summary: To assess the safety and descriptive efficacy of apixaban in pediatric subjects requiring anticoagulation for the treatment of a VTE.

sponsor_collaborators:
Bristol-Myers Squibb
Pfizer

location_facility: FSBI "NRMC PHOI n.a.Dmitry Rogachev" of Minzdrav Russia

location_facility: Children's Healthcare of Atlanta Center for Advanced Pediatrics-IDS Pharmacy

location_facility: Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: Medical University of South Carolina: Shawn Jenkins Women's and Children's Hospital

location_facility: Texas Children's Hospital- Wallace Tower

location_facility: Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)

location_facility: UCSF Mission Bay Pediatric Clinical Research Center

location_facility: AdventHealth Pediatric Oncology Hematology at Orlando

location_facility: Children's Hematology and Oncology a division of Kidz medical Service

location_facility: CHRU de Montpellier - Hopital Arnaud de Villeneuve

location_facility: State Autonomous Healthcare Institution "Children's Republican Clinical Hospital of Ministry of

location_facility: Children's Hospital Colorado - Investigational Drug Services

location_facility: Levine Children's Hospital, Pediatric Research

location_facility: Dnipropetrovsk Regional Children's Hospital

location_facility: Children's Healthcare of Atlanta Center for Advanced Pediatrics - Pediatric Research Unit

location_facility: University Hospitals Cleveland Medical Center

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: JDCH Division of Pediatric Hematology and Oncology

location_facility: Monroe Carell Jr. Children's Hospital at Vanderbilt

location_facility: O.P.D Hospital Civil de Guadalajara, Hospital Civil Fray Antonio Alcalde

location_facility: OU Medical Center Investigational Drug Pharmacy

location_facility: Children's Healthcare of Atlanta-Egleston

location_facility: University of Oklahoma Health Sciences Center

location_facility: Nemours/ Alfred I. duPont Hospital for Children

location_facility: Birmingham Women's and Children's NHS Foundation Trust

location_facility: Instituto Nacional De Cardiologia Ignacio Chavez

location_facility: Communal Institution "Zaporizhzhia Regional Clinical Children's Hospital"

location_facility: Medical University of South Carolina: Investigational Drug Services

location_facility: Ankara City Hospital Pediatric Hematology and Oncology Clinic

location_facility: Loma Linda University Children's Hospital

location_facility: Lucile Packard Children's Hosptial - Stanford University

location_facility: Connecticut Children's Medical Center Pharmacy

location_facility: State Autonomous Healthcare Institution of Sverdlovsk Region

location_facility: Riley Hospital for Children at IU Health

location_facility: Birmingham Children's Hospital NHS Foundation Trust

location_facility: Municipal enterprise "Dnipropetrovsk Regional Children's Clinical Hospital"

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

location_facility: Hacettepe University Faculty of Medicine, Ihsan Dogramaci Children's Hospital

location_facility: Baskent Universitesi Tip Fakultesi Cocuk Sagligi ve Hastaliklari ABD Cocuk Hematoloji Onkoloji BD

location_facility: AdventHealth Orlando-Pharmacy Investigational Drug Services

location_facility: Service d'Imagerie Medicale du Pr F. Laurent

location_facility: Investigational Drug Service, Duke University Hospital

location_facility: Hamilton Health Science Corporation/McMaster Children's Hospital

location_facility: Noah's Ark Children's Hospital for Wales

location_facility: New York-Presbyterian Morgan Stanley Children's Hospital

location_facility: Technische Universitat, Deutsches Herzzentrum Munchen

location_facility: University of Iowa Hospitals and Clinics

location_facility: University of California Davis Comprehensive Cancer Center

location_facility: Children's Hospital and Research Center Oakland

location_facility: Ege Universitesi Tip Fakultesi Cocuk Hastanesi Cocuk Hematoloji Bilim Dali

location_facility: University of Mississippi Medical Center

location_facility: Communal Enterprise "Dnipropetrovsk Specialized Clinical Medical Center of Mother and Child

location_facility: Bleeding and Clotting Disorders Institute

location_facility: Texas Children's Hospital- Main Hospital

title: A RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, SAFETY AND DESCRIPTIVE EFFICACY STUDY IN PEDIATRIC SUBJECTS REQUIRING ANTICOAGULATION FOR THE TREATMENT OF A VENOUS THROMBOEMBOLIC EVENT

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.

location_country:
Germany
Israel
United Kingdom
Australia
Austria
Mexico
United States
Spain
Turkey
Canada
Ukraine
Russian Federation
France


title: An International, Multicentre, Observational, Prospective, Longitudinal Cohort Study to Assess the Impact of Integrated Upper Limb Spasticity Management Including the Use of BoNT-A- Injections on Patient-centred Goal Attainment in Real Life Practice - ULIS III

acronym: ULIS III

summary: The primary purpose for this study is to understand the effect of botulinum toxin as a treatment integrated in the management of spasticity (stiffness) in the arm and/or hand, arising from any neurological condition. The study will look at the types of goals that people choose for treatment, and the extent to which these are achieved in different individuals.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Khat'kova SE, Baikova A, Maisonobe P, Khasanova DR. [Impact of integrated upper limb spasticity management including repeat botulinum toxin type A (BoNT-A) injections on patient-centred goal attainment in real-life practice: results from the prospective, observational Upper Limb International Spasticity cohort study (ULIS-III) in a Russian subpopulation]. Zh Nevrol Psikhiatr Im S S Korsakova. 2021;121(11):39-48. doi: 10.17116/jnevro202112111139. Russian.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Media Sphere Publishing Group

ReferenceCitation: Turner-Stokes L, Jacinto J, Fheodoroff K, Brashear A, Maisonobe P, Lysandropoulos A, Ashford S; Upper Limb International Spasticity-III (ULIS-III) study group. Assessing the effectiveness of upper-limb spasticity management using a structured approach to goal-setting and outcome measurement: First cycle results from the ULIS-III Study. J Rehabil Med. 2021 Jan 1;53(1):jrm00133. doi: 10.2340/16501977-2770.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Medical Journals Sweden AB

ReferenceCitation: Turner-Stokes L, Ashford S, Jacinto J, Maisonobe P, Balcaitiene J, Fheodoroff K. Impact of integrated upper limb spasticity management including botulinum toxin A on patient-centred goal attainment: rationale and protocol for an international prospective, longitudinal cohort study (ULIS-III). BMJ Open. 2016 Jun 17;6(6):e011157. doi: 10.1136/bmjopen-2016-011157.

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

repository_institution: PubMed Central - Europe PMC

repository_institution: King's College London - Research Portal

repositories_concat: PubMed Central;kclpure.kcl.ac.uk

repositories_institution:
King's College London - Research Portal
PubMed Central - Europe PMC

publisher_dissemination: British Medical Journal

lead_sponsor: Ipsen

location_country:
Germany
Italy
Poland
Russian Federation
Portugal
Hong Kong
Australia
Brazil
Austria
Mexico
United States
Taiwan
Philippines
France

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: Pavlov First Saint-Petersburg State Medical University

location_facility: Regional State Budgetary Healthcare Institution "City Hospital N°5"

location_facility: Azienda Ospedaliero Universitaria Policlinico "G Martino"

location_facility: Hospital dos Clinicas Universitaria de Sao Paulo

location_facility: Klinikum rechts der Isar der Technischen Universitaet Muenchen

location_facility: National Institute of Neurology/Rehabilitation

location_facility: Azienda Ospedaliero Universitaria di Ferrara

location_facility: Institut Universitaire de Réadaptation de Clémenceau

location_facility: Federal State Hospital for Treatment and Rehabilitation

location_facility: Interregional Cinical and Diagnostic Centre

location_facility: Centre Régional de Rééducation et Réadaptation Fonctionnelle

location_facility: Liverpool Brain Injury Rehabilitation Unit

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico

lead_sponsor_type: industriel

status_simplified: Completed


title: Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: The PROMIZING Study

acronym: PROMIZING

summary: For adult patients with acute respiratory failure requiring invasive mechanical ventilation, does a ventilation strategy using proportional assist ventilation with load-adjustable gain factors (PAV+) result in a shorter duration of time spent on mechanical ventilation than a ventilation strategy using pressure support ventilation (PSV)?

study_start_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Supportive Care

ipd_sharing: No

lead_sponsor: Lawson Health Research Institute

collaborators: Canadian Institutes of Health Research (CIHR)

location_country:
Italy
Argentina
Saudi Arabia
Spain
Greece
Canada
France

location_facility: Institut Universitaire de cardiologie et de pneumologie de Quebec

location_facility: Sunnybrook Hospital - Health Sciences Centre

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Centre Hospitalier Universitaire (CHU) de Rouen

location_facility: San Giovanni Battista University Hospital

location_facility: London Health Sciences Centre - University Hospital

location_facility: Hôpital Henri Mondor (Assistance Publique-Hôpitaux de Paris)

location_facility: El Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno"

location_facility: Centre hospitalier de l'Université de Montréal (CHUM)

location_facility: Centre Hospitalier Universitaire (CHU) de Angers

intervention_type: Other


title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients With Cystic Fibrosis

summary: This study is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of CTX-4430 administered once-daily for 48 weeks for treatment of CF.

primary_purpose: Treatment

lead_sponsor: Celtaxsys, Inc.

location_country:
Germany
Italy
United Kingdom
Belgium
United States
Canada
France

location_facility: Universiy of Tennessee Medical Center UHS

location_facility: Carl-Gustav-Klinikum Dresden, Mukoviszidose Centrum "Christiane Herzog"

location_facility: Pediatric Pulmonary and Cystic Fibrosis Clinic, Stanford University

location_facility: University of California Davis Medical Center

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

location_facility: University of Mississippi Medical Center

location_facility: Banner University of Arizona Medical Center

location_facility: University of Oklahoma Health Sciences Center

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: Institut für klinische Forschung Pneumologie

intervention_type: Drug


type: EudraCT Number

title: Phase IIa, Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Assess the Safety and Efficacy of Subcutaneously Administered BI 655066/ABBV-066 (Risankizumab) as add-on Therapy Over 24 Weeks in Patients With Severe Persistent Asthma.

summary: The objectives of this trial are primarily to evaluate the efficacy and safety of BI 655066/ABBV-066 (risankizumab) as compared to placebo over a 24-week treatment period in severe asthma patients. The primary endpoint is time to first asthma worsening during the planned 24 week treatment period for active vs. placebo treated patients on top of standard of care therapy. Upon demonstration of a meaningful clinical response, another important objective is the identification of biomarkers that can be used to target patients who will likely respond to treatment with BI 655066/ABBV-066 (risankizumab).

