title: Fissure Closure With the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema; A Multicenter, Prospective Trial

acronym: CONVERT

summary:
This is a prospective, open-label, multi-center, single-arm study to be conducted at up to 20 investigational sites. The Study plans to enroll up to 140 subjects with severe emphysema and collateral ventilation in the target lobe. This protocol is designed to evaluate the utility of the AeriSeal System to occlude collateral air channels in a target lung lobe with collateral ventilation (CV) and convert the target lung lobe to having little to no collateral ventilation. Subjects can then receive Zephyr Valves to achieve atelectasis in the targeted lobe, once AeriSeal has converted the CV+ lobe to a CV- one. Therefore, the study will have two Stages:

• Stage 1 will address the closure of the lobar fissure gaps (or collateral air channels) to block collateral ventilation (CV) with the AeriSeal System; conversion of the CV+ target lobe to CV-. Conversion of collateral ventilation will be evaluated by Chartis after 45 days. In the case of unsuccessful conversion, a second treatment of AeriSeal may be attempted, provided that the total application volume from both the initial and the repeat treatments does not exceed 40 mL in up to three (3) segments.

Clinical Assessments post-AeriSeal will be conducted at 28 and 45 days after first treatment and repeated after the second treatment, if applicable. For the purpose of protocol follow-up, the Day 45 post-AeriSeal final treatment will equal Day 0 for Stage 2.

• Stage 2 will include successfully converted subjects; CV+ to CV- conversion in Stage 1. Converted CV- target lobes will follow standard of care and receive CE marked Zephyr Endobronchial valves per the Zephyr IFU to perform bronchoscopic lung volume reduction (BLVR).

Clinical assessments will be conducted at 45 Days, 3-months, 6-months, and 12-months post-Zephyr Valve procedure.

lead_sponsor: Pulmonx Corporation

location_country:
Germany
Italy
United Kingdom
Australia
Netherlands
Switzerland
France

location_facility: ASST Spedali Civili, University Hospital


study_start_date_type: Actual

acronym: GeoMETry-III

intervention_type: Drug

lead_sponsor: Novartis Pharmaceuticals

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

status: Completed

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

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

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

study_completion_date_type: Actual

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

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Completed


lead_sponsor: UCB Biopharma SRL

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

status: Terminated

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

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

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

status_simplified: Unknown


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

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

status: Active, not recruiting

study_completion_date_type: Anticipated

primary_purpose: Other

ipd_sharing: No

lead_sponsor: XVIVO Perfusion

location_country:
Germany
Italy
United Kingdom
Sweden
Austria
Belgium
Spain
France

location_facility: Universitätsklinik der Ruhr-Universität Bochum

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

intervention_type: Device

status_simplified: Ongoing


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

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

status: Recruiting

enrollment_type: Anticipated

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

lead_sponsor: Amgen

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

location_facility: General Children Hospital Panagioti and Aglaias Kyriakou

location_facility: Hospices Civils de Lyon Hopital Femme Mere Enfant

location_facility: Ippokrateio General Hospital of Thessaloniki

location_facility: Great Ormond Street Hospital for Children

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

location_facility: Universitaetsklinikum Heidelberg, Zentrum fuer Kinder und Jugendmedizin

location_facility: Uniwersytecki Szpital Dzieciecy w Krakowie

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

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


acronym: ILLUMINATE-B

lead_sponsor: Alnylam Pharmaceuticals

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

ReferenceType: derived

ReferenceCitation: Hayes W, Sas DJ, Magen D, Shasha-Lavsky H, Michael M, Sellier-Leclerc AL, Hogan J, Ngo T, Sweetser MT, Gansner JM, McGregor TL, Frishberg Y. Efficacy and safety of lumasiran for infants and young children with primary hyperoxaluria type 1: 12-month analysis of the phase 3 ILLUMINATE-B trial. Pediatr Nephrol. 2023 Apr;38(4):1075-1086. doi: 10.1007/s00467-022-05684-1. Epub 2022 Aug 1.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

license_normalized: no license

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

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

oa_host_type: publisher

repositories_concat: closed

publisher_dissemination: Elsevier

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

location_country:
Germany
France
United Kingdom
United States
Israel


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

location_facility:
Novartis Investigative Site
Highlands Oncology Group

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

location_country:
Germany
France
Belgium
United States
Spain
Israel


type: Other Grant/Funding Number

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

acronym: PAPAartis

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

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

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

ReferenceCitation: Petroff D, Czerny M, Kolbel T, Melissano G, Lonn L, Haunschild J, von Aspern K, Neuhaus P, Pelz J, Epstein DM, Romo-Aviles N, Piotrowski K, Etz CD. Paraplegia prevention in aortic aneurysm repair by thoracoabdominal staging with 'minimally invasive staged segmental artery coil embolisation' (MIS(2)ACE): trial protocol for a randomised controlled multicentre trial. BMJ Open. 2019 Mar 4;9(3):e025488. doi: 10.1136/bmjopen-2018-025488.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: PubMed Central - Europe PMC

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repository_normalized: Pure (Denmark)

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repository_normalized: dnet

repositories:
PubMed Central
Pure (Denmark)
dnet

repositories_concat: PubMed Central;Pure (Denmark);dnet

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

ipd_sharing: Undecided

lead_sponsor: University of Leipzig

collaborators: European Clinical Research Infrastructure Network

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

location_facility: Universitäts-Herzzentrum Freiburg/ Bad Krozingen

location_facility: Paracelsus Universität - Klinikum Nürnberg

location_facility: Westdeutsches Herz und Gefäßzentrum Essen

intervention_type: Procedure

lead_sponsor_type: academique


title: An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations

summary: A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations ("OFF" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations ("OFF" Episodes)

ipd_sharing_description: Individual Patient Data (IPD) for this study may be made available upon request via the Clinical Study Data Request site.

lead_sponsor: Sumitomo Pharma America, Inc.

location_country:
Germany
Italy
United Kingdom
Austria
Spain
France

location_facility: St. Josef Hospital, Klnikum der Ruhr-Universitat-Bochum, Neurologische Klinik

location_facility: Centre d'Investigation Clinique, CIC 43, CHU Purpan, Hopital Pierre-Paul Riquet, place du Dr. Baylac, Hall D, 2 eme etage -TSA

location_facility: Istituto Clinico Humanitas, Dipartmento di Neurologia 1

location_facility: Universitatsklinikum Carol Gustav Carus an der TU dDresden, Klinik umd Poliklinik fur Neurologie

location_facility: 10W, Imperial Memory/PD Research Unit, Imperial College Healthcare NHS Trust

location_facility: University Hospitals Plymouth NHS Trust-Derriford Hospital-The Lind Research Center, Level 5, Terence Lewis Building

location_facility: Hospital de la Santa Creu i Sant Pau c/Mas de Casanovas 90

location_facility: IRCCS San Raffaele Pisana-Clinical Trial Center

location_facility: NHS Forth Valley, Pennine Actue NHS Trust, Fairfield General Hospital

location_facility: Charite-University Medicine Berlin, Department of Neurology, Campus charite Mitte

location_facility: Academic Neuroscience Department, C Floor, South Block, Nottingham University Hospitals NHS Trust Queens Medical Centre

location_facility: AOU San Giovanni di Dio e Ruggid'Aragona-CEMAND

location_facility: Medical University Innsbruck, Neurolgy Dept

location_facility: King's College Hospital NHS Foundation Trust

location_facility: A.O.U. Universita degli Studi della Campania "Luigi Vanvitelli" Dipartamento di Scienze Mediche e Chirurgiche Avanzate

location_facility: Klinken Beelitz GmbH Neurologisches Fachkrankenhaus fur Bewegungsstorungen/Parkinson

location_facility: CINAC, Hospital Universitario HB Pueta del Sur

location_facility: Hospital Universitario de Cruces, Neurology

location_facility: St. Joseph Krankenhaus Berlin - Weissensee, Abteilung fur Neurologie

location_facility: Wilhelminenspital, Department of Neurology

location_facility: Klinikum rechts der Isar der Technischen Universitat Munchen

location_facility: University Hospital Policlinico-Vittorio Emanuele, Department "G.F. Ingrassia", Section of Neurosciences


acronym: LemKids

lead_sponsor: Genzyme, a Sanofi Company

summary:
Primary Objective:

To evaluate the efficacy, safety, and tolerability of alemtuzumab intravenously (IV) in pediatric participants from 10 to less than (<) 18 years of age with Relapsing Remitting Multiple Sclerosis (RRMS) who have disease activity on prior DMT.

Secondary Objective:

To assess the pharmacokinetics (PK), pharmacodynamics (PD), anti-drug antibody (ADA) formation, and potential effects of alemtuzumab on other multiple sclerosis (MS) disease characteristics such as cognition and quality of life (QoL).

location_facility:
Investigational Site Number :7920001
Investigational Site Number :6160003
Investigational Site Number :7920003
Investigational Site Number :8260002
Investigational Site Number :7920004
Investigational Site Number :5280001
Investigational Site Number :7920002
Investigational Site Number :0560001
Investigational Site Number :6160001
Investigational Site Number :6430001
Investigational Site Number :2500002
Investigational Site Number :2500001
Investigational Site Number :3800005
Investigational Site Number :6430004
Investigational Site Number :0400001
Investigational Site Number :3800001
Investigational Site Number :6200001
Investigational Site Number :6430005
Investigational Site Number :6430002
Investigational Site Number :6160002
Investigational Site Number :3800004

title: A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Paediatric Patients With Relapsing Remitting Multiple Sclerosis (RRMS) With Disease Activity on Prior Disease Modifying Therapy (DMT)

type: Other Identifier

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

location_country:
Italy
Poland
Portugal
United Kingdom
Netherlands
Austria
Belgium
Turkey
Russian Federation
France


title: Prospective Multi-Center, Single Arm Post-Market Study (PMS) of the Shockwave Medical, Inc. Coronary Lithoplasty® System in Coronary Arteries

summary: The objective of this post market study is to examine the safety and performance of the Shockwave Coronary Intravascular Lithotripsy System for the treatment of narrowed coronary arteries before the doctor places a stent.

