title: Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses

summary:
This study intends to assess the ability of contrast-enhanced ultrasound in the detection of benign and malignant ovarian masses compared to unenhanced ultrasound.

By using an intravascular contrast agent, this noninvasive and feasible imaging technique will allow the investigators to define specific microcirculation patterns in 100 women with ovarian lesions.

The intravascular contrast agent properties will be compared between benign and malignant adnexal masses.

The final purpose of this ultrasonography is to allow the early detection of tumors and to improve the characterization between benign and malignant lesions.

ReferenceCitation: Tailor A, Jurkovic D, Bourne TH, Collins WP, Campbell S. Sonographic prediction of malignancy in adnexal masses using multivariate logistic regression analysis. Ultrasound Obstet Gynecol. 1997 Jul;10(1):41-7. doi: 10.1046/j.1469-0705.1997.10010041.x.

ReferenceCitation: MacSweeney JE, Cosgrove DO, Arenson J. Colour Doppler energy (power) mode ultrasound. Clin Radiol. 1996 Jun;51(6):387-90. doi: 10.1016/s0009-9260(96)80155-3. No abstract available.

ReferenceCitation: Timmerman D, Bourne TH, Tailor A, Collins WP, Verrelst H, Vandenberghe K, Vergote I. A comparison of methods for preoperative discrimination between malignant and benign adnexal masses: the development of a new logistic regression model. Am J Obstet Gynecol. 1999 Jul;181(1):57-65. doi: 10.1016/s0002-9378(99)70436-9.

ReferenceCitation: Kinkel K, Hricak H, Lu Y, Tsuda K, Filly RA. US characterization of ovarian masses: a meta-analysis. Radiology. 2000 Dec;217(3):803-11. doi: 10.1148/radiology.217.3.r00dc20803.

ReferenceCitation: Suren A, Osmers R, Kulenkampff D, Kuhn W. Visualization of blood flow in small ovarian tumor vessels by transvaginal color Doppler sonography after echo enhancement with injection of Levovist. Gynecol Obstet Invest. 1994;38(3):210-2. doi: 10.1159/000292481.

ReferenceCitation: Orden MR, Gudmundsson S, Kirkinen P. Contrast-enhanced sonography in the examination of benign and malignant adnexal masses. J Ultrasound Med. 2000 Nov;19(11):783-8. doi: 10.7863/jum.2000.19.11.783. Erratum In: J Ultrasound Med 2001 Jan;20(1):20.

ReferenceCitation: Morel DR, Schwieger I, Hohn L, Terrettaz J, Llull JB, Cornioley YA, Schneider M. Human pharmacokinetics and safety evaluation of SonoVue, a new contrast agent for ultrasound imaging. Invest Radiol. 2000 Jan;35(1):80-5. doi: 10.1097/00004424-200001000-00009.


title: Severe Acute Respiratory Failure in Hematology and Cancer Patients Without Bronchoalveolar Lavage. A Multicentric Randomized Controlled Trial

summary: The MiniMax® study is a multicenter randomized controlled study aimed at demonstrating that a combination of non-invasive diagnostic tools are as effective as fiberoptic bronchoscopy and bronchoalveolar lavage (FO-BAL) in performing the etiological diagnosis of acute respiratory failure in cancer patients.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Diagnostic

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Dunagan DP, Baker AM, Hurd DD, Haponik EF. Bronchoscopic evaluation of pulmonary infiltrates following bone marrow transplantation. Chest. 1997 Jan;111(1):135-41. doi: 10.1378/chest.111.1.135.

ReferenceCitation: White P, Bonacum JT, Miller CB. Utility of fiberoptic bronchoscopy in bone marrow transplant patients. Bone Marrow Transplant. 1997 Oct;20(8):681-7. doi: 10.1038/sj.bmt.1700957.

ReferenceCitation: Murray PV, O'Brien ME, Padhani AR, Powles R, Cunningham D, Jeanes A, Ashley S. Use of first line bronchoalveolar lavage in the immunosuppressed oncology patient. Bone Marrow Transplant. 2001 May;27(9):967-71. doi: 10.1038/sj.bmt.1703020.

ReferenceType: derived

ReferenceCitation: Azoulay E, Mokart D, Lambert J, Lemiale V, Rabbat A, Kouatchet A, Vincent F, Gruson D, Bruneel F, Epinette-Branche G, Lafabrie A, Hamidfar-Roy R, Cracco C, Renard B, Tonnelier JM, Blot F, Chevret S, Schlemmer B. Diagnostic strategy for hematology and oncology patients with acute respiratory failure: randomized controlled trial. Am J Respir Crit Care Med. 2010 Oct 15;182(8):1038-46. doi: 10.1164/rccm.201001-0018OC. Epub 2010 Jun 25.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Service de Réanimation Médicale de l'Hôpital Saint-Louis

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Completed


title: Qualitative and Quantitative Study of Fetal Movements Using Multichannel Ultrasound Pulsed Doppler in Normal and Pathologic Pregnancy

summary:
To enable an investigation of fetal movements, the researchers have developed a multichannel ultrasound pulsed Doppler called ACTIFOETUS. This new fetal monitor includes three transducers of four sensors which are placed on three different zones of the mother's abdomen. One of the transducers is aimed at the fetal heart, another at the lower limbs and one transducer at the thorax and the fetal upper limbs to detect heart and body movements. The signals are analysed and processed by software which computes a number of parameters describing the movements.

Ninety pregnant women from 28 weeks gestation will be monitored over a 40 minute period every month or every 2 weeks in case of pathological pregnancy. The final purpose will be to develop a system of home monitoring as an indicator of fetal well-being.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceCitation: Hammacher K, Huter KA, Bokelmann J, Werners PH. Foetal heart frequency and perinatal condition of the foetus and newborn. Gynaecologia. 1968;166(4):349-60. doi: 10.1159/000302346. No abstract available.

ReferenceCitation: Karlsson B, Berson M, Helgason T, Geirsson RT, Pourcelot L. Effects of fetal and maternal breathing on the ultrasonic Doppler signal due to fetal heart movement. Eur J Ultrasound. 2000 Mar;11(1):47-52. doi: 10.1016/s0929-8266(99)00071-3.

ReferenceCitation: Melendez TD, Rayburn WF, Smith CV. Characterization of fetal body movement recorded by the Hewlett-Packard M-1350-A fetal monitor. Am J Obstet Gynecol. 1992 Sep;167(3):700-2. doi: 10.1016/s0002-9378(11)91574-9.

ReferenceCitation: Timor-Tritsch I, Zador I, Hertz RH, Rosen MG. Classification of human fetal movement. Am J Obstet Gynecol. 1976 Sep 1;126(1):70-7. doi: 10.1016/0002-9378(76)90467-1.

ReferenceCitation: Shinozuka N, Yamakoshi Y. Measurement of fetal movements using multichannel ultrasound pulsed Doppler: autorecognition of fetal movements by maximum entropy method. Med Biol Eng Comput. 1993 Jul;31 Suppl:S59-66. doi: 10.1007/BF02446651.

ReferenceCitation: Manning FA. Fetal biophysical profile. Obstet Gynecol Clin North Am. 1999 Dec;26(4):557-77, v. doi: 10.1016/s0889-8545(05)70099-1.

lead_sponsor: University Hospital, Tours

status_simplified: Unknown


title: Contrast-Enhanced Ultrasound and Neoadjuvant Chemotherapy of Breast Cancer: Relationship Between Early Vascular Changes of the Tumor and Late Tumoral Response

summary:
This study intends to assess the ability of contrast-enhanced ultrasound to make the efficacy of chemotherapy in breast cancer precise.

This real-time noninvasive and feasible imaging technique allows us, the investigators at University Hospital Tours, to evaluate early vascular changes of breast tumors during treatment. These vascular changes may precede long-term tumoral regression. Imaging of primary breast lesions may be of value in the prediction of late treatment response.

An ultrasound will be performed before the initiation, and after the second and the last dose of chemotherapy.

To investigate the changes occurring in the vascularization of tumors, we will use an intravascular ultrasound contrast agent SonoVue (sulphur hexafluoride microbubbles).

This agent is a microbubbles preparation that is stable, resistant to pressure, and specifically designed to be used as a contrast agent for ultrasound imaging of angiogenesis.

design_allocation: Non-Randomized

ReferenceCitation: Singh S, Pradhan S, Shukla RC, Ansari MA, Kumar A. Color Doppler ultrasound as an objective assessment tool for chemotherapeutic response in advanced breast cancer. Breast Cancer. 2005;12(1):45-51. doi: 10.2325/jbcs.12.45.

ReferenceCitation: Watermann D, Madjar H, Sauerbrei W, Hirt V, Prompeler H, Stickeler E. Assessment of breast cancer vascularisation by Doppler ultrasound as a prognostic factor of survival. Oncol Rep. 2004 Apr;11(4):905-10.

ReferenceCitation: Folkman J. Angiogenesis in cancer, vascular, rheumatoid and other disease. Nat Med. 1995 Jan;1(1):27-31. doi: 10.1038/nm0195-27.

ReferenceCitation: Hansen S, Grabau DA, Rose C, Bak M, Sorensen FB. Angiogenesis in breast cancer: a comparative study of the observer variability of methods for determining microvessel density. Lab Invest. 1998 Dec;78(12):1563-73.

ReferenceCitation: Hansen S, Grabau DA, Sorensen FB, Bak M, Vach W, Rose C. The prognostic value of angiogenesis by Chalkley counting in a confirmatory study design on 836 breast cancer patients. Clin Cancer Res. 2000 Jan;6(1):139-46.

ReferenceCitation: Smith IC, Welch AE, Hutcheon AW, Miller ID, Payne S, Chilcott F, Waikar S, Whitaker T, Ah-See AK, Eremin O, Heys SD, Gilbert FJ, Sharp PF. Positron emission tomography using [(18)F]-fluorodeoxy-D-glucose to predict the pathologic response of breast cancer to primary chemotherapy. J Clin Oncol. 2000 Apr;18(8):1676-88. doi: 10.1200/JCO.2000.18.8.1676.

ReferenceCitation: Schelling M, Avril N, Nahrig J, Kuhn W, Romer W, Sattler D, Werner M, Dose J, Janicke F, Graeff H, Schwaiger M. Positron emission tomography using [(18)F]Fluorodeoxyglucose for monitoring primary chemotherapy in breast cancer. J Clin Oncol. 2000 Apr;18(8):1689-95. doi: 10.1200/JCO.2000.18.8.1689.

ReferenceCitation: Denis F, Bougnoux P, Paon L, le Floch O, Tranquart F. Radiosensitivity of rat mammary tumors correlates with early vessel changes assessed by power Doppler sonography. J Ultrasound Med. 2003 Sep;22(9):921-9. doi: 10.7863/jum.2003.22.9.921.

ReferenceCitation: Denis F, Colas S, Chami L, Louisot P, Le Floch O, Tranquart F, Bougnoux P. Changes in tumor vascularization after irradiation, anthracyclin, or antiangiogenic treatment in nitrosomethyl ureas-induced rat mammary tumors. Clin Cancer Res. 2003 Oct 1;9(12):4546-52.

ReferenceCitation: Kook SH, Kwag HJ. Value of contrast-enhanced power Doppler sonography using a microbubble echo-enhancing agent in evaluation of small breast lesions. J Clin Ultrasound. 2003 Jun;31(5):227-38. doi: 10.1002/jcu.10172.

ReferenceCitation: Solesvik OV, Rofstad EK, Brustad T. Vascular changes in a human malignant melanoma xenograft following single-dose irradiation. Radiat Res. 1984 Apr;98(1):115-28.


acronym: DYS-AUT

summary: Developmental dyslexia is a frequent learning disability. The aim of this study is to compare auditory evoked cortical responses to syllables and tones in developmental dyslexia and controls (paired with age, gender). The study is conducted in 3 groups of subjects :8-10 years ; 11-17 years and 18-25 years. We suppose that cortical responses should be different in developmental dyslexia and controls.


title: fMRI Study of Grasping in Autistic Patients

summary: The aim of the study is to localise brain regions involved in objects recognition, in planification and adjustment of grasping, in prehension with and without eye control. The study is conducted in normal and autistic adults. We hypothesize different activations in these two populations.

status: Terminated

time_perspective: Other


title: An Open Label, Multi-national Study of Oral Desmopressin in Previously Untreated Children Aged 5 to 15 Years With Primary Nocturnal Enuresis

acronym: DRIP

summary:
To evaluate the overall response to desmopressin treatment among previously untreated enuretic children aged 5-15 years after 3 and 6 months of treatment.

