title: Type 3 Von Willebrand International Registries Inhibitor Prospective Study

summary: International Registries and Prospective Study on Type 3 Von Willebrand's Disease (VWD3), aimed to assess number, types and risk factors for bleeding and the efficacy and safety of plasma-derived and/or recombinant Von Willebrand Factor (VWF) concentrates used to treat VWD patients.

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ReferenceCitation: Federici AB, Mannucci PM, Castaman G, Baronciani L, Bucciarelli P, Canciani MT, Pecci A, Lenting PJ, De Groot PG. Clinical and molecular predictors of thrombocytopenia and risk of bleeding in patients with von Willebrand disease type 2B: a cohort study of 67 patients. Blood. 2009 Jan 15;113(3):526-34. doi: 10.1182/blood-2008-04-152280. Epub 2008 Sep 19.

ReferenceCitation: Gritti G, Cortelezzi A, Bucciarelli P, Rezzonico F, Lonati S, La Marca S, Silvestris I, Federici AB. Circulating and progenitor endothelial cells are abnormal in patients with different types of von Willebrand disease and correlate with markers of angiogenesis. Am J Hematol. 2011 Aug;86(8):650-6. doi: 10.1002/ajh.22070. Epub 2011 May 31.

ReferenceCitation: Abshire TC, Federici AB, Alvárez MT, Bowen J, Carcao MD, Cox Gill J, Key NS, Kouides PA, Kurnik K, Lail AE, Leebeek FW, Makris M, Mannucci PM, Winikoff R, Berntorp E; VWD PN. Prophylaxis in severe forms of von Willebrand's disease: results from the von Willebrand Disease Prophylaxis Network (VWD PN). Haemophilia. 2013 Jan;19(1):76-81. doi: 10.1111/j.1365-2516.2012.02916.x. Epub 2012 Jul 23.

ReferenceCitation: Castaman G, Goodeve A, Eikenboom J; European Group on von Willebrand Disease. Principles of care for the diagnosis and treatment of von Willebrand disease. Haematologica. 2013 May;98(5):667-74. doi: 10.3324/haematol.2012.077263. Review.

ReferenceCitation: Federici AB, Bucciarelli P, Castaman G, Mazzucconi MG, Morfini M, Rocino A, Schiavoni M, Peyvandi F, Rodeghiero F, Mannucci PM. The bleeding score predicts clinical outcomes and replacement therapy in adults with von Willebrand disease. Blood. 2014 Jun 26;123(26):4037-44. doi: 10.1182/blood-2014-02-557264. Epub 2014 Apr 30.

ReferenceCitation: Abdul-Kadir R, McLintock C, Ducloy AS, El-Refaey H, England A, Federici AB, Grotegut CA, Halimeh S, Herman JH, Hofer S, James AH, Kouides PA, Paidas MJ, Peyvandi F, Winikoff R. Evaluation and management of postpartum hemorrhage: consensus from an international expert panel. Transfusion. 2014 Jul;54(7):1756-68. doi: 10.1111/trf.12550. Epub 2014 Mar 12. Erratum in: Transfusion. 2015 Mar;55(3):691.

ReferenceCitation: Makris M, Federici AB, Mannucci PM, Bolton-Maggs PHB, Yee TT, Abshire T, Berntorp E. The natural history of occult or angiodysplastic gastrointestinal bleeding in von Willebrand disease. Haemophilia. 2015 May;21(3):338-342. doi: 10.1111/hae.12571. Epub 2014 Nov 7.

ReferenceCitation: Federici AB. Clinical and laboratory diagnosis of VWD. Hematology Am Soc Hematol Educ Program. 2014 Dec 5;2014(1):524-30. doi: 10.1182/asheducation-2014.1.524. Epub 2014 Nov 18. Review.

ReferenceCitation: Holm E, Abshire TC, Bowen J, Álvarez MT, Bolton-Maggs P, Carcao M, Federici AB, Gill JC, Halimeh S, Kempton C, Key NS, Kouides P, Lail A, Landorph A, Leebeek F, Makris M, Mannucci P, Mauser-Bunschoten EP, Nugent D, Valentino LA, Winikoff R, Berntorp E. Changes in bleeding patterns in von Willebrand disease after institution of long-term replacement therapy: results from the von Willebrand Disease Prophylaxis Network. Blood Coagul Fibrinolysis. 2015 Jun;26(4):383-8. doi: 10.1097/MBC.0000000000000257.

ReferenceCitation: Randi AM, Laffan MA. Von Willebrand factor and angiogenesis: basic and applied issues. J Thromb Haemost. 2017 Jan;15(1):13-20. doi: 10.1111/jth.13551. Review.

ReferenceCitation: Federici AB. Current and emerging approaches for assessing von Willebrand disease in 2016. Int J Lab Hematol. 2016 May;38 Suppl 1:41-9. doi: 10.1111/ijlh.12540. Review.

ReferenceCitation: De Jong A, Eikenboom J. Developments in the diagnostic procedures for von Willebrand disease. J Thromb Haemost. 2016 Mar;14(3):449-60. doi: 10.1111/jth.13243. Epub 2016 Feb 12. Review.

ReferenceCitation: Abshire T, Cox-Gill J, Kempton CL, Leebeek FW, Carcao M, Kouides P, Donfield S, Berntorp E. Prophylaxis escalation in severe von Willebrand disease: a prospective study from the von Willebrand Disease Prophylaxis Network. J Thromb Haemost. 2015 Sep;13(9):1585-9. doi: 10.1111/jth.12995. Epub 2015 Jul 14. Review.

ReferenceCitation: Engelen ET, van Galen KP, Schutgens RE. Thalidomide for treatment of gastrointestinal bleedings due to angiodysplasia: a case report in acquired von Willebrand syndrome and review of the literature. Haemophilia. 2015 Jul;21(4):419-29. doi: 10.1111/hae.12701. Epub 2015 Apr 30. Review.

ReferenceCitation: Franchini M, Mannucci PM. Gastrointestinal angiodysplasia and bleeding in von Willebrand disease. Thromb Haemost. 2014 Sep 2;112(3):427-31. doi: 10.1160/TH13-11-0952. Epub 2014 Jun 5. Review.

ReferenceCitation: Randi AM, Laffan MA, Starke RD. Von Willebrand factor, angiodysplasia and angiogenesis. Mediterr J Hematol Infect Dis. 2013 Sep 2;5(1):e2013060. doi: 10.4084/MJHID.2013.060. Review.

ReferenceCitation: Thachil J, Hay CR, Campbell S. Tamoxifen for recurrent bleeds due to angiodysplasia in von Willebrand's disease. Haemophilia. 2013 Sep;19(5):e313-5. doi: 10.1111/hae.12196. Epub 2013 Jun 4.

ReferenceCitation: Castaman G, Federici AB, Tosetto A, La Marca S, Stufano F, Mannucci PM, Rodeghiero F. Different bleeding risk in type 2A and 2M von Willebrand disease: a 2-year prospective study in 107 patients. J Thromb Haemost. 2012 Apr;10(4):632-8. doi: 10.1111/j.1538-7836.2012.04661.x.

ReferenceCitation: Starke RD, Ferraro F, Paschalaki KE, Dryden NH, McKinnon TA, Sutton RE, Payne EM, Haskard DO, Hughes AD, Cutler DF, Laffan MA, Randi AM. Endothelial von Willebrand factor regulates angiogenesis. Blood. 2011 Jan 20;117(3):1071-80. doi: 10.1182/blood-2010-01-264507. Epub 2010 Nov 3.

ReferenceCitation: Veyradier A, Balian A, Wolf M, Giraud V, Montembault S, Obert B, Dagher I, Chaput JC, Meyer D, Naveau S. Abnormal von Willebrand factor in bleeding angiodysplasias of the digestive tract. Gastroenterology. 2001 Feb;120(2):346-53.

ReferenceCitation: Bowers M, McNulty O, Mayne E. Octreotide in the treatment of gastrointestinal bleeding caused by angiodysplasia in two patients with von Willebrand's disease. Br J Haematol. 2000 Mar;108(3):524-7.

ReferenceCitation: Van Belle E, Rauch A, Vincent F, Robin E, Kibler M, Labreuche J, Jeanpierre E, Levade M, Hurt C, Rousse N, Dally JB, Debry N, Dallongeville J, Vincentelli A, Delhaye C, Auffray JL, Juthier F, Schurtz G, Lemesle G, Caspar T, Morel O, Dumonteil N, Duhamel A, Paris C, Dupont-Prado A, Legendre P, Mouquet F, Marchant B, Hermoire S, Corseaux D, Moussa K, Manchuelle A, Bauchart JJ, Loobuyck V, Caron C, Zawadzki C, Leroy F, Bodart JC, Staels B, Goudemand J, Lenting PJ, Susen S. Von Willebrand Factor Multimers during Transcatheter Aortic-Valve Replacement. N Engl J Med. 2016 Jul 28;375(4):335-44. doi: 10.1056/NEJMoa1505643.