ReferenceCitation: Kereiakes DJ, Di Mario C, Riley RF, Fajadet J, Shlofmitz RA, Saito S, Ali ZA, Klein AJ, Price MJ, Hill JM, Stone GW. Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1337-1348. doi: 10.1016/j.jcin.2021.04.015. Epub 2021 May 3.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ReferenceCitation: Ali ZA, Nef H, Escaned J, Werner N, Banning AP, Hill JM, De Bruyne B, Montorfano M, Lefevre T, Stone GW, Crowley A, Matsumura M, Maehara A, Lansky AJ, Fajadet J, Di Mario C. Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses: The Disrupt CAD II Study. Circ Cardiovasc Interv. 2019 Oct;12(10):e008434. doi: 10.1161/CIRCINTERVENTIONS.119.008434. Epub 2019 Sep 25.

evidence: open (via page says license)

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories_concat: Zenodo

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Shockwave Medical, Inc.

location_country:
Germany
Italy
United Kingdom
Denmark
Sweden
Netherlands
Belgium
Spain
France

location_facility: Universitaets-Herzzentrum Freiburg- Bad Krozingen

location_facility: Oxford University Hospitals, John Radcliffe Hospital


title: Phase I Study of Intratumoral CV8102 in Patients With Advanced Melanoma, Squamous Cell Carcinoma of the Skin, Squamous Cell Carcinoma of the Head and Neck, or Adenoid Cystic Carcinoma

summary:
This study evaluates intratumoral administration of CV8102 in patients with advanced melanoma, squamous cell carcinoma of the skin, squamous cell carcinoma of the head and neck, or adenoid cystic carcinoma.

Patients will receive CV8102 as single agent or in combination with SoC anti-PD-1 therapy.

status: Unknown status

design_allocation: Non-Randomized

ReferenceCitation: Lutz J, Meister M, Habbeddine M, Fiedler K, Kowalczyk A, Heidenreich R. Local immunotherapy with the RNA-based immune stimulator CV8102 induces substantial anti-tumor responses and enhances checkpoint inhibitor activity. Cancer Immunol Immunother. 2023 May;72(5):1075-1087. doi: 10.1007/s00262-022-03311-4. Epub 2022 Nov 2.

repositories_concat: PubMed Central

lead_sponsor: CureVac

collaborators:
Syneos Health
Cromos Pharma LLC

sponsor_collaborators:
CureVac
Syneos Health
Cromos Pharma LLC

location_country:
Germany
Austria
Spain
Russian Federation
France

location_facility: Universitätsklinikum Erlangen,Hautklinik, Internistisches Zentrum (INZ)

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Hospital Duran i Reynals - Institut Catala dOncologia ICO

location_facility: Center for Personalized Oncology, I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation

location_facility: Hospital Universitario Marqus de Valdecilla Santander

location_facility: Saint-Petersburg State University, Clinic of advanced medical technologies n. a. Nicolay I. Pirogov.

location_facility: Universitäts-Hautklinik, Abtl. Dermatologische Onkologie

location_facility: FSBI "National Medical Research Oncology Center n.a. N.N. Petrov

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg

location_facility: Universitätsklinikum Münster, Klinik für Hautkrankheiten, ZiD- Zentrum für innovative Dermatologie

location_facility: Medizinische Klinik III, Universitätsklinikum Bonn, Hämatologie, Immunonkologie und Rheumatologie

location_facility: FSBI "National Medical Research Center of Oncology n.a. N.N. Blokhin" of the Ministry of Healthcare of the Russian Federation

location_facility: Universitätsklinikum Schleswig-Holstein, Klinik für Dermatologie, Allergologie und Venerologie

location_facility: Universitätsklinik für Dermatologie der Paracelsus medizinischen Privatuniversität Salzburg

intervention_type: Biological


title: A Randomized, Double-blind, Placebo-controlled, Dose-ranging, Study to Evaluate the Efficacy, Safety and Tolerability of Single Doses of BCX7353 as an Acute Attack Treatment in Subjects With Hereditary Angioedema

summary: This 3-part study will evaluate the efficacy and safety of an oral kallikrein inhibitor, BCX7353, in the treatment angioedema attacks in subjects with Type I or II hereditary angioedema (HAE). In each study part, subjects will treat 3 attacks with BCX7353 (2 attacks) or placebo (1 attack), in a randomly allocated order. In Part 1, the dose of 750mg will be assessed relative to placebo in up to 36 patients. If this is shown to be effective, then a further 12 patients will be enrolled at a 500mg dose (Part 1), followed by a further 12 (if efficacy still shown) at a dose of 250mg (Part 3) to determine the minimum effective dose of BCX7353 compared to placebo for treating HAE attacks. Efficacy will be determined by subject diary entries completed at pre-defined times post-dose.

lead_sponsor: BioCryst Pharmaceuticals

location_country:
Germany
Italy
Poland
North Macedonia
Hungary
Israel
Denmark
Romania
United Kingdom
Switzerland
Austria
France

location_facility:
Study Center
Study center


title: Validation of the "Toronto Aortic Stenosis Quality of Life Questionnaire" in Patients Undergoing Surgical Aortic Valve Replacement or Transfemoral Transcatheter Aortic Valve Implantation The TASQ Registry

acronym: TASQ

summary: Prospective, multi-centre, multi-national registry with a follow-up of 3 months, in five European countries and Canada (Toronto), with elective patients undergoing TF-TAVI (n=120) and isolated SAVR (n=120), respectively and a control group of 50 patients receiving medical treatment only. All patient groups will fill in three different questionnaires to assess quality of life in 5 different languages (English, French, German, Italian and Spanish). One of these will be a new questionnaire, the Toronto Aortic Stenosis QoL (Quality of Life) questionnaire (TASQ).

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Frank D, Kennon S, Bonaros N, Romano M, Lefevre T, Di Mario C, Stefano P, Ribichini FL, Himbert D, Urena-Alcazar M, Salgado-Fernandez J, Cuenca Castillo JJ, Garcia B, Kurucova J, Thoenes M, Luske C, Bramlage P, Styra R. Trial protocol for the validation of the 'Toronto Aortic Stenosis Quality of Life (TASQ) Questionnaire' in patients undergoing surgical aortic valve replacement (SAVR) or transfemoral (TF) transcatheter aortic valve implantation (TAVI): the TASQ registry. Open Heart. 2019 May 21;6(1):e001008. doi: 10.1136/openhrt-2019-001008. eCollection 2019.

ReferenceType: result

ReferenceCitation: Frank D, Kennon S, Bonaros N, Stastny L, Romano M, Lefevre T, Di Mario C, Stefano P, Ribichini F, Himbert D, Urena-Alcazar M, Salgado-Fernandez J, Castillo JJC, Garcia Del Blanco B, Deutsch C, Sykorova L, Kurucova J, Thoenes M, Luske CM, Bramlage P, Styra R. Aortic valve replacement: validation of the Toronto Aortic Stenosis Quality of Life Questionnaire. ESC Heart Fail. 2021 Feb;8(1):270-279. doi: 10.1002/ehf2.12961. Epub 2020 Nov 18.

publisher_dissemination: Wiley

ReferenceCitation: Kennon S, Styra R, Bonaros N, Stastny L, Romano M, Lefevre T, Di Mario C, Stefano P, Ribichini FL, Himbert D, Urena-Alcazar M, Salgado-Fernandez J, Cuenca Castillo JJ, Garcia B, Deutsch C, Sykorova L, Kurucova J, Thoenes M, Luske C, Bramlage P, Frank D. Quality of life after transcatheter or surgical aortic valve replacement using the Toronto Aortic Stenosis Quality of Life Questionnaire. Open Heart. 2021 Nov;8(2):e001821. doi: 10.1136/openhrt-2021-001821.

repository_institution: University of Florence - Florence Research

repositories_concat: PubMed Central;flore.unifi.it

lead_sponsor: Institut für Pharmakologie und Präventive Medizin

location_country:
Germany
Italy
United Kingdom
Austria
Spain
Canada
France

location_facility: Structual Interventional Cardiology, University Hospital Careggi

location_facility: Department of Medicine, University of Verona

location_facility: UKSH University Clinical Center Schleswig-Holstein

location_facility: University Health Network, Toronto General Hospital


title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 2 Dose Regimens of Orally Administered SENS-111 (100 mg and 200 mg) Given During 4 Days in Patients Suffering From Acute Unilateral Vestibulopathy

summary: A multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 2 dose-regimens of orally administered SENS-111 (100mg and 200mg) given during 4 days in patients suffering from Acute Unilateral Vestibulopathy (AUV)

lead_sponsor: Sensorion

location_country:
Germany
Italy
Hungary
Israel
United States
Korea, Republic of
Czechia
France

location_facility: Pécsi Tudományegyetem, ÁOK Klinikai Központ

location_facility: Bajcsy-Zsilinszky Kórház és Rendelőintézet

location_facility: St. Paul's Hospital, The Catholic University of Korea

location_facility: Seoul National University Bundang Hospital

location_facility: Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ


title: Efficacy and Safety of CD5024 1% in Acne Vulgaris

summary: Exploratory, multi-center, randomised, investigator-blinded, vehicle controlled study using intra-individual comparison involving subjects with acne vulgaris on face to evaluate the efficacy of CD5024 1% cream over a 6-week treatment period compared to its vehicle.

lead_sponsor: Galderma R&D

location_country: Germany Canada France

location_facility:
Galderma Investigational Site (# 8060)
Galderma Investigational site
Galderma investigational site


lead_sponsor: Samsung Bioepis Co., Ltd.

summary: A Long-term Follow-up Study for Cardiac Safety in the Patients with HER2 Positive Early or Locally Advanced Breast Cancer Who Have Completed the SB3-G31-BC

ReferenceCitation: Pivot X, Pegram M, Cortes J, Luftner D, Lyman GH, Curigliano G, Bondarenko I, Yoon YC, Kim Y, Kim C. Three-year follow-up from a phase 3 study of SB3 (a trastuzumab biosimilar) versus reference trastuzumab in the neoadjuvant setting for human epidermal growth factor receptor 2-positive breast cancer. Eur J Cancer. 2019 Oct;120:1-9. doi: 10.1016/j.ejca.2019.07.015. Epub 2019 Aug 21.

