title: A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of CSL112 in Subjects with Acute Coronary Syndrome

acronym: AEGIS-II / ApoA-I Event reducinG in Ischemic Syndromes II

lead_sponsor: CSL Behring LLC


title: Advanced Understanding of Staphylococcus Aureus Infections in Europe - Surgical Site Infections

acronym: ASPIRE-SSI

summary: ASPIRE-SSI is a prospective, observational, multicentre cohort study among adult surgical patients, which aims to determine the incidence of healthcare-associated S. aureus infections, particularly S. aureus surgical site infections (SSIs), across Europe and to assess the most important risk factors for this type of infection.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: Undecided

lead_sponsor: UMC Utrecht

sponsor_collaborators:
UMC Utrecht
MedImmune LLC

location_country:
Italy
United Kingdom
Romania
Netherlands
Belgium
Spain
Czechia
Estonia
Serbia
France

location_facility: Institute for Orthopedic Surgery Banjica

location_facility: Centre Hospitalier Universitaire de Limoges

location_facility: Prof. C.C. Iliescu Cardiovascular Diseases Institute

location_facility: The Pennine Acute Hospitals NHS Trust Manchester

location_facility: York Teaching Hospitals NHS Foundation Trust

location_facility: Derby Teaching Hospitals NHS Foundation Trust

location_facility: Azienda Ospedaliera Universitaria Ospedali Riuniti, Ancona

location_facility: South Tees Hospitals NHS Foundation Trust

location_facility: Brighton & Sussex University Hospital NHS Trust

location_facility: Hospital Universitario Central de Asturias

location_facility: Carol Davila University of Medicine and Pharmacy Bucharest

location_facility: Algemeen Ziekenhuis Sint-Lucas & Volkskliniek Gent

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

type: EudraCT Number

title: A SINGLE-ARM, OPEN-LABEL, MULTICENTER, EXTENDED TREATMENT, SAFETY STUDY IN PATIENTS TREATED WITH TALAZOPARIB

summary: This is a single-arm, open-label, extended treatment, safety study in patients treated with talazoparib in qualifying studies.

study_type: Interventional

primary_purpose: Treatment

ipd_sharing: Yes

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

sponsor_collaborators:
Pfizer
Medivation, Inc.

location_country:
Germany
Moldova, Republic of
Poland
Hungary
United Kingdom
United States
Canada
Russian Federation
France

location_facility: Arensia Exploratory Medicine, Institutia Medico-Sanitara Publica Institutul Oncologic

location_facility: Frauenklinik des Universitaetsklinikums Erlangen

location_facility: Orszagos Onkologiai Intezet "B" Belgyogyaszati-Onkologiai Osztaly es Klinikai Farmakologiai Osztaly

location_facility: Fort Wayne Medical Oncology and Hematology, Inc.

location_facility: UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D.

location_facility: Indiana University Health Melvin and Bren Simon Cancer Center

location_facility: St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare

location_facility: FSBEI HE " First Moscow State Medical University n.a. I.M. Sechenov" of the MoH of the RF

location_facility: CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont, Onkologiai Osztaly

location_facility: (IRB# 16-001189) Ronald Reagan UCLA Medical Center, Drug Information Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: UCLA Hematology/Oncology - Santa Clarita

intervention_type: Drug


type: Registry Identifier

title: Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients With Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant

acronym: MOVES-PD

summary:
Primary Objectives:

Part 1: To determine the safety and tolerability of 4, 8, and 15 milligrams of GZ/SAR402671 (venglustat) administered orally for 4 weeks, as compared to placebo in participants with early-stage Parkinson's disease (PD) carrying a glucocerebrosidase gene (GBA) mutation or other pre-specified variants.
Part 2: To determine the efficacy of GZ/SAR402671 administered orally daily, as compared to placebo in participants with early-stage PD carrying a GBA mutation or other pre-specified variants.

Secondary Objectives:

Part 1:

To assess the pharmacokinetic (PK) profile of oral dosing of GZ/SAR402671 in plasma when administered in early-stage PD participants carrying a GBA mutation.
To assess the exposure of GZ/SAR402671 in cerebrospinal fluid (CSF) when administered in early-stage PD participants carrying a GBA mutation.

Part 2:

To demonstrate overall safety and tolerability of GZ/SAR402671 administered orally for 52 weeks in early-stage PD participants carrying a GBA mutation as compared to placebo.
To assess the pharmacodynamic response to daily oral dosing of GZ/SAR402671 in plasma and CSF as measured by glucosylceramide (GL-1) when administered in early-stage PD participants carrying a GBA mutation over a 52-week period.

status: Terminated

design_allocation: Randomized

ReferenceType: derived

ReferenceCitation: Peterschmitt MJ, Saiki H, Hatano T, Gasser T, Isaacson SH, Gaemers SJM, Minini P, Saubadu S, Sharma J, Walbillic S, Alcalay RN, Cutter G, Hattori N, Hoglinger GU, Marek K, Schapira AHV, Scherzer CR, Simuni T, Giladi N, Sardi SP, Fischer TZ; MOVES-PD Investigators. Safety, Pharmacokinetics, and Pharmacodynamics of Oral Venglustat in Patients with Parkinson's Disease and a GBA Mutation: Results from Part 1 of the Randomized, Double-Blinded, Placebo-Controlled MOVES-PD Trial. J Parkinsons Dis. 2022;12(2):557-570. doi: 10.3233/JPD-212714.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says Open Access)

host_type: publisher

license: unspecified-oa

license_normalized: unspecified-oa

version: publishedVersion

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

host_type: repository

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: DZNE - DZNE Pub

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
PubMed Central
UCL Discovery
pub.dzne.de

unpaywall_oa_status: hybrid

publisher_dissemination: IOS Press

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

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Germany
Italy
Portugal
Israel
Norway
Singapore
Japan
Sweden
United Kingdom
Austria
United States
Spain
Greece
Taiwan
Canada
France

location_facility:
Investigational Site Number :8400018
Investigational Site Number :3800006
Investigational Site Number :3000002
Investigational Site Number :8400002
Investigational Site Number :8260002
Investigational Site Number :6200002
Investigational Site Number :8400017
Investigational Site Number :8400009
Investigational Site Number :8400008
Investigational Site Number :8400004
Investigational Site Number :1240002
Investigational Site Number :8400011
Investigational Site Number :8260001
Investigational Site Number :8400006
Investigational Site Number :7240001
Investigational Site Number :1240003
Investigational Site Number :7520001
Investigational Site Number :8400019
Investigational Site Number :1240001
Investigational Site Number :8400015
Investigational Site Number :8400016
Investigational Site Number :8400001
Investigational Site Number :3800003
Investigational Site Number :3760002
Investigational Site Number :8400020
Investigational Site Number :8400014
Investigational Site Number :3760001
Investigational Site Number :8400021
Investigational Site Number :3920004
Investigational Site Number :3920001
Investigational Site Number :7020001
Investigational Site Number :8400005
Investigational Site Number :1580001
Investigational Site Number :2500001
Investigational Site Number :3800002
Investigational Site Number :3920005
Investigational Site Number :3920002
Investigational Site Number :0400001
Investigational Site Number :7240002
Investigational Site Number :2760002
Investigational Site Number :3800001
Investigational Site Number :2760001
Investigational Site Number :3760004
Investigational Site Number :7020002
Investigational Site Number :6200003
Investigational Site Number :8400010
Investigational Site Number :5780001
Investigational Site Number :8400012
Investigational Site Number :3760003
Investigational Site Number :3920003
Investigational Site Number :8400013
Investigational Site Number :3800004

status_simplified: Unknown


acronym: ODYSSEY KIDS

lead_sponsor: Sanofi

summary:
Primary Objective:

To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 8 weeks of treatment in heterozygous familial hypercholesterolemia (heFH) participants aged of 8 to 17 years, with LDL-C >=130 milligrams per deciliter (mg/dL) (3.37 millimoles per litre [mmol/L]) on optimal stable daily dose of statin therapy +/- other lipid modifying therapies (LMTs) or a stable dose of non-statin LMTs in case of intolerance to statins for at least 4 weeks prior to the screening period.

Secondary Objective:

To evaluate the safety and tolerability of alirocumab.
To evaluate the pharmacokinetics profile of alirocumab.
To evaluate the effects of alirocumab on other lipid parameters.

ReferenceCitation: Daniels S, Caprio S, Chaudhari U, Manvelian G, Baccara-Dinet MT, Brunet A, Scemama M, Loizeau V, Bruckert E. PCSK9 inhibition with alirocumab in pediatric patients with heterozygous familial hypercholesterolemia: The ODYSSEY KIDS study. J Clin Lipidol. 2020 May-Jun;14(3):322-330.e5. doi: 10.1016/j.jacl.2020.03.001. Epub 2020 Mar 28. Erratum In: J Clin Lipidol. 2020 Sep - Oct;14(5):741.

oa_host_type: publisher

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories_concat: closed

publisher_dissemination: Elsevier

sponsor_collaborators:
Sanofi
Regeneron Pharmaceuticals

location_facility:
Investigational Site Number 7520001
Investigational Site Number 6430001
Investigational Site Number 2030003
Investigational Site Number 6430004
Investigational Site Number 7240001
Investigational Site Number 5780001
Investigational Site Number 7100001
Investigational Site Number 1240001
Investigational Site Number 8400005
Investigational Site Number 7240004
Investigational Site Number 5280001
Investigational Site Number 8400001
Investigational Site Number 8400002
Investigational Site Number 2500001
Investigational Site Number 2030001
Investigational Site Number 2030002

title: An 8-Week Open-Label, Sequential, Repeated Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia Followed by an Extension Phase

source: euctr

design_allocation: Non-Randomized

location_country:
Norway
Sweden
Netherlands
United States
Spain
South Africa
Czechia
Canada
Russian Federation
France


acronym: FINCH 2

lead_sponsor: Gilead Sciences

summary: The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 12.

ReferenceType: result

ReferenceCitation: Genovese MC, Kalunian KC, Walker D, Gottenberg JE, De Vlam K, Mozaffarian N, et al. Safety and Efficacy of Filgotinib in a Phase 3 Trial of Patients with Active Rheumatoid Arthritis and Inadequate Response or Intolerance to Biologic Dmards [Abstract No. L06]. ACR/ARHP Annual Meeting; 2018 19-24 October; Chicago, IL, USA.

