title: A Multi-center, Non-randomized Study to Evaluate the Safety and Effectiveness of the Abre Venous Self-expanding Stent System in Patients With Symptomatic Iliofemoral Venous Outflow Obstruction

summary: Evaluate the safety and effectiveness of the Abre venous self-expanding stent system for treatment of symptomatic iliofemoral venous outflow obstruction in patients with venous occlusive disease.

ReferenceCitation: Murphy E, Gibson K, Sapoval M, Dexter DJ, Kolluri R, Razavi M, Black S. Pivotal Study Evaluating the Safety and Effectiveness of the Abre Venous Self-Expanding Stent System in Patients With Symptomatic Iliofemoral Venous Outflow Obstruction. Circ Cardiovasc Interv. 2022 Feb;15(2):e010960. doi: 10.1161/CIRCINTERVENTIONS.121.010960. Epub 2022 Feb 2.

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Medtronic Endovascular

location_country:
Ireland
Italy
Germany
United Kingdom
United States
France

location_facility: Galway University Hospitals - University Hospital Galway

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

location_facility: University College London Hospitals NHS Foundation Trust - University College London Hospitals

location_facility: Assistance Publique - Hôpitaux de Marseille - Hôpital Nord


title: Persona Partial Knee Clinical Outcomes Study

summary: The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona Partial Knee System.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Zimmer Biomet

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

location_facility: Harrogate and District NHS Foundation Trust

location_facility: Avon Orthopaedic Centre, Southmead Hospital

location_facility: Henry County Orthopedics and Sports Medicine

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Ongoing


intervention_type: Drug

acronym: JZP-258 Efficacy Study

lead_sponsor: Jazz Pharmaceuticals

summary: This is a double-blind, placebo-controlled, randomized-withdrawal, multicenter study of the efficacy and safety of JZP-258.

ReferenceType: derived

ReferenceCitation: Dauvilliers Y, Sonka K, Bogan RK, Partinen M, Del Rio Villegas R, Foldvary-Schaefer N, Skowronski R, Chen A, Black J, Skobieranda F, Thorpy MJ. Changes in Cataplexy Frequency in a Clinical Trial of Lower-Sodium Oxybate with Taper and Discontinuation of Other Anticataplectic Medications. CNS Drugs. 2022 Jun;36(6):633-647. doi: 10.1007/s40263-022-00926-0. Epub 2022 May 30. Erratum In: CNS Drugs. 2022 Jul;36(7):785-786.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

license_normalized: no license

repository_institution: University of Helsinki - Helda

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories_concat: HELDA - Digital Repository of the University of Helsinki;PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

ReferenceCitation: Bogan RK, Thorpy MJ, Dauvilliers Y, Partinen M, Del Rio Villegas R, Foldvary-Schaefer N, Skowronski R, Tang L, Skobieranda F, Sonka K. Efficacy and safety of calcium, magnesium, potassium, and sodium oxybates (lower-sodium oxybate [LXB]; JZP-258) in a placebo-controlled, double-blind, randomized withdrawal study in adults with narcolepsy with cataplexy. Sleep. 2021 Mar 12;44(3):zsaa206. doi: 10.1093/sleep/zsaa206. Erratum In: Sleep. 2021 Jul 9;44(7): Sleep. 2021 Nov 12;44(11):

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

repository_normalized: HAL

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

publisher_dissemination: Oxford University Press

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Hospital Vithas Nuestra Señora de America

status: Completed

title: A Double-Blind, Placebo-Controlled, Randomized-Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Finland
Belgium
United States
Spain
Czechia
France

status_simplified: Completed


type: U.S. NIH Grant/Contract

title: Craniosynostosis Network

summary: Craniosynostosis (CS) is a common malformation occurring in ~4 per 10,000 live births in which the sutures between skull bones close too early, causing long-term problems with brain and skull growth. Infants with CS typically require extensive surgical treatment and may experience many perioperative complications, including hemorrhage and re-synostosis. Even with successful surgery, children can experience developmental and learning disabilities or vision problems. Most often, CS appears as isolated nonsyndromic CS (NSC). Of the several subtypes of CS, unilateral or bilateral fusion of the coronal suture is the second most common form of CS accounting for 20-30% of all NSC cases. The etiology of coronal NSC (cNSC) is not well understood, although the published literature suggests that it is a multifactorial condition. About 5-14% of coronal craniosynostosis patients have a positive family history, with a specific genetic etiology identified in >25% of cNSC cases, suggesting a strong genetic component in the pathogenesis of this birth defect. The causes for cNSC and its phenotypic heterogeneity remain largely unknown. An international team of investigators will generate large genomic and gene expression datasets on samples from patients with cNSC. State-of-the-art imaging, genetic, and developmental and systems biology approaches will be used to quantitatively model novel pathways and networks involved in the development of cNSC. Novel variant-, gene- and network-level analyses will be performed on the genomic data obtained from cNSC cases, their relatives, and controls to identify novel variants and genetic regions associated with cNCS. Quantitative, analytical, and functional validations of these predictions will provide insights into the etiology and possible therapeutic targets for CS and potentially other bone-related disorders.

study_type: Observational

time_perspective: Other

ReferenceType: background

ReferenceCitation: Heuze Y, Holmes G, Peter I, Richtsmeier JT, Jabs EW. Closing the Gap: Genetic and Genomic Continuum from Syndromic to Nonsyndromic Craniosynostoses. Curr Genet Med Rep. 2014 Sep 1;2(3):135-145. doi: 10.1007/s40142-014-0042-x.

ReferenceCitation: Heuze Y, Singh N, Basilico C, Jabs EW, Holmes G, Richtsmeier JT. Morphological comparison of the craniofacial phenotypes of mouse models expressing the Apert FGFR2 S252W mutation in neural crest- or mesoderm-derived tissues. Bone. 2014 Jun;63:101-9. doi: 10.1016/j.bone.2014.03.003. Epub 2014 Mar 13.

ReferenceCitation: Heuze Y, Martinez-Abadias N, Stella JM, Arnaud E, Collet C, Garcia Fructuoso G, Alamar M, Lo LJ, Boyadjiev SA, Di Rocco F, Richtsmeier JT. Quantification of facial skeletal shape variation in fibroblast growth factor receptor-related craniosynostosis syndromes. Birth Defects Res A Clin Mol Teratol. 2014 Apr;100(4):250-9. doi: 10.1002/bdra.23228. Epub 2014 Feb 27.

ReferenceCitation: Di Rocco F, Biosse Duplan M, Heuze Y, Kaci N, Komla-Ebri D, Munnich A, Mugniery E, Benoist-Lasselin C, Legeai-Mallet L. FGFR3 mutation causes abnormal membranous ossification in achondroplasia. Hum Mol Genet. 2014 Jun 1;23(11):2914-25. doi: 10.1093/hmg/ddu004. Epub 2014 Jan 12.

ReferenceCitation: Justice CM, Yagnik G, Kim Y, Peter I, Jabs EW, Erazo M, Ye X, Ainehsazan E, Shi L, Cunningham ML, Kimonis V, Roscioli T, Wall SA, Wilkie AO, Stoler J, Richtsmeier JT, Heuze Y, Sanchez-Lara PA, Buckley MF, Druschel CM, Mills JL, Caggana M, Romitti PA, Kay DM, Senders C, Taub PJ, Klein OD, Boggan J, Zwienenberg-Lee M, Naydenov C, Kim J, Wilson AF, Boyadjiev SA. A genome-wide association study identifies susceptibility loci for nonsyndromic sagittal craniosynostosis near BMP2 and within BBS9. Nat Genet. 2012 Dec;44(12):1360-4. doi: 10.1038/ng.2463. Epub 2012 Nov 18.

ReferenceCitation: Heuze Y, Martinez-Abadias N, Stella JM, Senders CW, Boyadjiev SA, Lo LJ, Richtsmeier JT. Unilateral and bilateral expression of a quantitative trait: asymmetry and symmetry in coronal craniosynostosis. J Exp Zool B Mol Dev Evol. 2012 Mar;318(2):109-22. doi: 10.1002/jezb.21449.

ReferenceCitation: Martinez-Abadias N, Heuze Y, Wang Y, Jabs EW, Aldridge K, Richtsmeier JT. FGF/FGFR signaling coordinates skull development by modulating magnitude of morphological integration: evidence from Apert syndrome mouse models. PLoS One. 2011;6(10):e26425. doi: 10.1371/journal.pone.0026425. Epub 2011 Oct 28.

ReferenceCitation: Heuze Y, Boyadjiev SA, Marsh JL, Kane AA, Cherkez E, Boggan JE, Richtsmeier JT. New insights into the relationship between suture closure and craniofacial dysmorphology in sagittal nonsyndromic craniosynostosis. J Anat. 2010 Aug;217(2):85-96. doi: 10.1111/j.1469-7580.2010.01258.x. Epub 2010 Jun 22.

ReferenceCitation: Wang Y, Sun M, Uhlhorn VL, Zhou X, Peter I, Martinez-Abadias N, Hill CA, Percival CJ, Richtsmeier JT, Huso DL, Jabs EW. Activation of p38 MAPK pathway in the skull abnormalities of Apert syndrome Fgfr2(+P253R) mice. BMC Dev Biol. 2010 Feb 22;10:22. doi: 10.1186/1471-213X-10-22.

ReferenceCitation: Percival CJ, Kawasaki K, Huang Y, Weiss KM, Jabs EW, Li R, Richtsmeier JT. Building Bones. Percival CJ, Richtsmeier JT, editors. Cambridge. Cambridge University Press; 2017. Chapter 2, The contribution of angiogenesis to variation in bone development and evolution; 26-51p.

ReferenceCitation: Kawasaki K, Richtsmeier JT. Building Bones. Percival CJ, Richtsmeier JT, editors. Cambridge. Cambridge University Press; 2017. Chapter 3, Association of the chondrocranium and dermatocranium in early skull development; 52-78p.

ReferenceCitation: Kawasaki K, Richtsmeier J. Building Bones. Percival CJ, Richtsmeier JT, editors. Cambridge. Cambridge University Press; 2017. Chapter Appendix, Appendix to Chapter 3 ; 303-315p.

ReferenceCitation: Singh N, Dutka T, Reeves RH, Richtsmeier JT. Chronic up-regulation of sonic hedgehog has little effect on postnatal craniofacial morphology of euploid and trisomic mice. Dev Dyn. 2016 Feb;245(2):114-22. doi: 10.1002/dvdy.24361. Epub 2015 Dec 6.

