intervention_type: Biological

lead_sponsor: Pfizer

summary: This is an open-label study (a study in which the doctors and participants know which drug or vaccine is being administered) in children who previously received a 4-dose series of a pneumococcal conjugate vaccine (PnC) during infancy in Study 6096A1-008-EU (NCT00366678). In this study, participants will receive an additional dose of 13-valent pneumococcal conjugate vaccine. The purpose of this study is to evaluate persistence, if any, of the antibody response by measuring any remaining pneumococcal antibodies since the previous study. This study will also evaluate the safety and immunogenicity of 13-valent pneumococcal conjugate vaccine when administered at least 24 months after the last dose of pneumococcal conjugate vaccine.

title: A Phase 3, Open-label Study to Evaluate Persistence of the Antibody Response Elicited by Pneumococcal Conjugate Vaccine in Healthy Children Who Have Been Previously Immunized With a 4-Dose Series of a Pneumococcal Conjugate Vaccine During Infancy in Study 6096A1-008-EU and the Safety and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Administered at Least 24 Months After the Last Toddler Dose of Pneumococcal Conjugate Vaccine


title: A Phase II Study of Azacitidine (Vidaza®) Combined to Epoetin Beta (NeoRecormon®) in IPSS Low-risk and Intermediate-1 MDS Patients, Resistant to ESA

summary: The study is aimed to treat low-risk MDS patients,who are dependent on red-blood cell transfusion due to disease-related anemia, and who have a proven resistance towards treatment with erythropoetin-stimulating agents (ESA). The study randomizes patients to receive a treatment with the demethylating agent 5-azacytidine alone or in combination with an ESA. The study thus evaluates, if efficacy of 5-azacytidine, notably on the red-blood cell transfusion-dependence is comparable/inferior to a combination treatment with azacitidine and an ESA (that is if 5-azacytidine can overcome the resistance towards ESA). Being a phase II study, the study assesses, duration of erythroid response, overall survival and time to progression as well as toxicity.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Thepot S, Ben Abdelali R, Chevret S, Renneville A, Beyne-Rauzy O, Prebet T, Park S, Stamatoullas A, Guerci-Bresler A, Cheze S, Tertian G, Choufi B, Legros L, Bastie JN, Delaunay J, Chaury MP, Sanhes L, Wattel E, Dreyfus F, Vey N, Chermat F, Preudhomme C, Fenaux P, Gardin C; Groupe Francophone des Myelodysplasies (GFM). A randomized phase II trial of azacitidine +/- epoetin-beta in lower-risk myelodysplastic syndromes resistant to erythropoietic stimulating agents. Haematologica. 2016 Aug;101(8):918-25. doi: 10.3324/haematol.2015.140988. Epub 2016 May 26.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

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

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

lead_sponsor: Groupe Francophone des Myelodysplasies

collaborators:
Celgene Corporation
Roche Pharma AG

sponsor_collaborators:
Groupe Francophone des Myelodysplasies
Celgene Corporation
Roche Pharma AG

location_facility:
Hôpital Brabois
Hôpital Purpan
Hôpital Boulogne Sur Mer
Hôpital Reims
Hôpital de la Côte Basque
Hôpital Edouard Herriot
Hôpital Saint Vincent
Hôpital Henri Becquerel
Hôpital Avignon
CHU d'Amiens
Hôpital Versailles
Hôpital Hôtel Dieu
Hôpital kremlin Bicêtre
Hôpital Jean-Bernard
Hôpital Maréchal Joffre
Hôpital Cochin
Hôpital La Source
Hopital Avicenne
Hôpital le Bocage
Hôpital Angers
Hôpital Huriez
Hôpital Saint Antoine
Hôpital Saint Louis
Hôpital Hautepierre
Hôpital Lariboisière
Hôpital Limoges
Hopital Clémenceau
Hôpital Paoli-Calmettes
Hôpital Archet1

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: Comparison of Nicotinamide and Sevelamer Hydrochloride on Phosphatemia Control on Chronic Hemodialysed Patients

acronym: NICOREN

summary: The comparison between nicotinamide and sevelamer aims to demonstrate, in chronic hemodialysed patients, the non-inferiority of nicotinamide in terms of control of the phosphatemia. Secondary objectives is to compare the two treatments in terms of efficiency in other biological parameters, vascular calcification and bone mass loss and on the clinical and biological tolerance and finally to explore the roles of metabolites of nicotinamide.

status: Terminated

ReferenceType: background

ReferenceCitation: Goldsmith D, Ritz E, Covic A. Vascular calcification: a stiff challenge for the nephrologist: does preventing bone disease cause arterial disease? Kidney Int. 2004 Oct;66(4):1315-33. doi: 10.1111/j.1523-1755.2004.00895.x.

ReferenceCitation: Foley RN, Parfrey PS, Sarnak MJ. Epidemiology of cardiovascular disease in chronic renal disease. J Am Soc Nephrol. 1998 Dec;9(12 Suppl):S16-23.

ReferenceCitation: K/DOQI: (Kidney Disease Outcomes Quality Initiative) of the National Kidney Foundation. Am J Kidney Dis suppl 3, october 2003.

ReferenceCitation: Jungers P, Choukroun G, Robino C, Massy ZA, Taupin P, Labrunie M, Man NK, Landais P. Epidemiology of end-stage renal disease in the Ile-de-France area: a prospective study in 1998. Nephrol Dial Transplant. 2000 Dec;15(12):2000-6. doi: 10.1093/ndt/15.12.2000.

ReferenceCitation: Kalantar-Zadeh K, Block G, Humphreys MH, Kopple JD. Reverse epidemiology of cardiovascular risk factors in maintenance dialysis patients. Kidney Int. 2003 Mar;63(3):793-808. doi: 10.1046/j.1523-1755.2003.00803.x.

ReferenceCitation: Collins R, Armitage J, Parish S, Sleigh P, Peto R; Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 5963 people with diabetes: a randomised placebo-controlled trial. Lancet. 2003 Jun 14;361(9374):2005-16. doi: 10.1016/s0140-6736(03)13636-7.

ReferenceCitation: London GM, Guerin AP, Marchais SJ, Metivier F, Pannier B, Adda H. Arterial media calcification in end-stage renal disease: impact on all-cause and cardiovascular mortality. Nephrol Dial Transplant. 2003 Sep;18(9):1731-40. doi: 10.1093/ndt/gfg414.

ReferenceCitation: Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol. 2004 Aug;15(8):2208-18. doi: 10.1097/01.ASN.0000133041.27682.A2.

ReferenceCitation: Shahapuni I, Mansour J, Harbouche L, Maouad B, Benyahia M, Rahmouni K, Oprisiu R, Bonne JF, Monge M, El Esper N, Presne C, Moriniere P, Choukroun G, Fournier A. How do calcimimetics fit into the management of parathyroid hormone, calcium, and phosphate disturbances in dialysis patients? Semin Dial. 2005 May-Jun;18(3):226-38. doi: 10.1111/j.1525-139X.2005.18318.x.

ReferenceCitation: Ghazali A, Fardellone P, Pruna A, Atik A, Achard JM, Oprisiu R, Brazier M, Remond A, Moriniere P, Garabedian M, Eastwood J, Fournier A. Is low plasma 25-(OH)vitamin D a major risk factor for hyperparathyroidism and Looser's zones independent of calcitriol? Kidney Int. 1999 Jun;55(6):2169-77. doi: 10.1046/j.1523-1755.1999.00480.x.

ReferenceCitation: Goldsmith DJ, Covic A, Sambrook PA, Ackrill P. Vascular calcification in long-term haemodialysis patients in a single unit: a retrospective analysis. Nephron. 1997;77(1):37-43. doi: 10.1159/000190244.

ReferenceCitation: Teng M, Wolf M, Lowrie E, Ofsthun N, Lazarus JM, Thadhani R. Survival of patients undergoing hemodialysis with paricalcitol or calcitriol therapy. N Engl J Med. 2003 Jul 31;349(5):446-56. doi: 10.1056/NEJMoa022536.

ReferenceCitation: Fournier AE, Johnson WJ, Taves DR, Beabout JW, Arnaud CD, Goldsmith RS. Etiology of hyperparathyroidism and bone disease during chronic hemodialysis. I. Association of bone disease with potentially etiologic factors. J Clin Invest. 1971 Mar;50(3):592-8. doi: 10.1172/JCI106529.

ReferenceCitation: Argiles A, Kerr PG, Canaud B, Flavier JL, Mion C. Calcium kinetics and the long-term effects of lowering dialysate calcium concentration. Kidney Int. 1993 Mar;43(3):630-40. doi: 10.1038/ki.1993.92.

ReferenceCitation: Indridason OS, Quarles LD. Comparison of treatments for mild secondary hyperparathyroidism in hemodialysis patients. Durham Renal Osteodystrophy Study Group. Kidney Int. 2000 Jan;57(1):282-92. doi: 10.1046/j.1523-1755.2000.00819.x.

ReferenceCitation: Locatelli F, Covic A, Chazot C, Leunissen K, Luno J, Yaqoob M. Optimal composition of the dialysate, with emphasis on its influence on blood pressure. Nephrol Dial Transplant. 2004 Apr;19(4):785-96. doi: 10.1093/ndt/gfh102.

ReferenceCitation: Chertow GM, Burke SK, Raggi P; Treat to Goal Working Group. Sevelamer attenuates the progression of coronary and aortic calcification in hemodialysis patients. Kidney Int. 2002 Jul;62(1):245-52. doi: 10.1046/j.1523-1755.2002.00434.x.

ReferenceCitation: Fournier A, Said S, Ghazali A, Sechet A, Ezaitouni F, Marie A, Westeel PF, Moriniere P, Boudailliez B. The clinical significance of adynamic bone disease in uremia. Adv Nephrol Necker Hosp. 1997;27:131-66. No abstract available.

ReferenceCitation: London GM, Marty C, Marchais SJ, Guerin AP, Metivier F, de Vernejoul MC. Arterial calcifications and bone histomorphometry in end-stage renal disease. J Am Soc Nephrol. 2004 Jul;15(7):1943-51. doi: 10.1097/01.asn.0000129337.50739.48.

ReferenceCitation: Delmez JA, Tindira CA, Windus DW, Norwood KY, Giles KS, Nighswander TL, Slatopolsky E. Calcium acetate as a phosphorus binder in hemodialysis patients. J Am Soc Nephrol. 1992 Jul;3(1):96-102. doi: 10.1681/ASN.V3196.

ReferenceCitation: Ben Hamida F, el Esper I, Compagnon M, Moriniere P, Fournier A. Long-term (6 months) cross-over comparison of calcium acetate with calcium carbonate as phosphate binder. Nephron. 1993;63(3):258-62. doi: 10.1159/000187207.

ReferenceCitation: Yang H, Curinga G, Giachelli CM. Elevated extracellular calcium levels induce smooth muscle cell matrix mineralization in vitro. Kidney Int. 2004 Dec;66(6):2293-9. doi: 10.1111/j.1523-1755.2004.66015.x.

ReferenceCitation: Porsti I, Fan M, Koobi P, Jolma P, Kalliovalkama J, Vehmas TI, Helin H, Holthofer H, Mervaala E, Nyman T, Tikkanen I. High calcium diet down-regulates kidney angiotensin-converting enzyme in experimental renal failure. Kidney Int. 2004 Dec;66(6):2155-66. doi: 10.1111/j.1523-1755.2004.66006.x.

ReferenceCitation: Cozzolino M, Staniforth ME, Liapis H, Finch J, Burke SK, Dusso AS, Slatopolsky E. Sevelamer hydrochloride attenuates kidney and cardiovascular calcifications in long-term experimental uremia. Kidney Int. 2003 Nov;64(5):1653-61. doi: 10.1046/j.1523-1755.2003.00284.x.

ReferenceCitation: Taal MW, Roe S, Masud T, Green D, Porter C, Cassidy MJ. Total hip bone mass predicts survival in chronic hemodialysis patients. Kidney Int. 2003 Mar;63(3):1116-20. doi: 10.1046/j.1523-1755.2003.00837.x.

ReferenceCitation: Parfitt AM. Renal bone disease: a new conceptual framework for the interpretation of bone histomorphometry. Curr Opin Nephrol Hypertens. 2003 Jul;12(4):387-403. doi: 10.1097/00041552-200307000-00007.

