acronym: THEIA

lead_sponsor: Janssen Research & Development, LLC

summary: The primary purpose of this study is to evaluate the efficacy of guselkumab compared to placebo, in combination with a 26-week glucocorticoid (GC) taper regimen, in adult participants with new-onset or relapsing giant cell arteritis (GCA).

location_facility: ASUI Santa Maria della Misericordia di Udine

location_facility: Azianeda Ospedaliera dell'alto adige - Ospedale di Brunico

title: A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis

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

location_country:
Germany
Italy
Poland
Israel
Belgium
United States
Spain
Canada
France


type: EudraCT Number

type: Other Identifier

title: OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

summary:
This study, A3921210 is designed to evaluate the efficacy, safety and pharmacokinetics (PK) of tofacitinib in pediatric participants with moderately to severely active UC. In the US and EU, patients with prior TNFi failure or intolerance will be enrolled. Outside of the US or EU, patients having had inadequate response or intolerance to oral or IV corticosteroids or azathioprine or 6-mercaptopurine or TNFi will be enrolled.

All eligible participants will initially receive open label tofacitinib at a dose expected to produce equivalent systemic exposure to that observed in adults receiving 5 mg BID with the option for individual dose increase to 10 mg BID adult dose equivalent if dose escalation criteria are met.

The primary objective of this study is to evaluate the efficacy of tofacitinib based on remission in pediatric participants with moderately to severely active UC. The primary endpoint is remission by central read Mayo score following 44 weeks in the maintenance phase. Remission is defined by a Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0.

The study Design is an open-label Phase 3 study that includes a screening period of up to 4-weeks duration, an 8-week or 16-week induction phase, a 44-week maintenance phase, and a 24-month extension phase for pediatric participants with moderately to severely active UC. Participants will have a follow-up visit 4 weeks after the last dose of study intervention and a telephone contact 8 weeks later to assess for any adverse events (AEs)/serious adverse events (SAEs). The total maximum duration of this study will be up to 180 weeks.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: result

ReferenceCitation: Benchimol EI, Bernstein CN, Bitton A, Carroll MW, Singh H, Otley AR, Vutcovici M, El-Matary W, Nguyen GC, Griffiths AM, Mack DR, Jacobson K, Mojaverian N, Tanyingoh D, Cui Y, Nugent ZJ, Coulombe J, Targownik LE, Jones JL, Leddin D, Murthy SK, Kaplan GG. Trends in Epidemiology of Pediatric Inflammatory Bowel Disease in Canada: Distributed Network Analysis of Multiple Population-Based Provincial Health Administrative Databases. Am J Gastroenterol. 2017 Jul;112(7):1120-1134. doi: 10.1038/ajg.2017.97. Epub 2017 Apr 18.

oa_host_type: repository

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

host_type: repository

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: publishedVersion

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405. No abstract available.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

repository_institution: University of Liège - Open Repository and Bibliography

repository_institution: University of Geneva - Archive ouverte UNIGE

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

license: cc-by

license_normalized: cc-by

repository_institution: Russian Cardiology Society - Russian Cardiology Journal

unpaywall_oa_status: bronze

publisher_dissemination: Oxford University Press

ReferenceCitation: Kelsen JR, Sullivan KE, Rabizadeh S, Singh N, Snapper S, Elkadri A, Grossman AB. North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition Position Paper on the Evaluation and Management for Patients With Very Early-onset Inflammatory Bowel Disease. J Pediatr Gastroenterol Nutr. 2020 Mar;70(3):389-403. doi: 10.1097/MPG.0000000000002567.

oa_host_type: publisher

repositories_concat: closed

ReferenceCitation: Turner D, Otley AR, Mack D, Hyams J, de Bruijne J, Uusoue K, Walters TD, Zachos M, Mamula P, Beaton DE, Steinhart AH, Griffiths AM. Development, validation, and evaluation of a pediatric ulcerative colitis activity index: a prospective multicenter study. Gastroenterology. 2007 Aug;133(2):423-32. doi: 10.1053/j.gastro.2007.05.029. Epub 2007 May 21.

ReferenceCitation: Otley A, Smith C, Nicholas D, Munk M, Avolio J, Sherman PM, Griffiths AM. The IMPACT questionnaire: a valid measure of health-related quality of life in pediatric inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 2002 Oct;35(4):557-63. doi: 10.1097/00005176-200210000-00018.

ReferenceCitation: Marcovitch L, Nissan A, Mack D, Otley A, Hussey S, Mclean B, Lewis M, Croft N, Barakat FM, Griffiths AM, Turner D. Item Generation and Reduction Toward Developing a Patient-reported Outcome for Pediatric Ulcerative Colitis (TUMMY-UC). J Pediatr Gastroenterol Nutr. 2017 Mar;64(3):373-377. doi: 10.1097/MPG.0000000000001259.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Queen Mary University of London - Queen Mary Research Online

version: submittedVersion

ReferenceCitation: Taylor SJ, Whincup PH, Hindmarsh PC, Lampe F, Odoki K, Cook DG. Performance of a new pubertal self-assessment questionnaire: a preliminary study. Paediatr Perinat Epidemiol. 2001 Jan;15(1):88-94. doi: 10.1046/j.1365-3016.2001.00317.x.

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

location_country:
Finland
Germany
Italy
Poland
Slovakia
Hungary
Israel
United Kingdom
Australia
Japan
Netherlands
Sweden
Belgium
United States
Spain
Canada
France

location_facility: Women's and Children's Hospital, Women's and Children's Health Network Inc.

location_facility: Osaka Medical and Pharmaceutical University Hospital

location_facility: Sahlgrenska Sjukhuset, Drottning Silvias Barn- och Ungdomssjukhus

location_facility: CUIMC Research Pharmacy - Milstein Hospital (Pharmacy Only)

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Connecticut Children's Ambulatory Surgical Center

location_facility: University of California, San Francisco Pediatric Clinical Research Center (PCRC)

location_facility: Hospital Materno-Infantil de Málaga (Hospital Regional Universitario de Málaga)

location_facility: Instytut "Pomnik - Centrum Zdrowia Dziecka"

location_facility: Azienda USL di Bologna - IRCCS ISNB - Programma Gastroenterologia Pediatrica

location_facility: Morgan Stanley Children's Hospital, CUIMC

location_facility: Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center at Mount Sinai

location_facility: Hôpital Universitaire Des Enfants Reine Fabiola

location_facility: Buerger Center for Advanced Pediatric Care

location_facility: Texas Children's Hospital - Clinical Research Center

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Szpital Uniwersytecki nr 1 im. dr. A. Jurasza w Bydgoszczy

location_facility: Schneider Children's Medical Center of Israel

location_facility: Atlantic Children's Health-Pediatric Gastroenterology & Nutrition

location_facility: Texas Children's Hospital - Wallace Tower

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Hospital Infantil Universitario Niño Jesus

location_facility: Northwell Health - Cohen Children's Medical Center

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

location_facility: Texas Children's Hospital - RRO Regulatory (Administrative Offices - Regulatory Location)

location_facility: Weill Cornell Medicine - New York Presbyterian Hospital

location_facility: Karolinska Universitetssjukhuset Barngastroenterologi, hepatologi och nutrition

location_facility: National Center for Child Health and Development

location_facility: The Hospital for Sick Children - Division of Gastroenterology, Hepatology and Nutrition

location_facility: London Health Sciences Centre - Children's Hospital

location_facility: University of California, San Francisco Benioff Children's Hospital

location_facility: Atlantic Health System- Morristown Medical Center (Pharmacy)

location_facility: Stollery Children's Hospital University of Alberta

location_facility: Erasmus Medical Center - Sophia Children's Hospital

location_facility: Goryeb Children's Hospital (Endoscopy only)

location_facility: Mount Sinai Hospital Endoscopy Center (Endoscopy Only)

location_facility: Borsod- Abauj- Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz

location_facility: Outpatient Pediatric Research Center Children's Healthcare of Atlanta

location_facility: Sachsska Children's and Youth Hospital/South General Hospital

location_facility: Aichi Children's Health and Medical Center

location_facility: Mount Sinai Hospital (Investigational Drug Pharmacy)

location_facility: Columbia University Irving Medical Center

location_facility: Texas Children's Hospital - Feigin Tower (Administrative Offices - Research Administrative Offices)

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


lead_sponsor: Wave Life Sciences Ltd.

summary: WVE-HDSNP2-002 is an open-label extension (OLE) study to evaluate the safety, tolerability, PK, PD, and clinical effects of WVE-120102 in adult patients with early manifest HD who carry a targeted single nucleotide polymorphism, rs362331 (SNP2). To participate in the study, patients must have completed the Phase 1b/2a clinical study WVE-HDSNP2-001.