ReferenceCitation: Trainor PA, Richtsmeier JT. Facing up to the challenges of advancing Craniofacial Research. Am J Med Genet A. 2015 Jul;167(7):1451-4. doi: 10.1002/ajmg.a.37065. Epub 2015 Mar 28.

ReferenceType: result

ReferenceCitation: Flaherty K, Singh N, Richtsmeier JT. Understanding craniosynostosis as a growth disorder. Wiley Interdiscip Rev Dev Biol. 2016 Jul;5(4):429-59. doi: 10.1002/wdev.227. Epub 2016 Mar 22.

oa_host_type: repository

repository_institution: PubMed Central - Europe PMC

version: acceptedVersion

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Ye X, Guilmatre A, Reva B, Peter I, Heuze Y, Richtsmeier JT, Fox DJ, Goedken RJ, Jabs EW, Romitti PA. Mutation Screening of Candidate Genes in Patients with Nonsyndromic Sagittal Craniosynostosis. Plast Reconstr Surg. 2016 Mar;137(3):952-961. doi: 10.1097/01.prs.0000479978.75545.ee.

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

version: submittedVersion

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

ReferenceCitation: Musy M, Flaherty K, Raspopovic J, Robert-Moreno A, Richtsmeier JT, Sharpe J. A quantitative method for staging mouse embryos based on limb morphometry. Development. 2018 Apr 5;145(7):dev154856. doi: 10.1242/dev.154856.

evidence: open (via free pdf)

evidence: open (via crossref license, author manuscript)

license: publisher-specific, author manuscript

license_normalized: publisher-specific

publisher_dissemination: The Company of Biologists

ReferenceCitation: Heuze Y, Kawasaki K, Schwarz T, Schoenebeck JJ, Richtsmeier JT. Developmental and Evolutionary Significance of the Zygomatic Bone. Anat Rec (Hoboken). 2016 Dec;299(12):1616-1630. doi: 10.1002/ar.23449.

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

repository_institution: University of Edinburgh - Edinburgh Research Explorer

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

repositories_institution: University of Edinburgh - Edinburgh Research Explorer

ReferenceCitation: Motch Perrine SM, Stecko T, Neuberger T, Jabs EW, Ryan TM, Richtsmeier JT. Integration of Brain and Skull in Prenatal Mouse Models of Apert and Crouzon Syndromes. Front Hum Neurosci. 2017 Jul 25;11:369. doi: 10.3389/fnhum.2017.00369. eCollection 2017.

ReferenceCitation: Lee C, Richtsmeier JT, Kraft RH. A COMPUTATIONAL ANALYSIS OF BONE FORMATION IN THE CRANIAL VAULT USING A COUPLED REACTION-DIFFUSION-STRAIN MODEL. J Mech Med Biol. 2017 Jun;17(4):1750073. doi: 10.1142/S0219519417500737. Epub 2017 May 29.

ReferenceCitation: Lesciotto KM, Heuze Y, Jabs EW, Bernstein JM, Richtsmeier JT. Choanal Atresia and Craniosynostosis: Development and Disease. Plast Reconstr Surg. 2018 Jan;141(1):156-168. doi: 10.1097/PRS.0000000000003928.

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

ReferenceCitation: Motch Perrine SM, Wu M, Stephens NB, Kriti D, van Bakel H, Jabs EW, Richtsmeier JT. Mandibular dysmorphology due to abnormal embryonic osteogenesis in FGFR2-related craniosynostosis mice. Dis Model Mech. 2019 May 30;12(5):dmm038513. doi: 10.1242/dmm.038513.

ReferenceCitation: Norwood JN, Zhang Q, Card D, Craine A, Ryan TM, Drew PJ. Anatomical basis and physiological role of cerebrospinal fluid transport through the murine cribriform plate. Elife. 2019 May 7;8:e44278. doi: 10.7554/eLife.44278.

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

repositories_institution:
Cold Spring Harbor Laboratory - bioRxiv
PubMed Central - Europe PMC

ReferenceCitation: Lee C, Richtsmeier JT, Kraft RH. A coupled reaction-diffusion-strain model predicts cranial vault formation in development and disease. Biomech Model Mechanobiol. 2019 Aug;18(4):1197-1211. doi: 10.1007/s10237-019-01139-z. Epub 2019 Apr 20.

ReferenceCitation: Sewda A, White SR, Erazo M, Hao K, Garcia-Fructuoso G, Fernandez-Rodriguez I, Heuze Y, Richtsmeier JT, Romitti PA, Reva B, Jabs EW, Peter I. Nonsyndromic craniosynostosis: novel coding variants. Pediatr Res. 2019 Mar;85(4):463-468. doi: 10.1038/s41390-019-0274-2. Epub 2019 Jan 14.

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

ReferenceCitation: Lesciotto KM, Richtsmeier JT. Craniofacial skeletal response to encephalization: How do we know what we think we know? Am J Phys Anthropol. 2019 Jan;168 Suppl 67(Suppl 67):27-46. doi: 10.1002/ajpa.23766.

ReferenceCitation: Flaherty K, Richtsmeier JT. It's about Time: Ossification Center Formation in C57BL/6 Mice from E12(-)E16. J Dev Biol. 2018 Dec 15;6(4):31. doi: 10.3390/jdb6040031.

ReferenceCitation: Holmes G, O'Rourke C, Motch Perrine SM, Lu N, van Bakel H, Richtsmeier JT, Jabs EW. Midface and upper airway dysgenesis in FGFR2-related craniosynostosis involves multiple tissue-specific and cell cycle effects. Development. 2018 Oct 5;145(19):dev166488. doi: 10.1242/dev.166488.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Martinez-Abadias N, Mateu Estivill R, Sastre Tomas J, Motch Perrine S, Yoon M, Robert-Moreno A, Swoger J, Russo L, Kawasaki K, Richtsmeier J, Sharpe J. Quantification of gene expression patterns to reveal the origins of abnormal morphogenesis. Elife. 2018 Sep 20;7:e36405. doi: 10.7554/eLife.36405.

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

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

repositories_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

ReferenceCitation: Holmes G, Zhang L, Rivera J, Murphy R, Assouline C, Sullivan L, Oppeneer T, Jabs EW. C-type natriuretic peptide analog treatment of craniosynostosis in a Crouzon syndrome mouse model. PLoS One. 2018 Jul 26;13(7):e0201492. doi: 10.1371/journal.pone.0201492. eCollection 2018.

ReferenceCitation: Richtsmeier JT. A century of development. Am J Phys Anthropol. 2018 Apr;165(4):726-740. doi: 10.1002/ajpa.23379. No abstract available.

ReferenceCitation: Starbuck JM, Cole TM 3rd, Reeves RH, Richtsmeier JT. The Influence of trisomy 21 on facial form and variability. Am J Med Genet A. 2017 Nov;173(11):2861-2872. doi: 10.1002/ajmg.a.38464. Epub 2017 Sep 21.

ReferenceCitation: Weiss K, Buchanan A, Richtsmeier J. How are we made?: Even well-controlled experiments show the complexity of our traits. Evol Anthropol. 2015 Jul-Aug;24(4):130-6. doi: 10.1002/evan.21454. No abstract available.

ReferenceCitation: Lee C, Richtsmeier JT, Kraft RH. A computational analysis of bone formation in the cranial vault in the mouse. Front Bioeng Biotechnol. 2015 Mar 19;3:24. doi: 10.3389/fbioe.2015.00024. eCollection 2015.

ReferenceCitation: Pitirri MK, Richtsmeier JT, Kawasaki M, Coupe AP, Perrine SM, Kawasaki K. Come together over me: Cells that form the dermatocranium and chondrocranium in mice. Anat Rec (Hoboken). 2023 Jul 27. doi: 10.1002/ar.25295. Online ahead of print.

ReferenceCitation: Lesciotto KM, Tomlinson L, Leonard S, Richtsmeier JT. Embryonic and early postnatal cranial bone volume and tissue mineral density values for C57BL/6J laboratory mice. Dev Dyn. 2022 Jul;251(7):1196-1208. doi: 10.1002/dvdy.458. Epub 2022 Feb 7.

ReferenceCitation: Pitirri MK, Durham EL, Romano NA, Santos JI, Coupe AP, Zheng H, Chen DZ, Kawasaki K, Jabs EW, Richtsmeier JT, Wu M, Motch Perrine SM. Meckel's Cartilage in Mandibular Development and Dysmorphogenesis. Front Genet. 2022 May 16;13:871927. doi: 10.3389/fgene.2022.871927. eCollection 2022.

ReferenceCitation: Wu M, Kriti D, van Bakel H, Jabs EW, Holmes G. Laser Capture Microdissection of Mouse Embryonic Cartilage and Bone for Gene Expression Analysis. J Vis Exp. 2019 Dec 18;(154). doi: 10.3791/60503.

ReferenceCitation: Kawasaki K, Mikami M, Goto M, Shindo J, Amano M, Ishiyama M. The Evolution of Unusually Small Amelogenin Genes in Cetaceans; Pseudogenization, X-Y Gene Conversion, and Feeding Strategy. J Mol Evol. 2020 Mar;88(2):122-135. doi: 10.1007/s00239-019-09917-0. Epub 2019 Nov 22.

ReferenceCitation: Pitirri MK, Kawasaki K, Richtsmeier JT. It takes two: Building the vertebrate skull from chondrocranium and dermatocranium. Vertebr Zool. 2020 Apr;70(4):587-600. Epub 2020 Oct 28.

ReferenceCitation: Holmes G, Gonzalez-Reiche AS, Lu N, Zhou X, Rivera J, Kriti D, Sebra R, Williams AA, Donovan MJ, Potter SS, Pinto D, Zhang B, van Bakel H, Jabs EW. Integrated Transcriptome and Network Analysis Reveals Spatiotemporal Dynamics of Calvarial Suturogenesis. Cell Rep. 2020 Jul 7;32(1):107871. doi: 10.1016/j.celrep.2020.107871.

ReferenceCitation: Lam AS, Liu CC, Deutsch GH, Rivera J, Perkins JA, Holmes G, Jabs EW, Cunningham ML, Dahl JP. Genotype-Phenotype Correlation of Tracheal Cartilaginous Sleeves and Fgfr2 Mutations in Mice. Laryngoscope. 2021 Apr;131(4):E1349-E1356. doi: 10.1002/lary.29060. Epub 2020 Sep 4.