ReferenceCitation: Brightling CE, Nair P, Cousins DJ, Louis R, Singh D. Risankizumab in Severe Asthma - A Phase 2a, Placebo-Controlled Trial. N Engl J Med. 2021 Oct 28;385(18):1669-1679. doi: 10.1056/NEJMoa2030880.

oa_colors: green other

evidence: open (via free article)

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

license: cc-by

license_normalized: cc-by

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

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

lead_sponsor: AbbVie

sponsor_collaborators:
AbbVie
Boehringer Ingelheim

location_country:
Germany
Poland
United Kingdom
Netherlands
Belgium
United States
Korea, Republic of
Taiwan
Canada
France

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

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Specjalistyczny Osrodek Alergologiczno-Intern. ALL-MED

location_facility: Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH

location_facility: Univ. Hospital in Krakow,Pulmonology Clinical Dept

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Hamburger Institut für Therapieforschung GmbH (HIT)

location_facility: Washington University School of Medicine

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Gibinski Univ.Clin.Cnter of Silesian Med.Uni.Katowice,Outpat

location_facility: Respiratory and Sleep Disorders Specialists

location_facility: IFG Institut für Gesundheitsförderung GmbH

location_facility: Clinical Research Trials of Florida, Inc.

location_facility: Leids Universitair Medisch Centrum (LUMC)


title: A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Dolutegravir Plus Rilpivirine From Current INI-, NNRTI-, or PI-based Antiretroviral Regimen in HIV-1-Infected Adults Who Are Virologically Suppressed

summary: The aim of this study is to determine if virologically suppressed human immunodeficiency virus type 1 (HIV-1) infected adults on an antiretroviral regimen (including 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed upon switching to a two-drug regimen with dolutegravir (DTG) + rilpivirine (RPV). The study will primarily assess the non-inferiority antiviral activity of switching to DTG + RPV once daily compared to continuation of current antiretroviral regimen (CAR) up to Week 48 with a switch visit for eligible subjects in the CAR group to initiate DTG + RPV therapy at Week 52. CAR will include 2 NRTIs plus 1 HIV-1 integrase inhibitor (INI), or 1 non-nucleoside reverse transcriptase inhibitor (NNRTI), or 1 protease inhibitor (PI). The study will include a 148-week open-label treatment phase, comprising of an Early Switch Phase (Day 1 to Week 52) and a Late Switch Phase (Week 52 to Week 148). The participants fulfilling the study eligibility criteria will participate in the Early Switch Phase where they will either switch from their CAR to DTG + RPV, or continue taking their CAR, until Week 52. At the end of Early Switch Phase, eligible participants will proceed to the Late Switch Phase where all participants in both DTG + RPV and CAR treatment groups will receive DTG + RPV therapy until Week 148. After Week 148, subjects may be eligible to continue to receive DTG +RPV in the Continuation Phase. The study is planned to be conducted in approximately 476 participants.

ReferenceType: background

ReferenceCitation: Llibre JM, Hung CC, Brinson C, et al. Efficacy, safety, and tolerability of dolutegravir plus rilpivirine for the maintenance of virologic suppression in HIV-1-infected adults: the phase III, randomized, open-label, active-controlled, noninferiority SWORD-1 and SWORD-2 studies. Lancet [epublished ahead of print] 6 January 2018.

ReferenceCitation: Aboud M, Orkin C, Podzamczer D, Bogner JR, Baker D, Khuong-Josses MA, Parks D, Angelis K, Kahl LP, Blair EA, Adkison K, Underwood M, Matthews JE, Wynne B, Vandermeulen K, Gartland M, Smith K. Efficacy and safety of dolutegravir-rilpivirine for maintenance of virological suppression in adults with HIV-1: 100-week data from the randomised, open-label, phase 3 SWORD-1 and SWORD-2 studies. Lancet HIV. 2019 Sep;6(9):e576-e587. doi: 10.1016/S2352-3018(19)30149-3. Epub 2019 Jul 12.

publisher_dissemination: Elsevier

ReferenceCitation: Llibre JM, Hung CC, Brinson C, Castelli F, Girard PM, Kahl LP, Blair EA, Angelis K, Wynne B, Vandermeulen K, Underwood M, Smith K, Gartland M, Aboud M. Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1: phase 3, randomised, non-inferiority SWORD-1 and SWORD-2 studies. Lancet. 2018 Mar 3;391(10123):839-849. doi: 10.1016/S0140-6736(17)33095-7. Epub 2018 Jan 6. Erratum In: Lancet. 2018 Feb 1;:

ReferenceCitation: McComsey GA, Lupo S, Parks D, Poggio MC, De Wet J, Kahl LP, Angelis K, Wynne B, Vandermeulen K, Gartland M, Cupo M, Aboud M; 202094 Sub-Study Investigators. Switch from tenofovir disoproxil fumarate combination to dolutegravir with rilpivirine improves parameters of bone health. AIDS. 2018 Feb 20;32(4):477-485. doi: 10.1097/QAD.0000000000001725.

oa_host_type: repository

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_normalized: dnet

repositories:
PubMed Central
dnet

repositories_concat: PubMed Central;dnet

unpaywall_oa_status: green

publisher_dissemination: Wolters Kluwer Health

ipd_sharing: Yes

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: ViiV Healthcare

collaborators:
Janssen Pharmaceuticals
GlaxoSmithKline

sponsor_collaborators:
ViiV Healthcare
Janssen Pharmaceuticals
GlaxoSmithKline

location_country:
Germany
Italy
United Kingdom
Argentina
Australia
Netherlands
Belgium
United States
Spain
Taiwan
Canada
Russian Federation
France


acronym: OPTIMUM

lead_sponsor: Actelion

summary: International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis

ReferenceCitation: Kappos L, Fox RJ, Burcklen M, Freedman MS, Havrdova EK, Hennessy B, Hohlfeld R, Lublin F, Montalban X, Pozzilli C, Scherz T, D'Ambrosio D, Linscheid P, Vaclavkova A, Pirozek-Lawniczek M, Kracker H, Sprenger T. Ponesimod Compared With Teriflunomide in Patients With Relapsing Multiple Sclerosis in the Active-Comparator Phase 3 OPTIMUM Study: A Randomized Clinical Trial. JAMA Neurol. 2021 May 1;78(5):558-567. doi: 10.1001/jamaneurol.2021.0405.

oa_colors: green hybrid

evidence: open (via free pdf)

unpaywall_oa_status: hybrid

publisher_dissemination: American Medical Association

location_facility:
Investigator Site 3813
Investigator Site 1604
Investigator Site 3604
Investigator Site 8006
Investigator Site 2602
Investigator Site 8015
Investigator Site 3009
Investigator Site 1403
Investigator Site 4005
Investigator Site 1307
Investigator Site 2021
Investigator Site 1109
Investigator Site 3717
Investigator Site 3823
Investigator Site 8101
Investigator Site 3723
Investigator Site 4010
Investigator Site 3829
Investigator Site 8018
Investigator Site 2101
Investigator Site 2110
Investigator Site 3220
Investigator Site 2607
Investigator Site 8311
Investigator Site 2508
Investigator Site 3502
Investigator Site 3821
Investigator Site 2701
Investigator Site 9004
Investigator Site 3001
Investigator Site 3007
Investigator Site 3207
Investigator Site 8013
Investigator Site 3213
Investigator Site 3808
Investigator Site 3703
Investigator Site 2702
Investigator Site 3401
Investigator Site 2015
Investigator Site 3825
Investigator Site 1713
Investigator Site 3715
Investigator Site 3721
Investigator Site 1715
Investigator Site 2902
Investigator Site 3834
Investigator Site 3203
Investigator Site 2708
Investigator Site 8113
Investigator Site 3202
Investigator Site 2802
Investigator Site 3713
Investigator Site 1705
Investigator Site 3403
Investigator Site 3836
Investigator Site 3603
Investigator Site 1409
Investigator Site 2905
Investigator Site 3814
Investigator Site 3839
Investigator Site 1501
Investigator Site 3208
Investigator Site 3217
Investigator Site 3815
Investigator Site 2601
Investigator Site 3805
Investigator Site 2202
Investigator Site 3716
Investigator Site 3724
Investigator Site 3904
Investigator Site 3837
Investigator Site 3503
Investigator Site 3803
Investigator Site 1602
Investigator Site 1413
Investigator Site 7409
Investigator Site 2910
Investigator Site 3606
Investigator Site 2909
Investigator Site 3205
Investigator Site 1502
Investigator Site 8040
Investigator Site 2707
Investigator Site 3902
Investigator Site 3807
Investigator Site 1505
Investigator Site 1113
Investigator Site 2807
Investigator Site 8065
Investigator Site 8102
Investigator Site 3802
Investigator Site 4006
Investigator Site 8042
Investigator Site 1405
Investigator Site 2003
Investigator Site 3903
Investigator Site 8036
Investigator Site 3722
Investigator Site 3504
Investigator Site 4004
Investigator Site 3811
Investigator Site 1605
Investigator Site 3819
Investigator Site 3711
Investigator Site 3006
Investigator Site 3801
Investigator Site 3818
Investigator Site 1102
Investigator Site 2212
Investigator Site 2502
Investigator Site 1509
Investigator Site 3831
Investigator Site 3730
Investigator Site 3010
Investigator Site 1104
Investigator Site 3002
Investigator Site 3605
Investigator Site 3835
Investigator Site 3905
Investigator Site 3833
Investigator Site 3725
Investigator Site 2603
Investigator Site 7410
Investigator Site 2811
Investigator Site 2509
Investigator Site 3602
Investigator Site 1603
Investigator Site 8045
Investigator Site 3840
Investigator Site 1506
Investigator Site 3718
Investigator Site 1703
Investigator Site 3004
Investigator Site 2606
Investigator Site 2103
Investigator Site 3214
Investigator Site 3216
Investigator Site 3810
Investigator Site 3219
Investigator Site 8120
Investigator Site 3822
Investigator Site 1706
Investigator Site 1303
Investigator Site 9104
Investigator Site 3008
Investigator Site 2804
Investigator Site 1301
Investigator Site 3701
Investigator Site 2703
Investigator Site 2903
Investigator Site 3003
Investigator Site 3812
Investigator Site 2709
Investigator Site 3402
Investigator Site 3215
Investigator Site 2711
Investigator Site 1504
Investigator Site 3714
Investigator Site 3842
Investigator Site 1107
Investigator Site 3906
Investigator Site 2506

title: Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled, Superiority Study to Compare the Efficacy and Safety of Ponesimod to Teriflunomide in Subjects With Relapsing Multiple Sclerosis

source: euctr

location_country:
Finland
Germany
Poland
Bosnia and Herzegovina
Turkey
Croatia
Czechia
Canada
Serbia
France
Belarus
Lithuania
Portugal
Hungary
United States
Latvia
Ukraine
Romania
Italy
United Kingdom
Sweden
Mexico
Spain
Greece
Bulgaria
Georgia
Russian Federation
Israel


type: Other Identifier

title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of LX4211 as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

summary: This Phase 3 study was intended to demonstrate superiority of either Sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy.