location_facility: Institut du Cerveau et de la Moelle Epinière

location_facility: Queen Elizabeth University Hospital - PPDS

location_facility: Odense University Hospital and University of Southern Denmark

location_facility: Centre Hospitalier de l-Universite de Montreal

location_facility: Royal Devon and Exeter Hospital NHS Trust

status: Terminated

title: A Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120102 in Patients With Huntington's Disease

source: euctr

enrollment_type: Actual

study_completion_date_type: Actual

location_country:
Germany
Poland
United Kingdom
Denmark
Australia
Canada
France

status_simplified: Unknown


summary: WVE-HDSNP1-002 is an open-label extension (OLE) study to evaluate the safety, tolerability, PK, PD, and clinical effects of WVE-120101 in adult patients with early manifest HD who carry a targeted single nucleotide polymorphism, rs362307 (SNP1). To participate in the study, patients must have completed the Phase 1b/2a clinical study WVE-HDSNP1-001.

title: A Multicenter, Open-label Extension Study to Evaluate the Safety, Pharmacodynamics, and Clinical Effects of WVE-120101 in Patients With Huntington's Disease

ipd_sharing: No


intervention_type: Biological

acronym: HILLIER

lead_sponsor: AstraZeneca

summary: The purpose of the study is to compare the efficacy and safety of benralizumab versus placebo and to compare benralizumab dosing regimens during extension period.

sponsor_collaborators:
AstraZeneca
Iqvia Pty Ltd

title: A Phase 2 Multinational, Randomized, Double-blind, Parallel-group, 16-week Placebo-controlled Study With a 36-Week Extension to Investigate the Use of Benralizumab for Patients With Moderate to Severe Atopic Dermatitis Despite Treatment With Topical Medications (The HILLIER Study)

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.

design_allocation: Randomized

location_country:
Poland
Australia
United States
Korea, Republic of
Spain
Czechia
Bulgaria
France


title: An Open-Label, Multi-Center, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7283420 as a Single Agent in Hematologic and Molecular Relapsed/Refractory Acute Myeloid Leukemia

summary: This open-label, entry-into-human (EIH) study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of RO7283420. Escalating doses of RO7283420 will be administered to participants with Acute Myeloid Leukemia (AML) in order to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D).

status: Completed

design_allocation: Non-Randomized

ReferenceType: derived

ReferenceCitation: Augsberger C, Hanel G, Xu W, Pulko V, Hanisch LJ, Augustin A, Challier J, Hunt K, Vick B, Rovatti PE, Krupka C, Rothe M, Schonle A, Sam J, Lezan E, Ducret A, Ortiz-Franyuti D, Walz AC, Benz J, Bujotzek A, Lichtenegger FS, Gassner C, Carpy A, Lyamichev V, Patel J, Konstandin N, Tunger A, Schmitz M, von Bergwelt-Baildon M, Spiekermann K, Vago L, Jeremias I, Marrer-Berger E, Umana P, Klein C, Subklewe M. Targeting intracellular WT1 in AML with a novel RMF-peptide-MHC-specific T-cell bispecific antibody. Blood. 2021 Dec 23;138(25):2655-2669. doi: 10.1182/blood.2020010477. Erratum In: Blood. 2022 Mar 31;139(13):2086-2087.

publisher_dissemination: American Society of Hematology

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Hoffmann-La Roche

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

location_facility: Hospital Universitario la Fe; Servicio de Hematologia

location_facility: Peter MacCallum Cancer Centre; Medical Oncology

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia

location_facility: Uniklinikum "Carl Gustav Carus"; Med. Klinik 1; Hämatologie, Zelltherapie und Medizinische Onkologie

location_facility: Ospedale Santa Chiara; Unita Operativa Di Ematologia

location_facility: Institut Catala d?Oncologia Hospital Germans Trias i Pujol

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Institut Paoli Calmettes; Departement D' Onco-Hematologie

location_facility: Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III

location_facility: Hospital Univ. 12 de Octubre; Servicio de Hematologia

location_facility: Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT

location_facility: China Medical University Hospital; Oncology and Hematology

location_facility: Hopital De Haut Leveque; Hematologie Clinique

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: National Taiwan Universtiy Hospital; Division of Hematology

location_facility: National Cheng Kung University Hospital; Oncology

location_facility: Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia

status_simplified: Completed


title: Abbott Vascular Medical Device Registry

acronym: AV-MDR

summary: The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Abbott Medical Devices

location_country:
Germany
Italy
Hungary
Australia
Netherlands
Austria
Belgium
Switzerland
United States
China
Spain
United Arab Emirates
Taiwan
France

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

location_facility: UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz

location_facility: University Hospital - Univ. of Alabama at Birmingham (UAB)

location_facility: Cardioangiologisches Centrum am Bethanien Krankenhaus

location_facility: Hospital General Universitario de Alicante

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: Inselspital - University Hospital of Bern

location_facility: Universitätsklinikum Schleswig-Holstein Campus Kiel

intervention_type: Device


lead_sponsor: Boehringer Ingelheim

summary:
This study is open to adults with borderline personality disorder. The purpose of this study is to find out whether a medicine called BI 1358894 helps to reduce symptoms in people with borderline personality disorder. Four different doses of BI 1358894 are tested in the study.

Participants are put into 5 groups by chance. Participants in 4 of the 5 groups take different doses of BI 1358894. Participants in the fifth group take placebo. Participants take BI 1358894 and placebo as tablets once a day. Placebo tablets look like BI 1358894 tablets but do not contain any medicine.

Participants are in the study for about 5 months. During this time, they visit the study site about 12 times and get about 6 phone calls. At the visits, doctors ask participants about their symptoms. The results between the BI 1358894 groups and the placebo group are then compared. The doctors also regularly check the general health of the participants.

ReferenceCitation: Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.

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

repository_normalized: Pure (Denmark)

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

repository_institution: University of Nottingham - Repository@Nottingham

repositories:
PubMed Central
Pure (Denmark)
nottingham-repository.worktribe.com

publisher_dissemination: Wiley

location_facility: University Multiprofile Hospital for Active Treatement "Alexandrovska" EAD

location_facility: Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)

location_facility: IRCCS San Giovanni Di Dio Fatebenefratelli

location_facility: Fundación FunDaMos para la asistencia e investigación en psiquiatría

location_facility: University at Buffalo, The State University of New York

location_facility: Clinica Privada de Salud Mental Santa Teresa de Avila

location_facility: Centro de Estudios Clinicos de Queretaro S.C

location_facility: "Filipopolis" - Ambulatory for Group Practice for Specialized Care in Psychiatry

location_facility: Zentralinstitut für seelische Gesundheit

location_facility: Klinikum der Universität München - Campus Innenstadt

location_facility: Centro de Investigacion y Asistencia en Psiquiatria (CIAP)

location_facility: Podlassian Center of Psychogeriatry, Bialystok

location_facility: Peninsula Therapeutic and Research Group

location_facility: Pacific Clinical Research Management Group LLC

location_facility: CEN (Centro Especializado Neurociencias)

location_facility: Instituto Médico de la Fundación Estudios Clínicos

location_facility: Universitair Psychiatrisch Centrum Duffel (UPC Duffel)

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: Monash Alfred Psychiatry Research Centre

location_facility: Region Zealand, Psychiatric Research Unit

title: A Phase II Randomized, Double-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of 4 Oral Doses of BI 1358894 Once Daily Over 12 Week Treatment Period in Patients With Borderline Personality Disorder

ipd_sharing_description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

location_country:
Germany
Italy
Poland
Argentina
Denmark
Australia
Japan
Sweden
Mexico
Belgium
United States
Spain
Czechia
Bulgaria
France


acronym: PAGANINI

lead_sponsor: Bayer

summary:
Researchers in this study want to find the optimal therapeutic dose of drug BAY1817080 for patients with long-standing cough with or without clear causes (refractory and/or unexplained chronic cough, RUCC). Study drug BAY1817080 is a new drug under development for the treatment of long-standing cough. It blocks proteins that are expressed by the airway sensory nerves which are oversensitive in patients with long-standing cough. This prevents the urge to cough. Researchers also want to learn the safety of the study drug and how well it works in reducing the cough frequency, severity and urge-to-cough.

Participants in this study will receive either the study drug or placebo (a placebo looks like the test drug but does not have any medicine in it) tablets twice daily for 12 weeks. Observation for each participant will last about 18 weeks in total. Participants will be asked to wear a digital device to record the cough and to complete questionnaires every day to document the symptoms. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.

ReferenceType: background

ReferenceCitation: Fletcher MC. Selectivity of the P2X3 receptor antagonist Eliapixant, and its potential use in the treatment of endometriosis. Purinergic Signal. 2022 Mar;18(1):1-3. doi: 10.1007/s11302-021-09831-5. Epub 2022 Jan 3. No abstract available.

publisher_dissemination: Springer-Nature

location_facility: Akdeniz Universitesi Tip Fakultesi Hastanesi

location_facility: Japan community health care organization Kanazawa Hospital

location_facility: Investigación en Alergias y Enfermedades Respiratorias-INAER

location_facility: Sureyyapasa Gogus Hasalikleri. ve Gogus Cerrahisi EAH

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: EKBC, Uj Szent Janos Korhaz es Szakrendelo

location_facility: Zentrum f. ambulante pneumologische Forschung Marburg GbR

location_facility: University of Occupational and Environmental Health

location_facility: City Clinical Hospital n.a. D.D. Pletnev

location_facility: Burlington Lung Clinic (BLC) Clinical Research

location_facility: Bellingham Asthma, Allergy & Immunology Clinic

location_facility: Pharmaceutical Research & Consulting, Inc.

location_facility: Ordinace pro TBC a respiracni nemoci, s.r.o.