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

location_facility: Wielkopolskie Centrum Onkologii, im Marii Sklodowskiej-Curie

location_facility: SBI of Ryazan region "Regional Clinical Oncological Dispensary"

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej

location_facility: FSI "Scientific and Research Institution of Oncology n.a. N.N.Petrov" of Ministry of Healthcare and SD of RF

location_facility: Communal Institution Cherkasy Regional Oncological Dispensary of Cherkasy Regional Council

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii I Radioterapii

location_facility: Saint-Petersburg SBHI "City Clinical Oncology Dispensary"

location_facility: Spitalul Clinic Filantropia, Compartimentul Oncologie Ginecologica

location_facility: Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy

location_facility: Non-state Healthcare Institution "Roadway Clinical Hospital of OJSC Russian Railways"

location_facility: Complex Oncological Center - Vratsa, EOOD

location_facility: Regional Communal Institution Sumy Regional Clinical Oncological Dispensary

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca

location_facility: SBHI "Saint-Petersburg Scientific and Practical Center of Specialized Methods of Medical Help (oncological)

location_facility: Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

location_facility: Spitalul Clinic Municipal de Urgenta Timisoara

location_facility: Communal Institution Dnipropetrovsk City Multifield Clinical Hospital No.4 of Dnipropetrovsk Regional Council

location_facility: Bialostockie Centrum Onkologii im.M.Sklodowskiej-Curie w Bialymstoku

location_facility: Communal Institution of Kherson Regional Council Kherson Regional Oncological Dispensary

location_facility: SC Centrul Medical Unirea SRL-Policlinica Baneasa, Specialitatea Oncologie Medicala

location_facility: Spitalul Municipal Ploiesti, Sectia Oncologie Medicala

location_facility: S.I. Russian Oncological Research Center n.a. N.N. Blokhin

location_facility: BHI of Omsk Region "Clinical Oncology Dispensary"

location_facility: Centre Hospitalier de Belfort-Montbeliard

location_facility: Federal State Budgetary Institution "Federal Medical Research Center n.a. P.A Gertsen" of Ministry of healthcare of RF/3

location_facility: SHBI of Yaroslavl Region "Regional Clinical Oncology Hospital"

location_facility: Communal Institution Zaporizhzhia Regional Clinical Oncological Dispensary of Zaporizhzhia Regional Council

location_facility: Spitalul Clinic Judetean de Urgenta Cluj Napoca

location_facility: SBHI "Leningrad Regional Oncology Dispensary"

location_facility: Vinnytsia Regional Clinical Oncological Dispensary

location_facility: Uzhgorod Central City Clinical Hospital City Oncological Center

location_facility: Lviv State Oncological Regional Treatment and Diagnostic Center

location_facility: Communal Non-commercial Enterprise Regional Center of Oncology

location_facility: SBHI of Moscow City "Moscow City Oncology Hospital №62" of Moscow Healthcare Department

location_facility: Samodzielny Publiczny ZOZ Opolskiego Centrum Onkologii w Opolu im. T. Koszarowskiego

title: A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 Positive Early or Locally Advanced Breast Cancer Who Have Completed the SB3-G31-BC

location_country:
Poland
Romania
Czechia
Bulgaria
Ukraine
Russian Federation
France


title: Prospective, Controlled, Double-Blind, Randomized Multicentric Study On The Efficacy And Safety Of An Early Target Controlled Plasma Volume Replacement Therapy With A Balanced Gelatine Solution vs A Balanced Electrolyte Solution In Patients With Severe Sepsis

acronym: GENIUS

summary: This prospective, double-blind randomized controlled trial evaluates the differences in terms of efficacy and safety of gelatin based resuscitation as compared to crystalloid based resuscitation in two parallel groups of patients with severe sepsis / septic shock.

ReferenceCitation: Marx G, Zacharowski K, Ichai C, Asehnoune K, Cerny V, Dembinski R, Ferrer Roca R, Fries D, Molnar Z, Rosenberger P, Sanchez-Sanchez M, Schurholz T, Dehnhardt T, Schmier S, von Kleist E, Brauer U, Simon TP. Efficacy and safety of early target-controlled plasma volume replacement with a balanced gelatine solution versus a balanced electrolyte solution in patients with severe sepsis/septic shock: study protocol, design, and rationale of a prospective, randomized, controlled, double-blind, multicentric, international clinical trial : GENIUS-Gelatine use in ICU and sepsis. Trials. 2021 Jun 2;22(1):376. doi: 10.1186/s13063-021-05311-8.

repositories_concat: PubMed Central;frl.publisso.de

lead_sponsor: B. Braun Melsungen AG

location_country: Germany Austria Spain Czechia France

location_facility: Masarykova nemocnice v Ústí nad Labem, o.z.

location_facility: Universitätsinstitut - Johannes Wesling Klinikum MInden


title: Effects of Oral Nutrition Supplements in Children With Disease Associated Underweight

acronym: MIntS

summary:
The purpose of this study is to test whether the provision of ONS to malnourished children across Europe, in addition to standard counselling, will improve weight gain and other outcomes.

The hypothesis to be tested is:

• Supplementation with ONS in malnourished paediatric patients will lead to increased WFH gain, as well as less malnutrition related complications (e.g. infections).

Primary outcome • The change in BMI z-score over the intervention period of 3 months

Secondary outcomes

• The change in WFH-weight for height (z-scores) over the intervention period of 3 months

primary_purpose: Supportive Care

lead_sponsor: Dr. Michael Chourdakis

collaborators: General Hospital Of Thessaloniki Ippokratio

collaborators: Russian Medical Academy of Postgraduate Education

collaborators: Ludwig-Maximilians - University of Munich

collaborators: Aghia Sophia Children's Hospital of Athens

collaborators: Children's Memorial Health Institute, Poland

location_country:
Poland
Norway
Iran, Islamic Republic of
Belgium
Greece
Croatia
Turkey
Russian Federation
France

location_facility: Aristotle University of Thessaloniki, School of Medicine

location_facility: 1st Paediatric Dept, Hippokration Hospital, AUTH

location_facility: Hospital Jeanne de Flandre, Pediatrics Department, CHRU

location_facility: Department of Pediatrics, Women and Children's Division, Oslo University Hospital

location_facility: 3rd Paediatric Dept, Hippokration Hospital, AUTH

location_facility: Tehran University of Medical Sciences Tehrān, Children Medical Center

location_facility: The Children's Memorial Health Institute

intervention_type: Dietary Supplement


title: Safety and Tolerability of Single and Repeated Doses of ODM-203: An Open-label, Non-randomised, Uncontrolled, Dose Escalation, Multicentre, First-in-Human Study in Subjects With Advanced Solid Tumours

summary: The purpose of this first-in-human study is to evaluate the safety and tolerability of escalating doses of ODM-203 in subjects with advanced solid tumours and to determine the maximum tolerated dose and dose limiting toxicities.

ReferenceCitation: Bono P, Massard C, Peltola KJ, Azaro A, Italiano A, Kristeleit RS, Curigliano G, Lassen U, Arkenau HT, Hakulinen P, Garratt C, Ikonen T, Mustonen MVJ, Rodon JA. Phase I/IIa, open-label, multicentre study to evaluate the optimal dosing and safety of ODM-203 in patients with advanced or metastatic solid tumours. ESMO Open. 2020 Dec;5(6):e001081. doi: 10.1136/esmoopen-2020-001081.

repositories:
PubMed Central
UCL Discovery
air.unimi.it

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

repositories_institution: University College London - UCL Discovery

lead_sponsor: Orion Corporation, Orion Pharma

location_country:
Finland
Italy
United Kingdom
Denmark
Spain
France

location_facility: Helsinki University Central Hospital, Department of Oncology


title: Study to Improve Outcomes in Aortic Stenosis. International, Multi-center, Prospective, Observation and Interventional Cohort Registry

acronym: IMPULSE

summary: The purpose of this study is to narrow the gap between patients being diagnosed with severe aortic stenosis and those being appropriately monitored and treated. For this purpose a prospective survey of current practice (3 months) will be conducted followed by a six month period of intervention during which a variety of quality improvements measures will be implemented. There will then be a 3 month follow-up period during which the legacy of this initiative will be monitored during which no intervention will be carried out.

ReferenceCitation: Steeds RP, Lutz M, Thambyrajah J, Serra A, Schulz E, Maly J, Aiello M, Rudolph TK, Lloyd G, Bortone AS, Hauptmann KE, Clerici A, Delle-Karth G, Rieber J, Indolfi C, Mancone M, Belle L, Lauten A, Arnold M, Bouma BJ, Deutsch C, Kurucova J, Thoenes M, Bramlage P, Frey N, Messika-Zeitoun D. Facilitated Data Relay and Effects on Treatment of Severe Aortic Stenosis in Europe. J Am Heart Assoc. 2019 Oct;8(19):e013160. doi: 10.1161/JAHA.119.013160. Epub 2019 Sep 24.

ReferenceCitation: Frey N, Steeds RP, Rudolph TK, Thambyrajah J, Serra A, Schulz E, Maly J, Aiello M, Lloyd G, Bortone AS, Hauptmann KE, Clerici A, Delle Karth G, Rieber J, Indorfi C, Mancone M, Belle L, Lauten A, Arnold M, Bouma BJ, Lutz M, Pohlmann C, Kurucova J, Thoenes M, Bramlage P, Messika-Zeitoun D; IMPULSE registry group. Symptoms, disease severity and treatment of adults with a new diagnosis of severe aortic stenosis. Heart. 2019 Nov;105(22):1709-1716. doi: 10.1136/heartjnl-2019-314940. Epub 2019 Jul 13.

sponsor_collaborators: Institut für Pharmakologie und Präventive Medizin

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

location_facility: IKEM - Institute for Clinical and Experimental Medicine

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: UKSK Campus Kiel, Klinik für Kardiologie und Angiologie

location_facility: Università degli Studi di Bari Aldo Moro


title: The Eurocyst Initiative: Building a Reference Center Network Across EUROpe to Establish a Large-scale Longitudinal Observational Cohort of Autosomal Dominant polyCYSTic Kidney Disease (ADPKD) Patients

summary: EuroCYST initiative aims to build a large, well-characterized cohort of Autosomal Dominant polyCYSTic Kidney Disease (ADPKD) subjects who are followed in a longitudinal observational cohort study has the potential to identify progression factors and biomarkers, and to assess disease stage specific mortality, morbidity and health care costs.

