title: Multicenter International Study of Oxaliplatin/ 5FU-LV in the Adjuvant Treatment of Colon Cancer

summary:
To evaluate the FOLFOX regimen versus LV5FU2 in the adjuvant treatment of stage II and III colon cancer.

Primary objective: Disease Free Survival (DFS) Secondary objective: Overall Survival (OS), safety (including long term toxicity)

ReferenceCitation: Andre T, Boni C, Mounedji-Boudiaf L, Navarro M, Tabernero J, Hickish T, Topham C, Zaninelli M, Clingan P, Bridgewater J, Tabah-Fisch I, de Gramont A; Multicenter International Study of Oxaliplatin/5-Fluorouracil/Leucovorin in the Adjuvant Treatment of Colon Cancer (MOSAIC) Investigators. Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med. 2004 Jun 3;350(23):2343-51. doi: 10.1056/NEJMoa032709.

ReferenceCitation: Gallois C, Shi Q, Meyers JP, Iveson T, Alberts SR, de Gramont A, Sobrero AF, Haller DG, Oki E, Shields AF, Goldberg RM, Kerr R, Lonardi S, Yothers G, Kelly C, Boukovinas I, Labianca R, Sinicrope FA, Souglakos I, Yoshino T, Meyerhardt JA, Andre T, Papamichael D, Taieb J. Prognostic Impact of Early Treatment and Oxaliplatin Discontinuation in Patients With Stage III Colon Cancer: An ACCENT/IDEA Pooled Analysis of 11 Adjuvant Trials. J Clin Oncol. 2023 Feb 1;41(4):803-815. doi: 10.1200/JCO.21.02726. Epub 2022 Oct 28.

ReferenceCitation: Webster-Clark M, Keil AP, Robert N, Frytak JR, Boyd M, Sturmer T, Sanoff H, Westreich D, Lund JL. Comparing Trial and Real-world Adjuvant Oxaliplatin Delivery in Patients With Stage III Colon Cancer Using a Longitudinal Cumulative Dose. JAMA Oncol. 2022 Oct 13;8(12):1821-4. doi: 10.1001/jamaoncol.2022.4445. Online ahead of print.

publisher_dissemination: American Medical Association

ReferenceCitation: Cohen R, Taieb J, Fiskum J, Yothers G, Goldberg R, Yoshino T, Alberts S, Allegra C, de Gramont A, Seitz JF, O'Connell M, Haller D, Wolmark N, Erlichman C, Zaniboni A, Lonardi S, Kerr R, Grothey A, Sinicrope FA, Andre T, Shi Q. Microsatellite Instability in Patients With Stage III Colon Cancer Receiving Fluoropyrimidine With or Without Oxaliplatin: An ACCENT Pooled Analysis of 12 Adjuvant Trials. J Clin Oncol. 2021 Feb 20;39(6):642-651. doi: 10.1200/JCO.20.01600. Epub 2020 Dec 23.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

ReferenceCitation: Salem ME, Yin J, Goldberg RM, Pederson LD, Wolmark N, Alberts SR, Taieb J, Marshall JL, Lonardi S, Yoshino T, Kerr RS, Yothers G, Grothey A, Andre T, De Gramont A, Shi Q. Evaluation of the change of outcomes over a 10-year period in patients with stage III colon cancer: pooled analysis of 6501 patients treated with fluorouracil, leucovorin, and oxaliplatin in the ACCENT database. Ann Oncol. 2020 Apr;31(4):480-486. doi: 10.1016/j.annonc.2019.12.007. Epub 2020 Jan 16.

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Auclin E, Andre T, Taieb J, Banzi M, Van Laethem JL, Tabernero J, Hickish T, de Gramont A, Vernerey D. Association of post-operative CEA with survival and oxaliplatin benefit in patients with stage II colon cancer: a post hoc analysis of the MOSAIC trial. Br J Cancer. 2019 Aug;121(4):312-317. doi: 10.1038/s41416-019-0521-7. Epub 2019 Jul 12.

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

repositories_concat: PubMed Central;ddd.uab.cat

ReferenceCitation: Andre T, de Gramont A, Vernerey D, Chibaudel B, Bonnetain F, Tijeras-Raballand A, Scriva A, Hickish T, Tabernero J, Van Laethem JL, Banzi M, Maartense E, Shmueli E, Carlsson GU, Scheithauer W, Papamichael D, Moehler M, Landolfi S, Demetter P, Colote S, Tournigand C, Louvet C, Duval A, Flejou JF, de Gramont A. Adjuvant Fluorouracil, Leucovorin, and Oxaliplatin in Stage II to III Colon Cancer: Updated 10-Year Survival and Outcomes According to BRAF Mutation and Mismatch Repair Status of the MOSAIC Study. J Clin Oncol. 2015 Dec 10;33(35):4176-87. doi: 10.1200/JCO.2015.63.4238. Epub 2015 Nov 2.

ReferenceCitation: Tournigand C, Andre T, Bonnetain F, Chibaudel B, Lledo G, Hickish T, Tabernero J, Boni C, Bachet JB, Teixeira L, de Gramont A. Adjuvant therapy with fluorouracil and oxaliplatin in stage II and elderly patients (between ages 70 and 75 years) with colon cancer: subgroup analyses of the Multicenter International Study of Oxaliplatin, Fluorouracil, and Leucovorin in the Adjuvant Treatment of Colon Cancer trial. J Clin Oncol. 2012 Sep 20;30(27):3353-60. doi: 10.1200/JCO.2012.42.5645. Epub 2012 Aug 20.

location_country:
Germany
Poland
Australia
France
Portugal
Hungary
Denmark
Switzerland
Belgium
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Spain
Greece
Israel

location_facility: sanofi-aventis Australia & New Zealand administrative office


title: EURopean Trial In Atrial Fibrillation or Flutter Patients Receiving Dronedarone for the maIntenance of Sinus Rhythm (EURIDIS)

acronym: EURIDIS

summary:
To assess the efficacy of dronedarone versus placebo for the maintenance of normal sinus rhythm after electrical, pharmacological or spontaneous conversion of atrial fibrillation/atrial flutter (AF/AFL).

To assess the efficacy of dronedarone versus placebo on AF/AFL-related symptoms.

To assess the efficacy of dronedarone versus placebo on ventricular rate control in case of AF/AFL recurrence.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Singh BN, Connolly SJ, Crijns HJ, Roy D, Kowey PR, Capucci A, Radzik D, Aliot EM, Hohnloser SH; EURIDIS and ADONIS Investigators. Dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter. N Engl J Med. 2007 Sep 6;357(10):987-99. doi: 10.1056/NEJMoa054686.

ReferenceType: derived

ReferenceCitation: Handelsman Y, Bunch TJ, Rodbard HW, Steinberg BA, Thind M, Bigot G, Konigsberg L, Wieloch M, Kowey PR. Impact of dronedarone on patients with atrial fibrillation and diabetes: A sub-analysis of the ATHENA and EURIDIS/ADONIS studies. J Diabetes Complications. 2022 Jul;36(7):108227. doi: 10.1016/j.jdiacomp.2022.108227. Epub 2022 Jun 8.

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: Sanofi

location_country:
Finland
Germany
Italy
Poland
Hungary
United Kingdom
Denmark
Netherlands
Belgium
Spain
Czech Republic
France

location_facility:
Sanofi-Aventis Administrative Office
Sanofi- Aventis Administrative Office

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children Treated With SAIZEN®

summary: The study aims at identifying the predictive markers after one month of Saizen therapy in Growth Hormone Deficiency (GHD) and Turner Syndrome children.

study_start_date_type: Actual

design_allocation: Non-Randomized

ReferenceCitation: Stevens A, Clayton P, Tato L, Yoo HW, Rodriguez-Arnao MD, Skorodok J, Ambler GR, Zignani M, Zieschang J, Della Corte G, Destenaves B, Champigneulle A, Raelson J, Chatelain P. Pharmacogenomics of insulin-like growth factor-I generation during GH treatment in children with GH deficiency or Turner syndrome. Pharmacogenomics J. 2014 Feb;14(1):54-62. doi: 10.1038/tpj.2013.14. Epub 2013 Apr 9.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

publisher_dissemination: Springer

ReferenceCitation: Stevens A, Murray P, De Leonibus C, Garner T, Koledova E, Ambler G, Kapelari K, Binder G, Maghnie M, Zucchini S, Bashnina E, Skorodok J, Yeste D, Belgorosky A, Siguero JL, Coutant R, Vangsoy-Hansen E, Hagenas L, Dahlgren J, Deal C, Chatelain P, Clayton P. Gene expression signatures predict response to therapy with growth hormone. Pharmacogenomics J. 2021 Oct;21(5):594-607. doi: 10.1038/s41397-021-00237-5. Epub 2021 May 27.

license: cc-by

license_normalized: cc-by

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

repository_institution: Cold Spring Harbor Laboratory - bioRxiv

repository_normalized: bioRxiv

version: submittedVersion

repositories:
PubMed Central
bioRxiv
www.repositoriosalud.es

repositories_institution:
Cold Spring Harbor Laboratory - bioRxiv
PubMed Central - Europe PMC

publisher_dissemination: Springer-Nature

ReferenceCitation: Murray PG, Stevens A, De Leonibus C, Koledova E, Chatelain P, Clayton PE. Transcriptomics and machine learning predict diagnosis and severity of growth hormone deficiency. JCI Insight. 2018 Apr 5;3(7):e93247. doi: 10.1172/jci.insight.93247. eCollection 2018 Apr 5.

oa_colors: green gold

evidence: open (via free pdf)

repository_institution: The University of Manchester - Research Explorer

repository_normalized: Pure (Denmark)

version: acceptedVersion

repositories:
PubMed Central
Pure (Denmark)

repositories_concat: PubMed Central;Pure (Denmark)

unpaywall_oa_status: gold

publisher_dissemination: American Society for Clinical Investigation

ReferenceCitation: Valsesia A, Chatelain P, Stevens A, Peterkova VA, Belgorosky A, Maghnie M, Antoniazzi F, Koledova E, Wojcik J, Farmer P, Destenaves B, Clayton P; PREDICT Investigator group. GH deficiency status combined with GH receptor polymorphism affects response to GH in children. Eur J Endocrinol. 2015 Dec;173(6):777-89. doi: 10.1530/EJE-15-0474. Epub 2015 Sep 4.

location_country:
Germany
Italy
Norway
Argentina
Singapore
Australia
Sweden
United Kingdom
Austria
Spain
Canada
Russian Federation
France

location_facility:
Local Medical Information Office
Local Medical InformationOffice


title: An Eight-Week, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of One Fixed 100 mg Dose of Saredutant in Patients With Major Depressive Disorder

summary:
The purpose of the study is to evaluate the efficacy and safety of saredutant (or SR48968C) in patients with depression.

The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to placebo in patients with depression.

