acronym: CTCL

lead_sponsor: Galderma R&D

summary: To assess the efficacy, safety and pharmacokinetics in participants treated with CD11301 gel vs. placebo for early stage CTCL (IA, IB, or IIA).

ReferenceCitation: Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Wiley

title: A Randomized, Double-blind, Multi-centre, Placebo-controlled, Parallel-arm Phase 2 Trial to Assess Safety, Efficacy and Pharmacokinetics of CD11301 0.03% and 0.06% Gel in the Treatment of Cutaneous T-Cell Lymphoma (CTCL), Stages IA, IB and IIA

ipd_sharing_description: No intent to share information.

location_country:
United States
Germany
France


type: EudraCT Number

title: An Open-Label, Multi-Center Phase 1 Study to Investigate the Safety and Tolerability of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients With CD20+ B-Cell Malignancies Previously Treated With CD20-Directed Antibody Therapy (ELM-1)

summary: This study has two parts with distinct study objectives and study design. In part A, odronextamab is studied as an intravenous (IV) administration with a dose escalation and a dose expansion phase for B-NHL and CLL. The dose escalation phase for B-NHL and the CLL study are closed at the time of protocol amendment 17. In part B, odronextamab is studied as a subcutaneous (SC) administration with a dose finding and a dose expansion phase for B-NHL.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Bannerji R, Arnason JE, Advani RH, Brown JR, Allan JN, Ansell SM, Barnes JA, O'Brien SM, Chavez JC, Duell J, Rosenwald A, Crombie JL, Ufkin M, Li J, Zhu M, Ambati SR, Chaudhry A, Lowy I, Topp MS. Odronextamab, a human CD20xCD3 bispecific antibody in patients with CD20-positive B-cell malignancies (ELM-1): results from the relapsed or refractory non-Hodgkin lymphoma cohort in a single-arm, multicentre, phase 1 trial. Lancet Haematol. 2022 May;9(5):e327-e339. doi: 10.1016/S2352-3026(22)00072-2. Epub 2022 Apr 1.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Zhu M, Olson K, Kirshner JR, Khaksar Toroghi M, Yan H, Haber L, Meagher C, Flink DM, Ambati SR, Davis JD, DiCioccio AT, Smith EJ, Retter MW. Translational findings for odronextamab: From preclinical research to a first-in-human study in patients with CD20+ B-cell malignancies. Clin Transl Sci. 2022 Apr;15(4):954-966. doi: 10.1111/cts.13212. Epub 2022 Jan 7.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

lead_sponsor: Regeneron Pharmaceuticals

location_country:
Germany
France
United Kingdom
United States
Israel

location_facility: Rambam Health Care Campus - Hematology and Bone Marrow Transplantation Institute

location_facility: Dana Farber Cancer Institute (Massachusetts General Hospital and Beth Israel)

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Validation Trial for a Multi-parameter Diagnostic Blood Test for the Diagnosis of Alzheimer's Disease

acronym: RH-VAL

summary: The purpose of this study is to validate a diagnostic test that combines different blood markers to identify and correctly classify patients with Alzheimer's disease (AD) compared to individuals with behavioural variant frontotemporal dementia (bvFTD, patient control) versus cognitively healthy individuals (healthy control).

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Raman Health Technologies, S.L.

location_country: Spain Belgium France

location_facility: Centre Mémoire paris Nord Ile de France GH Saint-Louis Lariboisière Fernand Widal

location_facility: Cognitive and Behavioral Disease Center and Alzheimer's Institute

status_simplified: Completed


title: MEDICI - t(11;14) and BCL2 Expression in Patients With Multiple Myeloma: Prevalence, Stability Across Lines of Therapy and Concordance Across Sample Types

acronym: MEDICI

summary:
Multiple myeloma (MM) is a rare cancer caused by abnormal survival of plasma cells (blood cells). Most trial participants with MM relapse (cancer has come back) or become non- responsive to treatment and remission gets shorter after each line of treatment. This is a study to assess t(11;14) and BCL2 expression in adult participants with newly diagnosed and relapsed/refractory (R/R) MM.

Approximately 500 adult participants with newly confirmed or relapsed/refractory (R/R) multiple myeloma (MM) will be enrolled in around 15-20 countries.

Participants will receive standard of care while participating in this study. No drug will be administered as a part of this study.

Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide bone marrow and blood samples.

lead_sponsor: AbbVie

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Turkey
Croatia
Czechia
Canada
France
Slovenia
United States
Romania
Italy
Norway
Netherlands
Saudi Arabia
Spain
Greece
Taiwan
Israel

location_facility: Hospital de Clinicas de Porto Alegre /ID# 224274

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 224690

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 229524

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 229281

location_facility: Real e Benemérita Associação Portuguesa de Beneficência /ID# 224305

location_facility: Hadassah Medical Center-Hebrew University /ID# 224884

location_facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 224608

location_facility: Fakultni nemocnice Hradec Kralove /ID# 224089

location_facility: Instytut Hematologii i Transfuzjologii /ID# 227039

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 228919

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 223702

location_facility: Instituto COI de Educacao e Pesquisa /ID# 224245

location_facility: Hospital Universitario de Salamanca /ID# 224803

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 225749

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola /ID# 227038

location_facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein /ID# 224303

location_facility: Bagcilar Medipol Mega Universite Hastanesi /ID# 225515

location_facility: Hospital Universitario 12 de Octubre /ID# 225617

location_facility: Taichung Veterans General Hospital /ID# 227084

location_facility: Klinicki bolnicki centar Zagreb /ID# 226969

location_facility: Hospital Clinic de Barcelona /ID# 224804

location_facility: University of Texas Southwestern Medical Center /ID# 223865

location_facility: Maastricht Universitair Medisch Centrum /ID# 224694

location_facility: Princess Noorah Oncology Center /ID# 224968

location_facility: Hospital Italiano de Buenos Aires /ID# 224153


summary: The main objective of this study is to evaluate the efficacy of the combination of venetoclax plus ibrutinib for treating adults with T-cell prolymphocytic leukemia (T-PLL).

location_facility: Dana-Farber Cancer Institute /ID# 207728

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 208726

location_facility: Azienda Sanitaria Universitaria Giuliano Isontina /ID# 211487

location_facility: Medizinische Universitaet Wien /ID# 208497

location_facility: Oxford University Hospitals NHS Foundation Trust /ID# 211264

location_facility: Helsinki University Hospital /ID# 208108

location_facility: Universitair Medisch Centrum Groningen /ID# 207990

location_facility: University of Texas MD Anderson Cancer Center /ID# 207746

location_facility: The Royal Marsden NHS Foundation Trust /ID# 211263

title: A Prospective, Open-Label, Single-Arm, Phase 2, Multicenter Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Subjects With T-Cell Prolymphocytic Leukemia

source: euctr

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

location_country:
Finland
Germany
Italy
United Kingdom
Australia
Netherlands
Austria
United States
France

ipd_sharing: Yes


title: A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects With Crohn's Disease

summary: This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).

ReferenceCitation: D'Haens G, Panes J, Louis E, Lacerda A, Zhou Q, Liu J, Loftus EV Jr. Upadacitinib Was Efficacious and Well-tolerated Over 30 Months in Patients With Crohn's Disease in the CELEST Extension Study. Clin Gastroenterol Hepatol. 2022 Oct;20(10):2337-2346.e3. doi: 10.1016/j.cgh.2021.12.030. Epub 2021 Dec 27.

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

license: cc-by

license_normalized: cc-by

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

location_country:
Germany
Italy
Poland
New Zealand
Slovakia
Hungary
Israel
Denmark
Norway
Romania
Netherlands
United Kingdom
Belgium
United States
Spain
Czechia
Canada
France

location_facility: Magyar Elhizastudomanyi Kozpont Kft. /ID# 149907

location_facility: Univ California, San Francisco /ID# 149987

location_facility: Manchester University NHS Foundation Trust /ID# 150006

location_facility: Gastroenterology Associates of Central Georgia, LLC /ID# 149870

location_facility: Oxford University Hospitals NHS Foundation Trust /ID# 149963

location_facility: The Chaim Sheba Medical Center /ID# 149945

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 149897

location_facility: Virginia Mason Medical Center /ID# 150042

location_facility: Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 149863

location_facility: NYU Langone Long Island Clinical Research Associates /ID# 149976

location_facility: Options Health Research, LLC /ID# 150010

location_facility: Hospital Universitario La Paz /ID# 149997

location_facility: Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 149890

location_facility: Nature Coast Clinical Research - Inverness /ID# 149975

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 149936

location_facility: Lovisenberg Diakonale Sykehus /ID# 149967

location_facility: Toronto Digestive Disease Asso /ID# 149877

location_facility: University of British Columbia (UBC) - Gordon and Leslie Diamond Health Care Ce /ID# 149876

location_facility: CHU Amiens-Picardie Site Sud /ID# 149921

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 149958

location_facility: Royal Victoria Hospital / McGill University Health Centre /ID# 149871

