title: A Phase I, Open-Label, Non-Randomized, Dose-Escalating Safety, Tolerability and Pharmacokinetic Study of TAS-114 in Combination With S-1 in Patients With Advanced Solid Tumors

summary: A Phase I, Open-Label, International, Multicenter, Non-Randomized, Dose-Escalating Safety, Tolerance and Pharmacokinetic Study of Oral Administration of TAS-114 in Combination with S-1 in a Twice Daily Schedule for 14 Days in Patients with Advanced Solid Tumors.

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ReferenceCitation: Fukushima M, Satake H, Uchida J, Shimamoto Y, Kato T, Takechi T, Okabe H, Fujioka A, Nakano K, Ohshimo H, Takeda S, Shirasaka T. Preclinical antitumor efficacy of S-1: a new oral formulation of 5-fluorouracil on human tumor xenografts. Int J Oncol. 1998 Oct;13(4):693-8.

ReferenceCitation: Shirasaka T, Shimamoto Y, Fukushima M. Inhibition by oxonic acid of gastrointestinal toxicity of 5-fluorouracil without loss of its antitumor activity in rats. Cancer Res. 1993 Sep 1;53(17):4004-9.

ReferenceCitation: Van Cutsem E, Moiseyenko VM, Tjulandin S, Majlis A, Constenla M, Boni C, Rodrigues A, Fodor M, Chao Y, Voznyi E, Risse ML, Ajani JA; V325 Study Group. Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group. J Clin Oncol. 2006 Nov 1;24(31):4991-7.

ReferenceCitation: Johnston PG, Fisher ER, Rockette HE, Fisher B, Wolmark N, Drake JC, Chabner BA, Allegra CJ. The role of thymidylate synthase expression in prognosis and outcome of adjuvant chemotherapy in patients with rectal cancer. J Clin Oncol. 1994 Dec;12(12):2640-7.

ReferenceCitation: Johnston PG, Lenz HJ, Leichman CG, Danenberg KD, Allegra CJ, Danenberg PV, Leichman L. Thymidylate synthase gene and protein expression correlate and are associated with response to 5-fluorouracil in human colorectal and gastric tumors. Cancer Res. 1995 Apr 1;55(7):1407-12.

ReferenceCitation: Lenz HJ, Leichman CG, Danenberg KD, Danenberg PV, Groshen S, Cohen H, Laine L, Crookes P, Silberman H, Baranda J, Garcia Y, Li J, Leichman L. Thymidylate synthase mRNA level in adenocarcinoma of the stomach: a predictor for primary tumor response and overall survival. J Clin Oncol. 1996 Jan;14(1):176-82.

ReferenceCitation: Peters GJ, van der Wilt CL, van Groeningen CJ, Smid K, Meijer S, Pinedo HM. Thymidylate synthase inhibition after administration of fluorouracil with or without leucovorin in colon cancer patients: implications for treatment with fluorouracil. J Clin Oncol. 1994 Oct;12(10):2035-42.

ReferenceCitation: Aschele C, Debernardis D, Casazza S, Antonelli G, Tunesi G, Baldo C, Lionetto R, Maley F, Sobrero A. Immunohistochemical quantitation of thymidylate synthase expression in colorectal cancer metastases predicts for clinical outcome to fluorouracil-based chemotherapy. J Clin Oncol. 1999 Jun;17(6):1760-70.

ReferenceCitation: Ichikawa W, Takahashi T, Suto K, Yamashita T, Nihei Z, Shirota Y, Shimizu M, Sasaki Y, Hirayama R. Thymidylate synthase predictive power is overcome by irinotecan combination therapy with S-1 for gastric cancer. Br J Cancer. 2004 Oct 4;91(7):1245-50.

ReferenceCitation: Ladner RD. The role of dUTPase and uracil-DNA repair in cancer chemotherapy. Curr Protein Pept Sci. 2001 Dec;2(4):361-70. Review.

ReferenceCitation: Quesada-Soriano I, Casas-Solvas JM, Recio E, Ruiz-Pérez LM, Vargas-Berenguel A, González-Pacanowska D, García-Fuentes L. Kinetic properties and specificity of trimeric Plasmodium falciparum and human dUTPases. Biochimie. 2010 Feb;92(2):178-86. doi: 10.1016/j.biochi.2009.10.008. Epub 2009 Oct 29.

ReferenceCitation: Canman CE, Radany EH, Parsels LA, Davis MA, Lawrence TS, Maybaum J. Induction of resistance to fluorodeoxyuridine cytotoxicity and DNA damage in human tumor cells by expression of Escherichia coli deoxyuridinetriphosphatase. Cancer Res. 1994 May 1;54(9):2296-8.

ReferenceCitation: Koehler SE, Ladner RD. Small interfering RNA-mediated suppression of dUTPase sensitizes cancer cell lines to thymidylate synthase inhibition. Mol Pharmacol. 2004 Sep;66(3):620-6.

ReferenceCitation: Ladner RD, Lynch FJ, Groshen S, Xiong YP, Sherrod A, Caradonna SJ, Stoehlmacher J, Lenz HJ. dUTP nucleotidohydrolase isoform expression in normal and neoplastic tissues: association with survival and response to 5-fluorouracil in colorectal cancer. Cancer Res. 2000 Jul 1;60(13):3493-503.

ReferenceCitation: Nobili S, Napoli C, Landini I, Morganti M, Cianchi F, Valanzano R, Tonelli F, Cortesini C, Mazzei T, Mini E. Identification of potential pharmacogenomic markers of clinical efficacy of 5-fluorouracil in colorectal cancer. Int J Cancer. 2011 Apr 15;128(8):1935-45. doi: 10.1002/ijc.25514.

ReferenceCitation: Takatori H, Yamashita T, Honda M, Nishino R, Arai K, Yamashita T, Takamura H, Ohta T, Zen Y, Kaneko S. dUTP pyrophosphatase expression correlates with a poor prognosis in hepatocellular carcinoma. Liver Int. 2010 Mar;30(3):438-46. doi: 10.1111/j.1478-3231.2009.02177.x. Epub 2009 Nov 30.

ReferenceCitation: McIntosh EM, Haynes RH. dUTP pyrophosphatase as a potential target for chemotherapeutic drug development. Acta Biochim Pol. 1997;44(2):159-71. Review.

ReferenceCitation: Wilson PM, Fazzone W, LaBonte MJ, Deng J, Neamati N, Ladner RD. Novel opportunities for thymidylate metabolism as a therapeutic target. Mol Cancer Ther. 2008 Sep;7(9):3029-37. doi: 10.1158/1535-7163.MCT-08-0280.

ReferenceCitation: Hayashi T, Yamaguchi S, Kito S, Tanaka G, Kurokawa K, Hirota T. [An oral repeated dose toxicity study of a new antineoplastic agent S-1 in dogs. I. A 13-week repeated dose toxicity study. II. An ophthalmologic toxicity recovery study]. J Toxicol Sci. 1996 Nov;21 Suppl 3:527-44. Japanese.

ReferenceCitation: Zhu AX, Clark JW, Ryan DP, Meyerhardt JA, Enzinger PC, Earle CC, Fuchs CS, Regan E, Anbe H, Houghton M, Zhang J, Urrea P, Kulke MH. Phase I and pharmacokinetic study of S-1 administered for 14 days in a 21-day cycle in patients with advanced upper gastrointestinal cancer. Cancer Chemother Pharmacol. 2007 Feb;59(3):285-93. Epub 2006 Jun 20.

ReferenceCitation: Benson AB 3rd, Ajani JA, Catalano RB, Engelking C, Kornblau SM, Martenson JA Jr, McCallum R, Mitchell EP, O'Dorisio TM, Vokes EE, Wadler S. Recommended guidelines for the treatment of cancer treatment-induced diarrhea. J Clin Oncol. 2004 Jul 15;22(14):2918-26.

ReferenceCitation: American Society of Clinical Oncology, Kris MG, Hesketh PJ, Somerfield MR, Feyer P, Clark-Snow R, Koeller JM, Morrow GR, Chinnery LW, Chesney MJ, Gralla RJ, Grunberg SM. American Society of Clinical Oncology guideline for antiemetics in oncology: update 2006. J Clin Oncol. 2006 Jun 20;24(18):2932-47. Epub 2006 May 22. Erratum in: J Clin Oncol. 2006 Nov 20;24(33):5341-2.

ReferenceCitation: Du Bois D, Du Bois EF. A formula to estimate the approximate surface area if height and weight be known. 1916. Nutrition. 1989 Sep-Oct;5(5):303-11; discussion 312-3.

ReferenceCitation: Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.

ReferenceCitation: Saito K, Nagashima H, Noguchi K, Yoshisue K, Yokogawa T, Matsushima E, Tahara T, Takagi S. First-in-human, phase I dose-escalation study of single and multiple doses of a first-in-class enhancer of fluoropyrimidines, a dUTPase inhibitor (TAS-114) in healthy male volunteers. Cancer Chemother Pharmacol. 2014 Mar;73(3):577-83. doi: 10.1007/s00280-014-2383-2. Epub 2014 Jan 23.

ReferenceCitation: Ajani JA, Rodriguez W, Bodoky G, Moiseyenko V, Lichinitser M, Gorbunova V, Vynnychenko I, Garin A, Lang I, Falcon S. Multicenter phase III comparison of cisplatin/S-1 with cisplatin/infusional fluorouracil in advanced gastric or gastroesophageal adenocarcinoma study: the FLAGS trial. J Clin Oncol. 2010 Mar 20;28(9):1547-53. doi: 10.1200/JCO.2009.25.4706. Epub 2010 Feb 16.

lead_sponsor: Taiho Oncology, Inc.

location_country: Italy Belgium France Switzerland

location_facility: IOSI Istituto Oncologico della Svizzera Italiana


type: EudraCT Number

title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma

acronym: DYNAMO + R

summary: A study to evaluate the safety and efficacy of duvelisib administered in combination with rituximab vs placebo in combination with rituximab in patients with previously treated CD20-positive follicular lymphoma who are not suitable candidates for chemotherapy.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: SecuraBio

location_country: Italy Australia France Poland

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: TRANSLINK: A Prospective, Multi-center, Multi-national, Non Randomized, Open, Study to Defining the Role of Xeno-directed and Immune Events (SVD) in Patients Receiving Animal-derived Bioprosthetic Heart Valves.

acronym: TRANSLINK

summary: Cardiac valve disorders are widely spread in the general population and represents the third most frequent cardiovascular illness after coronary disease and arterial hypertension. In this context, aortic valve stenosis (the central pathology in this project) is the most common form of valve disease. Cardiac valve replacement is in the vast majority of cases the first line therapy for degenerative heart-valve diseases. These are represented by mechanical and bioprosthetic valve (BHV). In the vast majority of cases, BHV are derived from animals and from a biological standpoint are classified as xenografts. BHV are severely penalised by a premature structural damage, with ultimate valve failure occurring around 10 years after surgery in 5 to 30% of cases, depending on the type of BHV used. Several factors [including dyslipidaemia, gender, valve position] may contribute to the ultimate failure of the BHV and there has been increasing evidence recently of a substantial immune reaction elicited by the implanted BHV. This immune response is still poorly understood. It may lead to adverse immune reactions and this will be thoroughly investigated by the TRANSLINK team. In this light, the TRANSLINK project aims to provide the necessary data to demonstrate beyond any reasonable doubt the central role of the anti-BHV immune response in the premature failure of BHV and to provide efficient strategies to enable safe implantation of BHV valves in currently unsuitable candidates

study_start_date_type: Actual

status: Completed

design_allocation: Non-Randomized

primary_purpose: Health Services Research

lead_sponsor: Nantes University Hospital

location_country: Italy Canada France Spain

location_facility: University Hospital Vall d'Hebron, Barcelona, Spain

location_facility: University of Padova Medical School, Italy

location_facility: University Hospital of Bellvitge, Barcelona, Spain

intervention_type: Other

lead_sponsor_type: academique

status_simplified: Completed


title: International, Multicenter, Non-interventional, Prospective, Longitudinal Study to Investigate the Effectiveness of Botulinum Toxin A (Dysport®) Injections in Patients Suffering From Post-stroke Arm Spasticity With Respect to Early, Medium or Late Start of Treatment.

acronym: EARLYBIRD

summary:
Botulinum toxin A (BoNT-A) is effective and safe in alleviating post-stroke spasticity and reducing the burden of associated symptoms.