ReferenceCitation: Susen S, Rauch A, Van Belle E, Vincentelli A, Lenting PJ. Circulatory support devices: fundamental aspects and clinical management of bleeding and thrombosis. J Thromb Haemost. 2015 Oct;13(10):1757-67. doi: 10.1111/jth.13120. Epub 2015 Sep 25. Review.

ReferenceCitation: Blatchford O, Murray WR, Blatchford M. A risk score to predict need for treatment for upper-gastrointestinal haemorrhage. Lancet. 2000 Oct 14;356(9238):1318-21.

ReferenceCitation: Gerson LB, Fidler JL, Cave DR, Leighton JA. ACG Clinical Guideline: Diagnosis and Management of Small Bowel Bleeding. Am J Gastroenterol. 2015 Sep;110(9):1265-87; quiz 1288. doi: 10.1038/ajg.2015.246. Epub 2015 Aug 25.

ReferenceCitation: Strate LL, Gralnek IM. ACG Clinical Guideline: Management of Patients With Acute Lower Gastrointestinal Bleeding. Am J Gastroenterol. 2016 Apr;111(4):459-74. doi: 10.1038/ajg.2016.41. Epub 2016 Mar 1. Erratum in: Am J Gastroenterol. 2016 May;111(5):755.

ReferenceCitation: Jackson CS, Gerson LB. Management of gastrointestinal angiodysplastic lesions (GIADs): a systematic review and meta-analysis. Am J Gastroenterol. 2014 Apr;109(4):474-83; quiz 484. doi: 10.1038/ajg.2014.19. Epub 2014 Mar 18. Review.

ReferenceCitation: Martin-Grace J, Tamagno G. Somatostatin analogs in the medical management of occult bleeding of the lower digestive tract. Gastroenterol Res Pract. 2015;2015:702921. doi: 10.1155/2015/702921. Epub 2015 Mar 9. Review.

ReferenceCitation: Holleran G, Hall B, Breslin N, McNamara D. Long-acting somatostatin analogues provide significant beneficial effect in patients with refractory small bowel angiodysplasia: Results from a proof of concept open label mono-centre trial. United European Gastroenterol J. 2016 Feb;4(1):70-6. doi: 10.1177/2050640614559121. Epub 2015 Nov 5.

location_country:
Spain
Italy
United Kingdom
Iran, Islamic Republic of
Netherlands
Finland
Sweden
Hungary
France
Germany

location_facility: Ahvaz Jundishpur University of Medical Sciences - Research Center for Thalassemia & Hemoglobinopathy - Division of Hematology & Oncology

location_facility: Azienda Ospedaliera Policlinico Consorziale di Bari - Unità Operativa Semplice di Emostasi e Trombosi

location_facility: Central Manchester University Hospital NHS Foundation Trust - Manchester Royal Infirmary - Manchester Royal Eye Hospital

location_facility: Seid-ol-Shohada Hospital - Hemophilia Center - Esfahan University of Medical Science

location_facility: Centre Régional de Traitement de l'Hémophilie - Laboratoire d'Hématologie

location_facility: Nemazee Hospital Hemophilia Center - Shiraz University of Medical Science

location_facility: Centro Emofilia e Trombosi - Fondazione Angelo Bianchi Bonomi - IRCCS Ospedale Ca' Granda - Dip. di Medicina Interna - Università degli Studi di Milano

location_facility: Dipartimento di Biotecnologie Cellulari ed Ematologia - Università "Sapienza" di Roma - Policlinico Umberto I

location_facility: Helsinki University Central Hospital, Department Internal Medicine, Coagulation Disorders, at Haematology and Laboratory Services

location_facility: Hospital Universitari General Vall d'Hebron - Unidad de Hemofilia

location_facility: Thrombosis Hemostasis Research Center - Vali-Asr Hospital - Emam Khmeini Complex Hospital - Tehran University of Medical Science

location_facility: Iranian Hemophilia Comprehensive Treatment Centre - Iranian Hemophilia Society

location_facility: Lund University - Centre for Thrombosis and Haemostasis - Skane University Hospital

location_facility: Mofid Comprehensive Care Centre for Children with Hemophilia - Shahid Beheshti University of Medical Science

location_facility: Leiden University Medical Center - Department of Hematology - Hemostasis and Thrombosis Center

location_facility: Dipartimento di Terapie Cellulari ed Ematologia - Centro Malattie Emorragiche e Trombotiche - Ospedale San Bortolo

location_facility: Institut d'Hématologie - Hôpital Cardiologique - University of Lille - Haematology Department

location_facility: Erasmus Medical Center - Department of Hematology

location_facility: Azienda Ospedaliera Universitaria Careggi - Agenzia per l'Emofilia - Centro di Riferimento Coagulopatie Congenite

location_facility: Hemophilia- Thalassaemia Center of Mashhad (Sarvar Clinic) - Mashad University of Medical Science

location_facility: St. Istvan & St. Laszlo Hospital of Budapest - Hematology and Stem Cell Transplantation

location_facility: Complejo Hospitalario Universitario de A Coruña - Servicio de Hematología y Hemoterapia

location_facility: University Clinic Bonn - Institute of Experimental Haematology & Transfusion Medicine

location_facility: Department of Haematology, Haemostasis, Oncology and Stem Cell Transplantation - Hannover Medical School - Haemophilia Care Centre

location_facility: University Children's Hospital - Department of Pediatric Hematology and Oncology


type: EudraCT Number

title: Open Label Study to Evaluate the Pharmacokinetics of Fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects With Clostridium Difficile Infection (CDI)

acronym: PROFILE

summary:
The purpose of this study is to investigate the plasma pharmacokinetics (PK) of fidaxomicin (FDX) and primary metabolite OP-1118 in Subjects with Inflammatory Bowel Disease (IBD) and C. difficile Infection (CDI).

This study will also compare CDI clinical response to the microbiological response in terms of magnitude of reduction of C. difficile total viable count and spore count during treatment with FDX and if achieved; the time to microbial eradication; determine time to negative CDI toxin assay in stool specimens during treatment with FDX; assess the stool concentrations of FDX and metabolite OP-1118 throughout therapy; assess the length of hospital stay, readmissions and resource utilization for IBD patients receiving FDX; record the incidence and severity of Adverse Events (AEs) and document the impact of treatment on Quality of Life as measured by the changes in Short Inflammatory Bowel Disease Questionnaire (IBDQ) score.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Högenauer C, Mahida Y, Stallmach A, Marteau P, Rydzewska G, Ivashkin V, Gargalianos-Kakolyris P, Michon I, Adomakoh N, Georgopali A, Tretter R, Karas A, Reinisch W. Pharmacokinetics and safety of fidaxomicin in patients with inflammatory bowel disease and Clostridium difficile infection: an open-label Phase IIIb/IV study (PROFILE). J Antimicrob Chemother. 2018 Dec 1;73(12):3430-3441. doi: 10.1093/jac/dky368.

ipd_sharing: No

ipd_sharing_description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

lead_sponsor: Astellas Pharma Europe Ltd.

location_country:
Poland
United Kingdom
Italy
Austria
Greece
Russian Federation
France

location_facility:
Site PL48002
Site RU70001
Site GR30004
Site RU70002
Site IT39001
Site RU70003
Site AT43001
Site PL48003
Site FR33001
Site GB44002
Site IT39003
Site FR33002

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Prospective Non-therapeutic Study in Patients Diagnosed With Niemann-Pick Disease Type C in Order to Characterise the Individual Patient Disease Profile and Historic Signo-symptomatology Progression Pattern

summary:
This is a prospective non-therapeutic observational study in NP-C patients. The aim is to characterize the individual patient disease progression profile through the historical and 6 months prospective evaluation of clinical, imaging, biological(biomarkers) and quality of life data.

