title: An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients With AL Amyloidosis Following at Least One Prior Line of Therapy

summary:
This is a phase 1/2 open label study of melphalan flufenamide (melflufen) in combination with dexamethasone for participants with Al amyloidosis following at least one prior line of therapy. Melflufen will be administered on Day 1 of each 28-day cycle in combination with dexamethasone on days 1 and 2.

In both phases, treatment of each individual participant will continue for up to 8 cycles or until any stopping events occur.

Approximately 46 participants will be enrolled.

The study was intended to be a Phase 1/2 trial but was early terminated and never moved forward to Phase 2.

lead_sponsor: Oncopeptides AB

location_country:
Spain
Greece
United Kingdom
United States
France
Israel
Norway
Germany
Czechia

location_facility: Centre Hospitalier Universitaire de Limoges

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Oslo University Hospital - Rikshospitalet


title: Pilot Study to Assess Success Factors and Barriers for Preparation of a Phase 3 Study With ExPEC10V in Adults Aged 60 Years or Older and in Stable Health

summary: The purpose of this study is to collect information from study participants who develop an invasive disease caused by Extraintestinal pathogenic E. coli (ExPEC) during a period of 12 months. This information will be used to support the development of a new vaccine to prevent ExPEC infections.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: MJM Bonten

location_country:
Spain
Italy
United Kingdom
Canada
United States
France
Japan
Germany

location_facility: - Andalusian Public Foundation for Health Research Management in Seville (FISEVI)

lead_sponsor_type: industriel

status_simplified: Completed


ipd_sharing: Yes

status: Active, not recruiting

primary_purpose: Other

intervention_type: Drug

title: A Phase Ib/II, Multicenter, Open-label, Dose Escalation Study of LGX818 in Combination With MEK162 in Adult Patients With BRAF V600 - Dependent Advanced Solid Tumors

study_completion_date_type: Anticipated

lead_sponsor: Pfizer

type: Other Identifier

type: EudraCT Number

source: euctr

design_allocation: Non-Randomized

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Sullivan RJ, Weber J, Patel S, Dummer R, Carlino MS, Tan DSW, Lebbé C, Siena S, Elez E, Wollenberg L, Pickard MD, Sandor V, Ascierto PA. A Phase Ib/II Study of the BRAF Inhibitor Encorafenib Plus the MEK Inhibitor Binimetinib in Patients with BRAFV600E/K -mutant Solid Tumors. Clin Cancer Res. 2020 Oct 1;26(19):5102-5112. doi: 10.1158/1078-0432.CCR-19-3550. Epub 2020 Jul 15.

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Spain
Italy
Australia
Canada
Switzerland
United States
France
Belgium
Singapore

location_facility: H. Lee Moffitt Cancer Center & Research Institute, Inc.

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Ophthalmic Consultants of Boston Inc (OCB)

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Hospital Universitario Vall d'Hebrón - PPDS

location_facility: Sir Mortimer B. Davis-Jewish General Hospital

location_facility: Hospital Universitario HM Sanchinarro ? CIOCC

location_facility: Service de radiologie - Hopital Saint Louis

location_facility: Istituto Nazionale per lo studio e la cura dei tumori Fondazione Giovanni Pascale

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda

summary: This is a multi-center, open-label, dose finding, Phase Ib dose escalation study to estimate the MTD(s) and/or RP2D(s) for the dual combination of LGX818 and MEK162 and the triple combination of LGX818 and MEK162 and LEE011, followed each independently by a Phase II part to assess the clinical efficacy and to further assess the safety of the combinations in selected patient populations. Oral LGX818 and MEK162 will be administered on a continuous schedule. Oral LEE011 will be administered once daily on a three weeks on, one week off schedule. Patients will be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurs first. A cycle is defined as 28 days. The dose escalation parts of the trial will be conducted in adult patients with BRAF V600-dependent advanced solid tumors and is expected to enroll at least 18 patients for the dual combination and at least 12 patients for the triple combination. The dose escalation will be guided by a Bayesian logistic regression model (BLRM). Following MTD/RP2D declaration, patients will be enrolled in three Phase II arms for the dual combination and one Phase II arm for the triple combination. All patients will be followed for 30 days for safety assessments after study drugs discontinuation. All patients enrolled in the Phase II part of the study will be followed for survival.

status_simplified: Ongoing


title: Treatment of Resistant Hypertension Using a Radiofrequency Percutaneous Transluminal Angioplasty Catheter (REDUCE-HTN) - POST MARKET APPROVAL CLINICAL SURVEILLANCE STUDY

acronym: REDUCE-HTN

summary: The Study objective is to assess the performance of the Vessix V2 Renal Denervation System for the treatment of uncontrolled hypertension using an innovative percutaneous Radio Frequency (RF) balloon catheter renal denervation device.

primary_purpose: Treatment

ReferenceType: result

ReferenceCitation: Sievert H, Schofer J, Ormiston J, Hoppe UC, Meredith IT, Walters DL, Azizi M, Diaz-Cartelle J, Cohen-Mazor M. Renal denervation with a percutaneous bipolar radiofrequency balloon catheter in patients with resistant hypertension: 6-month results from the REDUCE-HTN clinical study. EuroIntervention. 2015 Feb;10(10):1213-20. doi: 10.4244/EIJY14M12_01.

ReferenceCitation: Persu A, Sapoval M, Azizi M, Monge M, Danse E, Hammer F, Renkin J. Renal artery stenosis following renal denervation: a matter of concern. J Hypertens. 2014 Oct;32(10):2101-5. doi: 10.1097/HJH.0000000000000323.

lead_sponsor: Boston Scientific Corporation

location_country:
Austria
Australia
Netherlands
New Zealand
Switzerland
France
Belgium
Germany

location_facility: Switzerland University Hospital Clinic for Cardiology

location_facility: St. Vincenz Krankenhaus Abt. Kardiologie

location_facility: University Hospital of Geneva, Cardiology Center

location_facility: Salzburger Landeskliniken Universitats Krankenhaus

location_facility: Vascular Center Berlin, Ev. Königin Elisabeth Hospital

location_facility: Hamburg University Cardiovascular Center

location_facility: CardioVascular Center, Sankt Katharinen Krakenhaus

location_facility: Monash Cardiovascular Research Centre (Monash Heart)

location_facility: The Prince Charles Hospital, Cardiology Clinical Research Centre

location_facility: Saarland University Hospital Department of Internal Medicine III Non-surgical Intensive Care, Cardiology and Angiology

intervention_type: Device


acronym: Ellipse™

title: Efficacy and Safety of Liraglutide in Combination With Metformin Versus Metformin Monotherapy on Glycaemic Control in Children and Adolescents With Type 2 Diabetes

lead_sponsor: Novo Nordisk A/S

type: Registry Identifier

design_allocation: Randomized

ReferenceType: background

ReferenceCitation: Tamborlane WV, Barrientos-Pérez M, Fainberg U, Frimer-Larsen H, Hafez M, Hale PM, Jalaludin MY, Kovarenko M, Libman I, Lynch JL, Rao P, Shehadeh N, Turan S, Weghuber D, Barrett T; Ellipse Trial Investigators. Liraglutide in Children and Adolescents with Type 2 Diabetes. N Engl J Med. 2019 Aug 15;381(7):637-646. doi: 10.1056/NEJMoa1903822. Epub 2019 Apr 28.

ReferenceCitation: Bensignor MO, Bomberg EM, Bramante CT, Divyalasya TVS, Hale PM, Ramesh CK, Rudser KD, Kelly AS. Effect of liraglutide treatment on body mass index and weight parameters in children and adolescents with type 2 diabetes: Post hoc analysis of the ellipse trial. Pediatr Obes. 2021 Aug;16(8):e12778. doi: 10.1111/ijpo.12778. Epub 2021 Feb 25.

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
United States
Belgium
Romania
Poland
Portugal
Austria
Australia
Russian Federation
Puerto Rico
India
Israel
Turkey
Mexico
Norway
Malaysia
Sweden
Egypt
Brazil
Lebanon
Canada
Hungary
North Macedonia
Germany
Denmark
Taiwan
Greece
New Zealand
Thailand
France
Netherlands
Morocco

summary: This trial is conducted globally. The aim of this trial is to assess the efficacy and safety of liraglutide in the paediatric population in order to potentially address the unmet need for treatment of children and adolescents with type 2 diabetes.


title: A Phase 3, Double-Blind Extension Study Evaluating the Efficacy and Safety of Two Different Dose Levels of Single-Agent Idelalisib (GS-1101) for Previously Treated Chronic Lymphocytic Leukemia A Companion Trial to Study GS-US-312-0116: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia

summary: The primary objective of this extension study (GS-US-312-0117) that is a companion study to Study GS-US-312-0116 (NCT01539512), is to evaluate the effect of idelalisib on the onset, magnitude, and duration of tumor control. Randomization was done in study GS-US-312-0116, and carried forward to study GS-US-312-117.

status: Terminated

ReferenceCitation: Coutre SE, Furman RR, Sharman, JP, Cheson BD, Pagel JM, Hillmen P, et al. Second Interim Analysis of a Phase 3 Study of Idelalisib (Zydelig®) Plus Rituximab for Relapsed Chronic Lymphocytic Leukemia: Efficacy Analysis in Patient Subpopulations with Del(17p) and Other Adverse Prognostic Factors. Blood 2014; 124 (21):330

ReferenceCitation: Sharman JP, Coutre SE, Furman RR, Cheson BD, Pagel JM, Hillmen P, et al. Efficacy of Idelalisib in CLL Subpopulations Harboring Del(17p) and Other Adverse Prognostic Factors: Results from a Phase 3, Randomized, Double-blind, Placebo-controlled Trial [Poster 7011]. American Society of Clinical Oncology (ASCO) 50th Annual Meeting; 2014 May 30-June 3; Chicago, IL. J Clin Oncol 32:5s, 2014 (suppl; abstr 7011)

ReferenceCitation: Sharman JP, Coutre SE, Furman RR, Cheson BD, Pagel JM, Hillmen P, Barrientos JC, Zelenetz AD, Kipps TJ, Flinn IW, Ghia P, Eradat H, Ervin T, Lamanna N, Coiffier B, Pettitt AR, Ma S, Tausch E, Cramer P, Huang J, Mitra S, Hallek M, O'Brien SM, Stilgenbauer S. Final Results of a Randomized, Phase III Study of Rituximab With or Without Idelalisib Followed by Open-Label Idelalisib in Patients With Relapsed Chronic Lymphocytic Leukemia. J Clin Oncol. 2019 Jun 1;37(16):1391-1402. doi: 10.1200/JCO.18.01460. Epub 2019 Apr 17.

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

lead_sponsor: Gilead Sciences

location_country:
United Kingdom
Italy
United States
France
Germany

location_facility: Rocky Mountain Blood and Marrow Transplant Program

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc.

location_facility: Hämatologische und Internistische Gemeinschaftspraxis Dres. Eckart / Häcker

location_facility: Yakima Valley Memorial Hospital/North Star Lodge

location_facility: Ventura County Hematology Oncology Specialists

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: University of California, San Diego - Moores Cancer Center

location_facility: Georgetown University Medical Center Lombardi Cancer Center

status_simplified: Unknown


title: The Effectiveness of Managed Transition in Improving the Health and Social Outcomes for Young People Transitioning From Child to Adult Mental Health Care: the MILESTONE Study

acronym: MILESTONE

summary: This study evaluates the longitudinal health and social outcomes of adolescent mental health service users who are at the transition boundary of their child and adolescent mental health service, and whether the implementation of a model of managed transition at the service boundary benefits them, as compared to usual care.

status: Unknown status

primary_purpose: Health Services Research

enrollment_type: Anticipated

ReferenceCitation: Gerritsen SE, Maras A, van Bodegom LS, Overbeek MM, Verhulst FC, Wolke D, Appleton R, Bertani A, Cataldo MG, Conti P, Da Fonseca D, Davidović N, Dodig-Ćurković K, Ferrari C, Fiori F, Franić T, Gatherer C, De Girolamo G, Heaney N, Hendrickx G, Kolozsvari A, Levi FM, Lievesley K, Madan J, Martinelli O, Mastroianni M, Maurice V, McNicholas F, O'Hara L, Paul M, Purper-Ouakil D, de Roeck V, Russet F, Saam MC, Sagar-Ouriaghli I, Santosh PJ, Sartor A, Schandrin A, Schulze UME, Signorini G, Singh SP, Singh J, Street C, Tah P, Tanase E, Tremmery S, Tuffrey A, Tuomainen H, van Amelsvoort TAMJ, Wilson A, Walker L, Dieleman GC; Milestone consortium. Cohort profile: demographic and clinical characteristics of the MILESTONE longitudinal cohort of young people approaching the upper age limit of their child mental health care service in Europe. BMJ Open. 2021 Dec 16;11(12):e053373. doi: 10.1136/bmjopen-2021-053373.