The hypothesis for this non-interventional study in arm spasticity (AS-NIS early BIRD) is no significant difference between naïve and pre-treated patients. The patients will be divided in sub-groups according to the time interval between occurrence of stroke and start of treatment (early, medium and late start of treatment according to the first and third quartiles time distribution). It is hypothesized that the "early" start of treatment group will have a reduced modified Ashworth scale (MAS) on the elbow and wrist flexors when compared to the "late" start of treatment group.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Ipsen

location_country: Austria Switzerland Netherlands France Germany


title: A Phase I, Open-label, Multi-center, Dose Escalation Study of Oral CGM097, a p53/HDM2-interaction Inhibitor, in Adult Patients With Selected Advanced Solid Tumors

summary: This is a first in human phase I study of single agent CGM097 in patients with advanced solid tumors who have progressed despite standard therapy or for whom no standard therapy exists. The tumor must be characterized by p53wt status. The study consists of a dose escalation part where patients will receive escalating doses of CGM097, and a dose expansion part in which patients are given CGM097 at the maximum tolerated dose (MTD) or Recommended Phase 2 Dose (RP2D). Each dose escalation step will be decided based on the recommendation from an adaptive Bayesian logistic regression model (BLRM).

ReferenceType: derived

ReferenceCitation: Bauer S, Demetri GD, Halilovic E, Dummer R, Meille C, Tan DSW, Guerreiro N, Jullion A, Ferretti S, Jeay S, Van Bree L, Hourcade-Potelleret F, Wuerthner JU, Fabre C, Cassier PA. Pharmacokinetic-pharmacodynamic guided optimisation of dose and schedule of CGM097, an HDM2 inhibitor, in preclinical and clinical studies. Br J Cancer. 2021 Aug;125(5):687-698. doi: 10.1038/s41416-021-01444-4. Epub 2021 Jun 17.

family: Bauer

full_name: Sebastian Bauer

given: Sebastian

sequence: first

family: Demetri

full_name: George D. Demetri

given: George D.

sequence: additional

family: Halilovic

full_name: Ensar Halilovic

given: Ensar

family: Dummer

full_name: Reinhard Dummer

given: Reinhard

family: Meille

full_name: Christophe Meille

given: Christophe

family: Tan

full_name: Daniel S. W. Tan

given: Daniel S. W.

family: Guerreiro

full_name: Nelson Guerreiro

given: Nelson

family: Jullion

full_name: Astrid Jullion

given: Astrid

family: Ferretti

full_name: Stephane Ferretti

given: Stephane

family: Jeay

full_name: Sebastien Jeay

given: Sebastien

family: Van Bree

full_name: Laurence Van Bree

given: Laurence

family: Hourcade-Potelleret

full_name: Florence Hourcade-Potelleret

given: Florence

family: Wuerthner

full_name: Jens U. Wuerthner

given: Jens U.

family: Fabre

full_name: Claire Fabre

given: Claire

family: Cassier

full_name: Philippe A. Cassier

given: Philippe A.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: British Journal of Cancer

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

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

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: acceptedVersion

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Pharmacokinetic–pharmacodynamic guided optimisation of dose and schedule of CGM097, an HDM2 inhibitor, in preclinical and clinical studies

ipd_sharing: No

lead_sponsor: Novartis Pharmaceuticals

location_country:
United States
Switzerland
France
Singapore
Germany

location_facility:
Novartis Investigative Site
Dana Farber Cancer Institute SC (2)


title: BEtter Control of Blood Pressure in Hypertensive pAtients Monitored Using the BEtter Control of Blood Pressure in Hypertensive pAtients Monitored Using the HOTMAN® sYstem

acronym: BEAUTY

summary: The purpose of this study is to demonstrate that monitoring hemodynamic parameters and then applying a predefined algorithm of drug selection (i.e. integrated hemodynamic management - IHM) improves the control of systolic blood pressure (SBP) at ambulatory blood pressure monitoring (ABPM) in hypertensive patients, as compared to classical drug selection (i.e. without IHM) during a 6 months intensive treatment program.

ReferenceCitation: Fadl Elmula FE, Rebora P, Talvik A, Salerno S, Miszkowska-Nagórna E, Liu X, Heinpalu-Kuum M, Comotti T, Larstorp AC, Rostrup M, Świerblewska E, Valsecchi MG, Kjeldsen SE, Viigimaa M, Narkiewicz K, Parati G, Laurent S; BEtter control of blood pressure in hypertensive pAtients monitored Using the HOTMAN sYstem (BEAUTY) Study Investigators. A randomized and controlled study of noninvasive hemodynamic monitoring as a guide to drug treatment of uncontrolled hypertensive patients. J Hypertens. 2015 Dec;33(12):2534-45. doi: 10.1097/HJH.0000000000000749.

family: Fadl Elmula

full_name: Fadl Elmula M. Fadl Elmula

given: Fadl Elmula M.

family: Rebora

full_name: Paola Rebora

given: Paola

family: Talvik

full_name: Anneli Talvik

given: Anneli

family: Salerno

full_name: Sabrina Salerno

given: Sabrina

family: Miszkowska-Nagórna

full_name: Eliza Miszkowska-Nagórna

given: Eliza

family: Liu

full_name: Xiaoqiu Liu

given: Xiaoqiu

family: Heinpalu-Kuum

full_name: Marika Heinpalu-Kuum

given: Marika

family: Comotti

full_name: Tommaso Comotti

given: Tommaso

family: Larstorp

full_name: Anne C. Larstorp

given: Anne C.

family: Rostrup

full_name: Morten Rostrup

given: Morten

family: Świerblewska

full_name: Ewa Świerblewska

given: Ewa

family: Valsecchi

full_name: Maria Grazia Valsecchi

given: Maria Grazia

family: Kjeldsen

full_name: Sverre E. Kjeldsen

given: Sverre E.

family: Viigimaa

full_name: Margus Viigimaa

given: Margus

family: Narkiewicz

full_name: Krzysztof Narkiewicz

given: Krzysztof

family: Parati

full_name: Gianfranco Parati

given: Gianfranco

family: Laurent

full_name: Stéphane Laurent

given: Stéphane

journal_name: Journal of Hypertension

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Hemo Sapiens, Inc.

location_country: Italy France Poland Norway Estonia

location_facility: Hypertension Unit, Dpt of Hypertension and diabetology, Medical University of Gdansk

intervention_type: Device


title: Randomized Study to Assess the Effect of ThRombus Aspiration on Flow Area in STEMI Patients: an Optical Frequency Domain Imaging (OFDI) Study

acronym: TROFI

summary: The purpose of the study it to evaluate whether primary percutaneous coronary intervention (primary PCI) with a new thrombectomy device as compared to primary PCI without thrombectomy increases minimal flow area after stenting for treatment of patients presenting with ST-segment elevation myocardial infarction (STEMI) as assessed by OFDI.

ReferenceType: background

ReferenceCitation: Van de Werf F, Bax J, Betriu A, Blomstrom-Lundqvist C, Crea F, Falk V, Filippatos G, Fox K, Huber K, Kastrati A, Rosengren A, Steg PG, Tubaro M, Verheugt F, Weidinger F, Weis M; ESC Committee for Practice Guidelines (CPG). Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation: the Task Force on the Management of ST-Segment Elevation Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J. 2008 Dec;29(23):2909-45. doi: 10.1093/eurheartj/ehn416. Epub 2008 Nov 12.

ReferenceCitation: Zijlstra F, Hoorntje JC, de Boer MJ, Reiffers S, Miedema K, Ottervanger JP, van 't Hof AW, Suryapranata H. Long-term benefit of primary angioplasty as compared with thrombolytic therapy for acute myocardial infarction. N Engl J Med. 1999 Nov 4;341(19):1413-9.

ReferenceCitation: Grines CL, Cox DA, Stone GW, Garcia E, Mattos LA, Giambartolomei A, Brodie BR, Madonna O, Eijgelshoven M, Lansky AJ, O'Neill WW, Morice MC. Coronary angioplasty with or without stent implantation for acute myocardial infarction. Stent Primary Angioplasty in Myocardial Infarction Study Group. N Engl J Med. 1999 Dec 23;341(26):1949-56.

ReferenceCitation: Sianos G, Papafaklis MI, Daemen J, Vaina S, van Mieghem CA, van Domburg RT, Michalis LK, Serruys PW. Angiographic stent thrombosis after routine use of drug-eluting stents in ST-segment elevation myocardial infarction: the importance of thrombus burden. J Am Coll Cardiol. 2007 Aug 14;50(7):573-83. Epub 2007 Jul 30.

ReferenceCitation: Sianos G, Papafaklis MI, Vaina S, Daemen J, van Mieghem CA, Van Domburg RT, Michalis LK, de Jaegere P, Serruys PW. Rheolytic thrombectomy in patients with ST-elevation myocardial infarction and large thrombus burden: the Thoraxcenter experience. J Invasive Cardiol. 2006 Jul;18 Suppl C:3C-7C.

ReferenceCitation: Haeck JD, Koch KT, Bilodeau L, Van der Schaaf RJ, Henriques JP, Vis MM, Baan J Jr, Van der Wal AC, Piek JJ, Tijssen JG, Krucoff MW, De Winter RJ. Randomized comparison of primary percutaneous coronary intervention with combined proximal embolic protection and thrombus aspiration versus primary percutaneous coronary intervention alone in ST-segment elevation myocardial infarction: the PREPARE (PRoximal Embolic Protection in Acute myocardial infarction and Resolution of ST-Elevation) study. JACC Cardiovasc Interv. 2009 Oct;2(10):934-43. doi: 10.1016/j.jcin.2009.07.013.

ReferenceCitation: Ikari Y, Sakurada M, Kozuma K, Kawano S, Katsuki T, Kimura K, Suzuki T, Yamashita T, Takizawa A, Misumi K, Hashimoto H, Isshiki T; VAMPIRE Investigators. Upfront thrombus aspiration in primary coronary intervention for patients with ST-segment elevation acute myocardial infarction: report of the VAMPIRE (VAcuuM asPIration thrombus REmoval) trial. JACC Cardiovasc Interv. 2008 Aug;1(4):424-31. doi: 10.1016/j.jcin.2008.06.004.

ReferenceCitation: Vlaar PJ, Svilaas T, Vogelzang M, Diercks GF, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan E, Suurmeijer AJ, Zijlstra F. A comparison of 2 thrombus aspiration devices with histopathological analysis of retrieved material in patients presenting with ST-segment elevation myocardial infarction. JACC Cardiovasc Interv. 2008 Jun;1(3):258-64. doi: 10.1016/j.jcin.2008.03.014.

ReferenceCitation: Sardella G, Mancone M, Bucciarelli-Ducci C, Agati L, Scardala R, Carbone I, Francone M, Di Roma A, Benedetti G, Conti G, Fedele F. Thrombus aspiration during primary percutaneous coronary intervention improves myocardial reperfusion and reduces infarct size: the EXPIRA (thrombectomy with export catheter in infarct-related artery during primary percutaneous coronary intervention) prospective, randomized trial. J Am Coll Cardiol. 2009 Jan 27;53(4):309-15. doi: 10.1016/j.jacc.2008.10.017.

ReferenceCitation: Sardella G, Mancone M, Nguyen BL, De Luca L, Di Roma A, Colantonio R, Petrolini A, Conti G, Fedele F. The effect of thrombectomy on myocardial blush in primary angioplasty: the Randomized Evaluation of Thrombus Aspiration by two thrombectomy devices in acute Myocardial Infarction (RETAMI) trial. Catheter Cardiovasc Interv. 2008 Jan 1;71(1):84-91.

ReferenceCitation: Silva-Orrego P, Colombo P, Bigi R, Gregori D, Delgado A, Salvade P, Oreglia J, Orrico P, de Biase A, Piccalò G, Bossi I, Klugmann S. Thrombus aspiration before primary angioplasty improves myocardial reperfusion in acute myocardial infarction: the DEAR-MI (Dethrombosis to Enhance Acute Reperfusion in Myocardial Infarction) study. J Am Coll Cardiol. 2006 Oct 17;48(8):1552-9. Epub 2006 Sep 26.