Patients will be offered enrollment into a Phase II/III study on arimoclomol at the end of the study.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Mengel E, Bembi B, Del Toro M, Deodato F, Gautschi M, Grunewald S, Grønborg S, Héron B, Maier EM, Roubertie A, Santra S, Tylki-Szymanska A, Day S, Symonds T, Hudgens S, Patterson MC, Guldberg C, Ingemann L, Petersen NHT, Kirkegaard T, Í Dali C. Clinical disease progression and biomarkers in Niemann-Pick disease type C: a prospective cohort study. Orphanet J Rare Dis. 2020 Nov 23;15(1):328. doi: 10.1186/s13023-020-01616-0. Erratum in: Orphanet J Rare Dis. 2021 Jun 1;16(1):246.

lead_sponsor: KemPharm Denmark A/S

location_country:
Denmark
Poland
Spain
Italy
United Kingdom
Switzerland
France
Germany

location_facility: Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia"

location_facility: University Hospital Copenhagen (Rigshospitalet)


ipd_sharing: Undecided

title: A Phase Ib/II, Open-label, Multicenter Study of Oral HDM201 in Combination With Oral LEE011 in Adult Patients With Liposarcoma

lead_sponsor: Novartis Pharmaceuticals

source: euctr

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country: Taiwan Spain Canada Singapore France Germany

summary: To determine the MTD/RP2D of the HDM201 and LEE011 combination and evaluate whether the combination is safe and has beneficial effects in patients with liposarcoma.


type: Other Identifier

title: Assessing the Severity of Metabolic-related Liver Injuries in Aging HIV-monoinfected Patients: a European Multicentre Study

acronym: ANRS ECHAM

summary: This study will allow to assess liver related injuries in HIV patients.

primary_purpose: Diagnostic

lead_sponsor: ANRS, Emerging Infectious Diseases

location_country: Germany France Belgium

location_facility: Center for HIV and Hepato-Gastroenterology

intervention_type: Procedure

lead_sponsor_type: academique


title: A Non-interventional Retrospective Study of the Current Treatment Practice in European Haemophilia Care

summary: To describe the current treatment practice during 12 months for previously treated patients diagnosed with haemophilia A or haemophilia B.

time_perspective: Retrospective

lead_sponsor: Swedish Orphan Biovitrum

location_country:
Spain
Italy
United Kingdom
Sweden
France
Belgium
Germany

location_facility: Swedish Orphan Biovitrum Investigational Site


acronym: GadaCAD 1

title: Multicenter Open-label Study to Evaluate Efficacy of Gadobutrol-enhanced Cardiac Magnetic Resonance Imaging (CMRI) for Detection of Significant Coronary Artery Disease (CAD) in Subjects With Known or Suspected CAD by a Blinded Image Analysis

lead_sponsor: Bayer

location_country:
United Kingdom
New Zealand
Switzerland
Korea, Republic of
United States
France
Germany

summary:
Participants being evaluated for suspected or known Coronary artery Disease (CAD) based on signs and/or symptoms, will be invited to participate in the study. The duration for a participant in the study may range from 2 days to 4-6 weeks. One to four visits to the study doctor will be required.

This study will investigate the diagnostic results of gadobutrol-enhanced Cardiac Magnetic Resonance Imaging (CMRI) images regarding the detection (sensitivity) and exclusion (specificity) of coronary artery disease utilizing a uniform image acquisition software. The CMR images will be tested either against the results from routine clinical Coronary Angiography (CA) or those from Computed Tomography Angiography (CTA), which is used as the standard of reference. The CA/CTA may have been performed up to 4 weeks prior to enrollment or be scheduled up to 4/6 weeks after the study.

CMRI and CA/CTA images will be collected for an independent image review (blinded read).


title: SD01 Master Study (Safety and Efficacy Study)

summary: The study is designed to confirm safety and efficacy of the SD01 ICD (implantable cardioverter-defibrillator) lead.

status: Active, not recruiting

study_completion_date_type: Anticipated

lead_sponsor: Biotronik SE & Co. KG

location_country: Latvia Hungary France Germany Czechia

location_facility: Städtisches Klinikum München Bogenhausen

location_facility: Bovas P. Stradina KUS Latvian Center of Cardiology

intervention_type: Device

status_simplified: Ongoing


title: A Phase II Randomized Study of TTField Therapy (150 kHz) Versus Supportive Care in Non-small Cell Lung Cancer Patients With 1-5 Brain Metastases Following Optimal Standard Local Treatment

summary: The study is a prospective, randomly controlled phase II trial, designed to test the efficacy, safety and neurocognitive outcomes of a medical device, the NovoTTF-100A, in the treatment of NSCLC patients with controlled systemic disease, following optimal standard local treatment for 1-5 brain metastases (BM). The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

status: Unknown status

design_allocation: Randomized

ReferenceType: background

ReferenceCitation: Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95.

ReferenceCitation: Kirson ED, Dbalý V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. Epub 2007 Jun 5.

ReferenceCitation: Kirson ED, Giladi M, Gurvich Z, Itzhaki A, Mordechovich D, Schneiderman RS, Wasserman Y, Ryffel B, Goldsher D, Palti Y. Alternating electric fields (TTFields) inhibit metastatic spread of solid tumors to the lungs. Clin Exp Metastasis. 2009;26(7):633-40. doi: 10.1007/s10585-009-9262-y. Epub 2009 Apr 23.

ReferenceCitation: Pless M, Weinberg U. Tumor treating fields: concept, evidence and future. Expert Opin Investig Drugs. 2011 Aug;20(8):1099-106. doi: 10.1517/13543784.2011.583236. Epub 2011 May 9. Review.

ReferenceCitation: Stupp R, Wong ET, Kanner AA, Steinberg D, Engelhard H, Heidecke V, Kirson ED, Taillibert S, Liebermann F, Dbalý V, Ram Z, Villano JL, Rainov N, Weinberg U, Schiff D, Kunschner L, Raizer J, Honnorat J, Sloan A, Malkin M, Landolfi JC, Payer F, Mehdorn M, Weil RJ, Pannullo SC, Westphal M, Smrcka M, Chin L, Kostron H, Hofer S, Bruce J, Cosgrove R, Paleologous N, Palti Y, Gutin PH. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012 Sep;48(14):2192-202. doi: 10.1016/j.ejca.2012.04.011. Epub 2012 May 18.

ReferenceCitation: Pless, M., et al. A Phase II Study of Tumor Treating Fields (TTFields) in Combination with Pemetrexed for Advanced Non Small Cell Lung Cancer (NSCLC). in ESMO 2010. 2010. Milan: Ann Oncol.

ReferenceCitation: Weinberg, U., et al. An Open Label Pilot Study of Tumor Treating Fields (TTFields) in Combination with Pemetrexed for Advanced Non-small Cell Lung Cancer (NSCLC). in ERS Annual Congress. 2010. Publisher: Abstract 363.

lead_sponsor: NovoCure Ltd.

location_country:
Poland
Spain
Italy
Czech Republic
France

location_facility: ICO L'Hospitalet - Hospital Duran i Reynals

location_facility: Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

intervention_type: Other

status_simplified: Unknown


title: A Phase I/II Dose Schedule Finding Study of ch14.18/CHO Continuous Infusion Combined With Subcutaneous Aldesleukin (IL-2) in Patients With Primary Refractory or Relapsed Neuroblastoma

acronym: LTI

summary: The main aim of this clinical trial is to find a way of giving ch14.18/CHO, in combination with subcutaneous aldesleukin (IL-2) and oral isotretinoin (13-cis-RA), to children and young people with primary refractory or relapsed neuroblastoma without intravenous morphine.

enrollment_type: Anticipated

lead_sponsor: St. Anna Kinderkrebsforschung

location_country:
Spain
Italy
Austria
United Kingdom
France
Israel
Germany

location_facility: Birmingham Children's Hospital NHS Foundation Trust

location_facility: Alder Hey Children's NHS Foundation Trust

location_facility: Great Ormond Street Hospital for Children NHS Foundation Trust

location_facility: University College Hospitals NHS Foundation Trust

location_facility: Schneider Children's Medical Centre of Israel

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: University Hospitals Bristol NHS Foundation Trust


title: Sidus(TM) Stem-Free Shoulder - A Multi-center, Prospective, Non-controlled Post Market Clinical Follow-up Study.

summary:
This post market clinical follow-up study is designed to confirm safety and performance of the Sidus Stem-Free Shoulder when used in hemi or total shoulder arthroplasty.

The safety of the implant will be evaluated by monitoring the frequency and incidence of all kinds of adverse events.

The performance will be determined by analyzing the implant survival, overall pain and functional performances (based on Constant & Murley score and ASES score), subject quality of life (EuroQol EQ5D) and radiographic parameters (e.g. radiolucencies, osteolysis, component migration) of study subjects who received the Sidus Stem-Free Shoulder.

