERT

summary: This is a prospective observational clinical multicentric study in ICU with acute renal failure requiring renal replacement therapy.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Repeated Low-frequency Transcranial Magnetic Stimulation Reduces Cue-induced Craving: a Randomized, Prospective, Double-blind, Sham-controlled, Cross-over Study

acronym: STIMJEU

summary: The aim of this study is to evaluate the effect of repeated low-frequency Transcranial Magnetic Stimulation (rTMS) of the right dorsolateral prefrontal cortex, combined with gambling cues, on gambling craving. Participants are pathological gamblers. A single real stimulation and a single shame stimulation are administered in a random order for each participant (cross-over study).

lead_sponsor: Nantes University Hospital


title: Reproducibility of Plasma Nucleosomes and Free DNA as Markers for Venous Thromboembolism

summary: The main objective of this study is to evaluate, for 15 healthy volunteers and for 15 patients with a history of venous thromboembolism (VTE), the monthly variation (over 6 months) of plasma nucleosome and free DNA concentrations.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Role of Proteasomes in a Dermatological Autoimmune Disease: Bullous Pemphigoid

summary: The primary objective of this study is to describe and compare plasmatic anti-proteasome auto-antibody concentrations among three distinct groups: (1) patients suffering from bullous pemphigoide; (2) patients suffering from other dermatological auto-immune diseases; (3) an elderly control group.

time_perspective: Cross-Sectional


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.

location_facility: Hospices Civils de Lyon- Centre Hospitalier Lyon Sud


title: Estimate the Efficiency of the Association of an Injection of Ketamine and the Venlafaxine in the Severe Major Depressive Disorder for Six Weeks.

acronym: KETADEP

summary: The objective of this study is to evaluate the effectiveness of ketamine (infusion of 0.5mg/kg) and venlafaxine compared to the use of venlafaxine alone in the treatment of major depression (MADRS score ≥ 20 ) to six weeks of treatment.


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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ReferenceCitation: Fessler HE, Brower RG, Wise RA, Permutt S. Effects of positive end-expiratory pressure on the canine venous return curve. Am Rev Respir Dis. 1992 Jul;146(1):4-10.

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ReferenceCitation: Versprille A. The pulmonary circulation during mechanical ventilation. Acta Anaesthesiol Scand Suppl. 1990;94:51-62. Review.

ReferenceCitation: Brower R, Wise RA, Hassapoyannes C, Bromberger-Barnea B, Permutt S. Effect of lung inflation on lung blood volume and pulmonary venous flow. J Appl Physiol (1985). 1985 Mar;58(3):954-63.

ReferenceCitation: Vieillard-Baron A, Chergui K, Augarde R, Prin S, Page B, Beauchet A, Jardin F. Cyclic changes in arterial pulse during respiratory support revisited by Doppler echocardiography. Am J Respir Crit Care Med. 2003 Sep 15;168(6):671-6. Epub 2003 Jul 17.

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ReferenceCitation: Abel JG, Salerno TA, Panos A, Greyson ND, Rice TW, Teoh K, Lichtenstein SV. Cardiovascular effects of positive pressure ventilation in humans. Ann Thorac Surg. 1987 Feb;43(2):198-206.

ReferenceCitation: Fessler HE, Brower RG, Wise RA, Permutt S. Mechanism of reduced LV afterload by systolic and diastolic positive pleural pressure. J Appl Physiol (1985). 1988 Sep;65(3):1244-50.

ReferenceCitation: Ferguson ND, Fan E, Camporota L, Antonelli M, Anzueto A, Beale R, Brochard L, Brower R, Esteban A, Gattinoni L, Rhodes A, Slutsky AS, Vincent JL, Rubenfeld GD, Thompson BT, Ranieri VM. The Berlin definition of ARDS: an expanded rationale, justification, and supplementary material. Intensive Care Med. 2012 Oct;38(10):1573-82. Epub 2012 Aug 25. Erratum in: Intensive Care Med. 2012 Oct;38(10):1731-2.

ReferenceCitation: Acute Respiratory Distress Syndrome Network, Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8.

ReferenceCitation: Gattinoni L, Pesenti A. The concept of "baby lung". Intensive Care Med. 2005 Jun;31(6):776-84. Epub 2005 Apr 6.

ReferenceCitation: Lachmann B. Open up the lung and keep the lung open. Intensive Care Med. 1992;18(6):319-21.

ReferenceCitation: Bond DM, McAloon J, Froese AB. Sustained inflations improve respiratory compliance during high-frequency oscillatory ventilation but not during large tidal volume positive-pressure ventilation in rabbits. Crit Care Med. 1994 Aug;22(8):1269-77.

ReferenceCitation: Fujino Y, Goddon S, Dolhnikoff M, Hess D, Amato MB, Kacmarek RM. Repetitive high-pressure recruitment maneuvers required to maximally recruit lung in a sheep model of acute respiratory distress syndrome. Crit Care Med. 2001 Aug;29(8):1579-86.

ReferenceCitation: Lu Q, Capderou A, Cluzel P, Mourgeon E, Abdennour L, Law-Koune JD, Straus C, Grenier P, Zelter M, Rouby JJ. A computed tomographic scan assessment of endotracheal suctioning-induced bronchoconstriction in ventilated sheep. Am J Respir Crit Care Med. 2000 Nov;162(5):1898-904.

ReferenceCitation: Richard JC, Maggiore SM, Jonson B, Mancebo J, Lemaire F, Brochard L. Influence of tidal volume on alveolar recruitment. Respective role of PEEP and a recruitment maneuver. Am J Respir Crit Care Med. 2001 Jun;163(7):1609-13.

ReferenceCitation: Claesson J, Lehtipalo S, Winsö O. Do lung recruitment maneuvers decrease gastric mucosal perfusion? Intensive Care Med. 2003 Aug;29(8):1314-21. Epub 2003 Jul 8.

ReferenceCitation: Bein T, Kuhr LP, Bele S, Ploner F, Keyl C, Taeger K. Lung recruitment maneuver in patients with cerebral injury: effects on intracranial pressure and cerebral metabolism. Intensive Care Med. 2002 May;28(5):554-8. Epub 2002 Apr 12.

ReferenceCitation: Fan E, Wilcox ME, Brower RG, Stewart TE, Mehta S, Lapinsky SE, Meade MO, Ferguson ND. Recruitment maneuvers for acute lung injury: a systematic review. Am J Respir Crit Care Med. 2008 Dec 1;178(11):1156-63. doi: 10.1164/rccm.200802-335OC. Epub 2008 Sep 5. Review.

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ReferenceCitation: Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010.