location_facility: Cotton-O'Neil Clinical Res Ctr /ID# 149900

location_facility: Texas Digestive Disease Consultants - Southlake /ID# 149869

location_facility: Clin Res Inst of Michigan, LLC /ID# 150008

location_facility: Hepato-Gastroenterologie HK, s.r.o. /ID# 149882

location_facility: Assaf Harofeh Medical Center /ID# 149943

location_facility: Washington University-School of Medicine /ID# 149899

location_facility: Texas Digestive Disease Consultants - Southlake /ID# 149989

location_facility: CHRU Nancy - Hopitaux de Brabois /ID# 149896

location_facility: The Ctr for Gastro Disorders /ID# 150012

location_facility: GIRI Gastrointestinal Research Institute /ID# 149878

location_facility: Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 149996

location_facility: Universitair Medisch Centrum Utrecht /ID# 149933

location_facility: Investigative Clinical Research /ID# 149886

location_facility: Centrum Medyczne Szpital Swietej Rodziny /ID# 149979

location_facility: Kansas City Research Institute /ID# 149888

location_facility: University of Florida - Archer /ID# 150033

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 149978

location_facility: University of Alberta - Zeidler Ledcor Centre /ID# 149873

location_facility: Medizinisches Versorgungszentrum Portal 10 /ID# 149930

location_facility: Cabinet Particular Policlinic Algomed /ID# 149993


title: Mechanisms of Very Late Bioresorbable Scaffold Thrombosis Assessed by Optical Coherence Tomography: Insights From the International INVEST Registry

acronym: INVEST

summary:
Bioresorbable vascular scaffold (BVS, ABSORB BVS1.1, Abbott Vascular) has been approved (CE mark) and is used in daily clinical practice. While recent randomized controlled trials comparing BVS versus metallic drug-eluting stent showed higher risk of definite or probable device thrombosis after BVS implantation, the causes underlying thrombotic events occurring beyond one year after scaffold implantation remain unclear and require investigation in an independent manner.

The INVEST registry is a world-wide, multi-center, observational, retrospective, investigator-initiated registry, which will include any patients who suffered from very late (>1 year) scaffold thrombosis, underwent optical coherence tomography (OCT) at the time of thrombosis and provided informed consent for the further use of their health related data for this registry.

time_perspective: Cross-Sectional

ReferenceType: background

ReferenceCitation: Serruys PW, Chevalier B, Sotomi Y, Cequier A, Carrie D, Piek JJ, Van Boven AJ, Dominici M, Dudek D, McClean D, Helqvist S, Haude M, Reith S, de Sousa Almeida M, Campo G, Iniguez A, Sabate M, Windecker S, Onuma Y. Comparison of an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent for the treatment of coronary artery stenosis (ABSORB II): a 3 year, randomised, controlled, single-blind, multicentre clinical trial. Lancet. 2016 Nov 19;388(10059):2479-2491. doi: 10.1016/S0140-6736(16)32050-5. Epub 2016 Oct 30. Erratum In: Lancet. 2017 Feb 25;389(10071):804.

ReferenceCitation: Kimura T, Kozuma K, Tanabe K, Nakamura S, Yamane M, Muramatsu T, Saito S, Yajima J, Hagiwara N, Mitsudo K, Popma JJ, Serruys PW, Onuma Y, Ying S, Cao S, Staehr P, Cheong WF, Kusano H, Stone GW; ABSORB Japan Investigators. A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds vs. everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan. Eur Heart J. 2015 Dec 14;36(47):3332-42. doi: 10.1093/eurheartj/ehv435. Epub 2015 Sep 1.

ReferenceCitation: Onuma Y, Sotomi Y, Shiomi H, Ozaki Y, Namiki A, Yasuda S, Ueno T, Ando K, Furuya J, Igarashi K, Kozuma K, Tanabe K, Kusano H, Rapoza R, Popma JJ, Stone GW, Simonton C, Serruys PW, Kimura T. Two-year clinical, angiographic, and serial optical coherence tomographic follow-up after implantation of an everolimus-eluting bioresorbable scaffold and an everolimus-eluting metallic stent: insights from the randomised ABSORB Japan trial. EuroIntervention. 2016 Oct 20;12(9):1090-1101. doi: 10.4244/EIJY16M09_01.

ReferenceCitation: Raber L, Brugaletta S, Yamaji K, O'Sullivan CJ, Otsuki S, Koppara T, Taniwaki M, Onuma Y, Freixa X, Eberli FR, Serruys PW, Joner M, Sabate M, Windecker S. Very Late Scaffold Thrombosis: Intracoronary Imaging and Histopathological and Spectroscopic Findings. J Am Coll Cardiol. 2015 Oct 27;66(17):1901-14. doi: 10.1016/j.jacc.2015.08.853.

ReferenceCitation: de Jaegere P, Mudra H, Figulla H, Almagor Y, Doucet S, Penn I, Colombo A, Hamm C, Bartorelli A, Rothman M, Nobuyoshi M, Yamaguchi T, Voudris V, DiMario C, Makovski S, Hausmann D, Rowe S, Rabinovich S, Sunamura M, van Es GA. Intravascular ultrasound-guided optimized stent deployment. Immediate and 6 months clinical and angiographic results from the Multicenter Ultrasound Stenting in Coronaries Study (MUSIC Study). Eur Heart J. 1998 Aug;19(8):1214-23. doi: 10.1053/euhj.1998.1012.

ReferenceCitation: Taniwaki M, Radu MD, Zaugg S, Amabile N, Garcia-Garcia HM, Yamaji K, Jorgensen E, Kelbaek H, Pilgrim T, Caussin C, Zanchin T, Veugeois A, Abildgaard U, Juni P, Cook S, Koskinas KC, Windecker S, Raber L. Mechanisms of Very Late Drug-Eluting Stent Thrombosis Assessed by Optical Coherence Tomography. Circulation. 2016 Feb 16;133(7):650-60. doi: 10.1161/CIRCULATIONAHA.115.019071. Epub 2016 Jan 13.

ReferenceCitation: Yamaji K, Ueki Y, Souteyrand G, Daemen J, Wiebe J, Nef H, Adriaenssens T, Loh JP, Lattuca B, Wykrzykowska JJ, Gomez-Lara J, Timmers L, Motreff P, Hoppmann P, Abdel-Wahab M, Byrne RA, Meincke F, Boeder N, Honton B, O'Sullivan CJ, Ielasi A, Delarche N, Christ G, Lee JKT, Lee M, Amabile N, Karagiannis A, Windecker S, Raber L. Mechanisms of Very Late Bioresorbable Scaffold Thrombosis: The INVEST Registry. J Am Coll Cardiol. 2017 Nov 7;70(19):2330-2344. doi: 10.1016/j.jacc.2017.09.014.

ipd_sharing: No

lead_sponsor: Insel Gruppe AG, University Hospital Bern

location_country:
Germany
Italy
Hong Kong
Singapore
Netherlands
Austria
Belgium
Switzerland
Spain
France

location_facility: Department of Cardiovascular Medicine, Hypertension and Heart Failure Unit, Health Innovation Lab (Hi-Lab) Clinique Pasteur

location_facility: Department of Cardiology, Asklepios Klinik St. Georg

location_facility: 5th Medical Department with Cardiology, Kaiser Franz Josef Hospital

location_facility: Department of Cardiology, Stadtspital Triemli

location_facility: Cardiac Department, National University Heart Centre

location_facility: Department of Cardiology, University Hospital Leuven

location_facility: Department of Cardiology, University of Giessen

location_facility: Hospital Universitari de Bellvitge, Institut d' Investigació Biomèdica de Bellvitge, Universitat de Barcelona, L' Hospitalet de Llobregat, Spain.

location_facility: Deutsches Herzzentrum München, Technische Universität München,

location_facility: Department of Cardiology, University Medical Centre Utrecht

location_facility: Academic Medical Center, University of Amsterdam

location_facility: Department of Cardiology, CH F Mitterand, Pau Université Cedex, France.

location_facility: Heart Center, Segeberger Kliniken GmbH, Academic Teaching Hospital of the Universities of Kiel

location_facility: Cardiology Department, CHU Clermont-Ferrand

location_facility: Cardiology Division, Department of Medicine, Queen Elizabeth Hospital

location_facility: Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.

location_facility: Cardiology Division, Department of Medicine, Pamela Youde Nethersole Eastern Hospital

location_facility: Department of Cardiology, University Hospital Caremeau

intervention_type: Device

lead_sponsor_type: academique


lead_sponsor: Novartis Pharmaceuticals

summary: This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDL-C).

ReferenceCitation: Reijman MD, Schweizer A, Peterson ALH, Bruckert E, Stratz C, Defesche JC, Hegele RA, Wiegman A. Rationale and design of two trials assessing the efficacy, safety, and tolerability of inclisiran in adolescents with homozygous and heterozygous familial hypercholesterolaemia. Eur J Prev Cardiol. 2022 Jul 20;29(9):1361-1368. doi: 10.1093/eurjpc/zwac025.

publisher_dissemination: Oxford University Press

ReferenceCitation: Warden BA, Duell PB. Inclisiran: A Novel Agent for Lowering Apolipoprotein B-containing Lipoproteins. J Cardiovasc Pharmacol. 2021 Aug 1;78(2):e157-e174. doi: 10.1097/FJC.0000000000001053.

publisher_dissemination: Wolters Kluwer Health

location_facility: Lipids Center Sheba Medical Center, Israel

location_facility: University Medical Centre Ljubljana, Div. of Pediatric Dept. of Endocrinology, Diabetes and Metabolic Diseases

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Nucleo de Pesquisa Clinica do Rio Grande do Sul

location_facility: Institute of the complex problems of cardiovascular disease

location_facility: Hippokrateion General Hospital of Athens Greece

location_facility: Unidade de pesquisa clinica - Hospital Universitario Walter Cantidio

location_facility: Setor de Lípides, Aterosclerose e Biologia

title: Two Part (Double-blind Inclisiran Versus Placebo [Year 1] Followed by Open-label Inclisiran [Year 2]) Randomized Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Inclisiran in Adolescents (12 to Less Than 18 Years) With Heterozygous Familial Hypercholesterolemia and Elevated LDL-cholesterol (ORION-16)

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

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

design_allocation: Randomized

location_country:
Germany
Poland
Taiwan
Argentina
Brazil
Turkey
Czechia
Canada
France
Slovenia
Slovakia
Hungary
Switzerland
United States
Lebanon
Malaysia
Italy
Norway
United Kingdom
Netherlands
Spain
Greece
South Africa
Jordan
Russian Federation
Israel


lead_sponsor: Daiichi Sankyo, Inc.

summary:
A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).

