title: Randomized Study Comparing Pleural Drainage by Videothoracoscopy to Medical Drainage in Infectious Pleural Effusion

acronym: VIDMED

summary:
Infectious pleural effusion is a classic complication of pneumonia and often require pleural drainage.

There is no consensus between surgical drainage and medical drainage indication in first intention to treat an empyema.

Usually surgery is proposed in second intention after failure of medical drainage.

Videothoracoscopy is well accepted in diagnosis and treatment of pleural pathologies. The morbidity of this approach is very low with good results and become the gold standard in different pleural diseases. The medical drainage can be also very efficient but its results depends of the evolution of the pleural effusion. The rate of failure is estimated around 25%.

Then, the aim of our study is to compare surgical drainage and medical drainage in first intention. The first end-point will be the hospital stay (day). Hospital discharge will be strict, following different objective criteria of healing allowing comparison between these two approaches of drainage.

To answer this question we will randomized 50 patients in 2 years with a multicenter recruitment.

lead_sponsor: University Hospital, Rouen

location_facility:
University Hospital
UH Rouen


title: Randomized Trial Comparing Digestive and Urinary Dysfunction Secondary to 2 Surgical Techniques Used in the Management of Deep Endometriosis Infiltrating the Rectum: Colorectal Resection and Rectal Nodules Excision (ENDORE)

acronym: ENDORE

summary: The purpose of this study is to determine whether performing colorectal resection in deep endometriosis infiltrating the rectum is responsible for a higher rate of postoperative digestive and urinary dysfunction when compared to rectal nodules excision (conservation of the rectum).

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Roman H, Tuech JJ, Huet E, Bridoux V, Khalil H, Hennetier C, Bubenheim M, Branduse LA. Excision versus colorectal resection in deep endometriosis infiltrating the rectum: 5-year follow-up of patients enrolled in a randomized controlled trial. Hum Reprod. 2019 Dec 1;34(12):2362-2371. doi: 10.1093/humrep/dez217. Erratum in: Hum Reprod. 2020 Mar 27;35(3):736.

name: Endometriosis Center, Clinique Tivoli-Ducos, Bordeaux 33000, France

name: Department of Obstetrics and Gynecology, Aarhus University Hospital, Aarhus, Denmark

family: Roman

full_name: Horace Roman

given: Horace

sequence: first

name: Department of Surgery, Rouen University Hospital, Rouen 76031, France

family: Tuech

full_name: Jean-Jacques Tuech

given: Jean-Jacques

family: Huet

full_name: Emmanuel Huet

given: Emmanuel

family: Bridoux

full_name: Valérie Bridoux

given: Valérie

family: Khalil

full_name: Haitham Khalil

given: Haitham

name: Expert Center in the Diagnosis and Multidisciplinary Management of Endometriosis, Rouen University Hospital, Rouen 76031, France

family: Hennetier

full_name: Clotilde Hennetier

given: Clotilde

name: Department of Biostatistics, Rouen University Hospital, Rouen 76031, France

family: Bubenheim

full_name: Michael Bubenheim

given: Michael

name: Department of Public Health and Management, Carol Davila University of Medicine and Pharmacy Bucharest, Romania

family: Brinduse

full_name: Lacramioara Aurelia Brinduse

given: Lacramioara Aurelia

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Human Reproduction

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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)

license_normalized: no license

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Roman H, Chanavaz-Lacheray I, Ballester M, Bendifallah S, Touleimat S, Tuech JJ, Farella M, Merlot B. High postoperative fertility rate following surgical management of colorectal endometriosis. Hum Reprod. 2018 Sep 1;33(9):1669-1676. doi: 10.1093/humrep/dey146.

name: Expert Center in the Diagnosis and Multidisciplinary Management of Endometriosis, Rouen University Hospital, Rouen, France

family: Chanavaz-Lacheray

full_name: Isabella Chanavaz-Lacheray

given: Isabella

sequence: additional

name: Department of Obstetrics and Gynecology, Tenon University Hospital, Assistance Publique Hôpitaux de Paris, Paris, France

name: GRC-6 UPMC: Centre Expert en Endométriose (C3E), Université Pierre et Marie Curie, Paris, France

name: Unité INSERM UMR_S 938, Université Pierre et Marie Curie, Paris, France

family: Ballester

full_name: Marcos Ballester

given: Marcos

family: Bendifallah

full_name: Sofiane Bendifallah

given: Sofiane

family: Touleimat

full_name: Salma Touleimat

given: Salma

name: Department of Surgery, Rouen University Hospital, 76031 Rouen, France

family: Farella

full_name: Marilena Farella

given: Marilena

family: Merlot

full_name: Benjamin Merlot

given: Benjamin

location_facility: Service de Gynécologie et Obstétrique, CHU Jean de Flandre

location_facility: Service de Gynécologique-Obstétricale et Reproduction Humaine, Hôpital Tenon, Université Pierre et Marie Curie Paris 6


title: Non Comparative, Monocentric, Prospective, Phase II, Study of Calcium Phosphate Cement MCPC Efficacy and Safety for Bone Filling in Vertebral Site

acronym: VERTEBRO-MCPC

summary:
The macroporous calcium phosphate cement, MCPC, which composition is close to bone, is malleable and biocompatible, and has intrinsic radio opacity and good ability to undergo mechanical constraints. After the filling of the bone cavity, the cement hardens. Interestingly, this calcium phosphate cement has no exothermic hardening (on the contrary, the ordinary cements used nowadays cause necrotic lesions in tissues around during this phase) and favours vascularisation, cellular colonisation and bone healing. Thanks to its resorbability, the MCPC cement is replaced little by little by a physiologic bone. This last property is very important for young people needing a vertebroplasty after a traumatism.

Thus, it will be tested in a low-invasive surgery, a non-percutaneous vertebroplasty, consisting in filling with the MCPC the body of the broken vertebra, after its stabilization thanks to 4 interpedicular screws. This protocol will be proposed to patients 1 to 3 weeks after the trauma having caused the fracture.

The follow up will last 12 months with 5 visits (2 days, and 3, 4, 6 and 12 months after vertebroplasty), 2 CT scanners before inclusion and at 12 months, 2 EOS (ultra low dose imager replacing classical radiography) at 5 and 12 months, questionnaires (visual analogic scale for pain, and quality of life with OSWESTRY and SF36 scales) before inclusion and at 2 days, and 3, 4, 6 and 12 months, and biological exams (CRP/VS, for inflammation) at each visit except 2 days after surgery. An osteodensitometry will be performed at 3 months.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Baroud G, Nemes J, Heini P, Steffen T. Load shift of the intervertebral disc after a vertebroplasty: a finite-element study. Eur Spine J. 2003 Aug;12(4):421-6. Epub 2003 Apr 1.

ReferenceCitation: Baroud G, Bohner M, Heini P, Steffen T. Injection biomechanics of bone cements used in vertebroplasty. Biomed Mater Eng. 2004;14(4):487-504.

ReferenceCitation: Berlemann U, Ferguson SJ, Nolte LP, Heini PF. Adjacent vertebral failure after vertebroplasty. A biomechanical investigation. J Bone Joint Surg Br. 2002 Jul;84(5):748-52.

ReferenceCitation: Berrington de González A, Darby S. Risk of cancer from diagnostic X-rays: estimates for the UK and 14 other countries. Lancet. 2004 Jan 31;363(9406):345-51.

ReferenceCitation: Black DM, Arden NK, Palermo L, Pearson J, Cummings SR. Prevalent vertebral deformities predict hip fractures and new vertebral deformities but not wrist fractures. Study of Osteoporotic Fractures Research Group. J Bone Miner Res. 1999 May;14(5):821-8.

ReferenceCitation: Cooper C, Atkinson EJ, O'Fallon WM, Melton LJ 3rd. Incidence of clinically diagnosed vertebral fractures: a population-based study in Rochester, Minnesota, 1985-1989. J Bone Miner Res. 1992 Feb;7(2):221-7.

ReferenceCitation: Deramond H, Wright NT, Belkoff SM. Temperature elevation caused by bone cement polymerization during vertebroplasty. Bone. 1999 Aug;25(2 Suppl):17S-21S.

ReferenceCitation: European Prospective Osteoporosis Study (EPOS) Group, Felsenberg D, Silman AJ, Lunt M, Armbrecht G, Ismail AA, Finn JD, Cockerill WC, Banzer D, Benevolenskaya LI, Bhalla A, Bruges Armas J, Cannata JB, Cooper C, Dequeker J, Eastell R, Felsch B, Gowin W, Havelka S, Hoszowski K, Jajic I, Janott J, Johnell O, Kanis JA, Kragl G, Lopes Vaz A, Lorenc R, Lyritis G, Masaryk P, Matthis C, Miazgowski T, Parisi G, Pols HA, Poor G, Raspe HH, Reid DM, Reisinger W, Schedit-Nave C, Stepan JJ, Todd CJ, Weber K, Woolf AD, Yershova OB, Reeve J, O'Neill TW. Incidence of vertebral fracture in europe: results from the European Prospective Osteoporosis Study (EPOS). J Bone Miner Res. 2002 Apr;17(4):716-24.

ReferenceCitation: Evans AJ, Jensen ME, Kip KE, DeNardo AJ, Lawler GJ, Negin GA, Remley KB, Boutin SM, Dunnagan SA. Vertebral compression fractures: pain reduction and improvement in functional mobility after percutaneous polymethylmethacrylate vertebroplasty retrospective report of 245 cases. Radiology. 2003 Feb;226(2):366-72.

ReferenceCitation: Finnern HW, Sykes DP. The hospital cost of vertebral fractures in the EU: estimates using national datasets. Osteoporos Int. 2003 Jun;14(5):429-36. Epub 2003 Apr 30.

ReferenceCitation: Galibert P, Deramond H, Rosat P, Le Gars D. [Preliminary note on the treatment of vertebral angioma by percutaneous acrylic vertebroplasty]. Neurochirurgie. 1987;33(2):166-8. French.

ReferenceCitation: Gauthier O, Müller R, von Stechow D, Lamy B, Weiss P, Bouler JM, Aguado E, Daculsi G. In vivo bone regeneration with injectable calcium phosphate biomaterial: a three-dimensional micro-computed tomographic, biomechanical and SEM study. Biomaterials. 2005 Sep;26(27):5444-53.

ReferenceCitation: Gheduzzi S, Webb JJ, Miles AW. Mechanical characterisation of three percutaneous vertebroplasty biomaterials. J Mater Sci Mater Med. 2006 May;17(5):421-6.

ReferenceCitation: Graham J, Ahn C, Hai N, Buch BD. Effect of bone density on vertebral strength and stiffness after percutaneous vertebroplasty. Spine (Phila Pa 1976). 2007 Aug 15;32(18):E505-11.

ReferenceCitation: Hulme PA, Krebs J, Ferguson SJ, Berlemann U. Vertebroplasty and kyphoplasty: a systematic review of 69 clinical studies. Spine (Phila Pa 1976). 2006 Aug 1;31(17):1983-2001. Review.

ReferenceCitation: Kado DM, Duong T, Stone KL, Ensrud KE, Nevitt MC, Greendale GA, Cummings SR. Incident vertebral fractures and mortality in older women: a prospective study. Osteoporos Int. 2003 Jul;14(7):589-94. Epub 2003 Jun 24.

ReferenceCitation: Kuklo TR, Polly DW, Owens BD, Zeidman SM, Chang AS, Klemme WR. Measurement of thoracic and lumbar fracture kyphosis: evaluation of intraobserver, interobserver, and technique variability. Spine (Phila Pa 1976). 2001 Jan 1;26(1):61-5; discussion 66.

ReferenceCitation: Lindsay R, Silverman SL, Cooper C, Hanley DA, Barton I, Broy SB, Licata A, Benhamou L, Geusens P, Flowers K, Stracke H, Seeman E. Risk of new vertebral fracture in the year following a fracture. JAMA. 2001 Jan 17;285(3):320-3.

ReferenceCitation: Molloy S, Riley LH 3rd, Belkoff SM. Effect of cement volume and placement on mechanical-property restoration resulting from vertebroplasty. AJNR Am J Neuroradiol. 2005 Feb;26(2):401-4.

ReferenceCitation: Old JL, Calvert M. Vertebral compression fractures in the elderly. Am Fam Physician. 2004 Jan 1;69(1):111-6. Review.

ReferenceCitation: Polikeit A, Nolte LP, Ferguson SJ. The effect of cement augmentation on the load transfer in an osteoporotic functional spinal unit: finite-element analysis. Spine (Phila Pa 1976). 2003 May 15;28(10):991-6.

ReferenceCitation: Riggs BL, Melton LJ 3rd. The worldwide problem of osteoporosis: insights afforded by epidemiology. Bone. 1995 Nov;17(5 Suppl):505S-511S. Review.