ReferenceCitation: Svilaas T, van der Horst IC, Zijlstra F. Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS)--study design. Am Heart J. 2006 Mar;151(3):597.e1-597.e7.

ReferenceCitation: Burzotta F, Trani C, Romagnoli E, Mazzari MA, Rebuzzi AG, De Vita M, Garramone B, Giannico F, Niccoli G, Biondi-Zoccai GG, Schiavoni G, Mongiardo R, Crea F. Manual thrombus-aspiration improves myocardial reperfusion: the randomized evaluation of the effect of mechanical reduction of distal embolization by thrombus-aspiration in primary and rescue angioplasty (REMEDIA) trial. J Am Coll Cardiol. 2005 Jul 19;46(2):371-6.

ReferenceCitation: De Luca G, Dudek D, Sardella G, Marino P, Chevalier B, Zijlstra F. Adjunctive manual thrombectomy improves myocardial perfusion and mortality in patients undergoing primary percutaneous coronary intervention for ST-elevation myocardial infarction: a meta-analysis of randomized trials. Eur Heart J. 2008 Dec;29(24):3002-10. doi: 10.1093/eurheartj/ehn389. Epub 2008 Sep 5. Review.

ReferenceCitation: Chevalier B, Gilard M, Lang I, Commeau P, Roosen J, Hanssen M, Lefevre T, Carrié D, Bartorelli A, Montalescot G, Parikh K. Systematic primary aspiration in acute myocardial percutaneous intervention: a multicentre randomised controlled trial of the export aspiration catheter. EuroIntervention. 2008 Aug;4(2):222-8.

ReferenceCitation: Vlaar PJ, Svilaas T, van der Horst IC, Diercks GF, Fokkema ML, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. Cardiac death and reinfarction after 1 year in the Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS): a 1-year follow-up study. Lancet. 2008 Jun 7;371(9628):1915-20. doi: 10.1016/S0140-6736(08)60833-8.

ReferenceCitation: Kubo T, Imanishi T, Takarada S, Kuroi A, Ueno S, Yamano T, Tanimoto T, Matsuo Y, Masho T, Kitabata H, Tsuda K, Tomobuchi Y, Akasaka T. Assessment of culprit lesion morphology in acute myocardial infarction: ability of optical coherence tomography compared with intravascular ultrasound and coronary angioscopy. J Am Coll Cardiol. 2007 Sep 4;50(10):933-9. Epub 2007 Aug 20.

ReferenceCitation: Gonzalo N, Barlis P, Serruys PW, Garcia-Garcia HM, Onuma Y, Ligthart J, Regar E. Incomplete stent apposition and delayed tissue coverage are more frequent in drug-eluting stents implanted during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction than in drug-eluting stents implanted for stable/unstable angina: insights from optical coherence tomography. JACC Cardiovasc Interv. 2009 May;2(5):445-52. doi: 10.1016/j.jcin.2009.01.012.

ReferenceCitation: Hara H, Nakamura M, Komatsu H, Ikeda N, Shinji H, Makino K, Itaya H, Yamamoto M, Itou N, Tsunoda T, Sugi K. Comparison of the in vitro performance of 6 and 7 French aspiration catheters. EuroIntervention. 2007 Feb;2(4):487-92.

ReferenceCitation: Grayson AD, Moore RK, Jackson M, Rathore S, Sastry S, Gray TP, Schofield I, Chauhan A, Ordoubadi FF, Prendergast B, Stables RH; North West Quality Improvement Programme in Cardiac Interventions. Multivariate prediction of major adverse cardiac events after 9914 percutaneous coronary interventions in the north west of England. Heart. 2006 May;92(5):658-63. Epub 2005 Sep 13.

ReferenceCitation: Guédès A, Keller PF, L'Allier PL, Lespérance J, Grégoire J, Tardif JC. Long-term safety of intravascular ultrasound in nontransplant, nonintervened, atherosclerotic coronary arteries. J Am Coll Cardiol. 2005 Feb 15;45(4):559-64.

ReferenceCitation: Johansson P, Lundén M, Ekström L, Grip L, Wennerblom B. Intensive use of intravascular ultrasound during coronary angioplasty. A six-month campaign. Scand Cardiovasc J. 2001 Mar;35(2):75-9.

ReferenceCitation: Vranckx P, Cutlip DE, Mehran R, Kint PP, Silber S, Windecker S, Serruys PW. Myocardial infarction adjudication in contemporary all-comer stent trials: balancing sensitivity and specificity. Addendum to the historical MI definitions used in stent studies. EuroIntervention. 2010 Feb;5(7):871-4.

ReferenceCitation: Muramatsu T, García-García HM, Onuma Y, Zhang YJ, Bourantas CV, Diletti R, Iqbal J, Radu MD, Ozaki Y, Serruys PW; TROFI investigators. Intimal flaps detected by optical frequency domain imaging in the proximal segments of native coronary arteries: an innocent bystander? Insights from the TROFI Trial. Circ J. 2013;77(9):2327-33. Epub 2013 Jun 15.

ReferenceCitation: Muramatsu T, García-García HM, Onuma Y, Zhang YJ, Bourantas CV, Diletti R, Iqbal J, Radu MD, Ozaki Y, Serruys PW; on behalf of the TROFI investigators. Intimal Flaps Detected by Optical Frequency Domain Imaging in the Proximal Segments of Native Coronary Arteries. Circ J. 2013 Jun 15. [Epub ahead of print]

ReferenceCitation: Muramatsu T, García-García HM, Lee IS, Bruining N, Onuma Y, Serruys PW. Quantitative optical frequency domain imaging assessment of in-stent structures in patients with ST-segment elevation myocardial infarction: impact of imaging sampling rate. Circ J. 2012;76(12):2822-31. Epub 2012 Aug 29.

lead_sponsor: Terumo Europe N.V.

location_country: Denmark Germany France Netherlands

location_facility:
Maastad Hospital
Clinique Pasteur
Universität Leipzig - Herzzentrum
Erasmus Medical Center
Aarhus University Hospital Skejby

intervention_type: Procedure


title: Multi-center, Double-blind, Randomized, Placebo-controlled, Cross-over Study to Demonstrate That a Single Infusion of Tezosentan Has Minimal Effect on Blood Pressure in Patients With Pulmonary Arterial Hypertension, Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or a Combination of Both.

summary: Multicenter, double-blind, randomized, placebo-controlled, cross-over study to demonstrate that a single infusion of tezosentan has minimal effect on blood pressure in patients with pulmonary arterial hypertension, treated with endothelin receptor antagonists, phosphodiesterase-5 inhibitors or a combination of both.

primary_purpose: Supportive Care

lead_sponsor: Idorsia Pharmaceuticals Ltd.

location_country:
United States
France
Japan

location_facility:
Hopital Antoine Beclere
National Cardiovascular Center
Keio University Hospital
Baylor College of Medicine
Osaka University Hospital


title: Observational Prospective Study of Survival, Treatment Patterns, Disease and Economic Outcomes in Patients With Metastatic Castrate-resistant Prostate Cancer (CRPC) With Progression During or After a First-line Docetaxel-based Regimen

acronym: PORTREAT

summary:
Primary Objective:

Describe real-life survival of CRPC patients who received first-line docetaxel and have disease progression

Secondary Objective:

Describe treatment patterns
Describe the characteristics and outcomes of patients who received second-line taxane-based treatment compared to others
Describe economic and patient-reported outcomes

lead_sponsor: Sanofi

location_country:
United States
France
Spain
Germany
United Kingdom


title: A Randomised, Double-blind, Placebo-controlled, Multiple-dose, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Lu AA24493 in Patients With Acute Ischemic Stroke

summary: The primary purpose of the study is to determine whether carbamylated erythropoietin (CEPO) dosed once daily for 5 days is a safe treatment for patients who have suffered an acute ischemic stroke.

lead_sponsor: H. Lundbeck A/S

location_country:
Netherlands
Finland
France
Singapore
United Kingdom


title: A Single Arm Phase II Study of Neoadjuvant Therapy Using Irinotecan Bead in Patients With Resectable Liver Metastases From Colorectal Cancer

acronym: PARAGON-II

summary: The objective of this study is to evaluate the safety and efficacy of Irinotecan Bead in the neoadjuvant treatment (i.e. the Irinotecan Bead is administered prior to surgery) of resectable liver metastases from colorectal cancer.

ReferenceCitation: Jones RP, Malik HZ, Fenwick SW, Terlizzo M, O'Grady E, Stremitzer S, Gruenberger T, Rees M, Plant G, Figueras J, Albiol M, Adam R, Awad S, Poston GJ. PARAGON II - A single arm multicentre phase II study of neoadjuvant therapy using irinotecan bead in patients with resectable liver metastases from colorectal cancer. Eur J Surg Oncol. 2016 Dec;42(12):1866-1872. doi: 10.1016/j.ejso.2016.07.142. Epub 2016 Aug 10.

family: Jones

full_name: R.P. Jones

family: Malik

full_name: H.Z. Malik

family: Fenwick

full_name: S.W. Fenwick

family: Terlizzo

full_name: M. Terlizzo

given: M.

family: O'Grady

full_name: E. O'Grady

given: E.

family: Stremitzer

full_name: S. Stremitzer

given: S.

family: Gruenberger

full_name: T. Gruenberger

given: T.

family: Rees

full_name: M. Rees

family: Plant

full_name: G. Plant

given: G.

family: Figueras

full_name: J. Figueras

given: J.

family: Albiol

full_name: M. Albiol

family: Adam

full_name: R. Adam

given: R.

family: Awad

full_name: S. Awad

family: Poston

full_name: G.J. Poston

journal_name: European Journal of Surgical Oncology (EJSO)

oa_host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: PARAGON II – A single arm multicentre phase II study of neoadjuvant therapy using irinotecan bead in patients with resectable liver metastases from colorectal cancer

ReferenceCitation: Jones RP, Dunne D, Sutton P, Malik HZ, Fenwick SW, Terlizzo M, O'Grady E, Koelblinger C, Stättner S, Stremitzer S, Gruenberger T, Poston GJ. Segmental and lobar administration of drug-eluting beads delivering irinotecan leads to tumour destruction: a case-control series. HPB (Oxford). 2013 Jan;15(1):71-7. doi: 10.1111/j.1477-2574.2012.00587.x. Epub 2012 Oct 16.

full_name: Robert P. Jones

given: Robert P.

family: Dunne

full_name: Declan Dunne

given: Declan

family: Sutton

full_name: Paul Sutton

given: Paul

full_name: Hassan Z. Malik

given: Hassan Z.

full_name: Stephen W. Fenwick

given: Stephen W.

full_name: Monica Terlizzo

given: Monica

full_name: Elizabeth O'Grady

title: Segmental and lobar administration of drug‐eluting beads delivering irinotecan leads to tumour destruction: a case–control series

location_facility: Basingstoke and North Hampshire NHS Foundation Trust

location_facility: Centre Hépato-Biliaire, Hôpital Paul Brousse


title: Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Lu AA24493 in Acute Ischemic Stroke

summary: The primary purpose of the study is to determine whether carbamylated erythropoietin (CEPO) is a safe treatment for patients who have suffered an acute ischemic stroke.


