title: Genetic Analysis of Familial Cases of Premature Ovarian Failure

acronym: FAMIOP

summary: The Premature ovarian failure (POF) is a rare syndrome observed in women under 40 who induced estrogen deficiency and often leads to infertility final. The etiologies of POF remain unknown in more than 85% of cases. There are 5-10 % of familial cases.The main objective of this study is to recruit, phenotype and genotype 20 families with at least two subjects with nonsyndromic POF in order to identify new loci using a single technical standard nucleotide polymorphisms (SNPs). This study will also include related population and population control.

ReferenceCitation: Lebedin YS, Gorchakov VD, Petrova EN, Kobylyansky AG, Raudla LA, Tatarsky AR, Bobkov EV, Adamova IY, Vasilov RG, Nasonov EL, et al. Ex vivo removal of IgE in atopic asthma by extracorporeal plasmoimmunoadsorption (EPIA): development of a clinical adsorbent. Int J Artif Organs. 1991 Aug;14(8):508-14.

ReferenceCitation: Knauff EA, Franke L, van Es MA, van den Berg LH, van der Schouw YT, Laven JS, Lambalk CB, Hoek A, Goverde AJ, Christin-Maitre S, Hsueh AJ, Wijmenga C, Fauser BC; Dutch POF Consortium. Genome-wide association study in premature ovarian failure patients suggests ADAMTS19 as a possible candidate gene. Hum Reprod. 2009 Sep;24(9):2372-8. doi: 10.1093/humrep/dep197. Epub 2009 Jun 9.

ReferenceCitation: Charbit B, Christin-Maitre S, Demolis JL, Soustre E, Young J, Funck-Brentano C. Effects of testosterone on ventricular repolarization in hypogonadic men. Am J Cardiol. 2009 Mar 15;103(6):887-90. doi: 10.1016/j.amjcard.2008.11.041. Epub 2009 Jan 24.

ReferenceCitation: Rousseau A, Ayoubi F, Deveaux C, Charbit B, Delmau C, Christin-Maitre S, Jaillon P, Uzan G, Simon T. Impact of age and gender interaction on circulating endothelial progenitor cells in healthy subjects. Fertil Steril. 2010 Feb;93(3):843-6. doi: 10.1016/j.fertnstert.2008.10.062. Epub 2008 Dec 25.

ReferenceCitation: Warcoin M, Lespinasse J, Despouy G, Dubois d'Enghien C, Lauge A, Portnoi MF, Christin-Maitre S, Stoppa-Lyonnet D, Stern MH. Fertility defects revealing germline biallelic nonsense NBN mutations. Hum Mutat. 2009 Mar;30(3):424-30. doi: 10.1002/humu.20904.

ReferenceCitation: Madelenat P, Koskas M; Groupe de reflexion sur la contraception progestative. [Update on the progestin-only contraception]. J Gynecol Obstet Biol Reprod (Paris). 2008 Nov;37(7):637-60. doi: 10.1016/j.jgyn.2008.06.013. Epub 2008 Sep 27. French.

ReferenceCitation: Beysen D, De Jaegere S, Amor D, Bouchard P, Christin-Maitre S, Fellous M, Touraine P, Grix AW, Hennekam R, Meire F, Oyen N, Wilson LC, Barel D, Clayton-Smith J, de Ravel T, Decock C, Delbeke P, Ensenauer R, Ebinger F, Gillessen-Kaesbach G, Hendriks Y, Kimonis V, Laframboise R, Laissue P, Leppig K, Leroy BP, Miller DT, Mowat D, Neumann L, Plomp A, Van Regemorter N, Wieczorek D, Veitia RA, De Paepe A, De Baere E. Identification of 34 novel and 56 known FOXL2 mutations in patients with Blepharophimosis syndrome. Hum Mutat. 2008 Nov;29(11):E205-19. doi: 10.1002/humu.20819.

ReferenceCitation: Chakhtoura Z, Bachelot A, Samara-Boustani D, Ruiz JC, Donadille B, Dulon J, Christin-Maitre S, Bouvattier C, Raux-Demay MC, Bouchard P, Carel JC, Leger J, Kuttenn F, Polak M, Touraine P; Centre des Maladies Endocriniennes Rares de la Croissance and Association Surrenales. Impact of total cumulative glucocorticoid dose on bone mineral density in patients with 21-hydroxylase deficiency. Eur J Endocrinol. 2008 Jun;158(6):879-87. doi: 10.1530/EJE-07-0887. Epub 2008 Apr 7.

ReferenceCitation: Christin-Maitre S. [Physiology of ovulation and mode of action of contraceptive pills]. Rev Prat. 2008 Jan 15;58(1):17-20. French.

ReferenceCitation: Christin-Maitre S. The role of hormone replacement therapy in the management of premature ovarian failure. Nat Clin Pract Endocrinol Metab. 2008 Feb;4(2):60-1. doi: 10.1038/ncpendmet0699. Epub 2007 Nov 20. No abstract available.

ReferenceCitation: Tachdjian G, Aboura A, Portnoi MF, Pasquier M, Bourcigaux N, Simon T, Rousseau G, Finkel L, Benkhalifa M, Christin-Maitre S. Cryptic Xp duplication including the SHOX gene in a woman with 46,X, del(X)(q21.31) and premature ovarian failure. Hum Reprod. 2008 Jan;23(1):222-6. doi: 10.1093/humrep/dem358. Epub 2007 Nov 1.

ReferenceCitation: Vinci G, Christin-Maitre S, Pasquier M, Bouchard P, Fellous M, Veitia RA. FOXO3a variants in patients with premature ovarian failure. Clin Endocrinol (Oxf). 2008 Mar;68(3):495-7. doi: 10.1111/j.1365-2265.2007.03052.x. Epub 2007 Sep 19. No abstract available.

ReferenceCitation: Laissue P, Christin-Maitre S, Bouchard P, Fellous M, Veitia RA. Mutations in the NOG gene are not a common cause of nonsyndromic premature ovarian failure. Clin Endocrinol (Oxf). 2007 Jun;66(6):900. doi: 10.1111/j.1365-2265.2007.02797.x. Epub 2007 Mar 23. No abstract available.

ReferenceCitation: Zanotti-Fregonara P, Khoury A, Duron F, Keller I, Christin-Maitre S, Kiffel T, Toubert ME, Devaux JY, Hindie E. Which thyroid cancer patients need periodic stimulation tests? Eur J Nucl Med Mol Imaging. 2007 Apr;34(4):541-6. doi: 10.1007/s00259-006-0279-z. Epub 2006 Nov 14.

ReferenceCitation: Roux C, Briot K, Dumarcet N, Bourgoin M, Chapurlat R, Christin-Maitre S, Cortet B, Costagliola D, Diebolt V, Lacoin F, Letombe B, Oberlin F, Orcel P, Ravaud P, Seret P, Thomas T, Vogel JY, Barna A, Nouyrigat E, Veyries ML, Yoldjian I. [Drug treatment of postmenopausal osteoporosis. What's New in 2006]. Presse Med. 2006 Oct;35(10 Pt 2):1529-39. doi: 10.1016/s0755-4982(06)74847-3. No abstract available. French.

ReferenceCitation: Laissue P, Christin-Maitre S, Touraine P, Kuttenn F, Ritvos O, Aittomaki K, Bourcigaux N, Jacquesson L, Bouchard P, Frydman R, Dewailly D, Reyss AC, Jeffery L, Bachelot A, Massin N, Fellous M, Veitia RA. Mutations and sequence variants in GDF9 and BMP15 in patients with premature ovarian failure. Eur J Endocrinol. 2006 May;154(5):739-44. doi: 10.1530/eje.1.02135.

ReferenceCitation: De Baere E, Copelli S, Caburet S, Laissue P, Beysen D, Christin-Maitre S, Bouchard P, Veitia R, Fellous M. Premature ovarian failure and forkhead transcription factor FOXL2: blepharophimosis-ptosis-epicanthus inversus syndrome and ovarian dysfunction. Pediatr Endocrinol Rev. 2005 Jun;2(4):653-60.

ReferenceCitation: Christin-Maitre S, Duron F. Fetal loss associated with excess thyroid hormone exposure. JAMA. 2004 Nov 3;292(17):2085-6; author reply 2086. doi: 10.1001/jama.292.17.2085-b. No abstract available.

ReferenceCitation: Ouzounian S, Christin-Maitre S. [What is menopause?]. Rev Prat. 2005 Feb 28;55(4):363-8. French.

ReferenceCitation: Simon T, Boutouyrie P, Gompel A, Christin-Maitre S, Laurent S, Thuillez C, Zannad F, Bernaud C, Jaillon P; CASHMERE investigators. Rationale, design and methods of the CASHMERE study. Fundam Clin Pharmacol. 2004 Feb;18(1):131-8. doi: 10.1111/j.1472-8206.2003.00233.x.

ReferenceCitation: Hulot JS, Demolis JL, Riviere R, Strabach S, Christin-Maitre S, Funck-Brentano C. Influence of endogenous oestrogens on QT interval duration. Eur Heart J. 2003 Sep;24(18):1663-7. doi: 10.1016/s0195-668x(03)00436-6.

ReferenceCitation: Christin-Maitre S, Ronci-Chaix N, Bouchard P. [Ovary genes and molecular pathology]. J Soc Biol. 2002;196(3):207-16. French.

ReferenceCitation: Rouen A, Rogers E, Kerlan V, Delemer B, Catteau-Jonard S, Reznik Y, Gompel A, Cedrin I, Guedj AM, Grouthier V, Brue T, Pienkowski C, Bachelot A, Chantot-Bastaraud S, Rousseau A, Simon T, Kott E, Siffroi JP, Touraine P, Christin-Maitre S. Whole exome sequencing in a cohort of familial premature ovarian insufficiency cases reveals a broad array of pathogenic or likely pathogenic variants in 50% of families. Fertil Steril. 2022 Apr;117(4):843-853. doi: 10.1016/j.fertnstert.2021.12.023. Epub 2022 Jan 31.

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

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

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hospital Saint-Antoine, Endocrinology service


type: Other Identifier

title: Study of Dopamine and Serotonin Transporters in Patients With Amyotrophic Lateral Sclerosis and Controls. Analysis With 123I-FP-CIT (Datscan) and 123I-ADAM Brain SPECT

acronym: DOSERAL

summary:
The purpose of this study is to study the transporters of serotonin and dopamine in ALS patients in relation with the clinical phenotype, i.e., patients without stiffness, patients with pyramidal stiffness, patients with mixed (pyramidal and extra pyramidal) stiffness.