ReferenceCitation: Santosh P, Singh J, Adams L, Mastroianni M, Heaney N, Lievesley K, Sagar-Ouriaghli I, Allibrio G, Appleton R, Davidović N, de Girolamo G, Dieleman G, Dodig-Ćurković K, Franić T, Gatherer C, Gerritsen S, Gheza E, Madan J, Manenti L, Maras A, Margari F, McNicholas F, Pastore A, Paul M, Purper-Ouakil D, Rinaldi F, Sakar V, Schulze U, Signorini G, Street C, Tah P, Tremmery S, Tuffrey A, Tuomainen H, Verhulst F, Warwick J, Wilson A, Wolke D, Fiori F, Singh S; MILESTONE Consortium. Validation of the Transition Readiness and Appropriateness Measure (TRAM) for the Managing the Link and Strengthening Transition from Child to Adult Mental Healthcare in Europe (MILESTONE) study. BMJ Open. 2020 Jun 23;10(6):e033324. doi: 10.1136/bmjopen-2019-033324.

ReferenceCitation: Santosh P, Adams L, Fiori F, Davidović N, de Girolamo G, Dieleman GC, Franić T, Heaney N, Lievesley K, Madan J, Maras A, Mastroianni M, McNicholas F, Paul M, Purper-Ouakil D, Sagar-Ouriaghli I, Schulze U, Signorini G, Street C, Tah P, Tremmery S, Tuomainen H, Verhulst FC, Warwick J, Wolke D, Singh J, Singh SP; MILESTONE Consortium. Protocol for the development and validation procedure of the managing the link and strengthening transition from child to adult mental health care (MILESTONE) suite of measures. BMC Pediatr. 2020 Apr 16;20(1):167. doi: 10.1186/s12887-020-02079-9.

ReferenceCitation: Tuomainen H, Schulze U, Warwick J, Paul M, Dieleman GC, Franić T, Madan J, Maras A, McNicholas F, Purper-Ouakil D, Santosh P, Signorini G, Street C, Tremmery S, Verhulst FC, Wolke D, Singh SP; MILESTONE consortium. Managing the link and strengthening transition from child to adult mental health Care in Europe (MILESTONE): background, rationale and methodology. BMC Psychiatry. 2018 Jun 4;18(1):167. doi: 10.1186/s12888-018-1758-z. Erratum in: BMC Psychiatry. 2018 Sep 14;18(1):295.

ReferenceCitation: Singh SP, Tuomainen H, Girolamo G, Maras A, Santosh P, McNicholas F, Schulze U, Purper-Ouakil D, Tremmery S, Franić T, Madan J, Paul M, Verhulst FC, Dieleman GC, Warwick J, Wolke D, Street C, Daffern C, Tah P, Griffin J, Canaway A, Signorini G, Gerritsen S, Adams L, O'Hara L, Aslan S, Russet F, Davidović N, Tuffrey A, Wilson A, Gatherer C, Walker L; MILESTONE Consortium. Protocol for a cohort study of adolescent mental health service users with a nested cluster randomised controlled trial to assess the clinical and cost-effectiveness of managed transition in improving transitions from child to adult mental health services (the MILESTONE study). BMJ Open. 2017 Oct 16;7(10):e016055. doi: 10.1136/bmjopen-2017-016055.

lead_sponsor: University of Warwick

location_country:
Croatia
United Kingdom
Ireland
Italy
Netherlands
France
Belgium
Germany

location_facility: Warwick Medical School, University of Warwick

intervention_type: Behavioral

lead_sponsor_type: academique


title: Phase I Open Label, Multi-center Study to Characterize the Safety, Tolerability and Pharmacokinetics of Intravenously Administered MIK665, a Mcl-1 Inhibitor, in Patients With Refractory or Relapsed Lymphoma or Multiple Myeloma

summary: The purpose of this first in human study is to assess safety, tolerability, PK and preliminary clinical activity and to estimate the MTD(s)/RDE(s) of MIK665 (also referred as S64315) as single agent administered intravenously (i.v.) in adult patients with refractory or relapsed lymphoma or multiple myeloma.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
Australia
United States
France
Japan
Germany

location_facility: MD Anderson Cancer Center/University of Texas MD Anderson CC


title: The Update of the EORTC Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-Breast 23) Phase 1-3

summary: The purpose of this study is to update the EORTC QLQ Breast (BR)-23 Module. Since the development of BR-23 published 1996 the standard therapy of breast cancer has changed. New therapies brought new side effects and different impact on QoL (quality of life) are not sufficiently covered by EORTC QLQ BR-23 and an update of the module could be useful, both from clinical and scientific point of view.

ReferenceCitation: Sprangers MA, Groenvold M, Arraras JI, Franklin J, te Velde A, Muller M, Franzini L, Williams A, de Haes HC, Hopwood P, Cull A, Aaronson NK. The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol. 1996 Oct;14(10):2756-68.

ReferenceCitation: Johnson C, Aaronson N, Blazeby JM et al. Guidelines for Developing Questionnaire Modules. 4ed.Bruessels, EORTC,2011

lead_sponsor: Medical University of Graz

location_country: Croatia Poland Spain Italy Austria Netherlands France Germany

location_facility: Jagiellonian University Medical College Krakow

location_facility: Instituto Nazionale Tumori Fondazione Pascale

intervention_type: Other


title: An Open-label, Multicenter, Single-arm, Phase I Dose-escalation With Efficacy Tail Extension Study of Vemurafenib (RO5185426) in Pediatric Patients With Surgically Incurable and Unresectable Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations

summary: This open-label, multicenter. single arm Phase I dose-escalation study with efficacy tail extension will evaluate the maximum tolerated dose/recommended dose, the safety and efficacy of vemurafenib (RO5185426) in pediatric participants (aged 12 through 17) with newly diagnosed or recurrent surgically incurable and unresectable Stage IIIC or Stage IV melanoma harboring BRAFV600 mutations. Participants will receive vemurafenib orally twice daily until disease progression or unacceptable toxicity occurs.

ReferenceCitation: Chisholm JC, Suvada J, Dunkel IJ, Casanova M, Zhang W, Ritchie N, Choi Y, Park J, Das Thakur M, Simko S, Wan Rachel Tam N, Ferrari A. BRIM-P: A phase I, open-label, multicenter, dose-escalation study of vemurafenib in pediatric patients with surgically incurable, BRAF mutation-positive melanoma. Pediatr Blood Cancer. 2018 May;65(5):e26947. doi: 10.1002/pbc.26947. Epub 2018 Jan 19.

lead_sponsor: Hoffmann-La Roche

location_country:
Poland
Spain
Italy
United Kingdom
Australia
United States
Israel
France
Germany
Slovakia


title: 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both Plus Mealtime Insulin in Patients With Type 2 Diabetes Mellitus With a 6-month Safety Extension Period

acronym: EDITION I

summary:
Primary Objective:

To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in HbA1c from baseline to endpoint (scheduled month 6) in adult participants with type 2 diabetes mellitus

Secondary Objectives:

To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal Hypoglycemia

ReferenceCitation: Riddle MC, Bolli GB, Ziemen M, Muehlen-Bartmer I, Bizet F, Home PD; EDITION 1 Study Investigators. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using basal and mealtime insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 1). Diabetes Care. 2014 Oct;37(10):2755-62. doi: 10.2337/dc14-0991. Epub 2014 Jul 30.

ReferenceCitation: Yale JF, Aroda VR, Charbonnel B, Sinclair AJ, Trescoli C, Cahn A, Bigot G, Merino-Trigo A, Brulle-Wohlhueter C, Bolli GB, Ritzel R. Glycaemic control and hypoglycaemia risk with insulin glargine 300 U/mL versus glargine 100 U/mL: A patient-level meta-analysis examining older and younger adults with type 2 diabetes. Diabetes Metab. 2020 Apr;46(2):110-118. doi: 10.1016/j.diabet.2018.10.002. Epub 2018 Oct 23.

ReferenceCitation: Bonadonna RC, Renard E, Cheng A, Fritsche A, Cali A, Melas-Melt L, Umpierrez GE. Switching to insulin glargine 300 U/mL: Is duration of prior basal insulin therapy important? Diabetes Res Clin Pract. 2018 Aug;142:19-25. doi: 10.1016/j.diabres.2018.03.041. Epub 2018 Apr 9.

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

lead_sponsor: Sanofi

location_country:
Romania
Latvia
Estonia
Netherlands
Finland
Canada
Hungary
United States
France
South Africa
Mexico
Germany
Czechia

location_facility:
Investigational Site Number 233006
Investigational Site Number 428001
Investigational Site Number 840114
Investigational Site Number 840022
Investigational Site Number 840058
Investigational Site Number 840012
Investigational Site Number 124017
Investigational Site Number 348018
Investigational Site Number 840156
Investigational Site Number 840116
Investigational Site Number 840129
Investigational Site Number 124021
Investigational Site Number 840091
Investigational Site Number 840098
Investigational Site Number 840053
Investigational Site Number 840055
Investigational Site Number 428004
Investigational Site Number 840013
Investigational Site Number 642003
Investigational Site Number 840123
Investigational Site Number 840085
Investigational Site Number 348013
Investigational Site Number 528004
Investigational Site Number 528006
Investigational Site Number 840018
Investigational Site Number 428002
Investigational Site Number 348017
Investigational Site Number 528005
Investigational Site Number 528001
Investigational Site Number 840045
Investigational Site Number 840117
Investigational Site Number 124001
Investigational Site Number 246005
Investigational Site Number 642001
Investigational Site Number 840102
Investigational Site Number 840136
Investigational Site Number 124024
Investigational Site Number 250004
Investigational Site Number 840066
Investigational Site Number 124011
Investigational Site Number 840076
Investigational Site Number 124006
Investigational Site Number 348011
Investigational Site Number 124022
Investigational Site Number 428003
Investigational Site Number 840080
Investigational Site Number 840100
Investigational Site Number 840059
Investigational Site Number 484007
Investigational Site Number 840104
Investigational Site Number 840084
Investigational Site Number 840070
Investigational Site Number 710008
Investigational Site Number 642009
Investigational Site Number 484003
Investigational Site Number 348009
Investigational Site Number 124019
Investigational Site Number 840004
Investigational Site Number 124023
Investigational Site Number 348003
Investigational Site Number 642004
Investigational Site Number 203006
Investigational Site Number 840155
Investigational Site Number 203005
Investigational Site Number 246001
Investigational Site Number 840120
Investigational Site Number 840032
Investigational Site Number 276003
Investigational Site Number 710006
Investigational Site Number 840122
Investigational Site Number 348010
Investigational Site Number 348008
Investigational Site Number 484001
Investigational Site Number 233005
Investigational Site Number 124002
Investigational Site Number 840002
Investigational Site Number 484006
Investigational Site Number 840003
Investigational Site Number 203008
Investigational Site Number 233001
Investigational Site Number 840078
Investigational Site Number 124005
Investigational Site Number 840041
Investigational Site Number 840071
Investigational Site Number 840047
Investigational Site Number 840106
Investigational Site Number 840001
Investigational Site Number 203002
Investigational Site Number 840048
Investigational Site Number 840083
Investigational Site Number 840126
Investigational Site Number 840159
Investigational Site Number 840148
Investigational Site Number 233002
Investigational Site Number 840086
Investigational Site Number 528002
Investigational Site Number 840020
Investigational Site Number 840133
Investigational Site Number 246002
Investigational Site Number 840152
Investigational Site Number 124009
Investigational Site Number 124015
Investigational Site Number 348012
Investigational Site Number 840107
Investigational Site Number 484004
Investigational Site Number 528007
Investigational Site Number 348005
Investigational Site Number 642007
Investigational Site Number 203007
Investigational Site Number 840060
Investigational Site Number 840042
Investigational Site Number 642005
Investigational Site Number 840007
Investigational Site Number 642002
Investigational Site Number 840011
Investigational Site Number 710005
Investigational Site Number 840097
Investigational Site Number 203004
Investigational Site Number 124018
Investigational Site Number 840068
Investigational Site Number 840090
Investigational Site Number 840089
Investigational Site Number 124025
Investigational Site Number 840075
Investigational Site Number 642006
Investigational Site Number 840092
Investigational Site Number 840015
Investigational Site Number 840065
Investigational Site Number 428006
Investigational Site Number 710003
Investigational Site Number 276006
Investigational Site Number 276002
Investigational Site Number 840062
Investigational Site Number 840127
Investigational Site Number 840143
Investigational Site Number 840016
Investigational Site Number 124014
Investigational Site Number 203009
Investigational Site Number 528008
Investigational Site Number 840036
Investigational Site Number 203010
Investigational Site Number 840019
Investigational Site Number 840146
Investigational Site Number 233003
Investigational Site Number 710001
Investigational Site Number 840082
Investigational Site Number 840035
Investigational Site Number 840008
Investigational Site Number 840145
Investigational Site Number 348015
Investigational Site Number 124020
Investigational Site Number 642008
Investigational Site Number 840124
Investigational Site Number 124004
Investigational Site Number 250002
Investigational Site Number 840021
Investigational Site Number 840039
Investigational Site Number 840034
Investigational Site Number 124008
Investigational Site Number 840121
Investigational Site Number 428005
Investigational Site Number 348002
Investigational Site Number 840112
Investigational Site Number 528009
Investigational Site Number 840043
Investigational Site Number 840057
Investigational Site Number 840009
Investigational Site Number 840023
Investigational Site Number 348007
Investigational Site Number 840081
Investigational Site Number 840119
Investigational Site Number 840074
Investigational Site Number 348006
Investigational Site Number 710004
Investigational Site Number 840010
Investigational Site Number 124007
Investigational Site Number 348014
Investigational Site Number 203001
Investigational Site Number 840050
Investigational Site Number 710002
Investigational Site Number 840052
Investigational Site Number 840049
Investigational Site Number 840079
Investigational Site Number 840099
Investigational Site Number 348001
Investigational Site Number 840005
Investigational Site Number 840067
Investigational Site Number 124026
Investigational Site Number 203003
Investigational Site Number 348004
Investigational Site Number 124010
Investigational Site Number 233004
Investigational Site Number 840103