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ReferenceCitation: Bleeker GB, Steendijk P, Holman ER, Yu CM, Breithardt OA, Kaandorp TA, Schalij MJ, van der Wall EE, Nihoyannopoulos P, Bax JJ. Assessing right ventricular function: the role of echocardiography and complementary technologies. Heart. 2006 Apr;92 Suppl 1:i19-26. Review.

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title: Randomized, Single Blind Study Comparing the Effect of Intermittent Versus Continuous Subglottic Secretion Drainage on Tracheal Mucosa Damages in Intensive Care Patients Requiring Prolonged Mechanical Ventilation

acronym: ASPIRE

summary: Endotracheal tubes with subglottic secretion drainage (incorporating a suction port above the cuff) have been shown to reduce the incidence of ventilator-associated pneumonia. Subglottic secretion drainage can be either continuous or intermittent. However, concerns about the safety of continuous subglottic secretion drainage were raised in an experimental study in sheep, which found widespread injuries to tracheal mucosa and/or submucosa. Our objective is therefore to compare intermittent versus continuous subglottic secretion drainage on tracheal mucosa damages in patients requiring mechanical ventilation for an expected duration of more than 24 hours.

ReferenceCitation: Seguin P, Perrichet H, Pabic EL, Launey Y, Tiercin M, Corre R, Brinchault G, Laviolle B. Effect of Continuous versus Intermittent Subglottic Suctioning on Tracheal Mucosa by the Mallinckrodt TaperGuard Evac Oral Tracheal Tube in Intensive Care Unit Ventilated Patients: A Prospective Randomized Study. Indian J Crit Care Med. 2018 Jan;22(1):1-4. doi: 10.4103/ijccm.IJCCM_350_17.

family: Seguin

full_name: Philippe Seguin

given: Philippe

family: Perrichet

full_name: Harmonie Perrichet

given: Harmonie

family: Pabic

full_name: Estelle Pabic

given: Estelle

family: Launey

full_name: Yoann Launey

given: Yoann

family: Tiercin

full_name: Marie Tiercin

given: Marie

family: Corre

full_name: Romain Corre

given: Romain

family: Brinchault

full_name: Graziella Brinchault

given: Graziella

family: Laviolle

full_name: Bruno Laviolle

given: Bruno

journal_name: Indian Journal of Critical Care Medicine

licence_repositories: cc-by-nc-nd cc-by-nc-sa

oa_colors: green other

oa_host_type: publisher;repository

evidence: oa journal (via observed oa rate)

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

host_type: repository

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_normalized: HAL

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories:
HAL
PubMed Central

publisher: Jaypee Brothers Medical Publishing

publisher_dissemination: Jaypee Brothers Medical Publishing

publisher_group: Jaypee Brothers Medical Publishing

publisher_normalized: Jaypee Brothers Medical Publishing

title: Effect of continuous versus intermittent subglottic suctioning on tracheal mucosa by the mallinckrodt taperguard evac oral tracheal tube in intensive care unit ventilated patients: A prospective randomized study

lead_sponsor: Rennes University Hospital

location_facility: Service de Réanimation Chirurgicale, Hôpital de Pontchaillou


title: Pharmacodynamic and Pharmacokinetic Assessment of Treprostinil Iontophoresis on the Forearm and the Fingers

acronym: TIPPS

summary: The purpose of the study is to assess skin blood flow after non-invasive local administration of treprostinil by using a low-intensity current (i.e. iontophoresis) on the forearm and the fingers of healthy volunteers and patients with systemic sclerosis. The investigators also aim at assessing the systemic bioavailability and dermal diffusion of treprostinil iontophoresis.

ReferenceCitation: Blaise S, Roustit M, Millet C, Ribuot C, Boutonnat J, Cracowski JL. Cathodal iontophoresis of treprostinil and iloprost induces a sustained increase in cutaneous flux in rats. Br J Pharmacol. 2011 Feb;162(3):557-65. doi: 10.1111/j.1476-5381.2010.01045.x.

ReferenceCitation: Cracowski JL, Minson CT, Salvat-Melis M, Halliwill JR. Methodological issues in the assessment of skin microvascular endothelial function in humans. Trends Pharmacol Sci. 2006 Sep;27(9):503-8. Epub 2006 Jul 31. Review.

ReferenceCitation: Herrick AL. Vascular function in systemic sclerosis. Curr Opin Rheumatol. 2000 Nov;12(6):527-33. Review.

ReferenceCitation: Kalia YN, Naik A, Garrison J, Guy RH. Iontophoretic drug delivery. Adv Drug Deliv Rev. 2004 Mar 27;56(5):619-58. Review.

ReferenceCitation: Murray AK, Moore TL, King TA, Herrick AL. Vasodilator iontophoresis a possible new therapy for digital ischaemia in systemic sclerosis? Rheumatology (Oxford). 2008 Jan;47(1):76-9.

ReferenceCitation: Gaillard-Bigot F, Roustit M, Jourdil JF, Stanke-Labesque F, Cracowski JL. Vascular Effects of Treprostinil Cutaneous Iontophoresis on the Leg, Finger, and Foot. J Clin Pharmacol. 2017 Sep;57(9):1215-1220. doi: 10.1002/jcph.898. Epub 2017 Apr 7.

name: Inserm CIC1406; Clinical Pharmacology Department; Grenoble Alps University Hospital; Grenoble France

family: Gaillard-Bigot

full_name: Florence Gaillard-Bigot

given: Florence

family: Roustit

full_name: Matthieu Roustit

given: Matthieu

name: Laboratory of Pharmacology; Grenoble Alps University Hospital; Grenoble France

family: Jourdil

full_name: Jean-François Jourdil

given: Jean-François

family: Stanke-Labesque

full_name: Françoise Stanke-Labesque

given: Françoise

family: Cracowski

full_name: Jean-Luc Cracowski

given: Jean-Luc

bso_classification: Chemistry

journal_name: The Journal of Clinical Pharmacology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

location_facility: CIC pharmacology - University Hopsital of Grenoble


title: Effect of Early Upper Arm Rehabilitation After Stroke Using Adaptative Video Games

acronym: MARGAUT

summary: The purpose of this study is to assess the efficiency of occupational therapy enhanced by "dedicated adaptative video games" in rehabilitation of the upper arm of stroke patients in the acute phase after their cerebro-vascular accident. Our hypothesis is that occupational therapy enhanced by dedicated adaptative video games is more efficient in improving motor recovery of the upper arm than conventional occupational therapy alone.