ReferenceCitation: Peters AL, McGuire DK, Danne T, Kushner JA, Rodbard HW, Dhatariya K, Sawhney S, Banks P, Jiang W, Davies MJ, Lapuerta P. Diabetic Ketoacidosis and Related Events With Sotagliflozin Added to Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of the inTandem 1 and 2 Studies. Diabetes Care. 2020 Nov;43(11):2713-2720. doi: 10.2337/dc20-0924. Epub 2020 Sep 14.

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

repository_institution: University of Illinois at Chicago - INDIGO

version: submittedVersion

repositories_concat: PubMed Central;figshare.com

publisher_dissemination: American Diabetes Association

ReferenceCitation: Danne T, Joish VN, Afonso M, Banks P, Sawhney S, Lapuerta P, Davies MJ, Buse JB, Lin D, Reaney M, Guillonneau S, Snoek FJ, Bailey TS, Polonsky WH. Improvement in Patient-Reported Outcomes in Adults with Type 1 Diabetes Treated with Sotagliflozin plus Insulin Versus Insulin Alone. Diabetes Technol Ther. 2021 Jan;23(1):70-77. doi: 10.1089/dia.2020.0068.

oa_host_type: publisher

evidence: open (via page says license)

publisher_dissemination: Mary Ann Liebert Inc

ReferenceCitation: Ervin C, Joish VN, Evans E, DiBenedetti D, Reaney M, Preblick R, Castro R, Danne T, Buse JB, Lapuerta P. Insights Into Patients' Experience With Type 1 Diabetes: Exit Interviews From Phase III Studies of Sotagliflozin. Clin Ther. 2019 Nov;41(11):2219-2230.e6. doi: 10.1016/j.clinthera.2019.09.003. Epub 2019 Oct 3.

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

ReferenceCitation: Danne T, Cariou B, Buse JB, Garg SK, Rosenstock J, Banks P, Kushner JA, McGuire DK, Peters AL, Sawhney S, Strumph P. Improved Time in Range and Glycemic Variability With Sotagliflozin in Combination With Insulin in Adults With Type 1 Diabetes: A Pooled Analysis of 24-Week Continuous Glucose Monitoring Data From the inTandem Program. Diabetes Care. 2019 May;42(5):919-930. doi: 10.2337/dc18-2149. Epub 2019 Mar 4.

repositories_concat: PubMed Central;p5547z03x

ReferenceCitation: Danne T, Cariou B, Banks P, Brandle M, Brath H, Franek E, Kushner JA, Lapuerta P, McGuire DK, Peters AL, Sawhney S, Strumph P. HbA1c and Hypoglycemia Reductions at 24 and 52 Weeks With Sotagliflozin in Combination With Insulin in Adults With Type 1 Diabetes: The European inTandem2 Study. Diabetes Care. 2018 Sep;41(9):1981-1990. doi: 10.2337/dc18-0342. Epub 2018 Jun 24.

lead_sponsor: Lexicon Pharmaceuticals

sponsor_collaborators:
Lexicon Pharmaceuticals
Sanofi

location_country:
Germany
Italy
Lithuania
Poland
Slovakia
Hungary
Israel
Romania
United Kingdom
Sweden
Netherlands
Austria
Belgium
Switzerland
Spain
Bulgaria
France


acronym: RELAY

lead_sponsor: Eli Lilly and Company

summary:
The main purpose of this study is to evaluate the efficacy and safety of ramucirumab in combination with erlotinib as compared to placebo in combination with erlotinib in previously untreated participants with stage IV non-small cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Exon 19-Del and Exon 21 L858R). Safety and tolerability of ramucirumab in combination with erlotinib will be assessed in Part A before proceeding to Part B.

The purpose of Part C is to determine the efficacy and safety of ramucirumab in combination with gefitinib in previously untreated East Asian participants with EGFR mutation-positive metastatic NSCLC and of ramucirumab in combination with osimertinib in those participants whose disease progressed on ramucirumab and gefitinib and that have T790M - positive metastatic NSCLC.

ReferenceCitation: Nakagawa K, Garon EB, Gao L, Callies S, Zimmermann A, Walgren R, Visseren-Grul C, Reck M. RELAY, ramucirumab plus erlotinib versus placebo plus erlotinib in untreated EGFR-mutated metastatic non-small cell lung cancer: exposure-response relationship. Cancer Chemother Pharmacol. 2022 Aug;90(2):137-148. doi: 10.1007/s00280-022-04447-x. Epub 2022 Jul 16.

evidence: open (via crossref license)

repository_institution: University of California - eScholarship University of California

repositories_concat: PubMed Central;escholarship.org

publisher_dissemination: Springer-Nature

ReferenceCitation: Nishio M, Nishio K, Reck M, Garon EB, Imamura F, Kawaguchi T, Yamaguchi H, Ikeda S, Hirano K, Visseren-Grul C, Ceccarelli M, Wijayawardana SR, Zimmermann A, Matsui T, Enatsu S, Nakagawa K. RELAY+: Exploratory Study of Ramucirumab Plus Gefitinib in Untreated Patients With EGFR-Mutated Metastatic NSCLC. JTO Clin Res Rep. 2022 Feb 26;3(4):100303. doi: 10.1016/j.jtocrr.2022.100303. eCollection 2022 Apr.

ReferenceCitation: Nadal E, Horinouchi H, Shih JY, Nakagawa K, Reck M, Garon EB, Wei YF, Kollmeier J, Frimodt-Moller B, Barrett E, Lipkovich O, Visseren-Grul C, Novello S. RELAY, Ramucirumab Plus Erlotinib Versus Placebo Plus Erlotinib in Patients with Untreated, Epidermal Growth Factor Receptor Mutation-Positive, Metastatic Non-Small-Cell Lung Cancer: Safety Profile and Manageability. Drug Saf. 2022 Jan;45(1):45-64. doi: 10.1007/s40264-021-01127-2. Epub 2021 Dec 20.

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

repositories_concat: PubMed Central;iris.unito.it

ReferenceCitation: Mitani S, Chen Y, Inoue K, Mori J, Gao L, Long A, Wakabayashi S. Clinical Impact of a Shortened Infusion Duration of Ramucirumab in Japanese Patients -A Model-Based Approach. Gan To Kagaku Ryoho. 2021 Nov;48(11):1381-1387.

ReferenceCitation: Nakagawa K, Garon EB, Seto T, Nishio M, Ponce Aix S, Paz-Ares L, Chiu CH, Park K, Novello S, Nadal E, Imamura F, Yoh K, Shih JY, Au KH, Moro-Sibilot D, Enatsu S, Zimmermann A, Frimodt-Moller B, Visseren-Grul C, Reck M; RELAY Study Investigators. Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Dec;20(12):1655-1669. doi: 10.1016/S1470-2045(19)30634-5. Epub 2019 Oct 4.

ReferenceCitation: Reck M, Garon EB, Paz-Ares L, Ponce S, Jaime JC, Juan O, Nadal E, Kiura K, Widau RC, He S, Dalal R, Lee P, Nakagawa K. Randomized, Double-Blind Phase Ib/III Study of Erlotinib With Ramucirumab or Placebo in Previously Untreated EGFR-Mutant Metastatic Non-Small-Cell Lung Cancer (RELAY): Phase Ib Results. Clin Lung Cancer. 2018 May;19(3):213-220.e4. doi: 10.1016/j.cllc.2017.11.003. Epub 2017 Nov 21.

ReferenceCitation: Garon EB, Reck M, Paz-Ares L, Ponce S, Jaime JC, Juan O, Nadal E, Lee P, Dalal R, Liu J, He S, Treat J, Nakagawa K. Treatment Rationale and Study Design for the RELAY Study: A Multicenter, Randomized, Double-Blind Study of Erlotinib With Ramucirumab or Placebo in Patients With Epidermal Growth Factor Receptor Mutation-Positive Metastatic Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2017 Jan;18(1):96-99. doi: 10.1016/j.cllc.2016.05.023. Epub 2016 Jun 8.

location_facility: Azienda per l'Assistenza Sanitaria n°5 "Friuli Occidentale"

location_facility: Institutul Oncologic Dr Trestioreanu Bucuresti

location_facility: Chang Gung Memorial Hospital - Kaohsiung

location_facility: Tokyo Met Cancer & Infectious Diseases Center Komagome Hp

location_facility: Kobe City Medical Center General Hospital

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Centre hospitalier universitaire Lapeyronie

location_facility: Hospital Universitario La Fe de Valencia

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH

location_facility: Niigata University Medical & Dental Hospital

location_facility: Policlinico S. Orsola Malpighi - Universita di Bologna

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Levine Cancer Institute- Carolinas Medical Center

location_facility: Hyogo Prefectual Amagasaki General Medical Center

location_facility: Foundation for Biomedical Research and innovation

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: Azienda Ospedaliero - Universitaria S. Luigi Gonzaga

location_facility: TRIO - Translational Research in Oncology-US, Inc.

location_facility: Gyeong-Sang National University Hospital

location_facility: Kliniken der Stadt Köln gGmbH Klinikum Köln-Merheim

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Cent

status: Active, not recruiting

title: A Multicenter, Randomized, Double-Blind Study of Erlotinib in Combination With Ramucirumab or Placebo in Previously Untreated Patients With EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer

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

study_completion_date_type: Anticipated

location_country:
Germany
Italy
United Kingdom
Hong Kong
Romania
Japan
United States
Korea, Republic of
Spain
Greece
Turkey
Taiwan
Canada
France

status_simplified: Ongoing


title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Episodic Cluster Headache

summary: The main purpose of this study is to evaluate the efficacy and safety of the study drug known as Galcanezumab in participants with episodic cluster headaches.