ReferenceCitation: Riggs BL, Parfitt AM. Drugs used to treat osteoporosis: the critical need for a uniform nomenclature based on their action on bone remodeling. J Bone Miner Res. 2005 Feb;20(2):177-84. doi: 10.1359/JBMR.041114. Epub 2004 Nov 16.

ReferenceCitation: Mansour J, Benyahia M, Harbouche L, Presne C, Moriniere P, Fournier A. Calcimetic AMG 073 at 50 and 100 mg per day. Kidney Int. 2003 Dec;64(6):2324-5. doi: 10.1046/j.1523-1755.2003.341_4.x. No abstract available.

ReferenceCitation: Manns B, Stevens L, Miskulin D, Owen WF Jr, Winkelmayer WC, Tonelli M. A systematic review of sevelamer in ESRD and an analysis of its potential economic impact in Canada and the United States. Kidney Int. 2004 Sep;66(3):1239-47. doi: 10.1111/j.1523-1755.2004.00877.x.

ReferenceCitation: Lacour B, Lucas A, Auchere D, Ruellan N, de Serre Patey NM, Drueke TB. Chronic renal failure is associated with increased tissue deposition of lanthanum after 28-day oral administration. Kidney Int. 2005 Mar;67(3):1062-9. doi: 10.1111/j.1523-1755.2005.00171.x. Erratum In: Kidney Int. 2005 Jul;68(1):427.

ReferenceCitation: Takahashi Y, Tanaka A, Nakamura T, Fukuwatari T, Shibata K, Shimada N, Ebihara I, Koide H. Nicotinamide suppresses hyperphosphatemia in hemodialysis patients. Kidney Int. 2004 Mar;65(3):1099-104. doi: 10.1111/j.1523-1755.2004.00482.x.

ReferenceCitation: Renaud H, Atik A, Herve M, Moriniere P, Hocine C, Belbrik S, Fournier A. Evaluation of vascular calcinosis risk factors in patients on chronic hemodialysis: lack of influence of calcium carbonate. Nephron. 1988;48(1):28-32. doi: 10.1159/000184864.

ReferenceCitation: Wanner C, Krane V, Marz W, Olschewski M, Asmus HG, Kramer W, Kuhn KW, Kutemeyer H, Mann JF, Ruf G, Ritz E; Deutsche Diabetes-Dialyse-Studie (4D) Study Group. Randomized controlled trial on the efficacy and safety of atorvastatin in patients with type 2 diabetes on hemodialysis (4D study): demographic and baseline characteristics. Kidney Blood Press Res. 2004;27(4):259-66. doi: 10.1159/000080241. Epub 2004 Aug 16.

ReferenceCitation: Gale EA, Bingley PJ, Emmett CL, Collier T; European Nicotinamide Diabetes Intervention Trial (ENDIT) Group. European Nicotinamide Diabetes Intervention Trial (ENDIT): a randomised controlled trial of intervention before the onset of type 1 diabetes. Lancet. 2004 Mar 20;363(9413):925-31. doi: 10.1016/S0140-6736(04)15786-3.

ReferenceCitation: Moe SM, Chertow GM, Coburn JW, Quarles LD, Goodman WG, Block GA, Drueke TB, Cunningham J, Sherrard DJ, McCary LC, Olson KA, Turner SA, Martin KJ. Achieving NKF-K/DOQI bone metabolism and disease treatment goals with cinacalcet HCl. Kidney Int. 2005 Feb;67(2):760-71. doi: 10.1111/j.1523-1755.2005.67139.x.

ReferenceCitation: Kauppila LI, Polak JF, Cupples LA, Hannan MT, Kiel DP, Wilson PW. New indices to classify location, severity and progression of calcific lesions in the abdominal aorta: a 25-year follow-up study. Atherosclerosis. 1997 Jul 25;132(2):245-50. doi: 10.1016/s0021-9150(97)00106-8.

ReferenceCitation: Wilson PW, Kauppila LI, O'Donnell CJ, Kiel DP, Hannan M, Polak JM, Cupples LA. Abdominal aortic calcific deposits are an important predictor of vascular morbidity and mortality. Circulation. 2001 Mar 20;103(11):1529-34. doi: 10.1161/01.cir.103.11.1529.

ReferenceCitation: Kiel DP, Kauppila LI, Cupples LA, Hannan MT, O'Donnell CJ, Wilson PW. Bone loss and the progression of abdominal aortic calcification over a 25 year period: the Framingham Heart Study. Calcif Tissue Int. 2001 May;68(5):271-6. doi: 10.1007/BF02390833. Erratum In: Calcif Tissue Int. 2004 Feb;74(2):208.

ReferenceCitation: Urena P, Bernard-Poenaru O, Ostertag A, Baudoin C, Cohen-Solal M, Cantor T, de Vernejoul MC. Bone mineral density, biochemical markers and skeletal fractures in haemodialysis patients. Nephrol Dial Transplant. 2003 Nov;18(11):2325-31. doi: 10.1093/ndt/gfg403.

ReferenceCitation: Genant HK, Wu CY, van Kuijk C, Nevitt MC. Vertebral fracture assessment using a semiquantitative technique. J Bone Miner Res. 1993 Sep;8(9):1137-48. doi: 10.1002/jbmr.5650080915.

ReferenceCitation: Grados F, Roux C, de Vernejoul MC, Utard G, Sebert JL, Fardellone P. Comparison of four morphometric definitions and a semiquantitative consensus reading for assessing prevalent vertebral fractures. Osteoporos Int. 2001;12(9):716-22. doi: 10.1007/s001980170046.

ReferenceCitation: Malluche M, Monier-faugère M, wang G, Frazao J, Coburn J, Baker N, McCary LC, Turner JA, Goodman WG: Cinaclacet Hcl reduces bone turn over and bone marrow fibrosa in hemodialysis patients with secondary hyperparathyroidism. ERA XLI congress. AbstractBook Lisboa:P218 (M016), 2004

ReferenceCitation: Dament J,Gill M, Confer S, Jones C, Webster J: The bone kinetics of lanthanum in dialysis patient treated with lanthanum carbonate up to 45 years. J Am Soc Nephrol 15 (Abstract):271A (poster FPO 948), 2004

ReferenceCitation: Malluche M, Faugère MC, Damment SJP, Webster I: No osteomalacia in dialysis patients treated with lanthanum carbonate up to 4.5 years. J Am Soc Nephrol 15 (supplt Abstract):p270A Poster F P0944,2004

ReferenceCitation: De Smet R, Thermote F, Lameire N, Vanholder R: SEVELAMER hydrochloride (Renagel(r)) adsorbs the uremic compounds indoxyl sulfate, indole and p-creso.[Abstract]. J Am Soc Nephrol 15, 2004

ReferenceCitation: Block GA, Martin KJ, de Francisco AL, Turner SA, Avram MM, Suranyi MG, Hercz G, Cunningham J, Abu-Alfa AK, Messa P, Coyne DW, Locatelli F, Cohen RM, Evenepoel P, Moe SM, Fournier A, Braun J, McCary LC, Zani VJ, Olson KA, Drueke TB, Goodman WG. Cinacalcet for secondary hyperparathyroidism in patients receiving hemodialysis. N Engl J Med. 2004 Apr 8;350(15):1516-25. doi: 10.1056/NEJMoa031633.

ReferenceCitation: Alsheikh-Ali A, Aboujaily HM, Stanek LJ, coll. e: Increases in HDL cholesterol are the strongest predictions of risk reduction in lipid intervention trials. Circulation 111 (suppltIII):813 Abstract 3754,2004

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility: Association pour le Développement de l'Hémodialyse

location_facility: Association Régionale Promotion Dialyse à domicile (ARPDD)

lead_sponsor_type: academique

status_simplified: Unknown


title: Observatory of Invasive Procedures and Bleeding in Patients Treated With New Oral Anticoagulants

acronym: GIHP-NACO

summary:
The arrival on the market of direct oral factor Xa and factor IIa inhibitors (dabigatran (Pradaxa®), rivaroxaban (Xarelto®), apixaban (Eliquis®) and others soon to come) raises novel questions among clinicians confronted with the emergency management of patients treated with these new drugs. It is likely that these new oral anticoagulants (NOACs) will eventually win a significant market share in the indications secondary prevention of venous thromboembolism and prevention of cardioembolic events in patients with nonvalvular atrial fibrillation, due to their net clinical benefit and their practicality of use compared with vitamin K antagonists (VKAs).

However, despite the fact that NOACs reduce the incidence of intracranial bleeding by about half compared with VKAs, the risk remains significant; furthermore, in clinical trials, these drugs had little or no effect on reducing the incidence of major extracranial bleeding. In everyday practice, where the indication could be expanded to unselected populations and due to a potential for misuse, it is likely that the incidence of bleeding complications will be higher than that reported in clinical trials. Indeed, the numerous alerts emanating from regulatory agencies in various countries (US, Australia, etc.) bear witness to this, and should serve as a reminder that these anticoagulants have a real potential for bleeding complications and, in the absence of an antidote, there is no validated management strategy.

Furthermore, as these drugs can be prescribed for months or years, patients may eventually be exposed to situations at high hemorrhagic risk, such as emergency surgery or invasive procedures, trauma, etc. Analysis of data from the trial : dabigatran versus warfarin in patients with atrial fibrillation (RE-LY) showed that during the two years of follow-up, approximately 25% of the patients underwent an invasive procedure, ranging from pacemaker insertion to major surgery. Thus, a large proportion of patients treated with NOACs are concerned by this issue.

In anticipation of a gradually increasing influx of patients in a critical situation (active bleeding or need to rapidly secure hemostasis before an invasive procedure), it is urgent to define the conduct to adopt based on the experience gained from the earliest cases. This is the objective of the French-speaking GIHP-NACO observatory set up by the GIHP (French Working Group on Perioperative Hemostasis).

For the moment, then, the management recommendations derive from expert opinions based on pharmacokinetic data and on the partial correction of NOAC-induced hypocoagulability by various nonspecific procoagulants (non-activated or activated prothrombin complex concentrates, recombinant factor VIIa). These procoagulants are currently used in an empirical manner to control bleeding, with as many successes as failures reported in the literature, and their benefit-risk ratio in these patients is therefore uncertain.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Pernod G, Albaladejo P, Godier A, Samama CM, Susen S, Gruel Y, Blais N, Fontana P, Cohen A, Llau JV, Rosencher N, Schved JF, de Maistre E, Samama MM, Mismetti P, Sie P; Working Group on Perioperative Haemostasis. Management of major bleeding complications and emergency surgery in patients on long-term treatment with direct oral anticoagulants, thrombin or factor-Xa inhibitors: proposals of the working group on perioperative haemostasis (GIHP) - March 2013. Arch Cardiovasc Dis. 2013 Jun-Jul;106(6-7):382-93. doi: 10.1016/j.acvd.2013.04.009. Epub 2013 Jun 25.

ReferenceCitation: Marlu R, Hodaj E, Paris A, Albaladejo P, Cracowski JL, Pernod G. Effect of non-specific reversal agents on anticoagulant activity of dabigatran and rivaroxaban: a randomised crossover ex vivo study in healthy volunteers. Thromb Haemost. 2012 Aug;108(2):217-24. doi: 10.1160/TH12-03-0179. Epub 2012 May 25. Erratum In: Thromb Haemost. 2013 Jan;109(1):169.

ReferenceCitation: Sie P, Samama CM, Godier A, Rosencher N, Steib A, Llau JV, Van der Linden P, Pernod G, Lecompte T, Gouin-Thibault I, Albaladejo P; Working Group on Perioperative Haemostasis; French Study Group on Thrombosis and Haemostasis. Surgery and invasive procedures in patients on long-term treatment with direct oral anticoagulants: thrombin or factor-Xa inhibitors. Recommendations of the Working Group on Perioperative Haemostasis and the French Study Group on Thrombosis and Haemostasis. Arch Cardiovasc Dis. 2011 Dec;104(12):669-76. doi: 10.1016/j.acvd.2011.09.001. Epub 2011 Oct 29.