ReferenceCitation: Genovese MC, Kalunian K, Gottenberg JE, Mozaffarian N, Bartok B, Matzkies F, Gao J, Guo Y, Tasset C, Sundy JS, de Vlam K, Walker D, Takeuchi T. Effect of Filgotinib vs Placebo on Clinical Response in Patients With Moderate to Severe Rheumatoid Arthritis Refractory to Disease-Modifying Antirheumatic Drug Therapy: The FINCH 2 Randomized Clinical Trial. JAMA. 2019 Jul 23;322(4):315-325. doi: 10.1001/jama.2019.9055. Erratum In: JAMA. 2020 Feb 4;323(5):480.

oa_colors: green other

evidence: open (via free pdf)

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: PubMed Central - Europe PMC

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

unpaywall_oa_status: bronze

publisher_dissemination: American Medical Association

ReferenceCitation: Combe B, Besuyen R, Gomez-Centeno A, Matsubara T, Sancho Jimenez JJ, Yin Z, Buch MH. Geographic Analysis of the Safety and Efficacy of Filgotinib in Rheumatoid Arthritis. Rheumatol Ther. 2023 Feb;10(1):35-51. doi: 10.1007/s40744-022-00494-1. Epub 2022 Oct 7.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: University of Illinois at Chicago - INDIGO

version: submittedVersion

repositories_concat: PubMed Central;figshare.com

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Bingham CO 3rd, Walker D, Nash P, Lee SJ, Ye L, Hu H, Khalid JM, Combe B. The impact of filgotinib on patient-reported outcomes and health-related quality of life for patients with active rheumatoid arthritis: a post hoc analysis of Phase 3 studies. Arthritis Res Ther. 2022 Jan 3;24(1):11. doi: 10.1186/s13075-021-02677-7.

license: cc-by

license_normalized: cc-by

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

ReferenceCitation: Takeuchi T, Matsubara T, Atsumi T, Amano K, Ishiguro N, Sugiyama E, Yamaoka K, Genovese MC, Kalunian K, Walker D, Gottenberg JE, de Vlam K, Bartok B, Pechonkina A, Kondo A, Gao J, Guo Y, Tasset C, Sundy JS, Tanaka Y. Efficacy and safety of filgotinib in Japanese patients with refractory rheumatoid arthritis: Subgroup analyses of a global phase 3 study (FINCH 2). Mod Rheumatol. 2022 Jan 5;32(1):59-67. doi: 10.1080/14397595.2020.1859675.

oa_host_type: repository

version: acceptedVersion

repositories_concat: LIRIAS (KU Leuven)

unpaywall_oa_status: green

publisher_dissemination: Oxford University Press

sponsor_collaborators:
Gilead Sciences
Galapagos NV

title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 Weeks in Combination With Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment

location_country:
Germany
Poland
Hungary
Argentina
Israel
Australia
Japan
Switzerland
Mexico
Belgium
United Kingdom
United States
Korea, Republic of
Spain
France

ipd_sharing: No


title: Non-Randomized, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Peginterferon Alfa-2a and Copegus Combination Therapy After Single and Multiple Doses in Patients With Chronic Hepatitis C and Moderate Renal Impairment, Severe Renal Impairment, or End-Stage Renal Disease Undergoing Hemodialysis

summary: This study will evaluate the pharmacokinetics (area under the curve [AUC], maximum concentration [Cmax], and other parameters) and tolerability of peginterferon alfa-2a and ribavirin combination therapy following single and multiple doses in participants with CHC infection and moderate to severe renal impairment or end-stage renal disease (ESRD) receiving hemodialysis. The anticipated time on study treatment is up to 48 weeks, and the target sample size is 48 individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
France
New Zealand
Brazil
United States
Sweden


title: A Phase 1 Study of an ERK1/2 Inhibitor (LY3214996) Administered Alone or in Combination With Other Agents in Advanced Cancer

summary: The purpose of this study is to determine the safety of an extracellular signal regulated kinase (ERK1/2) inhibitor LY3214996 administered alone or in combination with other agents in participants with advanced cancer.

ReferenceCitation: Bhagwat SV, McMillen WT, Cai S, Zhao B, Whitesell M, Shen W, Kindler L, Flack RS, Wu W, Anderson B, Zhai Y, Yuan XJ, Pogue M, Van Horn RD, Rao X, McCann D, Dropsey AJ, Manro J, Walgren J, Yuen E, Rodriguez MJ, Plowman GD, Tiu RV, Joseph S, Peng SB. ERK Inhibitor LY3214996 Targets ERK Pathway-Driven Cancers: A Therapeutic Approach Toward Precision Medicine. Mol Cancer Ther. 2020 Feb;19(2):325-336. doi: 10.1158/1535-7163.MCT-19-0183. Epub 2019 Nov 19.

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

repositories_institution: University of Illinois at Chicago - INDIGO

publisher_dissemination: American Association for Cancer Research

lead_sponsor: Eli Lilly and Company

location_country:
United States
Australia
Japan
France

location_facility: University of Texas MD Anderson Cancer Center


type: U.S. NIH Grant/Contract

title: Clinical Acceptance of the Artificial Pancreas: the International Diabetes Closed Loop (iDCL) Trial Research Site Training Protocol

summary: The objective of the study is for clinical staff to gain experience using the proposed artificial pancreas system named inControl and the inControl Cloud and assess 24/7 in-home usability prior to initiating a large randomized controlled trial.

primary_purpose: Other

ipd_sharing_description: Not yet determined

lead_sponsor: University of Virginia

collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

location_country:
United States
Italy
Netherlands
France

location_facility: Harvard University (Joslin Diabetes Center)

location_facility: University of Virginia Center for Diabetes Technology

location_facility: Barbara Davis Center, University of Colorado

intervention_type: Device

lead_sponsor_type: academique


title: A Multinational Phase IV Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis

acronym: TAURUS

summary:
The primary objective of this study is to investigate weekly prophylaxis dosing regimens used in standard clinical practice.

In addition the study will capture reported bleed rate, pattern of change in KOVALTRY prophylaxis dose & dosing frequency, reason for choice of treatment regimen, FVIII product switch pattern, patient treatment satisfaction and adherence, KOVALTRY pharmacokinetic data (if performed), KOVALTRY consumption, as well as safety data.

ReferenceCitation: Santoro C, Fuh B, Le PQ, Maes P, Berrueco R, Mingot-Castellano EM, von Mackensen S, Tueckmantel C, Cabre-Marquez JF, Wang M. Efficacy and safety in patients with haemophilia A switching to octocog alfa (BAY 81-8973): Final results of the global real-world study, TAURUS. Eur J Haematol. 2023 Jan;110(1):77-87. doi: 10.1111/ejh.13876. Epub 2022 Oct 17.

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

repositories:
PubMed Central
irua

repositories_concat: PubMed Central;irua

publisher_dissemination: Wiley

lead_sponsor: Bayer

location_country:
Germany
Italy
Slovenia
Colombia
Netherlands
Belgium
United States
Spain
Luxembourg
Greece
Taiwan
Canada
France

location_facility: University of Florida Health Cancer Center

location_facility: Nemours Children's Clinic - Division of Pediatric Hematology/Oncology - Jacksonsville

location_facility: Intermountain Hemophilia & Thrombosis Center

location_facility: Children's Rehabilitation Services/ University of South Alabama

location_facility: Henry Ford Hospital Adult Hemophilia and Thrombosis Treatment Center

location_facility: Children's Hospital at OU Medical Center

location_facility: East Carolina University - Brody School of Medicine

location_facility: Washington University Center for Bleeding and Blood Clotting Disorders

location_facility: Wake Forest University School of Medicine

location_facility: Comprehensive Center for Bleeding Disorders / Blood Center of Wisconsin

location_facility: University of Colorado Hemophilia and Thrombosis Center

intervention_type: Biological


acronym: VIOLET

summary: To evaluate the efficacy of long-term treatment with 2 mg aflibercept via different intravitreal (IVT) treatment regimens to participants with DME pretreated with 2 mg aflibercept every 8 weeks after 5 initial monthly injections for approximately 1 year or more (according to the EU label for the first year of treatment)

ReferenceCitation: Garweg JG, Stefanickova J, Hoyng C, Niesen T, Schmelter T, Leal S, Sivaprasad S; VIOLET Investigators. Dosing Regimens of Intravitreal Aflibercept for Diabetic Macular Edema Beyond the First Year: VIOLET, a Prospective Randomized Trial. Adv Ther. 2022 Jun;39(6):2701-2716. doi: 10.1007/s12325-022-02119-z. Epub 2022 Apr 12.

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

repository_institution: University of Bern - Bern Open Repository and Information System

title: An Open-label, Randomized, Active-controlled, Parallel-group, Phase-3b Study of the Efficacy, Safety, and Tolerability of Three Different Treatment Regimens of 2 mg Aflibercept Administered by Intravitreal Injections to Subjects With Diabetic Macular Edema (DME)

location_country:
Germany
Italy
Lithuania
Poland
Portugal
Slovakia
Hungary
United Kingdom
Switzerland
Austria
Spain
Czechia
Canada
France


title: PRediction of Opioid-induced Respiratory Depression In Patients Monitored by capnoGraphY (PRODIGY)

acronym: PRODIGY

summary:
PRODIGY is a prospective, multi-center, post-market, international cohort study. The primary objective of this study is to derive a score to identify subjects at risk to have respiratory depression (RD) episodes in patients undergoing opioid therapy in the hospital ward and monitored by capnography. The score will be derived by using subjects within the derivation cohort and internally validated using subjects within the validation cohort.

The primary endpoint used to derive the score will be the occurrence of RD episodes derived by Capnostream 20p device memory data combined with clinical data and validated by an independent Clinical Endpoint Committee (CEC) during the study course.

primary_purpose: Screening

ReferenceType: background

ReferenceCitation: Overdyk FJ, Carter R, Maddox RR, Callura J, Herrin AE, Henriquez C. Continuous oximetry/capnometry monitoring reveals frequent desaturation and bradypnea during patient-controlled analgesia. Anesth Analg. 2007 Aug;105(2):412-8. doi: 10.1213/01.ane.0000269489.26048.63.

ReferenceCitation: Jarzyna D, Jungquist CR, Pasero C, Willens JS, Nisbet A, Oakes L, Dempsey SJ, Santangelo D, Polomano RC. American Society for Pain Management Nursing guidelines on monitoring for opioid-induced sedation and respiratory depression. Pain Manag Nurs. 2011 Sep;12(3):118-145.e10. doi: 10.1016/j.pmn.2011.06.008.

ReferenceCitation: Cashman JN, Dolin SJ. Respiratory and haemodynamic effects of acute postoperative pain management: evidence from published data. Br J Anaesth. 2004 Aug;93(2):212-23. doi: 10.1093/bja/aeh180. Epub 2004 May 28.

ReferenceCitation: Sun Z, Sessler DI, Dalton JE, Devereaux PJ, Shahinyan A, Naylor AJ, Hutcherson MT, Finnegan PS, Tandon V, Darvish-Kazem S, Chugh S, Alzayer H, Kurz A. Postoperative Hypoxemia Is Common and Persistent: A Prospective Blinded Observational Study. Anesth Analg. 2015 Sep;121(3):709-715. doi: 10.1213/ANE.0000000000000836.