ReferenceCitation: Laffont I, Froger J, Jourdan C, Bakhti K, van Dokkum LEH, Gouaich A, Bonnin HY, Armingaud P, Jaussent A, Picot MC, Le Bars E, Dupeyron A, Arquizan C, Gelis A, Mottet D. Rehabilitation of the upper arm early after stroke: Video games versus conventional rehabilitation. A randomized controlled trial. Ann Phys Rehabil Med. 2020 May;63(3):173-180. doi: 10.1016/j.rehab.2019.10.009. Epub 2019 Dec 9.

family: Laffont

full_name: Isabelle Laffont

given: Isabelle

family: Froger

full_name: Jerome Froger

family: Jourdan

full_name: Claire Jourdan

given: Claire

family: Bakhti

full_name: Karima Bakhti

given: Karima

family: van Dokkum

full_name: Liesjet E.H. van Dokkum

given: Liesjet E.H.

family: Gouaich

full_name: Abdelkader Gouaich

given: Abdelkader

family: Bonnin

full_name: Huei Yune Bonnin

given: Huei Yune

family: Armingaud

full_name: Philippe Armingaud

family: Jaussent

full_name: Audrey Jaussent

given: Audrey

family: Picot

full_name: Marie Christine Picot

given: Marie Christine

family: Le Bars

full_name: Emmanuelle Le Bars

given: Emmanuelle

family: Dupeyron

full_name: Arnaud Dupeyron

given: Arnaud

family: Arquizan

full_name: Caroline Arquizan

given: Caroline

family: Gelis

full_name: Anthony Gelis

given: Anthony

family: Mottet

full_name: Denis Mottet

given: Denis

journal_name: Annals of Physical and Rehabilitation Medicine

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

lead_sponsor: University Hospital, Montpellier


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, François E, Plassot C, Phelip JM, Miglianico L, Dourthe LM, Bonichon N, Moreau L, Guimbaud R, Smith D, Achille E, Hervé R, Bons JM, Remy S, Faroux R, Villing AL, Mahamat A, Rabbia I, Soulié P, Baumgaertner I, Mathé 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.

family: Mineur

full_name: L. Mineur

given: L.

family: François

full_name: E. François

given: E.

family: Plassot

full_name: C. Plassot

given: C.

family: Phelip

full_name: J. M. Phelip

given: J. M.

family: Miglianico

full_name: L. Miglianico

family: Dourthe

full_name: L. M. Dourthe

given: L. M.

family: Bonichon

full_name: N. Bonichon

given: N.

family: Moreau

full_name: L. Moreau

family: Guimbaud

full_name: R. Guimbaud

given: R.

family: Smith

full_name: D. Smith

given: D.

family: Achille

full_name: E. Achille

family: Hervé

full_name: R. Hervé

family: Bons

full_name: J. M. Bons

family: Remy

full_name: S. Remy

given: S.

family: Faroux

full_name: R. Faroux

family: Villing

full_name: A. L. Villing

given: A. L.

family: Mahamat

full_name: A. Mahamat

given: A.

family: Rabbia

full_name: I. Rabbia

given: I.

family: Soulié

full_name: P. Soulié

given: P.

family: Baumgaertner

full_name: I. Baumgaertner

family: Mathé

full_name: N. Mathé

family: Vazquez

full_name: L. Vazquez

family: Boustany

full_name: R. Boustany

currency_apc_doaj: USD


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.

family: Neuzillet

full_name: Yann Neuzillet

given: Yann

family: Methorst

full_name: Charlotte Methorst

given: Charlotte

family: Schneider

full_name: Marc Schneider

given: Marc

family: Lebret

full_name: Thierry Lebret

given: Thierry

family: Rouanne

full_name: Mathieu Rouanne

given: Mathieu

family: Radulescu

full_name: Camelia Radulescu

given: Camelia

family: Molinie

full_name: Vincent Molinie

given: Vincent

family: Dreyfus

full_name: Jean-François Dreyfus

given: Jean-François

family: Pelcat

full_name: Veronique Pelcat

given: Veronique

family: Botto

full_name: Henry Botto

given: Henry

journal_name: Urologic Oncology: Seminars and Original Investigations

title: Assessment of diagnostic gain with hexaminolevulinate (HAL) in the setting of newly diagnosed non–muscle-invasive bladder cancer with positive results on urine cytology

lead_sponsor: Hopital Foch


title: Interests of Strengthening Isokinetic Upper Extremity Hemiparetic Sequelae in Patients

summary:
Stroke (CVA) is the leading cause of death and the leading cause of disability in developed countries as in developing countries (WHO, 2000). In the aftermath of a stroke, patients keep a permanent disability in 75% of cases and only one quarter of them is able to resume work. The post stroke sequelae are sensory-motor and cognitive.

According to literature data, 75-83% of patients who survive a stroke learn to walk only 25 to 45% recover use of their upper limb in activities of daily living (Friedman, 1990).

The existence of a phase called "plateau" in motor recovery after stroke has been suggested (Colautti, 2001). This would occur beyond the 4 th month and would correspond to a phase where the rehabilitation techniques used in the subacute phase are deemed less effective. Recently, Page (2004) speculated that this plateau phase is rather the consequence of adaptation to the type of patient follow-up training and not that of a limit to the possibilities of recovery. In an observational study on the recovery of upper limb conducted over a period of 4 years, Broeks (2004) showed a possible recovery beyond 16 weeks post stroke. The results of studies on different techniques for rehabilitation of chronic stroke patients tend to confirm the hypothesis of page. Therefore, varying the training parameters (type, intensity, frequency) could improve the functional capabilities of these patients, even at a distance of stroke.

Strength training is part of the management of hemiparetic patients. The results of several studies show an improvement in muscle strength and functional ability to walk after a building program isokinetic lower limb (Sharp, 1997).

The objective of our project is to evaluate the effectiveness of a building program of isokinetic muscle on the paretic limb motor recovery in hemiparetic patients over 6 months of a stroke.

ReferenceCitation: Coroian F, Jourdan C, Bakhti K, Palayer C, Jaussent A, Picot MC, Mottet D, Julia M, Bonnin HY, Laffont I. Upper Limb Isokinetic Strengthening Versus Passive Mobilization in Patients With Chronic Stroke: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Feb;99(2):321-328. doi: 10.1016/j.apmr.2017.08.490. Epub 2017 Sep 22.

family: Coroian

full_name: Flavia Coroian

given: Flavia

family: Jourdan

full_name: Claire Jourdan

given: Claire

family: Bakhti

full_name: Karima Bakhti

given: Karima

family: Palayer

full_name: Claire Palayer

family: Jaussent

full_name: Audrey Jaussent

given: Audrey

family: Picot

full_name: Marie-Christine Picot

given: Marie-Christine

family: Mottet

full_name: Denis Mottet

given: Denis

family: Julia

full_name: Marc Julia

family: Bonnin

full_name: Huey-Yune Bonnin

given: Huey-Yune

family: Laffont

full_name: Isabelle Laffont

given: Isabelle

journal_name: Archives of Physical Medicine and Rehabilitation

location_facility: Service de médecine Physique et de Réadaptation


title: Physical Trainig and Cognitive Activity on the MCI Patient

acronym: EPAC-M

summary:
Regular physical activity is now recognized as a key element of good physical and mental health and this all ages.