The Sidus Stem-Free Shoulder is not approved for use in the US.

lead_sponsor: Zimmer Biomet

location_country:
United Kingdom
Italy
Austria
France
Germany

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Centre Hospitalier Universitaire Toulouse


primary_purpose: Other

acronym: Not applicable

title: A Phase II, Parallel Group, Randomized, Multicentre, Open Label Study to Compare the Pharmacokinetics of Tacrolimus in De Novo Pediatric Allograft Recipients Treated With an Advagraf® or Prograf® Based Immunosuppressive Regimen, Including a Long-Term Follow-Up

location_country:
Poland
United Kingdom
Italy
France
Czechia

location_facility:
Site GB43
Site FR32
Site PL71
Site FR33
Site IT52
Site GB44
Site GB46
Site CZ61
Site GB42
Site GB45

summary:
The purpose of this study is to compare how the body absorbs and processes two different formulations of the anti-rejection medication tacrolimus (Advagraf® or Prograf®) in children receiving an organ transplant, and how safe and effective they are over a longer period of time.

This study is for children less than 16 years old. No minimum age has been set, however, to be included in this study participants must able to swallow the medication capsules intact.


title: ALFApump® System Versus Large Volume Paracentesis in the Treatment of Refractory Ascites. A Multicentre Randomised Controlled Study.

summary: This is a multicentre, open, randomised, and controlled trial conducted in sixty (60) patients diagnosed with refractory or recurrent ascites. Patients will be randomised (enrolled) to either treatment arm A- implanted with the ALFApump System or treatment arm B-standard of care with evacuation large volume paracentesis. The main aims of the study are to determine the paracentesis free survival, defined as the time to the first large volume therapeutic paracentesis > 5 litres. The secondary aims are to assess non-inferiority of cirrhosis-related complications in the group of patients randomized to the ALFApump system group, as well as nutritional effects, resource utilisation, patient quality of life and survival non-inferiority.

ReferenceCitation: Stepanova M, Nader F, Bureau C, Adebayo D, Elkrief L, Valla D, Peck-Radosavljevic M, McCune A, Vargas V, Simon-Talero M, Cordoba J, Angeli P, Rossi S, MacDonald S, Capel J, Jalan R, Younossi ZM. Patients with refractory ascites treated with alfapump® system have better health-related quality of life as compared to those treated with large volume paracentesis: the results of a multicenter randomized controlled study. Qual Life Res. 2018 Jun;27(6):1513-1520. doi: 10.1007/s11136-018-1813-8. Epub 2018 Feb 19.

ReferenceCitation: Bureau C, Adebayo D, Chalret de Rieu M, Elkrief L, Valla D, Peck-Radosavljevic M, McCune A, Vargas V, Simon-Talero M, Cordoba J, Angeli P, Rosi S, MacDonald S, Malago M, Stepanova M, Younossi ZM, Trepte C, Watson R, Borisenko O, Sun S, Inhaber N, Jalan R. Alfapump® system vs. large volume paracentesis for refractory ascites: A multicenter randomized controlled study. J Hepatol. 2017 Nov;67(5):940-949. doi: 10.1016/j.jhep.2017.06.010. Epub 2017 Jun 21. Erratum in: J Hepatol. 2018 Jan 29;:. J Hepatol. 2020 Mar;72(3):595-596.

lead_sponsor: Sequana Medical N.V.

location_country:
United Kingdom
Spain
Austria
Italy
France

location_facility: Vienna General Hospital and Medical School, AKH

location_facility: Centre Hospitalier Universitaire de Toulouse


title: A Multi-center, Parallel-group, Double-blind, Placebo-controlled Single and Multiple Dose Escalation Study to Assess the Safety and Tolerability and the Pharmacokinetic Properties of SAR228810 Given as IV Infusion or as SC Injection in Patients With Mild to Moderate Alzheimer's Disease.

summary:
Primary Objective:

- To assess the safety and tolerability of escalating single and multiple doses of SAR228810 in patients with Alzheimer's disease (AD)

Secondary Objective:

- To evaluate the pharmacokinetic properties of SAR228810 after escalating single and multiple doses of SAR228810 in AD patients

lead_sponsor: Sanofi

location_country:
Sweden
France
South Africa
Netherlands
Bulgaria

location_facility:
Investigational Site Number 100001
Investigational Site Number 752001
Investigational Site Number 250002
Investigational Site Number 752002
Investigational Site Number 710001
Investigational Site Number 528001
Investigational Site Number 250001
Investigational Site Number 752003


title: Randomized Controlled Study on the Effect of the Hemodiafiltration Plasma Sodium Biofeedback System on Cardiovascular Stability in Hemodialysis Patients

acronym: AIMS

summary: Aim of the present randomized controlled multinational trial is the comparison of a novel biofeedback system on sodium profiling applied to a endogenous hemodiafiltration therapy, with the standard (no sodium profiling) hemodiafiltration technique on the intradialytic overall and cardiovascular stability.

lead_sponsor: Azienda Ospedaliera di Lecco

location_country: Spain Italy France Belgium Germany

location_facility: Dept. of Nephrology and Dialysis Centre Pasteur Vallery Radat

location_facility: UO Nefrologia Dialisi e Trapianto Policlinico S. Orsola Malpighi

location_facility: Nephrology and Dialysis Unit Ospedali Riuniti


title: Dose Escalation, Safety, Pharmacokinetic and Pharmacodynamic, First in Man Study, of SAR125844 Single Agent Administered as Slow Intravenous Infusion in Adult Patients With Advanced Malignant Solid Tumors

acronym: SARMET

summary:
Primary Objectives:

To determine the maximum tolerated dose (MTD) of SAR125844. To confirm safety profile of SAR125844 when administered as single agent at the MTD.

To evaluate the preliminary anti-tumoral effect of SAR125844 in patients with MET-gene amplified solid tumors (including sub-group of MET-amplified non-small cell lung cancer [NSCLC] patients) and in patients with Phospho-MET positive tumors without MET-gene amplification.

Secondary Objectives:

To characterize the global safety profile including cumulative toxicities. To evaluate the pharmacokinetic profile of SAR125844 in the proposed dosing schedule(s).

To assess preliminary antitumor activity in patients with measurable/evaluable disease, according to RECIST 1.1 criteria.

To explore the pharmacodynamic effects (PD) of SAR125844. To explore MET gene amplification status in Circulating Tumoral Cells (CTCs) and on tumor biopsies collected during the study, in the escalation part only.

To evaluate other pharmacodynamic biomarkers and help selection of patients who could benefit from SAR125844.

To explore MET-gene amplification status in circulating DNA.

design_allocation: Non-Randomized

ReferenceCitation: Angevin E, Spitaleri G, Rodon J, Dotti K, Isambert N, Salvagni S, Moreno V, Assadourian S, Gomez C, Harnois M, Hollebecque A, Azaro A, Hervieu A, Rihawi K, De Marinis F. A first-in-human phase I study of SAR125844, a selective MET tyrosine kinase inhibitor, in patients with advanced solid tumours with MET amplification. Eur J Cancer. 2017 Dec;87:131-139. doi: 10.1016/j.ejca.2017.10.016. Epub 2017 Nov 14.

location_country:
United States
Italy
Spain
France

location_facility:
Investigational Site Number 380002
Investigational Site Number 250002
Investigational Site Number 840001
Investigational Site Number 724001
Investigational Site Number 380004
Investigational Site Number 724003
Investigational Site Number 250001
Investigational Site Number 380001


status: Terminated

primary_purpose: Prevention

acronym: PROGRESSION

title: A Long-term, Open-label, Non-comparative Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in Paediatric Solid Allograft Recipients

location_country:
Poland
Spain
United Kingdom
France
Belgium
Germany

location_facility: Site DE31 Kliniken der Medizinischen Hoc

location_facility: Site GB13 Cent. Manchester Uni. Hospital

summary: The purpose of this study, a follow up to study FG506-CL-0403, is to see how safe and effective Modigraf® is (Part A) and to see how safe and effective it is to change your child's medication from Modigraf® to Prograf® (Part B).


title: A Phase Ib/II, Multi-center, Open-label Study to Evaluate the Efficacy of AUY922 in Combination With Trastuzumab in Patients With Locally Advanced or Metastatic HER2-positive Breast Cancer, That Has Progressed After or During at Least One Trastuzumab-containing Regimen

ReferenceType: result

ReferenceCitation: Kong A, Rea D, Ahmed S, Beck JT, López López R, Biganzoli L, Armstrong AC, Aglietta M, Alba E, Campone M, Hsu Schmitz SF, Lefebvre C, Akimov M, Lee SC. Phase 1B/2 study of the HSP90 inhibitor AUY922 plus trastuzumab in metastatic HER2-positive breast cancer patients who have progressed on trastuzumab-based regimen. Oncotarget. 2016 Jun 21;7(25):37680-37692. doi: 10.18632/oncotarget.8974.

location_country:
Spain
Italy
United Kingdom
Sweden
United States
Singapore
France
Germany

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp

summary:
The phase Ib part of the trial will assess the MTD of AUY922 in combination with Trastuzumab in patients with Trastuzumab-refractory locally advanced or metastatic HER2+. The MTD is defined as the highest drug dosage not causing in the first cycle of treatment (28 days) medically unacceptable dose limiting toxicity (DLT).