ReferenceCitation: Kor JJ, Sprung J, Khanna AK, Weingarten TN. Continuous Monitoring Detected Respiratory Depressive Episodes in Proximity to Adverse Respiratory Events During the PRODIGY Trial. J Patient Saf. 2022 Dec 1;18(8):738-741. doi: 10.1097/PTS.0000000000001003. Epub 2022 Apr 27.

evidence: open (via page says license)

repositories_concat: PubMed Central

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Sim MA, Seet E, Khanna AK, Weingarten TN, Liew L, Law LS, Liu KE, Di Piazza F, Ti LK; PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) Group Investigators. Association Between Race and Opioid-Induced Respiratory Depression: An International Post Hoc Analysis of the Prediction of Opioid-induced Respiratory Depression In Patients Monitored by Capnography Trial. Anesth Analg. 2022 Nov 1;135(5):1097-1105. doi: 10.1213/ANE.0000000000006006. Epub 2022 Mar 29.

oa_host_type: closed

ReferenceCitation: Khanna AK, Jungquist CR, Buhre W, Soto R, Di Piazza F, Saager L; PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) Group Investigators. Modeling the Cost Savings of Continuous Pulse Oximetry and Capnography Monitoring of United States General Care Floor Patients Receiving Opioids Based on the PRODIGY Trial. Adv Ther. 2021 Jul;38(7):3745-3759. doi: 10.1007/s12325-021-01779-7. Epub 2021 May 24.

repository_institution: Georg-August-Universität Göttingen - GoeScholar  The Publication Server of the Georg-August-Universität Göttingen

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

ReferenceCitation: Khanna AK, Saager L, Bergese SD, Jungquist CR, Morimatsu H, Uezono S, Ti LK, Soto R, Jiang W, Buhre W. Opioid-induced respiratory depression increases hospital costs and length of stay in patients recovering on the general care floor. BMC Anesthesiol. 2021 Mar 20;21(1):88. doi: 10.1186/s12871-021-01307-8.

evidence: oa repository (via page says license)

repository_normalized: Research Square

repository_institution: Research Square - Research Square

repositories:
PubMed Central
Research Square

repositories_concat: PubMed Central;Research Square

ReferenceCitation: Urman RD, Khanna AK, Bergese SD, Buhre W, Wittmann M, Le Guen M, Overdyk FJ, Di Piazza F, Saager L. Postoperative opioid administration characteristics associated with opioid-induced respiratory depression: Results from the PRODIGY trial. J Clin Anesth. 2021 Jun;70:110167. doi: 10.1016/j.jclinane.2021.110167. Epub 2021 Jan 22.

ReferenceCitation: Khanna AK, Bergese SD, Jungquist CR, Morimatsu H, Uezono S, Lee S, Ti LK, Urman RD, McIntyre R Jr, Tornero C, Dahan A, Saager L, Weingarten TN, Wittmann M, Auckley D, Brazzi L, Le Guen M, Soto R, Schramm F, Ayad S, Kaw R, Di Stefano P, Sessler DI, Uribe A, Moll V, Dempsey SJ, Buhre W, Overdyk FJ; PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) Group Collaborators. Prediction of Opioid-Induced Respiratory Depression on Inpatient Wards Using Continuous Capnography and Oximetry: An International Prospective, Observational Trial. Anesth Analg. 2020 Oct;131(4):1012-1024. doi: 10.1213/ANE.0000000000004788.

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Khanna AK, Overdyk FJ, Greening C, Di Stefano P, Buhre WF. Respiratory depression in low acuity hospital settings-Seeking answers from the PRODIGY trial. J Crit Care. 2018 Oct;47:80-87. doi: 10.1016/j.jcrc.2018.06.014. Epub 2018 Jun 18.

location_country:
Germany
Singapore
Japan
Netherlands
United States
Spain
France

location_facility: The Ohio State University Wexner Medical Center

location_facility: The Jikei University School of Medicine Hospital

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Providence Regional Medical Center Everett


lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of this study of MCS110 with PDR001 was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of the combination of MCS110 with PDR001 in adult patients with solid tumors.

location_facility: Washington University School of Medicine

title: A Phase Ib/II, Open Label, Multicenter Study of MCS110 in Combination With PDR001 in Patients With Advanced Malignancies

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
Finland
Italy
Hong Kong
Japan
Switzerland
Belgium
United States
Korea, Republic of
Spain
France


title: Efficacy Study of Inecalcitol in Combination With Decitabine in Acute Myeloid Leukemia Patients Unfit for Standard Chemotherapy

summary: Evaluate the effect of the addition of inecalcitol to decitabine treatment on overall survival in previously untreated AML patients aged 65 years or more who are randomly assigned to receive decitabine with or without inecalcitol.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Hybrigenics Corporation

location_country:
United States
France

location_facility: Georgia Cancer Center-Augusta University

location_facility: University of Texas; M D Anderson Cancer Center

location_facility: Duke Cancer Institute, Duke Univ Medical Center


title: An Open-Label, Multicenter Study to Evaluate the Long-term Safety of Weekly Intravenous Alpha1-Proteinase Inhibitor (Human), Modified Process 60 mg/kg in Subjects With Pulmonary Emphysema Due to Alpha1-Antitrypsin Deficiency

acronym: SPARTA-OLE

summary: This is a 2-year open-label, multicenter extension of the double-blind, placebo-controlled GTi1201 study. The purpose of this study is to obtain an additional 2 years of safety data for intravenously administered Alpha1-MP 60 mg/kg/week in subjects with alpha1-antitrypsin deficiency (AATD).

status: Enrolling by invitation

lead_sponsor: Grifols Therapeutics LLC

location_country:
Finland
Poland
New Zealand
Denmark
Australia
Sweden
United States
Canada
Estonia
Russian Federation
France

location_facility: SBEI HPE Altai State Medical University of MoH and SD

location_facility: University of Texas Health Center at Tyler

location_facility: University Of Miami Hospital, Doctors Office West Building

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: St. Joseph's Hospital and Medical Center

location_facility: Instytut Gruzlicy i Chorob Pluc w Warszawie

location_facility: CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel


acronym: BALANCE

lead_sponsor: Protalix

summary: This was a randomized, double-blind, active control study of the enzyme replacement therapy (ERT) drug PRX-102 (pegunigalsidase alfa) in Fabry disease patients with impaired renal function. Patients who had been treated for approximately 1 year with agalsidase beta and who had been on a stable dose of that product for at least 6 months were randomized in a 2:1 ratio to either switch to PRX-102 or to continue treatment with agalsidase beta. Both treatments were delivered by intravenous infusions every two weeks, at a dosage of 1 mg/kg.

sponsor_collaborators:
Protalix
Chiesi Farmaceutici S.p.A.

location_facility: University of Iowa Hosptials and Clinics

location_facility: Eccles Primary Children's Outpatient Services Building

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Klinik und Poliklinik für Innere Medizin UniversitätsSpital Zürich

location_facility: Institute of Metabolism and Systems Research

location_facility: Haukeland University Hospital Klinisk Forskningspost

location_facility: Renal Disease Research Institute, LLC - Dallas

location_facility: Institute of Metabolic Disease, Baylor Healthcare

location_facility: Azienda Ospedaliera Universitaria "Federico II"

title: A Randomized, Double Blind, Active Control Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function in Patients With Fabry Disease Previously Treated With Agalsidase Beta

location_country:
Finland
Italy
Slovenia
Hungary
Norway
United Kingdom
Netherlands
Switzerland
United States
Spain
Czechia
France


title: Helicobacter Pylori Genome Project (HpGP)

summary:
Helicobacter pylori is a common bacterial infection. It can lead to severe stomach problems, including stomach cancer. Researchers want to look at samples of the bacteria. These H. pylori strains will be taken from chronically infected people. They want to identify the genetic and epigenetic differences in H. pylori strains. This could help predict which people who get infected with the bacteria will get stomach cancer. This could lead to the cancer being detected earlier. It could also mean less people get stomach cancer.

Objectives:

To study genetic variations of H. pylori strains based on samples from chronically infected people. To identify the features of strains that might lead to severe stomach problems or stomach cancer.

Eligibility:

People ages 30-70 years who need an upper endoscopy or who were recently diagnosed with stomach cancer

Design:

Participants will be screened by the doctor who does their procedure and a study nurse.

Participants who have endoscopy will have ~6 biopsies removed. These are tissue samples. They are about the size of a grain of rice. Participants will allow the study team to access reports from their stomach exam.

Participants with stomach cancer will donate some of the tissue that will be removed during their clinical care. They will allow the study team to access reports of their surgery. They will also allow them to access the microscope slides of their stomach.

time_perspective: Cross-Sectional

ReferenceCitation: Correa P, Haenszel W, Cuello C, Tannenbaum S, Archer M. A model for gastric cancer epidemiology. Lancet. 1975 Jul 12;2(7924):58-60. doi: 10.1016/s0140-6736(75)90498-5.

ReferenceCitation: Tomb JF, White O, Kerlavage AR, Clayton RA, Sutton GG, Fleischmann RD, Ketchum KA, Klenk HP, Gill S, Dougherty BA, Nelson K, Quackenbush J, Zhou L, Kirkness EF, Peterson S, Loftus B, Richardson D, Dodson R, Khalak HG, Glodek A, McKenney K, Fitzegerald LM, Lee N, Adams MD, Hickey EK, Berg DE, Gocayne JD, Utterback TR, Peterson JD, Kelley JM, Cotton MD, Weidman JM, Fujii C, Bowman C, Watthey L, Wallin E, Hayes WS, Borodovsky M, Karp PD, Smith HO, Fraser CM, Venter JC. The complete genome sequence of the gastric pathogen Helicobacter pylori. Nature. 1997 Aug 7;388(6642):539-47. doi: 10.1038/41483. Erratum In: Nature 1997 Sep 25;389(6649):412.

ReferenceCitation: Krebes J, Morgan RD, Bunk B, Sproer C, Luong K, Parusel R, Anton BP, Konig C, Josenhans C, Overmann J, Roberts RJ, Korlach J, Suerbaum S. The complex methylome of the human gastric pathogen Helicobacter pylori. Nucleic Acids Res. 2014 Feb;42(4):2415-32. doi: 10.1093/nar/gkt1201. Epub 2013 Dec 2.

lead_sponsor: National Cancer Institute (NCI)

collaborators: National Institute of Infectious Diseases, Japan

collaborators: National Institute for Basic Biology, Japan

collaborators: Instituto Mexicano de Seguro Social, Mexico

collaborators: Instituto de Biomedicina de Valencia, Spain

collaborators: Vanderbilt University Medical Center, USA

collaborators: Max von Pettenkofer-Institute of Hygiene and Medical Microbiology, Germany

location_country:
Germany
Poland
Taiwan
Argentina
Algeria
Japan
Brazil
Costa Rica
Kazakhstan
Turkey
Vietnam
Chile
Nepal
Canada
Kyrgyzstan
France
Lithuania
Colombia
Portugal
Nigeria
Switzerland
United States
Honduras
Latvia
Dominican Republic
Iceland
Kenya
Indonesia
India
Congo, The Democratic Republic of the
Sudan
Belgium
Malaysia
Peru
Ghana
Cameroon
Puerto Rico
Italy
Guatemala
Singapore
Iran, Islamic Republic of
Sweden
Mexico
Korea, Republic of
Spain
Bangladesh
Greece
Myanmar
South Africa
Jordan
Bulgaria
Russian Federation
Israel

location_facility: Centers for Disease Control and Prevention

location_facility: Jordan University of Science and Technology

location_facility: Instituto Nacional de Saúde Dr. Ricardo Jorge

location_facility: Lithuanian University of Health Sciences

location_facility: University of Jos / University Teaching Hospital

location_facility: Institut d'Investigació Biomédica de Bellvitge (Idibell)