ReferenceType: result

ReferenceCitation: Sandri F, Plavka R, Ancora G, Simeoni U, Stranak Z, Martinelli S, Mosca F, Nona J, Thomson M, Verder H, Fabbri L, Halliday H; CURPAP Study Group. Prophylactic or early selective surfactant combined with nCPAP in very preterm infants. Pediatrics. 2010 Jun;125(6):e1402-9. doi: 10.1542/peds.2009-2131. Epub 2010 May 3.

family: Sandri

full_name: F. Sandri

given: F.

family: Plavka

full_name: R. Plavka

family: Ancora

full_name: G. Ancora

family: Simeoni

full_name: U. Simeoni

given: U.

family: Stranak

full_name: Z. Stranak

given: Z.

family: Martinelli

full_name: S. Martinelli

family: Mosca

full_name: F. Mosca

family: Nona

full_name: J. Nona

family: Thomson

full_name: M. Thomson

family: Verder

full_name: H. Verder

given: H.

family: Fabbri

full_name: L. Fabbri

given: L.

family: Halliday

full_name: H. Halliday

journal_name: PEDIATRICS

publisher: American Academy of Pediatrics (AAP)

publisher_dissemination: American Academy of Pediatrics (AAP)

publisher_group: American Academy of Pediatrics (AAP)

publisher_normalized: American Academy of Pediatrics (AAP)

title: Prophylactic or Early Selective Surfactant Combined With nCPAP in Very Preterm Infants

lead_sponsor: Chiesi Farmaceutici S.p.A.

primary_purpose: Prevention

location_country: Italy France Czechia Spain Portugal

acronym: Curpap

location_facility:
Maternidade Alfredo da Costa
Hopital De La Conception
General Faculty Hospital
Hospital De Cruces
Ospedale Maggiore

source: euctr

title: An International, Open, Randomized, Controlled Study to Evaluate the Efficacy of Combining Prophylactic Curosurf® With Early Nasal CPAP Versus Early Nasal CPAP Alone in Very Preterm Infants at Risk of Respiratory Distress Syndrome

summary:
The primary objective of this study is to compare two methods of post-delivery stabilization and subsequent early respiratory care for reducing the need for MV and related secondary complications, such as BPD, in premature babies at high risk of RDS:

Early stabilization on nCPAP
Intubation, prophylactic surfactant (Curosurf®) administration shortly after delivery, and rapid extubation to nCPAP.

The data obtained from this comparison will be applied to test the hypothesis that preterm neonates at risk of RDS who are treated with prophylactic surfactant + nCPAP show less need for MV when compared to infants who receive nCPAP alone.


title: Phase II Study for Repeated Dosing of the Trifunctional Bispecific Anti-HER-2/Neu x Anti-CD3 Antibody Ertumaxomab in Patients With HER-2/Neu 1+ or 2+/FISH Negative Expressing Advanced or Metastatic Breast Cancer (Stage IIIb/IV) Progressing After Endocrine Treatment

summary:
The purpose of the study is to demonstrate clinical efficacy of the investigational trifunctional bispecific antibody ertumaxomab for treatment of patients with HER-2/neu 1+ or 2+ (FISH-) expressing advanced or metastatic breast cancer (stage III b/IV) which has progressed after endocrine therapy.

Ertumaxomab is a trifunctional bispecific antibody targeting Her-2/neu and CD3 on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory cells (e.g. macrophages, dendritic cells [DCs] and natural killer [NK] cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these immune cells, which can trigger a complex anti-tumor immune response.

enrollment_type: Anticipated

ReferenceCitation: Kiewe P, Hasmüller S, Kahlert S, Heinrigs M, Rack B, Marmé A, Korfel A, Jäger M, Lindhofer H, Sommer H, Thiel E, Untch M. Phase I trial of the trifunctional anti-HER2 x anti-CD3 antibody ertumaxomab in metastatic breast cancer. Clin Cancer Res. 2006 May 15;12(10):3085-91.

ReferenceCitation: Zeidler R, Mysliwietz J, Csánady M, Walz A, Ziegler I, Schmitt B, Wollenberg B, Lindhofer H. The Fc-region of a new class of intact bispecific antibody mediates activation of accessory cells and NK cells and induces direct phagocytosis of tumour cells. Br J Cancer. 2000 Jul;83(2):261-6.

ReferenceCitation: Zeidler R, Reisbach G, Wollenberg B, Lang S, Chaubal S, Schmitt B, Lindhofer H. Simultaneous activation of T cells and accessory cells by a new class of intact bispecific antibody results in efficient tumor cell killing. J Immunol. 1999 Aug 1;163(3):1246-52.

ReferenceCitation: Ruf P, Lindhofer H. Induction of a long-lasting antitumor immunity by a trifunctional bispecific antibody. Blood. 2001 Oct 15;98(8):2526-34.

lead_sponsor: Neovii Biotech

location_country: Italy Austria France Spain Germany

intervention_type: Biological


title: Fungemia Survey in Cancer Patients

summary:
RATIONALE: Gathering information about how often fungal infections of the blood occur in patients with cancer or in patients who have undergone stem cell transplant may help doctors learn more about the disease.

PURPOSE: This natural history study is collecting information about fungal infections of the blood over time from patients with cancer or from patients who have undergone a stem cell transplant.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country: Italy Switzerland France Belgium Germany

location_facility: Hopital Cantonal Universitaire de Geneve


title: A Double-Blind Placebo-Controlled Study of the Activity of AVE1625 at Doses of 10 mg and 40mg for 12 Weeks in Patients With Mild to Moderate Alzheimer's Disease

summary:
Primary: This study is being conducted to evaluate if AVE1625 is safe and tolerated in patients with Alzheimer's disease that is not too severe. There is also evaluation of whether patients who take the study medication improve compared to patients who take a placebo (sugar pill).

Secondary:The study will also evaluate the blood levels of the study medication, AVE1625 in patients who join the study.

location_country:
Italy
Sweden
Netherlands
France
United States


title: A Phase II, Randomized, Placebo-controlled Study to Evaluate the Immunogenicity and the Safety of 2 Schedules of an Homologous Prime-boost With the ALVAC-HIV vCP1452 in Chronically HIV-Infected Patients

acronym: MANON 02

summary: Prior pilot studies have shown that four monthly injections of ALVAC-HIV (vCP1433) are immunogenic in 60% HIV-infected patients with a boosting effect obtained after 1 or 2 injections followed by a plateau or a decrease of these responses prior to interrupting therapy. The goal of the present study is to look for an improved vaccination schedule in terms of strength and duration of the HIV-specific immunity induced by the HIV-recombinant canary pox vector ALVAC-HIV (vCP1452) by testing a strategy of immunization involving a first series of two versus three monthly injections followed by a boost three months later.

ReferenceCitation: Autran B, Debré P, Walker B, Katlama C. Therapeutic vaccines against HIV need international partnerships. Nat Rev Immunol. 2003 Jun;3(6):503-8. Review.

ReferenceCitation: Autran B, Costagliola D, Murphy R, Katlama C. Evaluating therapeutic vaccines in patients infected with HIV. Expert Rev Vaccines. 2004 Aug;3(4 Suppl):S169-77. Review.

ReferenceCitation: Autran B, Murphy RL, Costagliola D, Tubiana R, Clotet B, Gatell J, Staszewski S, Wincker N, Assoumou L, El-Habib R, Calvez V, Walker B, Katlama C; ORVACS Study Group. Greater viral rebound and reduced time to resume antiretroviral therapy after therapeutic immunization with the ALVAC-HIV vaccine (vCP1452). AIDS. 2008 Jul 11;22(11):1313-22. doi: 10.1097/QAD.0b013e3282fdce94.

family: Autran

full_name: Brigitte Autran

given: Brigitte

family: Murphy

full_name: Robert L Murphy

given: Robert L

family: Costagliola

full_name: Dominique Costagliola

given: Dominique

family: Tubiana

full_name: Roland Tubiana

given: Roland

family: Clotet

full_name: Bonaventura Clotet

given: Bonaventura

family: Gatell

full_name: Jose Gatell

given: Jose

family: Staszewski

full_name: Schlomo Staszewski

given: Schlomo

family: Wincker

full_name: Norma Wincker

given: Norma

family: Assoumou

full_name: Lambert Assoumou

given: Lambert

family: El-Habib

full_name: Raphaelle El-Habib

given: Raphaelle

family: Calvez

full_name: Vincent Calvez

given: Vincent

family: Walker

full_name: Bruce Walker

given: Bruce

family: Katlama

full_name: Christine Katlama

given: Christine

journal_name: AIDS

lead_sponsor: Objectif Recherche Vaccins SIDA

location_country:
Germany
United States
France
Spain

location_facility: Klinikum der Johann Nolfgang Goethe Universitat Zentrum des Innerin Medizin

location_facility: Service des maladies infectieuses et tropicales, Hopital Pitié-Salpétrière, Pavillon Laveran

location_facility: Servicios de Infecciosos, Hospital y clinic Provincial

location_facility: Fundacio Irsi Caixa Retrovirology Laboratory, Hospital Universitari Germans


title: A 3-Month, Open, Randomised Trial Comparing the Efficacy and Safety of the Association Valproate-Amisulpride to the Association Valproate-Haloperidol in Bipolar I Patients Suffering From a Manic Episode

summary:
The primary objective is:

To compare the efficacy of the association valproate-amisulpride (400 to 800 mg/day) to the association valproate-haloperidol (5 to 15 mg/day) in bipolar I patients suffering from a manic episode according to DSM IV TR (American Psychiatric Association [APA] 2000) and treated for a 3-month period.

The secondary objectives are:

To evaluate the clinical and biological safety of the association valproate-amisulpride to the association valproate-haloperidol;
To assess the patient status 3 weeks and 3 months after inclusion; and
To assess patient satisfaction at 3 months.

location_country:
France
Poland
Slovakia
Spain
Czech Republic


type: Other Identifier

title: Prospective Multicenter Trial Assessing the Efficacy of a Novel 3D Cartography-based Targeted Focal Microwave Therapy in Men With Localized Intermediate-risk Prostate Cancer

acronym: VIOLETTE

summary: Multicenter, prospective, European, single-arm, open-label, 12-month follow-up clinical trial. The purpose of this study is to evaluate the efficacy of a 3D cartography-based targeted microwave ablation for the treatment of the index lesion in patients with intermediate risk prostate cancer.

status: Recruiting

study_completion_date_type: Anticipated

lead_sponsor: Koelis

location_country: Belgium France

location_facility: Urologie Nantes Clinique & Institut d'Urologie - Site Atlantis

location_facility: Hôpital Cochin (Assistance Publique - Hôpitaux de Paris)

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Hôpital de la Pitié-Salpêtrière (Assistance Publique - Hôpitaux de Paris)

status_simplified: Ongoing


title: A Postmarketing Observational Cohort Study to Evaluate Effectiveness and Safety of Ponatinib (Iclusig®) in Patients With BCR-ABL Positive ALL in Standard Clinical Practice in Europe - "POSEIDON"

summary: The purpose of this study is to evaluate the effectiveness and safety of ponatinib (Iclusig®) in patients with BCR-ABL positive acute lymphoblastic leukemia (ALL) in standard clinical practice in Europe.

study_start_date_type: Anticipated

status: Withdrawn

time_perspective: Other

lead_sponsor: Incyte Biosciences International Sàrl

location_country: Germany France Czechia

location_facility:
University Hospital Bordeaux
University Hospital Angers
University Hospital Lyon
University Hospital Halle/Saale
University Hospital Munich
University Hospital Rostock
University Hospital Grenoble
University Hospital Amiens
Ihbt/Úhkt
University Cancer Institute Oncopole


title: An Open-label, Non-randomised, Multicentre, Comparative, Phase I Study to Determine the Pharmacokinetics, Safety and Tolerability of Olaparib Following a Single Oral 300 mg Dose to Patients With Advanced Solid Tumours and Normal Hepatic Function or Mild or Moderate Hepatic Impairment

summary: This is a 2-part study in patients with advanced solid tumours. Part A will investigate the PK of olaparib in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function; Part B will allow patients with mild or moderate hepatic impairment or normal hepatic function continued access to olaparib after the PK phase and will provide additional safety data.

primary_purpose: Other

lead_sponsor: AstraZeneca

location_country:
Netherlands
France
Czechia
United Kingdom
Korea, Republic of


title: Randomised, Double-blind, Placebo-controlled, Dose-ranging Phase II Study of APD421 for the Prevention of Post-operative Nausea and Vomiting

summary: To assess the efficacy and safety of different doses of APD421 in the prevention of post-operative nausea and vomiting (PONV) in adult patients at moderate to high-risk of PONV. Patients must be undergoing elective surgery under general anaesthesia (hysterectomy (any surgical technique), cholecystectomy (any surgical technique) or "other" elective surgery scheduled to last at least one hour from induction of anaesthesia), requiring at least one overnight stay in hospital, and have at least 2 of the following risk factors for PONV: Past history of PONV and/or motion sickness; Non-smoking status; Female gender; Planned opiate use for post-operative analgesia.