For such a goal the investigators will use SPECT to compare the binding of two specific tracers in ALS patients and in matched healthy controls.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Actual

collaborators: Association Française contre les Myopathies (AFM), Paris

collaborators: ARS (Association pour la Recherche sur la Sclérose Latérale Amyotrophique)

collaborators: Agence Générale des Equipements et Produits de Santé

location_facility:
Salpêtrière Hospital
Bretonneau Hospital

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Completed


title: Intake of Low Dose of Docosahexaenoic Acid: Effects on Platelet Functions and Redox Status in Diabetic Patients

summary:
Aim: to determine the effects of DHA supplementation:

on the platelet function through their aggregation and the pathway of arachidonic acid metabolism
on redox status on cells and plasma
on inflammation in 16 type 2 diabetic patients in a cross-over study comparing DHA (400 mg/day for 2 weeks) vs Sunflower oil (placebo). Each period is separated by a wash-out period of 6 to 9 weeks.

design_allocation: Randomized

primary_purpose: Other

ReferenceType: result

ReferenceCitation: Vericel E, Colas R, Calzada C, Le QH, Feugier N, Cugnet C, Vidal H, Laville M, Moulin P, Lagarde M. Moderate oral supplementation with docosahexaenoic acid improves platelet function and oxidative stress in type 2 diabetic patients. Thromb Haemost. 2015 Aug;114(2):289-96. doi: 10.1160/TH14-12-1003. Epub 2015 Apr 2.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

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

repository_normalized: HAL

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

repositories_concat: HAL

unpaywall_oa_status: green

publisher_dissemination: Georg Thieme

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre de Recherche en Nutrition Humaine (CRNH) Rhône-Alpes

intervention_type: Dietary Supplement


title: Bone Quality and Improvement of Fracture Risk Prediction

acronym: QUALYOR

summary: QUALYOR is a prospective study on the predictive value for fragility fracture of various new techniques assessing bone quality, among postmenopausal women with low bone mass.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

ReferenceType: derived

ReferenceCitation: Chapurlat R, Pialat JB, Merle B, Confavreux E, Duvert F, Fontanges E, Khacef F, Peres SL, Schott AM, Lespessailles E. The QUALYOR (QUalite Osseuse LYon Orleans) study: a new cohort for non invasive evaluation of bone quality in postmenopausal osteoporosis. Rationale and study design. Arch Osteoporos. 2017 Dec 27;13(1):2. doi: 10.1007/s11657-017-0412-6.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Springer-Nature

location_facility:
Centre Hospitalier d'Orléans
Hospices Civils de Lyon

intervention_type: Other

status_simplified: Ongoing


title: Surgery Combined With IMRT-IGRT in Locally-advanced Prostate Cancers

acronym: TARGET

summary:
Standard treatment of locally-advanced prostate cancers consists in the association of radiotherapy of prostate and seminal vesicles (SV) and androgen deprivation (AD) for 3 years. This treatment is usually preceded by pelvic lymphadenectomy to assess the possible extension to lymph nodes of prostatic cancer and to avoid irradiating the pelvis in case of no lymph node involvement. However, radiotherapy leads usually to about 30% of grade ≥2 risk of bladder and/or rectal toxicity. This risk particularly depends on the radiation volume. In the aim of lowering the toxicity, the treatment in this study will associate:

pelvic lymph node dissection and resection of seminal vesicles, allowing decreasing the radiation target volume to the prostate only (and not to irradiate the SV);
a high-precision radiotherapy technique combining Intensity Modulated Radiation Therapy (IMRT) and Image-Guided Radiation Therapy (IGRT).

primary_purpose: Treatment

lead_sponsor: Rennes University Hospital

sponsor_collaborators:
Rennes University Hospital
Center Eugene Marquis

location_facility: Service d'Urologie - Hôpital de Pontchaillou

intervention_type: Procedure


title: 10 Patients Bicentric Prospective Study of Hybrid Bone Substitution With Calcium-phosphate Ceramic Biomaterial and Autologous Bone Marrow for Mandibular Osteoradionecrosis (ORN) Treatment

acronym: ORN

summary: The main objective of the study is the cure of osteoradionecrosis (ORN) at 12 months.

lead_sponsor: Nantes University Hospital

location_facility:
Rennes University Hospital
Nantes University Hospital


title: Phase I Trial Evaluating Continuous Infusion of Cilengitide Together With Radiochemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer

summary:
This is a two-center study which includes 24 patients maximum on 36 months : 24 months accrual - 12 months follow up.

Eligible patients are included according to a standard 3+3 design.

Patients included in the trial will be treated with a combination of radiochemotherapy (standard radiotherapy of 66 Gy, 2 Gy per daily fraction, and cisplatin and vinorelbine based chemotherapy).

Cilengitide will be administered alone as continuous infusion two weeks before the radiochemotherapy and will then be continued during radiochemotherapy as continuous infusion.

The dose levels investigated will be applied to the continuous administration (a maximum of 4 dose levels).

After the end of concomitant radiochemotherapy, cilengitide will be administered i.v. at a dose of 2000 mg twice weekly until the end of chemotherapy.

The dose of Cilengitide administered after radiotherapy will not be increased. 4 dose levels are defined:12, 18, 27 et 40 mg /hour.

lead_sponsor: Institut Claudius Regaud

sponsor_collaborators:
Institut Claudius Regaud
Merck KGaA, Darmstadt, Germany

location_facility:
CHU Toulouse Larrey
Institut Claudius Regaud

lead_sponsor_type: industriel


type: Registry Identifier

title: Trisomy of Chromosome 21 Diagnosis by High Output Sequencing of Foetal Circulating DNA in Mother Blood at First Trimester of Pregnancy.

summary: Demonstrate that the High output shotgun sequencing of the foetal DNA in the maternal blood could allow a complete discrimination between the mothers of a trisomic fetus 21 or a DISOMIQUE foetus 21 from the first quarter of the pregnancy, and so to obtain a reliable alternative in invasive procedure.

location_facility:
Necker Enfants Malades
Chi Poissy St Germain


type: Other Grant/Funding Number

title: Exercise and Myopathies. Physical Training Introduction in Lifestyle of Facioscapulohumeral Dystrophy Patients: Functional, Tissue and Quality of Life Benefits.

summary: It is now accepted that physical activity is not deleterious in myopathies, including muscular dystrophies. In patients suffering from facioscapulohumeral dystrophy (FSHD), aerobic training has been reported to be associated to physiological and functional positive effects without alteration in quality of life. The review papers from Van der Kooi et al. (2005), Cup et al. (2007) and Féasson et al. (2010) suggest that the combination of endurance and strength training is even more relevant. Only a few controlled and randomized studies have been conducted on this topic. The impact of such training programs on the skeletal muscle regenerative capacities has not been yet addressed. Moreover, due to the fact that training programs are mainly performed on short-term supervised periods, there is a lack of knowledge regarding long-term effects, patient's autonomy and whether or not regular exercise practice can be maintained in patient's daily life. Also, only a few experiments have reported an integrative view of the potential benefits of such programs on functional, biological and quality of life.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

sponsor_collaborators: Association Française contre les Myopathies (AFM), Paris

location_facility:
CHU de Grenoble
CHU de Saint-Etienne


title: Glucose Tolerance in Patients With an Idiopathic Parkinson's Disease

summary:
Dysfunction of autonomic nervous system is an important non motor feature of Parkinson' disease (PD). Lewy body formation is widely distributed in hypothalamus and in sympathetic and parasympathetic systems. Animal studies suggest a link between hypothalamus sensing of substrates and glucose metabolism. Thus, hypothalamus lesions could lead to change in glucose metabolism. Recently, we showed that fasting blood glucose level was significantly higher in PD patients than in control group suggesting that glucose tolerance may be impaired in PD. Some studies provided evidence for higher diabetes prevalence in PD patients whereas others showed no difference or a reduced risk of diabetes prevalence in PD patients compared to healthy subjects.

So, the risk that a PD patient develops a glucose intolerance or a diabetes is not clearly established and merit to be studied considering the damageable consequences for patient healthy.

The aim of this prospective study was to determine the risk that a PD patient develop a glucose intolerance or a diabetes compared to a matched control group, using an oral glucose tolerance test (OGTT).

status: Unknown status

enrollment_type: Anticipated

ReferenceCitation: Beze S, Castellani L, Pereira B, Chiambaretta F, Durif F, Marques A. Two-year longitudinal follow-up of visual illusions and hallucinations in Parkinson's disease. J Neurol. 2022 Aug;269(8):4546-4554. doi: 10.1007/s00415-022-11074-2. Epub 2022 Mar 16.

ReferenceCitation: Marques A, Beze S, Pereira B, Chassain C, Monneyron N, Delaby L, Lambert C, Fontaine M, Derost P, Debilly B, Rieu I, Lewis SJG, Chiambaretta F, Durif F. Visual hallucinations and illusions in Parkinson's disease: the role of ocular pathology. J Neurol. 2020 Oct;267(10):2829-2841. doi: 10.1007/s00415-020-09925-x. Epub 2020 May 23.

ReferenceCitation: Marques A, Dutheil F, Durand E, Rieu I, Mulliez A, Fantini ML, Boirie Y, Durif F. Glucose dysregulation in Parkinson's disease: Too much glucose or not enough insulin? Parkinsonism Relat Disord. 2018 Oct;55:122-127. doi: 10.1016/j.parkreldis.2018.05.026. Epub 2018 May 31.

publisher_dissemination: Elsevier

lead_sponsor: University Hospital, Clermont-Ferrand

location_facility:
CHU Clermont-Ferrand
Chu Clermont-Ferrand

intervention_type: Behavioral

status_simplified: Unknown


title: Relevance of Plasma PCSK9 Concentration as a Biomarker in Acute Coronary Syndrome.

summary:
PCSK9 (Proprotein convertase subtilisin kexin type 9) plays a key role in LDL-cholesterol (LDLC) metabolism by inhibiting LDL receptor (LDLR) at post-transcriptional level. PCSK9 loss of function mutations are associated to decreased LDLC levels and a cardiovascular protection. In this context, the development of pharmacological inhibitors of PCSK9, in association with statins treatment, represents a major therapeutic issue for LDLC modulation. It was previously shown that PCSK9 plasmatic concentration correlated with plasmatic LDLC, TG and glucose concentrations. However, no data are available on predictive value of PCSK9 plasmatic level concerning coronary disease severity.

The main objective of this study is to determine whether plasmatic PCSK9 concentration is linked to coronary damage severity in patients with acute coronary syndrome.

location_facility:
Nantes University Hospital
Nantes University hospital


title: Comparison of the Effects of Aripiprazole and Risperidone on the Pattern of Brain Activation in Schizophrenic Patients During Emotional Tasks and With Reference to Controls

summary: After an initial screening visit, including an assessment of psychiatric disorders, patients stabilized on antipsychotic medication (aripiprazole or risperidone) for at least 6 weeks and control subjects will undergo an assessment using functional magnetic resonance imaging (fMRI) of the differences of patterns of brain activation during an emotional task

lead_sponsor: Qualissima

location_facility: Hôpital de la Conception - Service du Pr Dassa -147, boulevard Baille

location_facility: Sainte-Marguerite Hospital - Psychiatric service -Service du Pr Azorin - 270 boulevard de Sainte Marguerite

intervention_type: Genetic


title: An Open-Label, Multicenter, Single Arm QT Interval Prolongation Study of Eribulin Mesylate (E7389) in Patients With Advanced Solid Tumors

summary: The purpose of this study is to assess whether eribulin mesylate (E7389) has an impact on the electrocardiogram (ECG) with focus on cardiac repolarization, as measured by QT/QTc interval as well as through a pharmacokinetic-pharmacodynamic (PK/PD) analysis.

lead_sponsor: Eisai Limited

location_facility:
Medicale
Service d'Oncologie


title: Target Volume With a Pressure Controlled Ventilator in Obesity Hypoventilation Syndrome With Persistent Oxygen Desaturations With Continuous Positive Airway Pressure

acronym: OVO

summary: The purpose of this study is to investigate the evolution of daytime partial pressure of carbon dioxide in the blood (PaCO2) after 6 weeks of noninvasive ventilation-pressure support ventilation (NIV-PSV) with target volume versus continuous positive airway pressure (CPAP) alone versus NIV-PSV.

status: Withdrawn

primary_purpose: Supportive Care

lead_sponsor: Breas Medical S.A.R.L.

location_facility: GH Pitié-Salpétrière - Service de pneumologie et réanimation

intervention_type: Device


title: Cardiovascular Events at One Year of Patients Hospitalized for Critical Limb Ischaemia and Aspirin Resistant Using the VerifyNow®. Aspirin Resistance and Prognosis of Patients With Critical Limb Ischaemia

acronym: Aspirine

summary:
Acetylsalicylic acid (Aspirin, ASA) is the most widely prescribed drug used in primary and secondary prevention of cardiovascular disease. However, aspirin resistance has been described, mostly in cardiac patients and is an independent predictive factor for a poor survival. Two frequent conditions in patients with cardiovascular diseases, diabetes and hypercholesterolemia, are also considered as risk factors for aspirin resistance. Among patients with peripheral arterial disease, those with critical limb ischemia have the worst cardiovascular prognosis. At one year, 23% are dead, 25% have a major cardiovascular event and 25% have a major amputation (which can be combined). Aspirin resistance is poorly studied in these patients, and to our knowledge no study has been made to assess the prognosis value of aspirin resistance on cardiovascular outcomes in critical limb ischaemia patients.