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Sudan University of Science and Technology

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Evangelismos Hospital and Hellenic Pasteur Institute

location_facility: Chris Hani Baragwanath Academic Hospital


title: A Phase 1b Trial to Assess the Modulation of Biological Markers in Patients With Potentially Resectable Soft Tissue Sarcoma Treated With Olaratumab Monotherapy Followed by Olaratumab Plus Doxorubicin Combination Therapy

summary: The purpose of this study is to evaluate potential biomarkers and method of action, efficacy and safety of olaratumab in participants with soft tissue sarcoma (STS).

location_country:
Italy
United Kingdom
United States
Spain
France

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.


acronym: SKYPP

summary:
Primary Objective:

To describe the pharmacokinetic (PK) profile of sarilumab in patients aged 2-17 years with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) in order to identify the dose and regimen for adequate treatment of this population

Secondary Objective:

To describe the pharmacodynamic (PD) profile, the efficacy and the long-term safety of sarilumab in patients with pcJIA.

location_facility: Children's Hospital Los Angeles Site Number : 8400416

status: Active, not recruiting

title: An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered With Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase

location_country:
Finland
Germany
Italy
Poland
United Kingdom
Argentina
Netherlands
Mexico
United States
Spain
Chile
Czechia
Canada
Russian Federation
France

status_simplified: Ongoing


title: Effect of Adapalene 0.3% - Benzoyl Peroxide 2.5% Gel Versus Vehicle Gel on the Risk of Formation of Atrophic Acne Scars in Moderate to Severe Acne Subjects

acronym: OSCAR

summary:
This was a multi-centre, randomized, investigator blinded, vehicle controlled trial using intra-individual comparison (right half-face versus left half-face).

Participants with each half-face randomized to one of the two following treatments:

Adapalene 0.3 percent (%) - benzoyl peroxide (BPO) 2.5% gel (TactuPump® Forte).
Vehicle gel

The main objective of this trial was to evaluate the effect of Adapalene 0.3% - BPO 2.5% (ABPO Forte) gel versus vehicle gel on the risk of formation of atrophic acne scars in moderate to severe acne participants.

primary_purpose: Prevention

ReferenceCitation: Dreno B, Bissonnette R, Gagne-Henley A, Barankin B, Lynde C, Chavda R, Kerrouche N, Tan J. Long-Term Effectiveness and Safety of Up to 48 Weeks' Treatment with Topical Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in the Prevention and Reduction of Atrophic Acne Scars in Moderate and Severe Facial Acne. Am J Clin Dermatol. 2019 Oct;20(5):725-732. doi: 10.1007/s40257-019-00454-6.

ReferenceCitation: Dreno B, Bissonnette R, Gagne-Henley A, Barankin B, Lynde C, Kerrouche N, Tan J. Prevention and Reduction of Atrophic Acne Scars with Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in Subjects with Moderate or Severe Facial Acne: Results of a 6-Month Randomized, Vehicle-Controlled Trial Using Intra-Individual Comparison. Am J Clin Dermatol. 2018 Apr;19(2):275-286. doi: 10.1007/s40257-018-0352-y.

lead_sponsor: Galderma R&D

location_country: Canada France


lead_sponsor: Gamida Cell ltd

summary: This study is an open-label, controlled, multicenter, international, Phase III, randomized study of transplantation of NiCord® versus transplantation of one or two unmanipulated, unrelated cord blood units in patients with acute lymphoblastic leukemia or acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia or lymphoma, all with required disease features rendering them eligible for allogeneic transplantation.

ReferenceCitation: Horwitz ME, Stiff PJ, Cutler C, Brunstein C, Hanna R, Maziarz RT, Rezvani AR, Karris NA, McGuirk J, Valcarcel D, Schiller GJ, Lindemans CA, Hwang WYK, Koh LP, Keating A, Khaled Y, Hamerschlak N, Frankfurt O, Peled T, Segalovich I, Blackwell B, Wease S, Freedman LS, Galamidi-Cohen E, Sanz G. Omidubicel vs standard myeloablative umbilical cord blood transplantation: results of a phase 3 randomized study. Blood. 2021 Oct 21;138(16):1429-1440. doi: 10.1182/blood.2021011719.

evidence: open (via free article)

publisher_dissemination: American Society of Hematology

ReferenceCitation: Del Pozo Martin Y. 47th Annual Meeting of the EBMT. Lancet Haematol. 2021 May;8(5):e317-e318. doi: 10.1016/S2352-3026(21)00104-6. Epub 2021 Mar 31. No abstract available.

location_facility: Loyola University, Cardinal Bernardin Cancer Center

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: University of Minnesota Masonic Cancer Center

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo Pediatrics

location_facility: Chaim Sheba Medical Center, The Edmond and Lily Safra Children's hospital

location_facility: Hospital Universitari Vall d'Hebron pediatrics

location_facility: Manchester University NHS Foundation Trust

location_facility: Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA

location_facility: Prinses Maxima Centrum voor Kinderoncologie B.V.

location_facility: Dana-Dwek Children's Hospital, Tel-Aviv Sourasky Medical Center

location_facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

location_facility: Hospital Universitario y Politécnico La Fe (pediatric)

location_facility: The University of Maryland Medicine Center

title: A Multicenter, Randomized, Phase III Registration Trial of Transplantation of NiCord®, Ex Vivo Expanded, UCB-derived, Stem and Progenitor Cells, vs. Unmanipulated UCB for Patients With Hematological Malignancies

location_country:
France
Italy
Portugal
United Kingdom
Singapore
Brazil
Netherlands
United States
Spain
Israel


acronym: ACH

lead_sponsor: BioMarin Pharmaceutical

summary: This is a Phase 2, Open-Label, Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of BMN 111 in Children with Achondroplasia. The primary objective is to evaluate the long-term safety and tolerability of daily SC injections of BMN 111 in children with ACH who have completed two years of treatment in the 111-202 study.

ReferenceCitation: Savarirayan R, Irving M, Bacino CA, Bostwick B, Charrow J, Cormier-Daire V, Le Quan Sang KH, Dickson P, Harmatz P, Phillips J, Owen N, Cherukuri A, Jayaram K, Jeha GS, Larimore K, Chan ML, Huntsman Labed A, Day J, Hoover-Fong J. C-Type Natriuretic Peptide Analogue Therapy in Children with Achondroplasia. N Engl J Med. 2019 Jul 4;381(1):25-35. doi: 10.1056/NEJMoa1813446. Epub 2019 Jun 18.

publisher_dissemination: Massachusetts Medical Society

location_facility: Children's Hospital & Research Center Oakland

location_facility: Guys & St. Thomas NHS Foundation Trust Evelina Hospital

location_facility: Johns Hopkins McKusick - Institute of Genetic Medicine

location_facility: Ann and Robert H. Lurie Childrens Hospital of Chicago

title: A Phase 2, Open-Label, Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of BMN 111 in Children With Achondroplasia

location_country:
United States
United Kingdom
Australia
France


summary: This study is designed to provide continued access to intravenous (IV) Herceptin and to evaluate long-term outcomes and overall safety in participants with stable disease and human epidermal growth factor 2 (HER2)-overexpressing metastatic or locally advanced cancer who have completed a prior study with IV Herceptin.

ReferenceCitation: Muller V, Clemens M, Jassem J, Al-Sakaff N, Auclair P, Nuesch E, Holloway D, Shing M, Bang YJ. Long-term trastuzumab (Herceptin(R)) treatment in a continuation study of patients with HER2-positive breast cancer or HER2-positive gastric cancer. BMC Cancer. 2018 Mar 15;18(1):295. doi: 10.1186/s12885-018-4183-2.

repository_institution: Seoul National University - Seoul National University Open Repository

repositories_concat: PubMed Central;s-space.snu.ac.kr

title: A Single Arm, Multi-Center, International, Continuation Trial of Recombinant Humanized Antibody Herceptin (Trastuzumab) in Patients With HER2-Overexpressing Tumors

location_country:
Germany
Poland
Guatemala
Portugal
New Zealand
Hungary
Israel
United Kingdom
Australia
Belgium
Korea, Republic of
China
Spain
Panama
Serbia
Russian Federation
France


lead_sponsor: Acerta Pharma BV

summary: A Phase 2 Study to evaluate the Efficacy and Safety of ACP-196 (acalabrutinib) in Subjects with Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

ReferenceCitation: Rogers KA, Thompson PA, Allan JN, Coleman M, Sharman JP, Cheson BD, Jones D, Izumi R, Frigault MM, Quah C, Raman RK, Patel P, Wang MH, Kipps TJ. Phase II study of acalabrutinib in ibrutinib-intolerant patients with relapsed/refractory chronic lymphocytic leukemia. Haematologica. 2021 Sep 1;106(9):2364-2373. doi: 10.3324/haematol.2020.272500.

license: publisher-specific license

license_normalized: publisher-specific

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Mato AR, Nabhan C, Barr PM, Ujjani CS, Hill BT, Lamanna N, Skarbnik AP, Howlett C, Pu JJ, Sehgal AR, Strelec LE, Vandegrift A, Fitzpatrick DM, Zent CS, Feldman T, Goy A, Claxton DF, Bachow SH, Kaur G, Svoboda J, Nasta SD, Porter D, Landsburg DJ, Schuster SJ, Cheson BD, Kiselev P, Evens AM. Outcomes of CLL patients treated with sequential kinase inhibitor therapy: a real world experience. Blood. 2016 Nov 3;128(18):2199-2205. doi: 10.1182/blood-2016-05-716977. Epub 2016 Sep 6.

title: A Phase 2 Study of the Efficacy and Safety of ACP-196 in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
France
United Kingdom
Belgium
United States
Spain
Israel


lead_sponsor: Incyte Corporation

summary:
The purpose of the Study is to select a dose and assess the safety and tolerability of INCB057643 as a monotherapy (Part 1 and Part 2) and in combination with standard-of-care (SOC) agents (Part 3 and Part 4) for subjects with advanced malignancies.

Part 1 will determine the maximum tolerated dose of INCB057643 and/or a tolerated dose that demonstrates sufficient pharmacologic activity. Part 2 will further evaluate the safety, preliminary efficacy, PK, and PD of the dose(s) selected in Part 1 in select tumor types including solid tumors, lymphomas and other hematologic malignancies. Part 3 will determine the tolerated dose of INCB057643 in combination with select SOC agents; and assess the safety and tolerability of the combination therapy in select advanced solid tumors and hematologic malignancies. Part 4 will further evaluate the safety, preliminary efficacy, PK, and PD of the selected dose combination from Part 3 in 4 specific advanced solid tumor and hematologic malignancies.