lead_sponsor: Andreas L. Serra

location_country:
Germany
Italy
United Kingdom
Netherlands
Switzerland
Belgium
Spain
Turkey
Czech Republic
France

location_facility: University of Cambridge, Cambridge Cancer Center

location_facility: University of Sheffield Medical School Academic Unit of Nephrology Department of Infection and Immunity

location_facility: Centre hospitalier universitaire de Brest

location_facility: Istituto di Ricerche Farmacologiche "Mario Negri"


title: A Phase I, Open Label, Multicenter, Dose-escalation Study of HDM201 in Adult Patients With Advanced Solid and Hematological Tumors Characterized by Wild-type TP53

summary: To determine and evaluate a safe and tolerated dose of HDM201 in adult patients with selected advanced tumors characterized by wild-type TP53.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Singapore
Japan
Netherlands
United States
Spain
Taiwan
France

location_facility:
Dana Farber Cancer Institute SC-6
Memorial Sloan Kettering Onc. Dep
Novartis Investigative Site


acronym: POC

lead_sponsor: Italfarmaco

summary: The purpose of this study is to investigate in acromegalic patients the effect of different doses of ITF2984 on GH and IGF-1 concentrations and to investigate safety and tolerability of three different doses of ITF2984.

location_facility: University Children's Hospital of Cracow

location_facility: Klinika Endokrynologii Centrum Medycznego Kształcenia Podyplomowego

location_facility: Institutul de Endocrinologie C.I.Parhon, Sectia clinica de endocrinologie VI

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: Institutul de Endocrinologie C.I.Parhon, Sectia clinica de endocrinologie II

title: A Randomized, Multicenter, Phase II Study to Investigate Efficacy and Safety of ITF2984 in Acromegalic Patients

location_country:
Italy
Poland
Hungary
Romania
Netherlands
Spain
Serbia
Czech Republic
France


title: A Phase I, Open-label, Multi-arm, Multi-centre, Multi-dose, Dose Escalation Study of LTX-315 as Monotherapy or in Combination With Either Ipilimumab or Pembrolizumab in Patients With Transdermally Accessible Tumours

summary: The study will assess the safety, tolerability, PK and efficacy of different intra-tumoral dosing regimens of LTX-315; a lytic-peptide that induces long-term anti-cancer immune responses, as monotherapy or in combination with ipilimumab or pembrolizumab.

ReferenceCitation: Spicer J, Marabelle A, Baurain JF, Jebsen NL, Jossang DE, Awada A, Kristeleit R, Loirat D, Lazaridis G, Jungels C, Brunsvig P, Nicolaisen B, Saunders A, Patel H, Galon J, Hermitte F, Camilio KA, Mauseth B, Sundvold V, Sveinbjornsson B, Rekdal O. Safety, Antitumor Activity, and T-cell Responses in a Dose-Ranging Phase I Trial of the Oncolytic Peptide LTX-315 in Patients with Solid Tumors. Clin Cancer Res. 2021 May 15;27(10):2755-2763. doi: 10.1158/1078-0432.CCR-20-3435. Epub 2021 Feb 4.

oa_colors: green other

evidence: open (via free pdf)

evidence: oa repository (via page says license)

version: submittedVersion

unpaywall_oa_status: bronze

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Jebsen NL, Apelseth TO, Haugland HK, Rekdal O, Patel H, Gjertsen BT, Jossang DE. Enhanced T-lymphocyte infiltration in a desmoid tumor of the thoracic wall in a young woman treated with intratumoral injections of the oncolytic peptide LTX-315: a case report. J Med Case Rep. 2019 Jun 10;13(1):177. doi: 10.1186/s13256-019-2088-6.

repository_institution: University of Oslo - Duo Research Archive

repositories_concat: PubMed Central;munin.uit.no

lead_sponsor: Lytix Biopharma AS

collaborators:
Theradex
ICON plc

sponsor_collaborators:
Lytix Biopharma AS
Theradex
ICON plc

location_country:
Italy
United Kingdom
Norway
Belgium
France

location_facility: Oslo University Hospital Radiumhospitalet

location_facility: Cliniques Universitaires St-Luc, Service d'oncologie médicale


title: A Phase 2, Multicenter, Open-Label, Extension Study to Evaluate the Long-Term Safety, Clinical Activity, and Pharmacokinetics of ALN-TTR02 in Patients With Familial Amyloidotic Polyneuropathy Who Have Previously Received ALN-TTR02

summary: The purpose of this study is to evaluate the safety and tolerability of long-term dosing with ALN-TTR02 (patisiran) in patients with transthyretin (TTR) mediated amyloidosis (ATTR).

ReferenceCitation: Coelho T, Adams D, Conceicao I, Waddington-Cruz M, Schmidt HH, Buades J, Campistol J, Berk JL, Polydefkis M, Wang JJ, Chen J, Sweetser MT, Gollob J, Suhr OB. A phase II, open-label, extension study of long-term patisiran treatment in patients with hereditary transthyretin-mediated (hATTR) amyloidosis. Orphanet J Rare Dis. 2020 Jul 8;15(1):179. doi: 10.1186/s13023-020-01399-4.

repository_institution: Centro Hospitalar do Porto - Repositório Científico do Centro Hospitalar do Porto

repository_institution: Conselleria de Salut i Consum del Govern de les Illes Balears - Docusalut

repository_institution: RCAAP Project by FCT - Portuguese National Funding Agency for Science, Research and Technology - RCAAP Search Portal

repository_institution: University of Lisbon - Repositório da Universidade de Lisboa

repository_institution: Umeå University - DiVA at Umeå University

lead_sponsor: Alnylam Pharmaceuticals

location_country:
Germany
Portugal
Brazil
Sweden
United States
Spain
France


summary:
The objective of this survey is to establish the clinical course of vision loss and recovery in patients with a genetically confirmed diagnosis of Leber Hereditary Optic Neuropathy (LHON).

Visual acuity changes over time from onset of symptoms and from visual acuity nadir will be the main endpoint analysed.

The survey will collect historically documented visual acuity data for all patients at participating sites with a genetically confirmed diagnosis of LHON. No exclusion criteria apply. Patients are not required to attend the clinic for the survey.

Data will be collected in a completely anonymous manner. Ethical approvals and data release agreements will be obtained as required by local regulations.

time_perspective: Retrospective

lead_sponsor: Santhera Pharmaceuticals

collaborators: European Vision Institute Clinical Research Network

location_country: Slovenia Italy Denmark Belgium France

location_facility: Glostrup Hospital/National Eye Clinic of the Kennedy Center/University of Copenhagen Department of Ophthalmology


acronym: Emollients in the management of AD

lead_sponsor: Pierre Fabre Medicament

summary: The purpose of this study is to confirm that emollients play a major role in the maintenance therapy after clearing of inflammatory lesions and can reduce occurrence of flares in children with atopic dermatitis.

title: Emollients in the Management of Atopic Dermatitis in Children: Prevention of Flares.

location_country: Lithuania Poland Romania Estonia France


title: A Phase IIIb/IV Randomized, Controlled, Double-blind, Double-dummy, Parallel Group Study to Compare the Efficacy of Fidaxomicin to Vancomycin in the Sustained Clinical Cure of Clostridium Difficile Infection in Adults Receiving Immunosuppressive Therapy

acronym: FREEDOM

summary: The primary objective is to compare fidaxomicin versus vancomycin for the sustained clinical cure of Clostridium difficile Infection (CDI) in adult patients receiving immunosuppressive therapy.

lead_sponsor: Astellas Pharma Europe Ltd.

collaborators: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

location_country: Germany Poland Denmark Austria Spain Greece France

location_facility:
Universitätsklinikum Halle
Szpital Specjalistyczny w Brzo
Metaxa Anticancer Hospital
Hospital 12 de Octubre
H. U. de Bellvitge
Universitätsklinikum
Univ. Klinik für Innere Medizi
Charité
Institut Curie
General Hospital of Athens
Laiko General Hospital
H.U. Gregorio Maranon
University Hospital of Crete
Klinik I für Innere Medizin
Herlev University Hospital
Hôpital Necker


title: A Feasibility Study of the Mitralign Annuloplasty System for the Treatment of Chronic Functional Mitral Valve Regurgitation

acronym: ALIGN

summary: The purpose of this study is to test the safety and device performance of the Mitralign system ("MPAS") to treat functional mitral valve regurgitation.

lead_sponsor: Mitralign, Inc.

location_country: Paraguay Colombia Poland France

location_facility:
Bordeaux Heart University Hospital
Instytutem Kardiologii
Clinica CardioVID
Clinique Pasteur
Antonio Dager, MD
Sanatorio Italiano
American Heart of Poland S.A.
Centrum Medyczne HZP


summary: This study will evaluate the safety and efficacy of a carboxymethylcellulose based eye drop formulation compared with carboxymethylcellulose based preservative-free lubricant eye drops (OPTIVE™) in subjects with dry eye disease.

lead_sponsor: Allergan

location_country:
Germany
Italy
United Kingdom
Australia
Belgium
Spain
Russian Federation
France


title: A Phase 2, Open-Label, Multi-Dose, Dose Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Infusions of ALN-TTR02 in Patients With TTR Amyloidosis

summary: This was a multiple dose, dose escalation study designed to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of patisiran (ALN-TTR02) in participants with transthyretin (TTR) mediated amyloidosis (ATTR).

ReferenceCitation: Suhr OB, Coelho T, Buades J, Pouget J, Conceicao I, Berk J, Schmidt H, Waddington-Cruz M, Campistol JM, Bettencourt BR, Vaishnaw A, Gollob J, Adams D. Efficacy and safety of patisiran for familial amyloidotic polyneuropathy: a phase II multi-dose study. Orphanet J Rare Dis. 2015 Sep 4;10:109. doi: 10.1186/s13023-015-0326-6.

repositories_institution: Conselleria de Salut i Consum del Govern de les Illes Balears - Docusalut

repositories_institution: RCAAP Project by FCT - Portuguese National Funding Agency for Science, Research and Technology - RCAAP Search Portal

repositories_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia


title: Phase II Study of the BioVentrix PliCath HF™ System for the Treatment of Ischemic Cardiomyopathy

acronym: CONFIGURE-HF

summary: The purpose of this prospective, single-armed, multi-center clinical trial is to further establish the safety and feasibility of using the BioVentrix PliCath HF System for the treatment of left ventricular dysfunction in appropriate cohorts of humans suffering from heart failure.

