title: Follicular Lymphoma Outcomes in Relapsed/Refractory Patients Treated With Systemic Therapy in a Real-World Assessment (FLORA)

acronym: FLORA

summary:
Primary Objective:

To evaluate objective response rate (ORR) in adult patients with relapsed/refractory follicular lymphoma (r/r FL) grade 1-3a who are treated with currently available therapies in the real-world setting according to Lugano classification (Cheson, 2014) of malignant lymphoma and as assessed by independent central review.

Secondary Objectives:

To evaluate the following outcomes in adult patients with r/r FL grade 1-3a who are treated with currently available systemic therapies in the real-world setting:

Objective response rate (ORR) according to the Lugano classification and as assessed by treating physician evaluation

Complete response (CR) rate according to the Lugano classification and as assessed by:

Independent central review, and
Treating physician evaluation

Progression-free survival (PFS) according to the Lugano classification and as assessed by:

Independent central review, and
Treating physician evaluation
Overall survival (OS)

Duration of response (DOR) according to the Lugano classification and as assessed by:

Independent central review, and
Treating physician evaluation

Disease control rate (DCR) according to the Lugano classification and as assessed by:

Independent central review, and
Treating physician evaluation
Time to next treatment (TTNT)
Histological transformation (HT)


ipd_sharing: No

status: Recruiting

primary_purpose: Treatment

intervention_type: Drug

title: A Randomized, Open-Label, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral BCX9930 Monotherapy for the Treatment of PNH in Subjects With Inadequate Response to C5 Inhibitor Therapy

study_completion_date_type: Anticipated

lead_sponsor: BioCryst Pharmaceuticals

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

enrollment_type: Anticipated

location_country:
Taiwan
Spain
Italy
United Kingdom
Hungary
United States
France

summary: The purpose of this study is to determine the efficacy and safety of BCX9930 monotherapy for the treatment of PNH compared to continued C5 inhibitor therapy in adult PNH patients with residual anemia despite treatment with a C5 inhibitor.

lead_sponsor_type: industriel

status_simplified: Ongoing


ipd_sharing: Yes

acronym: cASPerCF

title: Prospective Validation and Clinical Evaluation of a New Posaconazole Dosing Regimen for Children and Adolescents With Cystic Fibrosis and Aspergillus Infection

lead_sponsor: Bambino Gesù Hospital and Research Institute

ReferenceType: background

ReferenceCitation: Armstead J, Morris J, Denning DW. Multi-country estimate of different manifestations of aspergillosis in cystic fibrosis. PLoS One. 2014 Jun 10;9(6):e98502. doi: 10.1371/journal.pone.0098502. eCollection 2014.

ReferenceCitation: Rowbotham NJ, Smith S, Prayle AP, Robinson KA, Smyth AR. Gaps in the evidence for treatment decisions in cystic fibrosis: a systematic review. Thorax. 2019 Mar;74(3):229-236. doi: 10.1136/thoraxjnl-2017-210858. Epub 2018 Oct 9.

ReferenceCitation: Boyle M, Moore JE, Whitehouse JL, Bilton D, Downey DG. The diagnosis and management of respiratory tract fungal infection in cystic fibrosis: A UK survey of current practice. Med Mycol. 2019 Feb 1;57(2):155-160. doi: 10.1093/mmy/myy014.

ReferenceCitation: Welzen ME, Brüggemann RJ, Van Den Berg JM, Voogt HW, Gilissen JH, Pajkrt D, Klein N, Burger DM, Warris A. A twice daily posaconazole dosing algorithm for children with chronic granulomatous disease. Pediatr Infect Dis J. 2011 Sep;30(9):794-7. doi: 10.1097/INF.0b013e3182195808.

ReferenceCitation: Groll AH, Abdel-Azim H, Lehrnbecher T, Steinbach WJ, Paschke A, Mangin E, Winchell GA, Waskin H, Bruno CJ. Pharmacokinetics and safety of posaconazole intravenous solution and powder for oral suspension in children with neutropenia: an open-label, sequential dose-escalation trial. Int J Antimicrob Agents. 2020 Sep;56(3):106084. doi: 10.1016/j.ijantimicag.2020.106084. Epub 2020 Jul 17.

ReferenceCitation: King J, Brunel SF, Warris A. Aspergillus infections in cystic fibrosis. J Infect. 2016 Jul 5;72 Suppl:S50-5. doi: 10.1016/j.jinf.2016.04.022. Epub 2016 May 11.

ReferenceCitation: Periselneris J, Nwankwo L, Schelenz S, Shah A, Armstrong-James D. Posaconazole for the treatment of allergic bronchopulmonary aspergillosis in patients with cystic fibrosis. J Antimicrob Chemother. 2019 Jun 1;74(6):1701-1703. doi: 10.1093/jac/dkz075.

ReferenceCitation: Dolton MJ, Bruggemann RJ, Burger DM, McLachlan AJ. Understanding variability in posaconazole exposure using an integrated population pharmacokinetic analysis. Antimicrob Agents Chemother. 2014 Nov;58(11):6879-85. doi: 10.1128/AAC.03777-14. Epub 2014 Sep 8.

ReferenceCitation: Castellani C, Duff AJA, Bell SC, Heijerman HGM, Munck A, Ratjen F, Sermet-Gaudelus I, Southern KW, Barben J, Flume PA, Hodková P, Kashirskaya N, Kirszenbaum MN, Madge S, Oxley H, Plant B, Schwarzenberg SJ, Smyth AR, Taccetti G, Wagner TOF, Wolfe SP, Drevinek P. ECFS best practice guidelines: the 2018 revision. J Cyst Fibros. 2018 Mar;17(2):153-178. doi: 10.1016/j.jcf.2018.02.006. Epub 2018 Mar 3. Review.

ReferenceCitation: Patel D, Popple S, Claydon A, Modha DE, Gaillard EA. Posaconazole therapy in children with cystic fibrosis and Aspergillus-related lung disease. Med Mycol. 2020 Jan 1;58(1):11-21. doi: 10.1093/mmy/myz015.

ReferenceCitation: Krishna G, Ma L, Martinho M, Preston RA, O'Mara E. A new solid oral tablet formulation of posaconazole: a randomized clinical trial to investigate rising single- and multiple-dose pharmacokinetics and safety in healthy volunteers. J Antimicrob Chemother. 2012 Nov;67(11):2725-30. doi: 10.1093/jac/dks268. Epub 2012 Jul 24.

ReferenceCitation: Tragiannidis A, Herbruggen H, Ahlmann M, Vasileiou E, Gastine S, Thorer H, Frohlich B, Muller C, Groll AH. Plasma exposures following posaconazole delayed-release tablets in immunocompromised children and adolescents. J Antimicrob Chemother. 2019 Dec 1;74(12):3573-3578. doi: 10.1093/jac/dkz359.

ipd_sharing_description: All IPD that underlie results in a publication

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

location_facility: Universitätsklinikum Essen,Pediatric Pulmonology and Cystic Fibrosis Center

location_facility: Centre hospitalier universitaire Dijon Bourgogne

location_facility: Hospital Universitario Materno Infantil Reina Sofia

location_facility: Birmingham Women's and Children's NHS Foundation Trust

location_facility: University Hospital Nottingham (Queens Medical Centre)

location_facility: Sheffield Childrens NHS Foundation Trust

location_facility: Cystic Fibrosis Center, 3rd Paediatric Dept, Aristotle University of Thessaloniki

location_facility: Universitätsklinikum Jena, Klinik für Kinder- und Jugendmedizin, Pädiatrische Pneumologie/Allergologie/Mukoviszidose-Zentrum

location_facility: Centre hospitalier universitaire de Montpellier

location_facility: Katholisches Klinikum Bochum gGMBH, Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum, St. Josef Hospital

location_facility: Medizinische Hochschule Hannover, Klinik für Pädiatrische Pneumologie, Allergologie und Neonatologie

location_facility: University Hospitals of North Midlands NHS Trust

location_facility: Centre hospitalier universitaire Grenoble Alpes

location_facility: University Medical Center Utrecht (UMCU)

location_facility: Technische Universität Dresden, Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinder- und Jugendmedizin

location_facility: Cystic Fibrosis Department, "Agia Sofia" Children's Hospital

location_facility: Hospital Universitario 12 de Octubre,Unidad Multidisciplinar Fibrosis Quística

location_facility: ASST Spedali Civili Paediatric department

location_facility: University Medical Center Groningen (UMCG)

location_facility: Radboud University Medical Center (RUMC)

location_facility: Centro Hospitalar Universitário Lisboa Norte EPE

location_facility: University of Parma Department of Medicine and Surgery

summary: This study will provide: (1) new insights in the prevalence of Aspergillus infection in children and adolescents with CF aged 8-17 yrs; (2) an in silico modelled dose of posaconazole for children and adolescents with CF and Aspergillus infection aged 8-17 yrs; (3) an intensive sampling PK study to define the optimal dose in a limited number of children and adolescents with CF and Aspergillus infection aged 8-17 yrs; (4) a prospective clinical validation to reduce the residual variability and to allow investigation into PK-PD; and (5) an efficacy evaluation of this dosing regimen to treat Aspergillus infection in children and adolescents with CF to inform future primary efficacy trials.

lead_sponsor_type: academique


title: A Randomised, Double-Blind, Vehicle-Controlled Phase 2 Study of Topically Applied INM-755 (Cannabinol) Cream in Patients With Epidermolysis Bullosa

summary: The purpose of this study is to evaluate the safety of INM-755 (cannabinol) cream and obtain preliminary evidence of efficacy in treating symptoms and healing wounds over a 28-day period in patients with epidermolysis bullosa (EB).

lead_sponsor: InMed Pharmaceuticals Inc.

location_country: Greece Austria France Israel Germany

location_facility: Andreas Syggros Hospital of Cutaneous Venereal Diseases

location_facility: Universitaetsklinik fuer Dermatologie, EB-Haus Austria


title: BoStOn SCientific Rhythm MAnagemenT REgiStry

acronym: SOCRATES

summary: SOCRATES is part of Boston Scientific's (BSC) Post-market surveillance system. The implementation of such systems is mandatory per local regulations such as the Regulation '(EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices' or short Medical Device Regulation (MDR). The SOCRATES design is therefore based on the BSC's commitment as well as external regulatory requirements to proactively and systematically gather, record and analyze relevant data on the quality, performance and safety of devices throughout their entire lifetime.

study_type: Observational

time_perspective: Other

lead_sponsor: Boston Scientific Corporation

location_country:
Spain
Greece
Italy
United Kingdom
France
Israel
Belgium
Germany

location_facility: Hospital Nuestra Señora de La Candelaria

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina

location_facility: CHRU de Brest, Hôpital de la Cavale Blanche

intervention_type: Procedure


title: Physician Initiated Trial Investigating ESAR (EVAR Plus Heli-FX EndoAnchors) and FEVAR for the Treatment of Aortic Aneurysms With Short Infrarenal Aortic Neck

summary: The aim of this randomized study is to compare the safety and performance of EndoVascular Aneurysm Repair with ESAR using Endurant + Heli-FX™ EndoAnchor™ system and FEVAR using customizable grafts from Cook (Zenith Fenestrated Graft) and Terumo (Fenestrated Anaconda Graft) for the treatment of aortic aneurysms with short aortic neck (4 to 15mm).

lead_sponsor: Prof. Giovanni Torsello

location_country: Spain Austria Netherlands France Germany

location_facility: Hospices Civils de lyon - Hôpital Edouard Herriot

location_facility: Hospital Ottakring, Institute for Vascular Surgery

location_facility: Centre Hospitalier Universitaire de Rennes

intervention_type: Device


status: Terminated

title: A Phase 2 Study to Evaluate the Safety and Tolerability of IMR-687 in Subjects With Beta Thalassemia

study_completion_date_type: Actual

lead_sponsor: Imara, Inc.

enrollment_type: Actual

location_country:
Denmark
United Kingdom
Greece
Georgia
Italy
Lebanon
Netherlands
Tunisia
France
Israel
Turkey
Malaysia
Morocco

location_facility: Manchester University NHS Foundation Trust

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Institut Universitaire du Cancer de Toulouse Oncopole

location_facility: Hospital Queen Elizabeth - Kota Kinabalu

location_facility: Amsterdam Universitair Medische Centra - Academisch Medisch Centrum

location_facility: Ippokrateio General Hospital of Thessaloniki

location_facility: Centre National de Greffe de la Moelle Osseuse

location_facility: Centre Hôpital Universitaire Farhat Hached

location_facility: Medinvest - Institute of Hematology and Transfusiology

location_facility: Azienda Ospedaliera Universitaria - Università degli Studi della Campania Luigi Vanvitelli

summary: A Study to Evaluate the Safety and Tolerability of IMR-687 in Subjects with Beta Thalassemia

status_simplified: Unknown


title: Outcomes and Prognostic Factors in Coronavirus Disease (COVID-19) in Very Old Intensive Care Patients

acronym: COVIP

summary: The primary aim is to study the short-term outcome of elderly ICU patients (≥ 70 years) suffering from COVID-19 using a multicenter and multi-national approach. The secondary aim is to investigate the properties of a simple frailty scale in this cohort, and in particular if this is an instrument that can be used for outcome prediction in this group. In addition, various other parameters of potential relevance for older critically ill patients will be studied.

time_perspective: Prospective

ReferenceCitation: Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24. Erratum in: Lancet Respir Med. 2020 Apr;8(4):e26.

