title: Breastmilk or Oral Sucrose Solution in Preterm Neonates for Procedural Pain: a Randomized, Controlled Study

acronym: BMoS

summary:
Hypothesis: Breastmilk has a more powerful analgesic effect than oral sucrose to avoid procedural pain in preterm neonates.

The objective is to test this hypothesis in a randomized, controlled study using a standardized and validated pain scale (DAN). The sample size is 21 preterm infants in each two groups. The main end point is a reduction of the risk to have a DAN superior to 1 from 80% with oral sucrose to 40% with breastmilk.

ReferenceCitation: Schollin J. Analgesic effect of expressed breast milk in procedural pain in neonates. Acta Paediatr. 2004 Apr;93(4):453-5. doi: 10.1080/08035250410027959.

ReferenceCitation: Carbajal R, Veerapen S, Couderc S, Jugie M, Ville Y. Analgesic effect of breast feeding in term neonates: randomised controlled trial. BMJ. 2003 Jan 4;326(7379):13. doi: 10.1136/bmj.326.7379.13.

ReferenceCitation: Carbajal R, Paupe A, Hoenn E, Lenclen R, Olivier-Martin M. [APN: evaluation behavioral scale of acute pain in newborn infants]. Arch Pediatr. 1997 Jul;4(7):623-8. doi: 10.1016/s0929-693x(97)83360-x. French.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Intercommunal de Creteil


title: Evaluation of Ischemic Preconditioning in Patients Undergoing Major Liver Resection With Intermittent Pedicular Clamping: A Multicentric Randomized Trial

acronym: HECLA

summary:
To evaluate the accuracy of ischemic preconditioning (IPC) as a protective maneuver against ischemia/reperfusion lesion in patients undergoing major liver resection with intermittent portal triad Clamping (IPTC).

Summary Background Data: For sake of safety and to avoid excessive blood loss during parenchymal transection, vascular inflow occlusion is an effective trick but may cause ischemic damage to the remnant liver and can lead to liver failure in case of chronic liver disease. IPTC has been proven to be superior to continuous hepatic pedicle clamping as it preserve liver remnant from severe ischemia/reperfusion lesion, so does IPC. Yet, if IPC is beneficial if liver resection is performed under IPTC has never been demonstrated in a randomised controlled trial (RCT). The investigators designed a RCT to assess the impact of IPC in patient undergoing major liver resection with intermittent vascular inflow occlusion.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Scatton O, Zalinski S, Jegou D, Compagnon P, Lesurtel M, Belghiti J, Boudjema K, Lentschener C, Soubrane O. Randomized clinical trial of ischaemic preconditioning in major liver resection with intermittent Pringle manoeuvre. Br J Surg. 2011 Sep;98(9):1236-43. doi: 10.1002/bjs.7626. Epub 2011 Jul 11.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Completed


title: Assistance Robotics for the Surgical Treatment of the Abdominal Wall Hernia

acronym: ARTE

summary:
The aim of this study is to prove the superiority of the robotic assistance in laparoscopic repair of abdominal wall hernias .

In this monocentric randomized controlled trial, the use of the DA VINCI robot might reduce the post-operative pain of the patient resulting in a 40% reduction of morphine consumption.

intervention_type: Device


type: Registry Identifier

type: Other Identifier

title: A Multicentric Phase III Trial Evaluating the Impact of a Radiation Boost (16Gy) After Breast Conserving Surgery and a Whole Breast Irradiation (50Gy) for DCIS

acronym: BONBIS

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether whole-breast radiation therapy is more effective when given with or without additional radiation therapy to the tumor in treating patients with ductal carcinoma in situ.

PURPOSE: This randomized phase III trial is studying breast-conserving surgery followed by whole-breast radiation therapy to see how well it works when given with or without additional radiation therapy to the tumor in treating women with ductal carcinoma in situ.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceType: background

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: Bartelink H, Horiot JC, Poortmans PM, Struikmans H, Van den Bogaert W, Fourquet A, Jager JJ, Hoogenraad WJ, Oei SB, Warlam-Rodenhuis CC, Pierart M, Collette L. Impact of a higher radiation dose on local control and survival in breast-conserving therapy of early breast cancer: 10-year results of the randomized boost versus no boost EORTC 22881-10882 trial. J Clin Oncol. 2007 Aug 1;25(22):3259-65. doi: 10.1200/JCO.2007.11.4991. Epub 2007 Jun 18.

ReferenceCitation: EORTC Breast Cancer Cooperative Group; EORTC Radiotherapy Group; Bijker N, Meijnen P, Peterse JL, Bogaerts J, Van Hoorebeeck I, Julien JP, Gennaro M, Rouanet P, Avril A, Fentiman IS, Bartelink H, Rutgers EJ. Breast-conserving treatment with or without radiotherapy in ductal carcinoma-in-situ: ten-year results of European Organisation for Research and Treatment of Cancer randomized phase III trial 10853--a study by the EORTC Breast Cancer Cooperative Group and EORTC Radiotherapy Group. J Clin Oncol. 2006 Jul 20;24(21):3381-7. doi: 10.1200/JCO.2006.06.1366. Epub 2006 Jun 26.

ReferenceCitation: Bijker N, Peterse JL, Duchateau L, Julien JP, Fentiman IS, Duval C, Di Palma S, Simony-Lafontaine J, de Mascarel I, van de Vijver MJ. Risk factors for recurrence and metastasis after breast-conserving therapy for ductal carcinoma-in-situ: analysis of European Organization for Research and Treatment of Cancer Trial 10853. J Clin Oncol. 2001 Apr 15;19(8):2263-71. doi: 10.1200/JCO.2001.19.8.2263.

ReferenceCitation: Cutuli B, Cohen-Solal-le Nir C, de Lafontan B, Mignotte H, Fichet V, Fay R, Servent V, Giard S, Charra-Brunaud C, Lemanski C, Auvray H, Jacquot S, Charpentier JC. Breast-conserving therapy for ductal carcinoma in situ of the breast: the French Cancer Centers' experience. Int J Radiat Oncol Biol Phys. 2002 Jul 15;53(4):868-79. doi: 10.1016/s0360-3016(02)02834-1.

ReferenceCitation: Cutuli B, Fourquet A, Luporsi E, Arnould L, Caron Y, Cremoux Pd, Dilhuydy JM, Fondrinier E, Fourme E, Giard-Lefevre S, Blanc-Onfroy ML, Lemanski C, Mauriac L, Sigal-Zafrani B, Tardivon A, This P, Tunon de Lara C, Kirova Y, Fabre N; Federation of French Cancer Centres (FNCLCC), et le groupe de travail SOR. [Standards, Options and Recommendations for the management of ductal carcinoma in situ of the breast (DCIS): update 2004]. Bull Cancer. 2005 Feb;92(2):155-68. French.

ReferenceCitation: Emdin SO, Granstrand B, Ringberg A, Sandelin K, Arnesson LG, Nordgren H, Anderson H, Garmo H, Holmberg L, Wallgren A; Swedish Breast Cancer Group. SweDCIS: Radiotherapy after sector resection for ductal carcinoma in situ of the breast. Results of a randomised trial in a population offered mammography screening. Acta Oncol. 2006;45(5):536-43. doi: 10.1080/02841860600681569.

ReferenceCitation: Ernster VL, Barclay J, Kerlikowske K, Grady D, Henderson C. Incidence of and treatment for ductal carcinoma in situ of the breast. JAMA. 1996 Mar 27;275(12):913-8.

ReferenceCitation: Fine JP. Regression modeling of competing crude failure probabilities. Biostatistics. 2001 Mar;2(1):85-97. doi: 10.1093/biostatistics/2.1.85.

ReferenceCitation: Fisher B, Dignam J, Wolmark N, Wickerham DL, Fisher ER, Mamounas E, Smith R, Begovic M, Dimitrov NV, Margolese RG, Kardinal CG, Kavanah MT, Fehrenbacher L, Oishi RH. Tamoxifen in treatment of intraductal breast cancer: National Surgical Adjuvant Breast and Bowel Project B-24 randomised controlled trial. Lancet. 1999 Jun 12;353(9169):1993-2000. doi: 10.1016/S0140-6736(99)05036-9.

ReferenceCitation: Fisher B, Land S, Mamounas E, Dignam J, Fisher ER, Wolmark N. Prevention of invasive breast cancer in women with ductal carcinoma in situ: an update of the National Surgical Adjuvant Breast and Bowel Project experience. Semin Oncol. 2001 Aug;28(4):400-18. doi: 10.1016/s0093-7754(01)90133-2.

ReferenceCitation: Gagliardi G, Lax I, Soderstrom S, Gyenes G, Rutqvist LE. Prediction of excess risk of long-term cardiac mortality after radiotherapy of stage I breast cancer. Radiother Oncol. 1998 Jan;46(1):63-71. doi: 10.1016/s0167-8140(97)00167-9.

ReferenceCitation: Ho AY, Atencio DP, Peters S, Stock RG, Formenti SC, Cesaretti JA, Green S, Haffty B, Drumea K, Leitzin L, Kuten A, Azria D, Ozsahin M, Overgaard J, Andreassen CN, Trop CS, Park J, Rosenstein BS. Genetic predictors of adverse radiotherapy effects: the Gene-PARE project. Int J Radiat Oncol Biol Phys. 2006 Jul 1;65(3):646-55. doi: 10.1016/j.ijrobp.2006.03.006.

ReferenceCitation: Houghton J, George WD, Cuzick J, Duggan C, Fentiman IS, Spittle M; UK Coordinating Committee on Cancer Research; Ductal Carcinoma in situ Working Party; DCIS trialists in the UK, Australia, and New Zealand. Radiotherapy and tamoxifen in women with completely excised ductal carcinoma in situ of the breast in the UK, Australia, and New Zealand: randomised controlled trial. Lancet. 2003 Jul 12;362(9378):95-102. doi: 10.1016/s0140-6736(03)13859-7.

ReferenceCitation: Omlin A, Amichetti M, Azria D, Cole BF, Fourneret P, Poortmans P, Naehrig D, Miller RC, Krengli M, Gutierrez Miguelez C, Morgan D, Goldberg H, Scandolaro L, Gastelblum P, Ozsahin M, Dohr D, Christie D, Oppitz U, Abacioglu U, Gruber G. Boost radiotherapy in young women with ductal carcinoma in situ: a multicentre, retrospective study of the Rare Cancer Network. Lancet Oncol. 2006 Aug;7(8):652-6. doi: 10.1016/S1470-2045(06)70765-3.

ReferenceCitation: Ozsahin M, Crompton NE, Gourgou S, Kramar A, Li L, Shi Y, Sozzi WJ, Zouhair A, Mirimanoff RO, Azria D. CD4 and CD8 T-lymphocyte apoptosis can predict radiation-induced late toxicity: a prospective study in 399 patients. Clin Cancer Res. 2005 Oct 15;11(20):7426-33. doi: 10.1158/1078-0432.CCR-04-2634.

ReferenceCitation: Solin LJ, Fourquet A, Vicini FA, Haffty B, Taylor M, McCormick B, McNeese M, Pierce LJ, Landmann C, Olivotto IA, Borger J, Kim J, de la Rochefordiere A, Schultz DJ. Mammographically detected ductal carcinoma in situ of the breast treated with breast-conserving surgery and definitive breast irradiation: long-term outcome and prognostic significance of patient age and margin status. Int J Radiat Oncol Biol Phys. 2001 Jul 15;50(4):991-1002. doi: 10.1016/s0360-3016(01)01517-6.

ipd_sharing: No

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

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

intervention_type: Radiation

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Association of Rituximab to Plasma Exchange in Adult Acquired Idiopathic Thrombotic Thrombocytopenic Purpura

acronym: PTTritux

summary:
Multicentric non-randomized phase II opened prospective study (10 centres involved).