To investigate the influence of possible predictive factors on response after 3 and 6 months of treatment.

To evaluate the proportion of patients achieving dryness. To evaluate the long-term safety profile of oral desmopressin in children with primary nocturnal enuresis.

primary_purpose: Treatment

ReferenceCitation: Van Herzeele C, Evans J, Eggert P, Lottmann H, Norgaard JP, Vande Walle J. Predictive parameters of response to desmopressin in primary nocturnal enuresis. J Pediatr Urol. 2015 Aug;11(4):200.e1-8. doi: 10.1016/j.jpurol.2015.03.007. Epub 2015 May 21.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Van Herzeele C, De Bruyne P, Evans J, Eggert P, Lottmann H, Norgaard JP, Vande Walle J. Safety profile of desmopressin tablet for enuresis in a prospective study. Adv Ther. 2014 Dec;31(12):1306-16. doi: 10.1007/s12325-014-0173-1. Epub 2014 Dec 12.

publisher_dissemination: Springer

ReferenceCitation: Lottmann H, Baydala L, Eggert P, Klein BM, Evans J, Norgaard JP. Long-term desmopressin response in primary nocturnal enuresis: open-label, multinational study. Int J Clin Pract. 2009 Jan;63(1):35-45. doi: 10.1111/j.1742-1241.2008.01956.x.

lead_sponsor: Ferring Pharmaceuticals

location_facility: Foundation Hospital Saint Joseph, 185, rue Raymond Losserand

intervention_type: Drug

lead_sponsor_type: industriel


title: A Pilot Study Evaluation of the Efficacy of SonoVue to Detect and Characterise Breast Lesions

summary:
Ultrasound is a well-established imaging modality for the evaluation of breast disease.

The investigators' objective is to characterise the properties of an intravascular ultrasonographic contrast agent SonoVue (sulphur hexafluoride microbubbles) to improve the diagnostic value of the ultrasound examination in patients with different breast lesions.

The final purpose of this ultrasonography is to allow the early detection of tumors and to improve the differentiation between benign and malignant lesions.

SonoVue® (sulphur hexafluoride microbubbles) is a microbubbles preparation that is stable, resistant to pressure, and specifically designed to be used as a contrast agent for ultrasound imaging.

Contrast-enhanced ultrasound could provide a non-invasive technique to evaluate the morphology of breast tumour vascularity.

ReferenceCitation: Kettenbach J, Helbich TH, Huber S, Zuna I, Dock W. Computer-assisted quantitative assessment of power Doppler US: effects of microbubble contrast agent in the differentiation of breast tumors. Eur J Radiol. 2005 Feb;53(2):238-44. doi: 10.1016/j.ejrad.2004.04.017.

ReferenceCitation: Martinez AM, Medina CJ, Bustos C, Hernandez JA. Assessment of breast lesions using Doppler with contrast agents. Eur J Gynaecol Oncol. 2003;24(6):527-30.

ReferenceType: result

ReferenceCitation: Cosgrove DO, Kedar RP, Bamber JC, al-Murrani B, Davey JB, Fisher C, McKinna JA, Svensson WE, Tohno E, Vagios E, et al. Breast diseases: color Doppler US in differential diagnosis. Radiology. 1993 Oct;189(1):99-104. doi: 10.1148/radiology.189.1.8372225.


title: Prospective Study Randomized Multicentric On the Optimization Of the Installation Of Stent By Measurement Of the Intra-Coronary Pressure

summary:
Hypothesis : it is known that the stent must be well opened out in order to avoid restenosis into the stent. Intra coronary pressure would allow the stent to be well deployed and so the restenose into the stent should diminish.

Primary purpose : this study intend to test the hypothesis of optimal spreading of coronary stent guided with pressure into coronary arteritis comparing 2 strategies with patients having a coronary procedure with stent, excluded patients with myocardial infarction.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Volcano Corporation


title: Variations of Hemispheric Lateralisation of Language Depending of Gender and Age.

summary: The purpose of this study is to determine whether gender and age modify cerebral activations during a silent word generation functional Magnetic Resonance task.


summary:
The purpose of this study is :

to look for changes induced by aging in a population of old subjects, during silent word generation tasks studied by fMRI.
to look for a possible link between these changes and alterations in language


title: Bronchial Ultrasonography Via a Fibrescope: Pilot Study in Tumoral Disease

summary:
The exploration of neoplastic pulmonary pathology is based on computed tomography and bronchoscopy. This allows targeted samples of the identified lesions.

A new ultrasonographic method is proposed as a non invasive and non irradiating technic by using a dedicated probe easily introduced via the channel of the fibrescope, so as to complete the identification of peripheral lesions.

ReferenceCitation: Kurimoto N, Miyazawa T, Okimasa S, Maeda A, Oiwa H, Miyazu Y, Murayama M. Endobronchial ultrasonography using a guide sheath increases the ability to diagnose peripheral pulmonary lesions endoscopically. Chest. 2004 Sep;126(3):959-65. doi: 10.1378/chest.126.3.959.

ReferenceCitation: Baba M, Sekine Y, Suzuki M, Yoshida S, Shibuya K, Iizasa T, Saitoh Y, Onuma EK, Ohwada H, Fujisawa T. Correlation between endobronchial ultrasonography (EBUS) images and histologic findings in normal and tumor-invaded bronchial wall. Lung Cancer. 2002 Jan;35(1):65-71. doi: 10.1016/s0169-5002(01)00284-7.

ReferenceCitation: Falcone F, Fois F, Grosso D. Endobronchial ultrasound. Respiration. 2003 Mar-Apr;70(2):179-94. doi: 10.1159/000070066.

intervention_type: Device


title: RESTIT : Evaluation of Resorbable Osteosynthesis Devices Versus Titanium in Maxillofacial Surgery - A Prospective Randomized Trial in Therapeutic Strategy

summary:
Primary objective : To evaluate the quality of fractures setting and osteotomy of the facial massif osteosynthesised with resorbable device PLLA/PGA compared with usual Titanium plates.

Secondary objective :

To evaluate the resorbable device ergonomy versus Titanium.
To evaluate the clinical tolerance of resorbable device versus Titanium.

Hypothesis :

Osteosynthesis with resorbable device demonstrates a non inferiority success probability regarding the success observed in osteosynthesis with Titanium, with a less important probability of re-operation.

Study duration : 14 months for each patient.

Study treatment :

Group I : Resorbable device PLLA/PGA.
Group II : Titanium device.

Study visits :

- Screening visit - Baseline with randomization and surgery - Day1 - Day 21 - Day 45(Traumatology)/Day 90 (orthognatic) - Month 6,12 and 14.

Randomization : Stratification by centres, mono or bimaxillar surgery and traumatologic or orthognatic criteria.

lead_sponsor: Hospices Civils de Lyon


title: Effect of Domperidone on QT Interval in Premature Infants

summary: 30 premature infants treated by domperidone upon decision of the attending neonatologist will have a daily recording of electrocardiogram for the first 7 seven days of treatment, and pharmacokinetics dosages at Day 7. Their ECG will be compared to 30 non treated premature infants, matched for gestational age, postnatal age and sex.

lead_sponsor: Nantes University Hospital


title: Pro-Inflammatory Effects of Two Different Doses of 17 Beta Estradiol in Menopausal Women

acronym: THS

summary: Primary purpose : Effects of two doses of hormone therapy on hsCRP. The effects of hormone replacement therapy on inflammatory markers are dose-dependent.

ReferenceCitation: Colditz GA, Willett WC, Stampfer MJ, Rosner B, Speizer FE, Hennekens CH. Menopause and the risk of coronary heart disease in women. N Engl J Med. 1987 Apr 30;316(18):1105-10. doi: 10.1056/NEJM198704303161801.

ReferenceCitation: Hodis HN, Mack WJ, Lobo RA, Shoupe D, Sevanian A, Mahrer PR, Selzer RH, Liu Cr CR, Liu Ch CH, Azen SP; Estrogen in the Prevention of Atherosclerosis Trial Research Group. Estrogen in the prevention of atherosclerosis. A randomized, double-blind, placebo-controlled trial. Ann Intern Med. 2001 Dec 4;135(11):939-53. doi: 10.7326/0003-4819-135-11-200112040-00005.

ReferenceCitation: Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J; Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. JAMA. 2002 Jul 17;288(3):321-33. doi: 10.1001/jama.288.3.321.

ReferenceCitation: Mendelsohn ME, Karas RH. The protective effects of estrogen on the cardiovascular system. N Engl J Med. 1999 Jun 10;340(23):1801-11. doi: 10.1056/NEJM199906103402306. No abstract available.

ReferenceCitation: Scarabin PY, Alhenc-Gelas M, Plu-Bureau G, Taisne P, Agher R, Aiach M. Effects of oral and transdermal estrogen/progesterone regimens on blood coagulation and fibrinolysis in postmenopausal women. A randomized controlled trial. Arterioscler Thromb Vasc Biol. 1997 Nov;17(11):3071-8. doi: 10.1161/01.atv.17.11.3071.

ReferenceCitation: Teede HJ, McGrath BP, Smolich JJ, Malan E, Kotsopoulos D, Liang YL, Peverill RE. Postmenopausal hormone replacement therapy increases coagulation activity and fibrinolysis. Arterioscler Thromb Vasc Biol. 2000 May;20(5):1404-9. doi: 10.1161/01.atv.20.5.1404.

ReferenceCitation: Conard J, Basdevant A, Thomas JL, Ochsenbein E, Denis C, Guyene TT, Degrelle H. Cardiovascular risk factors and combined estrogen-progestin replacement therapy: a placebo-controlled study with nomegestrol acetate and estradiol. Fertil Steril. 1995 Nov;64(5):957-62. doi: 10.1016/s0015-0282(16)57909-6.

ReferenceCitation: Ridker PM, Hennekens CH, Buring JE, Rifai N. C-reactive protein and other markers of inflammation in the prediction of cardiovascular disease in women. N Engl J Med. 2000 Mar 23;342(12):836-43. doi: 10.1056/NEJM200003233421202.

ReferenceCitation: Mallat Z, Heymes C, Ohan J, Faggin E, Leseche G, Tedgui A. Expression of interleukin-10 in advanced human atherosclerotic plaques: relation to inducible nitric oxide synthase expression and cell death. Arterioscler Thromb Vasc Biol. 1999 Mar;19(3):611-6. doi: 10.1161/01.atv.19.3.611.

ReferenceCitation: Mallat Z, Hugel B, Ohan J, Leseche G, Freyssinet JM, Tedgui A. Shed membrane microparticles with procoagulant potential in human atherosclerotic plaques: a role for apoptosis in plaque thrombogenicity. Circulation. 1999 Jan 26;99(3):348-53. doi: 10.1161/01.cir.99.3.348.

ReferenceCitation: Mallat Z, Benamer H, Hugel B, Benessiano J, Steg PG, Freyssinet JM, Tedgui A. Elevated levels of shed membrane microparticles with procoagulant potential in the peripheral circulating blood of patients with acute coronary syndromes. Circulation. 2000 Feb 29;101(8):841-3. doi: 10.1161/01.cir.101.8.841.

ReferenceCitation: Ridker PM, Hennekens CH, Rifai N, Buring JE, Manson JE. Hormone replacement therapy and increased plasma concentration of C-reactive protein. Circulation. 1999 Aug 17;100(7):713-6. doi: 10.1161/01.cir.100.7.713.

ReferenceCitation: Cushman M, Legault C, Barrett-Connor E, Stefanick ML, Kessler C, Judd HL, Sakkinen PA, Tracy RP. Effect of postmenopausal hormones on inflammation-sensitive proteins: the Postmenopausal Estrogen/Progestin Interventions (PEPI) Study. Circulation. 1999 Aug 17;100(7):717-22. doi: 10.1161/01.cir.100.7.717.

ReferenceCitation: Scarabin PY, Alhenc-Gelas M, Oger E, Plu-Bureau G. Hormone replacement therapy and circulating ICAM-1 in postmenopausal women--a randomised controlled trial. Thromb Haemost. 1999 May;81(5):673-5.

