title: MULTINATIONAL Retrospective Chart Review Study to Assess the Characteristics, Treatment Outcomes and Resource Use Among Adult Patients Hospitalised for Community-Acquired Pneumonia (CAP) or Complicated Skin and Soft Tissue Infections (cSSTI) Treated With Zinforo (REGISTERED) (Ceftaroline Fosamil) in a Usual Care Setting

summary: MULTINATIONAL Retrospective Chart Review Study to Assess the Characteristics, Treatment Outcomes and Resource Use Among Adult Patients Hospitalized for Community-Acquired Pneumonia (CAP) or Complicated Skin and Soft Tissue Infections (cSSTI) Treated with Zinforo® (ceftaroline fosamil) in a Usual Care Setting

time_perspective: Retrospective

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Italy
Colombia
Brazil
Spain
Greece
Russian Federation
France

location_facility: AHEPA General University Hospital of Thessaloniki

location_facility: AORN Ospedali dei Colli - Ospedale Monaldi

location_facility: Asst Spedali Civili Brescia and Universita Degli Studi di Brescia

location_facility: Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), Presidio Ospedaliero Universitario Santa

location_facility: BUZ UR First Republican Clinical Hospital under the Ministry of Healthcare of Udmurt Republic UR

location_facility: E.S.E. Hospital Universitario San Jorge de Pereira

location_facility: Croix-Rousse hospital, Hospices Civils de Lyon

location_facility: Republican Clinical Hospital named after G.G. Kuvatova

location_facility: Aou Citta Della Salute E Della Scienza Scdu Malattie Infettive 2


type: EudraCT Number

title: A first-time-in Human (FTIH), Phase I/II, Randomized, Multi-centric, Single-blind, Controlled Dose-escalation Study to Evaluate the Reactogenicity, Safety, Immunogenicity and Efficacy of GSK Biologicals' HBV Viral Vector Vaccines Given in a Prime-boost Schedule With Sequential or Co-administration of Adjuvanted Proteins Therapeutic Vaccine (GSK3528869A) in Chronic Hepatitis B Patients (18-65 Years Old) Well Controlled Under Nucleo(s)Tide Analogue (NA) Therapy

summary: A First-Time-In-Human study on GSK's therapeutic vaccines to evaluate the reactogenicity, safety, immunogenicity and efficacy on reduction of serum HBV surface antigen in HBV suppressed subjects under nucleo(s)tide treatment.

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: Anticipated

ipd_sharing: Yes

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

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Poland
United Kingdom
Hong Kong
Belgium
Spain
Thailand
Taiwan
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase 1b Open-Label Study Assessing the Pharmacokinetics, Tolerability, and Safety of Oral Trimetazidine in Subjects With Acute-on-Chronic Liver Failure

acronym: TRUST

summary: The study will assess the pharmacokinetics (PK), tolerability, and safety of oral trimetazidine administered to subjects with AD (ACLF Grade 0) or with ACLF Grade 1 or 2.

status: Suspended

design_allocation: Non-Randomized

primary_purpose: Other

ipd_sharing: No

lead_sponsor: Martin Pharmaceuticals

location_country: Germany Austria Belgium Spain France

location_facility: Universitätsklinikum Halle Klinik und Poliklinik für Innere Medizin I

location_facility: Hospital Marques de Valdecilla Santander

status_simplified: Unknown


lead_sponsor: Hoffmann-La Roche

summary: This is an open-label, multicenter, basket trial Phase II study to evaluate the antitumor activity of simlukafusp alfa in combination with atezolizumab in participants with advanced and/or metastatic solid tumors. Currently the focus is on participants with Head and Neck, oesophageal and cervical cancers with confirmed squamous cell carcinoma histology type.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: National Cheng Kung Uni Hospital; Dept of Hematology and Oncology

location_facility: Auckland City Hospital; Clinical Oncology

location_facility: Clinica Universidad de Navarra Madrid; Servicio de Oncología

location_facility: Adana Baskent University Hospital; Medical Oncology

location_facility: N.N.Burdenko Main Military Clinical Hospital; Oncology Dept

location_facility: National Cancer Centre; Medical Oncology

location_facility: Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty; Medikal Onkoloji Departmani

location_facility: Universitätsklinikum Essen; Innere Klinik (Tumorforschung)

location_facility: Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Oddzial Badan Wczesnych Faz

location_facility: Hopital Timone Adultes; Oncologie Medicale Et Usp

location_facility: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Hôpitaux Universit. de Genève Médecine Oncologie; Oncologie

location_facility: Seoul National University Bundang Hospital

location_facility: Akdeniz University Medical Faculty; Medical Oncology Department

location_facility: Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz

location_facility: Royal Marsden Hospital; Institute of Cancer Research

location_facility: University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center

location_facility: Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: START Madrid. Centro Integral Oncologico Clara Campal; CIOCC

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: START Madrid-FJD, Hospital Fundacion Jimenez Diaz

status: Terminated

title: An Open-Label, Multicenter, Phase II Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa (RO6874281), an Immunocytokine, Consisting of Interleukin-2 Variant (IL-2v) Targeting Fibroblast Activation Protein-Α (FAP), in Combination With Atezolizumab (Anti-PD-L1), Administered Intravenously, in Participants With Advanced and/or Metastatic Solid Tumors

source: euctr

enrollment_type: Actual

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

study_completion_date_type: Actual

location_country:
Germany
France
Poland
New Zealand
United Kingdom
Singapore
Switzerland
Belgium
United States
Korea, Republic of
Spain
Turkey
Taiwan
Russian Federation
Israel


summary: This open-label, randomized, multicenter, triple-arm Phase Ib/II study is designed to assess the efficacy, safety, tolerability, and pharmacokinetics of cobimetinib administered as a single agent (Arm A), cobimetinib plus venetoclax (Arm B), and cobimetinib plus venetoclax plus atezolizumab (Arm C) in participants with relapsed and refractory multiple myeloma. Two successive cohorts will evaluate the safety of cobimetinib plus venetoclax and that of cobimetinib plus venetoclax plus atezolizumab in the selected population during the safety run-in phase of the study. Once the dose levels have demonstrated acceptable safety during this phase, randomization will begin for all treatment arms (Arms A, B, and C).

location_facility: Uniwersytet Medyczny im.Karola Marcinkowskiego w Poznaniu

location_facility: Fakultni nemocnice Ostrava; Klinika hematoonkologie

location_facility: UNI-Klinikum Heidelberg Medizinische Klinik Innere Medizin V

location_facility: Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Oncology

location_facility: Oslo University Hospital HF, Rikshospitalet

location_facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

location_facility: Universitätsklinikum Tübingen Medizinische UNI-Klinik und Poliklinik Abt. Innere Medizin II

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia

location_facility: Univerzita Karlova v Praze a Vseobecna fakultni nemocnice v Praze - 1; Lekarska Fakulta - I

location_facility: Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik

location_facility: Medical University School; Dept. of Haematology

location_facility: Universtitätsklinikum Ulm; Klinik für Innere Medizin III

status: Completed

title: A Phase Ib/II Study of Cobimetinib Administered as Single Agent and in Combination With Venetoclax, With or Without Atezolizumab, in Patients With Relapsed and Refractory Multiple Myeloma

location_country: Germany Poland Norway Denmark Sweden Netherlands Spain Czechia France

status_simplified: Completed


title: Multicenter, International Online Documentation of Indications and Results of Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC Und PITAC) for Treating Malignant Peritoneal and Pleural Diseases

acronym: PIPACRegis

summary: Multicentric, international, web-based prospective documentation of the indications and results of Pressurized Aerosol Chemotherapy (so-called PIPAC or PITAC) for treating malignant pleural and peritoneal diseases. Indication is decided by the treating physician. There are no predefined inclusion or exclusion criteria.

status: Unknown status

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Graversen M, Detlefsen S, Bjerregaard JK, Pfeiffer P, Mortensen MB. Peritoneal metastasis from pancreatic cancer treated with pressurized intraperitoneal aerosol chemotherapy (PIPAC). Clin Exp Metastasis. 2017 Jun;34(5):309-314. doi: 10.1007/s10585-017-9849-7. Epub 2017 May 17.