All children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.

The study will find out if edoxaban is safer and more effective than the standard of care.

location_facility: Novant Health Heart and Vascular institute

location_facility: Children's Heart Centre at the American University of Beirut Medical Center

location_facility: Hadassah University Hospital - Ein Kerem

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

location_facility: University of California-San Francisco Department of Pediatrics - Hematology/Oncology

location_facility: Communal Institution Dnipropetrovsk Regional Pediatric Clinical Hospital of Dnipropetrovsk Regional Council, State Institution Dnipropetrovsk Medical Academy of MoH of Ukraine

location_facility: University of Florida College of Medicine

location_facility: Communal Healthcare Institution Regional Pediatric Clinical Hospital, Kharkiv National Medical University

location_facility: Wake Forest University Baptist Medical Center

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: McGill University Health Centre/Glen Site/Montreal Children's Hospital

location_facility: Pediatric and Congenital Cardiology and Pulmonology Department; Arnaud De Villeneuve University Hospital

location_facility: Pediatric Cardiology Department, Hospital Necker Enfants Malades, APHP, Université Paris Descartes

location_facility: Gottsegen Gyorgy Orszagos Kardiologiai Intezet

location_facility: Alexandria Clinical Research Center, Faculty of Medicine

location_facility: Vynnitsa Regional Children Clinical Hospital Policlinic Dept

location_facility: Erciyes University Medical Faculty, Department of Children Hospital

location_facility: Kasr Elainy School of Medicine, Abo Elreesh Hospital (Japanese Hospital), Ali Basha Ibrahim ST Faculty of Medicine Cairo University

location_facility: Ege University Faculty of Medicine Department of Child Health and Diseases

location_facility: Izmir-Dr. Behçet Uz. Pediatric Diseases and Surgery Training and Research Hospital- Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi

location_facility: Kepler Universitätsklinikum Med Campus IV

location_facility: Istanbul University Istanbul Medical Faculty

title: An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events

primary_purpose: Prevention

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

location_country:
India
Hungary
Israel
United Kingdom
Austria
Lebanon
United States
Spain
Turkey
Croatia
Canada
Ukraine
Egypt
France


type: Other Identifier

title: A Phase I, Multicenter, Open-label, Dose-escalation Study of Oral LGX818 in Adult Patients With Locally Advanced or Metastatic BRAF Mutant Melanoma

summary: CLGX818X2101 is a first-time in-human, phase I study to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of daily administered LGX818 (daily, twice daily and/or every-other-day), a RAF kinase inhibitor. Patients with locally advanced or metastatic melanoma harboring the BRAF V600 mutation (during dose escalation phase and expansion phase) and patients with metastatic colorectal cancer harboring the BRAF V600 mutation (during the expansion phase) will be enrolled. The study consists of a dose escalation part were cohorts of patients will receive escalating oral doses of LGX818, followed by a safety dose expansion part were patients will be treated with oral dose of LGX818 given at the MTD or RP2D.

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

lead_sponsor: Pfizer

location_country:
Norway
Australia
Japan
Switzerland
United States
Spain
France

location_facility: Hospital Universitario HM Sanchinarro_CIOCC

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: START MADRID_Hospital Universitario HM Sanchinarro - CIOCC

location_facility: Hospital Universitario Vall d'Hebron - PPDS


title: Robotic Minimally Invasive Inguinal Hernia Repair With Dexter

acronym: RAS-Ahead

summary: This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing primary transperitoneal unilateral or bilateral inguinal hernia repair.

status: Recruiting

lead_sponsor: Distalmotion SA

sponsor_collaborators:
Distalmotion SA
confinis AG

location_country: Germany Switzerland France

location_facility:
Kantonspital Winterthur
UKSH Kiel
Centre Hospitalier de Saintes


title: Molecular Taxonomy of Nodal Marginal Zone Lymphoma

summary: International retrospective observational cohort study aimed to describe a molecular classification for NMZL.

study_start_date_type: Anticipated

status: Not yet recruiting

time_perspective: Retrospective

lead_sponsor: International Extranodal Lymphoma Study Group (IELSG)

location_country: Italy Switzerland France

location_facility: IRCCS - Azienda Ospedaliero-Universitaria di Bologna

location_facility: Oncology Institute of Southern Switzerland and Institute of Oncology Research


title: Keeping Oral o Parental AnticoaguLation in the Acute Phase of Cardioembolic Ischemic

acronym: KOALA-IS

summary: This is an observational, prospective, multicenter, cohort study in patients with cardioembolic stroke and previous oral or parenteral anticoagulant therapy. Patients in which anticoagulante therapy is mantained will be compared to those in which it is interrupted, in terms of stroke or systemic embolism and haemorrhagic transformation.

lead_sponsor: Instituto de Investigación Hospital Universitario La Paz

collaborators:
Hospital Universitario La Paz
Daiichi Sankyo, Inc.
Fundación Freno al ICTUS

location_country: Spain France

location_facility: Jimenez Diaz Fundation University Hospital

intervention_type: Other


title: Clinical Evaluation of the Accuracy of AMR-DetecTool for the Diagnostic of Infections With Multi Drug Resistant (MDR) Bacteria

acronym: AMR DetecTool

summary:
The fight against bacteria is one of the greatest challenges faced by societies, especially with the spread of multi drug resistant (MDR) bacteria. The failure to stop the spread of antimicrobial resistance (AMR) is due to a lack of fast detection methods and proper strategies.

Novel, rapid and reliable detection and characterization tests are an urgent need for differentiating between bacterial and viral infections and identifying AMR, so that the most appropriate treatment can be given in a timely manner.

AMR-DetecTool or NG Detectool is a detection system for the direct detection of AMR in clinical samples. The clinical sample is directly processed and a result indicating if the bacteria are resistant to the most relevant antibiotics is immediately shown.

It allows for a dramatic reduction in the treatment decision time upon sample reception from 24 hours (current workflow) to 15-30 minutes.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

sponsor_collaborators:
Assistance Publique - Hôpitaux de Paris
EIT Health
NG Biotech
Commissariat A L'energie Atomique

location_country: Hungary Spain France

location_facility: Hospital Clínic School of Medicine, University of Barcelona

intervention_type: Diagnostic Test


title: EURECA (EUropeanRElapseCAlprotectin) Study - Calprotectin as Prediction Marker of Relapse in Patients With Quiescent Ulcerative Colitis

summary: This study will investigate the correlation of fecal calprotectin (FC) values to quiescent ulcerative colitis and to disease activity (relapse) as assessed by clinical data and endoscopy.

primary_purpose: Diagnostic

ReferenceCitation: Fiorino G, Danese S, Peyrin-Biroulet L, Sans M, Bonelli F, Calleri M, Zierold C, Pollastro R, Moretti F, Malesci A. LIAISON(R) Calprotectin for the prediction of relapse in quiescent ulcerative colitis: The EuReCa study. United European Gastroenterol J. 2022 Oct;10(8):836-843. doi: 10.1002/ueg2.12268. Epub 2022 Jul 4.

lead_sponsor: DiaSorin Inc.

location_country: Italy Spain France

location_facility: Centre Hospitalier Universitaire De Nancy (CHU de Nancy) Department Gastroenterology

location_facility: Centro Médico Teknon Gastroenterologia Adultos

location_facility: Istituto Clinico Humanitas Centro IBD Diparimento di Gastroenterologia


title: Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation. The PREVENTION Randomized Multicenter Study

acronym: PREVENTION

summary: Tracheal intubation (TI) is associated with a high risk of adverse events in critically ill patients and peri-intubation hemodynamic collapse is the most commonly observed. The primary aim of the PREVENTION trial is to compare the effect of the pre-emptive use of noradrenaline versus no peri-intubation use of noradrenaline on incidence of cardiovascular collapse following TI in adult critically ill patients. Patients with absolute indication or contraindication to vasopressor support will be excluded from this trial. Patients will be randomized 1:1 to a continuous infusion of noradrenaline started before induction titrated according to baseline mean arterial pressure. The primary outcome will be the incidence of cardiovascular collapse. Secondary outcomes will include lowest systolic blood pressure and cardiac arrest within 30 minutes from intubation.