ReferenceCitation: Singh R, Cohen ASA, Poulton C, Hjortshoj TD, Akahira-Azuma M, Mendiratta G, Khan WA, Azmanov DN, Woodward KJ, Kirchhoff M, Shi L, Edelmann L, Baynam G, Scott SA, Jabs EW. Deletion of ERF and CIC causes abnormal skull morphology and global developmental delay. Cold Spring Harb Mol Case Stud. 2021 Jun 11;7(3):a005991. doi: 10.1101/mcs.a005991. Print 2021 Jun.

ReferenceCitation: Holmes G, Gonzalez-Reiche AS, Saturne M, Motch Perrine SM, Zhou X, Borges AC, Shewale B, Richtsmeier JT, Zhang B, van Bakel H, Jabs EW. Single-cell analysis identifies a key role for Hhip in murine coronal suture development. Nat Commun. 2021 Dec 8;12(1):7132. doi: 10.1038/s41467-021-27402-5.

ipd_sharing_description: Clinical results from chromosomal analysis and DNA mutation analysis performed in CLIA approved laboratories with standard clinical genetic counseling will be given to the patient upon request. Individual research results will be made available to the individual from the PI or their primary care physician (PCP) who has obtained preliminary results from the PI from our non-CLIA laboratory, as long as the PCP can confirm and validate the lab results through a CLIA approved lab before the results are given to the subjects.

collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

location_country:
Germany
United Kingdom
United States
Spain
France

location_facility: Pennsylvania State Milton S. Hershey Medical Center

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

location_facility: Birth Defect Registries of New York State

location_facility: National Birth Defects Prevention Study at University of Iowa

location_facility: The International Craniosynostosis Consortium at University of California at Davis


lead_sponsor: Amgen

summary: A phase 2, multicenter, open-label, single arm clinical trial in adults with newly diagnosed aggressive high-risk DLBCL.

ReferenceCitation: Katz DA, Morris JD, Chu MP, David KA, Thieblemont C, Morley NJ, Khan SS, Viardot A, Martin Garcia-Sancho A, Rodriguez-Garcia G, Bastos-Oreiro M, Lee ST, Kormany W, Chen Y, Wong HL, Anderson AA, Katlinskaya Y, Avilion AA, Dai T, Gonzalez-Barca E. Open-label, phase 2 study of blinatumomab after frontline R-chemotherapy in adults with newly diagnosed, high-risk DLBCL. Leuk Lymphoma. 2022 Sep;63(9):2063-2073. doi: 10.1080/10428194.2022.2064981. Epub 2022 May 3.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

publisher_dissemination: Informa

title: 20150288 A Phase 2 Open-label Study Investigating the Safety and Efficacy of Blinatumomab After Frontline R-Chemotherapy in Adult Subjects With Newly Diagnosed High-risk Diffuse Large B-Cell Lymphoma (DLBCL)

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

location_country:
Germany
United Kingdom
United States
Spain
Canada
France

ipd_sharing: Yes


type: Other Identifier

title: A Phase I, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0077 as a Single Agent in Patients With Locally Advanced or Metastatic PIK3CA-Mutant Solid Tumors and in Combination With Endocrine and Targeted Therapies in Patients With Locally Advanced or Metastatic PIK3CA-Mutant Breast Cancer

summary: This is an open-label, multicenter, Phase I study designed to evaluate the safety, tolerability, and pharmacokinetics of inavolisib administered orally as a single agent in patients with locally advanced or metastatic PIK3CA-mutant solid tumors, including breast cancer, and in combination with standard-of-care endocrine and/or targeted therapies for the treatment of locally advanced or metastatic PIK3CA-mutant breast cancer. Participants will be enrolled in two stages: a dose-escalation stage (Stage I) and an expansion stage (Stage II). Participants will be assigned to one of seven regimens: inavolisib as a single agent (Arm A), inavolisib in combination with palbociclib and letrozole (Arm B), inavolisib in combination with letrozole (Arm C), inavolisib in combination with fulvestrant (Arm D), inavolisib in combination with palbociclib and fulvestrant (Arm E), inavolisib in combination with palbociclib, fulvestrant, and metformin (Arm F), and inavolisib in combination with trastuzumab and pertuzumab (and letrozole or fulvestrant, if applicable (Arm G)).

status: Recruiting

design_allocation: Non-Randomized

enrollment_type: Anticipated

lead_sponsor: Genentech, Inc.

location_country:
United Kingdom
United States
Spain
Canada
France

location_facility: Hospital Clinico Universitario de Valencia


lead_sponsor: Shire

summary: The purpose of this study is to determine if an investigational treatment is effective compared with placebo and PVP-Iodine in the treatment of adults and children with adenoviral conjunctivitis.

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: S. P. Medical College & Associated Group of Hospitals

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: M. S. Ramaiah Medical College and Hospital

location_facility: Hospital Universitari de Girona Dr Josep Trueta

location_facility: Andrew Gardner Logan, MD / dba Logan Ophthalmic Research, LLC

location_facility: ICARE Eye Hospital and Post Graduate Institute

location_facility: University of Waterloo School of Optometry and Vision Science

location_facility: Klinisches Studienzentrum der Augenklinik

location_facility: The Regents of the University of Michigan

location_facility: Nelson R Mandela School of Medicine Ophthalmology Department

location_facility: Complejo Asistencial Universitario de Burgos

location_facility: The Ottawa Hospital - General Campus, University of Ottawa Eye Institute

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: University of the Sunshine Coast Clinical Trials Centre

location_facility: K.L.E. Society's Dr. Prabhakar Kore Hospital and Medical Research Centre

location_facility: The Eye Center at Southern College of Optometry

location_facility: Pretoria Eye Institute Research Foundation

location_facility: Centrum Medyczne Uno-Med (Private Practice)

location_facility: Centrum Diagnostyki i Mikrochirurgii Oka LENS

location_facility: Vienna Institute for Research in Ocular Surgery

location_facility: McGill University Health Centre/Glen Site / Royal Victoria Hospital

location_facility: MediSphere Medical Research Center, an AMR affiliate

location_facility: DCT-Shah Research, LLC dba Discovery Clinical Trials

location_facility: Emerson Clinical Research Institute, LLC

status: Terminated

title: A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to PVP-Iodine and Placebo in the Treatment of Adenoviral Conjunctivitis

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
India
Hungary
Israel
United Kingdom
Australia
Austria
United States
Spain
South Africa
Peru
Canada
Estonia
France

status_simplified: Unknown


lead_sponsor: Gilead Sciences

summary: The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir velpatasvir (SOF/VEL) fixed-dose combination (FDC) with ribavirin (RBV) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) Class C cirrhosis.

ReferenceCitation: Flamm S, Lawitz E, Borg B, Charlton M, Landis C, Reddy R, et al. High Efficacy and Improvement in CPT Class With Sofosbuvir/Velpatasvir Plus Ribavirin for 12 Weeks in Patients With CPT C Decompensated Cirrhosis [Poster THU-138]. EASL: The International Liver Congress; 2019 10-14 April; Vienna, Austria.

location_facility: Hospital of the University of Pennsylvania

location_facility: Intermountain Liver Disease and Transplant Center

location_facility: Northwestern Memorial Hospital; Clinical Research Unit

location_facility: Southern Therapy and Advanced Research LLC

location_facility: Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia

location_facility: American Research Corporation at Texas Liver Institute

location_facility: University of Washington/ Harborview Medical Center

title: A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Subjects With Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

location_country:
United States
France


title: Pilot Study of Nivolumab in Pediatric Patients With Hypermutant Cancers

summary: This is an open-label, single arm, multi-center, pilot study of Nivolumab in pediatric patients with recurrent or refractory hypermutant malignancies aged 12 months to 18 years of age. This study is to assess clinical and radiological benefits of treatment with Nivolumab in children with hypermutated cancers, including those with bMMRD syndrome. It is our expectation that patients with bMMRD syndrome will account for the majority of patients enrolled on this study.

ReferenceCitation: Henderson JJ, Das A, Morgenstern DA, Sudhaman S, Bianchi V, Chung J, Negm L, Edwards M, Kram DE, Osborn M, Hawkins C, Bouffet E, Cho YJ, Tabori U. Immune Checkpoint Inhibition as Single Therapy for Synchronous Cancers Exhibiting Hypermutation: An IRRDC Study. JCO Precis Oncol. 2022 Mar;6:e2100286. doi: 10.1200/PO.21.00286. No abstract available.

evidence: open (via page says license)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Rittberg R, Harlos C, Rothenmund H, Das A, Tabori U, Sinha N, Singh H, Chodirker B, Kim CA. Immune Checkpoint Inhibition as Primary Adjuvant Therapy for an IDH1-Mutant Anaplastic Astrocytoma in a Patient with CMMRD: A Case Report-Usage of Immune Checkpoint Inhibition in CMMRD. Curr Oncol. 2021 Feb 1;28(1):757-766. doi: 10.3390/curroncol28010074.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

unpaywall_oa_status: gold

publisher_dissemination: MDPI

lead_sponsor: The Hospital for Sick Children

sponsor_collaborators:
The Hospital for Sick Children
Bristol-Myers Squibb

location_country:
France
Australia
United States
Canada
Israel

location_facility: Children's & Women's Health Centre of British Columbia

lead_sponsor_type: academique


acronym: STELARA

lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this study is to evaluate the pharmacokinetics (PK) of ustekinumab in subjects from 2 through less than (<) 18 years old in the USA, or 6 through less than (<) 18 years old in other countries and determine if it is similar to that observed in adults with moderately to severely active Crohn's disease (CD). Also to assess the safety, immunogenicity and efficacy of ustekinumab in the treatment of moderately to severely active CD. The main part of the study continues to Week 16, at which point all subjects who are receiving benefit from ustekinumab maintenance therapy (as determined by the investigator) are eligible to enter the long-term extension (LTE) and continue to receive ustekinumab. The study extension ends at Week 268 or upon availability of the LTE basket study (CNTO1275ISD3001) whichever occurs first. If participants do not consent/assent to the LTE basket study, they will continue safety follow-up for approximately 20 weeks after the last study agent administration.

location_facility: Children's Center For Digestive Healthcare, Llc

location_facility: Universitair Kinderziekenhuis Koningin Fabiola

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

location_facility: Center For Digestive Health Systems-Greenville

title: A Randomized Double-blind Pharmacokinetic Study of Ustekinumab in Pediatric Subjects With Moderately to Severely Active Crohn's Disease

location_country:
Germany
Poland
Belgium
United States
Canada
France


acronym: AWARD-PEDS

lead_sponsor: Eli Lilly and Company

summary: The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of the study drug dulaglutide compared to placebo in pediatric participants with type 2 diabetes. The study duration is approximately 60 weeks.