ReferenceCitation: Andrews JS, Kudrow D, Rettiganti M, Oakes T, Bardos JN, Wenzel R, Kuruppu DK, Gaul C, Martinez JM. Impact of Galcanezumab on Total Pain Burden: A Post Hoc Analysis of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study in Patients with Episodic Cluster Headache. J Pain Res. 2021 Jul 8;14:2059-2070. doi: 10.2147/JPR.S305066. eCollection 2021.

publisher_dissemination: Informa

ReferenceCitation: Goadsby PJ, Dodick DW, Leone M, Bardos JN, Oakes TM, Millen BA, Zhou C, Dowsett SA, Aurora SK, Ahn AH, Yang JY, Conley RR, Martinez JM. Trial of Galcanezumab in Prevention of Episodic Cluster Headache. N Engl J Med. 2019 Jul 11;381(2):132-141. doi: 10.1056/NEJMoa1813440.

location_country:
Finland
Germany
Italy
United Kingdom
Denmark
Netherlands
Belgium
United States
Spain
Greece
Canada
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."

location_facility: New England Institute for Clinical Research

location_facility: Michigan Head, Pain, and Neurological Institute

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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

location_facility: Migräne- und Kopfschmerzklinik GmbH & Co. KG

location_facility: Klinikum der Universität München Campus Großhadern


title: A Two-arm, Phase 1b/2 Study of Duvelisib Administered in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)

summary: A Two-arm, Phase 1b/2 Study of duvelisib Administered in Combination with Rituximab or Obinutuzumab in Subjects with Previously Untreated CD20+ Follicular Lymphoma.

status: Terminated

lead_sponsor: SecuraBio

location_country:
Italy
United Kingdom
Belgium
United States
Spain
France

status_simplified: Unknown


lead_sponsor: Amgen

summary:
The purpose of this study is to evaluate the efficacy of etanercept monotherapy compared to methotrexate monotherapy on maintenance of remission in participants with rheumatoid arthritis (RA) who were on etanercept plus methotrexate therapy.

This is a multicenter, randomized withdrawal, double-blind controlled study in participants with rheumatoid arthritis on etanercept plus methotrexate therapy who are in very good disease control for 6 months prior to study entry. The study will consist of a 30-day screening period, a 24-week open label run-in period, a 48-week double-blind treatment period and a 30-day safety follow-up period.

ReferenceCitation: Curtis JR, Trivedi M, Haraoui B, Emery P, Park GS, Collier DH, Aras GA, Chung J. Defining and characterizing sustained remission in patients with rheumatoid arthritis. Clin Rheumatol. 2018 Apr;37(4):885-893. doi: 10.1007/s10067-017-3923-z. Epub 2017 Dec 9.

ReferenceCitation: Curtis JR, Emery P, Karis E, Haraoui B, Bykerk V, Yen PK, Kricorian G, Chung JB. Etanercept or Methotrexate Withdrawal in Rheumatoid Arthritis Patients in Sustained Remission. Arthritis Rheumatol. 2021 May;73(5):759-768. doi: 10.1002/art.41589. Epub 2021 Mar 24.

ReferenceCitation: Curtis JR, Stolshek B, Emery P, Haraoui B, Karis E, Kricorian G, Collier DH, Yen PK, Bykerk VP. Effects of Disease-Worsening Following Withdrawal of Etanercept or Methotrexate on Patient-Reported Outcomes in Patients With Rheumatoid Arthritis: Results From the SEAM-RA Trial. J Clin Rheumatol. 2023 Jan 1;29(1):16-22. doi: 10.1097/RHU.0000000000001893. Epub 2022 Oct 22.

title: A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis

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

location_country:
Germany
Italy
Poland
Portugal
Hungary
Argentina
Mexico
United States
Spain
Greece
South Africa
Czechia
Bulgaria
Canada
France


acronym: Phase I trial of afatinib in pediatric tumours

lead_sponsor: Boehringer Ingelheim

summary:
Open-label, dose escalation, monotherapy, basket trial with biomarker specific MTD expansion cohort/Phase II part.

The trial will consist of 2 parts:

Dose finding part to determine the MTD
Biomarker specific MTD expansion cohort/Phase II part to assess clinical anti-tumour activity in included tumour types

ReferenceCitation: Andrade RC, Boroni M, Amazonas MK, Vargas FR. New drug candidates for osteosarcoma: Drug repurposing based on gene expression signature. Comput Biol Med. 2021 Jul;134:104470. doi: 10.1016/j.compbiomed.2021.104470. Epub 2021 May 7.

location_facility: The University of Texas Health Science Center at Houston

location_facility: Rigshospitalet, København, Børneonkologisk Afsnit 5002

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Azienda Ospedaliera Universitaria di Padova

location_facility: Hospital Infantil Universitario Niño Jesus

location_facility: St. Anna Children-Hospital, Children's Cancer Research, Wien

title: Phase I/II Open Label, Dose Escalation Trial to Determine the MTD, Safety, PK and Efficacy of Afatinib Monotherapy in Children Aged ≥1 Year to <18 Years With Recurrent/Refractory Neuroectodermal Tumours, Rhabdomyosarcoma and/or Other Solid Tumours With Known ErbB Pathway Deregulation Regardless of Tumour Histology

location_country:
Germany
Italy
United Kingdom
Denmark
Australia
Netherlands
Austria
Faroe Islands
United States
Spain
Canada
France


title: A Phase 2, Multicenter, Open-label, Single-arm Trial to Evaluate the Correlation Between Objective Response Rate and Baseline Intratumoral CD8+ Cell Density in Subjects With Unresected Stage IIIB to IVM1c Melanoma Treated With Talimogene Laherparepvec

summary: The study is a phase 2, multi centered, single arm study designed to evaluate the correlation between cluster of differentiation 8-positive (CD8+) cell density and objective response rate in adults with unresected stage IIIB to IVM1c melanoma. This study will also evaluate the safety and tolerability profile of talimogene laherparepvec.

ReferenceCitation: Malvehy J, Samoylenko I, Schadendorf D, Gutzmer R, Grob JJ, Sacco JJ, Gorski KS, Anderson A, Pickett CA, Liu K, Gogas H. Talimogene laherparepvec upregulates immune-cell populations in non-injected lesions: findings from a phase II, multicenter, open-label study in patients with stage IIIB-IVM1c melanoma. J Immunother Cancer. 2021 Mar;9(3):e001621. doi: 10.1136/jitc-2020-001621.

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Netherlands
Austria
Belgium
United States
Spain
Greece
Russian Federation
France


acronym: OI

summary: This is a prospective, multicenter, single-arm study in children 2 to 17 years of age with OI to evaluate efficacy and safety of denosumab.

title: To Evaluate the Effect of Denosumab in Lumbar Spine Bone Mineral Density (BMD) Z-score at 12 Months, as Assessed by Dual-energy X-ray Absorptiometry (DXA), in Children 2 to 17 Years of Age (at the Time of Screening) on a 3-Month Dosing Regimen With OI

location_country:
Germany
Italy
Poland
Bulgaria
Hungary
United Kingdom
Australia
Belgium
United States
Spain
Czechia
Canada
France


title: ABLATOR Ablation Observational Registry

acronym: ABLATOR

summary: The purpose of this registry is to assess the performance and clinical effectiveness of a combination of SJM mapping and ablation products in the treatment of subjects with atrial fibrillation (AF).

lead_sponsor: Abbott Medical Devices

location_country:
Germany
Italy
India
Portugal
United Kingdom
Netherlands
Austria
Belgium
Korea, Republic of
China
Saudi Arabia
Spain
Czechia
Canada
France

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Märkische Kliniken GmbH Klinikum Lüdenscheid

location_facility: Institut de Cardiologie de Quebec (Hôpital Laval)

location_facility: Herz- und Gefässzentrum am Krankenhaus Neu-Bethlehem

location_facility: Hospital general Universitario de Alicante

location_facility: Escorts Heart Institute and Research Centre

location_facility: Immanuel Klinikum Bernau - Herzzentrum Brandenburg

location_facility: Fuwai Heart Hospital & Cardiovascular Institute

location_facility: Third Xiangya Hospital of Central South University

location_facility: Ospedale San Giovanni di Dio - Torregalli


title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lebrikizumab in Patients With Persistent Moderate to Severe Atopic Dermatitis That is Inadequately Controlled by Topical Corticosteroids

summary: This randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of lebrikizumab administered subcutaneously (SC) in adult participants with persistent moderate to severe atopic dermatitis (AD) who are inadequately controlled by topical corticosteroids (TCS). The study includes a screening visit, a 2-week run-in period, a 12-week blinded treatment period, and an 8-week safety follow-up period. Following screening visit, eligible participants will enter in run-in period (Days - 14 to - 1) during which a protocol-specified topical therapy regimen will be initiated. At the end of the run-in period, participants who have: 1) demonstrated compliance with the protocol-specified TCS regimen, and 2) who continue to fulfill the eligibility criteria will be randomized.

lead_sponsor: Hoffmann-La Roche

location_country:
Finland
Germany
Poland
United Kingdom
Australia
Netherlands
Switzerland
United States
Korea, Republic of
Spain
Taiwan
Czechia
Canada
France

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Masarykova nemocnice o.z; kozni oddeleni

location_facility: Hospital Universitario La Paz; Servicio de dermatologia

location_facility: Hospital Universitario La Princesa, Servicio dermatologia

location_facility: SRH Wald-Klinikum Gera GmbH; Hautkrankheiten und Allergologie

location_facility: Helsinki University Central Hospital; Skin & Allergy Hospital

location_facility: Academisch Medisch Centrum Universiteit Amsterdam; Dermatology and VU University Medical Center

location_facility: University of Texas Medical School-Houston

location_facility: Newcastle University & The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Turku Central University Hospital; Dermatology and allergology

location_facility: UKSH Kiel; Klinik für Dermatologie, Venerologie und Allergologie

location_facility: Hopital Hotel Dieu Et Hme; Clinique Dermatologique

location_facility: Faculty Hospital; Department of Dermatology

location_facility: St George Dermatology and Skin Cancer Centre

location_facility: Tampere University Hospital; Dermatology and allergology

location_facility: Dr. Melinda Gooderham Medicine Professional Corporation

location_facility: Hospital General Universitario de Valencia; servicio de dermatología

location_facility: Uniwersyteckie Centeum Kliniczne GUMed; Klinika Dermatologii, Wenerologii i Alergologii