ReferenceCitation: Wechsler AS, Sadowski J, Kapelak B, Bartus K, Kalinauskas G, Rucinskas K, Samalavicius R, Annest L. Durability of epicardial ventricular restoration without ventriculotomy. Eur J Cardiothorac Surg. 2013 Sep;44(3):e189-92; discussion e192. doi: 10.1093/ejcts/ezt292. Epub 2013 Jun 5.

publisher_dissemination: Oxford University Press

lead_sponsor: BioVentrix

sponsor_collaborators:
BioVentrix
Ohio State University
CDI Centro Diagnostico Italiano
Advance Research Associates

location_country:
Italy
Lithuania
Poland
Portugal
United Kingdom
Austria
Latvia
Spain
Greece
Czechia
France

location_facility: Hospital Pitie Sal Petirere Institute of Cardiology

location_facility: Hospital Clinic and University of Barcelona


title: A Multi-center, Open Label, Uncontrolled, Phase IIA Clinical Trial Evaluating the Safety and Efficacy of NOX A12 in Combination With a Background Therapy of Bortezomib and Dexamethasone (VD) in Previously Treated Patients With Multiple Myeloma (MM)

summary: The purpose of this study is to evaluate the safety and efficacy of NOX A12 alone and in combination with a background therapy of bortezomib and dexamethasone (VD) chemotherapy in previously treated patients with multiple myeloma (MM).

ReferenceCitation: Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.

publisher_dissemination: Informa

lead_sponsor: TME Pharma AG

location_country: Germany Italy Austria France

location_facility: Wilhelminenspital, Department of Medicine I, Center of Oncology and Hematology

location_facility: University Hospital Freiburg, Medizinische Universitätsklinik, Innere Medizin I, Haematologie und Onkologie

location_facility: Niguarda Ca'Granda Hospital, Department of Hematology

location_facility: University Hospital Salzburg, Department of Medicine III, Center of Oncology and Hematology

location_facility: Hôpital Saint Antoine - Service des maladies du sang et de thérapie cellulaire

location_facility: University Hospital San Martino, Department of Hematology and Oncology

location_facility: University Hospital Münster, Medizinische Klinik und Poliklinik A

location_facility: Hôpital Huriez, Centre Hospitalier Régional Universitaire de Lille

location_facility: University Hospital Ulm, Zentrum für Innere Medizin,

location_facility: Sapienza University of Rome, Department of Hematology


title: Neural Cardiac Therapy for Heart Failure Study

acronym: NECTAR-HF

summary: The NECTAR-HF feasibility trial is designed to evaluate the application of right vagal nerve stimulation in heart failure patients with a New York Heart Association Class III, an ejection fraction equal to or less than 35 %, and a narrow QRS duration equal to or less than 130 ms.

ReferenceCitation: De Ferrari GM, Tuinenburg AE, Ruble S, Brugada J, Klein H, Butter C, Wright DJ, Schubert B, Solomon S, Meyer S, Stein K, Ramuzat A, Zannad F. Rationale and study design of the NEuroCardiac TherApy foR Heart Failure Study: NECTAR-HF. Eur J Heart Fail. 2014 Jun;16(6):692-9. doi: 10.1002/ejhf.80. Epub 2014 May 20.

ReferenceCitation: Zannad F, De Ferrari GM, Tuinenburg AE, Wright D, Brugada J, Butter C, Klein H, Stolen C, Meyer S, Stein KM, Ramuzat A, Schubert B, Daum D, Neuzil P, Botman C, Castel MA, D'Onofrio A, Solomon SD, Wold N, Ruble SB. Chronic vagal stimulation for the treatment of low ejection fraction heart failure: results of the NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) randomized controlled trial. Eur Heart J. 2015 Feb 14;36(7):425-33. doi: 10.1093/eurheartj/ehu345. Epub 2014 Aug 31.

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

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

evidence: oa repository (semantic scholar lookup)

ReferenceCitation: De Ferrari GM, Stolen C, Tuinenburg AE, Wright DJ, Brugada J, Butter C, Klein H, Neuzil P, Botman C, Castel MA, D'Onofrio A, de Borst GJ, Solomon S, Stein KM, Schubert B, Stalsberg K, Wold N, Ruble S, Zannad F. Long-term vagal stimulation for heart failure: Eighteen month results from the NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) trial. Int J Cardiol. 2017 Oct 1;244:229-234. doi: 10.1016/j.ijcard.2017.06.036. Epub 2017 Jun 10.

oa_host_type: closed

lead_sponsor: Boston Scientific Corporation

location_country:
Germany
Italy
United Kingdom
Netherlands
Belgium
Spain
Czechia
France

location_facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg

location_facility: Centre d'Investigation Clinique Pierre Drouin, CHU de Nancy

location_facility: The Heart Hospital, University College London Hospitals, NHS Foundation Trust

location_facility: Clínica Universitaria de Navarra, Avenida Pio XII s/n

location_facility: Liverpool Heart and Chest Hospital, NHS Foundation Trust

location_facility: University Hospitals Bristol, NHS Foundation Trust

location_facility: Imperial College Healthcare NHS Trust, St. Mary's Hospital

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Universitäres Herzzentrum GmbH, Universitätsklinikum Hamburg-Eppendorf


acronym: SBC-102 in Children with Growth Failure Due to Lysosomal Acid Lipase Deficiency

lead_sponsor: Alexion Pharmaceuticals, Inc.

summary: This was an open-label, repeat-dose, intra-participant dose-escalation study of SBC-102 (sebelipase alfa) in children with growth failure due to lysosomal acid lipase (LAL) Deficiency. Eligible participants received once-weekly (qw) infusions of sebelipase alfa for up to 5 years.

ReferenceCitation: Jones SA, Rojas-Caro S, Quinn AG, Friedman M, Marulkar S, Ezgu F, Zaki O, Gargus JJ, Hughes J, Plantaz D, Vara R, Eckert S, Arnoux JB, Brassier A, Le Quan Sang KH, Valayannopoulos V. Survival in infants treated with sebelipase Alfa for lysosomal acid lipase deficiency: an open-label, multicenter, dose-escalation study. Orphanet J Rare Dis. 2017 Feb 8;12(1):25. doi: 10.1186/s13023-017-0587-3.

title: An Open Label, Multicenter, Dose Escalation Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of SBC-102 (Sebelipase Alfa) in Children With Growth Failure Due to Lysosomal Acid Lipase Deficiency

location_country:
Ireland
United Kingdom
United States
Egypt
France


title: A Prospective Multicenter Randomized Study Comparing Photoselective Vaporization of the Prostate With the GreenLight XPS™ Laser System and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Hyperplasia

summary: The study compares procedural and post procedural outcomes for photoselective vaporization of the prostate (PVP) and transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction. The study requires use of the CE marked GreenLight XPS™ Laser System (GreenLight XPS) or a CE marked monopolar or bipolar loop TURP system for the treatment of benign prostatic hyperplasia (BPH).

ReferenceCitation: Thomas JA, Tubaro A, Barber N, d'Ancona F, Muir G, Witzsch U, Grimm MO, Benejam J, Stolzenburg JU, Riddick A, Pahernik S, Roelink H, Ameye F, Saussine C, Bruyere F, Loidl W, Larner T, Gogoi NK, Hindley R, Muschter R, Thorpe A, Shrotri N, Graham S, Hamann M, Miller K, Schostak M, Capitan C, Knispel H, Bachmann A. A Multicenter Randomized Noninferiority Trial Comparing GreenLight-XPS Laser Vaporization of the Prostate and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: Two-yr Outcomes of the GOLIATH Study. Eur Urol. 2016 Jan;69(1):94-102. doi: 10.1016/j.eururo.2015.07.054. Epub 2015 Aug 15.

ReferenceCitation: Bachmann A, Tubaro A, Barber N, d'Ancona F, Muir G, Witzsch U, Grimm MO, Benejam J, Stolzenburg JU, Riddick A, Pahernik S, Roelink H, Ameye F, Saussine C, Bruyere F, Loidl W, Larner T, Gogoi NK, Hindley R, Muschter R, Thorpe A, Shrotri N, Graham S, Hamann M, Miller K, Schostak M, Capitan C, Knispel H, Thomas JA. 180-W XPS GreenLight laser vaporisation versus transurethral resection of the prostate for the treatment of benign prostatic obstruction: 6-month safety and efficacy results of a European Multicentre Randomised Trial--the GOLIATH study. Eur Urol. 2014 May;65(5):931-42. doi: 10.1016/j.eururo.2013.10.040. Epub 2013 Nov 11.

location_country:
Germany
Italy
United Kingdom
Netherlands
Austria
Belgium
Switzerland
Spain
France

location_facility: Unita di chirurgia Urologica mininvasiva,Azienda Ospedatiera Sant'Andrea Hospital

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: Basingstoke and North Hampshire NHS Foundation Trust

location_facility: Universitatsklinikum Schleswig-Holstein, Campus Kiel

location_facility: UroForshungs GmbH, im St. hedwig Krankenhaus

location_facility: Diakoniekrankenhaus Rotenburg (W.) gGmbH

location_facility: RadBound University Njmegen Medical Centre

location_facility: Mid Yorkshire NHS Trust Dewsbury & District Hospital

location_facility: Krankenhaus der Barmherzigen Schwestern Linz

location_facility: Hospital Iniversitario Fundacion Alcorcon


title: A Phase I Open-Label Dose Escalation Study of the Focal Adhesion Kinase Inhibitor, GSK2256098, in Subjects With Solid Tumors

summary: This study is a Phase I dose escalation study in subjects with solid tumors. Part 1 will identify the maximum tolerated dose (MTD) using a dose-escalation procedure. Following identification of the MTD, enrollment into Parts 2, 3, 4 and 5 may be concurrent. Part 2 will explore further the safety, PK, tolerability, and anti-tumor activity of GSK2256098 in subjects with tumors known to overexpress focal adhesion kinase (FAK). Part 3 will characterize the range of biologically effective doses by assessing pharmacodynamic (PD) markers in hair, skin and tumor tissue at doses that will not go lower than 80 mg or above the MTD dose levels tested during the Phase 1 dose escalation. Part 4 will explore further the safety, PK, tolerability and anti-tumor activity of GSK2256098 in subjects with relapsed glioblastoma multiforme (GBM). The primary objective of this study is to determine the safety, tolerability, and MTD of GSK2256098. Secondary objectives are to characterize the pharmacokinetics (PK) of GSK2256098; to identify a range of biologically active doses; to explore the anti-tumor activity of GSK2256098, and to explore relationships between GSK2256098 PK, PD and clinical endpoints. Part 5 will investigate the time course, the extent of an apparent change in the PK of GSK2256098 following repeated dosing, and screen for potential CYP3A induction as a possible mechanism of reduced systemic exposure of GSK2256098 at Day 15 and later time points. The primary objective of this study is to determine the safety, tolerability, and MTD of GSK2256098.