ReferenceCitation: Falchook G, Rosen S, LoRusso P, Watts J, Gupta S, Coombs CC, Talpaz M, Kurzrock R, Mita M, Cassaday R, Harb W, Peguero J, Smith DC, Piha-Paul SA, Szmulewitz R, Noel MS, Yeleswaram S, Liu P, Switzky J, Zhou G, Zheng F, Mehta A. Development of 2 Bromodomain and Extraterminal Inhibitors With Distinct Pharmacokinetic and Pharmacodynamic Profiles for the Treatment of Advanced Malignancies. Clin Cancer Res. 2020 Mar 15;26(6):1247-1257. doi: 10.1158/1078-0432.CCR-18-4071. Epub 2019 Sep 16.

repository_institution: California Digital Library - eScholarship

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

location_facility: MultiCare Institute for Research and Innovation

location_facility: HÔPITAL SAINT-LOUIS, Service Hématologie Adultes

location_facility: Sarah Cannon Research Institute at Health One

location_facility: Institut Jules Bordet, Clinical Trial Conduct Unit

location_facility: Hematology - Oncology Associates of Treasure Coast

location_facility: University of Rochester, Wilmot Cancer Center

location_facility: University of North Carolina at Chapel Hill

title: A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies

location_country:
United States
Belgium
France


title: A Phase 1 Multicenter, Open-label, Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Antitumor Activity of MEDI0562 in Combination With Immune Therapeutic Agents in Adult Subjects With Advanced Solid Tumors

summary: The purpose of this study is to evaluate MEDI0562 in combination with immune therapeutic agents in adult subjects with select advanced solid tumors.

ReferenceCitation: Goldman JW, Piha-Paul SA, Curti B, Pedersen KS, Bauer TM, Groenland SL, Carvajal RD, Chhaya V, Kirby G, McGlinchey K, Hammond SA, Streicher K, Townsley DM, Chae YK, Voortman J, Marabelle A, Powderly J. Safety and Tolerability of MEDI0562, an OX40 Agonist mAb, in Combination with Durvalumab or Tremelimumab in Adult Patients with Advanced Solid Tumors. Clin Cancer Res. 2022 Sep 1;28(17):3709-3719. doi: 10.1158/1078-0432.CCR-21-3016.

lead_sponsor: MedImmune LLC

location_country:
United States
Netherlands
France


title: A Phase 2, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of NGM282 Administered for 12 Weeks in Patients With Primary Sclerosing Cholangitis

summary: The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Sclerosing Cholangitis.

ReferenceCitation: Sanyal AJ, Ling L, Beuers U, DePaoli AM, Lieu HD, Harrison SA, Hirschfield GM. Potent suppression of hydrophobic bile acids by aldafermin, an FGF19 analogue, across metabolic and cholestatic liver diseases. JHEP Rep. 2021 Feb 19;3(3):100255. doi: 10.1016/j.jhepr.2021.100255. eCollection 2021 Jun.

lead_sponsor: NGM Biopharmaceuticals, Inc

location_country:
United States
United Kingdom
Netherlands
France

location_facility:
NGM Clinical Study Site 108
NGM Clinical Study Site 124
NGM Clinical Study Site 405
NGM Clinical Study Site 111
NGM Clinical Study Site 301
NGM Clinical Study Site 125
NGM Clinical Study Site 117
NGM Clinical Study Site 114
NGM Clinical Study Site 116
NGM Clinical Study Site 121
NGM Clinical Study Site 112
NGM Clinical Study Site 115
NGM Clinical Study Site 103
NGM Clinical Study Site 119
NGM Clinical Study Site 105
NGM Clinical Study Site 110
NGM Clinical Study Site 501
NGM Clinical Study Site 109
NGM Clinical Study Site 102
NGM Clinical Study Site 122
NGM Clinical Study Site 126
NGM Clinical Study Site 402
NGM Clinical Study Site 120
NGM Clinical Study Site 407
NGM Clinical Study Site 502
NGM Clinical Study Site 101
NGM Clinical Study Site 404
NGM Clinical Study Site 503
NGM Clinical Study Site 107
NGM Clinical Study Site 106
NGM Clinical Study Site 505
NGM Clinical Study Site 113
NGM Clinical Study Site 118
NGM Clinical Study Site 401
NGM Clinical Study Site 504
NGM Clinical Study Site 104
NGM Clinical Study Site 406
NGM Clinical Study Site 127

intervention_type: Other


intervention_type: Genetic

lead_sponsor: bluebird bio

summary:
This is a multi-center, long-term safety and efficacy follow-up study for participants with cerebral adrenoleukodystrophy (CALD) who have received Lenti-D Drug Product (eli-cel) in a parent clinical study.

After completing a parent clinical study (approximately 2 years), eligible participants will be followed for an additional 13 years for a total of 15 years post-drug product infusion. No investigational drug product will be administered in this study.

location_facility: Lucile Packard Children's Hospital - Stanford

location_facility: Boston Children's Hospital/Massachusetts General Hospital

location_facility: Hospital das Clínicas da Universidade de São Paulo

title: Long-term Follow-up of Subjects With Cerebral Adrenoleukodystrophy Who Were Treated With Lenti-D Drug Product

ipd_sharing_description: Bluebird bio is committed to transparency and appropriately de-identified patient-level datasets and supporting documents may be shared following attainment of applicable marketing approvals associated with this study and consistent with criteria established by bluebird bio and/or industry best practices to maintain the privacy of study participants. For enquiries, please contact us at datasharing@bluebirdbio.com.

location_country:
Germany
Italy
United Kingdom
Argentina
Australia
Brazil
Netherlands
United States
France


title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome

summary: Study 1 and Study 3 are the prospective, merged analyses of 2 identical double-blind, placebo-controlled studies, ZX008-1501 and ZX008-1502, to assess the efficacy, safety, and pharmacokinetics of ZX008 when used as adjunctive therapy in pediatric and young adult subjects with Dravet syndrome. Study 1501 and Study 1502 were conducted in parallel; Study 1501 was conducted at approximately 30 study sites in North America; Study 1502 was conducted at approximately 30 study sites in Europe, Asia and Australia. Upon completion of the Baseline Period after initial Screening and Baseline charting of seizure frequency, subjects who qualified for the studies were randomized (1:1:1) in a double-blind manner to receive either 1 of 2 doses of ZX008 (0.2 mg/kg/day or 0.8 mg/kg/day; maximum dose: 30 mg/day) or placebo. Randomization was stratified by age group (< 6 years, ≥6 to 18 years) to achieve balance across treatment arms, with the target of 25% of subjects in each age group. All subjects were titrated to their randomized dose over a 14-day Titration Period. Following titration, subjects continued treatment at their randomly assigned dose over a 12-week Maintenance Period. Subjects exiting the study underwent a 2-week taper, unless they enrolled in a follow-on study. Subjects were followed for post-study safety monitoring.

ReferenceCitation: Sullivan J, Lagae L, Cross JH, Devinsky O, Guerrini R, Knupp KG, Laux L, Nikanorova M, Polster T, Talwar D, Ceulemans B, Nabbout R, Farfel GM, Galer BS, Gammaitoni AR, Lock M, Agarwal A, Scheffer IE; FAiRE DS Study Group. Fenfluramine in the treatment of Dravet syndrome: Results of a third randomized, placebo-controlled clinical trial. Epilepsia. 2023 Oct;64(10):2653-2666. doi: 10.1111/epi.17737. Epub 2023 Aug 17.

ReferenceCitation: Cross JH, Galer BS, Gil-Nagel A, Devinsky O, Ceulemans B, Lagae L, Schoonjans AS, Donner E, Wirrell E, Kothare S, Agarwal A, Lock M, Gammaitoni AR. Impact of fenfluramine on the expected SUDEP mortality rates in patients with Dravet syndrome. Seizure. 2021 Dec;93:154-159. doi: 10.1016/j.seizure.2021.10.024. Epub 2021 Nov 2.

repositories:
LIRIAS (KU Leuven)
UCL Discovery

repositories_concat: LIRIAS (KU Leuven);UCL Discovery

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Sullivan J, Specchio N, Devinsky O, Auvin S, Perry MS, Strzelczyk A, Gil-Nagel A, Dai D, Galer BS, Gammaitoni AR. Fenfluramine significantly reduces day-to-day seizure burden by increasing number of seizure-free days and time between seizures in patients with Dravet syndrome: A time-to-event analysis. Epilepsia. 2022 Jan;63(1):130-138. doi: 10.1111/epi.17106. Epub 2021 Oct 22.

ReferenceCitation: Lagae L, Sullivan J, Knupp K, Laux L, Polster T, Nikanorova M, Devinsky O, Cross JH, Guerrini R, Talwar D, Miller I, Farfel G, Galer BS, Gammaitoni A, Mistry A, Morrison G, Lock M, Agarwal A, Lai WW, Ceulemans B; FAiRE DS Study Group. Fenfluramine hydrochloride for the treatment of seizures in Dravet syndrome: a randomised, double-blind, placebo-controlled trial. Lancet. 2019 Dec 21;394(10216):2243-2254. doi: 10.1016/S0140-6736(19)32500-0. Epub 2019 Dec 17.

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repositories_concat: UCL Discovery;sdu.dk

ReferenceCitation: Sullivan J, Perry MS, Wheless JW, Galer B, Gammaitoni A. Fenfluramine responder analyses and numbers needed to treat: Translating epilepsy trial data into clinical practice. Eur J Paediatr Neurol. 2021 Mar;31:10-14. doi: 10.1016/j.ejpn.2021.01.005. Epub 2021 Jan 22.

lead_sponsor: Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

location_country:
Germany
Italy
United Kingdom
Denmark
Australia
Japan
Belgium
United States
Spain
Canada
France

location_facility: Istituto Pediatrico Giannina Gaslini Dipartimento di Neurologia

location_facility: Universitaetsklinik fuer Kinder- und Jugendmedizin Abteilung III

location_facility: Epilepsiezentrum / Neuropädiatrie Hedwig-von-Rittberg-Zentrum Für Kinder und Jugendliche

location_facility: British Columbia Children's Hospital BCCH

location_facility: Hospital Ruber Internacional Primera Planta Servicio de Neurologia

location_facility: Miami Children's Hospital Brain Institute

location_facility: Centre Hospitalier Universitaire Sainte-Justine

location_facility: National Epilepsy Center Shizuoka Institute

location_facility: Institute of Neurosciences Queens Elizabeth University Hospital

location_facility: U.O. Neurologia Dipartimento di Neuroscienze Ospedale Pediatrico Bambino Gesù, IRCS

location_facility: The Children's Hospital Westmead Dept. of Neurology and Neurosurgery

location_facility: Universitaetsklinikum Jena Klinik fuer Kinder- und Jugendmedizin Neuropaediatrie

location_facility: Kleinwachau Saechsisches Epilepsiezentrum Radeberggemeinnuetzige GmbH

location_facility: Great Ormonnd Street Hospital for Children NHS Foundation Trust

location_facility: Children's Health Queensland Hospital and Health Service at Lady Cilento Children's Hospital

location_facility: Schoen Klinik Vogtareuth Neuropaediatrie und Neurologische Rehabilitation, Epilepsiezentrum fuer Kinder und Jugendlische,Tagesklinik fuer Neuropaediatrie

location_facility: Clinica Universitaria de Navarra Fase 4. Segunda planta, Consulta de Pediatria

location_facility: Krankenhaus Mara Epilepsie-Zentrum Bethel

location_facility: Klinik für Neuropädiatrie Universitätsklinikum Schleswig Holstein Campus Kiel

location_facility: Tokyo Women's Medical University Hospital

location_facility: Ospedal Policlinico Giambattista Rossi diBorga Roma

location_facility: MultiCare Institute for Research & Innovation


acronym: CIRCLE

lead_sponsor: ThromboGenics

summary: The purpose of this study is to assess the efficacy and safety of up to 3 intravitreal injections of ocriplasmin (0.0625mg or 0.125mg), in subjects with moderate to very severe non-proliferative diabetic retinopathy (NPDR), to induce total posterior vitreous detachment (PVD) in order to reduce the risk of disease progression to proliferative diabetic retinopathy (PDR).