The secondary objectives are to evaluate the safety of saredutant, to evaluate the efficacy of saredutant on disability and quality of life in patients with depression, and to evaluate blood levels of saredutant.

location_country:
Germany
Portugal
Mexico
Croatia
Chile
Canada
Czech Republic
France


title: An Open Label, Randomized, Parallel Design Study to Investigate the Efficacy and Safety of Sevelamer Hydrochloride (Renagel®) Compared With Calcium Acetate in Peritoneal Dialysis Patients

summary: The purpose of this study is to demonstrate that sevelamer hydrochloride is non-inferior to calcium acetate for the treatment of hyperphosphataemia in patients receiving peritoneal dialysis.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Italy
United Kingdom
Denmark
Netherlands
Belgium
Spain
France

location_facility: The Churchill Hospital, Oxford Radcliffe Hospitals NHS Trust

location_facility: University Hospital ,Queen Elizabeth Hospital


title: A Double-blind, Randomized Study of Clopidogrel 75 mg/d vs Placebo, on a Background of ASA 75-100 mg/d,in Peripheral Arterial Disease (PAD) Patients Receiving a Unilateral Below Knee Bypass Graft.

summary:
Primary objective:

To evaluate whether clopidogrel 75 mg o.d. versus placebo (on a background of ASA 75-100 mg/d) will lead to an increased rate of primary patency, limb salvage and survival, in patients receiving a below knee bypass graft for the treatment of PAD.

Secondary objectives:

Comparison, between the two treatment groups, of :

Primary patency,
Assisted primary patency,
Cardiovascular death / myocardial infarction / stroke / any amputation above the ankle.
Ankle Brachial Pressure Index (ABPI) changes from baseline

enrollment_type: Anticipated

ReferenceCitation: Belch JJ, Dormandy J; CASPAR Writing Committee; Biasi GM, Cairols M, Diehm C, Eikelboom B, Golledge J, Jawien A, Lepantalo M, Norgren L, Hiatt WR, Becquemin JP, Bergqvist D, Clement D, Baumgartner I, Minar E, Stonebridge P, Vermassen F, Matyas L, Leizorovicz A. Results of the randomized, placebo-controlled clopidogrel and acetylsalicylic acid in bypass surgery for peripheral arterial disease (CASPAR) trial. J Vasc Surg. 2010 Oct;52(4):825-33, 833.e1-2. doi: 10.1016/j.jvs.2010.04.027. Epub 2010 Aug 1. Erratum In: J Vasc Surg. 2011 Feb;53(2):564. Biasi, B M [corrected to Biasi, G M].

sponsor_collaborators:
Sanofi
Bristol-Myers Squibb

location_country:
Finland
Germany
Italy
Poland
Hungary
United Kingdom
Australia
Sweden
Netherlands
Austria
Belgium
Switzerland
Spain
France


summary: This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of diabetic macular edema.

ReferenceCitation: Rittiphairoj T, Mir TA, Li T, Virgili G. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2020 Nov 17;11(11):CD005656. doi: 10.1002/14651858.CD005656.pub3.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Yoon YH, Boyer DS, Maturi RK, Bandello F, Belfort R Jr, Augustin AJ, Li XY, Bai Z, Hashad Y; Ozurdex MEAD Study Group. Natural history of diabetic macular edema and factors predicting outcomes in sham-treated patients (MEAD study). Graefes Arch Clin Exp Ophthalmol. 2019 Dec;257(12):2639-2653. doi: 10.1007/s00417-019-04464-2. Epub 2019 Oct 25.

ReferenceCitation: Danis RP, Sadda S, Li XY, Cui H, Hashad Y, Whitcup SM. Anatomical effects of dexamethasone intravitreal implant in diabetic macular oedema: a pooled analysis of 3-year phase III trials. Br J Ophthalmol. 2016 Jun;100(6):796-801. doi: 10.1136/bjophthalmol-2015-306823. Epub 2015 Nov 18.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Oxford - Oxford Academic Notes & Queries

publisher_dissemination: British Medical Journal

ReferenceCitation: Augustin AJ, Kuppermann BD, Lanzetta P, Loewenstein A, Li XY, Cui H, Hashad Y, Whitcup SM; Ozurdex MEAD Study Group. Dexamethasone intravitreal implant in previously treated patients with diabetic macular edema: subgroup analysis of the MEAD study. BMC Ophthalmol. 2015 Oct 30;15:150. doi: 10.1186/s12886-015-0148-2.

evidence: oa journal (via doaj)

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: University of Udine - Institutional Research Information System

repository_institution: University of Trieste https://www.units.it/ - ArTS Archivio della ricerca di Trieste

repository_institution: University of California - eScholarship University of California

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;air.unimi.it;air.uniud.it;arts.units.it;escholarship.org

lead_sponsor: Allergan

location_country:
Italy
Poland
Colombia
India
New Zealand
Hungary
Singapore
United Kingdom
Brazil
United States
Korea, Republic of
Taiwan
Canada
France


title: An Open-label, Multicenter, Multinational Study of the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Recombinant Human Acid Alpha-glucosidase Treatment in Patients Less Than 6 Months Old With Infantile-onset Pompe Disease

summary: Pompe disease (also known as glycogen storage disease type II, "GSD-II") is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. This study is being conducted to evaluate the safety and effectiveness of recombinant human acid alpha-glucosidase (rhGAA) as a potential enzyme replacement therapy for Pompe disease. Patients diagnosed with infantile-onset Pompe disease who are less than or equal to 6 months old will be studied.

ReferenceCitation: Kishnani PS, Goldenberg PC, DeArmey SL, Heller J, Benjamin D, Young S, Bali D, Smith SA, Li JS, Mandel H, Koeberl D, Rosenberg A, Chen YT. Cross-reactive immunologic material status affects treatment outcomes in Pompe disease infants. Mol Genet Metab. 2010 Jan;99(1):26-33. doi: 10.1016/j.ymgme.2009.08.003.

location_country:
France
United Kingdom
United States
Taiwan
Israel

location_facility: University of Florida College of Medicine

intervention_type: Biological


type: Registry Identifier

title: A Randomized Trial of Adjuvant Treatment With Radiation Plus Chemotherapy Versus Radiation Alone in High Risk Endometrial Carcinoma

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

PURPOSE: This randomized phase III trial is studying radiation therapy and chemotherapy to see how well they work compared to radiation therapy alone in treating patients with high-risk endometrial cancer.

ReferenceType: background

ReferenceCitation: Hogberg T, Signorelli M, de Oliveira CF, Fossati R, Lissoni AA, Sorbe B, Andersson H, Grenman S, Lundgren C, Rosenberg P, Boman K, Tholander B, Scambia G, Reed N, Cormio G, Tognon G, Clarke J, Sawicki T, Zola P, Kristensen G. Sequential adjuvant chemotherapy and radiotherapy in endometrial cancer--results from two randomised studies. Eur J Cancer. 2010 Sep;46(13):2422-31. doi: 10.1016/j.ejca.2010.06.002. Epub 2010 Jul 7.

ReferenceCitation: Hogberg T, Rosenberg P, Kristensen G, et al.: A randomized phase-III study on adjuvant treatment with radiation (RT) ± chemotherapy (CT) in early-stage high-risk endometrial cancer (NSGO-EC-9501/EORTC 55991). [Abstract] J Clin Oncol 25 (Suppl 18): A-5503, 274s, 2007.

lead_sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit

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

location_country:
Ireland
Italy
Poland
Portugal
Norway
United Kingdom
Netherlands
Belgium
Spain
South Africa
France

location_facility: Hospitais da Universidade de Coimbra (HUC)

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

location_facility: Fondazione I.R.C.C.S. Policlinico San Matteo

location_facility: Cazk Groeninghe - Campus Maria's Voorzienigheid

location_facility: Universitair Medisch Centrum St. Radboud - Nijmegen

location_facility: Centre for Cancer Research and Cell Biology at Belfast City Hospital

location_facility: Hospital Universitario Central de Asturias


title: A Randomised Trial in Relapsed Ovarian Cancer: Early Treatment Based on CA 125 Levels Alone Vs. Delayed Treatment Based On Conventional Clinical Indicators

summary:
RATIONALE: It is not yet known if treatment for recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer is more effective if it is begun when blood levels of CA 125 become elevated rather than waiting for other indicators of disease recurrence.

PURPOSE: This randomized phase III trial is studying early chemotherapy based on blood levels of CA 125 alone to see how well it works compared to chemotherapy based on conventional clinical indicators in patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.

ReferenceCitation: Markman M, Petersen J, Belland A, Burg K. CA-125 monitoring in ovarian cancer: patient survey responses to the results of the MRC/EORTC CA-125 Surveillance Trial. Oncology. 2010;78(1):1-2. doi: 10.1159/000292352. Epub 2010 Mar 6. No abstract available.

ReferenceCitation: Rustin GJ, van der Burg ME, Griffin CL, Guthrie D, Lamont A, Jayson GC, Kristensen G, Mediola C, Coens C, Qian W, Parmar MK, Swart AM; MRC OV05; EORTC 55955 investigators. Early versus delayed treatment of relapsed ovarian cancer (MRC OV05/EORTC 55955): a randomised trial. Lancet. 2010 Oct 2;376(9747):1155-63. doi: 10.1016/S0140-6736(10)61268-8.

ReferenceCitation: Rustin GJ, van der Burg ME: A randomized trial in ovarian cancer (OC) of early treatment of relapse based on CA125 level alone versus delayed treatment based on conventional clinical indicators (MRC OV05/EORTC 55955 trials). [Abstract] J Clin Oncol 27 (Suppl 18): A-1, 2009.

lead_sponsor: Medical Research Council

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

location_country:
Ireland
Italy
Portugal
United Kingdom
Netherlands
Austria
Belgium
Spain
South Africa
France

location_facility: Nijmegen Cancer Center at Radboud University Medical Center

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

location_facility: Academisch Medisch Centrum at University of Amsterdam

location_facility: Mount Vernon Cancer Centre at Mount Vernon Hospital

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center


type: Other Identifier

title: A Multicenter, Open-label, Phase 1 Study to Evaluate the Safety and Preliminary Efficacy of SOT201 in Patients With Advanced/Metastatic Solid Tumors

summary:
This is a Phase 1, open-label, dose escalation study to assess the safety, tolerability, and preliminary efficacy of SOT201 as monotherapy for participants aged 18 years or above with advanced unresectable or metastatic solid tumors

During dose escalation, the recommended dose(s) of SOT201 given every 3 weeks (Q3W) will be determined

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

ipd_sharing: No

lead_sponsor: SOTIO Biotech AG

location_country:
Belgium
United States
Spain
Czechia
France

location_facility: Hospital Universitari Vall d'Hebron - Vall d'Hebron Institut d'Oncologia (VHIO)

location_facility: Fakultni Nemocnice Olomouc (FNOL) - Onkologicka Klinika

status_simplified: Ongoing


title: Enlighten Study: The EV-ICD Post Approval Registry

summary: Medtronic is sponsoring Enlighten: The EV-ICD Post Approval Registry, to further confirm safety and effectiveness of EV-ICD in routine clinical practice, following commercial release of EV-ICD devices.

status: Recruiting

study_type: Observational

time_perspective: Prospective

lead_sponsor: Medtronic

location_country:
Germany
New Zealand
Denmark
Netherlands
Austria
Switzerland
United States
Spain
Czechia
France

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

location_facility: Kepler Universitätsklinikum Med Campus III

intervention_type: Device


title: Ascertaining the Radiologic Prognostic Importance of Extranodal Extension on Imaging (iENE) in Head and Neck Cancer Part of the Evaluation Prognostic and Predictive Indicators in Head and Neck Cancer (EPIC) Programme, Run Under the Auspices of the Head and Neck Inter Group (HNCIG, Www.Hncig.Org)

acronym: EPIC-iENE DATA

summary:
Extranodal extension (ENE) refers to the spread of head and neck squamous cell carcinoma (HNSCC) outside the lymph nodes. It is a well-known factor that indicates a poorer prognosis and outcome for patients who have undergone surgical removal of the cancer. In such cases, it is recommended to combine chemotherapy with radiation therapy after surgery.

