title: A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL)

lead_sponsor: Kite, A Gilead Company

ReferenceCitation: Ghione P, Palomba ML, Patel AR, Bobillo S, Deighton K, Jacobson CA, Nahas M, Hatswell AJ, Jung AS, Kanters S, Snider JT, Neelapu SS, Ribeiro MT, Brookhart MA, Ghesquieres H, Radford J, Gribben JG. Comparative effectiveness of ZUMA-5 (axi-cel) vs SCHOLAR-5 external control in relapsed/refractory follicular lymphoma. Blood. 2022 Aug 25;140(8):851-860. doi: 10.1182/blood.2021014375.

ReferenceCitation: Jacobson CA, Chavez JC, Sehgal AR, William BM, Munoz J, Salles G, Munshi PN, Casulo C, Maloney DG, de Vos S, Reshef R, Leslie LA, Yakoub-Agha I, Oluwole OO, Fung HCH, Rosenblatt J, Rossi JM, Goyal L, Plaks V, Yang Y, Vezan R, Avanzi MP, Neelapu SS. Axicabtagene ciloleucel in relapsed or refractory indolent non-Hodgkin lymphoma (ZUMA-5): a single-arm, multicentre, phase 2 trial. Lancet Oncol. 2022 Jan;23(1):91-103. doi: 10.1016/S1470-2045(21)00591-X. Epub 2021 Dec 8.

location_country:
United States
France

location_facility: Hackensack University Medical Center - John Theurer Cancer Center

location_facility: University of Miami Hospital and Clinics

location_facility: University of Rochester Medical Center (URMC)

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: Georgetown Lombardi Comprehensive Cancer Center

summary: This study will enroll approximately 160 adult subjects who have relapsed or refractory (r/r) iNHL to be infused with the study treatment, axicabtagene ciloleucel, to see if their disease responds to this experimental product and if this product is safe. Axicabtagene ciloleucel is made from the subjects own white blood cells which are genetically modified and grown to fight cancer. An objective response rate of 70% is targeted.


title: A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared With Investigator Choice in HLA-A*0201 Positive Patients With Previously Untreated Advanced Uveal Melanoma

summary: To evaluate the overall survival of HLA-A*0201 positive adult patients with previously untreated advanced UM receiving IMCgp100 compared to Investigator's Choice of dacarbazine, ipilimumab, or pembrolizumab.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Nathan P, Hassel JC, Rutkowski P, Baurain JF, Butler MO, Schlaak M, Sullivan RJ, Ochsenreither S, Dummer R, Kirkwood JM, Joshua AM, Sacco JJ, Shoushtari AN, Orloff M, Piulats JM, Milhem M, Salama AKS, Curti B, Demidov L, Gastaud L, Mauch C, Yushak M, Carvajal RD, Hamid O, Abdullah SE, Holland C, Goodall H, Piperno-Neumann S; IMCgp100-202 Investigators. Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma. N Engl J Med. 2021 Sep 23;385(13):1196-1206. doi: 10.1056/NEJMoa2103485.

lead_sponsor: Immunocore Ltd

location_country:
Poland
Spain
Italy
Russian Federation
Australia
Netherlands
Canada
United Kingdom
Switzerland
Ukraine
United States
France
Belgium
Germany

location_facility: The Angeles Clinic and Research Institute

location_facility: Central Adelaide Local Health Network, Royal Adelaide Hospital Cancer Center

location_facility: Hospital Universitario General de Valencia

location_facility: Washington University School of Medicine

location_facility: Institut Roi Albert II Cliniques Universitaires St-Luc

location_facility: Institut Catala d'Oncologia (ICO) - L'Hospitalet

location_facility: Nationales Centrum für Tumorerkrankungen

location_facility: Klinik und Poliklinik für Dermatologie und Allergologie

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: University of Miami - Sylvester Comprehensive Cancer Center

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

location_facility: Byers Eye Institute, Stanford University

location_facility: Federal State Budgetary Institution N.N. Blokhin National Medical Research Center of Oncology

location_facility: Federal State Budget Institution National Medical Research Center of Oncology

location_facility: Istituto Nazionale Tumori - IRCCS Fondazione "G. Pascale" - UOC Melanoma, Immunoterapia Oncologica e Terapie Innovative

location_facility: Universitaetsklinikum Koeln Dermatologie und Venerologie

location_facility: Winship Cancer Institute of Emory University

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Multicenter Phase 1/2, Open-Label Study of DCC-3014 to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor

summary: This is a multicenter, open-label Phase 1/2 study of DCC-3014 in patients with malignant solid tumors and tenosynovial giant cell tumor (TGCT). There will be 2 distinct parts in this study: Dose Escalation (Phase 1) and Expansion (Phase 2). Phase 1 will enroll both malignant solid tumor and TGCT patients. Phase 2 will comprise two cohorts (Cohort A and Cohort B) and will only enroll TGCT patients.

status: Recruiting

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Deciphera Pharmaceuticals LLC

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

location_facility: Hospital Universitario Virgen del Rocío, Sevilla

location_facility: Fondazione IRCCS Istituto Nazionale Dei Tumori

location_facility: M. Sklodowska-Curie Memorial Cancer Center

location_facility: Gustave Roussy Cancer Campus Grand Paris

intervention_type: Drug


status: Completed

acronym: EASE

title: Double Blind, Randomised, Vehicle Controlled, Phase III, Efficacy and Safety Study With 24-month Open-label Follow up of Oleogel-S10 in Patients With Inherited Epidermolysis Bullosa

study_completion_date_type: Actual

lead_sponsor: Amryt Research Limited

type: EudraCT Number

source: euctr

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Czechia
Hong Kong
Austria
Australia
Russian Federation
Argentina
Israel
Singapore
Brazil
Switzerland
Hungary
Germany
Denmark
Greece
Georgia
Ireland
France
Chile
Colombia

location_facility: National Children Specialized Hospital "Ohmatdyt" of Ministry of Health of Ukraine

location_facility: S/R National Center of Dermatology and Venerology

location_facility: Istituto Dermopatico dell'Immacolata IDI-IRCCS

location_facility: Kandang Kerbau (KK) Women's and Children's Hospital

location_facility: Semmelweis University, Faculty of Medicine

location_facility: University of Belgrade, School of Medicine

location_facility: Kinder- und Jugendkrankenhaus AUF DER BULT

location_facility: State Scientific Center for Dermatovenerology and Cosmetology

location_facility: Murdoch Childrens Research Institute Royal Children's Hospital

location_facility: Consutorios Medicos (Instituto de Neumonologia y Dermatologia)

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Hospital of Skin and Veneral Diseases "A. Syggros"

location_facility: Hospital Universitari de la Vall d'Hebron

location_facility: Birmingham Children's Hospital NHS Trust

location_facility: Centro de investigaciones Metabolicas, CINME

location_facility: Prince of Wales Hospital, The Chinese University of Hong Kong

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: University Hospital Brno, Children´s Hospital

summary:
This is a Phase III, Efficacy and Safety Study of Oleogel-S10 in Participants with Inherited Epidermolysis Bullosa (EB).

EB is a rare group of genetic skin fragility disorders characterised by blistering of the skin in response to minor injury. In most cases, onset of EB is at birth or shortly after. All participants affected by any type of EB share the main characteristic of repeatedly developing painful wounds that take days to months to heal. Current treatment of EB is primarily preventative and supportive including protection from mechanical forces by avoiding rubbing, early treatment of wounds to prevent infections, and protection of the wound with adequate non-adhesive dressings to enable healing.

Oleogel-S10 was authorised in 2016 in the European Union for treatment of partial thickness wounds in adults under the brand name Episalvan®. The active pharmaceutical ingredient in Oleogel-S10 is a refined birch bark extract, quantified to 72 to 88% betulin.

This clinical study of Oleogel-S10 in patients with inherited EB has been initiated to investigate whether Oleogel-S10 is effective for treatment of EB wounds and safe in the long term use.

