acronym: RAINBOW

summary: The purpose of this study was to determine if intravitreal ranibizumab is superior to laser ablation therapy in the treatment of retinopathy of prematurity (ROP).

ReferenceCitation: Fleck BW, Reynolds JD, Zhu Q, Lepore D, Marlow N, Stahl A, Li J, Weisberger A, Fielder AR; RAINBOW Investigator Group. Time Course of Retinopathy of Prematurity Regression and Reactivation After Treatment with Ranibizumab or Laser in the RAINBOW Trial. Ophthalmol Retina. 2022 Jul;6(7):628-637. doi: 10.1016/j.oret.2022.02.006. Epub 2022 Feb 22.

ReferenceCitation: Stahl A, Lepore D, Fielder A, Fleck B, Reynolds JD, Chiang MF, Li J, Liew M, Maier R, Zhu Q, Marlow N. Ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity (RAINBOW): an open-label randomised controlled trial. Lancet. 2019 Oct 26;394(10208):1551-1559. doi: 10.1016/S0140-6736(19)31344-3. Epub 2019 Sep 12.

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories_concat: UCL Discovery

title: RAINBOW Study: a Randomized, Controlled Study Evaluating the Efficacy and Safety of RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity

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

location_country:
Germany
Poland
Japan
Turkey
Croatia
Czechia
France
Lithuania
Slovakia
Hungary
Denmark
United States
India
Romania
Belgium
Malaysia
Estonia
Egypt
Italy
United Kingdom
Austria
Mexico
Saudi Arabia
Greece
Taiwan
Russian Federation


type: EudraCT Number

title: A Double-blind, Randomized, Placebo-controlled Phase 3 Study of Orally Administered PLX3397 in Subjects With Pigmented Villonodular Synovitis or Giant Cell Tumor of the Tendon Sheath

acronym: ENLIVEN

summary:
This is a Phase 3 clinical study, which aims to evaluate the effectiveness of an investigational drug called pexidartinib for the treatment of certain tumors for which surgical removal could cause more harm than good.

The main purpose of this study is to gather information about the investigational drug pexidartinib, which may help to treat tumors of pigmented villonodular synovitis (PVNS) or giant cell tumor of the tendon sheath (GCT-TS).

The study consists of two parts with a follow-up period. In Part 1, eligible study participants will be assigned to receive either pexidartinib or matching placebo for 24 weeks. A number of assessments will be carried out during the course of the study, including physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires. MRI scans will be used to evaluate the response of the tumors to the treatment. Some subjects, assigned to placebo in Part 1 transitioned to pexidartinib for Part 2.

Then a protocol amendment was written to allow only pexidartinib patients to continue into Part 2. Part 2 is a long-term treatment phase in which all participants receive open-label pexidartinib. There was also a follow-up period added to Part 2.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Healey JH, Tap WD, Gelhorn HL, Ye X, Speck RM, Palmerini E, Stacchiotti S, Desai J, Wagner AJ, Alcindor T, Ganjoo K, Martin-Broto J, Wang Q, Shuster D, Gelderblom H, van de Sande M. Pexidartinib Provides Modest Pain Relief in Patients With Tenosynovial Giant Cell Tumor: Results From ENLIVEN. Clin Orthop Relat Res. 2023 Jan 1;481(1):107-116. doi: 10.1097/CORR.0000000000002335. Epub 2022 Aug 24.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

license: cc-by

license_normalized: cc-by

repository_institution: Leiden University - Leiden Repository

unpaywall_oa_status: hybrid

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Lewis JH, Gelderblom H, van de Sande M, Stacchiotti S, Healey JH, Tap WD, Wagner AJ, Pousa AL, Druta M, Lin CC, Baba HA, Choi Y, Wang Q, Shuster DE, Bauer S. Pexidartinib Long-Term Hepatic Safety Profile in Patients with Tenosynovial Giant Cell Tumors. Oncologist. 2021 May;26(5):e863-e873. doi: 10.1002/onco.13629. Epub 2020 Dec 24.

evidence: open (via crossref license)

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

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

publisher_dissemination: Oxford University Press

ReferenceCitation: Tap W. ENLIVEN study: Pexidartinib for tenosynovial giant cell tumor (TGCT). Future Oncol. 2020 Sep;16(25):1875-1878. doi: 10.2217/fon-2020-0307. Epub 2020 Aug 5.

oa_host_type: publisher

repositories_concat: closed

publisher_dissemination: Future Science Ltd

ReferenceCitation: Tap WD, Gelderblom H, Palmerini E, Desai J, Bauer S, Blay JY, Alcindor T, Ganjoo K, Martin-Broto J, Ryan CW, Thomas DM, Peterfy C, Healey JH, van de Sande M, Gelhorn HL, Shuster DE, Wang Q, Yver A, Hsu HH, Lin PS, Tong-Starksen S, Stacchiotti S, Wagner AJ; ENLIVEN investigators. Pexidartinib versus placebo for advanced tenosynovial giant cell tumour (ENLIVEN): a randomised phase 3 trial. Lancet. 2019 Aug 10;394(10197):478-487. doi: 10.1016/S0140-6736(19)30764-0. Epub 2019 Jun 19.

oa_host_type: repository

version: acceptedVersion

repositories_concat: PubMed Central;www.repositoriosalud.es

unpaywall_oa_status: green

publisher_dissemination: Elsevier

ReferenceCitation: Gelhorn HL, Tong S, McQuarrie K, Vernon C, Hanlon J, Maclaine G, Lenderking W, Ye X, Speck RM, Lackman RD, Bukata SV, Healey JH, Keedy VL, Anthony SP, Wagner AJ, Von Hoff DD, Singh AS, Becerra CR, Hsu HH, Lin PS, Tap WD. Patient-reported Symptoms of Tenosynovial Giant Cell Tumors. Clin Ther. 2016 Apr;38(4):778-93. doi: 10.1016/j.clinthera.2016.03.008. Epub 2016 Apr 1.

repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central

ipd_sharing: Yes

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

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Denmark
Australia
Netherlands
United States
Spain
Canada
France

location_facility: Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie

location_facility: Istituto Nazionale Tumori-Fondazione IRCCS

location_facility: Washington University School of Medicine

intervention_type: Drug


title: A Six-Week, Double-Blind, Placebo-Controlled, Randomized- Withdrawal, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Obstructive Sleep Apnea (OSA)

acronym: OSA

summary: This trial is a 6-week, double-blind, placebo-controlled, randomized-withdrawal, multicenter study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.

ReferenceCitation: Strollo PJ Jr, Hedner J, Collop N, Lorch DG Jr, Chen D, Carter LP, Lu Y, Lee L, Black J, Pepin JL, Redline S; Tones 4 Study Investigators. Solriamfetol for the Treatment of Excessive Sleepiness in OSA: A Placebo-Controlled Randomized Withdrawal Study. Chest. 2019 Feb;155(2):364-374. doi: 10.1016/j.chest.2018.11.005. Epub 2018 Nov 22.

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

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Grenoble Ecole de Management

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

repositories_concat: HAL

lead_sponsor: Jazz Pharmaceuticals

location_country:
Germany
Finland
France
United States
Sweden

location_facility: The Research Center of Southern California

location_facility: Center for Sleep & Circadian Neurobiology

location_facility: Critical Care Pulmonary & Sleep Associates, LLC

lead_sponsor_type: industriel

status_simplified: Completed


acronym: CIMPACT

intervention_type: Other

lead_sponsor: UCB Biopharma S.P.R.L.

summary: The purpose of this study is to investigate the efficacy and safety of two dose levels of certolizumab pegol compared to active comparator and placebo in adults with moderate to severe chronic plaque psoriasis.

ReferenceType: result

ReferenceCitation: Lebwohl M, Blauvelt A, Paul C, Sofen H, Weglowska J, Piguet V, Burge D, Rolleri R, Drew J, Peterson L, Augustin M. Certolizumab pegol for the treatment of chronic plaque psoriasis: Results through 48 weeks of a phase 3, multicenter, randomized, double-blind, etanercept- and placebo-controlled study (CIMPACT). J Am Acad Dermatol. 2018 Aug;79(2):266-276.e5. doi: 10.1016/j.jaad.2018.04.013. Epub 2018 Apr 14.

ReferenceCitation: Warren RB, Lebwohl M, Sofen H, Piguet V, Augustin M, Brock F, C Arendt, Fierens F, Blauvelt A. Three-year efficacy and safety of certolizumab pegol for the treatment of plaque psoriasis: results from the randomized phase 3 CIMPACT trial. J Eur Acad Dermatol Venereol. 2021 Dec;35(12):2398-2408. doi: 10.1111/jdv.17486. Epub 2021 Aug 17.

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

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: California Digital Library - eScholarship

repositories_concat: PubMed Central;escholarship.org

publisher_dissemination: Wiley

ReferenceCitation: Blauvelt A, Paul C, van de Kerkhof P, Warren RB, Gottlieb AB, Langley RG, Brock F, Arendt C, Boehnlein M, Lebwohl M, Reich K. Long-term safety of certolizumab pegol in plaque psoriasis: pooled analysis over 3 years from three phase III, randomized, placebo-controlled studies. Br J Dermatol. 2021 Apr;184(4):640-651. doi: 10.1111/bjd.19314. Epub 2020 Sep 6.

repository_institution: Radboud University - Radboud Repository

repositories_concat: PubMed Central;repository.ubn.ru.nl

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

title: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled Study Followed by a Placebo-Controlled Maintenance Period and Open-Label Follow-Up to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects With Moderate to Severe Chronic Plaque Psoriasis

source: euctr

location_country:
Germany
Poland
Hungary
United Kingdom
Netherlands
United States
Czechia
Bulgaria
France


type: Other Identifier

title: BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction

acronym: BIO-GUARD-MI

summary: The BIO|GUARD-MI study investigates whether continuous arrhythmia monitoring and the consequent treatment after detected arrhythmias in patients after myocardial infarction with preserved cardiac function, but other risk factors, decreases the risk of major adverse cardiac events.

primary_purpose: Diagnostic

ReferenceCitation: Jons C, Sogaard P, Behrens S, Schrader J, Mrosk S, Bloch Thomsen PE. The clinical effect of arrhythmia monitoring after myocardial infarction (BIO-GUARD|MI):study protocol for a randomized controlled trial. Trials. 2019 Sep 11;20(1):563. doi: 10.1186/s13063-019-3644-5.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: Aalborg Universitet - VBN Forskningsportal

repository_normalized: Pure (Denmark)

repositories:
PubMed Central
Pure (Denmark)

repositories_concat: PubMed Central;Pure (Denmark)

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: Biotronik SE & Co. KG

collaborators: IHF GmbH - Institut für Herzinfarktforschung

location_country:
Germany
Poland
Slovakia
Hungary
Denmark
Australia
Netherlands
Austria
Belgium
United States
Latvia
Spain
Czechia
France

location_facility: Hôpital Gabriel Montpied, Clermont Ferrand

location_facility: Institute for Clinical and Experimental Medicine (IKEM)

location_facility: Universitätsklinikum Schleswig-Holstein (UKSH) - Campus Lübeck

location_facility: East-Slovak Cardiology Institute (VUSCH)

location_facility: Onze Lieve Vrouwe Gasthuis Amsterdam (OLVG)

location_facility: Charité Universitätsklinikum - Campus Benjamin Franklin

location_facility: Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

location_facility: Sjaellands Universitets Hospital, Roskilde

location_facility: Hungarian Defence Forces Military Hospital

location_facility: East Metropolitan Health Service Trading AS Royal Perth HOSPITAL

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Herz- und Gefäß- Klinik GmbH Bad Neustadt

location_facility: Klinika i Katedra Chorób Wewn. i Kardiologii

intervention_type: Device


title: A PHASE 1, OPEN-LABEL, DOSE ESCALATION STUDY OF PF-04518600 AS A SINGLE AGENT AND IN COMBINATION WITH PF-05082566 IN PATIENTS WITH SELECTED LOCALLY ADVANCED OR METASTATIC CANCERS

summary: To assess the safety and tolerability at increasing dose levels of PF-04518600 alone or in combination wtih PF-05082566 in patients with select advanced or metastatic carcinoma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

design_allocation: Non-Randomized

ReferenceCitation: Hamid O, Chiappori AA, Thompson JA, Doi T, Hu-Lieskovan S, Eskens FALM, Ros W, Diab A, Spano JP, Rizvi NA, Wasser JS, Angevin E, Ott PA, Forgie A, Yang W, Guo C, Chou J, El-Khoueiry AB. First-in-human study of an OX40 (ivuxolimab) and 4-1BB (utomilumab) agonistic antibody combination in patients with advanced solid tumors. J Immunother Cancer. 2022 Oct;10(10):e005471. doi: 10.1136/jitc-2022-005471.