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Dermatologia

location_facility: National Cheng-Kung University Hospital; Department of Dermatology

location_facility: Oregon Health & Science University; Department of Dermatology

location_facility: National Taiwan University Hospital; Department of Dermatology

location_facility: Northwestern University Feinberg School Of Medicine

location_facility: Hospital Ramon y Cajal; servicio dermatologia

location_facility: Chang Gung Medical Foundation;Kaohsiung Branch; Department of Dermatology

location_facility: HUGregorio Marañón, Servicio de dermatología

location_facility: University of Iowa Healthcare; Dermatology

location_facility: Royal Melbourne Hospital; Dermatology Department

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital; Skin Therapy Research Unit

location_facility: University of Colorado; Anschutz Cancer Pavilion

location_facility: Centre Hospitalier Lyon Sud; Dermatologie

location_facility: Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie

location_facility: Hopital l Archet 2; Ginestriere, Service de; Dermatologie

location_facility: Dermatology Clinical Research Center of San Antonio

location_facility: ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o

location_facility: Clinica Universitaria de Navarra; Servicio de Dermatologia

location_facility: Hopital Saint Andre CHU De Bordeaux; Dermatologie

location_facility: Universitätsspital Zürich; Dermatologische Klinik

location_facility: University Medical Center Groningen; Department of Dermatology

location_facility: Charles University School of Medicine; Deptartment of Dermatology


title: Randomised, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Combination Prophylaxis Against Post-operative Nausea and Vomiting in High-risk Patients

summary: A comparison of the efficacy of APD421 and placebo when combined with a standard anti-emetic in the prevention of PONV in patients at high risk of Post-operative Nausea and Vomiting (PONV).

primary_purpose: Prevention

lead_sponsor: Acacia Pharma Ltd

location_country:
United States
Germany
France

location_facility: Wake Forest University School of Medicine


intervention_type: Biological

acronym:
ANNEXA-4

 ANNEXA-4

lead_sponsor: Alexion Pharmaceuticals, Inc.

summary: The purpose of this study was to evaluate the hemostatic efficacy of andexanet alfa (andexanet) in participants receiving a factor Xa (FXa) inhibitor (apixaban, rivaroxaban, edoxaban, enoxaparin) who were experiencing an acute major bleed. The safety of andexanet was also studied.

ReferenceType: result

ReferenceCitation: Connolly SJ, Milling TJ Jr, Eikelboom JW, Gibson CM, Curnutte JT, Gold A, Bronson MD, Lu G, Conley PB, Verhamme P, Schmidt J, Middeldorp S, Cohen AT, Beyer-Westendorf J, Albaladejo P, Lopez-Sendon J, Goodman S, Leeds J, Wiens BL, Siegal DM, Zotova E, Meeks B, Nakamya J, Lim WT, Crowther M; ANNEXA-4 Investigators. Andexanet Alfa for Acute Major Bleeding Associated with Factor Xa Inhibitors. N Engl J Med. 2016 Sep 22;375(12):1131-41. doi: 10.1056/NEJMoa1607887. Epub 2016 Aug 30.

version: acceptedVersion

repositories:
PubMed Central
dnet
escholarship.org

repositories_concat: PubMed Central;dnet;escholarship.org

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

repositories_institution: University of California - eScholarship University of California

ReferenceCitation: Birocchi S, Fiorelli EM, Podda GM. Andexanet Alfa for Factor Xa Inhibitor Reversal. N Engl J Med. 2016 Dec 22;375(25):2498-9. doi: 10.1056/NEJMc1613270. No abstract available.

ReferenceCitation: Connolly SJ, Crowther M, Eikelboom JW, Gibson CM, Curnutte JT, Lawrence JH, Yue P, Bronson MD, Lu G, Conley PB, Verhamme P, Schmidt J, Middeldorp S, Cohen AT, Beyer-Westendorf J, Albaladejo P, Lopez-Sendon J, Demchuk AM, Pallin DJ, Concha M, Goodman S, Leeds J, Souza S, Siegal DM, Zotova E, Meeks B, Ahmad S, Nakamya J, Milling TJ Jr; ANNEXA-4 Investigators. Full Study Report of Andexanet Alfa for Bleeding Associated with Factor Xa Inhibitors. N Engl J Med. 2019 Apr 4;380(14):1326-1335. doi: 10.1056/NEJMoa1814051. Epub 2019 Feb 7.

ReferenceCitation: Costa OS, Connolly SJ, Sharma M, Beyer-Westendorf J, Christoph MJ, Lovelace B, Coleman CI. Andexanet alfa versus four-factor prothrombin complex concentrate for the reversal of apixaban- or rivaroxaban-associated intracranial hemorrhage: a propensity score-overlap weighted analysis. Crit Care. 2022 Jun 16;26(1):180. doi: 10.1186/s13054-022-04043-8.

ReferenceCitation: Huttner HB, Gerner ST, Kuramatsu JB, Connolly SJ, Beyer-Westendorf J, Demchuk AM, Middeldorp S, Zotova E, Altevers J, Andersohn F, Christoph MJ, Yue P, Stross L, Schwab S. Hematoma Expansion and Clinical Outcomes in Patients With Factor-Xa Inhibitor-Related Atraumatic Intracerebral Hemorrhage Treated Within the ANNEXA-4 Trial Versus Real-World Usual Care. Stroke. 2022 Feb;53(2):532-543. doi: 10.1161/STROKEAHA.121.034572. Epub 2021 Oct 14.

ReferenceCitation: Demchuk AM, Yue P, Zotova E, Nakamya J, Xu L, Milling TJ Jr, Ohara T, Goldstein JN, Middeldorp S, Verhamme P, Lopez-Sendon JL, Conley PB, Curnutte JT, Eikelboom JW, Crowther M, Connolly SJ; ANNEXA-4 Investigators. Hemostatic Efficacy and Anti-FXa (Factor Xa) Reversal With Andexanet Alfa in Intracranial Hemorrhage: ANNEXA-4 Substudy. Stroke. 2021 Jun;52(6):2096-2105. doi: 10.1161/STROKEAHA.120.030565. Epub 2021 May 10. Erratum In: Stroke. 2021 Aug;52(8):e525.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

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

repositories:
LIRIAS (KU Leuven)
PubMed Central
repository.ubn.ru.nl

repositories_concat: LIRIAS (KU Leuven);PubMed Central;repository.ubn.ru.nl

sponsor_collaborators: Portola Pharmaceuticals, LLC (a wholly owned subsidiary of Alexion Pharmaceuticals)

title: Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor Who Have Acute Major Bleeding (ANNEXA-4)

location_country:
Germany
United Kingdom
Japan
Netherlands
Belgium
United States
Spain
Canada
France


title: Expanded Clinical Study of the Tendyne Mitral Valve System

summary: The purpose of this study is to evaluate the safety and performance of the Tendyne Mitral Valve System in the treatment of severe mitral regurgitation in patents with functional disability greater than or equal to NYHA Class II, who are not suitable candidates for surgical replacement with otherwise available devices. Follow-up evaluations will be conducted through 5 years post implantation.

ReferenceCitation: Muller DWM, Sorajja P, Duncan A, Bethea B, Dahle G, Grayburn P, Babaliaros V, Guerrero M, Thourani VH, Bedogni F, Denti P, Dumonteil N, Modine T, Jansz P, Chuang ML, Blanke P, Leipsic J, Badhwar V. 2-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation. J Am Coll Cardiol. 2021 Nov 9;78(19):1847-1859. doi: 10.1016/j.jacc.2021.08.060.

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Muller DWM, Farivar RS, Jansz P, Bae R, Walters D, Clarke A, Grayburn PA, Stoler RC, Dahle G, Rein KA, Shaw M, Scalia GM, Guerrero M, Pearson P, Kapadia S, Gillinov M, Pichard A, Corso P, Popma J, Chuang M, Blanke P, Leipsic J, Sorajja P; Tendyne Global Feasibility Trial Investigators. Transcatheter Mitral Valve Replacement for Patients With Symptomatic Mitral Regurgitation: A Global Feasibility Trial. J Am Coll Cardiol. 2017 Jan 31;69(4):381-391. doi: 10.1016/j.jacc.2016.10.068. Epub 2016 Dec 28. Erratum In: J Am Coll Cardiol. 2017 Mar 7;69(9):1213.

location_country:
Germany
Italy
Norway
United Kingdom
Australia
Sweden
Netherlands
Switzerland
United States
France

location_facility: Honor Health Scottsdale Shea Medical Center

intervention_type: Device


lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this study is to evaluate three daratumumab dose schedules in participants with Smoldering Multiple Myeloma.

ReferenceCitation: Chari A, Munder M, Weisel K, Jenner M, Bygrave C, Petrucci MT, Boccadoro M, Cavo M, van de Donk NWCJ, Turgut M, Demirkan F, Karadogan I, Libby E, Kleiman R, Kuppens S, Bandekar R, Neff T, Heuck C, Qi M, Clemens PL, Goldschmidt H. Evaluation of Cardiac Repolarization in the Randomized Phase 2 Study of Intermediate- or High-Risk Smoldering Multiple Myeloma Patients Treated with Daratumumab Monotherapy. Adv Ther. 2021 Feb;38(2):1328-1341. doi: 10.1007/s12325-020-01601-w. Epub 2021 Jan 20.

ReferenceCitation: Landgren CO, Chari A, Cohen YC, Spencer A, Voorhees P, Estell JA, Sandhu I, Jenner MW, Williams C, Cavo M, van de Donk NWCJ, Beksac M, Moreau P, Goldschmidt H, Kuppens S, Bandekar R, Clemens PL, Neff T, Heuck C, Qi M, Hofmeister CC. Daratumumab monotherapy for patients with intermediate-risk or high-risk smoldering multiple myeloma: a randomized, open-label, multicenter, phase 2 study (CENTAURUS). Leukemia. 2020 Jul;34(7):1840-1852. doi: 10.1038/s41375-020-0718-z. Epub 2020 Feb 5.

endpoint_id: fhisxppmrqpajgzqkvft

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

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories:
PubMed Central
Zenodo
cris.unibo.it

repositories_concat: PubMed Central;Zenodo;cris.unibo.it

title: A Randomized Phase 2 Trial to Evaluate Three Daratumumab Dose Schedules in Smoldering Multiple Myeloma

location_country:
Germany
Israel
United Kingdom
Australia
Netherlands
United States
Turkey
Czechia
Canada
Russian Federation
France


title: A Multicenter, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of Evolocumab

summary: The purpose of this study was to characterize the safety and tolerability of long-term administration of evolocumab in adults with known coronary artery disease and hypercholesterolemia.