Hospitalized critical limb ischaemia patients will be tested for aspirin resistance using the bed-side point of care VerifyNow®, and will be followed during one year, including death, fatal and non-fatal acute coronary syndromes, cardiac decompensation, stroke, and major amputation.

lead_sponsor: University Hospital, Limoges

location_facility:
UH Toulouse
UH Bordeaux


title: The ITP-RITUX Cohort: An Observational Study on Rituximab Off-label Use for Immune ThrombocytoPenia.

acronym: ITP-RITUX

summary: The primary purpose of the study is to describe by a prospective observational study the serious adverse events occurring in patients treated off-label by rituximab for Immune Thrombocytopenia.

ReferenceCitation: Khellaf M, Charles-Nelson A, Fain O, Terriou L, Viallard JF, Cheze S, Graveleau J, Slama B, Audia S, Ebbo M, Le Guenno G, Cliquennois M, Salles G, Bonmati C, Teillet F, Galicier L, Hot A, Lambotte O, Lefrere F, Sacko S, Kengue DK, Bierling P, Roudot-Thoraval F, Michel M, Godeau B. Safety and efficacy of rituximab in adult immune thrombocytopenia: results from a prospective registry including 248 patients. Blood. 2014 Nov 20;124(22):3228-36. doi: 10.1182/blood-2014-06-582346. Epub 2014 Oct 7.

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

version: publishedVersion

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Hematology

lead_sponsor: Henri Mondor University Hospital

sponsor_collaborators:
Henri Mondor University Hospital
Roche Pharma AG

location_facility: National Reference Center for the Study of Auto Immune Cytopenia


title: Assessment of the FLOTRAC/VIGILEO Third Generation Software to Predict Fluid Responsiveness in Critically Ill Patient With Acute Circulatory Failure

acronym: FLOVAC

summary: Acute circulatory failure may be related to hypovolemia. Fluid loading increases stroke volume in approximatively half of challenges. Determining fluid responsiveness prevents unnecessary fluid loading. Passive leg raising (PLR) provides a transient increase of 300 ml in venous return for a short time. The measurement of stroke volume (SV) before and after a PLR test allows physician to detect fluid responsiveness, when stroke volume increases is higher than 15 %. Beside thermodilution, the use of non invasive device to measure stroke volume becomes largely employed. Arterial Pressure based Cardiac Output (APCO), provided by the Flotrac/Vigileo system, does not required specific materials nor repeated calibration. The third generation software is believed to be more accurate and more precise for SV measurement. The aim of this study is to test the performance of the Flotrac/Vigileo device in a situation of rapid venous return changes induced by PLR and then by fluid loading. Patients will be classify posteriorly in responders and non responders, according to the magnitude of the fluid loading-induced SV changes measured by transthoracic echocardiography.

status: Terminated

lead_sponsor: Hôpital Européen Marseille

location_facility:
Hopital Ambroise Paré
Hopital Paul Desbief


intervention_type: Biological

acronym: Open, phase II trial. 200 subjects aged 18 to 60 years will receive the non-adjuvanted vaccine

lead_sponsor: Sanofi Pasteur, a Sanofi Company

summary:
This study is designed to describe the immunogenicity of a pandemic A/H1N1 influenza vaccine in healthy adults given a lower vaccine dose and in a similar group given a full dose of the vaccine.

The primary objective is to describe describe the immune response of the inactivated, split-virion swine-origin A/H1N1 influenza vaccine without adjuvant.

title: Immunogenicity of the Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine Without Adjuvant in Healthy Adult Subjects

primary_purpose: Prevention

type: EudraCT Number

source: euctr


title: Bracing During Infantile Scoliosis: Airways Study by Acoustic Method, EOS™ Acquisition and Noninvasive Respiratory Muscles Assessment

acronym: MASI

summary:
Idiopathic juvenile thoracic scoliosis is a tridimensional deformation of the spine which may impact on the intrathoracic organs. Bracing is one of the oldest treatments of spinal deformities. It relies on the indirect manipulation of spinal curvatures in order to prevent curve progression, which may affect respiratory function.

The acoustic reflection method is based on the analysis of the reflection of a single transient planar wave giving the longitudinal cross-sectional area profile of the examined cavity. It is noninvasive and harmless.

The EOS™ device allows a double incidence, full body, and low-dose X-ray acquisition with thoracic 3D reconstruction.

The aim of the study is to evaluate the impact of bracing on the upper airways patency (by means of the acoustic method), on the breathing pattern (noninvasive respiratory muscles assessment), and on the thoracic penetration index (by means of the EOS™)

ReferenceType: background

ReferenceCitation: Donnelly LF, Bisset GS 3rd. Airway compression in children with abnormal thoracic configuration. Radiology. 1998 Feb;206(2):323-6. doi: 10.1148/radiology.206.2.9457181.

ReferenceCitation: Dubousset J, Charpak G, Skalli W, de Guise J, Kalifa G, Wicart P. [Skeletal and spinal imaging with EOS system]. Arch Pediatr. 2008 Jun;15(5):665-6. doi: 10.1016/S0929-693X(08)71868-2. No abstract available. French.

ReferenceCitation: Heary RF, Bono CM, Kumar S. Bracing for scoliosis. Neurosurgery. 2008 Sep;63(3 Suppl):125-30. doi: 10.1227/01.NEU.0000320387.93907.97.

ReferenceCitation: Jones RS, Kennedy JD, Hasham F, Owen R, Taylor JF. Mechanical inefficiency of the thoracic cage in scoliosis. Thorax. 1981 Jun;36(6):456-61. doi: 10.1136/thx.36.6.456.

ReferenceCitation: Margonato V, Fronte F, Rainero G, Merati G, Veicsteinas A. Effects of short term cast wearing on respiratory and cardiac responses to submaximal and maximal exercise in adolescents with idiopathic scoliosis. Eura Medicophys. 2005 Jun;41(2):135-40.

lead_sponsor: Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau

collaborators: Ecole Nationale Supérieure des Arts et Metiers


title: Neurotrophins Implications in Primary Sjögren Syndrome

acronym: Neuro-SGSp

summary:
Neurotrophins (NTs) constitute a family of growth factors, which regulated differentiation, proliferation, and survival of both neuronal cells and astrocytes. In recent years, several studies have provided evidences that the cellular effects of NGF " Nerve Growth Factor ", BDNF " Brain-Derived Neurotrophic Factor " and NT-3 are not limited to the nervous system. Indeed, neurotrophins and their receptors are widely expressed on non neuronal cells. Data concerning the implication of NTs and their receptors in the immune system maturation and in the regulation of normal and pathological immune responses are numerous and suggest the existence of a specific "neuro-immunomodulation" through these neuropeptides.

The aim of the study is to compare Sjögren's syndrome systemic activity to seric, lymphocytic and conjunctival levels of NTs (i.e NGF, BDNF and NT-3). A preliminary study has previously pointed out the link between high BDNF seric levels and Sjögren's systemic activity. The increased levels of BDNF were correlated to T cell activation. A similar correlation between high NGF level and hypergammaglobulinemia was also pointed out.

location_facility:
Opthalmologie
Médecine Interne


title: Evaluation of Muscle StO2 as a Prognostic Factor After Out of Hospital Cardiac Arrest

summary: Out of hospital cardiac arrest is a major health problem. Prognosis is still poor even after return to spontaneous circulation. The pathophysiology of cardiac arrest implies ischemia-reperfusion and sepsis like syndrome. These phenomenons can lead to microvascular dysfunction explaining probably multi-organ failure after cardiac arrest. Few means allow the exploration of microvascular function in human. Muscle StO2 is a technique allowing the assessment of microvascular function non-invasively. The aim of this study is to evaluate muscle StO2 as a prognostic factor after out of hospital cardiac arrest.

lead_sponsor: Department of Clinical Research and Innovation

collaborators: Centre Hospitalier Universitaire de Nice

location_facility:
CHU de Nice Hôpital Saint Roch
CHU de Nice -Hôpital l'Archet


title: Countermeasures for Sleepiness at the Wheel and Prediction of Inter- Individual Differences to Their Responses (KillSleep)

acronym: KILLSLEEP

summary: Sleep deprivation induces degradation of night-time driving ability via sleepiness. Because of conflicts between physiological needs and social or professional activities, it is necessary to develop affordable countermeasure to sleepiness. In real-life driving studies, nap and coffee are efficient countermeasures of sleepiness at the wheel. However the effect of caffeine is quick but brief and varies between individuals. There is a need for more knowledge in order to know what to recommend to drivers. Exposure to 460-nm monochromatic light (blue light) decreases subjective sleepiness and improves performances. One objective of this project is to investigate whether blue light exposure during driving would be useful in a real driving situation when sleepiness becomes acute. Owing to the fact that our knowledge of the effects of exercise on driving is very sparse and to the absolutely need to standardize the bouts of exercise that will be applied to the subjects. One objective of the present study will be to investigate in a simulator study the effects of a bout of moderate exercise on participants driving ability when sleepiness becomes acute. Nocturnal neurobehavioral performance varies widely between individuals and only certain subjects seem significantly affected by sleep loss. It is of interest to find biological markers for sleep drive to identify vulnerable drivers to sleep deprivation or to identify responders to sleepiness countermeasures (i.e., coffee and blue light). One objective of this study is to determine individual differences (genetic, hormonal and cognitive) in the impairment of driving skills induced by sleep loss and in the efficiency of countermeasures (blue light and coffee).

primary_purpose: Basic Science

ReferenceCitation: Taillard J, Capelli A, Sagaspe P, Anund A, Akerstedt T, Philip P. In-car nocturnal blue light exposure improves motorway driving: a randomized controlled trial. PLoS One. 2012;7(10):e46750. doi: 10.1371/journal.pone.0046750. Epub 2012 Oct 19.

lead_sponsor: University Hospital, Bordeaux

collaborators: INSERM ERI27 Mobilités Cognition et Temporalité

location_facility: CHU de Bordeaux Groupe Hospitalier Pellegrin


title: Study Impact, on Clinical Outcomes, Quality of Life and Costs of 2 Therapeutic Strategy (Monthly Natalizumab Versus Mitoxantrone Then Immunomodulator) at 3 Years of Follow-up for Aggressive Remitting Multiple Sclerosis

acronym: IQUALYSEP

summary: Cost-effectiveness study of 2 disease-modifying therapies (natalizumab versus mitoxantrone followed by immunomodulator) in the management of aggressive remitting multiple sclerosis

primary_purpose: Health Services Research

location_facility:
CHU Cavale Blanche
CHU Rennes


title: The Relation Between Dedicated Extremity MRI Synovitis and Structural Deterioration Radiographic in Patients With Rheumatoid Arthritis in Clinical Remission.Preliminary Study

summary:
The major aim of treatment for rheumatoid arthritis is remission. Nevertheless, structural radiographic progression is observed in 15 to 20% of patient getting remission. Numerous definitions of the remission proposed by literature remain imperfect.