ReferenceCitation: Arslanian SA, Hannon T, Zeitler P, Chao LC, Boucher-Berry C, Barrientos-Perez M, Bismuth E, Dib S, Cho JI, Cox D; AWARD-PEDS Investigators. Once-Weekly Dulaglutide for the Treatment of Youths with Type 2 Diabetes. N Engl J Med. 2022 Aug 4;387(5):433-443. doi: 10.1056/NEJMoa2204601. Epub 2022 Jun 4.

oa_host_type: publisher

evidence: open (via free article)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

location_facility: Florida Center for Endocrinology & Metabolism

location_facility: Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

location_facility: Division of Endocrinology, Diabetes, and Metabolism

location_facility: King Salman bin Abdulaziz Hospital - Diabetic Center

location_facility: Instituto Estadual de Diabetes e Endocrinologia

location_facility: Dr Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre

location_facility: Ondokuz Mayis University Medical Faculty

location_facility: Post Graduate Institute of Medical Education & Research

location_facility: Centro de Diabetes y Endocrinologia Pediatrica de PR

location_facility: Seattle Children's Hospital Research Foundation

location_facility: Cincinnati Childrens Hospital Medical Center

location_facility: Center of Excellence in Diabetes & Endocrinology

location_facility: Health Pharma Professional Research, S.A. de C.V.

location_facility: Hospital da Clinicas da Faculdade de Medicina da USP

location_facility: Deenanath Mangeshkar Hospital & Research Centre

title: A Randomized, Double-Blind Study With an Open-Label Extension Comparing the Effect of Once-Weekly Dulaglutide With Placebo in Pediatric Patients With Type 2 Diabetes Mellitus (AWARD-PEDS: Assessment of Weekly AdministRation of LY2189265 in Diabetes-PEDiatric Study)

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

location_country:
Germany
India
Hungary
United Kingdom
Brazil
Mexico
United States
Saudi Arabia
Turkey
Puerto Rico
France


acronym: HORIZON

lead_sponsor: Oncopeptides AB

summary: This study will evaluate melflufen in combination with dexamethasone in adult patients with relapsed or refractory multiple myeloma in whose disease is refractory to pomalidomide and/or an anti-CD38 monoclonal antibody. All patients in the study will be treated with melflufen on Day 1 and dexamethasone on Days 1, 8, 15 and 22 of each 28-day cycle.

ReferenceCitation: Richardson PG, Oriol A, Larocca A, Blade J, Cavo M, Rodriguez-Otero P, Leleu X, Nadeem O, Hiemenz JW, Hassoun H, Touzeau C, Alegre A, Paner A, Maisel C, Mazumder A, Raptis A, Moreb JS, Anderson KC, Laubach JP, Thuresson S, Thuresson M, Byrne C, Harmenberg J, Bakker NA, Mateos MV; HORIZON (OP-106) Investigators. Melflufen and Dexamethasone in Heavily Pretreated Relapsed and Refractory Multiple Myeloma. J Clin Oncol. 2021 Mar 1;39(7):757-767. doi: 10.1200/JCO.20.02259. Epub 2020 Dec 9.

endpoint_id: fhisxppmrqpajgzqkvft

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

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

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

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

ReferenceCitation: Larocca A, Leleu X, Touzeau C, Blade J, Paner A, Mateos MV, Cavo M, Maisel C, Alegre A, Oriol A, Raptis A, Rodriguez-Otero P, Mazumder A, Laubach J, Nadeem O, Sandberg A, Orre M, Torrang A, Bakker NA, Richardson PG. Patient-reported outcomes in relapsed/refractory multiple myeloma treated with melflufen plus dexamethasone: analyses from the Phase II HORIZON study. Br J Haematol. 2022 Feb;196(3):639-648. doi: 10.1111/bjh.17887. Epub 2021 Oct 21. Erratum In: Br J Haematol. 2022 Aug;198(3):609.

repositories_concat: PubMed Central;ddd.uab.cat

sponsor_collaborators:
Oncopeptides AB
Precision For Medicine

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Innovative Clinical Research Institute (ICRI)

location_facility: Institut Català d'Oncología (ICO) Badalona

location_facility: Hospital Universitario Fundación Jiménez Díaz

title: A Single Arm, Open-Label, Phase 2 Study of Melflufen in Combination With Dexamethasone in Patients With Relapsed Refractory Multiple Myeloma Who Are Refractory to Pomalidomide and/or an Anti-CD38 Monoclonal Antibody

location_country:
United States
Italy
Spain
France


intervention_type: Other

lead_sponsor: Novartis Pharmaceuticals

summary: This study will determine the dose-response relationship of VAY736 for key efficacy and safety parameters

ReferenceCitation: Bowman SJ, Fox R, Dorner T, Mariette X, Papas A, Grader-Beck T, Fisher BA, Barcelos F, De Vita S, Schulze-Koops H, Moots RJ, Junge G, Woznicki JN, Sopala MA, Luo WL, Hueber W. Safety and efficacy of subcutaneous ianalumab (VAY736) in patients with primary Sjogren's syndrome: a randomised, double-blind, placebo-controlled, phase 2b dose-finding trial. Lancet. 2022 Jan 8;399(10320):161-171. doi: 10.1016/S0140-6736(21)02251-0. Epub 2021 Nov 30.

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

repositories_concat: Pure (Denmark)

publisher_dissemination: Elsevier

title: Study of Safety and Efficacy of Multiple VAY736 Doses in Patients With Moderate to Severe Primary Sjogren's Syndrome (pSS)

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

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

location_country:
Germany
Poland
Argentina
Japan
Chile
France
Portugal
Hungary
United States
Romania
Belgium
Italy
United Kingdom
Netherlands
Austria
Spain
Taiwan
Russian Federation
Israel

ipd_sharing: Undecided


title: A Phase 1b Open-Label Study Investigating the Safety and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma

summary:
Primary Objective:

• To evaluate the safety and tolerability of subcutaneous (SC) blinatumomab dose administrations

Secondary Objectives:

To determine pharmacokinetics (PK) with continuous intravenous (cIV) and SC administrations
To estimate the maximum tolerated dose (MTD) tested for blinatumomab administered subcutaneously
To determine the incidence of anti-blinatumomab antibody formation following SC administration
To evaluate efficacy response following treatment with SC blinatumomab administration

Exploratory Objective:

To determine the pharmacodynamics (PD) time profiles for B-and T-lymphocytes as well as cytokine profiles during SC administration
To evaluate efficacy response following treatment with SC blinatumomab administration using Lugano criteria if positron emission tomography-computed tomography (PET/CT) is used for evaluation

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

location_country:
Germany
Italy
United Kingdom
Australia
United States
France

location_facility: Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII


title: A Longitudinal Observational Study of the Natural History and Management of Patients With Hepatocellular Carcinoma

summary: TARGET-HCC is a longitudinal, observational study of patients being managed for HCC in usual clinical practice. TARGET-HCC will create a research registry of participants with HCC within academic and community real-world practices in order to assess the safety and effectiveness of the entire spectrum of current and future therapies across diverse populations.

time_perspective: Prospective

ReferenceCitation: Cabrera R, Singal AG, Colombo M, Kelley RK, Lee H, Mospan AR, Meyer T, Newell P, Parikh ND, Sangro B, Reddy KR, Watkins S, Zink RC, Di Bisceglie AM. A Real-World Observational Cohort of Patients with Hepatocellular Carcinoma: Design and Rationale for TARGET-HCC. Hepatol Commun. 2020 Dec 21;5(3):538-547. doi: 10.1002/hep4.1652. eCollection 2021 Mar. Erratum In: Hepatol Commun. 2022 May;6(5):1248.

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: University of California - eScholarship University of California

repositories:
PubMed Central
UCL Discovery
escholarship.org

lead_sponsor: Target PharmaSolutions, Inc.

location_country:
Germany
Italy
United States
Spain
France

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: University of Florida Health Gastroenterology

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Northwestern University Division of Gastroenterology and Hepatology

location_facility: Clinical Research Institute@ Methodist Dallas Medical Center

location_facility: Providence Health & Services Cancer Clinical Trials

location_facility: University of Florida Hepatology Research at CTRB

location_facility: University of Iowa Hospitals and Clinics

location_facility: Rutgers-Robert Wood Johnson Medical School

location_facility: Vanderbilt University Medical Center - GI Research Office

location_facility: Northwell Health - Center for Liver Diseases

location_facility: University of Southern California/Norris Comprehensive Cancer Center

location_facility: University of North Carolina at Chapel Hill

location_facility: Center for Liver Disease and Transplant at CMC

location_facility: Schiff Center for Liver Diseases/University of Miami

location_facility: Southern Therapy and Advanced Research (STAR) LLC

location_facility: University of Texas Southwestern Medical Center


title: An Open-Label, Multicenter, Phase 2 Study of Iopofosine I 131 (CLR 131) in Patients With Relapsed or Refractory (R/R) Select B-Cell Malignancies (CLOVER-1) and Expansion Cohort in Patients With Waldenstrom Macroglobulinemia (CLOVER-WaM)

acronym: CLOVER-WaM

summary: Part A of this study evaluates iopofosine I 131 (CLR 131) in patients with select B-cell malignancies (multiple myeloma( MM), indolent chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), and central nervous system lymphoma (CNSL) who have been previously treated with standard therapy for their underlying malignancy. Part B (CLOVER-WaM) is a pivotal efficacy study evaluating IV administration of iopofosine I 131 in patients with WM that have received at least two prior lines of therapy.

lead_sponsor: Cellectar Biosciences, Inc.

location_country:
Finland
Israel
United Kingdom
Australia
Brazil
United States
Spain
Greece
Turkey
Czechia
France

location_facility:
Cellectar Biosciences
Cellectar Biosciences site
Cellectar Biosciences Site


title: Saline Hypertonic in Preschoolers With Cystic Fibrosis and Lung Structure as Measured by Computed Tomography (CT)

acronym: SHIP-CT

summary: The purpose of this study is to assess whether inhalation of 7% hypertonic saline (HS) twice daily for 48 weeks reduces structural lung disease as assessed by computed tomography (CT) in comparison with inhalation of 0.9% isotonic saline (IS) in preschool children (ages 3 to 6) with cystic fibrosis.

ReferenceCitation: Rosenow T, Oudraad MC, Murray CP, Turkovic L, Kuo W, de Bruijne M, Ranganathan SC, Tiddens HA, Stick SM; Australian Respiratory Early Surveillance Team for Cystic Fibrosis (AREST CF). PRAGMA-CF. A Quantitative Structural Lung Disease Computed Tomography Outcome in Young Children with Cystic Fibrosis. Am J Respir Crit Care Med. 2015 May 15;191(10):1158-65. doi: 10.1164/rccm.201501-0061OC.