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: City Consultative and Diagnostic Center #1

location_facility: Ambulancia klin. imunologie a alergologie, ANA JJ, s.r.o.

location_facility: Ostrowieckie Centrum Medyczne Sp. Cyw. A.O-C. K.C.

location_facility: Clinique de pneumologie et du sommeil de Lanaudière (CPSL)

location_facility: Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi

location_facility: California Allergy & Asthma Medical Group & Research Center

location_facility: Centro Médico Dra. De Salvo - Clinical Research Center

location_facility: Region Clinical Emergency Hospital n.a. M.A.Podgorbunskogo

location_facility: King's College Hospital - NHS Foundation Trust

location_facility: Praxis f. Lungen- und Bronchialheilkunde,

location_facility: Investigaciones en Patologías Respiratorias

location_facility: Centrum Medycyny Oddechowej Mroz Spolka Jawna

title: Randomized, Double-blind, Parallel Group, Phase 2b Dose-finding, Efficacy and Safety Study of 12-week Twice Daily Oral Administration of BAY 1817080 Compared to Placebo in the Treatment of Refractory and/or Unexplained Chronic Cough (RUCC)

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

location_country:
Germany
Poland
Argentina
Australia
Japan
Turkey
Czechia
Canada
France
Slovakia
Hungary
United States
Belgium
Italy
United Kingdom
Netherlands
Spain
Taiwan
Russian Federation


title: A Randomized, Double-blind, Placebo-controlled Clinical Trial of Once-daily Inhaled Molgramostim Nebulizer Solution in Adult Subjects With Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

summary: 160 subjects with autoimmune pulmonary alveolar proteinosis (aPAP) will be randomized to receive once daily treatment with inhaled molgramostim or placebo for 48 weeks. Subjects completing the 48 week placebo-controlled period will receive open-label treatment with once daily inhaled molgramostim for 96 weeks.

status: Active, not recruiting

lead_sponsor: Savara Inc.

location_country:
Germany
Ireland
Italy
Poland
Portugal
United Kingdom
Romania
Australia
Japan
Netherlands
Belgium
United States
Korea, Republic of
Spain
Greece
Turkey
Canada
France

location_facility: Severance Hospital - Yonsei University Health System - Pulmonary

location_facility: Tohoku University Hospital - Respiratory Tract Medicine

location_facility: National Hospital Organization Kinki-Chuo Chest medical Center

location_facility: UZ Leuven - Campus Gasthuisberg - Pneumologie

location_facility: Thoraxklinik Heidelberg gGmbH am Universitätsklinikum Heidelberg

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Ege University Hospital - Department of Pulmonology

location_facility: Chiba University Hospital - Respiratory Medicine

location_facility: Institutul de Pneumoftiziologie "Marius Nasta"

location_facility: University Of Arkansas For Medical Services

location_facility: Yedikule Chest Disease and Surgery Training and Research Hospital

location_facility: University of Pennsylvania Perelman School of Medicine - Pulmonology

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: University Institute of Cardiology and Respirology of Quebec

location_facility: St Joseph's Healthcare Hamilton Research

location_facility: Health Sciences University Gulhane Training and Research Hospital

location_facility: Royal Brompton and Harefield NHS Foundation Trust


title: A Phase 1b Open-label Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Administration of Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (ALL)

summary: The primary objective of this phase 1b study is to evaluate the safety and tolerability of blinatumomab and AMG 404 in combination in adults with R/R B-ALL and to estimate the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of AMG 404 when combined with continuous intravenous infusion (cIV) blinatumomab.

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

lead_sponsor: Amgen

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

location_facility: Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi

location_facility: Hospital Universitari Germans Trias i Pujol


title: A Phase 1 Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations

summary: This is an open-label, multicenter Phase 1 study to evaluate safety, tolerability and preliminary efficacy of oral LY3410738 in patients with isocitrate dehydrogenase 1 (IDH1) arginine 132 (R132)-mutant advanced solid tumors, including but not limited to cholangiocarcinoma, chondrosarcoma, and glioma or isocitrate dehydrogenase 2 (IDH2) arginine 140 (R140) or arginine 172 (R172) mutant cholangiocarcinoma.

lead_sponsor: Eli Lilly and Company

sponsor_collaborators:
Eli Lilly and Company
Loxo Oncology, Inc.

location_country:
Hong Kong
Singapore
Australia
Japan
United States
Korea, Republic of
Spain
Taiwan
France

location_facility: University of Chicago Pritzker School of Medicine

location_facility: South Texas Accelerated Research Therapeutics, LLC

location_facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest


title: Evaluation of InterStim Micro System Performance and Safety (ELITE) to Confirm Long-Term Outcomes - Post Market Clinical Follow-Up Study

acronym: ELITE

summary: Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the InterStim Micro System for sacral neuromodulation.

lead_sponsor: MedtronicNeuro

location_country:
United Kingdom
Netherlands
Switzerland
United States
Canada
France

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

location_facility: Louisiana State University Health Sciences Center New Orleans

location_facility: Maastricht Universitair Medisch Centrum (MUMC)

location_facility: Centre Hospitalier Universitaire De Rennes

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


title: A Phase I First-in-Human Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AZD8701 Administered Intravenously as Monotherapy and in Combination With Durvaluamb (MEDI4736) in Participants With Advanced Solid Tumours.

summary: The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of AZD8701 Alone and in Combination with Durvalumab (MEDI4736) in Adult Subjects with Select Advanced Solid Tumors

ReferenceCitation: Revenko A, Carnevalli LS, Sinclair C, Johnson B, Peter A, Taylor M, Hettrick L, Chapman M, Klein S, Solanki A, Gattis D, Watt A, Hughes AM, Magiera L, Kar G, Ireland L, Mele DA, Sah V, Singh M, Walton J, Mairesse M, King M, Edbrooke M, Lyne P, Barry ST, Fawell S, Goldberg FW, MacLeod AR. Direct targeting of FOXP3 in Tregs with AZD8701, a novel antisense oligonucleotide to relieve immunosuppression in cancer. J Immunother Cancer. 2022 Apr;10(4):e003892. doi: 10.1136/jitc-2021-003892.

oa_colors: green gold

evidence: oa journal (via doaj)

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

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:
United States
Spain
Canada
France


acronym: AARDVARC

summary: This is a Phase II, international, open-label, two-arm, non-randomised study of AZD4635 in participants with metastatic castration-resistant prostate cancer (mCRPC).

sponsor_collaborators: AstraZeneca Parexel

title: A Phase II, Open-label, Study to Assess the Efficacy, Safety, and Tolerability of AZD4635 in Combination With Durvalumab and in Combination With Cabazitaxel and Durvalumab in Patients Who Have Progressive Metastatic Castrate-Resistant Prostate Cancer (AARDVARC)

location_country:
Belgium
United States
Spain
Korea, Republic of
France


lead_sponsor: GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

summary: The primary objective for this trial is to determine the effect of GB002 (seralutinib) on improving pulmonary hemodynamics in subjects with World Health Organization (WHO) Group 1 PAH who are Functional Class (FC) II and III. The secondary objective for this trial is to determine the effect of GB002 (seralutinib) on improving exercise capacity in this population.

location_facility: CHU de Montpellier - Hopital Arnaud de Villeneuve

location_facility: Dept of Veterans Affairs Greater Los Angeles Healthcare System

location_facility: Medizinische Universitat Wien - Universitatsklinik fur Innere Medizin II

location_facility: Medical College of Wisconsin - Froedtert Hospital

location_facility: The Ohio State University Wexner Medical Center

location_facility: University of New Mexico Health Sciences Center

location_facility: LKH - Univ. Klinikum Graz - Universitatsklinik fur Innere Medizin

location_facility: Washington University School of Medicine

location_facility: Sir Mortimer B Davis Jewish General Hospital

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Medicines Research Limited

location_facility: Institute for Pulmonary Diseases of Vojvodina

location_facility: London Health Sciences Centre - Victoria Hospital

location_facility: The University of California San Francisco

location_facility: New York Presbyterian Hospital - Weill Cornell Medicine

location_facility: Zentrum fur Pulmonale Hypertonie Thoraxklinik-Heidelberg gGmbH

location_facility: The Lundquist Institute of Biomedical Innovation at Harbor-UCLA Medical Center

title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)

location_country:
Germany
United Kingdom
Australia
Austria
Belgium
United States
Spain
Czechia
Canada
Serbia
France


title: Distal Evaluation of Functional Performance With Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting

acronym: DEFINE GPS

summary: Multi-center, prospective, randomized controlled study comparing PCI guided by angiography versus iFR Co-Registration using commercially available Philips pressure guidewires and the SyncVision co-registration system, employing an adaptive design study for interim sample size re-estimation.

status: Enrolling by invitation

lead_sponsor: Philips Clinical & Medical Affairs Global

location_country:
Germany
Portugal
Israel
United Kingdom
Denmark
Australia
Sweden
Netherlands
Austria
Belgium
Mexico
United States
Spain
Switzerland
Canada
France

location_facility: Tampa Cardiovascular Innovations and Research

location_facility: Hospital Prof. Doutour Fernando Foneseca

location_facility: Albert Schweitzer Ziekenhuis / Hartcentum Dordrecht- Gorinchem

location_facility: Baylor Scott & White, The Heart Hospital Plano

location_facility: William Osler Health-Brampton Civic Hospital

location_facility: Hospital Universitario Marqués de Valdecillas

location_facility: Central Arkansas Veterans Healthcare System (CAVHS)


title: A Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis

acronym: BE MOVING

summary: The purpose of the study is to demonstrate the long-term safety, tolerability and efficacy of bimekizumab in patients with active axial spondyloarthritis (axSpA, also known as radiographic axSpa (r-axSpA)) including ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis (nr-axSpa).