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Chile
Czechia
Canada
France
Hungary
Switzerland
United States
Iceland
Belgium
Malaysia
Italy
Norway
United Kingdom
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation
Israel


title: A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)

summary: To investigate if Riociguat is effective in the treatment of systemic sclerosis

ReferenceCitation: Distler O, Pope J, Denton C, Allanore Y, Matucci-Cerinic M, de Oliveira Pena J, Khanna D. RISE-SSc: Riociguat in diffuse cutaneous systemic sclerosis. Respir Med. 2017 Jan;122 Suppl 1:S14-S17. doi: 10.1016/j.rmed.2016.09.011. Epub 2016 Sep 28.

lead_sponsor: Bayer

location_country:
Germany
Italy
New Zealand
Hungary
United Kingdom
Australia
Japan
Netherlands
Switzerland
Belgium
United States
Turkey
Czechia
Canada
France

location_facility: Cukurova Univ. Tip. Fak. Balcali Hastanesi

location_facility: Sir Mortimer B. Davis Jewish General Hospital

location_facility: Centre Hospitalier Universitaire - Grenoble

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Institute of Rheumatology Tokyo Women's Medical University

location_facility: Rutgers Robert Wood Johnson Medical School

location_facility: Universitair Medisch Centrum St. Radboud

location_facility: Medical University of South Carolina Medical Center


acronym: TROPOS

lead_sponsor: AstraZeneca

summary: A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Reducing Oral Corticosteroid dependent Asthma.

ReferenceCitation: Busse WW, Brusselle GG, Korn S, Kuna P, Magnan A, Cohen D, Bowen K, Piechowiak T, Wang MM, Colice G. Tralokinumab did not demonstrate oral corticosteroid-sparing effects in severe asthma. Eur Respir J. 2019 Jan 31;53(2):1800948. doi: 10.1183/13993003.00948-2018. Print 2019 Feb.

ReferenceCitation: Panettieri RA Jr, Wang M, Braddock M, Bowen K, Colice G. Tralokinumab for the treatment of severe, uncontrolled asthma: the ATMOSPHERE clinical development program. Immunotherapy. 2018 Mar 1;10(6):473-490. doi: 10.2217/imt-2017-0191. Epub 2018 Mar 14.

publisher_dissemination: Future Science Ltd

title: A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Reducing Oral Corticosteroid Use in Adults and Adolescents With Oral Corticosteroid Dependent Asthma (TROPOS)

location_country:
Germany
Poland
Netherlands
Belgium
United States
Ukraine
France


title: A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Roxadustat in the Maintenance Treatment of Anemia in End Stage Renal Disease Patients on Stable Dialysis

acronym: Pyrenees

summary: This study was conducted to explore a new therapy for anemia in participants with end stage renal disease (ESRD) on dialysis. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin (which contains iron) is important for the transport of oxygen in your blood. The purpose of this study was to evaluate if roxadustat is effective and safe in the maintenance treatment of anemia in ESRD participants on stable dialysis. Roxadustat was compared to epoetin alfa and darbepoetin alfa, commercially available medicines for treatment of anemia.

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.

publisher_dissemination: Wiley

ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Europe B.V.

sponsor_collaborators:
Astellas Pharma Europe B.V.
FibroGen

location_country:
Germany
Italy
Poland
Portugal
Slovakia
Hungary
United Kingdom
Romania
Belgium
Spain
Croatia
Czechia
Bulgaria
Georgia
Serbia
Russian Federation
France

location_facility:
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Site GB44079
Site GE99503
Site RS38120
Site PL48009
Site PT35114
Site BE32013
Site GB44010
Site HU36026
Site GB44008
Site RU70014


title: Cardiac Implantable Electronic Device (CIED) Antibiotic Envelope Infection Prevention Trial

acronym: WRAP-IT

summary: Medtronic , Inc. is sponsoring the World-wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT), a randomized, prospective, multi-center, single blinded, post-market, interventional clinical study. This study will evaluate the ability of the TYRX™ envelope to reduce major Cardiac Implantable Electronic Device (CIED) infections through 12-months post-procedure following CIED generator replacement, upgrade, revision, or de novo cardiac resynchronization therapy defibrillator (CRT-D) implant. Additionally, this large device study provides the unique opportunity to prospectively characterize the performance of Medtronic's lead monitoring features in subjects whose CIED system includes a transvenous right ventricular (RV) defibrillation lead. Finally, the WRAP-IT study will serve as a post-approval study for those geographies requiring a post-approval study of the TYRX™ envelope.

ReferenceCitation: Poole JE, Swerdlow CD, Tarakji KG, Mittal S, Ellenbogen KA, Greenspon AJ, Kennergren C, Philbert BT, Moore J, Jones RC, Schaller RD, Hansalia R, Simmers T, Mihalcz A, DeBus B, Lexcen DR, Gunderson B, Wilkoff BL. Clinical performance of implantable cardioverter-defibrillator lead monitoring diagnostics. Heart Rhythm. 2022 Mar;19(3):363-371. doi: 10.1016/j.hrthm.2021.10.032. Epub 2021 Nov 9.

ReferenceCitation: Sohail MR, Corey GR, Wilkoff BL, Poole JE, Mittal S, Kennergren C, Greenspon AJ, Cheng A, Lande JD, Lexcen DR, Tarakji KG. Clinical Presentation, Timing, and Microbiology of CIED Infections: An Analysis of the WRAP-IT Trial. JACC Clin Electrophysiol. 2021 Jan;7(1):50-61. doi: 10.1016/j.jacep.2020.07.021. Epub 2020 Oct 28.

ReferenceCitation: Wilkoff BL, Boriani G, Mittal S, Poole JE, Kennergren C, Corey GR, Krahn AD, Schloss EJ, Gallastegui JL, Pickett RA, Evonich RF, Roark SF, Sorrentino DM, Sholevar DP, Cronin EM, Berman BJ, Riggio DW, Khan HH, Silver MT, Collier J, Eldadah Z, Holbrook R, Lande JD, Lexcen DR, Seshadri S, Tarakji KG. Cost-Effectiveness of an Antibacterial Envelope for Cardiac Implantable Electronic Device Infection Prevention in the US Healthcare System From the WRAP-IT Trial. Circ Arrhythm Electrophysiol. 2020 Oct;13(10):e008503. doi: 10.1161/CIRCEP.120.008503. Epub 2020 Sep 11.

endpoint_id: nbfzapbzoypsdcgeiryx

repository_institution: University of Modena and Reggio Emilia - IRIS UNIMORE

repositories_concat: PubMed Central;iris.unimore.it

ReferenceCitation: Wilkoff BL, Boriani G, Mittal S, Poole JE, Kennergren C, Corey GR, Love JC, Augostini R, Faerestrand S, Wiggins SS, Healey JS, Holbrook R, Lande JD, Lexcen DR, Willey S, Tarakji KG; WRAP-IT Investigators. Impact of Cardiac Implantable Electronic Device Infection: A Clinical and Economic Analysis of the WRAP-IT Trial. Circ Arrhythm Electrophysiol. 2020 May;13(5):e008280. doi: 10.1161/CIRCEP.119.008280. Epub 2020 Apr 12.

ReferenceCitation: Mittal S, Wilkoff BL, Kennergren C, Poole JE, Corey R, Bracke FA, Curnis A, Addo K, Martinez-Arraras J, Issa ZF, Redpath C, Moubarak J, Khelae SK, Boersma LVA, Korantzopoulos P, Krueger J, Lande JD, Morss GM, Seshadri S, Tarakji KG. The World-wide Randomized Antibiotic Envelope Infection Prevention (WRAP-IT) trial: Long-term follow-up. Heart Rhythm. 2020 Jul;17(7):1115-1122. doi: 10.1016/j.hrthm.2020.02.011. Epub 2020 Feb 19.

repositories_concat: Zenodo

ReferenceCitation: Tarakji KG, Mittal S, Kennergren C, Corey R, Poole JE, Schloss E, Gallastegui J, Pickett RA, Evonich R, Philippon F, McComb JM, Roark SF, Sorrentino D, Sholevar D, Cronin E, Berman B, Riggio D, Biffi M, Khan H, Silver MT, Collier J, Eldadah Z, Wright DJ, Lande JD, Lexcen DR, Cheng A, Wilkoff BL; WRAP-IT Investigators. Antibacterial Envelope to Prevent Cardiac Implantable Device Infection. N Engl J Med. 2019 May 16;380(20):1895-1905. doi: 10.1056/NEJMoa1901111. Epub 2019 Mar 17.

repository_institution: University of Zurich - Zurich Open Repository and Archive

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Finland
Germany
Poland
Chile
Canada
France
Portugal
Slovakia
Denmark
Switzerland
United States
Belgium
China
Malaysia
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Saudi Arabia
Spain
Greece
Israel

location_facility: Prairie Education & Research Cooperative (Springfield IL)

location_facility: Saint Mary Medical Center (Langhorne PA)

location_facility: Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello

location_facility: Central Manchester University Hospitals NHS - Manchester Royal Infirmary

location_facility: SCL Physicians Heart Institute of Colorado

location_facility: Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.

location_facility: Oregon Health & Science University Hospital

location_facility: University of Oklahoma Health Science Center (OUHSC)

location_facility: Ziekenhuis Oost Limburg - Campus St.-Jan

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

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: The University of Vermont Medical Center Inc

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Helse Bergen HF - Haukeland Universitetssjukehus

location_facility: Northeast Ohio Cardiovascular Specialists

location_facility: Oklahoma Heart Hospital Research Foundation

location_facility: Upper Michigan Cardiovascular Associates PC

location_facility: University of Florida Health Shands Hospital

location_facility: Szpital Kliniczny Przemienienia Panskiego

location_facility: Liverpool Heart and Chest Hospital NHS Foundation Trust

location_facility: Hôpital de la Timone - Centre Hospitalier Universitaire de Marseille

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: University of California San Francisco UCSF Medical Center

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

location_facility: Virginia Commonwealth University Health System

location_facility: Wake Forest University Health Sciences / Baptist Medical Center / North Carolina Baptist Hospital

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

location_facility: Cardiovascular Research Foundation of Louisiana

location_facility: Hamilton General Hospital / Hamilton Health Sciences

location_facility: University of Pittsburgh Medical Center UPMC Presbyterian

location_facility: Washington University School of Medicine

location_facility: CHU Hôpiteaux de Rouen - Hôpital Charles Nicolle

location_facility: Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)

location_facility: Royal Brompton & Harefield NHS Foundation Trust - Harefield Hospital

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: Institut Jantung Negara - National Heart Institute

location_facility: The University Kansas Medical Center Research Institute Inc

location_facility: Stredoslovensky ustav srdcovych a cievnych chorob a.s

location_facility: Centre Hospitalier Universitaire Saint Étienne - Hôpital Nord

location_facility: University General Hospital of Heraklion

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: Clearwater Cardiovascular & Interventional Consultants

location_facility: Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Novant Health Heart and Vascular Institute

location_facility: University Hospitals Case Medical Center

location_facility: Universitäts-Herz-Zentrum Freiburg - Bad Krozingen

location_facility: North Memorial Heart and Vascular Institute

location_facility: University of Pittsburgh Medical Center UPMC Hamot

location_facility: Centennial Heart Cardiovascular Consultants LLC

location_facility: Great Lakes Heart and Vascular Institute PC


title: A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add-on to Insulin Therapy in Subjects With Type 1 Diabetes Mellitus

acronym: DEPICT 1

summary: The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes.