ReferenceCitation: Grass F, Vuagniaux A, Teixeira-Farinha H, Lehmann K, Demartines N, Hubner M. Systematic review of pressurized intraperitoneal aerosol chemotherapy for the treatment of advanced peritoneal carcinomatosis. Br J Surg. 2017 May;104(6):669-678. doi: 10.1002/bjs.10521.

ReferenceCitation: Hubner M, Teixeira Farinha H, Grass F, Wolfer A, Mathevet P, Hahnloser D, Demartines N. Feasibility and Safety of Pressurized Intraperitoneal Aerosol Chemotherapy for Peritoneal Carcinomatosis: A Retrospective Cohort Study. Gastroenterol Res Pract. 2017;2017:6852749. doi: 10.1155/2017/6852749. Epub 2017 Feb 26.

ReferenceCitation: Teixeira Farinha H, Grass F, Kefleyesus A, Achtari C, Romain B, Montemurro M, Demartines N, Hubner M. Impact of Pressurized Intraperitoneal Aerosol Chemotherapy on Quality of Life and Symptoms in Patients with Peritoneal Carcinomatosis: A Retrospective Cohort Study. Gastroenterol Res Pract. 2017;2017:4596176. doi: 10.1155/2017/4596176. Epub 2017 Feb 21.

ReferenceCitation: Tempfer CB, Hartmann F, Hilal Z, Rezniczek GA. Intraperitoneal cisplatin and doxorubicin as maintenance chemotherapy for unresectable ovarian cancer: a case report. BMC Cancer. 2017 Jan 6;17(1):26. doi: 10.1186/s12885-016-3004-8.

ReferenceCitation: Girshally R, Demtroder C, Albayrak N, Zieren J, Tempfer C, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) as a neoadjuvant therapy before cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. World J Surg Oncol. 2016 Sep 27;14(1):253. doi: 10.1186/s12957-016-1008-0.

ReferenceCitation: Graversen M, Pfeiffer P, Mortensen MB. [Treatment of peritoneal carcinomatosis with pressurized intraperitoneal aerosol chemotherapy]. Ugeskr Laeger. 2016 May 23;178(21):V11150928. Danish.

ReferenceCitation: Robella M, Vaira M, De Simone M. Safety and feasibility of pressurized intraperitoneal aerosol chemotherapy (PIPAC) associated with systemic chemotherapy: an innovative approach to treat peritoneal carcinomatosis. World J Surg Oncol. 2016 Apr 29;14:128. doi: 10.1186/s12957-016-0892-7.

ReferenceCitation: Tempfer CB, Rezniczek GA, Ende P, Solass W, Reymond MA. Pressurized Intraperitoneal Aerosol Chemotherapy with Cisplatin and Doxorubicin in Women with Peritoneal Carcinomatosis: A Cohort Study. Anticancer Res. 2015 Dec;35(12):6723-9. doi: 10.1055/s-0035-1560004.

ReferenceCitation: Nadiradze G, Giger-Pabst U, Zieren J, Strumberg D, Solass W, Reymond MA. Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) with Low-Dose Cisplatin and Doxorubicin in Gastric Peritoneal Metastasis. J Gastrointest Surg. 2016 Feb;20(2):367-73. doi: 10.1007/s11605-015-2995-9. Epub 2015 Oct 28.

ReferenceCitation: Demtroder C, Solass W, Zieren J, Strumberg D, Giger-Pabst U, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy with oxaliplatin in colorectal peritoneal metastasis. Colorectal Dis. 2016 Apr;18(4):364-71. doi: 10.1111/codi.13130.

ReferenceCitation: Hubner M, Teixeira H, Boussaha T, Cachemaille M, Lehmann K, Demartines N. [PIPAC--Pressurized intraperitoneal aerosol chemotherapy. A novel treatment for peritoneal carcinomatosis]. Rev Med Suisse. 2015 Jun 17;11(479):1325-30. French.

ReferenceCitation: Odendahl K, Solass W, Demtroder C, Giger-Pabst U, Zieren J, Tempfer C, Reymond MA. Quality of life of patients with end-stage peritoneal metastasis treated with Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC). Eur J Surg Oncol. 2015 Oct;41(10):1379-85. doi: 10.1016/j.ejso.2015.06.001. Epub 2015 Jun 21.

ReferenceCitation: Tempfer CB, Solass W, Buerkle B, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin and doxorubicin in a woman with pseudomyxoma peritonei: A case report. Gynecol Oncol Rep. 2014 Oct 18;10:32-5. doi: 10.1016/j.gore.2014.10.001. eCollection 2014 Dec.

ReferenceCitation: Giger-Pabst U, Solass W, Buerkle B, Reymond MA, Tempfer CB. Low-dose pressurized intraperitoneal aerosol chemotherapy (PIPAC) as an alternative therapy for ovarian cancer in an octogenarian patient. Anticancer Res. 2015 Apr;35(4):2309-14.

ReferenceCitation: Tempfer CB, Winnekendonk G, Solass W, Horvat R, Giger-Pabst U, Zieren J, Rezniczek GA, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy in women with recurrent ovarian cancer: A phase 2 study. Gynecol Oncol. 2015 May;137(2):223-8. doi: 10.1016/j.ygyno.2015.02.009. Epub 2015 Feb 18.

ReferenceCitation: Sabaila A, Fauconnier A, Huchon C. [Pressurized intraperitoneal aerosol chemotherapy (PIPAC): a new way of administration in peritoneal carcinomatosis of ovarian cancer]. Gynecol Obstet Fertil. 2015 Jan;43(1):66-7. doi: 10.1016/j.gyobfe.2014.11.012. Epub 2014 Dec 15. No abstract available. French.

ReferenceCitation: Tempfer CB, Solass W, Reymond MA. Pressurized intraperitoneal chemotherapy (PIPAC) in women with gynecologic malignancies: a review. Wien Med Wochenschr. 2014 Dec;164(23-24):519-28. doi: 10.1007/s10354-014-0312-y. Epub 2014 Sep 24.

ReferenceCitation: Tempfer CB, Celik I, Solass W, Buerkle B, Pabst UG, Zieren J, Strumberg D, Reymond MA. Activity of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) with cisplatin and doxorubicin in women with recurrent, platinum-resistant ovarian cancer: preliminary clinical experience. Gynecol Oncol. 2014 Feb;132(2):307-11. doi: 10.1016/j.ygyno.2013.11.022. Epub 2013 Nov 23.

ReferenceCitation: Solass W, Kerb R, Murdter T, Giger-Pabst U, Strumberg D, Tempfer C, Zieren J, Schwab M, Reymond MA. Intraperitoneal chemotherapy of peritoneal carcinomatosis using pressurized aerosol as an alternative to liquid solution: first evidence for efficacy. Ann Surg Oncol. 2014 Feb;21(2):553-9. doi: 10.1245/s10434-013-3213-1. Epub 2013 Sep 5.