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

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repositories:
HAL
PubMed Central
pure.eur.nl

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

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

publisher_dissemination: British Medical Journal

ReferenceCitation: Diab A, Hamid O, Thompson JA, Ros W, Eskens FALM, Doi T, Hu-Lieskovan S, Klempner SJ, Ganguly B, Fleener C, Wang X, Joh T, Liao K, Salek-Ardakani S, Taylor CT, Chou J, El-Khoueiry AB. A Phase I, Open-Label, Dose-Escalation Study of the OX40 Agonist Ivuxolimab in Patients with Locally Advanced or Metastatic Cancers. Clin Cancer Res. 2022 Jan 1;28(1):71-83. doi: 10.1158/1078-0432.CCR-21-0845. Epub 2021 Oct 6.

evidence: oa repository (via page says license)

version: submittedVersion

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

publisher_dissemination: American Association for Cancer Research

ipd_sharing: No

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

lead_sponsor: Pfizer

location_country:
United States
Japan
Netherlands
France

location_facility: Santa Monica UCLA Hematology & Oncology Clinic

location_facility: Columbia University Medical Center - Herbert Irving Pavilion

location_facility: The Angeles Clinic And Research Institute, A Cedars-Sinai Affiliate

location_facility: UConn Health, Neag Comprehensive Cancer Center

location_facility: Mass General/North Shore Center for Outpatient Care

location_facility: Beth Israel Deaconess Medical Center (BIDMC)

location_facility: Massachusetts General/Chelsea HealthCare Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Slotervaart Hospital/Antoni van Leeuwenhoek

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Medical Imaging Center of Southern California, Inc.


title: Long-term Follow-up at 10 Years of Patients Enrolled in the Fingolimod Phase II Program in Relapsing Multiple Sclerosis (MS)

acronym: ACROSS

summary: This study collected follow-up data on approximately 90% of participants who were randomized and received one dose of study drug in FTY720D2201 (D2201). No study drug was given or required. Participants were required to be assessed at one or two visits, preferably at the original study site, but the option to be interviewed via phone or seen at home was provided. Information was gathered also on deceased participants. Assessments were performed only once within an 8 week period and included medical history, Multiple Sclerosis (MS) and Multiple Sclerosis Disease Modifying Therapy (MS DMT) history, Expanded Disability Status Scale (EDSS), Magnetic Resonance Imaging (MRI), and Multiple Sclerosis Functional Composite (MSFC).

primary_purpose: Other

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Italy
Poland
Portugal
United Kingdom
Denmark
Switzerland
Spain
Canada
France


title: Attain Performa™ Left Ventricular Quadripolar Lead Post-Approval Study

summary: Lead survivability will be summarized.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Medtronic

location_country:
Germany
United Kingdom
Netherlands
Switzerland
Belgium
United States
Canada
France

location_facility:
St Luke's University Health Network
Hattiesburg Clinic


acronym: FUTURE 4

summary: The purpose of this study was to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with active PsA despite current or previous NSAID or DMARD therapy

ReferenceCitation: Pournara E, Kormaksson M, Nash P, Ritchlin CT, Kirkham BW, Ligozio G, Pricop L, Ogdie A, Coates LC, Schett G, McInnes IB. Clinically relevant patient clusters identified by machine learning from the clinical development programme of secukinumab in psoriatic arthritis. RMD Open. 2021 Nov;7(3):e001845. doi: 10.1136/rmdopen-2021-001845.

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

repository_institution: The University of Glasgow - Enlighten: Publications

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

ReferenceCitation: Kivitz AJ, Nash P, Tahir H, Everding A, Mann H, Kaszuba A, Pellet P, Widmer A, Pricop L, Abrams K. Efficacy and Safety of Subcutaneous Secukinumab 150 mg with or Without Loading Regimen in Psoriatic Arthritis: Results from the FUTURE 4 Study. Rheumatol Ther. 2019 Sep;6(3):393-407. doi: 10.1007/s40744-019-0163-5. Epub 2019 Jun 21.

title: A Phase III, Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab (150 mg) in Pre-filled Syringe, With or Without Loading Regimen, to Demonstrate Efficacy, Safety and Tolerability up to 2 Years in Patients With Active Psoriatic Arthritis (FUTURE 4)

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

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

location_country:
Germany
Italy
Poland
Bulgaria
United Kingdom
Australia
Sweden
Belgium
United States
Czechia
Canada
Russian Federation
France

ipd_sharing: Undecided


title: PV-10 Intralesional Injection vs Systemic Chemotherapy or Oncolytic Viral Therapy for Treatment of Locally Advanced Cutaneous Melanoma

summary: This is an international multicenter, open-label, randomized controlled trial (RCT) of single-agent intralesional PV-10 versus systemic chemotherapy or intralesional oncolytic viral therapy to assess treatment of locally advanced cutaneous melanoma in patients who (1) are not candidates for targeted therapy and (2) are not candidates for an immune checkpoint inhibitor. Subjects in the comparator arm will receive the Investigator's choice of dacarbazine (DTIC), temozolomide (TMZ) or intralesional talimogene laherparepvec as determined by Investigator preference and standard of care in the Investigator's country or region. Effectiveness will be assessed by comparison of progression-free survival (PFS) between all intent-to-treat (ITT) subjects in the two study treatment arms.

status: Terminated

lead_sponsor: Provectus Biopharmaceuticals, Inc.

location_country:
Germany
Italy
Mexico
United States
France

location_facility: IRCCS Instituto Nazionale Tumori "Fondazione Giovanni Pascale"

location_facility: Istituto Dermopatico dell'Immacolata (IDI IRCCS)

location_facility: Unité Cancéro-Dermatologie, Hôtel-Dieu CHU Nantes

location_facility: Azienda Sanitaria Azienda Ospedaliera Universitaria Senese

location_facility: Washington University School of Medicine - Dermatology

location_facility: Hautklinik Klinikum der Johannes Gutenberg Universität Hautkrebszentrum

location_facility: Klinik für Dermatologie, Venerologie und Allergologie Charite Universitätsmedizin Berlin

location_facility: Moffitt Cancer Center and Research Institute

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

location_facility: Centro de Estudios y Prevención del Cancer A.C.

location_facility: Sharp Memorial Hospital - Clinical Oncology Research

location_facility: Klinik für Dermatologie Universitätsklinikum Essen Studienzentrum

location_facility: Oklahoma Cancer Specialists and Research Institute

location_facility: St Luke's University Hospital and Health Network

status_simplified: Unknown


title: A Phase Ib/II Multi-center, Open Label, Dose Escalation Study of WNT974, LGX818 and Cetuximab in Patients With BRAFV600-mutant KRAS Wild-type Metastatic Colorectal Cancer Harboring Wnt Pathway Mutations

summary:
The purpose of this study is to assess the safety and anti-tumor activity of the triple combination of WNT974, LGX818 and cetuximab in BRAFV600-mutant mCRC with RNF43 mutations or RSPO fusions.

The design of this study is based upon the translational and pre-clinical data that suggest that Wnt pathway signals, increased due to RNF43 mutations or RSPO fusions, cooperate with the EGFR and BRAF signals to maintain the growth of BRAFV600 CRCs. Inhibition of these signals with the triple combination of WNT974, LGX818 and cetuximab may result in anti-tumor activity.

lead_sponsor: Array BioPharma

location_country:
Italy
Israel
Singapore
Australia
Netherlands
Belgium
United States
Spain
Canada
France

location_facility: Medical University of South Carolina Oncology Dept

location_facility: University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc

location_facility: Memorial Sloan-Kettering Cancer Center (MSKCC) MSKCC (3)

location_facility: University of Texas/MD Anderson Cancer Center Onc. Dept,


title: A Phase 1/2, Multicenter, Open-Label, Dose-Escalation Study of AG-221 in Subjects With Advanced Solid Tumors, Including Glioma, and With Angioimmunoblastic T-cell Lymphoma, That Harbor an IDH2 Mutation

summary: The purpose of this study is to evaluate the safety, pharmacokinetics, and clinical activity of enasidenib in adults with advanced solid tumors, including glioma, or with angioimmunoblastic T-cell lymphoma (AITL), with an isocitrate dehydrogenase-2 (IDH2) mutation.

lead_sponsor: Celgene

sponsor_collaborators:
Celgene
Celgene Corporation

location_country:
United States
France


title: ImThera Medical Targeted Hypoglossal Neurostimulation Study #3

summary: The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve stimulation with the ImThera Medical aura6000 System as a potential therapeutic option for individuals with moderate to severe OSA that have failed or do not tolerate PAP.

status: Unknown status

study_completion_date_type: Anticipated

lead_sponsor: ImThera Medical, Inc.

sponsor_collaborators:
ImThera Medical, Inc.
LivaNova

location_country:
Germany
France
Portugal
Belgium
United States
Israel

location_facility: Ear, Nose, and Throat Associates of South Florida


lead_sponsor: Bayer

summary: The objective of this study was to assess efficacy and safety of radium-223 dichloride in subjects with human epidermal growth factor receptor 2 negative (HER2 negative) hormone receptor positive breast cancer with bone metastases treated with hormonal treatment background therapy

title: A Phase II Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride Versus Placebo When Administered to Metastatic HER2 Negative Hormone Receptor Positive Breast Cancer Subjects With Bone Metastases Treated With Hormonal Treatment Background Therapy

location_country:
Finland
Germany
Ireland
Poland
Czechia
Canada
France
Hong Kong
Denmark
Switzerland
United States
Norway
Singapore
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Israel


title: A Multicenter, Randomized, Double Blind, Placebo Controlled, Multiple Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO6885247 Following 12 Weeks of Treatment in Adult and Pediatric Patients With Spinal Muscular Atrophy (MOONFISH).

summary: This multicenter, randomized, double-blind, 12-week, placebo-controlled multiple dose study will investigate the safety and tolerability of RO6885247 in adult and pediatric patients with spinal muscular atrophy (SMA).