Primary endpoint:

To evaluate the kinetics of B-cell depletion by rituximab and its pharmacokinetics in patients treated with rituximab in association with plasma exchanges.

Secondary endpoints:

To evaluate the tolerance of rituximab, the volume of plasma and the number of plasma exchange sessions required to achieve a durable complete remission, and to determinate the duration of B-cell depletion.
To evaluate the incidence of persistent severe acquired ADAMTS13 deficiency following treatment with rituximab, as well as the incidence of relapses.

ReferenceCitation: Benhamou Y, Paintaud G, Azoulay E, Poullin P, Galicier L, Desvignes C, Baudel JL, Peltier J, Mira JP, Pene F, Presne C, Saheb S, Deligny C, Rousseau A, Feger F, Veyradier A, Coppo P; French Reference Center for Thrombotic Microangiopathies. Efficacy of a rituximab regimen based on B cell depletion in thrombotic thrombocytopenic purpura with suboptimal response to standard treatment: Results of a phase II, multicenter noncomparative study. Am J Hematol. 2016 Dec;91(12):1246-1251. doi: 10.1002/ajh.24559. Epub 2016 Nov 8.

oa_host_type: publisher

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Wiley

intervention_type: Drug


title: Methodological Evaluation of Fluor 18 Labelled Fluoromisonidazole ([18F]-FMISO) Positon Emission Tomography-Computed Tomography (PET-CT) for Non Operated Glioblastoma

acronym: MISOGLIO

summary:
Hypoxia is recognized to be an independent predictor of clinical outcome in oncology. PET using [18F]-FMISO has been described to be useful for the non invasive assessment of hypoxia in cancer. The use of this radiotracer for brain tumours is very limited and there is no standard to acquire and quantify [18F]-FMISO uptake. So there is a need for a methodological evaluation of this PET tracer The purpose of this research is to define optimal parameters for acquisition and data exploitation to quantify [18F]-FMISO uptake and so predict clinical outcome in glioblastomas.

Low sensitivity to radiation of glioblastoma is partly caused by hypoxia. Hypoxia in tumours is not predicted by tumour size. Detecting and monitoring tissue oxygenation are of great interest to modify therapeutic strategies, including local dose escalation for radiotherapy or select chemotherapeutic agents with better impact in glioblastomas.

PET with appropriate radiotracers, especially [18F]-FMISO, enables non-invasive assessment of hypoxia. [18F]-FMISO only accumulates in viable hypoxic cells. So, it has been demonstrated that PET using 18F-FMISO is suitable to localize and quantify hypoxia. But there isn't any optimal acquisition protocol or standardized images quantification treatment. Thus, the interpretation of [18F]-FMISO PET images and the predictive value of [18F]-FMISO SUV (Standardized Uptake Value) remain unclear explaining the need of methodological approaches.

primary_purpose: Health Services Research

lead_sponsor: University Hospital, Bordeaux


title: Phase II Study of Evaluation of Fractionated Radio-immunotherapy With 90Y-DOTA-hLL2 as a Consolidation Therapy After First Line of Chemotherapy in Patients Older Than 60 With Disseminated Diffuse Large B-cell Lymphoma

summary:
Phase II, multi-centric, open-label, study.

Disseminated diffuse large B-cell lymphoma in patients older than 60: evaluation of fractionated radio-immunotherapy with 90Y-DOTA-hLL2 as a consolidation therapy after first line of chemotherapy.

status: Terminated

ReferenceCitation: Kraeber-Bodere F, Pallardy A, Maisonneuve H, Campion L, Moreau A, Soubeyran I, Le Gouill S, Tournilhac O, Daguindau E, Jardel H, Morineau N, Bouabdallah K, Gyan E, Moles MP, Gressin R, Berthou C, Sadot S, Moreau P, Deau B, Bodet-Milin C, Cazeau AL, Garin E, Salaun PY, Vuillez JP, Gouilleux-Gruart V, Barbet J, Wegener WA, Goldenberg DM, Lamy T, Soubeyran P. Consolidation anti-CD22 fractionated radioimmunotherapy with 90Y-epratuzumab tetraxetan following R-CHOP in elderly patients with diffuse large B-cell lymphoma: a prospective, single group, phase 2 trial. Lancet Haematol. 2017 Jan;4(1):e35-e45. doi: 10.1016/S2352-3026(16)30168-5. Epub 2016 Dec 8.

oa_host_type: closed

publisher_dissemination: Elsevier

lead_sponsor: French Innovative Leukemia Organisation

status_simplified: Unknown


title: Randomised, Controlled, Clinical Study to Compare the Effect of a Combination of Enamel Matrix Proteins and Straumann Bone Ceramic With Autogenous Bone in Deep-wide Intrabony Defects

summary: Randomised, controlled, clinical study to compare the effect of the combination of bone ceramic and enamel matrix proteins (test) versus autogenous bone graft alone (control) in the treatment of deep-wide intrabony defects

lead_sponsor: Institut Straumann AG

location_facility: Hôtel-Dieu, Université Paris 7 Denis Diderot


title: A National, Multicenter, Non-comparative Study Evaluating the Efficacy of the Combination of Levofloxacin (500 mg) and Rifampicin (600 or 900 mg Depending on Weight) Administered Once Daily by Oral Route, as Replacement of Empirical Antibiotic Therapy Given Intravenously With a Total Duration of 6 Weeks of the Antibiotic Therapy, in the Treatment of OsteoArticular Prosthetic Infections (OAPI), With a Two-stage Revision of the Prosthesis.

summary:
The primary objective is: to assess the microbiological success of the combination of levofloxacin and rifampicin, administered for 32 to 37 days, as oral replacement therapy of an empirical antibiotic therapy of a maximum of 5 to 10 days given intravenously, in the treatment of OsteoArticular Prosthetic Infections (OAPI), with a two-stage revision of the prosthesis.

The secondary endpoints are:

To assess the rate of clinical failure 12 months after the reimplantation of the prosthesis.
To assess the joint mobility function score 12 months after the reimplantation of the prosthesis.
To assess the safety of the combination of levofloxacin and rifampicin.
To investigate prognostic factors for success after the end of treatment and at 12 months after the reimplantation of the prosthesis.

design_allocation: Non-Randomized

lead_sponsor: Sanofi


title: Systematic Nutritional Care in Patients Receiving First-line Chemotherapy for Metastatic Gynecologic Cancer in a Phase II Study

summary:
RATIONALE: Learning about the effect of nutritional supplements on quality of life in patients receiving chemotherapy for cancer may help doctors plan the best treatment.

PURPOSE: This randomized phase II trial is studying nutritional supplements to see how well they work in improving quality of life during first-line chemotherapy in patients with metastatic gynecologic cancer.

status: Unknown status

primary_purpose: Supportive Care

enrollment_type: Anticipated

lead_sponsor: Centre Oscar Lambret


title: Polymorphisms of Genes Controlling Alveolar Development and Risk of Bronchopulmonary Dysplasia

acronym: GENBPD

summary:
Despite considerable obstetric and neonatal advances in the care of very low birth weight (VLBW) neonates, bronchopulmonary dysplasia (BPD) continues to occur among 20 to 40% of surviving infants, and new ways for combatting this disease must be found. BPD appears to result from arrested lung development, but its etiology has not yet been fully established. Besides the role of the exposure of the immature lung to injurious factors in the development of BPD, a genetic susceptibility for BPD in preterm infants was recently evidenced. Taking advantage of new genomic technologies, the objective of the investigators' project is to identify predisposing human genetic variants through:

a genome-wide association (GWA) study in VLBW neonates,
a candidate-gene association study, including selection of single nucleotide polymorphisms (SNPs) found in (a) and
functional studies of any SNP found to be convincingly associated with BPD in (a) and (b).

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Hadchouel A, Decobert F, Franco-Montoya ML, Halphen I, Jarreau PH, Boucherat O, Martin E, Benachi A, Amselem S, Bourbon J, Danan C, Delacourt C. Matrix metalloproteinase gene polymorphisms and bronchopulmonary dysplasia: identification of MMP16 as a new player in lung development. PLoS One. 2008 Sep 11;3(9):e3188. doi: 10.1371/journal.pone.0003188.

sponsor_collaborators: Centre Hospitalier Intercommunal Creteil


title: ANRS HC20 Pilot Study, Multicenter, Assessing the Effectiveness of an Optimized Anti HCV (360μg/Week Induction of PegIFN-alpha2a + 18mg/kg/j of RBV for 6 Months and Then Depending on the Virological Response to S12, Elongation up S72 to the Dual Anti HCV, With Accompanying Measures) on Sustained Virological Response in Patients With HCV Genotype 1 and 4 Non Responders and Co-infected With HIV.

acronym: ETOC

summary: The purpose of this study is to assess the effectiveness of an optimized anti HCV treatment (360μg per week of PegIFN-alpha2a + 18mg/kg/j of Ribavirin for 6 months.

ReferenceCitation: Laird ME, Mohsen A, Duffy D, Mamdouh R, LeFouler L, Casrouge A, El-Daly M, Rafik M, Abdel-Hamid M, Soulier A, Pawlotsky JM, Hezode C, Rosa I, Renard P, Mohamed MK, Bonnard P, Izopet J, Mallet V, Pol S, Albert ML, Fontanet A. Apolipoprotein H expression is associated with IL28B genotype and viral clearance in hepatitis C virus infection. J Hepatol. 2014 Oct;61(4):770-6. doi: 10.1016/j.jhep.2014.05.040. Epub 2014 Jun 4.

lead_sponsor: ANRS, Emerging Infectious Diseases

sponsor_collaborators:
ANRS, Emerging Infectious Diseases
Roche Pharma AG

location_facility: Hôpital Tenon Service des Maladies Infectieuses


title: Study Aiming at Researching Diagnostic Markers for the Recognition of Precancerous States, Tracking, Follow-up, and the Identification of New Therapeutic Targets for Mesothelioma in Patients With Atypical Mesothelial Hyperplasia.

summary:
RATIONALE: Studying levels of mesothelin and osteopontin in samples of blood from patients with mesothelioma or atypical mesothelial hyperplasia may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking at mesothelin and osteopontin as diagnostic markers in patients with mesothelioma or atypical hyperplasia.

lead_sponsor: University Hospital, Caen


title: Study Evaluating the Prognostic and Predictive Value of Response to First-Line Chemotherapy by Detection of Circulating Tumor Cells (CTC) in Patients With Metastatic Breast Cancer

summary:
RATIONALE: Measuring blood levels of tumor cells in patients with breast cancer may help doctors predict how patients will respond to treatment.

PURPOSE: This laboratory study is looking at blood levels of tumor cells in predicting response in patients receiving first-line chemotherapy for stage IV breast cancer.

lead_sponsor: Institut Curie

intervention_type: Other


title: Colon and Breast Cancer Diagnostics. Clinical Protocol Associated With Cancer of the Breast.

summary:
RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at tumor and blood samples from women with breast cancer.


title: Prospective Multicenter Study of Genetic Factors Predictive of the Pharmacodynamics of Trastuzumab in Patients With Metastatic Breast Cancer

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

PURPOSE: This clinical trial is studying the side effects of trastuzumab in treating women with metastatic breast cancer.

lead_sponsor: Centre Antoine Lacassagne


title: Factors Associated With the Variance of Oral Methadone Dosage at Steady State of Maintenance Treatment: Description of Bio-markers of Phenotype and Genotype.

acronym: METHADOSE

summary: The purpose of this study is to describe clinical, pharmacokinetic and genetic factors associated with the variance of oral methadone dosage for patients at the steady state of heroin dependence maintenance treatment. The hypothesis is that the investigators can predict 70% of the variance with few factors, including CYP 3A4 function measured with oral midazolam challenge.

time_perspective: Cross-Sectional

ReferenceType: result

ReferenceCitation: Hajj A, Ksouda K, Peoc'h K, Curis E, Messali A, Deveaux LL, Bloch V, Prince N, Mouly S, Scherrmann JM, Lepine JP, Laplanche JL, Drici MD, Vorspan F. KCNH2 polymorphism and methadone dosage interact to enhance QT duration. Drug Alcohol Depend. 2014 Aug 1;141:34-8. doi: 10.1016/j.drugalcdep.2014.04.027. Epub 2014 May 14.