title: A Phase 1 Multi-center, Open-label Dose Escalation and Expansion Study of PCA062 Administered Intravenously in Adult Patients With p-CAD Positive Tumors

summary: A first-in-human sttudy using PCA062 in patients with p-CAD positive solid tumors.

ReferenceCitation: Duca M, Lim DW, Subbiah V, Takahashi S, Sarantopoulos J, Varga A, D'Alessio JA, Abrams T, Sheng Q, Tan EY, Rosa MS, Gonzalez-Maffe J, Sand-Dejmek J, Fabre C, Martin M. A First-in-Human, Phase I, Multicenter, Open-Label, Dose-Escalation Study of PCA062: An Antibody-Drug Conjugate Targeting P-Cadherin, in Patients With Solid Tumors. Mol Cancer Ther. 2022 Apr 1;21(4):625-634. doi: 10.1158/1535-7163.MCT-21-0652.

location_country:
Spain
Italy
United States
France
Japan
Singapore


title: A Safety Open-label Study of Gevokizumab in the Treatment of Patients With Chronic Non-infectious Uveitis Disease, an eXtension Study. The EYEGUARD-X Study

acronym: EYEGUARD-X

summary: The objective of this study is to evaluate long-term safety of gevokizumab in patient with chronic non-infectious uveitis who previously well tolerated the study drug and may benefit from longterm treatment with gevokizumab.

ReferenceCitation: Tugal-Tutkun I, Pavesio C, De Cordoue A, Bernard-Poenaru O, Gül A. Use of Gevokizumab in Patients with Behçet's Disease Uveitis: An International, Randomized, Double-Masked, Placebo-Controlled Study and Open-Label Extension Study. Ocul Immunol Inflamm. 2018;26(7):1023-1033. doi: 10.1080/09273948.2017.1421233. Epub 2018 Jan 25.

ipd_sharing_description:
Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies:

submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
Taiwan
Portugal
Spain
Greece
Austria
Australia
Italy
United Kingdom
Tunisia
Korea, Republic of
France
Turkey
Germany

location_facility: Moorfields Eye Hospital NHS Foundation Trust

intervention_type: Biological


title: A Phase Ib, Multi-center, Open-label, Dose-escalation Study of PIM447 in Combination With Ruxolitinib (INC424) and LEE011 Administered Orally in Patients With Myelofibrosis

summary: This is a phase Ib study with the primary purpose is to estimate the MTD and/or RDE for the triple combination of PIM447, formerly LGH447, plus ruxolitinib and LEE011 as well as for the doublets, PIM447 plus ruxolitinib, and LEE011 plus ruxolitinib, in patients with myelofibrosis (MF). Each regimen will be assessed for safety, tolerability, pharmacokinetics (PK) and pharmacodynamic effects, and preliminary anti-myelofibrosis activity, including changes in spleen volume, JAK2V617F allele burden, and hematologic response.

location_country:
United Kingdom
Italy
Australia
Netherlands
Canada
France
Singapore
Germany


title: An Open-Label Extension of Study HGT-SAN-093 Evaluating the Safety and Efficacy Study of HGT-1410 (Recombinant Human Heparan N Sulfatase) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Mucopolysaccharidosis Type IIIA Disease

lead_sponsor: Shire

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

location_country:
Spain
Italy
United Kingdom
Netherlands
United States
France
Germany

location_facility: University of North Carolina at Chapel Hill

location_facility: Azienda Socio Sanitaria Territoriale - Asst di Monza

location_facility: Hospital Universitario Vall D'hebron - Ppds

summary: This extension study will allow participants to continue receiving treatment with HGT-1410 and to initiate treatment in patients who received no-treatment in Study HGT-SAN-093, and will evaluate the long-term safety and efficacy of the study drug.


title: Long-term Experience With Abatacept SC in Routine Clinical Practice

acronym: ASCORE

summary: The purpose of this study is to estimate the retention rate of Abatacept SC over 24 months in routine clinical practice, in rheumatoid arthritis patients, in each country involved in the study. The purpose of the UK substudy is to explore whether integrating self-assessment into routine care could maintain tight control (of inflammation/disease activity) and at potentially lower cost resulting in improved health outcomes and cost-effectiveness.

ReferenceCitation: Alten R, Mariette X, Flipo RM, Caporali R, Buch MH, Patel Y, Marsal S, Sanmartí R, Nurmohamed MT, Griffiths H, Peichl P, Bannert B, Chartier M, Connolly SE, Lozenski K, Rauch C. Retention of subcutaneous abatacept for the treatment of rheumatoid arthritis: real-world results from the ASCORE study: an international 2-year observational study. Clin Rheumatol. 2022 Aug;41(8):2361-2373. doi: 10.1007/s10067-022-06176-1. Epub 2022 May 10.

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Greece
Austria
Australia
Italy
Netherlands
Monaco
Switzerland
United Kingdom
France
Germany


title: A Phase I, Multicenter, Open-label Study of Oral LGH447 in Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome

summary: This study will assess the safety and preliminary efficacy of escalating doses of LGH447 monotherapy in AML and MDS and LGH447 in combination with midostaurin in AML.

location_country:
Italy
Australia
Netherlands
United States
France
Japan
Germany


type: Other Grant/Funding Number

title: Giant Intracranial Aneurysm Registry

summary: The purpose of this study is to generate detailed insight into which therapies of giant intracranial aneurysms are being conducted, to document the natural history and the outcome of treatment over 5 years after inclusion into the Registry and to follow imaging data of giant aneurysms over years after diagnosis.

ReferenceCitation: Dengler J, Heuschmann PU, Endres M, Meyer B, Rohde V, Rufenacht DA, Vajkoczy P; Giant Intracranial Aneurysm Study Group. The rationale and design of the Giant Intracranial Aneurysm Registry: a retrospective and prospective study. Int J Stroke. 2011 Jun;6(3):266-70. doi: 10.1111/j.1747-4949.2011.00588.x. Epub 2011 Apr 7.

ReferenceCitation: Dengler J, Rüfenacht D, Meyer B, Rohde V, Endres M, Lenga P, Uttinger K, Rücker V, Wostrack M, Kursumovic A, Hong B, Mielke D, Schmidt NO, Burkhardt JK, Bijlenga P, Boccardi E, Cognard C, Heuschmann PU, Vajkoczy P; Giant Intracranial Aneurysm Study Group. Giant intracranial aneurysms: natural history and 1-year case fatality after endovascular or surgical treatment. J Neurosurg. 2019 Dec 6;134(1):49-57. doi: 10.3171/2019.8.JNS183078.

ReferenceCitation: Haemmerli J, Lenga P, Hong B, Kursumovic A, Maldaner N, Burkhardt JK, Bijlenga P, Rüfenacht DA, Schmidt NO, Vajkoczy P, Dengler J. Clinical implications and radiographic characteristics of the relation between giant intracranial aneurysms of the posterior circulation and the brainstem. Acta Neurochir (Wien). 2019 Sep;161(9):1747-1753. doi: 10.1007/s00701-019-04016-x. Epub 2019 Jul 29.

ReferenceCitation: Lenga P, Hohaus C, Hong B, Kursumovic A, Maldaner N, Burkhardt JK, Bijlenga P, Rüfenacht DA, Schmidt NO, Vajkoczy P, Dengler J. Giant intracranial aneurysms of the posterior circulation and their relation to the brainstem: analysis of risk factors for neurological deficits. J Neurosurg. 2018 Aug 10;131(2):403-409. doi: 10.3171/2018.4.JNS172343.

ReferenceCitation: Durner G, Piano M, Lenga P, Mielke D, Hohaus C, Guhl S, Maldaner N, Burkhardt JK, Pedro MT, Lehmberg J, Rufenacht D, Bijlenga P, Etminan N, Krauss JK, Boccardi E, Hänggi D, Vajkoczy P, Dengler J; Giant Intracranial Aneurysm Study Group. Cranial nerve deficits in giant cavernous carotid aneurysms and their relation to aneurysm morphology and location. Acta Neurochir (Wien). 2018 Aug;160(8):1653-1660. doi: 10.1007/s00701-018-3580-2. Epub 2018 Jun 9.

ReferenceCitation: Maldaner N, Guhl S, Mielke D, Musahl C, Schmidt NO, Wostrack M, Rüfenacht DA, Vajkoczy P, Dengler J; Giant Intracranial Aneurysm Study Group. Changes in volume of giant intracranial aneurysms treated by surgical strategies other than direct clipping. Acta Neurochir (Wien). 2015 Jul;157(7):1117-23; discussion 1123. doi: 10.1007/s00701-015-2448-y. Epub 2015 May 23.

ReferenceCitation: Dengler J, Maldaner N, Bijlenga P, Burkhardt JK, Graewe A, Guhl S, Hong B, Hohaus C, Kursumovic A, Mielke D, Schebesch KM, Wostrack M, Rufenacht D, Vajkoczy P, Schmidt NO; Giant Intracranial Aneurysm Study Group. Perianeurysmal edema in giant intracranial aneurysms in relation to aneurysm location, size, and partial thrombosis. J Neurosurg. 2015 Aug;123(2):446-52. doi: 10.3171/2014.10.JNS141560. Epub 2015 Apr 17. Erratum in: J Neurosurg. 2015 Aug;123(2):478.