ReferenceCitation: Ramsey KA, Rosenow T, Turkovic L, Skoric B, Banton G, Adams AM, Simpson SJ, Murray C, Ranganathan SC, Stick SM, Hall GL; AREST CF. Lung Clearance Index and Structural Lung Disease on Computed Tomography in Early Cystic Fibrosis. Am J Respir Crit Care Med. 2016 Jan 1;193(1):60-7. doi: 10.1164/rccm.201507-1409OC.

ReferenceCitation: Tiddens HAWM, Chen Y, Andrinopoulou ER, Davis SD, Rosenfeld M, Ratjen F, Kronmal RA, Hinckley Stukovsky KD, Dasiewicz A, Stick SM; SHIP-CT Study Group. The effect of inhaled hypertonic saline on lung structure in children aged 3-6 years with cystic fibrosis (SHIP-CT): a multicentre, randomised, double-blind, controlled trial. Lancet Respir Med. 2022 Jul;10(7):669-678. doi: 10.1016/S2213-2600(21)00546-4. Epub 2022 Mar 11.

oa_host_type: closed

lead_sponsor: University of Washington, the Collaborative Health Studies Coordinating Center

location_country:
Italy
Denmark
Australia
Netherlands
Belgium
United States
Spain
Canada
France

location_facility: Copenhagen University Hospital Rigshospitalet

location_facility: Universitair Ziekenhuis Children's Hospital

location_facility: Washington University School of Medicine

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: Sophia Children's Hospital at Erasmus Medical Centre


title: A Phase 1b Dose Escalation Study Evaluating the Safety and Pharmacokinetics of Venetoclax in Combination With Azacitidine in Subjects With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)

summary: This is a Phase 1b, open-label, non-randomized, multicenter, dose-finding study evaluating venetoclax in combination with azacitidine in participants with treatment-naïve higher-risk MDS comprising a dose-escalation portion and a safety expansion portion.

lead_sponsor: AbbVie

sponsor_collaborators:
AbbVie
Genentech, Inc.

location_country:
Germany
Italy
United Kingdom
Australia
United States
Canada
France

location_facility: Vanderbilt University Medical Center /ID# 152738

location_facility: Weill Cornell Medical College /ID# 155524

location_facility: Columbia University Medical Center /ID# 153661

location_facility: University of Maryland School of Medicine /ID# 153669

location_facility: Oxford University Hospitals NHS Foundation Trust /ID# 222567

location_facility: Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 153139

location_facility: Universitaetsklinikum Halle (Saale) /ID# 153760

location_facility: Washington University-School of Medicine /ID# 153671

location_facility: UT MD Anderson Cancer Center /ID# 153809

location_facility: Duplicate_St. Vincent's Hospital, Darlinghurst /ID# 222846

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 153828

location_facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 153764

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 156492

location_facility: Oregon Health and Science University /ID# 152734

location_facility: Duplicate_Universitaetsklinikum Carl Gus /ID# 153958

location_facility: University Hospitals Birmingham NHS Foundation Trust /ID# 158810

location_facility: King's College Hospital NHS Foundation Trust /ID# 156489

location_facility: University of Arizona Cancer Center - North Campus /ID# 154155

location_facility: Universitatsklinikum Mannheim /ID# 153140

location_facility: Dana-Farber Cancer Institute /ID# 152735

location_facility: Tennessee Oncology-Nashville Centennial /ID# 222769

location_facility: The University of Chicago Medical Center /ID# 153673

location_facility: Concord Repatriation General Hospital /ID# 154958

location_facility: Universitaetsklinikum Leipzig /ID# 153142

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 153763


lead_sponsor: Novo Nordisk A/S

summary: Investigating single dose pharmacokinetics and safety of turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process in patients with severe haemophilia A

title: This Trial is Conducted in Europe and the United States of America. The Aim of This Trial is to Investigate Single Dose Pharmacokinetics (the Exposure of the Trial Drug in the Body) and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A.

location_country:
Germany
Denmark
Netherlands
United States
Spain
France


title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Cardiac and Renal Effects of Short Term Treatment With Elamipretide in Patients Hospitalized With Congestion Due to Heart Failure

summary: This is a phase 2 randomized, double-blind, placebo-controlled study to evaluate the cardiac and renal effects of short term treatment with elamipretide in patients hospitalized with congestion due to heart failure

lead_sponsor: Stealth BioTherapeutics Inc.

location_country:
Poland
Hungary
United Kingdom
Netherlands
Belgium
Latvia
Spain
Bulgaria
Serbia
France

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Complexo Hospitalario Universitario de A Coruña

location_facility: County St. George University Teaching Hospital, Department of Internal Medicine Cardiology

location_facility: Clinical Centre of Serbia, Institute for Cardiovascular Diseases

location_facility: Cardinal Stefan Wyszynski, Institute of Cardiology, Clinic Heart Failure and Transplantation

location_facility: Clinical Centre of Serbia, Emergency Centre

location_facility: Cardinal Stefan Wyszynski, Institute of Cardiology, Clinic of Coronary Heart Disease and Structural Heart Disease

location_facility: Department of Cardiology, "Multiprofile Regional Hospital for Active Treatement Dr. Stefan Cherkezov" AD

location_facility: Clinic of Cardiology, "Second Multiprofile Hospital for Active Treatement - Sofia" EAD

location_facility: Clinic of Internal Diseases, "Multiprofile Hospital for Active Treatment, "Sveta Anna Sofia" AD

location_facility: Zala County Hospital Cardiology Department

location_facility: Bieganski Provincial Specialist Hospital, Department of Cardiology, Clinic of Cardiology UM

location_facility: Clinic of Cardiology, "City Clinic University Multiprofile Hospital for Active Treatment" EOOD

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Clinical Hospital Centre Bezanijska kosa

location_facility: Department of Internal Diseases, "Multiprofile Hospital for Active Treatment Sveta Ekaterina - Dimitrovgrad" EOOD

location_facility: Hungarian Institute Of Cardiology, Department of Adult Cardiology

location_facility: Clinic of Cardiology, Multiprofile Hospital for Active Treatment National Heart Hospital" EAD

location_facility: Consorci Hospital General Universitari de Valencia

location_facility: Riga East Clinical University Hospital, Clinic Gailezers

location_facility: Semmelweis University Heart and Vascular Center

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Institute for Cardiovascular Diseases of Vojvodina

location_facility: Pauls Stradins Clinical University Hospital, Latvian Centre of Cardiology


acronym: FIREFISH

lead_sponsor: Hoffmann-La Roche

summary: Open-label, multi-center clinical study is to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamics (PD), and efficacy of Risdiplam (RO7034067) in infants with Type 1 spinal muscular atrophy (SMA). The study consists of two parts, an exploratory dose finding part (Part 1) and a confirmatory part (Part 2) which will investigate Risdiplam (RO7034067) for 24-months at the dose selected in Part 1.

ReferenceCitation: Masson R, Mazurkiewicz-Beldzinska M, Rose K, Servais L, Xiong H, Zanoteli E, Baranello G, Bruno C, Day JW, Deconinck N, Klein A, Mercuri E, Vlodavets D, Wang Y, Dodman A, El-Khairi M, Gorni K, Jaber B, Kletzl H, Gaki E, Fontoura P, Darras BT; FIREFISH Study Group. Safety and efficacy of risdiplam in patients with type 1 spinal muscular atrophy (FIREFISH part 2): secondary analyses from an open-label trial. Lancet Neurol. 2022 Dec;21(12):1110-1119. doi: 10.1016/S1474-4422(22)00339-8. Epub 2022 Oct 14.

repositories_concat: UCL Discovery

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Cances C, Vlodavets D, Comi GP, Masson R, Mazurkiewicz-Beldzinska M, Saito K, Zanoteli E, Dodman A, El-Khairi M, Gorni K, Gravestock I, Hoffart J, Scalco RS, Darras BT; ANCHOVY Working Group. Natural history of Type 1 spinal muscular atrophy: a retrospective, global, multicenter study. Orphanet J Rare Dis. 2022 Jul 29;17(1):300. doi: 10.1186/s13023-022-02455-x.

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

repositories_concat: PubMed Central;air.unimi.it

ReferenceCitation: Darras BT, Masson R, Mazurkiewicz-Beldzinska M, Rose K, Xiong H, Zanoteli E, Baranello G, Bruno C, Vlodavets D, Wang Y, El-Khairi M, Gerber M, Gorni K, Khwaja O, Kletzl H, Scalco RS, Fontoura P, Servais L; FIREFISH Working Group. Risdiplam-Treated Infants with Type 1 Spinal Muscular Atrophy versus Historical Controls. N Engl J Med. 2021 Jul 29;385(5):427-435. doi: 10.1056/NEJMoa2102047.

oa_colors: green other

ReferenceCitation: Baranello G, Darras BT, Day JW, Deconinck N, Klein A, Masson R, Mercuri E, Rose K, El-Khairi M, Gerber M, Gorni K, Khwaja O, Kletzl H, Scalco RS, Seabrook T, Fontoura P, Servais L; FIREFISH Working Group. Risdiplam in Type 1 Spinal Muscular Atrophy. N Engl J Med. 2021 Mar 11;384(10):915-923. doi: 10.1056/NEJMoa2009965. Epub 2021 Feb 24.

location_facility: Hospital Yeditepe University Kozyatagi; Pediatry

location_facility: Hospital Universitari Vall d'Hebron; Area Genética Clínica y Molecular

location_facility: Hopital Femme Mere Enfant; Medecine Physique et Readaptation Pediatrique ? L?ESCALE

location_facility: Policlinico Agostino Gemelli; Dipartimento di Neuropsichiatria Infantile

location_facility: King Faisal Specialist Hospital and Research Centre Building

location_facility: Instituto de Puericultura E Pediatria Martagão Gesteira

location_facility: Institute for Mother and Child Dr. Vukan Cupic

location_facility: Columbia University Medical Center; The Neurological Institute of New York