ReferenceCitation: Icick R, Peoc'h K, Ksouda K, Bloch V, Laplanche JL, Lepine JP, Bellivier F, Vorspan F. OPRM1 polymorphism and lifetime suicide attempts among stabilized, methadone-maintained outpatients. Psychiatry Res. 2014 Aug 15;218(1-2):259-60. doi: 10.1016/j.psychres.2014.04.035. Epub 2014 Apr 24. No abstract available.

ReferenceCitation: Mouly S, Bloch V, Peoc'h K, Houze P, Labat L, Ksouda K, Simoneau G, Decleves X, Bergmann JF, Scherrmann JM, Laplanche JL, Lepine JP, Vorspan F. Methadone dose in heroin-dependent patients: role of clinical factors, comedications, genetic polymorphisms and enzyme activity. Br J Clin Pharmacol. 2015 Jun;79(6):967-77. doi: 10.1111/bcp.12576.

oa_colors: green other

oa_host_type: publisher;repository

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

ReferenceCitation: Karsinti E, Fortias M, Dupuy G, Ksouda K, Laqueille X, Simonpoli AM, Touzeau D, Avril E, Orizet C, Belforte B, Coeuru P, Polomeni P, Icick R, Jarroir M, Bloch V, Scott J, Lepine JP, Bellivier F, Vorspan F. Anxiety disorders are associated with early onset of heroin use and rapid transition to dependence in methadone maintained patients. Psychiatry Res. 2016 Nov 30;245:423-426. doi: 10.1016/j.psychres.2016.04.064. Epub 2016 Jul 19.

ReferenceCitation: Marie-Claire C, Crettol S, Cagnard N, Bloch V, Mouly S, Laplanche JL, Bellivier F, Lepine JP, Eap C, Vorspan F. Variability of response to methadone: genome-wide DNA methylation analysis in two independent cohorts. Epigenomics. 2016 Feb;8(2):181-95. doi: 10.2217/epi.15.110. Epub 2016 Jan 21.

oa_host_type: repository

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

repository_normalized: HAL

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

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université d'Artois

repositories_concat: HAL

unpaywall_oa_status: green

publisher_dissemination: Future Science Ltd

ReferenceCitation: Icick R, Peoc'h K, Karsinti E, Ksouda K, Hajj A, Bloch V, Prince N, Mouly S, Bellivier F, Lepine JP, Laplanche JL, Vorspan F. A cannabinoid receptor 1 polymorphism is protective against major depressive disorder in methadone-maintained outpatients. Am J Addict. 2015 Oct;24(7):613-20. doi: 10.1111/ajad.12273. Epub 2015 Sep 1.

ReferenceCitation: Icick R, Vorspan F, Karsinti E, Ksouda K, Lepine JP, Brousse G, Mouly S, Bellivier F, Bloch V. Gender-specific study of recurrent suicide attempts in outpatients with multiple substance use disorders. J Affect Disord. 2018 Dec 1;241:546-553. doi: 10.1016/j.jad.2018.08.076. Epub 2018 Aug 13.


summary: Hip or knee arthroplasties allow a relief of pain and a good functional habilitative at patients suffering from degenerative osteoarthritis of these articulations with medium and long-term good results. The main objective of this study is to compare the efficiency in short and medium-term functional impact parlance of two surgical techniques: computer-assisted surgery and mini-invasive surgery compared to the conventional techniques thanks to an innovative technology of ambulatory analysis of walking.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique-Hopitaux de Marseille


summary: The aim of the study is to realize a bilateral transplantation of upper limbs. The first objective is functional but there are aesthetic and psychologic imperatives too. This open and descriptive study needs compatible donor and recipient. The sample should be realized simultaneously and the transplantation should be made by two coordinated teams according to this sequence : osteosynthesis, vascular anastomosis, sutures of tendons and nervous sutures. An immunosuppressant treatment should be initialized from the beginning of the intervention and continued for life. Rejections should be screened by regular clinical and histological examinations.

sponsor_collaborators: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: A Cluster-Randomized Two-Period Cross-Over Study Comparing Routine and on-Demand Prescription of Chest Radiographs in Mechanically Ventilated Adults : the RARE Study

acronym: RARE

summary: Current guidelines recommend Routine daily chest radiographs (CXRs) for mechanically ventilated patients in intensive care units (ICUs). However, some ICUs have shifted to an On-demand strategy, in which this CXR is only prescribed if warranted by the patient's status at the morning physical examination. Here the investigators compared Routine and On-demand strategies in 21 French ICUs. The working hypothesis was that CXR prescriptions would fall by at least 20% with the On-demand strategy, with no reduction in quality of care.

ReferenceCitation: Hejblum G, Chalumeau-Lemoine L, Ioos V, Boelle PY, Salomon L, Simon T, Vibert JF, Guidet B. Comparison of routine and on-demand prescription of chest radiographs in mechanically ventilated adults: a multicentre, cluster-randomised, two-period crossover study. Lancet. 2009 Nov 14;374(9702):1687-93. doi: 10.1016/S0140-6736(09)61459-8. Epub 2009 Nov 4.


title: Post Traumatic Stress Disorder and Neural Mechanisms Involved in Its Treatment

summary: The post traumatic stress disorder PTSD arises when the physiological response to stress does not come to its term. This study aims to explore the cognitive, psycho physiological and cerebral mechanisms involved in PTSD, in fear conditioning and face matching tasks, before and after treatment.PTSD patients will be recruited by Pr Jean-Claude Samuelian in his service at the Conception Hospital and by Pr Jean-Michel Azorin in his service at the Sainte Marguerite Hospital (Marseille) and will undergo either CBT or EMDR within those same services. The tasks they will be asked to perform will study the psycho physiological, cognitive and central mechanisms involved in PTSD and its treatment. All in all, 17 healthy controls will be recruited as well as 17 PTSD patients for each of the two treatment group.In terms of perspectives, this study would help isolate neural systems functionally involved in PTSD and its treatment. A better knowledge of those mechanisms would set room for the optimization of the current PTSD treatment.

primary_purpose: Basic Science


title: A Prospective, Randomized, Open-label, Multicenter Study Evaluating the Effects on Cognitive Functions of Adjuvant Endocrine Therapy in Postmenopausal Women With Breast Cancer.

summary:
RATIONALE: Estrogen can cause the growth of breast cancer cells. Aromatase inhibitors, such as letrozole, anastrozole, and exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. It is not yet known whether aromatase inhibitors or tamoxifen citrate have less effect on memory in patients receiving treatment for breast cancer.

PURPOSE: This randomized phase III trial is studying letrozole, anastrozole, or exemestane to see how they effect memory compared with tamoxifen citrate in treating postmenopausal women with breast cancer.


title: Multicenter Prospective Evaluation of a Predictive Test of Late Toxicities After Radiotherapy by the Rate of Radiation Induced CD8 T-Lymphocyte Apoptosis: Application to Breast and Prostate Cancers.

summary: The primary objective of this study is to evaluate the prediction of late toxicity by the radiation induced CD8 T-lymphocyte apoptosis

ReferenceCitation: Arriagada R, Mouriesse H, Sarrazin D, Clark RM, Deboer G. Radiotherapy alone in breast cancer. I. Analysis of tumor parameters, tumor dose and local control: the experience of the Gustave-Roussy Institute and the Princess Margaret Hospital. Int J Radiat Oncol Biol Phys. 1985 Oct;11(10):1751-7. doi: 10.1016/0360-3016(85)90027-6.

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: Bartelink H, Horiot JC, Poortmans P, Struikmans H, Van den Bogaert W, Barillot I, Fourquet A, Borger J, Jager J, Hoogenraad W, Collette L, Pierart M; European Organization for Research and Treatment of Cancer Radiotherapy and Breast Cancer Groups. Recurrence rates after treatment of breast cancer with standard radiotherapy with or without additional radiation. N Engl J Med. 2001 Nov 8;345(19):1378-87. doi: 10.1056/NEJMoa010874.

ReferenceCitation: Buchholz TA. Finding our sensitive patients. Int J Radiat Oncol Biol Phys. 1999 Oct 1;45(3):547-8. doi: 10.1016/s0360-3016(99)00255-2. No abstract available.

ReferenceCitation: Cesaretti JA, Stock RG, Lehrer S, Atencio DA, Bernstein JL, Stone NN, Wallenstein S, Green S, Loeb K, Kollmeier M, Smith M, Rosenstein BS. ATM sequence variants are predictive of adverse radiotherapy response among patients treated for prostate cancer. Int J Radiat Oncol Biol Phys. 2005 Jan 1;61(1):196-202. doi: 10.1016/j.ijrobp.2004.09.031.

ReferenceCitation: Crompton NE, Ozsahin M. A versatile and rapid assay of radiosensitivity of peripheral blood leukocytes based on DNA and surface-marker assessment of cytotoxicity. Radiat Res. 1997 Jan;147(1):55-60.

ReferenceCitation: Crompton NE, Shi YQ, Emery GC, Wisser L, Blattmann H, Maier A, Li L, Schindler D, Ozsahin H, Ozsahin M. Sources of variation in patient response to radiation treatment. Int J Radiat Oncol Biol Phys. 2001 Feb 1;49(2):547-54. doi: 10.1016/s0360-3016(00)01477-2.

ReferenceCitation: Delanian S, Balla-Mekias S, Lefaix JL. Striking regression of chronic radiotherapy damage in a clinical trial of combined pentoxifylline and tocopherol. J Clin Oncol. 1999 Oct;17(10):3283-90. doi: 10.1200/JCO.1999.17.10.3283.

ReferenceCitation: Delanian S, Porcher R, Balla-Mekias S, Lefaix JL. Randomized, placebo-controlled trial of combined pentoxifylline and tocopherol for regression of superficial radiation-induced fibrosis. J Clin Oncol. 2003 Jul 1;21(13):2545-50. doi: 10.1200/JCO.2003.06.064.

ReferenceCitation: Denis F, Garaud P, Bardet E, Alfonsi M, Sire C, Germain T, Bergerot P, Rhein B, Tortochaux J, Oudinot P, Calais G. Late toxicity results of the GORTEC 94-01 randomized trial comparing radiotherapy with concomitant radiochemotherapy for advanced-stage oropharynx carcinoma: comparison of LENT/SOMA, RTOG/EORTC, and NCI-CTC scoring systems. Int J Radiat Oncol Biol Phys. 2003 Jan 1;55(1):93-8. doi: 10.1016/s0360-3016(02)03819-1.

ReferenceCitation: Dewey WC, Ling CC, Meyn RE. Radiation-induced apoptosis: relevance to radiotherapy. Int J Radiat Oncol Biol Phys. 1995 Nov 1;33(4):781-96. doi: 10.1016/0360-3016(95)00214-8.

ReferenceCitation: Dubray B. [Late complications of radiotherapy. Role of the time factor]. Bull Cancer Radiother. 1995;82(2):98-100. No abstract available. French.

ReferenceCitation: Emami B, Lyman J, Brown A, Coia L, Goitein M, Munzenrider JE, Shank B, Solin LJ, Wesson M. Tolerance of normal tissue to therapeutic irradiation. Int J Radiat Oncol Biol Phys. 1991 May 15;21(1):109-22. doi: 10.1016/0360-3016(91)90171-y.