Oleogel-S10 will be compared to a control gel. The control gel is an identical looking sunflower oil gel that does not contain any active substance. The participant will receive either Oleogel-S10 or control gel for a double-blind study phase of 90 days. The probability that the participant will receive Oleogel-S10 is 50%, which means that they have a 1 in 2 chance of receiving Oleogel-S10. However, in the follow-up phase of the study all participants will be treated with Oleogel S10 for a period of 24 months.

This clinical study will be performed in several countries; in total, about 250 participants are expected to participate.

status_simplified: Completed


title: Phase Ib, Multicenter, Open Label Study of PDR001 in Combination With Platinum Doublet Chemotherapy and Other Immunooncology Agents in PD-L1 Unselected, Metastatic NSCLS Patients (ElevatION:NSCLC-101 Trial)

summary: The primary purpose of this study is to establish the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of PDR001 when administered in combination with platinum-doublet chemotherapy and other immunooncology agent(s) in treatment naive patients with PD-L1 unselected, advanced NSCLC, and to estimate the preliminary anti-tumor activity in this patient population.

status: Terminated

design_allocation: Non-Randomized

lead_sponsor: Novartis Pharmaceuticals

location_country:
Hong Kong
Spain
Italy
Netherlands
Canada
Korea, Republic of
France
United States
Singapore
Belgium
Germany
Czechia

location_facility: UCLA Santa Monica Hematology / Oncology SC-2

location_facility: Washington University School of Medicine SC

status_simplified: Unknown


title: A Post-approval Study of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

acronym: ONYX PAS

summary: To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Medtronic Vascular

location_country:
United States
France
Slovakia
Belgium

location_facility: Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz

location_facility: Columbia University Medical Center/NewYork Presbyterian Hospital

location_facility: Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s

location_facility: Ziekenhuis Oost Limburg - Campus Sint-Jan

location_facility: University Hospitals Cleveland Medical Center

location_facility: University of Michigan Health System - University Hospital

intervention_type: Device


title: Evaluation of Ablation Index and VISITAG™ Use for Pulmonary Vein Isolation (PVI) in Patients With Paroxysmal Atrial Fibrillation (PAF)

acronym: VISTAX

summary: The purpose of this study is to assess the safety, acute and long term effectiveness, during standard RF ablation procedures while using Ablation Index and VISITAG™ software in combination with a Thermocool SmartTouch® (ST) or SmartTouch Surroundflow® (STSF) catheter. Furthermore, the role of Ablation Index and VISITAG™ workflow in creating contiguous ablation lines is assessed. The study is a prospective, non-randomized, post-market clinical evaluation. Up to 330 patients will be included in this study. All patients who qualify based on the study specific requirements will be invited to participate. The total duration of the study is estimated to be about 24 months (12 months enrollment period and 12 months of follow up). The clinical investigation population include subjects undergoing RF ablation for treatment of drug resistant symptomatic paroxysmal AF. Prior to enrollment in the clinical investigation, all subjects must meet the inclusion/exclusion criteria and are suitable candidates for enrollment in a clinical investigation in the opinion of the investigator. Subjects must have failed at least one antiarrhythmic drug (AAD) (Type I or III, including β-blocker) as evidenced by recurrent or are intolerant of the AAD.

ReferenceCitation: Gupta D, Vijgen J, Potter T, Scherr D, Van Herendael H, Knecht S, Kobza R, Berte B, Sandgaard N, Albenque JP, Széplaki G, Stevenhagen Y, Taghji P, Wright M, Duytschaever M. Quality of life and healthcare utilisation improvements after atrial fibrillation ablation. Heart. 2021 Aug;107(16):1296-1302. doi: 10.1136/heartjnl-2020-318676. Epub 2021 May 5.

ReferenceCitation: Duytschaever M, Vijgen J, De Potter T, Scherr D, Van Herendael H, Knecht S, Kobza R, Berte B, Sandgaard N, Albenque JP, Szeplaki G, Stevenhagen YJ, Taghji P, Wright M, Macours N, Gupta D. Standardized pulmonary vein isolation workflow to enclose veins with contiguous lesions: the multicentre VISTAX trial. Europace. 2020 Nov 1;22(11):1645-1652. doi: 10.1093/europace/euaa157.

ipd_sharing: Yes

lead_sponsor: Biosense Webster, Inc.

location_country:
Denmark
United Kingdom
Ireland
Austria
Italy
Switzerland
France
Belgium
Netherlands

location_facility:
Clinique Clairval Marseille
Jessa Ziekenhuis
Medisch Spectrum Twente
Liverpool Heart and Chest Hospital
Ospedaliera Universitaria Pisana
ZOL Genk
Odense University Hospital
Policlinico Caisilino Roma
St. Thomas' Hospital
OLV Aalst
Herzzentrum, Luzerner Kantonsspital
AZ Sint-Jan
Gentofte Hospital
LKH Univ. Klinikum Graz
Clinique Pasteur
Aarhus Universitetshospital Skejby
Mater Private Heart & Vascular Centre


title: Phase 2 Study of Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib in Patients With Untreated Extensive-Stage Small Cell Lung Cancer (SCLC)

lead_sponsor: G1 Therapeutics, Inc.

ReferenceType: background

ReferenceCitation: Daniel D, Kuchava V, Bondarenko I, Ivashchuk O, Reddy S, Jaal J, Kudaba I, Hart L, Matitashvili A, Pritchett Y, Morris SR, Sorrentino JA, Antal JM, Goldschmidt J. Trilaciclib prior to chemotherapy and atezolizumab in patients with newly diagnosed extensive-stage small cell lung cancer: A multicentre, randomised, double-blind, placebo-controlled Phase II trial. Int J Cancer. 2020 Dec 21. doi: 10.1002/ijc.33453. [Epub ahead of print]

ReferenceCitation: Weiss J, Goldschmidt J, Andric Z, Dragnev KH, Gwaltney C, Skaltsa K, Pritchett Y, Antal JM, Morris SR, Daniel D. Effects of Trilaciclib on Chemotherapy-Induced Myelosuppression and Patient-Reported Outcomes in Patients with Extensive-Stage Small Cell Lung Cancer: Pooled Results from Three Phase II Randomized, Double-Blind, Placebo-Controlled Studies. Clin Lung Cancer. 2021 Sep;22(5):449-460. doi: 10.1016/j.cllc.2021.03.010. Epub 2021 Mar 26.

ReferenceCitation: Abraham I, Onyekwere U, Deniz B, Moran D, Chioda M, MacDonald K, Huang H. Trilaciclib and the economic value of multilineage myeloprotection from chemotherapy-induced myelosuppression among patients with extensive-stage small cell lung cancer treated with first-line chemotherapy. J Med Econ. 2021 Nov;24(sup1):71-83. doi: 10.1080/13696998.2021.2014163.

ReferenceCitation: Zeng R, Liu F, Fang C, Yang J, Luo L, Yue P, Gao B, Dong Y, Xiang Y. PIV and PILE Score at Baseline Predict Clinical Outcome of Anti-PD-1/PD-L1 Inhibitor Combined With Chemotherapy in Extensive-Stage Small Cell Lung Cancer Patients. Front Immunol. 2021 Oct 29;12:724443. doi: 10.3389/fimmu.2021.724443. eCollection 2021.

ReferenceCitation: Hussein M, Maglakelidze M, Richards DA, Sabatini M, Gersten TA, Lerro K, Sinielnikov I, Spira A, Pritchett Y, Antal JM, Malik R, Beck JT. Myeloprotective Effects of Trilaciclib Among Patients with Small Cell Lung Cancer at Increased Risk of Chemotherapy-Induced Myelosuppression: Pooled Results from Three Phase 2, Randomized, Double-Blind, Placebo-Controlled Studies. Cancer Manag Res. 2021 Aug 9;13:6207-6218. doi: 10.2147/CMAR.S313045. eCollection 2021.