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

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

location_facility: Russian Children Neuromuscular Center of Veltischev

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; Unità Operativa Complessa di Neurologia

location_facility: IRCCS Ospedale Pediatrico Bambino Gesù; U.O. Malattie Neuromuscolari e Neurodegenerative

location_facility: Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology

location_facility: Szpital Gdanskiego Uniwersytetu Medycznego; Clinic of developmental neurology

location_facility: Clinical Medical Center Zagreb; University Hospital Rebro Department of Paediatrics

location_facility: IRCCS Istituto Giannina Gaslini; U.O.S.D. Centro di Miologia e Patologie Neurodegenerative

location_facility: Hospital das Clinicas - FMUSP_X; Neurologia

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

location_facility: The Children?s Memorial Health Institute Department of Neurology and Epileptology

title: A Two Part Seamless, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Risdiplam (RO7034067) in Infants With Type 1 Spinal Muscular Atrophy

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

location_country:
Italy
Poland
Japan
Brazil
Switzerland
Belgium
United States
China
Saudi Arabia
Spain
Turkey
Croatia
Ukraine
Serbia
Russian Federation
France


title: A Prospective, Randomized, International, Multicenter, Double-arm, Controlled, Open-label Study of Riociguat in Patients With Pulmonary Arterial Hypertension (PAH) Who Are on a Stable Dose of Phosphodiesterase-5 Inhibitors (PDE-5i) With or Without Endothelin Receptor Antagonist (ERA), But Not at Treatment Goal

acronym: REPLACE

summary: To demonstrate the effectiveness of riociguat as replacement of phosphodiesterase-5 inhibitors (PDE-5i) therapy in pulmonary arterial hypertension (PAH) patients

ReferenceCitation: Hoeper MM, Al-Hiti H, Benza RL, Chang SA, Corris PA, Gibbs JSR, Grunig E, Jansa P, Klinger JR, Langleben D, McLaughlin VV, Meyer GMB, Ota-Arakaki J, Peacock AJ, Pulido T, Rosenkranz S, Vizza CD, Vonk-Noordegraaf A, White RJ, Chang M, Kleinjung F, Meier C, Paraschin K, Ghofrani HA, Simonneau G; REPLACE investigators. Switching to riociguat versus maintenance therapy with phosphodiesterase-5 inhibitors in patients with pulmonary arterial hypertension (REPLACE): a multicentre, open-label, randomised controlled trial. Lancet Respir Med. 2021 Jun;9(6):573-584. doi: 10.1016/S2213-2600(20)30532-4. Epub 2021 Mar 24.

lead_sponsor: Bayer

location_country:
Germany
Poland
Japan
Brazil
Turkey
Czechia
Canada
France
Portugal
Denmark
United States
Belgium
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan


title: A Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Effects of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Chronic Heart Failure and Preserved Ejection Fraction

acronym: PERSPECTIVE

summary: The purpose of this study is to evaluate the effect of LCZ696 compared to valsartan on cognitive function in patients with chronic heart failure and preserved ejection fraction. Cognitive function will be assessed using a comprehensive battery of tests with an evaluation of longitudinal change of cognitive domains including memory, executive function, and attention.

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

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

location_country:
Germany
Poland
Argentina
Australia
Turkey
Croatia
Canada
France
Lithuania
Switzerland
United States
Belgium
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation


title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacodynamics, and Pharmacokinetics of Lademirsen (SAR339375) for Subcutaneous Injection Administered Every Week in Patients With Alport Syndrome

acronym: HERA

summary:
Primary Objectives:

To assess the efficacy of lademirsen (SAR339375) in reducing the decline in renal function.
To assess the safety and tolerability of lademirsen (SAR339375) in participants with Alport syndrome.

Secondary Objectives:

To assess plasma pharmacokinetic (PK) parameters of the parent compound and its active major metabolite.
To assess the potential formation of anti-drug antibodies (ADAs) following administration of lademirsen (SAR339375).
To assess the pharmacodynamic effect of lademirsen (SAR339375) on miR-21 and on changes in renal injury and function biomarkers.

ReferenceCitation: Kashtan CE, Gross O. Clinical practice recommendations for the diagnosis and management of Alport syndrome in children, adolescents, and young adults-an update for 2020. Pediatr Nephrol. 2021 Mar;36(3):711-719. doi: 10.1007/s00467-020-04819-6. Epub 2020 Nov 6. Erratum In: Pediatr Nephrol. 2021 Jan 12;:

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

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Germany
United Kingdom
Australia
United States
China
Spain
France

location_facility: Universitätsmedizin Göttingen, Klinik für Nephrologie und Rheumatologie_Investigational Site Number :2760002

location_facility: Uniklinik Köln, Innere Medizin II - Nephrologie, Rheumatologie, Diabetologie und Allgemeine Innere Medizin_Investigational Site Number :2760001

location_facility: Columbia University Medical Center_Investigational Site Number :8400004

location_facility: University of Utah_Investigational Site Number :8400005

location_facility: The Cleveland Clinic Foundation_Investigational Site Number :8400001

location_facility: University of Minnesota Childrens' Hospital_Investigational Site Number :8400003


lead_sponsor: Italfarmaco

summary:
Primary Objective

The primary objective of the study was to establish the effects of givinostat versus placebo administered chronically over 18 months to slow disease progression in ambulant DMD subjects.

Secondary Objectives

The secondary objectives of this study were:

To assess the safety and tolerability of givinostat versus placebo administered chronically in DMD subjects
To evaluate the PK profile of givinostat administered chronically in DMD subjects
To evaluate the impact on quality of life (QoL) and activities of daily living of givinostat versus placebo administered chronically.

sponsor_collaborators:
Italfarmaco
Syneos Health

location_facility: Neuromuscular Research Center UC Davis Department of Physical Medicine and Rehabilitation

location_facility: Connecticut Children's Medical Center - Division Neurology

location_facility: Klinik un Policlinik fur Kinder und Jugendmedizin - Universitatsklinikum Hamburg Eppendorf

location_facility: The University of British Columbia, Children's and Womens Health Centre of BC Branch

location_facility: Hospital Universitari i Politécnic de la Fe - Servicio Neurologia

location_facility: CHU de Nantes - Hotel-Dieu - Hopital Nord Laennec, rez-de-chausse haut ail Ouest

location_facility: Fondazione Policlinico Universitario "A.Gemelli", UOC Neuropsichiatria Infantile

location_facility: Hospital Sant Joan de Déu - Neuromuscular Pathology Unit

location_facility: Holland Bloorview Kids Rehabilitation Hospital

location_facility: Hospital Materno-Infantil - Passeig de la Vall d'Hebron

location_facility: Kinsmen Research Centre - Alberta Children's Hospital - Alberta Health Services

location_facility: Hospital de La Citadelle, Centre de Référence des Maladies Neuromuscolaires (CRMN)

location_facility: The John Walton Muscular Dystrophy Research Centre - Freeman Hospital - Newcastle University - Institute of Genetic Medicine

location_facility: A.O.U. Policlinico G. Martino, U.O.C. Neurologia e Malattie Neuromuscolari

location_facility: Rady Children's Hospital center - UCSD Department of Neuroscience

location_facility: Centro Clinico NeMO Fondazione Serena ONLUS Area SUD

location_facility: Washington University School of Medicine in St Louis - Department of Neurology

location_facility: The Children's Hospital of Philadelphia Colket Translational Research Building

location_facility: University Hospitals Leuven, Neuromuscular Reference Centre, Child Neurology

location_facility: Universitatsklinikum Essen - Kinder und Jugendmedizin Neuropadiatrie

location_facility: The Robert Jones and Agnes Hunt Orthopaedic Hospital - NHS Foundation Trust

location_facility: Hopital Armand Trousseau I-Motion, Plateforme d'essais cliniques pédiatriques

location_facility: Virginia Commonwealth University Childrens Hospital of Richmond at Virginia Commonwealth University

location_facility: Ospedale Pediatrico Bambin Gesù, Malattie Neuromuscolari e Neurodegenerative

location_facility: IRCCS Istituto G.Gaslini, U.O.S.D. Centro Traslazionale di Miologia e Patologie Neurodegenerative

location_facility: Institute of Neurology - Schneider Children's Medical Center of Israel Kaplan, 14

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, UOS di Neurologia Pediatrica

location_facility: Clinic of Neurology and Psychiatry for Children and Youth - Neurology Department Dr. Subotic 6a,

location_facility: UCL Great Ormond Street Institute of Child Health, Dubowitz Neuromuscular Centre and MRC Centre for NMD

location_facility: Klinikum der Uniersitat Munchen - Campus Innenstadt

location_facility: Child Health Research Institute - Department of Pediatrics

location_facility: University of Minnesota - Department of Neurology

title: Randomised, Double Blind, Placebo Controlled, Multicentre Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Duchenne Muscular Dystrophy

location_country:
Germany
Italy
Israel
United Kingdom
Netherlands
Belgium
United States
Spain
Canada
Serbia
France


title: Multi-Center Clinical Evaluation of the ATTUNE Cementless Rotating Platform Total Knee Arthroplasty

summary: The primary objective of this study is to examine the change from pre-operative baseline to two year postoperative functional performance improvement for the ATTUNE primary, cementless TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score). This will be carried out for two configurations: cruciate retaining rotating platform (ATTUNE Cementless CR RP) and posterior stabilized rotating platform (ATTUNE Cementless PS RP).

lead_sponsor: DePuy Orthopaedics

location_country:
Germany
Ireland
New Zealand
United Kingdom
Netherlands
Austria
United States
Canada
France

location_facility: Krankenhaus der Barmherzigen Schwestern Ried im Innkreis

location_facility: Foothills Medical Centre, University of Calgary

location_facility: South Infirmary Victoria University Hospital

location_facility: Texas Tech University Heath Science Center

location_facility: Sevice de Chirurgie Orthoedique et Traumatologique

location_facility: Hampton Roads Orthopaedics and Sports Medicine

location_facility: Nottingham University Hospitals NHS Trust


title: Ventricular Tachycardia Antiarrhythmics or AblatioN In Structural Heart Disease 2

summary: A multicenter, randomized clinical trial to assess whether catheter ablation or antiarrhythmic drug therapy provides the most effective control of important clinical outcomes for patients with prior myocardial infarction and sustained monomorphic ventricular tachycardia (VT).

