title: Central Effects of Botulinum Toxin: Neurophysiological Study in Stroke Patients With Spastic Lower Limb

summary:
Spasticity is a motor disorder characterized by a velocity-dependent increase in tonic stretch reflex with exaggerated tendon jerk (Lance 1980). Patients with brain lesion often display spasticity due to the interruption of the descending pathways that control the spinal reflex networks, which results in hyperexcitability of the monosynaptic reflex triggered by stretch of the muscle spindles. Spasticity in lower limb muscle impairs the gait, especially in strokes that are the main cause of neurological disability. While 80% of the stroke survivors recover the ability to walk, the poor quality of their gait constitutes a serious handicap in daily life (Bensoussan et al. 2004; Bensoussan et al. 2006).

Local injection of Botulinum toxin (BTx) has become a mainstay of the treatment of focal spasticity, particularly in post-stroke patients. BTx weakens the excessive muscle contraction by blocking the release of acethylcholine from motoneuron terminals at the neuromuscular junction and transiently paralyzing the muscle for several months. Besides this peripheral action, BTx is assumed to have also a central effect (Curra et al. 2004; Gracies 2004; Krishnan 2005; Palomar and Mir 2012). In particular, by affecting also the fusimotor synapses on intrafusal muscles fibers (Rosales and Dressler 2010; Trompetto et al. 2008; Trompetto et al. 2006), BTx may reduce the discharge from muscle spindles, which may be indirectly responsible for functional changes in central motor mechanisms at both spinal and supraspinal levels. Animal experiments also suggested that BTx is carried by retrograde axonal transport to motoneuron soma and possibly transynaptically, and can affect the spinal cholinergic synaptic transmission in the spinal cord. Until now, electrophysiological findings are limited and controversial, probably due to the various motor disorders investigated, the physiological mechanisms tested and the different toxin injection protocols used in the few studies available (Frascarelli et al. 2011; Girlanda et al. 1997; Modugno et al. 1998; Naumann and Reiners 1997; Pauri et al. 2000; Priori et al. 1995; Wohlfarth et al. 2001). Hence, the central action of the toxin in spasticity remains uncertain.

lead_sponsor: Assistance Publique Hopitaux De Marseille


title: French Attitude Registry in Case of ICD Lead Replacement

acronym: FRAGILE

summary:
The average survival rate of a defibrillation lead is 91 to 99% at 2 years, 85-95% at 5 years and 60-72% at 8 years. We must also manage alerts for defibrillation probes with a higher complication rate than average. We will therefore be increasingly confronted with faulty sensors or at risk to be replaced.

There are no standardized approach for replacing defibrillation lead. A record made in the United States showed significant differences according to the teams strategy in case of failure of defibrillation lead in particular with regard to the decision to explant or abandon the probe.

The risk of extracting a defibrillation lead are well known with a major complication rate of 1.6 to 1.95%.

Regarding the risk of complications related to the abandonment of a probe we have less data. For some there is no risk to abandon a defibrillation lead. But others reported a complication rate of 5.5% related to pacing discontinued.

Main objective: Collect the attitude of different centers and different operators when replacing a failed defibrillation lead or "at risk." Explantation or abandonment of the sensor replaced.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Goette A, Cantu F, van Erven L, Geelen P, Halimi F, Merino JL, Morgan JM; Scientific Initiative Committee of the European Heart Rhythm Association. Performance and survival of transvenous defibrillation leads: need for a European data registry. Europace. 2009 Jan;11(1):31-4. doi: 10.1093/europace/eun301. Epub 2008 Nov 11.

ReferenceCitation: Wilkoff BL, Love CJ, Byrd CL, Bongiorni MG, Carrillo RG, Crossley GH 3rd, Epstein LM, Friedman RA, Kennergren CE, Mitkowski P, Schaerf RH, Wazni OM; Heart Rhythm Society; American Heart Association. Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management: this document was endorsed by the American Heart Association (AHA). Heart Rhythm. 2009 Jul;6(7):1085-104. doi: 10.1016/j.hrthm.2009.05.020. Epub 2009 May 22.

ReferenceCitation: Xu W, Moore HJ, Karasik PE, Franz MR, Singh SN, Fletcher RD. Management strategies when implanted cardioverter defibrillator leads fail: survey findings. Pacing Clin Electrophysiol. 2009 Sep;32(9):1130-41. doi: 10.1111/j.1540-8159.2009.02454.x.

ReferenceCitation: Rickard J, Wilkoff BL. Extraction of implantable cardiac electronic devices. Curr Cardiol Rep. 2011 Oct;13(5):407-14. doi: 10.1007/s11886-011-0198-x. Review.

ReferenceCitation: Wilkoff BL, Byrd CL, Love CJ, Hayes DL, Sellers TD, Schaerf R, Parsonnet V, Epstein LM, Sorrentino RA, Reiser C. Pacemaker lead extraction with the laser sheath: results of the pacing lead extraction with the excimer sheath (PLEXES) trial. J Am Coll Cardiol. 1999 May;33(6):1671-6.

ReferenceCitation: Glikson M, Suleiman M, Luria DM, Martin ML, Hodge DO, Shen WK, Bradley DJ, Munger TM, Rea RF, Hayes DL, Hammill SC, Friedman PA. Do abandoned leads pose risk to implantable cardioverter-defibrillator patients? Heart Rhythm. 2009 Jan;6(1):65-8. doi: 10.1016/j.hrthm.2008.10.012. Epub 2008 Oct 11.

ReferenceCitation: Suga C, Hayes DL, Hyberger LK, Lloyd MA. Is there an adverse outcome from abandoned pacing leads? J Interv Card Electrophysiol. 2000 Oct;4(3):493-9.

lead_sponsor: French Cardiology Society

lead_sponsor_type: industriel

status_simplified: Completed


title: Postoperative Rehabilitation After Cardiac Surgery in Patients at Risk of Respiratory Complications. Effects of a Continuous Bi-laterosternal Infusion of Ropivacaine Through Multihole Catheters.

acronym: BLS-Sterno

summary: Postoperative pain after cardiac surgery is a risk factor for postoperative complications. In cardiac surgery, pain is more intense during the first 48 hours and disturbs the patient's capacity of coughing, deep breathing, and early mobilisation. It may be responsible for respiratory complications such as bronchial or pulmonary infection, and may also delay the patient's rehabilitation and therefore prolong the duration of in-hospital stay. A previous pilot study performed in our department showed a sensible improvement of analgesia at movement and of rehabilitation with a continuous bilaterosternal infusion of local anaesthesia [Eljezi et al.. Reg Anesth Pain Med 2012; 37:166]. Such strategy shall be tested in a subpopulation of patients at risk for respiratory complication.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Eljezi V, Imhoff E, Bourdeaux D, Pereira B, Farhat M, Schoeffler P, Azarnoush K, Dualé C. Bilateral sternal infusion of ropivacaine and length of stay in ICU after cardiac surgery with increased respiratory risk: A randomised controlled trial. Eur J Anaesthesiol. 2017 Feb;34(2):56-65. doi: 10.1097/EJA.0000000000000564.

family: Eljezi

full_name: Vedat Eljezi

given: Vedat

sequence: first

family: Imhoff

full_name: Etienne Imhoff

given: Etienne

sequence: additional

family: Bourdeaux

full_name: Daniel Bourdeaux

given: Daniel

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Farhat

full_name: Mehdi Farhat

given: Mehdi

family: Schoeffler

full_name: Pierre Schoeffler

given: Pierre

family: Azarnoush

full_name: Kasra Azarnoush

given: Kasra

family: Dualé

full_name: Christian Dualé

given: Christian

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: European Journal of Anaesthesiology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: University Hospital, Clermont-Ferrand

intervention_type: Drug

lead_sponsor_type: academique


title: Feasibility Study of Ablathermy Focused Ultrasound (USF) of Breast Tumors Before Mastectomy

acronym: USF

summary: The treatment consists of tumor ablation by Ablathermy Focused Ultrasound (USF), guided by MRI, performed under local anesthesia and sedation.

status: Terminated

lead_sponsor: Institut Bergonié

intervention_type: Procedure

status_simplified: Unknown


title: Role of FCγRIIIA and FCγRIIA Receptor Polymorphisms in Cetuximab Activity Used in Palliative Treatment of Upper Aerodigestive Tract Tumours

acronym: FCRVADS

summary:
Hypothesis:

Cetuximab, an anti-EGFR antibody, is used with radiotherapy in the treatment of locally advanced and inoperable upper aerodigestive tract cancers. Actually, no predictive biomarkers of Cetuximab antitumor activity are known in this setting. It has been shown recently that FCγRIIIA and FCγRIIA receptor polymorphisms played a role in antitumor activity of trastuzumab and cetuximab.

The investigators therefore hypothesized that FCγRIIIA and FCγRIIA receptor polymorphisms may play a predictive role in Cetuximab effectiveness in upper aerodigestive tract cancers with recurrence or metastatic disease that make them inaccessible to loco regional treatment.

intervention_type: Other


acronym: MIM

type: EudraCT Number

source: euctr

title: Phase III Trial Evaluating the Effectiveness of a Dose Adjustment of IM on the Molecular Response in Patients With LMC in Chronic Phase Treated With IM 400 mg / Day for at Least Two Years, Complete Cytogenetic Response for at Least One Year

summary: The Imatinib Mesylate at a dose of 400 mg / day is the standard treatment for patients with CML-CP. Recent studies show that the quality of response rate (complete cytogenetic response and major molecular response rate) is dependent on the residual plasma Imatinib.


title: Development of a Technique to Identify New Genes by Studying and Cloning the Breakpoints of de Novo Apparently Balanced Chromosomal Translocations in Patients Presenting With Syndromic Psychomotor Retardation

summary: For every child with developmental delay, the investigators do a constitutional karyotype. This karyotype can reveal an apparently balanced chromosomal rearrangement (no visible loss or gain of genetic material), such as a translocation between two or more chromosomes of accidental occurrence (not transmitted by parents). However, an apparently balanced translocation does not explain the phenotype of the child. Among the hypotheses that could explain the child's symptoms, there is the possibility of another chromosomal abnormality at the translocation breakpoints, another defect elsewhere on the chromosomes or gene disruption at or near the breakpoints. Because the resolution of a constitutional karyotype is limited, these microanomalies can go undiagnosed. The goal of this study is to look for a microanomaly on a chromosome using a technology of higher resolution than that of the conventional karyotype. The proposed study uses DNA microarray technology on DNA extracted from blood lymphocytes to perform high-resolution analysis of all chromosomes to search for an unbalanced microrearrangement (such as loss or gain of chromosomal material). If no microrearrangement is found, the investigators will pursue by looking for a gene disruption defect at or near the breakpoints involved in the translocation. This will be done by first isolating the chromosomes involved in the translocation by flow cytometry and then hybridizing each of the isolated chromosomes on a new microarray. The purpose of this study is to find a possible cause to explain the phenotype (microrearrangement or gene disruption).