MAIN GOAL : Evaluate the effectiveness of physical training associated with a cognitive training in improving the cognitive function of patients diagnosed with Mild Cognitive Impairment (MCI).

DESIGN : Controlled randomized monocentric and prospective study with clinical benefit for the patient with three groups : one physical training and cognitive exercise group, one physical training without cognitive exercise group and one control group.

In agreement with the literature on the effects of physiological stress on cognitive performance, the investigators expect the best cognitive test scores in groups with exercise training compared with controls (35% versus 80% error), and better scores on the MMSE, IALD, depression Scale, Index of Pittsburg sleep quality and quality of Life Questionnaire. Furthermore the investigators hypothesize that this positive effect is greater in the physical training and cognitive exercise group compared with the physical training group only.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: A Phase 1, Randomized, Double-blind, Placebo- and Positive-controlled, 4-Period Crossover Trial to Assess the Effect of Anagrelide Hydrochloride on QT/QTc Interval in Healthy Men and Women.

summary: According to the ICH Guidance Document E14, all non-antiarrhythmic drugs should be evaluated for their ability to prolong the QT interval which represents the duration of ventricular depolarization and subsequent repolarization. The primary objective of the study is to assess the effect of anagrelide on QT/QTc interval following a therapeutic and supratherapeutic dose of anagrelide when compared to placebo and a positive control.

lead_sponsor: Shire


title: Medico-economic Evaluation Comparing the Use of Ultrasonic Scissors to the Conventional Techniques of Haemostasis in Thyroid Surgery by Cervicotomy

acronym: FOThyr

summary: The aim of our study is to evaluate the ultrasonic scissors (Harmonic Focus Ethicon Endo-Surgery Laboratory) as a device of hemostasis in thyroid surgery (total thyroidectomy) by cervicotomy, and to show a decrease in transient hypoparathyroidism compared to conventional techniques of haemostasis (clips, ligatures, and bipolar coagulation). Secondary objectives of the study are the evaluation of (i) recurrent nerve morbidity, (ii) postoperative bleeding, (iii) postoperative pain, (iv) cost of both techniques (microcosting), (v) the overall cost of the techniques at six months, (vi) a linking of costs and medical outcomes and (vii) an estimation of the potential impact of new technology on the organization of operating rooms (operating time).

ReferenceCitation: Christou N, Blanchard C, Pattou F, Volteau C, Brunaud L, Hamy A, Dahan M, Prades JM, Landecy G, Dernis HP, Lifante JC, Sebag F, Jegoux F, Babin E, Bizon A, Caillard C, Mathonnet M, Mirallié E. Advanced age does not increase morbidity after total thyroidectomy. Result of a prospective study. Am J Surg. 2019 Apr;217(4):767-771. doi: 10.1016/j.amjsurg.2018.07.029. Epub 2018 Jul 25.

family: Christou

full_name: Niki Christou

given: Niki

family: Blanchard

full_name: Claire Blanchard

family: Pattou

full_name: François Pattou

given: François

family: Volteau

full_name: Christelle Volteau

given: Christelle

family: Brunaud

full_name: Laurent Brunaud

given: Laurent

family: Hamy

full_name: Antoine Hamy

given: Antoine

family: Dahan

full_name: Marcel Dahan

given: Marcel

family: Prades

full_name: Jean-Michel Prades

given: Jean-Michel

family: Landecy

full_name: Gérard Landecy

given: Gérard

family: Dernis

full_name: Henri-Pierre Dernis

given: Henri-Pierre

family: Lifante

full_name: Jean-Christophe Lifante

given: Jean-Christophe

family: Sebag

full_name: Fréderic Sebag

given: Fréderic

family: Jegoux

full_name: Franck Jegoux

given: Franck

family: Babin

full_name: Emmanuel Babin

given: Emmanuel

family: Bizon

full_name: Alain Bizon

given: Alain

family: Caillard

full_name: Cécile Caillard

given: Cécile

family: Mathonnet

full_name: Muriel Mathonnet

given: Muriel

family: Mirallié

full_name: Eric Mirallié

given: Eric

journal_name: The American Journal of Surgery

ReferenceCitation: Blanchard C, Pattou F, Brunaud L, Hamy A, Dahan M, Mathonnet M, Volteau C, Caillard C, Durand-Zaleski I, Mirallié E; FOThyr Group. Randomized clinical trial of ultrasonic scissors versus conventional haemostasis to compare complications and economics after total thyroidectomy (FOThyr). BJS Open. 2017 May 9;1(1):2-10. doi: 10.1002/bjs5.2. eCollection 2017 Feb.

name: Clinique de Chirurgie Digestive et Endocrinienne; Centre Hospitalier Universitaire (CHU) de Nantes; Nantes France

full_name: C. Blanchard

given: C.

name: Chirurgie Générale et Endocrinienne, CHU Lille; Université de Lille; Lille France

full_name: F. Pattou

given: F.

name: Service de Chirurgie Digestive, Hépato-Biliaire et Endocrinienne; CHU Nancy - Hôpital de Brabois; Nancy France

full_name: L. Brunaud

name: Chirurgie Digestive et Endocrinienne; CHU Angers; Angers France

name: Chirurgie Thoracique, Pôle Voies Respiratoires; CHU de Toulouse - Hôpital Larrey; Toulouse France

name: Chirurgie Digestive, Générale et Endocrinienne; CHU de Limoges - Hôpital Dupuytren; Limoges France

name: Département Promotion; Délégation à la Recherche Clinique et à l'Innovation; Nantes France

name: Assistance Publique - Hôpitaux de Paris Unité de Recherche Clinique en Économie de la Santé d'Île-de-France; Hôpital de l'Hôtel-Dieu; Paris France

title: Randomized clinical trial of ultrasonic scissorsversusconventional haemostasis to compare complications and economics after total thyroidectomy (FOThyr)


title: Assessment of an Automated Telesurveillance System on the Incidence of Serious Falls in Nursing Homes

acronym: TELEHPAD

summary: 3 Nursing homes in the Limousin region will be equipped with the automated telesurveillance system. Patient will be selected by general practitioner and randomized into two groups after informed consent. One group will have cameras installed and the other will not and will act as a comparison group. Patient will be assessed three times during the study, at inclusion, 6 months and 12 months. Each assessment is composed of a standard geriatric assessment, a fall questionnaire, an autonomy scale (SMAF scale) and a quality of life questionnaire (EQ5D). Every falls will be considered as adverse events and will therefore be listed along the study and characterized in types and number.