Recently ultrasonography and MRI seem to be helpful in diagnosis and follow-up of rheumatoid arthritis.

Studies in patients with clinical remission are reporting 75 to 90% of persistent MRI and ultrasonography synovitis, 45% of cases with synovial activity.

To our knowledge, in such case few studies showed correlation between persistent imaging synovitis and structural radiographic progression.

On the other hand, no studies with extremity dedicated RMI in patients with remission are reported.

In this preliminary study, the investigators propose to evaluate in patients with rheumatoid arthritis remission and persistent dedicated MRI synovitis the structural radiographic progression at one year.

primary_purpose: Screening

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: Rheumatology Department, Nice University Hospital


title: Effect of Mechanical Ventilation With NAVA and PSV on Inspiratory Muscle Workload and Synchrony in Patients With Chronic Obstructive Pulmonary Disease

acronym: NAVASYNC

summary: NAVA used the electrical activity of the diaphragm (EAdi) to initiate and deliver in proportion of an inspiratory assistance. During inspiration, EAdi signal occurred earlier than airflow or pressure variations in the airway. The investigators hypothesized that NAVA improved patient-ventilator synchrony and reduced inspiratory workload as compared with pressure support ventilation delivered at two different cycling criteria (25 and 50 %).

location_facility:
Hopital Paul Desbief
Fondation Hôpital Ambroise Paré


title: Pilot Study of Auto-immune Abnormalities Associated With Down Syndrome

acronym: IMMUTRI

summary: The purpose of the study is to identify biological data linked to auto immune abnormalities associated with Down Syndrome.

time_perspective: Cross-Sectional

ReferenceCitation: Friedman DL, Kastner T, Pond WS, O'Brien DR. Thyroid dysfunction in individuals with Down syndrome. Arch Intern Med. 1989 Sep;149(9):1990-3.

lead_sponsor: Institut Jerome Lejeune

sponsor_collaborators:
Institut Jerome Lejeune
Fondation Jérôme Lejeune

location_facility: Laboratoire d'Immunologie Biologique (Unité INSERM U580)


title: Pilot Phase II Study of Docetaxel in Combination With a Dietary Phytonutrient in First Line Treatment of Hormone Independent Metastatic Prostate Cancer

acronym: PROTAXY

summary: RATIONALE : Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Dietary supplements, such as phytochemicals, may stop or delay the development of prostate cancer.

lead_sponsor: Centre Jean Perrin

location_facility:
Institut Jean Godinot
Centre Jean Perrin


title: Individual and Environmental Risk Factors of Unplanned Admissions of Elderly : RIEHO Inception Cohort

acronym: RIEHO

summary: The aim of this multicenter study is to investigate risk factors for unplanned hospitalizations, including individual and environmental factors, notably air pollution.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service de Court Séjour Gériatrique, CHU DE REIMS, HOPITAL MAISON-BLANCHE


title: Anatomo-functional Determinants of Cognitive Impairment After Acute Coronary Syndrome: A Brain MRI and Cerebral Perfusion Scintigraphy Study

acronym: COSCA

summary: The general purpose of the present pathophysiological study is to investigate the relation between cognitive impairment observed after an acute coronary syndrome and the presence of cerebral anatomo-functional abnormalities. This study will improve the investigators' understanding of the disease and will help in early diagnosis and prevention of vascular dementia in this population.

sponsor_collaborators:
University Hospital, Bordeaux
Université Victor Segalen Bordeaux 2

location_facility: Hôpital Cardiologique du Haut-Lévêque (CEPTA)


title: Identification of Genes Involved in the Pathogenesis of Gliomas by Transcriptome Analysis

summary:
RATIONALE: Studying the genes expressed in samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at tissue samples from patients with glioma or other brain tumors.

time_perspective: Retrospective

lead_sponsor: University Hospital, Montpellier

location_facility:
CHU Montpellier
Clinique Gui de Chauliac


title: Study of the Effect of the Chronic Electric Stimulation of the Hypothalamus/Fornix on Memory Impairment in Alzheimer Disease.

summary:
Alzheimer's Disease (AD) is the most common cause of dementia. Today no treatment had shown consistent efficacy to stop or slow down the disease. Recent report of enhancement of memory abilities by bilateral chronic deep brain stimulation (DBS) of the fornix in the hypothalamus suggests that neuromodulation of circuits involved in memory processes may have therapeutic implications in AD patients with memory decline.

The primary objectives of this prospective, non-controlled, pilot study are to assess the feasibility and safety of DBS in AD patients with mild cognitive and memory impairment, and to evaluate the efficacy of DBS to slow down or stabilize this decline. Five patients with AD (DSM IV) diagnosed less than two years, with mild cognitive decline (MMSE 20-24), and specific impairment of episodic memory will be included in a 2-year period. The evaluation criteria for feasibility will be the proportion of patients undergoing the procedure, chronic stimulation and evaluation process without adverse event (AE). Efficacy will be evaluated using numerous cognitive and memory testing including classical instrument used in AD clinical trials. Changes in behavioral scales, and changes in hypothalamic functions (clinical, biological and hormonal assessment) will evaluate safety and tolerance. Clinical, neuro-psychological, biological and imaging assessment will be performed 3 and one month before and 3, 6, 12 and 24 months after surgery. Bilateral electrodes (Medtronic 3389) will be implanted, by MR-guided frame-based stereotaxy, in the hypothalamic part of the fornix, and then connected to the generator (Kinetra, Medtronic). Chronic high-frequency stimulation will be delivered immediately after surgery.

The investigators expect to slow down, or to stabilize the spontaneous decline of MMSE and ADAS scores after 6, 12 and 24 months of stimulation. In case of efficacy, DBS might offer to AD patient the possibility to slow down/stabilize their symptoms, which no other treatment can currently offer, and to increase their quality of life.

sponsor_collaborators: Centre Hospitalier Universitaire de Nice

location_facility: Service de Neurochirurgie Hôpital Universitaire de Pasteur


acronym: Immunogenicity and Safety of a Vaccine Against Influenza (2009-2010 Northern Hemisphere Season)

summary:
This study is in support of the annual application for the variation of the vaccine strains for a marketing authorisation.

Objectives:

To evaluate compliance, in terms of immunogenicity, of the corresponding strength of the intradermal (ID) influenza vaccine Northern Hemisphere (NH) 2009-2010 formulation.
To describe the safety of the corresponding strength of the ID influenza vaccine, NH 2009-2010 formulation.

title: Immunogenicity and Safety of the Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation (Intradermal Route)


title: Evolution of Pulmonary Capillary Blood Volume (Vc) in Patients After a First Episode of Pulmonary Embolism.

acronym: VcEP

summary: The purpose of this monocentric, preliminary study is to assess the evolution of pulmonary capillary blood volume (Vc), measured by the double diffusion nitric oxide/carbon monoxide (NO/CO) method (Guenard et al.; Respir Physiol 1987), from the starting of the anticoagulant therapy to 6 months after, and to search correlations with the evolution of clinical (dyspnea and results of the 6 minutes walking test), biological (BNP; Troponin), echocardiographic (right ventricular dysfunction, pulmonary arterial pressure) and ventilation/perfusion lung scan data.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Departement of pneumology, CHU Saint-Etienne

location_facility: Department of Medicine and Therapeutic, CHU Saint-Etienne


title: IMPACT OF THERAPY INTENSIFICATION BY AN INTEGRASE INHIBITOR +/- CCR5 INHIBITOR ON THE LYMPHOID RESERVOIR FOR HIV-1 IN CHRONICALLY INFECTED PATIENTS

acronym: IntensVIH

summary:
To determine the efficacy of adding Isentress®, with or without Celsentri®, to effective conventional antiretroviral therapy (comprising at least 2 reverse transcriptase inhibitors and one boosted protease inhibitor), on residual HIV replication and blood cell and gut-associated lymphoid tissue reservoirs (reverse transcriptase inhibitors: RTIs, boosted protease inhibitors: PI/r).

To evaluate the effect of therapy intensification by means of an integrase inhibitor with or without CCR5 inhibitor treatment on the lymphoid reservoir in patients chronically infected with HIV-1, successfully treated with "conventional triple therapy", measured by:

residual plasma replication between 0 and 50 copies/ml
intracellular HIV RNA levels in circulating lymphocytes (PBMC) and lymphocytes in gut-associated rectal lymphoid tissue (RL).
proviral HIV DNA levels in PBMC and RL.

ReferenceCitation: Lafeuillade A, Assi A, Poggi C, Bresson-Cuquemelle C, Jullian E, Tamalet C. Failure of combined antiretroviral therapy intensification with maraviroc and raltegravir in chronically HIV-1 infected patients to reduce the viral reservoir: the IntensHIV randomized trial. AIDS Res Ther. 2014 Oct 7;11(1):33. doi: 10.1186/1742-6405-11-33. eCollection 2014.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer

collaborators:
Merck Sharp & Dohme LLC
Abbott

location_facility: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer, Service d'infectiologie

location_facility: Centre Hospitalier Intercommunal de Toulon La Seyne sur mer


title: Assessment of the MMP-1/TIMP-1 Ratio as a Predictor of Wound Healing in Diabetic Foot Ulcers

summary: The primary objective of this study is to assess the sensitivity and specificity of a MMP-1/TIMP-1 ratio equal to 0.24 at study entry to predict wound healing at 12 weeks' follow up visit.

lead_sponsor: University Hospital, Grenoble

location_facility: Service de Diabétologie du Pr Halimi, CHU Grenoble


title: Evaluation of the Efficiency of Autologous Platelet Gel (Platelet Rich Fibrin) Obtained From Own Patients' Blood Versus Vaselitulle in Dupuytren's Disease Postoperative Wound Healing

summary:
This study is a clinical, multicentric, randomised open trial. The objective is to evaluate the efficiency, in terms of wound healing speed, of peroperative application of autologous platelets gel versus standardized wound dressing. The wound Healing model used in this study is the " open palm " surgical treatment of Dupuytren's disease.

Dupuytren's disease is a fibroproliferative disease of the palmar and digital fascia of the hand that may lead to a fixed flexion contracture of the fingers.

The main indication for surgery is the loss of finger extension. In some cases of palmar Dupuytren's disease the surgical removal of diseased tissues may lead to a cutaneous loss of substance (" open palm technique "). This loss of substance is treated using vaseline dressing and the wound healing is obtained in 4 weeks.

Autologous platelets gel (Platelet Rich Fibrin) is obtained from the patient's own blood. Some recent studies have shown that it speeds up the wound healing and enhances the quality of the scar.

PRF belongs to a new generation of autologous platelet gel that are easily obtained after centrifugation of patient's own blood.

The Platelet Rich Fibrin (PRF) contains many wound healing factors : Three pro inflammatory cytokines ( IL1,IL6, TNF-alpha) , one anti-inflammatory cytokine (IL4) and a growth factor (VEGF).

The study will be running on 60 days, starting from the operation day. The wound healing evaluation will be achieved at day1, day2, day7, day14, day 21 day 28 and day 60.

The inclusion criteria are : age over 18, Dupuytren's disease with an indication of surgical treatment using the open palm technique, patients having signed the agreement form.

80 patients will be included in the study and divided into 2 groups . The first group of patients will receive PRF and the other group will receive vaseline dressings.