ReferenceCitation: Fine JP. Regression modeling of competing crude failure probabilities. Biostatistics. 2001 Mar;2(1):85-97. doi: 10.1093/biostatistics/2.1.85.

ReferenceCitation: Floyd DN, Cassoni AM. Intrinsic radiosensitivity of adult and cord blood lymphocytes as determined by the micronucleus assay. Eur J Cancer. 1994;30A(5):615-20. doi: 10.1016/0959-8049(94)90531-2.

ReferenceCitation: Hoeller U, Borgmann K, Bonacker M, Kuhlmey A, Bajrovic A, Jung H, Alberti W, Dikomey E. Individual radiosensitivity measured with lymphocytes may be used to predict the risk of fibrosis after radiotherapy for breast cancer. Radiother Oncol. 2003 Nov;69(2):137-44. doi: 10.1016/j.radonc.2003.10.001.

ReferenceCitation: Hsieh FY, Lavori PW. Sample-size calculations for the Cox proportional hazards regression model with nonbinary covariates. Control Clin Trials. 2000 Dec;21(6):552-60. doi: 10.1016/s0197-2456(00)00104-5.

ReferenceCitation: Iannuzzi CM, Atencio DP, Green S, Stock RG, Rosenstein BS. ATM mutations in female breast cancer patients predict for an increase in radiation-induced late effects. Int J Radiat Oncol Biol Phys. 2002 Mar 1;52(3):606-13. doi: 10.1016/s0360-3016(01)02684-0.

ReferenceCitation: Jacob R, Hanlon AL, Horwitz EM, Movsas B, Uzzo RG, Pollack A. Role of prostate dose escalation in patients with greater than 15% risk of pelvic lymph node involvement. Int J Radiat Oncol Biol Phys. 2005 Mar 1;61(3):695-701. doi: 10.1016/j.ijrobp.2004.06.023.

ReferenceCitation: Johansen J, Bentzen SM, Overgaard J, Overgaard M. Relationship between the in vitro radiosensitivity of skin fibroblasts and the expression of subcutaneous fibrosis, telangiectasia, and skin erythema after radiotherapy. Radiother Oncol. 1996 Aug;40(2):101-9. doi: 10.1016/0167-8140(96)01777-x.

ReferenceCitation: Kiltie AE, Ryan AJ, Swindell R, Barber JB, West CM, Magee B, Hendry JH. A correlation between residual radiation-induced DNA double-strand breaks in cultured fibroblasts and late radiotherapy reactions in breast cancer patients. Radiother Oncol. 1999 Apr;51(1):55-65. doi: 10.1016/s0167-8140(99)00030-4.

ReferenceCitation: Lartigau E, Dubray B, Mornex F. [Biological mechanisms of late effects of ionizing radiations]. Cancer Radiother. 1997;1(6):669-76. doi: 10.1016/s1278-3218(97)82943-5. French.

ReferenceCitation: Latouche A, Porcher R, Chevret S. Sample size formula for proportional hazards modelling of competing risks. Stat Med. 2004 Nov 15;23(21):3263-74. doi: 10.1002/sim.1915.

ReferenceCitation: Ozsahin M, Ozsahin H, Shi Y, Larsson B, Wurgler FE, Crompton NE. Rapid assay of intrinsic radiosensitivity based on apoptosis in human CD4 and CD8 T-lymphocytes. Int J Radiat Oncol Biol Phys. 1997 May 1;38(2):429-40. doi: 10.1016/s0360-3016(97)00038-2.

ReferenceCitation: Pepe MS, Mori M. Kaplan-Meier, marginal or conditional probability curves in summarizing competing risks failure time data? Stat Med. 1993 Apr 30;12(8):737-51. doi: 10.1002/sim.4780120803.

ReferenceCitation: Pollack A, Smith LG, von Eschenbach AC. External beam radiotherapy dose response characteristics of 1127 men with prostate cancer treated in the PSA era. Int J Radiat Oncol Biol Phys. 2000 Sep 1;48(2):507-12. doi: 10.1016/s0360-3016(00)00620-9.

ReferenceCitation: Pollack A, Zagars GK, Smith LG, Lee JJ, von Eschenbach AC, Antolak JA, Starkschall G, Rosen I. Preliminary results of a randomized radiotherapy dose-escalation study comparing 70 Gy with 78 Gy for prostate cancer. J Clin Oncol. 2000 Dec 1;18(23):3904-11. doi: 10.1200/JCO.2000.18.23.3904.

ReferenceCitation: Radford IR, Murphy TK. Radiation response of mouse lymphoid and myeloid cell lines. Part III. Different signals can lead to apoptosis and may influence sensitivity to killing by DNA double-strand breakage. Int J Radiat Biol. 1994 Feb;65(2):229-39. doi: 10.1080/09553009414550261.

ReferenceCitation: Romestaing P, Lehingue Y, Carrie C, Coquard R, Montbarbon X, Ardiet JM, Mamelle N, Gerard JP. Role of a 10-Gy boost in the conservative treatment of early breast cancer: results of a randomized clinical trial in Lyon, France. J Clin Oncol. 1997 Mar;15(3):963-8. doi: 10.1200/JCO.1997.15.3.963.

ReferenceCitation: Slonina D, Gasinska A. Intrinsic radiosensitivity of healthy donors and cancer patients as determined by the lymphocyte micronucleus assay. Int J Radiat Biol. 1997 Dec;72(6):693-701. doi: 10.1080/095530097142852.

ReferenceCitation: Stone HB, Coleman CN, Anscher MS, McBride WH. Effects of radiation on normal tissue: consequences and mechanisms. Lancet Oncol. 2003 Sep;4(9):529-36. doi: 10.1016/s1470-2045(03)01191-4.

ReferenceCitation: Thames HD, Hendry JH, Moore JV, Ang KK, Travis EL. The high steepness of dose-response curves for late-responding normal tissues. Radiother Oncol. 1989 May;15(1):49-53. doi: 10.1016/0167-8140(89)90117-5.

ReferenceCitation: Trotti A, Byhardt R, Stetz J, Gwede C, Corn B, Fu K, Gunderson L, McCormick B, Morrisintegral M, Rich T, Shipley W, Curran W. Common toxicity criteria: version 2.0. an improved reference for grading the acute effects of cancer treatment: impact on radiotherapy. Int J Radiat Oncol Biol Phys. 2000 Apr 1;47(1):13-47. doi: 10.1016/s0360-3016(99)00559-3.

ReferenceCitation: Trotti A, Colevas AD, Setser A, Rusch V, Jaques D, Budach V, Langer C, Murphy B, Cumberlin R, Coleman CN, Rubin P. CTCAE v3.0: development of a comprehensive grading system for the adverse effects of cancer treatment. Semin Radiat Oncol. 2003 Jul;13(3):176-81. doi: 10.1016/S1053-4296(03)00031-6.

ReferenceCitation: TROWELL OA. The sensitivity of lymphocytes to ionising radiation. J Pathol Bacteriol. 1952 Oct;64(4):687-704. doi: 10.1002/path.1700640403. No abstract available.

ReferenceCitation: Withers HR, Taylor JM, Maciejewski B. Treatment volume and tissue tolerance. Int J Radiat Oncol Biol Phys. 1988 Apr;14(4):751-9. doi: 10.1016/0360-3016(88)90098-3.

ReferenceCitation: Zelefsky MJ, Fuks Z, Hunt M, Yamada Y, Marion C, Ling CC, Amols H, Venkatraman ES, Leibel SA. High-dose intensity modulated radiation therapy for prostate cancer: early toxicity and biochemical outcome in 772 patients. Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):1111-6. doi: 10.1016/s0360-3016(02)02857-2.

ReferenceCitation: Azria D, Riou O, Castan F, Nguyen TD, Peignaux K, Lemanski C, Lagrange JL, Kirova Y, Lartigau E, Belkacemi Y, Bourgier C, Rivera S, Noel G, Clippe S, Mornex F, Hennequin C, Kramar A, Gourgou S, Pelegrin A, Fenoglietto P, Ozsahin EM. Radiation-induced CD8 T-lymphocyte Apoptosis as a Predictor of Breast Fibrosis After Radiotherapy: Results of the Prospective Multicenter French Trial. EBioMedicine. 2015 Oct 25;2(12):1965-73. doi: 10.1016/j.ebiom.2015.10.024. eCollection 2015 Dec.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: Université de Lausanne - SERVAL

repositories:
HAL
PubMed Central
serval.unil.ch

repositories_concat: HAL;PubMed Central;serval.unil.ch

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

unpaywall_oa_status: gold

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


title: Evaluation of Procedure Tuna Within the Framework of a Hospitalization of Short Duration

acronym: EPURE

summary: The TUNA is a known and already old technique. There exists, in the literature, a certain number of studies showing the long-term effectiveness (5 years), evaluated on the IPS and the flow mictional.This effectiveness is slightly lower than that of the endoscopic resection of prostate. This technique does not present the disadvantages of the surgery prostate sufferer on ejaculation. Moreover, it can be carried out in short hospitalization or ambulatory as it is the case in particular in the States Unis. The aim of the study which will be led by the AP-HP will be thus to test the feasibility of the TUNA during a hospitalization of less 24 hours.


title: "Body Composition Assessment in Healthy Full-term Neonates by Anthropometry, Air Displacement Plethysmography (PeaPod) and Multiple-frequency Bio-impedance Analysis (BIA)"

summary:
Low birth weight and prematurity are associated with adverse metabolic outcome in adult life. Yet it remains to be determined whether this outcome is the consequence of the low birth weight per se, or of the catch up growth achieved in Neonatology units using an early, 'aggressive' nutritional management. As a matter of fact, 'aggressive' nutrition may promote fat mass, rather than lean body mass accretion. Assessment of body composition therefore is key to evaluate the efficacy of the nutritional management of these infants. Scarce data is, however, available in the literature about the body composition of healthy full-term neonates in the first few days of life.

The aim of this study is to:

Evaluate the feasibility and reproducibility of a safe and non invasive method of measurement of infant body composition by Air Displacement Plethysmography (PeaPod). Anthropometry and BIA will be used as the reference techniques to assess the accuracy of the PeaPod
Describe the body composition (fat mass, fat free mass) of healthy full-term neonates in the first few weeks of life
Obtain data on the total body water content of healthy full term infants from BIA.

lead_sponsor: Nantes University Hospital


title: Les Cartes Sensori-motrices De La Parole : Corrélats Neuroanatomiques Des Systèmes De Perception Et De Production Des Voyelles Du Français

acronym: SPIM

summary: Speech develops through a co-structuring of auditory and motor representations, especially in the first years of life during language acquisition. In the present study, we will test by means of functional magnetic resonance imaging whether vowel perception and production might depend on a coordination of auditory and motor, articulatory, cortical maps. The outcome of this study will lead to a better understanding of whether both vowel perception and production are processed in the human brain and will provide important insight into brain-language relationships. Besides new theoretical perspectives on speech perception and production, this project might raise important questions concerning patients with speech disorders by identifying which aspects of speech perception and production are functionally linked.

lead_sponsor: University Hospital, Grenoble


title: Evaluation of Hepatic Mitochondrial Function in Sepsis

summary:
Multi-organ failure due to sepsis is a major cause of death in critically ill patients. But the mechanisms leading to this condition are not fully understood. Mitochondrial dysfunction has been shown in skeletal muscle of critically ill septic patients. Liver is very important in sepsis as it is responsible of the synthesis of several inflammatory proteins. Moreover hepatic failure is associated to a bad outcome.