ReferenceCitation: Brown NF, Williams M, Arkenau HT, Fleming RA, Tolson J, Yan L, Zhang J, Singh R, Auger KR, Lenox L, Cox D, Lewis Y, Plisson C, Searle G, Saleem A, Blagden S, Mulholland P. A study of the focal adhesion kinase inhibitor GSK2256098 in patients with recurrent glioblastoma with evaluation of tumor penetration of [11C]GSK2256098. Neuro Oncol. 2018 Nov 12;20(12):1634-1642. doi: 10.1093/neuonc/noy078. Erratum In: Neuro Oncol. 2020 Jun 9;22(6):894. Swartz, Lisa [removed].

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repositories:
PubMed Central
UCL Discovery
ora.ox.ac.uk

lead_sponsor: GlaxoSmithKline

location_country:
United Kingdom
Australia
France


title: EASE MITRAL Expertise-based Assessment Study on Clinical Efficacy of Profile 3D in MITRAL Valve Annuloplasty

summary: The goal of the study is to identify the patients suffering from a mitral valve condition who benefit from the implantation of a Profile 3D annuloplasty ring in terms of acute and long-term relief of mitral valve regurgitation.

ReferenceCitation: Doll N, Sheytanov V, Labrousse L, Chu MWA, Stefano P, Mokracek A, Baron O, Li S, Gunzinger R. Clinical performance of a three-dimensional saddle-shaped, rigid ring for mitral valve repair. Eur J Cardiothorac Surg. 2019 Feb 1;55(2):217-223. doi: 10.1093/ejcts/ezy215.

evidence: open (via free article)

lead_sponsor: Medtronic Bakken Research Center

location_country: Germany Italy Czechia Canada France

location_facility: London Health Sciences Centre, University Hospital

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Hôpital Haut - Leveque - CHU Pessac Cedex Bordeaux


title: A Multicenter, Open Label, Phase I /Randomised Phase II Study to Evaluate Safety, Pharmacokinetics and Efficacy of BIBF 1120 in Comparison With Oral Sorafenib for Advanced Hepatocellular Carcinoma Patients.

summary: The study aim is to determine maximally tolerated dose (MTD) of BIBF 1120 in HCC (hepatocellular cancer) and compare efficacy of BIBF 1120 to Sorafenib in HCC patients

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Poland
Hungary
United Kingdom
Romania
Netherlands
Austria
France

location_facility: 1199.37.43002 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.49006 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.44006 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.49001 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.44004 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.44002 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.31002 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.31001 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.48003 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.44005 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.40003 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.48002 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.44008 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.49008 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.40002 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.49004 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.44003 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.49002 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.43001 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.48001 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.49003 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.33001 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.44001 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.49005 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.49010 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.36001 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.33002 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.49009 Boehringer Ingelheim Investigational Site


lead_sponsor: Hoffmann-La Roche

summary: This is an open-label, multi-center, non-randomized study of the safety and tolerability of the combination of T-DM1 plus docetaxel for the treatment of participants with metastatic breast cancer (MBC) and of T-DM1 plus docetaxel with or without pertuzumab, for the treatment of participants with locally advanced breast cancer (LABC). The study comprises an initial dose finding (feasibility) part to determine the maximum tolerated dose (MTD) of T-DM1 and docetaxel, followed by an extension part aiming to consolidate the safety and efficacy of the recommended docetaxel/T-DM1 combination regimen.

ReferenceCitation: Martin M, Fumoleau P, Dewar JA, Albanell J, Limentani SA, Campone M, Chang JC, Patre M, Strasak A, de Haas SL, Xu J, Garcia-Saenz JA. Trastuzumab emtansine (T-DM1) plus docetaxel with or without pertuzumab in patients with HER2-positive locally advanced or metastatic breast cancer: results from a phase Ib/IIa study. Ann Oncol. 2016 Jul;27(7):1249-56. doi: 10.1093/annonc/mdw157. Epub 2016 Apr 6.

license: publisher-specific-oa

license_normalized: publisher-specific

title: An Open-Label, Multi-Center Phase I/II Study of the Safety and Tolerability of the Combination of Trastuzumab-MCC-DM1 (T-DM1) With Docetaxel, and Potentially Pertuzumab, for Treatment for Patients With Advanced Breast Cancer

location_country:
United States
Spain
United Kingdom
France


title: A Prospective, Unmasked, Randomized Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-Angle Glaucoma

acronym: SL

summary: Prospective, unmasked, randomized evaluation of the iStent in patients with primary open-angle glaucoma. Patients will be randomized to one of two groups: 1) iStent, or 2) medication.

ReferenceCitation: Fea AM, Belda JI, Rekas M, Junemann A, Chang L, Pablo L, Voskanyan L, Katz LJ. Prospective unmasked randomized evaluation of the iStent inject ((R)) versus two ocular hypotensive agents in patients with primary open-angle glaucoma. Clin Ophthalmol. 2014 May 7;8:875-82. doi: 10.2147/OPTH.S59932. eCollection 2014.

repositories_concat: PubMed Central;iris.unito.it

repositories_institution: University of Turin - Institutional Research Information System University of Turin

lead_sponsor: Glaukos Corporation

location_country:
Germany
Italy
Poland
United Kingdom
Austria
Spain
Armenia
Greece
France

location_facility: Universita' di Torino/Dipartimento di Fisiopatologia Clinica-Clinica Oculistica

location_facility: Azienda Ospedaliera S. Maria della Misericordia


title: A Phase I Study of Dasatinib With Bortezomib (Velcade®) and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

summary: The purpose of this study is to determine the safety and tolerability of dasatinib with bortezomib in the treatment of relapsed or refractory multiple myeloma.

lead_sponsor: Bristol-Myers Squibb

location_country:
United States
Italy
Spain
France

location_facility: Orlando Health, Inc. M.D. Anderson Cancer Center Orlando

location_facility: Winship Cancer Institute, Emory University


title: A Phase III, Double-Blind, Multi-Centre, Randomised, Parallel Group Design, Placebo-Controlled, Flexible Dose Study of MCI-196 in Combination With a Ca-Based Phosphate Binder in CKD Stage V Subjects on Dialysis With Hyperphosphatemia.

summary: This study consists of a 4 week run-in period with a Ca based phosphate binder and 12 weeks treatment period by MCI-196 or placebo, (both on Ca based phosphate binder). During the treatment period, MCI-196 or placebo will be titrated every 3 weeks.

lead_sponsor: Mitsubishi Tanabe Pharma Corporation

location_country: Macedonia, The Former Yugoslav Republic of


lead_sponsor: UCB Pharma SA

summary: The study will compare the efficacy and safety of brivaracetam with placebo in patients with Unverricht-Lundborg disease.

ReferenceCitation: Ben-Menachem E, Baulac M, Hong SB, Cleveland JM, Reichel C, Schulz AL, Wagener G, Brandt C. Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht-Lundborg disease: An open-label, long-term follow-up trial. Epilepsy Res. 2021 Feb;170:106526. doi: 10.1016/j.eplepsyres.2020.106526. Epub 2020 Dec 4.

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

repository_normalized: HAL

repositories_concat: HAL

ReferenceCitation: Kalviainen R, Genton P, Andermann E, Andermann F, Magaudda A, Frucht SJ, Schlit AF, Gerard D, de la Loge C, von Rosenstiel P. Brivaracetam in Unverricht-Lundborg disease (EPM1): Results from two randomized, double-blind, placebo-controlled studies. Epilepsia. 2016 Feb;57(2):210-21. doi: 10.1111/epi.13275. Epub 2015 Dec 15.

title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy and Safety of Brivaracetam Used as Adjunctive Treatment for 12 Weeks in Adolescent and Adult Patients (≥16 Years) With Genetically Ascertained Unverricht-Lundborg Disease

location_country: Finland Italy Réunion Sweden Netherlands Tunisia France


title: Autologous Stem Cell Transplantation for Crohn's Disease: ASTIC

summary:
Transplant study for patients with relapsing Crohn's disease demonstrating clear intolerance or toxicity to conventional treatment.

The purpose of this study is to determine whether there is a potential clinical benefit of hematopoietic stem cell mobilisation followed by high dose immuno-ablation and autologous stem cell transplantation versus hematopoietic stem cell mobilisation only followed by best clinical practice.