ReferenceCitation: Healey JS, Eikelboom J, Douketis J, Wallentin L, Oldgren J, Yang S, Themeles E, Heidbuchel H, Avezum A, Reilly P, Connolly SJ, Yusuf S, Ezekowitz M; RE-LY Investigators. Periprocedural bleeding and thromboembolic events with dabigatran compared with warfarin: results from the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) randomized trial. Circulation. 2012 Jul 17;126(3):343-8. doi: 10.1161/CIRCULATIONAHA.111.090464. Epub 2012 Jun 14. Erratum In: Circulation. 2012 Sep 4;126(10):e160. Heidbuchle, Hein [corrected to Heidbuchel, Hein].

ReferenceCitation: Heidbuchel H, Verhamme P, Alings M, Antz M, Hacke W, Oldgren J, Sinnaeve P, Camm AJ, Kirchhof P; European Heart Rhythm Association. European Heart Rhythm Association Practical Guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation. Europace. 2013 May;15(5):625-51. doi: 10.1093/europace/eut083.

ReferenceCitation: Godon A, Gabin M, Levy JH, Huet O, Chapalain X, David JS, Tacquard C, Sattler L, Minville V, Memier V, Blanie A, Godet T, Leone M, De Maistre E, Gruel Y, Roullet S, Vermorel C, Samama CM, Bosson JL, Albaladejo P; GIHP-NACO Study Group. Management of urgent invasive procedures in patients treated with direct oral anticoagulants: An observational registry analysis. Thromb Res. 2022 Aug;216:106-112. doi: 10.1016/j.thromres.2022.06.005. Epub 2022 Jun 22.

oa_host_type: publisher

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: University Hospital, Grenoble

sponsor_collaborators:
University Hospital, Grenoble
Floralis

location_country: Belgium France

location_facility: Hôpital d'Instruction des Armées Sainte-Anne

intervention_type: Other


title: Evaluation of the Strip PeriScreen for the Fast Diagnosis of the Spontaneous Infection of the Liquid of Ascites During the Cirrhosis

acronym: Per-DRISLA

summary:
The forecast of the spontaneous infection of the liquid of ascites (ISLA) at the cirrhotic patient is still burdened by a heavy mortality. The fast diagnosis of the ISLA is thus an essential stake to improve the forecast.

Investigators would so like to estimate the interest of the strip PeriScreen for the fast diagnosis of the ISLA at cirrhotic patients . Investigators plan to include 670 patients, what would allow to make out a will at least on ascites 2000 on about twenty centers for duration estimated of 12 months.

primary_purpose: Diagnostic

lead_sponsor: Centre Hospitalier Departemental Vendee

location_facility:
Hôpital Purpan
CH Dijon
CHU Nice
CH St Antoine
CH Rennes
CH Caen
CH Amiens
Hopîtal Beaujon
CH Saint-Denis - Hôpital de la Fontaine
Hopital Laennec
CH Rouen
Hopital Jolimont
CHRU de Brest
CH Gonesse
CH Lille
CH Yves Le Foll
CHD Vendée
CHU Besançon
CH Cholet
CH Orléans
CH Vannes
CH Reims


title: TRANSFORM - Observational Cohort Study of Aranesp Use in EU Haemodialysis Patients Switched From Mircera

acronym: TRANSFORM

summary: To describe the time course of hemoglobin concentration in EU hemodialysis patients switched from methoxy polyethylene glycol-epoetin beta (PEG epoetin beta; Mircera) to darbepoetin alfa (Aranesp).

ReferenceCitation: Donck J, Gonzalez-Tabares L, Chanliau J, Martin H, Stamatelou K, Manamley N, Farouk M, Addison J. Preservation of anemia control and weekly ESA dosage after conversion from PEG-Epoetin beta to darbepoetin alfa in adult hemodialysis patients: the TRANSFORM study. Adv Ther. 2014 Nov;31(11):1155-68. doi: 10.1007/s12325-014-0161-5. Epub 2014 Nov 1.

oa_colors: green hybrid

evidence: open (via page says license)

publisher_dissemination: Springer

lead_sponsor: Amgen

location_country: Germany Netherlands Switzerland Belgium Spain Greece France


title: Multinational European Trial for Children With the Opsoclonus Myoclonus Syndrome / Dancing Eye Syndrome

summary:
The OMS/DES study is a multinational European Trial for Children with the Opsoclonus Myoclonus Syndrome / Dancing Eye Syndrome.

This trial brought on the way by specialists of the EPNS (European Paediatric Neurology Society), the GPOH (Gesellschaft für Pädiatrische Hematologic und Oncologie) and the SIOPEN (SIOP (International Society Oncology Pediatric) Europe Neuroblastoma).

This protocol will investigate an escalating treatment schedule starting with a corticosteroid standard treatment with dexamethasone pulses (first step), which is followed, if response has been inadequate after 3 months of treatment, by the addition of CP (second step) and, if still no sufficient improvement, by the replacement of CP by Rituximab (third step). Treatment intensification is decided on the basis of standardized scoring of OMS/DES severity.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

lead_sponsor: Institut Curie

location_country:
France
Italy
United Kingdom
Switzerland
Austria
Spain
Sweden

location_facility: The Fundación para la Formación e Investigación Sanitarias de la Región de Murcia

location_facility: St. Anna Kinderkrebsforschung e.V. CHILDREN'S CANCER RESEARCH INSTITUTE

status_simplified: Ongoing


title: Comparative Double Blind Placebo Controlled Clinical Study on Tocilizumab Rapid Efficacy on Patients Relief in rheumatoïd Arthritis With an Inadequate Response to DMARDs or Anti TNF :TORPEDO

summary: This study will assess the onset and maintenance of effect of tocilizumab on relief in patients with active moderate or severe rheumatoid arthritis who have had an inadequate response to DMARDs or anti-TNF. For the first, double-blind, part of the study patients will be randomized to receive an iv infusion of either 8mg/kg tocilizumab or placebo. After 4 weeks this will be followed by 11 months treatment with tocilizumab 8mg/kg iv infusion every 4 weeks. Methotrexate or DMARD therapy will be continued throughout study treatment. Target sample size is >100.

lead_sponsor: Hoffmann-La Roche


title: Phase III Study Comparing Irradiation at a Dose of 80 Gy to Irradiation at 70 Gy in Unfavorable Prostate Cancers Associated With Prolonged Hormonal Therapy

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating patients with prostate cancer.

PURPOSE: This randomized phase III trial is comparing two radiation therapy regimens in treating patients with prostate cancer receiving hormone therapy.

enrollment_type: Anticipated

ipd_sharing: No

ipd_sharing_description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

lead_sponsor: UNICANCER

location_facility: Institut de Cancérologie de l'Ouest Paul Papin

location_facility: Institut de Cancérologie LUCIEN NEUWIRTH

location_facility: Centre de Cancérologie du Grand Montpellier

intervention_type: Radiation


title: Value of Contrast-enhanced Ultrasonography and Magnetic Resonance Enterography to Predict the Efficacy of Anti-TNF Therapy in Crohn's Disease Complicated by Symptomatic Small Bowel Stricture

acronym: CREOLE

summary:
The value of anti-TNF therapy in intestinal strictures related to Crohn's disease (CD) has not been clearly demonstrated. The results reported by some teams suggest no beneficial effect or even an increased risk of bowel obstruction in the case of stricture, while other publications indicate a favourable action of anti-TNF in this setting. The efficacy of anti-TNF in patients with intestinal stricture related to Crohn's disease could depend on the lesions responsible for the stricture, as anti-TNF agents are probably effective in inflammatory forms and useless or even potentially harmful in fibrotic forms. In practice, the decision is currently empirical and a trial of anti-TNF therapy is often proposed.

In view of the high incidence of intestinal strictures in CD and the need for a treatment as effective as anti-TNF in this setting, it is important to more clearly define the indications of these treatments guided by the information provided by modern imaging.

The aim of this prospective study is to determine whether certain signs detected by MR enterography and contrast-enhanced ultrasonography can help to predict failure of anti-TNF therapy in patients with CD presenting a symptomatic stricture of the small bowel and scheduled to receive this treatment.

ReferenceCitation: Bernstein CN, Greenberg H, Boult I, Chubey S, Leblanc C, Ryner L. A prospective comparison study of MRI versus small bowel follow-through in recurrent Crohn's disease. Am J Gastroenterol. 2005 Nov;100(11):2493-502. doi: 10.1111/j.1572-0241.2005.00239.x.

ReferenceCitation: Biancone L, Calabrese E, Petruzziello C, Onali S, Caruso A, Palmieri G, Sica GS, Pallone F. Wireless capsule endoscopy and small intestine contrast ultrasonography in recurrence of Crohn's disease. Inflamm Bowel Dis. 2007 Oct;13(10):1256-65. doi: 10.1002/ibd.20199.

ReferenceCitation: Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. doi: 10.1056/NEJMra072149. No abstract available.

ReferenceCitation: Chiorean MV, Sandrasegaran K, Saxena R, Maglinte DD, Nakeeb A, Johnson CS. Correlation of CT enteroclysis with surgical pathology in Crohn's disease. Am J Gastroenterol. 2007 Nov;102(11):2541-50. doi: 10.1111/j.1572-0241.2007.01537.x. Epub 2007 Sep 26.

ReferenceCitation: Esteban JM, Aleixandre A, Hurtado MJ, Maldonado L, Mora FJ, Nogues E. Contrast-enhanced power Doppler ultrasound in the diagnosis and follow-up of inflammatory abdominal masses in Crohn's disease. Eur J Gastroenterol Hepatol. 2003 Mar;15(3):253-9. doi: 10.1097/00042737-200303000-00008.

ReferenceCitation: Giorgio A, Ferraioli G, Tarantino L, de Stefano G, Scala V, Scarano F, Coppola C, Del Viscovo L. Contrast-enhanced sonographic appearance of hepatocellular carcinoma in patients with cirrhosis: comparison with contrast-enhanced helical CT appearance. AJR Am J Roentgenol. 2004 Nov;183(5):1319-26. doi: 10.2214/ajr.183.5.1831319.

ReferenceCitation: Guidi L, De Franco A, De Vitis I, Armuzzi A, Semeraro S, Roberto I, Papa A, Bock E, Gasbarrini G, Fedeli G. Contrast-enhanced ultrasonography with SonoVue after infliximab therapy in Crohn's disease. Eur Rev Med Pharmacol Sci. 2006 Jan-Feb;10(1):23-6.

ReferenceCitation: Holtmann M, Wanitschke R, Helisch A, Bartenstein P, Galle PR, Neurath M. [Anti-TNF antibodies in the treatment of inflammatory intestinal stenoses in Crohn's disease]. Z Gastroenterol. 2003 Jan;41(1):11-7. doi: 10.1055/s-2003-36677. German.

ReferenceCitation: Louis E, Boverie J, Dewit O, Baert F, De Vos M, D'Haens G; Belgian IBD Research Group. Treatment of small bowel subocclusive Crohn's disease with infliximab: an open pilot study. Acta Gastroenterol Belg. 2007 Jan-Mar;70(1):15-9.

ReferenceCitation: Masselli G, Brizi GM, Parrella A, Minordi LM, Vecchioli A, Marano P. Crohn disease: magnetic resonance enteroclysis. Abdom Imaging. 2004 May-Jun;29(3):326-34. doi: 10.1007/s00261-003-0116-9. No abstract available.

ReferenceCitation: Masselli G, Casciani E, Polettini E, Gualdi G. Comparison of MR enteroclysis with MR enterography and conventional enteroclysis in patients with Crohn's disease. Eur Radiol. 2008 Mar;18(3):438-47. doi: 10.1007/s00330-007-0763-2. Epub 2007 Sep 25.

ReferenceCitation: Negaard A, Mulahasanovic A, Reisaeter LA, Aasekjaer K, Sandvik L, Klow NE. Crohn's disease evaluated with magnetic resonance enteroclysis: diagnostic performance of experienced and inexperienced readers before and after training. Acta Radiol. 2008 Nov;49(9):967-74. doi: 10.1080/02841850802409539.

ReferenceCitation: Negaard A, Sandvik L, Mulahasanovic A, Berstad AE, Klow NE. Magnetic resonance enteroclysis in the diagnosis of small-intestinal Crohn's disease: diagnostic accuracy and inter- and intra-observer agreement. Acta Radiol. 2006 Dec;47(10):1008-16. doi: 10.1080/02841850600979071.