ReferenceCitation: Kranke P, Eberhart L, Motsch J, Chassard D, Wallenborn J, Diemunsch P, Liu N, Keh D, Bouaziz H, Bergis M, Fox G, Gan TJ. I.V. APD421 (amisulpride) prevents postoperative nausea and vomiting: a randomized, double-blind, placebo-controlled, multicentre trial. Br J Anaesth. 2013 Dec;111(6):938-45. doi: 10.1093/bja/aet251. Epub 2013 Jul 19.

family: Kranke

full_name: P. Kranke

given: P.

family: Eberhart

full_name: L. Eberhart

family: Motsch

full_name: J. Motsch

given: J.

family: Chassard

full_name: D. Chassard

given: D.

family: Wallenborn

full_name: J. Wallenborn

family: Diemunsch

full_name: P. Diemunsch

family: Liu

full_name: N. Liu

given: N.

family: Keh

full_name: D. Keh

family: Bouaziz

full_name: H. Bouaziz

family: Bergis

full_name: M. Bergis

given: M.

family: Fox

full_name: G. Fox

given: G.

family: Gan

full_name: T.J. Gan

journal_name: British Journal of Anaesthesia

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

lead_sponsor: Acacia Pharma Ltd

location_country:
Germany
United States
France

location_facility:
HELIOS Klinikum Aue
Charité - Universitätsmedizin
University Hospitals of Würzburg
Hôpital Huriez
Hautepierre Hospital
University Hospital
Hôpital FOCH
Klinikum Ludwigshafen
Philipps University
Universität Heidelberg
Duke University Medical Center
Hôpital mère enfant


title: Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of ATX-101 (Sodium Deoxycholate Injection) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area

summary: To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).

ReferenceCitation: McDiarmid J, Ruiz JB, Lee D, Lippert S, Hartisch C, Havlickova B. Results from a pooled analysis of two European, randomized, placebo-controlled, phase 3 studies of ATX-101 for the pharmacologic reduction of excess submental fat. Aesthetic Plast Surg. 2014 Oct;38(5):849-60. doi: 10.1007/s00266-014-0364-9. Epub 2014 Jul 2.

family: McDiarmid

full_name: James McDiarmid

given: James

family: Ruiz

full_name: Jesus Benito Ruiz

given: Jesus Benito

family: Lee

full_name: Daniel Lee

given: Daniel

family: Lippert

full_name: Susanne Lippert

given: Susanne

family: Hartisch

full_name: Claudia Hartisch

given: Claudia

family: Havlickova

full_name: Blanka Havlickova

given: Blanka

journal_name: Aesthetic Plastic Surgery

evidence: open (via page says license)

license: implied-oa

license_normalized: implied-oa

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: Springer

publisher_group: Springer

title: Results from a Pooled Analysis of Two European, Randomized, Placebo-Controlled, Phase 3 Studies of ATX-101 for the Pharmacologic Reduction of Excess Submental Fat

lead_sponsor: Kythera Biopharmaceuticals

location_country:
France
Belgium
Spain
Germany
United Kingdom


title: An International, Multi-center, Randomized, Controlled Trial Evaluating The Effect of Xenon on Post-operative Delirium in Elderly Patients Undergoing Hip Fracture Surgery

acronym: HIPELD

summary: The objective of this study is to evaluate the incidence of Post-Operative Delirium (POD), diagnosed with the Confusion Assessment Method (CAM), in elderly patients undergoing hip fracture surgery under general anaesthesia with xenon or sevoflurane, for a period of four days post-surgery.

ReferenceCitation: Coburn M, Sanders RD, Maze M, Nguyên-Pascal ML, Rex S, Garrigues B, Carbonell JA, Garcia-Perez ML, Stevanovic A, Kienbaum P, Neukirchen M, Schaefer MS, Borghi B, van Oven H, Tognù A, Al Tmimi L, Eyrolle L, Langeron O, Capdevila X, Arnold GM, Schaller M, Rossaint R; HIPELD Study Investigators. The hip fracture surgery in elderly patients (HIPELD) study to evaluate xenon anaesthesia for the prevention of postoperative delirium: a multicentre, randomized clinical trial. Br J Anaesth. 2018 Jan;120(1):127-137. doi: 10.1016/j.bja.2017.11.015. Epub 2017 Nov 21.

family: Coburn

full_name: M. Coburn

family: Sanders

full_name: R.D. Sanders

family: Maze

full_name: M. Maze

family: Nguyên-Pascal

full_name: M.-L. Nguyên-Pascal

family: Rex

full_name: S. Rex

given: S.

family: Garrigues

full_name: B. Garrigues

given: B.

family: Carbonell

full_name: J.A. Carbonell

family: Garcia-Perez

full_name: M.L. Garcia-Perez

family: Stevanovic

full_name: A. Stevanovic

given: A.

family: Kienbaum

full_name: P. Kienbaum

family: Neukirchen

full_name: M. Neukirchen

family: Schaefer

full_name: M.S. Schaefer

family: Borghi

full_name: B. Borghi

family: van Oven

full_name: H. van Oven

given: H.

family: Tognù

full_name: A. Tognù

family: Al Tmimi

full_name: L. Al Tmimi

given: L.

family: Eyrolle

full_name: L. Eyrolle

family: Langeron

full_name: O. Langeron

given: O.

family: Capdevila

full_name: X. Capdevila

given: X.

family: Arnold

full_name: G.M. Arnold

family: Schaller

full_name: M. Schaller

family: Rossaint

full_name: R. Rossaint

given: R.

full_name: Mark Coburn

given: Mark

full_name: Rolf Rossaint

given: Rolf

full_name: Ana Stevanovic

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University of California - eScholarship University of California

ReferenceCitation: Coburn M, Sanders RD, Maze M, Rossaint R; HIPELD Investigators. The Hip Fracture Surgery in Elderly Patients (HIPELD) study: protocol for a randomized, multicenter controlled trial evaluating the effect of xenon on postoperative delirium in older patients undergoing hip fracture surgery. Trials. 2012 Sep 27;13:180. doi: 10.1186/1745-6215-13-180.

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

repository_institution: California Digital Library - eScholarship

repository_institution: University of Valencia - Repository of Digital Objects for Teaching Research and Culture

location_country:
Italy
France
Belgium
Spain
Germany
United Kingdom

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Centre Hospitalier Régional Universitaire de Montpellier

location_facility: . Klinik für Anästhesiologie - Universitätsklinikum Düsseldorf

location_facility: CHU Pontchaillou - Université de Rennes 1

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Hospital Clinico Universitario de Valencia


title: An Open-Label, Multi-Center Controlled Clinical Trial Of Eculizumab in Adolescent Patients With Plasma Therapy-Sensitive Atypical Hemolytic Uremic Syndrome (AHUS)

acronym: aHUS

summary: The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of adolescent patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS).

ReferenceCitation: Pugh D, O'Sullivan ED, Duthie FA, Masson P, Kavanagh D. Interventions for atypical haemolytic uraemic syndrome. Cochrane Database Syst Rev. 2021 Mar 23;3:CD012862. doi: 10.1002/14651858.CD012862.pub2.

name: Department of Renal Medicine; Royal Infirmary of Edinburgh; Edinburgh UK

family: Pugh

full_name: Dan Pugh

given: Dan

name: Centre for Inflammation Research; Royal Infirmary of Edinburgh; Edinburgh UK

family: O'Sullivan

full_name: Eoin D O'Sullivan

given: Eoin D

family: Duthie

full_name: Fiona AI Duthie

given: Fiona AI

name: Department of Renal Medicine; Royal Free London NHS Foundation Trust; London UK

family: Masson

full_name: Philip Masson

given: Philip

name: Renal Department; Newcastle University/Freeman Hospital; Newcastle Upon Tyne UK

family: Kavanagh

full_name: David Kavanagh

given: David

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Legendre CM, Licht C, Muus P, Greenbaum LA, Babu S, Bedrosian C, Bingham C, Cohen DJ, Delmas Y, Douglas K, Eitner F, Feldkamp T, Fouque D, Furman RR, Gaber O, Herthelius M, Hourmant M, Karpman D, Lebranchu Y, Mariat C, Menne J, Moulin B, Nürnberger J, Ogawa M, Remuzzi G, Richard T, Sberro-Soussan R, Severino B, Sheerin NS, Trivelli A, Zimmerhackl LB, Goodship T, Loirat C. Terminal complement inhibitor eculizumab in atypical hemolytic-uremic syndrome. N Engl J Med. 2013 Jun 6;368(23):2169-81. doi: 10.1056/NEJMoa1208981.

family: Legendre

full_name: C.M. Legendre

family: Licht

full_name: C. Licht

given: C.

family: Muus

full_name: P. Muus

given: P.

family: Greenbaum

full_name: L.A. Greenbaum

family: Babu

full_name: S. Babu

family: Bedrosian

full_name: C. Bedrosian

family: Bingham

full_name: C. Bingham

family: Cohen

full_name: D.J. Cohen

family: Delmas

full_name: Y. Delmas

given: Y.

family: Douglas

full_name: K. Douglas

given: K.

family: Eitner

full_name: F. Eitner

given: F.

family: Feldkamp

full_name: T. Feldkamp

given: T.

family: Fouque

full_name: D. Fouque

given: D.

family: Furman

full_name: R.R. Furman

family: Gaber

full_name: O. Gaber

family: Herthelius

full_name: M. Herthelius

given: M.

family: Hourmant

full_name: M. Hourmant

repository_institution: Lund University - Lund University Publications

title: Terminal Complement Inhibitor Eculizumab in Atypical Hemolytic–Uremic Syndrome

location_country:
Italy
Sweden
Netherlands
France
Germany
United Kingdom
Canada


family: Pugh

full_name: Dan Pugh

family: O'Sullivan

full_name: Eoin D O'Sullivan

family: Duthie

full_name: Fiona AI Duthie

family: Masson

full_name: Philip Masson

family: Kavanagh

full_name: David Kavanagh

title: Interventions for atypical haemolytic uraemic syndrome

family: Legendre

full_name: C.M. Legendre

given: S.

given: O.

family: Karpman

full_name: D. Karpman

family: Lebranchu

repositories_institution: Lund University - Lund University Publications

title: An Open-label, Multi-center Controlled Clinical Trial of Eculizumab in Adult Patients With Plasma Therapy-sensitive Atypical Hemolytic Uremic Syndrome (AHUS)

summary: The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of adult patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS).


title: A Phase IV, Open-Label, Randomized, Multicenter Trial Assessing the Efficacy of a Treatment Maintenance Phase With Unboosted vs. Boosted Reyataz After an Induction Phase With Reyataz and Ritonavir in Treatment Naive HIV Patients (the INDUMA Study)

acronym: INDUMA

summary: The purpose of this study is to compare the proportion of subjects with HIV-1 RNA viral load < 50 c/mL through Week 48 of the Maintenance Phase among HIV-infected subjects with an initial undetectable viral load following an Induction Phase with an ATV/RTV containing HAART regimen, when switched to ATV versus remaining on ATV/RTV, whilst continuing their previous NRTI backbone.

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
United Kingdom
Spain
France
Ireland
Russian Federation
Portugal
Estonia
Germany
Latvia


title: Randomized Study of ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Non Previously Treated Patients Aged From 60 to 65 Years With Diffuse Large B-Cell Lymphoma

summary: The primary objective of this study is to evaluate the efficacy of doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone (ACVBP) plus rituximab in comparison to cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) plus rituximab in patients aged from 60 to 65 years with non-previously treated diffuse large B-cell lymphoma as measured by the event-free survival. The goal is to obtain a 10% increase of event-free survival at 3 years.

ReferenceCitation: Tilly H, Lepage E, Coiffier B, Blanc M, Herbrecht R, Bosly A, Attal M, Fillet G, Guettier C, Molina TJ, Gisselbrecht C, Reyes F; Groupe d'Etude des Lymphomes de l'Adulte. Intensive conventional chemotherapy (ACVBP regimen) compared with standard CHOP for poor-prognosis aggressive non-Hodgkin lymphoma. Blood. 2003 Dec 15;102(13):4284-9. Epub 2003 Aug 14.