As the number of cases of HNSCC related to the human papillomavirus (HPV) is increasing, treatment approaches have shifted towards using radiation therapy as the primary treatment method instead of surgery. This raises an important question about the significance of ENE observed through imaging tests (referred to as iENE) and its impact on the prognosis. Unfortunately, this question remains unanswered.

The objective of this project is to conduct a comprehensive study across multiple medical institutions. The investigators will gather data including scan results, histopathology reports, and data from patient charts from individuals who have been treated for head and neck cancer. The aim is to analyze and correlate the findings between the pathological evidence of ENE and the imaging results, while also assessing the prognostic value of iENE. Additionally, the investigators will explore the influence of HPV status on these factors.

By collecting and analyzing this data, the investigators hope to establish standardized criteria that can assist radiologists in accurately identifying ENE through imaging tests. This research is essential for enhancing our understanding of HNSCC and improving the effectiveness of diagnostic procedures and treatment planning.

time_perspective: Retrospective

ipd_sharing: Undecided

ipd_sharing_description: The data will bill kept in the HNCIG database, and might be shared with other researchers following a reasonable request (and following agreement by the HNCIG board)

lead_sponsor: Head and Neck Cancer International Group

location_country:
Germany
United Kingdom
Denmark
Australia
Switzerland
United States
Spain
France

location_facility:
Georges Pompidou European Hospital
University of Cologne
Royal Adelaide Hospital
Leeds Teaching Hospitals NHS Trust
Catalan Institute of Oncology
University Hospital Zürich
Copenhagen University Hospitals
Mount Sinai Health System
University Hospitals Birmingham
University of Pittsburgh Medical Center
Methodist Estabrook Cancer Center
Technical University of Munich

intervention_type: Other


title: Left Bundle Branch Area Pacing (LBBAP) Data Collection Registry

summary: The purpose of this registry is to evaluate the safety and effectiveness of LBBA pacing/sensing in patients already implanted with the Tendril STS 2088 lead.

status: Active, not recruiting

lead_sponsor: Abbott Medical Devices

location_country:
Italy
India
Singapore
United States
France

location_facility:
North Mississippi Medical Center
Hopital d'adulte de la Timone
National Heart Centre Singapore
Cardiology Consultants - Baptist Campus
The Madras Medical Mission
Arrhythmia Research Group
Medanta - The Medicity Hospital
Ospedale S.Maria della Misericordia
Tan Tock Seng Hospital
Geisinger Medical Center
Eisenhower Medical Center


title: ROSY-T: Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Osimertinib and Are Judged by the Investigator to Clinically Benefit From Continued Treatment

acronym: ROSY-T

summary: The rationale of the ROSY-T study is to continue to provide study treatment for patients who have participated in a parent study with osimertinib and who are continuing to derive clinical benefit from treatment at the end of such studies, as judged by the Investigator.

ipd_sharing: Yes

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

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for individual participant data (IPD), but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

sponsor_collaborators: AstraZeneca Parexel

location_country:
Poland
United Kingdom
Korea, Republic of
China
Thailand
Malaysia
Taiwan
France


type: EudraCT Number

title: A Multicentric Phase 1/2 Trial to Evaluate the Safety and Efficacy of SOT102 as Monotherapy and in Combination With Standard of Care Treatment in Patients With Gastric and Pancreatic Adenocarcinoma

summary: This trial will assess the MTD and RP2D of SOT102 administered as monotherapy (Part A) and in combination with first-line SoC treatment (mFOLFOX6 with nivolumab and nab-paclitaxel/ gemcitabine; Part B) and efficacy of SOT102 administered as monotherapy (Part C) and in combination with first-line SoC treatment (Part D) in patients with advanced inoperable or metastatic gastric/GEJ adenocarcinoma or inoperable or metastatic pancreatic adenocarcinoma.

status: Suspended

lead_sponsor: Sotio Biotech Inc.

location_facility: VHIO - Vall d'Hebron Institut d'Oncologia

location_facility: Washington University School of Medicine in St. Louis

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

status_simplified: Unknown


title: A Randomized, Placebo-controlled, Double-blind Study to Assess the Effect of TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure

acronym: INSIGHT

summary: This clinical study aims to assess the efficacy of TOTUM-854, a mix of 6 plant extracts, consumed twice a day on automated office blood pressure in subjects with moderately elevated blood pressure. The hypothesis is that TOTUM-854 is superior to placebo for decrease of automated office blood pressure after 12 weeks of consumption.

primary_purpose: Prevention

lead_sponsor: Valbiotis

sponsor_collaborators: Valbiotis Excelya

location_country: Bulgaria Poland France

location_facility: Diagnostic Consultative Center XX- Sofia EOOD

location_facility: Multiprofile Hospital for Active Treatment Cardiology Department

location_facility: Multiprofile Hospital for Active Treatment Sveta Karidad EAD, Cardiology Department

location_facility: Przychodnia Zespołu Lekarza Rodzinnego "Medyk"

location_facility: Multiprofile Hospital for Active Treatment - Uni Hospital OOD, Cardiology Department

location_facility: Diagnostic Consultative Center VII-Plovdiv South district EOOD, Cabinet of Endocrinology

location_facility: CHU Clermont Ferrand PIC/CIC Inserm 1405

intervention_type: Dietary Supplement


title: A Phase I/II, Multi-center, Open Label Study of DYP688 in Patients With Metastatic Uveal Melanoma (MUM) and Other GNAQ/11 Mutant Melanomas

summary: This is a FIH, phase I/II, open label, multi-center study of DYP688 as a single agent. The purpose of this study is to characterize the safety, tolerability, and anti-tumor activity of DYP688 as a single agent in patients with metastatic uveal melanoma (MUM) and other melanomas harboring GNAQ/11 mutations.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Australia
Netherlands
Switzerland
United States
Spain
France

location_facility: Memorial Sloane Kettering Cancer Center MSKCC

location_facility: Columbia University Medical Center- New York Presbyterian Onc Dept

location_facility: Massachusetts General Hospital Hematology Oncology


title: An Open-Label, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RO7443904 in Combination With Glofitamab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

summary: This is a first-in human, open-label, Phase 1 dose-escalation study in order to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for intravenous (IV) and/or subcutaneous (SC) dosing schemes of this combination treatment, and to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of this combination treatment in participants with relapsed/refractory B-cell non Hodgkin lymphoma (r/r NHL).

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
United Kingdom
Denmark
Australia
United States
France

location_facility: Peter MacCallum Cancer Centre; Department of Haematology

location_facility: CHRU Lille - Hôpital Claude Huriez; Service des Maladies du Sang

location_facility: Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia

location_facility: Leicester Royal Infirmary; Dept of Haematology

location_facility: Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT

location_facility: Cleveland Clinic Foundation; Hematology and Oncology


title: Perform Humeral System Study

acronym: PHS

summary: The purpose of this study is to collect data needed to satisfy the European Union (EU) Medical Device Regulation (MDR) clinical post-market surveillance (PMS) and reporting requirements, and to support future regulatory submissions and peer-reviewed publications on device performance and safety.

status: Enrolling by invitation

lead_sponsor: Stryker Trauma GmbH

location_country:
United States
Canada
Switzerland
France

location_facility: Roth McFarlane Hand and Upper Limb Centre


title: A Global, Phase 1/2, Open-Label, Dose Optimization Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of mRNA-3705 in Participants With Isolated Methylmalonic Acidemia Due to Methylmalonyl-CoA Mutase Deficiency

summary: This is a study of mRNA-3705 in participants with isolated elevated methylmalonic acid (MMA) due to methylmalonyl-coenzyme A (CoA) mutase (MUT) deficiency. The main goal of the study is to assess safety, pharmacokinetics, and pharmacodynamics of mRNA-3705.

lead_sponsor: ModernaTX, Inc.

location_country:
United Kingdom
Netherlands
United States
Spain
Canada
France

location_facility: Stollery Children's Hospital University of Alberta

location_facility: Birmingham Children's Hospital NHS Foundation Trust

location_facility: Lucile Packard Children's Hospital at Stanford


title: A Multi-center, Non-interventional Phase 0 Study for the Collection of Biospecimens From Patients With Parkinson's Disease.

summary: This study aims to collect, analyze and preserve biospecimens from patients with or without LRRK2-associated Parkinson's Disease for the purpose of discovering and developing new treatments and novel biomarkers.

status: Terminated

lead_sponsor: Neuron23 Inc.

location_country:
United States
Israel
Canada
France

location_facility: Rocky Mountain Movement Disorders Center

location_facility: Assistance Publique - Hospitaux de Paris


title: Real-World Outcomes Study on Subjects Treated With Radiofrequency Ablation

acronym: ROSTRA

summary:
ROSTRA is an international, prospective, non-randomized, single-arm, multi-center, and post-market study to collect real-world safety and effectiveness data on Abbott's IonicRF™Generator and compatible RFA accessories. This post-market study is intended to satisfy EU MDR requirements.

The study will enroll up to 180 subjects at up to 10 sites in Europe and the United States.

The total duration of the study is expected to be 19 months, including enrollment, data collection from all subjects, and study closeout.

location_country:
Germany
Netherlands
Belgium
United States
Spain
France

location_facility: Universitätsmedizin Berlin - Charité Campus Mitte

location_facility: Krankenhaus Neuwerk Maria von den Aposteln

location_facility: The Spine & Nerve Center of St Francis Hospital

location_facility: Hospital Clínico Universitario de Valencia


title: A Prospective Observational Study to Describe Clinical Outcomes of Alglucosidase Alfa Treatment in Patients ≤6 Months of Age With Infantile-onset Pompe Disease (IOPD)

summary:
Primary Objective:

To describe the effect of routine practice with alglucosidase alfa in patients with IOPD ≤6 months of age, on invasive ventilation-free survival after 52 weeks of treatment.

Secondary Objectives:

To describe the effect of routine practice with alglucosidase alfa on invasive ventilation-free survival and survival at 12 and 18 months of age, as well as on change in left ventricular mass (LVM) Z score, Alberta Infant Motor Scale (AIMS) score, body weight, body length, and head circumference Z scores, and urinary glucose tetrasaccharide (Hex4), at Week 52 of treatment.
To describe the safety, tolerability, and immunogenicity of alglucosidase alfa in the routine practice of IOPD treatment.