ReferenceCitation: Ferrarotto R, Anderson I, Medgyasszay B, García-Campelo MR, Edenfield W, Feinstein TM, Johnson JM, Kalmadi S, Lammers PE, Sanchez-Hernandez A, Pritchett Y, Morris SR, Malik RK, Csőszi T. Trilaciclib prior to chemotherapy reduces the usage of supportive care interventions for chemotherapy-induced myelosuppression in patients with small cell lung cancer: Pooled analysis of three randomized phase 2 trials. Cancer Med. 2021 Sep;10(17):5748-5756. doi: 10.1002/cam4.4089. Epub 2021 Aug 18.

location_country:
Spain
Latvia
Estonia
Ukraine
United States
France
Bulgaria

location_facility: H.U. Quirón Dexeus, Hospital Universitario

location_facility: Oklahoma University - Peggy and Charles Stephenson Cancer Center

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Dnipropetrovsk City Multispecialty Clinical Hospital #4

location_facility: UCLA Medical Center - Santa Monica Hematology And Oncology

location_facility: H. Donostia, Hospital Donostia- Servicio de Oncología

location_facility: Daugavpils Regional Hospital, Department of Oncology

location_facility: Redwood Regional Medical Group (RRMG) - Fountain Grove

location_facility: Hospital Universitario Ntra. Sra. de Valme

location_facility: Chernivtsi Regional Clinical Oncology Center

location_facility: The Alvin J. Siteman Cancer Center - Center for Advanced Med

location_facility: Pauls Stradiņš Clinical University Hospital, Oncology Clinic

location_facility: Lviv State Regional Treatment and Diagnostics Oncology Center

location_facility: St. Louis Cancer Care, LLP, North County

location_facility: East Tallinn Central Hospital Ltd., Clinic of Internal Medicine, Center for Oncology

location_facility: Northside Hospital - Georgia Cancer Specialists

location_facility: Multiprofile Hospital for Active Treatment "Serdika", Sofia

location_facility: Hospital Clinic de Barcelona- Servicio de Oncología Médica

location_facility: Trinity Health - Trinity CancerCare Center

summary:
This was a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing antitumor efficacy when administered with carboplatin, etoposide, and atezolizumab (E/P/A) therapy in first line treatment for patients with newly diagnosed extensive-stage SCLC.

The study was a randomized, double-blinded, placebo-controlled design. Approximately, 100 patients were randomized to trilaciclib + E/P/A or placebo + E/P/A in the study.


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.

lead_sponsor: Medtronic Endovascular

location_country:
United Kingdom
Italy
Ireland
United States
France
Germany

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

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

location_facility: Assistance Publique - Hôpitaux de Marseille - Hôpital Nord

location_facility: Galway University Hospitals - University Hospital Galway


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.

lead_sponsor: Zimmer Biomet

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

location_facility: Harrogate and District NHS Foundation Trust

location_facility: Henry County Orthopedics and Sports Medicine

location_facility: Avon Orthopaedic Centre, Southmead Hospital


intervention_type: Other

acronym: JZP-258 Efficacy Study

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

lead_sponsor: Jazz Pharmaceuticals

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.

ReferenceCitation: Bogan RK, Thorpy MJ, Dauvilliers Y, Partinen M, Del Rio Villegas R, Foldvary-Schaefer N, Skowronski R, Tang L, Skobieranda F, Šonka 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). pii: zsaa206. doi: 10.1093/sleep/zsaa206. Erratum in: Sleep. 2021 Jul 9;44(7):. Sleep. 2021 Nov 12;44(11):.

location_country:
Spain
Finland
France
United States
Belgium
Czechia

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Hospital Vithas Nuestra Señora de America

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


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.

time_perspective: Other

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. Review.

ReferenceCitation: Ye X, Guilmatre A, Reva B, Peter I, Heuzé 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.

ReferenceCitation: Heuzé 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.

ReferenceCitation: Heuzé 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: Heuzé Y, Martínez-Abadías N, Stella JM, Arnaud E, Collet C, García 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, Heuzé 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, Heuzé 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: Heuzé Y, Martínez-Abadías 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: Martínez-Abadías N, Heuzé 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: Heuzé 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: 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). pii: dev154856. doi: 10.1242/dev.154856.

ReferenceCitation: Heuzé 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.

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: 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). pii: 1750073. doi: 10.1142/S0219519417500737. Epub 2017 May 29.

ReferenceCitation: Lesciotto KM, Heuzé 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. Review.

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). pii: 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. pii: e44278. doi: 10.7554/eLife.44278.

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, García-Fructuoso G, Fernández-Rodriguez I, Heuzé 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.

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 67:27-46. 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). pii: E31. 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). pii: dev166488. doi: 10.1242/dev.166488.

ReferenceCitation: Martínez-Abadías 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. pii: e36405. doi: 10.7554/eLife.36405.

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. Review.

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: 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: 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.

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.

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.

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.

lead_sponsor: Icahn School of Medicine at Mount Sinai

location_country:
United Kingdom
Spain
United States
France
Germany

location_facility: Pennsylvania State Milton S. Hershey Medical Center

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

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


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)

lead_sponsor: Amgen

ReferenceCitation: Katz DA, Morris JD, Chu MP, David KA, Thieblemont C, Morley NJ, Khan SS, Viardot A, Martín García-Sancho A, Rodríguez-García G, Bastos-Oreiro M, Lee ST, Kormany W, Chen Y, Wong HL, Anderson AA, Katlinskaya Y, Avilion AA, Dai T, González-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.

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:
Spain
United Kingdom
Canada
United States
France
Germany

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


title: Setmelanotide (RM-493) Phase 2 Treatment Trial in Patients With Rare Genetic Disorders of Obesity

summary: The purpose of the study is to determine the effect of setmelanotide (RM-493) on weight, hunger assessments and other factors in patients with rare genetic disorders of obesity.

ReferenceCitation: Meyer JR, Krentz AD, Berg RL, Richardson JG, Pomeroy J, Hebbring SJ, Haws RM. Kidney failure in Bardet-Biedl syndrome. Clin Genet. 2022 Apr;101(4):429-441. doi: 10.1111/cge.14119.

lead_sponsor: Rhythm Pharmaceuticals, Inc.

location_country:
Spain
Greece
United Kingdom
Netherlands
Canada
United States
France
Israel
Germany

location_facility: Precision Medicine for Obesity Research: Gastroenterology & Hepatology Mayo Clinic

location_facility: Synexus Clinical Research US, Inc. - Phoenix Southeast

location_facility: Anschutz Health and Wellness Center University of Colorado Anschutz Medical Campus

location_facility: Service de pédiatrie CHU de la Réunion - Hôpital Félix Guyon

location_facility: Synexus Clinical Research US, Inc. - San Antonio

location_facility: Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC

location_facility: University of Florida College of Medicine

location_facility: Synexus Clinical Research US, Inc. - Plano

location_facility: Synexus Clinical Research US, Inc. - St. Petersburg

location_facility: Division of Endocrinology and Diabetes Children's National Hospital

location_facility: Synexus Clinical Research US, Inc. - Simon Williamson Clinic, PC

location_facility: Synexus Clinical Research US, Inc. - Cincinnati

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: Synexus Clinical Research US, Inc. - Chicago

location_facility: Edmond and Lily Safra Children's Hospital

location_facility: Vanderbilt University School of Medicine

location_facility: Hopital Trousseau - Nutrition et Gastroentérologie

location_facility: Synexus Clinical Research US, Inc. - Columbus

location_facility: Synexus Clinical Research US, Inc. - Akron

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Synexus Clinical Research US, Inc. - Primary Care Associates, PC


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)).

lead_sponsor: Genentech, Inc.

location_country:
United Kingdom
Spain
Canada
United States
France

location_facility: Hospital Clinico Universitario de Valencia


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

lead_sponsor: Shire

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:
Poland
Spain
Italy
Austria
Australia
Estonia
Canada
United Kingdom
Hungary
United States
France
India
Israel
Peru
South Africa
Germany

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: The Regents of the University of Michigan

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

location_facility: The Eye Center at Southern College of Optometry

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: MediSphere Medical Research Center, an AMR affiliate

location_facility: Klinisches Studienzentrum der Augenklinik

location_facility: Pretoria Eye Institute Research Foundation

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

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

location_facility: Emerson Clinical Research Institute, LLC

location_facility: University of the Sunshine Coast Clinical Trials Centre

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Hospital Universitari de Girona Dr Josep Trueta

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

location_facility: Centrum Diagnostyki i Mikrochirurgii Oka LENS

location_facility: M. S. Ramaiah Medical College and Hospital

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

location_facility: ICARE Eye Hospital and Post Graduate Institute

location_facility: University of Waterloo School of Optometry and Vision Science

location_facility: Complejo Asistencial Universitario de Burgos

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

location_facility: Centrum Medyczne Uno-Med (Private Practice)

location_facility: Nelson R Mandela School of Medicine Ophthalmology Department

location_facility: Vienna Institute for Research in Ocular Surgery

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.