lead_sponsor: University Hospital, Limoges


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.

family: Moustafa

full_name: Farès Moustafa

given: Farès

family: Dopeux

full_name: Loïc Dopeux

given: Loïc

family: Mulliez

full_name: Aurelien Mulliez

given: Aurelien

family: Boirie

full_name: Yves Boirie

given: Yves

family: Morand

full_name: Christine Morand

given: Christine

family: Gentes

full_name: Elodie Gentes

given: Elodie

family: Farigon

full_name: Nicolas Farigon

given: Nicolas

family: Richard

full_name: Damien Richard

given: Damien

family: Lebreton

full_name: Aurélien Lebreton

given: Aurélien

family: Teissandier

full_name: Dorian Teissandier

given: Dorian

family: Dutheil

full_name: Frederic Dutheil

given: Frederic

family: Schmidt

full_name: Jeannot Schmidt

given: Jeannot

journal_name: Clinical Nutrition

oa_host_type: repository

version: submittedVersion

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

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


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.

primary_purpose: Supportive Care

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier universitaire de Besançon


title: Impact of Tomotherapy on Xerostomia and Quality of Life of Patients With Cancer of the Upper Aero-digestive Tract

acronym: TOQUAL

summary: This is a study whose main objective is to evaluate prospectively the proportion of patients with severe xerostomia one year after treatment with tomotherapy for head and neck cancer.

lead_sponsor: Centre Francois Baclesse

intervention_type: Radiation


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.

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.

ReferenceCitation: Bourdaud N, François 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.

family: Bourdaud

full_name: N Bourdaud

given: N

family: François

full_name: C François

given: C

family: Jacqmarcq

full_name: O Jacqmarcq

given: O

family: Guye

full_name: M.-L. Guye

family: Jean

full_name: J Jean

given: J

family: Studer

full_name: C Studer

family: Engrand-Donal

full_name: C Engrand-Donal

family: Devys

full_name: J.-M. Devys

family: Boutin

full_name: F Boutin

given: F

family: Guyot

full_name: E Guyot

given: E

family: Bouazza

full_name: N Bouazza

family: Treluyer

full_name: J.-M. Treluyer

family: Orliaguet

full_name: G. A Orliaguet

given: G. A

journal_name: British Journal of Anaesthesia

lead_sponsor: Assistance Publique - Hôpitaux de Paris

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

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.


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).

lead_sponsor: Hospices Civils de Lyon

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

primary_purpose: Health Services Research

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, 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.

name: Department of Haematology CHU Nimes Univ Montpellier Nîmes France

name: Research Laboratory UPRES EA 2992 Montpellier University France

name: Faculty of Pharmaceutical and Biological Sciences Montpellier University France

family: Bouvier

full_name: Sylvie Bouvier

given: Sylvie

name: Department of Gynaecology and Obstetrics CHU Nimes Univ Montpellier Nîmes France

family: Mousty

full_name: Eve Mousty

given: Eve

family: Fortier

full_name: Mathieu Fortier

given: Mathieu

name: Department of Biostatistics, Epidemiology, Public Health and Innovation in Methodology CHU Nimes Univ Montpellier Nîmes France

family: Demattei

full_name: Christophe Demattei

given: Christophe

family: Mercier

full_name: Eric Mercier

given: Eric

family: Nouvellon

full_name: Eva Nouvellon

given: Eva

family: Chea

full_name: Mathias Chea

given: Mathias

family: Grosjean

full_name: Frédéric Grosjean

given: Frédéric

name: Department of Artificial Polymers Max Mousseron Institute of Biomolecules CNRS UMR 5247 Univ Montpellier Montpellier France

family: Letouzey

full_name: Vincent Letouzey

given: Vincent

name: I.M. Sechenov First Moscow State Medical University Moscow Russian Federation

family: Gris

full_name: Jean‐Christophe Gris

given: Jean‐Christophe

bso_classification: Biology (fond.)

journal_name: Journal of Thrombosis and Haemostasis

title: Placenta‐mediated complications: Nucleosomes and free DNA concentrations differ depending on subtypes


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.


title: Randomized, Monocentric and Multidisciplinary Study of the Effects of an Intensive Rehabilitation by Interval Training With Active Recovery in Peripheral Arterial Disease With Claudication

acronym: ARTEX

summary:
Rehabilitation is the first intention treatment of peripheral arterial disease (PAD) with claudication. Initially proposed in the sixty's, rehabilitation programs dedicated to patients with PAD have recently been proved effective and defined in many guidelines. Supervised walking training on treadmill is recommended. Usually patients walk up to a mild or moderate pain (evaluated at 3 or 4 on the claudication pain scale; maximum pain =5), then stop until pain completely subsides and walk again .

The Artex study assesses the efficacy of a fractionated mode of training avoiding pain by alternating short sequences of intensive training and active recovery (without rest).

ReferenceCitation: Villemur B, Marquer A, Gailledrat E, Benetreau C, Bucci B, Evra V, Rabeau V, De Angelis MP, Bouchet JY, Carpentier P, Pérennou D. New rehabilitation program for intermittent claudication: Interval training with active recovery: pilot study. Ann Phys Rehabil Med. 2011 Jul;54(5):275-81. doi: 10.1016/j.rehab.2011.05.003. Epub 2011 Jun 12. English, French.

ReferenceCitation: Tisi PV, Hulse M, Chulakadabba A, Gosling P, Shearman CP. Exercise training for intermittent claudication: does it adversely affect biochemical markers of the exercise-induced inflammatory response? Eur J Vasc Endovasc Surg. 1997 Nov;14(5):344-50.

ReferenceCitation: Strandness DE Jr. Exercise testing in the evaluation of patients undergoint direct arterial surgery. J Cardiovasc Surg (Torino). 1970 May-Jun;11(3):192-200.

ReferenceCitation: Spinhoven P, Ormel J, Sloekers PP, Kempen GI, Speckens AE, Van Hemert AM. A validation study of the Hospital Anxiety and Depression Scale (HADS) in different groups of Dutch subjects. Psychol Med. 1997 Mar;27(2):363-70.