ReferenceType: derived

ReferenceCitation: Kurtz F, Struller F, Horvath P, Solass W, Bosmuller H, Konigsrainer A, Reymond MA. Feasibility, Safety, and Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Metastasis: A Registry Study. Gastroenterol Res Pract. 2018 Oct 24;2018:2743985. doi: 10.1155/2018/2743985. eCollection 2018.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_concat: PubMed Central;pdfs.semanticscholar.org

unpaywall_oa_status: gold

publisher_dissemination: Hindawi

ipd_sharing_description: Requests can be addressed to the Scientific Advisory Board, AnInstitut für Qualitässicherung in der operativen Medizin gGmbH, Leipziger Str. 44, 39120 MAGDEBURG, Germany

lead_sponsor: Sabine Rhode

sponsor_collaborators:
Sabine Rhode
Ruhr University of Bochum

location_country:
Germany
Italy
Poland
Argentina
Denmark
Australia
Singapore
Switzerland
Austria
Belgium
Spain
Russian Federation
France

location_facility:
Hospital de Pilar
Roffo Cancer Institute
Hospices civils de Lyon
University Hospital Tübingen
SALK - Salzburger Landeskliniken
IRCC Torino Candiolo
University Hospital Gent (UZ Gent)
University Hospital Lausanne CHUV
Centre du Cancer
University Hospital Odense
Gersten Institute for Cancer Research
National University Hospital
Centre Hospitalier Universitaire
Peter MacCallum Cancer Centre
F. Łukaszczyk Oncology Centre

intervention_type: Combination Product


type: Other Identifier

title: A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-human Study of Orally Administered JNJ-56136379 to Evaluate Safety, Tolerability and Pharmacokinetics After Single Ascending Doses and One Multiple Dose Regimen in Healthy Subjects (Part I), and After Multiple Dose Regimens in Subjects With Chronic Hepatitis B (Part II)

summary: The purpose of this study is to evaluate pharmacokinetics and safety data including serious and other adverse events, physical examinations, vital signs, 12-lead electrocardiograms (ECGs) and clinical laboratory results (including biochemistry, hematology, and urine).

ReferenceCitation: Zoulim F, Lenz O, Vandenbossche JJ, Talloen W, Verbinnen T, Moscalu I, Streinu-Cercel A, Bourgeois S, Buti M, Crespo J, Manuel Pascasio J, Sarrazin C, Vanwolleghem T, Shukla U, Fry J, Yogaratnam JZ. JNJ-56136379, an HBV Capsid Assembly Modulator, Is Well-Tolerated and Has Antiviral Activity in a Phase 1 Study of Patients With Chronic Infection. Gastroenterology. 2020 Aug;159(2):521-533.e9. doi: 10.1053/j.gastro.2020.04.036. Epub 2020 Apr 25.

oa_colors: green other

evidence: open (via free pdf)

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_normalized: HAL

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

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

repositories: HAL irua

repositories_concat: HAL;irua

repositories_pmh: HAL irua

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Vandenbossche J, Jessner W, van den Boer M, Biewenga J, Berke JM, Talloen W, De Zwart L, Snoeys J, Yogaratnam J. Pharmacokinetics, Safety and Tolerability of JNJ-56136379, a Novel Hepatitis B Virus Capsid Assembly Modulator, in Healthy Subjects. Adv Ther. 2019 Sep;36(9):2450-2462. doi: 10.1007/s12325-019-01017-1. Epub 2019 Jul 2. Erratum In: Adv Ther. 2020 Mar 4;:

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Springer-Nature

lead_sponsor: Janssen Sciences Ireland UC

location_country:
Germany
Moldova, Republic of
Romania
Belgium
Spain
Malaysia
Taiwan
Bulgaria
Georgia
France


acronym: ENTERPRISE

lead_sponsor: Takeda

summary: The purpose of this study is to evaluate the percentage of participants with perianal fistula healing at Week 30 in 2 different dose regimens of vedolizumab intravenous (IV) 300 milligram (mg) in participants with fistulizing Crohn's disease (CD).

ReferenceCitation: Schwartz DA, Peyrin-Biroulet L, Lasch K, Adsul S, Danese S. Efficacy and Safety of 2 Vedolizumab Intravenous Regimens for Perianal Fistulizing Crohn's Disease: ENTERPRISE Study. Clin Gastroenterol Hepatol. 2022 May;20(5):1059-1067.e9. doi: 10.1016/j.cgh.2021.09.028. Epub 2021 Sep 29.

oa_host_type: publisher

evidence: open (via crossref license)

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Nottingham University Hospitals NHS Trust

title: A Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn's Disease (ENTERPRISE)

type: Registry Identifier

ipd_sharing_description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

location_country:
Italy
United Kingdom
Netherlands
United States
Spain
Canada
France


title: A Prospective, Multi-center Study to Evaluate the Safety and Performance of the Hyperion™ ASD and PDA Closure Systems.

summary: The purpose of this study is to determine the safety, performance and efficacy of the Hyperion™ Occluder Systems during treatment of ASD and PDA patients.

lead_sponsor: European Cardiovascular Research Center

sponsor_collaborators:
European Cardiovascular Research Center
Comed B.V.

location_country: Germany Algeria China France

location_facility: Centre Médico-chirurgical infantile Bou Ismail

location_facility: Hôpital cardiologique Haut-Leveque (CHU Bordeaux)

intervention_type: Device


title: A Phase 3, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin Administered for 12 Weeks in Treatment-Naïve Subjects With Chronic Genotype 1 or Genotype 4 HCV Infection

summary: The purpose of this study is to evaluate the efficacy, tolerability, and safety of 12-weeks of treatment with TMC435 plus pegylated interferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) in previously untreated adult participants with genotype 1 or genotype 4 chronic Hepatitis C Virus (HCV) infection.

ReferenceCitation: Asselah T, Moreno C, Sarrazin C, Gschwantler M, Foster GR, Craxi A, Buggisch P, Ryan R, Lenz O, Scott J, Van Dooren G, Lonjon-Domanec I, Schlag M, Buti M. An Open-Label Trial of 12-Week Simeprevir plus Peginterferon/Ribavirin (PR) in Treatment-Naive Patients with Hepatitis C Virus (HCV) Genotype 1 (GT1). PLoS One. 2016 Jul 18;11(7):e0158526. doi: 10.1371/journal.pone.0158526. eCollection 2016.

repository_institution: Nova Science Publishers, Inc. - Nova Science Publishers

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

repository_institution: University of Illinois at Chicago - INDIGO

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

publisher_dissemination: Public Library of Science

lead_sponsor: Janssen-Cilag International NV

location_country:
Germany
United Kingdom
Austria
Belgium
Saudi Arabia
Spain
France


title: Catheter Cryoablation Versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation.

summary: The purpose of this study is to evaluate the effectiveness of Pulmonary Vein Isolation (PVI) performed with the Arctic Front™ Advance Cardiac CryoAblation Catheter System as first-line therapy in comparison with antiarrhythmic drugs (AAD) in patients with paroxysmal atrial fibrillation (AF).