The aim of this study is to evaluate the hepatic mitochondrial function in sepsis.

study_start_date_type: Anticipated

status: Withdrawn

ReferenceCitation: Brealey D, Brand M, Hargreaves I, Heales S, Land J, Smolenski R, Davies NA, Cooper CE, Singer M. Association between mitochondrial dysfunction and severity and outcome of septic shock. Lancet. 2002 Jul 20;360(9328):219-23. doi: 10.1016/S0140-6736(02)09459-X.

ReferenceCitation: Fredriksson K, Hammarqvist F, Strigard K, Hultenby K, Ljungqvist O, Wernerman J, Rooyackers O. Derangements in mitochondrial metabolism in intercostal and leg muscle of critically ill patients with sepsis-induced multiple organ failure. Am J Physiol Endocrinol Metab. 2006 Nov;291(5):E1044-50. doi: 10.1152/ajpendo.00218.2006. Epub 2006 Jun 27. Erratum In: Am J Physiol Endocrinol Metab. 2007 Apr;292(4):E1240.

lead_sponsor: Professor C ICHAI


title: Evaluation of Oxidative Stress After Out of Hospital Cardiac Arrest Treated With Moderate Hypothermia

summary:
Cardiac arrest is a major health problem reaching 375000 cases in Europe each year. Only 5 to 31 % survive after an out of hospital cardiac arrest (OHCA). The main complication after OHCA is the anoxic encephalopathy. Recently mild hypothermia has shown a beneficial effect on survival. But the mechanisms underlying these therapy are not clear.

Cardiac arrest is an example of ischemia reperfusion of the entire body. And it is well demonstrated that reperfusion generates an oxidative stress. But it has never been shown in a clinical setting.

The aim of the study is to evaluate oxidative stress after out of hospital cardiac arrest treated with mild hypothermia.

lead_sponsor: Institut d'Anesthesiologie des Alpes Maritimes


title: Effect of Deep Brain Stimulation of the Hypothalamus/ Fornix on Memory Impairment in Patients With Alzheimer's Disease

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

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

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

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility: CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez


title: Fatty Liver and Ectopic Fat in Overweight and Obese Patients

summary: The aim of the study is to find new clinico-biological and medical imaging parameters associated with non alcoholic steatohepatitis in overweight and obese patients.

primary_purpose: Diagnostic

sponsor_collaborators: Centre Hospitalier Universitaire de Nice

location_facility: Hepatogastroenterology, Hôpital l'Archet, CHU de Nice


title: Intra-arrest Therapeutic Hypothermia in Prehospital Cardiac Arrest. Impact on Biomarker of Brain Damage.

acronym: HITUPPAC-BIO

summary: The aim is to precise the place of therapeutic hypothermia induced before Return of Spontaneous Circulation (ROSC) in pre hospital cardiac arrest. If we find a benefit in terms of biomarkers in inducing in early hypothermia compared to hypothermia induced only after arrival at the hospital, there will be arguments to develop a higher scale study, allowing to prove benefits in terms of survival and neurological status.

ReferenceCitation: Ferreira Da Silva IR, Frontera JA. Targeted temperature management in survivors of cardiac arrest. Cardiol Clin. 2013 Nov;31(4):637-55, ix. doi: 10.1016/j.ccl.2013.07.010.


title: Phase I Study of Gemcitabine, Capecitabine, and Erlotinib Together in Advanced Pancreatic Cancers

summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine given together with capecitabine and erlotinib in treating patients with advanced pancreatic cancer.


title: Characterization and Research of Predictive Markers of Neurotoxicity During Treatment With Oxaliplatin in Colorectal Carcinoma: a Genetic and Proteomic Approach. Phase II Multicenter Study

summary:
RATIONALE: Studying samples of blood in the laboratory from patients receiving oxaliplatin for cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to neurotoxicity.

PURPOSE: This phase II trial is studying biomarkers in predicting neurotoxicity in patients with colorectal cancer receiving oxaliplatin.

lead_sponsor: Institut Cancerologie de l'Ouest


title: Subclavian Vein Ultrasound Guided Cannulation in Adult: Transversal and Longitudinal Approach Comparison

acronym: CATETEL

summary: There is actually two techniques of subclavian vein ultrasonography-guided venous catheterization : the axial and longitudinal approach. Currently, nothing makes it possible to privilege one technique compared to the other. This study aims to determine the best ultrasonography-guided method.

ReferenceCitation: Taylor RW, Palagiri AV. Central venous catheterization. Crit Care Med. 2007 May;35(5):1390-6. doi: 10.1097/01.CCM.0000260241.80346.1B.

ReferenceCitation: Forestier F, Rossi H, Calderon J, Soubiron L, Bourdarias B, Janvier G. [Training for adult subclavian venous catheterization: use of real-time echography]. Ann Fr Anesth Reanim. 2002 Nov;21(9):698-702. doi: 10.1016/s0750-7658(02)00778-5. French.

ReferenceCitation: Brooks AJ, Alfredson M, Pettigrew B, Morris DL. Ultrasound-guided insertion of subclavian venous access ports. Ann R Coll Surg Engl. 2005 Jan;87(1):25-7. doi: 10.1308/1478708051441.


title: XERES Trial: Clinical Evaluation of Patients With Everolimus-eluting Stent " Xience V® " Implanted in the Treatment of Restenosis in Non-coated Metallic Stent (BMS In-stent Restenosis) During a 2 Year Clinical Follow-up Period

acronym: XERES

summary: Interventional, prospective, non-randomized, non-comparative, open and multicentric study of patients with everolimus-eluting stent " Xience V® " implanted in the treatment of restenosis in non-coated metallic stent (BMS in-stent restenosis) during a 2 year clinical follow-up period.

lead_sponsor: Abbott Medical Devices


title: Comparison of Performance of Three Laryngoscope Blades: Plastic Single Use, Metallic Single Use and Metallic Reusable Blades.

acronym: Laryngotest

summary: The purpose of this study is to determinate if there is a difference in performance provided by three laryngoscope blades: plastic single use, metallic single use and metallic reusable blades.

ReferenceCitation: Buleon C, Parienti JJ, Lesage A, Grandin W, Pouliquen E, Flais F, Simonet T, Gerard JL, Hanouz JL. Comparison of plastic and metallic single-use and metallic reusable laryngoscope blades: a randomised controlled trial. Eur J Anaesthesiol. 2013 Apr;30(4):163-9. doi: 10.1097/EJA.0b013e32835c1cdb.

publisher_dissemination: Wolters Kluwer Health


title: Renal MR Elastography: Normal Findings and Variability of Stiffness Measurements

summary:
MR Elastography is a new technique aimed at non-invasively measuring the stiffness of tissues. It has recently given interesting results in the assessment of liver fibrosis.

The objectives of the current study are:

to develop an imaging protocol for MR Elastography of the kidneys;
To calculate the stiffness of normal kidneys;
To evaluate the variability of the measurements of kidney stiffness by repeating the procedure twice on the same volunteers.

ReferenceCitation: Rouviere O, Souchon R, Pagnoux G, Menager JM, Chapelon JY. Magnetic resonance elastography of the kidneys: feasibility and reproducibility in young healthy adults. J Magn Reson Imaging. 2011 Oct;34(4):880-6. doi: 10.1002/jmri.22670. Epub 2011 Jul 18.

lead_sponsor: Hospices Civils de Lyon

location_facility: Department of Urinary an Vascular Radiology, Hôpital E. Herriot


acronym: AACER

summary:
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy together with radiation therapy and cetuximab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well chemotherapy given together with radiation therapy and cetuximab works in treating patients with head and neck cancer.

title: Phase II Study Evaluating Radiotherapy-chemotherapy and Cetuximab in Patients With Histologically Proven Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, Hypopharynx, or Larynx and With a Poor Prognosis After Complete Surgical Resection

source: euctr


title: Comparing Effectiveness of Oxygen Supplementation From a Portable Concentrator and a Liquid Oxygen Source During Walking Test in COPD Patients With Respiratory Failure

summary: The purpose of this study is to compare differences in oxygen delivery between portable oxygen concentrators (POCs) and liquid oxygen (LOs) portable units, pose a question if POCs are equally effective as LOs in reducing exercise-induced hypoxaemia. DESIGN: Randomized, single-blind clinical trial.

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

location_facility: Service de Pneumologie et Allergologie- Hôpital le Cluzeau. 23 av. D. Larrey


title: Intermittent Theta Burst Stimulation (iTBS) for the Treatment of Negative Symptoms in Schizophrenia

summary: The purpose of this study is to determine whether the iTBS is an effective treatment of the negative symptoms of schizophrenia.

lead_sponsor: Hôpital le Vinatier


summary:
Context. Nuclear imaging plays a central role in management of chromaffin-tissue derived tumors because tumor cells exhibit peptide receptors and proteins involved in metabolism that can be targeted with specific radiopharmaceutics. Recently, over expression dopamine-receptor D2 isoforms has been found in endocrine tumors.

Objective. The aim of the present study is to evaluate the feasibility of 123I-IBZM (a D2 agonist radiolabelled with 123I) in patients with PHEO and/or PGL. Diagnostic accuracy will be also compared to traditional SPECT imaging procedures.

ReferenceCitation: Saveanu A, Sebag F, Guillet B, Archange C, Essamet W, Barlier A, Palazzo FF, Taieb D. Targeting dopamine receptors subtype 2 (D2DR) in pheochromocytomas: head-to-head comparison between in vitro and in vivo findings. J Clin Endocrinol Metab. 2013 Dec;98(12):E1951-5. doi: 10.1210/jc.2013-2269. Epub 2013 Sep 5.

evidence: open (via free pdf)

publisher_dissemination: The Endocrine Society


title: Phase II Randomized Multicenter Study Comparing Brain Radiation in Combination With Temozolomide or Radiation Alone in Patients With Brain Metastases From Breast Cancer

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given alone or together with temozolomide in treating brain metastases secondary to breast cancer.

PURPOSE: This randomized phase II trial is studying how well radiation therapy given together with temozolomide works compared with radiation therapy given alone in treating women with brain metastases and breast cancer.

ReferenceCitation: Cao KI, Lebas N, Gerber S, Levy C, Le Scodan R, Bourgier C, Pierga JY, Gobillion A, Savignoni A, Kirova YM. Phase II randomized study of whole-brain radiation therapy with or without concurrent temozolomide for brain metastases from breast cancer. Ann Oncol. 2015 Jan;26(1):89-94. doi: 10.1093/annonc/mdu488. Epub 2014 Oct 29.

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

unpaywall_oa_status: hybrid


title: A Psoriasis Plaque Test Comparing LEO 29102 Cream and Its Different Combinations to Daivobet® Ointment and a Vehicle Control for the Treatment of Psoriasis Vulgaris

summary: The purpose of this trial is to evaluate the anti-psoriatic effect of LEO 29102 cream and its combination with calcipotriol and betamethasone using a psoriasis plaque test method.

primary_purpose: Other

lead_sponsor: LEO Pharma


title: Efficacy and Safety of Ethanol Lock Solution in Prevention of Catheter Related Bloodstream Infection for Patients Suffering Acute Renal Failure, and Hospitalized in Intensive Care Unit. A Multi-Center, Randomized, Versus Placebo, Double Blinded Clinical Trial.

acronym: ELVIS

summary: The primary objective of the study is to demonstrate the efficacy of 60% ethanol lock solution in preventing major catheter related infections in critically ill patients.

ReferenceCitation: Iachkine J, Buetti N, de Grooth HJ, Briant AR, Mimoz O, Megarbane B, Mira JP, Ruckly S, Souweine B, du Cheyron D, Mermel LA, Timsit JF, Parienti JJ. Development and validation of a multivariable prediction model of central venous catheter-tip colonization in a cohort of five randomized trials. Crit Care. 2022 Jul 7;26(1):205. doi: 10.1186/s13054-022-04078-x.

license: cc-by

license_normalized: cc-by

repository_institution: University of Geneva - Archive ouverte UNIGE

repositories_concat: PubMed Central;unige.ch

publisher_dissemination: Springer-Nature

ReferenceCitation: Almeida BM, Moreno DH, Vasconcelos V, Cacione DG. Interventions for treating catheter-related bloodstream infections in people receiving maintenance haemodialysis. Cochrane Database Syst Rev. 2022 Apr 1;4(4):CD013554. doi: 10.1002/14651858.CD013554.pub2.