ReferenceCitation: Ryu KS, Park CK, Kim MC, Kang JK. Dose-dependent epidural leakage of polymethylmethacrylate after percutaneous vertebroplasty in patients with osteoporotic vertebral compression fractures. J Neurosurg. 2002 Jan;96(1 Suppl):56-61.

ReferenceCitation: Zoarski GH, Snow P, Olan WJ, Stallmeyer MJ, Dick BW, Hebel JR, De Deyne M. Percutaneous vertebroplasty for osteoporotic compression fractures: quantitative prospective evaluation of long-term outcomes. J Vasc Interv Radiol. 2002 Feb;13(2 Pt 1):139-48.

lead_sponsor: University Hospital, Bordeaux

location_facility: Service d'orthopédie-traumatolologie (C), Hôpital Pellegrin

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Completed


title: Comparison of 2 Surgical Approaches in the Treatment of Degenerative Spondylolysthesis: Posterolateral Fusion With Instrumentation (GPLI) Plus or Minus Transforaminal Lumbar Interbody Fusion (TLIF)

acronym: SPONGIT

summary: This trial, conducted in adult patients with degenerative spondylolisthesis needing surgical treatment at one level, aimed at comparing two approaches of spinal fusion.

ReferenceCitation: Rosenberg NJ. Degenerative spondylolisthesis. Predisposing factors. J Bone Joint Surg Am. 1975 Jun;57(4):467-74.

ReferenceCitation: Frymoyer JW. Degenerative Spondylolisthesis: Diagnosis and Treatment. J Am Acad Orthop Surg. 1994 Jan;2(1):9-15.

ReferenceCitation: Cummins J, Lurie JD, Tosteson TD, Hanscom B, Abdu WA, Birkmeyer NJ, Herkowitz H, Weinstein J. Descriptive epidemiology and prior healthcare utilization of patients in the Spine Patient Outcomes Research Trial's (SPORT) three observational cohorts: disc herniation, spinal stenosis, and degenerative spondylolisthesis. Spine (Phila Pa 1976). 2006 Apr 1;31(7):806-14.

ReferenceCitation: Taylor VM, Deyo RA, Cherkin DC, Kreuter W. Low back pain hospitalization. Recent United States trends and regional variations. Spine (Phila Pa 1976). 1994 Jun 1;19(11):1207-12; discussion 13.

ReferenceCitation: Brown MD, Lockwood JM. Degenerative spondylolisthesis. Instr Course Lect. 1983;32:162-9.

ReferenceCitation: Kostuik JP, Harrington I, Alexander D, Rand W, Evans D. Cauda equina syndrome and lumbar disc herniation. J Bone Joint Surg Am. 1986 Mar;68(3):386-91.

ReferenceCitation: Magora A. Conservative treatment in spondylolisthesis. Clin Orthop Relat Res. 1976 Jun;(117):74-9.

ReferenceCitation: Matsunaga S, Ijiri K, Hayashi K. Nonsurgically managed patients with degenerative spondylolisthesis: a 10- to 18-year follow-up study. J Neurosurg. 2000 Oct;93(2 Suppl):194-8.

ReferenceCitation: Herkowitz HN. Spine update. Degenerative lumbar spondylolisthesis. Spine (Phila Pa 1976). 1995 May 1;20(9):1084-90. Review.

ReferenceCitation: Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Blood E, Hanscom B, Herkowitz H, Cammisa F, Albert T, Boden SD, Hilibrand A, Goldberg H, Berven S, An H; SPORT Investigators. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med. 2008 Feb 21;358(8):794-810. doi: 10.1056/NEJMoa0707136.

ReferenceCitation: Atlas SJ, Keller RB, Robson D, Deyo RA, Singer DE. Surgical and nonsurgical management of lumbar spinal stenosis: four-year outcomes from the maine lumbar spine study. Spine (Phila Pa 1976). 2000 Mar 1;25(5):556-62.

ReferenceCitation: Herkowitz HN, Kurz LT. Degenerative lumbar spondylolisthesis with spinal stenosis. A prospective study comparing decompression with decompression and intertransverse process arthrodesis. J Bone Joint Surg Am. 1991 Jul;73(6):802-8.

ReferenceCitation: Gibson JN, Grant IC, Waddell G. The Cochrane review of surgery for lumbar disc prolapse and degenerative lumbar spondylosis. Spine (Phila Pa 1976). 1999 Sep 1;24(17):1820-32.

ReferenceCitation: Fischgrund JS, Mackay M, Herkowitz HN, Brower R, Montgomery DM, Kurz LT. 1997 Volvo Award winner in clinical studies. Degenerative lumbar spondylolisthesis with spinal stenosis: a prospective, randomized study comparing decompressive laminectomy and arthrodesis with and without spinal instrumentation. Spine (Phila Pa 1976). 1997 Dec 15;22(24):2807-12.

ReferenceCitation: Kornblum MB, Fischgrund JS, Herkowitz HN, Abraham DA, Berkower DL, Ditkoff JS. Degenerative lumbar spondylolisthesis with spinal stenosis: a prospective long-term study comparing fusion and pseudarthrosis. Spine (Phila Pa 1976). 2004 Apr 1;29(7):726-33; discussion 733-4.

ReferenceCitation: Bono CM, Lee CK. Critical analysis of trends in fusion for degenerative disc disease over the past 20 years: influence of technique on fusion rate and clinical outcome. Spine (Phila Pa 1976). 2004 Feb 15;29(4):455-63; discussion Z5. Review.

ReferenceCitation: Ray CD. Threaded titanium cages for lumbar interbody fusions. Spine (Phila Pa 1976). 1997 Mar 15;22(6):667-79; discussion 679-80.

ReferenceCitation: Ekman P, Möller H, Tullberg T, Neumann P, Hedlund R. Posterior lumbar interbody fusion versus posterolateral fusion in adult isthmic spondylolisthesis. Spine (Phila Pa 1976). 2007 Sep 15;32(20):2178-83.

ReferenceCitation: Kim KT, Lee SH, Lee YH, Bae SC, Suk KS. Clinical outcomes of 3 fusion methods through the posterior approach in the lumbar spine. Spine (Phila Pa 1976). 2006 May 20;31(12):1351-7; discussion 1358.

ReferenceCitation: Dantas FL, Prandini MN, Ferreira MA. Comparison between posterior lumbar fusion with pedicle screws and posterior lumbar interbody fusion with pedicle screws in adult spondylolisthesis. Arq Neuropsiquiatr. 2007 Sep;65(3B):764-70.

ReferenceCitation: La Rosa G, Cacciola F, Conti A, Cardali S, La Torre D, Gambadauro NM, Tomasello F. Posterior fusion compared with posterior interbody fusion in segmental spinal fixation for adult spondylolisthesis. Neurosurg Focus. 2001 Apr 15;10(4):E9.

ReferenceCitation: Humphreys SC, Hodges SD, Patwardhan AG, Eck JC, Murphy RB, Covington LA. Comparison of posterior and transforaminal approaches to lumbar interbody fusion. Spine (Phila Pa 1976). 2001 Mar 1;26(5):567-71.

ReferenceCitation: Hackenberg L, Halm H, Bullmann V, Vieth V, Schneider M, Liljenqvist U. Transforaminal lumbar interbody fusion: a safe technique with satisfactory three to five year results. Eur Spine J. 2005 Aug;14(6):551-8. Epub 2005 Jan 26.

ReferenceCitation: Hee HT, Castro FP Jr, Majd ME, Holt RT, Myers L. Anterior/posterior lumbar fusion versus transforaminal lumbar interbody fusion: analysis of complications and predictive factors. J Spinal Disord. 2001 Dec;14(6):533-40.

ReferenceCitation: Lauber S, Schulte TL, Liljenqvist U, Halm H, Hackenberg L. Clinical and radiologic 2-4-year results of transforaminal lumbar interbody fusion in degenerative and isthmic spondylolisthesis grades 1 and 2. Spine (Phila Pa 1976). 2006 Jul 1;31(15):1693-8.

ReferenceCitation: Lowe TG, Tahernia AD. Unilateral transforaminal posterior lumbar interbody fusion. Clin Orthop Relat Res. 2002 Jan;(394):64-72.

ReferenceCitation: McAfee PC, DeVine JG, Chaput CD, Prybis BG, Fedder IL, Cunningham BW, Farrell DJ, Hess SJ, Vigna FE. The indications for interbody fusion cages in the treatment of spondylolisthesis: analysis of 120 cases. Spine (Phila Pa 1976). 2005 Mar 15;30(6 Suppl):S60-5.

ReferenceCitation: Potter BK, Freedman BA, Verwiebe EG, Hall JM, Polly DW Jr, Kuklo TR. Transforaminal lumbar interbody fusion: clinical and radiographic results and complications in 100 consecutive patients. J Spinal Disord Tech. 2005 Aug;18(4):337-46.

ReferenceCitation: Salehi SA, Tawk R, Ganju A, LaMarca F, Liu JC, Ondra SL. Transforaminal lumbar interbody fusion: surgical technique and results in 24 patients. Neurosurgery. 2004 Feb;54(2):368-74; discussion 374.

ReferenceCitation: Umehara S, Zindrick MR, Patwardhan AG, Havey RM, Vrbos LA, Knight GW, Miyano S, Kirincic M, Kaneda K, Lorenz MA. The biomechanical effect of postoperative hypolordosis in instrumented lumbar fusion on instrumented and adjacent spinal segments. Spine (Phila Pa 1976). 2000 Jul 1;25(13):1617-24.

ReferenceCitation: Kumar MN, Baklanov A, Chopin D. Correlation between sagittal plane changes and adjacent segment degeneration following lumbar spine fusion. Eur Spine J. 2001 Aug;10(4):314-9.

ReferenceCitation: Champain S, Benchikh K, Nogier A, Mazel C, Guise JD, Skalli W. Validation of new clinical quantitative analysis software applicable in spine orthopaedic studies. Eur Spine J. 2006 Jun;15(6):982-91. Epub 2005 Jun 17.

ReferenceCitation: Bridwell KH, Lenke LG, McEnery KW, Baldus C, Blanke K. Anterior fresh frozen structural allografts in the thoracic and lumbar spine. Do they work if combined with posterior fusion and instrumentation in adult patients with kyphosis or anterior column defects? Spine (Phila Pa 1976). 1995 Jun 15;20(12):1410-8.

ReferenceCitation: Rillardon L, Levassor N, Guigui P, Wodecki P, Cardinne L, Templier A, Skalli W. [Validation of a tool to measure pelvic and spinal parameters of sagittal balance]. Rev Chir Orthop Reparatrice Appar Mot. 2003 May;89(3):218-27. French.

ReferenceCitation: Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271-3.

ReferenceCitation: Prolo DJ, Oklund SA, Butcher M. Toward uniformity in evaluating results of lumbar spine operations. A paradigm applied to posterior lumbar interbody fusions. Spine (Phila Pa 1976). 1986 Jul-Aug;11(6):601-6.

ReferenceCitation: Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

ReferenceCitation: Finlay AY. Quality of life assessments in dermatology. Semin Cutan Med Surg. 1998 Dec;17(4):291-6. Review.

location_facility: Service de chirurgie orthopédique, Hôpital Pellegrin Tripode


title: Proteomic Approach Using Matrix-assisted Laser Desorption/Ionization Tandem Time-of-flight (MALDI-TOF/TOF) of Tumor Response in Rectal Carcinoma After Radiochemotherapy

acronym: PROTEORECTUM

summary: Treatment for locally-advanced rectal adenocarcinoma includes preoperative radiochemotherapy before surgery with total mesorectal excision in order to reduce tumor infiltration, facilitate oncologic surgery and improve survival. About fifty percent of these patients are good responders i.e. their tumor infiltration reduces in the rectal wall and regional lymph nodes in order to be graded ypT0 to T2 N0 after pathologic assessment (so called downstaging). At the opposite, bad responders (ypT3-4 and/or N+) are not sensitive to standard preoperative radiochemotherapy, and their survival is poor than good responders. Until now, response to preoperative radiochemotherapy cannot be anticipated before pathological assessment of surgical specimen. Proteomic analysis of sera from good and bad responders to preoperative radiochemotherapy could allow identification of early biomarkers of tumor response, and subsequently adaptation of treatment to increase preoperative treatment efficiency and survival in most patients.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Heald RJ, Ryall RD. Recurrence and survival after total mesorectal excision for rectal cancer. Lancet. 1986 Jun 28;1(8496):1479-82.

ReferenceCitation: Kapiteijn E, Marijnen CA, Nagtegaal ID, Putter H, Steup WH, Wiggers T, Rutten HJ, Pahlman L, Glimelius B, van Krieken JH, Leer JW, van de Velde CJ; Dutch Colorectal Cancer Group. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer. N Engl J Med. 2001 Aug 30;345(9):638-46.