ReferenceCitation: Dengler J, Maldaner N, Bijlenga P, Burkhardt JK, Graewe A, Guhl S, Nakamura M, Hohaus C, Kursumovic A, Schmidt NO, Schebesch KM, Wostrack M, Vajkoczy P, Mielke D; Giant Intracranial Aneurysm Study Group. Quantifying unruptured giant intracranial aneurysms by measuring diameter and volume--a comparative analysis of 69 cases. Acta Neurochir (Wien). 2015 Mar;157(3):361-8; discussion 368. doi: 10.1007/s00701-014-2292-5. Epub 2014 Dec 12.

lead_sponsor: Dr. med. Julius Dengler

location_country:
Italy
Austria
Netherlands
Russian Federation
Finland
Switzerland
France
Japan
Germany

location_facility: Department of Neurosurgery, Kantonsspital Aarau

location_facility: Department of Neurosurgery, Charité Berlin

location_facility: Department of Neurosurgery - University of Greifswald

location_facility: Department of Neurosurgery, University of Freiburg

location_facility: Department of Neurosurgery - University of Goettingen

location_facility: Department of Neurosurgery and Neuroradiology, Klinikum Deggendorf

location_facility: Department of Neurosurgery, Jikei University

location_facility: Department of Neurosurgery, Helsinki University Central

location_facility: Department of Neurology - Charité Berlin

location_facility: Department of Neuroradiology - Klinikum Hirslanden

location_facility: Department of Neurosurgery - University of Hamburg

location_facility: Department of Neuroradiology, University of Leipzig

location_facility: Department of Neuroradiology, Ospedale Niguarda Ca' Granda

location_facility: Department of Neurosurgery, University Hospital of Zurich

location_facility: Department of Neuroradiology, University Hospital

location_facility: Institut für Klinische Epidemiologie und Biometrie der Universität Wuerzburg

location_facility: Department of Neurosurgery, Burdenko Neurosurgical Institute

location_facility: Department of Neurosurgery - University of Geneva

location_facility: Department of Neurosurgery - University of Regensburg

location_facility: Department of Neurosurgery, Friedrich-Schiller-University

location_facility: Department of Neurosurgery - Technical University of Munich

location_facility: Department of Neurosurgery, Medical University Vienna


title: Phase II Study of the Tumor-targeting Human F16IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Paclitaxel in Patients With Metastatic Merkel Cell Carcinoma

summary:
There is no standard treatment for Merkel cell carcinoma(MCC), as no randomized trials have been conducted to establish standard of care. Despite a sizable number of objective responses induced by combination cyototoxic chemotherapy, a prolongation of patients overall survival has never been demonstrated.

This open-label, randomized, double-arm, multi-centre, phase II study of F16IL2 in combination with paclitaxel versus paclitaxel monotherapy, proposes to test the therapeutic efficacy of F16IL2 plus paclitaxel in patients with metastatic Merkel cell carcinoma, who are not amenable to surgery.

A total of 90 patients with Merkel cell carcinoma will be enrolled and treated during the study; 45 patients will receive the combination treatment of F16IL2 and paclitaxel (Arm A), and 45 patients will receive paclitaxel monotherapy (Arm B).

lead_sponsor: Philogen S.p.A.

location_country:
Denmark
Spain
United Kingdom
Austria
France
Germany

location_facility:
Eberhard-Karls- University Hospital
Saint-Louis- Hospital
Medical University Hospital
Universitätsklinik Essen
Nottingham Trent- University Hospital
Charité- Medical University Hospital
Herlev- University Hospital
ICMiD- University Hospital


title: Observational Study of Total Ankle Arthroplasty and Tibiotalar Arthrodesis

summary:
In case of severe ankle arthritis, the two common surgical treatments are tibiotalar arthrodesis and total ankle arthroplasty. Few studies have compared these treatments and it remains difficult to determine which operation is the better solution for end stage ankle arthritis.

The purpose of the present study is to analyze patient's outcome after each type of ankle surgery and to describe the decision making process.

status: Withdrawn

lead_sponsor: Integra LifeSciences Services

location_country:
Portugal
Spain
Italy
United Kingdom
France
Belgium
Netherlands

location_facility:
Musgrave Park Hospital
I.R.C.C.S. Istituto Ortopedico Galeazzi
Hospital Pedro Hispano
Hospital clinico y provincial
AZ Turnout - Clinic Sint-Jozef
Katholieke Universiteit Leuven
Clinique Axium
Sint Lucas Andreas Ziekenhuis


title: Study 200170: A Rollover Study to Provide Continued Treatment With Eltrombopag

summary: This study will provide continued access to treatment with eltrombopag for subjects who are currently participating in a GlaxoSmithKline (GSK) sponsored investigational study of eltrombopag (parent study) and to collect long term safety data.

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
Hong Kong
Romania
Greece
Ireland
Tunisia
Korea, Republic of
France
Peru
China
Belgium
Netherlands


title: A Randomised Open-Label Phase II Study to Assess the Efficacy & Safety of AZD4547 Monotherapy Versus Paclitaxel in Patients With Advanced Gastric Adenocarcinoma (Inc. Adenocarcinoma of the Lower Third of the Oesophagus or the Gastro-Oesophageal Junction)With FGFR2 Polysomy or Gene Amplification.

acronym: SHINE

summary: The purpose of this study is to assess the efficacy, safety and tolerability of AZD4547 compared with paclitaxel in patients with advanced gastric or lower-oesophageal cancer whose tumours are found to have FGFR2 polysomy or gene amplification.

lead_sponsor: AstraZeneca

location_country:
Taiwan
Romania
Spain
Italy
United Kingdom
Canada
Czech Republic
Ukraine
Hungary
Korea, Republic of
France
India
Belgium
Japan
Germany
Bulgaria


title: Combination Corticosteroids + 5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis.

summary: The role of steroids in the treatment of ulcerative Colitis (UC) is well established, and recommended by professional societies. However, there are no data investigating whether the addition and/or continuation of 5-aminosalicylic agents as combination therapy with systemic corticosteroids is superior to corticosteroids alone in patients with moderate-severe active UC. Thus, in practical terms, the decision regarding 5-aminosalicylic (to add or continue), on top of steroids treatment, is taken on an arbitrary basis. The aim of this study is to compare the efficacy of steroids alone Vs combination of steroids + 5-aminosalicylic in the treatment of moderate-severe UC exacerbation.

ReferenceCitation: Ben-Horin S, Har-Noy O, Katsanos KH, Roblin X, Chen M, Gao X, Schwartz D, Cheon JH, Cesarini M, Bojic D, Protic M, Theodoropoulou A, Abu-Kaf H, Engel T, Tang J, Veyrard P, Lin X, Mao R, Christodoulou D, Karmiris K, Knezevic-Ivanovski T; ComboMesa investigators. Corticosteroids and Mesalamine Versus Corticosteroids for Acute Severe Ulcerative Colitis: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2022 Mar 8. pii: S1542-3565(22)00213-0. doi: 10.1016/j.cgh.2022.02.055. [Epub ahead of print]

lead_sponsor: Sheba Medical Center

location_country:
Serbia
Italy
Greece
Korea, Republic of
Israel
France
China

location_facility: nstitute of Gastroenterology and Department of Internal Medicine, Yonsei University College of Medicine

location_facility: Department of Gastroenterology Venizeleio General Hospital, Leoforos Knosou

location_facility: Gastroenterology department, Soroka medical center

location_facility: Department of Gastroenterology and Hepatology,The First Affiliated Hospital of Sun Yat-sen University

location_facility: Service de Gastrologie-Entérologie-Hépatologie, Centre Hospitalier Universitaire de Saint-Étienne

location_facility: Department of Gastroenterology, University Hospital & Medical School of Ionnina

location_facility: 6th affiliated hospital of Sun yat-sen university

location_facility: Zvezdara University Clinical Center, Gastroenterology Department


title: Phase I-II Study of Vinblastine in Combination With Nilotinib in Children, Adolescents, and Young Adults With Refractory or Recurrent Low-Grade Glioma

acronym: VINILO

summary: Multicenter, open label, prospective study including successively a phase I trial and then a phase II trial Phase I : Open label, non-randomized, sequential dose escalation of both drugs, vinblastine and nilotinib.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

location_country:
Denmark
Spain
Italy
Austria
United Kingdom
Switzerland
France
Netherlands

location_facility: Cancer Research UK Clinical Trials Unit School of Cancer Sciences University of Birmingham


title: PHASE I-II STUDY OF VINBLASTINE IN COMBINATION WITH NILOTINIB IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS WITH REFRACTORY OR RECURRENT LOW-GRADE GLIOMA

ReferenceCitation: Vairy S, Le Teuff G, Bautista F, De Carli E, Bertozzi AI, Pagnier A, Fouyssac F, Nysom K, Aerts I, Leblond P, Millot F, Berger C, Canale S, Paci A, Poinsignon V, Chevance A, Ezzalfani M, Vidaud D, Di Giannatale A, Hladun-Alvaro R, Petit FM, Vassal G, Geoerger B, Le Deley MC, Grill J. Phase I study of vinblastine in combination with nilotinib in children, adolescents, and young adults with refractory or recurrent low-grade glioma. Neurooncol Adv. 2020 Jun 9;2(1):vdaa075. doi: 10.1093/noajnl/vdaa075. eCollection 2020 Jan-Dec.


title: A Phase II, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Adaptive Dose-ranging Study to Evaluate the Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis

summary: To evaluate the efficacy and safety of AIN457 versus placebo in patients with relapsing multiple sclerosis.

location_country:
Poland
Spain
Italy
Russian Federation
Czech Republic
France
Turkey
Belgium
Japan
Sweden


title: An Open-Label Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Etravirine (ETR) in Combination With Other Antiretrovirals (ARVs) in Antiretroviral Treatment-Experienced HIV-1 Infected Subjects

summary: The purpose of this study is to learn more about the safety and tolerability of etravirine. Etravirine is a type of non-nucleoside reverse transcriptase inhibitor (NNRTI) which has shown high activity against wild-type human immunodeficiency virus (HIV-1), and HIV strains resistant to other non-nucleotide agents.

ReferenceCitation: Arathoon E, Bhorat A, Silaghi R, Crauwels H, Lavreys L, Tambuyzer L, Vanveggel S, Opsomer M. Week 48 results of a Phase IV trial of etravirine with antiretrovirals other than darunavir/ritonavir in HIV-1-infected treatment-experienced adults. J Int AIDS Soc. 2014 Nov 2;17(4 Suppl 3):19783. doi: 10.7448/IAS.17.4.19783. eCollection 2014.

lead_sponsor: Janssen R&D Ireland

location_country:
Romania
Russian Federation
Argentina
Ukraine
Guatemala
Puerto Rico
United States
France
Peru
South Africa
Mexico


title: Multi Center, Prospective, Non-Randomized, Single-Arm Trial Evaluating the Clinical Safety and Performance Of the HeartWare MVAD® System For the Treatment of Advanced Heart Failure

summary: This multi-center, prospective, non-randomized, single-arm trial will investigate the safety and performance of the HeartWare® Miniaturized Ventricular Assist Device (MVAD®) system over 24 months in subjects with advanced heart failure

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
United Kingdom
Austria
Australia
France
Germany

location_facility:
Papworth Hospital NHS Foundation
Uniklinik Hamburg Eppendorf (UKE)
German Heart Institute Berlin DHZB
St. Vincents Hospital
Duesseldorf University Hospital
The Heart and Diabetes Center NRW
Medical University AKH Vienna
Hospitalier Pitié-Salpétrière
Hannover Medical School MHH
Freeman Hospital
University of Leipzig Heart Center


title: A Phase Ib/II, Open-label, Multicenter Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma

summary: A phase Ib dose-escalation study of the AEB071 and MEK162 combination in adult patients with confirmed metastatic uveal melanoma. Cohorts of 3-6 patients will be assessed for dose limiting toxicities (DLTs) during Cycle 1 until the maximum tolerated dose (MTD) of the combination therapy is determined. The MTD or Phase 2 Recommended Dose (P2RD) will be used in a Phase II part of the study, which will enrol 55 patients each into two randomized groups: the combination therapy or MEK162 alone. The Phase II part will continue until proof of concept is established. Patients will continue treatment as long as clinical benefit is seen and no limiting adverse toxicity is observed

lead_sponsor: Array Biopharma, now a wholly owned subsidiary of Pfizer

location_country:
Spain
United Kingdom
Netherlands
United States
France
Germany

location_facility: Memorial Sloan Kettering Cancer Center Dept of Onc..


title: A Randomized, Double-blind, Placebo-controlled Study Of The Safety And Efficacy Of Etanercept In Subjects With Rheumatoid Arthritis Who Have Had An Inadequate Response To Adalimumab Or Infliximab Plus Methotrexate

acronym: SERUM

summary: The first 12 weeks of this study will compare the efficacy of etanercept 50 mg once-weekly to placebo in subjects with rheumatoid arthritis who have not responded well to infliximab or adalimumab plus methotrexate. This comparison will be performed for all subjects and separately for subjects who are anti-drug antibody positive for one of these medications. From week 12 to week 24, all subjects will receive etanercept 50 mg once-weekly. The effect of anti-drug antibody status on the efficacy of etanercept as well as the safety profile of etanercept in these subjects will also be evaluated throughout the study.

lead_sponsor: Pfizer

location_country:
Hong Kong
Spain
Russian Federation
Australia
France
Israel
Belgium

location_facility: Scientific Institute of Rheumatology of Russian Academy of Medical Science

location_facility: Hospital Regional Universitario Carlos Haya. Hospital Civil

location_facility: LLC "Alliance Biomedical - Russian Group"

location_facility: GBOU VPO Moscow State University of Medicine and Dentistry

location_facility: LLC Research Medical Complex "Your Health" based on City Clinical Hospital #7

location_facility: Cliniques Universitaires Saint-Luc / Service de Rhumatologie


title: A Dose-finding Phase Ib Multicenter Study of Imatinib in Combination With the Oral Phosphatidyl-inositol 3-kinase (PI3K) Inhibitor BYL719 in Patients With Gastrointestinal Stromal Tumor (GIST) Who Failed Prior Therapy With Imatinib and Sunitinib

summary: The purpose of this study is to determine a maximum tolerated dose and/or recommended phase 2 dose of a combination of imatinib and BYL719 in the treatment of 3rd line GIST patients.