ReferenceCitation: Pavlovic N, Chierchia GB, Velagic V, Hermida JS, Healey S, Arena G, Badenco N, Meyer C, Chen J, Iacopino S, Anselme F, Dekker L, Scazzuso F, Packer DL, de Asmundis C, Pitschner HF, Piazza FD, Kaplon RE, Kuniss M; Cryo-FIRST Investigators. Initial rhythm control with cryoballoon ablation vs drug therapy: Impact on quality of life and symptoms. Am Heart J. 2021 Dec;242:103-114. doi: 10.1016/j.ahj.2021.08.007. Epub 2021 Sep 8.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country: Germany Italy Norway Argentina Australia Netherlands Belgium Croatia France

location_facility: Klinicki bolnicki centar Sestre Milosrdnice

location_facility: Heart Rhythm Management Centre, UZ Brussels - VUB Brussel


title: An Exploratory Phase II, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Pertuzumab and Herceptin (Trastuzumab) in Patients With HER2-Positive Metastatic Breast Cancer

summary: This study will evaluate the efficacy and safety of Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) in participants with metastatic breast cancer who have progressed on trastuzumab-based therapy (Cohorts 1 and 2), and will make a preliminary assessment of the efficacy and safety of single-agent pertuzumab (Cohort 3). Objective response rate and clinical benefit will be assessed. Pertuzumab will be administered at an initial dose of 840 milligrams (mg) intravenously (IV) on Day 1, followed by 420 mg IV every 3 weeks. Trastuzumab will be administered at the same schedule the participant was following before entry into the study. An additional cohort of participants at certain centers will receive pertuzumab monotherapy at an initial dose of 840 mg IV on Day 1, followed by 420 mg IV every 3 weeks. These participants may have trastuzumab added to the regimen in the event of progression during single-agent pertuzumab treatment.

location_country:
Italy
United Kingdom
Spain
Canada
France


title: A Multi-center, Open-label Phase IB Study of Escalating Doses of RO5045337, an Oral Small Molecule MDM2 Antagonist, in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma

summary: This multicenter, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and efficacy of RO5045337 in combination with doxorubicin in patients with soft tissue sarcoma. Cohorts of patients will receive escalating doses of RO5045337 orally on Days 1-5 (1-3) of each 28-day cycle in combination with doxorubicin 60 mg/m2 intravenously on Day 1 of each cycle for up to 6 cycles.

location_country:
United States
France


title: A Randomized, Double Blind, Cross-over Study to Evaluate the Safety and Efficacy of CNV1014802 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

summary: The study is a randomized, double blind, cross-over study to evaluate the safety and efficacy of CNV1014802 in subjects with neuropathic pain from lumbosacral radiculopathy.

lead_sponsor: Biogen

location_country: Czechia Denmark Sweden France


lead_sponsor: Horizon Pharma USA, Inc.

summary: Cystinosis is an inherited disease that if untreated, results in kidney failure as early as the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate immediate release) which must be taken every six hours for the rest of the patient's life to prevent complications of cystinosis. Cysteamine bitartrate delayed-release capsules (RP103) is a formulation of cysteamine bitartrate that is being studied to see if it can be given less frequently, once every 12 hours, and have similar results to four times a day Cystagon®.

ReferenceCitation: Dohil R, Fidler M, Barshop BA, Gangoiti J, Deutsch R, Martin M, Schneider JA. Understanding intestinal cysteamine bitartrate absorption. J Pediatr. 2006 Jun;148(6):764-9. doi: 10.1016/j.jpeds.2006.01.050.

ReferenceCitation: Fidler MC, Barshop BA, Gangoiti JA, Deutsch R, Martin M, Schneider JA, Dohil R. Pharmacokinetics of cysteamine bitartrate following gastrointestinal infusion. Br J Clin Pharmacol. 2007 Jan;63(1):36-40. doi: 10.1111/j.1365-2125.2006.02734.x.

ReferenceCitation: Levtchenko EN, van Dael CM, de Graaf-Hess AC, Wilmer MJ, van den Heuvel LP, Monnens LA, Blom HJ. Strict cysteamine dose regimen is required to prevent nocturnal cystine accumulation in cystinosis. Pediatr Nephrol. 2006 Jan;21(1):110-3. doi: 10.1007/s00467-005-2052-0. Epub 2005 Oct 27.

ReferenceCitation: Langman CB, Greenbaum LA, Grimm P, Sarwal M, Niaudet P, Deschenes G, Cornelissen EA, Morin D, Cochat P, Elenberg E, Hanna C, Gaillard S, Bagger MJ, Rioux P. Quality of life is improved and kidney function preserved in patients with nephropathic cystinosis treated for 2 years with delayed-release cysteamine bitartrate. J Pediatr. 2014 Sep;165(3):528-33.e1. doi: 10.1016/j.jpeds.2014.05.013. Epub 2014 Jun 16.

oa_colors: green hybrid

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Radboud University - Radboud Repository

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

repositories_concat: PubMed Central;repository.ubn.ru.nl

location_facility: Hôpital Arnaud Villeneuve - CHU Montpellier

location_facility: Texas Children's Hospital/Baylor University

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

location_facility: California Pacific Medical Center (CPMC) Research Institute

location_facility: Radboud University Nijmegen Medical Center

title: A Long-Term, Open-Label, Safety and Efficacy Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients With Cystinosis

location_country:
United States
Netherlands
France

ipd_sharing: Undecided


acronym: TENPIN

lead_sponsor: Astellas Pharma Inc

summary: Prevention of invasive fungal infection in high risk patients following liver transplant.

ReferenceCitation: Saliba F, Pascher A, Cointault O, Laterre PF, Cervera C, De Waele JJ, Cillo U, Langer RM, Lugano M, Goran-Ericzon B, Phillips S, Tweddle L, Karas A, Brown M, Fischer L; TENPIN (Liver Transplant European Study Into the Prevention of Fungal Infection) Investigators; TENPIN Liver Transplant European Study Into the Prevention of Fungal Infection Investigators. Randomized trial of micafungin for the prevention of invasive fungal infection in high-risk liver transplant recipients. Clin Infect Dis. 2015 Apr 1;60(7):997-1006. doi: 10.1093/cid/ciu1128. Epub 2014 Dec 17.

evidence: open (via page says license)

repository_institution: University of Padova - Padua Research Archive

repository_institution: Ghent University - Ghent University Academic Bibliography

repositories_institution: University of Antwerp - Institutional Repository University of Antwerp

publisher_dissemination: Oxford University Press

title: Randomized, Open Label, Non-inferiority Study of Micafungin Versus Standard Care for the Prevention of Invasive Fungal Disease in High Risk Liver Transplant Recipients

primary_purpose: Prevention

ipd_sharing_description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

location_country:
Germany
Ireland
Italy
Portugal
Hungary
United Kingdom
Romania
Sweden
Austria
Belgium
Saudi Arabia
Spain
Russian Federation
France


acronym: AS703026 in Hematological Malignancies

lead_sponsor: EMD Serono

summary:
This is an open-label, multi-center, dose-escalation trial of pimasertib (MSC1936369B) in blood and bone marrow cancers. The trial will be conducted in two parts:

Part 1 (safety run-in period): Will determine the maximum tolerated dose (MTD) of the study drug in subjects with advanced hematological malignancies.

Part 2: Will assess the anti-leukemic activity of the study drug in older subjects with newly diagnosed poor prognosis acute myeloid leukemia (AML) who are not candidates for intensive chemotherapy.