The speed and the quality of wound healing will be compared.We will also compare the number of patients with a complete wound healing at day 21 . Moreover,we will evaluate the pain during the dressings' change and the bleeding of the palmar wound.

For the wound healing speed , a difference of 7 days between the two groups will be considered as statistically significant.

Statistical analysis will be achieved using Chi2 test and Logrank test.

ReferenceCitation: Chignon-Sicard B, Georgiou CA, Fontas E, David S, Dumas P, Ihrai T, Lebreton E. Efficacy of leukocyte- and platelet-rich fibrin in wound healing: a randomized controlled clinical trial. Plast Reconstr Surg. 2012 Dec;130(6):819e-829e. doi: 10.1097/PRS.0b013e31826d1711.

location_facility: Centre Hospitalier Universitaire de Nice Hôpital de Cimiez


title: Allogenic Hematopoietic Stem Cell Transplantation (HSCT) From a Genoidentical Donor After a Reduced Intensity Conditioning Transplantation (RICT) Followed by an Early Preventive Treatment (Day 21) With Extracorporal Photopheresis After Transplantation.

acronym: ECP

summary:
ECP will be given to the patients [UVAR®XTS TM Therakos system, Johnson & Johnson] according to the following schedule:

Starting at day 21 after transplant, if hematologic recovery allowed it: 2 ECP per week the first 2 weeks, and 1 ECP per week during 1 month.

Total = 8 ECP after transplantation.

lead_sponsor: Hospices Civils de Lyon

location_facility: Hôpital Edouard Herriot, Service d'Hématologie

location_facility: Centre de Santé - Etablissement Français du Sang (EFS)


title: Age Influence on the Modifications of the Oral, Pharyngeal and Laryngeal Axis Alignment in Children Induced by Head Extension: an MRI Study

summary:
In pediatric anesthesia and in pediatric intensive care, tracheal intubation is one of the most important procedure. To achieve this procedure as fast as possible and in is best conditions, the physician should choose the head posture which a priori will enable at first the best glottic visualisation during laryngoscopy, and at second will facilitate the route of the tube from the larynx to the trachea.

Tracheal intubation is a procedure used for years, and many textbooks recommendations on the best head posture for tracheal intubation in paediatrics have been made. Briefly summarized, depending on the age of the child, the head should (or not) be slightly extended, and a pillow should (or not) be positioned under the occiput. These recommendations are questionable for three majors reasons:

despite an apparent consensus, some recommendations are quite different.
none are based on anatomical nor clinical studies
if for all of them, the age of the child is considered as critical point, but children are only grossly categorized in three categories (newborn, infants and old children). And the clinician has no way, facing a child, to make his choice between dichotomic attitudes.

Actually, the responses to these questions should need rigourous clinical studies on laryngoscopy, hard to design and very difficult to make. P.Adnet et coll. (Anesthesiology 2001) showed that an anatomical study with resonance magnetic imaging (MRI) can bring indirect but strong evidence and can be a first step leading to clinical studies. Many children need MRI study for different reasons, and it is fast and easy to get during their examination additional images of the superior airway.

In their unit, the investigators are experienced in this kind of study, as they recently published (Pediatric Anesthesia 2008) an MRI study demonstrating that in children, head extension improves the alignment of the visualisation axis on the laryngeal axis, but worsens the alignment of the pharyngeal axis on the laryngeal axis. However, patients included in their study were in major part infants, so the influence of the age could not be properly analyzed. Morevover, this study suffered of two main limitations, the lack of standardisation of head postures, and that a laryngeal mask the children, who were on general anesthesia (required for the MRI examination) were made using a laryngeal mask (as it was at this time the standard in their institution).

The investigators propose an MRI study of the influence of age on the consequences of head extension on the anatomic axes of the superior airway in children, with a prospective stratified on age study. Several modifications and improvement in the design of this study would diminished the limitations of the first study.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique - Hôpitaux de Marseille

location_facility: Assistance Publique-Hopitaux de Marseille


title: Phase II Study Evaluating the Effectiveness of the Exemestane (Aromasin) With Tamoxifen on the Rate of Clinical Response Menopausal in Patients With Locally Advanced Breast Tumors

acronym: TAMARO

summary: This is a Phase II non-randomized, open, uncontrolled and bi-centric study of hormonal induction by exemestane (Aromasin) + tamoxifen to evaluate the effectiveness of exemestane (Aromasin) with tamoxifen on the rate of clinical response menopausal in patients with tumors of locally advanced breast. Hormone therapy will be administered at a dose of 25mg/day for exemestane and 20 mg / day for 4 months for tamoxifen.

lead_sponsor: Institut Claudius Regaud

sponsor_collaborators:
Institut Claudius Regaud
PHARMACIA SAS

location_facility:
Institut Claudius Regaud
CHU de Toulouse Rangueil


title: Corticosteroid Sparing Effect of Methotrexate in Patients With Sarcoid- Associated Uveitis: A Double Blind, Randomized, Placebo Controlled-study -UVEXATE

acronym: UVEXATE

summary: The purpose of this study is to determine whether methotrexate is a effective corticosteroid sparing agent in the treatment of sarcoid-associated uveitis.

location_facility: Hôpital Avicenne - Service de Médecine Interne


title: Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies, Impact of Modafinil Treatment.

acronym: AUTOSOP

summary: The project will improve scientific knowledge regarding a recent law applying potentially to every french driver. It will give for the first time an indication on the impact of alerting treatments on driving risks. It will reinforce the links between different research environments (sleep physiopathology, clinical research, cognitive neurosciences, driver's supervision, virtual reality, pharmacology) among the RESAT network (Réseau Eveil Sommeil Attention Transport). It will stimulate data acquisition in technological research to better understand the difference between real and simulated driving

ReferenceCitation: Reyner LA, Horne JA, Reyner A. Gender- and age-related differences in sleep determined by home-recorded sleep logs and actimetry from 400 adults. Sleep. 1995 Feb;18(2):127-34. Erratum In: Sleep 1995 Jun;18(5):391.

ReferenceCitation: Guilleminault C, Pelayo R, Leger D, Philip P, Ohayon M. Sleep-disordered breathing and upper-airway anomalies in first-degree relatives of ALTE children. Pediatr Res. 2001 Jul;50(1):14-22. doi: 10.1203/00006450-200107000-00006.

ReferenceCitation: Philip P, Mitler M. Sleepiness at the wheel: symptom or behavior? Sleep. 2000 Jun 15;23 Suppl 4:S119-21. No abstract available.

ReferenceCitation: Findley LJ, Unverzagt ME, Suratt PM. Automobile accidents involving patients with obstructive sleep apnea. Am Rev Respir Dis. 1988 Aug;138(2):337-40. doi: 10.1164/ajrccm/138.2.337.

ReferenceCitation: Sleep apnea, sleepiness, and driving risk. American Thoracic Society. Am J Respir Crit Care Med. 1994 Nov;150(5 Pt 1):1463-73. doi: 10.1164/ajrccm.150.5.7952578. No abstract available.

ReferenceCitation: Barbe, Pericas J, Munoz A, Findley L, Anto JM, Agusti AG. Automobile accidents in patients with sleep apnea syndrome. An epidemiological and mechanistic study. Am J Respir Crit Care Med. 1998 Jul;158(1):18-22. doi: 10.1164/ajrccm.158.1.9709135.

ReferenceCitation: Teran-Santos J, Jimenez-Gomez A, Cordero-Guevara J. The association between sleep apnea and the risk of traffic accidents. Cooperative Group Burgos-Santander. N Engl J Med. 1999 Mar 18;340(11):847-51. doi: 10.1056/NEJM199903183401104.

ReferenceCitation: Lloberes P, Levy G, Descals C, Sampol G, Roca A, Sagales T, de la Calzada MD. Self-reported sleepiness while driving as a risk factor for traffic accidents in patients with obstructive sleep apnoea syndrome and in non-apnoeic snorers. Respir Med. 2000 Oct;94(10):971-6. doi: 10.1053/rmed.2000.0869.

ReferenceCitation: Masa JF, Rubio M, Findley LJ. Habitually sleepy drivers have a high frequency of automobile crashes associated with respiratory disorders during sleep. Am J Respir Crit Care Med. 2000 Oct;162(4 Pt 1):1407-12. doi: 10.1164/ajrccm.162.4.9907019.

ReferenceCitation: Sagaspe P, Taillard J, Chaumet G, Guilleminault C, Coste O, Moore N, Bioulac B, Philip P. Maintenance of wakefulness test as a predictor of driving performance in patients with untreated obstructive sleep apnea. Sleep. 2007 Mar;30(3):327-30.

ReferenceCitation: George CF, Boudreau AC, Smiley A. Effects of nasal CPAP on simulated driving performance in patients with obstructive sleep apnoea. Thorax. 1997 Jul;52(7):648-53. doi: 10.1136/thx.52.7.648.

ReferenceCitation: Poceta JS, Timms RM, Jeong DU, Ho SL, Erman MK, Mitler MM. Maintenance of wakefulness test in obstructive sleep apnea syndrome. Chest. 1992 Apr;101(4):893-7. doi: 10.1378/chest.101.4.893.

ReferenceCitation: Mitler MM, Walsleben J, Sangal RB, Hirshkowitz M. Sleep latency on the maintenance of wakefulness test (MWT) for 530 patients with narcolepsy while free of psychoactive drugs. Electroencephalogr Clin Neurophysiol. 1998 Jul;107(1):33-8. doi: 10.1016/s0013-4694(98)00044-3.

ReferenceCitation: Meurice JC, Marc I, Series F. Efficacy of auto-CPAP in the treatment of obstructive sleep apnea/hypopnea syndrome. Am J Respir Crit Care Med. 1996 Feb;153(2):794-8. doi: 10.1164/ajrccm.153.2.8564134.

ReferenceCitation: Tiihonen M, Partinen M. Polysomnography and maintenance of wakefulness test as predictors of CPAP effectiveness in obstructive sleep apnea. Electroencephalogr Clin Neurophysiol. 1998 Dec;107(6):383-6. doi: 10.1016/s0013-4694(98)00079-0.

ReferenceCitation: Randomized trial of modafinil for the treatment of pathological somnolence in narcolepsy. US Modafinil in Narcolepsy Multicenter Study Group. Ann Neurol. 1998 Jan;43(1):88-97. doi: 10.1002/ana.410430115.

ReferenceCitation: Findley LJ, Suratt PM, Dinges DF. Time-on-task decrements in "steer clear" performance of patients with sleep apnea and narcolepsy. Sleep. 1999 Sep 15;22(6):804-9. doi: 10.1093/sleep/22.6.804.

ReferenceCitation: Findley L, Unverzagt M, Guchu R, Fabrizio M, Buckner J, Suratt P. Vigilance and automobile accidents in patients with sleep apnea or narcolepsy. Chest. 1995 Sep;108(3):619-24. doi: 10.1378/chest.108.3.619.

ReferenceCitation: Grubb TC. Narcolepsy and highway accidents. JAMA. 1969 Sep 15;209(11):1720. No abstract available.

ReferenceCitation: Bartels EC, Kusakcioglu O. Narcolepsy: a possible cause of automobile accidents. Lahey Clin Found Bull. 1965;14(1):21-6. No abstract available.

ReferenceCitation: Aldrich MS. Automobile accidents in patients with sleep disorders. Sleep. 1989 Dec;12(6):487-94. doi: 10.1093/sleep/12.6.487.