The phase II part of the trial will assess any potential effect on efficacy of adding AUY922 to Trastuzumab in patients with Trastuzumab-refractory locally advanced or metastatic HER2+ breast cancer.

Both AUY922 and Trastuzumab will be administered as a weekly IV infusion. Treatment should be continued as long as the patient does not have disease progression and tolerates the treatment. The following reasons are examples of acceptable reasons for discontinuing the study; tumor progression (by RECIST, as assessed by the investigator), unacceptable toxicity, death, or discontinuation from the study for any other reason, such as patient refusal, withdrawn consent, lost to follow-up or investigator decision.


title: SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions

summary: The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery lesions in patients (Diabetic sub-study).

lead_sponsor: Abbott Medical Devices

location_country:
Poland
Spain
Italy
Austria
Netherlands
United Kingdom
Thailand
France
Israel
Malaysia
Germany

location_facility:
Lukas Krankenhaus Neuss
Maasstad Ziekenhuis
King's College Hospital
Salzburger Landeskliniken
Wessex Cardiac Unit
Hospital Belvigte de Barcelona
Hospital Virgen de la Arrixaca
Azienda Ospedaliera S. Gdi Dio Salerno
C.H.U. - Hopital Michallon
Hospital Santa Creu I Sant Pau
Azienda Ospedaliera di Padova
Sheba Medical Center
Azienda Ospedaliera Riuniti
Herzzentrum Siegburg GmbH
Clinico San Carlos
Institute Jantung Negara
Hospital Puerta de Hierro
IRCCS Policlinico San Matteo
Ospedale Civile
General De Alicante
Herzzentrum
Medical University of Bydgoszcz
Universitätsklinikum
King Chulalongkorn Memorial Hospital
Hospital General de Valencia
CHU Lille - Hôpital Cardiologique
La Paz
Medisch Centrum Alkmaar


title: A Phase 2 Study of Ataluren (PTC124®) as an Oral Treatment for Nonsense Mutation Methylmalonic Acidemia

lead_sponsor: PTC Therapeutics

ReferenceCitation: Welch EM, Barton ER, Zhuo J, Tomizawa Y, Friesen WJ, Trifillis P, Paushkin S, Patel M, Trotta CR, Hwang S, Wilde RG, Karp G, Takasugi J, Chen G, Jones S, Ren H, Moon YC, Corson D, Turpoff AA, Campbell JA, Conn MM, Khan A, Almstead NG, Hedrick J, Mollin A, Risher N, Weetall M, Yeh S, Branstrom AA, Colacino JM, Babiak J, Ju WD, Hirawat S, Northcutt VJ, Miller LL, Spatrick P, He F, Kawana M, Feng H, Jacobson A, Peltz SW, Sweeney HL. PTC124 targets genetic disorders caused by nonsense mutations. Nature. 2007 May 3;447(7140):87-91. Epub 2007 Apr 22.

ReferenceCitation: Hirawat S, Welch EM, Elfring GL, Northcutt VJ, Paushkin S, Hwang S, Leonard EM, Almstead NG, Ju W, Peltz SW, Miller LL. Safety, tolerability, and pharmacokinetics of PTC124, a nonaminoglycoside nonsense mutation suppressor, following single- and multiple-dose administration to healthy male and female adult volunteers. J Clin Pharmacol. 2007 Apr;47(4):430-44.

location_country:
United Kingdom
Italy
Switzerland
France
Belgium
Germany

location_facility: Istituti Clinici di Perfezionamento, Milano

location_facility: University Hospital, Department of Pediatrics

location_facility: ZNA Queen Paola Child Hospital and Provincial Centre for Metabolic Disorders

summary: Methylmalonic acidemia (MMA) is a rare genetic disorder caused by mutations in the gene for mitochondrial enzyme methylmalonyl-CoA mutase (MCM) or in one of the genes for adenosylcobalamin (AdoCbl). Lack of these proteins causes toxic elevations of methylmalonic acid (MMacid) in blood, urine, and other tissues. A specific type of mutation, called a nonsense (premature stop codon) mutation, is the cause of the disease in approximately 5% to 20% of participants with mutations in the MCM gene, and approximately 20% to >50% of participants with mutations in one of the AdoCbl genes. Ataluren is an orally delivered, investigational drug that acts to overcome the effects of the premature stop codon, potentially enabling the production of functional MCM/AdoCbl. This study is a Phase 2a trial evaluating the safety and activity of ataluren in participants with MMA due to a nonsense mutation. The main purpose of this study is to understand whether ataluren can safely decrease MMacid levels.


title: Evaluation of PillCam™ Colon 2 in Visualization of the Colon

summary: Evaluate accuracy of PCCE-2 in detecting patients with colonic polyps as compared to conventional colonoscopy.

lead_sponsor: Medtronic - MITG

location_country: Spain Italy Netherlands Sweden France Belgium Germany

location_facility: Academic Medical Center University of Amsterdam

location_facility: Chef de Service dHepato-Gastro-Enterologie et dAssistance Nutritionnelle CHU Nantes


title: Radiation Therapy and Concurrent Plus Adjuvant Temsirolimus (CCI-779) Versus Chemo-Irradiation With Temozolomide in Newly Diagnosed Glioblastoma Without Methylation of the MGMT Gene Promoter - A Randomized Multicenter, Open-Label, Phase II Study.

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

location_country:
Spain
Italy
United Kingdom
Netherlands
Switzerland
France
Belgium
Germany

location_facility: Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: ICO Badalona - Hospital Germans Trias i Pujol

location_facility: Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau

location_facility: Erasmus MC - Daniel den Hoed Cancer Center

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with temsirolimus or temozolomide in treating patients with glioblastoma.

PURPOSE: This randomized phase II trial is studying giving radiation therapy together with temsirolimus to see how well it works compared with giving radiation therapy together with temozolomide in treating patients with newly diagnosed glioblastoma.


acronym: Clinical phase III trial of Treosulfan-based conditioning vs. RIC

title: Clinical Phase III Trial to Compare Treosulfan-based Conditioning Therapy With Busulfan-based Reduced-intensity Conditioning (RIC) Prior to Allogeneic Haematopoietic Stem Cell Transplantation in Patients With AML or MDS Considered Ineligible to Standard Conditioning Regimens

lead_sponsor: medac GmbH

ReferenceCitation: Beelen DW, Trenschel R, Stelljes M, Groth C, Masszi T, Reményi P, Wagner-Drouet EM, Hauptrock B, Dreger P, Luft T, Bethge W, Vogel W, Ciceri F, Peccatori J, Stölzel F, Schetelig J, Junghanß C, Grosse-Thie C, Michallet M, Labussiere-Wallet H, Schaefer-Eckart K, Dressler S, Grigoleit GU, Mielke S, Scheid C, Holtick U, Patriarca F, Medeot M, Rambaldi A, Micò MC, Niederwieser D, Franke GN, Hilgendorf I, Winkelmann NR, Russo D, Socié G, Peffault de Latour R, Holler E, Wolff D, Glass B, Casper J, Wulf G, Menzel H, Basara N, Bieniaszewska M, Stuhler G, Verbeek M, Grass S, Iori AP, Finke J, Benedetti F, Pichlmeier U, Hemmelmann C, Tribanek M, Klein A, Mylius HA, Baumgart J, Dzierzak-Mietla M, Markiewicz M. Treosulfan or busulfan plus fludarabine as conditioning treatment before allogeneic haemopoietic stem cell transplantation for older patients with acute myeloid leukaemia or myelodysplastic syndrome (MC-FludT.14/L): a randomised, non-inferiority, phase 3 trial. Lancet Haematol. 2020 Jan;7(1):e28-e39. doi: 10.1016/S2352-3026(19)30157-7. Epub 2019 Oct 9.

location_country: Poland Italy Finland Hungary France Germany

location_facility: Helsinki University Central Hospital, Dept. of Medicine

location_facility: Johannes-Gutenberg-Universität Mainz, III. Medizinische Klinik

location_facility: Universitätsklinikum Carl Gustav Carus Dresden, Med. Klinik I

location_facility: Universitätsklinikum Leipzig, Haematologie, internistische Onkologie

location_facility: Klinikum Nürnberg, 5. Medizinische Klinik

location_facility: Policlinico GB Rossi (Borgo Roma), Div. di Ematologia

location_facility: St. Istvan and St. Laszlo Hospital of Budapest

location_facility: Clinica Ematologica ed Unita di Terapie Cellulari 'Carlo Melzi'

location_facility: Malteser Krankenhaus St. Franziskus-Hospital

location_facility: Klinikum Rechts der Isar der TU München, III. Med. Klinik

location_facility: Universitätsmedizin Goettingen, Haematolgie und Onkologie

summary: This randomized allogeneic transplantation protocol compares i.v. Treosulfan-based conditioning therapy with reduced intensity i.v. Busulfan-based conditioning in adult AML and MDS patients at increased risk for standard conditioning therapies. The protocol is based on results of previous phase I/II trials evaluating Treosulfan/Fludarabine conditioning prior to allogeneic haematopoietic stem cell transplantation. The reference arm (reduced intensity i.v. Busulfan/Fludarabine) is considered to be accepted medical practice for the study patient population.


title: Efficacy And Safety Of Eraxis/Ecalta (Anidulafungin) Compared To Cancidas (Caspofungin) In Neutropenic Patients With Invasive Candida Infection

summary: The purpose of this study is to gather information on the use of anidulafungin for the treatment of Candida infection in patients with an abnormal immune system. It is expected that anidulafungin will be at least as safe and as effective as the comparator drug, caspofungin.