ReferenceCitation: Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29.

ReferenceCitation: Nicolaï SP, Viechtbauer W, Kruidenier LM, Candel MJ, Prins MH, Teijink JA. Reliability of treadmill testing in peripheral arterial disease: a meta-regression analysis. J Vasc Surg. 2009 Aug;50(2):322-9. doi: 10.1016/j.jvs.2009.01.042.

ReferenceCitation: Meijer WT, Hoes AW, Rutgers D, Bots ML, Hofman A, Grobbee DE. Peripheral arterial disease in the elderly: The Rotterdam Study. Arterioscler Thromb Vasc Biol. 1998 Feb;18(2):185-92.

ReferenceCitation: McDermott MM, Ades P, Guralnik JM, Dyer A, Ferrucci L, Liu K, Nelson M, Lloyd-Jones D, Van Horn L, Garside D, Kibbe M, Domanchuk K, Stein JH, Liao Y, Tao H, Green D, Pearce WH, Schneider JR, McPherson D, Laing ST, McCarthy WJ, Shroff A, Criqui MH. Treadmill exercise and resistance training in patients with peripheral arterial disease with and without intermittent claudication: a randomized controlled trial. JAMA. 2009 Jan 14;301(2):165-74. doi: 10.1001/jama.2008.962. Erratum in: JAMA. 2012 Apr 25;307(16):1694.

ReferenceCitation: Le Faucheur A, Abraham P, Jaquinandi V, Bouyé P, Saumet JL, Noury-Desvaux B. Measurement of walking distance and speed in patients with peripheral arterial disease: a novel method using a global positioning system. Circulation. 2008 Feb 19;117(7):897-904. doi: 10.1161/CIRCULATIONAHA.107.725994. Epub 2008 Feb 4.

ReferenceCitation: Lechat P, Priollet P. [Prevention of major ischemic events in lower limb arterial disease: does aspirin play a role?]. J Mal Vasc. 2006 Jul;31(3):129-34. French.

ReferenceCitation: Kruidenier LM, Nicolaï SP, Hendriks EJ, Bollen EC, Prins MH, Teijink JA. Supervised exercise therapy for intermittent claudication in daily practice. J Vasc Surg. 2009 Feb;49(2):363-70. doi: 10.1016/j.jvs.2008.09.042. Epub 2008 Nov 22.

ReferenceCitation: Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. 2006 Mar 21;113(11):e463-654. Review.

ReferenceCitation: Harvey SB, Hotopf M, Overland S, Mykletun A. Physical activity and common mental disorders. Br J Psychiatry. 2010 Nov;197(5):357-64. doi: 10.1192/bjp.bp.109.075176.

ReferenceCitation: Montgomery PS, Gardner AW. The clinical utility of a six-minute walk test in peripheral arterial occlusive disease patients. J Am Geriatr Soc. 1998 Jun;46(6):706-11.

ReferenceCitation: Gardner AW, Skinner JS, Smith LK. Effects of handrail support on claudication and hemodynamic responses to single-stage and progressive treadmill protocols in peripheral vascular occlusive disease. Am J Cardiol. 1991 Jul 1;68(1):99-105.

ReferenceCitation: Gardner AW, Katzel LI, Sorkin JD, Goldberg AP. Effects of long-term exercise rehabilitation on claudication distances in patients with peripheral arterial disease: a randomized controlled trial. J Cardiopulm Rehabil. 2002 May-Jun;22(3):192-8.

ReferenceCitation: Gardner AW, Poehlman ET. Exercise rehabilitation programs for the treatment of claudication pain. A meta-analysis. JAMA. 1995 Sep 27;274(12):975-80.

ReferenceCitation: Gardner AW, Skinner JS, Cantwell BW, Smith LK. Progressive vs single-stage treadmill tests for evaluation of claudication. Med Sci Sports Exerc. 1991 Apr;23(4):402-8.

ReferenceCitation: Gardner AW, Poehlman ET. Assessment of free-living daily physical activity in older claudicants: validation against the doubly labeled water technique. J Gerontol A Biol Sci Med Sci. 1998 Jul;53(4):M275-80.

ReferenceCitation: Fife CE, Smart DR, Sheffield PJ, Hopf HW, Hawkins G, Clarke D. Transcutaneous oximetry in clinical practice: consensus statements from an expert panel based on evidence. Undersea Hyperb Med. 2009 Jan-Feb;36(1):43-53.

ReferenceCitation: Crowther RG, Spinks WL, Leicht AS, Quigley F, Golledge J. Relationship between temporal-spatial gait parameters, gait kinematics, walking performance, exercise capacity, and physical activity level in peripheral arterial disease. J Vasc Surg. 2007 Jun;45(6):1172-8.

ReferenceCitation: Bruce RA, Kusumi F, Hosmer D. Maximal oxygen intake and nomographic assessment of functional aerobic impairment in cardiovascular disease. Am Heart J. 1973 Apr;85(4):546-62.

ReferenceCitation: Bronas UG, Hirsch AT, Murphy T, Badenhop D, Collins TC, Ehrman JK, Ershow AG, Lewis B, Treat-Jacobson DJ, Walsh ME, Oldenburg N, Regensteiner JG; CLEVER Research Group. Design of the multicenter standardized supervised exercise training intervention for the claudication: exercise vs endoluminal revascularization (CLEVER) study. Vasc Med. 2009 Nov;14(4):313-21. doi: 10.1177/1358863X09102295.

ReferenceCitation: Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. Review.

ReferenceCitation: Baker JD, Dix DE. Variability of Doppler ankle pressures with arterial occlusive disease: an evaluation of ankle index and brachial-ankle pressure gradient. Surgery. 1981 Jan;89(1):134-7.

ReferenceCitation: ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. Erratum in: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.