ReferenceCitation: Coiffier B, Lepage E, Briere J, Herbrecht R, Tilly H, Bouabdallah R, Morel P, Van Den Neste E, Salles G, Gaulard P, Reyes F, Lederlin P, Gisselbrecht C. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002 Jan 24;346(4):235-42.

ReferenceCitation: Ghesquières H, Larrabee BR, Haioun C, Link BK, Verney A, Slager SL, Ketterer N, Ansell SM, Delarue R, Maurer MJ, Fitoussi O, Habermann TM, Peyrade F, Dogan A, Molina TJ, Novak AJ, Tilly H, Cerhan JR, Salles G. FCGR3A/2A polymorphisms and diffuse large B-cell lymphoma outcome treated with immunochemotherapy: a meta-analysis on 1134 patients from two prospective cohorts. Hematol Oncol. 2017 Dec;35(4):447-455. doi: 10.1002/hon.2305. Epub 2016 Jun 10.

name: Department of Hematology; Centre Hospitalier Lyon Sud; Pierre-Bénite France

name: Centre de Recherche en Cancérologie de Lyon - INSERM U 1052/CNRS UMR 5286/Centre Léon Bérard; Lyon France

name: Department of Health Sciences Research; Mayo Clinic; Rochester MN USA

family: Ghesquières

full_name: Hervé Ghesquières

given: Hervé

family: Larrabee

full_name: Beth R. Larrabee

given: Beth R.

name: Lymphoid Malignancies Unit, Hôpital Henri Mondor, Assistance Publique-Hôpitaux de Paris (AP-HP) and University Paris Est; Créteil France

family: Haioun

full_name: Corinne Haioun

given: Corinne

name: Holden Comprehensive Cancer Center; University of Iowa; Iowa City IA USA

family: Link

full_name: Brian K. Link

given: Brian K.

family: Verney

full_name: Aurélie Verney

given: Aurélie

family: Slager

full_name: Susan L. Slager

given: Susan L.

name: Department of Oncology; University Hospital; Lausanne Switzerland

family: Ketterer

full_name: Nicolas Ketterer

given: Nicolas

name: Division of Hematology, Department of Internal Medicine; Mayo Clinic; Rochester MN USA

family: Ansell

full_name: Stephen M. Ansell

given: Stephen M.

name: Department of Hematology; Necker Hospital; Paris France

family: Delarue

full_name: Richard Delarue

given: Richard

family: Maurer

full_name: Matthew J. Maurer

given: Matthew J.

name: Onco-Hematology, Polyclinique Bordeaux-Nord; Bordeaux France

family: Fitoussi

full_name: Olivier Fitoussi

given: Olivier

family: Habermann

full_name: Thomas M. Habermann

given: Thomas M.

name: Medical Oncology, Centre Antoine Lacassagne; Nice France

family: Peyrade

full_name: Fréderic Peyrade

given: Fréderic

name: Departments of Pathology and Laboratory Medicine; Memorial Sloan Kettering Cancer Center; New York NY USA

family: Dogan

full_name: Ahmet Dogan

given: Ahmet

name: Department of Pathology; Necker Hospital; Paris France

family: Molina

full_name: Thierry J. Molina

given: Thierry J.

family: Novak

full_name: Anne J. Novak

given: Anne J.

name: Department of Hematology; Centre Henri Becquerel; Rouen France

family: Tilly

full_name: Hervé Tilly

family: Cerhan

full_name: James R. Cerhan

given: James R.

family: Salles

full_name: Gilles Salles

given: Gilles

journal_name: Hematological Oncology

oa_host_type: repository

title: FCGR3A /2A polymorphisms and diffuse large B-cell lymphoma outcome treated with immunochemotherapy: a meta-analysis on 1134 patients from two prospective cohorts

ReferenceCitation: Copie-Bergman C, Cuillière-Dartigues P, Baia M, Briere J, Delarue R, Canioni D, Salles G, Parrens M, Belhadj K, Fabiani B, Recher C, Petrella T, Ketterer N, Peyrade F, Haioun C, Nagel I, Siebert R, Jardin F, Leroy K, Jais JP, Tilly H, Molina TJ, Gaulard P. MYC-IG rearrangements are negative predictors of survival in DLBCL patients treated with immunochemotherapy: a GELA/LYSA study. Blood. 2015 Nov 26;126(22):2466-74. doi: 10.1182/blood-2015-05-647602. Epub 2015 Sep 15.

name: Assistance Publique–Hôpitaux de Paris, Groupe Henri Mondor–Albert Chenevier, Département de Pathologie, Creteil, France;

name: Universite Paris-Est, Faculté de Médecine, Unité Mixte de Recherche Scientifique 955, Créteil, France;

name: Institut Gustave Roussy, Villejuif, France;

name: Assistance Publique–Hôpitaux de Paris, Hôpital Saint-Louis, Department of Pathology, Institut Universitaire d’Hématologie, Paris, France;

name: Assistance Publique–Hôpitaux de Paris, Hôpital Necker, Department of Hematology, Paris, France;

name: Assistance Publique–Hôpitaux de Paris, Hôpital Necker, Department of Pathology, Université Paris Descartes, Paris, France;

name: Hospices Civils de Lyon, Université Claude Bernard Lyon-1, Service d’Hématologie, Unité Mixte de Recherche 5239, Centre National de la Recherche Scientifique, Lyon, France;

name: Centre Hospitalier Universitaire Bordeaux, Université de Bordeaux, EA2406, Bordeaux, France;

name: Assistance Publique–Hôpitaux de Paris, Groupe Henri Mondor-Albert Chenevier, Unité Lymphoïde, Créteil, France;

name: Assistance Publique–Hôpitaux de Paris, Hôpital Saint-Antoine, Department of Pathology, Paris, France;

name: Service d’Hématologie, Institut Universitaire du Cancer, Toulouse, France;

name: Department of Pathology, Hôpital Maisonneuve-Rosemont, Montreal, Canada;

name: Pluridisciplinary Center for Oncology, University Hospital–Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland;

name: Centre de Lutte Contre le Cancer de Nice, Nice, France;

name: Institute of Human Genetics, Christian-Albrechts-University Kiel and University Hospital Schleswig-Holstein, Kiel, Germany;

name: Centre Henri Becquerel and INSERM Unité 918, Institut de Recherche et d'Innovation Biomédicale, Rouen, France;

name: Assistance Publique–Hôpitaux de Paris, Hôpital Necker, Department of Biostatistics, Paris, France;

name: Assistance Publique–Hôpitaux de Paris, Hôpital Necker, Department of Pathology, Université Paris Descartes, EA 7324, Paris, France

location_facility: Groupe d'Etude des Lymphomes de l'adulte

location_facility: Schweirische Arbeitsgruppe fur klinische Krebsforschung

location_facility: Service d'Hématologie - Centre Hospitalier Lyon-Sud


title: A PHASE III RANDOMIZED STUDY ON POSTOPERATIVE RADIO- AND CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED HEAD AND NECK CARCINOMAS

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy plus chemotherapy is more effective than radiation therapy alone in treating patients with head and neck cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of high-dose radiation therapy alone with high-dose radiation therapy plus cisplatin in treating patients with head and neck cancer who have undergone surgery to remove the cancer.

ReferenceCitation: Bernier J, Cooper JS, Pajak TF, van Glabbeke M, Bourhis J, Forastiere A, Ozsahin EM, Jacobs JR, Jassem J, Ang KK, Lefèbvre JL. Defining risk levels in locally advanced head and neck cancers: a comparative analysis of concurrent postoperative radiation plus chemotherapy trials of the EORTC (#22931) and RTOG (# 9501). Head Neck. 2005 Oct;27(10):843-50.

ReferenceCitation: Bernier J, Domenge C, Ozsahin M, Matuszewska K, Lefèbvre JL, Greiner RH, Giralt J, Maingon P, Rolland F, Bolla M, Cognetti F, Bourhis J, Kirkpatrick A, van Glabbeke M; European Organization for Research and Treatment of Cancer Trial 22931. Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer. N Engl J Med. 2004 May 6;350(19):1945-52.

ReferenceCitation: Bernier J, Domenge C, Eschwege F, et al.: Chemo-radiotherapy, as compared to radiotherapy alone, significantly increases disease-free and overall survival in head and neck cancer patients after surgery: results of EORTC phase III trial 22931. [Abstract] Int J Radiat Oncol Biol Phys 51(3 suppl 1): A-1, 1, 2001.

ReferenceCitation: Valley JF, Bernier J, Tercier PA, Fogliata-Cozzi A, Rosset A, Garavaglia G, Mirimanoff RO. Quality assurance of the EORTC radiotherapy trial 22931 for head and neck carcinomas: the dummy run. Radiother Oncol. 1998 Apr;47(1):37-44.

location_country:
Italy
Switzerland
Netherlands
United Kingdom
Poland
France
Belgium
Spain
Turkey
Slovenia

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centre de Lute Contre le Cancer,Georges-Francois Leclerc

location_facility: Istituti Fisioterapici Ospitalieri - Roma

location_facility: Dokuz Eylul University School of Medicine

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori

intervention_type: Radiation


title: Neo-adjuvant Chemotherapy Combined With Stereotactic Body Radiotherapy to the Primary Tumour +/- Durvalumab, +/- Oleclumab in Luminal B Breast Cancer: a Phase ll Randomised Trial

acronym: Neo-CheckRay

summary:
Neo-CheckRay is a multicenter, open-label phase II study that randomizes luminal B breast cancer subjects candidate for neo-adjuvant chemotherapy in a 1:1:1 ratio in 3 arms:

the combination of weekly paclitaxel followed by dose-dense doxorubicin-cyclophosphamide (ddAC) and pre-operative radiation therapy (boost dose) on the primary tumour
arm 1 with the addition of the anti-PD-L1 antibody durvalumab
arm 2 with the addition of the anti-CD73 antibody oleclumab The primary tumour will be excised 2-6 weeks after completion of ddAC. A safety run-in is planned for the 6 first subjects before starting the randomized phase II trial. Those 6 subjects will receive the treatment given in Arm 3.

ReferenceCitation: De Caluwé A, Buisseret L, Poortmans P, Van Gestel D, Salgado R, Sotiriou C, Larsimont D, Paesmans M, Craciun L, Stylianos D, Vandekerckhove C, Reyal F, Isabelle V, Eiger D, Piccart M, Romano E, Ignatiadis M. Neo-CheckRay: radiation therapy and adenosine pathway blockade to increase benefit of immuno-chemotherapy in early stage luminal B breast cancer, a randomized phase II trial. BMC Cancer. 2021 Aug 6;21(1):899. doi: 10.1186/s12885-021-08601-1.

family: De Caluwé

full_name: Alex De Caluwé

given: Alex

family: Buisseret

full_name: Laurence Buisseret

given: Laurence

family: Poortmans

full_name: Philip Poortmans

given: Philip

family: Van Gestel

full_name: Dirk Van Gestel

given: Dirk

family: Salgado

full_name: Roberto Salgado

given: Roberto

family: Sotiriou

full_name: Christos Sotiriou

given: Christos

family: Larsimont

full_name: Denis Larsimont

given: Denis

family: Paesmans

full_name: Marianne Paesmans

given: Marianne

family: Craciun

full_name: Ligia Craciun

given: Ligia

family: Stylianos

full_name: Drisis Stylianos

given: Drisis

family: Vandekerckhove

full_name: Christophe Vandekerckhove

given: Christophe

family: Reyal

full_name: Fabien Reyal

given: Fabien

family: Isabelle

full_name: Veys Isabelle

given: Veys

family: Eiger

full_name: Daniel Eiger

given: Daniel

family: Piccart

full_name: Martine Piccart

given: Martine

family: Romano

full_name: Emanuela Romano

given: Emanuela

family: Ignatiadis

full_name: Michail Ignatiadis

given: Michail

currency_apc_doaj: GBP

journal_name: BMC Cancer

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

location_facility: GZA - Ziekenhuizen (Campus St. Augustinus)


title: An Open-Label, Intrapatient Dose Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity, and Biological Activity of ATYR1940 in Patients With Limb Girdle and Facioscapulohumeral Muscular Dystrophies

acronym: FSHD

summary: The purpose of this study is to assess the safety and biological activity of ATYR1940 in patients with Limb Girdle (LGMD2B) or Facioscapulohumeral Muscular Dystrophy (FSHD).