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

lead_sponsor: Gilead Sciences

publications_result: 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.

ReferenceType: result

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_facility: Southern Therapy and Advanced Research LLC

location_facility: University of Washington/ Harborview Medical Center

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: Hospital of the University of Pennsylvania

location_facility: Northwestern Memorial Hospital; Clinical Research Unit

location_facility: Intermountain Liver Disease and Transplant Center

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.


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis

summary: This is a multicenter, Phase 3 randomized, placebo-controlled study designed to evaluate adalimumab in children 4 to 17 years old with polyarticular juvenile idiopathic arthritis (JIA) who are either methotrexate (MTX) treated or non-MTX treated.

ReferenceCitation: Horneff G, Seyger MMB, Arikan D, Kalabic J, Anderson JK, Lazar A, Williams DA, Wang C, Tarzynski-Potempa R, Hyams JS. Safety of Adalimumab in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, Psoriasis, and Crohn's Disease. J Pediatr. 2018 Oct;201:166-175.e3. doi: 10.1016/j.jpeds.2018.05.042. Epub 2018 Jul 25.

ReferenceCitation: Lovell DJ, Ruperto N, Goodman S, Reiff A, Jung L, Jarosova K, Nemcova D, Mouy R, Sandborg C, Bohnsack J, Elewaut D, Foeldvari I, Gerloni V, Rovensky J, Minden K, Vehe RK, Weiner LW, Horneff G, Huppertz HI, Olson NY, Medich JR, Carcereri-De-Prati R, McIlraith MJ, Giannini EH, Martini A; Pediatric Rheumatology Collaborative Study Group; Pediatric Rheumatology International Trials Organisation. Adalimumab with or without methotrexate in juvenile rheumatoid arthritis. N Engl J Med. 2008 Aug 21;359(8):810-20. doi: 10.1056/NEJMoa0706290.

lead_sponsor: Abbott

location_country:
Spain
Italy
Czech Republic
France
United States
Belgium
Germany
Slovakia

location_facility:
Site Reference ID/Investigator# 45545
Site Reference ID/Investigator# 638
Site Reference ID/Investigator# 640
Site Reference ID/Investigator# 625
Site Ref # / Investigator 45543
Site Reference ID/Investigator# 519
Site Reference ID/Investigator# 2501
Site Reference ID/Investigator# 406
Site Reference ID/Investigator# 3425
Site Ref # / Investigator 45523
Site Reference ID/Investigator# 516
Site Reference ID/Investigator# 631
Site Reference ID/Investigator# 644
Site Ref # / Investigator 45524
Site Reference ID/Investigator# 636
Site Reference ID/Investigator# 628
Site Reference ID/Investigator# 518
Site Reference ID/Investigator# 622
Site Reference ID/Investigator# 2235
Site Reference ID/Investigator# 641
Site Reference ID/Investigator# 642
Site Reference ID/Investigator# 3713
Site Reference ID/Investigator# 386
Site Ref # / Investigator 45522
Site Ref # / Investigator 45542
Site Reference ID/Investigator# 645
Site Reference ID/Investigator# 2538
Site Reference ID/Investigator# 627
Site Ref # / Investigator 45544
Site Reference ID/Investigator# 621
Site Ref # / Investigator 45525


title: A Randomized, Double-blind Study Comparing the Effect of Different Treatment Regimens of Intravenous Bonviva on Lumbar Bone Mineral Density in Women With Osteoporosis

summary: This study will assess the efficacy and safety of intravenous administration of Bonviva regimens in women with post-menopausal osteoporosis, compared to oral daily administration. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

ReferenceCitation: Bianchi G, Czerwinski E, Kenwright A, Burdeska A, Recker RR, Felsenberg D. Long-term administration of quarterly IV ibandronate is effective and well tolerated in postmenopausal osteoporosis: 5-year data from the DIVA study long-term extension. Osteoporos Int. 2012 Jun;23(6):1769-78. doi: 10.1007/s00198-011-1793-9.

lead_sponsor: Hoffmann-La Roche

location_country:
Denmark
Poland
Spain
Italy
United Kingdom
Australia
Mexico
Canada
Czech Republic
Hungary
United States
France
South Africa
Belgium
Norway
Germany


title: Randomized, Double-blind, Double Dummy, Parallel Groups, Multicenter Study to Compare the Efficacy and Safety of Monthly Oral Administration of 100 mg and 150 mg Ibandronate With 2.5 mg Daily Oral Ibandronate in Postmenopausal Osteoporosis

summary: This study will compare the efficacy and safety of different treatment regimens of oral Bonviva tablets in women with post-menopausal osteoporosis. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

location_country:
Denmark
Poland
Brazil
Romania
Spain
Italy
United Kingdom
Australia
Mexico
Canada
Switzerland
Hungary
United States
France
South Africa
Belgium
Norway
Germany
Czechia

intervention_type: Dietary Supplement


title: A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic / Pharmacodynamic Effects of a Targeted Exposure of Intravenous Repinotan in Patients With Acute Ischemic Stroke

summary: The purpose of this trial is to evaluate Repinotan HCl in patients with acute ischemic stroke. At study entry patients will be randomized to Repinotan HCl or placebo in a 1:1 ratio. The total treatment period wil be 72 hours.

lead_sponsor: Bayer

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


title: An Uncontrolled Phase II, Multi Center Trial Evaluating Antitumor Efficacy and Safety of Bay 59-8862 in Patients With Advanced Renal Cell Carcinoma

summary: In patients with renal cell cancer, most frequent methods of treatment include surgery, chemotherapy, hormonal therapy, and immunotherapy. Renal cell carcinoma is usually considered to be radioresistant and chemoresistant. In patients with metastatic disease, the options are limited. The taxanes are among the most commonly used class of chemotherapy agents in clinical oncology today but they are not effective in renal cancers; the development of Bay 59-8862 targets taxane-resistant tumors and the current protocol is designed to test the safety and efficacy of Bay 59-8862 in patients with advanced renal cell carcinoma.

location_country:
United Kingdom
Netherlands
Canada
United States
France
Germany


title: Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia in Recurrent or Refractory Non-Burkitt's, Non-Hodgkin's Lymphoma (NHL) or Hodgkin's Disease Receiving DHAP (Dexamethasone, High-Dose Cytarabine and Cisplatin) Chemotherapy

summary: Intensive chemotherapy is associated with significant thrombocytopenia, often requiring platelet transfusion to maintain platelet counts. This investigational drug has been demonstrated to increase platelet counts. This study will test the safety and efficacy of the investigational drug in the prevention of thrombocytopenia in patients with recurrent or refractory intermediate-grade or high-grade non-Burkitt's, non-Hodgkin's lymphoma (NHL), or Hodgkin's disease receiving DHAP (Dexamethasone, high-dose Cytarabine, and Cisplatin) chemotherapy.

primary_purpose: Prevention

lead_sponsor: Pfizer

location_country:
Poland
Hong Kong
Greece
Russian Federation
Australia
United States
France
Singapore


title: An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Renal Cancer

summary: This study will examine whether the investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause kidney cancer.

lead_sponsor: Novartis Pharmaceuticals

location_country:
United States
France

location_facility: Wayne State University Karmanos Cancer Center


ipd_sharing: Undecided

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

ReferenceCitation: Bowman SJ, Fox R, Dörner 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 Sjögren'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.

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

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


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:
United Kingdom
Italy
Australia
United States
France
Germany

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi


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.