ReferenceCitation: Villemur B, Thoreau V, Guinot M, Gailledrat E, Evra V, Vermorel C, Foote A, Carpentier P, Bosson JL, Pérennou D. Short interval or continuous training programs to improve walking distance for intermittent claudication: Pilot study. Ann Phys Rehabil Med. 2020 Nov;63(6):466-473. doi: 10.1016/j.rehab.2020.03.004. Epub 2020 Apr 6.

family: Villemur

full_name: Béatrice Villemur

given: Béatrice

family: Thoreau

full_name: Valérie Thoreau

given: Valérie

family: Guinot

full_name: Michel Guinot

given: Michel

family: Gailledrat

full_name: Elodie Gailledrat

given: Elodie

family: Evra

full_name: Véronique Evra

given: Véronique

family: Vermorel

full_name: Céline Vermorel

given: Céline

family: Foote

full_name: Alison Foote

given: Alison

family: Carpentier

full_name: Patrick Carpentier

given: Patrick

family: Bosson

full_name: Jean-Luc Bosson

given: Jean-Luc

family: Pérennou

full_name: Dominic Pérennou

given: Dominic

evidence: open (via free article)

lead_sponsor: University Hospital, Grenoble

location_facility: CHU Grenoble - Hôpital Sud - Clinique médecine physique de rééducation


title: Discontinued Administration (6 Months a Year) of Growth Hormone to Children With Very Short Stature and Having Suffered From Intrauterine Growth Retardation: Safety and Effect on Growth of Long-term Therapy

summary: This trial is conducted in Europe. The aim of this trial is to assess the safety of long-term growth hormone treatment in growth-retarded children with intrauterine growth retardation (IUGR) enrolled in trial GHRETARD/F/1/F.

lead_sponsor: Novo Nordisk A/S


title: Molecular Mechanism Identification in Inherited Arrhythmias and Valvulopathies From Induced Pluripotent Stem Cells

acronym: Diag-iPS

summary: The recent developments of research on iPS (induced pluripotent stem) cells lead to the establishment of mature cell lines such as cardiomyocytes or valvular interstitial cells with genetic and cellular characteristics of the donors. These cells represent a biological material more readily available to identify the pathophysiological mechanisms involved in the diseases of BrS or ERS patients, which will lead to the identification of genetic markers.

lead_sponsor: Nantes University Hospital


title: Behavioural Addictions Occurring During a Dopaminergic Treatment Prescribe Under Parkinson's Disease: Study of the Psychopathological, Neurological, Pharmacokinetic and Genetic Profiles.

acronym: PARKADD

summary:
This study is composed of a main study and an ancillary one. The objective of the main study is to define, on the psychopathological, neurological, pharmacokinetic and genetic plan, the predictive factors for developing a behavioural addiction (BA) secondarily to the dopaminergic treatment, associated or not to a dopamine dysregulation syndrome (DDS), in patients with Parkinson's disease.

3 particular profiles of patients will be established:

BA- : no secondary behavioural addiction
BA+/DDS-: secondary behavioural addiction, without dopamine dysregulation syndrome
BA+/DDS+: secondary behavioural addiction, with dopamine dysregulation syndrome

We wish in particular:

To differentiate, among the BA+ subjects, those for who is a DDS from those for who we can evoke a side effect of the dopaminergic treatment
To demonstrate that the BA+/DDS- subjects present pharmacokinetic particularities causing the occurrence of the BA.
To clarify the possible relationship between the dosage and the pharmacodynamics of the treatment (especially that of pramipexole) in one hand, and the developing of BA in the other hand.
Demonstrate that the subjects BA + / DDS- are individually genetic vulnerability (related to the dopamine system), originally from the occurrence of the BA.

This study has several levels of evaluation, we chose describe the methodology of the study in 3 axis : Psychopathology axis, Neurological axis and pharmacokinetic axis.

The pharmacokinetic aspects will be studied only on a part of the sample, in an ancillary study centered on the pharmacokinetic of the pramipexole (in its immediate release form).


title: Assessing the Impact of the Prostatic Photo-vaporization (PVP) With Greenlight Laser Using Prostatic MRI and Contrast-enhanced Ultrasound

acronym: PROPIL

summary:
The PVP by Greenlight laser 180W is becoming a potential therapeutic alternative in the treatment of benign prostatic hypertrophy (BPH) as recommended.

The PVP creates a prostatic box after the vaporization of the prostatic tissue of BPH. The underlying prostatic tissue is the site of an ischemic necrosis secondary to the thermal effects of proximity of the PVP. We intend to measure by prostatic MRI and contrast-enhanced ultrasound the necrosis.


title: Are Parents Privileged Listeners Their Baby ?

summary:
The crying baby is a sound signal including information relating to this individual identity or related to its physiological or motivational state.

The objective of the study is to determine the implementation of the recognition of individual tone of the baby by his parents and acoustic modulation of the baby based on parental response.

The detailed study of the acoustic structure of crying and analysis of parental perception will determine the dynamics during the first weeks of life of this recognition, and the influence of factors such as parental presence, or breastfeeding .

For this study is organized in three stages: first, the recording of the baby's crying Secondly, a listening test parental soundtracks and third analysis of the acoustic structure of crying and parental response.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

intervention_type: Behavioral


title: Comparison of Axillary Versus Subclavian Vein Strategies for Central Venous Catheterization Under Continuous Ultrasound Guidance: a Prospective, Randomized, Non-inferiority Study

summary: The main objective of this study is to compare the rate of successful establishment of a central venous catheter in the first two attempts of ultrasound-guided puncture between two techniques: (1) a subclavian technique versus (2) an axillary technique.

ReferenceCitation: Buzançais G, Roger C, Bastide S, Jeannes P, Lefrant JY, Muller L. Comparison of two ultrasound guided approaches for axillary vein catheterization: a randomized controlled non-inferiority trial. Br J Anaesth. 2016 Feb;116(2):215-22. doi: 10.1093/bja/aev458.

family: Buzançais

full_name: G. Buzançais

given: G.

family: Roger

full_name: C. Roger

given: C.

family: Bastide

full_name: S. Bastide

given: S.

family: Jeannes

full_name: P. Jeannes

given: P.

family: Lefrant

full_name: J.Y. Lefrant

family: Muller

full_name: L. Muller

given: L.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


title: Study of the Prevalence of a Chronic Inflammatory Condition of the Male Genital Tract at a Distance and Urethritis Following.

acronym: URIS

summary:
Men following after proven and treated urethritis, looking for signs of chronic genital inflammatory syndrome with oxidative stress.

This group of patients will be compared to a control group with no urethritis and no history of urogenital infection. Monocentric, prospective trial.

Duration of study : one year


title: Prognostic Study of Markers of Angiogenesis and Coagulability in Patients With Monoclonal Gammopathy

acronym: PACMoG

summary: Blood circulating endothelial cells (CEC) and microparticles (MPs) are described in the literature to be associated with vascular failures and dysfunction that reflect neo-angiogenesis and risk of thrombosis, respectively. There a few number of CEC in healthy patients although they significantly increase in several cancers including myeloma. However, no study explored to date a correlation of CEC and/or circulating endothelial progenitors (CEP) and MPs with the tumoral growth of monoclonal gammopathy. On the other hand, there is no study measuring the CEC and CEP directly in the bone marrow. The investigators aim is to evaluate these 2 original features in patients with monoclonal gammopathy: monoclonal gammopathy of undetermined signification (MGUS) and myeloma. This is a preliminary multicentric study.

lead_sponsor: Rennes University Hospital


title: Impact of a Checklist on the Rate of Late Cancellation in Ambulatory Surgery

acronym: AMBUPROG

summary: The purpose of this study is to evaluate the impact of a check list on the rate of late cancellation, i.e. the day before or the day of the ambulatory surgery.