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

lead_sponsor: UCB Biopharma SRL

location_country:
Germany
Poland
Hungary
United Kingdom
Japan
Netherlands
Belgium
United States
China
Spain
Turkey
Czechia
Bulgaria
France


acronym: COMMODORE 2

summary: A study designed to evaluate the non-inferiority of crovalimab compared with eculizumab in participants with PNH who have not been previously treated with complement inhibitor therapy. This study will enroll approximately 200 participants.

sponsor_collaborators:
Hoffmann-La Roche
Chugai Pharmaceutical

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Spitalul Clinic Municipal Filantropia Craiova

location_facility: Hospital Universitario Clinico San Carlos

location_facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol; Hematologia Clinica

location_facility: Centro Integrado de Oncologia de Curitiba

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Philippine General Hospital; Pulmonary Medicine

location_facility: Global Trial Research Center S.A. de C.V.

location_facility: Centro Hospitalar do Baixo Vouga E.P.E. - Hospital de Aveiro

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii

location_facility: Chang Gung Medical Foundation - Kaohsiung; Oncology

location_facility: Organizacion Medica de Investigacion (OMI)

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.

location_facility: *X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

location_facility: General Hospital of Thessaloniki G. Papanikolaou

location_facility: Kings College Hospital; Kings Clinical Research Facility

location_facility: Szpital Uniwersytecki nr2 im. dr J. Biziela

location_facility: Centro Hospitalar de Lisboa Central - Hospital D. Estefânia; Pediatrics

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: Centro Hospitalar do Porto - Hospital de Santo António

location_facility: Singapore General Hospital; Department of Haematology

location_facility: Nanfang Hospital, Southern Medical University

location_facility: The Chinese University of Hong Kong; Department of Medicine & Therapeutics

location_facility: Vilnius University Hospital Santariskiu Clinics, Public Institution; Cardiology

location_facility: Hospital Universitario de Gran Canaria Doctor Negrín; Servicio de Hematología

location_facility: National Taiwan Universtiy Hospital; Division of Hematology

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: Affiliated Hospital of Nantong University; Nephrology

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1

title: A Phase III, Randomized, Open-Label, Active-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Crovalimab Versus Eculizumab In Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Turkey
France
Lithuania
Portugal
Hong Kong
Ukraine
Romania
China
Malaysia
Philippines
United Kingdom
Singapore
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Sweden


acronym: VESTIGE

lead_sponsor: Sanofi

summary:
Primary Objective:

• To assess the effect of dupilumab on lung inflammation and related changes in airway volumes detectable by functional respiratory imaging

Secondary Objective:

To evaluate the effect of dupilumab at Week 24 on bronchodynamics, hyperinflation, airway resistance, airway wall thickness, ventilation defects and mucus plugging derived from high-resolution computed tomography (HRCT) scans, patient-reported outcomes, FeNO and spirometry.
To evaluate safety of dupilumab

sponsor_collaborators:
Sanofi
Regeneron Pharmaceuticals

location_facility: American Health Research Site Number : 8400005

location_facility: Allianz Research Institute Site Number : 8400020

location_facility: VitaLink Research - Spartanburg Site Number : 8400011

location_facility: University of Kansas School of Medicine Site Number : 8400008

location_facility: Velocity Clinical Research, Medford Site Number : 8400014

location_facility: The Lung Research Center Site Number : 8400010

location_facility: University of Michigan Site Number : 8400002

location_facility: Medical University of South Carolina - Pulmonary & Critical Care Clinical Research Program Site Number : 8400009

location_facility: VitaLink Research-Greenville Site Number : 8400013

location_facility: ~Spartanburg Medical Research Site Number : 8400004

title: Randomized, Double Blind, Placebo Controlled Study to Evaluate the Effect of Dupilumab on Airway Inflammation Through Assessments of Lung Function, Mucus Plugging and Other Lung Imaging Parameters in Patients With Asthma

type: Registry Identifier

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

location_country:
Italy
Portugal
United Kingdom
Denmark
Romania
Sweden
United States
Saudi Arabia
Spain
Taiwan
Bulgaria
Ukraine
France


summary:
This is a study in adolescents and adults with Generalized Pustular Psoriasis (GPP). People between 12 and 75 years old can take part in the study. The study is open to people who had GPP flare-ups in the past but whose skin is clear or almost clear when they join the study. The purpose of the study is to test 3 different doses of a medicine called spesolimab and to see whether it helps to prevent GPP flare-ups.

Participants are put into 4 groups by chance. Three groups get different doses of spesolimab. The fourth group gets a placebo. Placebo looks like spesolimab but does not contain any medicine.

Spesolimab and placebo are given as an injection under the skin. Participants are in the study for about 1 year and 4 months. During this time, they visit the study site about 15 times. For the first 11 months, participants get spesolimab or placebo injections every month. At the study visits, the doctors check participants' skin for signs of a new GPP flare-up. The doctors also check the general health of the participants.

If a participant has a GPP flare-up during the study, more visits may be necessary. In case of a flare-up, participants get a dose of spesolimab as an infusion into a vein.

ReferenceCitation: Morita A, Choon SE, Bachelez H, Anadkat MJ, Marrakchi S, Zheng M, Tsai TF, Turki H, Hua H, Rajeswari S, Thoma C, Burden AD. Design of Effisayil 2: A Randomized, Double-Blind, Placebo-Controlled Study of Spesolimab in Preventing Flares in Patients with Generalized Pustular Psoriasis. Dermatol Ther (Heidelb). 2023 Jan;13(1):347-359. doi: 10.1007/s13555-022-00835-6. Epub 2022 Nov 5.

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

location_facility: National Hospital of Dermatology and Venereology

location_facility: Uludag University Medicine Faculty Departmant of Dermatology

location_facility: Bezmi Alem Valide Sultan Vakif Gureba Egitim ve Arastirma Hastanesi

location_facility: Centro de Investigación de Enfermedades Autoinmunes S.C.

location_facility: Klinikum der Universität München - Campus Innenstadt

location_facility: The Second Affiliated Hospital Zhejiang University School of Medicine

location_facility: Chang Gung Medical Foundation (CGMF) - Linkou Bran

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Washington University School of Medicine

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: Second Affiliated Hospital of Xi'an JiaoTong University

location_facility: Center for Skin Research, Testing and Product Development

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: LLC Skin Disease Clinic of Pier Volkenstein, St. Petersburg

location_facility: Hedi Chaker Hospital, Department of Dermatology

location_facility: General Hospital of Thessaloniki "Ippokrateio"

location_facility: The First Hospital of China Medical University

location_facility: Tokyo Medical University Ibaraki Medical Center

location_facility: Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

location_facility: Sun yet-sen Memorial Hospital, Sun yet-sen Univesity

location_facility: FSBEI HE "Kirov State Medical University"

title: Effisayil™ 2: Multi-center, Randomized, Parallel Group, Double Blind, Placebo Controlled, Phase IIb Dose-finding Study to Evaluate Efficacy and Safety of BI 655130 (Spesolimab) Compared to Placebo in Preventing Generalized Pustular Psoriasis (GPP) Flares in Patients With History of GPP.

ipd_sharing_description:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

location_country:
Germany
Argentina
Japan
Thailand
Vietnam
Turkey
Chile
France
United States
Tunisia
Belgium
China
Malaysia
Philippines
Italy
Netherlands
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation


lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of this Phase II study is to assess the efficacy and safety of NIS793 with and without spartalizumab in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in untreated mPDAC.

location_facility: University of Pittsburgh Cancer Institute HIllman Cancer Center

location_facility: Massachusetts General Hospital Massachusetts General Hospital

title: A Phase II, Open Label, Randomized, Parallel Arm Study of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy Gemcitabine/Nab-paclitaxel, and Gemcitabine/Nab-paclitaxel Alone in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

location_country:
Finland
Germany
Italy
United Kingdom
Singapore
Australia
Switzerland
Austria
Belgium
United States
Spain
Taiwan
Czechia
France


title: Safety and Efficacy of GEN3009 (DuoHexaBody®-CD37) in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma - A First-in-Human, Open-label, Phase 1/2a Dose Escalation Trial With Dose Expansion Cohorts

summary: The drug that will be investigated in the study is an antibody, GEN3009. Since this is the first study of GEN3009 in humans, the main purpose is to evaluate safety. Besides safety, the study will determine the recommended GEN3009 dose to be tested in a larger group of patients and assess preliminary clinical activity of GEN3009. GEN3009 will be studied in a broad group of cancer patients, having different kinds of lymphomas. All patients will get GEN3009 either as a single treatment (monotherapy) or in combination with another antibody-candidate for treatment of cancer in the blood. The study consists of two parts: Part 1 tests increasing doses of GEN3009 ("escalation"), followed by Part 2 which tests the recommended GEN3009 dose from Part 1 ("expansion").