ReferenceCitation: Flaatten H, de Lange DW, Artigas A, Bin D, Moreno R, Christensen S, Joynt GM, Bagshaw SM, Sprung CL, Benoit D, Soares M, Guidet B. The status of intensive care medicine research and a future agenda for very old patients in the ICU. Intensive Care Med. 2017 Sep;43(9):1319-1328. doi: 10.1007/s00134-017-4718-z. Epub 2017 Feb 25. Review.

ReferenceCitation: Flaatten H, De Lange DW, Morandi A, Andersen FH, Artigas A, Bertolini G, Boumendil A, Cecconi M, Christensen S, Faraldi L, Fjølner J, Jung C, Marsh B, Moreno R, Oeyen S, Öhman CA, Pinto BB, Soliman IW, Szczeklik W, Valentin A, Watson X, Zaferidis T, Guidet B; VIP1 study group. The impact of frailty on ICU and 30-day mortality and the level of care in very elderly patients (≥ 80 years). Intensive Care Med. 2017 Dec;43(12):1820-1828. doi: 10.1007/s00134-017-4940-8. Epub 2017 Sep 21.

ReferenceCitation: Rockwood K, Stadnyk K, MacKnight C, McDowell I, Hébert R, Hogan DB. A brief clinical instrument to classify frailty in elderly people. Lancet. 1999 Jan 16;353(9148):205-6.

ReferenceCitation: Guidet B, de Lange DW, Boumendil A, Leaver S, Watson X, Boulanger C, Szczeklik W, Artigas A, Morandi A, Andersen F, Zafeiridis T, Jung C, Moreno R, Walther S, Oeyen S, Schefold JC, Cecconi M, Marsh B, Joannidis M, Nalapko Y, Elhadi M, Fjølner J, Flaatten H; VIP2 study group. The contribution of frailty, cognition, activity of daily life and comorbidities on outcome in acutely admitted patients over 80 years in European ICUs: the VIP2 study. Intensive Care Med. 2020 Jan;46(1):57-69. doi: 10.1007/s00134-019-05853-1. Epub 2019 Nov 29.

ReferenceCitation: Katz S, Downs TD, Cash HR, Grotz RC. Progress in development of the index of ADL. Gerontologist. 1970 Spring;10(1):20-30.

ReferenceCitation: Jung C, Wernly B, Muessig JM, Kelm M, Boumendil A, Morandi A, Andersen FH, Artigas A, Bertolini G, Cecconi M, Christensen S, Faraldi L, Fjølner J, Lichtenauer M, Bruno RR, Marsh B, Moreno R, Oeyen S, Öhman CA, Pinto BB, Soliman IW, Szczeklik W, Valentin A, Watson X, Zafeiridis T, De Lange DW, Guidet B, Flaatten H; VIP1 study group. Electronic address: hans.flaatten@uib.no. A comparison of very old patients admitted to intensive care unit after acute versus elective surgery or intervention. J Crit Care. 2019 Aug;52:141-148. doi: 10.1016/j.jcrc.2019.04.020. Epub 2019 May 2.

ReferenceType: derived

ReferenceCitation: Wolff G, Wernly B, Flaatten H, Fjølner J, Bruno RR, Artigas A, Pinto BB, Schefold JC, Kelm M, Binneboessel S, Baldia P, Beil M, Sivri S, van Heerden PV, Szczeklik W, Elhadi M, Joannidis M, Oeyen S, Flamm M, Zafeiridis T, Marsh B, Andersen FH, Moreno R, Boumendil A, De Lange DW, Guidet B, Leaver S, Jung C; COVIP Study Group. Sex-specific treatment characteristics and 30-day mortality outcomes of critically ill COVID-19 patients over 70 years of age-results from the prospective COVIP study. Can J Anaesth. 2022 Nov;69(11):1390-1398. doi: 10.1007/s12630-022-02304-2. Epub 2022 Aug 9.

ReferenceCitation: Polok K, Fronczek J, Artigas A, Flaatten H, Guidet B, De Lange DW, Fjølner J, Leaver S, Beil M, Sviri S, Bruno RR, Wernly B, Bollen Pinto B, Schefold JC, Studzińska D, Joannidis M, Oeyen S, Marsh B, Andersen FH, Moreno R, Cecconi M, Jung C, Szczeklik W; COVIP Study Group. Noninvasive ventilation in COVID-19 patients aged ≥ 70 years-a prospective multicentre cohort study. Crit Care. 2022 Jul 22;26(1):224. doi: 10.1186/s13054-022-04082-1.

ReferenceCitation: Bruno RR, Wernly B, Flaatten H, Fjølner J, Artigas A, Baldia PH, Binneboessel S, Bollen Pinto B, Schefold JC, Wolff G, Kelm M, Beil M, Sviri S, van Heerden PV, Szczeklik W, Elhadi M, Joannidis M, Oeyen S, Kondili E, Marsh B, Wollborn J, Andersen FH, Moreno R, Leaver S, Boumendil A, De Lange DW, Guidet B, Jung C; COVIP study group. The association of the Activities of Daily Living and the outcome of old intensive care patients suffering from COVID-19. Ann Intensive Care. 2022 Mar 18;12(1):26. doi: 10.1186/s13613-022-00996-9.

ReferenceCitation: Bruno RR, Wernly B, Wolff G, Fjølner J, Artigas A, Bollen Pinto B, Schefold JC, Kindgen-Milles D, Baldia PH, Kelm M, Beil M, Sviri S, van Heerden PV, Szczeklik W, Topeli A, Elhadi M, Joannidis M, Oeyen S, Kondili E, Marsh B, Andersen FH, Moreno R, Leaver S, Boumendil A, De Lange DW, Guidet B, Flaatten H, Jung C; COVIP study group. Association of chronic heart failure with mortality in old intensive care patients suffering from Covid-19. ESC Heart Fail. 2022 Jun;9(3):1756-1765. doi: 10.1002/ehf2.13854. Epub 2022 Mar 10.

ReferenceCitation: Guidet B, Jung C, Flaatten H, Fjølner J, Artigas A, Pinto BB, Schefold JC, Beil M, Sigal S, van Heerden PV, Szczeklik W, Joannidis M, Oeyen S, Kondili E, Marsh B, Andersen FH, Moreno R, Cecconi M, Leaver S, De Lange DW, Boumendil A; VIP2 and COVIP study groups. Increased 30-day mortality in very old ICU patients with COVID-19 compared to patients with respiratory failure without COVID-19. Intensive Care Med. 2022 Apr;48(4):435-447. doi: 10.1007/s00134-022-06642-z. Epub 2022 Feb 26. Erratum in: Intensive Care Med. 2022 Mar 31;:.

ReferenceCitation: Jung C, Mamandipoor B, Fjølner J, Bruno RR, Wernly B, Artigas A, Bollen Pinto B, Schefold JC, Wolff G, Kelm M, Beil M, Sviri S, van Heerden PV, Szczeklik W, Czuczwar M, Elhadi M, Joannidis M, Oeyen S, Zafeiridis T, Marsh B, Andersen FH, Moreno R, Cecconi M, Leaver S, De Lange DW, Guidet B, Flaatten H, Osmani V. Disease-Course Adapting Machine Learning Prognostication Models in Elderly Patients Critically Ill With COVID-19: Multicenter Cohort Study With External Validation. JMIR Med Inform. 2022 Mar 31;10(3):e32949. doi: 10.2196/32949.

ReferenceCitation: Polok K, Fronczek J, van Heerden PV, Flaatten H, Guidet B, De Lange DW, Fjølner J, Leaver S, Beil M, Sviri S, Bruno RR, Wernly B, Artigas A, Pinto BB, Schefold JC, Studzińska D, Joannidis M, Oeyen S, Marsh B, Andersen FH, Moreno R, Cecconi M, Jung C, Szczeklik W; COVIP study group. Association between tracheostomy timing and outcomes for older critically ill COVID-19 patients: prospective observational study in European intensive care units. Br J Anaesth. 2022 Mar;128(3):482-490. doi: 10.1016/j.bja.2021.11.027. Epub 2021 Nov 29.

ReferenceCitation: Jung C, Flaatten H, de Lange D, Beil M, Guidet B. The relationship between treatment limitations and pressure on intensive care units in elderly patients. Intensive Care Med. 2022 Jan;48(1):124-125. doi: 10.1007/s00134-021-06553-5. Epub 2021 Nov 5.

ReferenceCitation: Jung C, Fjølner J, Bruno RR, Wernly B, Artigas A, Bollen Pinto B, Schefold JC, Wolff G, Kelm M, Beil M, Sviri S, van Heerden PV, Szczeklik W, Czuczwar M, Joannidis M, Oeyen S, Zafeiridis T, Andersen FH, Moreno R, Leaver S, Boumendil A, De Lange DW, Guidet B, Flaatten H; , COVIP Study Group. Differences in mortality in critically ill elderly patients during the second COVID-19 surge in Europe. Crit Care. 2021 Sep 23;25(1):344. doi: 10.1186/s13054-021-03739-7.

ReferenceCitation: Bruno RR, Wernly B, Flaatten H, Fjølner J, Artigas A, Bollen Pinto B, Schefold JC, Binnebössel S, Baldia PH, Kelm M, Beil M, Sigal S, van Heerden PV, Szczeklik W, Elhadi M, Joannidis M, Oeyen S, Zafeiridis T, Wollborn J, Arche Banzo MJ, Fuest K, Marsh B, Andersen FH, Moreno R, Leaver S, Boumendil A, De Lange DW, Guidet B, Jung C; COVIP Study Group. Lactate is associated with mortality in very old intensive care patients suffering from COVID-19: results from an international observational study of 2860 patients. Ann Intensive Care. 2021 Aug 21;11(1):128. doi: 10.1186/s13613-021-00911-8.

ReferenceCitation: Jung C, Flaatten H, Fjølner J, Bruno RR, Wernly B, Artigas A, Bollen Pinto B, Schefold JC, Wolff G, Kelm M, Beil M, Sviri S, van Heerden PV, Szczeklik W, Czuczwar M, Elhadi M, Joannidis M, Oeyen S, Zafeiridis T, Marsh B, Andersen FH, Moreno R, Cecconi M, Leaver S, Boumendil A, De Lange DW, Guidet B; COVIP study group. The impact of frailty on survival in elderly intensive care patients with COVID-19: the COVIP study. Crit Care. 2021 Apr 19;25(1):149. doi: 10.1186/s13054-021-03551-3.