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

location_facility: Duke University Medical Center Site Number : 8400004

location_facility: Boston Children's Health Physicians Site Number : 8400002

location_facility: Cincinnati Children's Hospital Medical Center - PIN Site Number : 8400001

location_facility: Seattle Childrens Hospital and Regional Medical Center Site Number : 8400003


title: A Long Term Prospective Post Market Clinical Follow-up (PMCF) of the GYNECARE TVT EXACT® Continence System for the Treatment of Stress Urinary Incontinence

summary: The objective of this single arm, post market, clinical study is to evaluate the performance of Gynecare TVT EXACT® Continence System in women undergoing retropubic mid-urethral sling surgery for Stress Urinary Incontinence (SUI).

ipd_sharing_description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

lead_sponsor: Ethicon, Inc.

location_country:
Germany
Denmark
Sweden
Austria
United States
France

location_facility:
Herlev Hospital
Hopital Jeanne de Flandres
Duke University
Karolinska Institute
Institute for Female Pelvic Medicine
UPMC
Ordensklinikum Linz
Universitatsklinikum Tubingen


title: Psychosocial Care During the COVID-19 Pandemic in Acute Hospitals - an International Online Survey of Psychosomatic, Psychiatric and Psychological Consultation and Liaison (C&L) Services

summary: Heads of all psychosomatic, psychiatric and psychological consultation and liaison (C&L) services in acute care hospitals across all participating countries will be contacted and asked to participate in this international cross-sectional online survey. The survey consists of questions about care structures and their utilisation that psychosomatic, psychiatric and psychological C&L services have established in acute hospitals in the context of the COVID 19 pandemic.

time_perspective: Cross-Sectional

ReferenceCitation: Schaefert R, Stein B, Meinlschmidt G, Roemmel N, Huber CG, Hepp U, Saillant S, Fazekas C, Vitinius F. COVID-19-Related Psychosocial Care in General Hospitals: Results of an Online Survey of Psychosomatic, Psychiatric, and Psychological Consultation and Liaison Services in Germany, Austria, and Switzerland. Front Psychiatry. 2022 Jun 24;13:870984. doi: 10.3389/fpsyt.2022.870984. eCollection 2022.

publisher_dissemination: Frontiers

lead_sponsor: University Hospital, Basel, Switzerland

location_country:
Finland
Germany
Ireland
Italy
Poland
Portugal
Norway
United Kingdom
Iran, Islamic Republic of
Switzerland
Austria
Belgium
Spain
Greece
Canada
France

location_facility: University of Montreal, Department of Psychosomatic Medicine

location_facility: University Hospital Cologne, Department of Psychosomatics and Psychotherapy

location_facility: Oulu University Hospital and University of Oulu

location_facility: University Hospital Basel, Department of Psychosomatic Medicine

location_facility: Université de Paris, Service de Psychiatrie de l'adulte

location_facility: Medical University of Graz, University Hospital Graz

location_facility: TorontoSinai Health, University of Toronto, Department of Psychiatry

location_facility: University of Basel, Department of Psychiatry (UPK)

location_facility: Nuremberg Hospital, Department of Psychosomatic Medicine and Psychotherapy

location_facility: University of Medical Sciences, Department of Psychiatry

location_facility: Ghent University Hospital, Department of Psychiatry

lead_sponsor_type: academique


title: Outcome pRognostication of Acute Brain Injury With the NeuroloGical Pupil

acronym: ORANGE

summary:
The use of quantitative, automated, infrared technology for pupillary examination has long been used in ophthalmology and anesthesiology research. Its interest in neurocritical care has progressively grown, in parallel with the advancements in device technology. In this regard, the use of the noninvasive NPi®-200 pupillometer (Neuroptics, Laguna Hills, California, USA) allows the measurement of a series of dynamic pupillary variables (including the percentage pupillary constriction, latency, constriction velocity, and dilation velocity), which can be integrated into an algorithm, to compute the Neurological Pupil index (NPi). The NPi is a proprietary scalar index with values between 0 and 5 (with a 0.1 decimal precision), an NPi value < 3 indicating an abnormal pupillary reactivity. Importantly, the NPi is not influenced by sedation-analgesia, at the doses used in neurocritical care practice, and by mild hypothermia.

Preliminary single-center data recently demonstrated that abnormal NPi is associated with worse outcome in patients with traumatic and hemorrhagic ABI, and can be a useful adjunct for ICP monitoring and therapy. There is currently a great need for quantitative tools to predict early prognostication in ABI patients, and the NPi appears of potential great value.

We hypothesize that:

Abnormal NPi (defined as NPi <3) are strongly predictive of poor GOS-E (1-4) at 6 months after the acute event.
NPi=0 is strongly predictive of mortality (GOS 1).
Abnormal NPi is predictive of a higher ICP 20 index (number of end-hourly measures of ICP >20 mm Hg divided by the total number of measurements, multiplied by 100) and a greater burden of interventions needed to control ICP (measured by the Therapy Intensity Level scale for ICP management, Therapy Intensity Level (TIL) 4).

Methods This international multicentre prospective observational study aims to recruit >400 patients admitted to intensive care units.

Duration of the study 18 months, including 12-month of recruitment based on 60 patients/centre plus 6 months GOS-E follow-up.

ReferenceCitation: Sharshar T, Citerio G, Andrews PJ, Chieregato A, Latronico N, Menon DK, Puybasset L, Sandroni C, Stevens RD. Neurological examination of critically ill patients: a pragmatic approach. Report of an ESICM expert panel. Intensive Care Med. 2014 Apr;40(4):484-95. doi: 10.1007/s00134-014-3214-y. Epub 2014 Feb 13.

unpaywall_oa_status: bronze

ReferenceCitation: Chen JW, Gombart ZJ, Rogers S, Gardiner SK, Cecil S, Bullock RM. Pupillary reactivity as an early indicator of increased intracranial pressure: The introduction of the Neurological Pupil index. Surg Neurol Int. 2011;2:82. doi: 10.4103/2152-7806.82248. Epub 2011 Jun 21.

ReferenceCitation: Chen JW, Vakil-Gilani K, Williamson KL, Cecil S. Infrared pupillometry, the Neurological Pupil index and unilateral pupillary dilation after traumatic brain injury: implications for treatment paradigms. Springerplus. 2014 Sep 23;3:548. doi: 10.1186/2193-1801-3-548. eCollection 2014.

ReferenceCitation: Larson MD, Behrends M. Portable infrared pupillometry: a review. Anesth Analg. 2015 Jun;120(6):1242-53. doi: 10.1213/ANE.0000000000000314.

evidence: open (via free article)

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Larson MD, Singh V. Portable infrared pupillometry in critical care. Crit Care. 2016 Jun 22;20(1):161. doi: 10.1186/s13054-016-1349-7.

repositories_concat: PubMed Central;escholarship.org

repositories_institution: University of California - eScholarship University of California

ReferenceCitation: Volpi PC, Robba C, Rota M, Vargiolu A, Citerio G. Trajectories of early secondary insults correlate to outcomes of traumatic brain injury: results from a large, single centre, observational study. BMC Emerg Med. 2018 Dec 5;18(1):52. doi: 10.1186/s12873-018-0197-y.

repository_institution: University of Milano-Bicocca - BOA - Bicocca Open Archive

repository_institution: Università degli Studi di Brescia - Institutional Research Information System

repositories_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

ReferenceCitation: Han J, King NK, Neilson SJ, Gandhi MP, Ng I. External validation of the CRASH and IMPACT prognostic models in severe traumatic brain injury. J Neurotrauma. 2014 Jul 1;31(13):1146-52. doi: 10.1089/neu.2013.3003. Epub 2014 May 12.

ReferenceCitation: Couret D, Boumaza D, Grisotto C, Triglia T, Pellegrini L, Ocquidant P, Bruder NJ, Velly LJ. Reliability of standard pupillometry practice in neurocritical care: an observational, double-blinded study. Crit Care. 2016 Mar 13;20:99. doi: 10.1186/s13054-016-1239-z.

ReferenceCitation: Couret D, Simeone P, Freppel S, Velly L. The effect of ambient-light conditions on quantitative pupillometry: a history of rubber cup. Neurocrit Care. 2019 Apr;30(2):492-493. doi: 10.1007/s12028-018-0664-z. No abstract available.

ReferenceCitation: Olson DM, Stutzman S, Saju C, Wilson M, Zhao W, Aiyagari V. Interrater Reliability of Pupillary Assessments. Neurocrit Care. 2016 Apr;24(2):251-7. doi: 10.1007/s12028-015-0182-1.

ReferenceCitation: Hall CA, Chilcott RP. Eyeing up the Future of the Pupillary Light Reflex in Neurodiagnostics. Diagnostics (Basel). 2018 Mar 13;8(1):19. doi: 10.3390/diagnostics8010019.

repository_institution: University of Hertfordshire - University of Hertfordshire Research Archive

ReferenceCitation: Larson MD, Sessler DI. Pupillometry to guide postoperative analgesia. Anesthesiology. 2012 May;116(5):980-2. doi: 10.1097/ALN.0b013e318251d21b. No abstract available.

ReferenceCitation: Morelli P, Oddo M, Ben-Hamouda N. Role of automated pupillometry in critically ill patients. Minerva Anestesiol. 2019 Sep;85(9):995-1002. doi: 10.23736/S0375-9393.19.13437-2. Epub 2019 Mar 29.

ReferenceCitation: Shoyombo I, Aiyagari V, Stutzman SE, Atem F, Hill M, Figueroa SA, Miller C, Howard A, Olson DM. Understanding the Relationship Between the Neurologic Pupil Index and Constriction Velocity Values. Sci Rep. 2018 May 3;8(1):6992. doi: 10.1038/s41598-018-25477-7.

ReferenceCitation: Jahns FP, Miroz JP, Messerer M, Daniel RT, Taccone FS, Eckert P, Oddo M. Quantitative pupillometry for the monitoring of intracranial hypertension in patients with severe traumatic brain injury. Crit Care. 2019 May 2;23(1):155. doi: 10.1186/s13054-019-2436-3.

repositories_institution:
PubMed Central - Europe PMC
Université de Lausanne - SERVAL

ReferenceCitation: Aoun SG, Stutzman SE, Vo PN, El Ahmadieh TY, Osman M, Neeley O, Plitt A, Caruso JP, Aiyagari V, Atem F, Welch BG, White JA, Batjer HH, Olson DM. Detection of delayed cerebral ischemia using objective pupillometry in patients with aneurysmal subarachnoid hemorrhage. J Neurosurg. 2019 Jan 11;132(1):27-32. doi: 10.3171/2018.9.JNS181928.

publisher_dissemination: American Association of Neurological Surgeons

ReferenceCitation: Osman M, Stutzman SE, Atem F, Olson D, Hicks AD, Ortega-Perez S, Aoun SG, Salem A, Aiyagari V. Correlation of Objective Pupillometry to Midline Shift in Acute Stroke Patients. J Stroke Cerebrovasc Dis. 2019 Jul;28(7):1902-1910. doi: 10.1016/j.jstrokecerebrovasdis.2019.03.055. Epub 2019 Apr 25.

ReferenceCitation: Ong C, Hutch M, Barra M, Kim A, Zafar S, Smirnakis S. Effects of Osmotic Therapy on Pupil Reactivity: Quantification Using Pupillometry in Critically Ill Neurologic Patients. Neurocrit Care. 2019 Apr;30(2):307-315. doi: 10.1007/s12028-018-0620-y.

ReferenceCitation: Phillips SS, Mueller CM, Nogueira RG, Khalifa YM. A Systematic Review Assessing the Current State of Automated Pupillometry in the NeuroICU. Neurocrit Care. 2019 Aug;31(1):142-161. doi: 10.1007/s12028-018-0645-2.

ReferenceCitation: Oddo M, Sandroni C, Citerio G, Miroz JP, Horn J, Rundgren M, Cariou A, Payen JF, Storm C, Stammet P, Taccone FS. Quantitative versus standard pupillary light reflex for early prognostication in comatose cardiac arrest patients: an international prospective multicenter double-blinded study. Intensive Care Med. 2018 Dec;44(12):2102-2111. doi: 10.1007/s00134-018-5448-6. Epub 2018 Nov 26.