title: A Phase 2, Randomised, Double Masked, Sham Controlled, Multicentre Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total Posterior Vitreous Detachment (PVD) in Subjects With Non-proliferative Diabetic Retinopathy (NPDR)

location_country:
Germany
Italy
Hungary
Israel
United Kingdom
United States
Spain
Czechia
France


title: A Single-arm, Multi-Center, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients With Hepatic-Dominant Ocular Melanoma

acronym: FOCUS

summary: This study will evaluate patients who have melanoma that has spread from the eye to the liver: Patients in the study will be treated with Melphalan/HDS up to 6 total treatment, and will be followed until death. This study will evaluate the safety and effects of the treatment on how long patients live and how long it takes for the cancer to advance or respond to the treatment.

lead_sponsor: Delcath Systems Inc.

sponsor_collaborators:
Delcath Systems Inc.
IQVIA Biotech

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

location_facility: Ohio State University James Cancer Center

location_facility: University of Tennessee Health Science Center

location_facility: Charité Unversitätsmedizin Berlin Comprehensive Cancer Center

location_facility: University Hospital Southampton NHS Trust

location_facility: Universitätsklinikum Giessen und Marburg

intervention_type: Combination Product


title: Diagnostic and Therapeutic Applications of Microarrays in Heart Transplantation, a Multicenter Study (INTERHEART)

summary: Demonstrate the impact of the Molecular Microscope Diagnostic System as the standard of care for heart transplant patients.

status: Recruiting

ReferenceCitation: Loupy A, Duong Van Huyen JP, Hidalgo L, Reeve J, Racape M, Aubert O, Venner JM, Falmuski K, Bories MC, Beuscart T, Guillemain R, Francois A, Pattier S, Toquet C, Gay A, Rouvier P, Varnous S, Leprince P, Empana JP, Lefaucheur C, Bruneval P, Jouven X, Halloran PF. Gene Expression Profiling for the Identification and Classification of Antibody-Mediated Heart Rejection. Circulation. 2017 Mar 7;135(10):917-935. doi: 10.1161/CIRCULATIONAHA.116.022907. Epub 2017 Feb 1.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut Pasteur

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - hprints.org

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

repositories_concat: HAL

ReferenceCitation: Halloran PF, Potena L, Van Huyen JD, Bruneval P, Leone O, Kim DH, Jouven X, Reeve J, Loupy A. Building a tissue-based molecular diagnostic system in heart transplant rejection: The heart Molecular Microscope Diagnostic (MMDx) System. J Heart Lung Transplant. 2017 Nov;36(11):1192-1200. doi: 10.1016/j.healun.2017.05.029. Epub 2017 May 29.

ReferenceCitation: Halloran PF, Reeve J, Aliabadi AZ, Cadeiras M, Crespo-Leiro MG, Deng M, Depasquale EC, Goekler J, Jouven X, Kim DH, Kobashigawa J, Loupy A, Macdonald P, Potena L, Zuckermann A, Parkes MD. Exploring the cardiac response to injury in heart transplant biopsies. JCI Insight. 2018 Oct 18;3(20):e123674. doi: 10.1172/jci.insight.123674.

publisher_dissemination: American Society for Clinical Investigation

ReferenceCitation: Parkes MD, Aliabadi AZ, Cadeiras M, Crespo-Leiro MG, Deng M, Depasquale EC, Goekler J, Kim DH, Kobashigawa J, Loupy A, Macdonald P, Potena L, Zuckermann A, Halloran PF. An integrated molecular diagnostic report for heart transplant biopsies using an ensemble of diagnostic algorithms. J Heart Lung Transplant. 2019 Jun;38(6):636-646. doi: 10.1016/j.healun.2019.01.1318. Epub 2019 Feb 6.

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

repository_normalized: dnet

repositories_concat: dnet

ReferenceCitation: Halloran PF, Madill-Thomsen KS. The Molecular Microscope Diagnostic System: Assessment of Rejection and Injury in Heart Transplant Biopsies. Transplantation. 2023 Jan 1;107(1):27-44. doi: 10.1097/TP.0000000000004323. Epub 2022 Dec 8.

ReferenceCitation: Halloran PF, Madill-Thomsen K, Mackova M, Aliabadi-Zuckermann AZ, Cadeiras M, Crespo-Leiro MG, Depasquale EC, Deng M, Gokler J, Hall SA, Kim DH, Kobashigawa J, Macdonald P, Potena L, Shah K, Stehlik J, Zuckermann A, Reeve J. Molecular states associated with dysfunction and graft loss in heart transplants. J Heart Lung Transplant. 2023 Nov 30:S1053-2498(23)02132-0. doi: 10.1016/j.healun.2023.11.013. Online ahead of print.

ReferenceCitation: Halloran PF, Madill-Thomsen K, Aliabadi-Zuckermann AZ, Cadeiras M, Crespo-Leiro MG, Depasquale EC, Deng M, Gokler J, Kim DH, Kobashigawa J, Macdonald P, Potena L, Shah K, Stehlik J, Zuckermann A. Many heart transplant biopsies currently diagnosed as no rejection have mild molecular antibody-mediated rejection-related changes. J Heart Lung Transplant. 2022 Mar;41(3):334-344. doi: 10.1016/j.healun.2021.08.004. Epub 2021 Aug 26.

repository_institution: Universidade Da Coruña - RUC

ReferenceCitation: Madill-Thomsen KS, Reeve J, Aliabadi-Zuckermann A, Cadeiras M, Crespo-Leiro MG, Depasquale EC, Deng M, Goekler J, Kim DH, Kobashigawa J, Macdonald P, Potena L, Shah K, Stehlik J, Zuckermann A, Halloran PF. Assessing the Relationship Between Molecular Rejection and Parenchymal Injury in Heart Transplant Biopsies. Transplantation. 2022 Nov 1;106(11):2205-2216. doi: 10.1097/TP.0000000000004231. Epub 2022 Oct 21.

ReferenceCitation: Halloran PF. Integrating molecular and histologic interpretation of transplant biopsies. Clin Transplant. 2021 Apr;35(4):e14244. doi: 10.1111/ctr.14244. Epub 2021 Feb 17. No abstract available.

lead_sponsor: University of Alberta

location_country:
Italy
Australia
Austria
United States
Spain
Canada
France

location_facility: Division of Cardiology, University of Alberta

location_facility: Heart Failure and Heart Transplant Unit, University of Bologna

location_facility: Cardiovascular Medicine, University of Utah Health

location_facility: Department of Cardiac Surgery, Medical University of Vienna

location_facility: Service de Néphrologie-Dialyse Adultes , Hôpital Necker-Enfants Malades

location_facility: Alberta Transplant Applied Genomics Center, University of Alberta

location_facility: Virginia Commonwealth University, Division of Cardiology

location_facility: Cardiac Transplantation Laboratory, The Victor Chang Cardiac Research Institute

intervention_type: Procedure


title: A Multi-Center, Prospective, Observational Study to Assess Outcomes for Patients Treated for Lumbar Spinal Conditions Using an OLIF25™ and/or OLIF51™Approach

summary: The purpose of this single-arm observational study is to observe and document clinical outcomes of the OLIF25™ and OLIF51™ procedures in patients diagnosed with degenerative disc disease or degenerative scoliosis, and report the rate of adverse events of interest through the 24 months follow-up visit.

lead_sponsor: Medtronic Spinal and Biologics

location_country:
Italy
Portugal
Belgium
United States
Czechia
Puerto Rico
France

location_facility: Foundation for Orthopaedic Research and Education (FORE)

location_facility: Azienda Ospedaliera - Ospedale Civile di Legnano

location_facility: University of California San Francisco (UCSF)

location_facility: Alleghany Health Network Research Institute


title: Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Correction of Anemia in Subjects With Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CORRECTION)

summary: A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction of anemia and maintenance of hemoglobin (Hb) in participants with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)

ReferenceCitation: Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

ReferenceCitation: Chertow GM, Pergola PE, Farag YMK, Agarwal R, Arnold S, Bako G, Block GA, Burke S, Castillo FP, Jardine AG, Khawaja Z, Koury MJ, Lewis EF, Lin T, Luo W, Maroni BJ, Matsushita K, McCullough PA, Parfrey PS, Roy-Chaudhury P, Sarnak MJ, Sharma A, Spinowitz B, Tseng C, Tumlin J, Vargo DL, Walters KA, Winkelmayer WC, Wittes J, Eckardt KU; PRO2TECT Study Group. Vadadustat in Patients with Anemia and Non-Dialysis-Dependent CKD. N Engl J Med. 2021 Apr 29;384(17):1589-1600. doi: 10.1056/NEJMoa2035938.

lead_sponsor: Akebia Therapeutics

location_country:
Poland
New Zealand
Argentina
Australia
Brazil
France
Hungary
United States
Ukraine
Malaysia
Puerto Rico
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
South Africa
Bulgaria
Russian Federation
Israel

location_facility:
Research Site #1
Research Site
Research Site #2
Research Site #3


title: A Prospective, Multi-center, Post Market Randomized Controlled Trial Comparing VT Ablation Outcomes Using Remote MAGNETIC Navigation Guided Substrate Mapping and Ablation Versus Manual Approach in a Low LVEF Population

acronym: MAGNETIC-VT

summary: The study purpose is to demonstrate that ventricular tachycardia (VT) ablation using the Niobe™ ES system results in superior outcomes compared to a manual approach in subjects with ischemic scar VT in a low ejection fraction population.

ReferenceCitation: Di Biase L, Tung R, Szili-Torok T, Burkhardt JD, Weiss P, Tavernier R, Berman AE, Wissner E, Spear W, Chen X, Neuzil P, Skoda J, Lakkireddy D, Schwagten B, Lock K, Natale A; MAGNETIC VT investigators. MAGNETIC VT study: a prospective, multicenter, post-market randomized controlled trial comparing VT ablation outcomes using remote magnetic navigation-guided substrate mapping and ablation versus manual approach in a low LVEF population. J Interv Card Electrophysiol. 2017 Apr;48(3):237-245. doi: 10.1007/s10840-016-0217-3. Epub 2017 Jan 7.

lead_sponsor: Stereotaxis

location_country:
Denmark
Australia
Netherlands
Belgium
United States
Czechia
France

location_facility: Texas Cardiac Arrhythmia Research Foundation


lead_sponsor: Allergan

summary: This study will evaluate the intraocular pressure (IOP)-lowering effect and safety of Bimatoprost SR compared with selective laser trabeculoplasty in participants with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy (e.g., due to intolerance or nonadherence).