ReferenceCitation: Kheiri B, Barbarawi M, Zayed Y, Hicks M, Osman M, Rashdan L, Kyi HH, Bachuwa G, Hassan M, Stecker EC, Nazer B, Bhatt DL. Antiarrhythmic Drugs or Catheter Ablation in the Management of Ventricular Tachyarrhythmias in Patients With Implantable Cardioverter-Defibrillators: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Circ Arrhythm Electrophysiol. 2019 Nov;12(11):e007600. doi: 10.1161/CIRCEP.119.007600. Epub 2019 Nov 8.

lead_sponsor: John Sapp

collaborators: Ottawa Heart Institute Research Corporation

collaborators: Canadian Institutes of Health Research (CIHR)

location_country:
United States
Canada
France

location_facility: Fraser Health Authority - Royal Columbian Hospital

location_facility: Centre Hospitalier Univesitaire de Sherbrooke

location_facility: Centre Hospitalier de l'Universitaire de Montreal

location_facility: Institut Universitaire de cardiologie et pneumologie de Quebec - Laval University Hosptial

location_facility: Queen's University Health Sciences Centre


intervention_type: Biological

lead_sponsor: Archigen Biotech Limited

summary: This is a Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the statistical equivalence of efficacy, safety and immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in asymptomatic patients with Low Tumor Burden Follicular Lymphoma.

location_facility:
Research site
Research Site
Reasearch site

title: A Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the Efficacy, Safety, and Immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in Patients With Low Tumor Burden Follicular Lymphoma

location_country:
Germany
Italy
Hungary
United Kingdom
Australia
Mexico
United States
Korea, Republic of
Spain
South Africa
Turkey
Chile
Czechia
France


title: A Phase 1a/1b Study of a Novel Anti-PD-L1 Checkpoint Antibody (LY3300054) Administered Alone or in Combination With Other Agents in Advanced Refractory Solid Tumors (Phase 1a/1b Anti-PD-L1 Combinations in Tumors-PACT)

acronym: PACT

summary: The main purpose of this study is to evaluate the safety and tolerability of anti-programmed cell death ligand 1 (PD-L1) checkpoint antibody LY3300054 in participants with advanced refractory solid tumors.

ReferenceCitation: Hollebecque A, Chung HC, de Miguel MJ, Italiano A, Machiels JP, Lin CC, Dhani NC, Peeters M, Moreno V, Su WC, Chow KH, Galvao VR, Carlsen M, Yu D, Szpurka AM, Zhao Y, Schmidt SL, Gandhi L, Xu X, Bang YJ. Safety and Antitumor Activity of alpha-PD-L1 Antibody as Monotherapy or in Combination with alpha-TIM-3 Antibody in Patients with Microsatellite Instability-High/Mismatch Repair-Deficient Tumors. Clin Cancer Res. 2021 Dec 1;27(23):6393-6404. doi: 10.1158/1078-0432.CCR-21-0261. Epub 2021 Aug 31.

evidence: oa repository (via page says license)

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Patnaik A, Yap TA, Chung HC, de Miguel MJ, Bang YJ, Lin CC, Su WC, Italiano A, Chow KH, Szpurka AM, Yu D, Zhao Y, Carlsen M, Schmidt S, Vangerow B, Gandhi L, Xu X, Bendell J. Safety and Clinical Activity of a New Anti-PD-L1 Antibody as Monotherapy or Combined with Targeted Therapy in Advanced Solid Tumors: The PACT Phase Ia/Ib Trial. Clin Cancer Res. 2021 Mar 1;27(5):1267-1277. doi: 10.1158/1078-0432.CCR-20-2821. Epub 2020 Nov 23.

repository_institution: University of Illinois at Chicago - INDIGO

location_country:
Belgium
United States
Korea, Republic of
Spain
Taiwan
Canada
France

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Severance Hospital Yonsei University Health System


acronym:
POC in lupus nephrits

 Preuve de concept dans la néphropathie lupique

lead_sponsor: Boehringer Ingelheim

summary: The overall purpose of the study is to assess the efficacy of three different doses of BI 655064 against placebo as add-on therapy to standard of care (SOC) treatment for active lupus nephritis in order to characterize the dose-response relationship within the therapeutic range, and select the target dose for phase III development.

location_facility: Instituto Nacional de Cs Médicas y Nutrición S Zubiran

location_facility: University General Hospital of Heraklion

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck

location_facility: Angeles University Foundation Medical Center

location_facility: Norbert Barlicki University Clinical Hospital No.1, Lodz

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Feinstein Institute for Medical Research

location_facility: Hospital of the University of Occupational and Environmental Health

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Integral Rheumatology and Immunology Specialist

location_facility: Instituto Nacional de Cardiologia Ignacio Chavez

location_facility: University Clinical Hospital in Bialystok I

location_facility: Azienda Ospedaliera Universitaria di Padova

location_facility: CHU de Quebec-Universite Laval Research Centre

location_facility: Centro Hospitalar Universitário São João,EPE

location_facility: Columbia University Medical Center-New York Presbyterian Hospital

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

location_facility: NZOZ Centrum Medyczne AESKULAP,Private Prac, Radom

location_facility: General University Hospital Prague 2, Nephrology Clinic

title: A Double-blind, Randomised, Placebo-controlled Trial Evaluating the Effect of BI 655064 Administered as Sub-cutaneous Injections, on Renal Response After One Year of Treatment, in Patients With Active Lupus Nephritis

location_country:
Germany
Poland
Australia
Japan
Thailand
Czechia
Canada
Serbia
France
Portugal
Hong Kong
United States
Malaysia
Philippines
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
Greece


acronym: B-MIND

lead_sponsor: MorphoSys AG

summary: The purpose of the study is to compare the safety and efficacy of Tafasitamab with BEN versus RTX with BEN in adult patients with relapsed of refractory DLBCL.

sponsor_collaborators:
MorphoSys AG
ICON Clinical Research

location_facility:
MorphoSys Research Site
MorphoSys Research SIte
Morphosys Research site
Morphosys Research Site
MorphoSys

title: A Phase 2/3, Randomised, Multicentre Study of Tafasitamab With Bendamustine Versus Rituximab With Bendamustine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL) Who Are Not Eligible for High-Dose Chemotherapy (HDC) and Autologous Stem-Cell Transplantation (ASCT)

location_country:
Finland
Germany
Poland
New Zealand
Australia
Turkey
Croatia
Czechia
Canada
Serbia
France
Portugal
Hungary
United States
Romania
Italy
United Kingdom
Singapore
Austria
Korea, Republic of
Spain
Taiwan
Israel


title: A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men With Overactive Bladder (OAB) Symptoms While Taking the Alpha Blocker Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)

acronym: PLUS

summary: The purpose of the study was to assess the efficacy, safety, and tolerability of mirabegron versus placebo in men with overactive bladder (OAB) symptoms while taking tamsulosin hydrochloride for lower urinary tract symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH).

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

lead_sponsor: Astellas Pharma Global Development, Inc.

location_country:
Germany
Italy
Poland
United Kingdom
United States
Spain
Czechia
Canada
France

location_facility:
Site DE49003
Site US01075
Site US01069
Site US01068
Site CZ42004
Site PL48001
Site CA15003
Site US01031
Site US01094
Site FR33002
Site US01029
Site US01081
Site CZ42001
Site ES34009
Site GB44004
Site PL48004
Site US01056
Site US01015
Site PL48006
Site ES34003
Site US01042
Site US01070
Site ES34002
Site DE49001
Site US01041
Site US01016
Site GB44006
Site FR33004
Site US01072
Site US01025
Site CA15001
Site IT39005
Site US01026
Site DE49006
Site US01009
Site ES34007
Site US01097
Site ES34001
Site IT39006
Site US01064
Site IT39010
Site US01060
Site US01003
Site IT39002
Site US01019
Site CZ42005
Site CA15002
Site ES34006
Site CA15014
Site US01067
Site CA15005
Site DE49007
Site PL48005
Site ES34004
Site DE49004
Site US01034
Site DE49005
Site CA15011
Site IT39003
Site IT39001
Site CZ42006
Site US01078
Site CA15009
Site US01021
Site IT39008
Site PL48007
Site US01079
Site GB44011
Site US01005
Site DE49002
Site GB44005
Site US01012
Site CA15008
Site US01027
Site IT39004
Site US01061
Site US01063
Site GB44002
Site CZ42003


title: A Phase 1 Dose Escalation and Cohort Expansion Study of ERY974, An Anti-Glypican3 (GPC3)/CD3 Bispecific Antibody, in Patients With Advanced Solid Tumors

summary: This is the open label, multicenter Phase 1 study which consists of a dose escalation to determine the maximum tolerated dose (MTD) and cohort expansion to obtain a preliminary evaluation of anti-tumor activity. ERY974 is intravenously injected to patients with Glypican 3 positive advanced solid tumors until unacceptable toxicity or disease progression.

lead_sponsor: Chugai Pharmaceutical

location_country:
United States
Netherlands
France


title: Multi-center, Randomized, Parallel, Adaptive, Controlled Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System and Control (CSII, MDI and SAP) at Home

summary: The purpose of this study is to evaluate the safety and effectiveness of the Hybrid Closed Loop system (HCL) in adult and pediatric patients with type 1 diabetes in the home setting. A diverse population of patients with type 1 diabetes will be studied. The study population will have a large range for duration of diabetes and glycemic control, as measured by glycosylated hemoglobin (A1C). They will be enrolled in the study regardless of their prior diabetes regimen, including using Multiple Daily Injections (MDI), Continuous Subcutaneous Insulin Infusion (CSII) or Sensor-Augmented Pump therapy (SAP)

lead_sponsor: Medtronic Diabetes

location_country:
Germany
Italy
New Zealand
United Kingdom
Sweden
United States
Spain
Canada
France

location_facility: Texas Children's Hospital / Baylor University

location_facility: Westminster Endocrine & Diabetes Research Society

location_facility: Indiana University Health Riley Hospital for Children

location_facility: University of South Florida Diabetes Center

location_facility: Diabeteszentrum für Kinder und Jugendliche, Kinder- und Jugendkrankenhaus Auf der Bult

location_facility: Dept Internal Medicine, Örebro University Hospital

location_facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

location_facility: Center of Excellence in Diabetes & Endocrinology

location_facility: Diabetes and Glandular Disease Clinic, P.A.


acronym: Next MONARCH 1

lead_sponsor: Eli Lilly and Company

summary: The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancer.