ReferenceCitation: Zuercher P, Groen JL, Aries MJ, Steyerberg EW, Maas AI, Ercole A, Menon DK. Reliability and Validity of the Therapy Intensity Level Scale: Analysis of Clinimetric Properties of a Novel Approach to Assess Management of Intracranial Pressure in Traumatic Brain Injury. J Neurotrauma. 2016 Oct 1;33(19):1768-1774. doi: 10.1089/neu.2015.4266. Epub 2016 Feb 11.

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

ReferenceCitation: Wilson L, von Steinbuechel N, Menon DK, Maas AIR. Outcome assessment after traumatic brain injury - Authors' reply. Lancet Neurol. 2018 Apr;17(4):299-300. doi: 10.1016/S1474-4422(18)30045-0. Epub 2018 Mar 13. No abstract available.

ReferenceCitation: Oddo M, Taccone F, Galimberti S, Rebora P, Citerio G; Orange Study Group. Outcome Prognostication of Acute Brain Injury using the Neurological Pupil Index (ORANGE) study: protocol for a prospective, observational, multicentre, international cohort study. BMJ Open. 2021 May 11;11(5):e046948. doi: 10.1136/bmjopen-2020-046948.

ipd_sharing_description: Access to data The University of Milano-Bicocca has the property of all the data collected. The data resides at the University Milano-Bicocca as study Sponsor; all procedures will comply with the European Union (EU) regulation on data protection 2016/679 on the protection of natural persons regarding personal data processing and movement. Local site data will be co-owned by each participating centre, and they will be given access to local data for any scientific purpose upon request. By entering data into the ORANGE study database, each centre agrees that the chief can use these data for scientific purposes. Any requests for the use of the data set for subsequent studies will be made to the ORANGE study chief investigators. Any requests for the use of the data set for subsequent studies will be made to the ORANGE study chief investigators.

sponsor_collaborators:
University of Milano Bicocca
University of Lausanne
Université Libre de Bruxelles

location_country:
Germany
Italy
Norway
Switzerland
Belgium
United States
Spain
France

location_facility: Department of Neurology, University of California

location_facility: Department Anesthesia and Critical Care, University Hospital

location_facility: Hospital Clinic Universitari de València, University of Valencia

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV), University Hospital and University of Lausanne

location_facility: Erasme Hospital, Université Libre de Bruxelles


title: Natural History Study for Pediatric Patients With Early Onset of Either GM1 Gangliosidosis, GM2 Gangliosidoses, or Gaucher Disease Type 2

acronym: RETRIEVE

summary:
This study is being conducted to better understand the natural course of GM1 gangliosidosis, GM2 gangliosidoses and Gaucher disease Type 2 (GD2). Information is planned to be gathered on at least 180 patients with GM1 gangliosidosis, GM2 gangliosidoses, and Gaucher Disease type 2. Retrospective data collection is planned for at least 150 deceased patients (Group A). Group B is for patients alive at the time of enrollment. In Group B it is planned to prospectively collect more comprehensive data from at least 30 patients. The purpose of this study is to collect relevant information for a adequate design of a potential subsequent research program in these diseases.

In this study no therapy is being offered.

time_perspective: Other

lead_sponsor: Idorsia Pharmaceuticals Ltd.

location_country:
Germany
Italy
Portugal
United Kingdom
Brazil
Switzerland
Belgium
United States
Spain
France

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

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

location_facility: Centro Universitario Hospitalar de São João, EPE

location_facility: Great Ormond Street Hospital for Children NHS Found. Trust

location_facility: Lysosomal and Rare Disorders Research and Treatment Center

location_facility: Centro Hospitalar Universitario Lisboa Norte, EPE

location_facility: Hospital de Clínicas de Porto Alegre - HCPA

location_facility: AP-HP - Hôpitaux Universitaires Est Parisien


title: The RESPOND Outcomes Study - A Study in the RESPOND Consortium (RESPOND: International Cohort Consortium of Infectious Diseases)

summary: The RESPOND Outcomes study is a research study around use of antiretroviral and other relevant drugs and long-term clinical outcomes in patients living with HIV. Data collected in this study will be used to answer key unanswered questions regarding treatment of people living with HIV.

ReferenceCitation: Obel N, Omland LH, Kronborg G, Larsen CS, Pedersen C, Pedersen G, Sorensen HT, Gerstoft J. Impact of non-HIV and HIV risk factors on survival in HIV-infected patients on HAART: a population-based nationwide cohort study. PLoS One. 2011;6(7):e22698. doi: 10.1371/journal.pone.0022698. Epub 2011 Jul 25.

ReferenceCitation: Smith CJ, Ryom L, Weber R, Morlat P, Pradier C, Reiss P, Kowalska JD, de Wit S, Law M, el Sadr W, Kirk O, Friis-Moller N, Monforte Ad, Phillips AN, Sabin CA, Lundgren JD; D:A:D Study Group. Trends in underlying causes of death in people with HIV from 1999 to 2011 (D:A:D): a multicohort collaboration. Lancet. 2014 Jul 19;384(9939):241-8. doi: 10.1016/S0140-6736(14)60604-8.

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories_concat: UCL Discovery

ReferenceCitation: Schouten J, Wit FW, Stolte IG, Kootstra NA, van der Valk M, Geerlings SE, Prins M, Reiss P; AGEhIV Cohort Study Group. Cross-sectional comparison of the prevalence of age-associated comorbidities and their risk factors between HIV-infected and uninfected individuals: the AGEhIV cohort study. Clin Infect Dis. 2014 Dec 15;59(12):1787-97. doi: 10.1093/cid/ciu701. Epub 2014 Sep 2.

evidence: oa repository (semantic scholar lookup)

publisher_dissemination: Oxford University Press

ReferenceCitation: Chary A, Nguyen NN, Maiton K, Holodniy M. A review of drug-drug interactions in older HIV-infected patients. Expert Rev Clin Pharmacol. 2017 Dec;10(12):1329-1352. doi: 10.1080/17512433.2017.1377610. Epub 2017 Sep 19.

oa_host_type: closed

publisher_dissemination: Informa

ReferenceCitation: Weber R, Sabin CA, Friis-Moller N, Reiss P, El-Sadr WM, Kirk O, Dabis F, Law MG, Pradier C, De Wit S, Akerlund B, Calvo G, Monforte Ad, Rickenbach M, Ledergerber B, Phillips AN, Lundgren JD. Liver-related deaths in persons infected with the human immunodeficiency virus: the D:A:D study. Arch Intern Med. 2006 Aug 14-28;166(15):1632-41. doi: 10.1001/archinte.166.15.1632.

ReferenceCitation: Kattakuzhy S, Gross C, Emmanuel B, Teferi G, Jenkins V, Silk R, Akoth E, Thomas A, Ahmed C, Espinosa M, Price A, Rosenthal E, Tang L, Wilson E, Bentzen S, Masur H, Kottilil S; ASCEND Providers. Expansion of Treatment for Hepatitis C Virus Infection by Task Shifting to Community-Based Nonspecialist Providers: A Nonrandomized Clinical Trial. Ann Intern Med. 2017 Sep 5;167(5):311-318. doi: 10.7326/M17-0118. Epub 2017 Aug 8.

publisher_dissemination: American College of Physicians

ReferenceCitation: Falade-Nwulia O, Suarez-Cuervo C, Nelson DR, Fried MW, Segal JB, Sulkowski MS. Oral Direct-Acting Agent Therapy for Hepatitis C Virus Infection: A Systematic Review. Ann Intern Med. 2017 May 2;166(9):637-648. doi: 10.7326/M16-2575. Epub 2017 Mar 21.

oa_colors: green other

ReferenceCitation: van der Meer AJ, Veldt BJ, Feld JJ, Wedemeyer H, Dufour JF, Lammert F, Duarte-Rojo A, Heathcote EJ, Manns MP, Kuske L, Zeuzem S, Hofmann WP, de Knegt RJ, Hansen BE, Janssen HL. Association between sustained virological response and all-cause mortality among patients with chronic hepatitis C and advanced hepatic fibrosis. JAMA. 2012 Dec 26;308(24):2584-93. doi: 10.1001/jama.2012.144878.

ReferenceCitation: Friis-Moller N, Ryom L, Smith C, Weber R, Reiss P, Dabis F, De Wit S, Monforte AD, Kirk O, Fontas E, Sabin C, Phillips A, Lundgren J, Law M; D:A:D study group. An updated prediction model of the global risk of cardiovascular disease in HIV-positive persons: The Data-collection on Adverse Effects of Anti-HIV Drugs (D:A:D) study. Eur J Prev Cardiol. 2016 Jan;23(2):214-23. doi: 10.1177/2047487315579291. Epub 2015 Apr 16.

ReferenceCitation: Mocroft A, Lundgren JD, Ross M, Fux CA, Reiss P, Moranne O, Morlat P, Monforte Ad, Kirk O, Ryom L; Data Collection on Adverse events of Anti-HIV Drugs (D:A:D) Study. Cumulative and current exposure to potentially nephrotoxic antiretrovirals and development of chronic kidney disease in HIV-positive individuals with a normal baseline estimated glomerular filtration rate: a prospective international cohort study. Lancet HIV. 2016 Jan;3(1):e23-32. doi: 10.1016/S2352-3018(15)00211-8. Epub 2015 Nov 17.

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: University of Ferrara - Institutional Research Information System University of Ferrara

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repositories_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

ReferenceCitation: Bruyand M, Ryom L, Shepherd L, Fatkenheuer G, Grulich A, Reiss P, de Wit S, D Arminio Monforte A, Furrer H, Pradier C, Lundgren J, Sabin C; D:A:D study group. Cancer risk and use of protease inhibitor or nonnucleoside reverse transcriptase inhibitor-based combination antiretroviral therapy: the D: A: D study. J Acquir Immune Defic Syndr. 2015 Apr 15;68(5):568-77. doi: 10.1097/QAI.0000000000000523.

repositories_institution: University of Milano-Bicocca - BOA - Bicocca Open Archive

ReferenceCitation: Neesgaard B, Greenberg L, Miro JM, Grabmeier-Pfistershammer K, Wandeler G, Smith C, De Wit S, Wit F, Pelchen-Matthews A, Mussini C, Castagna A, Pradier C, d'Arminio Monforte A, Vehreschild JJ, Sonnerborg A, Anne AV, Carr A, Bansi-Matharu L, Lundgren JD, Garges H, Rogatto F, Zangerle R, Gunthard HF, Rasmussen LD, Necsoi C, van der Valk M, Menozzi M, Muccini C, Peters L, Mocroft A, Ryom L. Associations between integrase strand-transfer inhibitors and cardiovascular disease in people living with HIV: a multicentre prospective study from the RESPOND cohort consortium. Lancet HIV. 2022 Jul;9(7):e474-e485. doi: 10.1016/S2352-3018(22)00094-7. Epub 2022 Jun 7.