ReferenceCitation: Boyer A, Timsit JF, Klouche K, Canet E, Phan TN, Bohe J, Rubin S, Orieux A, Lautrette A, Gruson D, Souweine B. Aminoglycosides in Critically Ill Septic Patients With Acute Kidney Injury Receiving Continuous Renal Replacement Therapy: A Multicenter, Observational Study. Clin Ther. 2021 Jun;43(6):1116-1124. doi: 10.1016/j.clinthera.2021.04.011. Epub 2021 May 24.

version: submittedVersion

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

ReferenceCitation: Souweine B, Lautrette A, Gruson D, Canet E, Klouche K, Argaud L, Bohe J, Garrouste-Orgeas M, Mariat C, Vincent F, Cayot S, Cointault O, Lepape A, Guelon D, Darmon M, Vesin A, Caillot N, Schwebel C, Boyer A, Azoulay E, Bouadma L, Timsit JF. Ethanol lock and risk of hemodialysis catheter infection in critically ill patients. A randomized controlled trial. Am J Respir Crit Care Med. 2015 May 1;191(9):1024-32. doi: 10.1164/rccm.201408-1431OC.

publisher_dissemination: American Thoracic Society

lead_sponsor: University Hospital, Clermont-Ferrand


title: Research Factors Predictive of Treatment Failure With Erythropoietin Beta (NeoRecormon®) in Patients With Solid Tumors Treated With Chemotherapy

acronym: PLATON

summary:
RATIONALE: Epoetin beta may cause the body to make more red blood cells and may prevent or reduce side effects in patients undergoing chemotherapy for solid tumors.

PURPOSE: This clinical trial is studying how well epoetin beta works in patients undergoing chemotherapy for solid tumors.

ReferenceCitation: Beguin Y. Prediction of response to treatment with recombinant human erythropoietin in anaemia associated with cancer. Med Oncol. 1998 Aug;15 Suppl 1:S38-46.

ReferenceCitation: Bokemeyer C, Aapro MS, Courdi A, Foubert J, Link H, Osterborg A, Repetto L, Soubeyran P. EORTC guidelines for the use of erythropoietic proteins in anaemic patients with cancer. Eur J Cancer. 2004 Oct;40(15):2201-16. doi: 10.1016/j.ejca.2004.07.015.

ReferenceCitation: Bonomi AE, Cella DF, Hahn EA, Bjordal K, Sperner-Unterweger B, Gangeri L, Bergman B, Willems-Groot J, Hanquet P, Zittoun R. Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system. Qual Life Res. 1996 Jun;5(3):309-20. doi: 10.1007/BF00433915.

ReferenceCitation: Cella D. The Functional Assessment of Cancer Therapy-Anemia (FACT-An) Scale: a new tool for the assessment of outcomes in cancer anemia and fatigue. Semin Hematol. 1997 Jul;34(3 Suppl 2):13-9.

ReferenceCitation: Curt GA, Breitbart W, Cella D, Groopman JE, Horning SJ, Itri LM, Johnson DH, Miaskowski C, Scherr SL, Portenoy RK, Vogelzang NJ. Impact of cancer-related fatigue on the lives of patients: new findings from the Fatigue Coalition. Oncologist. 2000;5(5):353-60. doi: 10.1634/theoncologist.5-5-353.

ReferenceCitation: Del Mastro L, Gennari A, Donati S. Chemotherapy of non-small-cell lung cancer: role of erythropoietin in the management of anemia. Ann Oncol. 1999;10 Suppl 5:S91-4. doi: 10.1093/annonc/10.suppl_5.s91.

ReferenceCitation: Demetri GD, Kris M, Wade J, Degos L, Cella D. Quality-of-life benefit in chemotherapy patients treated with epoetin alfa is independent of disease response or tumor type: results from a prospective community oncology study. Procrit Study Group. J Clin Oncol. 1998 Oct;16(10):3412-25. doi: 10.1200/JCO.1998.16.10.3412.

ReferenceCitation: Glaspy J, Bukowski R, Steinberg D, Taylor C, Tchekmedyian S, Vadhan-Raj S. Impact of therapy with epoetin alfa on clinical outcomes in patients with nonmyeloid malignancies during cancer chemotherapy in community oncology practice. Procrit Study Group. J Clin Oncol. 1997 Mar;15(3):1218-34. doi: 10.1200/JCO.1997.15.3.1218.

ReferenceCitation: Groopman JE, Itri LM. Chemotherapy-induced anemia in adults: incidence and treatment. J Natl Cancer Inst. 1999 Oct 6;91(19):1616-34. doi: 10.1093/jnci/91.19.1616. Erratum In: J Natl Cancer Inst 2000 Mar 15;92(6):497.

ReferenceCitation: Littlewood TJ. The impact of hemoglobin levels on treatment outcomes in patients with cancer. Semin Oncol. 2001 Apr;28(2 Suppl 8):49-53. doi: 10.1016/s0093-7754(01)90213-1.

ReferenceCitation: Bokemeyer C, Aapro MS, Courdi A, Foubert J, Link H, Osterborg A, Repetto L, Soubeyran P; European Organisation for Research and Treatment of Cancer (EORTC) Taskforce for the Elderly. EORTC guidelines for the use of erythropoietic proteins in anaemic patients with cancer: 2006 update. Eur J Cancer. 2007 Jan;43(2):258-70. doi: 10.1016/j.ejca.2006.10.014. Epub 2006 Dec 19.

ReferenceCitation: Aapro M, Coiffier B, Dunst J, Osterborg A, Burger HU. Effect of treatment with epoetin beta on short-term tumour progression and survival in anaemic patients with cancer: A meta-analysis. Br J Cancer. 2006 Dec 4;95(11):1467-73. doi: 10.1038/sj.bjc.6603481. Epub 2006 Nov 21.

ReferenceCitation: Oberhoff C. Speed of haemoglobin response in patients with cancer: a review of the erythropoietic proteins. Support Care Cancer. 2007 Jun;15(6):603-611. doi: 10.1007/s00520-006-0191-x. Epub 2007 Feb 3.

ReferenceCitation: Pujade-Lauraine E, Topham C. Once-weekly treatment of anemia in patients with cancer: a comparative review of epoetins. Oncology. 2005;68(2-3):122-9. doi: 10.1159/000086957. Epub 2005 Jul 7.

ReferenceCitation: Veys N, Dhondt A, Lameire N. Pain at the injection site of subcutaneously administered erythropoietin: phosphate-buffered epoetin alpha compared to citrate-buffered epoetin alpha and epoetin beta. Clin Nephrol. 1998 Jan;49(1):41-4.

ReferenceCitation: Thomas ML. Impact of anemia and fatigue on quality of life in cancer patients: a brief review. Med Oncol. 1998 Aug;15 Suppl 1:S3-7.

ReferenceCitation: Vogelzang NJ, Breitbart W, Cella D, Curt GA, Groopman JE, Horning SJ, Itri LM, Johnson DH, Scherr SL, Portenoy RK. Patient, caregiver, and oncologist perceptions of cancer-related fatigue: results of a tripart assessment survey. The Fatigue Coalition. Semin Hematol. 1997 Jul;34(3 Suppl 2):4-12.

ReferenceCitation: Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997 Feb;13(2):63-74. doi: 10.1016/s0885-3924(96)00274-6.

ReferenceCitation: Harrell FE Jr, Lee KL, Mark DB. Multivariable prognostic models: issues in developing models, evaluating assumptions and adequacy, and measuring and reducing errors. Stat Med. 1996 Feb 28;15(4):361-87. doi: 10.1002/(SICI)1097-0258(19960229)15:43.0.CO;2-4.

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


title: Study of Ocular Blood Flow Using Laser Doppler Flowmetry in Patients With Glaucoma and/or OSAS

summary:
Obstructive sleep apnea syndrome (OSAS) is a common disease, with a prevalence evaluated between 5 - 7% in the general population. OSAS is characterized by recurrent episodes of partial or complete upper airway obstruction during sleep, which are nearly systematically associated with a desaturation-reoxygenation sequence, an admitted detrimental stimulus for the cardiovascular system. It has now been demonstrated that OSAS per se is able to generate hypertension, atherosclerosis and autonomic dysfunction (high sympathic tone and increase in baseline heart rate), all conditions possibly interacting with ocular vascular regulation. OSAS has major consequences on the ocular level since it is associated with a higher frequency of optic neuropathies, such as glaucoma and nonarteritic ischemic optic neuropathy (NAION), both with functional severe prognosis. Most of vascular changes associated with OSAS have been studied at the level of macrovasculature. In terms of physiopathology, the main effects on the vascular system in OSAS are sympathetic hyperactivity, oxidative stress, development of endothelial dysfunction, systemic inflammation and metabolic alterations such as the appearance of insulin resistance. All these mechanisms can affect the microcirculation of the eye, especially the optic nerve and choroid. Our hypothesis is that the eye microvasculature is affected by OSAS, and these lesions may be detected via a reduced autoregulation of blood flow in humans.

This project aims to demonstrate, quantify, and analyze the vascular modifications of the eye associated with OSAS trough a comparative clinical study on glaucoma patients and OSAS patients and matched healthy subjects for the regulation of the eye blood flow using confocal laser Doppler flowmetry (LDF). The regulation of the ocular blood flow will be assessed using several stimuli and measured using a new confocal LDF.

ReferenceCitation: Chiquet C, Lacharme T, Riva C, Almanjoumi A, Aptel F, Khayi H, Arnol N, Romanet JP, Geiser M. Continuous response of optic nerve head blood flow to increase of arterial blood pressure in humans. Invest Ophthalmol Vis Sci. 2014 Jan 23;55(1):485-91. doi: 10.1167/iovs.13-12975.

publisher_dissemination: Association for Research in Vision and Ophthalmology (ARVO)

ReferenceCitation: Khayi H, Pepin JL, Geiser MH, Tonini M, Tamisier R, Renard E, Baguet JP, Levy P, Romanet JP, Chiquet C. Choroidal blood flow regulation after posture change or isometric exercise in men with obstructive sleep apnea syndrome. Invest Ophthalmol Vis Sci. 2011 Dec 16;52(13):9489-96. doi: 10.1167/iovs.11-7936.


title: Phase II Multicenter Stratified Study Evaluating the Efficacy and Toxicity of Sorafenib in Treating Locally Advanced or Metastatic Angiosarcomas That Are Not Accessible to Curative Surgery

summary:
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with angiosarcoma that is locally advanced, metastatic, or unable to be removed by surgery.

ReferenceCitation: Penel N, Ray-Coquard I, Bal-Mahieu C, Chevreau C, Le Cesne A, Italiano A, Bompas E, Clisant S, Baldeyrou B, Lansiaux A, Robin YM, Bay JO, Piperno-Neumann S, Blay JY, Fournier C. Low level of baseline circulating VEGF-A is associated with better outcome in patients with vascular sarcomas receiving sorafenib: an ancillary study from a phase II trial. Target Oncol. 2014 Sep;9(3):273-7. doi: 10.1007/s11523-013-0299-0. Epub 2013 Nov 12.

publisher_dissemination: Springer

ReferenceCitation: Valentin T, Fournier C, Penel N, Bompas E, Chaigneau L, Isambert N, Chevreau C. Sorafenib in patients with progressive malignant solitary fibrous tumors: a subgroup analysis from a phase II study of the French Sarcoma Group (GSF/GETO). Invest New Drugs. 2013 Dec;31(6):1626-7. doi: 10.1007/s10637-013-0023-z. Epub 2013 Sep 5.