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.

lead_sponsor: Target PharmaSolutions, Inc.

location_country:
Spain
Italy
United States
France
Germany

location_facility: Schiff Center for Liver Diseases/University of Miami

location_facility: University of North Carolina at Chapel Hill

location_facility: Southern Therapy and Advanced Research (STAR) LLC

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Northwell Health - Center for Liver Diseases

location_facility: University of Iowa Hospitals and Clinics

location_facility: Center for Liver Disease and Transplant at CMC

location_facility: Vanderbilt University Medical Center - GI Research Office

location_facility: Providence Health & Services Cancer Clinical Trials

location_facility: University of Florida Hepatology Research at CTRB

location_facility: Rutgers-Robert Wood Johnson Medical School

location_facility: Northwestern University Division of Gastroenterology and Hepatology

location_facility: Clinical Research Institute@ Methodist Dallas Medical Center

location_facility: University of Florida Health Gastroenterology

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: University of Texas Southwestern Medical Center

location_facility: University of Southern California/Norris Comprehensive Cancer Center

location_facility: Hospital Universitario Marques de Valdecilla


title: A Randomized, Open-label Study of the Effect of Herceptin Plus Arimidex Compared With Arimidex Alone on Progression-free Survival in Patients With HER2-positive and Hormone-receptor Positive Metastatic Breast Cancer

summary: This 2 arm study assessed the safety and efficacy of adding intravenous trastuzumab (Herceptin®) to daily oral anastrozole (Arimidex®) tablets as first- and second-line treatment in postmenopausal patients with human epidermal growth factor receptor-2 (HER2) overexpressing metastatic breast cancer (ER+ve and/or PR+ve). Patients were randomized to receive either anastrazole 1 mg per os (po) daily, or anastrazole 1 mg po daily + a loading dose of Herceptin® 4 mg/kg intravenous (iv) followed by weekly doses of Herceptin® 2 mg/kg iv. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
South Africa
Poland
Hong Kong
Russian Federation
Australia
India
Israel
Turkey
Mexico
Norway
Sweden
Brazil
Canada
Hungary
China
Germany
Bulgaria
Taiwan
France
Netherlands


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

location_country:
United Kingdom
Italy
Australia
Canada
United States
France
Germany

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

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

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

location_facility: Duplicate_Universitaetsklinikum Carl Gus /ID# 153958

location_facility: Oregon Health and Science University /ID# 152734

location_facility: Concord Repatriation General Hospital /ID# 154958

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

location_facility: Columbia University Medical Center /ID# 153661

location_facility: Universitaetsklinikum Halle (Saale) /ID# 153760

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

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

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

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

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

location_facility: Universitatsklinikum Mannheim /ID# 153140

location_facility: Tennessee Oncology-Nashville Centennial /ID# 222769

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

location_facility: Vanderbilt University Medical Center /ID# 152738

location_facility: UT MD Anderson Cancer Center /ID# 153809

location_facility: Weill Cornell Medical College /ID# 155524

location_facility: Universitaetsklinikum Leipzig /ID# 153142

location_facility: Dana-Farber Cancer Institute /ID# 152735

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

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

location_facility: Univ Maryland School Medicine /ID# 153669


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.

lead_sponsor: Novo Nordisk A/S

type: Other Identifier

location_country:
Denmark
Spain
Netherlands
United States
France
Germany

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: Chimeric Anti-CD20 Monoclonal Antibody (Mabthera) in Remission Induction and Maintenance Treatment of Relapsed Follicular Non-Hodgkin's Lymphoma: A Phase III Randomized Clinical Trial - Intergroup Collaborative Study

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known whether chemotherapy is more effective with or without rituximab for relapsed non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying combination chemotherapy and rituximab to see how well they work compared to combination chemotherapy alone in treating patients with relapsed non-Hodgkin's lymphoma.

ReferenceCitation: Deconinck E, Miadi-Fargier H, Pen CL, Brice P. Cost effectiveness of rituximab maintenance therapy in follicular lymphoma: long-term economic evaluation. Pharmacoeconomics. 2010;28(1):35-46. doi: 10.2165/11314070-000000000-00000.

ReferenceCitation: Pompen M, Huijgens PC, et al.: Cost-effectiveness of rituximab for maintenance in patients with follicular non-Hodgkin's lymphoma in the Dutch setting. [Abstract] Blood 112 (11): A-2364, 2008.

ReferenceCitation: Van Oers MH, Hagenbeek A, Van Glabbeke M, Teodorovic I. Chimeric anti-CD20 monoclonal antibody (Mabthera) in remission induction and maintenance treatment of relapsed follicular non-Hodgkin's lymphoma: a phase III randomized clinical trial--Intergroup Collaborative Study. Ann Hematol. 2002 Oct;81(10):553-7. Epub 2002 Oct 17.

ReferenceCitation: van Oers MH, Tönnissen E, Van Glabbeke M, Giurgea L, Jansen JH, Klasa R, Marcus RE, Wolf M, Kimby E, Vranovsky A, Holte H, Hagenbeek A, van der Reijden BA. BCL-2/IgH polymerase chain reaction status at the end of induction treatment is not predictive for progression-free survival in relapsed/resistant follicular lymphoma: results of a prospective randomized EORTC 20981 phase III intergroup study. J Clin Oncol. 2010 May 1;28(13):2246-52. doi: 10.1200/JCO.2009.25.0852. Epub 2010 Apr 5.

ReferenceCitation: van Oers MH, Van Glabbeke M, Giurgea L, Klasa R, Marcus RE, Wolf M, Kimby E, van t Veer M, Vranovsky A, Holte H, Hagenbeek A. Rituximab maintenance treatment of relapsed/resistant follicular non-Hodgkin's lymphoma: long-term outcome of the EORTC 20981 phase III randomized intergroup study. J Clin Oncol. 2010 Jun 10;28(17):2853-8. doi: 10.1200/JCO.2009.26.5827. Epub 2010 May 3.

ReferenceCitation: van Oers MH, Klasa R, Marcus RE, Wolf M, Kimby E, Gascoyne RD, Jack A, Van't Veer M, Vranovsky A, Holte H, van Glabbeke M, Teodorovic I, Rozewicz C, Hagenbeek A. Rituximab maintenance improves clinical outcome of relapsed/resistant follicular non-Hodgkin lymphoma in patients both with and without rituximab during induction: results of a prospective randomized phase 3 intergroup trial. Blood. 2006 Nov 15;108(10):3295-301. Epub 2006 Jul 27.

ReferenceCitation: Mattiola I, Mantovani A, Locati M. The tetraspan MS4A family in homeostasis, immunity, and disease. Trends Immunol. 2021 Sep;42(9):764-781. doi: 10.1016/j.it.2021.07.002. Epub 2021 Aug 9. Review.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Denmark
Poland
Portugal
Slovenia
Italy
United Kingdom
Australia
New Zealand
Canada
Sweden
Hungary
France
South Africa
Belgium
Norway
Netherlands
Slovakia
Egypt

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

location_facility: Cancer Research Centre at Weston Park Hospital

location_facility: Medisch Centrum Rynmond Zuid - Lokatie: Clara

location_facility: Cancer Centre of Southeastern Ontario at Kingston General Hospital

location_facility: Fraser Valley Cancer Centre at British Columbia Cancer Agency

location_facility: Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre

location_facility: Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.