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Gribble SM, Prigmore E, Burford DC, Porter KM, Ng BL, Douglas EJ, Fiegler H, Carr P, Kalaitzopoulos D, Clegg S, Sandstrom R, Temple IK, Youings SA, Thomas NS, Dennis NR, Jacobs PA, Crolla JA, Carter NP. The complex nature of constitutional de novo apparently balanced translocations in patients presenting with abnormal phenotypes. J Med Genet. 2005 Jan;42(1):8-16.

lead_sponsor: University Hospital, Montpellier

location_facility: Laboratory of Chromosomal Genetics - Universitary Hospital

intervention_type: Biological


title: Observational Study of Oxygen Delivery During a Fractional Fluid Expansion

acronym: OR

summary: Fluid expansion during cardiocirculatory insufficiency was helped by cardiac output monitoring. However, the goal of fluid expansion was to increase the oxygen delivery, which consider cardiac output, but also Haemoglobin which decrease during a fluid challenge. The maximalization of cardiac output could decrease the oxygen delivery if the haemodilution was too wide. The aim of this study was to describe the oxygen delivery during a fluid expansion conducted for cardiac output maximalization, following actual guidelines.

time_perspective: Retrospective

lead_sponsor: University Hospital, Caen


title: Effect of a 3 Months Physical Activity Program on the Hormonal Regulation of Food Intake by Intense Physical Activity in Overweight Adolescents

acronym: APHRO

summary:
The primary purpose of this protocol is to assess the hormonal regulation of satiety by an intense exercise before and after a 3 month physical activity program. Hormones assessed are: leptin, grhélin, Cholecystokinin, Glucagon-Like-Peptid-1 (GLP-1), PYY.

It is well known that in overweight adults and children also, an intense physical exercise diminish the food intake relatively to the total energy expenditure and this effect is persistent after a 6 weeks physical activity program.

Our hypothesis are: a diminution of food intake after the intense physical exercise and a persistent diminution of food intake after the 3 month physical activity program, an augmentation of levels of GLP-1 and PYY during the intense exercise before and after the physical activity program, a diminution of the level of GLP-1 and leptin before and after the physical activity program

status: Suspended

intervention_type: Behavioral


summary: In the prospective monocentric open label trial patients with diabetic macular edema will be treated with intravitreal injections of ranibizumab given for 3 months then with laser grid at month 4. During follow-up a ranibizumab injection will be performed every 2 months in case of best-corrected visual acuity decreased more than 5 letters.

lead_sponsor: Poitiers University Hospital


title: Effect of Rotigotine Patch Treatment on Cardiovascular Markers in Idiopathic Restless Legs Syndrome : a Pilot Randomized, Placebo-controlled Study

summary:
Several studies report association between restless legs syndrome (RLS), HTA and cardiovascular diseases .

The mechanisms involved in this relationship remained unknown, but several evidences favor the role of periodic limb movements in sleep (PLMS), patterns frequently associated with RLS. Sympathetic overactivity is associated with PLMS with increased pulse rate and blood pressure coincident with PLMS. PLMS-related repetitive nocturnal blood pressure fluctuations could contribute to the risk of high blood pressure, heart disease, and stroke in patients with RLS, especially in the elderly. Several studies already reported that dopaminergic agonists reduce the severity of RLS and the PLMS index.

Do dopaminergic agonists reduce the risk of cardiovascular diseases and associated autonomic dysfunctions in patients with RLS ?

Nocturnal BP (blood pressure) decline has major clinical implications, and the loss of normal reduction in BP during sleep is associated with high risk of cardiovascular morbidity and mortality.

The main aim of this study was to evaluate the impact of rotigotine patch treatment on validated cardiovascular risk factors ambulatory BP during night, day and night-to-day ratio, and endothelial function in patients with idiopathic RLS compared to placebo.


title: Balloon Aortic Valvuloplasty Performed Without Heparin to Decrease Vascular and Bleeding Complications of the Procedure

acronym: HEPAVALV

summary: To assess if the non use of heparin sodium during balloon aortic valvuloplasty reduces serious complications due to the procedure, by decreasing the rate of vascular and hemorrhagic complications without increasing the rate of ischeamic events.


title: Influence of the Vitamin D Blood Levels on the Amyotrophic Lateral Sclerosis Phenotype

summary: The main objective of this study is to investigate the correlation between the rate of motor decline and blood levels of Vitamin D total. Secondary objectives are to investigate the relationship between blood levels of vitamin D and total disease duration of ALS, forced vital capacity, weight loss, age of onset and the start site of ALS.

primary_purpose: Basic Science


title: Follow-up of Patients' Physical Activity in Post-hospitalization by Implementation of Systems of Active Monitoring.

acronym: TICAA'DOM

summary: Physical exercise has been identified as a major item of many affecting many chronic diseases and stroke rehabilitation. It contributes to an improvement in the quality of life and to a decrease in the current treatment side-effects and mortality. Stroke in association with an inactive lifestyle lead to a decrease in physical capability and causes problems in daily activities. The physical capacity and the tolerance for exercise fall simultaneously leading to vicious circle of less and less mobility. Therefore, physical activity for the health is a valid and relevant way to improve the quality of life and to recover functional capacity. The aim of the study is the assessment of the effects of a incentive program for physical activity on people following/with stroke.

primary_purpose: Other

ReferenceCitation: Mandigout S, Chaparro D, Borel B, Kammoun B, Salle JY, Compagnat M, Daviet JC. Effect of individualized coaching at home on walking capacity in subacute stroke patients: A randomized controlled trial (Ticaa'dom). Ann Phys Rehabil Med. 2021 Jul;64(4):101453. doi: 10.1016/j.rehab.2020.11.001. Epub 2020 Nov 28.

family: Mandigout

full_name: Stéphane Mandigout

given: Stéphane

family: Chaparro

full_name: David Chaparro

given: David

family: Borel

full_name: Benoit Borel

given: Benoit

family: Kammoun

full_name: Benjamin Kammoun

given: Benjamin

family: Salle

full_name: Jean-Yves Salle

given: Jean-Yves

family: Compagnat

full_name: Maxence Compagnat

given: Maxence

family: Daviet

full_name: Jean-Christophe Daviet

given: Jean-Christophe

journal_name: Annals of Physical and Rehabilitation Medicine

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Effect of individualized coaching at home on walking capacity in subacute stroke patients: A randomized controlled trial (Ticaa’dom)

ReferenceCitation: Chaparro D, Daviet JC, Borel B, Kammoun B, Salle JY, Tchalla A, Mandigout S. Home-based physical activity incentive and education program in subacute phase of stroke recovery (Ticaa'dom): study protocol for a randomized controlled trial. Trials. 2018 Jan 25;19(1):68. doi: 10.1186/s13063-017-2410-9.

family: Tchalla

full_name: Achille Tchalla

given: Achille

currency_apc_doaj: GBP

journal_name: Trials

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_normalized: HAL

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

title: Home-based physical activity incentive and education program in subacute phase of stroke recovery (Ticaa’dom): study protocol for a randomized controlled trial


title: A Single Blind Cross Over Trial to Compare Osteopathic Compression of Pterygopalatine Node to Sham in Patients With Obstructive Sleep Apnea Syndrome and in Healthy Subjects

acronym: OSTEOSAOSII

summary: The main objective is to evaluate an osteopathic compression of pterygopalatine node in healthy subjects and patients suffering from obstructive apnea syndrome (OSA).

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service des pathologies du sommeil, Pitié-Salpêtrière hospital


type: Other Identifier

title: Functional Correlates of Bipolar Disorders and Effects of the Psychoeducation. Assessment by Functional and Anatomic Neuroimaging.

acronym: BIP-ED

summary: This research project follows two main objectives: 1) Assess anatomical and functional cerebral abnormalities in bipolar disorder. 2) Evaluate anatomical and functional changes after the application of a psychoeducational program in these patients. Specifically, this project aims to assess neurophysiological (fMRI - activation and functional connectivity) and neuroanatomical (morphometry and diffusion tensor imaging) specificities related to bipolar disorders and the therapeutic response to the psychoeducation. The results of this thesis project would also contribute to the validation of a pathophysiological model of the bipolar disorder.

ReferenceCitation: Favre P, Polosan M, Pichat C, Bougerol T, Baciu M. Cerebral Correlates of Abnormal Emotion Conflict Processing in Euthymic Bipolar Patients: A Functional MRI Study. PLoS One. 2015 Aug 5;10(8):e0134961. doi: 10.1371/journal.pone.0134961. eCollection 2015.

apc_source: openAPC

family: Favre

full_name: Pauline Favre

given: Pauline

family: Polosan

full_name: Mircea Polosan

given: Mircea

family: Pichat

full_name: Cédric Pichat

given: Cédric

family: Bougerol

full_name: Thierry Bougerol

given: Thierry

family: Baciu

full_name: Monica Baciu

given: Monica

bso_classification: Social sciences

currency_apc_doaj: USD

journal_name: PLOS ONE

repository_institution: Max Planck Society - MPG.PuRe

evidence: oa repository (via pmcid lookup)

license_normalized: no license

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_institution:
Max Planck Society - MPG.PuRe
PubMed Central - Europe PMC

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

lead_sponsor: University Hospital, Grenoble


title: Accuracy of Pleth Variability Index (PVI) in Predicting Response to Intravenous Fluid Load During Scoliosis Surgery in Children

acronym: PVI

summary:
Plethysmographic Variability index is a simple index accurate in predicting fluid responsiveness.

The aim of this study was to investigate its accuracy in predicting fluid response to intravenous fluid challenge during scoliosis surgery in children.

ReferenceType: result

ReferenceCitation: Feldman JM, Sussman E, Singh D, Friedman BJ. Is the pleth variability index a surrogate for pulse pressure variation in a pediatric population undergoing spine fusion? Paediatr Anaesth. 2012 Mar;22(3):250-5. doi: 10.1111/j.1460-9592.2011.03745.x. Epub 2011 Dec 6.

family: Feldman

full_name: Jeffrey M. Feldman

given: Jeffrey M.

family: Sussman

full_name: Emily Sussman

given: Emily

family: Singh

full_name: Devika Singh

given: Devika

family: Friedman

full_name: Ben J. Friedman

given: Ben J.

journal_name: Pediatric Anesthesia

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

location_facility: Department of Anesthesiology, Robert Debre University Hospital


title: Is Access to Liver Transplantation Similar in Alcoholic or Not Patients? A Prospective Cohort Study

acronym: TRANSALC

summary: The purpose of this study is to determine whether there are reasons other than medical reasons that could limit access to liver transplantation in alcoholic patients.