ReferenceCitation: Ray-Coquard I, Italiano A, Bompas E, Le Cesne A, Robin YM, Chevreau C, Bay JO, Bousquet G, Piperno-Neumann S, Isambert N, Lemaitre L, Fournier C, Gauthier E, Collard O, Cupissol D, Clisant S, Blay JY, Penel N; French Sarcoma Group (GSF/GETO). Sorafenib for patients with advanced angiosarcoma: a phase II Trial from the French Sarcoma Group (GSF/GETO). Oncologist. 2012;17(2):260-6. doi: 10.1634/theoncologist.2011-0237. Epub 2012 Jan 27.

lead_sponsor: Centre Oscar Lambret


title: Sublingual Milk Immunotherapy in Children With IgE-mediated Cow Milk Protein Allergy

acronym: Lactaide

summary: Sublingual immunotherapy is developing in the treatment of aeroallergens allergy. The hypothesis is that such process may be applied to food allergy, more precisely to milk. A previous series of 8 patients indicates the likely effectiveness of this technique (Allergy, 2006).

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
ESPCI Paris


title: Ductal Carcinoma in Situ: Protocol Evaluating the Assessment of Extension of Disease by MRI

summary:
RATIONALE: Diagnostic procedures, such as MRI, may help find ductal carcinoma in situ and find out how far the disease has spread.

PURPOSE: This clinical trial is studying how well MRI works in assessing tumor size in women with ductal carcinoma in situ.

lead_sponsor: Centre Antoine Lacassagne


title: New Analgesic Strategy Combining Nitrous Oxide, Nefopam, Acetaminophen and Morphine Compared to the Usal Antalgic Strategy (Acetaminophen and Morphine) for the Treatment of Acute Sickle Cell Disease Pain in the Emergency Room

acronym: DREPANOX

summary:
Quality of life of adult patients with sickle cell disease is deeply impaired by severe adverse medical events that inadvertently occur throughout their time life. Indeed, patients not presenting a life threatening condition often present to the emergency department with sickle cell disease crisis related pain. Currently, the effectiveness of specific analgesic strategies for treating sickle cell disease crisis related pain are mostly based on acetaminophen and opioid derivates combination along with oxygen delivery. Those strategies are effective but may last up to half an hour to obtain pain relief. This delay mostly depends on the availability of venous access and on individual patient response to treatment. Nitrous oxide is a volatile efficient analgesic therapy that has been repeatedly shown to allow rapid analgesia in the emergency department setting.

The investigators hypothesise that a new analgesic strategy (rapid optimized analgesic strategy) including nitrous oxide and nefopam would be as safe and more rapidly effective than current analgesic strategy.

location_facility: Henri Mondor Hospital, Emergency Department


title: Influence of Protein Hydrolysis on Dietary Protein Digestibility and Metabolism in Healthy Subjects

summary: Hydrolysis of dietary protein may impact their gastrointestinal kinetics and further metabolism. The primary goal of this work was to measure the metabolic fate of intact or hydrolyzed protein using a protein of good nutritional quality, i.e., casein. A second aim of this study was to assess the true ileal digestibility of dietary protein using different methods including the hydrolyzed casein method and to measure its possible effect on endogenous intestinal N losses in humans.

ReferenceCitation: Deglaire A, Moughan PJ, Airinei G, Benamouzig R, Tome D. Intact and hydrolyzed casein lead to similar ileal endogenous protein and amino acid flows in adult humans. Am J Clin Nutr. 2020 Jan 1;111(1):90-97. doi: 10.1093/ajcn/nqz268.

ReferenceCitation: Deglaire A, Fromentin C, Fouillet H, Airinei G, Gaudichon C, Boutry C, Benamouzig R, Moughan PJ, Tome D, Bos C. Hydrolyzed dietary casein as compared with the intact protein reduces postprandial peripheral, but not whole-body, uptake of nitrogen in humans. Am J Clin Nutr. 2009 Oct;90(4):1011-22. doi: 10.3945/ajcn.2009.27548. Epub 2009 Aug 19.

lead_sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement


title: Assessment of the Prevalence and Mutational Spectrum of Genes AHI1, NPHP1 and CEP290 in Joubert Syndrome and Cerebello-oculo-renal Syndromes

acronym: JSCORS

summary:
Primary objective:

assessment of the prevalence of AHI1 mutations in Joubert syndrome and cerebello-oculo-renal syndromes (JS/CORS)

Secondary objective:

assessment of the prevalence of CEP290 mutations and NPHP1 homozygous deletions in JS/CORS
caracterization of mutational spectrum of AHI1, NPHP1, CEP290 genes in JS/CORS.
evaluation of genotype-phenotype correlation in JS/CORS.

intervention_type: Biological


title: Molecular Study of Factors Involved in JAK-STAT Signalling Pathway in Familial Myeloproliferative Disorders

acronym: SMP

summary: The main goal of the study is to progress in our understanding of the molecular basis of myeloproliferative disorders of the bone marrow (polycythemia vera, essential thrombocythemia, primary myelofibrosis). The study will focus on the genes encoding factors implicated in the JAK-STAT pathway which has an essential role in these diseases

location_facility: Department of Hematology, Hospital Saint Antoine


title: Long Term Evolution of the Anterograde Refractory Period of Accessory Duct in the Wolff-Parkinson-White Syndrome

acronym: WPW

summary:
The study consists of the realization of a new esophageal stimulation for patients already stimulated 10 years ago.

The investigators would like to make a long term evaluation of the evolution of anterograde effective refractory period of accessory duct in the WPW syndrome.

This study will be realized by esophageal stimulation.

lead_sponsor: Nantes University Hospital


title: Efficacy of Transdermal Nicotine, on Motor Symptoms in Advanced Parkinson's Disease(One Daily Administration).A Controlled Randomised Study, in Two Parallel Groups and Single Blind in 40 Patients.

summary:
Medical treatment of idiopathic Parkinson disease motor symptoms requires dopaminergic drugs, with long term disabling side effects. (fluctuations, dyskinesia, ON/OFF phenomena). Use of nicotine in Parkinson's disease has been suggested by the lowest prevalence of smokers among Parkinsonian patients. However, controlled studies provided conflicting results. One of our patients showed a substantial decrease of his parkinsonian symptoms under transdermal nicotine-therapy. Currently, this patient has been treated since 8 years with an excellent safety, especially on cardiovascular level. Otherwise, the investigators performed an open pilot safety and feasibility study in 6 patients, which demonstrated the possibility of a controlled study. In this study, all patients received daily doses during several months until 105 mg/day and could, in parallel, decrease their L-Dopa and agonists doses, improving their motor scores.

The investigators now propose a phase II, controlled, single blind and randomised efficacy study (n=40) in 2 parallel groups. (1 group transdermal nicotine-therapy / 1 control group without additional therapy) The main objective is to verify the correlation between UPDRS (score III) motor score and the administrated nicotine dose. This study will also allow the evaluation of nicotine neuroprotective effect. The incrementation phase by weekly steps of 5 mg until 20 mg, then 10 mg to reach 90 mg/j or the maximal tolerated dose, will last on 11 weeks and will be followed by a 28 weeks phase at this stable dose. After this maximal dose "plateau phase", treatment will be progressively decreased by 15 mg weekly steps, over a de 6-week period followed by a five-week wash out phase.

Taking into account results from the pilot study, a long-term high doses treatment, seems to be liable to improve patients who deeply suffer from their disease. This is why the investigators now propose this monocentric institutional project.

ReferenceCitation: Villafane G, Cesaro P, Rialland A, Baloul S, Azimi S, Bourdet C, Le Houezec J, Macquin-Mavier I, Maison P. Chronic high dose transdermal nicotine in Parkinson's disease: an open trial. Eur J Neurol. 2007 Dec;14(12):1313-6. doi: 10.1111/j.1468-1331.2007.01949.x. Epub 2007 Oct 17.

location_facility: Groupe Hospitalier Albert Chenevier Henri Mondor


title: Phase I Study - Hypofractionated Cyberknife Radiotherapy Combined With Neoadjuvant Chemotherapy for Breast Tumors

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. Drugs used in chemotherapy, such as docetaxel, epirubicin, cyclophosphamide, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of radiation therapy when given together with docetaxel followed by standard therapy in treating women with breast cancer.


title: Interest of Occlusion of Permeable Foramen Ovale After a Cryptogenic Cerebrovacular Accident.

acronym: FOPasa

summary:
Facing the lack of recommandations of Neurology and cardiology societies, the investigators decided in 2002 some Good Medical Practices to define a specific and precise population for whom the closure of permeable oval formaen after a first CVA seem to be necessary. Current survey of these patients after implantation of a prothesis in interauricular septum is defined by a consultation at 1, 3 and 6 months after surgery for a clinical exam and an echocardiography. One year after implantation, the investigators systematically realized a control by MRI associated to a contrast echography.

In the aim of evaluating the investigators' medical practice, the investigators decided to do an observational study which will permit us to judge of the interest or lack of interest of our "Good medical practice" before the publication of prospective and randomised clinical studies.

time_perspective: Retrospective


title: Long-term Oxygen Treatment (LTOT) in Chronic Obstructive Pulmonary Disease: Factors Influencing Survival: Survival Factors in COPD Treated by Long-term Oxygen Therapy

summary:
The purpose of this prospective cohort study is to determine factors involved in survival in new COPD patients treated by long-term oxygen therapy.

Background: long-term oxygen therapy is indicated in patients with severe COPD. No studies have been performed in the past 20-25 years to examine the results of early clinical trials. Further studies are necessary to understand the utility of oxygen therapy in severe COPD.

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

location_facility: Service de Pneumologie, Hôpital du Cluzeau


title: Adjuvant Treatment by Intra-arterial Injection of Lipiodol-labeled Iodine-131 in Preventing Recurrence of Hepatocellular Carcinoma After Curative Treatment

summary:
RATIONALE: Iodine I 131 ethiodized oil may help prevent or delay the recurrence of cancer. It is not yet known whether iodine I 131 ethiodized oil is more effective than non-radiolabeled ethiodized oil in preventing recurrent cancer in patients who have undergone treatment for liver cancer.

PURPOSE: This randomized phase III trial is studying iodine I 131 ethiodized oil to see how well it works compared with non-radiolabeled ethiodized oil in preventing recurrent cancer in patients who have undergone treatment for liver cancer.


title: Multicenter (Phase II) Study of Oncoplastic Surgical Techniques for Breast Conservation in Breast Cancers

summary:
RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery.

PURPOSE: This phase II trial is studying different breast-conserving surgery techniques in treating women with breast cancer.


title: Phase II Multicenter Study Evaluating the Tolerability and Efficacy of RAD001 (Everolimus) in Patients With Relapsed or Metastatic Endometrial Cancer

acronym: ENDORAD

summary:
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well everolimus works in treating patients with relapsed or metastatic endometrial cancer.

ReferenceCitation: Ray-Coquard I, Favier L, Weber B, Roemer-Becuwe C, Bougnoux P, Fabbro M, Floquet A, Joly F, Plantade A, Paraiso D, Pujade-Lauraine E. Everolimus as second- or third-line treatment of advanced endometrial cancer: ENDORAD, a phase II trial of GINECO. Br J Cancer. 2013 May 14;108(9):1771-7. doi: 10.1038/bjc.2013.183. Epub 2013 Apr 23.