ReferenceCitation: De Rosa FG, Busca A, Capparella MR, Yan JL, Aram JA. Invasive Candidiasis in Patients with Solid Tumors Treated with Anidulafungin: A Post Hoc Analysis of Efficacy and Safety of Six Pooled Studies. Clin Drug Investig. 2021 Jun;41(6):539-548. doi: 10.1007/s40261-021-01024-7. Epub 2021 Apr 23.

ReferenceCitation: Kontoyiannis DP, Bassetti M, Nucci M, Capparella MR, Yan JL, Aram J, Hogan PA. Anidulafungin for the treatment of candidaemia caused by Candida parapsilosis: Analysis of pooled data from six prospective clinical studies. Mycoses. 2017 Oct;60(10):663-667. doi: 10.1111/myc.12641. Epub 2017 Jun 9.

ReferenceCitation: Kullberg BJ, Vasquez J, Mootsikapun P, Nucci M, Paiva JA, Garbino J, Yan JL, Aram J, Capparella MR, Conte U, Schlamm H, Swanson R, Herbrecht R. Efficacy of anidulafungin in 539 patients with invasive candidiasis: a patient-level pooled analysis of six clinical trials. J Antimicrob Chemother. 2017 Aug 1;72(8):2368-2377. doi: 10.1093/jac/dkx116.

lead_sponsor: Pfizer

location_country:
Poland
Bosnia and Herzegovina
Italy
Russian Federation
France
Slovakia


title: Randomized Phase III Intergroup Trial in Resected Stage 2 (Dukes B) Colon Cancer: 6-Month Infusional 5FU-CPT11 (+/- Folinic Acid) Versus Observation - Determination of Biologic Predictive and Response Factors

summary:
RATIONALE: Drugs used in chemotherapy, such as irinotecan, leucovorin, and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known whether combination chemotherapy is more effective than observation alone in treating patients who have undergone surgery for colon cancer.

PURPOSE: This randomized phase III trial is studying irinotecan and fluorouracil with or without leucovorin to see how well they work compared to observation alone in treating patients who have undergone surgery for stage II colon cancer.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_country: Portugal Spain Italy France Germany Egypt

location_facility: Instituto Portugues de Oncologia Centro do Porto, S. A.

location_facility: Centre Hospitalier Universitaire Ambroise Pare - Boulogne

location_facility: Universita Degli Studi di Florence - Policlinico di Careggi


title: An International Field Study of the Reliability and Validity of the EORTC-QLQ-C30 and a Disease Specific Questionnaire Module (the EORTC OES-24) in Assessing the Quality of Life of Patients With Oesophageal Cancer

summary:
RATIONALE: Questionnaires that measure quality of life may improve the ability to plan treatment for patients who have cancer of the esophagus.

PURPOSE: This clinical trial studies quality-of-life assessments of patients with cancer of the esophagus who are receiving treatment.

ReferenceCitation: Conroy T, Etienne PL, Adenis A, Ducreux M, Paillot B, Oliveira J, Seitz JF, Francois E, Van Cutsem E, Wagener DJ, Kohser F, Daamen S, Praet M, Gorlia T, Baron B, Wils J; European Organisation for Research and Treatment of Cancer Gastrointestinal Tract Cancer Cooperative Group. Vinorelbine and cisplatin in metastatic squamous cell carcinoma of the oesophagus: response, toxicity, quality of life and survival. Ann Oncol. 2002 May;13(5):721-9.

location_country:
Spain
United Kingdom
Australia
Switzerland
Sweden
France
Norway
Germany

location_facility: Hopital Cantonal Universitaire de Geneva


title: Liver Investigation: Testing Marker Utility in Steatohepatitis (LITMUS): Assessment & Validation of Imaging Modality Performance Across the NAFLD Spectrum in a Prospectively Recruited Cohort

summary: The LITMUS Imaging Study is a prospectively recruited, observational study of patients with histologically characterised non-alcoholic fatty liver disease (NAFLD). It aims to evaluate the diagnostic performance of imaging biomarkers (ultrasound elastography and magnetic resonance biomarkers) against NAFLD histological scores in a cross-sectional analysis and the natural history of NAFLD in a longitudinal study.

status: Recruiting

lead_sponsor: University of Oxford

location_country:
Spain
Greece
Italy
United Kingdom
Finland
Switzerland
Sweden
United States
France
Germany

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Le Centre de Recherche Clinique (CRC) du CHU d'Angers

location_facility: UNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität Mainz

location_facility: Institute of Biomedicine of Sevilla (IBiS), Virgen del Rocío University Hospital

location_facility: The Newcastle Upon Tyne Hospitals Nhs Foundation Trust

location_facility: Institut ICAN - Institute of Cardiometabolism And Nutrition Hôpital de la Pitié Salpêtrière

location_facility: Department of Medical Sciences University of Torino


title: A Phase 3 Study to Evaluate the Safety and Pharmacokinetics of Berotralstat Prophylaxis in Children With Hereditary Angioedema Who Are 2 to < 12 Years of Age

acronym: APeX-P

summary: The purpose of this study is to evaluate the pharmacokinetics (PK) and safety of berotralstat to determine the appropriate weight-based dose for pediatric participants 2 to < 12 years old for prophylactic treatment to prevent attacks of hereditary angioedema (HAE).

lead_sponsor: BioCryst Pharmaceuticals

location_country:
Poland
Spain
Italy
Austria
United Kingdom
Canada
Israel
France
Romania
Germany

location_facility:
Investigative Site #2
Investigative Site #1


title: HYDROchlorothiazide to PROTECT Polycystic Kidney Disease Patients and Improve Their Quality of Life

acronym: HYDRO-PROTECT

summary:
Autosomal dominant polycystic kidney disease (ADPKD) is characterized by progressive formation of renal cysts which ultimately lead to a loss of renal function.

Tolvaptan (a V2R antagonist) is currently the only effective treatment for preserving renal function in ADPKD. However, side-effects such as polyuria limit its tolerability and thereby the therapeutic potential. This study will test whether co-administration with hydochlorothiazide can improve V2RA efficacy (slowing kidney function decline) and tolerability (quality of life) in ADPKD. Approximately 300 patients will be enrolled.

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: University Medical Center Groningen

location_country:
Spain
United Kingdom
Netherlands
United States
France
Belgium
Germany

location_facility:
Necker-Enfants Malades Hospital
University Hospital Cologne
University of Sheffield Medical School
Fundación Puigvert
University Medical Center Groningen
University Hospital Leuven
Erasmus University Medical Center
Hospital La Cavale Blanche
Haga Hospital
Addenbrooke's Hospital
Tufts Medical Center
Charité University Hospital
Amsterdam University Medical Center


title: A Phase 1b, Open-label, Single-arm, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Treatment With JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, HBeAg-negative Participants With Chronic Hepatitis B Virus Infection

acronym: OSPREY

summary: The purpose of this study is to evaluate the efficacy of the study intervention based on hepatitis B surface antigen (HBsAg) levels.

ipd_sharing: Yes

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Poland
Taiwan
Spain
Italy
United Kingdom
New Zealand
France
Belgium

location_facility: Chang Gung Memorial Hospital Linkou Branch

location_facility: Azienda Ospedaliero Universitaria Pisana

intervention_type: Biological


title: A Retrospective Observational Multicenter Study on the Management and Outcome of Patients With Systemic AL Amyloidosis in Europe

summary: This is a retrospective, observational, multicenter study to collect Real-World Evidence (RWE) data on systemic AL-AMY patients in Europe. Data from paper/electronic medical records and/or electronic databases from key reference centers in Europe will be used. Data will either be entered by the site staff in the electronic Case Report Form (eCRF) or, where feasible, transferred directly, always in accordance to local regulations.