ReferenceType: result

ReferenceCitation: Russotto V, Myatra SN, Laffey JG, Tassistro E, Antolini L, Bauer P, Lascarrou JB, Szuldrzynski K, Camporota L, Pelosi P, Sorbello M, Higgs A, Greif R, Putensen C, Agvald-Ohman C, Chalkias A, Bokums K, Brewster D, Rossi E, Fumagalli R, Pesenti A, Foti G, Bellani G; INTUBE Study Investigators. Intubation Practices and Adverse Peri-intubation Events in Critically Ill Patients From 29 Countries. JAMA. 2021 Mar 23;325(12):1164-1172. doi: 10.1001/jama.2021.1727. Erratum In: JAMA. 2021 May 24;:null.

oa_colors: green other

evidence: open (via free pdf)

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

repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central;iris.unife.it

unpaywall_oa_status: bronze

publisher_dissemination: American Medical Association

ReferenceCitation: Russotto V, Myatra SN, Laffey JG. What's new in airway management of the critically ill. Intensive Care Med. 2019 Nov;45(11):1615-1618. doi: 10.1007/s00134-019-05757-0. Epub 2019 Sep 16. No abstract available.

oa_host_type: publisher

publisher_dissemination: Springer-Nature

ReferenceCitation: Janz DR, Casey JD, Semler MW, Russell DW, Dargin J, Vonderhaar DJ, Dischert KM, West JR, Stempek S, Wozniak J, Caputo N, Heideman BE, Zouk AN, Gulati S, Stigler WS, Bentov I, Joffe AM, Rice TW; PrePARE Investigators; Pragmatic Critical Care Research Group. Effect of a fluid bolus on cardiovascular collapse among critically ill adults undergoing tracheal intubation (PrePARE): a randomised controlled trial. Lancet Respir Med. 2019 Dec;7(12):1039-1047. doi: 10.1016/S2213-2600(19)30246-2. Epub 2019 Oct 1.

version: acceptedVersion

lead_sponsor: University of Turin, Italy

collaborators: Istituto Di Ricerche Farmacologiche Mario Negri

location_country: Ireland Italy France

location_facility:
Galway University Hospitals
CHU de Nantes
University Hospital San Luigi Gonzaga


type: Other Grant/Funding Number

title: A Randomized Controlled Multicenter Study for Evaluating a Digital Support System in Childhood Obesity Treatment (EurEvira)

acronym: EurEvira

summary: Evira is a digital support system newly developed for treatment of childhood obesity. Through daily weighings at home using a special scale together with a message function in the Evira application, enabling fast and easy communication with the clinic, parents and the clinicians can easily follow the child's weight development. The purpose of this randomized controlled study is to evaluate the effect of adding Evira to the already locally used life-style treatment of childhood obesity.

ipd_sharing_description: Anonymized data for the main outcome will be available upon date of scientific publications. To preserve individual case and anonymity, more detailed data and additional variables will be available upon request.

lead_sponsor: Karolinska Institutet

collaborators:
Lund University
Evira AB

sponsor_collaborators:
Karolinska Institutet
Lund University
Evira AB

location_country: Sweden Norway France

location_facility:
St. Olavs Hospital
Kalmar barnklinik
Hôpital Robert Debré

intervention_type: Behavioral


title: Association Between Premature Birth and Its Comorbidities With NO and the HPG Activation at Minipuberty

acronym: miniNO

summary: Case-control study of inhaled Nitric Oxide (iNO) treatment of full-term and preterm infants. The main objective of this study is to investigate the association between premature birth and its later comorbidities (neuroendocrine, metabolic, cognitive, etc) with iNO treatment and the maturation of the HPG axis during minipuberty.

lead_sponsor: National and Kapodistrian University of Athens

collaborators: Centre Hospitalier Universitaire Vaudois

location_country: Greece Switzerland France

location_facility: Centre Hospitalier Regional Et Universitaire de Lille


acronym: BRIDGE

intervention_type: Biological

lead_sponsor: Mario Negri Institute for Pharmacological Research

summary:
Standard treatment for stage III Non-Small Cells Lung Cancer (NSCLC) not eligibile for surgery is concomitant chemoradiotherapy. However median progression free survival and overall survival is still poor with only 15% of patients alive at 5 years. The addition of maintenance therapy with durvalumab after chemoradiation showed a significant benefit in PFS and OS, with good tolerability and no concerns in terms of safety. However, about 30% of patients with stage III are not eligible to concurrent chemoradiotherapy because of large volumes of the tumor. To date, these patients are initially treated with chemotherapy with the aim of reducing tumor volumes and allowing sequential radiotherapy. Response rate ranges between 25-30% and majority of patients will not become suitable for radiotherapy.

The combination of immunotherapy plus standard chemotherapy in advanced stages doubles response rates and provides major tumor shrinkage compared to standard chemotherapy alone. For these reasons, the investigators want to exploit the synergistic effect of immunotherapy combined with chemotherapy in the induction phase, in order to render suitable for radiotherapy a larger number of patients, and in a second phase the synergistic effect with radiotherapy.

Based on these premises the investigators designed a single arm, phase 2 trial to determine the efficacy and safety of combining immunotherapy with the drug durvalumab in association with standard chemotherapy and subsequently with standard radiotherapy, followed by a treatment of maintenance with only durvalumab.

The study population includes patients with NSCLC not eligible for surgery or concurrent chemoradiation at diagnosis because of large tumor volumes.

BRIDGE trial aims to evaluate the proportion of patients who did not progress and who achieved a mean lung dose <20 Gy and/or a lung V20<35% (response) after part 1. The primary objective of the study is to increase the proportion of patients eligible for immunotherapy plus radiotherapy after induction with durvalumab and chemotherapy, in comparison with historical controls.

This study will last approximately 60 months and will include approximately 65 eligible patients in 3 international cancer centres of excellence.

ReferenceCitation: Alexandrov LB, Nik-Zainal S, Wedge DC, Aparicio SA, Behjati S, Biankin AV, Bignell GR, Bolli N, Borg A, Borresen-Dale AL, Boyault S, Burkhardt B, Butler AP, Caldas C, Davies HR, Desmedt C, Eils R, Eyfjord JE, Foekens JA, Greaves M, Hosoda F, Hutter B, Ilicic T, Imbeaud S, Imielinski M, Jager N, Jones DT, Jones D, Knappskog S, Kool M, Lakhani SR, Lopez-Otin C, Martin S, Munshi NC, Nakamura H, Northcott PA, Pajic M, Papaemmanuil E, Paradiso A, Pearson JV, Puente XS, Raine K, Ramakrishna M, Richardson AL, Richter J, Rosenstiel P, Schlesner M, Schumacher TN, Span PN, Teague JW, Totoki Y, Tutt AN, Valdes-Mas R, van Buuren MM, van 't Veer L, Vincent-Salomon A, Waddell N, Yates LR; Australian Pancreatic Cancer Genome Initiative; ICGC Breast Cancer Consortium; ICGC MMML-Seq Consortium; ICGC PedBrain; Zucman-Rossi J, Futreal PA, McDermott U, Lichter P, Meyerson M, Grimmond SM, Siebert R, Campo E, Shibata T, Pfister SM, Campbell PJ, Stratton MR. Signatures of mutational processes in human cancer. Nature. 2013 Aug 22;500(7463):415-21. doi: 10.1038/nature12477. Epub 2013 Aug 14. Erratum In: Nature. 2013 Oct 10;502(7470):258. Imielinsk, Marcin [corrected to Imielinski, Marcin].

ReferenceCitation: Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Ozguroglu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8.

evidence: open (via free article)

repository_institution: University of Liège - Open Repository and Bibliography

version: submittedVersion

repositories_institution: University of Liège - Open Repository and Bibliography

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Faivre-Finn C, Reck M, Vansteenkiste J, Spigel DR, Wadsworth C, Melillo G, Taboada M, Dennis PA, Ozguroglu M; PACIFIC Investigators. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. N Engl J Med. 2018 Dec 13;379(24):2342-2350. doi: 10.1056/NEJMoa1809697. Epub 2018 Sep 25.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: The University of Manchester - Research Explorer

repository_normalized: Pure (Denmark)

repositories:
LIRIAS (KU Leuven)
Pure (Denmark)

repositories_concat: LIRIAS (KU Leuven);Pure (Denmark)

repositories_institution: The University of Manchester - Research Explorer

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ReferenceCitation: Gandhi L, Rodriguez-Abreu D, Gadgeel S, Esteban E, Felip E, De Angelis F, Domine M, Clingan P, Hochmair MJ, Powell SF, Cheng SY, Bischoff HG, Peled N, Grossi F, Jennens RR, Reck M, Hui R, Garon EB, Boyer M, Rubio-Viqueira B, Novello S, Kurata T, Gray JE, Vida J, Wei Z, Yang J, Raftopoulos H, Pietanza MC, Garassino MC; KEYNOTE-189 Investigators. Pembrolizumab plus Chemotherapy in Metastatic Non-Small-Cell Lung Cancer. N Engl J Med. 2018 May 31;378(22):2078-2092. doi: 10.1056/NEJMoa1801005. Epub 2018 Apr 16.

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ReferenceCitation: Paterson AM, Brown KE, Keir ME, Vanguri VK, Riella LV, Chandraker A, Sayegh MH, Blazar BR, Freeman GJ, Sharpe AH. The programmed death-1 ligand 1:B7-1 pathway restrains diabetogenic effector T cells in vivo. J Immunol. 2011 Aug 1;187(3):1097-105. doi: 10.4049/jimmunol.1003496. Epub 2011 Jun 22.