ReferenceCitation: Parente F, Greco S, Molteni M, Anderloni A, Maconi G, Bianchi Porro G. Modern imaging of Crohn's disease using bowel ultrasound. Inflamm Bowel Dis. 2004 Jul;10(4):452-61. doi: 10.1097/00054725-200407000-00022.

ReferenceCitation: De Pascale A, Garofalo G, Perna M, Priola S, Fava C. Contrast-enhanced ultrasonography in Crohn's disease. Radiol Med. 2006 Jun;111(4):539-50. doi: 10.1007/s11547-006-0049-9. Epub 2006 May 25. English, Italian.

ReferenceCitation: Pelletier AL, Kalisazan B, Wienckiewicz J, Bouarioua N, Soule JC. Infliximab treatment for symptomatic Crohn's disease strictures. Aliment Pharmacol Ther. 2009 Feb 1;29(3):279-85. doi: 10.1111/j.1365-2036.2008.03887.x. Epub 2008 Nov 8.

ReferenceCitation: Di Sabatino A, Fulle I, Ciccocioppo R, Ricevuti L, Tinozzi FP, Tinozzi S, Campani R, Corazza GR. Doppler enhancement after intravenous levovist injection in Crohn's disease. Inflamm Bowel Dis. 2002 Jul;8(4):251-7. doi: 10.1097/00054725-200207000-00003.

ReferenceCitation: Rieder F, Brenmoehl J, Leeb S, Scholmerich J, Rogler G. Wound healing and fibrosis in intestinal disease. Gut. 2007 Jan;56(1):130-9. doi: 10.1136/gut.2006.090456. No abstract available.

ReferenceCitation: Di Sabatino A, Pender SL, Jackson CL, Prothero JD, Gordon JN, Picariello L, Rovedatti L, Docena G, Monteleone G, Rampton DS, Tonelli F, Corazza GR, MacDonald TT. Functional modulation of Crohn's disease myofibroblasts by anti-tumor necrosis factor antibodies. Gastroenterology. 2007 Jul;133(1):137-49. doi: 10.1053/j.gastro.2007.04.069. Epub 2007 May 5.

ReferenceCitation: Sallomi DF. The use of contrast-enhanced power Doppler ultrasound in the diagnosis and follow-up of inflammatory abdominal masses associated with Crohn's disease. Eur J Gastroenterol Hepatol. 2003 Mar;15(3):249-51. doi: 10.1097/00042737-200303000-00007.

ReferenceCitation: Schlottmann K, Kratzer W, Scholmerich J. Doppler ultrasound and intravenous contrast agents in gastrointestinal tract disorders: current role and future implications. Eur J Gastroenterol Hepatol. 2005 Mar;17(3):263-75. doi: 10.1097/00042737-200503000-00003.

ReferenceCitation: Schreyer AG, Geissler A, Albrich H, Scholmerich J, Feuerbach S, Rogler G, Volk M, Herfarth H. Abdominal MRI after enteroclysis or with oral contrast in patients with suspected or proven Crohn's disease. Clin Gastroenterol Hepatol. 2004 Jun;2(6):491-7. doi: 10.1016/s1542-3565(04)00168-5.

ReferenceCitation: Serra C, Menozzi G, Labate AM, Giangregorio F, Gionchetti P, Beltrami M, Robotti D, Fornari F, Cammarota T. Ultrasound assessment of vascularization of the thickened terminal ileum wall in Crohn's disease patients using a low-mechanical index real-time scanning technique with a second generation ultrasound contrast agent. Eur J Radiol. 2007 Apr;62(1):114-21. doi: 10.1016/j.ejrad.2006.11.027. Epub 2007 Jan 18.

ReferenceCitation: Solt J, Hertelendi A, Szilagyi K. [Balloon catheter dilatation of lower gastrointestinal tract stenoses: long-term results]. Orv Hetil. 2002 Aug 4;143(31):1835-40. Hungarian.

ReferenceCitation: Sorrentino D. Role of biologics and other therapies in stricturing Crohn's disease: what have we learnt so far? Digestion. 2008;77(1):38-47. doi: 10.1159/000117306. Epub 2008 Feb 19.

ReferenceCitation: Warnaar N, Hofker HS, Maathuis MH, Niesing J, Bruggink AH, Dijkstra G, Ploeg RJ, Schuurs TA. Matrix metalloproteinases as profibrotic factors in terminal ileum in Crohn's disease. Inflamm Bowel Dis. 2006 Sep;12(9):863-9. doi: 10.1097/01.mib.0000231568.43065.ed.

ReferenceCitation: Bouhnik Y, Carbonnel F, Laharie D, Stefanescu C, Hebuterne X, Abitbol V, Nachury M, Brixi H, Bourreille A, Picon L, Bourrier A, Allez M, Peyrin-Biroulet L, Moreau J, Savoye G, Fumery M, Nancey S, Roblin X, Altwegg R, Bouguen G, Bommelaer G, Danese S, Louis E, Zappa M, Mary JY; GETAID CREOLE Study Group. Efficacy of adalimumab in patients with Crohn's disease and symptomatic small bowel stricture: a multicentre, prospective, observational cohort (CREOLE) study. Gut. 2018 Jan;67(1):53-60. doi: 10.1136/gutjnl-2016-312581. Epub 2017 Jan 24.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

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

repository_normalized: HAL

repository_institution: University of Liège - Open Repository and Bibliography

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - MINES ParisTech

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

publisher_dissemination: British Medical Journal

lead_sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

location_facility:
Chu Amiens
Hopital Beaujon
Hopital Avicennes
Chu Nantes
Hopital Lariboisiere
Hopital Saint Louis
Chu Tours
Hopital Bicetre
Chu Montpellier
Chu Reims
Ulb - Clinique Saint Luc
Hopital Bichat
Hopital Cochin
Hopital St Antoine
Chu Besancon
Chru Lille
Chu Rouen
CHU NICE


type: Registry Identifier

title: A RANDOMIZED CONTROLLED STUDY IN NEWLY DIAGNOSED SEVERE APLASTIC ANEMIA PATIENTS RECEIVING ANTITHYMOCYTE GLOBULIN (ATG), CYCLOSPORIN A, WITH OR WITHOUT G-CSF

acronym: SAA-G-CSF

summary: The purpose of this study is to examine the effect of G-CSF on disease free survival and overall survival in aplastic anaemia patients who also receive ATG and Cyclosporin A.

ReferenceCitation: Tichelli A, de Latour RP, Passweg J, Knol-Bout C, Socie G, Marsh J, Schrezenmeier H, Hochsmann B, Bacigalupo A, Samarasinghe S, Rovo A, Kulasekararaj A, Roth A, Eikema DJ, Bosman P, Bader P, Risitano A, Dufour C; SAA Working Party of the EBMT. Long-term outcome of a randomized controlled study in patients with newly diagnosed severe aplastic anemia treated with antithymocyte globulin and cyclosporine, with or without granulocyte colony-stimulating factor: a Severe Aplastic Anemia Working Party Trial from the European Group of Blood and Marrow Transplantation. Haematologica. 2020 May;105(5):1223-1231. doi: 10.3324/haematol.2019.222562. Epub 2019 Oct 3.

ReferenceCitation: Tichelli A, Schrezenmeier H, Socie G, Marsh J, Bacigalupo A, Duhrsen U, Franzke A, Hallek M, Thiel E, Wilhelm M, Hochsmann B, Barrois A, Champion K, Passweg JR. A randomized controlled study in patients with newly diagnosed severe aplastic anemia receiving antithymocyte globulin (ATG), cyclosporine, with or without G-CSF: a study of the SAA Working Party of the European Group for Blood and Marrow Transplantation. Blood. 2011 Apr 28;117(17):4434-41. doi: 10.1182/blood-2010-08-304071. Epub 2011 Jan 13.

lead_sponsor: European Society for Blood and Marrow Transplantation

location_country:
Germany
Italy
United Kingdom
Sweden
Netherlands
Switzerland
Greece
Czech Republic
France

location_facility: St George's Hospital/ St George's University of London


title: Are the Continous Glucose Monitoring Systems Able to Improve Long Term Glycaemic Control in Type 1 Diabetic Patients With Poor Metabolic Control?

summary: The "Capteur Evadiac" study group, composed of French and Belgian diabetologists, has designed a 1 year randomized controlled multicenter study in order to define what should be the best clinical way of using continuous glucose monitoring in the long term to improve metabolic control in uncontrolled type 1 diabetes patients.

primary_purpose: Supportive Care

ReferenceCitation: Riveline JP, Schaepelynck P, Chaillous L, Renard E, Sola-Gazagnes A, Penfornis A, Tubiana-Rufi N, Sulmont V, Catargi B, Lukas C, Radermecker RP, Thivolet C, Moreau F, Benhamou PY, Guerci B, Leguerrier AM, Millot L, Sachon C, Charpentier G, Hanaire H; EVADIAC Sensor Study Group. Assessment of patient-led or physician-driven continuous glucose monitoring in patients with poorly controlled type 1 diabetes using basal-bolus insulin regimens: a 1-year multicenter study. Diabetes Care. 2012 May;35(5):965-71. doi: 10.2337/dc11-2021. Epub 2012 Mar 28.

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

location_facility:
CHU Toulouse
CHU Rennes
Hopital Edouard Herriot
CHU La Pitié Salpetrière
CHU Jean Minjoz
Hopital Bellevue
CHU de Reims-Hôpital Américain
CHU Hôpital Jeanne d'Arc
CHU Sart Tilman Liège
CHU Robert Debré
CH SUD Francilien
CHU Nantes
Hopital Hotel Dieu
CHU de Reims-Hôpital Robert debré
CHU Marseille Hôpitaux Sud
CHU Strasbourg
Chu Montpellier
University Hospital Grenoble
Hopital Haut Leveque

intervention_type: Device


title: A Randomized Phase II Study of Clofarabine / Intermediate-Dose Cytarabine (CLARA)Versus High-Dose Cytarabine (HDAC) as Consolidation in Younger Patients With Newly-Diagnosed Acute Myeloid Leukemia (AML).

acronym: CLARA

summary:
This study is a phase II randomized multicenter study. Patients will be enrolled at time of diagnosis and will receive one or two cycles of induction chemotherapy. Patients, without indication of intensification by allogeneic stem cell transplantation and/or without HLA (Human Leukocyte Antigen)-compatible donor, who attain a CR after one or two cycles of induction chemotherapy, will be eligible for the study Clofarabine / Intermediate-Dose Cytarabine (CLARA)versus High-Dose Cytarabine (HDAC)and will be randomized between 3 courses of CLARA chemotherapy and 3 courses of HDAC chemotherapy as consolidation.

We will compare efficacy and toxicity among the two arms.

ReferenceCitation: Michallet M, Sobh M, Morisset S, Deloire A, Raffoux E, de Botton S, Caillot D, Chantepie S, Girault S, Berthon C, Bertoli S, Lepretre S, Leguay T, Castaigne S, Marolleau JP, Pautas C, Malfuson JV, Veyn N, Braun T, Gastaud L, Suarez F, Schmidt A, Gressin R, Bonmati C, Celli-Lebras K, El-Hamri M, Ribaud P, Dombret H, Thomas X, Bergeron A. Antifungal Prophylaxis in AML Patients Receiving Intensive Induction Chemotherapy: A Prospective Observational Study From the Acute Leukaemia French Association (ALFA) Group. Clin Lymphoma Myeloma Leuk. 2022 May;22(5):311-318. doi: 10.1016/j.clml.2021.10.011. Epub 2021 Oct 25.

oa_host_type: closed

ReferenceCitation: Fenwarth L, Thomas X, de Botton S, Duployez N, Bourhis JH, Lesieur A, Fortin G, Meslin PA, Yakoub-Agha I, Sujobert P, Dumas PY, Recher C, Lebon D, Berthon C, Michallet M, Pigneux A, Nguyen S, Chantepie S, Vey N, Raffoux E, Celli-Lebras K, Gardin C, Lambert J, Malfuson JV, Caillot D, Maury S, Ducourneau B, Turlure P, Lemasle E, Pautas C, Chevret S, Terre C, Boissel N, Socie G, Dombret H, Preudhomme C, Itzykson R. A personalized approach to guide allogeneic stem cell transplantation in younger adults with acute myeloid leukemia. Blood. 2021 Jan 28;137(4):524-532. doi: 10.1182/blood.2020005524.

oa_colors: green other

evidence: open (via free article)

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

repositories_concat: LillOA (Lille Open Archive)

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Hematology

lead_sponsor: Hospices Civils de Lyon

location_facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

location_facility: Centre Hospitalier Regional et Universitaire d'Angers


type: EudraCT Number

title: A Risk-Adapted Strategy of the Use of Dose-Dense Chemotherapy in Patients With Poor-Prognosis Disseminated Non-Seminomatous Germ Cell Tumors

summary:
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This randomized phase III trial is comparing two different combination chemotherapy regimens to see how well they work in treating patients with stage II or stage III non-seminomatous germ cell tumors.