sponsor_collaborators:
Rigshospitalet, Denmark
Gilead Sciences
ViiV Healthcare

location_country:
Germany
Italy
United Kingdom
Denmark
Australia
Sweden
Netherlands
Austria
Belgium
Switzerland
Spain
Georgia
France

location_facility: The EuroSIDA Study, CHIP, Rigshospitalet

location_facility: Royal Free HIV Cohort Study, Royal Free Hospital

location_facility: The ATHENA (AIDS Therapy Evaluation in the Netherlands) national observational HIV cohort, Stichting HIV Monitorin, AMC, University of Amsterdam

location_facility: PISCIS Cohort Study, Germans Trias i Pujol University Hospital

location_facility: Swiss HIV Cohort Study (SHCS), University Hospital Zurich

location_facility: The Australian HIV Observational Database (AHOD)

location_facility: Swedish InfCare HIV Cohort, Karolinska University Hospital

location_facility: Georgian National AIDS Health Information System (AIDS HIS), IDACIRC

location_facility: Austrian HIV Cohort Study (AHIVCOS), Medizinische Universität Innsbruch

location_facility: Modena HIV Cohort, Università degli Studi di Modena

location_facility: Frankfurt HIV Cohort Study, Goethe-University Frankfurt

location_facility: San Raffaele Scientific Institute, Ospedale San Raffaele

location_facility: Italian Cohort Naive Antiretrovirals (ICONA)

location_facility: Nice HIV Cohort, Centre Hospitalier Universitaire de Nice


title: An Open-label Study to Evaluate the Safety and Pharmacokinetics of Migalastat HCl in Subjects With Fabry Disease and Amenable GLA Variants and Severe Renal Impairment or End-Stage Renal Disease Treated With Hemodialysis

summary: An Open-label Study to Evaluate the Safety and Pharmacokinetics of Migalastat HCl in Subjects with Fabry Disease and Amenable GLA Variants and Severe Renal Impairment (SRI) or End Stage Renal Disease (ESRD)

lead_sponsor: Amicus Therapeutics

location_country:
Australia
Japan
United States
Spain
France

location_facility: Hospital Universitari(o) de Bellvitge (HUB) Feixa Llarga

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Lysosomal and Rare Disorders Research and Treatment Center, Inc

location_facility: Internal Medicine Unit Croix Saint Simon Hospital


title: Randomized Controlled Clinical Study to Assess the Benefit of Non-invasive PGT-A, by the Analysis of Spent Blastocyst Media, as a Tool for Embryo Prioritization in Infertile Patients Undergoing Assisted Reproduction.

summary:
Chromosomal aneuploidies are linked with spontaneous miscarriages and abnormal offspring in human pregnancies. In addition, some types of aneuploidies are reported to prevent implantation. Thus, there is a need to identify the embryos with highest implantation potential on in vitro fertilization (IVF) programs.

Since embryo morphology and kinetics have a weak association with embryo ploidy, trophectoderm biopsy plus Next-Generation Sequencing (NGS) is becoming a very popular approach to determine the embryo chromosomal status. This technique is called Preimplantation Genetic Testing for Aneuploidy (PGT-A). Although shown to be efficient, it is invasive for the embryo, requires specific technical skills and it remains expensive. Therefore, the development of a non-invasive, rapid and cheaper method for assessing embryo ploidy status would represent a progress in the field of IVF.

The non-invasive approach has been explored by some groups that analyzed the Spent Blastocyst Medium (SBM) where the embryo was incubated up to the time of transfer or freezing. In daily routine, this media is discarded after finishing the culture of the embryo. Importantly, though, this media reportedly contains traces of embryonic cell-free DNA (cfDNA) that can represent the genetic load of the embryo.

On the basis of that, the hypothesis of this study is that embryo prioritization according to the analysis of the embryonic cfDNA in the SBM could improve ongoing pregnancy rate in 10 percentual points compared to standard blastocyst transfer based on morphology.

primary_purpose: Diagnostic

lead_sponsor: Igenomix

location_country:
Italy
Argentina
Brazil
United States
Spain
France

location_facility: Società Italiana Studi di Medicina della Riproduzione (S.I.S.M.e.R.)

location_facility: Crecer: Centro de Reproducción y Genética Humana

location_facility: Nilo Frantz - Centro de Reprodução Humana

intervention_type: Diagnostic Test


title: Vascular Access Outcome Measure for Function: a vaLidation Study In haemoDialysis (VALID)

acronym: VALID

summary: A functioning vascular access provides a lifeline for patients requiring haemodialysis but vascular access dysfunction remains one of the leading causes of excessive morbidity, mortality and healthcare costs in this group. Despite increasing numbers of vascular access trials, successful interventions to improve vascular access function have been sparse and compromised by highly variable, often selectively reported outcome measures of limited relevance to patients and health professionals. Through engagement of all relevant stakeholders including patients and caregivers, vascular access function, defined by the need for interventions to enable and maintain the use of a vascular access for haemodialysis, has been identified as one of the most critically important outcome measures for trials in haemodialysis. This prospective, multi-centre, multinational validation study aims to assess the accuracy and feasibility of measuring vascular access function part of routine clinical practice and across different clinical settings to ensure successful global implementation of this core outcome measure in future trials in haemodialysis.

ReferenceCitation: Viecelli AK, Teixeira-Pinto A, Valks A, Baer R, Cherian R, Cippa PE, Craig JC, DeSilva R, Jaure A, Johnson DW, Kiriwandeniya C, Kopperschmidt P, Liu WJ, Lee T, Lok C, Madhan K, Mallard AR, Oliver V, Polkinghorne KR, Quinn RR, Reidlinger D, Roberts M, Sautenet B, Hooi LS, Smith R, Snoeijs M, Tordoir J, Vachharajani TJ, Vanholder R, Vergara LA, Wilkie M, Yang B, Yuo TH, Zou L, Hawley CM; VALID Investigator Team. Study protocol for Vascular Access outcome measure for function: a vaLidation study In hemoDialysis (VALID) : A multi-center, multinational validation study to assess the accuracy and feasibility of measuring vascular access function in clinical practice. BMC Nephrol. 2022 Nov 19;23(1):372. doi: 10.1186/s12882-022-02987-1.

repository_institution: University of Adelaide - Adelaide Research & Scholarship (AR&S)

repository_institution: Griffith University, Queensland, Australia - Griffith Research Online

repositories_institution: Ghent University - Ghent University Academic Bibliography

ipd_sharing_description: Individual participant data that underlie the results reported in the primary publication, after deidentification (text, tables, figures and appendices) will be available for individual participant data meta-analysis.

lead_sponsor: The University of Queensland

sponsor_collaborators:
The University of Queensland
Australasian Kidney Trials Network

location_country:
United Kingdom
Australia
Netherlands
Switzerland
Malaysia
Canada
France

location_facility: Centre Hospitalier Régional Universitaire de Tours


lead_sponsor: Celltrion

summary: This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC over Placebo SC in Patients With Moderately to Severely Active Crohn's Disease

location_facility: Dr.Carol Davila Emergency University Central Military Hospital

location_facility: Municipal Nonprofit Enterprise Zaporizhzhia Regional Clinical Hospital Zaporizhzhia Regional Council

location_facility: Fakultna nemocnica s poliklinikou F. D. Roosevelta

location_facility: University General Hospital of Heraklion

location_facility: Fondazione Policlinico Universitario A Gemelli-Rome

location_facility: Diagnostic and Consulting Center Aleksandrovska EOOD

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Szpital Uniwersytecki Nr 2 im. dr Jana Biziela w Bydgoszczy, Centrum Endoskopii Zabiegowej, Poradnia

location_facility: Communal Non-Commercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council

title: A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease

source: euctr

location_country:
Germany
Poland
Japan
Turkey
Croatia
Czechia
Serbia
France
Belarus
Slovakia
Hungary
United States
Latvia
Ukraine
India
Romania
Peru
Moldova, Republic of
Italy
Mexico
Spain
Greece
South Africa
Bulgaria
Russian Federation
Israel


title: A Real World Evidence Prospective Cohort Study in the Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective

acronym: PROMETCO

ReferenceCitation: Koopman M, Pinto C, Bodoky G, Garcia-Carbonero R, Marti FM, Bachet JB. Rationale and design of the PROMETCO study: a real-world, prospective, longitudinal cohort on the continuum of care of metastatic colorectal cancer from a clinical and patient perspective. Future Oncol. 2022 Apr;18(11):1313-1320. doi: 10.2217/fon-2021-1333. Epub 2022 Jan 19.

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

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

repositories_concat: HAL

publisher_dissemination: Future Science Ltd

lead_sponsor: Servier Affaires Médicales

location_country:
Germany
Ireland
Italy
Slovenia
Portugal
Hungary
Argentina
United Kingdom
Sweden
Netherlands
Austria
Belgium
Switzerland
Spain
Greece
Croatia
Czechia
France

location_facility: University Hospital in Hradec Kralove Clinic of Oncology and Radiotherapy

location_facility: The Adelaide & Meath Hospital-Dublin Incorporating The National Children's Hospital

location_facility: Del-Pesti Centrum Korhaz OHII, Szent Laszlo Korhaz Telephely

location_facility: Cancer Research UK, Department of Medical Oncology-The Christie NHS Foundation Trust

location_facility: Centro Des Estudos Egas Moniz - Hospital Santa Maria

location_facility: UniversitaetsSpital Zuerich (University Hospital Zurich)


title: Prospective Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile Dysfunction

acronym: PHOENIX

summary: Prospective collection of pre-defined parameters on the surgical treatment of male erectile dysfunction using Penile Prosthesis Implants (PPIs).

ipd_sharing_description: Investigators may share anonymized individual data with residents/urologist interested to analyze and publish the results of the registry

lead_sponsor: European Association of Urology Research Foundation

collaborators:
Boston Scientific Corporation
Coloplast A/S

location_country:
Germany
Italy
Portugal
United Kingdom
Sweden
Belgium
Spain
France

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Azienda Ospedaliero-Universitaria "Ospedali Riuniti" di Foggia

location_facility: Centro Hospitalar Universitario Lisboa Norte

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna

location_facility: Marques de Valdecilla University Hospital


acronym: INFORM2 NivEnt

lead_sponsor: University Hospital Heidelberg

summary: The aim of this trial is to determine preliminary activity of the combination treatment with nivolumab and entinostat in children and adolescents with high risk refractory/relapsed/progressive tumors harboring a high mutational load, high PD-L1 mRNA expression or focal MYC(N) amplification and explore activity in biomarker low tumors (low mutational load, low PD-L1 mRNA expression and non-MYC(N) amplified).

ReferenceCitation: van Tilburg CM, Witt R, Heiss M, Pajtler KW, Plass C, Poschke I, Platten M, Harting I, Sedlaczek O, Freitag A, Meyrath D, Taylor L, Balasubramanian GP, Jager N, Pfaff E, Jones BC, Milde T, Pfister SM, Jones DTW, Kopp-Schneider A, Witt O. INFORM2 NivEnt: The first trial of the INFORM2 biomarker driven phase I/II trial series: the combination of nivolumab and entinostat in children and adolescents with refractory high-risk malignancies. BMC Cancer. 2020 Jun 5;20(1):523. doi: 10.1186/s12885-020-07008-8.

repository_institution: PubMed Central - Europe PMC

sponsor_collaborators:
University Hospital Heidelberg
German Cancer Research Center

location_facility: Hopp Children's Cancer Center Heidelberg (KiTZ)

title: INFORM2 Exploratory Multinational Phase I/II Combination Study of Nivolumab and Entinostat in Children and Adolescents With Refractory High-risk Malignancies

ipd_sharing_description:
The pseudonymized data will be shared for transparency reasons in the context of publications and after publication with other physicians and scientists (national and international academia) to promote and accelerate research on causes and treatment development of oncological diseases.