ReferenceCitation: van Baal WM, Smolders RG, van der Mooren MJ, Teerlink T, Kenemans P. Hormone replacement therapy and plasma homocysteine levels. Obstet Gynecol. 1999 Oct;94(4):485-91. doi: 10.1016/s0029-7844(99)00412-3.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
French Health Products Safety Agency
FRM
Solvay Pharmaceuticals


title: PET and MRI in the Follow-up of Neoadjuvant Chemotherapy of Breast Cancer

summary: Predict and follow thanks to imaging the response to neoadjuvant chemotherapy in locally advanced breast carcinoma. Hypothesis : FLT-(18F)PET will be a predictor superior to both FDG-(18F) PET and MRI

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Pierre and Marie Curie University


title: Effect of the Positive Expiratory Pressure on the Right Ventricular Function in Patient With Adult Respiratory Distress Syndrome Ventilated With Limited Plateau Pressure

summary: The objective of this study is to analyze by trans-oesophageal echocardiography the effect on the right ventricle of positive expiratory pressure (PEP) level variations with constant plate pressure among patients with syndrome of acute respiratory distress of the adult (SDRA). The assumption tested is that a high level of PEP increases the impedance with the ejection of the right ventricle independently of the level of plate pressure. The effect on the right ventricular preload will be checked via the analysis of the respiratory variability of the diameter of the higher vena cava.

ReferenceCitation: Bouadma L, Lellouche F, Cabello B, Taille S, Mancebo J, Dojat M, Brochard L. Computer-driven management of prolonged mechanical ventilation and weaning: a pilot study. Intensive Care Med. 2005 Oct;31(10):1446-50. doi: 10.1007/s00134-005-2766-2. Epub 2005 Aug 23.

ReferenceCitation: Lacherade JC, Auburtin M, Cerf C, Van de Louw A, Soufir L, Rebufat Y, Rezaiguia S, Ricard JD, Lellouche F, Brun-Buisson C, Brochard L. Impact of humidification systems on ventilator-associated pneumonia: a randomized multicenter trial. Am J Respir Crit Care Med. 2005 Nov 15;172(10):1276-82. doi: 10.1164/rccm.200408-1028OC. Epub 2005 Aug 26.

ReferenceCitation: Mekontso Dessap A, Charron C, Devaquet J, Aboab J, Jardin F, Brochard L, Vieillard-Baron A. Impact of acute hypercapnia and augmented positive end-expiratory pressure on right ventricle function in severe acute respiratory distress syndrome. Intensive Care Med. 2009 Nov;35(11):1850-8. doi: 10.1007/s00134-009-1569-2. Epub 2009 Aug 4.

location_facility: HOPITAL HENRI MONDOR Department of Neurosurgery


title: Evaluation of Lidocaine Continuous Intravenous Administration for Postoperative Recovery After Colorectal Surgery

summary: The purpose of this study is to check if lidocaine intravenous administration during surgery and 24 hours after surgery, associated with standardised management of the patient, helps to accelerate recovery and to improve the quality of recovery, after surgery for colic or rectal neoplasms.


title: Does Dose Adjustment of Nicotine Replacement Therapies According to Saliva Cotinine Increase Efficacy of These Treatments of Assistance To the Nicotinic Weaning Of the High-Risk Patients?

acronym: ADONIS

summary: Nicotine replacement therapies (NRT) have proven efficacy to help smokers quit. However, their effectiveness is low. This study aims to answer the question: Does the dose adjustment of NRT according the saliva concentration of nicotine's main metabolite: cotinine improve their efficacy compared with the lack of dose adjustment (usual care) in smoking patients with smoking related disease condition.

ReferenceCitation: Dale LC, Hurt RD, Offord KP, Lawson GM, Croghan IT, Schroeder DR. High-dose nicotine patch therapy. Percentage of replacement and smoking cessation. JAMA. 1995 Nov 1;274(17):1353-8.

ReferenceCitation: Berlin I, Singleton EG, Heishman SJ. Cross validation of the prognostic and diagnostic utility of tobacco craving in a general and a pregnant sample of treatment-seeking smokers. Drug Alcohol Depend. 2015 Sep 1;154:174-83. doi: 10.1016/j.drugalcdep.2015.06.034. Epub 2015 Jun 29.

ReferenceCitation: Berlin I, Singleton EG, Heishman SJ. Predicting smoking relapse with a multidimensional versus a single-item tobacco craving measure. Drug Alcohol Depend. 2013 Oct 1;132(3):513-20. doi: 10.1016/j.drugalcdep.2013.03.017. Epub 2013 Apr 23.

ReferenceCitation: Berlin I, Jacob N, Coudert M, Perriot J, Schultz L, Rodon N. Adjustment of nicotine replacement therapies according to saliva cotinine concentration: the ADONIS* trial-a randomized study in smokers with medical comorbidities. Addiction. 2011 Apr;106(4):833-43. doi: 10.1111/j.1360-0443.2010.03306.x. Epub 2011 Feb 14.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
French Health Products Safety Agency

location_facility: Groupe Hospitalier Pitié-Salpétrière, Unité de Recherche Clinique


title: Evaluation of Viral Efficacy and Safety of a Reduced Dose of Stavudine (d4T): THE PHOENIX STUDY

summary: Lipodystrophie, peripheral neuropathy and mitochondrial toxicity has been associated to stavudine at standard doses The aim of this study is to evaluate the efficacy of reduced doses of stavudine (30 mg b.i.d.) in HIV patients with controlled viral load and body weight > 60 kg, receiving an antiretroviral therapy containing stavudine 40 mg b.i.d.

lead_sponsor: Groupe Hospitalier Pitie-Salpetriere

sponsor_collaborators:
Groupe Hospitalier Pitie-Salpetriere
Bristol-Myers Squibb

location_facility: Service de Maladies Infectieuses Hôpital Pitié-Salpêtrière


title: A Prospective, Randomized, Multi-Center Comparison of the Cypher Sirolimus-Eluting and the Taxus Paclitaxel-Eluting Stent Systems.

summary: The main objective of this study is to compare the performance of the Cypher sirolimus-eluting and the Taxus paclitaxel-eluting stent systems in a prospective, multi-center, randomized clinical study.

ReferenceCitation: Morice MC, Colombo A, Meier B, Serruys P, Tamburino C, Guagliumi G, Sousa E, Stoll HP; REALITY Trial Investigators. Sirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions: the REALITY trial: a randomized controlled trial. JAMA. 2006 Feb 22;295(8):895-904. doi: 10.1001/jama.295.8.895.

lead_sponsor: Cordis Corporation


title: An Open-label Study to Evaluate the Efficacy and Safety of add-on Memantine [5-10 mg b.i.d (10-20 mg/Day)] to Rivastigmine [1.5-6 mg b.i.d. (3-12 mg/Day)] Treatment in Patients With Alzheimer's Disease Who Continued With Rivastigmine Treatment After a Previous Decline While on Donepezil or Galantamine Treatment

summary: This is a prospective, multicenter, open-label study. Following screening and baseline assessments, eligible patients will be switched to rivastigmine and will enter the 16 week run-in rivastigmine treatment phase. After completion of assessments at the end of the run-in phase, patients who were not sufficiently stabilized on rivastigmine alone will receive add-on memantine to their rivastigmine treatment; patients who were stabilized on rivastigmine alone will have completed and be discontinued from the study.

lead_sponsor: Novartis


title: Predictors of the Response to Adalimumab in Rheumatoid Arthritis

summary:
Rheumatoid arthritis (RA) is the most common inflammatory rheumatic disease which is characterized by joint inflammation (clinical involvement), by osteo-cartilaginous lesions (structural damage) and generally by bone involvement. All those features lead to great disability. Because it represents a major problem of the public health care system, RA has been selected as one of the main objectives of the government for the next five years.

RA patients who do not respond to DMARDs require a treatment by TNF-a blocking agents. However, no information is available to predict the clinical, structural and bone responses to those new drugs that can be responsible of severe side-effects. Moreover, they are particularly expensive since their yearly cost is estimated between 75000 and 112500 k euros for the G4 region.

The purpose of the present research project is to determine potential predictive factors of the response to a new TNF-a blocker ie adalimumab. To address this question, several investigations will be performed including measurement of different blood markers, particularly bone markers, well-defined autoantibodies and new autoantibody populations identified by proteomic analysis, large-scale analysis of gene expression with cDNA arrays from blood mononuclear cells, and use of different imaging tools.

The criteria of judgement will be the clinical, structural and bone responses to those new agents.

This study requires the recruitment of about 100 patients receiving adalimumab for a 1-year period.

At the end of the study, we hope to identify predictive factors of the response to adalimumab, which will lead to a better management of this TNF-a blocker. Indeed, they will be prescribed only for the patients who are likely to respond to those drugs. Thus, this study should allow to elaborate theranostic algorithms. Such an approach will have great benefits for the patients: more rapid efficacy, less severe side-reactions and lower costs.

ReferenceCitation: Vittecoq O, Guillou C, Hardouin J, Gerard B, Berenbaum F, Constantin A, Rincheval N, Combe B, Lequerre T, Cosette P. Validation in the ESPOIR cohort of vitamin K-dependent protein S (PROS) as a potential biomarker capable of predicting response to the methotrexate/etanercept combination. Arthritis Res Ther. 2022 Mar 21;24(1):72. doi: 10.1186/s13075-022-02762-5.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Golinski ML, Vandhuick T, Derambure C, Freret M, Lecuyer M, Guillou C, Hiron M, Boyer O, Le Loet X, Vittecoq O, Lequerre T. Dysregulation of RasGRP1 in rheumatoid arthritis and modulation of RasGRP3 as a biomarker of TNFalpha inhibitors. Arthritis Res Ther. 2015 Dec 26;17:382. doi: 10.1186/s13075-015-0894-9.

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

repository_institution: PubMed Central - Europe PMC

ReferenceCitation: Ternant D, Ducourau E, Fuzibet P, Vignault C, Watier H, Lequerre T, Le Loet X, Vittecoq O, Goupille P, Mulleman D, Paintaud G. Pharmacokinetics and concentration-effect relationship of adalimumab in rheumatoid arthritis. Br J Clin Pharmacol. 2015 Feb;79(2):286-97. doi: 10.1111/bcp.12509.

oa_colors: green other

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Wiley

ReferenceCitation: Blache C, Lequerre T, Roucheux A, Beutheu S, Dedreux I, Jacquot S, Le Loet X, Boyer O, Vittecoq O. Number and phenotype of rheumatoid arthritis patients' CD4+CD25hi regulatory T cells are not affected by adalimumab or etanercept. Rheumatology (Oxford). 2011 Oct;50(10):1814-22. doi: 10.1093/rheumatology/ker183. Epub 2011 Jul 26.

lead_sponsor: University Hospital, Rouen


title: A Randomized Study With the Sirolimus Coated Modified BX Velocity Balloon-Expandable Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions

acronym: RAVEL

summary: The main objective of this study is to assess the safety and effectiveness of the sirolimus coated Bx VELOCITY stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the bare metal Bx VELOCITY balloon-expandable stent. Both stents will be mounted on the Raptor Rapid Exchange Delivery Stent System.

ReferenceCitation: Hoffmann R, Morice MC, Moses JW, Fitzgerald PJ, Mauri L, Breithardt G, Schofer J, Serruys PW, Stoll HP, Leon MB. Impact of late incomplete stent apposition after sirolimus-eluting stent implantation on 4-year clinical events: intravascular ultrasound analysis from the multicentre, randomised, RAVEL, E-SIRIUS and SIRIUS trials. Heart. 2008 Mar;94(3):322-8. doi: 10.1136/hrt.2007.120154. Epub 2007 Aug 29.

ReferenceCitation: Fajadet J, Morice MC, Bode C, Barragan P, Serruys PW, Wijns W, Constantini CR, Guermonprez JL, Eltchaninoff H, Blanchard D, Bartorelli A, Laarman GJ, Perin M, Sousa JE, Schuler G, Molnar F, Guagliumi G, Colombo A, Ban Hayashi E, Wulfert E. Maintenance of long-term clinical benefit with sirolimus-eluting coronary stents: three-year results of the RAVEL trial. Circulation. 2005 Mar 1;111(8):1040-4. doi: 10.1161/01.CIR.0000156334.24955.B2. Epub 2005 Feb 21.