ReferenceCitation: Perut V, Conti F, Scatton O, Soubrane O, Calmus Y, Vidal-Trecan G. Might physicians be restricting access to liver transplantation for patients with alcoholic liver disease? J Hepatol. 2009 Oct;51(4):707-14. doi: 10.1016/j.jhep.2009.04.018. Epub 2009 May 28.

ReferenceCitation: Cohen C, Benjamin M. Alcoholics and liver transplantation. The Ethics and Social Impact Committee of the Transplant and Health Policy Center. JAMA. 1991 Mar 13;265(10):1299-301.

ReferenceCitation: Lucey MR, Beresford TP. Alcoholic liver disease: to transplant or not to transplant? Alcohol Alcohol. 1992 Mar;27(2):103-8. Review.

ReferenceCitation: Ubel PA. Transplantation in alcoholics: separating prognosis and responsibility from social biases. Liver Transpl Surg. 1997 May;3(3):343-6.

ReferenceCitation: Vidal-Trécan G, Kone V, Pilette C, Nousbaum JB, Doll J, Buffet C, Eugene C, Podevin P, Boutet O, Puyeo J, Conti F, Calmus Y. Subjective parameters markedly limit the referral of transplantation candidates to liver transplant centres. Liver Int. 2016 Apr;36(4):555-62. doi: 10.1111/liv.13030. Epub 2015 Dec 21.

name: Public Health Unit: Risk Management and Quality of Care; Paris Centre University Hospital Group, AP-HP; Paris France

name: Department of Public Health, Faculty of Medicine; Paris Descartes University, Sorbonne Paris Cité; Paris France

name: Research Unit (INSERM U1153) Methods Team, Methods of Therapeutic Evaluation of Chronic Diseases; Research Center Epidemiology and Biostatistics; Sorbonne Paris Cité; Paris France

family: Vidal-Trécan

full_name: Gwenaëlle Vidal-Trécan

given: Gwenaëlle

family: Kone

full_name: Victoria Kone

given: Victoria

name: Hepatogastroenterology Department; CHG du Mans; Le Mans France

family: Pilette

full_name: Christophe Pilette

given: Christophe

name: Hepatogastroenterology Department; CHU de Brest; Brest France

family: Nousbaum

full_name: Jean-Baptiste Nousbaum

given: Jean-Baptiste

name: Hepatogastroenterology Department; CHG de Versailles; Versailles France

family: Doll

full_name: Jacques Doll

given: Jacques

name: Hepatogastroenterology Department; CHU Kremlin Bicètre; Kremlin Bicètre France

family: Buffet

full_name: Catherine Buffet

given: Catherine

name: Hepatogastroenterology Department; CHG de Poissy; Poissy France

family: Eugene

full_name: Claude Eugene

given: Claude

name: Centre de Reference en Addictologie, Pitie-Salpetriere Hospital, AP-HP; Paris Descartes University; Paris France

family: Podevin

full_name: Philippe Podevin

given: Philippe

name: Hepatogastroenterology Department; CHG de Bagnoles sur Cèze; Bagnoles sur Cèze France

family: Boutet

full_name: Olivier Boutet

given: Olivier

name: Hepatogastroenterology Department; CHG de Carcassonne; Carcassonne France

family: Puyeo

full_name: Jacques Puyeo

name: Centre de Transplantation Hepatique, Pitie-Salpetriere Hospital, AP-HP; Paris Descartes University; Paris France

family: Conti

full_name: Filomena Conti

given: Filomena

family: Calmus

full_name: Yvon Calmus

given: Yvon

journal_name: Liver International


title: Efficacy and Pharmacokinetic/Pharmacodynamic Parameters of Cefoxitin in Women With Acute Pyelonephritis Without Severity Symptoms Due to Extended-spectrum β-lactamase Producing Escherichia Coli.

acronym: FOXICOLI

summary: Escherichia coli is the primary cause of urinary tract infections and Gram-negative bacteremia worldwide. Since the early years of the 21st century, E.coli has acquired a new mechanism of resistance to antibiotics: extended spectrum β-lactamase (ESBL), type CTX-M. These ESBL inactivate most β-lactams, the preferred class of antibiotics for the treatment of severe E.coli infections. Moreover, the strains that produce these ESBL are often resistant to other classes of antibiotics. Their rapid spread constitutes a major public health concern because of a serious risk of therapeutic impasse. Treatment options in cases of infection with ESBL-producing E.coli are often limited to carbapenems, a class of more recently developed β-lactams. Carbapenems have a very wide spectrum of activity but their effectiveness is threatened by the emergence of strains producing carbapenemases. The development of therapeutic alternatives to treat ESBL-producing E.coli infections is therefore essential. Cephamycins, including cefoxitin, are β-lactams marketed in the seventies but their use was practically abandoned when wide spectrum antibiotics became available. They are distinguished by the presence of an α-methoxy group in position 7 which interferes with the action of the extended-spectrum β-lactamase and renders it ineffective against cephamycins. Cefoxitin is therefore active in vitro against ESBL-producing E.coli and offers the advantage of a narrower antibacterial spectrum, thus reducing the selection pressure and the emergence of resistance. However, the in vivo activity of cefoxitin for the treatment of ESBL-producing E.coli infections has never been measured. Furthermore, available pharmacokinetic and pharmacodynamic (PK/PD) data for cefoxitin are dated and incomplete, which raises many questions concerning the optimal dosage regimen. We have shown in a mouse model of ESBL-producing E. coli CTX-M pyelonephritis that cefoxitin efficacy is comparable to that of carbapenems without selecting resistant mutants. Cefoxitin could thus constitute an alternative to carbapenems for the treatment of pyelonephritis caused by ESBL-producing E.coli.


title: Usefulness of a Short-time But Very Early Specialized Follow-up After Hospitalization for Acute Heart Failure: a Randomized Controlled Trial.

acronym: ECAD-HF

summary:
After decompensated heart failure, a number of patients have high risk of early rehospitalization as well as death. Specialized medical management for a short period but very early after discharge could be critical for optimizing care and improving early outcome.

This study aims to compare such early intensive medical management with usual care in high-risk patients after discharge.

location_facility: Service de Cardiologie - Hopital Lariboisière


title: Trial of Autonomic neuroModulation for trEatment of Chronic Heart Failure

acronym: TAME-HF

summary: The purpose of this clinical investigation is to evaluate the safety and efficacy of Spinal Cord Stimulation (SCS) in advanced heart failure (HF) patients with Implantable Cardioverter Defibrillator (ICD) but not indicated for Cardiac Resynchronization Therapy (CRT).

status: Withdrawn

lead_sponsor: Abbott Medical Devices

intervention_type: Device


title: Evaluation of the Impact of Care Based on Sensory Support for Elderly Patients Suffering From Alzheimer'S-type Neurodegenerative Disease

acronym: SensiCare

summary: The main objective of this study is to evaluate the effect of 3 months of "Snoezelen-type" multi-sensory care sessions on NeuroPsychiatric Inventory Questionnaire (NPI-Q) scores for patients with Alzheimer's-type neurodegenerative disease.

primary_purpose: Supportive Care

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Centre de Gérontologie de Serre Cavalier


title: Etude Phase I/II d'immunothérapie Par protéine recWT1-A10+AS01B après Greffe allogénique de Cellules Souches

summary:
Patients with acute or chronic myeloid leukemia, or myelodysplastic syndrome, underwent allogeneic stem cell transplantation from HLA-identical donor (related or unrelated) after reduced-intensity conditioning regimen.

If WT1 expression is detectable on tumor cells, they will receive an immune therapy 60 days after allograft.

6 administrations every 2 weeks of the protein recwt1-A10+AS01B will be administrated.

The safety and immunological efficacy of this immune therapy after hematopoietic stem cells transplantation with reduced intensity conditioning will be evaluated.

lead_sponsor: Institut Paoli-Calmettes


title: Optimizing Communication During Nasal Mechanical Ventilation

acronym: PHONOVNI

summary: Mechanical ventilation is one of the only treatment that has improved survival of patients with neuromuscular respiratory failure. As disease progresses, some patients may require longer ventilation period. Non invasive mechanical ventilation is the preferred method of ventilation but it may interfere with speech and communication of patients who require ventilation throughout the day. The investigators are evaluating the effect on speech and communication of a ventilation device which allows patients to momentarily and voluntarily withhold ventilation if they want to speak. This should allow the patients to have a more fluid speech.

lead_sponsor: Centre d'Investigation Clinique et Technologique 805


title: Evaluation of the Diagnostic Value of Portable Ultrasound for Dyspneic Patient Support in the Emergency Department: a Randomized Study

acronym: VSCAN-DYSP

summary: The main objective of our study is to compare the effects of two care strategies for dyspneic patients on the length of hospital stay: (1) standard care (=contextual analysis + conventional clinical chest radiography) versus (2) standard care + pleuropulmonary ultrasound.

primary_purpose: Prevention

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Effects of Abnormal Respiratory Mechanics and Assisted Mechanical Ventilation on Neuro Regulation of Respiration

acronym: RegAIN

summary:
Due to recent technological improvements, it is now possible to record the electrical activity of the diaphragm (Eadi), a direct expression of the central nervous system respiratory center activity. By providing a relatively easy-to-use technique to record Eadi the NAVA (Neurally Adjusted Ventilatory Assist) technology offers a new opportunity to explore the effects of various interventions on neural inspiratory activity in human subjects during spontaneous and assisted ventilation both for normal and simulated abnormal respiratory mechanics.

The main aim of this project is to measure and compare the components of Eadi signal, the direct reflect of the respiratory centers activity, under various conditions of normal and simulated altered respiratory mechanics (either obstructive or restrictive respiratory mechanics° in order to better understand the neuroregulation of breathing. The second aim of the present project is to perform a similar analysis regarding the effects of various modes (Pressure Support and NAVA) and various levels of assisted ventilation both in case of normal and abnormal respiratory mechanics. Based on the information recorded on Eadi and flow and pressure signals, the last aim of this project is to correlate Eadi and pneumatic derived parameters both during spontaneous breathing and assisted ventilation.