ReferenceCitation: Påhlman L, Glimelius B. Radiotherapy additional to surgery in the management of primary rectal carcinoma. Acta Chir Scand. 1990 Jun-Jul;156(6-7):475-85. Review.

ReferenceCitation: Swedish Rectal Cancer Trial, Cedermark B, Dahlberg M, Glimelius B, Påhlman L, Rutqvist LE, Wilking N. Improved survival with preoperative radiotherapy in resectable rectal cancer. N Engl J Med. 1997 Apr 3;336(14):980-7. Erratum in: N Engl J Med 1997 May 22;336(21):1539.

ReferenceCitation: Randomised trial of surgery alone versus radiotherapy followed by surgery for potentially operable locally advanced rectal cancer. Medical Research Council Rectal Cancer Working Party. Lancet. 1996 Dec 14;348(9042):1605-10.

ReferenceCitation: Gérard JP, Conroy T, Bonnetain F, Bouché O, Chapet O, Closon-Dejardin MT, Untereiner M, Leduc B, Francois E, Maurel J, Seitz JF, Buecher B, Mackiewicz R, Ducreux M, Bedenne L. Preoperative radiotherapy with or without concurrent fluorouracil and leucovorin in T3-4 rectal cancers: results of FFCD 9203. J Clin Oncol. 2006 Oct 1;24(28):4620-5.

ReferenceCitation: Sauer R, Becker H, Hohenberger W, Rödel C, Wittekind C, Fietkau R, Martus P, Tschmelitsch J, Hager E, Hess CF, Karstens JH, Liersch T, Schmidberger H, Raab R; German Rectal Cancer Study Group. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med. 2004 Oct 21;351(17):1731-40.

ReferenceCitation: Bosset JF, Collette L, Calais G, Mineur L, Maingon P, Radosevic-Jelic L, Daban A, Bardet E, Beny A, Ollier JC; EORTC Radiotherapy Group Trial 22921. Chemotherapy with preoperative radiotherapy in rectal cancer. N Engl J Med. 2006 Sep 14;355(11):1114-23. Erratum in: N Engl J Med. 2007 Aug 16;357(7):728.

ReferenceCitation: Bosset JF, Calais G, Mineur L, Maingon P, Radosevic-Jelic L, Daban A, Bardet E, Beny A, Briffaux A, Collette L. Enhanced tumorocidal effect of chemotherapy with preoperative radiotherapy for rectal cancer: preliminary results--EORTC 22921. J Clin Oncol. 2005 Aug 20;23(24):5620-7. Epub 2005 Jul 11.

ReferenceCitation: Vecchio FM, Valentini V, Minsky BD, Padula GD, Venkatraman ES, Balducci M, Miccichè F, Ricci R, Morganti AG, Gambacorta MA, Maurizi F, Coco C. The relationship of pathologic tumor regression grade (TRG) and outcomes after preoperative therapy in rectal cancer. Int J Radiat Oncol Biol Phys. 2005 Jul 1;62(3):752-60.

ReferenceCitation: Rödel C, Martus P, Papadoupolos T, Füzesi L, Klimpfinger M, Fietkau R, Liersch T, Hohenberger W, Raab R, Sauer R, Wittekind C. Prognostic significance of tumor regression after preoperative chemoradiotherapy for rectal cancer. J Clin Oncol. 2005 Dec 1;23(34):8688-96. Epub 2005 Oct 24.

ReferenceCitation: García-Aguilar J, Hernandez de Anda E, Sirivongs P, Lee SH, Madoff RD, Rothenberger DA. A pathologic complete response to preoperative chemoradiation is associated with lower local recurrence and improved survival in rectal cancer patients treated by mesorectal excision. Dis Colon Rectum. 2003 Mar;46(3):298-304.

ReferenceCitation: Moore HG, Gittleman AE, Minsky BD, Wong D, Paty PB, Weiser M, Temple L, Saltz L, Shia J, Guillem JG. Rate of pathologic complete response with increased interval between preoperative combined modality therapy and rectal cancer resection. Dis Colon Rectum. 2004 Mar;47(3):279-86.

ReferenceCitation: Collette L, Bosset JF, den Dulk M, Nguyen F, Mineur L, Maingon P, Radosevic-Jelic L, Piérart M, Calais G; European Organisation for Research and Treatment of Cancer Radiation Oncology Group. Patients with curative resection of cT3-4 rectal cancer after preoperative radiotherapy or radiochemotherapy: does anybody benefit from adjuvant fluorouracil-based chemotherapy? A trial of the European Organisation for Research and Treatment of Cancer Radiation Oncology Group. J Clin Oncol. 2007 Oct 1;25(28):4379-86.

ReferenceCitation: Habr-Gama A, Perez RO, Nadalin W, Nahas SC, Ribeiro U Jr, Silva E Sousa AH Jr, Campos FG, Kiss DR, Gama-Rodrigues J. Long-term results of preoperative chemoradiation for distal rectal cancer correlation between final stage and survival. J Gastrointest Surg. 2005 Jan;9(1):90-9; discussion 99-101.

ReferenceCitation: Peeters KC, van de Velde CJ, Leer JW, Martijn H, Junggeburt JM, Kranenbarg EK, Steup WH, Wiggers T, Rutten HJ, Marijnen CA. Late side effects of short-course preoperative radiotherapy combined with total mesorectal excision for rectal cancer: increased bowel dysfunction in irradiated patients--a Dutch colorectal cancer group study. J Clin Oncol. 2005 Sep 1;23(25):6199-206.

ReferenceCitation: Murata A, Brown CJ, Raval M, Phang PT. Impact of short-course radiotherapy and low anterior resection on quality of life and bowel function in primary rectal cancer. Am J Surg. 2008 May;195(5):611-5; discussion 615. doi: 10.1016/j.amjsurg.2007.12.034.

ReferenceCitation: Pollack J, Holm T, Cedermark B, Holmström B, Mellgren A. Long-term effect of preoperative radiation therapy on anorectal function. Dis Colon Rectum. 2006 Mar;49(3):345-52.

ReferenceCitation: Lopez-Crapez E, Bibeau F, Thézenas S, Ychou M, Simony-Lafontaine J, Thirion A, Azria D, Grenier J, Senesse P. p53 status and response to radiotherapy in rectal cancer: a prospective multilevel analysis. Br J Cancer. 2005 Jun 20;92(12):2114-21.

ReferenceCitation: Günther K, Dimmler A, Rödel F, Reulbach U, Merkel S, Bittorf BR, Matzel KE, Papadopoulos T, Hohenberger W, Sauer R, Rödel C. P27 does not predict histopathological response to radiochemotherapy in rectal cancer. J Surg Res. 2003 Aug;113(2):179-88.

ReferenceCitation: Rau B, Sturm I, Lage H, Berger S, Schneider U, Hauptmann S, Wust P, Riess H, Schlag PM, Dörken B, Daniel PT. Dynamic expression profile of p21WAF1/CIP1 and Ki-67 predicts survival in rectal carcinoma treated with preoperative radiochemotherapy. J Clin Oncol. 2003 Sep 15;21(18):3391-401. Epub 2003 Jul 28. Erratum in: J Clin Oncol. 2004 Feb 1;22(3):576.

ReferenceCitation: Komuro Y, Watanabe T, Tsurita G, Muto T, Nagawa H. Evaluating the combination of molecular prognostic factors in tumor radiosensitivity in rectal cancer. Hepatogastroenterology. 2005 May-Jun;52(63):666-71.

ReferenceCitation: Smith FM, Reynolds JV, Miller N, Stephens RB, Kennedy MJ. Pathological and molecular predictors of the response of rectal cancer to neoadjuvant radiochemotherapy. Eur J Surg Oncol. 2006 Feb;32(1):55-64. Epub 2005 Dec 1. Review.

ReferenceCitation: Barratt PL, Seymour MT, Stenning SP, Georgiades I, Walker C, Birbeck K, Quirke P; UKCCCR AXIS trial collaborators. Adjuvant X-ray and Fluorouracil Infusion Study. DNA markers predicting benefit from adjuvant fluorouracil in patients with colon cancer: a molecular study. Lancet. 2002 Nov 2;360(9343):1381-91.

ReferenceCitation: Giralt J, Eraso A, Armengol M, Rosselló J, Majó J, Ares C, Espin E, Benavente S, de Torres I. Epidermal growth factor receptor is a predictor of tumor response in locally advanced rectal cancer patients treated with preoperative radiotherapy. Int J Radiat Oncol Biol Phys. 2002 Dec 1;54(5):1460-5.

ReferenceCitation: Smith FM, Reynolds JV, Kay EW, Crotty P, Murphy JO, Hollywood D, Gaffney EF, Stephens RB, Kennedy MJ. COX-2 overexpression in pretreatment biopsies predicts response of rectal cancers to neoadjuvant radiochemotherapy. Int J Radiat Oncol Biol Phys. 2006 Feb 1;64(2):466-72. Epub 2005 Oct 5.

ReferenceCitation: Komuro Y, Watanabe T, Hosoi Y, Matsumoto Y, Nakagawa K, Tsuno N, Kazama S, Kitayama J, Suzuki N, Nagawa H. The expression pattern of Ku correlates with tumor radiosensitivity and disease free survival in patients with rectal carcinoma. Cancer. 2002 Sep 15;95(6):1199-205.

ReferenceCitation: Rödel F, Hoffmann J, Distel L, Herrmann M, Noisternig T, Papadopoulos T, Sauer R, Rödel C. Survivin as a radioresistance factor, and prognostic and therapeutic target for radiotherapy in rectal cancer. Cancer Res. 2005 Jun 1;65(11):4881-7.

ReferenceCitation: Milas L, Mason KA, Ariga H, Hunter N, Neal R, Valdecanas D, Krieg AM, Whisnant JK. CpG oligodeoxynucleotide enhances tumor response to radiation. Cancer Res. 2004 Aug 1;64(15):5074-7.

ReferenceCitation: Rödel C, Grabenbauer GG, Papadopoulos T, Bigalke M, Günther K, Schick C, Peters A, Sauer R, Rödel F. Apoptosis as a cellular predictor for histopathologic response to neoadjuvant radiochemotherapy in patients with rectal cancer. Int J Radiat Oncol Biol Phys. 2002 Feb 1;52(2):294-303.

ReferenceCitation: Ghadimi BM, Grade M, Difilippantonio MJ, Varma S, Simon R, Montagna C, Füzesi L, Langer C, Becker H, Liersch T, Ried T. Effectiveness of gene expression profiling for response prediction of rectal adenocarcinomas to preoperative chemoradiotherapy. J Clin Oncol. 2005 Mar 20;23(9):1826-38.

ReferenceCitation: Smith FM, Gallagher WM, Fox E, Stephens RB, Rexhepaj E, Petricoin EF 3rd, Liotta L, Kennedy MJ, Reynolds JV. Combination of SELDI-TOF-MS and data mining provides early-stage response prediction for rectal tumors undergoing multimodal neoadjuvant therapy. Ann Surg. 2007 Feb;245(2):259-66.

ReferenceCitation: Hudelist G, Singer CF, Pischinger KI, Kaserer K, Manavi M, Kubista E, Czerwenka KF. Proteomic analysis in human breast cancer: identification of a characteristic protein expression profile of malignant breast epithelium. Proteomics. 2006 Mar;6(6):1989-2002.