ReferenceCitation: Jung C, Bruno RR, Wernly B, Joannidis M, Oeyen S, Zafeiridis T, Marsh B, Andersen FH, Moreno R, Fernandes AM, Artigas A, Pinto BB, Schefold J, Wolff G, Kelm M, De Lange DW, Guidet B, Flaatten H, Fjølner J; COVIP study group. Inhibitors of the renin-angiotensin-aldosterone system and COVID-19 in critically ill elderly patients. Eur Heart J Cardiovasc Pharmacother. 2021 Jan 16;7(1):76-77. doi: 10.1093/ehjcvp/pvaa083.

lead_sponsor: Heinrich-Heine University, Duesseldorf

location_country: Norway Denmark France Germany

location_facility: Department of Anaestesia and Intensive Care, Haukeland University Hospital

location_facility: Hôpitaux de Paris, Hôpital Saint-Antoine, service de réanimation médicale

location_facility: Department of Intensive Care, Aarhus University Hospital

location_facility: INSERM, UMR_S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique

location_facility: Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique

location_facility: Department of Clinical Medecine,University of Bergen

location_facility: Division of Cardiology, Pulmonary Disease and Vascular Medicine


title: Prospective, Multicenter Study for the Evaluation of Safety and Performance of the Interscope EndoRotor Endoscopic Mucosal Resection System for the Removal of Alimentary Tract Mucosa in the Colon

summary:
The EndoRotor® is intended for use (USA labeling) in endoscopic procedures by a trained gastroenterologist to resect and remove tissue, not intended for biopsy, of the gastrointestinal (GI) system including post-endoscopic mucosal resection (EMR) tissue persistence with a scarred base and residual tissue from the peripheral margins following EMR.

In this trial investigators will conduct a post-market, prospective, non-randomized, multi-center study for the treatment of subjects with the need for resection of recurrent flat or sessile colorectal lesions where EndoRotor is the primary resection modality of persistent adenoma with a scarred base.

status: Completed

lead_sponsor: Interscope, Inc.

location_country:
Germany
United States
Italy
France

location_facility: Università Cattolica del Sacro Cuore, Instituto di Clinica Chirurgica

location_facility: Humanitas Research Hospital & Humanitas University

location_facility: Fondazione Poliambulanza Istituto Ospedaliero

location_facility: Clinic and Polyclinic for Interdisciplinary Endoscopy University Hospital Hamburg Eppendorf

status_simplified: Completed


title: A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of ION464 Administered Intrathecally to Adults With Multiple System Atrophy

acronym: HORIZON

summary:
The primary objectives are to evaluate the safety and tolerability of multiple doses of ION464 administered via intrathecal (IT) injection (Part 1) and to evaluate the long-term safety and tolerability of ION464 (Part 2) in participants with multiple system atrophy (MSA).

The secondary objectives are to evaluate the pharmacodynamic (PD) effect of ION464 on the level of a potential biomarker of target engagement (Parts 1 and 2) and to evaluate the pharmacokinetic (PK) profile of ION464 in serum (Part 1).

lead_sponsor: Ionis Pharmaceuticals, Inc.

location_country: Austria Germany France

location_facility: Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg


title: Phase I, Open Label, Non-randomised, Non-comparative, Multi-center Study, Evaluating S65487, a Bcl-2 Inhibitor Intravenously Administered, in Patients With Relapsed or Refractory Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma or Chronic Lymphocytic Leukemia

summary: The purpose of this first in human study is to assess safety, tolerability, Pharmacokinetic (PK) and preliminary clinical activity and to estimate the Maximum Tolerated Doses (MTD(s))/ Recommended Phase 2 Doses (RP2D(s)) of S65487 as single agent administered intravenously (i.v.) in adult patients with refractory or relapsed Acute Myeloid Leukemia (AML), Non-Hodgkin Lymphoma (NHL), Multiple Myeloma (MM) or Chronic Lymphocytic Leukemia (CLL).

design_allocation: Non-Randomized

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
Australia
France
Spain
United Kingdom

location_facility: CHU de Nice - Hôpital l'Archet 1 Hématologie clinique

location_facility: Centre Hospitalier Universitaire de Lille Hôpital Huriez

location_facility: Hospital Clínico Universitario de Salamanca- Servicio de Hematología (4a planta)

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Clínica Universidad Navarra- Servicio de Hematología

location_facility: Hospital Universitario La Fe - Servicio de Hematología - Torre F - Planta 7

location_facility: The Alfred Hospital Malignant Haematology & Stem Cell Transplantation Services


title: One-arm, Multi-center, International Prospective Study to Assess the Efficacy of Medi-tate Temporary Implantable Nitinol Device (iTind) in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH)

summary:
A total of up to 200 Symptomatic BPH subjects subjects will be enrolled into the study.

Study duration will be 12 months post implantation with a follow-up visits at Year 2 and Year 3.

status: Active, not recruiting

lead_sponsor: Medi-Tate Ltd.

location_country: Spain Italy Australia Switzerland France Germany

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Sydney Adventist Hospital Clinical School of the University of Sydney


type: Other Identifier

title: Study of TG02 in Elderly Newly Diagnosed or Adult Relapsed Patients With Anaplastic Astrocytoma or Glioblastoma: A Phase Ib Study

acronym: STEAM

summary: This is a three parallel cohort, open-labeled, non-randomized, multicenter study. All three cohorts will enroll independently.

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

location_country: Austria Netherlands Switzerland France Germany

location_facility: Klinikum Der J.W. Goethe Universitaet-Klinik und Poliklinik fur Neurochirurgie

location_facility: Erasmus MC Cancer Institute - location Daniel den Hoed

location_facility: Universitaetskliniken der Uni Wien - Universitaetsklinikum Wien - AKH uniklinieken

location_facility: Universitaetskliniken Regensburg - Universitaetsklinikum Regensburg

location_facility: CHU de Lyon - CHU Lyon - Hopital neurologique Pierre Wertheimer

location_facility: Universitaetsklinikum Heidelberg - UniversitaetsKlinikum Heidelberg - Head Hospital

location_facility: Assistance Publique - Hopitaux de Marseille - Hôpital de La Timone

intervention_type: Radiation


title: A Randomised, Single-blind, Active Controlled, Multi-centre Trial to Evaluate the Efficacy, Safety, Tolerability, Acceptability and Palatability of PMF104 Compared to a Conventional PEG-electrolyte Solution in Children Aged From 2 to Less Than 6, From 6 to Less Than 12, and Adolescents From 12 to Less Than 18 Years of Age Requiring a Diagnostic Procedure Concerning the Colon

summary: A randomised, single-blind, active controlled, multi-centre trial to evaluate the efficacy, safety, tolerability, acceptability and palatability of PMF104 compared to a conventional PEG-electrolyte solution in paediatric subjects requiring a diagnostic procedure concerning the colon.

status: Unknown status

lead_sponsor: Alfasigma S.p.A.

location_country: France Italy Belgium

location_facility: Ospedale Maggiore "C.A. Pizzardi" AUSL Bologna

location_facility: University and Pediatric Hospital of Lyon

location_facility: Azienda Ospedaliera Universitaria "G. Martino"

location_facility: Pediatric Gastroenterology, Hepatology and Nutrition Children's University Hospital


title: A Phase IB Combination Study of Rucaparib (CO-338) and Atezolizumab (MPDL3280A) in Participants With Advanced Gynecologic Cancers and Triple-Negative Breast Cancer

summary: This is a Phase Ib, open-label, non-randomized study in patients with previously treated advanced ovarian or endometrial cancer (Part 1) and platinum-sensitive ovarian cancer or triple-negative breast cancer (TNBC) (Part 2) to investigate the dose, safety, pharmacokinetics, and preliminary efficacy of rucaparib in combination with atezolizumab. The study is conducted in 2 parts: a Dose-Finding Phase (Part 1) and a Dose-Expansion Phase (Part 2)

lead_sponsor: Hoffmann-La Roche

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust

location_facility: Centre Hospitalier Lyon Sud; Service d'Oncologie Médicale

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital


title: Proof-of-Performance Study of RABIOPRED Assay as an In Vitro Diagnostic Test to Identify Patients With Rheumatoid Arthritis Who Are Unlikely to Show Response to 1st Treatment With Anti-TNFα and Methotrexate Combination.

acronym: RABIOPRED

summary: RABIOPRED is an in vitro non-invasive blood test, which aims to identify patients with rheumatoid arthritis (RA) who are not likely to respond to anti-TNFα and methotrexate combination therapy.

lead_sponsor: TcLand Expression S.A.

location_country: France Turkey Israel Netherlands Czechia

location_facility:
Institute of Rheumatology
Istanbul University
University of Marmara
CHU Strasbourg Hautepierre
CHU Nice
Leiden University Medical Center
CHU-Montpellier
Tel Aviv Surasky Medical Center

intervention_type: Biological


title: A Prospective, Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon PTA Catheter for Treatment of Dysfunctional Native and Synthetic AV Fistulae

acronym: AVR

summary: The purpose of this Registry is to enroll patients presenting with clinical and hemodynamic abnormalities in native or synthetic (grafts) arteriovenous (AV) fistulae located in the arm. Subjects will be treated with the Lutonix DCB carrying the CE Mark per current IFU and followed clinically for a minimum of 12 months.

lead_sponsor: C. R. Bard

location_country:
Poland
Taiwan
Portugal
Saudi Arabia
Italy
Austria
Greece
United Kingdom
Switzerland
France
Singapore
Turkey
Germany

location_facility: NephroCare Portugal, S.A. NephroCare Lumia

location_facility: Azienda Ospedaliera Di Pisa - Ospedale Cisanello

location_facility: Klinika Chirurgii Naczyniowej University Hospital nr 1

location_facility: King Abdullah International Medical Research Center


title: Double Blind, Multicentre, Randomized, Placebo-controlled Trial to Evaluate Safety and Efficacy of Pitolisant in Children From 6 to Less Than 18 Years With Narcolepsy With/Without Cataplexy, Followed by a Prolonged Open-label Period

lead_sponsor: Bioprojet

location_country:
Italy
Russian Federation
Finland
France
Netherlands

location_facility: I.M. Sechenov First Moscow State Medical University

location_facility: V.M. Behterev National Medical Research Psychiatry and Neurology Center

location_facility: Scientific-Research Medical Complex "Your Health"

location_facility: N.I. Balaban Crimea Repiblic Clinical Psychiatric Hospital No. 1

summary: The purpose of this multicenter double blind study is to assess efficacy and safety of Pitolisant versus placebo in paediatric Narcoleptic patients with or without cataplexy.


title: A Phase 2, Open-label, Multiple Ascending Dose Study to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Patients With Paroxysmal Nocturnal Hemoglobinuria

summary: The primary purpose of this study is to evaluate the safety, tolerability, and efficacy of multiple intravenous (IV) doses of ravulizumab administered to complement inhibitor treatment-naïve participants with PNH.

ReferenceCitation: Röth A, Rottinghaus ST, Hill A, Bachman ES, Kim JS, Schrezenmeier H, Terriou L, Urbano-Ispizua Á, Wells RA, Jang JH, Kulasekararaj AG, Szer J, Aguzzi R, Damokosh AI, Shafner L, Lee JW. Ravulizumab (ALXN1210) in patients with paroxysmal nocturnal hemoglobinuria: results of 2 phase 1b/2 studies. Blood Adv. 2018 Sep 11;2(17):2176-2185. doi: 10.1182/bloodadvances.2018020644.

lead_sponsor: Alexion Pharmaceuticals

location_country:
Taiwan
Spain
United Kingdom
Canada
Korea, Republic of
France
Germany


title: A Clinical Study of the CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System (Transapical Delivery System)

summary:
The purpose of the study is to evaluate the initial short and long-term safety and performance of the CardiAQ™ Transcatheter Mitral Valve Implantation System using the Transapical Delivery System.