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
United Kingdom
Sweden
Netherlands
Switzerland
United States
Turkey
Canada
France

location_facility: Ch Pitie Salpetriere; Institut de Myologie

location_facility: Fondazione IRCCS Istituto Neurologico "Carlo Besta"; UO di Neurologia dello Sviluppo

location_facility: UCL; GAP Unit, Institute of Child Health, UCL

location_facility: Policlinico Agostino Gemelli; Dipartimento di Neuropsichiatria Infantile

location_facility: UMC Utrecht; Polkliniek Neuromusculaire ziekten

location_facility: Drottning Silvias Barn- och ungdomssjukhus; Kliniken för barnmedicin

location_facility: Universitäts-Kinderspitalbeider Basel_Abteilung für Neuro- und Entwicklungspädiatrie

location_facility: Hacettepe University, School of Medicine; Pediatrics Department; Pediatrics Child Neurology Unit

location_facility: MRC Neuromuscular Centre - Institute of Genetic Medicine


acronym: PUPs B-LONG

intervention_type: Biological

lead_sponsor: Bioverativ, a Sanofi company

summary: The primary objective of the study was to evaluate the safety of recombinant coagulation factor IX Fc fusion protein (rFIXFc, BIIB029) in previously untreated patients (PUPs) with severe hemophilia B. Secondary objectives were to evaluate the efficacy of rFIXFc in the prevention and treatment of bleeding episodes in PUPs, and to evaluate rFIXFc consumption for prevention and treatment of bleeding episodes in PUPs.

ReferenceCitation: Nolan B, Klukowska A, Shapiro A, Rauch A, Recht M, Ragni M, Curtin J, Gunawardena S, Mukhopadhyay S, Jayawardene D, Winding B, Fischer K, Liesner R. Final results of the PUPs B-LONG study: evaluating safety and efficacy of rFIXFc in previously untreated patients with hemophilia B. Blood Adv. 2021 Jul 13;5(13):2732-2739. doi: 10.1182/bloodadvances.2020004085.

evidence: open (via free article)

publisher_dissemination: American Society of Hematology

sponsor_collaborators:
Bioverativ, a Sanofi company
Swedish Orphan Biovitrum

location_facility:
Hopital Cardiologique - CHU Lille
Research Site

title: An Open-Label, Multicenter Evaluation of the Safety and Efficacy of Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc; BIIB029) in the Prevention and Treatment of Bleeding in Previously Untreated Patients With Severe Hemophilia B

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:
Ireland
Italy
Poland
New Zealand
United Kingdom
Denmark
Australia
Sweden
Netherlands
United States
France


summary: The purpose of this study was to collect safety and tolerability data on LCZ696 in eligible PARADIGM-HF patients who received open-label investigational drug. The parent PARADIGM-HF (NCT01035255) trial was terminated early due to compelling efficacy of LCZ696 in patients with heart failure with reduced ejection fraction (HFrEF) after the final pre-specified interim analysis in March 2014.

title: A Multicenter Study to Evaluate Safety and Tolerability in Patients With Chronic Heart Failure and Reduced Ejection Fraction From PARADIGM-HF Receiving Open Label LCZ696

location_country:
Finland
Germany
Poland
Argentina
Brazil
Thailand
Turkey
Chile
Czechia
Canada
France
Lithuania
Portugal
Slovakia
Hungary
Hong Kong
Denmark
United States
Latvia
India
Romania
Belgium
Malaysia
Peru
Estonia
Philippines
Italy
Guatemala
United Kingdom
Singapore
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
Panama
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


title: REPRISE III: Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Randomized Clinical Evaluation

acronym: REPRISE III

summary: The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve System and LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at extreme or high risk for surgical valve replacement.

ReferenceCitation: Rizik DG, Rajagopal V, Makkar RR, Bajwa T, Kleiman NS, Linke A, Kereiakes DJ, Waksman R, Thourani VH, Stoler RC, Mishkel GJ, Iyer VS, Buchbinder M, Gotberg M, Bjursten H, Allocco DJ, Reardon MJ. Long-term Outcomes of Transcatheter Aortic Valve Replacement With the Lotus Valve vs CoreValve/EvolutR: A Secondary Analysis of the REPRISE III Randomized Clinical Trial. JAMA Netw Open. 2022 Oct 3;5(10):e2238792. doi: 10.1001/jamanetworkopen.2022.38792.

publisher_dissemination: American Medical Association

ReferenceCitation: Goel K, O'Leary JM, Barker CM, Levack M, Rajagopal V, Makkar RR, Bajwa T, Kleiman N, Linke A, Kereiakes DJ, Waksman R, Allocco DJ, Rizik DG, Reardon MJ, Lindman BR. Clinical Implications of Physical Function and Resilience in Patients Undergoing Transcatheter Aortic Valve Replacement. J Am Heart Assoc. 2020 Sep;9(17):e017075. doi: 10.1161/JAHA.120.017075. Epub 2020 Aug 28.

ReferenceCitation: Meduri CU, Kereiakes DJ, Rajagopal V, Makkar RR, O'Hair D, Linke A, Waksman R, Babliaros V, Stoler RC, Mishkel GJ, Rizik DG, Iyer VS, Schindler J, Allocco DJ, Meredith IT, Feldman TE, Reardon MJ. Pacemaker Implantation and Dependency After Transcatheter Aortic Valve Replacement in the REPRISE III Trial. J Am Heart Assoc. 2019 Nov 5;8(21):e012594. doi: 10.1161/JAHA.119.012594. Epub 2019 Oct 23.

ReferenceCitation: Reardon MJ, Feldman TE, Meduri CU, Makkar RR, O'Hair D, Linke A, Kereiakes DJ, Waksman R, Babliaros V, Stoler RC, Mishkel GJ, Rizik DG, Iyer VS, Gleason TG, Tchetche D, Rovin JD, Lhermusier T, Carrie D, Hodson RW, Allocco DJ, Meredith IT; Reprise III Investigators. Two-Year Outcomes After Transcatheter Aortic Valve Replacement With Mechanical vs Self-expanding Valves: The REPRISE III Randomized Clinical Trial. JAMA Cardiol. 2019 Mar 1;4(3):223-229. doi: 10.1001/jamacardio.2019.0091.

oa_colors: green other

evidence: open (via free pdf)

unpaywall_oa_status: bronze

ReferenceCitation: Asch FM, Vannan MA, Singh S, Khandheria B, Little SH, Allocco DJ, Meredith IT, Feldman TE, Reardon MJ, Weissman NJ. Hemodynamic and Echocardiographic Comparison of the Lotus and CoreValve Transcatheter Aortic Valves in Patients With High and Extreme Surgical Risk: An Analysis From the REPRISE III Randomized Controlled Trial. Circulation. 2018 Jun 12;137(24):2557-2567. doi: 10.1161/CIRCULATIONAHA.118.034129. Epub 2018 Mar 12.

ReferenceCitation: Feldman TE, Reardon MJ, Rajagopal V, Makkar RR, Bajwa TK, Kleiman NS, Linke A, Kereiakes DJ, Waksman R, Thourani VH, Stoler RC, Mishkel GJ, Rizik DG, Iyer VS, Gleason TG, Tchetche D, Rovin JD, Buchbinder M, Meredith IT, Gotberg M, Bjursten H, Meduri C, Salinger MH, Allocco DJ, Dawkins KD. Effect of Mechanically Expanded vs Self-Expanding Transcatheter Aortic Valve Replacement on Mortality and Major Adverse Clinical Events in High-Risk Patients With Aortic Stenosis: The REPRISE III Randomized Clinical Trial. JAMA. 2018 Jan 2;319(1):27-37. doi: 10.1001/jama.2017.19132.

location_country:
Germany
Australia
Netherlands
United States
Canada
France

location_facility: St. John's Hospital - Prairie Cardiovascular Consultants

location_facility: McGill University Health Centre, Royal Victoria Hospital

location_facility: Methodist DeBakey Heart & Vascular Center

location_facility: Veteran's Administration Palo Alto Medical Center

location_facility: Abbott Northwestern Hospital - Minneapolis Heart Institute

location_facility: Erasmus MC - University Medical Center Rotterdam

location_facility: Lindner Center for Research and Education at The Christ Hospital

location_facility: NC Heart and Vascular Research - Rex Hospital

location_facility: Hospital of the University of Pennsylvania

location_facility: Ohio Health Research and Innovation Institute - Riverside Methodist Hospital

location_facility: Cardiac & Vascular Rearch Center of Northern Michigan - Northern Michigan Hospital

location_facility: University of California at Davis Medical Center

location_facility: Washington University School of Medicine - Barnes Jewish Medical Center

location_facility: Wake Forest University School of Medicine


lead_sponsor: Alios Biopharma Inc.

summary: This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect of single and multiple doses of ALS-008176 in infants hospitalized with respiratory syncytial virus (RSV)

location_facility: Institute for Mother and Child Care "Alfred Rusescu"

location_facility: The University of California at San Diego

location_facility: Long Beach Memorial Medical Center/Miller Children's and Women's Hospital of Long Beach

location_facility: Siriraj Hospital, Mahidol University Department of Pediatrics

location_facility: NHO Shikoku Medical Center for Children and Adults

location_facility: Tokyo Metropolitan Children's Medical Center

location_facility: The University of North Carolina at Chapel Hill

location_facility: Canadian Centre for Vaccinology IWK Health Centre

location_facility: Children's Hospital/University of Tennessee

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Texas Children's Hospital/Baylor College of Medicine

location_facility: The Children's Hospital Research Institute of Manitoba

location_facility: Hospital de Especialidades Pediatricas "Omar Torrijos Herrera"

location_facility: Arkansas Children's Hospital Research Institute

location_facility: Hospital Materno Infantil Jose Dominog de Obaldila

location_facility: Khon Kaen University Department of Pediatrics

location_facility: National Center for Child Health and Development

location_facility: The Research Institute at Nationwide Children's Hospital

location_facility: Hokkaido P.W.F.A.C. Asahikawa-Kosei General Hospital

location_facility: National Hospital Organization Saitama National Hospital

location_facility: Phramongkutklao Hospital Department of Pediatrics

location_facility: Chulalongkorn University Department of Pediatrics

location_facility: Fundacion Cardio Infantil Instituto de Cardiologia

title: A Randomized, Double-blind, Placebo-controlled, 2-Part Study of Orally Administered ALS-008176 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Dosing and Multiple Ascending Dosing in Infants Hospitalized With Respiratory Syncytial Virus (RSV) Infection

location_country:
Colombia
New Zealand
United Kingdom
Romania
Australia
Japan
United States
Thailand
Panama
South Africa
Chile
Taiwan
Canada
France


title: An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Migalastat Hydrochloride Monotherapy in Subjects With Fabry Disease

summary: This is an open-label extension study intended to provide continued treatment with migalastat hydrochloride (HCl) for participants with Fabry disease who completed treatment of a previous migalastat HCl study. The study assessed the long-term safety and effectiveness of migalastat HCl.