lead_sponsor: European Myeloma Network

location_country:
Portugal
Spain
Greece
Austria
Italy
Netherlands
United Kingdom
France
Germany
Czechia

location_facility: Service de Néphrologie, Hémodialyse Et Transplantation Rénale, Hôpital Jean Bernard, Chu Poitiers

location_facility: Centre Hospitalier Universitaire de Limoges, Department of Clinical Hematology and Cell Therapy

location_facility: Servicio de Hematología, Hospital Clínic de Barcelona

location_facility: University Hospital Ostrava, Clinic of Hematooncology

location_facility: Alexandra Hospital, University of Athens School of Medicine, Department of Clinical Therapeutics

location_facility: Allgemeines Krankenhaus Der Stadt Wien (General Hopsital), Universitätsklinik Für Innere Medizin I Klinische Abteilung Für Onkologie (Clinic of Internal Medicine I), Medizinische Universität Wien

location_facility: Centro Hospitalar E Universitário São João

location_facility: University College London Medical School, Uk Royal Free Hospital

location_facility: Fundação Champalimaud, Hematology Research, Imunology - Medical School, Nova University

location_facility: University Medical Center Utrecht, Umc Utrecht, Department of Hematology

location_facility: Universität Heidelberg, Department of Internal Medicine V: Hematology, Oncology and Rheumatology

location_facility: Centro Per Lo Studio E La Cura Delle Amiloidosi Sistemiche Padiglione Forlanini


title: An Open-label Study to Provide Berotralstat Access to Subjects With Type 1 and 2 Hereditary Angioedema Who Were Previously Enrolled in Berotralstat Studies

acronym: APeX-A

summary: This is a phase 3b open-label study providing access to berotralstat for HAE patients who were previously enrolled in berotralstat studies.

location_country:
Poland
North Macedonia
Korea, Republic of
France
South Africa
Slovakia
Czechia


title: A Prospective, Open-label, Multicenter, Randomized Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Renal Allograft Recipients Aged 12 to Less Than 18 Years of Age to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Italy
United Kingdom
Netherlands
United States
France
Belgium
Germany

location_facility: University of Alabama at Birmingham - School of Medicine

summary: The purpose of this study is to evaluate the benefits and risks of conversion of existing adolescent kidney allograft recipients aged 12 to less than 18 years of age to a belatacept-based immunosuppressive regimen as compared to continuation of a calcineurin inhibitor-based regimen and their adherence to immunosuppressive medications.


title: A Prospective, Open, Non-comparative, Post-market Clinical Follow-up Investigation to Confirm Safety and Performance of Avance Solo NPWT System in Low to Moderate Exuding Acute (Traumatic Wounds and Flaps and Grafts), as Well as Subacute (e.g., Dehisced Wounds) Wounds

acronym: ASOLO-SW

summary: The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm safety and performance of Avance® Solo NPWT System in low to moderate exuding acute (traumatic wounds and flaps and grafts), as well as subacute (e.g., dehisced wounds) wounds when used in accordance with the Instructions for Use, for up to 28 days.

lead_sponsor: Molnlycke Health Care AB

location_country: Germany France Italy Belgium

location_facility: A.O.U. Citta della Salute e della Scienza di Torino - A.O.U. Molinette San Giovanni Battista


title: DiamondTemp Global Registry

summary: The DiamondTemp™ Global Registry is a prospective, global, multi-center, observational post-market registry.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

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

location_facility: John Paul II Upper Silesian Medical Centre

location_facility: Ospedale di Conegliano - S. Maria dei Battuti

location_facility: University Hospitals Coventry & Warwickshire

location_facility: Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum


title: A PROSPECTIVE, MULTI-CENTER, SINGLE-ARM, POST MARKET OBSERVATIONAL STUDY TO EVALUATE THE SAFETY AND CLINICAL PERFORMANCE OF THE ARCHIMEDES BIODEGRADABLE BILIARY AND PANCREATIC STENT

acronym: AM GI Registry

summary:
Significant experience with biodegradable materials has been reported in the orthopedic literature; in particular; biodegradable stents have been used in the endovascular and urologic epithelium. Stents are typically made from polymeric materials including Polylactic Acid (PLA), Polyglycolide (PGA), Polydioxanone (PDO), Polyethyleneglycol (PEG), Polycaprolactone (PCL), etc., which have been cleared or approved by the FDA and CE-marked as drug carriers, sutures, and bone fixatives. The material is degraded by hydrolysis in, e.g., lactic acid, which is removed from the body by normal metabolic pathways. In the field of gastroenterology, these stents were first introduced in patients with an esophageal stenosis with encouraging results, although esophageal hyperplasia was a frequently encountered complication.

For biliary applications, biodegradable stents have been evaluated in several in-vitro and animal studies that demonstrated that the stents were safe and well tolerated. These stents provided an adequate radial force and resulted in complete stricture resolution within several months. The stents did not show any signs of biliary hyperplasia or integration in the epithelium. Moreover, they seem to have a self-clearing effect on attached biofilm as the outer layer sloughs during the degradation process similarly to the exfoliation of human skin. Also, the stent could be removed from the bile duct, thus offering the possibility of extraction if necessary at various times after implantation.

In 2010, Petryl was the first to use a biodegradable stent in the human bile duct. A stent was successfully placed using percutaneous transhepatic cholangiograpy in two patients with a postsurgical intrahepatic biliary stricture. Transient cholangitis was the only complication encountered and during the two years of follow-up, the bile duct remained patent.

Later, Mauri et al. presented in 2013 and 2016 results of a 107 patient study on a polydioxanone biodegradable biliary stent. The results have been published in the Journal of the European Society of Radiology. The authors concluded that percutaneous placement of a biodegradable biliary stent is a feasible and safe strategy to treat benign biliary strictures refractory to standard bilioplasty, with promising results in the mid-term period.

Prior to this study, the ARCHIMEDES device was assessed in the ARCHIMEDES Investigational study which has completed enrolment with 53 patients included, and the results are not yet published. In this study approximately half the stents were deployed in the bile duct (53%) and half in the pancreatic duct. All 53 patients have either completed, exited, or no longer have the study device. No patient remains in the study with a stent in place during the time of the last patient follow-ups. The study concluded without any device-related SAE. Bilirubin was reduced by 25.6%, which exceeded the >20% clinical success criterion, quality of life score improved from 3.7 to 7.9, procedural success was rated 1.4 (good to excellent), and technical success was achieved in all 53 patients.

Data from the ARCHIMEDES Investigational study was used for CE Mark approval, which was obtained in June 2018.

lead_sponsor: QualiMed Innovative Medizinprodukte GmbH

location_country: Slovenia Italy Spain Finland France Israel Belgium Germany

location_facility: Endoscopy Unit, Humanitas Research Hospital

location_facility: AUSL Romagna Ospedale Morgagni - Pierantoni

location_facility: Fondazione Policlinico Universitario Agostino Gemelli


title: Stereotactic Body Radiotherapy in Addition to Standard of Care Treatment in Patients With Rare Oligometastatic Cancers (OligoRARE): a Randomized, Phase 3, Open-label Trial

acronym: OligoRARE

summary:
This is a randomized open-label multicentre Phase III superiority study of the effect of adding SBRT to the standard of care treatment on overall survival in patients with rare oligometastatic cancers.

Patients will be randomized in a 1:1 ratio between current standard of care treatment vs. standard of care treatment + SBRT to all sites of known metastatic disease.