lead_sponsor: Genmab

location_country:
Denmark
Netherlands
Belgium
United States
Spain
France

location_facility: University Hospitals Cleveland Medical Center

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: University of Pennsylvania School of Medicine

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol

location_facility: Medical University of South Carolina (MUSC)

location_facility: Universitair Medisch Centrum Groningen (UMCG)

location_facility: The University of Texas Southwestern Medical Center

location_facility: University of Iowa Holden Comprehensive Cancer Center


acronym: PHOENYCS GO

summary: The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

location_country:
Germany
Poland
Argentina
Australia
Chile
Czechia
Canada
Serbia
France
Colombia
Hungary
Denmark
United States
Romania
Belgium
Peru
Philippines
Italy
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria


intervention_type: Other

lead_sponsor: Pfizer

summary: The study will evaluate the safety and efficacy of gene therapy in boys with DMD. It is a randomized, double-blind, placebo-controlled study with two thirds of participants assigned to gene therapy. The one third of participants who are randomized to the placebo arm will have an opportunity for treatment with gene therapy at the beginning of the second year.

location_facility: University of Utah Clinical Neurosciences Center

location_facility: Ronald Reagan UCLA Medical Center (Investigational Drug Section)

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Ronald Reagan UCLA Medical Center - Drug Information Center

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: National Center of Neurology and Psychiatry

location_facility: Hyogo College of Medicine College Hospital

location_facility: Saint Petersburg State Paediatric Medical University

location_facility: State Autonomous Healthcare Institution of Sverdlovsk Region Children's City Clinical Hospital No 9

location_facility: Pusan National University Yangsan Hospital

location_facility: University of Utah Hospital & Clinics Investigational Drug Services

location_facility: Children's Hospital - London Health Sciences Centre

location_facility: Schneider Children's Medical Center of Israel

location_facility: Hadassah University Medical Center, Ein Kerem

location_facility: University of Iowa Hospitals and Clinics

location_facility: KU Clinical Research Center - Clinical and Translational Science Unit (CTSU) - Rainbow

location_facility: University of Kansas Hospital - Investigational Pharmacy

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: University of Utah Imaging and Neurosciences Center

location_facility: Alder Hey Children's NHS Foundation Trust

location_facility: Great Ormond Street Institute of Child Health

location_facility: Children's Specialty Group, PLLC Division of Child & Adolescent Neurology

location_facility: University of Kansas Hospital - Pediatric and Pediatric ICU - Operating Room

location_facility: Inselspital, University Children's Hospital Berne

location_facility: University of Utah Center for Clinical & Tranlational Science

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust, Royal Victoria Infirmary

location_facility: KU Clinical Research Center - Clinical and Translational Science Unit (CTSU) - Fairway

title: A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF 06939926 FOR THE TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY

location_country:
Germany
Italy
Israel
United Kingdom
Australia
Japan
Switzerland
Belgium
United States
Korea, Republic of
Spain
Taiwan
Canada
Russian Federation
France


title: Phase 1/2 Study of IMC-F106C in Advance PRAME-Positive Cancers

summary: IMC-F106C is an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-F106C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME

lead_sponsor: Immunocore Ltd

location_country:
United States
United Kingdom
New Zealand
France

location_facility: University of California Davis Comprehensive Center

location_facility: University of Washington - Fred Hutchinson Cancer Center

location_facility: Winship Cancer Institute of Emory university

location_facility: University of Utah - Huntsman Cancer Institute

location_facility: Abramson Cancer Center of the University of Pennsylvania

location_facility: University of California - San Francisco

location_facility: University of Oklahoma Peggy and Charles Stephenson Cancer Center

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Houston Lee Moffitt Cancer Center & Research Institute

location_facility: The University of Chicago Medical Center


lead_sponsor: Ultragenyx Pharmaceutical Inc

summary: The primary objective of the study is to evaluate the safety and tolerability of multiple-ascending doses of GTX-102 administered by intrathecal (IT) injection to participants with Angelman Syndrome (AS).

location_facility: Great Ormond Street Hospital for Children

location_facility: The Edmond and Lily Safra Children's Hospital

location_facility: Oxford University Hospitals NHS Foundation Trust

title: A Phase 1/2 Open-label, Multiple-dose, Dose-escalating Clinical Trial of the Safety and Tolerability of GTX-102 in Pediatric Patients With Angelman Syndrome (AS)

location_country:
Germany
Israel
United Kingdom
Australia
United States
Spain
Canada
France


title: A Global Post Market Evaluation of Terumo Aortic Endovascular Grafts

acronym: TiGER

summary: Multi-arm, multi-center, open label, prospective observational registry designed to obtain safety and performance data on the use of CE marked and custom Terumo Aortic endovascular grafts.

ipd_sharing: Undecided

lead_sponsor: Vascutek Ltd.

sponsor_collaborators:
Vascutek Ltd.
Bolton Medical

location_country:
Germany
Italy
Portugal
United Kingdom
Netherlands
Switzerland
Belgium
United States
Spain
France

location_facility: University of Colorado Anschutz Medical Campus

location_facility: Hospital Universitari Valle Hebrón de Barcelona

location_facility: Hôpital Pneumologique et Cardiovasculaire Louis-Pradel

location_facility: Hospital Universitario Central de Asturias, Oviedo

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Baylor, Scott & White Health (BSW Health)

location_facility: Azienda Ospedaliera Universitaria Senese


title: Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy After Replacement of Tricuspid Valve With Transcatheter Device

summary: Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System

lead_sponsor: Edwards Lifesciences

location_country:
United States
Canada
Switzerland
France

location_facility: Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval (IUCPQ-ULaval)

location_facility: Columbia University Irving Medical Center / NYPH

location_facility: Hospital of the University of Pennsylvania

location_facility: CHU Bordeaux, Hôpital Cardiologique Haut Lévêque


lead_sponsor: AstraZeneca

summary: This study is randomized, open-label, parallel-group, multicentre Phase 2 study aimed to compare the efficacy and safety of oral AZD9833 versus intramuscular (IM) fulvestrant in women with advanced breast cancer.

title: SERENA-2: A Randomised, Open-Label, Parallel-Group, Multicentre Phase 2 Study Comparing the Efficacy and Safety of Oral AZD9833 Versus Fulvestrant in Women With Advanced ER-Positive HER2-Negative Breast Cancer

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

location_country:
Germany
Italy
Poland
Portugal
Hungary
Israel
United Kingdom
Belgium
United States
Korea, Republic of
Spain
Ukraine
Canada
Georgia
Russian Federation
France


title: Evaluation of Efficacy, Safety and Tolerability of NGM282 (Aldafermin) in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (ALPINE 4)

summary: A multi-center evaluation of aldafermin in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis.

lead_sponsor: NGM Biopharmaceuticals, Inc

location_country:
Germany
Poland
United Kingdom
Hong Kong
Australia
Belgium
United States
Puerto Rico
France


summary: The purpose of this two part multicenter, randomized, double-blind, placebo-controlled, Phase III study is to evaluate the efficacy and safety of alpelisib compared to alpelisib matching-placebo in combination with trastuzumab and pertuzumab as maintenance treatment of patients with HER2-positive advanced breast cancer whose tumor harbors a PIK3CA mutation following induction therapy with a taxane in combination with trastuzumab and pertuzumab. Part 1 is the open-label, safety run-in part of the study, designed to confirm the recommended phase 3 dose (RP3D) dose of alpelisib in combination with trastuzumab and pertuzumab. Following Part 1, Part 2 will be initiated, which is the randomized, Phase III part of the study.

location_facility: University Of California Los Angeles Reg-5

title: EPIK-B2: A Two Part, Phase III, Multicenter, Randomized (1:1), Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation

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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Italy
Belgium
United States
China
Spain
Malaysia
Turkey
France


lead_sponsor: Takeda

summary:
The main aim of this study is to check if repeated subcutaneous (SC) injections of lanadelumab can prevent angioedema attacks in teenagers and adults with non-histaminergic angioedema with normal C1-INH. Another aim is to check if they tolerate the repeated SC injections.