ReferenceCitation: Fizazi K, Pagliaro L, Laplanche A, Flechon A, Mardiak J, Geoffrois L, Kerbrat P, Chevreau C, Delva R, Rolland F, Theodore C, Roubaud G, Gravis G, Eymard JC, Malhaire JP, Linassier C, Habibian M, Martin AL, Journeau F, Reckova M, Logothetis C, Culine S. Personalised chemotherapy based on tumour marker decline in poor prognosis germ-cell tumours (GETUG 13): a phase 3, multicentre, randomised trial. Lancet Oncol. 2014 Dec;15(13):1442-1450. doi: 10.1016/S1470-2045(14)70490-5. Epub 2014 Nov 13.

oa_host_type: repository

unpaywall_oa_status: green

location_country:
United States
Slovakia
France

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

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

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: M. D. Anderson Cancer Center at University of Texas


title: Study of Second Look Surgery With or Without Chemotherapy Intraperitoneally, in the Event of Risk of Intraperitoneal Recurrence

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs in different ways may kill more tumor cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of second-look surgery with or without intraperitoneal infusions of mitomycin and fluorouracil in treating patients who have colorectal cancer that is recurrent to the peritoneum.

location_facility: Centre Hospitalier Universitaire de Dijon


title: A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment With PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects With Parkinson's Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED)

acronym: AMBLED

summary: This will be a double-blind, randomised, placebo-controlled parallel-arm phase II proof of concept in subjects with PD treated with a stable dose of levodopa who are experiencing both end-of-dose wearing off and Levodopa-Induced Dyskinesia (LID)

lead_sponsor: Prexton Therapeutics

location_country:
Germany
Italy
United Kingdom
Austria
Spain
France

location_facility: Clinical Ageing Research Unit, Campus for Ageing and Vitality

location_facility: Universitätsklinik für Innere Medizin VI Innsbruck, Neurologisches Studienzentrum

location_facility: Università degli Studi di Roma "La Sapienza"

location_facility: IRCCS Fondazione Ospedale San Camillo (SC)

location_facility: University Hospital Erlangen - Abteilung fur Molekulare Neurologie

location_facility: Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

location_facility: Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan

location_facility: Hospital Universitari General de Catalunya

location_facility: Fondazione Universita G. D'Annunzio Centro Studi sull'invecchiamento Centro di Ricerca Clinica

location_facility: CHU Grenoble - Pôle Psychiatrie et Neurologie

location_facility: Imperial College Healthcare NHS Trust - Charing Cross Hospital

location_facility: Practice for Neurology, Psychiatry & Psychotherapy Dr. med. I. Schoell & colleagues

location_facility: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

location_facility: Plymouth Hospitals NHS Trust - Derriford Hospital

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero di Santa Chiara

location_facility: Centre Hospitalier Universitaire d'Amiens


title: Phase I-II Study of Association of Deferasirox, Vitamin D and Azacytidine as Treatment of High Risk MDS (IPSS Int-2 and High)

acronym: GFM-EXVD-AZA

summary:
Determinate safety and response rate of the association Deferasirox -Vitamine D - Azacitidine in treatment of high risk MDS

Deferasirox Exjade:

The dose of Deferasirox will be assigned according to the ferritin level. Dose escalation is scheduled during the phase I, with 5 additional patients per group.

The maximal tolerated dose of Deferasirox will be required for the phase II of the study.

The first dose will be assigned according to the ferritin level of the patient at time of inclusion:

5 mg/kg/d if the ferritin is >300ng/ml and < 1000ng/ml in Group 1 10 mg/kg/d if the ferritin is ≥1000ng/ml) in Group 2

Group 1 : Ferritin 300 to 1000ng /ml:

cohort 1 : 5 mg/kg/d
cohort 2 : 10mg/kg/d
cohort 3 : 15 mg/kg/d

Group 2 : Ferritin > 1000ng /ml:

cohort 1 : 10 mg/kg/d
cohort 2 : 15mg/kg/d

cohort 3 : 20 mg/kg/d

5 patients will be treated by cohort. In absence of toxicity (extra-hematological toxicity grade 3 or 4 or hematological grade 4), 5 additional patients will be included in the next cohort.

Deferasirox will be administrated once daily during all the study period. Uvedose will be administrated once weekly during all the study period (100.000 UI P.O).

Azacitidine will be administrated sc at 75 mg/m²/d, during 7 days, J1 to J7 of each cycles(One cycle is 28 days)

During phase I and II, Deferasirox will always be associated with Vitamin D and Azacitidine

Patients will be received 6 cycles of treatment (except if progression, unacceptable toxicity or withdrawn of patients occured) After 3 and 6 cycles, an evaluation will be done to evaluate the efficacy of the treatment.

No dose modification of deferasirox will be done after 3 cycles of treatment except in case of progression). After 6 cycles, patients with CR, PR, marrow CR or HI will be treated with the same dose of Deferasirox until progression .

status: Unknown status

design_allocation: Non-Randomized

sponsor_collaborators:
Groupe Francophone des Myelodysplasies
Novartis

location_facility:
Hôpital Avicenne
CHU Nantes
CHU Le Mans
Hôpital Saint Vincent de Paul
Hôpital saint Louis
Centre Hospitalier de Boulogne sur Mer
CHU Brabois
Hôpital cochin
Centre Catherine de Sienne
IUCT Oncopole Toulouse
CHU Poitiers
CHU Limoges
GENT
Centre Hospitalier de La Cote Basque
Hôpital Necker


title: Clinical Status Monitoring in ICD Patients by Physiological Diagnosis (PhD) Function

acronym: TUTOR

summary: The purpose of this study is to evaluate the performance of advanced features, that have been implemented in the PARADYM ICD Platform offering single chamber (VR - model 8250), dual Chamber (DR - 8550) and Cardiac Resynchronization System with defibrillation capabilities (PARADYM CRT System, model 8750) in a general ICD population.

lead_sponsor: LivaNova

location_country: Germany Italy Portugal Belgium France

location_facility: Centre Hospitalier Universitaire de La Timone

location_facility: Praxis Westend Studien GbR, Medianzentrum Haus 9

location_facility: Ccn: Centre Cardiologique Du Nord St Denis

location_facility: Hospital de Santa Cruz - Carnaxide (Adragão)

location_facility: CENTRE HOSP. HENRI DUFFAUT - Service de Cardiologie AVIGNON

location_facility: Algemeen Ziekenhuis Middelheim Lindendref 1 2020 Antwerpen

location_facility: HOPITAL ARNAUD DE VILLENEUVE - Service de Cardiologie

location_facility: Centre Hospitalier Universitaire D'Amiens


title: Demonstration of the Medical Interest of the VisioCyt® Artificial Intelligence Test

acronym: DMIA

summary: European, multicenter clinical trial with VisioCyt®, an in vitro diagnostic medical device. VisioCyt® is an innovative solution for the early diagnosis of bladder cancer.

status: Recruiting

lead_sponsor: Vitadx

collaborators: FONDATION FORCE POUR L'INNOVATION ET LA RECHERCHE EN SANTE

location_country: Spain Belgium France

location_facility:
CHU Nantes
CHU Grenoble
CHU de Caen
Hôpital Académique ERASME
Hôpital Pitié-Salpétrière, APHP
CHU Toulouse
CHU Tours
Hopital Foch
Hôpital Bichat-Claude Bernard,
Clinique la Croix du Sud
CHU de Rennes
CHU Strasbourg
Pr Maria Jose Ribal
CHU Angers
CHU de Clermont Ferrand


acronym: Quidam

lead_sponsor: Nantes University Hospital

summary: The specific aim of this study is to determine whether hydroquinidine administration can prevent heart from appearance of ventricular arrhythmia detected by the automatic implantable defibrillator (ICD).

sponsor_collaborators:
Nantes University Hospital
Sanofi

location_facility:
CHU Nantes
CHU Grenoble
CHU Montpellier
AP-HM Marseille
CHU Toulouse
CHU Tours
CHU Rennes
CHRU Lille
CHU Poitiers
CHU Bordeaux
CHU Brest
CHU Lyon
CHU Strasbourg
AP-HP Paris Lariboisière
CHU Nancy
CHU Angers
CHU Amiens

title: BRD 06/2-D (Quidam) "Evaluation of the Interest of Oral Hydroquinidine Administration to Treat Patients With Brugada Syndrome, High Cardiac Arrhythmic Risk and Implanted With an Implantable Cardioverter Defibrillator"

source: euctr


title: European Phase III Study Comparing a Radiation Dose Escalation Using 2 Different Approaches : External Beam Radiation Therapy Versus Endocavitary Radiation Therapy With Contact X-ray Brachytherapy 50 kiloVolts (kV) for Patients With Rectal Adenocarcinoma

acronym: OPERA

summary:
The investigators propose to conduct a randomised study on cT2, cT3a-b tumours less than 5 cm using two different techniques of radiotherapy boost following neoadjuvant chemoradiotherapy (nCRT) (CAP45): EBRT (9 Gy/5 fractions) or CXB (90 Gy/3 fractions). The endpoint will be organ preservation at 3 years without non-salvageable local pelvic recurrence. The proof of this concept will be of most benefit for all patients but especially for the elderly who usually are not fit for or keen to undergo major surgery.

The hypothesis of this study is to determine whether the addition of an endocavitary boost with CXB after standard treatment with nCRT, increases the chance of rectum and anus preservation by 20%-unites in early rectal adenocarcinoma without locally progressive disease (organ preservation in control arm 20%, in experimental arm 40%).

Main objective To demonstrate that neoadjuvant chemoradiotherapy in combination with a boost given with CXB (Arm B) is superior to the same neoadjuvant therapy plus a boost with EBRT alone (Arm A) in terms of rectum (organ) preservation without non salvageable local disease at 3 years post treatment start, or permanent deviating stoma.

Study Design Open-label, phase III, prospective, multi-centre, international, randomised 1:1, 2 arm study designed to evaluate the efficacy of a CXB boost versus an EBRT boost.

lead_sponsor: Centre Antoine Lacassagne

collaborators: Institut de Cancérologie Lucien Neuwirth

collaborators: The Clatterbridge Cancer Centre NHS Foundation Trust

collaborators: Nottingham University Hospitals NHS Trust

collaborators: Royal Surrey County Hospital NHS Foundation Trust

location_country:
Denmark
Sweden
United Kingdom
France

location_facility: Hôpital de la Croix Rouge Française - Centre de Radiothérapie St Louis

location_facility: Centre d'oncologie et de radiothérapie Mâcon

location_facility: Hospices Civils de Lyon - Centre Hospitalier Lyon-Sud

location_facility: Hospices Civils de Lyon - Hôpital de la Croix Rousse


title: Evaluation of the SafeR Mode in Patients With a Dual Chamber Pacemaker Indication

acronym: ANSWER

summary:
The aim of this study is to assess the benefits from the AAISafeR/SafeR algorithm of Symphony 2550 or REPLY DR in a wide range of pacemaker patients.

The expected benefits will be a result of the reduction of the percentage of ventricular pacing.

It contributes to the longevity of the cardiac pacemaker and has an effect on the incidence of sustained (or persistent) Atrial Fibrillation and Heart Failure. These clinical benefits are a result of spontaneous ventricular activation which ensures a more physiological ventricular activation.