ReferenceCitation: Le Moguen K, Lincet H, Marcelo P, Lemoisson E, Heutte N, Duval M, Poulain L, Vinh J, Gauduchon P, Baudin B. A proteomic kinetic analysis of IGROV1 ovarian carcinoma cell line response to cisplatin treatment. Proteomics. 2007 Nov;7(22):4090-101.

location_facility: Laboratoire d'anatomie pathologique, University Hospital, Bordeaux


title: French Lumbar Total Disk Replacement Observational Study (FLTDR Observational Study)

acronym: PTDL

summary:
Primary Objective:

To evaluate the rate of re-operation during the first 5 years following the fitting of lumbar total disk replacement at the operated level and / or floors above and / or underlying, whatever the reasons

status: Unknown status

lead_sponsor: Medtronic France SAS

location_facility:
C.H.P. Clairval
Polyclinique Du Bois
Clinique de Blanc Mesnil
Hopital Paul d'Egine
Hopital Prive Cannes Oxford
Clinique Chirurgicale du Mail
APM La Timone
CH Meulan - Les Mureaux
Hôpital Privé Paul d'Egine
Chu Henri Mondor
Nouvelle Clinique de l'Union
Hôpital Privé Marsielle Beauregard
Clinique Saint Charles
Groupe Hospitalier Paris St Joseph
Centre Medical Chateau Gaillard
Clinique Herbert
Clinique Du Parc
C.H.R.U. de Dijon
Hôpital les Franciscaines
Aphm Hopital de La Conception
G H U Caremeau
Hopital Bicetre (Ap-Hp)
Hopital Saint-Joseph
Hôpitaux Universitaires de Strasbourg
Polyclinique Bordeaux Rive Droite
Clinique Privé Jean Villar
Centre Aquitain du Dos
Hôpital privé de la Loire
Hopital Maison Blanche Chu Reims
Cmc Ambroise Pare
Polyclinique Du Parc
Hopital P. Wertheimer
CH Louis Pasteur
C.H.U. Nantes Hotel-Dieu
Clinique HERBERT
Hopital Européen
CH BESANCON - Hôpital Jean Minjoz
Polyclinique Saint Andre
CHU de Bordeaux - CHU Pellegrin
Clinique Jules Verne
Clinique Du Grand Large
CHU de Nice
Hopital Lariboisiere
Clinique Medipole Garonne
Polyclinique Saint Martin
Clinique de Vitrolles
CHU Bordeaux
Hopital Charles Nicolle Chu Rouen
Clinique Belledonne
CHU de Nice - HOPITAL PASTEUR
Clinique SAINT JEAN
Clinique Saint Jean
C.H.U. D Angers
Clinique Saint-George
Chu Pellegrin
Nouvelles Cliniques Nantaises
Polyclinique Du Sidobre
Chr Orleans
Clinique de Fontiane Les Dijon
Clinique Du Croise Laroche
Hopital Lapeyronie
Hôpital Privé les Franciscaines
Hopital Roger Salengro
Polyclinique de Bois Bernard
Hôpital Européen Georges Pompidou
Clinique des Cèdres
CHRU Dijon le Bocage Central

lead_sponsor_type: industriel

status_simplified: Unknown


title: Evaluation of a New Diagnostic Approach to Familial Amyloid Neuropathy by Mutation of the TTR Gene in a Population of Idiopathic Chronic Neuropathies

acronym: TTR-FAP

summary: TTR-FAP is a rare disabling inherited disorder that predominantly affects the peripheral nervous system and the heart. Due to an important phenotypic and genetic heterogeneity, the diagnosis is often delayed, preventing therefore early onset treatment. Our project is to evaluate the prevalence of TTR-FAP in a series of 130 patients with from chronic neuropathy of undetermined aetiology through a systematic screening of TTR mutations.

study_start_date_type: Actual

primary_purpose: Diagnostic

location_facility: Reference center for neuromuscular diseases

intervention_type: Genetic


title: Ultrasound Monitoring of Fetuses With Vascular Intra-uterine Growth Restriction (IUGR) Using the Isthmus Systolic Index (ISI): Feasibility, Comparison to Normal Fetuses and Association With Perinatal Mortality

acronym: f-ISI-RCIU

summary: Fetuses with IUGR, there is a correlation between Doppler indices of cardiovascular function and perinatal mortality. An index of systolic flow velocities at the aortic isthmus (ISI) has previously been described in a population of normal fetuses. Fetuses with IUGR, the velocities recorded in the aortic isthmus could be affected and the normal development of the ISI should be changed, because of the increase in placental resistance on one hand, and the gradual deterioration ventricular functions on the other one. Investigators hypothesize that the ISI index in the context of placental insufficiency could provide additional arguments on the extraction timing, the prognosis and the fetal extraction mode to severe hypoxia. The primary outcome of the study is to evaluate in an exploratory manner the feasibility and the potential interest of longitudinal monitoring of fetuses with IUGR by Doppler systolic isthmus and the calculation of the ISI index.

location_facility: Service de gynécologie-obstétrique et de médecine fœtale

intervention_type: Other


title: Familial Analysis of Keratoconus Risk

acronym: AFRIK

summary:
The principal objective of this study is to evaluate the frequency of KC inside family of patients with confirmed KC.

It's a familial, epidemiological, prospective, single-center study.

ReferenceCitation: Millodot M, Shneor E, Albou S, Atlani E, Gordon-Shaag A. Prevalence and associated factors of keratoconus in Jerusalem: a cross-sectional study. Ophthalmic Epidemiol. 2011 Apr;18(2):91-7. doi: 10.3109/09286586.2011.560747.

ReferenceCitation: Weed KH, MacEwen CJ, Giles T, Low J, McGhee CN. The Dundee University Scottish Keratoconus study: demographics, corneal signs, associated diseases, and eye rubbing. Eye (Lond). 2008 Apr;22(4):534-41. Epub 2007 Jan 19.

ReferenceCitation: Assiri AA, Yousuf BI, Quantock AJ, Murphy PJ. Incidence and severity of keratoconus in Asir province, Saudi Arabia. Br J Ophthalmol. 2005 Nov;89(11):1403-6. Erratum in: Br J Ophthalmol. 2006 Aug;90(8):1071.

ReferenceCitation: Owens H, Gamble G. A profile of keratoconus in New Zealand. Cornea. 2003 Mar;22(2):122-5.

ReferenceCitation: McMonnies CW, Boneham GC. Keratoconus, allergy, itch, eye-rubbing and hand-dominance. Clin Exp Optom. 2003 Nov;86(6):376-84.

ReferenceCitation: Falls HF, Allen AW. Dominantly inherited keratoconus. J Genet Hum. 1969 Oct;17(3):317-24.

ReferenceCitation: Kemp EG, Lewis CJ. Measurement of total and specific IgE levels in the management of a family exhibiting a high incidence of keratoconus. Acta Ophthalmol (Copenh). 1984 Aug;62(4):524-9.

ReferenceCitation: Ihalainen A. Clinical and epidemiological features of keratoconus genetic and external factors in the pathogenesis of the disease. Acta Ophthalmol Suppl. 1986;178:1-64.

ReferenceCitation: Rabinowitz YS, Garbus J, McDonnell PJ. Computer-assisted corneal topography in family members of patients with keratoconus. Arch Ophthalmol. 1990 Mar;108(3):365-71.

ipd_sharing: No

location_facility: Centre de Référence National du Kératocône Service d'ophtalmologie - Hôpital Pellegrin


title: Vasculopathy, Inflammation and Systemic Sclerosis: The Role of Endothelial Cell Activation and OX40/OX40L in Modulation of T Lymphocyte Activation

acronym: VISS

summary: It is a study of basic research with mechanistically objectives and including clinical biological samples.

design_allocation: Non-Randomized

primary_purpose: Other

location_facility: Service de Rhumatologie - Tripode - Hôpital Pellegrin

intervention_type: Biological


title: Volumetric MR-HIFU Ablation of Uterine Fibroids: Factors Influencing Intraprocedural Thermal Parameters

acronym: PERAGUS

summary:
Magnetic resonance (MR)-guided high-intensity focused ultrasound (HIFU) ablation is increasingly being used worldwide to treat symptomatic uterine fibroids because of its excellent therapeutic efficacy in controlling symptoms and its excellent safety record. Despite the benefits, it should be recognized that MR HIFU ablation does not always yield good therapeutic outcomes. High signal intensity on T2-weighted MR images and a high volume transfer constant (or Ktrans) on dynamic contrast material-enhanced MR images are the most well-known risk factors for poor ablation outcomes as measured with the non-perfused volume (NPV) ratio (ie, NPV divided by fibroid volume).

The aim of this study is to assess the influence of fibroid perfusion (evaluated by MRI and contrast enhanced ultrasound), apparent diffusion coefficient (evaluated by MR-diffusion imaging) and fibroid stiffness (evaluated by ARFI) on ablation efficiency during uterine fibroid treatment by MR-HIFU.

intervention_type: Device


title: Investigation of Kritech Efficacy on Subjects Having Functional Discomfort Associated to Joints and Muscles Disorders

acronym: Easykrill

summary: Joints and muscles disorders are common symptoms in the population. They are characterized by swelling, pain, functional impairment and morning stiffness. These disorders can be really disabling and painful, affecting the person's quality life. The purpose of this clinical trial is to test Kritech (Krill oil) efficacy in reducing these symptoms in 154 subjects complaining functional discomfort associated to joints and muscles disorders.

primary_purpose: Supportive Care

lead_sponsor: Vivatech

location_facility: Plateforme de Recherche Clinique - CIC1401- Plurithématique Tripode 13A3 Hôpital PELLEGRIN


title: Preliminary Study for Selective Detection of the CD8+ Myelin Specific T Cell in the Blood of Multiple Sclerosis Patients (MS).

acronym: IMMUNOSEP

summary: Most experts in the field consider Multiple Sclerosis as the main auto immune disease of the central nervous system. In spite of many works, the data in the literature concerning the antigens targeted by the CD8+ T-Cell response are still contradictory and insufficient.

location_facility: Service de Neurologie - Tripode - Hôpital Pellegrin


title: Cohort Study on the Age-related Macular Degeneration: Incidence and Research for Predisposing Factors

acronym: ECLAIR

summary: Age-related Macular Degeneration (AMD) is the most cause of blindness in the industrialised countries. There are few epidemiological studies on the incidence of this disease. Studying the incidence of AMD in an elderly French population and identifying the predisposing factors is very important to allow a major advance in the epidemiological knowledge of AMD. This study will contribute to the identification of the clinical, genetic and modifiable parameters associated at the risk of developing AMD. This could result in means prevention as well as in the identification of subjects as high risk of AMD

ReferenceCitation: Cougnard-Grégoire A, Delyfer MN, Korobelnik JF, Rougier MB, Malet F, Le Goff M, Dartigues JF, Colin J, Barberger-Gateau P, Delcourt C. Long-term blood pressure and age-related macular degeneration: the ALIENOR study. Invest Ophthalmol Vis Sci. 2013 Mar 28;54(3):1905-12. doi: 10.1167/iovs.12-10192.

ReferenceCitation: Merle B, Delyfer MN, Korobelnik JF, Rougier MB, Colin J, Malet F, Féart C, Le Goff M, Dartigues JF, Barberger-Gateau P, Delcourt C. Dietary omega-3 fatty acids and the risk for age-related maculopathy: the Alienor Study. Invest Ophthalmol Vis Sci. 2011 Jul 29;52(8):6004-11. doi: 10.1167/iovs.11-7254.

ReferenceCitation: Delcourt C, Delyfer MN, Rougier MB, Amouyel P, Colin J, Le Goff M, Malet F, Dartigues JF, Lambert JC, Korobelnik JF. Associations of complement factor H and smoking with early age-related macular degeneration: the ALIENOR study. Invest Ophthalmol Vis Sci. 2011 Jul 29;52(8):5955-62. doi: 10.1167/iovs.10-6235.

location_facility: Unité Médicale Rétine Neuro-Ophtalmologie - Service d'Ophtalmologie - Hopital Pellegrin


title: Transplantation of Ex-vivo Expanded Human Cord Blood Hematopoietic Stem Cells Expanded: Evaluation of Hematopoietic and Immunologic Reconstitution After a Reduced-intensity Conditioning Regimen

acronym: GRAPA

summary:
This program offers the opportunity to receive an allogeneic transplant to try to control the malignant hematologic in the absence of acceptable conventional donor and with a risk-benefit ratio equivalent to that which would be expected with a transplant from a more conventional donor.

An economy of means in that this method could serve as an alternative to 2 units of placental blood transplantation. The current cost of disposal of a unit of placental blood from a bank is approximately 22000 € (Source: Biomedicine Agency, 2007 rates). The amplification process as controlled by "EFSAL" is 12000 €. Therefore, buying a unit and ex-vivo amplification is more economical. Moreover, the availability of placental blood is not infinite, and the use of one unit per patient will also save resources that can be valuable for certain groups of patients.

In the longer term, methods of amplification of specific immunocompetent cells (from the fraction of CD 34 neg cells) are already being evaluated in the laboratory. They allow to consider a faster recovery, better and more targeted, including cells against the disease for which transplantation is performed.

ReferenceCitation: Petersdorf EW. Risk assessment in haematopoietic stem cell transplantation: histocompatibility. Best Pract Res Clin Haematol. 2007 Jun;20(2):155-70. Review.

ReferenceCitation: Koh LP, Chao NJ. Umbilical cord blood transplantation in adults using myeloablative and nonmyeloablative preparative regimens. Biol Blood Marrow Transplant. 2004 Jan;10(1):1-22. Review.

ReferenceCitation: Barker JN, Weisdorf DJ, DeFor TE, Blazar BR, McGlave PB, Miller JS, Verfaillie CM, Wagner JE. Transplantation of 2 partially HLA-matched umbilical cord blood units to enhance engraftment in adults with hematologic malignancy. Blood. 2005 Feb 1;105(3):1343-7. Epub 2004 Oct 5.

ReferenceCitation: Castello S, Podestà M, Menditto VG, Ibatici A, Pitto A, Figari O, Scarpati D, Magrassi L, Bacigalupo A, Piaggio G, Frassoni F. Intra-bone marrow injection of bone marrow and cord blood cells: an alternative way of transplantation associated with a higher seeding efficiency. Exp Hematol. 2004 Aug;32(8):782-7.