Participants will receive a SC injection of lanadelumab every two weeks for 26 weeks. The first two doses of lanadelumab will be given at the study clinic. Once a participant (and/or parent/caregiver) has been appropriately trained, lanadelumab can be self-injected. Visits to the study clinic are planned for the first, third and fourth week and then every 4 weeks.

sponsor_collaborators: Takeda Development Center Americas, Inc.

location_facility: Klinikum rechts der Isar der TUM, HNO Klinik und Poliklinik

location_facility: Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

location_facility: "ALL-MED" Specjalistyczna Opieka Medyczna Medyczny Instytut Badawczy

location_facility: Service médecine interne, hôpital Saint Antoine

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona

location_facility: CHU Grenoble Alpes, service de médecine interne, bureau de recherche clinique

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Seattle Allergy & Asthma Research Institute

location_facility: University of South Florida Asthma, Allergy & Immunology

location_facility: NZOZ Homeo Medicus, Poradnia Alergologiczna

location_facility: DAI di Medicina Interna, Immunologia Clinica, Patologia Clinica, Malattie Infettive

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Clinique Specialisee en Allergie de la Capitale

location_facility: Allergy and Asthma Clinical Research Inc

location_facility: Complexo Hospitalario Universitario de Vigo

location_facility: Institute for Asthma & Allergy - Chevy Chase

location_facility: Jay M Kashkin, MD Allergy, Asthma and Immunology

title: A Phase 3, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

location_country:
Germany
Italy
Poland
Hungary
Japan
Netherlands
United States
Spain
Canada
France


title: The Value of FEops HEARTguideTM Patient-Specific Computational Simulation in the Planning of Percutaneous Left Atrial Appendage Closure With the AmplatzerTM AmuletTM Device (PREDICT-LAA)

summary:
To ensure a successful percutaneous left atrial appendage (LAA) closure, it is important to select the correct size of the closure device used for each patient. To define and measure the size of the LAA, 2D transesophageal echocardiography (TEE) has been typically used. An increasing number of hospitals recently switched to measure the size of the LAA using a cardiac computed tomography (CT) scan. Although this CT scan helps to better define and measure the LAA, it is still difficult to determine the exact anticipated 'landing zone' or 'position' of the closure device. A novel strategy of preprocedural planning includes the use of preoperative computer simulations based on CT imaging (Feops HEARTguideTM), where the device is deployed with a computer simulation into the patient-specific LAA anatomy to provide the operator both optimal and suboptimal scenario's showing different sizes and positions of the closure device.

The aim of this study is to assess whether use of FEops HEARTguide computer simulations based on cardiac CT-imaging can contribute to a better preprocedural planning and improved procedural outcomes of percutaneous LAA closure procedures with an Amplatzer Amulet device.

The PREDICT-LAA trial will investigate the possible positive effect of a computer simulation using a CT scan of the LAA performed prior to the procedure. The hypothesis is that by using this new computer simulation, better planning of the intervention can be obtained.

status: Unknown status

primary_purpose: Supportive Care

ReferenceCitation: Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov 19;312(19):1988-98. doi: 10.1001/jama.2014.15192. Erratum In: JAMA. 2015 Mar 10;313(10):1061.

ReferenceCitation: Chow DH, Bieliauskas G, Sawaya FJ, Millan-Iturbe O, Kofoed KF, Sondergaard L, De Backer O. A comparative study of different imaging modalities for successful percutaneous left atrial appendage closure. Open Heart. 2017 Jun 30;4(2):e000627. doi: 10.1136/openhrt-2017-000627. eCollection 2017.

ReferenceCitation: Korsholm K, Jensen JM, Nielsen-Kudsk JE. Intracardiac Echocardiography From the Left Atrium for Procedural Guidance of Transcatheter Left Atrial Appendage Occlusion. JACC Cardiovasc Interv. 2017 Nov 13;10(21):2198-2206. doi: 10.1016/j.jcin.2017.06.057. Epub 2017 Aug 30.

ReferenceCitation: Otton JM, Spina R, Sulas R, Subbiah RN, Jacobs N, Muller DW, Gunalingam B. Left Atrial Appendage Closure Guided by Personalized 3D-Printed Cardiac Reconstruction. JACC Cardiovasc Interv. 2015 Jun;8(7):1004-6. doi: 10.1016/j.jcin.2015.03.015. No abstract available.

ReferenceCitation: de Jaegere P, Rocatello G, Prendergast BD, de Backer O, Van Mieghem NM, Rajani R. Patient-specific computer simulation for transcatheter cardiac interventions: what a clinician needs to know. Heart. 2019 Mar;105(Suppl 2):s21-s27. doi: 10.1136/heartjnl-2018-313514.

ReferenceCitation: Rocatello G, El Faquir N, De Santis G, Iannaccone F, Bosmans J, De Backer O, Sondergaard L, Segers P, De Beule M, de Jaegere P, Mortier P. Patient-Specific Computer Simulation to Elucidate the Role of Contact Pressure in the Development of New Conduction Abnormalities After Catheter-Based Implantation of a Self-Expanding Aortic Valve. Circ Cardiovasc Interv. 2018 Feb;11(2):e005344. doi: 10.1161/CIRCINTERVENTIONS.117.005344.

ReferenceCitation: Bavo AM, Wilkins BT, Garot P, De Bock S, Saw J, Sondergaard L, De Backer O, Iannaccone F. Validation of a computational model aiming to optimize preprocedural planning in percutaneous left atrial appendage closure. J Cardiovasc Comput Tomogr. 2020 Mar-Apr;14(2):149-154. doi: 10.1016/j.jcct.2019.08.010. Epub 2019 Aug 20.

ReferenceCitation: Swaans MJ, Huijboom MFM, Boersma LVA. Fluoroscopic Guidance: An Echo From the Past? JACC Cardiovasc Interv. 2021 Aug 23;14(16):1827-1829. doi: 10.1016/j.jcin.2021.07.003. No abstract available.

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Garot P, Iriart X, Aminian A, Kefer J, Freixa X, Cruz-Gonzalez I, Berti S, Rosseel L, Ibrahim R, Korsholm K, Odenstedt J, Nielsen-Kudsk JE, Saw J, Sondergaard L, De Backer O. Value of FEops HEARTguide patient-specific computational simulations in the planning of left atrial appendage closure with the Amplatzer Amulet closure device: rationale and design of the PREDICT-LAA study. Open Heart. 2020 Aug;7(2):e001326. doi: 10.1136/openhrt-2020-001326.

lead_sponsor: Rigshospitalet, Denmark

collaborators: Feops Abbott

sponsor_collaborators:
Rigshospitalet, Denmark
Feops
Abbott

location_country: Italy Denmark Sweden Belgium Spain Canada France

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Hopital Civil Marie Curie CHU de Charleroi

intervention_type: Procedure

lead_sponsor_type: academique


title: A First In Human Study of the MCL-1 Inhibitor, ABBV-467

summary: This first-in-human study will evaluate the safety and tolerability of ABBV-467 in adult participants with relapsed/refractory multiple myeloma (MM).

lead_sponsor: AbbVie

location_country:
France
Australia
Japan
United States
Spain
Taiwan
Israel

location_facility: Nagoya City University Hospital /ID# 214696

location_facility: Hospital Universitario Virgen de la Victoria /ID# 214756

location_facility: China Medical University Hosp /ID# 209323

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 215480

location_facility: Prisma Health Cancer Institute-Faris Road /ID# 219076

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 214672

location_facility: National Cancer Center Hospital /ID# 214801

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 217170

location_facility: University of Arizona Cancer Center - North Campus /ID# 219102

location_facility: Lifespan Cancer Institute at Rhode Island Hospital /ID# 215418

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 214739

location_facility: National Cancer Center Hospital East /ID# 214697

location_facility: National Taiwan University Hospital /ID# 209322

location_facility: Hospital Universitario Vall d'Hebron /ID# 214690

location_facility: St Vincent's Hospital Melbourne /ID# 222066


title: A Post-Market Study Assessment of the Safety and Performance of the MitraClip G4 System

summary: This primary objective of the EXPAND G4 study is to confirm the safety and performance of the MitraClip G4 System in a post-market setting.

lead_sponsor: Abbott Medical Devices

sponsor_collaborators:
Abbott Medical Devices
Abbott

location_country:
Germany
France
Italy
Japan
Netherlands
United States
Saudi Arabia
Spain
Canada
Israel

location_facility: Herzzentrum Dresden GmbH Universitätsklinik

location_facility: Cardiology Associates of Fairfield County, PC

location_facility: Hospital Alvaro Cunqueiro Dept of Interventional Cardiology

location_facility: Medizinische Einrichtungen der Universitat zu Koln

location_facility: Hudson Valley Cardiovascular Practice, P.C.

location_facility: UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universitat Mainz

location_facility: University of California - Davis Medical Center

location_facility: The Sakakibara Heart Insitute of Okayama

location_facility: Medizinische Einrichtungen der Universität Düsseldorf

location_facility: Klinikum der Ruprecht-Karls-Universität Heidelberg

location_facility: Immanuelklinikum Bernau und Herzzentrum Brandenburg

location_facility: Institut de Cardiologie de Montreal (Montreal Heart Inst.)


lead_sponsor: Amgen

summary:
This study was created to provide subjects who complete Week 52 (end of Apremilast Extension Phase) of study CC-10004-PPSO-003 the option to continue to receive open-label apremilast therapy.