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

ReferenceCitation: Tredan O, Treilleux I, Wang Q, Gane N, Pissaloux D, Bonnin N, Petit T, Cretin J, Bonichon-Lamichhane N, Priou F, Lavau-Denes S, Mari V, Freyer G, Lebrun D, Alexandre J, Ray-Coquard I. Predicting everolimus treatment efficacy in patients with advanced endometrial carcinoma: a GINECO group study. Target Oncol. 2013 Dec;8(4):243-51. doi: 10.1007/s11523-012-0242-9. Epub 2012 Dec 13.

lead_sponsor: ARCAGY/ GINECO GROUP


title: Modifications of Hormone Receptors and Biological Parameters of Metastatic Breast Cancer Treated With First-line Chemotherapy. Prospective Biological Study.

summary:
RATIONALE: Studying biopsy samples in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This clinical trial is studying biopsy samples in women who are receiving first-line chemotherapy for metastatic breast cancer.

lead_sponsor: Centre Jean Perrin


title: Phase II Study Treatment of High Risk Non-Hodgkin's Lymphomas

summary: Phase II multicenter pilot trial (073) evaluating tandem HDT with PBSC support in aa-IPI=3 untreated aggressive NHL.

ReferenceCitation: Monjanel H, Deconinck E, Perrodeau E, Gastinne T, Delwail V, Moreau A, Francois S, Berthou C, Gyan E, Milpied N; GOELAMS. Long-term follow-up of tandem high-dose therapy with autologous stem cell support for adults with high-risk age-adjusted international prognostic index aggressive non-Hodgkin Lymphomas: a GOELAMS pilot study. Biol Blood Marrow Transplant. 2011 Jun;17(6):935-40. doi: 10.1016/j.bbmt.2010.11.017. Epub 2010 Nov 23.

lead_sponsor: French Innovative Leukemia Organisation

sponsor_collaborators:
French Innovative Leukemia Organisation
Amgen


title: Phase II Study of AB1010 in Patients With Relapse or Refractory Multiple Myeloma With t(4/14) Translocation Expressing or Not Expressing FGFR3

summary: This phase 2 study was designed to assess the safety and efficacy of masitinib (AB1010) in patients with relapsing/refractory t(4;14) Multiple Myeloma. Response and progression were assessed according to the Bladé revised IMWG criteria1 from lowest point.

lead_sponsor: AB Science


title: Treatment of Melasma With Stabilized Kligman Preparation Associated or Not With Pulsed Dye Laser; a Comparative Prospective Study

summary:
Melasma is an acquired disorder of pigmentation that leads to irregular pigmented patches on the face. Treatment is difficult and to date the best treatment option is the combination of hydroquinone, retinoic acid and steroids combined in topical daily application (called Kligman's trio). Q-switched pigmentary lasers are usually ineffective and can induce post inflammatory hyperpigmentation (PIH). Intense pulsed light can sometimes improve melasma but also induce PIH which limit their use. Recently, pulsed dye laser were demonstrated to be effective in treating some pigmentary defects. Associating blanching cream with hydroquinone to prevent PIH after laser or intense pulsed light has been already reported with success.

The objective of the study is to compare in a prospective intra individual comparative trial the association of pulsed dye laser plus stabilized Kligman's trio to Kligman's trio alone. The secondary objective was to study the frequency and the intensity of the potential side effects including PIH.

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Effect of Monosodium Glutamate on Gastric Emptying and Postprandial Nitrogen in Healthy Volunteers

summary: There are receptors to free glutamate in the oral cavity and stomach that may mediate effects of this amino acid on gastrointestinal physiology. The investigators hypothesize that a chronic supplementation of monosodium glutamate (MSG) could modulate gastric emptying and the further metabolism of dietary protein in healthy subjects.

ReferenceCitation: Boutry C, Matsumoto H, Airinei G, Benamouzig R, Tome D, Blachier F, Bos C. Monosodium glutamate raises antral distension and plasma amino acid after a standard meal in humans. Am J Physiol Gastrointest Liver Physiol. 2011 Jan;300(1):G137-45. doi: 10.1152/ajpgi.00299.2010. Epub 2010 Oct 28.

sponsor_collaborators: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

intervention_type: Dietary Supplement


title: A Multi-center, Inpatient and Ambulatory, Phase 2, Double Blind, Randomized, Placebo-controlled Proof of Concept Study of CYR-101 in Patients With DSM-IV Schizophrenia

summary: This Phase II study will test whether CYR-101, a CNS-active compound with novel pharmacological profile and devoid of dopamine D2 receptor binding properties, is efficacious when administered orally in the management of patients with a diagnosis of DSM-IV schizophrenia.

lead_sponsor: Cyrenaic Pharmaceuticals

location_facility: Centre Hospitalier Universitaire de Nancy (CHU)


title: An Open-label, Multi-centre, Clinical Study to Collect Information on the Clinical Use of Argatroban in Patients With Heparin Induced Thrombocytopenia (HIT) Type II Who Require Parenteral Antithrombotic Therapy

summary: The purpose of this study is to collect data on the clinical management of Argatroban in patients with suspected or confirmed heparin-induced thrombocytopenia Type II, with or without ongoing thrombosis who require parenteral antithrombotic therapy

ReferenceCitation: Tardy-Poncet B, Nguyen P, Thiranos JC, Morange PE, Biron-Andreani C, Gruel Y, Morel J, Wynckel A, Grunebaum L, Villacorta-Torres J, Grosjean S, de Maistre E. Argatroban in the management of heparin-induced thrombocytopenia: a multicenter clinical trial. Crit Care. 2015 Nov 11;19:396. doi: 10.1186/s13054-015-1109-0.

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UJM - Université Jean Monnet

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

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

lead_sponsor: Mitsubishi Tanabe Pharma Corporation


title: Longitudinal (Weekly) Follow-up of Active Plaques in Multiple Sclerosis With 3 Teslas Multi-modality MRI Using Diffusion, Perfusion, Venography and Proton Spectroscopy

acronym: IRM 3T-SEP

summary:
It is difficult to determinate prognostic criteria of Multiple Sclerosis with conventional MRI insofar as physiopathology is not well-known: the precise sequences of events leading to plaque formation and axonal injury are still not completely understood.

Some elements involved in plaque formation can be studied thanks to MR techniques (cerebrospinal fluid and periveinular spaces, neuronal injury, microglia, and cerebral microcirculation's dysfunction).

This study aims at giving a better understanding of MS plaques' physiopathology, using data from modern MRI through a longitudinal followed up with weakly MR 3T examination.

ReferenceCitation: Hannoun S, Roch JA, Durand-Dubief F, Vukusic S, Sappey-Marinier D, Guttmann CR, Cotton F. Weekly multimodal MRI follow-up of two multiple sclerosis active lesions presenting a transient decrease in ADC. Brain Behav. 2015 Feb;5(2):e00307. doi: 10.1002/brb3.307. Epub 2015 Jan 16.

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

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

lead_sponsor: Hospices Civils de Lyon

location_facility: Services de Neurologie A et Service de Neuroradiologie, Pôle transversal d'imagerie, Hôpital Neurologique


title: PERIGEE :Randomized Study Evaluating the Effectiveness of the Use of Prosthesis With Trans-obturator Way for the Correction of Anterior Prolapse.

summary: The classical surgical treatment of an anterior prolapse is the use of autologous tissue. In front of the high rate of recurrences with this technique, the use of synthetic prosthesis made their appearance. But the drawback of the use of prosthesis is their tolerability. The system Perigee®, a prosthetic kit by trans-obturator way, was designed to obtain high efficiency in the correction of the prolapse while reducing the risk of complications. The lack of prospective and randomized studies makes difficult to assess the interest. The investigators, therefore, have put in place a randomized prospective study seeking the evaluation of the system Perigee® compared to the conventional surgical technique.

ReferenceCitation: Lamblin G, Van-Nieuwenhuyse A, Chabert P, Lebail-Carval K, Moret S, Mellier G. A randomized controlled trial comparing anatomical and functional outcome between vaginal colposuspension and transvaginal mesh. Int Urogynecol J. 2014 Jul;25(7):961-70. doi: 10.1007/s00192-014-2344-7. Epub 2014 Feb 27.


title: MAP-IDM: Identification of Molecular Markers of Sudden Death at the Acute Phase of Myocardial Infarction. A Case Control Study

acronym: MAP-IDM

summary:
We propose a comparative case-control study on the 2 following groups of patients:

Cases: 500 patients with ventricular fibrillation at the acute phase of myocardial infarct,
Controls: 500 patients without ventricular fibrillation at the acute phase of myocardial infarct.

The primary endpoint in this study is the correlation phenotype/genotype of sudden death at the acute phase of myocardial infarct.

The first phase of the study, including patients' recruitment, clinical and biological data collection, will last 82 months. The second phase will concern the genotype/phenotype analysis and the identification of polymorphisms associated with a sudden death risk after a myocardial infarction.

This study will allow a better knowledge of the mechanisms of sudden death and the identification of new risk markers.

ReferenceCitation: Chevalier P, Moreau A, Bessiere F, Richard S, Chahine M, Millat G, Morel E, Paganelli F, Lesavre N, Placide L, Montestruc F, Ankou B, Puertas RD, Asatryan B, Deliniere A; MAP-IDM Investigators. Identification of Cx43 variants predisposing to ventricular fibrillation in the acute phase of ST-elevation myocardial infarction. Europace. 2023 Feb 8;25(1):101-111. doi: 10.1093/europace/euac128.

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

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

publisher_dissemination: Oxford University Press

intervention_type: Genetic


title: Genetic Determinants of Phosphocalcic Metabolism in Hemodialysis Patients

acronym: ARNOGENE

summary: Searching for high morbi-mortality risk Klotho variants in dialysis patients

ReferenceCitation: Marcais C, Maucort-Boulch D, Drai J, Dantony E, Carlier MC, Blond E, Genet L, Kuentz F, Lataillade D, Legrand E, Moreau-Gaudry X, Jean G, Fouque D; ARNOGENE Project. Circulating Klotho Associates With Cardiovascular Morbidity and Mortality During Hemodialysis. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3154-3161. doi: 10.1210/jc.2017-00104.


title: An Open-label, One-sequence Crossover Study to Evaluate the Effect of Multiple Doses of YM178 on the Pharmacokinetics of Warfarin in Healthy Subjects

summary: This study investigates whether YM178 has an effect on the pharmacokinetics of warfarin, to exclude any drug-drug interaction between YM178 and warfarin, and evaluates the safety and tolerability of warfarin alone and combined with YM178.

lead_sponsor: Astellas Pharma Inc


title: Assessment of Endothelial Vasomotricity After Treatment by Nicotinic Acid in Patients Presenting a Recent Acute Coronary Syndrome.

acronym: EVANACS

summary:
The investigators' work proposes to evaluate the effectiveness of the Acid Nicotinique (Niaspan®), only molecule currently marketed, ready to raise the plasmatic levels of HDL-c. This effectiveness will be tested among patients having presented recently an acute coronary syndrome. The effectiveness of the molecule will be appreciated versus placebo after randomization.

The technique of evaluation of this effectiveness will be the analysis of the vasodilatation endothelial-dependent measured on the level huméral (by echography high resolution).

The awaited result is an improvement of 2% in value absolute of this vasodilatation between the initial test and the end of study for the patients receiving the acid nicotinic versus those receiving the placebo (3 months of treatment after inclusion). The calculation of the sample necessary to achieve this goal envisages 70 patients led at the end of the study, divided into two groups of treatment (acid nicotinic or Placebo).

Such a result if it were obtained would be higher than that found in studies evaluating the effect on the vasomotricity endothelial statins or inhibitors of the enzyme of conversion.

lead_sponsor: French Cardiology Society

sponsor_collaborators:
French Cardiology Society
Merck Serono International SA


title: Validation of a Semiquantitative Screening Assay for PSA

summary: The aim of the study is to compare the diagnostic performances of a simple and rapid PSA assay on whole blood to the standard plasma PSA assay.

lead_sponsor: Institut Curie