The primary objective of this trial is to assess if the addition of stereotactic body radiotherapy (SBRT) to standard of care treatment improves overall survival (OS) as compared to standard of care treatment alone in patients with rare oligometastatic cancers.

location_country: France Italy Switzerland Belgium

location_facility: Gasthuiszusters Antwerpen - Sint-Augustinus

intervention_type: Radiation


title: A Phase III, Randomized, Controlled, Open-label, Multicenter, Global Study of Capmatinib Versus SoC Docetaxel Chemotherapy in Previously Treated Patients With EGFR wt, ALK Negative, Locally Advanced or Metastatic (Stage IIIB/IIIC or IV) NSCLC Harboring MET Exon 14 Skipping Mutation (METΔex14).

acronym: GeoMETry-III

summary: The purpose of the study is to learn whether the study drug (capmatinib) helps to control lung cancer better compared to a single agent chemotherapy (docetaxel) and whether it is safe when given to patients suffering from a particular type of lung cancer. This type of cancer is called non-small cell lung cancer (NSCLC) with certain specific genetic alterations (called mutations) of a gene called MET, within a specific part of the gene called exon 14.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Brazil
Portugal
Spain
Italy
Netherlands
Korea, Republic of
India
France
Belgium
Germany


title: A First-in-human, Two-part Clinical Study to Assess the Safety, Tolerability and Activity of IV Doses of ICT01 as Monotherapy and in Combination With a Checkpoint Inhibitor, in Patients With Advanced-stage, Relapsed/Refractory Cancer

acronym: EVICTION

summary: Part 1 will be a dose escalation study of IV ICT01 (a monoclonal antibody targeting BTN3A) as monotherapy in patients with advanced solid or hematologic tumors, followed by a cohort examining the combination of ICT01 plus pembrolizumab (Keytruda). Part 2 will be a cohort expansion into 2 solid tumor indications and one hematologic malignancy for ICT01 monotherapy, and 3 solid tumor indications for the combination of ICT01 plus pembrolizumab.

lead_sponsor: ImCheck Therapeutics

location_country:
Spain
United Kingdom
United States
France
Belgium
Germany

location_facility: University Carl Gustav Carus Clinical Trial Unit


title: A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

lead_sponsor: UCB Biopharma SRL

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

location_country:
Poland
Taiwan
United Kingdom
Greece
Georgia
Italy
Russian Federation
Ukraine
Hungary
Korea, Republic of
United States
France
Romania
Japan
Bulgaria
Moldova, Republic of

summary: The purpose of this study is to demonstrate the clinical efficacy of rozanolixizumab in maintenance treatment and assess safety and tolerability of rozanolixizumab in adult study participants with primary immune thrombocytopenia (ITP).


title: A Phase 1/2 Trial of a Novel Therapeutic Vaccine (EO2401) in Combination With Immune Check Point Blockade, for Treatment of Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma

acronym: Spencer

summary: This is a multicenter, Phase 1/2, First-In-Human study to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EO2401 in Metastatic Adrenocortical Carcinoma, or Malignant Pheochromocytoma/Paraganglioma.

lead_sponsor: Enterome

location_country:
Denmark
Spain
Italy
Netherlands
Sweden
United States
France
Germany

location_facility:
Karolinska University Hospital
Máxima Medisch Centrum
Azienda Ospedaliera Spedali Civili
Lmu Klinikum
Rigshospitalet
Universitätsklinikum Würzburg
Centre Léon Bérard
Institut Gustave Roussy
MD Anderson Cancer Center
Hospital Universitari Vall d'Hebron


title: Non-ischemic Preservation of the Donor Heart in Heart Transplantation - a Randomized, Controlled, Multicenter Trial

summary: The study intends to compare standard ischemic cold static storage (ICSS) of retrieved hearts intended to be transplanted, to non-ischemic heart preservation (NIHP) in a randomized clinical multicentre trial. The primary hypothesis is that the non-ischemic hypothermic cardioplegic preservation (NIHP) is safe and superior to ischemic cold static storage (ICSS) of donor hearts. The study will investigate the safety and superiority of the new methodology in terms of improved immediate and prolonged organ function in adult heart transplanted patients.

lead_sponsor: XVIVO Perfusion

location_country:
Spain
Italy
Austria
United Kingdom
Sweden
France
Belgium
Germany

location_facility: Institut de cardiologie, Chirurgie thoracique et cardiovasculaire La Pitié Salpetrière

location_facility: Universitätsklinik der Ruhr-Universität Bochum


title: Phase 3, Single-arm, Open-label, Multidose, Titration, Pharmacokinetic, Pharmacodynamic, and Safety Study of Etelcalcetide in Children and Adolescents ≥ 2 to < 18 Years of Age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis

summary: Assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in pediatric subjects between ≥ 2 to < 18 years of age, with chronic kidney disease (CKD) on hemodialysis

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

lead_sponsor: Amgen

location_country:
Poland
Portugal
Spain
Greece
Italy
United Kingdom
Lithuania
Hungary
France
Belgium
Germany
Czechia

location_facility: Zentrum für Kinder und Jugendmedizin des Universitätsklinikums Heidelberg

location_facility: Hospices Civils de Lyon Hopital Femme Mere Enfant

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar

location_facility: Centro Hospitalar Universitario do Porto - Hospital de Santo Antonio

location_facility: Great Ormond Street Hospital for Children

location_facility: Ippokrateio General Hospital of Thessaloniki

location_facility: General Children Hospital Panagioti and Aglaias Kyriakou

location_facility: Uniwersytecki Szpital Dzieciecy w Krakowie

location_facility: Childrens Hospital, Affiliate of Vilnius University Hospital Santaros Klinikos


acronym: ILLUMINATE-B

title: ILLUMINATE-B: An Open-Label Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Lumasiran in Infants and Young Children With Primary Hyperoxaluria Type 1

lead_sponsor: Alnylam Pharmaceuticals

ReferenceCitation: Hayes W, Sas DJ, Magen D, Shasha-Lavsky H, Michael M, Sellier-Leclerc AL, Hogan J, Ngo T, Sweetser MT, Gansner JM, McGregor TL, Frishberg Y. Efficacy and safety of lumasiran for infants and young children with primary hyperoxaluria type 1: 12-month analysis of the phase 3 ILLUMINATE-B trial. Pediatr Nephrol. 2022 Aug 1. doi: 10.1007/s00467-022-05684-1. [Epub ahead of print]

ReferenceCitation: Sas DJ, Magen D, Hayes W, Shasha-Lavsky H, Michael M, Schulte I, Sellier-Leclerc AL, Lu J, Seddighzadeh A, Habtemariam B, McGregor TL, Fujita KP, Frishberg Y; ILLUMINATE-B Workgroup. Phase 3 trial of lumasiran for primary hyperoxaluria type 1: A new RNAi therapeutic in infants and young children. Genet Med. 2022 Mar;24(3):654-662. doi: 10.1016/j.gim.2021.10.024. Epub 2021 Dec 8.

location_country:
United Kingdom
United States
Israel
France
Germany

summary: The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of lumasiran in infants and young children with confirmed primary hyperoxaluria type 1 (PH1).


title: Phase II Multicenter Randomized Two-arm Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Pretreated Adult Patients With EGFR Wild-type ALK Rearrangement Negative Advanced/Metastatic Non-small Cell Lung Cancer

location_country:
Spain
United States
France
Israel
Belgium
Germany

location_facility:
Highlands Oncology Group
Novartis Investigative Site

summary: The purpose of this trial was to evaluate the safety and efficacy of capmatinib in combination with spartalizumab in adult participants with epidermal growth factor receptor (EGFR) wild type (for exon 19 deletions and exon 21 L858R substitution mutations), anaplastic lymphoma kinase (ALK) rearrangement negative in locally advanced (stage IIIB, not eligible for definitive chemo-radiation) or metastatic (stage IV) Non-small cell lung cancer (NSCLC) after failure of platinum doublet and checkpoint inhibitor treatment.


type: Other Grant/Funding Number

title: Paraplegia Prevention in Aortic Aneurysm Repair by Thoracoabdominal Staging With 'Minimally-Invasive Segmental Artery Coil-Embolization': A Randomized Controlled Multicentre Trial - PAPAartis

acronym: PAPAartis

summary:
Aortic aneurysms represent the most common and dangerous aortic diseases. Although conventional aortic repair techniques cure the disease, there is a high risk of paraplegia particularly in extensive thoracoabdominal aneurysms due to impaired blood supply to the spinal cord.

The PAPA-ARTiS trial will assess the clinical safety and efficacy of the MISACE (Minimally-Invasive Segmental Artery Coil-Embolization) procedure, a novel therapeutic concept to reduce the risk of paraplegia due to aneurysm repair.

The study investigates the MISACE procedure as a potential pre-treatment prior to open or endovascular aneurysm repair in patients with thoracoabdominal aortic aneurysms. Patients will be randomized to one of the two treatment strategies: a) aneurysm repair without MISACE pre-treatment, or b) aneurysm repair with MISACE pre-treatment.

ReferenceCitation: Petroff D, Czerny M, Kölbel T, Melissano G, Lonn L, Haunschild J, von Aspern K, Neuhaus P, Pelz J, Epstein DM, Romo-Avilés N, Piotrowski K, Etz CD. Paraplegia prevention in aortic aneurysm repair by thoracoabdominal staging with 'minimally invasive staged segmental artery coil embolisation' (MIS²ACE): trial protocol for a randomised controlled multicentre trial. BMJ Open. 2019 Mar 4;9(3):e025488. doi: 10.1136/bmjopen-2018-025488.

lead_sponsor: University of Leipzig

location_country:
Poland
United Kingdom
Italy
Austria
Netherlands
Switzerland
Sweden
France
Germany

location_facility: Paracelsus Universität - Klinikum Nürnberg

location_facility: Westdeutsches Herz und Gefäßzentrum Essen

location_facility: Universitäts-Herzzentrum Freiburg/ Bad Krozingen