ReferenceCitation: Abizaid A, Costa MA, Blanchard D, Albertal M, Eltchaninoff H, Guagliumi G, Geert-Jan L, Abizaid AS, Sousa AG, Wuelfert E, Wietze L, Sousa JE, Serruys PW, Morice MC; Ravel Investigators. Sirolimus-eluting stents inhibit neointimal hyperplasia in diabetic patients. Insights from the RAVEL Trial. Eur Heart J. 2004 Jan;25(2):107-12. doi: 10.1016/j.ehj.2003.11.002.

ReferenceCitation: Regar E, Serruys PW, Bode C, Holubarsch C, Guermonprez JL, Wijns W, Bartorelli A, Constantini C, Degertekin M, Tanabe K, Disco C, Wuelfert E, Morice MC; RAVEL Study Group. Angiographic findings of the multicenter Randomized Study With the Sirolimus-Eluting Bx Velocity Balloon-Expandable Stent (RAVEL): sirolimus-eluting stents inhibit restenosis irrespective of the vessel size. Circulation. 2002 Oct 8;106(15):1949-56. doi: 10.1161/01.cir.0000034045.36219.12.

ReferenceCitation: Serruys PW, Degertekin M, Tanabe K, Abizaid A, Sousa JE, Colombo A, Guagliumi G, Wijns W, Lindeboom WK, Ligthart J, de Feyter PJ, Morice MC; RAVEL Study Group. Intravascular ultrasound findings in the multicenter, randomized, double-blind RAVEL (RAndomized study with the sirolimus-eluting VElocity balloon-expandable stent in the treatment of patients with de novo native coronary artery Lesions) trial. Circulation. 2002 Aug 13;106(7):798-803. doi: 10.1161/01.cir.0000025585.63486.59.

ReferenceCitation: Morice MC, Serruys PW, Barragan P, Bode C, Van Es GA, Stoll HP, Snead D, Mauri L, Cutlip DE, Sousa E. Long-term clinical outcomes with sirolimus-eluting coronary stents: five-year results of the RAVEL trial. J Am Coll Cardiol. 2007 Oct 2;50(14):1299-304. doi: 10.1016/j.jacc.2007.06.029. Epub 2007 Sep 17.

ReferenceCitation: Spaulding C, Daemen J, Boersma E, Cutlip DE, Serruys PW. A pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med. 2007 Mar 8;356(10):989-97. doi: 10.1056/NEJMoa066633. Epub 2007 Feb 12.


title: Safety and Efficacy Registry of Bx Cypher Stent in the Revascularisation of Patients With Significant Risk of Restenosis

summary:
The objective of this study is to establish the safety and efficacy of the treatment with Cypher DES in diabetic patients with documented ischemia due to stenosis (small coronary artery 2.5 -3 mm in lumen diameter, with lesion between 15 mm 30 mm in length, ) in native coronary arteries.

The objective of this study is to document that the use of Cypher DES in these diabetic patients undergoing percutaneous revascularization for stenosis is safe.

Safety will be assessed over a period of 12 months.

ReferenceCitation: Lablanche JM, Commeau P; Investigateurs du Registre BRIDGE. [BRIDGE registry (safety and efficacy registry Bx Cyper stent in the RevascularIzation of patients with siGnificative risk of rEstenosis): protocol description and preliminary results]. Ann Cardiol Angeiol (Paris). 2004 May;53 Suppl 1:29s-31s. doi: 10.1016/s0003-3928(04)90006-6. No abstract available. French.

location_facility: Université de Lille, Hôpital cardiologique


title: Functional and Molecular Characterisation of Oesophageal Distal Epithelium: Correlations With Acid and Non Acid Reflux

summary: This study aims to characterize the permeability as well as some protein involved in the cell junction in the oesophageal epithelium in patients with GORD symptoms. In addition these patients will be characterized for their reflux especially by pH-impedancemetry, Bilitec and oesophageal acid perfusion test. Correlations between the characteristics of the reflux and the biological results will be calculated.


title: Study of Follicle Stimulating Hormone (FSH) Receptor in Women With Low Antral Follicle Count

summary:
The deficit in the total number of antral follicles is associated with a reduction of the ovarian fertility potential in young women.

The principal objective of this study is to evaluate the relationship between FSH receptor polymorphism and antral follicle count.

The investigators have designed a study of FSH receptor polymorphisms P1 and P2 as an association with a low antral follicle count in the ovary.

location_facility: Antoine Beclere Hospital, Obstetrics and Gynaecology and Reproduction Medicine Service


title: Efficacy and Safety of Botulinum Toxin A for the Treatment of Refractory Overactive Bladder (OAB). A Multicenter Phase II, Randomized, Double-blind, Placebo Controlled 6 Month Study . VESITOX

summary: Overactive bladder induce urgency, urge incontinence, nocturia and pollakiuria. This condition is often resistant to anticholinergic drugs used as a first line treatment for this purpose. Moreover muscarinic side effects (constipation, mouth dryness) often limits the use of those treatments. This study is designed to evaluate the efficacy and safety of botulinum toxin A injected into the detrusor muscle to control symptoms and improve quality of life for patients resistant or intolerant to anticholinergic drugs.

ReferenceCitation: Rajkumar GN, Small DR, Mustafa AW, Conn G. A prospective study to evaluate the safety, tolerability, efficacy and durability of response of intravesical injection of botulinum toxin type A into detrusor muscle in patients with refractory idiopathic detrusor overactivity. BJU Int. 2005 Oct;96(6):848-52. doi: 10.1111/j.1464-410X.2005.05725.x.

ReferenceCitation: Denys P, Le Normand L, Ghout I, Costa P, Chartier-Kastler E, Grise P, Hermieu JF, Amarenco G, Karsenty G, Saussine C, Barbot F; VESITOX study group in France. Efficacy and safety of low doses of onabotulinumtoxinA for the treatment of refractory idiopathic overactive bladder: a multicentre, double-blind, randomised, placebo-controlled dose-ranging study. Eur Urol. 2012 Mar;61(3):520-9. doi: 10.1016/j.eururo.2011.10.028. Epub 2011 Oct 25.


title: Evaluation De l'Efficacité Du Rituximab (Mabthéra) Chez l'Adulte Atteint d'Un Purpura thrombopénique Auto-Immun Chronique Et sévère Et Candidat à La splénectomie

summary: The goal of this study is to evaluate the clinical effectiveness of the rituximab at the adults with a chronic immune thrombocytopenic purpura (>=6 months of evolution) and severe (platelets <= 30x109/L) and candidate to a splenectomy. The objective is to obtain after a treatment by the rituximab a satisfactory response to one year, defined by a number of platelets higher than 50x109/L and at least 2 times superior with the persistent initial figure without treatment during one year after the end of the treatment.

ReferenceCitation: Michel M, Chanet V, Galicier L, Ruivard M, Levy Y, Hermine O, Oksenhendler E, Schaeffer A, Bierling P, Godeau B. Autoimmune thrombocytopenic purpura and common variable immunodeficiency: analysis of 21 cases and review of the literature. Medicine (Baltimore). 2004 Jul;83(4):254-263. doi: 10.1097/01.md.0000133624.65946.40.

ReferenceCitation: Godeau B, Porcher R, Fain O, Lefrere F, Fenaux P, Cheze S, Vekhoff A, Chauveheid MP, Stirnemann J, Galicier L, Bourgeois E, Haiat S, Varet B, Leporrier M, Papo T, Khellaf M, Michel M, Bierling P. Rituximab efficacy and safety in adult splenectomy candidates with chronic immune thrombocytopenic purpura: results of a prospective multicenter phase 2 study. Blood. 2008 Aug 15;112(4):999-1004. doi: 10.1182/blood-2008-01-131029. Epub 2008 May 7.

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
Etablissement Français du Sang


title: ACE Trial :Not Worn-Out Aneurism of the Abdominal Aorta Under Renal " Surgery Versus Endoprosthesis "

acronym: ACE

summary:
Abdominal aortic aneurysm (AAA) is a life threatening disease. There is a consensus to propose surgical repair in patients with a reasonable operative risk when the AAA exceeds 5 cm in diameter.

The aim of the study is to compare the mortality and the occurrence of severe general, vascular and local complications in two groups of patients treated by either by open surgery or by EVAR (EndoVascular Aneurysm Repair). The main outcome criteria and the secondary endpoint are respectively the survival without severe complications and minor morbidity.

ReferenceCitation: Lederle FA. Endovascular repair of abdominal aortic aneurysm--round two. N Engl J Med. 2005 Jun 9;352(23):2443-5. doi: 10.1056/NEJMe058126. No abstract available.

ReferenceCitation: Becquemin JP, Pillet JC, Lescalie F, Sapoval M, Goueffic Y, Lermusiaux P, Steinmetz E, Marzelle J; ACE trialists. A randomized controlled trial of endovascular aneurysm repair versus open surgery for abdominal aortic aneurysms in low- to moderate-risk patients. J Vasc Surg. 2011 May;53(5):1167-1173.e1. doi: 10.1016/j.jvs.2010.10.124. Epub 2011 Jan 26.


title: Efficacy and Safety of the Albumin Dialysis MARS® Therapy in Patients With Fulminant and Subfulminant Hepatic Failure

summary:
The purpose of this study is to improve the survival rate of those patients with acute fulminant hepatitis through treatment with the MARS® extra-corporal liver-purification system by:

Reducing the number of patients who die before a graft is available
Increasing the chances of survival without a liver transplant
Reducing the pre- and post-operative mortality in transplant patients

ReferenceCitation: Novelli G, Rossi M, Pretagostini R, Novelli L, Poli L, Ferretti G, Iappelli M, Berloco P, Cortesini R. A 3-year experience with Molecular Adsorbent Recirculating System (MARS): our results on 63 patients with hepatic failure and color Doppler US evaluation of cerebral perfusion. Liver Int. 2003;23 Suppl 3:10-5. doi: 10.1034/j.1478-3231.23.s.3.4.x.

ReferenceCitation: Saliba F, Camus C, Durand F, Mathurin P, Letierce A, Delafosse B, Barange K, Perrigault PF, Belnard M, Ichai P, Samuel D. Albumin dialysis with a noncell artificial liver support device in patients with acute liver failure: a randomized, controlled trial. Ann Intern Med. 2013 Oct 15;159(8):522-31. doi: 10.7326/0003-4819-159-8-201310150-00005.

publisher_dissemination: American College of Physicians


title: Evaluation of the Effectiveness of Stimulation Cortex Sensorimotor for the Treatment of Rebel Neuropathic Pains

summary:
The pains chronic neurogeneses remain difficult to treat whatever are their origin and their localization. The pharmacological therapeutic arsenal answers only partially the symptomatology often very invalidating which these chronic painful patients present. Electric stimulations of the central nervous system currently validated, in particular of the posterior cords of marrow made a significant improvement in a certain number of indications. Nevertheless, considerable patients are not relieved significantly, in particular those presenting of the pains neurogeneses of central origin (syndromes thalamic for example). It is within this framework that recently the stimulation of the sensorimotor cortex developed.

Principal objective: evaluation of the technique of stimulation under cortical on neuropathic pains .

ReferenceCitation: Drouot X, Oshino S, Jarraya B, Besret L, Kishima H, Remy P, Dauguet J, Lefaucheur JP, Dolle F, Conde F, Bottlaender M, Peschanski M, Keravel Y, Hantraye P, Palfi S. Functional recovery in a primate model of Parkinson's disease following motor cortex stimulation. Neuron. 2004 Dec 2;44(5):769-78. doi: 10.1016/j.neuron.2004.11.023.