Requests for access to pseudonymized patient data for non-INFORM-related scientific purposes will be reviewed by a Data Access Committee consisting of the INFORM Board, and the participating investigators. A positive statement of the respective ethic committee and a signed data protection commitment are requested. Requests should be addressed to the coordinating investigator Prof. Olaf Witt. Results of scientific research based on the INFORM2 NivEnt data may be used for academic teaching, research and scientific publications or presentations at scientific meetings.

location_country: Germany Australia Sweden Netherlands Austria Switzerland France


title: A Survivorship Project to UnerstAnd and to impRove Long-Term Outcomes for Acute Myeloid Leukemia Patients (SPARTA): the Sparta Platform

summary: This international observational study aims at examining the patterns of health-related quality of life differences between long-term acute myeloid leukemia patients and their healthy peers from the general population.

status: Unknown status

lead_sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

location_country:
Slovenia
Italy
North Macedonia
Slovakia
Belgium
Turkey
Croatia
France

location_facility: U.O. di Ematologia - Casa Sollievo della Sofferenza

location_facility: Orbassano Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2

location_facility: Divisione di Ematologia Ospedale A. Perrino

location_facility: U.O. di Ematologia con trapianto - A.U. Policlinico "Paolo Giaccone"

location_facility: Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova

location_facility: Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria

location_facility: Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto

location_facility: Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. LANCISI - G. SALESI

location_facility: Les Hôpitaux Universitaires de Strasbourg

location_facility: UOC di Ematologia-Centro Emofilia e Trombosi - Ospedale Ascalesi - ASL Napoli 1

location_facility: Milano Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano

location_facility: Torino Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista

location_facility: U.O. Ematologia con trapianto - Azienda Ospedaliero-Universitaria Policlinico di Bari

location_facility: Divisione di Ematologia - Ospedale S.Eugenio

location_facility: Ematologia Policlinico - Università degli Studi di Roma Tor Vergata (PTV)

location_facility: Istituto di Semeiotica Medica - Ematologia - Università Cattolica del Sacro Cuore - Policlinico A. Gemelli

location_facility: Università degli Studi di Padova - Ematologia ed Immunologia Clinica

location_facility: Ankara University School Of Medicine Cebeci Campus Adult Hematology Department and BMT Unit

location_facility: ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO

location_facility: Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia

location_facility: Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi

location_facility: UOC Ematologia Ospedale " Monsignor Raffaele Dimiccoli"

location_facility: Roma Divisione Ematologia - Università Campus Bio-Medico

location_facility: Università degli Studi "Sapienza" - Dip Medicina di Precisione e Ricerca Traslazionale UOC Ematologia

location_facility: Divisione clinicizzata di Ematologia - Dipartimento di Scienze Mediche - Osp. Ferrarotto

location_facility: IRCCS_AOU San Martino-IST.Clinica Ematologica

location_facility: S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro

location_facility: Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia


acronym: MATINS

lead_sponsor: Faron Pharmaceuticals Ltd

summary:
This is a first in human study to identify whether FP-1305 is suitable to use in humans. The previous pre-clinical studies have demonstrated that FP-1305 binds to a receptor known as CLEVER-1. CLEVER-1 has been shown to support tumour growth. No significant adverse events were witnessed in primates and the dose used will be 300 fold lower than the dose provided to primates which showed no toxicity.

The patients with advanced melanoma, uveal melanoma, cholangiocarcinoma, gallbladder cancer, ER+ breast, gastric, ovarian, pancreatic, colorectal, liver or anaplastic thyroid cancer who have exhausted all licenced therapeutic options will die due to their disease. Based on the investigator's existing data CLEVER-1 is expressed in these tumour types. Inhibition of CLEVER-1 with FP-1305 may have an anti-tumour effect in these patients.

ReferenceCitation: Hollmen M, Maksimow M, Rannikko JH, Karvonen MK, Vainio M, Jalkanen S, Jalkanen M, Mandelin J. Nonclinical Characterization of Bexmarilimab, a Clever-1-Targeting Antibody for Supporting Immune Defense Against Cancers. Mol Cancer Ther. 2022 Jul 5;21(7):1207-1218. doi: 10.1158/1535-7163.MCT-21-0840.

repository_institution: University of Turku - UTUPub

repositories_concat: PubMed Central;www.utupub.fi

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Virtakoivu R, Rannikko JH, Viitala M, Vaura F, Takeda A, Lonnberg T, Koivunen J, Jaakkola P, Pasanen A, Shetty S, de Jonge MJA, Robbrecht D, Ma YT, Skytta T, Minchom A, Jalkanen S, Karvonen MK, Mandelin J, Bono P, Hollmen M. Systemic Blockade of Clever-1 Elicits Lymphocyte Activation Alongside Checkpoint Molecule Downregulation in Patients with Solid Tumors: Results from a Phase I/II Clinical Trial. Clin Cancer Res. 2021 Aug 1;27(15):4205-4220. doi: 10.1158/1078-0432.CCR-20-4862. Epub 2021 Jun 2.

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_institution: University of Oulu - University of Oulu Repository - Jultika

evidence: oa repository (via free pdf)

repository_normalized: medRxiv

repositories_institution: Erasmus University Rotterdam - EUR Research Repository

location_facility: Erasmus University Medical Center Rotterdam

location_facility: START Madrid - CIOCC Hospital HM Sanchinarro

location_facility: The University of Texas Health Science Center at San Antonio

title: A Phase I/II Open-Label, Three-Part, Dose-Finding and Separate Cohort Expansion Trial to Assess the Safety, Tolerability and Preliminary Efficacy of Repeated Doses of CLEVER-1 Antibody FP-1305, in Subjects With Advanced Solid Tumours

location_country:
Finland
United Kingdom
Netherlands
United States
Spain
France


title: A Two-Part, Randomized, Open-label, Multicenter, Phase 2a/2b Study of the Efficacy, Safety, and Pharmacokinetics of KRT-232 Compared to Ruxolitinib in Patients With Phlebotomy-Dependent Polycythemia Vera

summary:
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, for the treatment of patients with phlebotomy-dependent polycythemia vera (PV). Inhibition of MDM2 in PV is a new mechanism of action in PV. In Part A, patients must be resistant or intolerant to hydroxyurea or have undergone treatment with interferon. In Part B, patients must be resistant or intolerant to hydroxyurea.

This study is a global, open-label Phase 2a/2b study to determine the efficacy and safety of KRT-232. In Part A of the study, patients will be randomly assigned to 5 arms with 2 different doses and 3 different dosing schedules of KRT 232. In Part B of the study, patients will be randomized either to treatment with KRT-232 administered at the recommended dose and schedule from Part A or to treatment with ruxolitinib.

lead_sponsor: Kartos Therapeutics, Inc.

location_country:
Germany
Poland
Hungary
United States
Spain
France

location_facility: Center Hospitalier Universitaire d'Angers

location_facility: Békés Megyei Központi Kórház Pándy Kálmán Tagkórház

location_facility: Washington University School of Medicine

location_facility: University of Southern California Norris Comprehensive Cancer Center

location_facility: Gemeinschaftspraxis Haematologie - Onkologie - Hauptstelle

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku


acronym: CAPtivate

lead_sponsor: Ultragenyx Pharmaceutical Inc

summary: Determine the long-term safety of DTX301 following a single intravenous (IV) dose in adults with late-onset ornithine transcarbamylase (OTC) deficiency.

location_facility: Queen Elizabeth Hospital, Department of Endocrinology

location_facility: Hospital Clinico Universitario de Santiago

location_facility: University Hospital Cleveland Medical Center/Case Western Reserve University

location_facility: Hospital Universitario de Cruces. Servicio de Pediatria

title: A Long-Term Follow-up Study to Evaluate Safety and Efficacy of Adeno-Associated Virus (AAV) Serotype 8 (AAV8)-Mediated Gene Transfer of Human Ornithine Transcarbamylase (OTC) in Adults With Late-Onset OTC Deficiency

location_country:
United Kingdom
United States
Spain
Canada
France


lead_sponsor: Wave Life Sciences Ltd.

summary: This is a Phase 1, double-blind, placebo-controlled, single ascending dose cohort study to evaluate the safety, tolerability, and plasma concentrations of WVE-210201 in ambulatory and non-ambulatory male pediatric patients with DMD amenable to exon 51 skipping intervention.

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Radbound University Nijmegen Medical Care

location_facility: U.O.C di Neurologia e Malattie Neuromuscolari Centro Clinico Nemo Sud

location_facility: London Health Sciences Centre - Hospital

location_facility: UCL Institute of Child Health & Great Ormond Street Hospital for Children

title: A Multicenter, Double-blind, Placebo-controlled, Phase 1 Study of WVE-210201 Administered Intravenously to Patients With Duchenne Muscular Dystrophy

location_country:
Italy
United Kingdom
Netherlands
Belgium
United States
Canada
France


lead_sponsor: Taiho Oncology, Inc.

summary: This is a First-in-Human (FIH), 2-part, Phase 1/2, open-label, multicenter study design to evaluate the safety, tolerability, PK, pharmacodynamics, PGx, and efficacy of TAS0728. This study consists of Phase 1 and Phase 2 components in subjects with advanced solid tumors with HER2 or HER3 overexpression, amplification, or mutation who have progressed despite standard therapy or for which no standard therapy exists, particularly urothelial cancer, biliary tract cancer, metastatic breast cancer, non-small cell lung cancer and colorectal cancer.

ReferenceCitation: Piha-Paul SA, Azaro A, Arkenau HT, Oh DY, Galsky MD, Pal SK, Hamada K, He Y, Yamamiya I, Benhadji KA, Hollebecque A. A first-in-human phase I study of TAS0728, an oral covalent binding inhibitor of HER2, in patients with advanced solid tumors with HER2 or HER3 aberrations. Invest New Drugs. 2021 Oct;39(5):1324-1334. doi: 10.1007/s10637-021-01104-7. Epub 2021 Mar 27.

evidence: oa repository (via page says license)

repository_normalized: Research Square

repository_institution: Research Square - Research Square

repositories:
PubMed Central
Research Square

repositories_concat: PubMed Central;Research Square

ReferenceCitation: Irie H, Ito K, Fujioka Y, Oguchi K, Fujioka A, Hashimoto A, Ohsawa H, Tanaka K, Funabashi K, Araki H, Kawai Y, Shimamura T, Wadhwa R, Ohkubo S, Matsuo K. TAS0728, A Covalent-binding, HER2-selective Kinase Inhibitor Shows Potent Antitumor Activity in Preclinical Models. Mol Cancer Ther. 2019 Apr;18(4):733-742. doi: 10.1158/1535-7163.MCT-18-1085. Epub 2019 Feb 20.