ReferenceCitation: Lindsay JO, Allez M, Clark M, Labopin M, Ricart E, Rogler G, Rovira M, Satsangi J, Farge D, Hawkey CJ; ASTIC trial group; European Society for Blood and Marrow Transplantation Autoimmune Disease Working Party; European Crohn's and Colitis Organisation. Autologous stem-cell transplantation in treatment-refractory Crohn's disease: an analysis of pooled data from the ASTIC trial. Lancet Gastroenterol Hepatol. 2017 Jun;2(6):399-406. doi: 10.1016/S2468-1253(17)30056-0. Epub 2017 Apr 6.

oa_host_type: repository

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: acceptedVersion

unpaywall_oa_status: green

ReferenceCitation: Hawkey CJ, Allez M, Clark MM, Labopin M, Lindsay JO, Ricart E, Rogler G, Rovira M, Satsangi J, Danese S, Russell N, Gribben J, Johnson P, Larghero J, Thieblemont C, Ardizzone S, Dierickx D, Ibatici A, Littlewood T, Onida F, Schanz U, Vermeire S, Colombel JF, Jouet JP, Clark E, Saccardi R, Tyndall A, Travis S, Farge D. Autologous Hematopoetic Stem Cell Transplantation for Refractory Crohn Disease: A Randomized Clinical Trial. JAMA. 2015 Dec 15;314(23):2524-34. doi: 10.1001/jama.2015.16700.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories_concat: LIRIAS (KU Leuven)

publisher_dissemination: American Medical Association

location_country:
Italy
United Kingdom
Switzerland
Belgium
Spain
Canada
France

location_facility: Dipatimento di Medicina Interna E Gastroenterologia

location_facility: Casa Sollievo Della Sofferenza IRCCS Hospital

location_facility: Universita di Bologna Interna e Gastroenterologia Policlinico Saint Orsola

location_facility: Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena

location_facility: Hospital Universitari Germans Trias I Pujol, Dept of Gastroenterology


title: Randomized, Double-blind, Placebo-controlled, Parallel-group Pilot Study to Assess Efficacy, Safety and Pharmacokinetics of 2 Schedules of Reparixin in the Prevention of Delayed Graft Function After Kidney Transplant in High Risk Patients

summary: The chemokine CXCL8 plays a key role in the recruitment and activation of polymorphonuclear neutrophils in post-ischemia reperfusion injury after solid organ transplantation. Reparixin is a novel, specific inhibitor of CXCL8. This study is configured to explore the safety and efficacy of reparixin in preventing the delayed graft function (DGF) after kidney transplantation.

primary_purpose: Prevention

lead_sponsor: Dompé Farmaceutici S.p.A

location_facility: Divisione di Nefrologia e Dialisi, Ospedali Riuniti di Bergamo

location_facility: Renal Transplant Unit, Hopital Clinic i Provincial de Barcelona

location_facility: Service de Nephrologie et Transplantation, Hopital Lapeyronie, Centre Hospitalier Universitaire Montpellier

location_facility: Transplant Center, University of Minnesota Medical School

location_facility: Divisione di Nefrologia e Dialisi, Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Università degli Studi di Padova, Clinica Chirurgica III

location_facility: Service de Transplantation et Soins Intensifs Nephrologiques, Hopital Necker

location_facility: Division of Nephrology, Institut Catala de la Salut, Ciutat Sanitaria i Universitaria de Bellvitge

location_facility: Division of Transplantation, Drexel University College of Medicine


title: Phase II Study of Glivec (Imatinib) in Locally Advanced and/or Metastatic Soft Tissue Sarcomas Expressing the t(17;22)(q22;q13) Translocation Resulting in a COL1A1/PDGF-beta Fusion Protein i.e. DermatoFibroSarcoma Protuberans (DFSP) and Giant Cell Fibroblastoma (GCF)

summary:
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with locally advanced or metastatic dermatofibrosarcoma protuberans or giant cell fibroblastoma.

ReferenceCitation: Rutkowski P, Van Glabbeke M, Rankin CJ, Ruka W, Rubin BP, Debiec-Rychter M, Lazar A, Gelderblom H, Sciot R, Lopez-Terrada D, Hohenberger P, van Oosterom AT, Schuetze SM; European Organisation for Research and Treatment of Cancer Soft Tissue/Bone Sarcoma Group; Southwest Oncology Group. Imatinib mesylate in advanced dermatofibrosarcoma protuberans: pooled analysis of two phase II clinical trials. J Clin Oncol. 2010 Apr 1;28(10):1772-9. doi: 10.1200/JCO.2009.25.7899. Epub 2010 Mar 1.

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

location_country:
United Kingdom
Netherlands
Belgium
France

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital


title: A Study to Assess the Incidence of Deep Vein Thrombosis (DVT) Following Prophylactic Intravenous Administration of Recombinant Human Antithrombin(rhAT) to Hereditary Antithrombin (AT) Deficient Patients in High Risk Situations.

acronym: rhAT

summary: Patients with hereditary antithrombin (AT) deficiency are at increased risk of venous thrombosis and pulmonary embolism, particularly during certain high risk procedures. The trial is focusing on patients with confirmed hereditary antithrombin deficiency who are undergoing a surgical procedure or induced/spontaneous labor and delivery. The study will test the safety and efficacy of recombinant human antithrombin (rhAT) by infusing rhAT prior to, during and following the period of risk or surgical procedure.

ReferenceCitation: DeJongh J, Frieling J, Lowry S, Drenth HJ. Pharmacokinetics of recombinant human antithrombin in delivery and surgery patients with hereditary antithrombin deficiency. Clin Appl Thromb Hemost. 2014 May;20(4):355-64. doi: 10.1177/1076029613516188. Epub 2013 Dec 11.

publisher_dissemination: SAGE Publications

lead_sponsor: rEVO Biologics

location_country:
Germany
Italy
France
United Kingdom
United States
Sweden


title: Open Label Phase II Study on XR5000 Administered as a 5 Day Infusion in Advanced Non Small Cell Lung Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of acridine carboxamide in treating patients who have advanced non-small cell lung cancer that cannot be treated with surgery.

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

location_country: Germany Italy Denmark Austria Spain France

location_facility: Haemato-Onkologische Praxis und Tagesklinik

location_facility: Istituti Fisioterapici Ospitalieri - Roma

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

location_facility: Centre de Lute Contre le Cancer,Georges-Francois Leclerc


title: A Randomized, Double-Blind, Placebo-Controlled Study of Intravenously Administered ALE.F02 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Renal Sparing in Antineutrophil Cytoplasmic Antibody-Associated Vasculitis With Rapidly Progressive Glomerulonephritis

summary:
The goal of this clinical trial is to learn if a new drug that might help protect and preserve kidney function in antineutrophil cytoplasmic antibody (ANCA) associated vasculitis (AAV). AAV is a type of autoimmune disease where the body's own immune system attacks itself, and in the case of AAV the body attacks its own small blood vessels. There are many small blood vessels in the kidneys meaning the kidneys are commonly affected in AAV.

The main questions it aims to answer are:

Is the new drug well tolerated and safe?
Can the new drug protect and preserve kidney functions when is added to standard therapy?

Researchers will compare the following groups to see how the new drug is tolerated and what effect to preserve kidney tissue has:

Group A: Standard treatment + ALE.F02 lower dose infusions
Group B: Standard treatment + ALE.F02 higher dose infusions
Group C: Standard treatment + placebo infusions (inactive substance)

The Treatment period will consist of 24 weeks beginning on Day 1, during which time participants will receive 13 infusions of the study medicine, along with standard therapy for kidney inflammation due to AAV. During the treatment period, participants will have the following assessments:

A brief physical examination focusing on their skin any pre-existing medical conditions that you have.
Collection of blood and urine samples for routine safety tests and to assess renal function.

Collection of blood samples:

To measure the amount of study medicine in their blood. This is called pharmacokinetics (PK) and it is tested to see how study medicine enters, moves through, and exits the body.
To test for antidrug antibodies (ADA). To check if their body create antibodies against the study medicine, as this could reduce its effect.
To measure biomarkers. Biomarkers are specific compounds in the body (can be protein, hormones, or genetic molecules) that indicate normal or abnormal processes taking place in your body and may be a sign of an underlying condition or disease (for example glucose levels are used as biomarker in managing diabetes). They are used to see how well the body responds to a treatment for a disease or condition.
Collection of urine to measure urine markers of vasculitis/inflammation called biomarkers.
Urine pregnancy test. A urine pregnancy test is a quick medical test that can tell if a woman is pregnant or not by checking for a hormone which is produced during pregnancy, usually in the urine.
Chest High Resolution Computed Tomography (HRCT) scan to check whether they have vasculitis affecting their lungs. A CT scan uses special x-ray equipment to take detailed pictures of body tissues and organs to diagnose and monitor conditions in various parts of the body. For the CT scan, they will need to lie still on a table. At Week 24 a second lung CT scan will be performed for participants whose initial scan showed lung vasculitis to see whether your lung vasculitis is getting better or ongoing/worse.

lead_sponsor: Alentis Therapeutics AG

location_country: Italy Denmark Sweden Spain Czechia France

location_facility: Institut klinicke a experimentalni mediciny


type: Registry Identifier

title: A Phase I Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection

summary: This is a first in human (FIH), multi-center, dose-finding, and dose-escalation Phase I clinical study of RO7565020 to investigate the safety and tolerability and to characterize the pharmacokinetics and pharmacodynamics following single and/or multiple doses of RO7565020 in healthy participants and/or virologically suppressed participants with chronic hepatitis B (CHB).

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical 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).

location_country:
New Zealand
Hong Kong
United States
Korea, Republic of
Spain
Taiwan
Bulgaria
France

location_facility: Acibadem City Clinic Tokuda Hospital Ead

location_facility: Chang Gung Medical Foundation Linkou Branch

location_facility: Hallym University Chuncheon Sacred Heart Hospital

location_facility: New Zealand Clinical Research - Auckland


title: Continuing Treatment for Participants Who Have Participated in a Prior Protocol Investigating CC-122

summary: The purpose of the study is to provide CC-122 treatment to participants who have been receiving treatment in other CC-122 clinical trials investigating CC-122 for more than 5 years (CC-122-ST-001 [NCT01421524], CC-122-ST-002 [NCT02509039], CC-122-DBCL-001 [NCT02031419], and CC-122-NHL-001 [NCT02417285]), receiving clinical benefit from the treatment and to monitor the safety and tolerability of CC-122.

ipd_sharing_description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

location_country:
United States
Japan
Netherlands
France

location_facility: Weill Medical College Of Cornell University

location_facility: Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest

location_facility: University of Wisconsin Carbone Cancer Center


title: A European Multi-centre Prospective Cohort Study in Patients Hospitalized for an Acute Exacerbation of COPD

summary: The CATALINA study is a prospective cohort study embedded within CICERO (Collaboration In COPD ExaceRbatiOns, a European Respiratory Society supported Clinical Research Collaboration), designed to collect standardised, longitudinal clinical data and biological samples in 20 centres across Europe.

lead_sponsor: Wim Janssens

sponsor_collaborators:
Wim Janssens
European Respiratory Society
AstraZeneca
Roche Pharma AG

location_country:
Germany
Italy
United Kingdom
Sweden
Netherlands
Belgium
Spain
France

location_facility: University Medical Centre of Gießen & Marburg


title: AnaTomic Stenosis Severity Derived From Computed Tomography as a Prognostic Marker in Patients With Low-flow Low-gradient Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation

acronym: ATLAS TAVI

summary: The ATLAS TAVI Registry is a retrospective, investigator-initiated, multicenter registry including patients, who underwent Transcatheter Aortic Valve Implantation (TAVI) for classical or paradoxical low-flow, low-gradient aortic stenosis (LFLG AS) with available non-contrast MSCT data on aortic valve calcification (AVC). The main objective of this study is the assessment of outcome after TAVI according to AVC density severity in patients with LFLG AS.