ReferenceCitation: Paz-Ares L, Luft A, Vicente D, Tafreshi A, Gumus M, Mazieres J, Hermes B, Cay Senler F, Csoszi T, Fulop A, Rodriguez-Cid J, Wilson J, Sugawara S, Kato T, Lee KH, Cheng Y, Novello S, Halmos B, Li X, Lubiniecki GM, Piperdi B, Kowalski DM; KEYNOTE-407 Investigators. Pembrolizumab plus Chemotherapy for Squamous Non-Small-Cell Lung Cancer. N Engl J Med. 2018 Nov 22;379(21):2040-2051. doi: 10.1056/NEJMoa1810865. Epub 2018 Sep 25.

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repository_institution: Universidad de Las Palmas de Gran Canaria - Acceda

repositories_institution: Universidad de Las Palmas de Gran Canaria - Acceda

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ReferenceCitation: Stewart R, Morrow M, Hammond SA, Mulgrew K, Marcus D, Poon E, Watkins A, Mullins S, Chodorge M, Andrews J, Bannister D, Dick E, Crawford N, Parmentier J, Alimzhanov M, Babcook JS, Foltz IN, Buchanan A, Bedian V, Wilkinson RW, McCourt M. Identification and Characterization of MEDI4736, an Antagonistic Anti-PD-L1 Monoclonal Antibody. Cancer Immunol Res. 2015 Sep;3(9):1052-62. doi: 10.1158/2326-6066.CIR-14-0191. Epub 2015 May 5.

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ReferenceCitation: Zou W, Chen L. Inhibitory B7-family molecules in the tumour microenvironment. Nat Rev Immunol. 2008 Jun;8(6):467-77. doi: 10.1038/nri2326.

sponsor_collaborators: Mario Negri Institute for Pharmacological Research

sponsor_collaborators: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

title: BRIDGE Trial: Phase II Trial of durvalumaB and chemotheRapy Induction Followed by Durvalumab and Radiotherapy in larGe volumE Stage III NSCLC

collaborators: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano


title: Evaluation of the Daily Intake of 0.5 L of Water Saturated With Molecular Hydrogen for 21 Days in COVID-19 Patients Treated in Ambulatory Care. Double-blind, Randomized, Comparative Study

acronym: HYDRO COVID

summary:
Through its anti-inflammatory role, molecular hydrogen could have a beneficial effect in preventing the runaway inflammatory reactions that lead to complications of Covid-19.

This hypothesis is supported by numerous preclinical and theoretical arguments, as well as by some Chinese clinical studies (the Chinese guidelines for the management of Covid-19 recommend the inhalation of hydrogen), a recommendation whose interest has just been confirmed by a publication describing the very positive results of a clinical study in China.

Through its anti-inflammatory role, molecular hydrogen could have a beneficial effect in preventing the runaway inflammatory reactions that lead to complications of Covid-19.

The ingestion of water saturated with molecular hydrogen has been the subject of several clinical studies in other indications than Covid-19, and no side effects of this ingestion have been reported. A recent publication recommends initiating clinical trials using a hydrogen fortified beverage.

ReferenceCitation: Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum In: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.

ReferenceCitation: Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.

license: unspecified-oa

license_normalized: unspecified-oa

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

ReferenceCitation: Thompson BT, Chambers RC, Liu KD. Acute Respiratory Distress Syndrome. N Engl J Med. 2017 Aug 10;377(6):562-572. doi: 10.1056/NEJMra1608077. No abstract available.

ReferenceCitation: TY - JOUR AU - Russell, Grace AU - Veal, David AU - Rehman, Mubasher AU - Adukwu, Emmanuel AU - LeBaron, Tyler AU - Hancock, John PY - 2020/06/22 SP - T1 - An Overview of SARS-CoV-2 (COVID-19) Infection and the Importance of Molecular Hydrogen as an Adjunctive Therapy DO - 10.20455/ros.2020.829 JO - Reactive Oxygen Species ER -

ReferenceCitation: Dole M, Wilson FR, Fife WP. Hyperbaric hydrogen therapy: a possible treatment for cancer. Science. 1975 Oct 10;190(4210):152-4. doi: 10.1126/science.1166304.

ReferenceCitation: Ohsawa I, Ishikawa M, Takahashi K, Watanabe M, Nishimaki K, Yamagata K, Katsura K, Katayama Y, Asoh S, Ohta S. Hydrogen acts as a therapeutic antioxidant by selectively reducing cytotoxic oxygen radicals. Nat Med. 2007 Jun;13(6):688-94. doi: 10.1038/nm1577. Epub 2007 May 7.

ReferenceCitation: Itoh T, Hamada N, Terazawa R, Ito M, Ohno K, Ichihara M, Nozawa Y, Ito M. Molecular hydrogen inhibits lipopolysaccharide/interferon gamma-induced nitric oxide production through modulation of signal transduction in macrophages. Biochem Biophys Res Commun. 2011 Jul 22;411(1):143-9. doi: 10.1016/j.bbrc.2011.06.116. Epub 2011 Jun 23.

ReferenceCitation: Manaenko A, Lekic T, Ma Q, Zhang JH, Tang J. Hydrogen inhalation ameliorated mast cell-mediated brain injury after intracerebral hemorrhage in mice. Crit Care Med. 2013 May;41(5):1266-75. doi: 10.1097/CCM.0b013e31827711c9.

ReferenceCitation: Xie K, Yu Y, Zhang Z, Liu W, Pei Y, Xiong L, Hou L, Wang G. Hydrogen gas improves survival rate and organ damage in zymosan-induced generalized inflammation model. Shock. 2010 Nov;34(5):495-501. doi: 10.1097/SHK.0b013e3181def9aa.

ReferenceCitation: Xie K, Fu W, Xing W, Li A, Chen H, Han H, Yu Y, Wang G. Combination therapy with molecular hydrogen and hyperoxia in a murine model of polymicrobial sepsis. Shock. 2012 Dec;38(6):656-63. doi: 10.1097/SHK.0b013e3182758646.

ReferenceCitation: Xie K, Yu Y, Huang Y, Zheng L, Li J, Chen H, Han H, Hou L, Gong G, Wang G. Molecular hydrogen ameliorates lipopolysaccharide-induced acute lung injury in mice through reducing inflammation and apoptosis. Shock. 2012 May;37(5):548-55. doi: 10.1097/SHK.0b013e31824ddc81.

ReferenceCitation: LeBaron TW, Kura B, Kalocayova B, Tribulova N, Slezak J. A New Approach for the Prevention and Treatment of Cardiovascular Disorders. Molecular Hydrogen Significantly Reduces the Effects of Oxidative Stress. Molecules. 2019 May 31;24(11):2076. doi: 10.3390/molecules24112076.

ReferenceCitation: Ohta S. Molecular hydrogen as a preventive and therapeutic medical gas: initiation, development and potential of hydrogen medicine. Pharmacol Ther. 2014 Oct;144(1):1-11. doi: 10.1016/j.pharmthera.2014.04.006. Epub 2014 Apr 24.

ReferenceCitation: Ono H, Nishijima Y, Adachi N, Sakamoto M, Kudo Y, Kaneko K, Nakao A, Imaoka T. A basic study on molecular hydrogen (H2) inhalation in acute cerebral ischemia patients for safety check with physiological parameters and measurement of blood H2 level. Med Gas Res. 2012 Aug 23;2(1):21. doi: 10.1186/2045-9912-2-21.

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ReferenceCitation: Fontanari P, Badier M, Guillot C, Tomei C, Burnet H, Gardette B, Jammes Y. Changes in maximal performance of inspiratory and skeletal muscles during and after the 7.1-MPa Hydra 10 record human dive. Eur J Appl Physiol. 2000 Mar;81(4):325-8. doi: 10.1007/s004210050050.

ReferenceCitation: Zhou ZQ, Zhong CH, Su ZQ, Li XY, Chen Y, Chen XB, Tang CL, Zhou LQ, Li SY. Breathing Hydrogen-Oxygen Mixture Decreases Inspiratory Effort in Patients with Tracheal Stenosis. Respiration. 2019;97(1):42-51. doi: 10.1159/000492031. Epub 2018 Sep 18.

ReferenceCitation: Hu Y, Sun J, Dai Z, Deng H, Li X, Huang Q, Wu Y, Sun L, Xu Y. Prevalence and severity of corona virus disease 2019 (COVID-19): A systematic review and meta-analysis. J Clin Virol. 2020 Jun;127:104371. doi: 10.1016/j.jcv.2020.104371. Epub 2020 Apr 14.

ReferenceCitation: Verity R, Okell LC, Dorigatti I, Winskill P, Whittaker C, Imai N, Cuomo-Dannenburg G, Thompson H, Walker PGT, Fu H, Dighe A, Griffin JT, Baguelin M, Bhatia S, Boonyasiri A, Cori A, Cucunuba Z, FitzJohn R, Gaythorpe K, Green W, Hamlet A, Hinsley W, Laydon D, Nedjati-Gilani G, Riley S, van Elsland S, Volz E, Wang H, Wang Y, Xi X, Donnelly CA, Ghani AC, Ferguson NM. Estimates of the severity of coronavirus disease 2019: a model-based analysis. Lancet Infect Dis. 2020 Jun;20(6):669-677. doi: 10.1016/S1473-3099(20)30243-7. Epub 2020 Mar 30. Erratum In: Lancet Infect Dis. 2020 Apr 15;: Lancet Infect Dis. 2020 May 4;:

ReferenceCitation: Chow SC, Shao J, Wang H. A note on sample size calculation for mean comparisons based on noncentral t-statistics. J Biopharm Stat. 2002 Nov;12(4):441-56. doi: 10.1081/BIP-120016229.