ReferenceCitation: Shpall EJ, Quinones R, Giller R, Zeng C, Baron AE, Jones RB, Bearman SI, Nieto Y, Freed B, Madinger N, Hogan CJ, Slat-Vasquez V, Russell P, Blunk B, Schissel D, Hild E, Malcolm J, Ward W, McNiece IK. Transplantation of ex vivo expanded cord blood. Biol Blood Marrow Transplant. 2002;8(7):368-76.

ReferenceCitation: Ljungman P, Urbano-Ispizua A, Cavazzana-Calvo M, Demirer T, Dini G, Einsele H, Gratwohl A, Madrigal A, Niederwieser D, Passweg J, Rocha V, Saccardi R, Schouten H, Schmitz N, Socie G, Sureda A, Apperley J; European Group for Blood and Marrow. Allogeneic and autologous transplantation for haematological diseases, solid tumours and immune disorders: definitions and current practice in Europe. Bone Marrow Transplant. 2006 Mar;37(5):439-49.

ReferenceCitation: Brunstein CG, Barker JN, Weisdorf DJ, DeFor TE, Miller JS, Blazar BR, McGlave PB, Wagner JE. Umbilical cord blood transplantation after nonmyeloablative conditioning: impact on transplantation outcomes in 110 adults with hematologic disease. Blood. 2007 Oct 15;110(8):3064-70. Epub 2007 Jun 14.

ReferenceCitation: Gluckman E, Rocha V. Donor selection for unrelated cord blood transplants. Curr Opin Immunol. 2006 Oct;18(5):565-70. Epub 2006 Aug 8. Review.

ReferenceCitation: Takahashi S. Leukemia: cord blood for allogeneic stem cell transplantation. Curr Opin Oncol. 2007 Nov;19(6):667-72. Review.

ReferenceCitation: Kobari L, Pflumio F, Giarratana M, Li X, Titeux M, Izac B, Leteurtre F, Coulombel L, Douay L. In vitro and in vivo evidence for the long-term multilineage (myeloid, B, NK, and T) reconstitution capacity of ex vivo expanded human CD34(+) cord blood cells. Exp Hematol. 2000 Dec;28(12):1470-80.

ReferenceCitation: Duchez P, Dazey B, Douay L, Vezon G, Ivanovic Z. An efficient large-scale thawing procedure for cord blood cells destined for selection and ex vivo expansion of CD34+ cells. J Hematother Stem Cell Res. 2003 Oct;12(5):587-9.

ReferenceCitation: Dazey B, Duchez P, Letellier C, Vezon G, Ivanovic Z; French Cord Blood Network. Cord blood processing by using a standard manual technique and automated closed system "Sepax" (Kit CS-530). Stem Cells Dev. 2005 Feb;14(1):6-10.

ReferenceCitation: Ivanovic Z, Duchez P, Dazey B, Hermitte F, Lamrissi-Garcia I, Mazurier F, Praloran V, Reiffers J, Vezon G, Boiron JM. A clinical-scale expansion of mobilized CD 34+ hematopoietic stem and progenitor cells by use of a new serum-free medium. Transfusion. 2006 Jan;46(1):126-31.

ReferenceCitation: Barker JN, Weisdorf DJ, DeFor TE, Blazar BR, Miller JS, Wagner JE. Rapid and complete donor chimerism in adult recipients of unrelated donor umbilical cord blood transplantation after reduced-intensity conditioning. Blood. 2003 Sep 1;102(5):1915-9. Epub 2003 May 8.

ReferenceCitation: Ljungman P, Bregni M, Brune M, Cornelissen J, de Witte T, Dini G, Einsele H, Gaspar HB, Gratwohl A, Passweg J, Peters C, Rocha V, Saccardi R, Schouten H, Sureda A, Tichelli A, Velardi A, Niederwieser D; European Group for Blood and Marrow Transplantation. Allogeneic and autologous transplantation for haematological diseases, solid tumours and immune disorders: current practice in Europe 2009. Bone Marrow Transplant. 2010 Feb;45(2):219-34. doi: 10.1038/bmt.2009.141. Epub 2009 Jul 6.

location_facility: Service des maladies du sang - Hôpital Haut-Lévêque - avenue de Magellan

location_facility: Service d'Hématologie, Hôpital Hôtel Dieu, CHU de Nantes - 1 Place Alexis Ricordeau

location_facility: Service d'hématologie et d'Oncologie Clinique - Hôpital Lapeyronie - 371 avenue du Doyen Gaston GIRAUD


title: A Prospective and Retrospective, Open Label Study to Collect Clinical Data to Document Clinical Performance and Safety in Total Knee Arthroplasty Using HLS Implants

summary: The purpose of this study is to evaluate clinical performance and safety in total knee arthroplasty using HLS implants.

status: Recruiting

time_perspective: Other

lead_sponsor: Corin

location_facility: Hopital de la Croix-Rousse, Hospices Civils de Lyon

status_simplified: Ongoing


title: Exploration of Angiogenesis in Decompensated Developmental Venous Abnormalities

acronym: Explor-AVD

summary: The purpose of our study is to demonstrate by blood samples in situ in the vascular lesion (performed during any cerebral catheterization for an embolization of arteriovenous malformation) the existence of angiogenic growth factors and inflammatory factors that would confirm the decompensation of venous ischemia.

primary_purpose: Basic Science

lead_sponsor: Hopital Foch


title: Safety and Tolerability of Yaq-001 in Patients With Non-Alcoholic Steatohepatitis ("NASH-Safety")

summary:
Gut-derived endotoxaemia, microbial imbalance and bacterial translocation play an increasingly recognized role in the progression from non-alcoholic fatty liver disease (NAFLD) to its more advanced state, NASH (non-alcoholic steatohepatitis). Animal model studies confirmed that Yaq-001 reduces liver injury and prevents steatosis in these models which leads to the theoretical potential of Yaq-001 altering the microbiome and gut permeability in patients with NASH.

The purpose of this clinical trial is to study the safety and tolerability of Yaq-001 in patients with NASH. Results from this study will lead to the design of future pivotal performance and safety trials for registration purposes.

Candidate patients must be between 18-70 years old and have a clinical diagnosis of NASH, determined histologically or phenotypically, as well as meeting other clinical inclusion/exclusion criteria.

Eligible patients will be randomly assigned to receive standard of care treatment plus Yaq-001, or standard of care treatment plus placebo).

The treatment lasts for 48 weeks. During treatment, the patient will have 6 study visits. At all the visits, the patients will undergo a routine physical examination, electrocardiogram, collection of blood and urine samples. On three occasions the patients will be asked to provide additional samples of blood, urine and stool for analysis outside the hospital. On two occasions the patient will have a liver Multiscan and on three occasions the patient will have a liver Fibroscan.

70 patients from 9 hospitals in UK, France, Italy, Portugal, Spain and Switzerland will participate in this study.

study_start_date_type: Anticipated

lead_sponsor: Yaqrit Ltd

location_country:
Italy
Switzerland
France
Spain
United Kingdom
Portugal

location_facility: Hospital Clinic of Barcelona , Liver Unit,

location_facility: Inselspital Universitaet Bern, Department for Visceral Surgery and Medicine

location_facility: Hospital Beaujon, Hepatology and Liver Intensive Care,

location_facility: Policlinico S.Orsola Malpighi, Department of Medical and Surgical Sciences

location_facility: Royal Free Hospital, Institute of Liver and Digestive Disease

location_facility: Azienda Ospedaliera di Padova, Hepatic Emergencies Unit

location_facility: Hospital Ramon y Cajal, Department of Gastroenterology and Hepatology


title: Early Detection of Anthracycline Cardiotoxicity by Echocardiographic Analysis of Myocardial Deformation in 2D Strain

summary:
It is now accepted that the anticancer properties of anthracyclines were allowed in many malignancies improve the prognosis of affected populations.

However, the cardiotoxicity of anthracyclines is responsible for an interruption of this treatment by alteration of potentially irreversible myocardial contraction and high mortality.

An earlier detection of adverse myocardial anthracycline chemotherapy would allow the adaptation of the regimen by reducing the number of interruptions of antitumor and strengthening monitoring. Optimizing the therapeutic antitumor and generate an increase in survival of patients treated.

location_facility: Service de Cardiologie et Maladies Vasculaires, Hopital du Haut Lévêque


title: Phase II Non Comparative, Open Study to Assess the Efficacy and Safety of the Botulinum Toxin Type A in Patients With Restless Legs Syndrome (RLS)

acronym: SOXIS

summary: Restless Legs Syndrome (RLS) is a common sensori-motor disorder that causes sensory discomfort and motor restlessness, most often in the legs, which improves with movement. Although medications are available to treat the disorder, many people either experience side effects that prevent them from continuing on the medication or do not sufficiently respond to current RLS medications. Recently, botulinum toxin type A (BNT) has been reported to relief RLS in patients with severe symptoms but this was not confirmed by other anecdotal reports. The investigators propose to test the efficacy of BNT on RLS symptoms by designing a more controlled study. Ultimately, this may lead to extend the therapeutic arsenal of this disorder.

ReferenceCitation: Rotenberg JS, Canard K, Difazio M. Successful treatment of recalcitrant restless legs syndrome with botulinum toxin type-A. J Clin Sleep Med. 2006 Jul 15;2(3):275-8.

ReferenceCitation: Ghorayeb I, Burbaud P. Failure of botulinum toxin A to relieve restless legs syndrome. Sleep Med. 2009 Mar;10(3):394-5. doi: 10.1016/j.sleep.2008.03.002. Epub 2008 May 29.

ReferenceCitation: Nahab FB, Peckham EL, Hallett M. Double-blind, placebo-controlled, pilot trial of botulinum toxin A in restless legs syndrome. Neurology. 2008 Sep 16;71(12):950-1. doi: 10.1212/01.wnl.0000325994.93782.a1.

ReferenceCitation: Ghorayeb I, Bénard A, Vivot A, Tison F, Burbaud P. A phase II, open-label, non-comparative study of Botulinum toxin in Restless Legs Syndrome. Sleep Med. 2012 Dec;13(10):1313-6. doi: 10.1016/j.sleep.2012.08.019. Epub 2012 Oct 11.

family: Ghorayeb

full_name: Imad Ghorayeb

given: Imad

family: Bénard

full_name: Antoine Bénard

given: Antoine

family: Vivot

full_name: Alexandre Vivot

given: Alexandre

family: Tison

full_name: François Tison

given: François

family: Burbaud

full_name: Pierre Burbaud

given: Pierre

journal_name: Sleep Medicine

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

intervention_type: Drug


title: Effects of Gallopamil on Bronchial Smooth Muscle Remodelling in Severe Asthma: a Double Blind Study.

acronym: REMODEL'ASTHME

summary: Severe asthma is a difficult to treat disease, characterized by bronchial remodelling, which is an abnormal repair process that contributes to the development of poorly reversible airway narrowing. Such remodelling is now considered as one of the main prognostic factors. Gallopamil-sensitive calcium influx plays a key role in this remodelling process in vitro. The objective of this study is to compare the effects of gallopamil versus placebo on the bronchial smooth muscle remodelling in severe asthmatic patients.

ReferenceCitation: Trian T, Benard G, Begueret H, Rossignol R, Girodet PO, Ghosh D, Ousova O, Vernejoux JM, Marthan R, Tunon-de-Lara JM, Berger P. Bronchial smooth muscle remodeling involves calcium-dependent enhanced mitochondrial biogenesis in asthma. J Exp Med. 2007 Dec 24;204(13):3173-81. Epub 2007 Dec 3.

ReferenceCitation: Girodet PO, Dournes G, Thumerel M, Begueret H, Dos Santos P, Ozier A, Dupin I, Trian T, Montaudon M, Laurent F, Marthan R, Berger P. Calcium channel blocker reduces airway remodeling in severe asthma. A proof-of-concept study. Am J Respir Crit Care Med. 2015 Apr 15;191(8):876-83. doi: 10.1164/rccm.201410-1874OC.

family: Girodet

full_name: Pierre-Olivier Girodet

given: Pierre-Olivier

family: Dournes

full_name: Gaël Dournes

given: Gaël

family: Thumerel

full_name: Matthieu Thumerel

given: Matthieu

family: Begueret

full_name: Hugues Begueret

given: Hugues

family: Santos

full_name: Pierre Dos Santos

given: Pierre Dos

family: Ozier

full_name: Annaig Ozier

given: Annaig

family: Dupin

full_name: Isabelle Dupin

given: Isabelle

family: Trian

full_name: Thomas Trian

given: Thomas

family: Montaudon

full_name: Michel Montaudon

given: Michel

family: Laurent

full_name: François Laurent

family: Marthan

full_name: Roger Marthan

given: Roger

family: Berger

full_name: Patrick Berger

given: Patrick

journal_name: American Journal of Respiratory and Critical Care Medicine

publisher: American Thoracic Society

publisher_dissemination: American Thoracic Society

publisher_group: American Thoracic Society

publisher_normalized: American Thoracic Society

title: Calcium Channel Blocker Reduces Airway Remodeling in Severe Asthma. A Proof-of-Concept Study

location_facility: Hôpital Haut-Lévêque - Centre Hospitalier Universitaire de Bordeaux


title: Real Time Continuous Glucose Monitoring With Glucoday® as an Assistant for Intensive Insulin Therapy in Diabetic Cardiothoracic Surgery Patients: a Randomized Study Comparing Blood Glucose Measurements Alone or Associated to Continue Glucose Monitoring

acronym: MARGE

summary:
An increased risk of adverse outcome is noted for diabetic patients admitted in surgery intensive care units (ICU). Tight glycemic control with intensive insulin therapy dramatically reduces in-hospital mortality and adverse outcome. Devices recording continuously interstitial glucose monitoring (CGM) may be an aid in patients of ICU in whom normoglycemia become a target.