ReferenceCitation: Narita I, Ohashi T, Sakai N, Hamazaki T, Skuban N, Castelli JP, Lagast H, Barth JA. Efficacy and safety of migalastat in a Japanese population: a subgroup analysis of the ATTRACT study. Clin Exp Nephrol. 2020 Feb;24(2):157-166. doi: 10.1007/s10157-019-01810-w. Epub 2019 Dec 30.

lead_sponsor: Amicus Therapeutics

location_country:
Italy
United Kingdom
Argentina
Denmark
Australia
Brazil
Japan
Austria
Belgium
United States
Spain
Turkey
Canada
Egypt
France


lead_sponsor: Ionis Pharmaceuticals, Inc.

summary: This study evaluates the safety and tolerability of extended dosing with IONIS-TTR Rx in patients with Familial Amyloid Polyneuropathy.

ReferenceCitation: Brannagan TH, Coelho T, Wang AK, Polydefkis MJ, Dyck PJ, Berk JL, Drachman B, Gorevic P, Whelan C, Conceicao I, Plante-Bordeneuve V, Merlini G, Obici L, Plana JMC, Gamez J, Kristen AV, Mazzeo A, Gentile L, Narayana A, Olugemo K, Aquino P, Benson MD, Gertz M; NEURO-T. T. R. Open-Label Extension Investigators. Long-term efficacy and safety of inotersen for hereditary transthyretin amyloidosis: NEURO-TTR open-label extension 3-year update. J Neurol. 2022 Dec;269(12):6416-6427. doi: 10.1007/s00415-022-11276-8. Epub 2022 Jul 31.

repository_institution: University of Lisbon - Repositório da Universidade de Lisboa

repositories_concat: PubMed Central;repositorio.ul.pt

ReferenceCitation: Karam C, Brown D, Yang M, Done N, Zhu JJ, Greatsinger A, Bozas A, Vera-Llonch M, Signorovitch J. Long-term treatment effects of inotersen on health-related quality of life in patients with hATTR amyloidosis with polyneuropathy: Analysis of the open-label extension of the NEURO-TTR trial. Muscle Nerve. 2022 Oct;66(4):438-446. doi: 10.1002/mus.27675. Epub 2022 Aug 4.

oa_host_type: closed

ReferenceCitation: Yarlas A, Lovley A, McCausland K, Brown D, Vera-Llonch M, Conceicao I, Karam C, Khella S, Obici L, Waddington-Cruz M. Early Data on Long-term Impact of Inotersen on Quality-of-Life in Patients with Hereditary Transthyretin Amyloidosis Polyneuropathy: Open-Label Extension of NEURO-TTR. Neurol Ther. 2021 Dec;10(2):865-886. doi: 10.1007/s40120-021-00268-x. Epub 2021 Aug 5.

ReferenceCitation: Brannagan TH, Wang AK, Coelho T, Waddington Cruz M, Polydefkis MJ, Dyck PJ, Plante-Bordeneuve V, Berk JL, Barroso F, Merlini G, Conceicao I, Hughes SG, Kwoh J, Jung SW, Guthrie S, Pollock M, Benson MD, Gertz M; NEURO-TTR open-label extension investigators. Early data on long-term efficacy and safety of inotersen in patients with hereditary transthyretin amyloidosis: a 2-year update from the open-label extension of the NEURO-TTR trial. Eur J Neurol. 2020 Aug;27(8):1374-1381. doi: 10.1111/ene.14285. Epub 2020 May 29.

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

repositories_concat: PubMed Central;repositorio.chporto.pt

location_facility: UKM; Universitätsklinikum Münster, Klinik für Transplantationsmedizin

location_facility: University College London - National Amyloidosis Centre

location_facility: Federal University of Rio de Janeiro - University Hospital

location_facility: Johns Hopkins University Bayview Medical Center

location_facility: Universita Degli Studi Di Messina - Azienda Ospedaliera Universitaria Policlinico "Gaetano Martino"

location_facility: CHU Bicetre Aphp French Referral Center for FAP/Cornamyl Network

location_facility: CHU Henri Mondor - Department of Neurology

location_facility: Boston University School of Medicine - Amyloid Treatment & Research Program

location_facility: CHP-HGSA, Unidade Clinica de Paramiloidose

location_facility: Columbia University Medical Center - The Neurological Institute

location_facility: Centro per lo Studio e la Cura delle Amiloidosi Sistemiche - Fondazione IRCCS Policlinico San Matteo

title: An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of ISIS 420915 in Patients With Familial Amyloid Polyneuropathy (FAP)

location_country:
Germany
Italy
Portugal
United Kingdom
Argentina
Brazil
United States
Spain
France


title: A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects Who Previously Received Talimogene Laherparepvec in Amgen or BioVEX-Sponsored Clinical Trials

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
Poland
Hungary
United Kingdom
Switzerland
Austria
United States
Korea, Republic of
Spain
Greece
South Africa
Canada
Russian Federation
France

location_facility: FSBI N N Blokhin Russian Oncology Research Center Ministry of Health of Russian Federation

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: University of Texas MD Anderson Cancer Center

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

location_facility: University of South Alabama Mitchell Cancer Institute

location_facility: University of Utah Huntsman Cancer Institute

location_facility: Investigative Clinical Research of Indiana, LLC

location_facility: The West Clinic PC dba West Cancer Center

location_facility: H Lee Moffitt Cancer Center and Research Institute

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

location_facility: FSBI Scientific and Research Oncology Institute named after N N Petrov

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

location_facility: Yonsei University Health System Severance Hospital

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien

location_facility: Centre Hospitalier Universitaire de Nantes, Hôpital Hôtel Dieu

location_facility: Greenville Health System Institute for Translational Oncology Research

location_facility: University of North Carolina Chapel Hill

location_facility: University of Arkansas for Medical Sciences

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Allina Health System dba Virginia Piper Cancer Institute

location_facility: Wake Forest Baptist Health Medical Center

location_facility: Hospital General Universitario de Valencia

location_facility: Providence Oncology and Hematology Care Eastside

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII


acronym: HIBISCUS I

summary: This Phase III, double-blind, placebo and active-comparator controlled, multicenter study will investigate the efficacy and safety of etrolizumab in induction of remission in participants with moderately to severely active ulcerative colitis (UC) who are naÏve to tumor necrosis factor (TNF) inhibitors and refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment. In addition to this study, a second Phase III trial with identical study design (GA28949; NCT02171429) was independently conducted.

ReferenceCitation: Rubin DT, Dotan I, DuVall A, Bouhnik Y, Radford-Smith G, Higgins PDR, Mishkin DS, Arrisi P, Scalori A, Oh YS, Tole S, Chai A, Chamberlain-James K, Lacey S, McBride J, Panes J; HIBISCUS Study Group. Etrolizumab versus adalimumab or placebo as induction therapy for moderately to severely active ulcerative colitis (HIBISCUS): two phase 3 randomised, controlled trials. Lancet Gastroenterol Hepatol. 2022 Jan;7(1):17-27. doi: 10.1016/S2468-1253(21)00338-1. Epub 2021 Nov 17. Erratum In: Lancet Gastroenterol Hepatol. 2022 Apr;7(4):e8.

ReferenceCitation: Sandborn WJ, Vermeire S, Tyrrell H, Hassanali A, Lacey S, Tole S, Tatro AR; Etrolizumab Global Steering Committee. Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program. Adv Ther. 2020 Jul;37(7):3417-3431. doi: 10.1007/s12325-020-01366-2. Epub 2020 May 22.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León

location_facility: Stavropol Regional Clinical Diagnostic Consultative Center

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: SBHI of NN region "RCH of NN n.a. N.A.Semashko"

location_facility: Medical and Sanitary Division of Severstal

location_facility: Gastroenterology Associates of Central Georgia

location_facility: General Hospital "Djordje Joanovic"; Gastroenterology

location_facility: FSBI "State Scientific Centre of Coloproctology" of the MoH of RF; Gastroenterology

location_facility: Wojewodzki Specjalistyczny Szpital w Olsztynie

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta

location_facility: 7 Szpital Marynarki Wojennej z Przychodnia SPZOZ im. W. Lasinskiego

location_facility: M.V. Sklifosovskyi Poltava RCH Outpatient UMSA HSEIU Ukrainian Medical Stomatological Academy

location_facility: Centro Integral en Reumatología S.A. de C.V. (CIRSA)

location_facility: CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC

location_facility: RCI Chernivtsi RCH Gastroenterology Bukovinsky SMU

location_facility: Specjalistyczna Praktyka Lekarska Dr med. Marek Horynski; endoskopia

location_facility: CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv

location_facility: Hospital Universitario Clementino Fraga Filho - UFRJ

location_facility: SPb SBIH "City Multy-field Hospital # 2"; Intensive Pulmonology and Thoracal Surgery

location_facility: SBEI of HPE "Omsk SMA" Ministry of healthcare of RF"

location_facility: SBEI HPE Altai State Medical University of MoH and SD; Out-patient Department

location_facility: CI of Kyiv RC Regional Clinical Hospital #2

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: LLC International Medical Centre "SOGAZ"

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

location_facility: FSMEI HPE "Military Medical Academy n.a. S.M.Kirov"of Minist

location_facility: Medical Center of Limited Liability Company Medical Clinic Blagomed

location_facility: Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

location_facility: Rocky Mountain Gastroenterology Associates, P.L.L.C.; Gastroenterology

location_facility: Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital

location_facility: UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

title: Phase III, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Induction of Remission) and Safety of Etrolizumab Compared With Adalimumab and Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Are Naive to TNF Inhibitors

location_country:
Poland
Slovakia
Argentina
Hong Kong
Australia
Brazil
Mexico
United States
Ukraine
Bulgaria
Estonia
Serbia
Russian Federation
France


title: Restorelle® Transvaginal Mesh Versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse, Restorelle 522 Study

summary: The purpose of this study is to collect information on the safety and effectiveness of Restorelle Direct Fix mesh and the surgical procedure to implant Restorelle. These results will be compared to the safety and effectiveness results in patients who have native tissue repair (without mesh) as their pelvic organ prolapse treatment.

lead_sponsor: Coloplast A/S

location_country:
Australia
Netherlands
Belgium
United States
Canada
France

location_facility: Centre for Advanced Reproductive Endosurgery

location_facility: Central Texas Urogynecology and Continence Center

location_facility: Premier Medical Group of Hudson Valley, PC

location_facility: Wellspan Urogynecology and Pelvic Reconstructive Surgery

location_facility: MedStar Washington Hospital Center, National Center for Advanced Pelvic Surgery

location_facility: The Institute for Female Pelvic Medicine and Reconstructive Surgery

location_facility: Center for Urogynecology and Pelvic Surgery, Christiana Care Health System

location_facility: Female Pelvic Medicine & Urogynecology Institute of MI

location_facility: Women's Pelvic Health and Continence Center


title: A 24-week Double-blind Treatment and 24-week Follow-up, Randomized, Multicenter, Placebo-controlled, Phase IIa/IIb Study to Evaluate Safety and Efficacy of i.v. Bimagrumab on Total Lean Body Mass and Physical Performance in Patients After Surgical Treatment of Hip Fracture

summary: The purpose of this study was to assess if bimagrumab is safe and effective in patients with muscle wasting (atrophy) after hip fracture surgery.