The benefits will be assessed by comparing the incidence of atrial arrhythmias and the evolution of the haemodynamic status of the patients (QOL, echo and BNP)

location_country:
Germany
Italy
United Kingdom
United States
Spain
France

location_facility: Complejo Hospitalario Arquitecto Marcide

location_facility: Hospital Clinico universitario de Santiago


title: Prospective Evaluation of the Resection Margins and the Ganglionic Status Using a Quality Standard Resection for Adenocarcinoma of the Head of the Pancreas.

acronym: MRP

summary: This multicentric prospective study evaluates the role of the margins resection and the ganglionic status when using a quality standard for the resection of adenocarcinoma of the head of the pancreas.

ReferenceCitation: Delpero JR, Jeune F, Bachellier P, Regenet N, Le Treut YP, Paye F, Carrere N, Sauvanet A, Adham M, Autret A, Poizat F, Turrini O, Boher JM. Prognostic Value of Resection Margin Involvement After Pancreaticoduodenectomy for Ductal Adenocarcinoma: Updates From a French Prospective Multicenter Study. Ann Surg. 2017 Nov;266(5):787-796. doi: 10.1097/SLA.0000000000002432.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Delpero JR, Bachellier P, Regenet N, Le Treut YP, Paye F, Carrere N, Sauvanet A, Autret A, Turrini O, Monges-Ranchin G, Boher JM. Pancreaticoduodenectomy for pancreatic ductal adenocarcinoma: a French multicentre prospective evaluation of resection margins in 150 evaluable specimens. HPB (Oxford). 2014 Jan;16(1):20-33. doi: 10.1111/hpb.12061. Epub 2013 Mar 7.

evidence: open (via crossref license)

lead_sponsor: Institut Paoli-Calmettes

location_facility:
Hopital Beaujon
Hopital de L'Antiquaille
Chu de Bordeaux
Chu D'Angers
Hopitial Saint Antoine
Chu de Clermont-Ferrand
Centre Val D'Aurelle Paul Lamarque
Institut Paoli-Calmettes
Hopital Ambroise Pare
Chu Purpan
Hopital Cochin
Chu La Conception
Hotel Dieu
Hopital de La Croix-Rousse
Hopital Tenon
Hopital Henri Mondor
Hopital Pitie-Salpetriere
Hospices Civils de Lyon
Hopital Pontchaillou
Hopitaux Universitaires de Strasbourg

intervention_type: Procedure


acronym: CaboPoint

lead_sponsor: Ipsen

summary: The overall objective of this study is to evaluate the efficacy and safety of cabozantinib as 2nd line treatment in subjects with unresectable, locally advanced or metastatic RCC with a clear-cell component, who progressed after prior Checkpoint Inhibitors (CPI) therapy with ipilimumab and nivolumab in combination or CPI combined with Vascular Endothelial Growth Factor (VEGF)-targeted therapy.

ReferenceCitation: Albiges L, Schmidinger M, Taguieva-Pioger N, Perol D, Grunwald V, Guemas E. CaboPoint: a phase II study of cabozantinib as second-line treatment in patients with metastatic renal cell carcinoma. Future Oncol. 2022 Mar;18(8):915-926. doi: 10.2217/fon-2021-1006. Epub 2021 Dec 16.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: Future Science Ltd

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: University Cancer Center Hamburg Eppendorf

location_facility: CHU de Nîmes - Institut de Cancérologie du Gard

location_facility: Klinikum Der Friedrich-Schiller-Universitaet Jena

location_facility: Otto-von-Guericke-Universität University hospital Magdeburg

location_facility: University Hospital Carl Gustav Carus Dresden

location_facility: The Netherlands Cancer Institute - Oncology

location_facility: Caritas Krankenhaus St.Josef Klinik für Urologie

location_facility: Western General Hospital - Edinburgh Cancer Centre

location_facility: Royal Cornwall Hospital (RCH) - Sunrise Centre

title: A Phase II, Multicentre, Open-label Study of Cabozantinib as 2nd Line Treatment in Subjects With Unresectable, Locally Advanced or Metastatic Renal Cell Carcinoma With a Clear-Cell Component Who Progressed After 1st Line Treatment With Checkpoint Inhibitors.

ipd_sharing_description: Where patient data can be anonymized, Ipsen will share all individual participant data that underlie the results reported in the published journal article with qualified researchers who provide a valid research question. Study documents, such as the study protocol and clinical study report, are not always available

location_country:
Germany
United Kingdom
Netherlands
Austria
Switzerland
Spain
France

ipd_sharing: Yes


title: Optimization With SonR Method in the ClinicAl pRactice

acronym: OSCAR

summary: Evaluate the percentage of patients optimized at least once every month by the SonR automatic optimization method, until M6 follow-up, in Heart failure (HF) patients prevalently in sinus rhythm

location_country: Germany Italy Portugal Austria Spain France

location_facility: Centro Hospitalar Lisboa Norte (CHLN) - Hospital de Santa Maria


title: Prospective Evaluation of the Efficacy of Sirolimus (Rapamune®) in the Treatment of Severe Arteriovenous Malformations

acronym: MAV-RAPA

summary:
The aim of the study is to evaluate the efficacy and safety of sirolimus (oral form), to decrease the volume and symptoms due to superficial arteriovenous malformations (AVM).

Sirolimus has properties that reduce the activity of the immune system (immunosuppressant), to fight against the proliferation of cancer cells (anti- tumor) and also reduce the proliferation of blood vessels (anti -vascular). Sirolimus is primarily used in transplant patients to prevent organ transplant rejection. Many animal and laboratory studies were carried out and demonstrate in particular the activity of sirolimus on vessels. It is this anti- vascular effect that could help treat arteriovenous malformations.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility:
UCL
CHU Montpellier
CHU Nice
APHP
CHU Tours
CHRU Lille
CHU Bordeaux
CHU Dijon
HCL Lyon
CHU Strasbourg
CHU Nancy
APHM
CHU Amiens


lead_sponsor: Sanofi

summary:
Primary Objective:

To compare Insuman Implantable 400 IU/ml versus Insuplant 400 IU/ml with respect to the pump refill accuracy during a 4 refill cycle period (i.e. the comparative phase); To assess efficacy measured by hemoglobin glycosylated (HBA1c) change in Insuman Implantable 400 IU/ml group versus Insuplant 400 IU/ml group after a 4 refill cycle period (i.e. the comparative phase).

Secondary Objective:

To assess efficacy, safety, refill accuracy evolution and device interventions during the open-label treatment period with Insuman To evaluate daily insulin doses To assess Anti-Insulin Antibodies (ADAs or AIA) levels during all study phases

ReferenceCitation: Schaepelynck P, Riveline JP, Renard E, Hanaire H, Guerci B, Baillot-Rudoni S, Sola-Gazagnes A, Catargi B, Fontaine P, Millot L, Martin JF, Tachouaft H, Jeandidier N; EVADIAC Group. Assessment of a new insulin preparation for implanted pumps used in the treatment of type 1 diabetes. Diabetes Technol Ther. 2014 Sep;16(9):582-9. doi: 10.1089/dia.2013.0369. Epub 2014 Apr 15.

publisher_dissemination: Mary Ann Liebert Inc

location_facility:
Investigational Site Number 250-011
Investigational Site Number 528002
Investigational Site Number 056-001
Investigational Site Number 250-005
Investigational Site Number 528003
Investigational Site Number 250-003
Investigational Site Number 250-012
Investigational Site Number 250-001
Investigational Site Number 528001
Investigational Site Number 250-008
Investigational Site Number 752-001
Investigational Site Number 250-009
Investigational Site Number 250-010
Investigational Site Number 250-004
Investigational Site Number 250-006
Investigational Site Number 250-002
Investigational Site Number 250-007

title: Evaluation of Insuman Implantable 400 IU/ml in Patients With Type 1 Diabetes Treated With the Medtronic MiniMed Implantable Pump System Using Insuplant 400IU/ml

location_country: Sweden Netherlands Belgium France


title: Post-Authorisation Safety Study of Paediatric Patients Initiating Selumetinib: A Multiple-Country Prospective Cohort Study

summary:
Neurofibromatosis type 1 (NF1) is a rare, autosomal dominant genetic disorder that is caused by germline mutations in the NF1 tumour suppressor gene, which encodes the tumour suppressor protein neurofibromin 1. Plexiform neurofibromas (PN) are histologically benign nerve sheath tumours, which typically grow along large nerves and plexi.

On 5 March 2020, a centralised Marketing Authorisation Application was submitted to the European Medicines Agency (EMA), Marketing Authorisation in EU was granted on 17 Jun 2021.

As part of the approval process, a Risk Management Plan (RMP) was developed and submitted to the EMA to summarise the safety concerns emerging from the clinical development program. The RMP included additional pharmacovigilance plans for a noninterventional Post-authorisation Safety Study (PASS) to further characterise the safety of selumetinib in paediatric patients with NF1-related PN in routine clinical practice.

The planned non-interventional PASS will address gaps in knowledge identified by the RMP, including the important identified risk and some of the potential risks and missing information on long-term developmental toxicity in children, by characterising the safety profile associated with selumetinib use among paediatric patients (ages > 8 to < 18 years old) with a diagnosis of NF1 with symptomatic, inoperable PN.

This study is a specific obligation in the context of a conditional marketing authorisation for selumetinib (ie, Category 2 PASS). Study results will contribute to updating the safety profile of selumetinib in a relatively large population of patients with different personal characteristics across multiple health care systems and patterns of real-world clinical practice in the European Union (EU) and in the UK.

The study will enrol 2 cohorts:

The Base Cohort includes all enrolled patients aged 3 to < 18 years.
The Nested Prospective Cohort will include the subset of Base Cohort patients aged 8 to < 18 years who have not reached Tanner Stage V on the index date.

ReferenceCitation: EMA2017b EMA. Guideline on good pharmacovigilance practices (GVP). Module VIII - Post-authorisation safety studies (EMA/813938/2011 Rev 3). European Medicines Agency; 09 October 2017b. Available at: https://www.ema.europa.eu/documents/scientificguideline/ guideline-good-pharmacovigilance-practices-gvp-

ReferenceCitation: Zhou Q. [Recommendations for the conduct, reporting, editing and publication of scholarly work in medical journals]. Zhonghua Gan Zang Bing Za Zhi. 2014 Oct;22(10):781-91. No abstract available. Chinese.

ReferenceCitation: ISPE. Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug Saf. 2008 Feb;17(2):200-8. doi: 10.1002/pds.1471. No abstract available.

ReferenceCitation: KOSELUGO (selumetinib) KOSELUGO (selumetinib) capsules, for oral use, initial US Approval: 2020. Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. USPI revised April 2020, Reference ID 4590044.

ReferenceCitation: von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. 2007 Oct 20;370(9596):1453-7. doi: 10.1016/S0140-6736(07)61602-X.

ipd_sharing_description: The study protocol, study progress reports, and final study report will be included in regulatory communications in line with the RMP, PSUR, and other regulatory reporting requirements. Study reports will be prepared using a template following the GVP Module VIII Section B.6.3.

lead_sponsor: AstraZeneca

location_country:
Germany
Portugal
United Kingdom
Switzerland
Austria
Spain
France


title: Cross-sectional Survey to Collect Treatment Experience Feedback From Patients, Physicians, Nurses and Carers After Switching to Paliperidone Palmitate 3-monthly

summary: The purpose of this study is to explore the experience with paliperidone palmitate 3-month formulation (PP3M) treatment of participants and their corresponding physicians, nurses and carers, to understand the impact of less frequent injections from their perspective.

time_perspective: Cross-Sectional

lead_sponsor: Janssen-Cilag International NV

location_country:
Germany
Italy
Hungary
United Kingdom
Belgium
Spain
France

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili

location_facility: Kemenesaljai Egyesített Kórház-Szakorvosi Rendelointézet

location_facility: Centre Médico Psychologique De Courbevoie

location_facility: Centre Medico Psychologique Le Rembrandt


title: A Phase II Study of the Efficacy and Safety of Lenalidomide Combined to Escalating Doses of Chemotherapy in Intermediate-2-or High Risk MDS and AML With Del 5q

acronym: GFM-Chimio-Rev

summary: In this trial, the investigators will test the combination of escalating doses of chemotherapy (starting at relatively low dose) with lenalidomide in intermediate-2-or high risk MDS and AML with del 5 q31. It is hoped that this combined therapy will further increase response rate in intermediate-2-or high risk MDS and AML with del 5 q31, without major toxicity in comparison to historical results obtained with chemotherapy alone in the same subset of patients.