ReferenceCitation: LeBaron, T. W., McCullough M. L. and Ruppman Sr K. H., A novel functional beverage for COVID-19 and other conditions: Hypothesis and preliminary data, increased blood flow, and wound healing, Journal of Translational Science, 6(2020), pp 1-6, doi: 10.15761/JTS.1000380

ReferenceCitation: Guan WJ, Wei CH, Chen AL, Sun XC, Guo GY, Zou X, Shi JD, Lai PZ, Zheng ZG, Zhong NS. Hydrogen/oxygen mixed gas inhalation improves disease severity and dyspnea in patients with Coronavirus disease 2019 in a recent multicenter, open-label clinical trial. J Thorac Dis. 2020 Jun;12(6):3448-3452. doi: 10.21037/jtd-2020-057. No abstract available. Erratum In: J Thorac Dis. 2020 Aug;12(8):4591-4592.

ReferenceCitation: Haute Autorité de Santé. Réponses rapides dans le cadre de la Covid-19 - Prise en charge de premier recours des patients suspectés de Covid-19. Paris,18 juin 2020. Mise à jour en nov. 2020

lead_sponsor: AGIR à Dom

sponsor_collaborators:
AGIR à Dom
Laboratoire TIMC-IMAG
DrinkHRW, British Columbia, Canada

location_country: Serbia Morocco France

location_facility:
Public Health Center
Casablanca center
Timc-Imag (Umr5525 Uga-Cnrs)

intervention_type: Dietary Supplement


title: Integrated Care of Co-morbidities vs Standard Care After Acute Hypercapnic Respiratory Failure in the Intensive Care Unit: a Randomized Controlled Trial

acronym: TMIRA

summary: The study will assess the potential benefit of implementing a complex bundle of interventions to treat important - often unrecognized - comorbidities in patients surviving an episode of Acute Hypercapnic Respiratory Failure (AHRF). This study will also provide a comparative analysis of the costs and health consequences of two alternative strategies to inform decision making about healthcare. All interventions are individually evidence-based and seem sound to hypothesize that implementing such interventions might improve patient's outcome and reduce the financial burder of repeated hospitalization in AHRF survivors.

status: Terminated

lead_sponsor: CTU

collaborators: Dan Adler is not working anymore at UGeneva, and nobody replaced him. This study is stopped

location_country: Switzerland France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

status_simplified: Unknown


title: A Prospective, Randomized, Multicentric Clinical Evaluation Comparing a Monofocal Extended Depth of Focus IOL With a Monofocal IOL

acronym: MonoeDOF

summary:
Post-market, prospective, randomized, single-masked, multi-center clinical study investigating the safety and effectiveness of the Monofocal Extended Depth of Focus Intraocular Lens (Mono-EDoF IOL) when compared to a Standard Monofocal Intraocular Lens.

Primary Objectives:

To evaluate the distance VA of the study IOLs
To evaluate the intermediate VA of the study IOLs
To explore the safety profile with regards to visual disturbances

ReferenceCitation: Black S. Successful Restoration of Visual Acuity with an Extended Range of Vision Intraocular Lens after Multifocal Laser Ablation. Case Rep Ophthalmol. 2016 Oct 11;7(3):193-197. doi: 10.1159/000450675. eCollection 2016 Sep-Dec.

ReferenceCitation: Bostanci Ceran B, Takmaz T, Can I, Demirok G, Uysal BS. Clinical outcomes and optical performance of four differentmultifocal intraocular lenses. Turk J Med Sci. 2016 Apr 19;46(3):597-603. doi: 10.3906/sag-1403-24.

ReferenceCitation: Cillino S, Casuccio A, Di Pace F, Morreale R, Pillitteri F, Cillino G, Lodato G. One-year outcomes with new-generation multifocal intraocular lenses. Ophthalmology. 2008 Sep;115(9):1508-16. doi: 10.1016/j.ophtha.2008.04.017. Epub 2008 Jun 5.

ReferenceCitation: Cochener B; Concerto Study Group. Clinical outcomes of a new extended range of vision intraocular lens: International Multicenter Concerto Study. J Cataract Refract Surg. 2016 Sep;42(9):1268-1275. doi: 10.1016/j.jcrs.2016.06.033.

ReferenceCitation: Davison JA, Simpson MJ. History and development of the apodized diffractive intraocular lens. J Cataract Refract Surg. 2006 May;32(5):849-58. doi: 10.1016/j.jcrs.2006.02.006.

ReferenceCitation: de Silva SR, Evans JR, Kirthi V, Ziaei M, Leyland M. Multifocal versus monofocal intraocular lenses after cataract extraction. Cochrane Database Syst Rev. 2016 Dec 12;12(12):CD003169. doi: 10.1002/14651858.CD003169.pub4.

ReferenceCitation: Harman FE, Maling S, Kampougeris G, Langan L, Khan I, Lee N, Bloom PA. Comparing the 1CU accommodative, multifocal, and monofocal intraocular lenses: a randomized trial. Ophthalmology. 2008 Jun;115(6):993-1001.e2. doi: 10.1016/j.ophtha.2007.08.042. Epub 2007 Nov 26.

ReferenceCitation: Hashemi H, Khabazkhoob M, Soroush S, Shariati R, Miraftab M, Yekta A. The location of incision in cataract surgery and its impact on induced astigmatism. Curr Opin Ophthalmol. 2016 Jan;27(1):58-64. doi: 10.1097/ICU.0000000000000223.

ReferenceCitation: Kaymak H, Hohn F, Breyer DR, Hagen P, Klabe K, Gerl RH, Mueller M, Auffarth GU, Gerl M, Kretz FT. [Functional Results 3 Months after Implantation of an "Extended Range of Vision" Intraocular Lens]. Klin Monbl Augenheilkd. 2016 Aug;233(8):923-7. doi: 10.1055/s-0042-104064. Epub 2016 Jul 6. German.

ReferenceCitation: Lan J, Huang YS, Dai YH, Wu XM, Sun JJ, Xie LX. Visual performance with accommodating and multifocal intraocular lenses. Int J Ophthalmol. 2017 Feb 18;10(2):235-240. doi: 10.18240/ijo.2017.02.09. eCollection 2017.

ReferenceCitation: Pedrotti E, Bruni E, Bonacci E, Badalamenti R, Mastropasqua R, Marchini G. Comparative Analysis of the Clinical Outcomes With a Monofocal and an Extended Range of Vision Intraocular Lens. J Refract Surg. 2016 Jul 1;32(7):436-42. doi: 10.3928/1081597X-20160428-06.

ReferenceCitation: Prasher P, Sandhu JS. Prevalence of corneal astigmatism before cataract surgery in Indian population. Int Ophthalmol. 2017 Jun;37(3):683-689. doi: 10.1007/s10792-016-0327-z. Epub 2016 Aug 27.

ReferenceCitation: TECNIS Symfony DFU

ReferenceCitation: Ruiz-Mesa R, Abengozar-Vela A, Aramburu A, Ruiz-Santos M. Comparison of visual outcomes after bilateral implantation of extended range of vision and trifocal intraocular lenses. Eur J Ophthalmol. 2017 Jun 26;27(4):460-465. doi: 10.5301/ejo.5000935. Epub 2017 Jan 28.

ReferenceCitation: Weeber HA, Meijer ST, Piers PA. Extending the range of vision using diffractive intraocular lens technology. J Cataract Refract Surg. 2015 Dec;41(12):2746-54. doi: 10.1016/j.jcrs.2015.07.034.

ReferenceCitation: Attia MSA, Auffarth GU, Kretz FTA, Tandogan T, Rabsilber TM, Holzer MP, Khoramnia R. Clinical Evaluation of an Extended Depth of Focus Intraocular Lens With the Salzburg Reading Desk. J Refract Surg. 2017 Oct 1;33(10):664-669. doi: 10.3928/1081597X-20170621-08.

publisher_dissemination: SLACK, Inc.

ReferenceCitation: Bellucci R. Multifocal intraocular lenses. Curr Opin Ophthalmol. 2005 Feb;16(1):33-7. doi: 10.1097/00055735-200502000-00006.

lead_sponsor: Advanced Vision Science, Inc.

location_country:
United Kingdom
Portugal
France

location_facility:
Oxford Eye Hospital
University Hospital Pellegrin
Hospital de Braga

intervention_type: Procedure


title: A Phase I/IIa Clinical Trial to Assess Feasibility, Safety and Antitumor Activity of Autologous SLAMF7 CAR-T Cells in Multiple Myeloma

summary:
Multiple myeloma (MM) is a rare hematologic malignancy of aberrant plasma cells.

There is a high and currently unmet medical need for novel, innovative treatment concepts to improve the therapeutic outcome and prognosis of patients suffering from MM.

There is definitive evidence that MM is susceptible to immune-based therapies from pre-clinical investigations and early clinical trials.

CARAMBA-1 is a first-in-human clinical trial of adoptive immunotherapy with autologous signaling lymphocytic activation molecule F7 (SLAMF7) chimeric antigen receptor (CAR)-T cells in patients with advanced MM that have exhausted conventional therapies.