ReferenceCitation: Gaucher S, Boutron I, Marchand-Maillet F, Baron G, Douard R, Béthoux JP; AMBUPROG Group Investigators. Assessment of a Standardized Pre-Operative Telephone Checklist Designed to Avoid Late Cancellation of Ambulatory Surgery: The AMBUPROG Multicenter Randomized Controlled Trial. PLoS One. 2016 Feb 1;11(2):e0147194. doi: 10.1371/journal.pone.0147194. eCollection 2016.

family: Gaucher

full_name: Sonia Gaucher

given: Sonia

family: Boutron

full_name: Isabelle Boutron

given: Isabelle

family: Marchand-Maillet

full_name: Florence Marchand-Maillet

given: Florence

family: Baron

full_name: Gabriel Baron

given: Gabriel

family: Douard

full_name: Richard Douard

given: Richard

family: Béthoux

full_name: Jean-Pierre Béthoux

given: Jean-Pierre

journal_name: PLOS ONE

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

evidence: oa repository (semantic scholar lookup)

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science


title: Phase III Study of Efficacy of High Dose Erythropoietin to Prevent Hypoxic-ischemic Encephalopathy Sequelae in Term Newborn

acronym: Neurepo

summary: The purpose of this study is to determine the efficacy of high dose Erythropoietin to improve survival and neurologic outcome in asphyxiated term newborn undergoing cooling.

ReferenceCitation: Zhu C, Kang W, Xu F, Cheng X, Zhang Z, Jia L, Ji L, Guo X, Xiong H, Simbruner G, Blomgren K, Wang X. Erythropoietin improved neurologic outcomes in newborns with hypoxic-ischemic encephalopathy. Pediatrics. 2009 Aug;124(2):e218-26. doi: 10.1542/peds.2008-3553. Epub 2009 Jul 27.

ReferenceCitation: Goodarzi MO, Carmina E, Azziz R. DHEA, DHEAS and PCOS. J Steroid Biochem Mol Biol. 2015 Jan;145:213-25. doi: 10.1016/j.jsbmb.2014.06.003. Epub 2014 Jul 5. Review.


title: Neuropsychological Approach of Pedophilic Behaviors, a Pilot Study in a Population of Inmates Pedophilic Offenders

summary: Pedophilic behaviors represent a public health problem with serious consequences. The investigators hypothesize a disruption in the decision-making strategies among sex offenders pedophiles. Highlight this type of abnormality would offer a specific treatment of a possible neuropsychological deficit (with cognitive remediation for instance) and perhaps avoid recurrences of this type of behavior.

lead_sponsor: University Hospital, Montpellier


title: Postoperative Analgesia in Third Molar Surgery Under General Anesthesia: Ropivacaine Versus Placebo

acronym: RopiMol

summary: The main objective of this study is to demonstrate the superiority of local analgesia with ropivacaine versus placebo on postoperative pain during the first 24 hours following bilateral surgery of all four third molars under general anesthesia.

ReferenceCitation: Ghezal H, Bouvet S, Kabani S, Ripart J, Cuvillon P. Ropivacaine versus placebo on postoperative analgesia and chronic pain following third molar extraction: A Prospective Randomized Controlled Study. J Stomatol Oral Maxillofac Surg. 2020 Apr;121(2):113-117. doi: 10.1016/j.jormas.2019.07.005. Epub 2019 Jul 18.

family: Ghezal

full_name: H. Ghezal

given: H.

family: Bouvet

full_name: S. Bouvet

family: Kabani

full_name: S. Kabani

family: Ripart

full_name: J. Ripart

given: J.

family: Cuvillon

full_name: P. Cuvillon

journal_name: Journal of Stomatology, Oral and Maxillofacial Surgery

evidence: open (author manuscript)

version: acceptedVersion


title: Is the Residual Gastric Volume After Sleeve Gastrectomy an Objective Criterion to Adapt the Treatment Strategy After Failure?

acronym: GASTROMANCH

summary:
Obesity is a worldwide health problematic whose incidence is increasing especially in developed countries. The surgical management of this illness consists in different techniques such as Laparoscopic Sleeve Gastrectomy but this treatment could not be efficient enough. The causes of failure after Laparoscopic Sleeve Gastrectomy are not known but could include the residual gastric volume.

The aim of the present study was to determine whether the residual gastric volume is involved in Laparoscopic Sleeve Gastrectomy's failure.

ReferenceCitation: Péquignot A, Dhahria A, Mensah E, Verhaeghe P, Badaoui R, Sabbagh C, Regimbeau JM. Stapling and Section of the Nasogastric Tube during Sleeve Gastrectomy: How to Prevent and Recover? Case Rep Gastroenterol. 2011;5(2):350-4. doi: 10.1159/000329706. Epub 2011 Jul 6.

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.

ReferenceCitation: Sabbagh C, Verhaeghe P, Dhahri A, Brehant O, Fuks D, Badaoui R, Regimbeau JM. Two-year results on morbidity, weight loss and quality of life of sleeve gastrectomy as first procedure, sleeve gastrectomy after failure of gastric banding and gastric banding. Obes Surg. 2010 Jun;20(6):679-84. doi: 10.1007/s11695-009-0007-4. Epub 2009 Nov 10.

ReferenceCitation: Fuks D, Verhaeghe P, Brehant O, Sabbagh C, Dumont F, Riboulot M, Delcenserie R, Regimbeau JM. Results of laparoscopic sleeve gastrectomy: a prospective study in 135 patients with morbid obesity. Surgery. 2009 Jan;145(1):106-13. doi: 10.1016/j.surg.2008.07.013. Epub 2008 Sep 30.

ReferenceCitation: Fuks D, Dumont F, Berna P, Verhaeghe P, Sinna R, Sabbagh C, Demuynck F, Yzet T, Delcenserie R, Bartoli E, Regimbeau JM. Case report-complex management of a postoperative bronchogastric fistula after laparoscopic sleeve gastrectomy. Obes Surg. 2009 Feb;19(2):261-264. doi: 10.1007/s11695-008-9643-3. Epub 2008 Aug 12.

lead_sponsor: Centre Hospitalier Universitaire, Amiens