ReferenceCitation: Lefaucheur JP, Drouot X, Menard-Lefaucheur I, Zerah F, Bendib B, Cesaro P, Keravel Y, Nguyen JP. Neurogenic pain relief by repetitive transcranial magnetic cortical stimulation depends on the origin and the site of pain. J Neurol Neurosurg Psychiatry. 2004 Apr;75(4):612-6. doi: 10.1136/jnnp.2003.022236.


title: Effect of Iron-Chelating Therapy in Friedreich Ataxia. Study Phase I/II

summary: Friedreich ataxia, an autosomal recessive condition, ascribed to frataxin gene expansion, has been shown to result from an iron- induced injury to the mitochondrial respiratory chain. Buffering free radicals with short-chain quinones (Idebenone) protects the patients against cardiomyopathy but not CNS involvement. Removing CNS iron should limit the impact of the neurological symptoms of the disease.


title: Efficiency of Capsule Endoscopy and Push Enteroscopy in Obscure Gastrointestinal Bleeding. A Prospective Randomized Study.

summary: Capsule endoscopy (CE) is a safe and effective tool for the assessment of obscure gastrointestinal bleeding (OGIB). However, its real efficacy and its position in the diagnostic algorithm of OGIB vs. push enteroscopy (PE) remain unknown since in previous studies both techniques were performed in all included patients The purpose of this protocol is to conduct a randomized prospective controlled trial in patients with OGIB comparing a strategy based on CE or PE followed by the alternative exploration only when the first line exploration was negative. The main outpoint of this study concerns the diagnostic yield of the two explorations. Second endpoint concerns the clinical relevance of the two strategies tested (CE ± PE vs. CE ± PE) in terms of diagnostic yield, clinical outcome, therapeutic impact and added explorations

ReferenceCitation: Adler DG, Knipschield M, Gostout C. A prospective comparison of capsule endoscopy and push enteroscopy in patients with GI bleeding of obscure origin. Gastrointest Endosc. 2004 Apr;59(4):492-8. doi: 10.1016/s0016-5107(03)02862-1.


title: Randomised Prospective Comparison of the nonmyélo-Ablative Allograft and the Traditional Allograft in Acute Myeloid Leukaemia in Complete Remission of the Adult

summary: The allograft of marrow in its technique of reference (myélo-ablative (MA) condition by cyclophosphamide and total body irradiation (TBI) with strong amounts) therapeutic is recognized acute myeloid leukaemia (AML) of the adult for the patients of less than 55 years, because it offers chances of cure higher than chemotherapy or the auto-graft. However, mortality related to the traditional graft is approximately 30% to 1 year. The recent use of the non-myélo-ablative graft (NMA), in which the anti-leukaemia effect rests exclusively on the allogenic effect "graft-versus-leukaemia" makes it possible to obtain among patients of more than 55 years in complete reemission (CR), survivals without relapses comparable with the traditional allograft among patients of more than 35 years. The major interest of NMA graft is to reduce early mortality related to the graft. This reduction should be all the more significant as the patient is younger, and thus bring to a better survival. There is not, at the present hour, of prospective comparative study of the two procedures of graft. Taking into account the results observed after NMA graft among patients of more than 55 years, and taking into account the toxicity of the standard graft between 35 and 55 years, it is essential to now compare the 2 approaches among patients who do not have a counter-indication for one or the other, in the age bracket where the toxicity of the traditional graft is highest.

ReferenceCitation: Gratwohl A, Brand R, Frassoni F, Rocha V, Niederwieser D, Reusser P, Einsele H, Cordonnier C; Acute and Chronic Leukemia Working Parties; Infectious Diseases Working Party of the European Group for Blood and Marrow Transplantation. Cause of death after allogeneic haematopoietic stem cell transplantation (HSCT) in early leukaemias: an EBMT analysis of lethal infectious complications and changes over calendar time. Bone Marrow Transplant. 2005 Nov;36(9):757-69. doi: 10.1038/sj.bmt.1705140.


title: Therapeutical Impact of a Reassessment Strategy in the Diagnosis of Coronary Heart Disease in Elderly

acronym: IRIDIA

summary:
Despite the effectiveness of beta-blockers and antiplatelet agents for secondary prevention of coronary heart disease, this treatments are underused in the elderly because of diagnosis uncertainty and underuse of efficient treatment.

in a first time, diagnosis reassessment with invasive technique if necessary. in a second time, treatment reassessment.

intervention_type: Other


title: Homeopathy Assessment in Terms of the Consumption of Analgesics After Knee Ligamentoplasty

summary:
This is an add-on, double blind, and randomised clinical trial with three groups: a homeopathic group, a placebo group, and a temporal control group.

The aim of this trial is to assess the effect of homeopathy on the consumption of morphine delivered by PCA (patient control analgesia) for 24 hours after a knee ligamentoplasty.

ReferenceCitation: Barnes J, Resch KL, Ernst E. Homeopathy for postoperative ileus? A meta-analysis. J Clin Gastroenterol. 1997 Dec;25(4):628-33. doi: 10.1097/00004836-199712000-00016. Erratum In: J Clin Gastroenterol 1998 Apr;26(3):231.

ReferenceCitation: Ernst E. A systematic review of systematic reviews of homeopathy. Br J Clin Pharmacol. 2002 Dec;54(6):577-82. doi: 10.1046/j.1365-2125.2002.01699.x.

ReferenceCitation: Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV, Jonas WB. Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet. 1997 Sep 20;350(9081):834-43. doi: 10.1016/s0140-6736(97)02293-9. Erratum In: Lancet 1998 Jan 17;351(9097):220.

ReferenceCitation: Lokken P, Straumsheim PA, Tveiten D, Skjelbred P, Borchgrevink CF. Effect of homoeopathy on pain and other events after acute trauma: placebo controlled trial with bilateral oral surgery. BMJ. 1995 Jun 3;310(6992):1439-42. doi: 10.1136/bmj.310.6992.1439.

ReferenceCitation: Cucherat M, Haugh MC, Gooch M, Boissel JP. Evidence of clinical efficacy of homeopathy. A meta-analysis of clinical trials. HMRAG. Homeopathic Medicines Research Advisory Group. Eur J Clin Pharmacol. 2000 Apr;56(1):27-33. doi: 10.1007/s002280050716.

lead_sponsor: University Hospital, Grenoble


title: Prospective Study of the Influence of the Humidification Mode on Ventilation Parameters and Arterial Blood Gases in Non Invasive Ventilation

summary: To humidify gases during non invasive ventilation, both to heated humidifier (HH) and heat and moisture exchanger (HME) are routinely used. Patients receiving non invasive ventilation for acute respiratory failure were randomized to HME or HH. The purpose of this study was to evaluate respiratory parameters and arterial blood gases (ABG) of patients during NIV with small dead space HME compared to HH.

lead_sponsor: University Hospital, Bordeaux

location_facility: Département de Réanimation Médicale, Hôpital Pellegrin-Tripode, Place A. Raba Léon,


title: Study of Ponderal Load in Parkinsonian Patients After Deep Brain Stimulation of the Subthalamic Nucleus

summary: The aim of this trial is to verify that neurostimulated parkinsonian patients gain weight and to study its link with an energetic balance change.

primary_purpose: Prevention

location_facility: Service de neurologie Hôpital Haut-Lévêque


title: PLASMACARD - Fresh Frozen Plasma in Cardiac Surgery: Descriptive and Prognostic Study

acronym: PLASMACARD

summary:
Despite experts' recommendations, the consumption of Fresh frozen plasma (FFP) is very heterogeneous among French cardiac surgery centers. This probably reflects heterogeneous practices that are not characterized and whose outcomes on morbidity and mortality are not documented.

The principal objective of the study is to describe transfusional strategies of FFP in patients undergoing cardiac surgery. The other objectives are: to assess the conformity of FFP transfusion or lack of transfusion to current French authorities' recommendations, to describe the post-operative mortality and morbidity and to assess the prognostic role of FFP on mortality and morbidity. Prognostic analyses will take into account other prognostic factors of mortality and morbidity.

1500 patients undergoing cardiac surgery and presenting with a serious bleeding (or transfused with FFP without bleeding) will be included in the study.

location_facility: Département d'anesthésie-réanimation II (DAR II), Hôpital Haut-Lévêque, Av de Magellan


title: Randomized, Multicenter Phase III Trial Comparing Adjuvant Treatment With PegIntron Over 36 Months Versus Reference Treatment With IntronA Over 18 Months in Cutaneous Melanoma Patients AJCC Stage II (>=1.5 mm Clinically Node Negative)

acronym: EADO

summary: Melanoma with a tumor thickness >= 1.5mm without clinically detectable nodes represents an increasing population with relapse rate of more than 50%. Adjuvant therapy with low doses of IFN alpha can provide a benefit in this group. However, the impact of low dose IFN alpha is not sustained after the treatment period. A longer treatment may prolong the benefit and thus have a more clear-cut impact on disease-free and overall survival. The tolerance and the impact on quality of life are limiting factors in a group of patients whose individual course is not necessarily poor. PegIntron may be better tolerated than instant release interferon, and thus make this treatment more acceptable in terms of toxicity and quality of life. Thus treatment schedule with PegIntron is not expected to increase the cost of standard care significantly.

ReferenceCitation: Grob JJ, Jouary T, Dreno B, Asselineau J, Gutzmer R, Hauschild A, Leccia MT, Landthaler M, Garbe C, Sassolas B, Herbst RA, Guillot B, Chene G, Pehamberger H. Adjuvant therapy with pegylated interferon alfa-2b (36 months) versus low-dose interferon alfa-2b (18 months) in melanoma patients without macrometastatic nodes: an open-label, randomised, phase 3 European Association for Dermato-Oncology (EADO) study. Eur J Cancer. 2013 Jan;49(1):166-74. doi: 10.1016/j.ejca.2012.07.018. Epub 2012 Sep 10.

oa_host_type: publisher

evidence: open (via free pdf)

sponsor_collaborators:
University Hospital, Bordeaux
Schering-Plough


title: Efficacy of a Therapeutic Strategy in Peripheral Neuropathic Pain: Intravenous Sodium Valproate Followed by Oral Route Treatment Versus Placebo (Clinical and Neurophysiologic Evaluation)

summary: The purpose of this study is to determine whether valproate is effective and well tolerated in the treatment of neuropathic peripheral pain. The drug is administered by intravenous route followed by oral route during 4 weeks.

sponsor_collaborators:
University Hospital, Bordeaux
Sanofi-Synthelabo

location_facility: Unité de traitement de la douleur chronique, Hôpital Pellegrin, CHU de Bordeaux


title: Randomized Placebo-Controlled Trial of a Triple Therapy Combining Peginterferon Alfa-2a Plus Ribavirin Plus Amantadine Versus Peginterferon Alfa-2a Plus Ribavirin Plus Placebo in Hepatitis C-Infected Patients Non Responders to a First-Line Therapy of Interferon and Ribavirin

acronym: PEGARI

summary: Response to a second-line anti-HCV treatment in non responder patients to a first-line dual therapy remains very poor. Preliminary studies of amantadine suggest that this drug could be potentially effective to treat hepatitis C.

sponsor_collaborators:
University Hospital, Bordeaux
Hoffmann-La Roche

location_facility: Service d'hépato-Gastro-Entérologie - Hôpital Haut Leveque - avenue de Magellan


title: Efficacy of Docetaxel (J 15) and Celecoxib in Metastatic Prostate Cancer

summary: Clinical response to chemotherapy. Biological parameter (PSA) and RECIST evaluation. Association of Docetaxel (J 15) and Celecoxib.


title: Effect of Glutamine on Gastric Emptying and Length of Parenteral Nutrition in Premature Neonates

summary: This study investigates the effects of enterally supplied glutamine on gastric emptying, intestinal transit, age of total enteral nutrition and age at the end of hospitalisation. Forty neonates, aged at least 2 days and free of acute illness participate in a prospective, randomised, double-blind study. All are fed with parenteral and enteral nutrition enriched with glutamine (0.7 g/kg/per day, group 1) or isonitrogenous control (group 2). Gastric emptying is analysed by sequential measure of intragastric residue by diluted polyethylene glycol (PEG) 4000. Intestinal transit is analysed by Rouge Carmin test.

intervention_type: Dietary Supplement


title: Clinical Evaluation of Maintenance BCG Immunotherapy in Superficial Bladder Tumors

summary: Evaluation of maintenance BCG immunotherapy (dose 27 mg) in superficial bladder tumors. Two randomized arms (every 3 or 6 months) will be studied for a population of 300 patients.

intervention_type: Biological


title: Transcriptome Analysis Through a Dedicated Macro-array and TcLandscape Repertoire Analysis for Diagnosis of Myositis.

acronym: MYOARRAY

summary:
The diagnosis of the different forms of inflammatory myopathies (polymyositis, dermatomyositis, inclusion-body myositis...) remains difficult which may lead to unappropriate patient care.