The CARAMBA-1 clinical trial is an open-label, non-randomized, multicenter clinical trial which combines a phase I dose-escalation part with a phase IIa dose-expansion part to assess feasibility, safety and anti-myeloma activity of SLAMF7 CAR-T cells.

The CARAMBA project and the CARAMBA-1 clinical trial are supported by the European Union in the Horizon 2020 research and innovation program.

lead_sponsor: Wuerzburg University Hospital

sponsor_collaborators:
Wuerzburg University Hospital
European Union

location_country: Germany Spain France

location_facility: Clinical Trials Unit, Clinica Universidad de Navarra

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Early Clinical Trial Unit University Hospital Wuerzburg


title: Clinical Investigation to Assess the Efficacy and the Safety of VisuXL® Ophthalmic Gel Administered in Patients Affected by Moderate Dry Eye Disease (DED): a Randomized, Cross Over, Double Blind Study

summary: This is a post-market, european multicenter study. This is a randomized, cross-over, double blind study with competitive enrolment, aimed to enroll a total of 90 patients with a diagnosis of moderate dry eye disease (DED).

status: Unknown status

lead_sponsor: VISUfarma SpA

location_facility: ASST-Santi Paolo e Carlo-Presidio San Paolo


title: Phase II, Multicenter, Open-label, Rct With an Adaptive Design, to Assess Efficacy of Intravenous Administration of Oxytocin in Hospitalized Patients Affected by COVID-19

summary:
Introduction There are currently no treatments with demonstrated efficacy for COVID-19 infection. Epidemiological evidence points to the existence of intrinsic protection factors which make young persons and women more resistant to the infection, whereas older patients with multiple illnesses, above all with heart disease, are at greatest risk. This trial proposes treatment initiated in the early stages of the disease, when clinical worsening is most likely, with intravenous Oxytocin (OT), an endogenous hormone currently safely used in clinical practice. The selection of this molecule is based on numerous experimental and clinical observations, which show its activity in modulating resistance to pathogens, in mitigating overall cardiovascular risk, and in acting on the production of Nitric Oxide (ON) in the lungs, which is emerging as a key therapeutic factor for the improvement of respiratory function in patients with SARS-COVID 19. Finally, OT is physiologically produced by the human body, especially in the female sex and in the age ranges that coincide with most resistant patients. In routine clinical practice, OT exhibits an excellent therapeutic index, in absence of significant adverse effects.

Primary aim To assess the effects of Oxytocin in addition to standard therapy, with respect to Standard of Care (SoC), in reducing the number of patients who enter a critical stage Secondary aim

To describe:

Mortality 28 days after randomization
Time to mechanical ventilation during the study
Duration of dependency on oxygen supply
Length of stay
Temporal trend of clinical improvement (7-category ordinal scale)
Safety analysis

status: Withdrawn

lead_sponsor: Azienda Ospedaliero-Universitaria di Parma

location_country: Italy France

location_facility: Azienda Ospedaliero Universitaria di Parma


title: Open Label, Phase I Study to Assess and Compare the Pharmacokinetic Parameters After Single Oral Administration of MD1003 100 mg in Hepatic Impaired Patients and Healthy Subjects With Normal Hepatic Function

summary:
This is a Phase 1, multicentric, open-label,two arms to assess and compare the effect of single oral administration of MD1003 on the pharmacokinetic parameters in hepatic impaired patients and healthy subjects with normal hepatic function.

The planned enrollment is 16 subjects (8 impaired patients and 8 healthy subjects).

primary_purpose: Other

lead_sponsor: MedDay Pharmaceuticals SA

sponsor_collaborators:
MedDay Pharmaceuticals SA
Eurofins Optimed

location_country: Hungary France

location_facility:
Clinical Research Units Hungary Ltd.
DRC Drug Research Center Ltd.
Eurofins Optimed


title: Obstetric Outcomes of Women Suffering From Hereditary Fibrinogen Disorders

acronym: FIBRINOGEST

summary: The aim of this observational study is to evaluate the prevalence of uncomplicated pregnancies in women suffering from congenital fibrinogen disorders (i.e, hypofibrinogenemia, dysfibrinogenemia, hypodysfibrinogenemia) as well as to describe pregnancies outcomes in such diseases.

lead_sponsor: University Hospital, Geneva

sponsor_collaborators:
University Hospital, Geneva
Swiss Hemophilia Network

location_country: Switzerland Slovakia France

location_facility: Jessenius Faculty of Medicine and University Hospital


title: A Phase I/II Safety and Dose Evaluation Study of OXB-102 (AXO-Lenti-PD) in Patients With Bilateral Idiopathic Parkinson's Disease (SUNRISE-PD)

acronym: SUNRISE-PD

summary: This study consists of two parts. Part A will evaluate the safety and tolerability of multiple doses of OXB-102 (AXO-Lenti-PD) in participants with Parkinson's disease. Part B will assess the safety and efficacy of the selected dose of OXB-102 in participants with Parkinson's disease.

ReferenceCitation: McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS: 1. GENE THERAPY FOR PARKINSON'S, 2. PHASE 3 STUDY IN FOCUS - INTEC PHARMA'S ACCORDION PILL, 3. CLINICAL TRIALS RESOURCES. J Parkinsons Dis. 2019;9(2):251-264. doi: 10.3233/JPD-199001. No abstract available.

oa_colors: green hybrid

evidence: open (via page says Open Access)

license: cc-by-nc

license_normalized: cc-by-nc

unpaywall_oa_status: hybrid

publisher_dissemination: IOS Press

lead_sponsor: Sio Gene Therapies

location_country:
United Kingdom
France

location_facility: University of Cambridge, Centre for Brain Repair

location_facility: The National Hospital for Neurology and Neurosurgery

location_facility: Service de Neurochirurgie, Hôpital Henri Mondor


title: An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects With Giant Cell Rich Tumors of Bone

summary: An open-label, multi-center, phase 2 study of the efficacy of denosumab in subjects with giant cell rich tumors of bone. The population will consist of subjects with the following tumor types: aneurysmal bone cysts (ABC), giant cell granuloma (GCG) and other giant cell rich lesions (primary bone, non-malignant).

lead_sponsor: Leiden University Medical Center

sponsor_collaborators:
Leiden University Medical Center
Amgen

location_country: Italy Netherlands France

location_facility:
Istituto Ortopedico Rizzoli
Leiden University Medical Center
Centre Léon Bérard


lead_sponsor: Novartis Pharmaceuticals

summary: This was a Phase 2, open label, single arm, multiple dose study to assess efficacy, safety, pharmacokinetics and pharmacodynamics of iptacopan when administered in addition to Standard of care (SoC) in patients with paroxysmal nocturnal hemoglobinuria (PNH) with signs of active hemolysis.

ReferenceCitation: Risitano AM, Roth A, Soret J, Frieri C, de Fontbrune FS, Marano L, Alashkar F, Benajiba L, Marotta S, Rozenberg I, Milojevic J, End P, Nidamarthy PK, Junge G, Peffault de Latour R. Addition of iptacopan, an oral factor B inhibitor, to eculizumab in patients with paroxysmal nocturnal haemoglobinuria and active haemolysis: an open-label, single-arm, phase 2, proof-of-concept trial. Lancet Haematol. 2021 May;8(5):e344-e354. doi: 10.1016/S2352-3026(21)00028-4. Epub 2021 Mar 23.

title: An Open Label, Single Arm, Multiple Dose Study to Assess Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of LNP023 When Administered in Addition to Standard of Care (SoC) in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) With Signs of Active Hemolysis

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

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

location_country: Germany Italy France


title: Delivery of Audiovisual Information on Early Medical Abortion to Women in Europe Via Digital Technology: is it Acceptable and Informative?

acronym: EMAVID

summary:
The majority of abortions in the United Kingdom (UK) are performed before 9 weeks (63 days) gestation using a method known as Early Medical Abortion (EMA). EMA involves an assessment visit and provision of two types of medication .

The assessment visit usually involves Ultrasound to confirm gestation, detailed personal history, safeguarding assessment and contraception planning, before arranging treatment and follow up.

The process is long and lots of information is given to women attending the service. In NHS Lothian (National Health Service, Lothian Health Board), the average appointment length for combined assessment and provision of the first part of treatment is 3 hours.

Despite how common abortion is ( 1 in 3), many women presenting for abortion care are not aware of what the procedure will involve. This may in part to the social stigma surrounding abortion and unintended pregnancy in general. This stigma can in turn result in feelings of anxiety and shame about the decision to terminate a pregnancy.

There is evidence that short videos shown to patients prior to abortion or contraception consultations can improve their ability to recall information and can make them feel more confident about the procedure.

Additionally, abortion care providers have found patients who have seen videos to be better prepared and informed and this allows consultations to progress more easily and allow greater time for discussion of contraceptive methods.

We have prepared a video approximately 3 minutes in length to provide information about EMA. It summarises the process described above using simple language and animated characters. The video has been translated into French, Portuguese and Swedish and has been adapted to reflect subtle differences in practice and law in these countries. We have partners in services in these three countries who will be conducting the trial there in accordance with this protocol and their own local ethics and clinical governance requirements.

primary_purpose: Health Services Research

ReferenceCitation: Michie L, Cameron ST, Glasier A, Johnstone A. Giving information about the contraceptive implant using a DVD: is it acceptable and informative? A pilot randomised study. J Fam Plann Reprod Health Care. 2016 Jul;42(3):194-200. doi: 10.1136/jfprhc-2015-101186. Epub 2015 Aug 6.