The study will enroll patients with moderate to severe mitral valve regurgitation who are considered high or extreme risk for mortality and morbidity from conventional open heart surgery.

lead_sponsor: Edwards Lifesciences

location_country:
Denmark
France
Netherlands
United Kingdom

location_facility: Centre hospitalier régional universitaire de Lille

location_facility: Centre Hospitalier Universiatier de Toulouse


primary_purpose: Diagnostic

title: DOTAREM® Pharmacokinetics, Safety and Efficacy Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive)

lead_sponsor: Guerbet

location_country: Austria Poland France Hungary

location_facility: Instytut Pomnik -Centrum Zdrowia Dziecka

location_facility: Borsod-Abaúj-Zemplén University County Hospital

location_facility: Uniwersytecki Szpital Dziecięcy w Lublinie

location_facility: Department of Molecular and Neurological Clinical and Research Center

summary:
The main purpose of the study is to evaluate the pharmacokinetics of DOTAREM® in the body of children aged less than 2 years thanks to several blood samples (3 ml in total) taken following the administration of DOTAREM®.

DOTAREM® is a contrast agent commonly used for enhancement of Magnetic Resonance Imaging (MRI) to potentially improve the quality of the images and help the diagnosis. Children aged less than 2 years scheduled to undergo routine gadolinium-enhanced MRI of any body region may take part in the study. In this case they will receive DOTAREM®, a solution injected at the standard dose of 0.2mL/kg (0.1 mmol/kg) of body weight.


title: Benefit of Dual-chamber Pacing With Closed Loop Stimulation (CLS) in Tilt-induced Cardioinhibitory Reflex Syncope. A Randomized Double-blind Parallel Trial.

acronym: BIOSync CLS

summary: The purpose of this study is to assess whether the Closed Loop Stimulation (CLS) in addition to the DDD pacing is effective in reducing syncopal recurrences. The study hypothesis is that DDD pacing with CLS stimulation is able to prevent syncopal recurrences completely or partially by transforming syncope in pre-syncope.

ReferenceCitation: Brignole M, Russo V, Arabia F, Oliveira M, Pedrote A, Aerts A, Rapacciuolo A, Boveda S, Deharo JC, Maglia G, Nigro G, Giacopelli D, Gargaro A, Tomaino M; BioSync CLS trial Investigators. Cardiac pacing in severe recurrent reflex syncope and tilt-induced asystole. Eur Heart J. 2021 Feb 1;42(5):508-516. doi: 10.1093/eurheartj/ehaa936.

ReferenceCitation: Brignole M, Tomaino M, Aerts A, Ammirati F, Ayala-Paredes FA, Deharo JC, Del Rosso A, Hamdan MH, Lunati M, Moya A, Gargaro A; BIOSync Study Steering Committee. Benefit of dual-chamber pacing with Closed Loop Stimulation in tilt-induced cardio-inhibitory reflex syncope (BIOSync trial): study protocol for a randomized controlled trial. Trials. 2017 May 4;18(1):208. doi: 10.1186/s13063-017-1941-4. Erratum in: Trials. 2017 Jun 8;18(1):269.

lead_sponsor: Biotronik SE & Co. KG

location_country: Portugal Spain Italy Canada France Netherlands

location_facility: A.O. Dei Colli - Monaldi - University of Campania "Luigi Vanvitelli"

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Hospital Universitario Nuestra Senora de la Candelaria

location_facility: Azienda Ospedaliera Pia Fondazione di Culto e Religione Cardinale G. Panico


title: Prospective, Randomized, Multicentre Clinical Study of the Hemoteq Ranger™ Paclitaxel-Coated PTA Balloon Catheter (Ranger DCB) in Comparison to Uncoated PTA Balloons in Femoropopliteal Lesions

acronym: RANGER-SFA

summary: The primary objective of this study is to prove the superior performance of the Ranger™ paclitaxel-coated PTA balloon catheter for angioplasty for femoropopliteal artery lesions when compared to non-coated balloons at six months post-procedure when comparing Late Lumen Loss (LLL). Study statistical hypothesis: The %-mean loss of luminal diameter as assessed by angiography at six months follow-up after treatment of the femoropopliteal artery with Ranger DCB study devices is lower than the %-mean loss of luminal diameter after treatment with uncoated PTA balloon control devices.

ReferenceCitation: Bausback Y, Willfort-Ehringer A, Sievert H, Geist V, Lichtenberg M, Del Giudice C, Sauguet A, Diaz-Cartelle J, Marx C, Ströbel A, Schult I, Scheinert D; RANGER SFA Investigators. Six-Month Results From the Initial Randomized Study of the Ranger Paclitaxel-Coated Balloon in the Femoropopliteal Segment. J Endovasc Ther. 2017 Aug;24(4):459-467. doi: 10.1177/1526602817710770. Epub 2017 May 31.

lead_sponsor: Hemoteq AG

location_facility: Hopital Europeen Georges-Pompidou (HEGP)


title: Minitub: Prospective Registry of Sentinel Node (SN) Positive Melanoma Patients With Minimal SN Tumor Burden Who Undergo Completion Lymph Node Dissection (CLND) or Nodal Observation

acronym: Minitub

summary:
The purpose of this registry is to collect data in order to discover whether melanoma patients with minimal SN tumor burden should undergo a complete lymph node dissection (CLND) or not.

Currently, if a patient has a positive (or metastatic) SN, this patient will be offered a CLND, which is a surgical intervention aiming to remove all lymph nodes from the same nodal basin as the SN. However, if the positive (or metastatic) SN is only minimally involved, some centers and/or countries do not offer a CLND routinely. As a matter of fact, the CLND procedure does not increase survival for patients with a minimal SN tumor burden, but can add prognostic information, potentially useful in the subsequent decision-making process. However, this is a surgical operation for the patient, which might be accompanied by significant side effects. Moreover, only approximately 20% of patients with a metastatic SN have further lymph node metastases in the same basin, which means that about 4 patients out of 5 will not benefit from a CLND. Thus, there is an urgent need to identify which SN positive patients could be safely spared from a CLND. It has been demonstrated that breast cancer patients with minimal SN tumor burden can be safely managed with nodal observation only, without performing a CLND. There is evidence that the same situation exists in melanoma as well, but this needs to be validated and this is why we are conducting this registry.

The results of this registry will be crucial to establish an accepted standard of care (CLND or nodal observation) for melanoma patients with minimal SN tumor burden.

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

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Guy's and St Thomas' NHS - St Thomas Hospital

location_facility: Charite - Universitaetsmedizin Berlin - Campus Mitte

location_facility: Cambridge University Hospital NHS - Addenbrookes Hospital

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: St Helens & Knowsley NHS Trust - Whiston Hospital

location_facility: Erasmus MC Cancer Institute - location Daniel den Hoed

location_facility: Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

location_facility: Istituto Oncologico Veneto IRCCS - Ospedale Busonera


title: A Phase 2, Single-arm, Open-label, Multicenter Study of the Histone Deacetylase Inhibitor (HDACi) JNJ-26481585 in Subjects With Previously Treated Stage Ib-IVa Cutaneous T-cell Lymphoma

summary: The purpose of this study is to determine the overall cutaneous response rate (participants who achieve a complete response or partial response) based on the modified severity weighted assessment tool criteria.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Portugal
Spain
United Kingdom
United States
France
Germany


title: A Phase II Study of Elacytarabine (CP-4055) Plus Idarubicin as Second Course Remission-Induction Therapy in Patients With Acute Myeloid Leukaemia

summary: The main objective of this study is to assess the biological activity of elacytarabine in combination with idarubicin in patients with acute myeloid leukaemia who has failed the first course of a remission-induction treatment with cytarabine (ara-C). In addition, the correlation between hENT1 (human equilibrative nucleoside transporter 1) and overall survival will be studied.

lead_sponsor: Clavis Pharma

location_country:
Norway
Germany
United States
France

location_facility: Charite University Hospital Benjamin Franklin


acronym: CT03 Core

title: A Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of Tobrineb®/Actitob®/Bramitob® (Tobramycin Solution for Nebulisation, 300mg Twice Daily in 4mL Unit Dose Vials) Compared to TOBI® in the Treatment of Patients With Cystic Fibrosis and Chronic Infection With Pseudomonas Aeruginosa

lead_sponsor: Chiesi Farmaceutici S.p.A.

ReferenceType: result

ReferenceCitation: Mazurek H, Chiron R, Kucerova T, Geidel C, Bolbas K, Chuchalin A, Blanco-Aparicio M, Santoro D, Varoli G, Zibellini M, Cicirello HG, Antipkin YG. Long-term efficacy and safety of aerosolized tobramycin 300 mg/4 ml in cystic fibrosis. Pediatr Pulmonol. 2014 Nov;49(11):1076-89. doi: 10.1002/ppul.22989. Epub 2014 Jan 24.

location_country:
Poland
Spain
Russian Federation
Ukraine
Hungary
France
Germany
Czechia

location_facility: Pädiatrische Pneumologie und Allergologie, Mukovizidose-Zentrum, Zentrum für Kinderheilkunde und Jugendmedizin

location_facility: Hospital Universitario Miguel Servet (Children)

location_facility: Centrum pro cystickou fibrosu, Pediatricka klinika UK 2.LF, Fakultní nemocnice v Motole

location_facility: Donetsk Regional Children Clinical Hospital

location_facility: Hopital Arnaud de Villeneuve, Clinique des maladies respiratoires

location_facility: Specjalistyczny ZOZ nad Matka i Dzieckiem, Poradnia Leczenia Mukowiscydozy

location_facility: Federal State Institution: Scientific Research Pulmonology Institute under the Roszdrav

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Orvos- és Gyógyszerésztudományi Centrum

location_facility: HELIOS Klinikum Krefeld, Zentrum für Kinder- und Jugendmedizin

location_facility: I Oddzial Chorob Dzieciecych, Wojewodzki Specjalistyczny Szpital Dzieciecy

location_facility: State Medical Institution: Republican Childrens Clinical Hospital under the Ministry of Health of the Republic of Tatarstan

location_facility: Dnipropetrovsk City Children Clinical Hospital # 2

location_facility: Zaporizhya Regional Clinical Children Hospital

location_facility: Saint-Petersburg State Medical Institution: City Children's Hospital of Saint Olga

location_facility: Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Science of Ukraine

location_facility: State Higher Educational Institution: Burdenko Voronezh State Medical Academy under the Roszdrav

location_facility: Oddzial Kliniczny Interny Dzieciecej i Alergologii, Wojewodzki Szpital Specjalistyczny

location_facility: Minicipal Medical Institution: Children's Clinical Hospital #1

location_facility: State Medical Institution: Regional Children's Hospital Pulmonology Department

location_facility: Odesa Regional Children Clinical Hospital

location_facility: Complejo Hospitalario Universitario A Coruña (Hospital Materno-Infantil Teresa Herrera)

location_facility: State Higher Educational Institution: Bashkir State Medical University under the Roszdrav

location_facility: Institute of Phthysiology and Pulmonology n.a., F.G.Yanovskiy of the Academy of Medical Science of Ukraine

location_facility: Lviv Regional Children Specialized Clinical Hospital

location_facility: Simferopol Central District Clinical Hospital

location_facility: Klinika Pediatrii Instytut Matki I Dziecka

location_facility: Poradnia Mukowiscydozy Wojewodzkiej, Przychodni Specjalistycznej dla Dzieci, Szpitala Wojewodzkiego Nr 2

location_facility: Klinika Pneumonologii i Mukowiscydozy, Instytut Gruzlicy i Chorob Pluc w Rabce Zdroj

location_facility: Federal State Institution "Nizhegorodskiy Research Institute of Children's Gastroenterology of Russian Medical Technologies"

location_facility: Hospital Universitario Ntra Sra. De la Candelaria

location_facility: Klinika Pneumonologii, Alergologii Dzieciecej i Immunologii Klinicznej Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu

location_facility: Regional State Medical Institution: Smolensk Regional Children's Clinical Hospital

location_facility: Dzieciecy Szpital Kliniczny Akademii Medycznej, Klinika Chorob Pluc I Reumatologii

location_facility: State Medical Institution: Filatov Chidren's City Clinical Hospital #13

summary: The objectives of the study are to demonstrate that Tobrineb®/Actitob®/Bramitob® is non-inferior to TOBI® in the primary efficacy variable, forced expiratory volume in one second (FEV1) percent of predicted normal, and to compare the safety in participants with cystic fibrosis and chronic infection of the lungs with Pseudomonas aeruginosa.