location_facility: Nanaimo Cancer Clinic at Nanaimo Regional General Hospital

location_facility: Northeastern Ontario Regional Cancer Centre

location_facility: Westmead Breast Centre at NSW Breast Cancer Institute

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

location_facility: London Regional Cancer Program at London Health Sciences Centre

location_facility: Medisch Centrum Rynmond-Zuid - Lokatie Zuider

location_facility: British Columbia Cancer Agency - Centre for the Southern Interior

location_facility: Maxima Medisch Centrum - locatie Eindhoven

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

location_facility: St. George Hospital and Community Health Service

location_facility: Haukeland Hospital - University of Bergen

location_facility: Karolinska University Hospital - Huddinge

location_facility: British Columbia Cancer Agency - Vancouver Cancer Centre

location_facility: Cancer Therapy Centre at Liverpool Hospital

location_facility: Twee Steden Ziekenhuis Vestiging Tilburg

location_facility: Nijmegen Cancer Center at Radboud University Medical Center

location_facility: Mount Vernon Cancer Centre at Mount Vernon Hospital

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

location_facility: Newfoundland Cancer Treatment and Research Foundation

location_facility: Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre

location_facility: Velindre Cancer Center at Velinde Hospital

location_facility: University Medical Center Rotterdam at Erasmus Medical Center

location_facility: Ottawa Hospital Regional Cancer Centre - General Campus

location_facility: Hotel Dieu Health Sciences Hospital - Niagara

location_facility: McGill Cancer Centre at McGill University

location_facility: Sahlgrenska University Hospital at Gothenburg University

location_facility: Leeds General Infirmary at Leeds Teaching Hospital NHS Trust

location_facility: Sydney Cancer Centre at Royal Prince Alfred Hospital

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: Cross Cancer Institute at University of Alberta

location_facility: Allan Blair Cancer Centre at Pasqua Hospital

location_facility: Centro di Riferimento Oncologico - Aviano

location_facility: Institute of Oncology at Prince of Wales Hospital

location_facility: Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre

location_facility: Windsor Regional Cancer Centre at Windsor Regional Hospital

location_facility: Royal Free and University College Medical School

location_facility: Academisch Medisch Centrum at University of Amsterdam

location_facility: Royal Marsden NHS Foundation Trust - Surrey

location_facility: Royal Marsden NHS Foundation Trust - London

location_facility: Ijselmeer Ziekenhuis - Zuiderzeeziekenhuis

location_facility: Trillium Health Centre - Mississauga Site

location_facility: Margaret and Charles Juravinski Cancer Centre

location_facility: Berkshire Cancer Centre at Royal Berkshire Hospital

location_facility: Rigshospitalet - Copenhagen University Hospital

location_facility: University of Auckland School of Medicine


title: Treatment of Relapsed Acute Myelogenous Leukemia Consisting of Intermediate Dose Cytosine Arabinoside (ARA-C) Plus Interspaced Continuous Infusion Idarubicin, Followed by Continuous Infusion of Low-Dose ARA-C, A Phase II Study by the EORTC-LCG

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of cytarabine plus idarubicin in treating patients who have relapsed acute myelogenous leukemia.

status: Unknown status

location_country: Croatia Portugal Italy France Turkey Belgium Netherlands

location_facility: Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

intervention_type: Procedure


title: Comparative Study of Intravesical BCG Standard Dose Long-Term Maintenance Versus BCG 1/3 Dose Long-Term Maintenance Versus BCG Standard Dose Short-Term Maintenance Versus BCG 1/3 Dose Short-Term Maintenance in Intermediate and High Risk Ta, T1 Papillary Carcinoma of the Urinary Bladder

summary:
RATIONALE: Biological therapies such as BCG use different ways to stimulate the immune system and stop cancer cells from growing.

PURPOSE: This randomized phase III trial is studying four different regimens of BCG and comparing how well they work in treating patients who have undergone surgery for bladder cancer.

ReferenceCitation: Cambier S, Sylvester RJ, Collette L, Gontero P, Brausi MA, van Andel G, Kirkels WJ, Silva FC, Oosterlinck W, Prescott S, Kirkali Z, Powell PH, de Reijke TM, Turkeri L, Collette S, Oddens J. EORTC Nomograms and Risk Groups for Predicting Recurrence, Progression, and Disease-specific and Overall Survival in Non-Muscle-invasive Stage Ta-T1 Urothelial Bladder Cancer Patients Treated with 1-3 Years of Maintenance Bacillus Calmette-Guérin. Eur Urol. 2016 Jan;69(1):60-9. doi: 10.1016/j.eururo.2015.06.045. Epub 2015 Jul 23.

ReferenceCitation: Brausi M, Oddens J, Sylvester R, Bono A, van de Beek C, van Andel G, Gontero P, Turkeri L, Marreaud S, Collette S, Oosterlinck W. Side effects of Bacillus Calmette-Guérin (BCG) in the treatment of intermediate- and high-risk Ta, T1 papillary carcinoma of the bladder: results of the EORTC genito-urinary cancers group randomised phase 3 study comparing one-third dose with full dose and 1 year with 3 years of maintenance BCG. Eur Urol. 2014 Jan;65(1):69-76. doi: 10.1016/j.eururo.2013.07.021. Epub 2013 Jul 24.

ReferenceCitation: Oddens J, Brausi M, Sylvester R, Bono A, van de Beek C, van Andel G, Gontero P, Hoeltl W, Turkeri L, Marreaud S, Collette S, Oosterlinck W. Final results of an EORTC-GU cancers group randomized study of maintenance bacillus Calmette-Guérin in intermediate- and high-risk Ta, T1 papillary carcinoma of the urinary bladder: one-third dose versus full dose and 1 year versus 3 years of maintenance. Eur Urol. 2013 Mar;63(3):462-72. doi: 10.1016/j.eururo.2012.10.039. Epub 2012 Nov 2.

location_country:
Portugal
Romania
United Kingdom
Greece
Austria
Italy
France
Israel
Turkey
Belgium
Netherlands

location_facility: St. James's University Hospital at Leeds Teaching Hospital NHS Trust

location_facility: Azienda Ospedaliera Maggiore Della Carita

location_facility: University Medical Center Rotterdam at Erasmus Medical Center

location_facility: Azienda Ospedale S. Luigi - Universita Di Turin

location_facility: Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

location_facility: Dokuz Eylul University School of Medicine

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel


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 subjects with Alport syndrome

Secondary Objectives:

To assess plasma pharmacokinetic (PK) parameters of the parent compound and its metabolites
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. Review. 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:
Spain
United Kingdom
Australia
United States
France
China
Germany

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

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

location_facility: Columbia University Medical Center_Investigational Site Number :8400004

location_facility: The Cleveland Clinic Foundation_Investigational Site Number :8400001

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

location_facility: University of Utah_Investigational Site Number :8400005


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

summary:
it is a randomised, double blind, parallel group, placebo controlled study. A total of 179 male ambulant subjects will be randomised 2:1 (givinostat:placebo).

Subjects will be stratified for their concomitant use of steroids in 4 strata:

Deflazacort daily regimen
Deflazacort intermittent regimen
Other steroids daily regimen
Other steroids intermittent regimen. The study duration is planned for 19 months.

lead_sponsor: Italfarmaco

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

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

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

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

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

location_facility: Connecticut Children's Medical Center - Division Neurology

location_facility: Hospital Sant Joan de Déu - Neuromuscular Pathology Unit

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

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

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

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

location_facility: University of Minnesota - Department of Neurology

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

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

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

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

location_facility: Klinikum der Uniersitat Munchen - Campus Innenstadt

location_facility: Centro Clinico NeMO Fondazione Serena ONLUS Area SUD

location_facility: Universitatsklinikum Essen - Kinder und Jugendmedizin Neuropadiatrie

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

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

location_facility: Holland Bloorview Kids Rehabilitation Hospital

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

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

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

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

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

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

location_facility: Ospedale Pediatrico Bambin Gesù, Malattie Neuromuscolari e Neurodegenerative

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

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

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

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

location_facility: Child Health Research Institute - Department of Pediatrics


title: A Prospective, Multi-center, Post-Market Clinical Follow-Up Study to Evaluate the Safety and Effectiveness of ALLEVYN Gentle Border

summary: The clinical study will evaluate the safety and effectiveness of the ALLEVYN Gentle Border. The study is a post-market clinical follow-up to assess clinical performance and safety of ALLEVYN Gentle Border with new wound contact layer to support performance claims.

lead_sponsor: Smith & Nephew Orthopaedics AG

location_country:
Germany
France
United Kingdom

location_facility: University Hospital Erlangen, Department of Dermatology

location_facility: Northumbria Healthcare NHS Foundation Trust

location_facility: Klinikum Oldenburg, University Clinic for Dermatology and Allergy

location_facility: Niels-Stensen-Kliniken Christliches Klinikum Melle GmbH


title: Clinical and Radiological Outcomes of Medacta Shoulder System

summary: This is a post-marketing surveillance on Medacta Shoulder System

lead_sponsor: Medacta International SA

location_country: Germany France Switzerland

location_facility: Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen,

location_facility: Clinique du Sport et de Chirurgie Orthopédique

location_facility: Klinik und Poliklinik für Orthopädie, Physikalische Medizin und Rehabilitation