ReferenceCitation: Melin J, Tang W, Rekic D, Hamren B, Penland RC, Boulton DW, Parkinson J. Dapagliflozin Pharmacokinetics Is Similar in Adults With Type 1 and Type 2 Diabetes Mellitus. J Clin Pharmacol. 2022 Oct;62(10):1227-1235. doi: 10.1002/jcph.2062. Epub 2022 May 2.

repository_institution: Authorea - Authorea

repository_normalized: Authorea - Authorea

repositories:
Authorea - Authorea
PubMed Central

repositories_concat: Authorea - Authorea;PubMed Central

ReferenceCitation: Groop PH, Dandona P, Phillip M, Gillard P, Edelman S, Jendle J, Xu J, Scheerer MF, Thoren F, Iqbal N, Repetto E, Mathieu C. Effect of dapagliflozin as an adjunct to insulin over 52 weeks in individuals with type 1 diabetes: post-hoc renal analysis of the DEPICT randomised controlled trials. Lancet Diabetes Endocrinol. 2020 Oct;8(10):845-854. doi: 10.1016/S2213-8587(20)30280-1.

ReferenceCitation: Mathieu C, Dandona P, Birkenfeld AL, Hansen TK, Iqbal N, Xu J, Repetto E, Scheerer MF, Thoren F, Phillip M. Benefit/risk profile of dapagliflozin 5 mg in the DEPICT-1 and -2 trials in individuals with type 1 diabetes and body mass index >/=27 kg/m2. Diabetes Obes Metab. 2020 Nov;22(11):2151-2160. doi: 10.1111/dom.14144. Epub 2020 Aug 20.

repository_institution: Elsevier - Scopus

repository_normalized: Pure (Denmark)

repositories:
LIRIAS (KU Leuven)
PubMed Central
Pure (Denmark)

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

repositories_institution:
Elsevier - Scopus
KU Leuven - Lirias

ReferenceCitation: Parkinson J, Tang W, Astrand M, Melin J, Ekholm E, Hamren B, Boulton DW. Model-based characterization of the relationship between dapagliflozin systemic exposure and HbA1c response in patients with type 1 diabetes mellitus. Diabetes Obes Metab. 2019 Jun;21(6):1381-1387. doi: 10.1111/dom.13664. Epub 2019 Mar 14.

ReferenceCitation: Dandona P, Mathieu C, Phillip M, Hansen L, Tschope D, Thoren F, Xu J, Langkilde AM; DEPICT-1 Investigators. Efficacy and Safety of Dapagliflozin in Patients With Inadequately Controlled Type 1 Diabetes: The DEPICT-1 52-Week Study. Diabetes Care. 2018 Dec;41(12):2552-2559. doi: 10.2337/dc18-1087. Epub 2018 Oct 23.

ReferenceCitation: Dandona P, Mathieu C, Phillip M, Hansen L, Griffen SC, Tschope D, Thoren F, Xu J, Langkilde AM; DEPICT-1 Investigators. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT-1): 24 week results from a multicentre, double-blind, phase 3, randomised controlled trial. Lancet Diabetes Endocrinol. 2017 Nov;5(11):864-876. doi: 10.1016/S2213-8587(17)30308-X. Epub 2017 Sep 14. Erratum In: Lancet Diabetes Endocrinol. 2017 Dec;5(12 ):e8.

location_country:
Finland
Germany
Italy
Hungary
Israel
Denmark
Australia
Romania
Sweden
Austria
Belgium
Mexico
United States
Spain
United Kingdom
Canada
France


title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lulizumab Pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects With Active Systemic Lupus Erythematosus

summary: Study evaluating the safety and efficacy of a novel biologic in the treatment of systemic lupus erythematosus in male and female adults. Patients who qualify will be randomized to either active BMS-931699 or placebo for initially, up to 24 weeks. Patients who complete the initial 24 weeks of treatment and who are responding to therapy will have the option to continue receiving BMS-931699 as part of a long-term extension (LTE). Disease activity and safety will be assessed over the course of the study through laboratory values, various rating scales accepted in systemic lupus erythematosus studies and patient self reporting.

primary_purpose: Other

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Poland
Argentina
Japan
Brazil
Chile
Canada
France
Colombia
Hungary
United States
Romania
Lebanon
Peru
Puerto Rico
Italy
Netherlands
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation

location_facility: Servicos Especializados em Reumatologia SER

location_facility: Allegheny-Singer Research Institute (Asri)

location_facility: Consultorio Medico de Reumatologia Dr.Jesus Alberto Lopez Garcia

location_facility: Center For Rheumatology, Immunology And Arthritis

location_facility: Centro de Radiodiagnostico Computarizado Medico de Tabasco S.A. de C.V.

location_facility: Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac

location_facility: Hospital General De Agudos J.M. Ramos Mejia

location_facility: CPCLIN Centro de Pesquisas Clinicas LTDA

location_facility: The University of North Carolina at Chapel Hill

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S.C.

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Toronto Western Hospital, University Health Network

location_facility: Joint and Muscle Medical Care and Research Institute (JMMCRI)

location_facility: Centro Integral En Reumatologia Sa De Cv

location_facility: The Feinstein Institute For Medical Research

location_facility: Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.

location_facility: Centre De Recherche Musculo-Squelettique

location_facility: CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.

location_facility: Beth Israel Deaconess Med. Center Div. Of Gastroenterology

location_facility: Unidad Reumatologica Las Americas, S.C. P.

location_facility: Medyczne Centrum Hetmanska Indywidualna Spec. Praktyka Lekar

location_facility: Instituto para el DeSarrollo Integral de la Salud S de RL de CV

location_facility: Rheumatology Associates Of North Alabama, P.C.

location_facility: Instituto de Asistencia Reumatologica Integral

location_facility: Valerius Med Group & Res Ctr Of Greater Long Beach, Inc.

location_facility: Instituto De Investigaciones Clinicas De Mar Del Plata

location_facility: Instituto Nacional De Ciencias Medicas Y Nutricion S.Z.


summary:
The objective of this study is to assess efficacy and safety of radium 223 dichloride in subjects with human epidermal growth factor receptor 2 (HER2) negative hormone receptor positive breast cancer with bone metastases treated with exemestane and everolimus

After implementation of CSP Amendment 10, only a limited number of subjects will remain in this study, in order to reduce the burden to study subjects, collection of data will be reduced and will focus mainly on acute safety, SSE, and OS. Once subjects are rolled over, the long-term safety will be collected and assessed entirely in the separate extended safety follow-up study.

title: A Phase II Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus When Administered to Metastatic HER2 Negative Hormone Receptor Positive Breast Cancer Subjects With Bone Metastases

location_country:
Germany
Italy
Poland
Israel
Hong Kong
Norway
Japan
Singapore
Switzerland
Austria
Belgium
United Kingdom
United States
Korea, Republic of
Spain
Taiwan
France


lead_sponsor: Octapharma

summary: The rationale of this study is to further fine-tune and individualize prophylactic treatment of patients with severe Haemophilia A with the goal of keeping the trough FVIII level above 1% between doses. Because trough FVIII levels are likely to be important predictors of the efficacy of prophylaxis, the focus of this study is on pharmacokinetic (PK) data.

location_facility: Centre Hospitalier Universitaire Félix Guyon

location_facility: Centre Régional de Traitement de l'hémophilie

location_facility: Hospital of the Univ of Occupational and Environmental Health

location_facility: Centre Régional de Traitement de l'Hémophilie

location_facility: Hôpital Purpan - Centre de Traitment Regional de l'Hemophilie Pole

location_facility: PHI Institute of Transfusion Medicine of Republic of Macedonia

location_facility: St. Marianna Univ School of Medicine Hospital

title: Prospective, Open-label, Multi-centre Phase 3b Study to Assess the Efficacy and Safety of Personalized Prophylaxis With Human-cl rhFVIII in Previously Treated Adult Patients With Severe Haemophilia A

location_country:
Finland
Slovenia
North Macedonia
Japan
Netherlands
United States
Croatia
Canada
France


title: A Multi-centre, Double-blind, Parallel-group, Randomized Controlled Study to Investigate the Efficacy, Safety and Tolerability of Orally Administered BI 409306 During a 12-week Treatment Period Compared to Placebo in Patients With Alzheimer Disease

summary: The study is designed to compare the effects of 4 different doses of orally administered BI 409306 to placebo in patients with Alzheimers Disease

ReferenceCitation: Frolich L, Wunderlich G, Thamer C, Roehrle M, Garcia M Jr, Dubois B. Evaluation of the efficacy, safety and tolerability of orally administered BI 409306, a novel phosphodiesterase type 9 inhibitor, in two randomised controlled phase II studies in patients with prodromal and mild Alzheimer's disease. Alzheimers Res Ther. 2019 Feb 12;11(1):18. doi: 10.1186/s13195-019-0467-2.

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

location_country:
Germany
Italy
Poland
Portugal
United Kingdom
Netherlands
Austria
Belgium
United States
Spain
Canada
France

location_facility: Institut universitaire de geriatrie Sherbrooke

location_facility: Private Practice for Psychiatry and Neurology

location_facility: True North Clinical Research Halifax, Inc.

location_facility: True North Clinical Research Kentville, Inc.

location_facility: Memory Enhancement Center of America, Inc.

location_facility: Non-Public Outpatient Clinic "Synapsa" Pawel Polrola, Kielce

location_facility: Hospital Universitario Fundación Alcorcón

location_facility: Hospital Universitari General de Catalunya

location_facility: Landeskrankenhaus Hall, Abt.f. Psychatrie & Psychotherapie A

location_facility: Zentralinstitut für seelische Gesundheit

location_facility: Podlassian Center of Psychogeriatry, Bialystok

location_facility: Reg. Specialist Hospital Wroclaw, Research & Develop. Center

location_facility: Non-Public Outpat. Clinic "Dom Sue Ryder", PALLMED Sp. z o.o

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Neurologie und Psychiatrie / Psychotherapie

location_facility: Non-Public Outpatient Clinic Neuro-Kard Ilkowski & Partners

location_facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: Orange County Neuropsychiatric Research Center LLC

location_facility: ANI Neurology, PLLC, dba Alzheimer's Memory Center


title: Study 200977: Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine in the Treatment of Subjects With Type 2 Diabetes Mellitus: The Switch Study

summary: This Phase IIIb, randomized, open-label, parallel group, active control, multicenter, treat to-target study of 26 weeks' treatment duration will evaluate the efficacy and safety of once-weekly albiglutide as replacement of prandial insulin in subjects with type 2 diabetes mellitus (T2DM) failing to achieve adequate glycemic control on their current basal bolus insulin regimen (with or without metformin). Approximately 794 subjects will be randomly assigned in a 1:1 ratio to 1 of 2 treatment groups: albiglutide + insulin glargine (with insulin lispro discontinuation at Week 4) (with or without metformin) or to intensification of insulin glargine + insulin lispro (with or without metformin). The study will comprise 4 study periods : Screening (2 weeks), Standardization (4 weeks), Treatment (26 weeks), and Post treatment Follow up (4 weeks). The total duration of a subject's participation will be approximately 36 weeks.