ReferenceCitation: Hofbauer LC, Witvrouw R, Varga Z, Shiota N, Cremer M, Tanko LB, Rooks D, Auberson LZ, Arkuszewski M, Fretault N, Schubert-Tennigkeit AA, Papanicolaou DA, Recknor C. Bimagrumab to improve recovery after hip fracture in older adults: a multicentre, double-blind, randomised, parallel-group, placebo-controlled, phase 2a/b trial. Lancet Healthy Longev. 2021 May;2(5):e263-e274. doi: 10.1016/S2666-7568(21)00084-2.

location_country:
Germany
Argentina
Australia
Japan
Turkey
Chile
Czechia
France
Colombia
Hungary
Switzerland
United States
Belgium
United Kingdom
Austria
Mexico
Spain
Taiwan
Russian Federation


title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Phase 2a Safety, Tolerability, and Pharmacodynamic Study of Two Doses of an Histone Deacetylase Inhibitor (FRM-0334) in Subjects With Prodromal to Moderate Frontotemporal Dementia With Granulin Mutation

summary: The purposes of this study are to investigate the safety, tolerability, and pharmacodynamics of FRM-0334 in subjects with prodromal to moderate frontotemporal dementia with granulin mutation.

enrollment_type: Anticipated

ReferenceCitation: Ljubenkov PA, Edwards L, Iaccarino L, La Joie R, Rojas JC, Koestler M, Harris B, Boeve BF, Borroni B, van Swieten JC, Grossman M, Pasquier F, Frisoni GB, Mummery CJ, Vandenberghe R, Le Ber I, Hannequin D, McGinnis SM, Auriacombe S, Onofrj M, Goodman IJ, Riordan HJ, Wisniewski G, Hesterman J, Marek K, Haynes BA, Patzke H, Koenig G, Hilt D, Moebius H, Boxer AL. Effect of the Histone Deacetylase Inhibitor FRM-0334 on Progranulin Levels in Patients With Progranulin Gene Haploinsufficiency: A Randomized Clinical Trial. JAMA Netw Open. 2021 Sep 1;4(9):e2125584. doi: 10.1001/jamanetworkopen.2021.25584.

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

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

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

repository_institution: University of Geneva - Archive ouverte UNIGE

repositories_concat: HAL;LIRIAS (KU Leuven);PubMed Central;oskar-bordeaux.fr;pure.eur.nl;unige.ch

repositories_institution: Erasmus University Rotterdam - EUR Research Repository

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

lead_sponsor: FORUM Pharmaceuticals Inc

location_country:
Italy
United Kingdom
Netherlands
Belgium
United States
France

location_facility: Perelman School of Medicine, University of Pennsylvania

location_facility: Fondazione Universita Gabriele D'Annunzio di Chieti

location_facility: IRCCS - Centro S. Giovanni di Dio FateBeneFratelli

location_facility: The National Hospital for Neurology and Neuroscience

location_facility: Neurological Clinic, University of Brescia, AO Civil Hospital of Brescia


title: Diffusion Weighted Imaging (DWI) or Computerized Tomography Perfusion (CTP) Assessment With Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention (DAWN)

acronym: DAWN

summary: The purpose of the study is to evaluate the hypothesis that Trevo thrombectomy plus medical management leads to superior clinical outcomes at 90 days as compared to medical management alone in appropriately selected subjects experiencing an acute ischemic stroke when treatment is initiated within 6-24 hours after last seen well.

ReferenceCitation: Roaldsen MB, Lindekleiv H, Mathiesen EB. Intravenous thrombolytic treatment and endovascular thrombectomy for ischaemic wake-up stroke. Cochrane Database Syst Rev. 2021 Dec 1;12(12):CD010995. doi: 10.1002/14651858.CD010995.pub3.

repository_institution: University of Oslo - Duo Research Archive

repositories_concat: PubMed Central;munin.uit.no

ReferenceCitation: Liebeskind DS, Saber H, Xiang B, Jadhav AP, Jovin TG, Haussen DC, Budzik RF, Bonafe A, Bhuva P, Yavagal DR, Hanel RA, Ribo M, Cognard C, Sila C, Hassan AE, Smith WS, Saver JL, Nogueira RG; DAWN Investigators. Collateral Circulation in Thrombectomy for Stroke After 6 to 24 Hours in the DAWN Trial. Stroke. 2022 Mar;53(3):742-748. doi: 10.1161/STROKEAHA.121.034471. Epub 2021 Nov 3.

ReferenceCitation: Liebeskind DS, Saber H, Bhuva P, Xiang B, Yoo AJ, Jadhav AP, Haussen DC, Budzik RF, Bonafe A, Yavagal DR, Hanel RA, Ribo M, Cognard C, Sila C, Hassan AE, Smith WS, Saver JL, Nogueira RG, Jovin TG. Serial ASPECTS in the DAWN Trial: Infarct Evolution and Clinical Impact. Stroke. 2021 Oct;52(10):3318-3324. doi: 10.1161/STROKEAHA.120.033477. Epub 2021 Jul 20.

ReferenceCitation: Tekle WG, Hassan AE, Jadhav AP, Haussen DC, Budzik RF, Bonafe A, Bhuva P, Yavagal DR, Hanel RA, Ribo M, Cognard C, Sila CA, Smith WS, Saver JL, Liebeskind DS, Shields R, Nogueira RG, Jovin TG; DAWN Trial Investigators. Impact of Periprocedural and Technical Factors and Patient Characteristics on Revascularization and Outcome in the DAWN Trial. Stroke. 2020 Jan;51(1):247-253. doi: 10.1161/STROKEAHA.119.026437. Epub 2019 Nov 20.

ReferenceCitation: Aghaebrahim A, Jadhav AP, Hanel R, Sauvageau E, Granja MF, Zhang Y, Haussen DC, Budzik RF, Bonafe A, Bhuva P, Ribo M, Cognard C, Sila C, Yavagal D, Hassan AE, Smith WS, Saver J, Liebeskind DS, Nogueira RG, Jovin TG; DAWN Investigators. Outcome in Direct Versus Transfer Patients in the DAWN Controlled Trial. Stroke. 2019 Aug;50(8):2163-2167. doi: 10.1161/STROKEAHA.119.025710. Epub 2019 Jul 15.

ReferenceCitation: Nogueira RG, Jadhav AP, Haussen DC, Bonafe A, Budzik RF, Bhuva P, Yavagal DR, Ribo M, Cognard C, Hanel RA, Sila CA, Hassan AE, Millan M, Levy EI, Mitchell P, Chen M, English JD, Shah QA, Silver FL, Pereira VM, Mehta BP, Baxter BW, Abraham MG, Cardona P, Veznedaroglu E, Hellinger FR, Feng L, Kirmani JF, Lopes DK, Jankowitz BT, Frankel MR, Costalat V, Vora NA, Yoo AJ, Malik AM, Furlan AJ, Rubiera M, Aghaebrahim A, Olivot JM, Tekle WG, Shields R, Graves T, Lewis RJ, Smith WS, Liebeskind DS, Saver JL, Jovin TG; DAWN Trial Investigators. Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct. N Engl J Med. 2018 Jan 4;378(1):11-21. doi: 10.1056/NEJMoa1706442. Epub 2017 Nov 11.

publisher_dissemination: Massachusetts Medical Society

lead_sponsor: Stryker Neurovascular

location_country:
Australia
United States
Spain
Canada
France

location_facility: Toronto Western Hospital - University Health Network

location_facility: JFK Neuroscience Institute at JFK Medical Center

location_facility: University Hospitals Case Medical Center

location_facility: Florida Hospital; Neuroscience Research Center

location_facility: Emory University at Grady Memorial Hospital

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: Riverside Methodist Hospital/ Ohio Health Research Institute


title: A Phase II, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of RO5520985 (Vanucizumab) Plus FOLFOX Versus Bevacizumab Plus FOLFOX in Patients With Previously Untreated Metastatic Colorectal Cancer

acronym: McCAVE

summary: This is a Phase 2 multicenter, randomized, parallel arms, double-blind study of vanucizumab to evaluate the efficacy and safety of vanucizumab in combination with oxaliplatin, folinic acid, and 5-fluorouracil (5-FU) (mFOLFOX-6) versus bevacizumab (Avastin) + mFOLFOX-6 in participants with previously untreated metastatic colorectal cancer (mCRC). The study consists of 2 parts: a safety run-in open-label, single-arm part (Part 1) and a randomized, parallel-arms, double-blind part (Part 2). During Part 1 at least 6 eligible participants will receive 2000 milligrams (mg) vanucizumab every 2 weeks + mFOLFOX-6 in order to confirm the dose and schedule that will be used in Part 2. In Part 2, all eligible participants will be randomized in a ratio of 1:1 to receive either mFOLFOX-6 + vanucizumab or mFOLFOX-6 + bevacizumab. Study treatment (induction and maintenance) will be given on Day 1 of each 14-day cycle. Induction therapy will consist of up to 8 cycles of mFOLFOX-6 plus either bevacizumab or vanucizumab. Maintenance therapy will consist of 5-fluorouracil and folinic acid plus either vanucizumab or bevacizumab for up to 24 months or until disease progression, unacceptable toxicity, Investigator decision or consent withdrawal, whichever occurs first.

location_country:
United Kingdom
Australia
Austria
Belgium
United States
Spain
France

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

location_facility: University of California San Diego Medical Center

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: HM Sanchinarro - CIOCC; Servicio de Oncologia

location_facility: Va Greater Los Angeles Healthcare System

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Aberdeen Royal Infirmary; Medical Oncology Dept

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: California Cancer Associates for Research & Excellence, Inc.