acronym: CERTAIN 2

title: A Phase IIIB, Multi-center, Open Label Follow-up Study to Evaluate the Safety and Efficacy of Certolizumab Pegol Administered Concomitantly With DMARDs in Patients With Active Rheumatoid Arthritis Who Participated in C87076.

lead_sponsor: UCB Pharma

location_country: Poland Italy Austria France Germany

summary: To continue to assess the clinical safety and efficacy of Certolizumab Pegol as add-on therapy with stable-dose Disease Modifying Anti-Rheumatic Drugs (DMARDs)


title: An Open-label, International, Multi-Center, Phase I/II, Dose-escalation Trial Investigating the Safety of Zalutumumab, a Human Monoclonal Epidermal Growth Factor Receptor Antibody in Combination With Radiotherapy, in Patients With Stage III, IVa or IVb Locally Advanced Squamous Cell Carcinoma of the Head and Neck Ineligible for Platinum Based Chemotherapy

summary: The purpose of this study is to investigate the safety of zalutumumab in combination with radiotherapy as the treatment of patients with head and neck cancer who are not eligible for platinum based chemotherapy.

lead_sponsor: Genmab

location_country:
France
United Kingdom
Belgium

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Centre Georges-Francois Leclerc Hospital


title: Tolerability, Safety and Treatment Response of Flexible Doses of Paliperidone ER in Acutely Exacerbated Subjects With Schizophrenia

acronym: PERTAIN

summary: The purpose of this study is to evaluate the tolerability, safety and treatment response of flexible doses of paliperidone extended-release (ER; designed to slowly release a drug in the body over an extended period of time) tablets in participants with acute schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

lead_sponsor: Janssen-Cilag International NV

location_country: Croatia Poland Lithuania France Israel Romania Germany


title: A Randomized, Multicenter, Open-label, 6-month Study to Explore the Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare

summary: The study will investigate the efficacy and safety of enteric-coated mycophenolate sodium in combination with two different corticosteroid (CS) regimes for the induction of remission of a lupus nephritis flare. Patients will be randomly allocated to standard CS regimen (group I) or to a reduced dose CS regimen (group II)

lead_sponsor: Novartis Pharmaceuticals

location_country:
Taiwan
Spain
Greece
Italy
United Kingdom
Hungary
France
Colombia
Germany

location_facility:
Novartis Investigative Site
Novartis


title: Phase I Study of SRC/ABL Tyrosine Kinase Inhibitor Dasatinib [BMS-354825] in Children and Adolescents With Relapsed or Refractory Leukemia, Protocol ITCC 005

summary: The purpose of this clinical research study was to establish a recommended phase 2 once daily (QD) dose of dasatinib and to assess the efficacy of the investigational drug for relapsed or refractory (resistant to previous treatment) leukemia in children and adolescents. The side effects that this oral investigational drug may have in children, and the levels of the drug in the blood, will be studied at different doses.

ReferenceCitation: Zwaan CM, Rizzari C, Mechinaud F, Lancaster DL, Lehrnbecher T, van der Velden VH, Beverloo BB, den Boer ML, Pieters R, Reinhardt D, Dworzak M, Rosenberg J, Manos G, Agrawal S, Strauss L, Baruchel A, Kearns PR. Dasatinib in children and adolescents with relapsed or refractory leukemia: results of the CA180-018 phase I dose-escalation study of the Innovative Therapies for Children with Cancer Consortium. J Clin Oncol. 2013 Jul 1;31(19):2460-8. doi: 10.1200/JCO.2012.46.8280. Epub 2013 May 28.

lead_sponsor: Bristol-Myers Squibb

location_country:
United Kingdom
Italy
Austria
Netherlands
France
Germany


title: Molecular Mechanisms of Disease Progression and Renoprotective Pharmacotherapy in Children With Chronic Renal Failure

acronym: ESCAPE

summary: In children with chronic kidney disease, progression to end-stage renal failure is associated with high patient morbidity and poor quality of life. In adults, inhibition of the renin angiotensin system (RAS) slows down the rate of renal failure progression. This concept is as yet unproven in children, in whom chronic renal failure (CRF) is more commonly due to hypo/dysplastic malformations than to acquired glomerulopathies as typical for adult chronic kidney disease. The current project aims at assessing the genetic and molecular mechanisms and cardiovascular consequences of progressive CRF and to develop a strategy of pharmacological renoprotection in children.

ReferenceCitation: ESCAPE Trial Group, Wühl E, Trivelli A, Picca S, Litwin M, Peco-Antic A, Zurowska A, Testa S, Jankauskiene A, Emre S, Caldas-Afonso A, Anarat A, Niaudet P, Mir S, Bakkaloglu A, Enke B, Montini G, Wingen AM, Sallay P, Jeck N, Berg U, Caliskan S, Wygoda S, Hohbach-Hohenfellner K, Dusek J, Urasinski T, Arbeiter K, Neuhaus T, Gellermann J, Drozdz D, Fischbach M, Möller K, Wigger M, Peruzzi L, Mehls O, Schaefer F. Strict blood-pressure control and progression of renal failure in children. N Engl J Med. 2009 Oct 22;361(17):1639-50. doi: 10.1056/NEJMoa0902066.

ReferenceCitation: Tabatabaeifar M, Schlingmann KP, Litwin M, Emre S, Bakkaloglu A, Mehls O, Antignac C, Schaefer F, Weber S; ESCAPE Trial Group. Functional analysis of BMP4 mutations identified in pediatric CAKUT patients. Pediatr Nephrol. 2009 Dec;24(12):2361-8. doi: 10.1007/s00467-009-1287-6. Epub 2009 Aug 14.

ReferenceCitation: Gimpel C, Wühl E, Arbeiter K, Drozdz D, Trivelli A, Charbit M, Gellermann J, Dusek J, Jankauskiene A, Emre S, Schaefer F; ESCAPE Trial Group. Superior consistency of ambulatory blood pressure monitoring in children: implications for clinical trials. J Hypertens. 2009 Aug;27(8):1568-74. doi: 10.1097/HJH.0b013e32832cb2a8.

ReferenceCitation: Grenda R, Wühl E, Litwin M, Janas R, Sladowska J, Arbeiter K, Berg U, Caldas-Afonso A, Fischbach M, Mehls O, Sallay P, Schaefer F; ESCAPE Trial group. Urinary excretion of endothelin-1 (ET-1), transforming growth factor- beta1 (TGF- beta1) and vascular endothelial growth factor (VEGF165) in paediatric chronic kidney diseases: results of the ESCAPE trial. Nephrol Dial Transplant. 2007 Dec;22(12):3487-94. Epub 2007 Sep 26.

ReferenceCitation: Chinali M, de Simone G, Matteucci MC, Picca S, Mastrostefano A, Anarat A, Caliskan S, Jeck N, Neuhaus TJ, Peco-Antic A, Peruzzi L, Testa S, Mehls O, Wühl E, Schaefer F; ESCAPE Trial Group. Reduced systolic myocardial function in children with chronic renal insufficiency. J Am Soc Nephrol. 2007 Feb;18(2):593-8. Epub 2007 Jan 10.

ReferenceCitation: Schönfelder EM, Knüppel T, Tasic V, Miljkovic P, Konrad M, Wühl E, Antignac C, Bakkaloglu A, Schaefer F, Weber S; ESCAPE Trial Group. Mutations in Uroplakin IIIA are a rare cause of renal hypodysplasia in humans. Am J Kidney Dis. 2006 Jun;47(6):1004-12.

ReferenceCitation: Matteucci MC, Wühl E, Picca S, Mastrostefano A, Rinelli G, Romano C, Rizzoni G, Mehls O, de Simone G, Schaefer F; ESCAPE Trial Group. Left ventricular geometry in children with mild to moderate chronic renal insufficiency. J Am Soc Nephrol. 2006 Jan;17(1):218-26. Epub 2005 Nov 9.

ReferenceCitation: Wühl E, Mehls O, Schaefer F; ESCAPE Trial Group. Antihypertensive and antiproteinuric efficacy of ramipril in children with chronic renal failure. Kidney Int. 2004 Aug;66(2):768-76.

ReferenceCitation: Jourdan C, Wühl E, Litwin M, Fahr K, Trelewicz J, Jobs K, Schenk JP, Grenda R, Mehls O, Tröger J, Schaefer F. Normative values for intima-media thickness and distensibility of large arteries in healthy adolescents. J Hypertens. 2005 Sep;23(9):1707-15.

ReferenceCitation: Litwin M, Wühl E, Jourdan C, Trelewicz J, Niemirska A, Fahr K, Jobs K, Grenda R, Wawer ZT, Rajszys P, Tröger J, Mehls O, Schaefer F. Altered morphologic properties of large arteries in children with chronic renal failure and after renal transplantation. J Am Soc Nephrol. 2005 May;16(5):1494-500. Epub 2005 Mar 16.

ReferenceCitation: Wühl E, Hadtstein C, Mehls O, Schaefer F; ESCAPE Trial Group. Ultradian but not circadian blood pressure rhythms correlate with renal dysfunction in children with chronic renal failure. J Am Soc Nephrol. 2005 Mar;16(3):746-54. Epub 2005 Jan 12.

ReferenceCitation: Hadtstein C, Wühl E, Soergel M, Witte K, Schaefer F; German Study Group for Pediatric Hypertension. Normative values for circadian and ultradian cardiovascular rhythms in childhood. Hypertension. 2004 Mar;43(3):547-54. Epub 2004 Jan 26.

ReferenceCitation: Wühl E, Hadtstein C, Mehls O, Schaefer F; Escape Trial Group. Home, clinic, and ambulatory blood pressure monitoring in children with chronic renal failure. Pediatr Res. 2004 Mar;55(3):492-7. Epub 2003 Nov 19.

lead_sponsor: Heidelberg University

location_country:
Poland
Portugal
Serbia
Italy
Lithuania
Czech Republic
Switzerland
Sweden
Hungary
France
Turkey
Germany

location_facility: Medical University of Gdansk, Pediatric Nephrology Department

location_facility: Azienda Ospedaliera, Istitui Clinici di Perfezionamento, Servizio die Emodialisi Pediatrica

location_facility: University Children's Hospital, Dept. of Nephrology

location_facility: University Hospital Hamburg-Eppendorf, University Children's Hospital, Dept. of Pediatric Nephrology

location_facility: University Hospital Essen, Department of Pediatrics, Pediatric Nephrology Unit

location_facility: Vilnius University Children's Hospital, Pediatric Department, Nephrology Unit

location_facility: Hopital Necker, Division of Pediatric Nephrology

location_facility: Cukurova University School of Medicine, Dept. of Pediatric Nephrology

location_facility: Ospedale Pediatrico Bambino Gesù, Division of Nephrology and Dialysis

location_facility: Hospital S. Joao-Faculade de Medicina do Porto, Dept. of Pediatrics

location_facility: Clinic of Pediatrics, Pomeranian Academy of Medicine

location_facility: Children's Memorial Health Hospital, Nephrology and Kidney Transplantation Department

location_facility: Johannes Gutenberg University Mainz, Department of Pediatrics,

location_facility: University Hospital Motol, 1st Department of Pediatrics

location_facility: Faculty of Medicine Belgrade, University Children's Hospital, Nephrology Unit

location_facility: Ospedale Infantile Regina Margherita, U.O.A. Nefrologia, Dialisi, Trapianto

location_facility: Philipps University Marburg, Dept. of Pediatrics

location_facility: Humboldt University Berlin, Charité Children's Hospital, Department of Pediatric Nephrology

location_facility: Urban Hospital St. Georg, Department of Pediatrics, Pediatric Nephrology Unit

location_facility: Ege University Medical Faculty, Dept. of Pediatric Nephrology

location_facility: Hacettepe University, Faculty of Medicine, Pediatric Nephrology and Rheumatology

location_facility: Istanbul University, Cerrahpasa Medical Faculty, Dept, of Pediatrics

location_facility: Azienda Ospedaliera die Padova. U.O. Nefrologia Dialisi e Trapianto - Dipartimento di Pediatria

location_facility: Karolinska Institute, Huddinge University Hospital, Dept. of Pediatrics

location_facility: University of Istanbul, Istanbul Medical Faculty, Dept. of Pediatrics

location_facility: Semmelweis University Budapest, 1st Department of Pediatrics

location_facility: Division of Pediatric Nephrology, Children's Hospital, University of Heidelberg

location_facility: Hannover Medical School, Children's Hospital Div. II, Pediatric Nephrology

location_facility: Jagellonian University Medical College, Department of Pediatric Nephrology


title: A Multi-center, Phase 2, Open-Label Study of Fabrazyme (Recombinant Human a-Galactosidase A) Replacement Therapy in Pediatric Patients With Fabry Disease

summary: People with Fabry disease have an alteration in their genetic material (DNA) which causes a deficiency of the a-galactosidase A enzyme. This enzyme helps to break down and remove certain types of fatty substances called "glycolipids". These glycolipids are normally present within the body in most cells. In people with Fabry disease, glycolipids build up in various tissues such as the liver, kidney, skin, and blood vessels because a-galactosidase A is not present, or is present in small quantities. The build up of glycolipid levels (also referred to as "globotriaosylceramide" or "GL-3") in these tissues is thought to cause the clinical symptoms that are common to Fabry disease. Symptoms commonly appear during childhood with pain in the hands and feet. This study explored the safety, efficacy and pharmacokinetics of Fabrazyme in pediatric patients aged between 7 and 15 years.