Practically, by using the NAVA recording technology, the investigators will perform a physiological study on normal volunteers to explore the effects of normal and simulated abnormal respiratory mechanics on Eadi, flow and pressure signals (airway, oesophageal and transdiaphragmatic pressures) in order to better understand the neuroregulation of breathing. Thirty healthy volunteers with documented normal lung function tests will be included in the study (obstructive respiratory mechanics will be simulated in 15 healthy volunteers and respiratory mechanics will be simulated in 15 healthy volunteers).

ReferenceCitation: Piquilloud L, Beloncle F, Richard JM, Mancebo J, Mercat A, Brochard L. Information conveyed by electrical diaphragmatic activity during unstressed, stressed and assisted spontaneous breathing: a physiological study. Ann Intensive Care. 2019 Aug 14;9(1):89. doi: 10.1186/s13613-019-0564-1.

family: Piquilloud

full_name: Lise Piquilloud

given: Lise

family: Beloncle

full_name: François Beloncle

given: François

family: Richard

full_name: Jean-Christophe M. Richard

given: Jean-Christophe M.

family: Mancebo

full_name: Jordi Mancebo

given: Jordi

family: Mercat

full_name: Alain Mercat

given: Alain

family: Brochard

full_name: Laurent Brochard

given: Laurent

journal_name: Annals of Intensive Care

repository_institution: Université de Lausanne - SERVAL

repository_institution: University of Toronto - TSpace

repository_normalized: localhost

repositories:
PubMed Central
localhost
serval.unil.ch

repositories_institution:
PubMed Central - Europe PMC
University of Toronto - TSpace
Université de Lausanne - SERVAL

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: University Hospital, Angers

location_facility: Medical Intensive Care Unit, University Hospital of Angers


title: Bacteriophages Effects on Pseudomonas Aeruginosa Presents in Sputum of Cystic Fibrosis (CF) Patients

acronym: MUCOPHAGES

summary: Pulmonary phage therapy to treat bacterial infections of the respiratory tract have been investigated in animals. The aim of the present study is to evaluate the efficacy of bacteriophages in infecting Pseudomonas aeruginosa (PA) strains present in sputum samples. A cocktail of 10 bacteriophages will be applied on 60 sputum samples obtained from cystic fibrosis (CF) patients during 6 hours.We will determine the bacteria and bacteriophages strains in sputum samples collected. Then the sensitivity of individual colony will be tested.

location_facility: CHU de Montpellier - Hôpital Arnaud de Villeneuve CRCM


title: Effect of URELL(Cranberry Vaccinium Macrocarpon)Consumption on the Prevalence of Recurrent Urinary Tract Infection and Asymptomatic Bacteriuria During Pregnancy.

summary: Evaluation of the effect of URELL consumption on the occurrence of recurrent urinary tract infection (Acute cystitis, pyelonephritis and asymptomatic bacteriuria).

lead_sponsor: Hopital Foch


title: A French Non Interventional Multicentric Cohort Study in Patients With Colorectal Dysplasia in Intestinal Inflammatory Diseases

summary:
The main purpose is to describe clinical practices nowadays prospectively about patients with a dysplasia diagnosis or another histological lesions.

It will be identified colic situation during the initial colonoscopy after dysplasia diagnosis or atypical lesion.

Also the frequency and the type of monitoring conducted about these patients(surgical and endoscopic treatments).

The main criterion evaluation will be the surgical and endoscopic rates during the time.

The treatments offered such as surgical, endoscopic ones or none of them will be followed.

Finally, the outcome of these patients: stability, lesion disappearance, surgery or development of cancer with frequencies for each of them and relationships with histological abnormal colorectal lesion will be measured.

status: Active, not recruiting

lead_sponsor: Hôpital Edouard Herriot

status_simplified: Ongoing


title: Comparison of Difficult Intubation Rates Using McGrath Mac Video Laryngoscope vs Standard Macintosh Laryngoscope in Critically Ill Patients - a Prospective Interventional Study

summary: Difficult intubation is associated with a worse outcome in intensive care unit (ICU). New videolaryngoscope devices are proposed to improve airway management in ICU patients. We aimed to compare a new videolaryngoscope called " McGrath Mac Video Laryngoscope" vs standard Macintosh Laryngoscope in critically ill patients on difficult intubation and/or Cormack 3-4 rates in a prospective interventional study.The present study was conducted to test the hypothesis that the implementation of a quality-improvement process for airway management using a new videolaryngoscope would be associated with a decreased incidence of difficult intubation and/or Cormack 3-4.

location_facility: Centre Hospitalier Universitaire Montpellier, Saint Eloi


title: Evaluation of Efficacy and Patient Acceptance of Sound Amplifier Téo First, in Mild and Moderate Presbycusis Patient 60 Years of Age and Older, With no Previous Hearing Aid.

acronym: TEO FIRST

summary:
A personal sound amplifying device (PASP) like Teo First is a wearable electronic product that is not intended to compensate for impaired hearing, but rather is intended for non-hearing impaired consumers to amplify sounds in the environment for a number of reasons, such as for recreational activities. Nevertheless, a lot of mild and moderate impaired hearing people don't want to buy and wear all day a real hearing aid.

The goal of our study is to evaluate the benefit of such a device for mild and moderate presbycusis patient 60 years of age and older, with no previous hearing aid.

ReferenceCitation: Sacco G, Gonfrier S, Teboul B, Gahide I, Prate F, Demory-Zory M, Turpin JM, Vuagnoux C, Genovese P, Schneider S, Guérin O, Guevara N. Clinical evaluation of an over-the-counter hearing aid (TEO First®) in elderly patients suffering of mild to moderate hearing loss. BMC Geriatr. 2016 Jul 9;16:136. doi: 10.1186/s12877-016-0304-4.

family: Sacco

full_name: Guillaume Sacco

given: Guillaume

family: Gonfrier

full_name: Sébastien Gonfrier

given: Sébastien

family: Teboul

full_name: Bernard Teboul

given: Bernard

family: Gahide

full_name: Ivan Gahide

given: Ivan

family: Prate

full_name: Fredéric Prate

given: Fredéric

family: Demory-Zory

full_name: Mathilde Demory-Zory

given: Mathilde

family: Turpin

full_name: Jean-Michel Turpin

given: Jean-Michel

family: Vuagnoux

full_name: Claire Vuagnoux

given: Claire

family: Genovese

full_name: Philippe Genovese

family: Schneider

full_name: Stéphane Schneider

given: Stéphane

family: Guérin

full_name: Olivier Guérin

family: Guevara

full_name: Nicolas Guevara

given: Nicolas

journal_name: BMC Geriatrics

lead_sponsor: Centre Hospitalier Universitaire de Nice


type: Registry Identifier

title: Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery

summary:
The idea is to assess the predictive value of flow magnetic resonance imaging (flow MRI) for patient suffering normal pressure hydrocephalus (NPH) planned for surgery. By now, the depletive lumbar puncture is the best test assessing the efficacy of a forthcoming surgery. The idea is to demonstrate that flow MRI can be as effective as lumbar puncture in term of predictive value of surgery response.

In that way, cerebrospinal fluid (CSF) dynamics are evaluated by a single non invasive examination. CSF flow is measured at the Sylvius' aqueduct, cervical, arachnoid space and 4th ventricle levels.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


acronym: AIRPEDIA

summary:
The aim of the study is to assess the cost-effectiveness of telemedicine in the care of chronic diabetic foot ulcers.

Patients will be randomized into 2 groups: 1/conventional care group with iterative visits to diabetes specialist or 2/innovative care (telemedicine group).

the health insurance system perspective is adopted.

ReferenceCitation: Hazenberg CE, Bus SA, Kottink AI, Bouwmans CA, Schönbach-Spraul AM, van Baal SG. Telemedical home-monitoring of diabetic foot disease using photographic foot imaging--a feasibility study. J Telemed Telecare. 2012 Jan;18(1):32-6. doi: 10.1258/jtt.2011.110504. Epub 2011 Nov 8.

ReferenceCitation: Foltynski P, Ladyzynski P, Migalska-Musial K, Sabalinska S, Ciechanowska A, Wojcicki J. A new imaging and data transmitting device for telemonitoring of diabetic foot syndrome patients. Diabetes Technol Ther. 2011 Aug;13(8):861-7. doi: 10.1089/dia.2011.0004. Epub 2011 May 13.

ReferenceCitation: Bowling FL, King L, Paterson JA, Hu J, Lipsky BA, Matthews DR, Boulton AJ. Remote assessment of diabetic foot ulcers using a novel wound imaging system. Wound Repair Regen. 2011 Jan-Feb;19(1):25-30. doi: 10.1111/j.1524-475X.2010.00645.x. Epub 2010 Dec 6.

ReferenceCitation: Larsen SB, Clemensen J, Ejskjaer N. A feasibility study of UMTS mobile phones for supporting nurses doing home visits to patients with diabetic foot ulcers. J Telemed Telecare. 2006;12(7):358-62.

ReferenceCitation: Wilbright WA, Birke JA, Patout CA, Varnado M, Horswell R. The use of telemedicine in the management of diabetes-related foot ulceration: a pilot study. Adv Skin Wound Care. 2004 Jun;17(5 Pt 1):232-8.

ReferenceCitation: Muller M, David-Tchouda S, Margier J, Oreglia M, Benhamou PY. Comment on Rasmussen et al. A Randomized Controlled Trial Comparing Telemedical and Standard Outpatient Monitoring of Diabetic Foot Ulcers. Diabetes Care 2015;38:1723-1729. Diabetes Care. 2016 Jan;39(1):e9-10. doi: 10.2337/dc15-1659.

family: Muller

full_name: Marie Muller

given: Marie

family: David-Tchouda

full_name: Sandra David-Tchouda

given: Sandra

family: Margier

full_name: Jennifer Margier

given: Jennifer

family: Oreglia

full_name: Maurine Oreglia

given: Maurine

family: Benhamou

full_name: Pierre-Yves Benhamou

given: Pierre-Yves

journal_name: Diabetes Care

oa_host_type: publisher

evidence: open (via free pdf)

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

title: Comment on Rasmussen et al. A Randomized Controlled Trial Comparing Telemedical and Standard Outpatient Monitoring of Diabetic Foot Ulcers. Diabetes Care 2015;38:1723–1729


title: Assessment of the Subcutaneous Reinjection of Human Autologous Adipose-derived Stromal Vascular Fraction (Celution® System) in the Hands of Patients Suffering From Systemic Sclerosis

summary:
Systemic sclerosis is an autoimmune disease characterized by skin lesions and visceral responsible for significant morbidity. Microcirculatory disorders and tissue fibrosis are excessive severity of the disease. This condition can affect the hands with a major functional consequence severely impairing the quality of life of patients.