ReferenceCitation: Ades L, Prebet T, Stamatoullas A, Recher C, Guieze R, Raffoux E, Bouabdallah K, Hunault M, Wattel E, Stalnikiewicz L, Toma A, Dombret H, Vey N, Sebert M, Gardin C, Chaffaut C, Chevret S, Fenaux P. Lenalidomide combined with intensive chemotherapy in acute myeloid leukemia and higher-risk myelodysplastic syndrome with 5q deletion. Results of a phase II study by the Groupe Francophone Des Myelodysplasies. Haematologica. 2017 Apr;102(4):728-735. doi: 10.3324/haematol.2016.151894. Epub 2016 Dec 29.

lead_sponsor: Groupe Francophone des Myelodysplasies

sponsor_collaborators:
Groupe Francophone des Myelodysplasies
Celgene Corporation

location_facility: Hopital Purpan Service d'Hématologie Clinique


title: An Open Label, Multicenter Phase II Study of Intravenous SAR3419, an Anti-CD19 Antibody-Maytansine Conjugate, in Combination With Rituximab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphomas

summary:
Primary Objective:

Participants Achieving an Objective Response Rate (Cheson 2007)

Secondary Objectives:

Progression Free Survival
Overall Survival
Response Duration

location_country: Norway Austria France

location_facility:
Investigational Site Number 250005
Investigational Site Number 250011
Investigational Site Number 250007
Investigational Site Number 250006
Investigational Site Number 250009
Investigational Site Number 250002
Investigational Site Number 250008
Investigational Site Number 250003
Investigational Site Number 250004
Investigational Site Number 250001
Investigational Site Number 250010
Investigational Site Number 040002
Investigational Site Number 578001


title: Randomized RCT Comparing HH and HME During NIV in Acute Respiratory Failure

summary:
Comparison of humidification devices during non invasive ventilation, in acute respiratory failure.

The hypothesis was, due to dead space, lower humidification, a reduced efficiency of the technique (NIV) when HME are used in comparison with HH.

ReferenceCitation: Lellouche F, L'Her E, Abroug F, Deye N, Rodriguez PO, Rabbat A, Jaber S, Fartoukh M, Conti G, Cracco C, Richard JC, Ricard JD, Mal H, Mentec H, Loisel F, Lacherade JC, Taille S, Brochard L. Impact of the humidification device on intubation rate during noninvasive ventilation with ICU ventilators: results of a multicenter randomized controlled trial. Intensive Care Med. 2014 Feb;40(2):211-219. doi: 10.1007/s00134-013-3145-z. Epub 2013 Nov 26.

evidence: open (via free pdf)

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_country: Italy Canada Tunisia France

location_facility: Réanimation Médicale - Centre Hospitalier Intercommunal de Poissy

location_facility: Réanimation Médicale - Hôpital Louis Mourier

location_facility: Istituto di anestesiologia e Rianimazione - Università Cattolica Policlinico A. Gemelli

location_facility: Réanimation pneumologique, Hôpital Pitié Salpétrière

location_facility: Réanimation du Service de Pneumologie - Centre Hospitalier Beaujon

location_facility: Réanimation Médicale, Hôpital Charles Nicolle

location_facility: Réanimation Polyvalente - CHU Fatima Bourguiba

location_facility: Réanimation du Service Pneumologie - Hôtel Dieu

location_facility: Département d'Anesthésie - Hôpital de l'Enfant Jésus

location_facility: Département d'Anesthésie-Réanimation "B" - CHU Saint Eloi


title: The Efficacy of Minoxidil in Children With Williams-Beuren Syndrome: a Randomized Clinical Trial.

acronym: Williams

summary:
The Williams-Beuren syndrome (WBS) is a sporadic congenital disorder characterized by a multisystem developmental impairment. This syndrome is caused by a microdeletion in chromosome 7q11.23 that encompasses loss of the elastin locus.

Elastin, which is part of the extracellular matrix, controls proliferation of vascular smooth muscle cells (VSMCs) and stabilizes arterial structure. Loss of elastin gene in WBS patients has been claimed to provide a biological basis for the abnormal elastic fibre properties leading to cardiovascular abnormalities like supravalvular aortic stenosis (SVAS), hypertension, arteriosclerosis and stenosis in more than 50% of WBS children.

These cardiovascular pathologies result in important consequences and neither curative nor preventive medicinal treatments exist at this time. Surgery is needed in more than half cases, while it is often leading to complications.

Minoxidil is a well-known antihypertensive drug used in adults and children. Furthermore, according to animal studies, minoxidil seems to increase arterial elastin content by decreasing elastase activity in these tissues. Other data demonstrate that minoxidil specifically stimulate elastin synthesis.

Working Hypothesis:If insufficient elastin synthesis leads to vascular complications and arterial hypertension in children with WBS, restoration of sufficient quantity of elastin should then result in prevention or inhibition of vascular malformations and improvement in arterial tension. Therefore, as a pharmacological agent capable to stimulate elastin expression, minoxidil might be a useful drug for the treatment of abnormal elastin metabolism in WBS children.

Objective:To evaluate the efficacy of minoxidil on cardiovascular structure in children with Williams Beuren syndrome.

Methodology: randomized controlled trial on two parallel group (23 patients in each arm) Main criterion:variation of carotid Intima-media thickness (IMT) before and after 12 months of treatment with Minoxidil versus placebo Secondary intermediate criteria of the vascular properties are arterial stiffness, cardiac and renal stenosis, arterial tension.

Total study duration:30 months including a 12 month-recruitment period

ReferenceCitation: Kassai B, Bouye P, Gilbert-Dussardier B, Godart F, Thambo JB, Rossi M, Cochat P, Chirossel P, Luong S, Serusclat A, Canterino I, Mercier C, Rabilloud M, Pivot C, Pirot F, Ginhoux T, Coopman S, Grenet G, Gueyffier F, Di-Fillippo S, Bertholet-Thomas A. Minoxidil versus placebo in the treatment of arterial wall hypertrophy in children with Williams Beuren Syndrome: a randomized controlled trial. BMC Pediatr. 2019 May 28;19(1):170. doi: 10.1186/s12887-019-1544-1.

license: cc-by

license_normalized: cc-by

publisher_dissemination: Springer-Nature

location_facility: Service de Cardiologie - Hôpital des Enfants

location_facility: Service de Cardiologie, Hôpital Saint-André, CHU Bordeaux

location_facility: Département de Pédiatrie, Hôpital Femme Mère Enfant

location_facility: Service de Cardiologie Pédiatrique, CHU Angers

location_facility: Service de Physiologie, Explorations Fonctionnelles, Hôpital Robert Debré

location_facility: Service de Génétique Médicale, CHU La Milétrie

location_facility: Département de Pédiatrie- Service de Cardiologie, CHU Grenoble

location_facility: Service de Cardiologie Infantile, CHU Nancy

location_facility: Unité de Pharmacologie Clinique, Hôpital Robert Debré

location_facility: Service des Maladies Cardiovasculaires Infantiles et Congénitales, CHRU Lille

location_facility: Service de Néphrologie Pédiatrique, Hôpital Pellegrin, CHU Bordeaux

location_facility: Service de Néphrologie Pédiatrique - Hôpital des Enfants, CHU Toulouse

location_facility: Service de Néphrologie Pédiatrique, CHRU de Lille

location_facility: Service de Pathologie Cardiaque Congénitale du Fœtus, de l'Enfant et de l'Adulte, Hôpital Haut Lévêque, CHU de Bordeaux

location_facility: Service de Génétique Médicale, Hôpital Pellegrin, CHU Bordeaux

location_facility: Service de Cardiologie Pédiatrique, Hôpital Necker Enfants Malades

location_facility: Service de Cardiologie Pédiatrique, Hôpital Cardiovasculaire L. Pradel


title: Randomised Multicentric Phase III Study Comparing Observation Versus Post-surgery Radiotherapy After Complete Exeresis With Margins Greater Than or Equal to 1 cm in Soft Tissues Members Sarcoma.

summary:
Soft tissue sarcomas represent less than 1% of malignant tumors in adults and sarcomas members represent 60% of them.

These rare tumors involve complex multidisciplinary care better in centers having expertise.

Loco-regional therapy strategies have evaluated over time for tumors of members leading to propose more often the combination of a large conservative tumor excision with radiotherapy. Results have been demonstrated equivalent to those of an amputation in terms of local control and survival.

The local recurrence rate for sarcomas of the members of any kind after surgery with or without radiotherapy in the literature varies from 10 to 30%.

The main objective is to achieve a low recurrence rate while maintaining the function. The question remains the possibility of an absence of irradiation in selected cases in a de-escalation therapy order.

lead_sponsor: Institut Claudius Regaud

location_facility: Institut de Cancérologie de l'Ouest - Centre Paul Papin

location_facility: Institut de Cancérologie de l'Ouest - Centre René Gauducheau

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


title: A Phase IIIb, Open Label Extension Study Evaluating The Safety And Tolerability of AMX0035 Up To 108 Weeks In Adult Participants With Amyotrophic Lateral Sclerosis (ALS) Previously Enrolled In Study A35-004 (PHOENIX)

summary: The primary objective is to evaluate the safety and tolerability of AMX0035 over 108 weeks of open label treatment for participants previously enrolled in Study A35-004 (PHOENIX).

status: Enrolling by invitation

lead_sponsor: Amylyx Pharmaceuticals Inc.

location_country:
Germany
Ireland
Italy
Poland
Portugal
United Kingdom
Sweden
Netherlands
Belgium
Spain
France

location_facility: Hôpitaux Universitaires de Marseille Timone

location_facility: Salford Royal Hospital Barnes Clinical Research Team

location_facility: Sheffield Institute for Translational Neuroscience (SITraN)

location_facility: Università degli Studi della Campania Luigi Vanvitelli

location_facility: Biodonostia Health Research Institute; Hospital Universitario Donostia

location_facility: Hopital Gabriel Montpied Service de Neurologie

location_facility: Centro Hospitalar Universitário Lisboa-Norte

location_facility: Medizinische Fakultät Mannheim der Universität Heidelberg

location_facility: Hospital Universitari de Bellvitge-IDIBELL

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: Hospices Civils de Lyon Hôpital Neurologique Pierre Wertheimer Cellule Mutualisée de Recherche Clinique (CMRC)

location_facility: Azienda Ospedaliero Universitaria Di Modena

location_facility: Le Centre Hospitalier Régional Universitaire de Tours

location_facility: Università degli Studi di Bari Aldo Moro

location_facility: Trinity College Dublin/Beaumont Hospital


title: Point Of Care UltraSonography to Perform Risk-stratification of Patients With Suspected or Confirmed COVID-19 - POCUSCO Study

acronym: POCUSCO

summary:
COVID-19 pandemic has developed worldwide in less than 4 months. While most patients have a mild or uncomplicated disease (80%), approximately 15% need hospital care and 5% intensive care. Severe cases are characterized by pulmonary involvement which may progress to acute respiratory distress syndrome (ARDS). Early identification of patients who are likely to get worse is therefore a major issue.

While, chest X-ray has poor diagnostic performances, pulmonary computed tomography (CT scan) seems very sensitive (97%) and quite specific of COVID-19. Sub-pleural bilateral ground-glass pattern can precede the positivity of RT-PCR for SARS-CoV-2. CT scan is now considered as the best imaging test to assess COVID-19 patients and is recommended as first-line diagnosis tool by the French Society of Radiology (SFR). However, performing CT scan in all or many patients with suspected COVID-19 may result in radiology department overload, especially, taking into account bio-cleaning between patients. Moreover, CT scan may lead to adverse effects including induced cancer due to the cumulative diagnostic irradiation.

Chest ultrasonography may be an alternative to CT scan. It is a simple, non-invasive, non-irradiating, inexpensive and available at the point of care (POCUS). Most of emergency physicians and many other specialists (pneumologists, infectious disease or intensive care physicians) are trained to perform chest POCUS and use it in their everyday practice. Multiple studies have demonstrated its superiority to chest X-ray for the detection of pneumonia. In ARDS, a scoring has been developed and has shown good correlation with mortality. POCUS is very effective in detecting peripheral patterns and seems appropriate to explore COVID-19 patients.