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: University of Texas - MD Anderson Cancer Center

location_facility: Hospital Hotel Dieu, Service D'Hematologie

location_facility: Hospital Edouard Herriot, Service d'Hematologie Clinique

location_facility: Hospital Saint Louis, Service des Maladies du Sang

location_facility: CHU du Haut-Leveque, Service des Maladies du Sang Unite de Recherche Clinique

title: Phase II Trial With Safety-Run-In of MEK Inhibitor MSC1936369B in Subjects With Poor Prognosis Acute Myeloid Leukemia and Other Hematological Malignancies


title: A Phase I/II Study of CP-4055 in Patients With Refractory/Relapsed Hematologic Malignancies

summary: Patients with refractory or relapsed hematologic malignancies will receive CP-4055 intravenously(IV) on Day 1-5 every three weeks until complete response or disease worsening/progressing

lead_sponsor: Clavis Pharma

location_country:
Germany
Italy
Norway
United Kingdom
United States
France

location_facility: Mew York Medical College, Division of Oncology

location_facility: Centre Hospitalier Universitaire CHU de Toulouse, Hopital Purpan

location_facility: Westfälische Wilhelms-Universität Münster Medizinische Klinik und Polikinik Innere Medizin A

location_facility: Department of Internal Medicine Klinikum der Johann Wolfgang Goethe-Universität Medizinische Klinik II

location_facility: University Hospital Benjamin Franklin Med.Clinic III

location_facility: Centre Hospitalier Universitaire, CHU de Lyon, Service d'Hematologie Clinique

location_facility: Institute for Drug Development (IDD), Cancer Therapy and Research Center, 7979 Wurzbach Rd.

location_facility: Department of Hematology, Ullevål University Hospital, University of Oslo

location_facility: Institute of Hematology & Medical Oncology L and A Serágnoli University of Bologna

location_facility: Universitá degli Studi di Roma Ematologia- Policlinico Tor Vergata

location_facility: Hematology Service, Hôpital Beaujon and Hôpital Avicenne


title: Phase II, Placebo Controlled, Parallel Group, Double Blind, Randomised, Multicentre Trial Comparing the Anastrozole (Arimidex®) Placebo Combination to the Anastrozole - ZD1839 (Iressa™) Combination as Neoadjuvant Treatment in Postmenopausal Women With Stage I-IIIB Breast Cancer and Oestrogen Receptor (ER) and/or Progesterone (PgR) Positive Tumours

summary: The purpose of this study is to compare the changes in a proliferation biomarker in subjects receiving Anastrozole or Anastrozole/ZD1839 combination.

lead_sponsor: AstraZeneca

location_country:
Portugal
Hungary
United Kingdom
Sweden
Spain
Czech Republic
France


title: A Prospective Multicenter, Parallel Group Study With A Single Blind Phase And A Double Blind Randomised Phase, To Evaluate The Efficacy And Satisfaction Of Viagra (Sildenafil Citrate) High Dose (100mg) Titration Compared With 50mg Dose, In Men With Erectile Dysfunction

summary: To evaluate the efficacy of Viagra dose titration to 100mg versus 50mg in men with erectile dysfunction, based on responses to the IIEF questionnaire as measured at the beginning and at the end of double blind treatment, comparing the group titrated to 100mg vs. the group maintained on 50mg.

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
France
Italy
United Kingdom
Spain
Greece
Canada
Russian Federation
Israel


title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Adults and Adolescents With Erythropoietic Protoporphyria or X-Linked Protoporphyria

acronym: INSPIRE

summary: To investigate the efficacy of MT-7117 on time to onset and severity of first prodromal symptoms (burning, tingling, itching, or stinging) associated with sunlight exposure in adults and adolescents with EPP or XLP.

status: Recruiting

lead_sponsor: Mitsubishi Tanabe Pharma America Inc.

location_country:
Italy
Poland
United Kingdom
Australia
Japan
Netherlands
United States
Spain
Czechia
Bulgaria
France

location_facility: Institute for Clinical and Experimental Medicine - IKEM

location_facility: Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Louis-Mourier

location_facility: U.O.C. Medicina Interna Azienda ospedaliero Universitaria Policlinico di Modena

location_facility: University of California at San Francisco

location_facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Materno-Infantile - Burlo Garofolo - Clinica Pediatrica

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre

location_facility: Azienda Sanitaria Ospedaliera Santa Croce E Carle - Cuneo

location_facility: Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia

location_facility: Southampton General Hospital - University Hospital Southampton NHS Foundation Trust

location_facility: The University of Texas Medical Branch (UTMB)

location_facility: Hospital General Universitario De Valencia

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano

location_facility: University Of Miami School Of Medicine, Center For Liver Diseases

location_facility: Hôpital Bichat - Hospital Bichat-Hopitaux Universitaires Paris Nord Val de Seine

location_facility: Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)

location_facility: University Multi-Profile Hospital for Active Treatment (UMHAT) St. Ivan Rilski - Porphyria Center


title: A Phase 3, Randomized, Double-blinded, Placebo-controlled, Multicenter Study to Evaluate Efficacy and Safety of ALXN1850 (Recombinant Alkaline Phosphatase) Administered Subcutaneously in Adolescent (12 to < 18 Years of Age) and Adult Participants With Hypophosphatasia Who Have Not Previously Been Treated With Asfotase Alfa

acronym: HICKORY

summary: The primary objective of this study is to assess the efficacy of ALXN1850 versus placebo on functional outcomes in adolescent and adult participants with HPP who have not previously been treated with asfotase alfa.

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing_description: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

lead_sponsor: Alexion Pharmaceuticals, Inc.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Czechia
Canada
France
Slovakia
United States
India
Belgium
China
Italy
United Kingdom
Austria
Korea, Republic of
Spain
Taiwan
Israel


title: CAMPFIRE: Children's and Young Adult Master Protocol for Innovative Pediatric Research

acronym: CAMPFIRE

summary: The main purpose of the master is to help the research sites and sponsor carry out several clinical trials more efficiently by providing a common research protocol. Individual clinical trials under this master protocol define drug/disease-specific research goals and activities to test them. New studies will be added as new drugs emerge against different cancers. Participation in the trial will depend on how long the benefit lasts.

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

lead_sponsor: Eli Lilly and Company

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

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Hyogo Prefectural Kobe Children's Hospital

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

location_facility: Seattle Children's Hospital Research Foundation

location_facility: Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia

location_facility: University of Texas Southwestern Medical Center at Dallas

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

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

location_facility: Children's Healthcare of Atlanta, Inc. at Egleston

location_facility: Golisano Children's Hospital of Southwest Florida


title: A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of Any Body Region (Except CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)

acronym: Quanti OBR

summary:
Researchers are looking for a better way to help people with any known or suspected problems (except brain or spinal cord-related problems) scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI).

MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject contrast agent into a patient's vein to perform a "contrast-enhanced" MRI (CE-MRI). Such CE-MRI may help identify certain health problems or improve the evaluation.

The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI.

The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect known or suspected problems (except brain or spinal cord-related problems) with gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent.

The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein.

Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits.

At the start or during the study, the doctors and their study team will:

take blood and urine samples
do physical examinations
check blood pressure and heart rate
review the MRI scans obtained in the study and decide on the diagnosis
ask the participants questions about how they are feeling and what adverse events they are having.