Adipose tissue is used in plastic surgery for over a century for the filling of depressions in the skin. In addition to the volume effect, a trophic effect on the surrounding tissue was noted. It is shown that the stromal vascular fraction is responsible for this regenerative effect.

In a previous study the investigators have demonstrated in a mouse model that the subcutaneous adipose tissue provides a trophic effect on SSc skin lesions by reducing the fibrosis of the dermis and providing a pro angiogenic.

Objectives and means:

This is a clinical study evaluating an innovative cell therapy procedure. The objective of this study was to evaluate the effects of injection of autologous stromal vascular fraction of adipose origin according to the system Celution ® (Cytori Therapeutics, Inc.., United Kingdom) in digital in patients with scleroderma cutaneous hands.

Eleven patients with scleroderma with the hands will be included in the study. Due to the nature of the orphan disease, a longitudinal study be conducted, where each patient will have own control.

The evaluation will be pre and post operative for a period of six months. This evaluation will be based on clinical criteria (trophic balance, functional) and laboratory (capillaroscopy, Doppler ultrasound of the arteries of the forearm, laser-Doppler tissue).

Project schedule and implementation phases:

The project will run over a period of twelve months. Patients will be followed for a period of six months. Analyzes clinical, paraclinical, and exploitation of results will be achieved over a period of six months.

Expected Results: This study will validate the functional and trophic effects of reinjection of autologous stromal vascular fraction of adipose tissue issue on the fingers of patients with scleroderma.

Conclusion: This innovative cell therapy could represent an alternative treatment for patients with scleroderma in check, intolerant or insufficiently relieved by medical treatment currently available in the scleroderma hand

ReferenceCitation: Granel B, Daumas A, Jouve E, Harlé JR, Nguyen PS, Chabannon C, Colavolpe N, Reynier JC, Truillet R, Mallet S, Baiada A, Casanova D, Giraudo L, Arnaud L, Veran J, Sabatier F, Magalon G. Safety, tolerability and potential efficacy of injection of autologous adipose-derived stromal vascular fraction in the fingers of patients with systemic sclerosis: an open-label phase I trial. Ann Rheum Dis. 2015 Dec;74(12):2175-82. doi: 10.1136/annrheumdis-2014-205681. Epub 2014 Aug 11.

family: Granel

full_name: Brigitte Granel

given: Brigitte

family: Daumas

full_name: Aurélie Daumas

given: Aurélie

family: Jouve

full_name: Elisabeth Jouve

given: Elisabeth

family: Harlé

full_name: Jean-Robert Harlé

given: Jean-Robert

family: Nguyen

full_name: Pierre-Sébastien Nguyen

given: Pierre-Sébastien

family: Chabannon

full_name: Christian Chabannon

given: Christian

family: Colavolpe

full_name: Nathalie Colavolpe

given: Nathalie

family: Reynier

full_name: Jean-Charles Reynier

given: Jean-Charles

family: Truillet

full_name: Romain Truillet

given: Romain

family: Mallet

full_name: Stéphanie Mallet

given: Stéphanie

family: Baiada

full_name: Antoine Baiada

given: Antoine

family: Casanova

full_name: Dominique Casanova

given: Dominique

family: Giraudo

full_name: Laurent Giraudo

family: Arnaud

full_name: Laurent Arnaud

family: Veran

full_name: Julie Veran

given: Julie

family: Sabatier

full_name: Florence Sabatier

given: Florence

family: Magalon

full_name: Guy Magalon

given: Guy

journal_name: Annals of the Rheumatic Diseases

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

publisher: BMJ

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: Randomized Phase III Study of Gemcitabine/Cisplatine (GC) Versus High-dose Intensity Methotrexate, Vinblastine, Doxorubicine and Cisplatin (HD-MVAC) in the Perioperative Setting for Patients With Locally Advanced Transitional Cell Cancer of the Bladder

acronym: VESPER

summary: Radical cystectomy remains the gold standard treatment for invasive non metastatic transitional cell cancer (TCC) of the bladder. In contemporary series, specific survival rates are about 60 to 65% at 5 years, decreasing for locally advanced disease to 45-50% in patients with nonorgan-confined lymph-node negative tumours and to 30-35% in patients with lymph node positive tumours. Perioperative chemotherapy (adjuvant ou neoadjuvant) has been developed in order to improve these results. Thanks to randomized trials and meta-analysis, it can be concluded that perioperative chemotherapy increases overall survival with an absolute benefit of 5%, equating to a survival rate of 50% at 5 years for nonorgan-confined tumours. However, the chemotherapy administration time and the optimal chemotherapy regimen to be delivered are not yet determined. Meta-analyses have shown that the benefit is only observed for chemotherapy regimens including cisplatin. In daily management 4 to 6 cycles of gemcitabine and cisplatin are delivered since this combination has been shown to yield a similar efficacy with a better tolerance as compared to the MVAC regimen (methotrexate, vinblastine, doxorubicin and cisplatin) in the metastatic setting. As HD-MVAC has been shown to be associated with higher response rates than MVAC in bladder metastatic disease, also a better efficacy of HD-MVAC can be suspected in the perioperative setting. Investigators therefore designed a randomized phase III study to compare the efficacy of GC and HD-MVAC in term of progression-free survival in patients for whom chemotherapy has been decided, before or after radical cystectomy. Secondary endpoints include overall survival, side effects, response rate in the neoadjuvant setting and ancillary studies focusing on gemcitabine and cisplatin sensitivity. The total number of patients projected is 500. The number of patients is based on the median progression-free survival rate of 50% at 3 years observed in patients treated with GC (standard arm A) in the perioperative setting. An absolute improvement of 10% (HR=0.74) is expected with HD-MVAC (experimental arm B) with a=0.05 and b=0.20. An interim analysis is planned after the occurrence of 174 events. With an estimated uniform accrual rate of 140 patients per year for 3.5 years and exponential survival, the final analysis is expected to occur 8 years after the start of the trial.

lead_sponsor: University Hospital, Rouen


title: Mesure de l'Index de Pression Systolique de Cheville après Test d'Effort Maximal.

acronym: VICTOR

summary:
Estimate the response of ankle to brachial pressure index to incremental maximum exercise in subjects free from prior cardiovascular disease.

Estimate morbi-mortality of included patients over a 5 years follow up.

primary_purpose: Diagnostic

ReferenceCitation: Congnard F, Abraham P, Vincent F, Le Tourneau T, Carre F, Hupin D, Hamel JF, Vielle B, Bruneau A. Ankle to brachial systolic pressure index at rest increases with age in asymptomatic physically active participants. BMJ Open Sport Exerc Med. 2015 Nov 25;1(1):e000081. eCollection 2015.


title: Benefits Study of a Respiratory Gating Protocol for Positron Emission Tomography: Application on the Lungs

acronym: PneumoTEP

summary:
Fluorodeoxyglucose (FDG) positron emission tomography (PET) is now widely used for cancer imaging purpose, notably for preoperative work-up. It aims at visualizing organs metabolism. In case of cancer, metabolism is, classically, increased and some hot spots are visible on PET images. Because of respiratory motion some lung tumours (especially the smallest ones) can be falsely interpreted by the clinician.

The investigators developed a respiratory-gated PET method in order to reduce the motion issue. The investigators designed a study to investigate its effect on lung cancer (primary or metastasis) to check if it improves the sensitivity/specificity of PET imaging of the lungs.

To that aim, patients presenting a lung nodule on a CT examination can be proposed to participate this study. After the standard PET acquisition (acquired in free-breathing), an additional 10 minutes respiratory-gated PET acquisition is performed without additional injection. After that, a breath-hold (~10s) CT is performed.

ReferenceCitation: Daouk J, Leloire M, Fin L, Bailly P, Morvan J, El Esper I, Saidi L, Moullart V, François G, Jounieaux V, Meyer ME. Respiratory-gated 18F-FDG PET imaging in lung cancer: effects on sensitivity and specificity. Acta Radiol. 2011 Jul 1;52(6):651-7. doi: 10.1258/ar.2011.110018. Epub 2011 Apr 21.

name: Nuclear Medicine Department Amiens University Hospital, Amiens

name: Medical School, University of Picardy Jules Verne, Amiens

family: Daouk

full_name: Joël Daouk

given: Joël

family: Leloire

full_name: Marie Leloire

given: Marie

name: Clinical Trial and Innovation Department, Amiens University Hospital, Amiens

family: Fin

full_name: Loïc Fin

given: Loïc

family: Bailly

full_name: Pascal Bailly

given: Pascal

family: Morvan

full_name: Julie Morvan

family: El Esper

full_name: Isabelle El Esper

given: Isabelle

family: Saidi

full_name: Lazhar Saidi

given: Lazhar

family: Moullart

full_name: Véronique Moullart

given: Véronique

name: Department of Respiratory Medicine, Amiens University Hospital, Amiens, France

family: François

full_name: Géraldine François

given: Géraldine

family: Jounieaux

full_name: Vincent Jounieaux

given: Vincent

family: Meyer

full_name: Marc-Etienne Meyer

given: Marc-Etienne

journal_name: Acta Radiologica

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

ReferenceCitation: Daouk J, Bailly P, Kamimura M, Sacksick D, Jounieaux V, Meyer ME. Positron emission tomography-based evidence of low-amplitude respiratory motion in patients with chronic obstructive pulmonary disease. Ann Nucl Med. 2015 May;29(4):319-24. doi: 10.1007/s12149-014-0945-3. Epub 2015 Jan 8.

family: Kamimura

full_name: Mitsuhiro Kamimura

given: Mitsuhiro

family: Sacksick

full_name: David Sacksick

given: David

journal_name: Annals of Nuclear Medicine


title: Co-analgesic Effects of Dexamethasone and Pregabalin After Lumbar Slipped Disc Surgery

acronym: DEXA-PG-HD

summary:
The aim of the study is to show a decrease in postoperative pain during the first postoperative mobilization surgery lumbar disc herniation through a co-analgesia with a single dose of dexamethasone, pregabalin, or a combination of these two products.

Pain assessed by simple numerical scale will be also evaluated during the 48 first post-operative hours.

Determining an optimal co-analgesic protocol through the results of this study could help develop validation studies with larger scale such as a medico-economic component. In addition, these study protocols are easy to apply (ponctual administration) and inexpensive.