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

location_country:
United States
Canada
France

location_facility: Centre Hospitalier Univesitaire de Sherbrooke

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

location_facility: Queen's University Health Sciences Centre

location_facility: Fraser Health Authority - Royal Columbian Hospital

location_facility: Centre Hospitalier de l'Universitaire de Montreal


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

lead_sponsor: Archigen Biotech Limited

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

location_facility:
Reasearch site
Research site
Research Site

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.


title: ELectrical COupling Information From The Rhythmia HDx Mapping System And DireCtSense Technology In The Treatment Of Paroxysmal AtriaL FibrIllation- A Non-RandomiZed, ProspEctive Study

acronym: LOCALIZE

summary: The objective of the study is to collect data on the use of the Rhythmia HDx mapping system running commercially available Software Version 2.0 or any future commercially available Software Version with DirectSense technology and the IntellaMap OrionTM mapping catheter in patients indicated for ablation treatment for de-novo Paroxysmal Atrial Fibrillation (PAF). The study will collect specific information to characterize the DirectSense technology in subjects undergoing catheter-based endocardial mapping and ablation for de-novo PAF using a commercial Rhythmia HDx mapping system. The clinical local impedance data will be used in order to generate usage guidance on the DirectSense local impedance feature in the management of de-novo PAF cases requiring Pulmonary Vein Isolation (PVI) and in order to further develop a future lesion indexing feature.

ReferenceCitation: García-Bolao I, Ramos P, Luik A, S Sulkin M, R Gutbrod S, Oesterlein T, I Laughner J, Richards E, Meyer C, Yue A, Ullah W, Shepherd E, Das M. Local Impedance Drop Predicts Durable Conduction Block in Patients With Paroxysmal Atrial Fibrillation. JACC Clin Electrophysiol. 2022 May;8(5):595-604. doi: 10.1016/j.jacep.2022.01.009. Epub 2022 Feb 23.

ipd_sharing_description: No requests for study data have been made at this time, however Boston's Scientific's policy on data sharing can be found at http://www.bostonscientific.com/en-US/data-sharing-requests.html

lead_sponsor: Boston Scientific Corporation

location_country:
Germany
France
Spain
United Kingdom

location_facility:
Southampton General Hospital
Universitäres Herzzentrum Hamburg
Stadtisches Klinikum Karlsruhe
Clinica Universitaria de Navarra
Freeman Hospital
CHU de Bordeaux


title: Multi-centre, Open-label, Single Arm, Phase I Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacogenomics and Efficacy of a Single Intravenous Dose of BI 655130 in Patients With Active Generalized Pustular Psoriasis.

summary: This is a phase I, open label, single group study that is being performed to assess the safety, tolerability, Pharmacokinetics (PK) , Pharmacogenomics (PGx) and efficacy of a single dose of BI 655130 in adult patients with active Generalized Pustular Psoriasis (GPP).

primary_purpose: Supportive Care

lead_sponsor: Boehringer Ingelheim

location_country:
Taiwan
Tunisia
Korea, Republic of
France
Japan
Malaysia

location_facility: Hedi Chaker Hospital, Department of Dermatology


title: Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis: A Protocol of a Multi-center Prospective Randomized Investigator Blinded Trial.

acronym: COMBOMESA

summary:
The role of steroids in the treatment of severe ulcerative colitis (UC) exacerbation is well established and recommended by professional societies. Similarly, 5-aminosalycilates (5-ASA) agents in the form of mesalamine/mesalzine are well established proven therapy in mild-moderate UC, and the combination of oral 5-ASA with topical (per-rectal enema) 5-ASA was shown to be superior to oral 5ASA alone in patients with mild moderate UC. Thus, in most cases, when a patient with UC experiences a flare while taking 5-ASA therapy, treatment is usually optimized by maximizing the oral dose to 4gr/day and adding topical therapy until the flare is controlled. If this is unhelpful, or if the flare is severe to begin with, corticosteroids are usually prescribed. However, there are very scarce data comparing steroids versus 5-ASA in the treatment of severe UC exacerbation.

The aim of this study is to compare the efficacy of steroids alone vs. combination of steroids + 5-ASA in the treatment of moderate-severe UC exacerbation.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_country:
Serbia
Italy
Greece
Korea, Republic of
France
Israel

location_facility: Department of Gastroenterology Venizeleio General Hospital, Leoforos Knosou

location_facility: Zvezdara University Clinical Center, Gastroenterology Department

location_facility: Institute of Gastroenterology and Department of Internal Medicine, Yonsei University College of Medicine

lead_sponsor_type: academique


title: An Open-label Study to Evaluate the Efficacy and Safety of Revusiran in Patients With Transthyretin-mediated Familial Amyloidotic Polyneuropathy With Disease Progression Post-Orthotopic Liver Transplant

summary: The purpose of this study was to evaluate the safety and effectiveness of revusiran (ALN-TTRSC) in adults with transthyretin-mediated amyloidosis (ATTR), whose disease has continued to worsen after liver transplantation. Dosing has been discontinued; patients are being followed-up for safety.

lead_sponsor: Alnylam Pharmaceuticals

location_country:
Portugal
Spain
United Kingdom
Sweden
France
Germany

location_facility:
Clinical Trial Site
Clinical Trial SIte


type: Other Grant/Funding Number

type: Registry Identifier

title: Early Sleep Apnea Treatment in Stroke: A Multicenter, Randomized, Rater-Blinded, Clinical Trial of Adaptive Servo-Ventilation

acronym: eSATIS

summary:
Investigating the interrelation of stroke and sleep-disordered breathing (SDB) is of major importance. First because of the high occurrence rate of stroke and the fact that it is a frequent cause of long-term disability in adulthood. Second because SDB (obstructive, central and mixed forms) affects more than 50% of stroke survivors and has a detrimental effect on clinical stroke outcome. Third, spontaneous and learning-dependent sleep-associated neuroplasticity may be affected by SDB following stroke worsening stroke rehabilitation. Therefore, it is crucial to investigate whether early treatment of SDB with Adaptive Servo-Ventilation (ASV), the treatment device of choice to treat obstructive, central and mixed forms of SDB, has a beneficial effect on the evolution of the lesion volume and on clinical stroke outcome.

To this end, the investigators recruit and prospectively follow 3 groups of patients with ischemic stroke over 1 year. During the first night after hospital admission due to acute stroke, nocturnal breathing is assessed by means of a respiratory polygraphy. Patients with significant sleep disordered breathing, defined as an Apnea-Hypopnea-Index (AHI) > 20/h, are randomized to ASV treatment or no treatment (sSDB ASV+ or sSDB ASV-). ASV treatment starts the second night following hospital admission and ends 90 days later. Stroke patients without SDB (AHI < 5 / h) serve as a control group (no SDB) to observe the evolution of the lesion volume and stroke outcome without the additional burden of SDB.

Lesion volume one day after hospital admission due to acute stroke (after potential lysis therapy) measured by Diffusion Weighted Imaging will be subtracted from lesion volume measured by T2-weighted volumetry assessed 90(+/-7) days following stroke and compared between patients with and without ASV treatment (sSDB ASV+ and sSDB ASV-) as well as patients without SDB (no SDB). Short- and long-term clinical stroke outcomes are assessed by clinical scales and questionnaires 4 to 7 days, 3 months and 1 year following stroke. Cognitive outcome is assessed during hospitalization (within the first week following stroke) and after the treatment period of 90 days by neuropsychological tests assessing attention and memory. In addition, baseline assessment of physiological parameters such as blood pressure and endothelial function/arterial stiffness are assessed during the first weeks following stroke and at the end of the treatment period, i.e. approximately 90 days following stroke.

ReferenceCitation: Brown DL, Chervin RD, Kalbfleisch JD, Zupancic MJ, Migda EM, Svatikova A, Concannon M, Martin C, Weatherwax KJ, Morgenstern LB. Sleep apnea treatment after stroke (SATS) trial: is it feasible? J Stroke Cerebrovasc Dis. 2013 Nov;22(8):1216-24. doi: 10.1016/j.jstrokecerebrovasdis.2011.06.010. Epub 2011 Jul 23.