Objective 1 : to develop and evaluate the diagnostic value of a dedicated DNA-array (myoARRAY) for adult-onset muscular diseases with focus on inflammatory myopathies.

Objective 2 : to evaluate the diagnostic value of T cell repertoire (TcLand) analysis to distinguish different forms of inflammatory myopathies.

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


title: Bilateral Laryngeal Paralysis Reinnervation. Speech and Ventilatory Results Analysis

summary: Bilateral laryngeal reinnervation induces a rise in laryngeal resistance and speech alteration. The aim of this study is to propose laryngeal reinnervation by a phrenic nerve root to patients with bilateral laryngeal paralysis.


title: Endoscopic Follow-up of Low Grade Precancerous Bronchial Lesions in High Risk Patients (SELEPREBB1)

summary:
The goal of this multicentric French randomized trial is to determine the best auto fluorescence bronchial endoscopic follow-up strategy in high risk patients bearing low grade bronchial precancerous lesions. Subjects will be randomly assigned to one of the following arm :

(A) every 6 months clinical and chest Xrays follow-up without intermediate endoscopy, (B) every 6 months clinical and chest Xrays follow-up including repeated autofluorescence endoscopy and biopsies on a 6 months basis in case of low grade dysplasia or on a one year basis in patients without dysplasia.

After 36 months follow-up, each patient from the two groups will be subjected to a final autofluorescence endoscopy and biopsy and a Spiral Chest Xray.

The final analysis will compare between the two groups :

The probability of progression from an initially identified low grade lesion to a high grade lesion
The probability of respiratory epithelial tract progression assessed by the occurrence of a lung cancer or high grade lesion.
The characteristics of lung cancers detected in each arm
In both arm, the influence of risk factors and persistent exposure to tobacco on lesion evolutivity.

ReferenceCitation: Thiberville L, Moreno-Swirc S, Vercauteren T, Peltier E, Cave C, Bourg Heckly G. In vivo imaging of the bronchial wall microstructure using fibered confocal fluorescence microscopy. Am J Respir Crit Care Med. 2007 Jan 1;175(1):22-31. doi: 10.1164/rccm.200605-684OC. Epub 2006 Oct 5.

ReferenceCitation: Guisier F, Deslee G, Birembaut P, Escarguel B, Chapel F, Bota S, Metayer J, Lachkar S, Capron F, Homasson JP, Taulelle M, Quintana M, Raspaud C, Messelet D, Benzaquen J, Hofman P, Baddredine J, Paris C, Cales V, Laurent P, Vignaud JM, Menard O, Copin MC, Ramon P, Bouchindhomme B, Tavernier JY, Quintin I, Quiot JJ, Galateau-Salle F, Zalcman G, Piton N, Thiberville L. Endoscopic follow-up of low-grade precancerous bronchial lesions in high-risk patients: long-term results of the SELEPREBB randomised multicentre trial. Eur Respir J. 2022 Sep 15;60(3):2101946. doi: 10.1183/13993003.01946-2021. Print 2022 Sep.

publisher_dissemination: European Respiratory Society

ReferenceCitation: Salaun M, Roussel F, Bourg-Heckly G, Vever-Bizet C, Dominique S, Genevois A, Jounieaux V, Zalcman G, Bergot E, Vergnon JM, Thiberville L. In vivo probe-based confocal laser endomicroscopy in amiodarone-related pneumonia. Eur Respir J. 2013 Dec;42(6):1646-58. doi: 10.1183/09031936.00191911. Epub 2012 Sep 27.


title: Evaluation of the Efficacy and Tolerance of 2 Dosages of Type A Botulinic Toxin in Neurogenic Areactive Bladder Resistant to Oral Medical Treatment

summary: The purpose of this study is to determine the efficacy and tolerance of 2 dosages (750 versus 500 units) of the Dysport type A botulinic toxin for patient suffering from neurogenic urinary incontinence by an overactive bladder and the failure of anticholinergic drugs.

ReferenceCitation: Grise P, Ruffion A, Denys P, Egon G, Chartier Kastler E. Efficacy and tolerability of botulinum toxin type A in patients with neurogenic detrusor overactivity and without concomitant anticholinergic therapy: comparison of two doses. Eur Urol. 2010 Nov;58(5):759-66. doi: 10.1016/j.eururo.2010.06.035. Epub 2010 Jul 3.


title: Gene Expression Profiling in PBMCs as a Tool for Prediction of Infliximab Responsiveness in Rheumatoid Arthritis

summary:
The objective of the study is to identify and validate predictive markers of infliximab responsiveness in RA patients by 2 approaches: i) measuring biochemical, immunological and bone markers in sera because of their involvement in pathogenic mechanisms; ii) identifying gene-expression signatures in PBMCs by the transcriptomic analysis.

Patients with active RA (ACR criteria) were given i.v. 3 mg/kg infliximab associated with metotrexate at weeks 0, 2, 6, and every 8th week. Infliximab efficacy was evaluated at week 14, using the EULAR response criteria.

Just before the starting of infliximab treatment, the following parameters were measured in the sera: i) immunological tests: rheumatoid factor (IgA, IgG, IgM), anti-CCP, autoAb recognizing the 27 C-terminal fragment (ACAST-C27) and domain I (ACAST-DI) of calpastatin, anti-G6PI, anti a-enolase, anti-keratin and anti-perinuclear factor; ii) biochemical markers: CRP, MMP-1, MMP-3, TIMP-1, TIMP-2; markers of bone resorption: pyridinolin, deoxypyridinolin, osteoprotegerin, sRANKL, COMP. The predictive value of each parameter for a response/non-response to infliximab was analysed using Fischer's exact, Mann-Whitney and Chi2 tests.
A blood sample was collected just before the onset of infliximab treatment and total RNAs were extracted from the peripheral blood mononuclear cells. The [33P] radiolabeled mRNAs were hybridized (duplicate or triplicate) over a set of 10.000 human cDNA probes spotted at a high density on nylon membranes. Data were normalized and filtered to allow the comparison between RNA samples. Statistical analyses were performed with the R software and hierarchical clustering was performed with the Cluster and Tree View softwares.


title: Comparative Effects of Glutamine and Glucose on Intestinal Protein Metabolism in Healthy Humans

summary:
Gut barrier plays a major role in defence of the organism. During catabolic states, like major surgery or inflammation, gut barrier could be altered. It has been reported that preoperative nutritional support may have beneficial effects on clinical outcome in patients with surgery on gastrointestinal tract. Glutamine, which is a conditionally essential amino, have been reported to modulate inflammatory, antioxidant responses and protein metabolism in intestine. In addition, glutamine supply improves clinical outcome in critically ill patients. Antioxidant micronutrients may also have some beneficial effects in intestine by improving antioxidant response and might also regulate protein expression. Nevertheless, effects of glutamine combined to antioxidant micronutrients have not been evaluated.

Thus, the aim of this study will be to assess the influence of glutamine and glutamine-antioxidant micronutrients-containing solutions on intestinal response in humans.

ReferenceCitation: Goichon A, Coeffier M, Claeyssens S, Lecleire S, Cailleux AF, Bole-Feysot C, Chan P, Donnadieu N, Lerebours E, Lavoinne A, Boyer O, Vaudry D, Dechelotte P. Effects of an enteral glucose supply on protein synthesis, proteolytic pathways, and proteome in human duodenal mucosa. Am J Clin Nutr. 2011 Sep;94(3):784-94. doi: 10.3945/ajcn.110.009738. Epub 2011 Jul 27.


title: Gene Expression Profiling in PBMCs as a Tool for Prediction of Anakinra Responsiveness in Rheumatoid Arthritis

summary:
The objective of the study is to identify and validate predictive markers of anakinra responsiveness in RA patients by a transcriptomic approach.

Patients with active RA (ACR criteria) were given subcutaneous anakinra (100mg/d) 3 associated with metotrexate. Anakinra efficacy was evaluated at week 12, using the EULAR response criteria.

A blood sample was collected just before the onset of anakinra treatment and total RNAs were extracted from the peripheral blood mononuclear cells. The [33P] radiolabeled mRNAs were hybridized (duplicate or triplicate) over a set of 10.000 human cDNA probes spotted at a high density on nylon membranes. Data were normalized and filtered to allow the comparison between RNA samples. Statistical analyses were performed with the R software and hierarchical clustering was performed with the Cluster and Tree View softwares.

ReferenceCitation: Bansard C, Lequerre T, Derambure C, Vittecoq O, Hiron M, Daragon A, Pouplin S, Daveau M, Boyer O, Tron F, Le Loet X, Salier JP. Gene profiling predicts rheumatoid arthritis responsiveness to IL-1Ra (anakinra). Rheumatology (Oxford). 2011 Feb;50(2):283-92. doi: 10.1093/rheumatology/keq344. Epub 2010 Nov 8.


title: Genesis of Scleroderma: Role of Environmental Factors in 100 Patients With Scleroderma and 300 Healthy Controls

summary:
Scleroderma is an autoimmune disease of unknown origin. Recently, the role of environmental factors, and particularly toxic drug exposure, in the genesis of scleroderma has been suggested.

This prompted us to conduct this prospective, case-control, multicentric study, including 2 groups of subjects:

100 patients with scleroderma
300 sex- and age-matched healthy controls. The aim of our study is to determine whether exposure to toxics is higher in patients with scleroderma compared with healthy controls.


title: Traitment of Patients Presenting Pemphigus With Anti CD20 (Mabthera).

summary: to treat in an open non comparative clinical study patients presenting pemphigus with corticodependance, corticoresistance and contre-indication to systemic steroids.

primary_purpose: Health Services Research

ReferenceCitation: Joly P, Mouquet H, Roujeau JC, D'Incan M, Gilbert D, Jacquot S, Gougeon ML, Bedane C, Muller R, Dreno B, Doutre MS, Delaporte E, Pauwels C, Franck N, Caux F, Picard C, Tancrede-Bohin E, Bernard P, Tron F, Hertl M, Musette P. A single cycle of rituximab for the treatment of severe pemphigus. N Engl J Med. 2007 Aug 9;357(6):545-52. doi: 10.1056/NEJMoa067752.


title: Weekly Cisplatin/Irinotecan and Radiotherapy in Patients With Locally Advanced Esophageal Cancer: Phase II Trial

summary: The standard non surgical therapy of locally advanced esophageal cancer is based on a definitive concurrent chemoradiotherapy regimen with fluorouracil and cisplatin. One of the alternative regimen which is being studied is the combination of a weekly cisplatin and irinotecan schedule with radiotherapy. This multicentric phase II clinical trial primarily aimed to evaluate the clinical complete response rate and secondary objectives were toxicity profile and survival.


title: Prospective Clinical and Biological Follow-up of Acquired Haemophilia : SACHA Study

summary: the aims of SACHA study was to appreciate prevalence, evolution and follow-up, treatment response of patients with acquired hemophilia with biological and clinical data. Inclusion criteria were factor VIIIc below 30% associated with presence of Facgteur VIII inhibitor (titer > 1 u Bethesda. Clinical and biologival data were obtained at Day 0 (as soon as possible and at 1, 3, 6 and 12 months.Informations were notified to co-investigators with the help of two french medical society (Internal medicine, french haemostasis and thrombosis society.

ReferenceCitation: Wootla B, Christophe OD, Mahendra A, Dimitrov JD, Repesse Y, Ollivier V, Friboulet A, Borel-Derlon A, Levesque H, Borg JY, Andre S, Bayry J, Calvez T, Kaveri SV, Lacroix-Desmazes S. Proteolytic antibodies activate factor IX in patients with acquired hemophilia. Blood. 2011 Feb 17;117(7):2257-64. doi: 10.1182/blood-2010-07-296103. Epub 2010 Dec 3.


title: Small Bowel Motor Impairment in Scleroderma: Results of a Prospective 5-year Manometric Follow-up

summary:
Small bowel involvement is still recognized to be associated with great morbidity and mortality in SSc patients, leading particularly to malabsorption and intestinal pseudo-obstruction. Intestinal disorders directly related to SSc have, in fact, been reported to be one of the most common causes of death.