ReferenceCitation: Wraith JE, Tylki-Szymanska A, Guffon N, Lien YH, Tsimaratos M, Vellodi A, Germain DP. Safety and efficacy of enzyme replacement therapy with agalsidase beta: an international, open-label study in pediatric patients with Fabry disease. J Pediatr. 2008 Apr;152(4):563-70, 570.e1. doi: 10.1016/j.jpeds.2007.09.007. Epub 2007 Dec 3.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Poland
United States
United Kingdom
France

location_facility: Great Ormond Street Hospital for Sick Children


title: A Randomized Phase III Study to Assess Intensification of the Conditioning Regimen for Allogenic Stem Cell Transplantation (ALLO-SCT) for Leukemia or Myelodysplastic Syndrome With a High Risk of Relapse

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of idarubicin plus peripheral stem cell transplantation using the patient's own or donated stem cells in treating patients with leukemia or myelodysplastic syndrome.

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

location_country: Italy Netherlands France Belgium Germany

location_facility:
Hopital Edouard Herriot
Leiden University Medical Center
University Medical Center Nijmegen
Azienda Policlinico Umberto Primo
Institut Jules Bordet
Institut Gustave Roussy
Ospedale San Eugenio
Hotel Dieu de Paris
Eberhard Karls Universitaet


title: EPOS Discoid Meniscus (DiMe) Project: a Prospective Multicentric Cohort Protocol

acronym: DiMe

summary: The aims of this Discoid Meniscus (DiMe) project are to analyze DM tears characteristics in the pediatric European population to describe current treatment options in symptomatic DM, and to evaluate clinical outcomes. To reach these objectives, a prospective database including symptomatic DM and variables associated with DM characteristics, type of tears, treatment, imaging, and clinical follow-up will be implemented. Data collection platform will provide future studies to understand the best treatment option for skeletally immature patient with symptomatic DM according to their history and lesion characteristics.

ReferenceCitation: Turati M, Anghilieri FM, Accadbled F, Piatti M, Di Benedetto P, Moltrasio F, Zatti G, Zanchi N, Bigoni M. Discoid meniscus in human fetuses: A systematic review. Knee. 2021 Jun;30:205-213. doi: 10.1016/j.knee.2021.04.006. Epub 2021 May 1.

ReferenceCitation: Ahn JH, Lee SH, Yoo JC, Lee YS, Ha HC. Arthroscopic partial meniscectomy with repair of the peripheral tear for symptomatic discoid lateral meniscus in children: results of minimum 2 years of follow-up. Arthroscopy. 2008 Aug;24(8):888-98. doi: 10.1016/j.arthro.2008.03.002. Epub 2008 May 5.

ReferenceCitation: Wasser L, Knörr J, Accadbled F, Abid A, Sales De Gauzy J. Arthroscopic treatment of discoid meniscus in children: clinical and MRI results. Orthop Traumatol Surg Res. 2011 May;97(3):297-303. doi: 10.1016/j.otsr.2010.11.009. Epub 2011 Mar 23.

ReferenceCitation: Kinugasa K, Hamada M, Yonetani Y, Matsuo T, Mae T, Nakata K, Horibe S. Discoid lateral meniscal repair without saucerization for adolescents with peripheral longitudinal tear. Knee. 2019 Jun;26(3):803-808. doi: 10.1016/j.knee.2019.03.007. Epub 2019 May 7.

ReferenceCitation: Matsuo T, Kinugasa K, Sakata K, Ohori T, Mae T, Hamada M. Post-operative deformation and extrusion of the discoid lateral meniscus following a partial meniscectomy with repair. Knee Surg Sports Traumatol Arthrosc. 2017 Feb;25(2):390-396. doi: 10.1007/s00167-016-4393-6. Epub 2016 Dec 23.

ReferenceCitation: Nepple JJ, Milewski MD, Shea KG. Research in Osteochondritis Dissecans of the Knee: 2016 Update. J Knee Surg. 2016 Oct;29(7):533-538. Epub 2016 Aug 17. Review. Erratum in: J Knee Surg. 2016 Nov;29(8):696.

ReferenceCitation: Moksnes H, Engebretsen L, Seil R. The ESSKA paediatric anterior cruciate ligament monitoring initiative. Knee Surg Sports Traumatol Arthrosc. 2016 Mar;24(3):680-7. doi: 10.1007/s00167-015-3746-x. Epub 2015 Aug 7.

ReferenceCitation: Scott EJ, Westermann R, Glass NA, Hettrich C, Wolf BR, Bollier MJ. Performance of the PROMIS in Patients After Anterior Cruciate Ligament Reconstruction. Orthop J Sports Med. 2018 May 25;6(5):2325967118774509. doi: 10.1177/2325967118774509. eCollection 2018 May.

ReferenceCitation: Grant-Beuttler M, Jennings J, McCauley C, Dulay R, Grossnickle K, Kill K, Hay J. Development of an Electronic Version of The Children's Self-Perceptions of Adequacy in and Predilection for Physical Activity (CSAPPA) Scale. Pediatr Exerc Sci. 2017 Feb;29(1):153-160. doi: 10.1123/pes.2016-0115. Epub 2016 Oct 21.

ReferenceCitation: Briggs KK, Lysholm J, Tegner Y, Rodkey WG, Kocher MS, Steadman JR. The reliability, validity, and responsiveness of the Lysholm score and Tegner activity scale for anterior cruciate ligament injuries of the knee: 25 years later. Am J Sports Med. 2009 May;37(5):890-7. doi: 10.1177/0363546508330143. Epub 2009 Mar 4.

ReferenceCitation: Dietvorst M, Reijman M, van Groningen B, van der Steen MC, Janssen RPA. PROMs in paediatric knee ligament injury: use the Pedi-IKDC and avoid using adult PROMs. Knee Surg Sports Traumatol Arthrosc. 2019 Jun;27(6):1965-1973. doi: 10.1007/s00167-017-4687-3. Epub 2017 Sep 19.

ReferenceCitation: Outerbridge RE. The etiology of chondromalacia patellae. 1961. Clin Orthop Relat Res. 2001 Aug;(389):5-8.

ReferenceCitation: CholeS Study Group, West Midlands Research Collaborative. Population-based cohort study of outcomes following cholecystectomy for benign gallbladder diseases. Br J Surg. 2016 Nov;103(12):1704-1715. doi: 10.1002/bjs.10287. Epub 2016 Aug 26. Erratum in: Br J Surg. 2018 Aug;105(9):1222.

ReferenceCitation: Courtney A, O'Connell R, Rattay T, Kim B, Cutress RI, Kirwan CC, Gandhi A, Fairbrother P, Sharma N, Cartlidge CWJ, Horgan K, McIntosh SA, Leff DR, Vidya R, Potter S, Holcombe C, Copson E, Coles CE, Dave RV. The B-MaP-C study: Breast cancer management pathways during the COVID-19 pandemic. Study protocol. Int J Surg Protoc. 2020;24:1-5. doi: 10.1016/j.isjp.2020.07.003. Epub 2020 Jul 29.

lead_sponsor: University of Milano Bicocca

location_country:
Portugal
United Kingdom
Italy
Finland
Switzerland
France
Belgium

location_facility: Department of Orthopaedic Surgery, Hôpital des Enfants, CHU de Toulouse

location_facility: SHEFFIELD CHILDREN'S NHS NHS Foundation Trust,

location_facility: Department of Pediatric Orthopaedics, Hospital Pediátrico de -Coimbra

location_facility: Centre hospitalier universitaire vaudois (CHUV)


acronym: WISARD

title: An Open-Label, Multi-Centre, Randomised, Switch Study to Evaluate the Virological Efficacy Over 96 Weeks Of 2-Drug Therapy With DTG/RPV FDC in Antiretroviral Treatment-Experienced HIV-1 Infected Subjects Virologically Suppressed With NNRTIs Resistance Mutation K103N

lead_sponsor: NEAT ID Foundation

location_country:
Spain
Italy
United Kingdom
France
Belgium
Germany

location_facility: ASST GOM Niguarda Milano, Dep. Infectious Disease

location_facility: Hospital General Universitario de Alicante

location_facility: Infectious Diseases Unit Hospital de la Santa Creu i Sant Pau

location_facility: ASST FBF SACCO- I Division of Infectious Diseases 1

location_facility: North Bristol NHS Trust, Southmead Hospital

location_facility: ASST FBF SACCO- I Division of Infectious Diseases 3

summary:
HIV-1 infected subjects that experience virological failure while on non nucleoside reverse-transcriptase inhibitors (NNRTIs), including those with the K103N mutation, are usually switched to a boosted PI-based regimen or other antiretroviral (ARV) combinations. The same is true for subjects who need to start antiretroviral therapy and have acquired virus that is already resistant to antiretrovirals. These "second line" combinations are often associated with numerous issues that can have a potential impact on the quality of life (QoL) of these patients. Therefore a simpler and better tolerated alternative second line treatment option would be a useful tool for the clinical management of these patients.

The aim of this study is to assess the efficacy and tolerability of a dual combined therapy of Dolutegravir (DTG) 50 mg OD + Rilpivirine (RPV) 25 mg OD in virologically suppressed participants with previous virological failure with NNRTIs and having the clinically significant mutation K103N. The secondary objective of the study is to assess whether a simplification of the treatment in terms of pill burden, long term metabolic toxicity and potential for drug interactions improves the QOL of the participants. The study will also evaluate DTG & RPV concentrations in the blood plus changes in cell associated virus.