lead_sponsor: aTyr Pharma, Inc.

location_country:
Denmark
United States
France

location_facility: Kennedy Krieger Institute; The Johns Hopkins University School of Medicine

location_facility: Centre d'nvestigation Clinique - Centre de Pharmacologie Clinique et d'Evaluations Thérapeutiques (CICCPCET)

location_facility: Institut de Myologie, Hôpital Pitié-Salpêtrière

location_facility: Rigshospitalet, University of Copenhagen

location_facility: University of California, Irvine, ALS and Neuromuscular Center


ReferenceCitation: Luyt CE, Clavel M, Guntupalli K, Johannigman J, Kennedy JI, Wood C, Corkery K, Gribben D, Chastre J. Pharmacokinetics and lung delivery of PDDS-aerosolized amikacin (NKTR-061) in intubated and mechanically ventilated patients with nosocomial pneumonia. Crit Care. 2009;13(6):R200. doi: 10.1186/cc8206. Epub 2009 Dec 10.

family: Luyt

full_name: Charles-Edouard Luyt

given: Charles-Edouard

family: Clavel

full_name: Marc Clavel

given: Marc

family: Guntupalli

full_name: Kalpalatha Guntupalli

given: Kalpalatha

family: Johannigman

full_name: Jay Johannigman

given: Jay

family: Kennedy

full_name: John I Kennedy

given: John I

family: Wood

full_name: Christopher Wood

given: Christopher

family: Corkery

full_name: Kevin Corkery

given: Kevin

family: Gribben

full_name: Dennis Gribben

given: Dennis

family: Chastre

full_name: Jean Chastre

given: Jean

journal_name: Critical Care

lead_sponsor: Bayer

location_country:
United States
France

title: An Open-Label, Multicenter, Multinational Study to Assess the Safety,Tolerability and Pharmacokinetics of Aerosolized Amikacin Delivered Via the Pulmonary Drug Delivery System (NKTR-061) in Intubated and Mechanically- Ventilated Patients With Nosocomial Pneumonia

summary: This study is to understand how the inhaled form of amikacin is spread throughout the human body and how it is eliminated from the body and to make sure that giving an inhaled form of Amikacin to patients is safe and well tolerated


ReferenceCitation: Carpentier A, Canney M, Vignot A, Reina V, Beccaria K, Horodyckid C, Karachi C, Leclercq D, Lafon C, Chapelon JY, Capelle L, Cornu P, Sanson M, Hoang-Xuan K, Delattre JY, Idbaih A. Clinical trial of blood-brain barrier disruption by pulsed ultrasound. Sci Transl Med. 2016 Jun 15;8(343):343re2. doi: 10.1126/scitranslmed.aaf6086.

ReferenceCitation: Idbaih A, Canney M, Belin L, Desseaux C, Vignot A, Bouchoux G, Asquier N, Law-Ye B, Leclercq D, Bissery A, De Rycke Y, Trosch C, Capelle L, Sanson M, Hoang-Xuan K, Dehais C, Houillier C, Laigle-Donadey F, Mathon B, André A, Lafon C, Chapelon JY, Delattre JY, Carpentier A. Safety and Feasibility of Repeated and Transient Blood-Brain Barrier Disruption by Pulsed Ultrasound in Patients with Recurrent Glioblastoma. Clin Cancer Res. 2019 Jul 1;25(13):3793-3801. doi: 10.1158/1078-0432.CCR-18-3643. Epub 2019 Mar 19.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_country: Belgium France Switzerland

acronym: SonoFIRST

location_facility: Centre hospitalier Universitaire d'Angers

location_facility: Centre hospitalier universitaire vaudois CHUV

location_facility: Hospices Civils de Lyon, Hôpital Pierre Wertheimer

location_facility: APHP-Sorbonne, Pitié Salpêtrière Hospital

title: Multisite Open-label Randomized Phase II Clinical Trial in Newly Diagnosed Glioblastoma Treated by Concurrent Temoradiation and Adjuvant Temozolomide +/- Ultrasound-induced Blood Brain Barrier Opening.

summary:
Glioblastoma (GBM) is an aggressive cancer with a progression-free survival (PFS) of 7 months and an overall survival (OS) of 15 months. Many therapeutic approaches have failed to improve the prognosis of patients to date. One of the main reasons is the presence of blood brain barrier (BBB) which limits therapeutic agents uptake in the brain. GBM is also considered to have a "cold" (unresponsive) immunological microenvironment due to factors released by the tumor and the presence of BBB limiting the transit of immune cells from the systemic circulation. Therefore, by-passing the BBB appears as a promising strategy.

The objective of the Phase II clinical trial, SonoFIRST, is to evaluate if the use of therapeutic ultrasound device, sonoCloud-9 (SC9) could improve the progression free survival of newly diagnosed GBM patients, treated by concurrent temoradiation and adjuvant temozolomide. The transient opening of the BBB by ultrasound with the SonoCloud-9 (SC9) device, predicts the increase in the penetration of temozolomide (TMZ) into the brain and the stimulation of cerebral immunity with the prospect of improving the survival of 160,000 new brain tumor patients each year in Europe and the United States.


title: CAOCT Study is a Prospective, Multi-centre, Single Cohort, Diagnostic Accuracy Study, Planned to Include 131 Patients in About 3 European Countries After Successful Return of Spontaneous Circulation After Out of Hospital Cardiac Arrest

summary: Out-of-hospital cardiac arrest (OHCA) is a leading cause of sudden death in Europe and the United States. Mortality is currently close to 40% among those patients who had been successfully resuscitated after OHCA associated with ventricular fibrillation or pulseless ventricular tachycardia . Coronary artery disease is observed in up to 70% of patients with OHCA and immediate coronary angiography . Current European and American guidelines recommend immediate coronary angiography with primary angioplasty in OHCA patients with ST-segment elevation on ECG after successful resuscitation . Furthermore, the identification of the culprit lesion by coronary angiography among patients with an acute coronary syndrome (ACS) and no OHCA is challenging. In a recent cardiac magnetic resonance study, Heitner et al. found that in almost half of the patients with non-ST segment elevation ACS, the culprit lesion was not properly detected or identified by coronary angiography. In the Coronary Angiography after cardiac arrest (COACT) trial, a randomized controlled trial comparing immediate versus delayed coronary angiography after OHCA in patients without ST segment elevation on ECG, some degree of coronary artery disease was found in 64.5% of the patients in the immediate angiography group and an unstable coronary lesion was identified in only 13.6% of the patients. However, in survivors of OHCA without ST segment elevation on ECG, the use of intra coronary optical computerized tomography (OCT) led to identification of plaque rupture (27%), plaque erosion (36%) and coronary thrombosis (59%) undetected on angiography. There is hence a clear need to improve causality diagnosis among patients resuscitated after OHCA and without ST segment elevation on ECG, and, in the case of coronary artery disease detection, to better identify the culprit vessel/lesion ultimately leading to a targeted treatment. These are the reasons why we have designed a prospective, multi-centre, single cohort, diagnostic accuracy study: to better explore the incidence of a true ACS among OHCA survivors and to evaluate the accuracy of angiography to detect the culprit lesion when compared to OCT.

ReferenceCitation: McDonnell SJ, Gates S, Perkins GD. Utstein recommendations for reporting out of hospital cardiac arrest (OHCA) registry studies-A review of the literature. Resuscitation. 2017;118:e103.

ReferenceCitation: Miller LM, Gal A. Cardiovascular system and lymphatic vessels. Pathologic basis of veterinary disease. 2017:561.

ReferenceCitation: Hepler MD, Schafer MF. Chapter 18 - Surgical Treatment of Lumbar Spinal Disorders. In: Benzon HT, Rathmell JP, Wu CL, Turk DC, Argoff CE, editors. Raj's Practical Management of Pain (Fourth Edition). Philadelphia: Mosby; 2008. p. 389-400.

ReferenceCitation: Marso SP. 23 - Revascularization Approaches. In: de Lemos JA, Omland T, editors. Chronic Coronary Artery Disease: Elsevier; 2018. p. 337-54.

ReferenceCitation: Ibrahim K, editor Increased rate of stentthrombosis due to clopidogrel resistance in patients in therapeutic hypothermia after sudden cardiac death. European Heart Journal; 2011: OXFORD UNIV PRESS GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND.

ReferenceCitation: Degrell P, Picard F, Combaret N, Mogi S, Motreff P, Cariou A, Varenne O. Coronary atherothrombosis in cardiac arrest survivors without ST-segment elevation on ECG. Resuscitation. 2019 Jun;139:189-191. doi: 10.1016/j.resuscitation.2019.01.046. Epub 2019 Mar 27.

family: Degrell

full_name: Philippe Degrell

given: Philippe

family: Picard

full_name: Fabien Picard

family: Combaret

full_name: Nicolas Combaret

given: Nicolas

family: Mogi

full_name: Satoshi Mogi

given: Satoshi

family: Motreff

full_name: Pascal Motreff

given: Pascal

family: Cariou

full_name: Alain Cariou

given: Alain

family: Varenne

full_name: Olivier Varenne

given: Olivier

journal_name: Resuscitation

evidence: open (via free pdf)

ReferenceCitation: Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018 Jun 12;137(24):2635-2650. doi: 10.1161/CIRCULATIONAHA.117.029289. Review.

name: Cardialysis, Rotterdam, The Netherlands (H.M.G.-G., Y.O., M.-a.M., G.A.v.E.).

name: Interventional Cardiology, MedStar Washington Hospital Center, DC (H.M.G.-G.).

family: Garcia-Garcia

full_name: Hector M. Garcia-Garcia

given: Hector M.

name: Interventional Cardiology, Cork University Hospital, Ireland (E.P.M.).

family: McFadden

full_name: Eugène P. McFadden

given: Eugène P.

name: US Food and Drug Administration, Washington, DC (A.F., B.Z.).

family: Farb

full_name: Andrew Farb

given: Andrew

name: Zena and Michael A. Weiner Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (R.M.).

family: Mehran

full_name: Roxana Mehran

given: Roxana

name: Clinical Trials Center, Cardiovascular Research Foundation and Division of Cardiology, Columbia University Medical Center, New York, NY (G.W.S.).

family: Stone

full_name: Gregg W. Stone

given: Gregg W.

name: Mid America Heart Institute, University of Missouri, Kansas City (J.S.).

family: Spertus

full_name: John Spertus

given: John

family: Onuma

full_name: Yoshinobu Onuma

given: Yoshinobu

family: Morel

full_name: Marie-angèle Morel

given: Marie-angèle

family: van Es

full_name: Gerrit-Anne van Es

given: Gerrit-Anne

family: Zuckerman

full_name: Bram Zuckerman

given: Bram

name: Stanford University Medical Center, CA (W.F.F.).

family: Fearon

full_name: William F. Fearon

given: William F.

name: Nuffield Department of Surgery, University of Oxford, United Kingdom (D.T.).

family: Taggart

name: Department of Cardiothoracic Surgery, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands (A.-P.R.).

name: Duke University Medical Center/Duke Clinical Research Institute, Durham, NC (M.W.K.).

name: Hartcentrum Hasselt and Faculty of Medicine and Life Sciences University of Hasselt, Belgium (P.V.).

name: Bern University Hospital, Switzerland (S.W.).

name: Harvard Clinical Research Institute, Boston, MA (D.C.).

name: Beth Israel Deaconess Medical Center, Boston, MA (D.C.).

name: Centre for International Cardiovascular Health, Imperial College London, United Kingdom (P.W.S.)