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Oö. Gesundheits- und Spitals-AG/LKH Steyr

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

location_facility: Institut De Cancerologie De L'Ouest; Medical Oncology


title: A Long-Term Non-Interventional Postmarketing Study to Assess Safety and Effectiveness of Humira® (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD) - CAPE

acronym: CAPE

summary: This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in pediatric patients with moderately to severely active CD who are treated as recommended in the local product label.

status: Active, not recruiting

lead_sponsor: AbbVie

location_country:
Germany
Ireland
Bosnia and Herzegovina
Croatia
Czechia
Canada
France
Lithuania
Portugal
Denmark
United States
Romania
Estonia
Puerto Rico
Italy
United Kingdom
Sweden
Netherlands
Spain
Greece
Bulgaria
Israel

location_facility: University of Manitoba / Health Scuience Centre / John Buhler Research Centre /ID# 141310

location_facility: Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 138462

location_facility: Children's Hospital Colorado /ID# 137261

location_facility: CCA Braga - Hospital de Braga /ID# 138269

location_facility: Hospital Universitario La Paz /ID# 161152

location_facility: Univ Alabama, Birmingham CCC /ID# 146060

location_facility: Hospital Regional Universitario de Malaga /ID# 144289

location_facility: Duplicate_Ha'Emek Medical Center /ID# 156316

location_facility: Fakultni nemocnice Hradec Kralove /ID# 128521

location_facility: Univ of Mississippi Med Ctr,US /ID# 137239

location_facility: University Of Vermont Medical /ID# 137263

location_facility: Columbia Univ Medical Center /ID# 144475

location_facility: Alder Hey Children's NHS Foundation Trust /ID# 138013

location_facility: St George's University Hospitals NHS Foundation Trust /ID# 131590

location_facility: Spitalul Clinic de Urgenta pentru Copii ?Louis Turcanu? /ID# 130251

location_facility: Universitaetsklinikum Erlangen /ID# 137274

location_facility: Compl Hospital Univer de Vigo /ID# 136999

location_facility: Krajska zdravotni a.s. Masarykova nemocnice v Usti nad Labem o.z. /ID# 129829

location_facility: Edmond And Lily Safra Children /ID# 148730

location_facility: Froehlich Gemeinschaftspraxis /ID# 127975

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 147690

location_facility: Hospital Infantil Universitario Nino Jesus /ID# 165738

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 137014

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca /ID# 138460

location_facility: Hospital Universitario de Girona Doctor Josep Trueta /ID# 147572

location_facility: CCMC - Steven and Alexandra Cohen Children's Medical Center of New York /ID# 137266

location_facility: Epsom & St Helier University Hospital NHS Trust /ID# 150097

location_facility: OSI Ezkerraldea-Enkarterri-Cruces /ID# 141781

location_facility: Hospital Universitario 12 de Octubre /ID# 136998

location_facility: University Hospital Southampton NHS Foundation Trust /ID# 147538

location_facility: ASST Fatebenefratelli Sacco/Ospedale dei Bambini Vittore Buzzi /ID# 141679

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 127809

location_facility: A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 152684

location_facility: Private practice: Dr. Shervin Rabizadeh /ID# 137269

location_facility: Emory Midtown Infectious Disease Clinic /ID# 144274

location_facility: Azienda Ospedaliero-Universitaria di Parma /ID# 147441

location_facility: Duplicate_Universitaetsklinikum Freiburg /ID# 130010

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 147438

location_facility: Assaf Harofeh Medical Center /ID# 157182

location_facility: Children's Hospital New Orleans /ID# 144477

location_facility: Universitaetsklinikum Regensburg /ID# 137140

location_facility: Klinicki bolnicki centar Sestre milosrdnice /ID# 128256

location_facility: Children's Ctr Digestive, US /ID# 144625

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 139400

location_facility: Hospital General de Granollers /ID# 140882

location_facility: Manchester University NHS Foundation Trust /ID# 128476

location_facility: ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 144279

location_facility: Azienda Sanitaria Locale di Pescara /ID# 141307

location_facility: A.O.U. Policlinico G. Martino /ID# 141683

location_facility: University Clinical Center Tuzla /ID# 130638

location_facility: Duplicate_POLICLINICO PAOLO GIACCONE /ID# 138410

location_facility: Hospital Universitario Vall d'Hebron /ID# 146015

location_facility: Fakultni nemocnice Kralovske Vinohrady /ID# 127697

location_facility: Vilnius University Hospital Santaros Klinikos /ID# 127810

location_facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 141667

location_facility: Connecticut Children's Medical Center - Hartford /ID# 137265

location_facility: Hospital Universitario Puerta de Hierro, Majadahonda /ID# 157872

location_facility: Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 149029

location_facility: Schneider Children's Medical Center /ID# 152683

location_facility: Spitalul Clinic de Urgenta Pentru Copii Grigore Alexandrescu /Id# 130358

location_facility: Ctr. Gastroenterologia Ped Oes /ID# 140875

location_facility: Cambridge University Hospitals NHS Foundation Trust /ID# 143779

location_facility: Duplicate_Universita di Napoli Federico II /ID# 144280

location_facility: Hospital Universitario A Coruna - CHUAC /ID# 137235

location_facility: Christliches Kinderhospital Osnabrueck /ID# 136629

location_facility: Hospital Universitario Severo Ochoa /ID# 141545

location_facility: Hospital Universitario Vall d'Hebron /ID# 141778

location_facility: Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 146013

location_facility: Nemours Children's Health System /ID# 148498

location_facility: SUNY Upstate Medical University /ID# 148437

location_facility: Columbia Univ Medical Center /ID# 144440

location_facility: Children's Clinic Of Tartu Uni /ID# 146017

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 138146

location_facility: Hospital Universitari Son Espases /ID# 147446

location_facility: Hospital Universitario y Politecnico La Fe /ID# 141847

location_facility: Karolinska University Hospital Solna /ID# 129045

location_facility: Massachusetts General Hospital /ID# 141552

location_facility: Multicare Institute for Research and Innovation /ID# 152120

location_facility: General Hospital of Thessaloniki Gennimatas /Id# 163658

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 127696

location_facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 141962

location_facility: NHS Greater Glasgow and Clyde /ID# 127436

location_facility: The Lady Davis Carmel Medical Center /ID# 151519

location_facility: Sheffield Children's NHS Foundation Trust /ID# 130370

location_facility: Ospedale Maggiore Carlo Alberto Pizzardi /ID# 147347

location_facility: University Hospital of Derby and Burton NHS Foundation Trust /ID# 131592

location_facility: Medical University of South Carolina /ID# 144473

location_facility: Children's Hospital Los Angeles /ID# 141551

location_facility: Universitaetsklinikum Muenster /ID# 148441

location_facility: Universitaetsklinikum Aachen /ID# 126591

location_facility: Birmingham Women's and Children's NHS Foundation Trust /ID# 136631

location_facility: Univ California, San Francisco /ID# 141312

location_facility: Spitalul Clinic de Urgenta pentru Copii- Pediatrie II-Nefrologie Pediatrica /ID# 131297

location_facility: Rady Children's Hospital San Diego /ID# 140883

location_facility: Hospital Universitario Central de Asturias /ID# 163053

location_facility: Penn State Child Hosp.Hersh,PA /ID# 144476

location_facility: Children's Hospital Oklahoma /ID# 144047

location_facility: Hospital Universitario Dr. Peset /ID# 159484

status_simplified: Ongoing


lead_sponsor: Novartis Pharmaceuticals

summary: Assessed the new film-coated tablet formulation to the currently approved dispersible tablet formulation with regards to overall safety, Gastrointestinal (GI) tolerability, palatability, satisfaction and compliance

ReferenceCitation: Taher AT, Origa R, Perrotta S, Kouraklis A, Ruffo GB, Kattamis A, Goh AS, Huang V, Zia A, Herranz RM, Porter JB. Patient-reported outcomes from a randomized phase II study of the deferasirox film-coated tablet in patients with transfusion-dependent anemias. Health Qual Life Outcomes. 2018 Nov 19;16(1):216. doi: 10.1186/s12955-018-1041-5.

repository_institution: PubMed Central - Europe PMC

repository_institution: University College London - UCL Discovery

repositories:
PubMed Central
UCL Discovery
iris.unica.it

location_facility: Weill Cornell Medical College-Cornell University Onc Dept

location_facility: Lurie Children's Hospital of Chicago Onc Dept

location_facility: Children's Hospital of Philadelphia Onc. Dept

location_facility: Children's Hospital Boston Department of Hematology

location_facility: Children's Hospital of Orange County Onc Dept

title: A Randomized, Open-label, Multicenter, Two Arm, Phase II Study to Investigate the Benefits of an Improved Deferasirox Formulation (Film-coated Tablet)

location_country:
Germany
Italy
United Kingdom
Argentina
Austria
Lebanon
Mexico
United States
Saudi Arabia
Spain
Thailand
Greece
Malaysia
United Arab Emirates
Russian Federation
France


summary:
This was a 4-part (Part A, Part B, Part C and Part D), Phase I/IIa, multi-center, open label, study in pediatric subjects with refractory or recurrent tumors.

Part A was a repeat dose, dose escalation and expansion phase that identified the recommended phase II dose (RP2D) of trametinib monotherapy. Part B evaluated the preliminary activity of trametinib monotherapy in 4 disease-specific cohorts of subjects. Part C was aimed to determine the safety, tolerability and preliminary activity of the RP2D of trametinib in combination with a limited dose escalation of dabrafenib. Part D evaluated the preliminary activity of trametinib in combination with dabrafenib in 2 disease-specific cohorts of subjects.

The overall goal of this trial was to efficiently establish safe, pharmacologically relevant dose of trametinib monotherapy and trametinib in combination with dabrafenib in infants, children and adolescents and determine preliminary activity of trametinib monotherapy and trametinib in combination with dabrafenib in selected recurrent, refractory or unresectable childhood tumors.

ReferenceCitation: Bouffet E, Geoerger B, Moertel C, Whitlock JA, Aerts I, Hargrave D, Osterloh L, Tan E, Choi J, Russo M, Fox E. Efficacy and Safety of Trametinib Monotherapy or in Combination With Dabrafenib in Pediatric BRAF V600-Mutant Low-Grade Glioma. J Clin Oncol. 2023 Jan 20;41(3):664-674. doi: 10.1200/JCO.22.01000. Epub 2022 Nov 14.

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

repositories_institution: University College London - UCL Discovery

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Shahid S, Kushner BH, Modak S, Basu EM, Rubin EM, Gundem G, Papaemmanuil E, Roberts SS. Association of BRAF V600E mutations with vasoactive intestinal peptide syndrome in MYCN-amplified neuroblastoma. Pediatr Blood Cancer. 2021 Oct;68(10):e29265. doi: 10.1002/pbc.29265. Epub 2021 Jul 31.

title: An Open-Label, Dose-Escalation, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of the MEK Inhibitor Trametinib in Children and Adolescents Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Children and Adolescents With Cancers Harboring V600 Mutations

location_country:
United Kingdom
Australia
United States
Canada
France


title: Open-label Study to Assess the Long-term Safety and Efficacy of Momelotinib in Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post Essential Thrombocythemia Myelofibrosis, Polycythemia Vera or Essential Thrombocythemia

summary: This open-label study is to determine the long-term safety and tolerability of momelotinib in previously enrolled study participants with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), post-essential thrombocythemia myelofibrosis (post-ET MF), polycythemia vera (PV), or essential thrombocythemia (ET), who have tolerated and achieved stable disease or better with momelotinib treatment while enrolled in a previous clinical trial.

lead_sponsor: Sierra Oncology LLC - a GSK company

location_country:
Germany
Australia
United States
Canada
France


title: VIRTUS Safety and Efficacy of the Veniti Vici™ Venous Stent System (Veniti, Inc.) When Used to Treat Clinically Significant Chronic Non-malignant Obstruction of the Iliofemoral Venous Segment

acronym: VIRTUS

summary: This is a prospective, multi-center, single arm, non-randomized study to define safety and efficacy of the Veniti Vici™ Venous Stent System in relation to pre-defined Objective Performance goals. A maximum of 200 patients at up to 45 centers worldwide will be enrolled. Thirty (30) feasibility patients will be enrolled at approximately 7-10 centers and 170 pivotal patients will be enrolled at approximately 45 centers worldwide. The follow-up period is 36 months.