ReferenceCitation: O'Hanlon JF, Volkerts ER. Hypnotics and actual driving performance. Acta Psychiatr Scand Suppl. 1986;332:95-104. doi: 10.1111/j.1600-0447.1986.tb08985.x.

ReferenceCitation: Ramaekers JG, O'Hanlon JF. Acrivastine, terfenadine and diphenhydramine effects on driving performance as a function of dose and time after dosing. Eur J Clin Pharmacol. 1994;47(3):261-6. doi: 10.1007/BF02570506.

ReferenceCitation: Philip P, Sagaspe P, Moore N, Taillard J, Charles A, Guilleminault C, Bioulac B. Fatigue, sleep restriction and driving performance. Accid Anal Prev. 2005 May;37(3):473-8. doi: 10.1016/j.aap.2004.07.007.

ReferenceCitation: Philip P, Sagaspe P, Taillard J, Valtat C, Moore N, Akerstedt T, Charles A, Bioulac B. Fatigue, sleepiness, and performance in simulated versus real driving conditions. Sleep. 2005 Dec;28(12):1511-6. doi: 10.1093/sleep/28.12.1511.

ReferenceCitation: Philip P, Taillard J, Moore N, Delord S, Valtat C, Sagaspe P, Bioulac B. The effects of coffee and napping on nighttime highway driving: a randomized trial. Ann Intern Med. 2006 Jun 6;144(11):785-91. doi: 10.7326/0003-4819-144-11-200606060-00004.

ReferenceCitation: Mitler MM, Gujavarty KS, Browman CP. Maintenance of wakefulness test: a polysomnographic technique for evaluation treatment efficacy in patients with excessive somnolence. Electroencephalogr Clin Neurophysiol. 1982 Jun;53(6):658-61. doi: 10.1016/0013-4694(82)90142-0.

ReferenceCitation: Sangal RB, Thomas L, Mitler MM. Maintenance of wakefulness test and multiple sleep latency test. Measurement of different abilities in patients with sleep disorders. Chest. 1992 Apr;101(4):898-902. doi: 10.1378/chest.101.4.898.

ReferenceCitation: Lee KA, Hicks G, Nino-Murcia G. Validity and reliability of a scale to assess fatigue. Psychiatry Res. 1991 Mar;36(3):291-8. doi: 10.1016/0165-1781(91)90027-m.

ReferenceCitation: Vallieres A, Morin CM. Actigraphy in the assessment of insomnia. Sleep. 2003 Nov 1;26(7):902-6. doi: 10.1093/sleep/26.7.902.

ReferenceCitation: Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

location_facility:
GENNPHASS - CHU de Bordeaux
AP-HP - Hôpital de l'Hôtel-Dieu


title: Phase I Open Label Trial to Assess Safety of BIBW 2992 With Vinorelbine in Solid Tumors Known to Overexpress HER2 and/or EGFR

summary: To determine the maximum tolerated dose, safety, pharmacokinetics and anti-tumour efficacy of oral BIBW 2992 in combination with intravenous or oral vinorelbine

lead_sponsor: Boehringer Ingelheim

location_facility: 1200.69.3302 Boehringer Ingelheim Investigational Site

location_facility: 1200.69.3301 Boehringer Ingelheim Investigational Site


title: Psychological and Emotional Impacts of Participation in Randomized Clinical Studies in Medical Oncology

summary:
RATIONALE: Gathering information from patients who received treatment for metastatic cancer while participating in a phase II or phase III randomized clinical trial and from patients receiving standard treatment off-trial may help doctors learn more about the psychological and emotional results of being in a clinical trial.

PURPOSE: This clinical trial is comparing the psychological and emotional impact of participating in a randomized clinical trial with the impact of standard treatment in patients with metastatic cancer.

lead_sponsor: Centre Oscar Lambret

location_facility:
Centre Oscar Lambret
Laboratoire URECA


title: Potential Role for Nocturnal PtcCO2 Monitoring in the Close Follow up of ALS Patients.

summary:
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease affecting motoneurons, with a prevalence around 5/100.000. Respiratory muscle involvement is a major feature in ALS and remains the main prognostic factor. Timing and rate of progression of this respiratory muscle involvement is also highly variable among individuals.

Respiratory manifestations justify a careful follow up including clinical evaluation, pulmonary function tests and blood gases. Prognostic value of respiratory muscle assessment has been clearly demonstrated in ALS, although several cut off values have been published. The clinical benefit of non invasive ventilation (NIV) is well established in ALS, but the optimal criteria for its initiation remain debated .

The 1999 consensus for NIV selected classical criteria to consider NIV in patients with respiratory symptoms suggesting hypoventilation: daytime hypercapnia (PaCO2 > 45 mmHg), nocturnal SaO2 < 89 % more than 5 consecutive minutes and for progressive neuromuscular disorders (NMD) (mainly ALS), a vital capacity (VC) < 50 % pred or a PImax < 60 cmH2O.

Besides daytime clinical and PFT assessment, nocturnal evaluation is essential in ALS. The prevalence of sleep apnea ranges from 16 % to 76 %.

Transcutaneous PCO2 (tcPCO2) is an attractive technique to evaluate non invasively nocturnal hypoventilation. The technique is well validated in different settings. Its use in neuromuscular disorders (NMD) is recent. In particular one study has demonstrated a high predictive value of tcPCO2 for the development of daytime hypoventilation within 1 year. To our knowledge, this technique has not been specifically assessed in ALS. There is a potential role for nocturnal PtcCO2 monitoring in the close follow up of ALS patients. Indeed, a close respiratory follow up of ALS patients is essential to determine the optimal timing of NIV, avoiding the occurence of unexpected acute respiratory failure.

lead_sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

location_facility: Pôle des maladies respiratoires et service EFR- Centre hospitalier Regional Universitaire


title: Efficacy of a Special Oral Nutritional Supplement on Nutritional Status of Malnourished Elderly Patients

acronym: Nutri-PA

summary:
The aim of this study is to evaluate in malnourished elderly patients the nutritional efficacy of a new nutritional supplement enriched in different specific pharmaco nutrients (leucine, micronutrients, omega-3) appearing in the form of a cake of high caloric density and palatability.

The primary endpoint is the outcome of fat-free mass measured by multiple frequence bio-impedance analysis.

lead_sponsor: University Hospital, Rouen

location_facility:
Centre Hospitalier de Dieppe
UHRouen


title: Cardiac Rehabilitation of Heart Failure Patients by Telemedicine: a Randomized Multicenter Study.

acronym: READ

summary: The purpose of the READ study is to compare the continuation of the cardiac rehabilitation at home with clinical follow-up, therapeutic education, and advice on the training at the stamina, via telemedicine with the classic strategy in day hospital.

lead_sponsor: University Hospital, Caen

location_facility:
William Harvey Center
Centre Hospitalier de la Côte Fleurie


title: Evaluation of the Efficacy of Autoadjusted Positive Pressure Devices for the Treatment of Obstructive Sleep Apnea Syndrome

summary:
Obstructive Sleep Apnea Syndrome (OSAS) is a common condition that leads to daytime sleepiness and loss of vigilance and, in addition, increased risk of cardiovascular events. The most effective treatment consists in ventilation by mask with continuous positive airway pressure (CPAP), that prevents collapse of the upper airway. However the degree of collapsibility of the pharynx may vary in relation to position, sleep stage, or alcohol or sedative consumption. Thus, CPAP treatment (invented in 1981) has evolved with the development of more sophisticated equipment that permits adapted variations in pressure levels (autoCPAP) with the objective adjusted pressure to avoid airways obstruction with minimal pressure.

Different models of autoCPAP function with different signals and event detection algorithms with different modes of reaction to events. These machines are marketed with CE certification, that guarantees electrical security, but there is to date, no requirement for pre-marketing clinical validation. Nonetheless inadequate treatment may leave patients at risk of accidents and cardiovascular events. These machines can be bench tested using test equipment that can measure with accuracy the response to simulated events, but the testing equipment cannot simulate the diversity of clinical situations, nor the residual level of microarousals that may persist. Thus these bench tests need to be supplemented by clinical studies. The investigators objective is to test the efficacy of these machines on residual sleep-related events during a one night autotitration polysomnography. We develop a prospective, multicentre, non randomised study with autotitration polysomnography only for one night. These clinical results will be compared with the results of bench tests in order to evaluate the pertinence of the bench tests and their eventual utility to simplify clinical evaluation. The perspective of developing a reliable testing protocol may eventually play a role in the certification of these machines.

sponsor_collaborators: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

location_facility: Service explorations fonctionnelles - Hopital La Miletrie


title: Randomized Controled Multicentric Trial, of Non Inferiority, Comparing Two Durations of Antibiotherapy (5 Days Versus 10 Days) in COMMUNAUTARY Acute Uncomplicated Pyelonephritis.

acronym: DTP

summary:
The purpose of this study is to compare the efficacy of 5 days versus 10 days treatment duration in uncomplicated acute pyelonephritis.

Acute pyelonephritis is a common disease and the treatment duration is not found on scientific evidence. If a short treatment is equal to standard duration, it will possible to shortening antibiotherapy with ecologic and economic advantage.

location_facility:
University hospital of Garches
university hospital of TOURS


title: Damage to DNA Caused by UV-A Irradiation: Photochemical Mechanism and Cutaneous Parameters Involved in the Formation of Cyclobutane Pyrimidine Dimers

acronym: DIMUVA

summary: The DIMUVA study aims to evaluate the correlation between cutaneous phototype and the nature and quantity of damage caused to cutaneous DNA after exposure to UV-A radiation.

ReferenceCitation: Brash DE. Sunlight and the onset of skin cancer. Trends Genet. 1997 Oct;13(10):410-4. doi: 10.1016/s0168-9525(97)01246-8.

ReferenceCitation: Melnikova VO, Ananthaswamy HN. Cellular and molecular events leading to the development of skin cancer. Mutat Res. 2005 Apr 1;571(1-2):91-106. doi: 10.1016/j.mrfmmm.2004.11.015.

ReferenceCitation: Cadet J, Sage E, Douki T. Ultraviolet radiation-mediated damage to cellular DNA. Mutat Res. 2005 Apr 1;571(1-2):3-17. doi: 10.1016/j.mrfmmm.2004.09.012. Epub 2005 Jan 26.

ReferenceCitation: Douki T, Reynaud-Angelin A, Cadet J, Sage E. Bipyrimidine photoproducts rather than oxidative lesions are the main type of DNA damage involved in the genotoxic effect of solar UVA radiation. Biochemistry. 2003 Aug 5;42(30):9221-6. doi: 10.1021/bi034593c.