ReferenceCitation: Rosenstock J, Nino A, Soffer J, Erskine L, Acusta A, Dole J, Carr MC, Mallory J, Home P. Impact of a Weekly Glucagon-Like Peptide 1 Receptor Agonist, Albiglutide, on Glycemic Control and on Reducing Prandial Insulin Use in Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy: A Randomized Trial. Diabetes Care. 2020 Oct;43(10):2509-2518. doi: 10.2337/dc19-2316. Epub 2020 Jul 21.

ipd_sharing_description: IPD for this study is available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

sponsor_collaborators: GlaxoSmithKline PPD

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Brazil
Mexico
United States
Korea, Republic of
Spain
South Africa
Canada
Philippines
France


title: A Phase Ib Study of the Safety and Pharmacology of Atezolizumab Administered With Obinutuzumab in Patients With Relapsed/Refractory Follicular Lymphoma or Atezolizumab Administered With Obinutuzumab or Tazemetostat in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

summary: This open-label, multicenter, global study is designed to assess the safety, tolerability, preliminary efficacy, and pharmacokinetics of intravenous atezolizumab (MPDL3280A) and obinutuzumab in participants with refractory or relapsed follicular lymphoma (FL) or atezolizumab and obinutuzumab or tazemetostat administered in participants with refractory or relapsed diffuse large B-cell lymphoma (DLBCL). The anticipated duration of this study is approximately 4.5 years.

design_allocation: Non-Randomized

ReferenceCitation: Palomba ML, Cartron G, Popplewell L, Ribrag V, Westin J, Huw LY, Agarwal S, Shivhare M, Hong WJ, Raval A, Chang AC, Penuel E, Morschhauser F. Combination of Atezolizumab and Tazemetostat in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma: Results From a Phase Ib Study. Clin Lymphoma Myeloma Leuk. 2022 Jul;22(7):504-512. doi: 10.1016/j.clml.2021.12.014. Epub 2021 Dec 24.

ReferenceCitation: Palomba ML, Till BG, Park SI, Morschhauser F, Cartron G, Marks R, Shivhare M, Hong WJ, Raval A, Chang AC, Penuel E, Popplewell LL. Combination of Atezolizumab and Obinutuzumab in Patients with Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-Cell Lymphoma: Results from a Phase 1b Study. Clin Lymphoma Myeloma Leuk. 2022 Jul;22(7):e443-e451. doi: 10.1016/j.clml.2021.12.010. Epub 2021 Dec 24.

location_country:
Germany
Italy
United Kingdom
United States
France

location_facility: Hopital Claude Huriez - CHU Lille; Service des maladies du sang

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: University of North Carolina at Chapel Hill


acronym: SUNSHINE

summary: The purpose of this study was to investigate the clinical response to fidaxomicin oral suspension or tablets and vancomycin oral liquid or capsules in pediatric participants with Clostridium difficile-associated diarrhea (CDAD). It also investigated the recurrence/sustained clinical response to and safety of fidaxomicin and vancomycin, as well as acceptance of the fidaxomicin oral suspension formulation.

ReferenceCitation: Wolf J, Kalocsai K, Fortuny C, Lazar S, Bosis S, Korczowski B, Petit A, Bradford D, Croos-Dabrera R, Incera E, Melis J, van Maanen R. Safety and Efficacy of Fidaxomicin and Vancomycin in Children and Adolescents with Clostridioides (Clostridium) difficile Infection: A Phase 3, Multicenter, Randomized, Single-blind Clinical Trial (SUNSHINE). Clin Infect Dis. 2020 Dec 17;71(10):2581-2588. doi: 10.1093/cid/ciz1149.

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

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

repositories_concat: HAL;PubMed Central;University of Melbourne - Minerva Access;Zenodo;air.unimi.it

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

publisher_dissemination: Oxford University Press

ReferenceCitation: Borali E, De Giacomo C. Clostridium Difficile Infection in Children: A Review. J Pediatr Gastroenterol Nutr. 2016 Dec;63(6):e130-e140. doi: 10.1097/MPG.0000000000001264.

sponsor_collaborators:
Astellas Pharma Europe B.V.
Merck Sharp & Dohme LLC

location_facility:
Site FR33001
Site US10032
Site US10008
Site IT39001
Site PL48004
Site US10025
Site BE32001
Site DE49003
Site PL48006
Site ES34003
Site US10034
Site PL48014
Site PL48012
Site PL48007
Site US10038
Site BE32003
Site PL48002
Site FR33005
Site ES34002
Site FR33007
Site HU36006
Site US10010
Site DE49001
Site DE49002
Site US10015
Site ES34004
Site DE49004
Site HU36004
Site IT39004
Site RO40005
Site CA15003
Site DE49006
Site US10022
Site DE49010
Site US10014
Site US10027
Site ES34007
Site US10028
Site FR33002
Site US10004
Site US10030
Site US10037
Site FR33008
Site BE32002

title: A Phase 3, Multicenter, Investigator-blind, Randomized, Parallel Group Study to Investigate the Safety and Efficacy of Fidaxomicin Oral Suspension or Tablets Taken q12h, and Vancomycin Oral Liquid or Capsules Taken q6h, for 10 Days in Pediatric Subjects With Clostridium Difficile-associated Diarrhea

location_country:
Germany
Italy
Poland
Hungary
Romania
Belgium
United States
Spain
Canada
France


title: A Randomized, Multicenter, Open Label Study of MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in Anthracycline Naive Patients With Locally Advanced/Metastatic HER2-Positive Breast Cancer

acronym: HERMIONE

summary: This study is an open label, randomized, multicenter trial of MM-302 plus trastuzumab. The trial is designed to demonstrate whether MM-302 plus trastuzumab is more effective than the chemotherapy of physician's choice (CPC) plus trastuzumab in locally advanced/metastatic HER2-positive breast cancer patients. Patients may not have been previously treated with an anthracycline in any setting. Patients must have received prior treatment with trastuzumab in any setting, have either progressed or are intolerant to ado-trastuzumab emtansine in the metastatic or locally advanced setting, have either progressed or are intolerant to pertuzumab in the metastatic or locally advanced setting or had disease recurrence within 12 months of pertuzumab treatment in the neoadjuvant or adjuvant setting.

ReferenceCitation: Miller K, Cortes J, Hurvitz SA, Krop IE, Tripathy D, Verma S, Riahi K, Reynolds JG, Wickham TJ, Molnar I, Yardley DA. HERMIONE: a randomized Phase 2 trial of MM-302 plus trastuzumab versus chemotherapy of physician's choice plus trastuzumab in patients with previously treated, anthracycline-naive, HER2-positive, locally advanced/metastatic breast cancer. BMC Cancer. 2016 Jun 3;16:352. doi: 10.1186/s12885-016-2385-z.

repository_institution: PubMed Central - Europe PMC

lead_sponsor: Merrimack Pharmaceuticals

location_country:
France
Germany
Italy
Austria
Belgium
United States
Spain
Canada
Czech Republic

location_facility: Florida Cancer Specialists & Research Institute

location_facility: AKh Allgemeines Krankenhaus der Stadt Linz

location_facility: Smilow Cancer Hospital at Yale New Haven Hospital

location_facility: University of Minnesota- Masonic Cancer Center

location_facility: The Center for Cancer and Blood Disorders

location_facility: GZA Ziekenhuizen - Campus Sint-Augustinus

location_facility: North Shore Hematology Oncology Associates

location_facility: The University of Texas- MD Anderson Cancer Center

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

location_facility: Institut de Cancerologie de l'Ouest site Paul Papin

location_facility: Greenville Health System Cancer Institute

location_facility: Johns Hopkins Medicine- The Sidney Kimmel Comprehensive Cancer Center

location_facility: Azienda Socio Sanitaria Territoriale di Cremona

location_facility: University of Miami Comprehensive Cancer Center

location_facility: Northwestern University- Robert H. Lurie Comprehensive Cancer Center

location_facility: Texas Oncology- Central Austin Cancer Center

location_facility: Hospital Universitario Arnau de Vilanova

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Azienda Ospedaliero-Universitaria di Bologna

location_facility: Centro Riferimento Oncologico, IRCCS, Istituto Nazionale Tumori

location_facility: UF Health Cancer Center at Orlando Health

location_facility: University of Alberta- Cross Cancer Institute

location_facility: Bon Secours Saint Francis Hospital Cancer Center

location_facility: Hospital Universitario Virgen de la Macarena

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: Istituto Nazionale Tumori, IRCCS Fondazione G. Pascale


title: A Phase 2, Multicenter, Randomized, Open-label Trial Assessing the Efficacy and Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Resectable, Stage IIIB to IVM1a Melanoma

summary: This is a phase 2, multicenter, randomized, open-label study to estimate the efficacy of talimogene laherparepvec as a neoadjuvant treatment followed by surgery compared to surgery alone in subjects with completely resectable stage IIIB, IIIC, or IVM1a melanoma.

ReferenceCitation: Dummer R, Gyorki DE, Hyngstrom J, Berger AC, Conry R, Demidov L, Sharma A, Treichel SA, Radcliffe H, Gorski KS, Anderson A, Chan E, Faries M, Ross MI. Neoadjuvant talimogene laherparepvec plus surgery versus surgery alone for resectable stage IIIB-IVM1a melanoma: a randomized, open-label, phase 2 trial. Nat Med. 2021 Oct;27(10):1789-1796. doi: 10.1038/s41591-021-01510-7. Epub 2021 Oct 4.

location_country:
Poland
Australia
Brazil
Switzerland
United States
Spain
Greece
Russian Federation
France