ReferenceCitation: Pantaleo MA, Heinrich MC, Italiano A, Valverde C, Schöffski P, Grignani G, Reyners AKL, Bauer S, Reichardt P, Stark D, Berhanu G, Brandt U, Stefanelli T, Gelderblom H. A multicenter, dose-finding, phase 1b study of imatinib in combination with alpelisib as third-line treatment in patients with advanced gastrointestinal stromal tumor. BMC Cancer. 2022 May 6;22(1):511. doi: 10.1186/s12885-022-09610-4.

lead_sponsor: Novartis Pharmaceuticals

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

location_facility: Oregon Health and Science University Dept. of OHSU (3)


title: An Exploratory Evaluation of Interleukin 28B (IL28B) Genotype, Single Nucleotide Polymorphisms (SNP) of rs12356193, Protein and RNA Biomarkers in Serum Samples (Stored, Already Obtained From Completed Studies) From Subjects With HBe-antigen Positive or Negative Chronic Hepatitis B, Who Have Completed Therapy for Hepatitis B With Pegasys ± Lamivudine.

summary: This retrospective study will evaluate the association of biomarkers and the treatment response of patients with chronic hepatitis B, who have completed therapy with Pegasys (peginterferon alfa-2a) ± lamivudine. For the analysis stored serum samples obtained from patients will be used; no actual patients are involved.

time_perspective: Retrospective

ReferenceCitation: van Bömmel F, van Bömmel A, Krauel A, Wat C, Pavlovic V, Yang L, Deichsel D, Berg T, Böhm S. Serum HBV RNA as a Predictor of Peginterferon Alfa-2a Response in Patients With HBeAg-Positive Chronic Hepatitis B. J Infect Dis. 2018 Aug 24;218(7):1066-1074. doi: 10.1093/infdis/jiy270.

location_country:
Taiwan
Hong Kong
Italy
Russian Federation
Australia
New Zealand
Thailand
Korea, Republic of
France
Singapore


primary_purpose: Basic Science

acronym: The ONE Study Reference Group Trial

title: Reference Group Trial for The ONE Study: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation

lead_sponsor: University of Regensburg

ReferenceCitation: Sawitzki B, Harden PN, Reinke P, Moreau A, Hutchinson JA, Game DS, Tang Q, Guinan EC, Battaglia M, Burlingham WJ, Roberts ISD, Streitz M, Josien R, Böger CA, Scottà C, Markmann JF, Hester JL, Juerchott K, Braudeau C, James B, Contreras-Ruiz L, van der Net JB, Bergler T, Caldara R, Petchey W, Edinger M, Dupas N, Kapinsky M, Mutzbauer I, Otto NM, Öllinger R, Hernandez-Fuentes MP, Issa F, Ahrens N, Meyenberg C, Karitzky S, Kunzendorf U, Knechtle SJ, Grinyó J, Morris PJ, Brent L, Bushell A, Turka LA, Bluestone JA, Lechler RI, Schlitt HJ, Cuturi MC, Schlickeiser S, Friend PJ, Miloud T, Scheffold A, Secchi A, Crisalli K, Kang SM, Hilton R, Banas B, Blancho G, Volk HD, Lombardi G, Wood KJ, Geissler EK. Regulatory cell therapy in kidney transplantation (The ONE Study): a harmonised design and analysis of seven non-randomised, single-arm, phase 1/2A trials. Lancet. 2020 May 23;395(10237):1627-1639. doi: 10.1016/S0140-6736(20)30167-7. Erratum in: Lancet. 2020 Jun 27;395(10242):1972.

location_country:
United Kingdom
Italy
United States
France
Germany

location_facility: Guy's Hospital in affiliation with King's College London

location_facility: Churchill Hospital in affiliation with the University of Oxford

summary: To investigate the progression of the immunological response in living-donor kidney transplant recipients treated with a standard immunosuppressive regimen. Clinical, immunological, and health-economic data collected during this Reference Group Trial will be used to corroborate historical renal transplantation statistics and generate reference ranges for future clinical studies that will test immunoregulatory cell therapy as an adjunct immunosuppressive treatment in renal transplantation.


title: Randomized, Long-Term Administration of pH-Neutral PD Solutions Containing Lactate (BALANCE) or Bicarbonate (BICAVERA) in Children

acronym: BIOKID

summary:
Peritoneal Dialysis (PD) is the preferred treatment modality in children with end-stage renal disease. Unfortunately progressive alterations of the peritoneal membrane occur with time on PD, leading to a continuous loss of peritoneal transport function. Recently, double-chambered PD solutions with less Glucose Degradation Products (GDPs) and neutral pH have been approved for the European market. Short term administration suggests comparable clearance rates compared with conventional solutions. In vitro studies demonstrate an improved local immune defense system. To compensate for metabolic acidosis, the available solutions either contain lactate or bicarbonate, the impact of either buffer on long term acidosis control and peritoneal membrane integrity, however, is unknown.

The prospective, European multi-center study will provide the first long term administration of pH neutral, low GDP solutions in children. 60 children will randomly be treated with a bicarbonate (BicaVera) and a lactate based solution (Balance), respectively. The primary end point will be the effect of either PD-solution on peritoneal transport characteristics (D/P Creatinine). Secondary end-points will be the effects on ultrafiltration capacity, acid-base balance, peritoneal morphology, incidence and severity of peritonitis, and on surrogate parameters of biocompatibility and carbonyl stress. Moreover, potential genetic determinants of the peritoneal transporter status and of the continued morphological transformation of the peritoneum will be assessed.

After a 2 month run-in period, using a conventional, acidic, single-chambered PD-solution, the patients will be randomized to a 10 month study period using BicaVera and Balance, respectively. Dialysis regime and follow up in the out-patient clinic will be performed according to clinical needs (every 4 weeks); episodes of peritonitis will be treated according to international guidelines. Bicarbonate supplements will be prescribed at a dose of 0.5 mmol/kg *d, if blood bicarbonate levels fall below 17 mmol/l. PD adequacy will be verified by routine, monthly venous blood sampling and a capillary blood gas analysis. 2-5 ml of blood will be drawn for analysis of relevant gene polymorphisms. At study entry, after 3, 6 and 10 months, a 24h dialysate- and urine collection, a peritoneal equilibration test an intraperitoneal pressure measurement will be performed. Peritoneal biopsies will be obtained at any time of abdominal surgery. Adverse events will be screened meticulously. The trial will be carried out in accordance with the German medicines act (AMG) and other local requirements, with particular reference to the ICH guidelines for Good Clinical Practice, and the declaration of Helsinki. At study end, the patients will decide together with the responsible physician which PD-fluid should be used further one.

ReferenceCitation: Nau B, Schmitt CP, Almeida M, Arbeiter K, Ardissino G, Bonzel KE, Edefonti A, Fischbach M, Haluany K, Misselwitz J, Kemper MJ, Rönnholm K, Wygoda S, Schaefer F; European Pediatric Peritoneal Dialysis Study Group. BIOKID: randomized controlled trial comparing bicarbonate and lactate buffer in biocompatible peritoneal dialysis solutions in children [ISRCTN81137991]. BMC Nephrol. 2004 Oct 14;5:14.

ReferenceCitation: Schmitt CP, Nau B, Gemulla G, Bonzel KE, Hölttä T, Testa S, Fischbach M, John U, Kemper MJ, Sander A, Arbeiter K, Schaefer F. Effect of the dialysis fluid buffer on peritoneal membrane function in children. Clin J Am Soc Nephrol. 2013 Jan;8(1):108-15. doi: 10.2215/CJN.00690112. Epub 2012 Nov 2.

lead_sponsor: Heidelberg University

location_country: Italy Austria Finland France Germany

location_facility:
University Children's Hospital
University Children´s Hospital


acronym: PARTITA

summary: The purpose of this study is to assess whether the burden of untreated non-sustained ventricular tachycardias (VTs), or episodes treated with anti-tachycardia pacing, correlates with appropriate implantable cardiac defibrillator (ICD) shock therapies and to evaluate if the timing of radiofrequency VT ablation affects the prognosis of ICD recipients.

ReferenceCitation: Reddy VY, Reynolds MR, Neuzil P, Richardson AW, Taborsky M, Jongnarangsin K, Kralovec S, Sediva L, Ruskin JN, Josephson ME. Prophylactic catheter ablation for the prevention of defibrillator therapy. N Engl J Med. 2007 Dec 27;357(26):2657-65.

ReferenceCitation: Kuck KH, Schaumann A, Eckardt L, Willems S, Ventura R, Delacrétaz E, Pitschner HF, Kautzner J, Schumacher B, Hansen PS; VTACH study group. Catheter ablation of stable ventricular tachycardia before defibrillator implantation in patients with coronary heart disease (VTACH): a multicentre randomised controlled trial. Lancet. 2010 Jan 2;375(9708):31-40. doi: 10.1016/S0140-6736(09)61755-4.

ReferenceCitation: Sweeney MO, Sherfesee L, DeGroot PJ, Wathen MS, Wilkoff BL. Differences in effects of electrical therapy type for ventricular arrhythmias on mortality in implantable cardioverter-defibrillator patients. Heart Rhythm. 2010 Mar;7(3):353-60. doi: 10.1016/j.hrthm.2009.11.027. Epub 2009 Dec 2.

ReferenceCitation: Poole JE, Johnson GW, Hellkamp AS, Anderson J, Callans DJ, Raitt MH, Reddy RK, Marchlinski FE, Yee R, Guarnieri T, Talajic M, Wilber DJ, Fishbein DP, Packer DL, Mark DB, Lee KL, Bardy GH. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med. 2008 Sep 4;359(10):1009-17. doi: 10.1056/NEJMoa071098.

ReferenceCitation: Varma N, Epstein AE, Irimpen A, Schweikert R, Love C; TRUST Investigators. Efficacy and safety of automatic remote monitoring for implantable cardioverter-defibrillator follow-up: the Lumos-T Safely Reduces Routine Office Device Follow-up (TRUST) trial. Circulation. 2010 Jul 27;122(4):325-32. doi: 10.1161/CIRCULATIONAHA.110.937409. Epub 2010 Jul 12.

ReferenceCitation: Varma N, Michalski J, Epstein AE, Schweikert R. Automatic remote monitoring of implantable cardioverter-defibrillator lead and generator performance: the Lumos-T Safely RedUceS RouTine Office Device Follow-Up (TRUST) trial. Circ Arrhythm Electrophysiol. 2010 Oct;3(5):428-36. doi: 10.1161/CIRCEP.110.951962. Epub 2010 Aug 17.

ReferenceCitation: Gilliam FR, Hayes DL, Boehmer JP, Day J, Heidenreich PA, Seth M, Jones PW, Stein KM, Saxon LA. Real world evaluation of dual-zone ICD and CRT-D programming compared to single-zone programming: the ALTITUDE REDUCES study. J Cardiovasc Electrophysiol. 2011 Sep;22(9):1023-9. doi: 10.1111/j.1540-8167.2011.02086.x. Epub 2011 May 31.

ReferenceCitation: Carbucicchio C, Santamaria M, Trevisi N, Maccabelli G, Giraldi F, Fassini G, Riva S, Moltrasio M, Cireddu M, Veglia F, Della Bella P. Catheter ablation for the treatment of electrical storm in patients with implantable cardioverter-defibrillators: short- and long-term outcomes in a prospective single-center study. Circulation. 2008 Jan 29;117(4):462-9. doi: 10.1161/CIRCULATIONAHA.106.686534. Epub 2008 Jan 2.