ReferenceCitation: Tomfohr LM, Hemmen T, Natarajan L, Ancoli-Israel S, Loredo JS, Heaton RK, Bardwell W, Mills PJ, Lee RR, Dimsdale JE. Continuous positive airway pressure for treatment of obstructive sleep apnea in stroke survivors: what do we really know? Stroke. 2012 Nov;43(11):3118-23. doi: 10.1161/STROKEAHA.112.666248. Epub 2012 Sep 27. Review.

ReferenceCitation: Duss SB, Brill AK, Baillieul S, Horvath T, Zubler F, Flügel D, Kägi G, Benz G, Bernasconi C, Ott SR, Korostovtseva L, Sviryaev Y, Salih F, Endres M, Tamisier R, Gouveris H, Winter Y, Denier N, Wiest R, Arnold M, Schmidt MH, Pépin JL, Bassetti CLA. Effect of early sleep apnoea treatment with adaptive servo-ventilation in acute stroke patients on cerebral lesion evolution and neurological outcomes: study protocol for a multicentre, randomized controlled, rater-blinded, clinical trial (eSATIS: early Sleep Apnoea Treatment in Stroke). Trials. 2021 Jan 22;22(1):83. doi: 10.1186/s13063-020-04977-w.

ReferenceCitation: Brill AK, Rösti R, Hefti JP, Bassetti C, Gugger M, Ott SR. Adaptive servo-ventilation as treatment of persistent central sleep apnea in post-acute ischemic stroke patients. Sleep Med. 2014 Nov;15(11):1309-13. doi: 10.1016/j.sleep.2014.06.013. Epub 2014 Aug 1.

ReferenceCitation: Bravata DM, Concato J, Fried T, Ranjbar N, Sadarangani T, McClain V, Struve F, Zygmunt L, Knight HJ, Lo A, Richerson GB, Gorman M, Williams LS, Brass LM, Agostini J, Mohsenin V, Roux F, Yaggi HK. Continuous positive airway pressure: evaluation of a novel therapy for patients with acute ischemic stroke. Sleep. 2011 Sep 1;34(9):1271-7. doi: 10.5665/SLEEP.1254.

ReferenceCitation: Parra O, Sánchez-Armengol A, Bonnin M, Arboix A, Campos-Rodríguez F, Pérez-Ronchel J, Durán-Cantolla J, de la Torre G, González Marcos JR, de la Peña M, Carmen Jiménez M, Masa F, Casado I, Luz Alonso M, Macarrón JL. Early treatment of obstructive apnoea and stroke outcome: a randomised controlled trial. Eur Respir J. 2011 May;37(5):1128-36. doi: 10.1183/09031936.00034410. Epub 2010 Sep 16.

ReferenceCitation: Minnerup J, Ritter MA, Wersching H, Kemmling A, Okegwo A, Schmidt A, Schilling M, Ringelstein EB, Schäbitz WR, Young P, Dziewas R. Continuous positive airway pressure ventilation for acute ischemic stroke: a randomized feasibility study. Stroke. 2012 Apr;43(4):1137-9. doi: 10.1161/STROKEAHA.111.637611. Epub 2011 Dec 22.

ReferenceCitation: Ryan CM, Bayley M, Green R, Murray BJ, Bradley TD. Influence of continuous positive airway pressure on outcomes of rehabilitation in stroke patients with obstructive sleep apnea. Stroke. 2011 Apr;42(4):1062-7. doi: 10.1161/STROKEAHA.110.597468. Epub 2011 Mar 3.

ReferenceCitation: Barbé F, Durán-Cantolla J, Sánchez-de-la-Torre M, Martínez-Alonso M, Carmona C, Barceló A, Chiner E, Masa JF, Gonzalez M, Marín JM, Garcia-Rio F, Diaz de Atauri J, Terán J, Mayos M, de la Peña M, Monasterio C, del Campo F, Montserrat JM; Spanish Sleep And Breathing Network. Effect of continuous positive airway pressure on the incidence of hypertension and cardiovascular events in nonsleepy patients with obstructive sleep apnea: a randomized controlled trial. JAMA. 2012 May 23;307(20):2161-8. doi: 10.1001/jama.2012.4366.

ReferenceCitation: Craig SE, Kohler M, Nicoll D, Bratton DJ, Nunn A, Davies R, Stradling J. Continuous positive airway pressure improves sleepiness but not calculated vascular risk in patients with minimally symptomatic obstructive sleep apnoea: the MOSAIC randomised controlled trial. Thorax. 2012 Dec;67(12):1090-6. doi: 10.1136/thoraxjnl-2012-202178. Epub 2012 Oct 30.

ReferenceCitation: Marin JM, Agusti A, Villar I, Forner M, Nieto D, Carrizo SJ, Barbé F, Vicente E, Wei Y, Nieto FJ, Jelic S. Association between treated and untreated obstructive sleep apnea and risk of hypertension. JAMA. 2012 May 23;307(20):2169-76. doi: 10.1001/jama.2012.3418.

lead_sponsor: University Hospital Inselspital, Berne

location_country:
Russian Federation
Germany
France
Switzerland

location_facility: Federal State Budgetary Institution "Almazov National Medical Research Centre" of the Ministry of Health of the Russian Federation

location_facility: Department and Out-Patient Care of Neurology, Charité Center Neurology, Neurosurgery and Psychiatry CC 15, Department of Neurology with Experimental Neurology, Center for Stroke Research Berlin (CSB)

location_facility: Neurology Department, Cantonal Hospital St.Gallen

location_facility: Department of Neurology, Pulmonary Medicine and Institute of Diagnostic and Interventional Neuroradiology, Bern University Hospital

location_facility: Clinic universitaire de physiologie, sommeil et exercice, Centre Hospitalier Universitaire (CHU) de Grenoble

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, HNO-Universitätsklinik, Klinik und Poliklinik für Neurologie


title: Continuing Treatment for Subjects Who Have Participated on a Prior Protocol Investigating Dasatinib

summary: The purpose of this study is to continue to provide dasatinib to patients that are currently participating in another dasatinib trial that is ending and for which there is no other option to provide dasatinib.

lead_sponsor: Bristol-Myers Squibb

location_country: Poland France


summary: This study will evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex®) compared to ranibizumab (Lucentis®) in patients with branch retinal vein occlusion (BRVO).

ReferenceCitation: Bandello F, Augustin A, Tufail A, Leaback R. A 12-month, multicenter, parallel group comparison of dexamethasone intravitreal implant versus ranibizumab in branch retinal vein occlusion. Eur J Ophthalmol. 2018 Nov;28(6):697-705. doi: 10.1177/1120672117750058. Epub 2018 Apr 9.

lead_sponsor: Allergan

location_country:
Spain
Italy
United Kingdom
France
Israel
Germany


acronym: B-MIND

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)

lead_sponsor: MorphoSys AG

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

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

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.


title: Phase III Study of Docetaxel in Combination With Gemcitabine Versus Docetaxel in Combination With Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer

summary: This is a phase III randomized study which compares two different regimens of chemotherapy. The purpose of the study is to determine which of the two regimens will make the tumor smaller or disappear, and for how long. In addition the disease-related symptoms will be evaluated. The safety of the drugs will be determined based upon evaluation of the side effects

ReferenceCitation: Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5:CD011220. doi: 10.1002/14651858.CD011220.pub2.

lead_sponsor: Eli Lilly and Company

location_country:
Spain
Italy
United Kingdom
Netherlands
France
Germany

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


title: The International Trifecta and Epic Valve-in-Valve Registry: Detailed Insights Into Management Strategies and Outcomes

summary: Non-randomized, open label, non-interventional, multicenter registry to describe risk factors, management strategies, and clinical outcomes in patients undergoing Valve in Valve (ViV) transcatheter aortic valve implantation (TAVI) in a previously implanted Trifecta or Epic valve using retrospective registry data from large volume centers

time_perspective: Retrospective

lead_sponsor: Leipzig Heart Institute GmbH

location_country: Germany France Netherlands Belgium

location_facility: Heart Center Leipzig University Hospital

location_facility: Heart Center Dresden University Hospital


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:
Netherlands
United States
France