ReferenceCitation: Razavi MK, Black S, Gagne P, Chiacchierini R, Nicolini P, Marston W; VIRTUS Investigators. Pivotal Study of Endovenous Stent Placement for Symptomatic Iliofemoral Venous Obstruction. Circ Cardiovasc Interv. 2019 Dec;12(12):e008268. doi: 10.1161/CIRCINTERVENTIONS.119.008268. Epub 2019 Dec 13.

ReferenceCitation: Razavi M, Marston W, Black S, Bentley D, Neglen P. The initial report on 1-year outcomes of the feasibility study of the VENITI VICI VENOUS STENT in symptomatic iliofemoral venous obstruction. J Vasc Surg Venous Lymphat Disord. 2018 Mar;6(2):192-200. doi: 10.1016/j.jvsv.2017.10.014. Epub 2017 Dec 28.

lead_sponsor: Boston Scientific Corporation

location_country:
Ireland
Germany
United Kingdom
Netherlands
United States
Spain
France

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: New York Presbyterian Hospital/Cornell University

location_facility: The University of North Carolina at Chapel Hill


lead_sponsor: PTC Therapeutics

summary: The primary objective of this study is to determine the long-term safety and tolerability of ataluren in participants with nonsense mutation cystic fibrosis (nmCF) who completed participation in the double-blind study PTC124-GD-009-CF (NCT00803205), as assessed by adverse events and laboratory abnormalities. The secondary objective of this study includes the assessment of the efficacy of ataluren, as measured by forced expiratory volume in 1 second (FEV1) and pulmonary exacerbation rate, and other safety parameters (for example, 12-lead electrocardiogram [ECG] measurements, vital signs).

location_facility: Hadassah University Hospital - Mount Scopus

location_facility: Karolinska University Hospital, Huddinge

location_facility: Hôpital Universitaire des Enfants Reine Fabiola

title: An Open-Label Safety and Efficacy Study for Patients With Nonsense Mutation Cystic Fibrosis Previously Treated With Ataluren (PTC124)

location_country:
France
Italy
Sweden
Belgium
United States
Spain
Israel


title: Evaluation for the Effectiveness of Evolution® Biliary Stent System-Fully Covered

summary: The Evolution® Biliary Stent System-Fully Covered study is a clinical trial approved by the US FDA to evaluate the effectiveness of the Evolution® Biliary Stent System-Fully Covered when used in palliation of malignant neoplasms in the biliary tree.

primary_purpose: Supportive Care

lead_sponsor: Cook Group Incorporated

location_country:
United States
Canada
Netherlands
France

location_facility:
Wake Forest Baptist Medical Center
Erasmus Medish Centrum
Moffitt Cancer Center
St. Michael's Hospital
Hôpital Edouard Herriot
Borland-Groover Clinic
University of Pittsburgh Medical Center
University of Virginia Health System
Indiana University Hospital
University of Colorado Hospital
Hôpital L'Archet 2
Centre Hospitalier de 1'Université


title: A Phase 2 Study of LY2835219 for Patients With Previously Treated Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer

acronym: MONARCH 1

summary: The main purpose of this study is to evaluate whether the study drug known as abemaciclib is effective in treating participants with breast cancer who have already tried other drug treatments.

ReferenceCitation: Dickler MN, Tolaney SM, Rugo HS, Cortes J, Dieras V, Patt D, Wildiers H, Hudis CA, O'Shaughnessy J, Zamora E, Yardley DA, Frenzel M, Koustenis A, Baselga J. MONARCH 1, A Phase II Study of Abemaciclib, a CDK4 and CDK6 Inhibitor, as a Single Agent, in Patients with Refractory HR+/HER2- Metastatic Breast Cancer. Clin Cancer Res. 2017 Sep 1;23(17):5218-5224. doi: 10.1158/1078-0432.CCR-17-0754. Epub 2017 May 22. Erratum In: Clin Cancer Res. 2018 Nov 1;24(21):5485.

repository_institution: California Digital Library - eScholarship

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

repository_normalized: dnet

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Eli Lilly and Company

location_country:
United States
Spain
Belgium
France

location_facility: Northern Arizona Hematology & Oncology Associates

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

location_facility: HOPE Hematology Oncology Physicians and Extenders

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center

location_facility: The Center for Cancer and Blood Disorders


title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Bronchoscopy Study to Evaluate the Effects of Lebrikizumab on Airway Eosinophilic Inflammation in Patients With Uncontrolled Asthma on Inhaled Corticosteroids and a Second Controller Medication

summary: This Phase II, randomized, double-blind, placebo-controlled, multicenter study will evaluate the effects of lebrikizumab on airway eosinophilic inflammation in participants with uncontrolled asthma who are using inhaled corticosteroid (ICS) treatment and a second controller medication. Enrolled participants will undergo a 3-week screening period during which assessments, including a bronchoscopy procedure, will be made. Participants will subsequently be randomized to receive lebrikizumab or placebo by subcutaneous (SC) injection on Day 1, Day 8, Week 4, and Week 8. Participants will continue their standard of care therapy throughout the study. End of treatment assessments will be taken at Week 12. Total study period, including screening and follow-up, is expected to last 23 weeks.

ReferenceCitation: Austin CD, Gonzalez Edick M, Ferrando RE, Solon M, Baca M, Mesh K, Bradding P, Gauvreau GM, Sumino K, FitzGerald JM, Israel E, Bjermer L, Bourdin A, Arron JR, Choy DF, Olsson JK, Abreu F, Howard M, Wong K, Cai F, Peng K, Putnam WS, Holweg CTJ, Matthews JG, Kraft M, Woodruff PG; CLAVIER Investigators. A randomized, placebo-controlled trial evaluating effects of lebrikizumab on airway eosinophilic inflammation and remodelling in uncontrolled asthma (CLAVIER). Clin Exp Allergy. 2020 Dec;50(12):1342-1351. doi: 10.1111/cea.13731. Epub 2020 Oct 4.

repository_institution: Washington University School of Medicine - Digital Commons@Becker

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

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

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

repositories:
HAL
PubMed Central
digitalcommons.wustl.edu

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

location_country:
Ireland
France
United Kingdom
United States
Canada
Sweden

location_facility: Wake Forest University Baptist Medical Center; Gastroenterology & Digestive Health

location_facility: Queen's University Belfast; NICRN Respiratory Research Office

location_facility: Temple University Hospital ; Lung Center

location_facility: Groupe Hospitalier Sud - Hôpital Haut Lévêque

location_facility: University of Pittsburgh Medical Center Health System

location_facility: McMaster University Health Sciences Center

location_facility: University of Miami School of Medicine - Sylvester at Deerfield

location_facility: Brigham and Women's Hospital; Pulmonary Division

location_facility: University of California Davis Health System; Division of Pulmonary and Critical Care Medicine

location_facility: University of Iowa Hospitals & Clinics; Internal Medicine


title: A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-399, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors

summary: This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-399 as monotherapy and in combination with osimertinib, erlotinib, and nivolumab in participants with advanced solid tumors likely to express c-Met. Enrollment is closed for the monotherapy arms, Arm A, and Arm D.

ReferenceCitation: Camidge DR, Barlesi F, Goldman JW, Morgensztern D, Heist R, Vokes E, Spira A, Angevin E, Su WC, Hong DS, Strickler JH, Motwani M, Dunbar M, Parikh A, Noon E, Blot V, Wu J, Kelly K. Phase Ib Study of Telisotuzumab Vedotin in Combination With Erlotinib in Patients With c-Met Protein-Expressing Non-Small-Cell Lung Cancer. J Clin Oncol. 2023 Feb 10;41(5):1105-1115. doi: 10.1200/JCO.22.00739. Epub 2022 Oct 26.

repositories_concat: PubMed Central;digitalcommons.wustl.edu

repositories_institution: Washington University School of Medicine - Digital Commons@Becker

ReferenceCitation: Camidge DR, Morgensztern D, Heist RS, Barve M, Vokes E, Goldman JW, Hong DS, Bauer TM, Strickler JH, Angevin E, Motwani M, Parikh A, Sun Z, Bach BA, Wu J, Komarnitsky PB, Kelly K. Phase I Study of 2- or 3-Week Dosing of Telisotuzumab Vedotin, an Antibody-Drug Conjugate Targeting c-Met, Monotherapy in Patients with Advanced Non-Small Cell Lung Carcinoma. Clin Cancer Res. 2021 Nov 1;27(21):5781-5792. doi: 10.1158/1078-0432.CCR-21-0765. Epub 2021 Aug 23.

ReferenceCitation: Strickler JH, Weekes CD, Nemunaitis J, Ramanathan RK, Heist RS, Morgensztern D, Angevin E, Bauer TM, Yue H, Motwani M, Parikh A, Reilly EB, Afar D, Naumovski L, Kelly K. First-in-Human Phase I, Dose-Escalation and -Expansion Study of Telisotuzumab Vedotin, an Antibody-Drug Conjugate Targeting c-Met, in Patients With Advanced Solid Tumors. J Clin Oncol. 2018 Nov 20;36(33):3298-3306. doi: 10.1200/JCO.2018.78.7697. Epub 2018 Oct 4. Erratum In: J Clin Oncol. 2019 Jan 20;37(3):261.

repository_institution: University of California - eScholarship University of California

location_country:
Finland
Italy
Japan
Netherlands
Belgium
United States
Korea, Republic of
Taiwan
France

location_facility: Dana-Farber Cancer Institute /ID# 168782

location_facility: University of California, Davis Comprehensive Cancer Center /ID# 129805

location_facility: Summit Medical Group-Florham Park /ID# 217651

location_facility: China Medical University Hospital /ID# 217494

location_facility: AP-HM - Hopital de la Timone /ID# 151570

location_facility: Washington University-School of Medicine /ID# 143798

location_facility: Northwell Health - Monter Cancer Center /ID# 218170

location_facility: National Cancer Center Hospital /ID# 217571

location_facility: Massachusetts General Hospital /ID# 129804

location_facility: Herbert Herman Cancer Center /ID# 149858

location_facility: Universitair Ziekenhuis Antwerpen /ID# 170118

location_facility: University of California, Los Angeles /ID# 148295

location_facility: University of Texas MD Anderson Cancer Center /ID# 154648

location_facility: Taipei Veterans General Hosp /ID# 217392

location_facility: Duplicate_Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRCCS /ID# 164077

location_facility: Mary Crowley Cancer Research /ID# 123760

location_facility: Montefiore Medical Park at Eastchester /ID# 218445

location_facility: Univ of Colorado Cancer Center /ID# 123759

location_facility: National Cancer Center Hospital East /ID# 217570

location_facility: Yonsei University Health System Severance Hospital /ID# 217333

location_facility: The Catholic University of Korea, ST. Vincent's Hospital /ID# 233378

location_facility: National Taiwan University Hospital /ID# 167173

location_facility: Virginia Cancer Specialists - Fairfax /ID# 165708

location_facility: The University of Chicago Medical Center /ID# 136995

location_facility: National Cheng Kung University Hospital /ID# 167175

location_facility: Radboud Universitair Medisch Centrum /ID# 246908


title: Medtronic PERIcardial SurGical AOrtic Valve ReplacemeNt Pivotal Trial A Multi-center, Non-randomized Trial to Determine the Safety and Effectiveness of the Model 400 Aortic Valve Bioprosthesis in Patients With Aortic Valve Disease

acronym: PERIGON

summary: To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis.