ReferenceCitation: Dumaz N, Drougard C, Sarasin A, Daya-Grosjean L. Specific UV-induced mutation spectrum in the p53 gene of skin tumors from DNA-repair-deficient xeroderma pigmentosum patients. Proc Natl Acad Sci U S A. 1993 Nov 15;90(22):10529-33. doi: 10.1073/pnas.90.22.10529.

sponsor_collaborators:
University Hospital, Grenoble
Commissariat A L'energie Atomique

location_facility: Department of Dermatology, University Hospital Grenoble

location_facility: Centre d'investigation Clinique ,University Hospital Grenoble

intervention_type: Radiation


title: Phase II Study of High Dose Nebulized Amikacin in Patients With Pneumonia Undergoing Mechanical Ventilation

acronym: DARTAGNAN

summary: Inclusion of patients undergoing mechanical ventilation and presenting a pneumonia in order to determine serum pharmacokinetics of nebulized amikacin. The primary aim is to determine the dose of amikacin to be nebulized in order to observe amikacin serum concentrations close to but inferior to those observed after standart intravenous amikacin infusion.

lead_sponsor: Association Pour La Promotion A Tours De La Reanimation Medicale

location_facility: Service de réanimation médicale polyvalente. Hôpital Bretonneau CHRU

location_facility: Service de réanimation médicale. Hôpital La Source. CH Orléans


title: Effects of Parenteral L-carnitine Supplementation in Premature Neonates

acronym: CarniPrema

summary:
Background: Carnitine is the essential cofactor for various enzyme activities of human metabolism, especially for the mitochondrial carnitine shuttle that transfers long-chain fatty acids as acylcarnitine esters across the inner mitochondrial membrane for Beta-oxidation and energy production. Intracellular carnitine deficiency induces an impairment of long-chain fatty acid oxidation. In human, approximately 75% of carnitine comes from the diet and 25% from endogenous liver synthesis. In the neonatal period, more specifically in the premature, liver synthesis capacity is reduced because of immaturity of the biosynthetic pathway, and carnitine levels are related to exogenous sources. Traditionally, carnitine is not added to parenteral nutrition. Indeed, without enteral feeds and carnitine supplementation of parenteral nutrition, preterm infants' plasma carnitine levels fall during the first weeks of life, particularly in subjects requiring a prolonged exclusive parenteral nutrition. The potential deleterious role of carnitine deficiency has not been clearly demonstrated in these infants. However, most patients with primary carnitine deficiency, a genetic defect of carnitine transport inducing a severe carnitine deficiency, commonly develop liver symptoms (encompassing visceral steatosis, hyperammonemia and recurrent hypoketotic hypoglycemias) and/or cardiomyopathy and myopathy. In these latter patients, carnitine supplementation improves all the symptoms.

Hypothesis: Carnitine deficiency of the premature and very low birth weight infants may be one of the factors involved in the liver disease frequently associated with prolonged parenteral nutrition, and may have deleterious effects on cardiac and muscle metabolism and functions.

Aims: To demonstrate beneficial effects of parenteral carnitine supplementation in premature neonates for liver, heart and muscle metabolism and functions.

Study Type: Multicentric prospective and randomised study

Subjects: Premature and very low birth weight neonates, defined by gestational age minor or equal to 28 weeks and/or birth weight minor or equal to 1000 grams, 80 subjects will be enrolled during 2.5 years

Interventions: Arm 1 (experimental): parenteral carnitine supplementation (9 ± 1 mg/kg/d), from day 4, until than enteral nutrition provides sufficient carnitine source; Arm 2 (Placebo comparator): parenteral supplementation with an equivalent volume of sterile water.

lead_sponsor: University Hospital, Tours

location_facility: Hôpital Clocheville, University Hospital, Tours


title: Efficacy of Median Nerve Block Performed Using Echographic Guidance

summary: Observational study of the efficacy of median nerve blocks performed using echographic guidance in patients presenting with or without carpal tunnel syndrome.

lead_sponsor: Hopital Foch

location_facility:
Hôpital Privé de l'Ouest Parisien
Hopital Foch


title: Orbitofrontal Cortex (OFC) Influence on Addictive Behaviour in Medication Overuse Headache (MOH) Deriving From Migraine

acronym: MOH-PET

summary:
Medication Overuse Headache (MOH) is an illness affecting about 1,5 % of the general population. It is characterized by chronic headache occurring for at least 15 days a month, by a use of antimigraine drugs during at least 3 months for more than 10 days a month (for ergots, triptans, opiate derivates and combined analgesics) or for more than 15 days a month (for simple analgesics). The chronic headache must have occurred during the period of antimigraine drug abuse and the headache must have returned to its episodical pattern after withdrawal of antimigraine drugs. But, about 50% of the MOH patients will relapse during the first year following the antimigraine drugs withdrawal.

The pathophysiology of MOH is still largely unknown, and the role of antimigraine drug abuse in the transformation from migraine through MOH is not fully understood.

ReferenceCitation: Meyer M, Di Scala G, Edde M, Dilharreguy B, Radat F, Allard M, Chanraud S. Brain structural investigation and hippocampal tractography in medication overuse headache: a native space analysis. Behav Brain Funct. 2017 Apr 8;13(1):6. doi: 10.1186/s12993-017-0124-5.

lead_sponsor: University Hospital, Bordeaux

location_facility: CHU de Bordeaux - Hôpital Tastet Girard Centre Anti douleur

location_facility: C.H.U. de Bordeaux - Groupe Hospitalier Pellegrin - Service Médecine nucléaire


title: Platform for the Prospective Mother-child Study of the Determinants of Autism Spectrum Disorder and Neurodevelopmental Disorders Neurodevelopmental Disorders

acronym: MARIANNE

summary:
Neurodevelopmental disorders such as attention deficit disorder with or without hyperactivity, autism spectrum disorder, language and social communication disorder, motor coordination disorder, learning disorder (dyslexia, dyscalculia, dysorthography), intellectual development disorder are frequent and long-lasting developmental difficulties that can be observed in children in various domains. They are often associated and have a significant impact on daily functioning at school and at home.

The rate of people affected by neurodevelopmental disorders including autism spectrum disorder have increased significantly over the past 20 years. Improved screening only partly explains this evolution.

A genetic predisposition plays an important role in the occurrence of these disorders, however, current scientific data suggest a multifactorial origin. Exposures such as those related to the use of pesticides, air pollution or the presence of endocrine disruptors in our diet could be involved in the genesis of neurodevelopmental disorders, particularly during intrauterine life, a period of great vulnerability.

The current diagnostic pathways for autism rarely enable the early identification of babies at risk. Without early detection and timely targeted intervention, these children have a poor health outcome and do not reach their full potential.

The general objective of the MARIANNE cohort is to constitute a French research infrastructure dedicated to research on the biological and environmental determinants of neurodevelopmental disorders including autism.

This cohort is based on the follow-up of 1200 families with already a child affected by an autism spectrum disorder, which implies a high risk of neurodevelopmental disorders including autism spectrum disorder for the siblings, and of 500 families from the general population with no excess risk of neurodevelopmental disorders. The total number of subjects to be included (mother, father, unborn child and ASD sibling for the HR group) is thus 6300.

The inclusion of these families will be at the beginning of a new pregnancy and the follow-up will be carried out from the second trimester of pregnancy until the children are 6 years old, the age at which the diagnosis of neurodevelopmental disorders is possible.

Biological, clinical, social and environmental data will be collected at different stages of the follow-up and will be included into a large database.

status: Recruiting

sponsor_collaborators:
University Hospital, Montpellier
University Hospital, Lille
Hospices Civils de Lyon
University Hospital of Saint-Etienne
University Hospital, Rouen
University Hospital, Toulouse
Hôpital le Vinatier


title: Survey on the Clinical Assessment of the Psychological Status of a Patient Over 75 Years Old in Oncology During the Realization of the G8 Score

acronym: CADEPO

summary:
The goal of this observational study is to make a statement concerning the identification of depressive symptoms at the time of the realization of the G8 score in patients over 75 with cancer and followed in oncology.

The main question it aims to answer are:

Compare the medical hetero-evaluation of depressive symptoms via the G8 "neuro-psychiatric disorders" item score with a self-evaluation via the GDS-15 score
Evaluate the number of patients over 75 treated with antidepressants
Evaluate the proportion of patients with depressive symptoms according to the predisposing factors
Compare the number of patients followed in oncogeriatrics over the period from 01/01/2022 to 02/28/2022 and the period from 01/01/2023 to 02/28/2023

Participants will complete a self-questionnaire (GDS-15 score) as well as a socio-demographic sheet.

ipd_sharing: No

lead_sponsor: Hopital Nord Franche-Comte


title: Impact of Cardiopulmonary Bypass Flow on Cerebral Autoregulation in Cardiac Surgery, a Cross-over Study

acronym: FLOWMAPCA

summary:
Cerebral autoregulation is defined by the capacity of the brain to maintain a constant cerebral blood flow (CBF) despite variations of arterial pressure. However, when the arterial pressure is below a critical threshold, cerebral blood decreases.

This critical threshold is called the lower limit of cerebral autoregulation (LLA).

Cardiopulmonary bypass is a unique environment wherein systemic blood flow is totally controlled by the cardiopulmonary bypass pump. High pump flows combined with low arterial pressures has been shown to not compromise neurologic postoperative outcomes.

Our hypothesis is that that LLA may depend on the cardiopulmonary bypass flow, ie the LLA may decrease when the cardiopulmonary bypass flow increases, explaining why low arterial pressure may be well tolerated.

lead_sponsor: Clinique de la Sauvegarde

collaborators: GCS Ramsay Santé pour l'Enseignement et la Recherche


title: " Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia " The pediaPREM Study.

acronym: pediaPREM

summary:
Children undergoing general anesthesia for surgery commonly need sedative and anxiolytic premedication but little clinical evidence supports is benefit for children older than 7 years old.

The aim of this prospective randomized clinical trial is to assess the impact of pharmacologic premedication on perioperative children experience.

lead_sponsor: University Hospital, Montpellier


title: Tissu Adipeux épicardique et rigidité artérielle Chez Les Personnes Vivant Avec un diabète

acronym: METAB-CV-PWV

summary: The present study is a retrospective and prospective current care cohort that will allow us to evaluate the relationship between epicardial fat volume and increased arterial stiffness in a person living with diabetes.

time_perspective: Other

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Assessment of the Effects of Maela Connected Follow-up on Well-being and Pain After Lumbar Spine Surgery

acronym: HOSPITEL

summary:
Digital technologies could reduce the length of hospital stay and improve post-operative recuperation after discharge by offering a remote follow-up. No study has investigated the effects of connected follow-up on lumbar spine inpatients.

The purpose of this project is to assess the effects of connected follow-up on pain and quality of life after lumbar spine surgery.

lead_sponsor: Centre Hospitalier Universitaire, Amiens


title: Multicenter National Observational and Prospective Study of a Cohort of Children With Molluscum Contagiosum (MC) Treated With a 5% Solution of Potassium Hydroxide (Molutrex®) Applied Locally to the Skin

acronym: SERENITE

summary:
Molutrex® a 5% potassium hydroxide solution for topical application to the skin. Molutrex® is intended for the superficial treatment of certain types of warts, molluscum contagiosum and is composed of potassium hydroxide (5%) purified water. With regard to the 2017/745 RDM, he is a class IIa medical device. In accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017 relating to medical devices, as part of the Molutrex® Post-Marketing Monitoring Plan, the objective of this study is to have data on the performance , safety and suitability for real-life use of Molutrex® in a prospective cohort of patients with molluscum contagiosum.

Since molluscum contagiosum is most prevalent in children, and potassium hydroxide is used very little in adults (because most often they are immunocompromised patients requiring other antiviral treatments), the study will be conducted in children aged 2 to 10 years. This population represents the majority of patients treated with Molutrex®, although the product can be used in adults. The study includes 2 visits, the objective of the study being to evaluate the percentage of children healed at 45 days, healing defined by a reduction of more than 90% in the number of lesions present at inclusion in the study.

ipd_sharing: Undecided

lead_sponsor: Laboratoire Dermatologique ACM

sponsor_collaborators:
Laboratoire Dermatologique ACM
Clin-Experts


title: Biological Signatures (Proteomics, Metabolomics and Genotoxicity) Associated With Occupational Exposure to PAH Mixtures and Relation With Exposure Biomarkers: Support for the Derivation of Biological Limit Values

acronym: PAH-ProMetGen

summary:
This research project aims at better understanding the early biological effects resulting from occupational exposure to complex Polycyclic Aromatic Hydrocarbon (PAH) mixtures.