ReferenceCitation: Hamilton E, Cortes J, Ozyilkan O, Chen SC, Petrakova K, Manikhas A, Jerusalem G, Hegg R, Huober J, Zhang W, Chen Y, Martin M. nextMONARCH Phase 2 randomized clinical trial: overall survival analysis of abemaciclib monotherapy or in combination with tamoxifen in patients with endocrine-refractory HR + , HER2- metastatic breast cancer. Breast Cancer Res Treat. 2022 Aug;195(1):55-64. doi: 10.1007/s10549-022-06662-9. Epub 2022 Jul 12.

repository_institution: University of Liège - Open Repository and Bibliography

repositories_concat: PubMed Central;orbi.ulg.ac.be

location_facility: Saint-Petersburg city clinical oncology dispensary

location_facility: Republic Oncology Dispensary of MoH of Republic Tatarstan

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

location_facility: The Center for Cancer and Blood Disorders

location_facility: Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária LTDA

location_facility: St-Petersburg scientifical practical center of specialized kinds of medical care (oncological)

location_facility: University of Wisconsin-Madison Hospital and Health Clinic

title: A Randomized, Open-Label, Phase 2 Study of Abemaciclib Plus Tamoxifen or Abemaciclib Alone, in Women With Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer

location_country:
Germany
Italy
Argentina
Brazil
Austria
Belgium
Mexico
United States
Spain
Turkey
Taiwan
Czechia
Russian Federation
France


title: Phase 3B Open-Label Extension Study to Evaluate the Safety and Efficacy of Aceneuramic Acid Extended-Release (Ace-ER) Tablets in Patients With GNE Myopathy (GNEM) or Hereditary Inclusion Body Myopathy (HIBM)

summary: The objective of this study is to evaluate the long-term safety and efficacy of Ace-ER treatment in subjects with GNEM.

lead_sponsor: Ultragenyx Pharmaceutical Inc

location_country:
France
Italy
United Kingdom
United States
Bulgaria
Canada
Israel

location_facility: Hadassah-Hebrew University Medical Center

location_facility: Washington University School of Medicine, St. Louis

location_facility: Institut de Myologie GH Pitié-Salpêtrière


acronym: EDITION JUNIOR

lead_sponsor: Sanofi

summary:
Primary Objective:

To compare the efficacy of a new formulation of insulin glargine (HOE901-U300) to Lantus in terms of change of HbA1c from baseline to endpoint (month 6) in children and adolescents with type 1 diabetes mellitus.

.

Secondary Objectives:

To compare HOE901-U300 and Lantus in terms of:

Percentage of participants reaching target HbA1c and fasting plasma glucose (FPG).
To assess the safety of HOE901-U300 including analysis of events of hypoglycemia, events of hyperglycemia with ketosis, and development of anti-insulin-antibodies.

ReferenceCitation: Danne T, Tamborlane WV, Malievsky OA, Franco DR, Kawamura T, Demissie M, Niemoeller E, Goyeau H, Wardecki M, Battelino T. Efficacy and Safety of Insulin Glargine 300 Units/mL (Gla-300) Versus Insulin Glargine 100 Units/mL (Gla-100) in Children and Adolescents (6-17 years) With Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial. Diabetes Care. 2020 Jul;43(7):1512-1519. doi: 10.2337/dc19-1926. Epub 2020 May 19.

license: unspecified-oa

license_normalized: unspecified-oa

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: American Diabetes Association

location_facility:
Investigational Site Number 0320006
Investigational Site Number 3800006
Investigational Site Number 4280002
Investigational Site Number 8400008
Investigational Site Number 2080001
Investigational Site Number 2760003
Investigational Site Number 8400030
Investigational Site Number 0320002
Investigational Site Number 6420004
Investigational Site Number 3800005
Investigational Site Number 4840005
Investigational Site Number 6430002
Investigational Site Number 6430004
Investigational Site Number 7240003
Investigational Site Number 6160001
Investigational Site Number 8400032
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title: 6-Month, Multicenter, Randomized, Open-label, 2-Arm, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Injected Once Daily in Children and Adolescents Age 6 - 17 Years With Type 1 Diabetes Mellitus With a 6-month Safety Extension Period

location_country:
Germany
Poland
Argentina
Japan
Brazil
Chile
Czechia
Canada
Serbia
France
Hungary
Denmark
United States
Latvia
North Macedonia
Romania
Italy
United Kingdom
Sweden
Mexico
Spain
Bulgaria
Russian Federation
Israel


title: A Phase I/II, Multi-center, Randomized, Placebo-Controlled, Study Designed to Assess the Safety, Tolerability, and Pharmacokinetics of PTI-428 in Subjects With Cystic Fibrosis

summary: This trial will consist of three arms: Part A, Part B, and Part C. Part A has two groups. The first group will enroll adult subjects with cystic fibrosis (CF) into a single ascending dose (SAD) treatment group. The second group will enroll adult subjects with CF, including those on background treatment with ORKAMBI® and those not on a cystic fibrosis transmembrane conductance regulator (CFTR) modulator, into a multiple ascending dose (MAD) treatment group. Part B will enroll adult subjects with CF currently on stable ORKAMBI® background therapy for a minimum of 3 months into a Phase II treatment group consisting of two cohorts. Part C will enroll adult subjects with CF, including those on background treatment with KALYDECO® and those not on a CFTR modulator, into a Phase II treatment group consisting of three cohorts. Approximately 136 subjects will be enrolled.

lead_sponsor: Proteostasis Therapeutics, Inc.

location_country:
Germany
Denmark
United States
Canada
France

location_facility: St. Luke's Cystic Fibrosis Center of Idaho

location_facility: University of Florida College of Medicine

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: Universitaetsklinikum Frankfurt-Zentrum der Inneren Medizin

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Groupe Hospitalier Pellegrin - Hôpital des Enfants

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

location_facility: Northwestern University Memorial Hospital

location_facility: St. Paul's Hospital Pacific Lung Research Center

location_facility: University of Oklahoma Health Sciences Center

location_facility: Institut de Recherches Cliniques de Montreal


title: Prospective Registry on User Experience With The Mapping System For Ablation Procedures

acronym: TRUE-HD

summary: This is an observational, prospective, non-randomized, multicenter, post approval study being conducted in the United States, Europe and Asia-Pacific Regions.

lead_sponsor: Boston Scientific Corporation

location_country:
Germany
United Kingdom
Hong Kong
Australia
Netherlands
United States
Spain
France

location_facility: Strong Memorial Hospital of the University of Rochester


title: A Phase 3, Randomized, Active Controlled Study to Evaluate Maintenance of Response, Safety and Patient Reported Outcomes in Acromegaly Patients Treated With Octreotide Capsules vs. Parenteral Somatostatin Receptor Ligands

acronym: MPOWERED

summary:
Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial (OPTMAL; NCT03252353), oral octreotide capsules demonstrated sustained biochemical response up to 13 months in patients with acromegaly previously managed with somatostatin analog injections (ref).

The objective of this study was to compare the efficacy, safety, and patient reported outcomes (PROs) between oral octreotide capsules and injectable somatostatin receptor ligands (SRLs).

ReferenceCitation: Melmed S, Popovic V, Bidlingmaier M, Mercado M, van der Lely AJ, Biermasz N, Bolanowski M, Coculescu M, Schopohl J, Racz K, Glaser B, Goth M, Greenman Y, Trainer P, Mezosi E, Shimon I, Giustina A, Korbonits M, Bronstein MD, Kleinberg D, Teichman S, Gliko-Kabir I, Mamluk R, Haviv A, Strasburger C. Safety and efficacy of oral octreotide in acromegaly: results of a multicenter phase III trial. J Clin Endocrinol Metab. 2015 Apr;100(4):1699-708. doi: 10.1210/jc.2014-4113. Epub 2015 Feb 9. Erratum In: J Clin Endocrinol Metab. 2016 Oct;101(10 ):3863. J Clin Endocrinol Metab. 2020 Dec 1;105(12):

ReferenceCitation: Melmed S. New therapeutic agents for acromegaly. Nat Rev Endocrinol. 2016 Feb;12(2):90-8. doi: 10.1038/nrendo.2015.196. Epub 2015 Nov 27.

ReferenceCitation: Fleseriu M, Dreval A, Bondar I, Vagapova G, Macut D, Pokramovich YG, Molitch ME, Leonova N, Raverot G, Grineva E, Poteshkin YE, Gilgun-Sherki Y, Ludlam WH, Patou G, Haviv A, Gordon MB, Biermasz NR, Melmed S, Strasburger CJ. Maintenance of response to oral octreotide compared with injectable somatostatin receptor ligands in patients with acromegaly: a phase 3, multicentre, randomised controlled trial. Lancet Diabetes Endocrinol. 2022 Feb;10(2):102-111. doi: 10.1016/S2213-8587(21)00296-5. Epub 2021 Dec 22. Erratum In: Lancet Diabetes Endocrinol. 2022 Mar;10(3):e3.

repository_institution: Leiden University - Leiden Repository

lead_sponsor: Chiasma, Inc.

location_country:
Germany
Italy
Lithuania
Poland
Hungary
United Kingdom
Romania
Austria
United States
Spain
Serbia
Russian Federation
France

location_facility: Novosibirsk State Regional Clinical Hospital

location_facility: Clinical Centre of Serbia, Clinic for Endocrinology Diabetes and Metabolic Diseases

location_facility: John H. Stroger, Jr. Hospital of Cook County

location_facility: Universitätsklinik für Innere Medizin Klinische Abteilung für Endokrinologie und Diabetologie

location_facility: Università di Pisa Dipartimento di Medicina Clinica e Sperimentale

location_facility: University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital

location_facility: Federal State Budgetary Institution "V. A. Almazov Federal North-West Medical Research Centre" of the Ministry of Health of the Russian Federation

location_facility: Central Manchester University Hospitals NHS Foundation Trust, Manchester Royal Infirmary

location_facility: Regional State Budgetary Healthcare Institution Regional State Hospital

location_facility: Antrium Multidisciplinary Medical Clinic

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu, Klinika Endokrynologii, Diabetologii i Leczenia Izotopami

location_facility: The Ohio State University Wexner Medical Center

location_facility: Katedra i Klinika Endokrynologii i Chorob Wewnetrznych Gdanski Uniwersytet Medyczny

location_facility: Praxis für Endokrinologie und Diabetologie Dr M Droste

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: Fondazione Policlinico Universitario A. Gemelli Università Cattolica del S.Cuore S.C. Endocrinologia e Malattie del Metabolismo

location_facility: Campus Del Hospital Universitario Virgen del Rocio

location_facility: Washington University School of Medicine

location_facility: Szegedi Tudományegyetem, I. Belgyógyászati Klinika

location_facility: Sechenov Moscow First State Medical University

location_facility: Keck Medical Center of University of Southern California

location_facility: Vladimirsky Moscow Regional Research Clinical Institute

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Rutgers - Robert Wood Johnson Medical School

location_facility: "C.I. Parhon" National Institute of Endocrinology I Clinical Endocrinology Department - Endemic goitier and its complications

location_facility: Policlinico di Monserrato U.O.C. Endocrinologia e Diabetologia

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Interregional Clinical Diagnostic Center