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

primary_purpose: Diagnostic

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

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

lead_sponsor: Bayer

location_country:
Germany
Italy
Poland
Hungary
Argentina
United Kingdom
Japan
Sweden
United States
China
Korea, Republic of
Turkey
Taiwan
Czechia
Bulgaria
Canada
France

location_facility: Karolinska University Hospital Huddinge Radiology

location_facility: Clinica Universitaria Reina Fabiola | Consultorios Externos

location_facility: London Health Sciences Centre (LHSC) - University Hospital

location_facility: Sanatorio Allende | Departamento de Investigación Clínica

location_facility: Acibadem City Clinic | University Multiprofile Hospital for Active Treatment Tokuda - Radiology Department

location_facility: Instituto Alexander Fleming | Sede Central - Departamento de Diagnostico por Imagenes

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Taipei Medical University - Shuang Ho Hospital

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Centre Hospitalier Universitaire - Angers

location_facility: Universitätsmed Göttingen Institut f. Diag&Interv Radiologie

location_facility: Hospital of the University of Occupational and Environmental Health, Japan

location_facility: Universitätsklinikum Essen - Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie - 21197

location_facility: University of Missouri Hospital and Clinic - Neuroradiology

location_facility: The First Affiliated Hospital of Jinan University

location_facility: National Hospital Organization Kanmon Medical Center

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Japan Organization of Occupational Health and Safety Sanin Rosai Hospital

location_facility: Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz, Kozponti Diagnosztikai Centrum

location_facility: Multiprofile Hospital for Active Treatment Central Onco Hospital | Independent Medical Diagnostic Laboratory Mediscan

location_facility: Helios Herzzentrum Leipzig - Abteilung für Radiologie

location_facility: Universitätsklinikum Aachen / Klinik für Diagnostische und Interventionelle Radiologie

location_facility: University Multiprofile Hosp. for Active Treat. Sveti Ivan

location_facility: Princess Margaret Hospital-University Health Network

location_facility: Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital

location_facility: Nanfang Hospital, Southern Medical University

location_facility: Huai'an First People's Hospital, Nanjing Medical University

location_facility: Centre Hospitalier Universitaire de Dijon

location_facility: Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi

location_facility: Koc Universitesi Tip Fakultesi - Radyoloji

location_facility: University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Radiology Department

location_facility: Lokman Hekim Universitesi Tip Fakultesi - Radyoloji

location_facility: Pennsylvania State University College of Medicine

location_facility: Beijing Chaoyang Hospital, Capital Medical University

location_facility: Chi Mei Medical Center - Medical Imaging Department

location_facility: Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice

location_facility: National Hospital Organization Kanazawa Medical Center

location_facility: Public Central Hospital of Matto Ishikawa

location_facility: Taipei Medical University Hospital - Medical Imaging department

location_facility: Binali Yildirim Universitesi Mengucek Gazi EAH - Radyoloji

location_facility: University Multiprofile Hospital for Active Treatment Sveti Georgi | Base II - Imaging Diagnostic Department

location_facility: University Multiprofile Hospital for Active Treatment Dr Georgi Stranski Pleven | Surgery Department


title: A Randomized, Double-blind Study Evaluating Pharmacokinetic Similarity of ABP 206 Compared With OPDIVO® (Nivolumab) in Resected Stage III or Stage IV Melanoma Subjects in the Adjuvant Setting

summary: The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of ABP 206 compared with OPDIVO® (nivolumab) in subjects with resected advanced melanoma.

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

lead_sponsor: Amgen

location_country:
Germany
Italy
Taiwan
Japan
Brazil
Netherlands
United States
Bosnia and Herzegovina
Korea, Republic of
Spain
Malaysia
Croatia
Chile
South Africa
Thailand
Georgia
Serbia
France

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.R.L

location_facility: Azienda ospedaliero Universitaria Senese - Policlinico Le Scotte

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: Nagoya City University Hospital - Dermatology

location_facility: Kumamoto University Hospital - Dermatology

location_facility: Institute for Oncology and Radiology of Serbia

location_facility: King Chulalongkorn Memorial Hospital [Medical Oncology]

location_facility: Hospital Universitario Virgen De La Macarena

location_facility: Taipei Municipal Wanfang Hospital - Managed by Taipei Medical University

location_facility: University Clinical Centre of the Republic of Srpska - Gastroenterology

location_facility: Charité - Universitätsmedizin Berlin KöR

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Taipei Medical University - Shuang Ho Hospital Ministry of Health and Welfare


title: A Phase 1/2 Study of BMS-986449 Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors

summary: The purpose of this study is to evaluate the safety and efficacy of BMS-986449 alone and in combination with nivolumab in participants with advanced solid tumors.

ipd_sharing_description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Netherlands
Belgium
United States
Spain
France

location_facility: Yale New Haven Hospital-Smilow Cancer Center

location_facility: The Angeles Clinic and Research Institute - West Los Angeles Office

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

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

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII


title: A Phase 1, Multicenter, Open-Label Study Of CC-97540 (BMS-986353), CD19-Targeted Nex-T Chimeric Antigen Receptor (CAR) T Cells, in Participants With Severe, Refractory Systemic Lupus Erythematosus (SLE)

summary: The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory Systemic Lupus Erythematosus (SLE).

ipd_sharing_description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

lead_sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

collaborators: Bristol-Myers Squibb Services Unlimited Company

location_country:
Germany
Italy
Belgium
United States
Spain
France

location_facility: Atlantic Health System Overlook Medical Center

location_facility: The University of Texas Health Science Center at Houston

location_facility: University of Massachusetts Chan Medical School

location_facility: Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou

location_facility: Washington University School of Medicine

location_facility: Columbia University Irving Medical Center

location_facility: The University of North Carolina at Chapel Hill


title: An Open-Label, Multicenter Switch Study Evaluating Changes in Blood Pressure in Participants With Narcolepsy Switching From High-Sodium Oxybate to XYWAV

summary: The aim of this study is to quantify the change in blood pressure when participants with narcolepsy treated with high-sodium oxybate are transitioned to XYWAV, a low-sodium oxybate. The results of this study may provide health care providers (HCPs), patients, and payers with important new information regarding BP changes related to differences in sodium content between available oxybates for the treatment of narcolepsy.

lead_sponsor: Jazz Pharmaceuticals

location_country:
Italy
Belgium
United States
Spain
Czechia
France

location_facility: University Hospitals Cleveland Medical Center

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Advanced Respiratory and Sleep Medicine, PLLC

location_facility: Florida Pediatric Research Institute, LLC

location_facility: Ospedale San Raffaele (San Raffaele Turro)

location_facility: IRCCS Istituto de Scienze Neurologiche di Bologna (ISNB)

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Hospital Universitario Araba - Sede Santiago


title: A Multicenter Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Target Engagement of GSK3858279 in Adult Participants With Chronic Diabetic Peripheral Neuropathic Pain (DPNP) /NEPTUNE-17

summary: This is a multicenter randomized, double-blind, placebo-controlled phase 2 study to evaluate efficacy, safety, tolerability, pharmacokinetics, and target engagement of GSK3858279 in adult participants with chronic Diabetic Peripheral Neuropathic Pain (DPNP). The primary objective of the study is to assess the efficacy of GSK3858279 in participants with DPNP who have been unable to sufficiently manage their pain.

ipd_sharing_description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Poland
United Kingdom
Japan
United States
China
Korea, Republic of
Spain
South Africa
Turkey
Canada
France


title: A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions

summary: The main aim is to evaluate the safety and tolerability of TAK-861 on participants with type 1 and type 2 narcolepsy from previous parent studies, TAK-861-2001 (NCT05687903) and TAK-861-2002 (NCT05687916).