Current biomarkers used as part of biomonitoring campaigns are biomarkers of exposure, not numerous and poorly related to health effects.

The aim of this study is thus to improve our understanding of biological consequences of such exposures, both in terms of proteins deregulation, metabolism deregulation and genotoxicity.

lead_sponsor: University Hospital, Grenoble


title: Intracranial Dural Arteriovenous Fistula Related Pulsatile Tinnitus . Endovascular Treatment by Venous Stenting : An Efficacy Study

acronym: INVENT

summary: The goal of this randomized trial to assess the angiographic efficacy of venous stenting in dural arteriovenous fistulae (DAVF) via improvment on Cognard's Classification as compared to no intervention at 6 months Participants belonging to experimental group will be treated using venous stenting. DAVF will be assessed by angiography at 6 months follow-up. Participants belonging to control group will be followed accordingly to standard of care (no treatment). After 6 months, control group patients can be treated by any means accordinlgly to standard of care.

study_start_date_type: Anticipated

status: Not yet recruiting

collaborators: French Ministry of Social Affairs and Health


title: Predictive Value of the DD4 Questionnaire on Depressive Relapse After Hospitalization.

acronym: PRADESH

summary: This is a prospective, longitudinal, single-center observational study of data from the medical records of patients hospitalized after a characterized depressive episode and reviewed three months after hospital discharge, as part of a normally scheduled evaluation.

lead_sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche


title: Single-center Comparative Study of Variation in Acetabular Anteversion According to Pelvic Tilt in Patients With Femoro-acetabular Impingement and Healthy Volunteers.

acronym: VARIA-CFA

summary: The main objective is to show that the upper acetabular anteversions calculated in standing, sitting, sitting hip in maximum flexion and supine positions are lower in patients with symptomatic DWI compared to healthy volunteers.

sponsor_collaborators: GCS Ramsay Santé pour l'Enseignement et la Recherche


title: Establishment of a Patient Library in Patients With Pruritus Sine Materia

acronym: PRURITHEQUE

summary: Very little is currently known about the pathophysiology of pruritus sine materia according to the etiology. The creation of this cohort should make it possible to improve our clinical and biological knowledge according to the etiology, by collecting blood, skin, feces, and clinical data.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest


title: Evaluation of the Interest of a Postural and Functional Analysis for the Follow-up of the Adapted Motor Activity of Patients Treated for Breast Cancer

acronym: APECS

summary:
The goal of this clinical trial is to evaluate the acceptability by patients treated for breast cancer of an adapted motor activity program over a period of 15 months controlled by a postural and functional analysis..

Participant population/health conditions: patients with newly operated breast cancer who are candidates for an adapted physical activity program


title: Interest of Freestyle Libre 2 as a Tool for Therapeutic Education in Recently Diagnosed Type 2 Diabetics Patients

acronym: FREEDIA

summary:
Therapeutic patient education (TPE) is a key element in the management of people living with type 2 diabetes.

The benefit of therapeutic education (TPE) has been clearly established on glycaemic control.

Continuous interstitial glucose monitoring (CGM) can be considered as a TPE tool for people living with diabetes. A direct reading of the effects of diet and physical activity on glycaemic levels could have an impact on the initiation and maintenance of therapeutic lifestyle modifications.

The investigators therefore propose a prospective randomised study in 2 arms :

a group of people living with diabetes receiving standard TPE vs
a group of people living with diabetes receiving standard TPE + FSL 28 days Ourmain objective is to determine the benefit of CGM on HbA1c at 3 months between 2 arms


title: Risk Factors and Progression of Keratoconus

acronym: FRPK

summary:
Primary objective :

Description of keratoconus at baseline and during progression in 200 participants followed by the ophthalmology departments of CHU Montpellier, CHU Bordeaux and CHU Toulouse during a 2-year period. Clinical outcome, histology of the cornea and tears proteomics will be assessed in 4 groups at different points in time:

At 6 months in participants with no intervention (risk reduction instructions: not to rub their eyes)
At 6 months in participants with no intervention that didn't comply with the risk reduction instructions
At 1 month in participants assigned to cross-linking surgery
At 1 month in participants assigned to intra corneal ring surgery If both eyes are affected, both will be evaluated with their own visit agenda. Visits for no surgery participants will be set at 6 months, 12 months and 24 months in the absence of intervention (apart from the behavioral risk reduction).

Visits for surgery participants will be set at D7, 1 month, 6 months, 12 months and 24 months after the procedure: cross-linking or placement of the intra corneal ring.

Secondary objective :

Description of the association between clinical outcomes, histological progression of the cornea and tears proteomics in time, 2 years period.

Comparison of tears proteomics in 36 participants with keratoconus followed at CHU of Montpellier and healthy participants at baseline .

location_facility: CHU Gui de Chauliac - Service d'Ophtamologie


title: Assessment of the Cognitive Load of the Landed Combatant in Virtual Reality.

acronym: ECCOREV

summary:
To support the landed soldier during operational missions in hostile environment, equipment must be designed to enable soldiers to cope with strong visual, auditory and informational demands. Technological solutions proposed by manufacturers are embodied in increasingly sophisticated systems.

These systems take too little account of the characteristics of the perceptive and cognitive skills of human beings in an action situation.

Cognitive load results from the interaction between, on the one hand, the characteristics of the task and the constraints it imposes, and on the other hand, the resources available to the individual, in terms of skills, motivation, physiological state and social support. The phenomenon of cognitive overload occurs when the individual no longer has sufficient resources to meet the demands of the task, which leads to a deterioration in his performance which, in high-risk situations, jeopardizes his safety.

Tasks are treated differently depending on their level of difficulty. We will base ourselves on Rasmussen's SRK (Skill Rule Knowledge) model, which describes three levels of information processing: level S refers to the (automatic) processing of sensory-motor and cognitive skills, level R refers to the execution of rules and procedures embedded in mental models, and level K refers to the mental activities of elaborating procedures, based on high-level cognitive mechanisms, such as anticipation, evaluation or planning. Multitasking situations are therefore generally composed of tasks of various levels of difficulty which lead to a higher or lower cost of cognitive control.

Thus, this study is aimed at identifying variations in the subjective level of cognitive load of landed combatants (group leaders) as a function of the level of difficulty of primary tasks.

lead_sponsor: Direction Centrale du Service de Santé des Armées

location_facility: Institut de Recherche Biomédicale des Armées


title: Real-Time Monitoring of Circulating Tumor DNA and Study of Prognostic Factors in Patients Treated With Anti-CD19 CAR-T Cells for Relapsed or Refractory Diffuse Large B-cell Lymphoma

acronym: RT-CAR

summary: The purpose of this study is to demonstrate that it is possible to report in real time (less than 3 weeks) to the hematologist the results of the molecular minimal residual disease (MRD) based on blood circulating tumor DNA (ctDNA) assessment taken approximately 7 days after the reinjection of the CAR-T cells, in order to be able to anticipate a possible progression of the disease and to be able to propose salvage or earlier adjuvant therapy to improve patient prognosis.

lead_sponsor: Centre Henri Becquerel


title: Study of Microvesicles in Pre-eclampsia

acronym: MICROVES-PE

summary:
A large number of studies on MVs from syncytiotrophoblasts support the hypothesis of their involvement in pre-eclampsia, via their multiple effects, among others as pro-coagulant, immuno-stimulatory and anti-angiogenic factors.

The main objective is to compare the total concentration of the main populations of MVs in the maternal blood of a population of pre-eclamptic patients to those of a population of non-pre-eclamptic patients.

collaborators: Laboratory of Chemistry and Biology of Membranes and Nano-objects (CBMN) of Bordeaux University


title: Feasibility and Acceptability of the MacuTest Website for Personalized AMD Risk Prediction and Prevention: Pilot Study

acronym: MACUTEST

summary: LEHA team of Bordeaux University has developed an Age-related Macular Degeneration (AMD) prediction algorithm (taking into account age, 49 genetic variants, the presence of early retinal abnormalities, tobacco consumption, food quality, blood pressure and education level) and is currently developing the MacuTest website, integrating this prediction algorithm. This platform offers participants the possibility to enter their personal lifestyle data, to couple them with an ophthalmological examination and a genetic test, in order to evaluate their personalized risk of AMD. The main objective of this pilot study is to evaluate the feasibility of estimating the predicted AMD risk

sponsor_collaborators:
University Hospital, Bordeaux
University of Bordeaux


title: Knowledge of Young Adults About Genital Herpes

acronym: HerpesG

summary: Despite sex education in schools and prevention campaigns concerning sexually transmitted infections, genital herpes remains frequent infection. In 2016, according to the World Health Organization, more than 490 million people worldwide were living with a genital herpes infection.

lead_sponsor: Université de Reims Champagne-Ardenne


title: Validation Externe Par Apprentissage Statistique et réduction Des Dimensions d'entrée de l'échelle D-PSY

acronym: D-Psy adultes

summary:
There have been debates about whether psychiatric disorders should be classified according to categories (categorical model) or according to a continuum between normal and pathological functioning (dimensional model). While the former is the main one used to facilitate reliability, it has several limitations. We will use machine learning to develop a predictive model, bridging the gap between the dimensional and categorical approaches. Psychometric measures obtained from a questionnaire will be collected. Then, a supervised descriptor selection approach will be applied to predict categorical outcomes from dimensional inputs. The resulting prediction will be based on nonlinear modeling based on universal approximators. We developed this input questionnaire with four main objectives: 1) to briefly scan most of the categories generally described in the international nosography; 2) to use a continuous scale following a dimensional approach; 3) to use positively oriented sentences to decrease social desirability bias; 4) to be less confronting for the patient.

The questionnaire is built on dimensions, whereas psychiatric diagnoses are built on categories. We will model the transition from one to the other. This approach will allow us to verify the hypotheses of diagnostic categories construction in psychopathology, integrated in the RDoC approach; and later on to standardize the psychometric measures used in cognitive-behavioral therapy treatments.

200 adults will undergo a standard clinical interview (SCID-5, First et al., 2017), and the psychological screening self-report questionnaire (D-Psy) and additional questionnaires measuring social desirability dissociation, phobia and autism.

ipd_sharing_description: No sharing plan

lead_sponsor: Institut pour la Pratique et l'Innovation en PSYchologie appliquée (Institut Pi-Psy)

intervention_type: Diagnostic Test


title: Prostaglandins Versus Trans-Cervical Balloon for Induction of Labor in Fetal Growth Restriction: a Multicenter Open-label Randomized Trial

acronym: PROBIN

summary:
The goal of this randomized trial is to compare two methods of induction in a fetal growth restriction population. The main question it aims to answer is:

• Is trans-cervical balloon superior to prostaglandins in reducing the cesarean section rate, without increasing neonatal morbidity? Participants will have an induction of labour by cervical ripening with trans-cervical balloon in the trans-cervical balloon catheter arm and with Prostaglandins in the Misoprostol arm.

Researchers will compare two methods of induction: trans-cervical balloon and prostaglandins to see if trans-cervical balloon is associated with a lower risk of cesarean delivery.

sponsor_collaborators: French Ministry of Social Affairs and Health

appel_a_projets: PHRCI

region: Nouvelle-Aquitaine

nom_etablissement: CHU DE BORDEAUX

type_etablissement: CH

acronyme: PROBIN

titre: Prostaglandines versus ballonnet trans-cervical pour le déclenchement du travail en  cas de ftus en restriction de croissance : essai randomisé ouvert multicentrique

discipline_principale: autre

nom_porteur: BOUCHGHOUL

prenom_porteur: Hanane