ReferenceCitation: Della Bella P, Baratto F, Tsiachris D, Trevisi N, Vergara P, Bisceglia C, Petracca F, Carbucicchio C, Benussi S, Maisano F, Alfieri O, Pappalardo F, Zangrillo A, Maccabelli G. Management of ventricular tachycardia in the setting of a dedicated unit for the treatment of complex ventricular arrhythmias: long-term outcome after ablation. Circulation. 2013 Apr 2;127(13):1359-68. doi: 10.1161/CIRCULATIONAHA.112.000872. Epub 2013 Feb 25.

ReferenceCitation: Vergara P, Trevisi N, Ricco A, Petracca F, Baratto F, Cireddu M, Bisceglia C, Maccabelli G, Della Bella P. Late potentials abolition as an additional technique for reduction of arrhythmia recurrence in scar related ventricular tachycardia ablation. J Cardiovasc Electrophysiol. 2012 Jun;23(6):621-7. doi: 10.1111/j.1540-8167.2011.02246.x. Epub 2012 Apr 4.

ReferenceCitation: Della Bella P, Baratto F, Vergara P, Bertocchi P, Santamaria M, Notarstefano P, Calò L, Orsida D, Tomasi L, Piacenti M, Sangiorgio S, Pentimalli F, Pruvot E, De Sousa J, Sacher F, Tritto M, Rebellato L, Deneke T, Romano SA, Nesti M, Gargaro A, Giacopelli D, Peretto G, Radinovic A. Does Timing of Ventricular Tachycardia Ablation Affect Prognosis in Patients With an Implantable Cardioverter Defibrillator? Results From the Multicenter Randomized PARTITA Trial. Circulation. 2022 Jun 21;145(25):1829-1838. doi: 10.1161/CIRCULATIONAHA.122.059598. Epub 2022 Apr 3.

ReferenceCitation: Kheiri B, Barbarawi M, Zayed Y, Hicks M, Osman M, Rashdan L, Kyi HH, Bachuwa G, Hassan M, Stecker EC, Nazer B, Bhatt DL. Antiarrhythmic Drugs or Catheter Ablation in the Management of Ventricular Tachyarrhythmias in Patients With Implantable Cardioverter-Defibrillators: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Circ Arrhythm Electrophysiol. 2019 Nov;12(11):e007600. doi: 10.1161/CIRCEP.119.007600. Epub 2019 Nov 8.

lead_sponsor: IRCCS San Raffaele

location_country: Portugal Italy Switzerland France Belgium Germany Czechia

location_facility: Centro Hospitalar Lisboa Norte, Hospital Universitário de Santa Maria

location_facility: Azienda Ospedaliera Valtellina e Valchiavenna

intervention_type: Procedure


title: Open, Multicentre, Randomised, Comparative, Prospective Trial With MD-3511356 Versus Standard Sun Protection Measures in Immunosuppressed Solid Organ Transplanted Patients for Prevention of UV-induced Carcinogenic Skin Alterations

summary: The purpose of this trial is to investigate the prevention of actinic keratoses and squamous cell carcinomas by local application of MD-3511356 in comparison to standard sun protection measures in immunosuppressed solid organ transplant recipients.

primary_purpose: Prevention

lead_sponsor: Spirig Pharma Ltd.

location_country:
United Kingdom
Ireland
Austria
Netherlands
Czech Republic
Switzerland
France
Turkey
Germany

location_facility: Hautklinik am Nationalen Zentrum für Tumorerkrankungen

location_facility: Klinikum der Charité Universitätsmedizin

location_facility: Universitätsspital Zürich, Dermatologische Klinik


title: A Phase III Randomized Study of TH (Paclitaxel and Trastuzumab) Versus THL (Paclitaxel, Trastuzumab and Lapatinib) in First Line Treatment of HER2-positive Metastatic Breast Cancer

acronym: TH V THL

summary: The proposed phase III randomised trial will compare the efficacy of trastuzumab and paclitaxel with trastuzumab, paclitaxel and lapatinib in first line treatment of HER2 positive metastatic breast cancer. The investigators will also examine potential predictive biomarkers of response to trastuzumab and lapatinib in pre-treatment biopsy samples and serum samples.

lead_sponsor: Cancer Trials Ireland

location_country: Portugal Spain Ireland Finland Israel France Norway Germany

location_facility: Hospital General Universitario de Valencia

location_facility: Complejo Hospitalario Xeral Calde / Hospital Lucus Augusti

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Interdisziplinäre Onkologische Zentrum München (IOZ München)

location_facility: Hospital Clinico Universitario 'Lozano Blesa'

location_facility: Hospital Universitari Arnau de Vilanova de Lleida


title: Efficacy and Safety of MRI-based Thrombolysis in Wake-up Stroke: a Randomised, Double-blind, Placebo-controlled Trial

acronym: WAKE-UP

summary: WAKE-UP is an investigator initiated European multicenter randomized controlled clinical trial of MRI based thrombolysis in acute stroke patients with unknown time of symptom onset, e.g. due to recognition of stroke symptoms on awakening. Objective of WAKE-UP is to prove efficacy and safety of MRI-based intravenous thrombolysis with Alteplase in patients waking up with stroke symptoms or patients with otherwise unknown symptom onset.

ReferenceCitation: Thomalla G, Simonsen CZ, Boutitie F, Andersen G, Berthezene Y, Cheng B, Cheripelli B, Cho TH, Fazekas F, Fiehler J, Ford I, Galinovic I, Gellissen S, Golsari A, Gregori J, Günther M, Guibernau J, Häusler KG, Hennerici M, Kemmling A, Marstrand J, Modrau B, Neeb L, Perez de la Ossa N, Puig J, Ringleb P, Roy P, Scheel E, Schonewille W, Serena J, Sunaert S, Villringer K, Wouters A, Thijs V, Ebinger M, Endres M, Fiebach JB, Lemmens R, Muir KW, Nighoghossian N, Pedraza S, Gerloff C; WAKE-UP Investigators. MRI-Guided Thrombolysis for Stroke with Unknown Time of Onset. N Engl J Med. 2018 Aug 16;379(7):611-622. doi: 10.1056/NEJMoa1804355. Epub 2018 May 16.

ReferenceCitation: Barow E, Quandt F, Cheng B, Gelderblom M, Jensen M, Königsberg A, Boutitie F, Nighoghossian N, Ebinger M, Endres M, Fiebach JB, Thijs V, Lemmens R, Muir KW, Pedraza S, Simonsen CZ, Gerloff C, Thomalla G. Association of White Blood Cell Count With Clinical Outcome Independent of Treatment With Alteplase in Acute Ischemic Stroke. Front Neurol. 2022 Jun 13;13:877367. doi: 10.3389/fneur.2022.877367. eCollection 2022.

ReferenceCitation: Schlemm L, Braemswig TB, Boutitie F, Vynckier J, Jensen M, Galinovic I, Simonsen CZ, Cheng B, Cho TH, Fiehler J, Puig J, Thijs V, Fiebach J, Muir K, Nighoghossian N, Ebinger M, Pedraza S, Thomalla G, Gerloff C, Endres M, Lemmens R, Nolte CH; WAKE-UP Investigators. Cerebral Microbleeds and Treatment Effect of Intravenous Thrombolysis in Acute Stroke: An Analysis of the WAKE-UP Randomized Clinical Trial. Neurology. 2022 Jan 18;98(3):e302-e314. doi: 10.1212/WNL.0000000000013055. Epub 2021 Nov 15.

ReferenceCitation: Lettow I, Jensen M, Schlemm E, Boutitie F, Quandt F, Cheng B, Ebinger M, Endres M, Fiebach JB, Thijs V, Lemmens R, Muir KW, Nighoghossian N, Pedraza S, Simonsen CZ, Gerloff C, Thomalla G; WAKE-UP Investigators. Serious Adverse Events and Their Impact on Functional Outcome in Acute Ischemic Stroke in the WAKE-UP Trial. Stroke. 2021 Dec;52(12):3768-3776. doi: 10.1161/STROKEAHA.120.033425. Epub 2021 Aug 26.

ReferenceCitation: Barow E, Boutitie F, Cheng B, Cho TH, Ebinger M, Endres M, Fiebach JB, Fiehler J, Nickel A, Puig J, Roy P, Lemmens R, Thijs V, Muir KW, Nighoghossian N, Pedraza S, Simonsen CZ, Gerloff C, Thomalla G. 24-hour blood pressure variability and treatment effect of intravenous alteplase in acute ischaemic stroke. Eur Stroke J. 2021 Jun;6(2):168-175. doi: 10.1177/23969873211014758. Epub 2021 Jun 18.

ReferenceCitation: Scheldeman L, Wouters A, Dupont P, Christensen S, Boutitie F, Cheng B, Ebinger M, Endres M, Fiebach JB, Gerloff C, Muir KW, Nighoghossian N, Pedraza S, Simonsen CZ, Ringelstein EB, Chamorro A, Grond M, Laage R, Schneider A, Thomalla G, Thijs V, Lemmens R. Reversible Edema in the Penumbra Correlates With Severity of Hypoperfusion. Stroke. 2021 Jul;52(7):2338-2346. doi: 10.1161/STROKEAHA.120.033071. Epub 2021 May 13.

ReferenceCitation: Königsberg A, Sehner S, Arlt S, Cheng B, Simonsen CZ, Boutitie F, Serena J, Thijs V, Ebinger M, Endres M, Fiebach JB, Lemmens R, Muir KW, Nighoghossian N, Pedraza S, Gerloff C, Thomalla G; WAKE-UP investigators. Effect of intravenous alteplase on post-stroke depression in the WAKE UP trial. Eur J Neurol. 2021 Jun;28(6):2017-2025. doi: 10.1111/ene.14797. Epub 2021 Mar 22.

ReferenceCitation: Grosch AS, Kufner A, Boutitie F, Cheng B, Ebinger M, Endres M, Fiebach JB, Fiehler J, Königsberg A, Lemmens R, Muir KW, Nighoghossian N, Pedraza S, Siemonsen CZ, Thijs V, Wouters A, Gerloff C, Thomalla G, Galinovic I. Extent of FLAIR Hyperintense Vessels May Modify Treatment Effect of Thrombolysis: A Post hoc Analysis of the WAKE-UP Trial. Front Neurol. 2021 Feb 4;11:623881. doi: 10.3389/fneur.2020.623881. eCollection 2020.

ReferenceCitation: Barow E, Pinnschmidt H, Boutitie F, Königsberg A, Ebinger M, Endres M, Fiebach JB, Fiehler J, Thijs V, Lemmens R, Muir KW, Nighoghossian N, Pedraza S, Simonsen CZ, Gerloff C, Thomalla G, Cheng B; WAKE-UP investigators. Symptoms and probabilistic anatomical mapping of lacunar infarcts. Neurol Res Pract. 2020 Aug 3;2:21. doi: 10.1186/s42466-020-00068-y. eCollection 2020.

ReferenceCitation: Schlemm L, Kufner A, Boutitie F, Nave AH, Gerloff C, Thomalla G, Simonsen CZ, Ford I, Lemmens R, Muir KW, Nighoghossian N, Pedraza S, Ebinger M, Endres M. Current Smoking Does Not Modify the Treatment Effect of Intravenous Thrombolysis in Acute Ischemic Stroke Patients-A Post-hoc Analysis of the WAKE-UP Trial. Front Neurol. 2019 Nov 22;10:1239. doi: 10.3389/fneur.2019.01239. eCollection 2019.

ReferenceCitation: Barow E, Boutitie F, Cheng B, Cho TH, Ebinger M, Endres M, Fiebach JB, Fiehler J, Ford I, Galinovic I, Nickel A, Puig J, Roy P, Wouters A, Thijs V, Lemmens R, Muir KW, Nighoghossian N, Pedraza S, Simonsen CZ, Gerloff C, Thomalla G; WAKE-UP investigators. Clinical Characteristics and Outcome of Patients with Lacunar Infarcts and Concurrent Embolic Ischemic Lesions. Clin Neuroradiol. 2020 Sep;30(3):511-516. doi: 10.1007/s00062-019-00800-5. Epub 2019 Jun 3.