In order to compare the first line treatment (boosted PI and/or other antiretroviral combinations) and the DTG+RPV combination, two thirds of study participants will be switched to DTG+RPV immediately and receive DTG+RPV for 96 weeks. The other third will be switched after 48 weeks of continuing on their first line treatment and receive DTG+RPV for 48 weeks. All participants will then be followed up for a further 30 days. Participants will be recruited from sites across Europe, and randomised onto either arm of the study. After randomisation, participants will attend approximately 10 visits over the course of two years.


title: PROton Versus Photon Therapy for Esophageal Cancer - a Trimodality Strategy (PROTECT) A Multicenter International Randomized Phase III Study of Neoadjuvant Proton Versus Photon Chemoradiotherapy in Locally Advanced Esophageal Cancer

acronym: PROTECT

summary: The PROTECT trial will test the hypothesis that proton (PT) -enabled radiation dose reductions to sensitive, normal tissues will result in lower rates of treatment-related pulmonary complications in esophageal cancer compared to standard photon therapy (XT).

lead_sponsor: University of Aarhus

location_country:
Denmark
United Kingdom
Italy
Netherlands
Switzerland
France
Belgium
Germany

location_facility: Azienda Provinciale Per I Servizi Sanitari (APSS)

location_facility: University College London Hospital (UCLH)

location_facility: Stichting Maastricht Radiation Oncology (MAASTRO)

location_facility: Centro Nazionale di Adroterapia Oncologica (CNAO)


title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial With a Single Arm run-in Period to Evaluate the Safety and Efficacy of Sodium Thiosulfate (BYON5667) Eye Drops to Reduce Ocular Toxicity in Cancer Patients Treated With SYD985

summary: This multicenter, randomized, double-blind, placebo-controlled trial with a single arm run-in period is to evaluate the safety and efficacy of sodium thiosulfate (BYON5667) eye drops to reduce ocular toxicity in cancer patients treated with the antibody-drug conjugate (ADC) SYD985

primary_purpose: Prevention

lead_sponsor: Byondis B.V.

location_country: France Spain Belgium

location_facility: ICO I'Hospitalet - Hospital Duran i Reynals


title: A Randomized, Controlled, Pilot Study to Evaluate Safety and Feasibility of Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) Therapy in Patients With ST Elevation Inferior Wall Myocardial Infarction Presenting With TIMI 0 or 1 and Symptom Duration ≤ 12 Hours Treated Adjunct to Percutaneous Coronary Intervention (PCI) Compared to Standard PCI.

acronym: PiCSO-AMI-V

summary: The objective of this study is to assess safety and feasibility of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) therapy in patients with extensive ST elevation inferior wall myocardial infarction presenting with TIMI 0 or 1 and symptom duration ≤ 12 hours undergoing percutaneous coronary intervention (PCI) compared to standard PCI.

lead_sponsor: Miracor Medical SA

location_country:
Denmark
United Kingdom
Latvia
Switzerland
France

location_facility: EOC Ospedale Regionale di Lugano - Civico

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: CHU Hôpiteaux de Bordeaux, Hôpital Haut Lévéque

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Pauls Stradins Clinical University Hospital


title: A Multi-center, Open-label Study to Determine the Dose and Safety of Oral Asciminib in Pediatric Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia in Chronic Phase (Ph+ CML-CP), Previously Treated With One or More Tyrosine Kinase Inhibitors

summary: The aim of this study is to support development of asciminib in the pediatric population (1 to <18 years) previously treated with one or more TKIs. Full extrapolation of the efficacy of asciminib from adult to pediatric patients will be conducted. Full extrapolation is based on the concept that CML in the pediatric population has the same pathogenesis, similar clinical characteristics and progression pattern as in adults.

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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Poland
Greece
Italy
Russian Federation
Thailand
Hungary
Korea, Republic of
United States
France
Turkey
Japan
Germany

location_facility: Columbia University Medical Center- New York Presbyterian

location_facility: Dana Farber Cancer Institute Dept.of DFCI


title: A Randomized, Subject and Investigator Blinded, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of CMK389 in Patients With Moderate to Severe Atopic Dermatitis

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: Poland Spain Hungary France Germany Czechia

summary: The main purpose of this phase 2 study is to assess the efficacy and safety of CMK389 in patients with atopic dermatitis.


title: EP Device Registry

summary: This study will provide ongoing, high quality data on the safety, performance, and clinical benefits of Abbott's EP devices in a real-world setting.

lead_sponsor: Abbott Medical Devices

location_country: Portugal Spain Italy Austria Netherlands Hungary France India Germany Czechia

location_facility: Deutsches Herzzentrum München des Freistaates Bayern

location_facility: Medizinische Einrichtungen der Universität zu Köln

location_facility: Sree Chitra Tirunal Institute for Medical Sciences & tech.

location_facility: Postgraduate Institute of Medical Education & Research

intervention_type: Other


title: Retrospective Chart Review Study of Patients With PIK3CA-Related Overgrowth Spectrum (PROS) Who Have Received Alpelisib as Part of a Compassionate Use Program (EPIK-P1)

summary:
The study is a site-based retrospective non-interventional medical chart review of pediatric and adult male and female patients with PIK3CA-Related Overgrowth Spectrum (PROS). Patient-level data are abstracted from medical charts of all eligible patients at all participating sites.

Information from patients treated with alpelisib is used to describe the efficacy and safety of alpelisib in PROS patients.

time_perspective: Retrospective

location_country:
Spain
Ireland
Australia
United States
France

location_facility:
Novartis Investigative Site
Boston Childrens Hospital


title: Wright™ Elbow Outcomes Clinical Study (WELBOW)

acronym: WELBOW

summary: WELBOW study is an international, ambispective and prospective, single arm, multicenter, observational, non-comparative, Post-Market Clinical Follow-up (PMCF).

lead_sponsor: Stryker Trauma GmbH

location_country:
United Kingdom
Canada
France
Belgium
Sweden

location_facility:
CHU Tours
Wrightington Hospital
Linköping University
Clinique du parc
Lawson Health Research Institute
Sjukhuset i Varberg Hospital
Rouen University Hospital
AZ Herentals


title: Immunogenicity and Safety of a High-Dose Quadrivalent Influenza Vaccine Administered by the Intramuscular Route in Subjects 60 Years of Age and Older

lead_sponsor: Sanofi Pasteur, a Sanofi Company

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

location_country: Poland Italy Netherlands France Belgium Germany

location_facility:
Investigational Site Number 3800003
Investigational Site Number 2760005
Investigational Site Number 5280001
Investigational Site Number 2500001
Investigational Site Number 2760003
Investigational Site Number 2760002
Investigational Site Number 6160002
Investigational Site Number 6160004
Investigational Site Number 2760001
Investigational Site Number 2500003
Investigational Site Number 0560001
Investigational Site Number 6160003
Investigational Site Number 6160001
Investigational Site Number 0560002
Investigational Site Number 3800001
Investigational Site Number 2760004
Investigational Site Number 2500004

summary:
Primary Objective:

To demonstrate that high-dose quadrivalent influenza vaccine (QIV-HD) induces an immune response that is superior to the responses induced by standard-dose quadrivalent influenza vaccine (QIV-SD) for all 4 virus strains 28 days post-vaccination in participants 60 to 64 years of age and in participants 65 years of age and older.

Secondary Objective:

Immunogenicity: To further describe the immune response induced by QIV-HD and QIV-SD in all participants by age group, in pooled age groups, and by vaccine group (QIV-HD; QIV-SD).
Safety: To describe the safety profile of all participants by age group, in pooled age groups, and by vaccine group (QIV-HD; QIV-SD).


title: High-Density (HD) Wave Mapping in Subjects With Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy

acronym: WAVE-MAP AF

summary: The aim is to use the GRID to characterize the atrial substrate and develop a model for predicting recurrence rates after a single procedure using a PVI only approach and a contact catheter.

ipd_sharing: Undecided

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

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Complexo Hospitalario Universitario de Santiago


title: A Randomized, Double-Blind (Sponsor-unblinded), Placebo-Controlled, Adaptive Trial to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of GSK3640254 in HIV-1 Infected Treatment-Naïve Adults

summary: Infection with HIV-1 continues to be a serious health threat throughout the world. Chronic exposure to combination anti-retroviral therapy identified anti-retroviral associated long-term toxicities. Hence, there is a need to prevent these co-morbidities. GSK3640254 is a next-generation HIV-1 Maturation Inhibitor (MI) which may be effective for HIV-1 infection. This study will evaluate the antiviral effect, safety, tolerability and pharmacokinetics/ pharmacodynamics of GSK3640254 in HIV-1 infected treatment-naive adults. This study will consists of two parts; Part 1 and Part 2. Part 1 will evaluate two active doses of GSK3640254, 200 milligrams (mg) (Cohort 1) and 10 mg (Cohort 2) along with placebo to match GSK3640254 Mesylate salt. Part 2 will evaluate three active doses of GSK3640254. Dose level 1 of GSK3640254 that can provide at least 30 percent of the maximum effect (Cohort 1), dose level 2 of GSK3640254 that can provide at least 75 percent of the maximum effect (Cohort 2) and dose level 3 of GSK3640254 that can provide at least 90 percent of the maximum effect (Cohort 3). These doses are anticipated to be 5 mg, 40 mg and 100 mg respectively, but could be modified based on data obtained in Part 1. Subjects will also receive placebo to match GSK3640254 Mesylate salt in Part 2 of the study. All doses will be administered after a moderate fat meal. This study will consist of Screening period (up to 14 days), Treatment period (Day 1- Day 10), post-dose Follow-up (Day 11- Day 17) and final Follow-up (Day 18-24). A total of approximately 34 subjects will be enrolled, of which, 14 subjects will be randomized in Part 1 and 20 in Part 2 of the study. Six subjects will be enrolled in each of the active dose cohorts and 2 subjects will be enrolled in each of the placebo cohorts.

ReferenceCitation: Spinner CD, Felizarta F, Rizzardini G, Philibert P, Mitha E, Domingo P, Stephan CJ, DeGrosky M, Bainbridge V, Zhan J, Dumitrescu TP, Jeffrey JL, Xu J, Halliday F, Gan J, Johnson M, Gartland M, Joshi SR, Lataillade M. Phase IIa Proof-of-Concept Evaluation of the Antiviral Efficacy, Safety, Tolerability, and Pharmacokinetics of the Next-Generation Maturation Inhibitor GSK3640254. Clin Infect Dis. 2022 Sep 14;75(5):786-794. doi: 10.1093/cid/ciab1065.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: ViiV Healthcare

location_country:
Spain
Italy
United States
France
South Africa
Germany


title: A Multicentre, Open-label, Three-arm Randomised Phase II Trial Assessing the Safety and Efficacy of the HSP90 Inhibitor Ganetespib in Combination With Carboplatin Followed by Maintenance Treatment With Niraparib Versus Ganetespib Plus Carboplatin Followed by Ganetespib and Niraparib Versus Carboplatin in Combination With Standard Chemotherapy Followed by Niraparib Maintenance Treatment in Platinum-sensitive Ovarian Cancer Patients

acronym: EUDARIO

summary:
This study will be performed in women with platinum-sensitive, high-grade serous, high-grade endometrioid, undifferentiated epithelial ovarian cancer, carcinosarcoma, fallopian tube or primary peritoneal cancer (proven by central histo-pathological review).

A total of 120 subjects will be randomized (1:1:1) to three different treatment arms: (A) Standard arm (arm A): Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175 mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000 mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral daily, q4w) // (B) First experimental arm (arm B): Ganetespib (150 mg/m2, d1, q3w) in combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment with Niraparib (200/ 300 mg oral daily, q4w) // (C) Second experimental arm (arm C): Ganetespib (150 mg/m² d1, q3w i.v.) plus Carboplatin (AUC5 d1, q3w i.v.) followed by Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w).

Chemotherapy treatment will be given for 6 cycles, maintenance treatment with Ganetespib will be given for a maximum of 9 months or until disease progression, maintenance treatment with Niraparib can continue until disease progression.

lead_sponsor: Universitaire Ziekenhuizen KU Leuven

location_country: Italy Austria France Belgium Germany

location_facility: Kliniken Essen Mitte, Evang. Huyssens- Stiftung/Knappschaft GmbH

location_facility: Fondazione IRCCS Istituto Nazionale dei tumori Milano

location_facility: Centre de lutte contre le cancer Francois Baclesse


title: First Randomized Study of Pressure-controlled Intermittent Coronary Sinus Occlusion (PiCSO) in Acute Myocardial Infarction

acronym: PiCSO-AMI-I

summary: The objective of this study is to assess efficacy and safety of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) therapy started post flow restoration but prior to stenting during percutaneous coronary intervention (PCI) compared to standard PCI in the setting of acute ST-segment elevation anterior myocardial infarction (STEMI).

location_country:
Denmark
United Kingdom
Latvia
Switzerland
France
Germany

location_facility: EOC Ospedale Regionale di Lugano - Civico

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: CHU Hôpiteaux de Bordeaux, Hôpital Haut Lévéque


title: Osse Registry for Patients With Lipodystrophy Run by the European Consortium of Lipodystrophies (ECLip)

acronym: ECLip Registry

summary:
Given the lack of knowledge on lipodystrophies, the medical and social responsibility for the persons affected by it calls for the monitoring of the progression over long periods of time. Sensible clinical and basic research into rare diseases such as lipodystrophy is only possible in multi-location networks with sufficient case numbers. Also, reliable information on the incidence of certain manifestation patterns, health status, etc. is of utmost importance for health care and health policy in this rare disease.