In a previous prospective study, we have demonstrated the high prevalence of small intestinal involvement in SSc patients, using upper intestinal manometry; in turn, 88% of our SSc patients had upper intestinal motor disturbances. However, to date, no authors have yet analyzed the course of upper intestinal motor dysfunction in SSc.

The aims of this study were therefore to assess the 5-year course of small bowel motor disorders, using manometry in patients with systemic sclerosis (SSc), and to investigate for an association between upper intestinal motor dysfunction outcome and other clinical manifestations of SSc.


title: Characterization of T Cell Response in Hypersensitivity Syndrome

summary: immunological study of the T cell repertoire phenotype and functionality in hypersensitivity syndrome.

ReferenceCitation: Picard D, Janela B, Descamps V, D'Incan M, Courville P, Jacquot S, Rogez S, Mardivirin L, Moins-Teisserenc H, Toubert A, Benichou J, Joly P, Musette P. Drug reaction with eosinophilia and systemic symptoms (DRESS): a multiorgan antiviral T cell response. Sci Transl Med. 2010 Aug 25;2(46):46ra62. doi: 10.1126/scitranslmed.3001116.


title: Prospective Evaluation of Mandibular Advancement by Herbst Device in the Treatment of Moderate Obstructive Sleep Apnea Syndrome

summary: The purpose of this study is to determine if the mandibular advancement by Herbst device is effective in the treatment of moderate obstructive sleep apnea patients.


summary: to compare efficacity and tolerance of two stratégies of dermoval application in treatment of bullous pemphigus.


title: Catheter Ablation as the First Line Therapy for Symptomatic Typical Atrial Flutter: A Multicenter Randomized Study of Cost/Effectiveness

summary: Catheter ablation of typical atrial flutter is a well established technique with a high acute success rate and very low complication and recurrence rates. It has also been shown that ablation of recurrent symptomatic typical atrial flutter led to a clear improvement in quality of life. We sought to evaluate the cost/effectiveness of catheter ablation as the first line therapy in patient suffering from their first symptomatic typical atrial flutter episode. This study is a multicenter trial in which patients with a first symptomatic episode of typical atrial flutter are randomized to undergo ablation or to receive antiarrhythmic drugs after electrical cardioversion. Clinical examination, quality of life questionnaires,12 leads ECG and 24-hour Holter monitoring are performed at 1, 3, 6 and 12 months following randomization.The primary end-point is the absence of recurrence of typical atrial flutter at - and 12 months of follow up. The secondary end points are the cost and the cost/effectiveness ratio of these two approaches.


summary:
Noninvasive ventilation (NIV) is now a major therapeutic option to manage patients with acute hypercapnic respiratory failure (AHRF). Otherwise, patient-ventilator interfaces are determinant to get an optimal NIV efficacy in parallel with ventilatory comfort.

Facial masks during NIV are associated with deleterious consequences like gas leaks around the mask, skin breakdown (especially on the nasal bridge), claustrophobia and mask discomfort. In order to limit these side effects, a cephalic interface has been recently designed. Cephalic mask covers the whole anterior surface of the face and excessive mask fit pressure is therefore spread over a larger surface outside the nose area. However, this mask has a high volume that may interfere with NIV efficacy and may also induce claustrophobic sensations.

The aim of this study is to compare the clinical efficacy and tolerance of a cephalic mask versus a conventional oronasal mask during AHRF.

location_facility: Pulmonary & Intensive Care Department - Rouen University Hospital,


title: Cortical Pharyngeal Area: Excitability, Facilitation and Plasticity in Healthy Subjects

summary:
The aims of this study are in four experimental sessions. The aims are:

to characterize the excitability of the cortical pharyngeal area with pharyngeal pressure and electromyograms (EMGs), at rest, in awake healthy subjects;
to study its facilitation by inspiration and deglutition; and
to study its plasticity by respiration and swallowing.


title: Neuromodulation of Aspiration Secondary to Stroke

summary: Aspiration could induce major respiratory affection. They are often present after stroke. The aim of this study is to facilitate swallowing recuperation in stroke patients using peripheral laryngeal stimulation and to understand its mechanisms using motor evoked potential and cortical evoked potential.


title: Evoked Responses of External Anal Sphincter After Cortical and Lombo-sacral Magnetic Stimulations

summary: Anal incontinence and constipation are frequently observed in patients with neurological disease. The purpose of this study is to evaluate the neurological control of the anal sphincter in healthy subjects, patients with neurological disease by a new electrophysiological technique. This technique consists in recordings of anal sphincter responses after magnetic stimulations of the cortex and the sacral nerves.

status: Withdrawn


title: Effects of Phrenic Nerve Stimulation During Swallowing : Experimental Model of Aspiration

summary: the purpose of this study is to compare the oesophageal depression induced by bilateral phrenic nerve stimulation during swallowing in patients with neurological laryngeal aspiration


title: Cerebral Activity During Rectal Pain in Patients With Irritable Bowel Syndrome or Inflammatory Bowel Disease:Resonance Magnetic Imaging Study.

summary: Irritable bowel syndrome is responsible for chronic abdominal pain, diarrhea and/or constipation. It is a very frequent problem. However, the exact cause of irritable bowel syndrome remains unknown. The purpose of this study is to look for a different cerebral response by magnetic resonance imaging after rectal stimulation in patients with irritable bowel syndrome compared to healthy subjects and to patients with digestive organic disease. Our hypothesis is that irritable bowel syndrome could be a problem of cerebral integration of visceral stimulation.


title: Radiofrequency of Breast Cancers : Pilot Study in Non Surgical Patients

acronym: RF SEIN

summary: To treat breast tumors in non surgical patients with percutaneous technique (radiofrequency). Prospective evaluation of treatment efficiency and tolerance based on clinical and radiological evaluation

lead_sponsor: Institut Bergonié

location_facility: Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest


title: Effect of Ketamine, at the Induction and Its Maintenance to Prevent the Post-operative Pain: Clinical Trial in Cancerology

acronym: KETAMINE

summary: The surgery of breast cancer is responsible for post-operative pain, needing in about 30% some morphine consumption; like that, the association of ketamine with general anaesthesia may decrease morphine's use and so its adverse effects. The purpose is to evaluate the analgesic effect of a receptor NMDA's antagonist ( ketamine)


title: Plasma Coagulation Parameters and Hypercoagulability After Breast Cancer Surgery

acronym: EHC

summary: The risk of deep venous thrombosis after radical breast surgery is known. The objective of this study is to explore hypercoagulability after radical breast cancer surgery by studying several factors for haemostasis before, during and after surgery. Ultrasound Doppler examination is realised between 24 and 72 hours post-operatively. Hypercoagulability is defined by a significant increasing level of thrombin-antithrombin, D-dimer and the endogen thrombin potential.


title: Effects of Intraoperative Nitrous Oxide on Postoperative Pain for Patients With Current Opioid Treatment After Vertebroplasty.

acronym: PROTOX

summary: Peroperative opioids are known to induce N-Methyl-D-Aspartate dependent enhancement of postoperative hyperalgesia. For patients with current opioid treatment, these phenomena could be exagerated and could produce greater postoperative opioid consumption and higher pain score. Since Nitrous oxide has anti- N-Methyl-D-Aspartate properties, the aim of this study was to evaluate, in patients with current opioid treatment, the effects of peroperative Nitous oxide on postoperative opioid consumption and pain score, after vertebroplasty.

location_facility: Institut Bergonié - Centre Régional de Luttre Contre le Cancer DE Bordeaux et du Sud Ouest


title: Impact of a Socio-aesthetic Intervention on Body Image and Quality of Life in Patients With Mastectomy or Tumorectomy for Breast Cancer.

acronym: ASE K SEIN

summary: The aim of this study is to evaluate the impact of a socio-aesthetic intervention on body image and quality of life in post-surgical patients with mastectomy or tumorectomy for breast cancer.Two groups of randomized subjects were constituted. Patients of the experimental group received 2 or 3 aesthetic care during the first post-surgical week, whereas those of the control group not. Body image, quality of life and diverse other personality variables were assessed at three different times: surgical operation day before, exit day before of hospitalization and three months afterwards. Our general hypothesis is that subjects who receive aesthetic care report levels significantly higher of corporal satisfaction and of quality of life at the end of the hospitalization and three months later than patients of the control group.

intervention_type: Behavioral


title: Randomized Trial to Evaluate the Analgesic Efficacy of Inter Pleural Ropivacaine Road in Post Thoracotomy Pain for Oncologic Surgery

acronym: ROPAL 1

summary:
The purposes of this study are:

To determine the efficacy of inter pleural analgesia
To determine the plasmatic concentration of ropivacaine by inter pleural road


summary: Image quality in coronary artery computed tomography is influenced by the heart rate variation during the examination. The purpose of this clinical trial is to investigate the change in heart rate following injection of a contrast medium called Visipaque™ (iodixanol). Image quality and diagnostic quality of the examination will be evaluated.

lead_sponsor: GE Healthcare


title: Study of Histological Modifications, of Pro-apoptotic Effects and of Modifications in Apoptosis Regulators Observed After Stopping 5-ASA Treatment in Patients With Inactive Ulcerative Colitis (Clinical and Endoscopic Remission) Taking 5-ASA

summary: Male or female, 18 years of age or older. Ulcerative Colitis described according usual criteria, diagnosed for at least 1 year. Oral maintenance treatment with 5-aminosalicylic acid (5-ASA) only for at least 3 months with a dosage of 2 to 3 g/day. Clinical remission for at least 3 months (Mayo Clinic score) and endoscopic remission (endoscopic score of Mayo Clinic) at the inclusion. Signed informed consent form.

location_facility: Hôpital Saint Antoine, Service d'hépato-Gastroentérologie


title: A 6-week Open Label Cross-over Study With 2 Different Daily Doses of Minirin® Oral Lyophilisate (120 μg and 240 μg) and 2 Different Daily Doses of Minirin® Tablet (0.2 mg and 2 x 0.2 mg) in Children and Adolescents With Primary Nocturnal Enuresis (PNE)

acronym: PALAT

summary:
To evaluate the preference of subjects for Minirin® oral lyophilisate treatment compared with Minirin® tablet treatment after 6 weeks.

To compare efficacy of the 2 formulations at the end of the 6-week treatment period using diary card data.

To compare ease of use of both formulations at 3 and 6 weeks using a VAS-scale. To validate a PNE Quality of Life (QoL) questionnaire. To evaluate safety. To compare compliance with the 2 formulations

ReferenceCitation: Caldwell PH, Codarini M, Stewart F, Hahn D, Sureshkumar P. Alarm interventions for nocturnal enuresis in children. Cochrane Database Syst Rev. 2020 May 4;5(5):CD002911. doi: 10.1002/14651858.CD002911.pub3.

oa_host_type: repository

unpaywall_oa_status: green

ReferenceCitation: Juul KV, Van Herzeele C, De Bruyne P, Goble S, Walle JV, Norgaard JP. Desmopressin melt improves response and compliance compared with tablet in treatment of primary monosymptomatic nocturnal enuresis. Eur J Pediatr. 2013 Sep;172(9):1235-42. doi: 10.1007/s00431-013-1992-9. Epub 2013 May 16.

oa_colors: green hybrid

evidence: open (via crossref license)

unpaywall_oa_status: hybrid

location_facility: Service de Chirurrgie Viscerale Pediatrique Hospital Necker-Enfants Malades


title: A Phase II Randomized Study to Compare Skin Late Toxicities of Concomitant Letrozole-Radiotherapy and Radiotherapy Followed by Letrozole as Adjuvant Therapy for Postmenopausal Women With Receptor (ER and/or PgR) Positive Tumors

summary: This trial will compare grade 2 or greater late skin toxicities of concomitant letrozole-radiotherapy and radiotherapy followed by letrozole as adjuvant therapy for postmenopausal women with receptor (estrogen receptor [ER] and/or progesterone receptor [PgR]) positive tumors. Each drug will be prescribed for 5 years.

study_start_date_type: Actual

ReferenceCitation: Azria D, Pelegrin A, Dubois JB, Mirimanoff RO, Ozsahin M. Radiation therapy and tamoxifen: concurrent or sequential? It's no longer the question! J Clin Oncol. 2005 Jun 20;23(18):4239-41; author reply 4241-2. doi: 10.1200/JCO.2004.00.8623. No abstract available.