The mini-invasive device (Glucoday®) should provide real-time glucose concentrations in order to quickly adjust insulin infusion rates. The objective of MARGE study is to compare percent of time in normoglycemia based on conventional monitoring (discontinuous glucose monitoring) and Glucoday to conventional monitoring alone. The MARGE study is a multicenter (2 centers), randomized, single blind trial.

Several studies have shown that hyperglycemia is associated with poor outcomes in hospitalized patients. Postoperative glucose levels are a significant predictor of infection rates after cardiac surgery and death rate. Based on these observational studies, a randomized controlled intervention trial in surgical ICU patients demonstrated that intensive insulin therapy reduced the overall in-hospital mortality by 34 % and stream infection by 46 %. Using continuous glycemic monitoring (CGM) it has been shown that intensive insulin therapy based on discontinuous glucose monitoring revealed that normoglycemia is achieved only 22 % of time. The researchers' aim is to determine if real time CGM with a new generation mini invasive device, Glucoday® S, would allow quickly adjusting insulin infusions rates according to interstitial glucose levels and decreasing both hyperglycemic and hypoglycemic excursions. This study will further investigate whether application of real time CGM to titrate insulin therapy to target glycemia in a tight range (80-110 mg/dl) can improve diabetic patient outcome after coronary artery bypass grafting (CABG).

status: Terminated

primary_purpose: Prevention

ReferenceCitation: Calafiore AM, Di Mauro M, Di Giammarco G, Contini M, Vitolla G, Iacò AL, Canosa C, D'Alessandro S. Effect of diabetes on early and late survival after isolated first coronary bypass surgery in multivessel disease. J Thorac Cardiovasc Surg. 2003 Jan;125(1):144-54.

ReferenceCitation: Capes SE, Hunt D, Malmberg K, Gerstein HC. Stress hyperglycaemia and increased risk of death after myocardial infarction in patients with and without diabetes: a systematic overview. Lancet. 2000 Mar 4;355(9206):773-8. Review.

ReferenceCitation: Furnary AP, Gao G, Grunkemeier GL, Wu Y, Zerr KJ, Bookin SO, Floten HS, Starr A. Continuous insulin infusion reduces mortality in patients with diabetes undergoing coronary artery bypass grafting. J Thorac Cardiovasc Surg. 2003 May;125(5):1007-21.

ReferenceCitation: Furnary AP, Zerr KJ, Grunkemeier GL, Starr A. Continuous intravenous insulin infusion reduces the incidence of deep sternal wound infection in diabetic patients after cardiac surgical procedures. Ann Thorac Surg. 1999 Feb;67(2):352-60; discussion 360-2.

ReferenceCitation: Koschinsky T, Heinemann L. Sensors for glucose monitoring: technical and clinical aspects. Diabetes Metab Res Rev. 2001 Mar-Apr;17(2):113-23. Review.

ReferenceCitation: Malmberg K. Prospective randomised study of intensive insulin treatment on long term survival after acute myocardial infarction in patients with diabetes mellitus. DIGAMI (Diabetes Mellitus, Insulin Glucose Infusion in Acute Myocardial Infarction) Study Group. BMJ. 1997 May 24;314(7093):1512-5.

ReferenceCitation: Malmberg K, Norhammar A, Wedel H, Rydén L. Glycometabolic state at admission: important risk marker of mortality in conventionally treated patients with diabetes mellitus and acute myocardial infarction: long-term results from the Diabetes and Insulin-Glucose Infusion in Acute Myocardial Infarction (DIGAMI) study. Circulation. 1999 May 25;99(20):2626-32.

ReferenceCitation: Malmberg K, Rydén L, Wedel H, Birkeland K, Bootsma A, Dickstein K, Efendic S, Fisher M, Hamsten A, Herlitz J, Hildebrandt P, MacLeod K, Laakso M, Torp-Pedersen C, Waldenström A; DIGAMI 2 Investigators. Intense metabolic control by means of insulin in patients with diabetes mellitus and acute myocardial infarction (DIGAMI 2): effects on mortality and morbidity. Eur Heart J. 2005 Apr;26(7):650-61. Epub 2005 Feb 23.

ReferenceCitation: Maran A, Crepaldi C, Tiengo A, Grassi G, Vitali E, Pagano G, Bistoni S, Calabrese G, Santeusanio F, Leonetti F, Ribaudo M, Di Mario U, Annuzzi G, Genovese S, Riccardi G, Previti M, Cucinotta D, Giorgino F, Bellomo A, Giorgino R, Poscia A, Varalli M. Continuous subcutaneous glucose monitoring in diabetic patients: a multicenter analysis. Diabetes Care. 2002 Feb;25(2):347-52.

ReferenceCitation: McAlister FA, Man J, Bistritz L, Amad H, Tandon P. Diabetes and coronary artery bypass surgery: an examination of perioperative glycemic control and outcomes. Diabetes Care. 2003 May;26(5):1518-24.

ReferenceCitation: Van den Berghe G. How does blood glucose control with insulin save lives in intensive care? J Clin Invest. 2004 Nov;114(9):1187-95. Review.

ReferenceCitation: van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67.

location_facility: Service d'endocrinologie-Diabétologie - Hôpital Haut-Lévêque - CHU de Bordeaux


title: Double Blind, Randomised, Placebo-controlled Study of Propranolol in Infantile Capillary Hemangiomas

acronym: HEMANGIOMA

summary:
The investigators observed that Propranolol, a beta-blocker commonly used in children was efficient to control the growth of alarming hemangiomas of the face.

The primary objective of this study is to determine the efficiency of 1 month-early treatment of propranolol in infants aged less than 4 months affected by an hemangioma without any consequences on vital or functional structure and not justifying corticosteroids.

The secondary objectives are:

the kinetic of the hemangioma evolution in infants treated by propranolol
Observance
Safety

ReferenceCitation: Léauté-Labrèze C, Dumas de la Roque E, Hubiche T, Boralevi F, Thambo JB, Taïeb A. Propranolol for severe hemangiomas of infancy. N Engl J Med. 2008 Jun 12;358(24):2649-51. doi: 10.1056/NEJMc0708819.

ReferenceCitation: Tortoriello TA, Snyder CS, Smith EO, Fenrich AL Jr, Friedman RA, Kertesz NJ. Frequency of recurrence among infants with supraventricular tachycardia and comparison of recurrence rates among those with and without preexcitation and among those with and without response to digoxin and/or propranolol therapy. Am J Cardiol. 2003 Nov 1;92(9):1045-9.

ReferenceCitation: Villain E, Denjoy I, Lupoglazoff JM, Guicheney P, Hainque B, Lucet V, Bonnet D. Low incidence of cardiac events with beta-blocking therapy in children with long QT syndrome. Eur Heart J. 2004 Aug;25(16):1405-11.

ReferenceCitation: Kilian K. Hypertension in neonates causes and treatments. J Perinat Neonatal Nurs. 2003 Jan-Mar;17(1):65-74; quiz 75-6. Review.

ReferenceCitation: Fritz KI, Bhat AM. Effect of beta-blockade on symptomatic dexamethasone-induced hypertrophic obstructive cardiomyopathy in premature infants: three case reports and literature review. J Perinatol. 1998 Jan-Feb;18(1):38-44. Review.


lead_sponsor: EspeRare Foundation

location_country:
Italy
United Kingdom
France
Spain

location_facility: UCL Institute of Child Health and Great Ormond Street Hospital

type: EudraCT Number

source: euctr

title: A Phase Ib, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of Rimeporide in Patients With Duchenne Muscular Dystrophy

summary: In Duchenne Muscular Dystrophy (DMD) there is an imbalance between the levels of calcium and sodium in the muscles cells which is thought to be important in the damage which occurs overtime. Sodium/proton type 1 exchanger (NHE-1) inhibition is an innovative pathway that has proved to efficiently prevent the accumulation of muscle damage (inflammation and fibrosis) in animal models of muscular dystrophies and heart failure. Based on prior safety and efficacy results in animal and humans, NHE-1 inhibition with Rimeporide represents a new therapeutic approach with no restriction on age and on genetic subtypes which could be combined to other treatments that restore or augment dystrophin.This study examines the safety and tolerability and effects on the muscles of rimeporide, in patients aged 6 to 14 years with Duchenne Muscular Dystrophy (DMD).


title: Evaluation of Satisfaction Regarding Home Healthcare Provider (HHP) Management of Type 1 Diabetic Patients Equipped With the "Closed-loop" Automated Insulin Delivery System (or "Artificial Pancreas"), Under Normal Conditions of Use

acronym: SATURN

summary: SATURN study aims at evaluating Home Healthcare Provider (HHP) Management of type 1 diabetic patients using a closed-loop automatic insulin delivery system (or artificial pancreas), and specifically satisfaction and interactions of all people involved (patients, HHPs, hospital healthcare teams) after 1 and 3 months of follow-up, under normal conditions of use.

primary_purpose: Health Services Research

lead_sponsor: Air Liquide Santé International

location_facility:
CHU de Nantes - Hôpital Nord Laennec
CHU de Toulouse - Hôpital Rangueil


title: Towards Improving Information, Testing and Treatment for Partners of People Diagnosed With STIs in Testing Centres and Sexual Health Clinics, the Not'IST Study

acronym: Not'IST

summary:
Since the 2000s, the incidence of bacterial STIs increases, mainly among men who have sex with men but also among heterosexual men and women with multiple sexual partners. A partner notification (PN) approach could break transmission chains and curb STI epidemics. PN brings together a set of interventions to help people diagnosed with STIs to inform their partners, encourage them to get tested, so that they can access treatment or prevention. A PN approach, systematically offered at STI diagnosis, has not yet been implemented in France and needs to be evaluated. In 2018, the Conseil National du Sida (French National AIDS Council) stated in favor of a formalized PN approach, particularly in testing centers, which carry out a large part of STI diagnoses.

The aim of our research project is to build interventions facilitating information, testing and treatment of partners of people diagnosed with STIs in testing centers and sexual health clinics.

Step 1: A cross-sectional study

Primary objective

To describe the PN practices of people diagnosed with an STI in testing centers and sexual health clinics without any intervention

Secondary objectives

To describe the profiles of people diagnosed with an STI in testing centers or sexual health clinics and therefore likely to receive an intervention to help them notify their partners;
To describe the profiles of people notified by their partners and who attend testing centers or sexual health clinics for STI testing;
To describe the notification received by these notified partners and identify the facilitators of testing use following notification.

Step 2: A qualitative study

Objectives

To evaluate the acceptability of testing center staff for an STI notification program in general and discuss the feasibility of interventions pre-identified by a literature review;
In a collaborative (researchers and staffs) approach, to adapt these interventions to (1) the testing centers working and (2) the needs of their users identified in the cross-sectional study.

Expected results

This study is the first step in implementation of a PN program as part of a comprehensive management of STI diagnoses in France.

status: Not yet recruiting

time_perspective: Cross-Sectional

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility:
CeGIDD de Lille
CeGIDD - La Joliette
Centre de santé sexuelle - LE 190
Institut Alfred Fournier
CeGIDD - Saint Adrien
CeGIDD d'Aix-en-Provence


title: ICU Diaries Impact of an ICU Diary on the Psychological Well-being of the Patients and Their Relatives. Mixed Multicenter Randomized Study With Blind Evaluation

acronym: ICU-diary

summary: The purpose of this study is to assess the influence of an ICU diary implemented during the ICU stay on the psychological well-being of patients and families after ICU discharge.