ReferenceCitation: Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.

repository_institution: Queen's University Belfast - Research Portal

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

location_facility: Ophthalmic Clinical Hospital V.P. Vyhodtseva

location_facility: CHU de Bordeaux Hopital Pellegrin Service Ophtalmologie

location_facility: Chiang Mai University CMU - Maharaj Nakhon Chiang Mai Hospital

location_facility: Centrum Diagnostykii Mikrochirurgii Oka LENS ul.

location_facility: S. Fyodorov Eye Microsurgery Federal State Institution, Novosibirsk Branch

title: A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension

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

location_country:
Poland
Singapore
Denmark
Australia
United States
Spain
Thailand
Russian Federation
France


title: A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB067 Administered to Adult Subjects With Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation

acronym: VALOR (Part C)

summary:
The primary objectives of Parts A and B of this study are to evaluate the safety, tolerability, and pharmacokinetics (PK) of ascending doses of tofersen in adults with ALS and a documented superoxide dismutase 1 (SOD1) mutation. The primary objective of Part C of this study is to evaluate the clinical efficacy of tofersen administered to adults with ALS and a confirmed SOD1 mutation.

The secondary objective of Parts A and B of this study is to evaluate the effects of tofersen on levels of total SOD1 protein in the cerebrospinal fluid (CSF). The secondary objectives of Part C are to evaluate the safety, tolerability, pharmacodynamic (PD), and biomarker effects of tofersen.

ReferenceCitation: Miller TM, Cudkowicz ME, Genge A, Shaw PJ, Sobue G, Bucelli RC, Chio A, Van Damme P, Ludolph AC, Glass JD, Andrews JA, Babu S, Benatar M, McDermott CJ, Cochrane T, Chary S, Chew S, Zhu H, Wu F, Nestorov I, Graham D, Sun P, McNeill M, Fanning L, Ferguson TA, Fradette S; VALOR and OLE Working Group. Trial of Antisense Oligonucleotide Tofersen for SOD1 ALS. N Engl J Med. 2022 Sep 22;387(12):1099-1110. doi: 10.1056/NEJMoa2204705.

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

ReferenceCitation: Miller T, Cudkowicz M, Shaw PJ, Andersen PM, Atassi N, Bucelli RC, Genge A, Glass J, Ladha S, Ludolph AL, Maragakis NJ, McDermott CJ, Pestronk A, Ravits J, Salachas F, Trudell R, Van Damme P, Zinman L, Bennett CF, Lane R, Sandrock A, Runz H, Graham D, Houshyar H, McCampbell A, Nestorov I, Chang I, McNeill M, Fanning L, Fradette S, Ferguson TA. Phase 1-2 Trial of Antisense Oligonucleotide Tofersen for SOD1 ALS. N Engl J Med. 2020 Jul 9;383(2):109-119. doi: 10.1056/NEJMoa2003715.

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

lead_sponsor: Biogen

sponsor_collaborators:
Biogen
Ionis Pharmaceuticals, Inc.

location_country:
Germany
Italy
Poland
United Kingdom
Denmark
Australia
Japan
Belgium
United States
Korea, Republic of
Canada
France

location_facility: Northwestern University Feinberg School of Medicine

location_facility: ALS Center - Dept. of Neuroscience "Rita Levi Montalcini", University of Turin

location_facility: University of California San Diego Medical Center

location_facility: University of Calgary - Health Sciences Centre

location_facility: New Orleans Center for Clinical Research/Volunteer Research Group, an AMR Company


title: Tracking Outcomes and Practice in Pediatric Pulmonary Hypertension

summary:
The TOPP-2 registry is an international, non-interventional, prospective registry including children and adolescents newly diagnosed with pulmonary hypertension (PH) to gain further insights in the disease course and long-term outcome of PH in childhood.

Patients will undergo clinical assessments and receive standard medical care, as determined by treating physicians in their daily clinical practice. The TOPP-2 registry is specifically designed to capture the variables that have been proposed as treatment goals in PePH and the reasons for changes in treatment strategy.

The TOPP-2 registry uses the new clinical classification of PH as outlined at the 5th World Symposium for Pulmonary Hypertension (WSPH) in Nice 2013 and includes new characterizations for children with PH.

The registry is planned and implemented under the scientific leadership of the Association for Pediatric Pulmonary Hypertension (PePH), independently from the financial sponsors.

All enrolled patients will have a follow-up period of 18 months.

location_country:
Germany
Italy
Poland
Colombia
Hungary
Israel
Australia
Brazil
Japan
Mexico
Netherlands
Sweden
United States
China
Saudi Arabia
Switzerland
Canada
France

location_facility: Hadassah, Hebrew University Medical Center

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Vanderbilt University Children's Hospital

location_facility: University of Colorado Denver School of Medicine, Children's Hospital Colorado

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


title: A Randomised Two Arm Open Label Controlled Trial Comparing Standard Immediate Cord Clamping Versus Deferring Cord Clamping for 60 Seconds or More in Babies Born Less Than 30 Weeks of Gestation to Determine Which Cord Clamping Method Results in Improved Survival and Less Disability.

acronym: APTS

summary: To establish if placental transfusion, using deferred cord clamping for 60 seconds or more while holding the baby at or below the level of the placenta, will improve survival without disability compared with standard early cord clamping in preterm babies less than 30 weeks of gestation.

lead_sponsor: University of Sydney

collaborators: National Health and Medical Research Council, Australia

location_country:
New Zealand
United Kingdom
Australia
United States
Pakistan
Canada
France

location_facility:
Liverpool Hospital
Flinders Medical Centre
Aga Khan University Hospital
Christchurch Hospital
Royal Hospital for Women
University of Vermont Medical Centre
Royal North Shore Hospital
John Hunter Hospital
Nepean Hospital
Monash Medical Centre
Auckland Hospital
Mater Mother's Hospital
Craigavon Area Hospital
IWK Health Center
Dunedin Hospital
Waikato Hospital
King Edward Memorial Hospital
Royal Jubilee Maternity Hospital
Canberra Hospital
Royal Prince Alfred Hospital
Baylor College of Medicine
Wellington Hospital
Royal Brisbane and Women's Hospital
Hôpital Antoine-Béclère
Townsville Hospital
Mercy Hospital for Women


acronym: SHINE

summary: The primary objective is to evaluate the long-term safety and tolerability of nusinersen (ISIS 396443) administered by intrathecal (IT) injection to participants with Spinal Muscular Atrophy (SMA) who previously participated in investigational studies of nusinersen. The secondary objective is to examine the long-term efficacy of nusinersen administered by IT injection to participants with SMA who previously participated in investigational studies of nusinersen.

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

location_facility: Gillette Children's Specialty Healthcare

location_facility: Aichi Children's Health and Medical Center

location_facility: Sydney Children's Hospital Clinical Research Centre

location_facility: Department of Neuroscience, Università di Messina, AOU Polic

location_facility: Marmara University Pendik Training and Research Hospital

location_facility: Washington University School of Medicine

location_facility: Istituto Giannina Gaslini, Centro Traslazionale di Miologia

location_facility: Universitair Kinderziekenhuis Koningin Fabiola

location_facility: Pediatric Neurology Unit, Catholic University

location_facility: MRC Centre for Neuromuscular Diseases at Newcastle

title: An Open-Label Extension Study for Patients With Spinal Muscular Atrophy Who Previously Participated in Investigational Studies of ISIS 396443

location_country:
Germany
Italy
United Kingdom
Hong Kong
Australia
Japan
Sweden
Belgium
United States
Korea, Republic of
Spain
Turkey
Canada
France


title: An International, Multicenter, Open-label Study to Evaluate Safety, Tolerability, Biodistribution, Dosimetry and Preliminary Efficacy of 177Lu-OPS201 for the Therapy of Somatostatin Receptor-positive Neuroendocrine Tumors (NETs)

summary: The purpose of this clinical phase I/II study was to investigate the safety and tolerability of satoreotide tetraxetan (177Lu-IPN01072, formerly known as 177Lu-OPS201) used for the treatment of patients with neuroendocrine tumors (NETs). The secondary objectives of this study were the assessment of biodistribution, dosimetry and preliminary efficacy of satoreotide tetraxetan.

lead_sponsor: Ipsen

location_country:
United Kingdom
Denmark
Australia
Switzerland
Austria
United States
Canada
France

location_facility: University Hospital Basel, Department of Nuclear Medicine

location_facility: CHU de Quebec - Universite Laval Research Center, Department of Radiology and Nuclear Medicine

location_facility: MD Anderson Cancer Center, Department of Nuclear Medicine

location_facility: Peter MacCallum Cancer Centre, Molecular Imaging and Targeted Therapeutics Laboratory

location_facility: Ramsay Hollywood Private Hospital, Department of Nuclear Medicine

location_facility: CHU de Nantes, Hotel Dieu, Service de Medecine Nucleaire

location_facility: Royal Free Hospital, Department of Nuclear Medicine

location_facility: University Hospital Aarhus, Department of Hepatology and Gastroenterology

location_facility: University Hospital Vienna, Department of Nuclear Medicine


lead_sponsor: Novartis Pharmaceuticals

summary:
This extension study will provide data to further evaluate the efficacy, safety, and tolerability of three doses of BYM338 and to assess the long-term effects of BYM338 in patients with sporadic inclusion body myositis. The extension study was planned to consist of a Screening epoch (to assess patient eligibility), followed by a Treatment Period 1 epoch (double-blind and placebo-controlled), and a Treatment Period 2 epoch (open-label). A Post-treatment Follow-up (FUP) epoch was also planned for patients who discontinued prematurely. Patients who complete the core study and qualify for this extension study entered Treatment Period 1 and continued on the study drug to which they were randomized in the core study (either to one of the three bimagrumab doses (1 mg/kg, 3 mg/kg, and 10mg/kg) or placebo) during Treatment Period 1. Thus, Treatment Period 1 was double-blind and placebo-controlled. Participants were to continue in Treatment Period 1 until the dose with the best benefit-risk profile was determined from the core study data and selected (duration of Treatment Period 1 was estimated to be between 6 and 8 months). Once the dose with the best benefit-risk profile was selected, all participants (including those who were receiving placebo) were planned to enter Treatment Period 2 and switch to open-label treatment with bimagrumab at the selected dose. The core study has been completed but since the core study did not meet the primary end point (no bimagrumab dose was identified based on the core study efficacy results) the extension study was terminated as per protocol/sponsor's decision; therefore, no patients had entered Treatment Period 2. Instead, all patients were to return for the End of Treatment Period 1 (EOT1) visit at their next scheduled visit. As per protocol, all patients who discontinued study medication during Treatment Period 1 for any reason, including due to the study having been stopped as per protocol/sponsor's decision, were to have entered and complete the 6-month FUP after their EOT1 visit.

Due to the nature of the design of the core and extension studies and termination of study medication in the extension study, the treatment duration for individual patients varied considerably. Consequently, the number of patients contributing data to the efficacy analyses at Week 104 and later timepoints was decreased.