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.

lead_sponsor: Takeda

location_country:
Germany
Finland
Italy
Norway
Australia
Japan
Netherlands
Sweden
Switzerland
United States
Spain
France

location_facility: Stanford Center for Sleep Sciences and Medicine

location_facility: Medical University of South Carolina - PPDS

location_facility: Istituto Neurologico Mediterraneo Neuromed

location_facility: Universitaet Regensburg am Bezirksklinikum

location_facility: Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH

location_facility: Hospital Universitario Vall d'Hebron - PPDS


title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of Care in Refractory Status Epilepticus

summary: This is a multicenter, double-blind, randomized, placebo-controlled study that will evaluate the efficacy, safety, and tolerability of intravenous (IV) ganaxolone versus placebo co-administered with IV antiepileptic drug (AED) according to standard of care for the treatment of RSE. Approximately 70 participants will be randomized in a 1:1 ratio to receive ganaxolone IV solution or placebo IV solution along with standard of care (SOC) IV AED.

lead_sponsor: Marinus Pharmaceuticals

location_country:
Finland
Germany
Italy
Lithuania
Poland
Hungary
Israel
Denmark
United Kingdom
Switzerland
Austria
Belgium
Spain
Croatia
Czechia
France

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Azienda Ospedaliera Universitaria di Modena

location_facility: University of Osnabruck, Dep of Neurology, Osnabrück

location_facility: Universität- und Rehabilitationskliniken Ulm, RKU

location_facility: Paracelsus Medical University Salzburg, Christian Doppler University Hospital, Department of Neurology

location_facility: National Institute of Clinical Neurosciences

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Hôpital Universitaire de Bruxelles - Hôpital Erasme

location_facility: Vilnius University Hospital Santaros Klinikos

location_facility: Mazaryk University, Brno,The First Department of Neurology


title: A Multicenter, Phase 3, Open-Label Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mirikizumab in Participants 2 Years to Less Than 18 Years of Age With Moderately to Severely Active Ulcerative Colitis

summary: The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).

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

location_facility: Women'S and Children'S Hospital, Adelaide

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Uniwersytecki Szpital Dziecięcy w Krakowie

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Universitätsmedizin Mainz, Klinik und Poliklinik für Kinder

location_facility: National Center for Child Health and Development

location_facility: London Health Sciences Centre (LHSC) - Victoria Hospital

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.

location_facility: Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

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

location_facility: Instytut "Pomnik - Centrum Zdrowia Dziecka"

location_facility: University of California-San Francisco-Mission Bay

location_facility: Massachusetts General Hospital for Children

location_facility: Children's Center for Digestive Health Care, LLC

location_facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Cincinnati Childrens Hospital Medical Center

location_facility: Hadassah University Hospital - Mount Scopus

location_facility: Yokohama City University Medical Center, Center of IBD


title: A Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of CAL02 Administered Intravenously in Addition to Standard of Care in Subjects With Severe Community-Acquired Bacterial Pneumonia (SCABP)

summary: This is a placebo-controlled study to evaluate the addition of CAL02 to standard of care in treating hospitalized subjects diagnosed with severe community acquired bacterial pneumonia (SCABP) requiring critical care measures

lead_sponsor: Eagle Pharmaceuticals, Inc.

location_country:
Hungary
Argentina
Romania
Brazil
United States
Latvia
Spain
South Africa
Chile
Czechia
Georgia
France

location_facility: Pontificia Universidad Catolica de Chile

location_facility: LTD Simon Khechinashvili University Hospital

location_facility: Oblastní nemocnice Kolín, a.s., nemocnice Středočeského kraje

location_facility: Unidade de Pesquisa Clinica da Faculdade de Medicina de Botucatu

location_facility: Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatov

location_facility: Hospital Universitario de Tarragona Joan XXIII

location_facility: Hospital Interzonal General de Agudo Dr Jose Pena

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Hospital de Alta Complejidad Cuenca Alta SAMIC

location_facility: Pius Brinzeu County Emergency Clinical Hospital


title: A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active-Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants With Atrial Fibrillation

acronym: LIBREXIA-AF

summary: The purpose of this study is to evaluate if milvexian is at least as effective as apixaban for reducing the risk of the composite stroke and non- central nervous system (CNS) systemic embolism.

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

lead_sponsor: Janssen Research & Development, LLC

sponsor_collaborators:
Janssen Research & Development, LLC
Bristol-Myers Squibb

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Japan
Chile
Czechia
Canada
France
Lithuania
Portugal
Slovakia
Hungary
Denmark
United States
Romania
Belgium
Estonia
Italy
United Kingdom
Netherlands
Spain
South Africa
Taiwan
Bulgaria

location_facility: Poradnia Kardiologiczna Jaroslaw Jurowiecki

location_facility: Gemeinschaftspraxis Dres. Hagemann und Breiderhoff

location_facility: GFO Kliniken Bonn, Betriebsstaette St. Marien

location_facility: Hausärztlich-Kardiologisches MVZ Am Felsenkeller GmbH

location_facility: Cabinet Medical Cardiologie Cojocariu Titel Razvan

location_facility: SANTA FAMILIA Centrum Badan, Profilaktyki i Leczenia

location_facility: Dr. Nagy Laszlo Kardiologiai Maganrendeles

location_facility: Vita Verum Medical Egeszsegugyi Szolgaltato Bt.

location_facility: Medizinisches Versorgungszentrum Prof. Mathey, Prof. Schofer GmbH

location_facility: Internal Medicine Associates of Anderson

location_facility: Mission Cardiovascular Research Institute

location_facility: Centrul Medical de Diagnostic si Tratament Ambulator NEOMED

location_facility: National Hospital Organization Mito Medical Center

location_facility: The Cardiac & Vascular Institute Research Foundation

location_facility: West Houston Area Clinical Trial Consultants LLC

location_facility: Medizinisches Versorgungszentrum (MVZ) Dachau

location_facility: Multiprofile Hospital For Active Treatment National Cardiology Hospital, Ead

location_facility: Public Central Hospital of Matto Ishikawa

location_facility: Fondazione Toscana Gabriele Monasterio CNR

location_facility: MUDr. Zdenek Vomacka kardiologie a interna s.r.o.

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: Institutul de urgenta pentru Boli Cardiovasculare Prof. Dr. C.C. Iliescu Sectia cardiologie III

location_facility: MCBK Iwona Czajkowska Anna Podrażka- Szczepaniak S.C.

location_facility: Bay Area Cardiology Associates, P.A. - Brandon Office

location_facility: Centrum Medyczne Zdrowa J. Trębacz W. Zajdel s.j.

location_facility: PriMed Physicians, A Member of NE Medical Group

location_facility: The Wesley - St Andrew's Research Institute

location_facility: B.Miklaszewicz&D.Dabrowski CARDIMED Spolka Jawna

location_facility: Amarillo Heart Clinical Research Institute

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Paradigm Clinical Research Centers, Inc.

location_facility: Katholisches Klinikum Mainz; Innere Medizin I- Kardiologie

location_facility: Cardiology Associates of Fairfield County

location_facility: GP Dr. Haggenmiller PD Dr. Michael Jeserich

location_facility: UMHAT 'Heart and Brain Center for Excellence'

location_facility: Multiprofile Hospital for Active Treatment - Haskovo

location_facility: Centro Hospitalar Lisboa Ocidental - Hospital São Fracisco Xavier

location_facility: Western Connecticut Health Network/Danbury Hospital

location_facility: Private Practice - Dr. Krzysztof Cymerman

location_facility: Luminis Health Anne Arundel Medical Center

location_facility: Louisiana State University Health Sciences Center

location_facility: Cardiology Consultants of South Georgia Inc

location_facility: Centro Hospitalar Cova da Beira, EPE - Hospital Pêro da Covilhã

location_facility: ClinPhenomics GmbH Co KG Studienzentrum Frankfurt

location_facility: Sekishinkai Second Kawasaki Saiwai Clinic

location_facility: MUDr. Jan KVASNICKA CSc. Angiologie kardiologie a interna

location_facility: Helping Hands Health Center dba Helping Hands Evolution Research

location_facility: National Hospital Organization Kanazawa Medical Center

location_facility: The Curators of the University of Missouri on behalf of University of Missouri Health Care