ReferenceCitation: Momon A, Verdier B, Dolomie JO, Gardette M, Pereira B, Curt I, Dualé C. A Single Preoperative Administration of Dexamethasone, Low-dose Pregabalin, or a Combination of the 2, in Spinal Surgery, Does Not Provide a Better Analgesia Than a Multimodal Analgesic Protocol Alone. Clin J Pain. 2019 Jul;35(7):594-601. doi: 10.1097/AJP.0000000000000719.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Multicenter Randomized Study for Medico-economic Evaluation of Embolization With Flow Diverter Stent in the Endovascular Treatment of Unruptured Saccular Wide-necked Intracranial Aneurysms

acronym: EVIDENCE

summary: Unruptured saccular intracranial aneurysms larger than 7 mm can be treated with endovascular occlusion using detachable coils, with or without expendable stent assistance. A new endovascular technique has recently been developed, using flow diverter stents without associated coils. Clinical results already published are encouraging but have to be confirmed. Furthermore, these medical devices are expensive in comparison to the coiling strategy. The purpose of this study is to compare the clinical efficacy, safety, and cost-effectiveness of endovascular coiling and endovascular flow diversion for unrupted saccular intracranial aneurysms.

lead_sponsor: Hospices Civils de Lyon


title: Study of Microcirculatory Effects of Bevacizumab in Patients Treated for Metastatic Colon Cancer or Glioblastoma

acronym: BEVACAPI

summary:
The treatment of the most common cancers (colon, breast, lung, liver and kidney) has recently added a new therapeutic class known as the "anti-angiogenic". It was born from a better understanding of tumor growth requires the development of neo-vessels. These new vessels are of major importance for the viability of the tumor but also the birth of metastases. This neo-angiogenesis is complex and results from an imbalance between pro-angiogenic factors and anti-angiogenic factors. Growth factor VEGF and its receptors (VEGFR-1, VEGFR-2 and VEGFR-3) are a way of survival of endothelial cells required for tumor neoangiogenesis. The anti-angiogenic drugs currently available on the market are bevacizumab (Avastin ®), sunitinib (Sutent ®) and sorafenib (Nexavar ®). The mechanism of anti-angiogenic action of these three main drugs are pharmacological inhibition of the VEGF pathway.

These new anti-angiogenic therapies, however, have significant adverse effects are common and some other more serious but rare.

Hypertension is the most common side effect observed in patients treated with anti-VEGF. This is usually iatrogenic hypertension controlled by antihypertensive therapy and rarely compromises the pursuit of anti-angiogenic therapy. More rarely, it can have serious consequences malignant hypertension, severe hypertension refractory reversible posterior leukoencephalopathy associated with severe hypertension have also been reported.

The pathophysiology of hypertension may be due to the neutralization of major physiological effects of VEGF in endothelial cell and therefore the vascular wall.

The study of the microcirculation is not only useful in the diagnosis of microvascular but also macrovascular disease in the evaluation of chronic arterial and venous severe it determines the prognosis. In these indications, capillaroscopy remains the gold standard for all work pathophysiological because visualization of phenomena measured avoids artifacts and difficulties of interpretation. It then appealed to additional technology to directly measure the capillary pressure, capillary flow velocity, and indirectly assess capillary permeability and function of lymphatic canaliculi. The simplest of these technological inputs: video microscopy and digital image analysis, have also improved the practice of routine clinical capillaroscopy in its main field of application, evaluation of microangiopathy connective. The examination can be performed more quickly and easily archived and quantified.

Only two studies on 14 and 16 patients were able to see a decrease in capillary density correlated with the therapeutic activity of anti-angiogenic the tumor mass and metastasis.

Thus, we propose to quantify in a number of relatively large patient patients the decrease in capillary density as well as the relationship between the decrease in the number of capillaries and anti-tumor response.

The study will also aim to measure the prevalence of hypertension in patients treated with bevacizumab and to establish the link between these data and the modification of the capillary microcirculation.

design_allocation: Non-Randomized

ReferenceCitation: Fumet JD, Bertaut A, Bengrine L, Lapierre P, Vincent J, Ghiringhelli F, Falvo N. Capillary density has no value as an early biomarker of bevacizumab efficacy in metastatic colorectal cancers: a prospective clinical trial. Oncotarget. 2017 Dec 1;9(16):12599-12608. doi: 10.18632/oncotarget.22822. eCollection 2018 Feb 27.

name: Department of Medical Oncology, Centre Georges-François Leclerc, Dijon, France

family: Fumet

full_name: Jean-David Fumet

given: Jean-David

name: Department of Epidemiology and Biostatistics, Georges François Leclerc Center, Dijon, France

name: Center of Clinical Research, Georges François Leclerc Center, Dijon, France

family: Bertaut

full_name: Aurélie Bertaut

given: Aurélie

family: Bengrine

full_name: Leila Bengrine

given: Leila

family: Lapierre

full_name: Patricia Lapierre

given: Patricia

family: Vincent

full_name: Julie Vincent

family: Ghiringhelli

full_name: François Ghiringhelli

given: François

name: Department of Radiology, François-Mitterrand Teaching Hospital, Dijon, France

family: Falvo

full_name: Nicolas Falvo

given: Nicolas

journal_name: Oncotarget

publisher: Impact Journals, LLC

publisher_dissemination: Impact Journals, LLC

publisher_group: Impact Journals, LLC

publisher_normalized: Impact Journals, LLC

lead_sponsor: Centre Georges Francois Leclerc


title: Characterization of the Digestive Functions and the Enteric Nervous System in Obesity. Investigations of Relationships With Metabolism Disorders(EnteroNeurObesity)

summary: 60 patients scheduled for bariatric surgery will be included into 3 categories (20 patients with non complicated obesity, 20 patients with metabolic syndrome and 20 patients with a type 2 diabetes or hypertension). 20 volunteers will be enrolled as normal referents. The patients and the volunteers will have a classical pre-operative check-up (fibroscopy, oesophageal pHmetry and manometry) and extra investigations as isotopic gastric empty exam, lactulose oro-caecal transit exam, intestinal permeability test calculated by lactulose-manitol ratio urinary excretion. Intestinal and colonic biopsies will be also provided for studying permeability. For only patients, samples from the gastric resection will be provided for analysing the enteric nervous system and motricity.

lead_sponsor: Nantes University Hospital


title: Comparison of Two Strategies of Oropharyngeal and Tracheal Suctioning in Mechanically Ventilated Patients: a Pilot Trial

acronym: AMYLASPI

summary: The purpose of this study is to evaluate the impact of an optimized suctioning procedure on the risk of endotracheal microaspiration, measured by tracheal to oropharyngeal ratio of amylase enzymatic activity.

ipd_sharing: No

lead_sponsor: University Hospital, Bordeaux


title: Comparison of the Efficacy of Subthalamic Nucleus, Caudate Nucleus and Nucleus Accumbens Electric Stimulation in Severe and Resistant Obsessive-compulsive Disorder.

summary:
Deep brain stimulation (DBS) has been proposed for severe and resistant obsessive-compulsive disorder. This electrical stimulation has been tested on, and shown to be effective at, different targets (subthalamic nucleus, caudate nucleus & nucleus accumbens). However, the efficacies of each target have never been compared directly.

This protocol aims to do so, with the hypothesis that subthalamic (STN) stimulation will be more efficacious.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre d'investigation Clinique Pitié Salpêtrière


title: Evaluation of Cardiovascular Risk Profile in Adult Patients With Congenital Adrenal Hyperplasia Due to 21-hydroxylase Deficiency Diagnosed During Childhood

acronym: cardiohcs

summary: Treatment with glucocorticoids and mineralocorticoids has changed congenital adrenal hyperplasia (CAH) from a fatal to a chronic lifelong disease. Long-term treatment, in particular the chronic (over-)treatment with glucocorticoids, may have an adverse effect on the cardiovascular risk profile in adult CAH patients. The objective of this study was to evaluate the cardiovascular risk profile of adult CAH patients.

time_perspective: Cross-Sectional


title: Quantification of Biomechanical Parameters of Functional Task Time Up and Go in Hemiplegic Patients

acronym: TUG

summary: Investing the Timed Up and Go (TUG) Test in Hemiplegic Patients Using 3D Motion Analysis


title: Evaluation of the Short Effects of a Rehabilitation Session on Gait Parameters in Patients With a Lesion of the Central Nervous System

summary:
The aim of the study is to evaluate the short effects of a two rehabilitation session commonly performed in physical therapy,

muscle strengthening of the lower limbs and
effort reconditioning with cyclo ergometer, on gait characteristics (kinematics, kinetics and electromyographic) in patients with central nervous system lesion.


title: A Phase 2, Double-blind Randomized, Sequential Treatment Group, Placebo-controlled Study To Evaluate The Safety, Tolerability And Brain Cortico-striatal Function Of 2 Doses Of Pf-02545920 In Subjects With Early Huntington's Disease

summary: This study will evaluate the Safety, Tolerability and Brain Function of 2 doses of PF-0254920 in Subjects with Early Huntington's Disease.

lead_sponsor: Pfizer

location_facility: Centre d'Investigation Clinique (CIC)/ Institut du Cerveau et de la Möelle Epinière (ICM)


title: Comparative Study of the Efficiency of Zonisamide in Myoclonus Dystonia: A Monocentric , Randomized in Cross Over and Double Blind Study Versus Placebo Study

acronym: EpsilonZêta

summary:
Myoclonus Dystonia is a disease in which myoclonus distort the precision of movements and so cause a handicap in the movements of the everyday life. Response to oral medications may be incomplete and surgery may cause operating risk.

Zonisamide is an antiepileptic drug which could bring a therapeutic profit in Myoclonus Dystonia on the severity of the myoclonus.


title: Satisfaction and Quality of Life in Patients With a Diagnosis of DVT (Deep Venous Thrombosis) Who Take Rivaroxaban

acronym: SATORI

summary: National, multicenter, prospective, observational, non-interventional study. The objective is to determine if the switch from Vitamin K antagonists (VKA) to Xarelto in subjects treated with VKA with issues in deep venous thrombosis (DVT), and prevention of recurrent DVT and pulmonary embolism (PE) is associated with an improvement of the treatment satisfaction after 3 months. The treatment satisfaction will be measured by the Anti Clot Treatment Scale (ACTS) score.

lead_sponsor: Bayer


title: Satisfaction and Quality of Life in Patients With a Diagnosis of Non Valvular Atrial Fibrillation Who Take Rivaroxaban for Stroke Prevention

acronym: SAFARI

summary: National, multicenter, prospective, observational, non-interventional study. The objective is to determine if the switch from Vitamin K antagonists (VKA) to Xarelto in subjects treated with VKA with issues for stroke prevention in non valvular atrial fibrillation is associated with an improvement of the treatment satisfaction after 3 months. The treatment satisfaction will be measured by the Anti Clot Treatment Scale (ACTS) score.


title: Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma- A Randomized Multicenter Trial

acronym: ASTER

summary: To assess the efficacy of an Angiotensin-II inhibitor (Losartan) to reduce peritumoral edema in newly diagnosed glioblastoma patients.