ReferenceCitation: Cueff C, Serfaty JM, Cimadevilla C, Laissy JP, Himbert D, Tubach F, Duval X, Iung B, Enriquez-Sarano M, Vahanian A, Messika-Zeitoun D. Measurement of aortic valve calcification using multislice computed tomography: correlation with haemodynamic severity of aortic stenosis and clinical implication for patients with low ejection fraction. Heart. 2011 May;97(9):721-6. doi: 10.1136/hrt.2010.198853. Epub 2010 Aug 18.

ReferenceCitation: Clavel MA, Messika-Zeitoun D, Pibarot P, Aggarwal SR, Malouf J, Araoz PA, Michelena HI, Cueff C, Larose E, Capoulade R, Vahanian A, Enriquez-Sarano M. The complex nature of discordant severe calcified aortic valve disease grading: new insights from combined Doppler echocardiographic and computed tomographic study. J Am Coll Cardiol. 2013 Dec 17;62(24):2329-38. doi: 10.1016/j.jacc.2013.08.1621. Epub 2013 Sep 24.

ReferenceCitation: Clavel MA, Pibarot P, Messika-Zeitoun D, Capoulade R, Malouf J, Aggarval S, Araoz PA, Michelena HI, Cueff C, Larose E, Miller JD, Vahanian A, Enriquez-Sarano M. Impact of aortic valve calcification, as measured by MDCT, on survival in patients with aortic stenosis: results of an international registry study. J Am Coll Cardiol. 2014 Sep 23;64(12):1202-13. doi: 10.1016/j.jacc.2014.05.066.

ReferenceCitation: Ludwig S, Gossling A, Waldschmidt L, Linder M, Bhadra OD, Voigtlander L, Schafer A, Deuschl F, Schirmer J, Reichenspurner H, Blankenberg S, Schafer U, Westermann D, Seiffert M, Conradi L, Schofer N. TAVR for low-flow, low-gradient aortic stenosis: Prognostic impact of aortic valve calcification. Am Heart J. 2020 Jul;225:138-148. doi: 10.1016/j.ahj.2020.03.013. Epub 2020 Apr 8.

ReferenceCitation: Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Rodriguez Munoz D, Rosenhek R, Sjogren J, Tornos Mas P, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL; ESC Scientific Document Group. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017 Sep 21;38(36):2739-2791. doi: 10.1093/eurheartj/ehx391. No abstract available.

lead_sponsor: Universitätsklinikum Hamburg-Eppendorf

collaborators: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

location_country:
Germany
France
United Kingdom
Denmark
Netherlands
Canada
Israel

location_facility: University Heart and Vascular Center Hamburg

location_facility: Institut universitaire de cardiologie et de pneumologie de Québec, Université Laval


title: Annuloplasty Rings and Band Post-Market Clinical Follow-Up (ARB-PMCF) Study

acronym: ARB-PMCF

summary: ARB-PMCF is a multicenter, observational study of the safety and performance of Abbott annuloplasty devices used in surgical repair of mitral and tricuspid valve regurgitation. The devices included in this study are the SJM™ Rigid Saddle Ring and SJM Séguin Annuloplasty Ring, indicated for mitral valve repair, and the SJM Tailor™ Annuloplasty Ring and SJM Tailor Annuloplasty Band, indicated for mitral or tricuspid repair. Participants will be enrolled prior to undergoing mitral or tricuspid valve repair surgery including an Abbott annuloplasty implant and will complete annual follow-up visits through five years from implant. The study is being conducted to meet post-market clinical follow-up requirements of the European Union Medical Device Directives.

lead_sponsor: Abbott Medical Devices

location_country:
Germany
Italy
Netherlands
United States
Spain
Estonia
France

location_facility: Herzchirurgische Abteilung Klinikum Passau

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Herzzentrum-Bremen Klinikum Links der Weser

location_facility: Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Hopital Cardiovasculaire et Pneumologique Louis Pradel


title: A Multicenter, Open-label, Non-randomized, Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia

summary:
Primary Objectives:

Part A: To evaluate the safety and tolerability of subcutaneous injections of isatuximab in adults with wAIHA
Part B: To evaluate the efficacy of the selected dose in adults with wAIHA

Secondary Objectives:

Part A (Cohorts 2 and 3 only)
To evaluate the efficacy of isatuximab in adults with wAIHA
To evaluate the durability of response to isatuximab and time to response
To evaluate the impact of isatuximab treatment on fatigue

Part B

To evaluate the safety and tolerability of isatuximab in adults with wAIHA
To evaluate the durability of response to isatuximab and time to response
To evaluate the impact of isatuximab treatment on fatigue

Parts A (all Cohorts) and B

To evaluate the effect of isatuximab on markers of hemolysis
To characterize the pharmacokinetic profile of isatuximab in adults with wAIHA
To evaluate the immunogenicity of isatuximab

lead_sponsor: Sanofi

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

location_facility: University of Southern California-Site Number:8400001

location_facility: Investigational Site Number :3480001 Egyetem ÁOK, Belgyógyászati és Onkológiai Klinika, Klinikai Farmakológiai Részleg

location_facility: Investigational Site Number :3800001 Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Via F. Sforza 35

location_facility: Investigational Site Number :2760001 Universitätsklinikum Essen Klinik für Hämatologie und Stammzellentransplantation

location_facility: Fox Chase Cancer Center-Site Number:8400004


lead_sponsor: Institut de Recherches Internationales Servier

summary: The purpose of this study is to assess the safety, tolerability and clinical activity of the combination S64315 with azacitidine in patients with acute myeloid leukaemia.

location_facility: University of Texas MD Anderson Cancer Center Department of Leukemia, Division of Cancer Medicine

location_facility: H. Universitario Valle de Hebrón Servicio de Hematología

location_facility: H. Universitario La Fe Servicio de Hematologia

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

title: Phase I/II, International, Multicentre, Open-label, Non-randomised, Non-comparative, Study Evaluating the Safety, Tolerability and Clinical Activity of Intravenously Administered S64315, a Selective Mcl-1 Inhibitor, in Combination With Azacitidine in Patients With Acute Myeloid Leukaemia (AML)

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

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH).

The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

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

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

location_country:
United States
Spain
Australia
France


title: An Open-label, Randomized Study to Assess the Relative Bioavailability (BA) and Bioequivalence (BE) of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer

summary: The purpose of this study is to determine the relative bioavailability (rBA; Period 1) and bioequivalence (BE; Period 2 and 3) of various strengths and formulations of niraparib and abiraterone acetate (AA) at steady state under modified fasted conditions in participants with metastatic castration-resistant prostate cancer (mCRPC).

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

lead_sponsor: Janssen Research & Development, LLC

location_country:
Poland
United Kingdom
Sweden
Netherlands
Belgium
United States
Spain
Ukraine
Moldova, Republic of
Georgia
France

location_facility: Institut Bergonié, Centre de Lutte Contre le Cancer

location_facility: Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

location_facility: Sir Bobby Robson Unit, Northern Centre for Cancer Care


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

acronym: OligoRARE

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

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

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

collaborators:
Anticancer Fund, Belgium
Rising Tide Foundation

location_country:
Italy
United Kingdom
Switzerland
Belgium
France

location_facility: Gasthuiszusters Antwerpen - Sint-Augustinus

location_facility: University Hospitals Birmingham NHS Foundation Trust (UHB) - UHB-Queen Elisabeth Medical Centre

location_facility: Royal Marsden Hospital - site: Chelsea, London

intervention_type: Radiation


title: Prospective, Open Label, Single Arm, First in Human (FIH) Clinical Study to Assess Safety and Efficacy of the CorNeat Keratoprosthesis for the Treatment of Corneal Blindness

summary: Prospective, open label, single arm, First in Human (FIH) clinical study to assess safety and efficacy of the CorNeat Keratoprosthesis, a synthetic cornea, for the treatment of corneal blindness

lead_sponsor: CorNeat Vision Ltd.

location_country:
France
Netherlands
United States
Canada
Israel

location_facility:
Maastricht UMC+
University of British Columbia
Rabin Medical Center - Beilinson
Cincinnati Eye Institute
CHU de Montpellier
UHN - University Health Network
Hopital Fondation Adolphe de Rothschild
Amsterdam UMC - Location AMC


title: A Phase 1b, Randomized, Double-blinded, Placebo-controlled Study of Hydroxychloroquine in Outpatient Adults With COVID-19

summary:
Primary Objective:

To assess the effect of hydroxychloroquine versus placebo on nasopharyngeal SARS-CoV-2 viral load in outpatient adults with COVID-19

Secondary Objectives:

To assess the effect of hydroxychloroquine versus placebo on clinical signs and symptoms and progression of disease in outpatient adults with COVID-19
To assess the safety and tolerability of hydroxychloroquine in outpatient adults with COVID-19

location_country:
United States
Netherlands
Belgium
France

location_facility:
Investigational Site Number 2501001
Investigational Site Number 0561002
Investigational Site Number 5281001
Investigational Site Number 8400001
Investigational Site Number 0561001
Investigational Site Number 5281002
Investigational Site Number 2501002


title: A Phase 1, First-in-Human, Multicenter, Open-label, Dose-escalation Study of IPH5201 as Monotherapy or in Combination With Durvalumab ± Oleclumab in Advanced Solid Tumors

summary: The purpose of this study is to assess the safety and tolerability and to determine the dose of IPH5201 that can be used as monotherapy or in combination with durvalumab +/- oleclumab in subjects with advanced solid tumors.

lead_sponsor: MedImmune LLC

location_country:
United States
Spain
Switzerland
France


title: SYMBIOSIS Post-Market Registry

acronym: SYMBIOSIS

summary: The purpose of this observational, multi-center prospective, post-market registry is to confirm real-world device safety and performance, to ensure the continued acceptability of identified risks, and detect emerging risks.

lead_sponsor: Medtronic Cardiac Surgery

location_country: Germany Norway Netherlands Austria Belgium Spain Greece France

location_facility: Maastricht University Medical Center (MUMC+)