ReferenceCitation: Thomalla G, Boutitie F, Fiebach JB, Simonsen CZ, Nighoghossian N, Pedraza S, Lemmens R, Roy P, Muir KW, Heesen C, Ebinger M, Ford I, Cheng B, Cho TH, Puig J, Thijs V, Endres M, Fiehler J, Gerloff C. Effect of informed consent on patient characteristics in a stroke thrombolysis trial. Neurology. 2017 Sep 26;89(13):1400-1407. doi: 10.1212/WNL.0000000000004414. Epub 2017 Aug 25.

ReferenceCitation: Thomalla G, Boutitie F, Fiebach JB, Simonsen CZ, Pedraza S, Lemmens R, Nighoghossian N, Roy P, Muir KW, Ebinger M, Ford I, Cheng B, Galinovic I, Cho TH, Puig J, Thijs V, Endres M, Fiehler J, Gerloff C. Clinical characteristics of unknown symptom onset stroke patients with and without diffusion-weighted imaging and fluid-attenuated inversion recovery mismatch. Int J Stroke. 2018 Jan;13(1):66-73. doi: 10.1177/1747493017706245. Epub 2017 Apr 20.

ReferenceCitation: Thomalla G, Boutitie F, Fiebach JB, Simonsen CZ, Nighoghossian N, Pedraza S, Lemmens R, Roy P, Muir KW, Ebinger M, Ford I, Cheng B, Galinovic I, Cho TH, Puig J, Thijs V, Endres M, Fiehler J, Gerloff C; WAKE-UP Investigators. Stroke With Unknown Time of Symptom Onset: Baseline Clinical and Magnetic Resonance Imaging Data of the First Thousand Patients in WAKE-UP (Efficacy and Safety of MRI-Based Thrombolysis in Wake-Up Stroke: A Randomized, Doubleblind, Placebo-Controlled Trial). Stroke. 2017 Mar;48(3):770-773. doi: 10.1161/STROKEAHA.116.015233. Epub 2017 Feb 7.

lead_sponsor: Universitätsklinikum Hamburg-Eppendorf

location_country:
Denmark
Spain
United Kingdom
France
Belgium
Germany

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: Aarhus Universitetshospital, Aahrhus Sygehus

location_facility: Institut d'Investigacio Biomedica de Girona Doctor Josep Trueta


title: AURA Study: A Retrospective Non-interventional Study (NIS) to Assess the Effectiveness of Existing Anti vascUlar Endothelial Growth Factor (Anti VEGF) Treatment Regimens in Patients With Wet Age-related Macular Degeneration (wAMD)

acronym: AURA

summary: Retrospective, non-interventional, observational multi-center field study. Patients diagnosed with wet Age-related macular degeneration (wAMD) and having started treatment with ranibizumab between January 1, 2009 and August 31, 2009 must be consecutively screened and, if eligible, enrolled. Patients will be followed up at maximum until August 31, 2011. Switch to any other Anti vascUlar endothelial growth factor (anti VEGF) treatment will be documented and followed up. For each patient, demographics, medical history, administered treatments, results of ocular and visual assessments and other tests (where available) will be documented.

ReferenceCitation: Holz FG, Tadayoni R, Beatty S, Berger A, Cereda MG, Hykin P, Staurenghi G, Wittrup-Jensen K, Altemark A, Nilsson J, Kim K, Sivaprasad S. Key drivers of visual acuity gains in neovascular age-related macular degeneration in real life: findings from the AURA study. Br J Ophthalmol. 2016 Dec;100(12):1623-1628. doi: 10.1136/bjophthalmol-2015-308166. Epub 2016 Mar 30.

ReferenceCitation: Holz FG, Tadayoni R, Beatty S, Berger A, Cereda MG, Cortez R, Hoyng CB, Hykin P, Staurenghi G, Heldner S, Bogumil T, Heah T, Sivaprasad S. Multi-country real-life experience of anti-vascular endothelial growth factor therapy for wet age-related macular degeneration. Br J Ophthalmol. 2015 Feb;99(2):220-6. doi: 10.1136/bjophthalmol-2014-305327. Epub 2014 Sep 5.

lead_sponsor: Bayer

location_country:
United Kingdom
Ireland
Italy
Australia
Netherlands
Canada
Venezuela
France
Japan
Germany


title: A Prospective Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of the AcuFocus Corneal Inlay ACI 7000PDT Implanted Intrastromally for Modified Monovision in Presbyopic Subjects

summary: The purpose of this study is to determine if the AcuFocus Corneal Inlay ACI 7000PDT will provide an effective method of for the correction of presbyopia in patients who have normal distance vision but need correction such as glasses or contact lenses to see clearly at near.

lead_sponsor: AcuFocus, Inc.

location_country:
Spain
Austria
Australia
New Zealand
Philippines
France
Singapore
Turkey
Japan
Netherlands

location_facility: Univ. Klinik fur Agugenheilkunde und Optometrie, Paracelsus Medzinishe Privatuniversitat Salzburg

location_facility: Beyoğlu Goz Training and Research Hospital


title: A Phase II, Open Label, Parallel Group, Multi-center Study to Compare the Pharmacokinetics of Tacrolimus in Adult Subjects Undergoing Primary Allograft Transplantation Receiving an Advagraf® or Prograf® Based Immunosuppressive Regimen, Including a Long-term Follow-up

summary: Comparison of tacrolimus blood levels in adults who have received a transplant and are taking either Prograf or Advagraf anti-rejection therapy immediately following surgery. This is followed by checking of safety and effectiveness for one year.

lead_sponsor: Astellas Pharma Inc

location_country:
Taiwan
United Kingdom
Italy
Austria
France
Belgium


title: Contrast Enhanced Harmonic Endoscopic Ultrasound (CEH-EUS) Used in the Differentiation of Focal Pancreatic Masses

summary:
The aim of the study is to assess the accuracy of real-time perfusion imaging pattern of pancreatic focal lesions visualized by contrast-enhanced harmonic endoscopic ultrasound (CEH-EUS) for the differential diagnosis between chronic pseudotumoral pancreatitis and pancreatic cancer in a prospective multicenter design.

The study will include patients with focal pancreatic masses evaluated by CEH-EUS and EUS-FNA. The diagnosis is usually unknown in the moment of the initial evaluation, the patients being included based on a suspicion of focal pancreatic masses after transabdominal ultrasound, CT or MR examinations. However, after a complete evaluation, a final diagnosis will be reached based on the combination of EUS-FNA cytology/pathology, surgical pathology and minimum 12 months follow-up.

ReferenceCitation: Claudon M, Cosgrove D, Albrecht T, Bolondi L, Bosio M, Calliada F, Correas JM, Darge K, Dietrich C, D'Onofrio M, Evans DH, Filice C, Greiner L, Jäger K, Jong Nd, Leen E, Lencioni R, Lindsell D, Martegani A, Meairs S, Nolsøe C, Piscaglia F, Ricci P, Seidel G, Skjoldbye B, Solbiati L, Thorelius L, Tranquart F, Weskott HP, Whittingham T. Guidelines and good clinical practice recommendations for contrast enhanced ultrasound (CEUS) - update 2008. Ultraschall Med. 2008 Feb;29(1):28-44. doi: 10.1055/s-2007-963785.

ReferenceCitation: Seicean A, Badea R, Stan-Iuga R, Gulei I, Pop T, Pascu O. The added value of real-time harmonics contrast-enhanced endoscopic ultrasonography for the characterisation of pancreatic diseases in routine practice. J Gastrointestin Liver Dis. 2010 Mar;19(1):99-104.

ReferenceCitation: Hocke M, Schulze E, Gottschalk P, Topalidis T, Dietrich CF. Contrast-enhanced endoscopic ultrasound in discrimination between focal pancreatitis and pancreatic cancer. World J Gastroenterol. 2006 Jan 14;12(2):246-50.

ReferenceCitation: Săftoiu A, Iordache SA, Gheonea DI, Popescu C, Maloş A, Gorunescu F, Ciurea T, Iordache A, Popescu GL, Manea CT. Combined contrast-enhanced power Doppler and real-time sonoelastography performed during EUS, used in the differential diagnosis of focal pancreatic masses (with videos). Gastrointest Endosc. 2010 Oct;72(4):739-47. doi: 10.1016/j.gie.2010.02.056. Epub 2010 Aug 2.

ReferenceCitation: Seicean A. Endoscopic ultrasound in chronic pancreatitis: where are we now? World J Gastroenterol. 2010 Sep 14;16(34):4253-63. Review.

ReferenceCitation: Dietrich CF, Ignee A, Frey H. Contrast-enhanced endoscopic ultrasound with low mechanical index: a new technique. Z Gastroenterol. 2005 Nov;43(11):1219-23.

ReferenceCitation: Seicean A, Badea R, Stan-Iuga R, Mocan T, Gulei I, Pascu O. Quantitative contrast-enhanced harmonic endoscopic ultrasonography for the discrimination of solid pancreatic masses. Ultraschall Med. 2010 Dec;31(6):571-6. doi: 10.1055/s-0029-1245833. Epub 2010 Nov 15.

ReferenceCitation: Săftoiu A, Vilmann P, Dietrich CF, Iglesias-Garcia J, Hocke M, Seicean A, Ignee A, Hassan H, Streba CT, Ioncică AM, Gheonea DI, Ciurea T. Quantitative contrast-enhanced harmonic EUS in differential diagnosis of focal pancreatic masses (with videos). Gastrointest Endosc. 2015 Jul;82(1):59-69. doi: 10.1016/j.gie.2014.11.040. Epub 2015 Mar 16.

lead_sponsor: University of Medicine and Pharmacy Craiova

location_country:
Denmark
Spain
Italy
United Kingdom
France
Romania
Norway
Germany

location_facility: Gastroenterology and Gastrointestinal Endoscopy Unit, Vita Salute San Raffaele University

location_facility: Center of Gastroenterology and Hepatology, Fundeni Clinical Institute

location_facility: Department of Surgical Gastroenterology, Gentofte & Herlev Hospital, University of Copenhagen

location_facility: Hepatobiliary Surgery, Glasgow Royal Infirmary

location_facility: Insitute of Medicine, University of Bergen and National Centre for Ultrasound in Gastroenterology, Haukeland University Hospital

location_facility: Department of Internal Medicine II, Hospital Meiningen

location_facility: Center for Surgical Ultrasound, Department of Surgery, Odense University Hospital

location_facility: Institute of Hepatology, University College London

location_facility: Helios Klinikum, University of Witten/Herdecke

location_facility: Gastroenterology Department, University of Medicine and Pharmacy

location_facility: University Hospital, Santiago de Compostela


title: Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-Center Study of a Maintenance Therapy With Immunomodulator MGN1703 in Patients With Advanced Colorectal Carcinoma With Disease Control After Initial First-line Therapy

acronym: IMPACT

summary: This is a phase 2, randomized, double-blind, multi-center clinical study to evaluate efficacy and safety of a maintenance therapy with the immunomodulator MGN1703 compared to placebo control. The study will be conducted in patients with advanced colorectal carcinoma (AJCC Stage IV) with disease control after first-line standard chemotherapy regimens.

lead_sponsor: Mologen AG

location_country:
United Kingdom
Austria
Russian Federation
Czech Republic
France
Germany

location_facility: Klinik für Innere Medizin IV, Onkologie/ Hämatologie/ Hämostaseologie, Universitätsklinikum Halle (Saale)

location_facility: Kath. Marienkrankenhaus GmbH, Allgemeine Onkologie

location_facility: Klinik für Innere Medizin I, Abteilung für Klinische Onkologie, Medizinische Universität Wien

location_facility: Medizinische Klinik, Abteilung für Onkologie, Hämatologie Immunologie, Rheumatologie und Pulmologie Universität Tübingen, Immuntherapie, Station 65 Med. Klinik Abt. II

location_facility: Service de Cancérologie Digestive, Institut de Cancérologie Gustave Roussy

location_facility: Oncology Clinic, Faculty Hospital Olomouc

location_facility: Non-state health care institution "Central Clinical Hospital No. 2 named after N.A. Semashko OAO "RZHD"

location_facility: Onkologischer Schwerpunkt am Oskar-Helene-Heim

location_facility: Klinik für Innere Medizin, Klinik für Hämatologie, Onkologie, Immunologie, Universitätsklinikum Giessen und Marburg GmbH

location_facility: Schwerpunktpraxis für Hämatologie und Onkologie

location_facility: State Institution "Russian Scientific Oncology Center named after N.N. Blokhin RAMN"


title: Retrospective Safety Survey In Patients Included In Phase I-II NV1FGF Clinical Trials

acronym: TALISMAN S

summary: The objective of this study is to collect retrospectively long term safety data in patients who have participated in the previous phase I-II trials conducted with the compound.

lead_sponsor: Sanofi

location_country:
United Kingdom
Italy
Switzerland
United States
France
Belgium
Germany


title: Malnutrition and Outcome in Hospitalized Children in Europe (ESPEN Network Grant Project)

summary:
Malnutrition in children has even more severe consequences on disease course and long-term health than malnutrition in adults. According to prior studies, malnutrition affects about 15-30 % of hospitalized children in Europe (ESPGHAN 2005, Pawellek et al 2008, Joosten and Hulst 2008). However, available criteria for defining malnutrition in paediatric patients are inconsistent, not based on firm evidence, and not generally agreed upon. Current guidelines do not address assessment of and screening for childhood malnutrition. Therefore, a large number of affected children are not adequately diagnosed.