ReferenceCitation: Ursu R, Thomas L, Psimaras D, Chinot O, Le Rhun E, Ricard D, Charissoux M, Cuzzubbo S, Sejalon F, Quillien V, Hoang-Xuan K, Ducray F, Portal JJ, Tibi A, Mandonnet E, Levy-Piedbois C, Vicaut E, Carpentier AF. Angiotensin II receptor blockers, steroids and radiotherapy in glioblastoma-a randomised multicentre trial (ASTER trial). An ANOCEF study. Eur J Cancer. 2019 Mar;109:129-136. doi: 10.1016/j.ejca.2018.12.025. Epub 2019 Feb 1.

family: Ursu

full_name: R. Ursu

given: R.

family: Thomas

full_name: L. Thomas

given: L.

family: Psimaras

full_name: D. Psimaras

given: D.

family: Chinot

full_name: O. Chinot

given: O.

family: Le Rhun

full_name: E. Le Rhun

given: E.

family: Ricard

full_name: D. Ricard

family: Charissoux

full_name: M. Charissoux

given: M.

family: Cuzzubbo

full_name: S. Cuzzubbo

given: S.

family: Sejalon

full_name: F. Sejalon

given: F.

family: Quillien

full_name: V. Quillien

given: V.

family: Hoang-Xuan

full_name: K. Hoang-Xuan

given: K.

family: Ducray

full_name: F. Ducray

family: Portal

full_name: J.-J. Portal

family: Tibi

full_name: A. Tibi

given: A.

family: Mandonnet

full_name: E. Mandonnet

family: Levy-Piedbois

full_name: C. Levy-Piedbois

given: C.

family: Vicaut

full_name: E. Vicaut

family: Carpentier

full_name: A.F. Carpentier

journal_name: European Journal of Cancer

oa_host_type: repository

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

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

title: Angiotensin II receptor blockers, steroids and radiotherapy in glioblastoma—a randomised multicentre trial (ASTER trial). An ANOCEF study

location_facility: Neurology Department - Avicenne Hospital


title: RAS Blockade at Bedtime Versus on Awakening for the Prevention of Aldosterone Breakthrough

summary:
Objective:

To show that the frequency of aldosterone breakthrough is lower when RAS blockers are given at bedtime compared to on awaking, and to analyze the determinants and consequences of aldosterone breakthrough.

Duration of the study: Inclusion 2 years, follow-up one year, total 3 years Design: prospective, multicenter, randomized, controlled, open label, two parallel groups.

Main selection criteria:

Inclusion criteria

Chronic kidney disease stage 3 to 4,
ACEI (captopril, enalapril, or ramipril), and/or ARB (losartan, valsartan, or irbesartan) on awaking for at least three months,
History of hypertension or proteinuria > 0,5 g/24h or g/g créatininurie.

Exclusion criteria

Office blood pressure ≥ 160/100 mmHg,
Anti-aldosterone (spironolactone, eplerenone) or potassium sparing diuretics (modamide, amiloride), or direct renin inhibitor.

Evaluation criteria:

Primary: Serum aldosterone levels at one year.

Secondary:

Serum aldosterone/renin ratio,
24h urine aldosterone,
Significant aldosterone breakthrough defined by a >10% increase of serum aldosterone levels over baseline values,
Aldosterone breakthrough defined by an increase of serum aldosterone levels over baseline values,
HbA1c,
Urinary albumin/creatinine ratio (UACR) on spot morning urine samples,
Systolic home blood pressure (SBP),
Estimated glomerular filtration rate (eGFR) using the MDRD equation.

location_facility: Department of Nephrology, Nice University Hospital


title: Study of the Association Between Digital Osteoarthritis and Lower Limb Osteoarthritis (Knee and Hip) in Terms of Severity and Evolution - Khoala Group Ancillary Project / Cohort Khoala

acronym: Khoala

summary: Among the risk factors for lower limb osteoarthritis, if obesity is probably the most studied, digital osteoarthritis received increasing interest in recent years. Recent publications have highlighted a link between obesity and digital osteoarthritis, but also a very probable link between digital osteoarthritis and structural progression of knee osteoarthritis. Few data including hip exist and need to be confirmed on larger scale studies. We have with "Khoala" a national multiregional cohort of symptomatic gonarthrosis and coxarthrosis representative of the general population (which is rarely the case in the literature) including X ray, clinical and biological follow-up (hips and / or knees).

location_facility: Department of rheumatology, nice university hospital

intervention_type: Radiation


title: Assessment of Human Locomotion and Energy Expenditure Using Global Positioning Satellite and Accelerometry

acronym: ActiGPS

summary:
The aim of the study is to validate the association of the GPS and accelerometer tools in order to assess the humain locomotion during exercises.

The hypotheses are:

GPS and accelerometer together can assess the human locomotion
GPS and accelerometer together can assess the energy expenditure during exercises

ReferenceCitation: de Müllenheim PY, Dumond R, Gernigon M, Mahé G, Lavenu A, Bickert S, Prioux J, Noury-Desvaux B, Le Faucheur A. Predicting metabolic rate during level and uphill outdoor walking using a low-cost GPS receiver. J Appl Physiol (1985). 2016 Aug 1;121(2):577-88. doi: 10.1152/japplphysiol.00224.2016. Epub 2016 Jul 8.

name: Movement, Sport and Health Laboratory (EA 1274), Faculty of Sport Sciences, University of Rennes 2, Rennes, France;

family: de Müllenheim

full_name: Pierre-Yves de Müllenheim

given: Pierre-Yves

family: Dumond

full_name: Rémy Dumond

given: Rémy

name: Laboratory for Vascular Investigations and Sports Medicine, University Hospital, Angers, France;

name: Laboratory of Physiology, Institut National de la Santé et de la Recherche Médicale UMR 1083, Centre National de la Recherche Scientifique UMR 6214, Medical School, University of Angers, Angers, France;

family: Gernigon

full_name: Marie Gernigon

given: Marie

name: Clinical Investigation Center, Institut National de la Santé et de la Recherche Médicale CIC 1414, Rennes, France;

name: Heart Vessels Imaging Team, University Hospital, Rennes, France;

family: Mahé

full_name: Guillaume Mahé

given: Guillaume

name: Laboratory of Experimental and Clinical Pharmacology, Medical School, University of Rennes 1, Rennes, France;

family: Lavenu

full_name: Audrey Lavenu

given: Audrey

family: Bickert

full_name: Sandrine Bickert

given: Sandrine

name: Department of Sport Sciences and Physical Education, Ecole normale supérieure de Rennes, Campus de Ker Lann, Bruz, France;

family: Prioux

full_name: Jacques Prioux

given: Jacques

name: Institute of Physical Education and Sports Sciences (IFEPSA), Université Catholique de l'Ouest, Les Ponts-de-Cé, France; and

family: Noury-Desvaux

full_name: Bénédicte Noury-Desvaux

given: Bénédicte

family: Le Faucheur

full_name: Alexis Le Faucheur

given: Alexis

journal_name: Journal of Applied Physiology

publisher: American Physiological Society

publisher_dissemination: American Physiological Society

publisher_group: American Physiological Society

publisher_normalized: American Physiological Society


title: Electrophysiological Study of Interindividual Differences in Speech-understanding Among Cochlear Implant Patients

summary: Differences in speech-understanding and the quality of the subjective perception among cochlear implant patients (Digisonic SP) depends on numerous factors. The electrical field distribution (interaction between electrodes) could also explain the disparity of the performances? The objective of our study was to quantify the influence of the electrical field interactions between the channels of stimulation according to the vocal performances of the implanted subjects, for various subjective levels of electric stimulation.

primary_purpose: Health Services Research

ReferenceCitation: Guevara N, Hoen M, Truy E, Gallego S. A Cochlear Implant Performance Prognostic Test Based on Electrical Field Interactions Evaluated by eABR (Electrical Auditory Brainstem Responses). PLoS One. 2016 May 5;11(5):e0155008. doi: 10.1371/journal.pone.0155008. eCollection 2016.

family: Guevara

full_name: Nicolas Guevara

given: Nicolas

family: Hoen

full_name: Michel Hoen

given: Michel

family: Truy

full_name: Eric Truy

given: Eric

family: Gallego

full_name: Stéphane Gallego

given: Stéphane


title: A One Year Longitudinal Therapeutically Non-Interventional Study of MSRV-Env Burden in Normal Population as Assessed by PCR and ELISA in Blood

acronym: CONTROL

summary: This study intends to explore the levels of MSRV expression by analyzing the levels of MSRV transcripts in blood, as well as the levels of the MSRV-Env protein in serum in the normal population. This study is important for establishing a baseline to analyze results obtained in MS patients (another dedicated study is performed in parallel in MS patients). The study will be conducted over one year in a cohort of healthy subjects. The MSRV RNA level, MSRV-Env protein levels, reverse transcriptase activity, inflammatory markers assessed by cytokines levels will be analysed to define control levels in the normal population and their variation during one year. The data obtained in this study in healthy controls will be compared to those obtained in a parallel similar study, GN-E-002, conducted in different types of MS patients.

lead_sponsor: GeNeuro Innovation SAS

location_facility: Etablissement Français du Sang Rhône Alpes - 1 route de Taninges


title: MIBRAIN - Migraine and the Brain: Consequences, Causes, and Vascular Interaction

acronym: MIBRAIN

summary:
Migraine is a very common, chronic/intermittent and disabling neurovascular headache disorder that has long believed to have no severe consequences. Recent evidence, however, strongly suggest that migraine is associated with increased risk of ischemic stroke and there is initial evidence that migraine is associated with structural brain changes independent of the occurrence of stroke.

As migraine has strong links with the vascular system, it is plausible that vascular functions interact on the association between migraine and structural brain changes as well as cognition.

Our primary objectives are to investigate: (i) the relationship of migraine and migraine subtypes on magnetic resonance imaging (MRI) changes in a cohort of patients with active migraine; (ii) the relationship of migraine on cognitive performance among patients with active migraine; and (iii) the relationship of migraine and migraine specifics with vascular functions and morbidity. As secondary objective, we investigate whether the association of migraine on structural brain changes or cognitive performance is modified by vascular functions.