ReferenceCitation: Amato AA, Hanna MG, Machado PM, Badrising UA, Chinoy H, Benveniste O, Karanam AK, Wu M, Tanko LB, Schubert-Tennigkeit AA, Papanicolaou DA, Lloyd TE, Needham M, Liang C, Reardon KA, de Visser M, Ascherman DP, Barohn RJ, Dimachkie MM, Miller JAL, Kissel JT, Oskarsson B, Joyce NC, Van den Bergh P, Baets J, De Bleecker JL, Karam C, David WS, Mirabella M, Nations SP, Jung HH, Pegoraro E, Maggi L, Rodolico C, Filosto M, Shaibani AI, Sivakumar K, Goyal NA, Mori-Yoshimura M, Yamashita S, Suzuki N, Aoki M, Katsuno M, Morihata H, Murata K, Nodera H, Nishino I, Romano CD, Williams VSL, Vissing J, Zhang Auberson L; RESILIENT Study Extension Group. Efficacy and Safety of Bimagrumab in Sporadic Inclusion Body Myositis: Long-term Extension of RESILIENT. Neurology. 2021 Mar 23;96(12):e1595-e1607. doi: 10.1212/WNL.0000000000011626. Epub 2021 Feb 17.

repositories_concat: PubMed Central;www.zora.uzh.ch

repositories_institution: University of Zurich - Zurich Open Repository and Archive

title: Extension of the CBYM338B2203 Phase IIb/III Study to Evaluate the Long-term Efficacy, Safety and Tolerability of Intravenous BYM338 in Patients With Sporadic Inclusion Body Myositis

location_country:
Italy
United Kingdom
Denmark
Australia
Japan
Netherlands
Switzerland
Belgium
United States
France


acronym:
Safety and Efficacy study of QVM149 in asthmatic patients

 Sécurité d'emploi et efficacité du traitement QVM149 chez les patients asthmatiques

summary: The purpose of the trial was to evaluate the efficacy and safety of two different doses of QVM149 (QVM149 150/50/80 μg and QVM149 150/50/160 μg via Concept1) over two respective QMF149 doses (QMF149 150/160 μg and QMF149 150/320) μg via Concept1 in poorly controlled asthmatics as determined by pulmonary function testing and effects on asthma control.

ReferenceCitation: Chapman K, van Zyl-Smit R, Maspero J, Kerstjens HAM, Gon Y, Hosoe M, Tanase AM, Pethe A, Shu X, D'Andrea P. One time a day mometasone/indacaterol fixed-dose combination versus two times a day fluticasone/salmeterol in patients with inadequately controlled asthma: pooled analysis from PALLADIUM and IRIDIUM studies. BMJ Open Respir Res. 2021 Aug;8(1):e000819. doi: 10.1136/bmjresp-2020-000819.

repository_institution: PubMed Central - Europe PMC

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

repositories_concat: PubMed Central;pure.rug.nl

publisher_dissemination: British Medical Journal

ReferenceCitation: Kerstjens HAM, Maspero J, Chapman KR, van Zyl-Smit RN, Hosoe M, Tanase AM, Lavecchia C, Pethe A, Shu X, D'Andrea P; IRIDIUM trial investigators. Once-daily, single-inhaler mometasone-indacaterol-glycopyrronium versus mometasone-indacaterol or twice-daily fluticasone-salmeterol in patients with inadequately controlled asthma (IRIDIUM): a randomised, double-blind, controlled phase 3 study. Lancet Respir Med. 2020 Oct;8(10):1000-1012. doi: 10.1016/S2213-2600(20)30190-9. Epub 2020 Jul 9.

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

title: A Multicenter, Randomized, 52-week, Double-blind, Parallelgroup, Active Controlled Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma

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:
Finland
Germany
Ireland
Poland
Argentina
Japan
Thailand
Vietnam
Croatia
Chile
Canada
France
Lithuania
Colombia
Portugal
Slovakia
Hungary
Denmark
Switzerland
Latvia
India
Romania
Lebanon
Belgium
China
Peru
Estonia
Philippines
Italy
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
Greece
South Africa
Jordan
Bulgaria
Russian Federation
Israel


title: STandard Versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI): A Multi-Centre, Randomized, Controlled Trial (Principal Trial)

summary:
The objectives of this trial are to determine whether, in critically ill patients with severe acute kidney injury (AKI), randomization to accelerated initiation of renal replacement therapy (RRT), compared to standard initiation, leads to:

Improved survival (primary outcome); and
Recovery of kidney function (principal secondary outcome), defined as independence from RRT at 90 days

ReferenceCitation: STARRT-AKI Investigators; Canadian Critical Care Trials Group; Australian and New Zealand Intensive Care Society Clinical Trials Group; United Kingdom Critical Care Research Group; Canadian Nephrology Trials Network; Irish Critical Care Trials Group; Bagshaw SM, Wald R, Adhikari NKJ, Bellomo R, da Costa BR, Dreyfuss D, Du B, Gallagher MP, Gaudry S, Hoste EA, Lamontagne F, Joannidis M, Landoni G, Liu KD, McAuley DF, McGuinness SP, Neyra JA, Nichol AD, Ostermann M, Palevsky PM, Pettila V, Quenot JP, Qiu H, Rochwerg B, Schneider AG, Smith OM, Thome F, Thorpe KE, Vaara S, Weir M, Wang AY, Young P, Zarbock A. Timing of Initiation of Renal-Replacement Therapy in Acute Kidney Injury. N Engl J Med. 2020 Jul 16;383(3):240-251. doi: 10.1056/NEJMoa2000741. Erratum In: N Engl J Med. 2020 Jul 15;:

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

repositories_institution: Queen's University Belfast - Research Portal

ReferenceCitation: STARRT-AKI Investigators. Statistical analysis plan for the Standard versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI) trial. Crit Care Resusc. 2019 Sep;21(3):162-170.

ReferenceCitation: STARRT-AKI Investigators. STandard versus Accelerated initiation of Renal Replacement Therapy in Acute Kidney Injury: Study Protocol for a Multi-National, Multi-Center, Randomized Controlled Trial. Can J Kidney Health Dis. 2019 Jun 10;6:2054358119852937. doi: 10.1177/2054358119852937. eCollection 2019.

publisher_dissemination: SAGE Publications

lead_sponsor: Unity Health Toronto

collaborators: Canadian Institutes of Health Research (CIHR)

collaborators: National Institute for Health Research, United Kingdom

collaborators: Medical Research Institute of New Zealand

sponsor_collaborators: National Health and Medical Research Council, Australia

location_country:
Finland
Germany
Ireland
Italy
New Zealand
United Kingdom
Australia
Brazil
Switzerland
Austria
Belgium
United States
China
Canada
France

location_facility: Xiangya Hospital Central South University

location_facility: Trillium Health Partners - Credit Valley Hospital

location_facility: London Health Sciences Centre, University Hospital

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

location_facility: Centre hospitalier de l'université de Montréal (Notre Dame)

location_facility: Western Health (Footscray Hospital & Sunshine Hospital)

location_facility: Centre Hôspitalier universitaire de Sherbrooke (CHUS)

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Beijing Friendship Hospital, Capital Medical University

location_facility: Trillium Health Partners - Mississauga Hospital

location_facility: London Health Sciences Centre, Victoria Hospital

location_facility: Centre de sante et de services sociaux de Trois-Rivieres (CIUSSS MCQ)

location_facility: Eastern Hospital (Box Hill and Maroondah Hospital)

location_facility: Hospital de Clínicas de Porto Alegre - Rio Grande do Sul

location_facility: Centre Hospitalier Universitaire de Quebec (CHUQ)

location_facility: The First Affiliated Hospital of Xi'An Jiaotong University

location_facility: St. Paul's Hospital - Providence Health Care

location_facility: Centre hospitalier de l'université de Montréal (St. Luc)


acronym: TRITON

lead_sponsor: Actelion

summary: The objective of this clinical trial is to compare the efficacy and safety of an initial triple oral treatment regimen (macitentan, tadalafil, selexipag) versus an initial dual oral treatment regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-naïve patients with pulmonary arterial hypertension.

ReferenceCitation: Chin KM, Sitbon O, Doelberg M, Feldman J, Gibbs JSR, Grunig E, Hoeper MM, Martin N, Mathai SC, McLaughlin VV, Perchenet L, Poch D, Saggar R, Simonneau G, Galie N. Three- Versus Two-Drug Therapy for Patients With Newly Diagnosed Pulmonary Arterial Hypertension. J Am Coll Cardiol. 2021 Oct 5;78(14):1393-1403. doi: 10.1016/j.jacc.2021.07.057.

endpoint_id: fhisxppmrqpajgzqkvft

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec

location_facility: Washington University School of Medicine

location_facility: London Health Sciences Centre - Victoria Hospital

location_facility: Piedmont Pulmonary and Critical Care Research

location_facility: University of Texas Southwestern Medical Center

title: The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension: A Multi-center, Double-blind, Placebo-controlled, Phase 3b Study

location_country:
Germany
Ireland
Italy
United Kingdom
Denmark
Australia
Sweden
Netherlands
Austria
Belgium
Switzerland
United States
Spain
Canada
France


title: A Phase I, First-Time-in-Human Study of MEDI9197, a TLR 7/8 Agonist, Administered Intratumorally as a Single Agent in Subjects With Solid Tumors or CTCL and in Combination With Durvalumab and/or Palliative Radiation in Subjects With Solid Tumors

summary: To evaluate MEDI9197 when administered by intratumoral injection to subjects with solid tumors and in combination with durvalumab in subjects with solid tumors.

ReferenceCitation: Siu L, Brody J, Gupta S, Marabelle A, Jimeno A, Munster P, Grilley-Olson J, Rook AH, Hollebecque A, Wong RKS, Welsh JW, Wu Y, Morehouse C, Hamid O, Walcott F, Cooper ZA, Kumar R, Ferte C, Hong DS. Safety and clinical activity of intratumoral MEDI9197 alone and in combination with durvalumab and/or palliative radiation therapy in patients with advanced solid tumors. J Immunother Cancer. 2020 Oct;8(2):e001095. doi: 10.1136/jitc-2020-001095.

repository_institution: California Digital Library - eScholarship

repositories_concat: PubMed Central;escholarship.org

lead_sponsor: MedImmune LLC

location_country:
United States
Canada
France


title: A Prospective, Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon Percutaneous Transluminal Angioplasty (PTA) Catheter for Treatment of Below-the-Knee (BTK) Arteries

acronym: BTKRegistry

summary: The study will enroll patients presenting with claudication, or critical limb ischemia (Rutherford Category 3- 5) and an angiographically significant (≥ 70%) native artery lesion appropriate for angioplasty that is below the knee. Subjects will be treated with the Lutonix Drug Coated Balloon (DCB) carrying the CE Mark per current IFU and followed clinically for a minimum of 2 years.

lead_sponsor: C. R. Bard

location_country:
Germany
Italy
Portugal
United Kingdom
Switzerland
Austria
Belgium
Saudi Arabia
Spain
Greece
France

location_facility: Universitäts-Herzzentrum Freiburg Bad Krozingen

location_facility: Medical University Vienna, Department of Angiology

location_facility: Medical University Vienna, Department of Radiodiagnostic

location_facility: Hospital Santa Marta (C.H.Lisboa Central)

location_facility: A.O.U. Citta della Salute e della Scienza di Torino

location_facility: King Faisal Hospital and Medical research Center