ReferenceCitation: Garrouste-Orgeas M, Flahault C, Vinatier I, Rigaud JP, Thieulot-Rolin N, Mercier E, Rouget A, Grand H, Lesieur O, Tamion F, Hamidfar R, Renault A, Parmentier-Decrucq E, Monseau Y, Argaud L, Bretonnière C, Lautrette A, Badié J, Boulet E, Floccard B, Forceville X, Kipnis E, Soufir L, Valade S, Bige N, Gaffinel A, Hamzaoui O, Simon G, Thirion M, Bouadma L, Large A, Mira JP, Amdjar-Badidi N, Jourdain M, Jost PH, Maxime V, Santoli F, Ruckly S, Vioulac C, Leborgne MA, Bellalou L, Fasse L, Misset B, Bailly S, Timsit JF. Effect of an ICU Diary on Posttraumatic Stress Disorder Symptoms Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial. JAMA. 2019 Jul 16;322(3):229-239. doi: 10.1001/jama.2019.9058.

name: Infection, Antimicrobials, Modelling, Evolution (IAME), UMR 1137, INSERM, Paris Diderot University, Department of Biostatistics - HUPNVS. - AP-HP, UFR de Médecine - Bichat University Hospital, Paris, France

name: Department of Biostatistics, Outcomerea, Paris, France

name: Medical unit, French British Hospital, Levallois-Perret, France

family: Garrouste-Orgeas

full_name: Maité Garrouste-Orgeas

given: Maité

name: LPPS-EA4057, Laboratory of Psychopathology and Health Process, Paris Descartes University, Paris, France

family: Flahault

full_name: Cécile Flahault

given: Cécile

name: Medical ICU, Les Oudaries Hospital, La Roche-sur-Yon, Vendée, France

family: Vinatier

full_name: Isabelle Vinatier

name: Department of Intensive Care, Dieppe General Hospital, Dieppe, France

family: Rigaud

full_name: Jean-Philippe Rigaud

given: Jean-Philippe

name: Medical-Surgical ICU, General Hospital, Melun, France

family: Thieulot-Rolin

full_name: Nathalie Thieulot-Rolin

given: Nathalie

name: CRICS-TRIGGERSEP group, Medical-Surgical ICU, Tours University Hospital, Tours, France

family: Mercier

full_name: Emmanuelle Mercier

given: Emmanuelle

name: Medical-Surgical ICU, Rangueil University Hospital, Toulouse, France

family: Rouget

full_name: Antoine Rouget

name: Medical-Surgical ICU, Hospital Robert Boulin, Libourne, France

family: Grand

full_name: Hubert Grand

given: Hubert

name: Medical-Surgical ICU, General Hospital, La Rochelle, France

family: Lesieur

full_name: Olivier Lesieur

given: Olivier

name: Medical ICU, University Medical Center, Rouen, France

name: INSERM U-1096, University of Rouen, Rouen, France

family: Tamion

full_name: Fabienne Tamion

given: Fabienne

name: Medical ICU, Albert Michallon University Hospital, Grenoble, France

family: Hamidfar

full_name: Rebecca Hamidfar

given: Rebecca

name: Medical ICU, La Cavale Blanche University Hospital, Brest, France

family: Renault

full_name: Anne Renault

given: Anne

name: Group of medical ICUs, Lille University Hospital, Lille, France

family: Parmentier-Decrucq

full_name: Erika Parmentier-Decrucq

given: Erika

name: Medical-Surgical ICU, General Hospital, Périgueux, France

family: Monseau

full_name: Yannick Monseau

given: Yannick

name: Medical ICU, Edouard Herriot University Hospital, Lyon, France

family: Argaud

full_name: Laurent Argaud

given: Laurent

name: Medical ICU, Nantes University Hospital, Nantes, France

name: EA3826, Laboratory of Clinical and Experimental Therapeutics of Infections, University of Nantes, Nantes, France

family: Bretonnière

full_name: Cédric Bretonnière

given: Cédric

name: Medical ICU, Gabriel-Montpied University Hospital, Clermont Ferrand, France

name: LMGE UMR CNRS 6023, University of Clermont-Ferrand, Clermont Ferrand, France

family: Lautrette

full_name: Alexandre Lautrette

name: Medical-Surgical ICU, General Hospital Belfort-Montbéliard, Belfort, France

family: Badié

full_name: Julio Badié

given: Julio

name: Medical ICU, Beaumont General Hospital, Beaumont, France

family: Boulet

full_name: Eric Boulet

given: Eric

name: Medical ICU, Hospices Civils de Lyon, Edouard Herriot University Hospital, Lyon, France

family: Floccard

full_name: Bernard Floccard

given: Bernard

name: Medical-Surgical ICU, Great Hospital of East Francilien, Meaux, France

family: Forceville

full_name: Xavier Forceville

given: Xavier

name: Surgical ICU, Lille University Hospital, Lille, France

family: Kipnis

full_name: Eric Kipnis

name: Medical-Surgical ICU, Saint Joseph Hospital Network, Paris, France

family: Soufir

full_name: Lilia Soufir

given: Lilia

name: Medical ICU, Saint Louis University Hospital, Paris, France

name: Medical ICU, Saint Antoine University Hospital, Paris, France

name: Medical-Surgical ICU, Gustave Roussy Cancer Campus, Villejuif, France

name: Medical Surgical ICU, University Hospital Paris -Sud, Beclère University Hospital, Clamart, France

name: Medical-Surgical ICU, General Hospital, Troyes, France

name: Medical-Surgical ICU, General Hospital Victor Dupouy, Argenteuil, France

name: Medical ICU, Bichat University Hospital, Paris, France

name: Medical ICU, François Mitterrand University Hospital, Dijon, France

name: Medical ICU, Cochin University Hospital, Paris Centre Hospital Group, AP-HP, Paris, France

name: Medical-Surgical ICU, General Hospital René Dubos, Pontoise, France

name: Lille University, Inserm U1190, Lille, France

name: Surgical ICU, Henri Mondor University Hospital, Créteil, France

name: Medical ICU, Raymond Poincaré University Hospital, Garches, France

name: Medical ICU, General Hospital Robert Ballanger, Aulnay-Sous-Bois, France

name: Grenoble Alpes University, INSERM, University hospital Grenoble Alpes, HP2, Grenoble, France

ReferenceCitation: Garrouste-Orgeas M, Flahault C, Fasse L, Ruckly S, Amdjar-Badidi N, Argaud L, Badie J, Bazire A, Bige N, Boulet E, Bouadma L, Bretonnière C, Floccard B, Gaffinel A, de Forceville X, Grand H, Halidfar R, Hamzaoui O, Jourdain M, Jost PH, Kipnis E, Large A, Lautrette A, Lesieur O, Maxime V, Mercier E, Mira JP, Monseau Y, Parmentier-Decrucq E, Rigaud JP, Rouget A, Santoli F, Simon G, Tamion F, Thieulot-Rolin N, Thirion M, Valade S, Vinatier I, Vioulac C, Bailly S, Timsit JF. The ICU-Diary study: prospective, multicenter comparative study of the impact of an ICU diary on the wellbeing of patients and families in French ICUs. Trials. 2017 Nov 15;18(1):542. doi: 10.1186/s13063-017-2283-y.

location_facility: Medical and surgical Intensive Care unit


type: Other Identifier

title: Impact of Global Care of the Pain at Chronic Painful Patients Affected by Cystic Fibrosis

acronym: MUCO-SOPHRO

summary: The purpose of this study is to evaluate the impact of the global approach to the pain in cystic fibrosis patients with chronic or intermittent pain. The patients will receive in addition to an usual pharmacological and psychological management, sophrology sessions at home. The results of this study will provide a new strategy of management of the patient's pain.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Study of Subjective Perception of Motor Control During Psychogenic Disorders : Brain Mechanisms and Functional Imaging.

acronym: PERCMO-TNF

summary:
The aim of this study is to reveal neurobiological bases of the motor control of conscious perception, thanks to new techniques of functional cerebral imaging (MRI), and potentials deteriorations connected to neuropsychiatric disorders like conversion disorder.

The Hospital University Center of Grenoble will provide patients from Neurology department, characterized with non psychogenic epileptic seizures and abnormal psychogenic movements, from conversive origin.

Subjects will be scanned by Magnetic Resonance Imaging during a motor paradigm inducing a perceptive conflict between two informations : proprioceptive information coming from the action (drawing) and visual information (draw's mark) that appears on the screen when there is movement.

ReferenceCitation: Desmurget M, Grafton S. Forward modeling allows feedback control for fast reaching movements. Trends Cogn Sci. 2000 Nov 1;4(11):423-431.

ReferenceCitation: Wolpert DM, Ghahramani Z, Jordan MI. An internal model for sensorimotor integration. Science. 1995 Sep 29;269(5232):1880-2.

ReferenceCitation: Sabes PN. The planning and control of reaching movements. Curr Opin Neurobiol. 2000 Dec;10(6):740-6. Review.

ReferenceCitation: Rothwell JC, Traub MM, Day BL, Obeso JA, Thomas PK, Marsden CD. Manual motor performance in a deafferented man. Brain. 1982 Sep;105 (Pt 3):515-42.

ReferenceCitation: Ghez C, Hening W, Gordon J. Organization of voluntary movement. Curr Opin Neurobiol. 1991 Dec;1(4):664-71. Review.

ReferenceCitation: van Beers RJ, Baraduc P, Wolpert DM. Role of uncertainty in sensorimotor control. Philos Trans R Soc Lond B Biol Sci. 2002 Aug 29;357(1424):1137-45. Review.

ReferenceCitation: Fourneret P, Jeannerod M. Limited conscious monitoring of motor performance in normal subjects. Neuropsychologia. 1998 Nov;36(11):1133-40.

ReferenceCitation: Carson AJ, Stone J, Warlow C, Sharpe M. Patients whom neurologists find difficult to help. J Neurol Neurosurg Psychiatry. 2004 Dec;75(12):1776-8.

ReferenceCitation: Vuilleumier P, Chicherio C, Assal F, Schwartz S, Slosman D, Landis T. Functional neuroanatomical correlates of hysterical sensorimotor loss. Brain. 2001 Jun;124(Pt 6):1077-90. Erratum in: Brain. 2016 May;139(Pt 5):e29.

ReferenceCitation: Cojan Y, Waber L, Carruzzo A, Vuilleumier P. Motor inhibition in hysterical conversion paralysis. Neuroimage. 2009 Sep;47(3):1026-37. doi: 10.1016/j.neuroimage.2009.05.023. Epub 2009 May 18.

ReferenceCitation: Cojan Y, Vuilleumier P. Functional brain imaging of psychogenic paralysis during conversion and hypnosis

ReferenceCitation: Hallet M, cloninger CR, Fahn S, Halligan P, Jankovic J, Lang AE, Voon V Psychogenic movement disorders and other conversion disorders. Cambridge University Press 2011

ReferenceCitation: de Lange FP, Roelofs K, Toni I. Motor imagery: a window into the mechanisms and alterations of the motor system. Cortex. 2008 May;44(5):494-506. doi: 10.1016/j.cortex.2007.09.002. Epub 2007 Dec 23.

ReferenceCitation: Blakemore SJ, Wolpert DM, Frith CD. Abnormalities in the awareness of action. Trends Cogn Sci. 2002 Jun 1;6(6):237-242.

ReferenceCitation: de Lange FP, Roelofs K, Toni I. Increased self-monitoring during imagined movements in conversion paralysis. Neuropsychologia. 2007 May 15;45(9):2051-8. Epub 2007 Feb 11.

ReferenceCitation: Friston KJ, Holmes AP, Worsley KJ. How many subjects constitute a study? Neuroimage. 1999 Jul;10(1):1-5.

ReferenceCitation: Stone J, Carson A, Sharpe M. Functional symptoms in neurology: management. J Neurol Neurosurg Psychiatry. 2005 Mar;76 Suppl 1:i13-21. Review.

lead_sponsor: University Hospital, Grenoble


title: Evaluation of Improving Quality of Life of Fibromyalgia Patients Treated With a Plurifocal Program : a Controlled Study With 12 Months Monitoring.

acronym: Aquavip

summary: Comparison of two treatments of fibromyalgia; the QOL score should improve rather and, twelve months after the end of the program, remain higher in "Plurifocal educational group" than in control group

intervention_type: Behavioral


title: Prospective, Controlled, Single-arm Clinical Investigation for the Treatment of Subjects With Severe Symptomatic Aortic Valve Stenosis Using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-Man

summary: This is a prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-man

lead_sponsor: Cardiawave SA

location_country: France Netherlands

location_facility:
Hôpital Européen Georges Pompidou
Amphia Hospital


title: Fungal Biomarkers to Reduce Duration of Empirical Antifungal Therapy: a Randomized Comparative Study

acronym: STAFE

summary: The investigators hypothesized that the use of biomarkers of invasive fungal infections would increase the percentage of early discontinuation of empirical antifungal therapy and thus reduce the duration of treatment in ICU patients.