ReferenceCitation: Klautz RJM, Kappetein AP, Lange R, Dagenais F, Labrousse L, Bapat V, Moront M, Misfeld M, Zeng C, Sabik Iii JF; PERIGON Investigators. Safety, effectiveness and haemodynamic performance of a new stented aortic valve bioprosthesis. Eur J Cardiothorac Surg. 2017 Sep 1;52(3):425-431. doi: 10.1093/ejcts/ezx066.

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repository_institution: Leiden University - Leiden Repository

lead_sponsor: Medtronic Cardiac Surgery

sponsor_collaborators:
Medtronic Cardiac Surgery
Medtronic

location_country:
Germany
Italy
United Kingdom
Netherlands
Switzerland
United States
Canada
France

location_facility: London Health Sciences Centre - University Campus

location_facility: University of Michigan Cardiovascular Center

location_facility: Riverside Methodist Hospital (OhioHealth)

location_facility: New York-Presbyterian Hospital/Columbia University Medical Center

location_facility: Universitäts Klinikum Frankfurt - Goethe-Universität

location_facility: University of Southern California (USC) University Hospital

location_facility: Cardiothoracic and Vascular Surgeons (CTVS)

location_facility: Guy's & St Thomas' NHS Foundation Trust - St Thomas' Hospital

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

location_facility: Leids Universitair Medisch Centrum (LUMC)


title: Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration

acronym: BEACON

summary: This study will assess the safety and efficacy of the brimonidine intravitreal implant in participants with geographic atrophy due to age-related macular degeneration.

ReferenceCitation: Miere A, Capuano V, Kessler A, Zambrowski O, Jung C, Colantuono D, Pallone C, Semoun O, Petit E, Souied E. Deep learning-based classification of retinal atrophy using fundus autofluorescence imaging. Comput Biol Med. 2021 Mar;130:104198. doi: 10.1016/j.compbiomed.2020.104198. Epub 2020 Dec 28.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

evidence: open (author manuscript)

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

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

ReferenceCitation: Kuppermann BD, Patel SS, Boyer DS, Augustin AJ, Freeman WR, Kerr KJ, Guo Q, Schneider S, Lopez FJ; Brimo DDS Gen 1 Study Group. PHASE 2 STUDY OF THE SAFETY AND EFFICACY OF BRIMONIDINE DRUG DELIVERY SYSTEM (BRIMO DDS) GENERATION 1 IN PATIENTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION. Retina. 2021 Jan 1;41(1):144-155. doi: 10.1097/IAE.0000000000002789.

lead_sponsor: Allergan

location_country:
Germany
Italy
United Kingdom
Australia
United States
France

location_facility: "Centre Hospitalier Intercommunal de Creteil "

location_facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

location_facility: Clinical Research Unit, Level2, Bristol Eye Hospital, Lower Maudlin Street

location_facility: "Universitat Bonn, Abteilung fur Augenheilkunde "

location_facility: Casey Eye Institute, Oregon Health and Science University

location_facility: Universita degli Studi di Padova, Dipartimento di Neuroscienze

location_facility: Lions Eye Institute, University of Western Australia

location_facility: Frimley Park Hospital, Eye clinical trials Unit, Department of Opthalmology

location_facility: "Dir IV Clinica Oculistica di Milano, Ospedale Generale ""Luigi Sacco"" "

location_facility: "National Ophthalmic Research Institute Retina Consultants of Southwest Florida"

location_facility: Università di Cagliari (presidio San Giovanni di Dio)

location_facility: Charlotte Eye Ear Nose & Throat Associates, PA

location_facility: Mid Atlantic Retina, Wills Eye Retina Surgeons

location_facility: Retina Consultants of Southern Colorado, PC

location_facility: Royal Hallamshire Hospital, Eye Department

location_facility: Northern California Retina Vitreous Associates

location_facility: Retinal Consultants of Arizona, Ltd., Retinal Research Institute

location_facility: University of California, San Diego, Jacobs Retina Center, Shiley Eye Center


summary: The design of a phase I, open label, dose finding study was chosen in order to establish a safe and tolerated dose of single agent ABL001 in CML and Ph+ ALL patients who are relapsed or refractory to or are intolerant of TKIs, and of ABL001+Nilotinib, ABL001+Imatinib and ABL001+Dasatinib in Ph positive CML patients who are relapsed or refractory to TKIs.

ReferenceCitation: Li YF, Combes FP, Hoch M, Lorenzo S, Sy SKB, Ho YY. Population Pharmacokinetics of Asciminib in Tyrosine Kinase Inhibitor-Treated Patients with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic and Acute Phases. Clin Pharmacokinet. 2022 Oct;61(10):1393-1403. doi: 10.1007/s40262-022-01148-9. Epub 2022 Jun 28. Erratum In: Clin Pharmacokinet. 2022 Aug 17;:

ReferenceCitation: Hughes TP, Mauro MJ, Cortes JE, Minami H, Rea D, DeAngelo DJ, Breccia M, Goh YT, Talpaz M, Hochhaus A, le Coutre P, Ottmann O, Heinrich MC, Steegmann JL, Deininger MWN, Janssen JJWM, Mahon FX, Minami Y, Yeung D, Ross DM, Tallman MS, Park JH, Druker BJ, Hynds D, Duan Y, Meille C, Hourcade-Potelleret F, Vanasse KG, Lang F, Kim DW. Asciminib in Chronic Myeloid Leukemia after ABL Kinase Inhibitor Failure. N Engl J Med. 2019 Dec 12;381(24):2315-2326. doi: 10.1056/NEJMoa1902328.

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

location_facility: Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering

location_facility: University of Michigan Comprehensive Cancer Center SC

location_facility: Dana Farber Cancer Institute Hematology / Oncology

title: A Phase I, Multicenter, Open-label Study of Oral ABL001 in Patients With Chronic Myelogenous Leukemia (CML) or Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL)

location_country:
Germany
Italy
Singapore
Australia
Japan
Netherlands
United States
Korea, Republic of
Spain
France


title: An Open-label, Multi-center, Extension Study to Evaluate the Long-term Safety of Subcutaneous 240mg QGE031 Given Every 4 Weeks for 52 Weeks in Allergic Asthma Patients Who Completed Study CQGE031B2201

summary: This study planned to assess long-term safety of QGE031 during 12 months treatment in asthma patients who completed study CQGE031B2201.

location_country:
Finland
Germany
Poland
Argentina
Turkey
Czechia
Canada
France
Portugal
Slovakia
Hungary
United States
Romania
Italy
United Kingdom
Mexico
Korea, Republic of
South Africa
Russian Federation
Israel


title: Crossover From IDE Trial CLN0009, Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study, IDE G110066

acronym: CROSSOVER

summary: Crossover study for patients who were randomized to the Control Group in CLN0009 (NCT01608490).

sponsor_collaborators:
Boston Scientific Corporation
PneumRx, Inc.

location_country:
United Kingdom
Netherlands
United States
Canada
France

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)

location_facility: El Camino Hospital/Palo Alto Medical Foundation

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Royal Brompton Hospital & Chelsea Westminster

location_facility: University of Wisconsin School of Medicine & Public Health

location_facility: Illinois Lung and Critical Care Institute

location_facility: University of Alabama Lung Health Center

location_facility: University of Texas Health Sciences Center at San Antonio

location_facility: New York Presbyterian Columbia University Medical Center

location_facility: Yale University School of Medicine - Yale New Haven Hospital

location_facility: Emphysema COPD Research Center, University of Pittsburgh

location_facility: Pulmonary, Critical Care & Sleep Medicine Consultants,PCCS/St. Luke's Episcopal Hospital


acronym: Illuminate

lead_sponsor: Sumitomo Pharma America, Inc.

summary: A study to evaluate efficacy and safety of flexibly dosed Lurasidone in children and adolescents with bipolar I depression

ReferenceCitation: DelBello MP, Goldman R, Phillips D, Deng L, Cucchiaro J, Loebel A. Efficacy and Safety of Lurasidone in Children and Adolescents With Bipolar I Depression: A Double-Blind, Placebo-Controlled Study. J Am Acad Child Adolesc Psychiatry. 2017 Dec;56(12):1015-1025. doi: 10.1016/j.jaac.2017.10.006. Epub 2017 Oct 13.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: CI Lviv Regional Clinical Psychiatric Hospital

location_facility: Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda

location_facility: Chair of Psychiatry and Narcology, Vinnytsia National Medical University, O.I. Yushchenko Regional Psychoneurological Hospital

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval

location_facility: Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.

location_facility: CI Kherson Regional Psychiatric Hospital of Kherson RC

location_facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA

location_facility: Instituto de Informacion de Investigacion en Salud Mental

location_facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu

location_facility: RPsH #3 Сhildren Dept SHEI Ivano-Frankivsk SMU

location_facility: Family Psychiatry of The Woodlands, P.A.

location_facility: SI Institute of Neurology, Psychiatry and Narcology of NAMSU

location_facility: Vadaskert Alapitvany a Gyermekek Lelki Egeszsegeert

location_facility: University Hospitals Case Medical Center

location_facility: Seoul National University Bundang Hospital

location_facility: Consultorio Especializado Psiquiatría Infantil y Adolescentes

location_facility: SI Institute of Children and Adolescents Healthcare of NAMSU

location_facility: CI Odesa Regional Medical Center of Mental Health

location_facility: Ternopil RCCPH Dept of Psychiatry #9 (adolescent)& #8 (pediatric) Ternopil I.Ya. Gorbachevskyi SMU

location_facility: West Visayas State University Medical Center

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

location_facility: O.F. Maltcev Poltava RCPsH Children Dept Ukrainian Medical Stomatological Academy

title: A Randomized, 6-Week, Double-blind, Placebo-Controlled, Flexible Dose, Parallel-Group Study to Evaluate the Efficacy and Safety of Lurasidone in Children and Adolescent Subjects With Bipolar I Depression

location_country:
Poland
Colombia
Hungary
Mexico
United States
Korea, Republic of
Bulgaria
Ukraine
Puerto Rico
Philippines
France


acronym: NEO-EXT

lead_sponsor: Genzyme, a Sanofi Company

summary:
Primary Objective:

Long-term safety and pharmacokinetics (PK) of avalglucosidase alfa

Secondary Objective:

Long-term effect of avalglucosidase alfa on pharmacodynamic and exploratory efficacy variables

location_facility:
Investigational Site Number 208001
Investigational Site Number 840003
Investigational Site Number 276001
Investigational Site Number 840010
Investigational Site Number 826003
Investigational Site Number 276002
Investigational Site Number 840006
Investigational Site Number 250002
Investigational Site Number 840011
Investigational Site Number 840008
Investigational Site Number 250003
Investigational Site Number 840009
Investigational Site Number 528001
Investigational Site Number 840002
Investigational Site Number 056001
Investigational Site Number 276003
Investigational Site Number 840001

title: An Open-Label, Multicenter, Multinational Extension Study Of The Long-Term Safety And Pharmacokinetics Of Repeated Biweekly Infusions Of Avalglucosidase Alfa In Patients With Pompe Disease

location_country:
Germany
United Kingdom
Denmark
Netherlands
Belgium
United States
France