Previous studies suggest its interest in SARSCov2 infections for initial patient assessment and identification of lung damage. However, its performances have never been scientifically evaluated to date.

Our main hypothesis is that point of care lung ultrasonography performed during the initial examination may identify high-risk COVID-19 patients.

ReferenceType: result

ReferenceCitation: Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

license: unspecified-oa

license_normalized: unspecified-oa

evidence: oa repository (via page says license)

repository_normalized: medRxiv

version: submittedVersion

repositories:
PubMed Central
medRxiv

repositories_concat: PubMed Central;medRxiv

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Rodriguez-Morales AJ, Cardona-Ospina JA, Gutierrez-Ocampo E, Villamizar-Pena R, Holguin-Rivera Y, Escalera-Antezana JP, Alvarado-Arnez LE, Bonilla-Aldana DK, Franco-Paredes C, Henao-Martinez AF, Paniz-Mondolfi A, Lagos-Grisales GJ, Ramirez-Vallejo E, Suarez JA, Zambrano LI, Villamil-Gomez WE, Balbin-Ramon GJ, Rabaan AA, Harapan H, Dhama K, Nishiura H, Kataoka H, Ahmad T, Sah R; Latin American Network of Coronavirus Disease 2019-COVID-19 Research (LANCOVID-19). Electronic address: https://www.lancovid.org. Clinical, laboratory and imaging features of COVID-19: A systematic review and meta-analysis. Travel Med Infect Dis. 2020 Mar-Apr;34:101623. doi: 10.1016/j.tmaid.2020.101623. Epub 2020 Mar 13.

repositories_concat: PubMed Central;www.preprints.org

ReferenceCitation: Lichtenstein DA, Meziere GA. Relevance of lung ultrasound in the diagnosis of acute respiratory failure: the BLUE protocol. Chest. 2008 Jul;134(1):117-25. doi: 10.1378/chest.07-2800. Epub 2008 Apr 10. Erratum In: Chest. 2013 Aug;144(2):721.

ReferenceCitation: Zhao Z, Jiang L, Xi X, Jiang Q, Zhu B, Wang M, Xing J, Zhang D. Prognostic value of extravascular lung water assessed with lung ultrasound score by chest sonography in patients with acute respiratory distress syndrome. BMC Pulm Med. 2015 Aug 23;15:98. doi: 10.1186/s12890-015-0091-2.

ReferenceCitation: Morin F, Douillet D, Hamel JF, Rakotonjanahary J, Dupriez F, Savary D, Aube C, Riou J, Dubee V, Roy PM. Point-of-care ultrasonography for risk stratification of non-critical COVID-19 patients on admission (POCUSCO): a study protocol of an international study. BMJ Open. 2021 Feb 10;11(2):e041118. doi: 10.1136/bmjopen-2020-041118.

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

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

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

location_facility:
COUTURAUD Francis
JOLY Luc-Marie
SOULAT Louis
LE CONTE Philippe
MORIN François
BAUDIN Laure
DELOMAS Thomas
TAZAROURTE Karim
MARJANOVIC Nicolas
FLAMENT Thomas
Florence DUPRIEZ


title: A Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients With Parkinson's Disease

acronym: SKY

summary: The goal of this study is to evaluate the effects of deferiprone, an iron-chelating drug, in patients with Parkinson's disease. Participants will be randomized to receive one of four different dosages of deferiprone or placebo, and will take the assigned study product twice a day for nine months.

lead_sponsor: ApoPharma

location_country:
Germany
United Kingdom
Canada
France

location_facility: CHU de Bordeaux, Centre Expert Parkinson

location_facility: Hôpitaux Universitaires de Strasbourg, Hôpital de Hautepierre

location_facility: CHRU de Montpellier - Hôpital Gui de Chauliac

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: Centre Hospitalier Régional Universitaire de Lille, Hôpital Roger Salengro


title: Performance of Imaging for the Diagnosis of Small Hepatocellular Carcinoma (< 3 cm)on Cirrhosis

acronym: CHIC

summary: The purpose of this study is to evaluate 3 imaging techniques and their associations : MRI, CTscanner and enhanced contrast ultrasound for the diagnosis of small (< 3 cm) hepatocellular carcinoma for patients with cirrhosis.

ReferenceCitation: Paisant A, Vilgrain V, Riou J, Oberti F, Sutter O, Laurent V, Rodes A, Guiu B, Cassinotto C, Trillaud H, Bricault I, Michalak S, Bruno O, Ronot M, Aube C. Comparison of extracellular and hepatobiliary MR contrast agents for the diagnosis of small HCCs. J Hepatol. 2020 May;72(5):937-945. doi: 10.1016/j.jhep.2019.12.011. Epub 2019 Dec 21.

ReferenceCitation: Aube C, Oberti F, Lonjon J, Pageaux G, Seror O, N'Kontchou G, Rode A, Radenne S, Cassinotto C, Vergniol J, Bricault I, Leroy V, Ronot M, Castera L, Michalak S, Esvan M, Vilgrain V; CHIC Group. EASL and AASLD recommendations for the diagnosis of HCC to the test of daily practice. Liver Int. 2017 Oct;37(10):1515-1525. doi: 10.1111/liv.13429. Epub 2017 Apr 26.

publisher_dissemination: Wiley

lead_sponsor: University Hospital, Angers

location_facility:
Hôpital Brabois
Hôpital Saint Éloi
Hôpital Hôtel Dieu
Institut Gustave Roussy
CHU Angers
Hôpital de la croix rousse
Hôpital Paul Brousse
Chu
Hôpital Pontchaillou
Hôpital E. Herriot
Hôpital Nord
Hôpital Du Bocage
hôpital Beaujon
Hôpital Saint-André
Hôpital Saint Antoine
hôpital Henri Mondor
CHU
hôpital archet II
Hôpital Haut-Lévèque


title: A Multicentre, Randomized, Open-label Study to Evaluate the Efficacy andSafety of Fondaparinux Versus Low Molecular Weight Heparin(Nadroparin) in Patients Requiring Rigid or Semi-rigid Immobilization for at Least 21 Days and up to 45 Days Because of Isolated Non-surgical Below-Knee Injury

acronym: FONDACAST

summary: The purpose of this study is to evaluate the efficacy and safety of fondaparinux in comparison with a heparin (nadroparin) in preventing deep vein thrombosis (blood clots in the leg veins), whether symptomatic or detected by ultrasound, and pulmonary embolism (blood clots that migrate to the lungs) in patients with leg injuries below the knee that require a cast or other type of immobilization but not surgery.

primary_purpose: Prevention

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Italy
Netherlands
Spain
Russian Federation
France


lead_sponsor: Cephalon

summary: Breakthrough cancer pain (BTcP) is a common problem in patients with cancer. Fentanyl Buccal Tablet (FBT) is used for the treatment of BTP in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. FBT treatment should be individually titrated to an effective dose that provides adequate analgesia and minimizes undesirable effects. To reach the safest effective dose for the individual patient as soon as possible, the dose titration process is critical. The aim of this study, conducted under pragmatic conditions in a large-scale population of cancer patients is to compare the proportion of patients reaching an effective FBT dose after titration starting with either a 100 mcg dose or a 200 mcg dose.

title: A European Multicenter Open-Label Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients

location_country:
Germany
Ireland
Poland
Italy
United Kingdom
Spain
France


lead_sponsor: UNICANCER

summary:
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab and combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab and radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying giving bevacizumab together with chemotherapy before surgery and bevacizumab and radiation therapy after surgery to see how well it works in treating patients with inflammatory breast cancer.

ReferenceCitation: Bertucci F, Fekih M, Autret A, Petit T, Dalenc F, Levy C, Romieu G, Bonneterre J, Ferrero JM, Kerbrat P, Soulie P, Mouret-Reynier MA, Bachelot T, Lerebours F, Eymard JC, Deblock M, Lortholary A, Hardy-Bessard AC, Barthelemy P, Bonnefoi H, Charafe-Jauffret E, Bidard FC, Viens P, Lemonnier J, Pierga JY. Bevacizumab plus neoadjuvant chemotherapy in patients with HER2-negative inflammatory breast cancer (BEVERLY-1): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2016 May;17(5):600-11. doi: 10.1016/S1470-2045(16)00011-5. Epub 2016 Mar 28.

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

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

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Centre Hospitalier General Andre Boulloche

title: Phase II Study Evaluating the Efficacy and Tolerance of Bevacizumab (Avastin) in HER2- Inflammatory Breast Cancer

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported under the following conditions: the data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.


title: Intracranial Aneurysms Treatment With the OPTIMA Coil System

acronym: INSTANT

summary: International, non-randomized, European , multicenter, observational study to collect data for the treatment of intracranial aneurysms with OPTIMA coils system to further document its safety and efficacy

lead_sponsor: Balt Extrusion

location_country: Germany Italy Switzerland Austria Latvia Spain France

location_facility: HUG Hôpital cantonal universitaire de geneva

location_facility: University of Latvia, Faculty of Medicine

location_facility: CHU de Brest - Hôpital La Cavale Blanche

location_facility: Hospices Civils de Lyon - Hôpital Neurologique


acronym: CONDUCT

lead_sponsor: InDex Pharmaceuticals

summary: The purpose of this study was to evaluate efficacy of cobitolimod treatment at different dose levels and frequencies compared to placebo in patients with moderate to severe left-sided ulcerative colitis.

ReferenceCitation: Atreya R, Peyrin-Biroulet L, Klymenko A, Augustyn M, Bakulin I, Slankamenac D, Miheller P, Gasbarrini A, Hebuterne X, Arnesson K, Knittel T, Kowalski J, Neurath MF, Sandborn WJ, Reinisch W; CONDUCT study group. Cobitolimod for moderate-to-severe, left-sided ulcerative colitis (CONDUCT): a phase 2b randomised, double-blind, placebo-controlled, dose-ranging induction trial. Lancet Gastroenterol Hepatol. 2020 Dec;5(12):1063-1075. doi: 10.1016/S2468-1253(20)30301-0. Epub 2020 Oct 5.

title: A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients

location_country:
Germany
Poland
Hungary
Sweden
Spain
Czechia
Ukraine
Serbia
Russian Federation
France


title: Retrospective Non-interventional Study Evaluating Treatment Adaption During a One Year Follow-up After Completion of the 2-79-52030-207 Study in a Group of Acromegalic Patients With Macroadenoma Who Received 12 Injections of Lanreotide Autogel® 120 mg

summary: This non-interventional retrospective study aims to describe the therapeutic procedures and modalities received by patients and the correlation to hormone status, during a one year follow up from completion of the 2-79-52030-207 study.

time_perspective: Retrospective

location_country:
Germany
Italy
United Kingdom
Turkey
Czechia
France

location_facility: Klinikum der Johann Wolfgang, Goethe-Universität

location_facility: İstanbul Universitesi, Cerrahpaşa Tıp Fakültesi

location_facility: Groupement hôspitalier est Federation d'endocrinologie.


title: An Open Label Study to Assess the Effect of Avastin (Bevacizumab) Combined With First Line Paclitaxel-carboplatin or Second Line Tarceva (Erlotinib) on Progression-free Survival in Non-squamous Non-small Cell Lung Cancer Patients With Asymptomatic Untreated Brain Metastasis

summary: This study will assess the efficacy and safety of Avastin combined with first li ne paclitaxel-carboplatin (cohort 1) or second line Tarceva (cohort 2) in patien ts with non-squamous non-small cell lung cancer with asymptomatic untreated brai n metastasis. Two cohorts of patients will be studied; the first will receive Av astin 15mg/kg iv every 3 weeks combined with first line paclitaxel 200mg/m2 iv p lus carboplatin AUC6 iv every 3 weeks for a maximum of 6 cycles, and the second cohort will receive Avastin 15mg/kg iv every 3 weeks combined with second line T arceva 150mg/kg po.The anticipated time on study treatment is until disease prog ression, and the target sample size is 100-500 individuals.

lead_sponsor: Hoffmann-La Roche