ReferenceCitation: Azria D, Larbouret C, Cunat S, Ozsahin M, Gourgou S, Martineau P, Evans DB, Romieu G, Pujol P, Pelegrin A. Letrozole sensitizes breast cancer cells to ionizing radiation. Breast Cancer Res. 2005;7(1):R156-63. doi: 10.1186/bcr969. Epub 2004 Dec 7.

ReferenceCitation: Azria D, Gourgou S, Sozzi WJ, Zouhair A, Mirimanoff RO, Kramar A, Lemanski C, Dubois JB, Romieu G, Pelegrin A, Ozsahin M. Concomitant use of tamoxifen with radiotherapy enhances subcutaneous breast fibrosis in hypersensitive patients. Br J Cancer. 2004 Oct 4;91(7):1251-60. doi: 10.1038/sj.bjc.6602146.

ReferenceCitation: Azria D, Lemanski C, Zouhair A, Gutowski M, Belkacemi Y, Dubois JB, Romieu G, Ozsahin M. [Adjuvant treatment of breast cancer by concomitant hormonotherapy and radiotherapy: state of the art]. Cancer Radiother. 2004 Jun;8(3):188-96. doi: 10.1016/j.canrad.2004.01.003. French.

ReferenceCitation: Bourgier C, Kerns S, Gourgou S, Lemanski C, Gutowski M, Fenoglietto P, Romieu G, Crompton N, Lacombe J, Pelegrin A, Ozsahin M, Rosenstein B, Azria D. Concurrent or sequential letrozole with adjuvant breast radiotherapy: final results of the CO-HO-RT phase II randomized trial. Ann Oncol. 2016 Mar;27(3):474-80. doi: 10.1093/annonc/mdv602. Epub 2015 Dec 17.

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Azria D, Belkacemi Y, Romieu G, Gourgou S, Gutowski M, Zaman K, Moscardo CL, Lemanski C, Coelho M, Rosenstein B, Fenoglietto P, Crompton NE, Ozsahin M. Concurrent or sequential adjuvant letrozole and radiotherapy after conservative surgery for early-stage breast cancer (CO-HO-RT): a phase 2 randomised trial. Lancet Oncol. 2010 Mar;11(3):258-65. doi: 10.1016/S1470-2045(10)70013-9. Epub 2010 Feb 6.

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


title: Randomized Phase II Trial Followed by Phase III Trial With Molecular Biology Study, Comparing a Standard Bi-therapy vs 3 Arms of Intensified Chemotherapy in Patients With Unresectable or Not Optimally Resectable Colorectal Cancer Liver Metastases.

summary: Randomized, open label, multicentre phase II trial followed by phase III comparing overall survival after having selected the best experimental arm.

collaborators:
Pfizer
Sanofi
Chugai Pharmaceutical

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


title: Evaluation of the Effects of Long Term Non-Invasive Ventilation in Patient With Cystic Fibrosis and Chronic Hypercapnic Respiratory Failure.

summary: There is no randomised controlled trials to determine the clinical effects of long term Non-Invasive Ventilation in Cystic Fibrosis patients.

ReferenceCitation: Ellaffi M, Vinsonneau C, Coste J, Hubert D, Burgel PR, Dhainaut JF, Dusser D. One-year outcome after severe pulmonary exacerbation in adults with cystic fibrosis. Am J Respir Crit Care Med. 2005 Jan 15;171(2):158-64. doi: 10.1164/rccm.200405-667OC. Epub 2004 Oct 22.

ReferenceCitation: Moran F, Bradley J. Non-invasive ventilation for cystic fibrosis. Cochrane Database Syst Rev. 2003;(2):CD002769. doi: 10.1002/14651858.CD002769.

lead_sponsor: Cochin Hospital

location_facility: Department of pulmonary disease of Cochin Hospital (AP-HP)


title: Relationship Between Succinate Dehydrogenase Mutations and High-Altitude Illness Associated With Chemoreflex Failure

summary: This study is is the first step of a full study named CHEMOGENE because it explores the genetic determinant of an alteration of the chemoreflex. This reflex determines hyperventilation when the pressure of oxygen falls in the blood. This happens when subjects travel to high-altitude where oxygen levels diminish in the atmosphere. Subjects with such an altered chemoreflex are intolerant to altitude and develop pulmonary or cerebral edema associated with a severe headache. In this study we compare subjects tolerant to high altitude (8000 meters)to subjects intolerant to altitude. The chemoreflex is measured i.e. the hyperventilation associated with hypoxia and all subjects are scanned for the genes implicated in the mitochondrial respiratory chain. The idea is that subjects with an impaired oxygen sensing will exhibit an altered chemoreflex and will be intolerant to high-altitude.

time_perspective: Retrospective

ReferenceCitation: Gimenez-Roqueplo AP, Favier J, Rustin P, Rieubland C, Crespin M, Nau V, Khau Van Kien P, Corvol P, Plouin PF, Jeunemaitre X; COMETE Network. Mutations in the SDHB gene are associated with extra-adrenal and/or malignant phaeochromocytomas. Cancer Res. 2003 Sep 1;63(17):5615-21.

ReferenceCitation: Gimenez-Roqueplo AP, Favier J, Rustin P, Rieubland C, Kerlan V, Plouin PF, Rotig A, Jeunemaitre X. Functional consequences of a SDHB gene mutation in an apparently sporadic pheochromocytoma. J Clin Endocrinol Metab. 2002 Oct;87(10):4771-4. doi: 10.1210/jc.2002-020525.

ReferenceCitation: Gimenez-Roqueplo AP, Favier J, Rustin P, Mourad JJ, Plouin PF, Corvol P, Rotig A, Jeunemaitre X. The R22X mutation of the SDHD gene in hereditary paraganglioma abolishes the enzymatic activity of complex II in the mitochondrial respiratory chain and activates the hypoxia pathway. Am J Hum Genet. 2001 Dec;69(6):1186-97. doi: 10.1086/324413. Epub 2001 Oct 16.

lead_sponsor: Société Française de Cardiologie

location_facility: Centre d'Investigation Clinique, Hopital Pompidou


title: Efficacy of 15 mg and 50 mg of S18986 on Cognitive Symptoms in Mild Cognitive Impairment Patients Treated Over a 12-month Oral Administration Period

summary: The purpose of this study is to demonstrate a long term efficacy of S18986 versus placebo on episodic memory performance in patients with MCI

ipd_sharing: Yes

ipd_sharing_description:
Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies:

submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

lead_sponsor: Institut de Recherches Internationales Servier


title: Intracoronary Injection of Autologous Bone Marrow Mononuclear Cells for Severe Myocardial Infarction

summary: Emerging evidence suggests that stem cells and progenitor cells derived from bone marrow can be used to improve cardiac function in patients after acute myocardial infarction. In this randomised trial, we aim to assess whether intracoronary transfer of autologous bone-marrow cells could improve myocardial viability at 3 and 12 months' follow-up.

ReferenceCitation: Manrique A, Lemarchand P, Delasalle B, Lairez O, Sportouch-Duckan C, Lamirault G, Le Corvoisier P, Neuder Y, Richardson M, Lebon A, Roncalli J, Piot C, Trochu JN, Teiger E, Hossein-Foucher C, Le Tourneau T. Predictors of ventricular remodelling in patients with reperfused acute myocardial infarction and left ventricular dysfunction candidates for bone marrow cell therapy: insights from the BONAMI trial. Eur J Nucl Med Mol Imaging. 2016 Apr;43(4):740-8. doi: 10.1007/s00259-015-3279-z. Epub 2015 Dec 15.

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

repository_normalized: HAL

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

version: acceptedVersion

version: submittedVersion

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

ReferenceCitation: Roncalli J, Mouquet F, Piot C, Trochu JN, Le Corvoisier P, Neuder Y, Le Tourneau T, Agostini D, Gaxotte V, Sportouch C, Galinier M, Crochet D, Teiger E, Richard MJ, Polge AS, Beregi JP, Manrique A, Carrie D, Susen S, Klein B, Parini A, Lamirault G, Croisille P, Rouard H, Bourin P, Nguyen JM, Delasalle B, Vanzetto G, Van Belle E, Lemarchand P. Intracoronary autologous mononucleated bone marrow cell infusion for acute myocardial infarction: results of the randomized multicenter BONAMI trial. Eur Heart J. 2011 Jul;32(14):1748-57. doi: 10.1093/eurheartj/ehq455. Epub 2010 Dec 2.


summary: Determine the best strategy for proteinuria lowering in patients with proteinuria > 1 g/day receiving ACEI and ARB combination: either increase of ACEI and ARB dosage or increase of diuretic dosage.


title: Etude Multicentrique Ouverte Randomisée de Phase III Comparant l'Association de VELCADE®-Dexaméthasone à la Chimiothérapie de Type VAD Pour le Traitement Des Patients Porteurs de Myélome Multiple de Novo Jusqu'à l'âge de 65 Ans

summary: This is an open-label, multi-centre, randomised Phase III study, looking at a series of 480 patients up to the age of 65 with newly diagnosed multiple myeloma (MM) not previously treated. They will receive VAD or Velcade®/dexamethasone combination as induction treatment plus/minus (±) dexamethasone/cyclophosphamide/etoposide/cisplatin (DCEP) followed by autograft as first-line therapy, as the investigators try to compare the complete remission (CR) rate (with negative or positive immunofixation) at the end of their induction treatment.

ReferenceCitation: Sonneveld P, Goldschmidt H, Rosinol L, Blade J, Lahuerta JJ, Cavo M, Tacchetti P, Zamagni E, Attal M, Lokhorst HM, Desai A, Cakana A, Liu K, van de Velde H, Esseltine DL, Moreau P. Bortezomib-based versus nonbortezomib-based induction treatment before autologous stem-cell transplantation in patients with previously untreated multiple myeloma: a meta-analysis of phase III randomized, controlled trials. J Clin Oncol. 2013 Sep 10;31(26):3279-87. doi: 10.1200/JCO.2012.48.4626. Epub 2013 Jul 29.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Corthals SL, Kuiper R, Johnson DC, Sonneveld P, Hajek R, van der Holt B, Magrangeas F, Goldschmidt H, Morgan GJ, Avet-Loiseau H. Genetic factors underlying the risk of bortezomib induced peripheral neuropathy in multiple myeloma patients. Haematologica. 2011 Nov;96(11):1728-32. doi: 10.3324/haematol.2011.041434. Epub 2011 Jul 26.

ReferenceCitation: Moreau P, Attal M, Pegourie B, Planche L, Hulin C, Facon T, Stoppa AM, Fuzibet JG, Grosbois B, Doyen C, Ketterer N, Sebban C, Kolb B, Chaleteix C, Dib M, Voillat L, Fontan J, Garderet L, Jaubert J, Mathiot C, Esseltine D, Avet-Loiseau H, Harousseau JL; IFM 2005-01 study investigators. Achievement of VGPR to induction therapy is an important prognostic factor for longer PFS in the IFM 2005-01 trial. Blood. 2011 Mar 17;117(11):3041-4. doi: 10.1182/blood-2010-08-300863. Epub 2010 Nov 23. Erratum In: Blood. 2012 Nov 15;120(20):4274.


summary: Comparison between FDG-PET and MRI for the assessment of response to intensive chemotherapy in multiple myeloma patients.


title: Safety and Efficacy of Pravastatin in Relapsing-remitting MS: a Double Blind Placebo Controlled Study

summary: Therapeutic strategies for multiple sclerosis (MS) are essentially based on the use of immunomodulatory agents such as interferon b and glatirmere acetate, but their efficacy is quite limited, they are not well tolerated and they have a very high cost. Recent works showed an immunomodulatory effects of HMG-CoA reductase inhibitors (the so-called "statins"). In experimental allergic encephalopathy, a murine model of MS, statins inhibit the onset and progression of the disease through a shift from Th1 towards Th2 cytokine production. Other in vitro studies suggest the ability of statins to inhibit the lymphocyte migration through the blood brain barrier. Furthermore, in an open labeled human study in MS, statin regimen was associated with a decreased lesional activity assessed by MRI. Statins are well tolerated drugs, used for many years, with a low cost and with a putative efficacy in MS. The investigators suggest to test the pravastatin safety and efficacy on MRI criteria in a double-blind, placebo-controlled study in 40 patients with a relapsing-remitting MS.