This will be an observational study conducted in the Headache Center in Bordeaux. 300 patients have to be included (150 patients with migraine with aura and 150 patients with migraine without aura).

Inclusion criteria are: all patients with a clearly defined migraine (as per IHS[International Headache Classification] criteria) who are aged 30 and older, are able to fluently speak French, and who are willing to participate.

Exclusion criteria are: pregnant woman and patient who have a major psychiatric disease or major anxiety disorder or had a pacemaker (which would not allow to perform a MRI imaging).

The cognitive status in the patient cohort will be ascertained by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). In addition to the RBANS, we will use the HIT-6 (Headache Impact Test) and MIDAS (MIgraine Disability ASessment) and the depression scale CES-D (Center for Epidemiologic Studies Depression Scale).

Vascular risk status will be assessed by measurement of blood pressure and reports of vascular risk factors. The endothelial function will be measured with a noninvasive Peripheral Arterial Tone (PAT) signal technology using the EndoPAT device (Itamar Medical Inc, Framingham, MA).

For crude comparisons, chi-square tests will be used for categorical variables and t-test for continuous variables. Multivariable-multinominal modeling techniques will be utilized for the comparisons adjusting for potential confounding variables. All statistical tests will be two-tailed and a P <0.05 will be considered statistically significant.

location_facility: Centre Hospitalier Universitaire de Bordeaux


title: Prescription and Utilization of Low Molecular Weight Heparin in Usual Medical Practice for the Curative Treatment of Venous Thromboembolism in Patients With Cancer

summary: The study purpose is to document the prescription and the use of Low Molecular Weight Heparin in usual medical practice in patients with cancer and established Venous Thromboembolism. This study also aims at gathering epidemiological data on the Low Molecular Weight Heparin therapy of Venous Thromboembolism in patients with cancer.

lead_sponsor: LEO Pharma


title: Prevalence of POU4F3 (DFNA15) and SLC17A8 (DFNA25) Genes Mutations in Dominant Autosomal Deafness and Phenotypic Characterization of Carrier Patients.

summary: The study will allow to identify the prevalence of the SLC17A8 gene mutations in patients suffering from deafness. This phenotype also corresponds to DFNA15 deafness caused by POU4F3 : mutations of this gene will be screened as well.

lead_sponsor: University Hospital, Montpellier

intervention_type: Genetic


title: Observational Study of Risk Factors of Neuro-critical Care Complications Regarding Patients Undergoing Brain Tumour Neuro-surgery : a Prospective Validation of the Cranioscore.

acronym: Cranioscore

summary:
Patients undergoing a brain tumour neurosurgery with craniotomy may present rare but lifethreatening post-operative complications. There are currently no strong recommendations to help the clinician in an attempt to properly hospitalise these patients after their intervention (Neuro-ICU, ICU,surgical ward).

Determining risk factors of post-operative complications could optimise resources. Therefore hospitalisation in Neuro-ICU would be mandatory in only a little number of patients.

ReferenceCitation: Ziai WC, Varelas PN, Zeger SL, Mirski MA, Ulatowski JA. Neurologic intensive care resource use after brain tumor surgery: an analysis of indications and alternative strategies. Crit Care Med. 2003 Dec;31(12):2782-7.


title: Does Repetitive Transcranial Magnetic Stimulation (rTMS) Reduce Rectal Hypersensitivity in Patients With IBS ?

summary: The purpose of this study is to evaluate the efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) on rectal hypersensitivity in patients with irritable bowel syndrome (IBS) in a prospective, randomized, double-blind study.

location_facility: Physiology Unit-Rouen university Hospital


title: Prevalence of Obstructive Sleep Apnoea in Patients With Intermittent Claudication

acronym: WITH-SAS

summary: The main aim of this study is to determine how common undiagnosed obstructive sleep apnoea is in individuals with intermittent claudication.

time_perspective: Other

lead_sponsor: University Hospital, Angers


title: Reproducibility of the Ankle-Brachial Index Measurements After a Maximal Exercise

acronym: RICATEM

summary: Hemodynamic changes in the lower limbs are very important and rapid after maximal exercise. The automatic method allows a fastest measurement of the Ankle-Brachial Index (ABI). Thus, it appears important to know whether automatic assessment of ABI is as reliable and reproducible as the manual method.


title: Peripheral Primitive Fibromatosis. Study Evaluating a Simple Initial Monitoring With Search of Scalability Predictive Factors and Registration of Treatments in Case of Progression

acronym: WS-RT Fibro

summary: It's a monitoring study. The aim is to assess the progression free survival up to 3 years. Patients are not treated until progression. Search for scalability predictive factors and registration of treatments if progression.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Calorimetry, Insulin Resistance and Energy Metabolism Study to Understand the Risk of Obesity in Kidney Transplanted Patients

acronym: CALIMERO

summary: Weight gain is a common complication after transplantation. It has adverse effects such as hypertension, dyslipidemia, and insulin resistance. Weight gain is implicated in the increased cardiovascular risk and the long-term loss of graft function. Weight loss achieved by a suitable dietary intervention in these patients transplanted kidney can correct lipid disorders and facilitate balance blood pressure. The identification of mechanisms responsible for weight gain would suggest prevention strategies and allow to align the caloric energy needs of renal transplant patients.


title: Non-invasive Cortical Stimulation for Pharmacoresistant Neuropathic Pain: rTMS Versus tDCS

acronym: NI-MCS

summary: The aim of this study is to compare analgesic efficacy of two non invasive techniques based on motor cortex stimulation in neuropathic pain patients. High frequency repetitive transcranial magnetic stimulation (HF-rTMS) of primary motor cortex has been demonstrated to induce an analgesic effect significantly different from placebo; this effect is clinically useful if rTMS sessions are applied daily during five consecutive days. Transcranial direct current stimulation (tDCS) is a new approach of non invasive cortical stimulation but its efficacy in neuropathic pain has been not yet established. The investigators propose to compare the analgesic effect of 5 tDCS sessions applied daily to a similar protocol using HF-rTMS. In parallel to the clinical therapeutic evaluation, functional-MRI will be performed before and after the five sessions of rTMS and tDCS, in order to reveal the potential plasticity induced within motor somatotopic map of the primary motor cortex.

location_facility: Service de Neurologie Fonctionnelle et Epileptologie, Hôpital Neurologique de Lyon et Unité " Intégration Centrale de la Douleur ", 1028 Inserm - UCBL


title: Continuous EtCO2 Monitoring in Acute Self Poisoned Patients Admitted in an Emergency Department

acronym: CAPNOTOX

summary:
There is no consensus on monitoring criteria in acute self poisoning. Clinical scores, vital signs or lactatemia have failed to prove good predictive value.

The main acute self poisoning complication is decreased consciousness level with consequent increased risk of hypoxemia and aspiration pneumonitis.

Several clinical studies have recently shown that EtCO2 monitoring can be valuable in procedural sedation in the emergency department. It is able to predict hypoxemia before any SaO2 decrease and any complications related to these procedures.

We therefore hypothesized that EtCO2 could help in acute self poisoning patients' monitoring in the ED.

ReferenceCitation: Viglino D, Bourez D, Collomb-Muret R, Schwebel C, Tazarourte K, Dumanoir P, Paquier C, Danel V, Debaty G, Maignan M. Noninvasive End Tidal CO2 Is Unhelpful in the Prediction of Complications in Deliberate Drug Poisoning. Ann Emerg Med. 2016 Jul;68(1):62-70.e1. doi: 10.1016/j.annemergmed.2015.11.037. Epub 2016 Jan 23.

family: Viglino

full_name: Damien Viglino

given: Damien

family: Bourez

full_name: Delphine Bourez

given: Delphine

family: Collomb-Muret

full_name: Roselyne Collomb-Muret

given: Roselyne

family: Schwebel

full_name: Carole Schwebel

given: Carole

family: Tazarourte

full_name: Karim Tazarourte

given: Karim

family: Dumanoir

full_name: Perrine Dumanoir

given: Perrine

family: Paquier

full_name: Carole Paquier

family: Danel

full_name: Vincent Danel

given: Vincent

family: Debaty

full_name: Guillaume Debaty

family: Maignan

full_name: Maxime Maignan

given: Maxime

journal_name: Annals of Emergency Medicine

lead_sponsor: University Hospital, Grenoble


title: Impact of Reconstruction Method (Adaptive Statistical Iterative Reconstruction, Filtered Back Projection) Used in Computed Tomography on Bone Single-Photon- Emission-Computed-Tomography/Computed-Tomography Image Quality

acronym: AsirTest

summary:
The main objective of this study is to demonstrate the non-inferiority of SPECT image quality (as measured by the signal / noise ratio) obtained by ASIR reconstruction of very-low-dose CT acquisitions versus the quality of those obtained by filtered back projection (FBP) of low-dose CT acquisitions.

The lower limit of non-inferiority is set to -1, the average SPECT signal / noise ratio TEMP expected is between 5 and 6.

lead_sponsor: Centre Hospitalier Universitaire de Nīmes


summary: The purpose of this study is to determine whether pamidronate is effective and well-tolerated in the treatment of painful degenerative disk disease, also known as Modic type 1 changes

ReferenceCitation: Cecchetti S, Pereira B, Roche A, Deschaumes C, Abdi D, Coudeyre E, Dubost JJ, Mathieu S, Malochet-Guinamand S, Tournadre A, Couderc M, Vayssade M, Daron C, Soubrier M. Efficacy and safety of pamidronate in Modic type 1 changes: study protocol for a prospective randomized controlled clinical trial. Trials. 2014 Apr 9;15:117. doi: 10.1186/1745-6215-15-117.

family: Cecchetti

full_name: Stella Cecchetti

given: Stella

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Roche

full_name: Antoine Roche

given: Antoine

family: Deschaumes

full_name: Christophe Deschaumes

given: Christophe

family: Abdi

full_name: Dihya Abdi

given: Dihya

family: Coudeyre

full_name: Emmanuel Coudeyre

given: Emmanuel

family: Dubost

full_name: Jean-Jacques Dubost

given: Jean-Jacques

family: Mathieu

full_name: Sylvain Mathieu

given: Sylvain

family: Malochet-Guinamand

full_name: Sandrine Malochet-Guinamand

family: Tournadre

full_name: Anne Tournadre

given: Anne

family: Couderc

full_name: Marion Couderc

given: Marion

family: Vayssade

full_name: Marielle Vayssade

given: Marielle

family: Daron

full_name: Coline Daron

given: Coline

family: Soubrier

full_name: Martin Soubrier

given: Martin

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