Therefore, the European Consortium of Lipodystrophies (ECLip), an association of European experts on lipodystrophy, has launched a registry (OSSE) for lipodystrophies which is committed to help to improve the research conditions by consolidating this kind of information in a registry.

ReferenceCitation: von Schnurbein J, Adams C, Akinci B, Ceccarini G, D'Apice MR, Gambineri A, Hennekam RCM, Jeru I, Lattanzi G, Miehle K, Nagel G, Novelli G, Santini F, Santos Silva E, Savage DB, Sbraccia P, Schaaf J, Sorkina E, Tanteles G, Vantyghem MC, Vatier C, Vigouroux C, Vorona E, Araújo-Vilar D, Wabitsch M. European lipodystrophy registry: background and structure. Orphanet J Rare Dis. 2020 Jan 15;15(1):17. doi: 10.1186/s13023-020-1295-y.

ipd_sharing_description: Researches participating in the ECLip registry and third parties independently can request to perform research with the data.

lead_sponsor: University of Ulm

location_country:
Poland
Portugal
Slovenia
Italy
Austria
Netherlands
Russian Federation
Spain
United Kingdom
Hungary
France
Turkey
Germany
Cyprus

location_facility: Cyprus Institute of Neurology & Genetics

location_facility: Endocrinology Unit, Department of Clinical and Medical science, S. Orsola-Malpighi Hospital , University of Bologna

location_facility: Dept for Pediatrics and Adolescent Medicine, University of Ulm: Interdisciplinary obesity clinic

location_facility: University of Cambridge Metabolic Research Laboratories

location_facility: Tor Vergata University - Policlinico of Tor Vergata

location_facility: University Medical Center Ljubljana - Clinical Institute of Medical Genetics

location_facility: Endocrine Unit of University Hospital of Pisa

location_facility: Department of Internal Medicine (Endocrinology and Nephrology), University of Leipzig

location_facility: Institute of Human Genetics, Martin Luther University Halle-Wittenberg

location_facility: Abel Salazar Biomedical Sciences Institute - University of Porto

location_facility: Academic Medical Center, University of Amsterdam

location_facility: Med. Klinik B für Gastroenterologie und Hepatologie, Universitätsklinikum Münster

location_facility: Dokuz Eylul University School of Medicine

location_facility: University of Szeged, Department of Internal Medicine

location_facility: Pierre et Marie Curie School of Medicine, Sorbonne University


title: An International Multicentre, Open-Label First in Human Phase I/II Study to Evaluate the Safety, Tolerability, Biodistribution and Antitumour Activity of 177Lu-3BP-227 for the Treatment of Subjects With Solid Tumours Expressing Neurotensin Receptor 1

summary:
This study was being conducted to advance new treatment for patients with metastatic or locally advanced cancers expressing Neurotensin receptor 1 (NTSR1). This study was a first administration of a radioactive drug called 177Lu-3BP-227 to patients under controlled conditions of a clinical study. The purpose of this study is to evaluate how safe this investigational drug is as well to verify how well it is tolerated by patients after several intravenous administrations. In addition, the effect of the study drug on tumoral lesions and how it distributes throughout the body and at which rate it is removed from the body was evaluated. Since 177Lu-3BP-227 is a radio-labelled drug, it will also be measured how the emitted radiation is distributed throughout the body (dosimetry).

The study consisted of a phase I dose escalation part. The study originally planned to include a phase II study however due to early termination (not due to safety concerns) the study did not progress to phase II and was stopped during phase I. For the phase I dose escalation part, it was anticipated that approximately 30 subjects will be included, in up to six escalation steps. No expansion cohorts were implemented.

lead_sponsor: Ipsen

location_country:
Switzerland
United States
France
Belgium
Netherlands

location_facility: The University of Texas MD Anderson Cancer Center


title: Adjuvant Immunotherapy in Patients With Resected Gastric Cancer Following Preoperative Chemotherapy With High Risk for Recurrence (N+ and/or R1): an Open Label Randomized Controlled Phase-2-study

acronym: VESTIGE

summary:
The primary objective of the trial is to investigate if nivolumab plus ipilimumab given as adjuvant treatment improve disease free survival (DFS) in patients with stage Ib-IVa gastric and esophagogastric junction adenocarcinoma and high risk of recurrence (defined by ypN1-3 and/or R1 status) following neoadjuvant chemotherapy and resection.

Other study objectives:

To investigate the safety and effect of adjuvant immunotherapy on long term oncologic outcomes and quality of life of patients in the study
To correlate nutritional status assessment on outcomes and quality of life of patients

ReferenceCitation: Smyth E, Knödler M, Giraut A, Mauer M, Nilsson M, Van Grieken N, Wagner AD, Moehler M, Lordick F. VESTIGE: Adjuvant Immunotherapy in Patients With Resected Esophageal, Gastroesophageal Junction and Gastric Cancer Following Preoperative Chemotherapy With High Risk for Recurrence (N+ and/or R1): An Open Label Randomized Controlled Phase-2-Study. Front Oncol. 2020 Jan 30;9:1320. doi: 10.3389/fonc.2019.01320. eCollection 2019.

location_country:
Poland
Spain
Italy
United Kingdom
France
Israel
Norway
Germany
Czechia

location_facility: Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center

location_facility: Klinikum Rechts der isar Der Technische Universitaet Muenchen - Klinikum Rechts Der Isar

location_facility: Oslo University Hospital - Ullevaal Hospital

location_facility: Azienda Ospedaliera a Papa Giovanni XXIII

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Rambam Health Care Campus, Oncology Institute

location_facility: Universitaetsklinikum Tuebingen-Uni Kliniken Berg

location_facility: Institut Catalan d'Oncologia - ICO Badalona

location_facility: University College London Hospitals NHS Foundation Trust


title: A Modular, Multi-arm, Multi-part, First Time in Patient Study to Evaluate the Safety and Tolerability of OMO-1, Alone and in Combination With Anti-cancer Treatments, in Patients With Locally Advanced, Unresectable or Metastatic Solid Malignancies

summary: This is a modular, first time in patient, open-label, multicentre study of OMO-1, administered orally, alone and in combination with anti-cancer treatments, in patients with locally advanced, unresectable or metastatic solid malignancies.

lead_sponsor: Octimet Oncology N.V.

location_country:
United Kingdom
United States
France
Belgium
Netherlands

location_facility: UMCU Universitair Medisch Centrum Utrecht

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: University of Oxford, Department of Oncology


primary_purpose: Other

acronym: EASYKID

title: Efficacy, Safety and Tolerability of a Bowel Cleansing Preparation (Eziclen/Izinova®) in Paediatric Subjects Undergoing Colonoscopy: a Phase III, Multicentre, Randomised, Comparative Study Versus Klean-Prep® (PEG-Electrolytes), Administered on the Day Before Colonoscopy, Investigator-blinded, Non-inferiority in Adolescents of 12 to 17 Years of Age (Inclusive) >40 kg

location_country: Poland Italy Netherlands France Germany Czechia

location_facility: Universitätsklinikum Leipzig, Klinik und Poliklinik für Kinder- und Jugendmedizin

location_facility: Uniwersytecki Szpital Dziecięcy w Krakowie

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 6 Śląskiego

location_facility: ORN Santobono-Pausilipon Padiglione Santobono

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu

location_facility: Instytut "Pomnik - Centrum Zdrowia Dziecka"

location_facility: Uniwersytecki Szpital Dziecięcy w Lublinie

location_facility: Uniwersytecki Dziecięcy Szpital Kliniczny im. L. Zamenhofa w Białymstoku

summary: The purpose of the protocol is to demonstrate that Eziclen®/Izinova®, an osmotic sulphate-based laxative preparation given on the day before colonoscopy has non-inferior efficacy to Klean-Prep® (polyethylene glycol (PEG)-electrolytes) on colon cleansing in adolescents aged 12 to 17 years (inclusive) with a body weight >40 kg, scheduled to undergo a colonoscopy for a routinely accepted diagnostic indication.


title: A Phase II, Open Label, Multi-center, Multi-arm Study of Ceritinib in Patients With Advanced Solid Tumors and Hematological Malignancies Characterized by Genetic Abnormalities of Anaplastic Lymphoma Kinase (ALK)

lead_sponsor: Novartis Pharmaceuticals

location_country:
Denmark
Spain
Italy
Thailand
Korea, Republic of
France
Israel
Czechia

summary: This is Proof-of-Concept (POC) study to assess the preliminary antitumor activity and safety and tolerablity using ceritinib (LDK378) in the treatment of life threatening tumors that are characterized by ALK genetic alteration (and/or overexpression in some diseases).


title: A Randomized, Two-Period, Double-Blind Placebo-Controlled and Open-Label, Multicenter Extension Study to Determine the Long-Term Safety and Tolerability of JNJ-54861911 in Subjects in the Early Alzheimer's Disease Spectrum

lead_sponsor: Janssen Research & Development, LLC

ReferenceCitation: Novak G, Streffer JR, Timmers M, Henley D, Brashear HR, Bogert J, Russu A, Janssens L, Tesseur I, Tritsmans L, Van Nueten L, Engelborghs S. Long-term safety and tolerability of atabecestat (JNJ-54861911), an oral BACE1 inhibitor, in early Alzheimer's disease spectrum patients: a randomized, double-blind, placebo-controlled study and a two-period extension study. Alzheimers Res Ther. 2020 May 14;12(1):58. doi: 10.1186/s13195-020-00614-5.

location_country: Spain Netherlands Sweden France Belgium Germany

summary: The purpose of this study is to evaluate the long-term safety and tolerability of JNJ-54861911 in participants in the early Alzheimer's disease (AD [progressive brain disease that slowly destroys memory and thinking skills, and eventually even the ability to carry out the simplest tasks]) spectrum that have completed a Phase 1b or Phase 2 clinical trial with JNJ-54861911, who are willing to continue their assigned treatment.


title: Bifurcation Lesion Analysis and STenting / BLAST

acronym: BLAST

summary: The purpose of this research study is to determine if Intravascular Ultrasound (IVUS) grayscale and VH (Virtual Histology)-IVUS pre-stenting can assess more accurately the location, amount, and type of a blockage than angiogram alone. Additionally, this study is to determine if IVUS grayscale and VH-IVUS guidance will result in improved acute and long term procedural outcome vs. bifurcation stenting with only angiographic guidance in native coronary arteries.

lead_sponsor: Volcano Corporation

location_country:
Denmark
Poland
United Kingdom
Italy
Latvia
United States
France
Netherlands

location_facility: Saint Luke's Hospital-Mid America Heart Institute

location_facility: St. Thomas Hospital Cardiothoracic Centre

location_facility: Kardiologisk laboratorium/B-lab Skejby Sygehus

location_facility: Azienda Sanitaria Ospedaliera Molinette San Giovanni Battista al Torino Departp Emodinamica Universitaria

location_facility: Pauls Stradins Clinical University Hospital


title: A Phase 2a Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multi-center Study Investigating the Safety and Tolerability of JNJ-54861911 in Subjects With Early Alzheimer's Disease

summary: The purpose of this study is to evaluate the long-term safety and tolerability of JNJ-54861911 during 6 months of treatment in participants with early (predementia) alzheimer's disease (AD [degenerative disease of the brain characterized by the insidious onset of dementia, impairment of memory, judgment, attention span, and problem solving skills are followed by severe apraxias and a global loss of cognitive abilities]).