ReferenceCitation: Powell-Jackson R, Glasier A, Cameron ST. Benefits of using a digital video disk for providing information about abortion to women requesting termination of pregnancy. Contraception. 2010 Jun;81(6):537-41. doi: 10.1016/j.contraception.2010.01.015. Epub 2010 Feb 19.

ReferenceCitation: Reynolds-Wright JJ, Belleuvre F, Daberius A, Faucher P, Gemzell-Danielsson K, Cameron ST. Information on early medical abortion for women using an audiovisual animation vs face-to-face consultation: A consortium randomized and quasi-randomized trial. Acta Obstet Gynecol Scand. 2020 Dec;99(12):1611-1617. doi: 10.1111/aogs.13944. Epub 2020 Jul 12.

evidence: open (via crossref license)

repository_institution: University of Edinburgh - Edinburgh Research Explorer

ipd_sharing_description: Only anonymised responses to questionnaire will be shared between sites.

lead_sponsor: NHS Lothian

location_country:
United Kingdom
Sweden
France

location_facility: Chalmers Centre for Sexual and Reproductive Health


title: PULsecath mechanicaL Support Evaluation (PULSE) - Trial

acronym: PULSE

summary: The objective of this study is to determine ventricular loading conditions during and after PulseCath® iVAC2L support, and assess its impact on specific load dependent humoral factors and cardiac enzymes. These specific patterns are so far unknown and will be evaluated invasively.

ReferenceCitation: Bastos MB, McConkey H, Malkin O, den Uil C, Daemen J, Patterson T, Wolff Q, Kardys I, Schreuder J, Lenzen M, Zijlstra F, Redwood S, Van Mieghem NM. Effect of Next Generation Pulsatile Mechanical Circulatory Support on Cardiac Mechanics: The PULSE Trial. Cardiovasc Revasc Med. 2022 Sep;42:133-142. doi: 10.1016/j.carrev.2022.03.013. Epub 2022 Mar 14.

repository_institution: Erasmus University Rotterdam - EUR Research Repository

ReferenceCitation: Dedic A, Bastos MB, Van Mieghem NM. Pressure-Volume Loop Analysis in Percutaneous Coronary Intervention-Induced Shock. JACC Case Rep. 2020 Sep 23;2(12):1882-1883. doi: 10.1016/j.jaccas.2020.07.026. eCollection 2020 Oct.

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

repository_institution: Erasmus University, Rotterdam - RePub

repositories_concat: PubMed Central;pure.eur.nl;repub.eur.nl

lead_sponsor: Erasmus Medical Center

location_country:
United Kingdom
Netherlands
France

location_facility: Kings College London, St. Thomas' Hospital


title: Directional Lead: Investigation of Rotational Current Steering, Ease of Use of Clinical Effects Map, and Therapeutic Outcomes of Deep Brain Stimulation

acronym: DIRECT-DBS

summary: The primary objective is to characterize the programming effects of Boston Scientific Vercise™ PC System using the DBS Directional Lead for bilateral STN DBS for the treatment of Parkinson's disease in acute and chronic settings.

lead_sponsor: Boston Scientific Corporation

location_country: Germany Netherlands France

location_facility:
Academisch Medisch Centrum
CHU Grenoble - Hopital Michallon
Universitaetsklinikum Wuerzburg


title: SEMEiotic Oriented Technology for Individual's CardiOmetabolic Risk Self- assessmeNt and Self-monitoring

acronym: SEMEOTICONS

summary:
Cardio-metabolic risk factors include obesity, physical inactivity, smoke, alcohol abuse, high blood lipids or sugar and arterial hypertension. Systems for self-learning and self-monitoring may help people improve and maintain a healthy lifestyle through tailored suggestions about diet, weight control, physical activity, fatigue,stress.

SEMEOTICONS exploits the human face as an indicator of individual's health status and translates signs obtained from the face using contactless sensors into measures and descriptors to be automatically evaluated by a an interactive smart mirror. This "Wize Mirror" extracts descriptors from videos, images and gas concentration signals and integrates them in a virtual model used to compute and trace the evolution of an individual's wellness index. A health diary enables each individual to evaluate and personally relate his/her lifestyle to his/her well-being. Coaching messages are provided, in relation to the evolution of the wellness index and of each descriptor, to provide useful suggestions on correct lifestyle self-monitoring.

The purpose of this study is assess the accuracy of the information derived from the Wize Mirror in expressing the health status of the individual.

The reproducibility and repeatability study will evaluate whether measurements are stable over short time spans and whether they are influenced by meals light and temperature conditions.

To verify whether the Wize Mirror is able to detect variations in physical and emotional health status with appropriate lifestyle changes, the validation study will cross-check measurements from the Wize Mirror against reference clinical tests at enrolment and after 3 months of personalized suggestions for healthy behavior.

Reference tests include

Physician visit
Measurement of blood oxygen content and skin end products of sugar metabolism,body composition, energy expenditure, vascular function
Laboratory profile and exhaled gas composition
Questionnaires on quality of life and lifestyle (food, sleep, physical activity, smoking, alcohol, stress).

Wize Mirror measures include

3D reconstruction of face images for roundness, color, stress and fatigue
Heart and respiratory rate
Detection of skin sugar metabolism end-products and of eye lipid deposits
Small vessel vasodilating ability with local heating The results will allow to assess whether the Wize Mirror is easy to use and helpful for self-monitoring of cardio-metabolic risk.

lead_sponsor: Istituto di Fisiologia Clinica CNR

collaborators: Centre de Recherche en Nutrition Humaine Rhone-Alpe

location_facility: Istituto di Fisiologia Clinica del CNR UOS Milano


title: A First-in Human Phase I, Non-randomised, Open-label, Multi-center Dose Escalation Trial of BI 836880 Administered by Repeated Intravenous Infusions in Patients With Solid Tumors.

summary: This is a Phase I, non-randomized, uncontrolled, open-label, dose escalating study of BI 836880 administered intravenously. The eligible patient population will be patients with advanced solid tumours. At any time during the trial, it will not be permitted to escalate to a dose which does not fulfil the escalation with overdose control (EWOC) criterion

ReferenceCitation: Le Tourneau C, Becker H, Claus R, Elez E, Ricci F, Fritsch R, Silber Y, Hennequin A, Tabernero J, Jayadeva G, Luedtke D, He M, Isambert N. Two phase I studies of BI 836880, a vascular endothelial growth factor/angiopoietin-2 inhibitor, administered once every 3 weeks or once weekly in patients with advanced solid tumors. ESMO Open. 2022 Oct;7(5):100576. doi: 10.1016/j.esmoop.2022.100576. Epub 2022 Sep 13.

repository_institution: Augsburg University - OPUS - Augsburg University Publication Server

lead_sponsor: Boehringer Ingelheim

location_country: Germany France

location_facility:
INS Curie
Universitätsklinikum Augsburg
Universitätsklinikum Freiburg


title: A Randomized, Double-blind, Placebo-controlled, First-in-human, 3-part Study of Orally Administered JNJ-54257099 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (Part 1) and Food-effect (Part 2) in Healthy Subjects, and Multiple Doses in Subjects With Chronic Hepatitis C Infection (Part 3)

summary:
This is a Phase 1, randomized, double-blind, placebo-controlled, first-in-human, 3-part study in which the safety, tolerability, and pharmacokinetics of orally administered AL-704 will be assessed in healthy adult subjects and in adult subjects with CHC infection.

Part 1: Healthy adult subjects will receive one of 5 single ascending oral doses (SAD) of AL-704 ranging from 100 mg to 1,500 mg (Cohorts 1 to 5). Within each cohort subjects will be randomized to receive either AL-704 or placebo (n=8 per cohort; 6 assigned to AL-704 and 2 assigned to placebo), in a fasted state.

The planned dose-escalation scheme may be changed based on the emerging PK and safety data. Two additional cohorts (Cohorts 6 and 7) may be enrolled for evaluation of additional doses at the discretion of the Sponsor and Investigator, based on the emerging pharmacokinetic (PK) profile, and the presence of an acceptable safety profile.

Part 2: To assess the food effect on pharmacokinetics, 8 healthy subjects from one full Part 1 cohort who received a single dose of AL-704 or placebo in a fasted state, will receive the same single dose of AL-704 or placebo in a fed state in Part 2 after a washout period of 7-14 days (depending on PK results). It is expected that Cohort 3 of Part 1 (600 mg dose) will be selected, however this depends on the evaluation of available PK and safety data from Part 1 of the study.

Part 3: The following cohorts of 10 adult subjects each, with CHC infection, will be evaluated. Subjects with CHC genotype 1 infection (Cohorts 8 to 10) and subjects with CHC genotype 3 infection (Cohort 11) will be randomized to receive AL-704 or placebo for 7 consecutive days (n=10 per cohort, 8 assigned to AL-704 and 2 assigned to placebo) in a fed state. The treatment is anticipated to be administered in a once daily dose regimen or a twice daily dose regimen. The dose and dose regimen to be administered will be determined by the Sponsor depending on the PK and safety outcomes of previous cohorts.

lead_sponsor: Alios Biopharma Inc.

sponsor_collaborators:
Alios Biopharma Inc.
Janssen Pharmaceutica

location_country:
Moldova, Republic of
Georgia
France

location_facility: Biotrial Arensia