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

location_facility: City of Hope Comprehensive Cancer Center

title: A Phase 1/2, Open Label, Multicenter Study to Investigate the Safety, Pharmacokinetics, and Efficacy of TAS0728, an Oral Covalent Binding Inhibitor of HER2, in Subjects With Advanced Solid Tumors With HER2 or HER3 Abnormalities

location_country:
United States
Spain
United Kingdom
France


title: A Multicenter Study to Explore the Mechanism of Acquired Immune Escape In Patients With Metastatic Cancer Progressing on Checkpoint Inhibitor Therapy

summary: The purpose of this study is to identify mechanisms associated with acquired immune escape by comparing baseline and at-progression tissue samples from participants who derive clinical benefit from CPI treatment of metastatic cancer or hematologic malignancies.

primary_purpose: Basic Science

lead_sponsor: Hoffmann-La Roche

location_country:
United Kingdom
United States
Spain
Korea, Republic of
France

location_facility: Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology

location_facility: Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

location_facility: Clinica Universitaria de Navarra; Servicio de oncología

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Seoul National University Hospital; Department of Oncology

location_facility: Herbert Irving Comprehensive Cancer Center; Herbert Irving Pavillion

location_facility: Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology

intervention_type: Procedure


title: Clinical Trial Evaluation of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System

summary:
The objective of the study is to generate safety and performance data for the 4Tech TriCinch Coil System in symptomatic patients suffering from significant functional tricuspid regurgitation with annular dilatation.

The TriCinch Coil System is a percutaneous catheter-based medical device for tricuspid valve repair.

lead_sponsor: 4Tech Cardio Ltd.

location_country:
Germany
United Kingdom
Denmark
Australia
Netherlands
Belgium
France

location_facility: Brighton & Sussex University Hospitals - Sussex County Hospital


title: Phase 1b, Multi-arm, Open-label Study of PDR001 and/or MBG453 in Combination With Decitabine in Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome

summary: To characterize the safety and tolerability of 1) MBG453 as a single agent or in combination with PDR001 or 2) PDR001 and/or MBG453 in combination with decitabine or azacitidine in AML and intermediate or high- risk MDS patients, and to identify recommended doses for future studies.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Finland
United Kingdom
Australia
Netherlands
United States
Spain
France

location_facility: Oregon Health Sciences University Main Center


title: A Disease Registry for Patients With Tenosynovial Giant Cell Tumors (TGCT), Also Known as Pigmented Villonodular Synovitis (PVNS) and Giant Cell Tumor of the Tendon Sheath (GCT-TS)

acronym: TOP

summary:
TGCT is a rare disease that is difficult to manage, surgical resection is the primary treatment currently available. To date no disease registry exists and there is little data available detailing the management of patients with diffuse TGCT (d-TGCT), the burden of d-TGCT for patients (including pain, joint stiffness, swelling, reduced mobility and quality of life) or the economic impact of d-TGCT.

This study aims to collect data by an observational disease registry involving no intervention to the patient or changes to investigators treatment decisions.

ReferenceCitation: Bernthal NM, Spierenburg G, Healey JH, Palmerini E, Bauer S; TOPP Study Group; Gelderblom H, Staals EL, Lopez-Bastida J, Fronk EM, Ye X, Laeis P, van de Sande MAJ. The diffuse-type tenosynovial giant cell tumor (dt-TGCT) patient journey: a prospective multicenter study. Orphanet J Rare Dis. 2021 Apr 29;16(1):191. doi: 10.1186/s13023-021-01820-6.

repository_institution: Spanish National Research Council (CSIC) - DIGITAL.CSIC

repository_normalized: DIGITAL.CSIC (Spain)

repository_institution: California Digital Library - eScholarship

lead_sponsor: Daiichi Sankyo, Inc.

sponsor_collaborators:
Daiichi Sankyo, Inc.
Optimapharm

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

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Istituto Nazionale Tumori-Foundazione IRCCS


title: The RELIEF Trial: REduction or eLimination of mItral rEgurgitation in Degenerative or Functional Mitral Regurgitation With the CardiAQ-Edwards™ Transcatheter Mitral Valve

acronym: RELIEF

summary: Clinical study to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve

status: Withdrawn

lead_sponsor: Edwards Lifesciences

location_country: Germany Italy Denmark Netherlands Switzerland Canada France

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: Centre de recherche Institut Universitaire de Cardiologie et de Pneumologie de Québec (CRIUCPQ)

location_facility: St. Paul's Hospital, University of British Columbia


title: INCEPTUS: A Prospective, Non-Interventional Clinical Assessment Study in X Linked Myotubular Myopathy (XLMTM) Subjects Aged 3 Years and Younger

acronym: INCEPTUS

summary: This is a pre-Phase 1 prospective, non interventional clinical assessment study to evaluate XLMTM subjects aged 3 years and younger. Many of these clinically relevant measures have not yet been routinely assessed in this population and may provide important insight on the natural history of XLMTM and for future evaluation of potential therapies.

lead_sponsor: Astellas Gene Therapies

location_country:
Germany
United Kingdom
United States
Canada
France

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: National Institute of Neurological Disorders and Stroke/NIH Porter


title: A Randomised, Double-blind, Placebo-controlled Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis Patients

acronym: IMPALA

summary: This study evaluates inhaled molgramostim (recombinant human granulocyte macrophage-colony stimulating factor [rhGM-CSF]) in the treatment of autoimmune pulmonary alveolar proteinosis (aPAP) patients. A third of the patients will receive inhaled molgramostim once daily for 24 weeks, a third will receive inhaled molgramostim intermittently (7 days on, 7 days off) for 24 weeks and a third will receive inhaled matching placebo for 24 weeks.

ReferenceCitation: Trapnell BC, Inoue Y, Bonella F, Morgan C, Jouneau S, Bendstrup E, Campo I, Papiris SA, Yamaguchi E, Cetinkaya E, Ilkovich MM, Kramer MR, Veltkamp M, Kreuter M, Baba T, Ganslandt C, Tarnow I, Waterer G, Jouhikainen T; IMPALA Trial Investigators. Inhaled Molgramostim Therapy in Autoimmune Pulmonary Alveolar Proteinosis. N Engl J Med. 2020 Oct 22;383(17):1635-1644. doi: 10.1056/NEJMoa1913590. Epub 2020 Sep 7.

lead_sponsor: Savara Inc.

location_country:
Germany
Italy
Portugal
Slovakia
Israel
United Kingdom
Denmark
Australia
Japan
Netherlands
Switzerland
United States
Korea, Republic of
Spain
Greece
Turkey
Russian Federation
France

location_facility: Niigata University Medical and Dental Hospital

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: II. Pulmonary Department National Institut for TB, Lung Diseases and Chest Surgery

location_facility: Samsung Medical Center, Division of Pulmonary and Critical Care Medicine

location_facility: Asklepios Fachkliniken München - Gauting

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Westdeutsches Lungenzentrum am Universitätsklinikum Essen

location_facility: Yedikule Pulmonary Diseases and Pulmonary Surgery Training and Research Hospital

location_facility: Universitätsklinikum Schleswig-Holstein Zentralklinikum, Lübeck Medizinische Klinik III, Pneumologie

location_facility: National Hospital Organization Kinki-Chuo

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg

location_facility: Asan Medical Center, Division of Pulmonary and Critical Care Medicine


title: European Network-Paediatric Hodgkin Lymphoma Study Group (EuroNet-PHL) Second International Inter-Group Study for Classical Hodgkin Lymphoma in Children and Adolescents

summary: The EuroNet-PHL-C2 trial is an international, multicentre, randomised controlled trial with the aims to reduce the indication for radiotherapy in newly diagnosed patients with classical Hodgkin lymphoma without compromising cure rates and to investigate a chemotherapy intensification randomisation in intermediate and advanced classical Hodgkin lymphoma to compensate for reduction in radiotherapy.

lead_sponsor: University of Giessen

collaborators: Deutsche Krebshilfe e.V., Bonn (Germany)

location_country:
Germany
Ireland
Poland
New Zealand
Australia
Czechia
France
Slovakia
Denmark
Switzerland
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Spain
Israel

location_facility: Department of Medical Oncology Oslo University Hospital

location_facility: Department of Pediatric Hematology/Oncology (5054) The Child and Youth Clinic, University Hospital of Copenhagen

location_facility: Starship Blood and Cancer Centre, Starship Children's Hospital

location_facility: Pediatric Radiotherapy and Youth Area Unit C.R.O. - Centro di Riferimento Oncologico IRCCS

location_facility: CHUV - Centre Hospitalier Universitaire Vaudois = LS, Départment femme - meré - enfant, Service de pédiatrie, Unité d'hématologie-oncologie pédiatrique

location_facility: Paediatric haemato-oncology, University Hospitals of Leuven

location_facility: Dpt. of Pediatric Hematology and Oncology, Faculty Hospital Motol

location_facility: Clinic of Pediatric Oncology University Children's Hospital

location_facility: Princess Máxima Center for pediatric oncology

location_facility: Pediatric Hematology & Oncology Children´s University Hospital

location_facility: Tel Aviv University Schneider Children's Medical Center of Israel The Rina Zaizov Pediatric Hematology Oncology Division

location_facility: Royal Children's Hospital and Monash Medical Centre Royal Children's Hospital

location_facility: Service d'Oncohématologie, Hopital d'Ènfants Armand Trousseau

location_facility: Head of Department of Pediatric Oncology and Hematology, Polish-American Pediatric Institute, Jagiellonian University Medical Faculty

location_facility: Sección de Onco-Hematología Pediátrica Hospital Universitario Virgen Macarena y Virgen del Rocío

appel_a_projets: PHRCK

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

titre: EuroNet-PHL-C2. Second International Inter-Group Study for Classical Hodgkin's Lymphoma in Children, Adolescents and Young Adults

discipline_principale: cancer

nom_porteur: LANDMAN-PARKER

prenom_porteur: Judith


title: Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes - An Investigator-driven, Prospective, Randomised, Double-blind, Multi-centre Trial Initiated by the European Society of Cardiology and AFNET

acronym: NOAH

summary: NOAH is an investigator-initiated, prospective, parallel-group, double-blind, randomised, multi-centre trial. The objective of the trial is to demonstrate that oral anticoagulation using the NOAC edoxaban is superior to current therapy to pre-vent stroke, systemic embolism, or cardiovascular death in patients with AHRE and at least two stroke risk factors but without AF. The trial will be conducted in several European countries.

ReferenceCitation: Bertaglia E, Blank B, Blomstrom-Lundqvist C, Brandes A, Cabanelas N, Dan GA, Dichtl W, Goette A, de Groot JR, Lubinski A, Marijon E, Merkely B, Mont L, Piorkowski C, Sarkozy A, Sulke N, Vardas P, Velchev V, Wichterle D, Kirchhof P. Atrial high-rate episodes: prevalence, stroke risk, implications for management, and clinical gaps in evidence. Europace. 2019 Oct 1;21(10):1459-1467. doi: 10.1093/europace/euz172.

ReferenceCitation: Kirchhof P, Blank BF, Calvert M, Camm AJ, Chlouverakis G, Diener HC, Goette A, Huening A, Lip GYH, Simantirakis E, Vardas P. Probing oral anticoagulation in patients with atrial high rate episodes: Rationale and design of the Non-vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes (NOAH-AFNET 6) trial. Am Heart J. 2017 Aug;190:12-18. doi: 10.1016/j.ahj.2017.04.015. Epub 2017 May 3.

lead_sponsor: Atrial Fibrillation Network

collaborators: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

collaborators: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

location_country:
Germany
Italy
Poland
Portugal
Hungary
United Kingdom
Denmark
Romania
Sweden
Netherlands
Austria
Belgium
Spain
Greece
Czechia
Bulgaria
Ukraine
France

location_facility:
Several
Several Sites