ReferenceCitation: Rouzé A, Loridant S, Poissy J, Dervaux B, Sendid B, Cornu M, Nseir S; S-TAFE study group. Biomarker-based strategy for early discontinuation of empirical antifungal treatment in critically ill patients: a randomized controlled trial. Intensive Care Med. 2017 Nov;43(11):1668-1677. doi: 10.1007/s00134-017-4932-8. Epub 2017 Sep 22.

family: Rouzé

full_name: Anahita Rouzé

given: Anahita

family: Loridant

full_name: Séverine Loridant

given: Séverine

family: Poissy

full_name: Julien Poissy

given: Julien

family: Dervaux

full_name: Benoit Dervaux

given: Benoit

family: Sendid

full_name: Boualem Sendid

given: Boualem

family: Cornu

full_name: Marjorie Cornu

given: Marjorie

family: Nseir

full_name: Saad Nseir

given: Saad

journal_name: Intensive Care Medicine

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: University Hospital, Lille

location_facility: ICU, Salengro Hospital, University Hospital of Lille


title: Impact of a One-month Long Detoxification Diazepam Treatment on Early Alcohol Relapse

acronym: DIAMA

summary:
Alcohol-dependence is a medical condition that can lead to the occurrence of an alcohol withdrawal syndrome (AWS) in case of alcohol drinking cessation. Diazepam is the reference medication for preventing or treating AWS. The recommended average diazepam treatment duration is usually around one week, and this duration is generally not considered to impact the subsequent relapse rate in alcohol drinking.

However, several previous studies have found that patients experienced frequent anxious symptoms during the weeks following detoxification. Such symptoms may foster early relapse in alcohol drinking. Furthermore, it has been suggested that this anxiety could pertain to late withdrawal symptoms.

The DIAMA study hypothesizes that extending the diazepam detoxification treatment to one month can significantly reduce the cumulated relapse rate in alcohol drinking over the three following months.

location_facility: Outpatient Addiction Center "CSAPA - Le Pari"


title: Morphological and Functional Investigation of the Serotoninergic System in Multiple System Atrophy: a 18F-MPPF PET Study

acronym: SEROTAMS

summary: Multiple system atrophy (MSA) is a sporadic neurodegenerative disorder of the adult associated to a poor prognosis. MSA is clinically characterized by the association of extra-pyramidal, dysautonomic, cerebellar and pyramidal symptoms. Histological and biological studies have raised the hypothesis that, beside the well known dopamine deficiency, some of the symptoms could be related to a dysfunction in serotoninergic neurotransmission. Serotonin is involved in the modulation of several functions impaired in MSA, such as mood, motricity or sleep. The recent description of an association between loss of brainstem serotonin neurons and sudden death in patients with MSA reinforced the hypothesis of a critical role played by this neurotransmitter in the pathophysiology of this disease. Autoreceptors called 5-HT1a are strongly involved in the regulation of serotonin neurotransmission. During the last years several radio-ligands allowing in vivo PET quantification of 5-HT1a receptors, such as 18F-MPPF (4-(2'-methoxyphenyl)-1-[2'-(N-2''-piridinyl)-p-fluorobenzamide]methylpiperazine), were developed. Moreover, the investigators recently demonstrated the ability of this brain functional imaging method to investigate, in healthy volunteers, the functional properties of 5-HT1a autoreceptors through an evaluation of their desensitization after a single oral dose of fluoxetine.

location_facility:
CHU de Bordeaux
CHU Limoges
CHU de Toulouse


title: Predictives Factors of Cardiac Resynchronization Therapy: a Multimodal Analysis Using 2D Speckle Tracking Echocardiography Coupled With MIBG Myocardial Scintigraphy and Heart Failure Biomarkers

acronym: PREFAC-CRT

summary: Cardiac resynchronization therapy (CRT) is one of the lastest recommended treatments in patients with refractory symptomatic chronic heart failure with reduced ejection fraction (HFREF). Despite clear guidelines 20 to 40 % of implanted patients are not clinically ameliorated. They are called the "non responders". Patient selection seams to be one of the key to improve the efficiency of CRT. This protocol try to assess positive predictive factors to CRT by a multimodal approach.

lead_sponsor: University Hospital, Clermont-Ferrand


title: Safety and Tolerability of Yaq-001 in Patients With Cirrhosis ("CARBALIVE-SAFETY")

summary:
In patients with cirrhosis (scarring of the liver), bacterial fragments leak from the gut into the blood and cause harm. This study looks into a new way to lower the leakage of bacterial fragments into the blood.

Yaq-001 is a new type of carbon that in previous laboratory studies has been shown to have the ability to bind these bacterial fragments and so confine them to the gut. The purpose of this clinical trial is to test the product Yaq-001 for the first time in patients with cirrhosis.

This trial will assess if the treatment with Yaq-001 is safe, is well tolerated, and if it helps improve the overall health status of the cirrhotic patients.

Candidate patients must be at least 18 years old and have a clinical diagnosis of cirrhosis for any cause. Only postmenopausal women or with surgical sterilisation are eligible. Additional inclusion and exclusion criteria of medical nature will be determined with the investigator at the screening visit, by means of standard care routines plus an additional test to assess the bowel transit time.

Eligible patients will be randomly grouped to receive standard care treatment plus Yaq-001, or standard treatment plus placebo (non-active treatment). The use of placebo is necessary to better understand how safe and tolerable Yaq-001 really is.

The treatment lasts for 12 weeks. During treatment, the patient will be visited by a study doctor 5 times. At all the visits the patients will undergo a routine physical examination, electrocardiogram, collection of blood and urine samples. On three occasions the patients will be asked to provide additional samples of blood, urine and stool for analysis outside the hospital.

56 patients from 9 hospitals in UK, France, Italy, Portugal, Spain and Switzerland will participate in this study.

primary_purpose: Device Feasibility

location_facility: Inselspital Universitaet Bern, Department for Visceral Surgery and Medicine,

location_facility: Hospital Clinic of Barcelona , Liver Unit,


title: Evaluation of the Incidence of Acute Kidney Attack by Dosing Nephrocheck® in Severe Traumatized Patients

acronym: NEPHROTRAUMA

summary: Acute Kidney Injury (AKI) is a common complication of severe traumatized patients. The diagnosis is often delayed. The Nephrocheck® test allows an earlier assessment of renal stress. The objective of our study is to determine the incidence of risk of AKI in severe traumatized patients within the first 24 hours after their admission to our trauma center. The risk of AKI is defined by a NephroCheck® test >0.3

lead_sponsor: Hospices Civils de Lyon


title: Post-Market Evaluation of HEMOBLAST™ Bellows Performance and Safety in Open Gynecological, Urological, ENT, Head and Neck, and Vascular Surgeries

acronym: NOBLE-Open

summary: A prospective, multi-center, multi-national single arm study to evaluate the performance and safety of HEMOBLAST™ Bellows in open gynecological, urological, ENT and head and neck, and vascular surgery.

ipd_sharing: Undecided

lead_sponsor: Biom'Up France SAS

location_country: Austria Germany France

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Kliniken der Stadt Koln, Krankenhaus Merheim


title: Interest of COLchicine in the Treatment of Patients With Acute Myocardial INfarction and With Inflammatory Response

acronym: COLIN

summary:
Background:

Colchicine is an old well-known venerable drug routinely used in gout attacks for instance.

More recnetly it is regularly use in the treatment of pericarditis. It couls exert antiiflammatory effects targeting the adverse inflammation occuring incase of acute myocardial infarction, which is involved in poor outcomes or longer stay at hospital.

Endpoints:

Main endpoint: AUC CRP during the initial hospital stay

Secondary endpoints:

Clinical: oucomes
Imaging: ETT, MRI
Biological: various biomarkers

Method Randomized, controled, open-labbelled, comparing two parallel arms: conventionnal optimal treatment versus conventionnal optimal treatment + colchicine

lead_sponsor: University Hospital, Montpellier

location_facility: University Hospital Arnaud de Villeneuve


title: Indication of Permanent Cardiac Parcing After Tanscatheter Aortic Valve Implantation : Contribution of Electrophysioly Study

acronym: TAVISTIM

summary:
Since 2002, transcatheter aortic valve implantation (TAVI) has resulted in a dramatic change in the prognosis of patients with aortic valve stenosis illegible to surgery. However, this intervention may induce heavy conduction disorder due to the proximity of the aortic annulus and the conduction pathways. So far, there is no clear recommandation for clinical management of conduction disorder after TAVI. Standard criterion cannot be applied due to the multiple comorbidity factors observed in these patients. As described in conventional aortic valve surgery, a degree of inflammation and ischemia of the conduction pathways may be involved in the first days. This is the reason underlying the systematic implantation of epicardial electrodes. Such temporary back-up pacing is not possible in TAVI patients.

The primary end-point of this study is to confirm that standard criterion for pacing are reliable in post-TAVI conduction disorders and to analyze the contribution of a systematic electrophysiological study (EPS).

In TAVI patients, indications for pacing were persistent high-degree atrioventricular block (AVB) or bundle branch block appearance associated to HV interval longer than 70ms, 24 hours after the procedure.

After a two-month follow-up, clinical and ECG evaluation and 24-hour holter monitoring will be realized in patients without pacemaker and compared to data obtained from the devices in pacemaker-implanted patients (% of ventricular pacing > 1% ; presence of more than 1 AVB episod).


title: Efficiency Evaluation of Photodynamic Therapy With Photofrin® on Unresectable Type III or IV Cholangiocarcinomas - A Prospective, Multicentric and Randomized Study.

acronym: CK/PDT

summary:
Unresectable type III or IV cholangiocarcinoma has a very bad prognosis; survival median ranges between 6 and 9 months.

Survival depends on biliary drainage quality, obtained by plastic or metallic prothesis setting up in one or several hepatic segments.

Radiotherapy and/or chemotherapy didn't prove yet their efficiency on survival. In France, gemcitabin is recommended by the French Digestive Oncology Federation in metastatic tumours, in monotherapy or associated with cisplatin or oxaliplatin (Gemox) for patients in good general condition.

Photodynamic therapy has shown in 3 prospective studies - one randomized - with small patient series, a significative efficiency on survival and quality of life of treated patients, in comparison with historical series, or patients' groups whose biliary drainage was in most cases unefficient.

A new randomized study, including patients whose biliary drainage is efficient and comparing their becoming when they are treated by PDT in addition to current practice, or only by current practice, seems to be justified.

The principal objective of this study is to evaluate the efficiency of PDT with Photofrin® on patients with unresectable type III or IV cholangiocarcinoma.

lead_sponsor: University Hospital, Angers

location_facility:
UH Kremlin Bicêtre
Clinique Sainte Anne
Clinique du Trocadéro
UH Cochin
UH Charles Nicolle
UH Nantes
UH Hôpital Civil
UH Marseille Nord
UH La Timone
UH Rangueil
UH Henri Mondor
UH Claude Huriez
H Metz-Thionville
UH Angers
UH La Milétrie
UH Amiens
UH Purpan
H Beaujon


title: Transnational Randomized Study Comparing Carbon Ions Therapy Versus Conventional Radiotherapy - Including Protontherapy - for the Treatment of Radioresistant Tumors

acronym: ETOILE

summary: This is a transnational prospective randomized trial comparing definitive carbon ion therapy versus photon or combined photon and protontherapy as standard treatment for unresectable or macroscopically uncompleted resected radioresistant tumors. Eligible tumors are axial chordoma (except of base of skull), adenoid cystic carcinoma of head and neck (except of trachea) and sarcomas of any site (except chondrosarcoma of the skull base), non previously irradiated and without pre-planned surgery or chemotherapy after the clinical trial procedure. Randomization is balanced 1 for 1. Patients of the experimental arm are treated in carbon ions centers in Europe and patients of the standard arm are treated in France in their closest participating radiotherapy center. An accrual of 250 patients is needed and an absolute difference of 20% of relapse free survival at five years is awaited. The main endpoint is the progression free survival at five years. The trial is supported by the French program of clinical research and the national health insurance. Two associated studies are carried out: a radiobiological one looking for radioresistance markers in the sarcomas biopsies, and the second one is about medico economics.

location_facility: Pôle de radiothérapie, Centre Antoine-Lacassagne

location_facility: Radiothérapie, Institut Régional du Cancer Montpellier, ICM Val d'Aurelle

location_facility: Institut universitaire du cancer de Toulouse - Oncopole, Institut Claudius Regaud

location_facility: Radiothérapie, Hôpital A. Michallon, CHU de Grenoble

location_facility: Radiothérapie, CRLCC Institut Paoli Calmettes

location_facility: Radiothérapie, Hôpital de Haut Lévêque, CHU Bordeaux

location_facility: Radiothérapie, Institut de Cancérologie de Lorraine Alexis Vautrin

location_facility: Radiothérapie, CRLCC Institut Jean Godinot

location_facility: Institut Curie, site Hôpital de Paris et site d'Orsay (Centre de protonthérapie)

location_facility: Radiothérapie, Institut de Cancérologie de la Loire Lucien Neuwirtz

intervention_type: Radiation