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

ReferenceCitation: Heitner JF, Senthilkumar A, Harrison JK, Klem I, Sketch MH Jr, Ivanov A, Hamo C, Van Assche L, White J, Washam J, Patel MR, Bekkers SCAM, Smulders MW, Sacchi TJ, Kim RJ. Identifying the Infarct-Related Artery in Patients With Non-ST-Segment-Elevation Myocardial Infarction. Circ Cardiovasc Interv. 2019 May;12(5):e007305. doi: 10.1161/CIRCINTERVENTIONS.118.007305.

name: Department of Medicine, NewYork-Presbyterian Brooklyn Methodist Hospital, Brooklyn (J.F.H., A.I., C.H., T.J.S.).

name: Department of Medicine, Duke Cardiovascular Magnetic Resonance Center, Durham, NC (A.S., J.K.H., I.K., M.H.S., L.V.A., J. White, J. Washam, M.R.P., R.J.K.).

name: Department of Medicine, Maastricht University Medical Center, the Netherlands (S.C.A.M.B., M.W.S.).

title: Identifying the Infarct-Related Artery in Patients With Non–ST-Segment–Elevation Myocardial Infarction

ReferenceCitation: Lemkes JS, Janssens GN, van der Hoeven NW, Jewbali LSD, Dubois EA, Meuwissen M, Rijpstra TA, Bosker HA, Blans MJ, Bleeker GB, Baak R, Vlachojannis GJ, Eikemans BJW, van der Harst P, van der Horst ICC, Voskuil M, van der Heijden JJ, Beishuizen A, Stoel M, Camaro C, van der Hoeven H, Henriques JP, Vlaar APJ, Vink MA, van den Bogaard B, Heestermans TACM, de Ruijter W, Delnoij TSR, Crijns HJGM, Jessurun GAJ, Oemrawsingh PV, Gosselink MTM, Plomp K, Magro M, Elbers PWG, van de Ven PM, Oudemans-van Straaten HM, van Royen N. Coronary Angiography after Cardiac Arrest without ST-Segment Elevation. N Engl J Med. 2019 Apr 11;380(15):1397-1407. doi: 10.1056/NEJMoa1816897. Epub 2019 Mar 18.

name: From the Departments of Cardiology (J.S.L., G.N.J., N.W.H., N.R.), Intensive Care Medicine (P.W.G.E., H.M.O.-S.), and Epidemiology and Biostatistics (P.M.V.), Amsterdam University Medical Center VUmc, the Departments of Cardiology (J.P.H.) and Intensive Care Medicine (A.P.J.V.), Amsterdam University Medical Center AMC, and the Departments of Cardiology (M.A.V.) and Intensive Care Medicine (B.B.), Onze Lieve Vrouwe Gasthuis, Amsterdam, the Thorax Center, Erasmus Medical Center (L.S.D.J., E.A.D.), and the...

ReferenceCitation: Noc M, Fajadet J, Lassen JF, Kala P, MacCarthy P, Olivecrona GK, Windecker S, Spaulding C; European Association for Percutaneous Cardiovascular Interventions (EAPCI); Stent for Life (SFL) Group. Invasive coronary treatment strategies for out-of-hospital cardiac arrest: a consensus statement from the European association for percutaneous cardiovascular interventions (EAPCI)/stent for life (SFL) groups. EuroIntervention. 2014 May;10(1):31-7. doi: 10.4244/EIJV10I1A7. Review.

title: Invasive coronary treatment strategies for out-of-hospital cardiac arrest: a consensus statement from the European Association for Percutaneous Cardiovascular Interventions (EAPCI)/Stent for Life (SFL) groups

ReferenceCitation: O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the American College of Emergency Physicians and Society for Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. 2013 Jul 1;82(1):E1-27. doi: 10.1002/ccd.24776. Epub 2013 Jan 8. Review.

journal_name: Catheterization and Cardiovascular Interventions

title: 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction: Executive Summary: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines

ReferenceCitation: Patel N, Patel NJ, Macon CJ, Thakkar B, Desai M, Rengifo-Moreno P, Alfonso CE, Myerburg RJ, Bhatt DL, Cohen MG. Trends and Outcomes of Coronary Angiography and Percutaneous Coronary Intervention After Out-of-Hospital Cardiac Arrest Associated With Ventricular Fibrillation or Pulseless Ventricular Tachycardia. JAMA Cardiol. 2016 Nov 1;1(8):890-899. doi: 10.1001/jamacardio.2016.2860.

name: Division of Cardiology, University of Miami Miller School of Medicine, Miami, Florida

name: Cleveland Clinic Foundation, Cleveland, Ohio

name: Department of Medicine, Emory University School of Medicine, Atlanta, Georgia

name: Brigham and Woman’s Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts

ReferenceCitation: Roger VL, Weston SA, Killian JM, Pfeifer EA, Belau PG, Kottke TE, Frye RL, Bailey KR, Jacobsen SJ. Time trends in the prevalence of atherosclerosis: a population-based autopsy study. Am J Med. 2001 Mar;110(4):267-73.

ReferenceCitation: Zahger D. Immediate coronary angiography in survivors of out-of-hospital cardiac arrest. N Engl J Med. 1997 Oct 30;337(18):1321-2.

ReferenceCitation: Spaulding CM, Joly LM, Rosenberg A, Monchi M, Weber SN, Dhainaut JF, Carli P. Immediate coronary angiography in survivors of out-of-hospital cardiac arrest. N Engl J Med. 1997 Jun 5;336(23):1629-33.

ReferenceCitation: Jiangping S, Zhe Z, Wei W, Yunhu S, Jie H, Hongyue W, Hong Z, Shengshou H. Assessment of coronary artery stenosis by coronary angiography: a head-to-head comparison with pathological coronary artery anatomy. Circ Cardiovasc Interv. 2013 Jun;6(3):262-8. doi: 10.1161/CIRCINTERVENTIONS.112.000205. Epub 2013 May 21.

name: From the State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

title: Assessment of Coronary Artery Stenosis by Coronary Angiography

ReferenceCitation: Penela D, Magaldi M, Fontanals J, Martin V, Regueiro A, Ortiz JT, Bosch X, Sabaté M, Heras M. Hypothermia in acute coronary syndrome: brain salvage versus stent thrombosis? J Am Coll Cardiol. 2013 Feb 12;61(6):686-7. doi: 10.1016/j.jacc.2012.10.029. Epub 2012 Dec 19.

journal_name: Journal of the American College of Cardiology

title: Hypothermia in Acute Coronary Syndrome

ReferenceCitation: Joffre J, Varenne O, Bougouin W, Rosencher J, Mira JP, Cariou A. Stent thrombosis: an increased adverse event after angioplasty following resuscitated cardiac arrest. Resuscitation. 2014 Jun;85(6):769-73. doi: 10.1016/j.resuscitation.2014.02.013. Epub 2014 Feb 23.

title: Stent thrombosis: An increased adverse event after angioplasty following resuscitated cardiac arrest

ReferenceCitation: Bjelland TW, Hjertner Ø, Klepstad P, Kaisen K, Dale O, Haugen BO. Antiplatelet effect of clopidogrel is reduced in patients treated with therapeutic hypothermia after cardiac arrest. Resuscitation. 2010 Dec;81(12):1627-31. doi: 10.1016/j.resuscitation.2010.07.002. Epub 2010 Aug 19.

ReferenceCitation: Rosencher J, Gouffran G, Bougouin W, Varenne O. Optimal antiplatelet therapy in out-hospital cardiac arrest patients treated by primary percutaneous coronary intervention. Resuscitation. 2015 May;90:e7-8. doi: 10.1016/j.resuscitation.2015.02.030. Epub 2015 Mar 7.

ReferenceCitation: Adrie C, Adib-Conquy M, Laurent I, Monchi M, Vinsonneau C, Fitting C, Fraisse F, Dinh-Xuan AT, Carli P, Spaulding C, Dhainaut JF, Cavaillon JM. Successful cardiopulmonary resuscitation after cardiac arrest as a "sepsis-like" syndrome. Circulation. 2002 Jul 30;106(5):562-8.

location_facility: Clinical Center of Serbia. School of medicine


title: Inhaled Sedation in COVID-19-related Acute Respiratory Distress Syndrome (ISCA): an International Research Data Study in the Recent Context of Widespread Disease Resulting From the 2019 (SARS-CoV2) Coronavirus Pandemics (COVID-19)

acronym: ISCA

summary:
The authors hypothesized that inhaled sedation, either with isoflurane or sevoflurane, might be associated with improved clinical outcomes in patients with COVID-19-related ARDS, compared to intravenous sedation.

The authors therefore designed the "Inhaled Sedation for COVID-19-related ARDS" (ISCA) non-interventional, observational, multicenter study of data collected from the patients' medical records in order to:

assess the efficacy of inhaled sedation in improving a composite outcome of mortality and time off the ventilator at 28 days in patients with COVID-19-related ARDS, in comparison to a control group receiving intravenous sedation (primary objective),
investigate the effects of inhaled sedation, compared to intravenous sedation, on lung function as assessed by gas exchange and physiologic measures in patients with COVID-19-related ARDS (secondary objective),
report sedation practice patterns in critically ill patients during the COVID-19 pandemics (secondary objective).

time_perspective: Retrospective

ReferenceCitation: Blondonnet R, Quinson A, Lambert C, Audard J, Godet T, Zhai R, Pereira B, Futier E, Bazin JE, Constantin JM, Jabaudon M. Use of volatile agents for sedation in the intensive care unit: A national survey in France. PLoS One. 2021 Apr 15;16(4):e0249889. doi: 10.1371/journal.pone.0249889. eCollection 2021.

family: Blondonnet

full_name: Raiko Blondonnet

given: Raiko

family: Quinson

full_name: Audrey Quinson

given: Audrey

family: Lambert

full_name: Céline Lambert

given: Céline

family: Audard

full_name: Jules Audard

given: Jules

family: Godet

full_name: Thomas Godet

given: Thomas

family: Zhai

full_name: Ruoyang Zhai

given: Ruoyang

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Futier

full_name: Emmanuel Futier

given: Emmanuel

family: Bazin

full_name: Jean-Etienne Bazin

given: Jean-Etienne

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

family: Jabaudon

full_name: Matthieu Jabaudon

given: Matthieu

currency_apc_doaj: USD

journal_name: PLOS ONE

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

repository_normalized: HAL

repositories:
HAL
PubMed Central

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

ipd_sharing: Undecided

lead_sponsor: University Hospital, Clermont-Ferrand

location_country:
United States
Switzerland
France
Spain
Germany

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Beth Israel Deaconess Medical Center, Inc.

location_facility: University Medical Center Schleswig-Holstein


title: A Phase I, Open-label, Parallel Group Study to Investigate Olaparib Safety and Tolerability, Efficacy and Pharmacokinetics in Paediatric Patients With Solid Tumours

summary: A study to find out whether olaparib is safe and well tolerated when administered to children and adolescents with solid tumours

ipd_sharing: Yes

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

location_country:
France
Israel
Spain
Denmark
Germany
United Kingdom
Korea, Republic of


title: A Randomized Phase III Study of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery Alone for Patients With High Risk RetroPeritoneal Sarcoma (RPS)

summary:
This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival.

After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.

location_country:
Italy
France
Czechia
Poland
Slovakia
Spain
Germany
United Kingdom

location_facility: Hopitaux Universitaires de Strasbourg - Hautepierre

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology

location_facility: IRCCS - Fondazione Piemonte Inst di Candiolo

location_facility: Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol

location_facility: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital

location_facility: IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

location_facility: Policlinico Universitario Campus Bio-Medico- Oncology Center


title: PHIL Evaluation in the Endovascular Treatment of Intracranial Cerebral ArterioVenous Malformation a European Multi-center, Observational, Prospective, Single Arm and Open Label Study

summary: The primary objective of this study is to assess the efficacy and safety of PHIL® liquid embolic agent in endovascular embolization of cerebral arteriovenous malformations.

lead_sponsor: Microvention-Terumo, Inc.

location_country:
Sweden
France
Spain
Denmark
United Kingdom

location_facility: Hospital Universitario General de Catalunya

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Hospital Universitario Virgen de la Arrixaca


title: PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF, a European Multi-center, Observational, Prospective, Single Arm and Open Label Study.

summary: The primary objective of this study is to demonstrate the safety and efficacy of the PHIL® liquid in endovascular treatment of dural arteriovenous fistula.