One aim of this study is to assess the prevalence of malnutrition and patients at risk for malnutrition among at least 2700 hospitalized children mainly across Europe. In addition criteria to link anthropometric measurements and the prediction of outcome, i.e. length of hospital stay, shall be established. A further goal then is to establish agreed, evidence-based criteria for malnutrition in children with the purpose of leading to an agreed, evidence-based screening tool for paediatric malnutrition in developed countries. This tool shall include a set of simple questions, based on previously suggested tools. Thereby this study will provide a strong basis for implementing evidence-based nutritional interventions in paediatric patients by harmonisation of diagnostic criteria for childhood malnutrition in developed countries.

ReferenceCitation: Chourdakis M, Hecht C, Gerasimidis K, Joosten KF, Karagiozoglou-Lampoudi T, Koetse HA, Ksiazyk J, Lazea C, Shamir R, Szajewska H, Koletzko B, Hulst JM. Malnutrition risk in hospitalized children: use of 3 screening tools in a large European population. Am J Clin Nutr. 2016 May;103(5):1301-10. doi: 10.3945/ajcn.115.110700. Epub 2016 Apr 20.

ReferenceCitation: Hecht C, Weber M, Grote V, Daskalou E, Dell'Era L, Flynn D, Gerasimidis K, Gottrand F, Hartman C, Hulst J, Joosten K, Karagiozoglou-Lampoudi T, Koetse HA, Kolaček S, Książyk J, Niseteo T, Olszewska K, Pavesi P, Piwowarczyk A, Rousseaux J, Shamir R, Sullivan PB, Szajewska H, Vernon-Roberts A, Koletzko B. Disease associated malnutrition correlates with length of hospital stay in children. Clin Nutr. 2015 Feb;34(1):53-9. doi: 10.1016/j.clnu.2014.01.003. Epub 2014 Jan 11.

lead_sponsor: Ludwig-Maximilians - University of Munich

location_country:
Denmark
Croatia
Poland
United Kingdom
Greece
Italy
Netherlands
France
Israel
Romania
Germany

location_facility: Sophia Children's Hospital, Erasmus University

location_facility: Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico - Milano

location_facility: Rigshospitalet, Copenhagen University Hospital

location_facility: Dr. von Hauner Children's Hospital. Munich, Germany

location_facility: Beatrix Children's Hospital, University Medical Center Groningen

location_facility: The Children's Memorial Health Institute

location_facility: Paediatric Clinical Investigation Center Unit (CIC-9301-Inserm-CHU) and U995-Inserm, hospital Jeanne de Flandre, University hospital of Lille.


title: A 38-week Extension to a 24 Week Multicenter, Randomized, Double-masked, Placebo Controlled Study to Assess the Difference in the Rate of Recurrent Exacerbations in Behçet's Patients With Posterior or Panuveitis Treated With AIN457 vs Placebo Adjunctive to Standard-of-care Immunosuppressive Therapy (SHIELD Study)

acronym: SHIELD

summary: A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet's patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy

location_country:
Taiwan
Hong Kong
Jordan
Spain
Greece
Tunisia
Korea, Republic of
United States
France
Israel
Singapore
Turkey
Germany
Egypt


title: Evaluation of Safety and Effectiveness of the Formula PTX Balloon-Expandable Stent for Renal Artery Stenosis

summary: The purpose of the study is to evaluate the safety and effectiveness of the PTX-coating on the Formula PTX Balloon-Expandable Stent in treatment of renal artery stenosis.

lead_sponsor: Cook Group Incorporated

location_country:
Germany
France
United Kingdom
Czechia

location_facility: Institute for Clinical and Experimental Medicine

location_facility: Klinik Dr. Hancken im Elbe Klinikum Stade


title: A Phase III Open-Label, Single-Group, Extension Study to Obtain Long-Term Safety and Tolerability Data of Idebenone in the Treatment of Friedreich's Ataxia Patients.

summary: This is an Extension study of the MICONOS main randomised placebo-controlled trial (NCT00905268), and open to those patients completing the main study. The scientific aim of this extension study is to monitor safety and tolerability of idebenone over two years in patients with Friedreich's Ataxia.

lead_sponsor: Santhera Pharmaceuticals

location_country: Austria Netherlands France Belgium Germany

location_facility: UKE Hamburg Neuropädiatrie - Zentrum für Frauen, Kinder und Jugendmedizin

location_facility: Hôpital Erasme - Univeristé Libre de Bruxelles

location_facility: Hôpital de la Salpétrière - INSERM U679, Neurologie et Thérapeutique expérimentale

location_facility: Neurologische Universitätsklinik und Ploklinik - Universitätsklimikum Bonn

location_facility: Klinik II, Neuropädiatrie und Muskelerkrankungen - Universitätsklinik Freiburg

location_facility: Neurologische Klinik - Klinikum Grosshadern

location_facility: Neurologische Universitätsklinik und Poliklinik


title: A Multi-centre, Multinational, Open-label, Single-dose Acute Hemodynamic Study Followed by Multi-centre, Multinational, Randomized, Double-blind, Parallel-group, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy (Proof-of-concept) of ACT-293987 (NS-304) in the Treatment of Pulmonary Arterial Hypertension in Subjects Aged 18 Years and Over

summary: This is a multi-centre, multinational, open-label, single-dose acute hemodynamic study followed by randomized, double-blind, parallel-group, placebo controlled study. Eligible subjects will undergo an open-label, single-dose acute hemodynamic study with ACT-293987(NS-304) and 21 weeks of double-blind treatment during which subjects will receive either ACT-293987 (NS-304) or placebo b.i.d. Subjects who have completed the double-blind study can enter the open extension study (separate protocol) and receive administration of ACT-293987 (NS-304) if the subject wishes and the Investigator considers it appropriate.

ReferenceCitation: Simonneau G, Torbicki A, Hoeper MM, Delcroix M, Karlócai K, Galiè N, Degano B, Bonderman D, Kurzyna M, Efficace M, Giorgino R, Lang IM. Selexipag: an oral, selective prostacyclin receptor agonist for the treatment of pulmonary arterial hypertension. Eur Respir J. 2012 Oct;40(4):874-80. Epub 2012 Feb 23.

lead_sponsor: Actelion

location_country:
Poland
United Kingdom
Italy
Austria
Hungary
France
Belgium
Germany

location_facility: Department of Respiratory Medicine, Hannover Medical School

location_facility: Instytut Gruzilcy i Chorob Pluc, Klinika Chorob Wewnetrznych Klatki Piersiowej

location_facility: Gasthuisberg University Hospital, Pneumology

location_facility: Hospital Sant'Orsola Malpighi, Cardiology's Department

location_facility: Semmelweis University, Clinic of Pulmonology

location_facility: Medizinische Universitat Wien, Universitatsklinik fur Innere Medizin II, Kardiologie


title: A Randomised Double Blind, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of 2 Doses of Ketoprofen Lysinate Lozenges (6.25 mg & 12.5 mg) in Patients With Sore Throat

summary:
Primary Objective:

To compare the single-dose efficacy of ketoprofen lysinate lozenges (6.25 mg and 12.5 mg ketoprofen base) with placebo, on total pain relief summed over 15 to 120 min (TOTPAR15-120) after the first intake of study drug.

Secondary Objectives:

To compare the single-dose efficacy of ketoprofen lysinate lozenges (6.25mg and 12.5mg ) with placebo after the first intake on:

the total pain relief summed over 15 to 360min (TOTPAR15-360)
the changes from baseline of global throat pain intensity assessed over 15 to 120min and over 15 to 360min.
the changes from baseline of throat soreness over 15 to 120min and over 15 to 360min
the changes from baseline of swollen throat over 15 to 120min and over 15 to 360min To compare pain relief, global throat pain intensity, throat soreness and swollen throat in the evening of days 1, 2 and 3

To evaluate the safety of ketoprofen lysinate lozenges (6.25mg and 12.5mg ) and placebo at follow-up visit on:

Day 4: - adverse events and clinical examination Day 7: - adverse events reporting (followed by a clinical examination if needed)

location_country:
Spain
Russian Federation
Finland
France
Mexico
Germany
Egypt


title: A Phase III Double-blind, Randomised, Placebo-controlled Study of the Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia Patients

acronym: MICONOS

summary: The purpose of this trial is to study the efficacy, safety and tolerability of idebenone in 12 months of treatment in children and adults with Friedreich's Ataxia. This is a randomised placebo-controlled double-blind trial conducted in Europe. Efficacy outcomes include measures of neurological impairment and function, and measures of the heart.

location_country:
United Kingdom
Austria
Netherlands
France
Belgium
Germany

location_facility: Neurologische Klinik- klinikum Grosshadern

location_facility: Neurologische Universitätsklinik und Poliklinik- Universitätsklinikum Bonn

location_facility: Hôpital Erasme - Université Libre de Bruxelles

location_facility: Klinik II, Neuropädiatrie u.Muskelerkrankungen- Universitätsklinik Freiburg

location_facility: UKE Hamburg Neuropädiatrie-Zentum für Frauen, Kinder und Jugendmedizin

location_facility: National Hospital for Neurology & Neurosurgery

location_facility: University of Newcastle upon Tyne -Mitochondrial Research Group

location_facility: Hôpital de la Salpêtrière - INSERM U679, Neurologie et Thérapeutique expérimentale


title: A Multi-national, Randomised, DBPC, Phase II Study to Assess the Efficacy and Safety of Three Doses of SLIT Administered as rBet v 1 Tablets Once Daily to Patients Suffering From Birch Pollen Rhinoconjunctivitis

lead_sponsor: Stallergenes Greer

location_country:
Denmark
Poland
Russian Federation
Lithuania
Finland
Sweden
France
Germany

location_facility: SPZOZ Uniwersytecki Szpital Kliniczny Nr 1im.N.Barlickiego w Uniwersystetu Medycznego w Łodzi

location_facility: NHC, Hôpitaux Universitaires de Strasbourg

location_facility: Public Institution Kaunas Medical University Hospital

location_facility: National University Hospital - Allergy Unit 4222

summary: The purpose of this study is to determine the efficacy and safety of three doses of r Bet v1 administered as sublingual tablets in birch pollen allergic subjects.


acronym: IRIS

summary: This study will assist in the early detection of influenza resistant to antivirals and will monitor the clinical outcome of adults and children infected with influenza according to subtype and susceptibility. Participants clinically diagnosed with influenza will undergo a rapid diagnostic test and viral sampling at Baseline and on Days 3, 6, and 10. Participants will be clinically managed according to local guidelines and the decision to treat/not treat will be at the discretion of the Investigator.

ReferenceCitation: Roosenhoff R, Reed V, Kenwright A, Schutten M, Boucher CA, Monto A, Clinch B, Kumar D, Whitley R, Nguyen-Van-Tam JS, Osterhaus ADME, Fouchier RAM, Fraaij PLA. Viral Kinetics and Resistance Development in Children Treated with Neuraminidase Inhibitors: The Influenza Resistance Information Study (IRIS). Clin Infect Dis. 2020 Aug 22;71(5):1186-1194. doi: 10.1093/cid/ciz939.

ReferenceCitation: Fraaij PL, Schutten M, Javouhey E, Burleigh L, Outlaw R, Kumar D, Boucher CA. Viral shedding and susceptibility to oseltamivir in hospitalized immunocompromised patients with influenza in the Influenza Resistance Information Study (IRIS). Antivir Ther. 2015;20(6):633-42. doi: 10.3851/IMP2957. Epub 2015 Apr 7.

lead_sponsor: Hoffmann-La Roche

location_country:
Poland
Hong Kong
Australia
Netherlands
United States
France
Norway
Germany