The study will consist of up to 208 weeks of long-term treatment followed by an 8-week observational follow-up phase.

location_facility: Centre Hospitalier Universitaire Saint Pierre

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Moscow Scientific Practical Center of Dermatology Venerology and Cosmetology

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Larrey

location_facility: State Scientific Center for Dermatovenereology and Cosmetology

location_facility: Ural Scientific Research Institute of Dermatovenereology and Immunopathology

location_facility: Republican Clinical Dermatology and Venerology Dispensary

location_facility: Saint Petersburg State Pediatric Medical University

location_facility: Clinical Dispensary of Dermatology and Venereology of Krasnodar Territory of the Ministry of Health

location_facility: Pierre Wolkenshtein Skin Diseases Clinic LLC

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Azienda Ospedaliero Universitaria Di Cagliari

location_facility: National Medical Research Center for Children's Health

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Chelyabinsk Regional Clinical Skin and Venereal Dispensary

title: A Phase 3b, Multi Center, Open-label, Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

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:
Italy
Israel
Belgium
United States
Spain
Czechia
Canada
Russian Federation
France


title: MRX-800: A Long-Term Safety Study of Maralixibat, an Apical Sodium Dependent Bile Acid Transporter Inhibitor (ASBTi), in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat Study

acronym: MERGE

summary: Evaluate the long-term safety of maralixibat (MRX) in subjects with cholestatic liver disease including, but not limited to, Alagille Syndrome (ALGS), Progressive Familial Intrahepatic Cholestasis (PFIC) and Biliary Atresia.

lead_sponsor: Mirum Pharmaceuticals, Inc.

location_country:
Poland
United Kingdom
Australia
Belgium
United States
Spain
Canada
France

location_facility: Paediatric Liver Center, Kings College Hospital

location_facility: Hospital Universitario La Paz- Hospital Materno Infantil

location_facility: The Children's Memorial Health Institute

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


title: A Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Benralizumab in Patients With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)

acronym: ORCHID

summary: This is a randomized, double-blind, placebo-controlled, parallel-group, international, multicenter, Phase 3 study to evaluate the efficacy and safety of repeat dosing of benralizumab 30 mg administered subcutaneously (SC) versus placebo in patients with severe nasal polyposis.

ReferenceCitation: Chong LY, Piromchai P, Sharp S, Snidvongs K, Webster KE, Philpott C, Hopkins C, Burton MJ. Biologics for chronic rhinosinusitis. Cochrane Database Syst Rev. 2021 Mar 12;3(3):CD013513. doi: 10.1002/14651858.CD013513.pub3.

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

repository_institution: University of East Anglia - UEA Digital Repository

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.

location_country:
Italy
Poland
Hungary
Argentina
Australia
Japan
Belgium
United States
China
Thailand
Vietnam
Turkey
Chile
Taiwan
Bulgaria
Russian Federation
France


lead_sponsor: Merck Sharp & Dohme LLC

summary: This is a Phase 2 study to assess the efficacy, safety, and tolerability of gebasaxturev administered both intratumorally (ITu) and intravenously (IV) as combination therapy with pembrolizumab (MK-3475) versus pembrolizumab alone in anti-programmed cell death ligand 1 (anti-PD-L1)-treatment-naive participants with advanced/metastatic melanoma. The primary hypothesis of the study is that gebasaxturev administered either ITu or IV in combination with pembrolizumab results in a superior objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR), compared to pembrolizumab alone. This study will be terminated once all participants finish treatment with V937. Participants eligible to continue to receive pembrolizumab will be transferred to MK-3475-587 study.

ReferenceCitation: Deng JZ, Rustandi RR, Barbacci D, Swartz AR, Gulasarian A, Loughney JW. Reverse-Phase Ultra-Performance Chromatography Method for Oncolytic Coxsackievirus Viral Protein Separation and Empty to Full Capsid Quantification. Hum Gene Ther. 2022 Jul;33(13-14):765-775. doi: 10.1089/hum.2022.013. Epub 2022 Jun 1.

oa_colors: green hybrid

evidence: open (via page says license)

publisher_dissemination: Mary Ann Liebert Inc

location_facility: WITS Clinical Research CMJAH Clinical Trial Site ( Site 0101)

location_facility: Hospital Clinico Universitario de Valencia ( Site 0090)

location_facility: Onkologikoa - Instituto Oncologico de San Sebastian ( Site 0088)

location_facility: Clinica Universitaria de Navarra. ( Site 0082)

location_facility: Universitaetsklinikum Leipzig AOeR ( Site 2005)

location_facility: CHU de Grenoble Hopital Nord ( Site 2027)

location_facility: Severance Hospital Yonsei University Health System ( Site 1993)

location_facility: Centre Georges Francois Leclerc ( Site 2025)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 0040)

location_facility: Seoul National University Hospital ( Site 1992)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 0104)

location_facility: Policlinico Le Scotte - A.O. Senese ( Site 2039)

location_facility: The Queen Elizabeth Hospital ( Site 0143)

location_facility: Universitaetsklinikum Regensburg ( Site 2007)

location_facility: Hadassah Ein Kerem Medical Center ( Site 0042)

location_facility: Oslo Universitetssykehus Radiumhospitalet ( Site 0060)

location_facility: Clinical Research Unit - University of Pretoria ( Site 0102)

location_facility: Northwest Medical Specialties, PLLC ( Site 0006)

location_facility: Providence Portland Medical Center [Portland, OR] ( Site 0005)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 0002)

location_facility: Istituto Europeo di Oncologia ( Site 2040)

location_facility: Universitaetsklinikum Tuebingen-Hautklinik ( Site 2001)

location_facility: Little Company of Mary Hospital ( Site 0100)

title: A Phase 2, Randomized Clinical Study of Intravenous or Intratumoral Administration of V937 in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone in Participants With Advanced/Metastatic Melanoma

location_country:
Germany
Italy
Israel
Norway
Australia
United States
Korea, Republic of
Spain
South Africa
Chile
France


title: A Phase II Multi-center, Single Arm, Safety and Efficacy Study of MBG453 in Combination With Azacitidine and Venetoclax for the Treatment of Acute Myeloid Leukemia (AML) in Adult Patients Unfit for Chemotherapy

summary: This trial will seek to extend the preliminary findings of efficacy of MBG453 in combination with hypomethylating agents (HMA) by evaluating MBG453 in combination with the HMA azacitidine and the Bcl-2 inhibitor venetoclax.

location_country:
Germany
Italy
Australia
Japan
United States
Korea, Republic of
Spain
Taiwan
Canada
France

location_facility: Dana Farber Cancer Institute Dana Farber Cancer Int

location_facility: Levine Cancer Insitute Carolinas Healthcare System

location_facility: Huntsman Cancer Institute Univ of Utah .

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

location_facility: University of Iowa Hospitals and Clinics Univ of Iowa

location_facility: Mayo Clinic Rochester Dept. of Mayo Clinic (2)

location_facility: Chattanooga Oncology and Hematology Associates PC Tennessee Oncology Chattanooga


title: PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter

acronym: PROTECTED TAVR

summary: To demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR).

ReferenceCitation: Kapadia SR, Makkar R, Leon M, Abdel-Wahab M, Waggoner T, Massberg S, Rottbauer W, Horr S, Sondergaard L, Karha J, Gooley R, Satler L, Stoler RC, Messe SR, Baron SJ, Seeger J, Kodali S, Krishnaswamy A, Thourani VH, Harrington K, Pocock S, Modolo R, Allocco DJ, Meredith IT, Linke A; PROTECTED TAVR Investigators. Cerebral Embolic Protection during Transcatheter Aortic-Valve Replacement. N Engl J Med. 2022 Oct 6;387(14):1253-1263. doi: 10.1056/NEJMoa2204961. Epub 2022 Sep 17.

publisher_dissemination: Massachusetts Medical Society

ipd_sharing_description: The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html)

lead_sponsor: Boston Scientific Corporation

location_country:
Germany
Italy
Denmark
Australia
United States
France

location_facility: Kaiser Foundation Hospital - San Francisco

location_facility: University of Iowa Hospitals and Clinics

location_facility: University of California, Davis Medical Center

location_facility: Methodist Healthcare System of San Antonio dba Methodist Hospital

location_facility: South Denver Cardiology Associates PC and Swedish medical center

location_facility: Wake Forest University School of Medicine


acronym: MATIC

lead_sponsor: ALK-Abelló A/S

summary: A research study of how house dust mite tablets work compared to placebo in children aged between 5 and 11 years and who have allergy to house dust mites (MATIC)

ReferenceCitation: Field K, Blaiss MS. Sublingual Versus Subcutaneous Immunotherapy for Allergic Rhinitis: What Are the Important Therapeutic and Real-World Considerations? Curr Allergy Asthma Rep. 2020 Jun 16;20(9):45. doi: 10.1007/s11882-020-00934-4.

oa_host_type: closed

location_facility: Kingston General Hospital - Division of Allergy & Immunology

location_facility: Allergy & Asthma Specialists Medical Group and Research Center

location_facility: Oklahoma Institute of Allergy & Asthma Clinical Research, LLC

location_facility: California Allergy and Asthma Medical Group

location_facility: City Children's Clinical Hospital # 19" of Kharkiv City Council

location_facility: Dnipro City Children's Municipal Clinical Hospital #2

location_facility: Ambulancia klinickej imunologie a alergologie

location_facility: Pensacola Research Consultants, Inc. d.b.a. Avanza Medical Research Center

location_facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: Universitätsklinikum Düsseldorf - Zentrum f. Kinder- u. Jugendmedizin

location_facility: Outpatient Clinic for individual practice for specialized outpatient medical care in Allergology

location_facility: Alersa, s.r.o, Ambulancia klinickej alergológie a imunológie

location_facility: Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda, EAD, Clinic in Pediatrics

location_facility: Podkarpacki Ośrodek Pulmonologii i Alergologii Sp. z o.o.

location_facility: Children's Clinical Hospital of Poltava Regional Council

location_facility: Kryvyi Rih City Clinical Hospital #8'' of Kryvyi Rih City Council, Department of Pediatric Pulmonology; State Institution "Dnipropetrovsk Medical Academy of the Ministry of Health of Ukraine

location_facility: Multiprofile Hospital for active treatment, Department of Pediatrics

location_facility: Specialized Hospital For Active Treatment of Pneumo - Phtisiatric Diseases Dr Dimitar Gramatikov - Ruse

location_facility: Multiprofile Hospital for Active Treatment, Department of pneumology and phthisiatrics

location_facility: Allergy, Asthma & Clinical Research Center

location_facility: Communal Nonprofit Enterprise "Lviv City Children's Clinical Hospital", Allergology Department, Lviv City Children's Allergology Center

location_facility: Clinical Emergency Hospital" of Dnipro City Council, Department of Pediatric Allergology at the Allergology Center

location_facility: The Children's Research Institute, Department of Pediatrics, University of North Carolina Children's Hospital

location_facility: Center of Allergy Diagnosis and Treatment

location_facility: Prof. V.F. Voino-Yasenetsky Krasnoyarsk State Medical University

location_facility: Regional Children's Clinical Hospital of Vinnytsia Regional Council

location_facility: State Institution Phthisiology and Pulmonology Institute named after F.G. Yanovskyy of NAMS of Ukraine

location_facility: CHU de Montpellier - Service Pneumologie et Addictologie

location_facility: Clinique spécialisée en allergie de la capitale

location_facility: Hospital Universitario de Jerez de la Frontera

location_facility: West Ashley office: Charleston Allergy & Asthma

location_facility: Multiprofile Hospital for Active Treatment, Department of Pediatrics

location_facility: Institute of Pediatrics, Obstetrics and Gynecology named after Academician O. M. Lukianova of the National Academy of Medical Sciences of Ukraine

location_facility: Prywatny Gabinet Lekarski Malgorzata Pawlukiewicz

location_facility: Vital Prospects Clinical Research Institute, P.C.

location_facility: Centrum Alergologii Teresa Hofman Sp. z o.o.

location_facility: Aeroallergy Research Labs of Savannah, Inc.

location_facility: Klinikum der Johann-Wolfgang-Goethe Universität - Zentrum f. Kinder- u. Jugendmedizin

location_facility: Joel Liem Medicine Professional Corporation

location_facility: Allergy Partners of Western North Carolina

location_facility: Alergotest s.c. Specjalistyczne Centrum Medyczne Andrzej Emeryk

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska Elzbieta Matusz

location_facility: Chernivtsi Regional Children's Clinical Hospital, Department of Pediatrics and Children's Infectious Diseases

location_facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD

location_facility: All-Med" Specjalistyczna Opieka Medyczna, Medyczny Instytut Badawczy Marek Jutel

location_facility: O.S. Kolomiychenko Institute, Center of Allergic Diseases of Upper Respiratory Ways and Ear

location_facility: Allergy & Asthma Associates of Monmouth City

location_facility: Allergy & Asthma Medical Group and Research Center, A P.C.

location_facility: North-Western State Medical University named after I.I. Mechnikov, Ministry of Public Health of Russian Federation

location_facility: Regional Children Clinical Hospital, Infectious-Diagnostic Department

location_facility: City Children's Hospital #5" of Zaporizhzhya City Council, Allergology Department

location_facility: I.P. Pavlov Ryazan State Medical University

location_facility: Scientific Medical Center for General Therapy and Pharmacology

location_facility: City Children's Clinic № 16" of Kharkiv City Council

location_facility: Specjalistyczna Praktyka Lekarska Dr n. med. Joanna Orlicz-Widawska

title: A One-year Placebo-controlled Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) SLIT-tablet in Children (5-11 Years of Age) With HDM Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma

location_country:
Germany
Lithuania
Poland
Slovakia
United States
Spain
Ukraine
Bulgaria
Canada
Russian Federation
France


acronym: RSV MAT-004

lead_sponsor: GlaxoSmithKline

summary: The purpose of this study was to evaluate the safety and immune response to a single intramuscular (IM) dose of GSK Biologicals' investigational RSV maternal vaccine (RSVPreF3) in healthy pregnant women 18-40 years of age and in infants born to vaccinated mothers.

title: A Phase II, Randomised, Observer-blind, Placebo Controlled Multi-country Study to Assess the Safety, Reactogenicity and Immunogenicity of a Single Intramuscular Dose of GSK Biologicals' Investigational RSV Maternal Unadjuvanted Vaccine (GSK3888550A), in Healthy Pregnant Women Aged 18 to 40 Years and Infants Born to Vaccinated Mothers

primary_purpose: Prevention

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

location_country:
Finland
New Zealand
Australia
United States
Spain
Panama
South Africa
Canada
France


title: A Multicenter Observational Registry to Develop Ablation Parameter Guidance for Microwave Liver Ablation of Soft Tissue Lesions

summary: This is a multicenter, observational registry that follows patients for a total of 5 years from the date of the first liver ablation procedure with the NEUWAVE Microwave Ablation System.

time_perspective: Other

ipd_sharing_description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

lead_sponsor: Ethicon, Inc.

location_country:
Germany
United Kingdom
Singapore
Netherlands
United States
China
Korea, Republic of
France

location_facility: University of Miami, Miller School of Medicine

location_facility: The First Affiliated Hospital, Sun Yat-sen University

location_facility: Seoul National University Bundang Hospital (SNUBH)

location_facility: Renji Hospital, Shanghai Jiao Tong University School of Medicine


lead_sponsor: Eli Lilly and Company

summary: The reason for this study is to see if the study drug LY3295668 erbumine is safe in participants with relapsed/refractory neuroblastoma.

sponsor_collaborators: New Approaches to Neuroblastoma Therapy Consortium (NANT)

sponsor_collaborators: Innovative Therapies for Children with Cancer in Europe (ITCC)

location_facility: Great Ormond Street Hospital For Children NHS Foundation Trust

location_facility: Hospital Universitario La Fe de Valencia

location_facility: University of Chicago - Comer Children's Hospital

location_facility: Cincinnati Childrens Hospital Medical Center

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: The Children's Hospital for Cancer and Blood Disorders

title: A Phase 1 Study of Aurora Kinase A Inhibitor LY3295668 Erbumine as a Single Agent and in Combination in Patients With Relapsed/Refractory Neuroblastoma

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


title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Rising Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-994 in Patients With Narcolepsy With or Without Cataplexy (Narcolepsy Type 1 or Narcolepsy Type 2)

summary:
The main aims of the study are:

To check for side effects from TAK-994 and check what dose of TAK-994 participants can tolerate.
To check what dose range provides adequate relief of narcolepsy symptoms.
To check how much TAK-994 stays in the blood of participants, over time.

The study will have 4 parts. Participants can only join 1 of the parts.

A. Participants with type 1 narcolepsy will take either TAK-994 or placebo tablets for 28 days. A placebo looks just like TAK-994 but will not have any medicine in it.

B. Participants with type 1 narcolepsy will take 1 of 3 doses of TAK-994 or placebo tablets for 56 days.

C. Participants with type 1 narcolepsy in China only will take TAK-994 or placebo tablets for 56 days.

D. Participants with type 2 narcolepsy will take either TAK-994 or placebo tablets for 28 days.

location_country:
Finland
Italy
Hungary
Japan
Netherlands
United States
China
Korea, Republic of
Spain
Czechia
Canada
France

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: Florida Pulmonary Research Institute, LLC

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

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Xuanwu Hospital Capital Medical University

location_facility: Helene A. Emsellem, MD PC trading as "The Center for Sleep & Wake Disorders"

location_facility: The First Affiliated Hospital of Jinan University

location_facility: Medical University of South Carolina (MUSC)

location_facility: Delta Waves Sleep Disorders and Research Center

location_facility: Ohio Sleep Medicine and Neuroscience Institute

location_facility: Stichting Epilepsie Instelling Nederland, Heemstede

location_facility: Hospital Vithas Nuestra Senora de America

location_facility: Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche

location_facility: Neurocare, Inc., dba Neurocare Center for Research

location_facility: Hospital Universitario Araba Sede Santiago

location_facility: Kaiseikai Kita Shin Yokohama Internal Medicine Clinic

location_facility: Ospedale San Raffaele (San Raffaele Turro)

location_facility: Sleep Medicine Specialists of South Florida