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel

location_facility: Kardiologicka ambulancia MEDI M&M s.r.o.

location_facility: Lunacor s.r.o. - Ambulance kardiologie Centrum pro choroby srdce a cev

location_facility: St. Francis Physician Services, Inc, DBA Upstate Cardiology Research

location_facility: California Medical Research Associates, Inc.

location_facility: Klaipeda Seamen's Hospital, Public Institution

location_facility: Clinical Research Unit, University of Pretoria

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Centro de Estudios Cardiologicos y de Medicina Interna

location_facility: Hyogo Prefectural Amagasaki General Medical Center

location_facility: Cardiology Partners Clinical Research Institute

location_facility: Kenshinkai Minamino Cardiovascular Hospital

location_facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E

location_facility: Ascension Medical Group - St. John Clinic Infectious Disease

location_facility: Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika

location_facility: Medispol s.r.o Interna a kardiologicka ambulancia


title: A Phase 3, Multicenter, Long-Term Extension Study to Assess the Safety and Efficacy of Lebrikizumab in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

summary: The main purpose of this study is to assess the long-term safety and efficacy of lebrikizumab in participants 6 Months to <18 years of age with moderate-to-severe atopic dermatitis

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Mexico
United States
Spain
Taiwan
Canada
France

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden

location_facility: Chang Gung Memorial Hospital at Kaohsiung

location_facility: Hospital Universitario de Gran Canaria Doctor Negrín

location_facility: Respiratory Medicine Research Institute of Michigan, PLC

location_facility: CHOP-Centro De Especialidades De Mollabao

location_facility: PanAmerican Clinical Research - Cuernavaca

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: The University of Texas Health Science Center at Houston

location_facility: Integrative Skin Science and Research - Location 2

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: University Hospital,Kyoto Prefectural University of Medicine

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: The Pennsylvania Centre for Dermatology, LLC

location_facility: National Hospital Organization Sagamihara National Hospital

location_facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

location_facility: National Taiwan University Hospital - Hsinchu branch

location_facility: Instituto de Neumonología Y Dermatología

location_facility: Hospital Infantil de Mexico Federico Gomez

location_facility: Okayama City General Medical Center Okayama City Hospital

location_facility: Chang Gung Medical Foundation-Linkou Branch

location_facility: Centrum Badan Klinicznych PI-House sp. z o.o.


title: A Phase 2 Clinical Trial Investigating Oncolytic Immunotherapy in Combination With Atezolizumab and Bevacizumab for the Treatment of Patients With Advanced Microsatellite Stable and Mismatch Repair Proficient Colorectal Carcinoma

summary: This is an open-label, nonrandomized, Phase 2 clinical trial evaluating therapy with an oncolytic immunotherapy (RP2 or RP3) in combination with atezolizumab and bevacizumab in patients with advanced Microsatellite Stable and Mismatch Repair Proficient Colorectal Carcinoma.

lead_sponsor: Replimune Inc.

sponsor_collaborators:
Replimune Inc.
Roche Pharma AG

location_country:
Germany
United Kingdom
United States
Spain
France

location_facility: University of Washington Seattle Cancer Care Alliance

location_facility: University of Pennsylvania, Abramson Cancer Center

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Uniklinikum Heidelberg National Center for Tumors Heidelberg (NCT)

location_facility: LMU Klinikum, Medizinische Klinik und Poliklinikum III

location_facility: Centre Georges Francois Leclerc, Department of Oncology

location_facility: University of North Carolina at Chapel Hill

location_facility: Université Claude Bernard Lyon 1, Centre Hospitalier Lyon Sud

location_facility: Vall d' Hebron Institute of Oncology (VHIO) Hospital Universitario Vall d'Hebron

intervention_type: Biological


title: Millipede AspiRation for Revascularization in Stroke (MARRS) Study

acronym: MARRS

summary: The objectives of the study are to examine the performance and safety characteristics of the Millipede System when used for revascularization of patients with acute ischemic stroke due to Large Vessel Occlusions (LVOs) and to record associated clinical outcomes.

lead_sponsor: Perfuze

location_country:
United States
Spain
France

location_facility:
OHSU
Hôpital Fondation Adolphe de Rothschild
Thomas Jefferson
Stony Brook University Hospital
CHU Montpellier
Chru de Nancy
CHU de Toulouse
Yale University Hospital
Tampa General Hosital
UPMC
Emory
Vall d'Hebron
Valley Baptist Medical Center


title: A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)

summary:
The main aim of this study is to see how TAK-861 works on symptoms of narcolepsy, including excessive daytime sleepiness and cataplexy. Approximately 100 participants will take part in the study across North America, Europe and Asia Pacific.

The treatment (TAK-861 or placebo) will be administered for 8 or 12 weeks. After this treatment period the participant will have the option to participate in a separate, long- term extension study during which all participants will be treated with TAK-861.

location_facility: Woolcock Institute of Medical Research, Sleep and Circadian Research Group

location_facility: Stanford Center for Sleep Sciences and Medicine

location_facility: St. Lukes Sleep Medicine and Research Center

location_facility: IRCCS Istituto delle Scienze Neurologiche di Bologna, Dipartimento di Scienze Biomediche e Neuromotorie

location_facility: Delta Waves LLC - Hunt - PPDS, Sleep Disorder and Research Center

location_facility: National Center of Neurology and Psychiatry

location_facility: Medical University of South Carolina - PPDS

location_facility: Comprehensive Sleep Medicine Associates - Sugar Land

location_facility: RESM respiratory and sleep medical-care clinic, Yokoharna Building, 4Floor

location_facility: Istituto Neurologico Mediterraneo Neuromed, Centro Per La Diagnosi E la Cura Del Sonno

location_facility: Hospital General de Castello, Sleep Unit

location_facility: Universitaet Regensburg am Bezirksklinikum

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

location_facility: Somni Bene Institut fur Medizinische Forschung und Schlafmedizin Schwerin GmbH

location_facility: Universitaetsspital Bern, Department of Neurology

location_facility: Hospital Universitario Araba Santiago, Unidad Funcional de Sueno

location_facility: Gokeikai Osaka Kaisei Hospital, Yodogawa-Ku

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Fondazione PTV Policlinico Tor Vergata, Centro del Sonno e del Trattamento Neurologico delle Fragilta

location_facility: Hospital Clinic de Barcelona, Neurology Service, scale 8-4th floor


title: Open-label, Long-term Safety and Efficacy Study of Mim8 in Participants With Haemophilia A With or Without Inhibitors

summary: This study is looking at how Mim8 works in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used to avoid bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). When and how often the participants will receive Mim8 in this study depends on the treatment participant receives in the current Mim8 study participant is taking part in. The study will last for up to 5.5 years. The duration of the study depends on when the participant enrolled in this study. The study will end if Mim8 is approved and marketed in participant's country during the study, or the study will end in 2028, whichever comes first. Mim8 will be injected under the skin with a thin needle either once a week, once every two weeks or once a month. Participants will get up to 262 injections; the number of injections depends on how often participants will get injections. While taking part in this study, there are some restrictions about what medicine participants can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

lead_sponsor: Novo Nordisk A/S

location_country:
Germany
Ireland
Poland
Japan
Turkey
Canada
Serbia
France
Lithuania
Portugal
Slovakia
Denmark
Switzerland
United States
Latvia
India
Romania
Belgium
China
Malaysia
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Saudi Arabia
Spain
South Africa
Taiwan
Bulgaria
Israel


title: An Integrated Pharmacokinetic and Safety Open-label Basket Trial of Daprodustat for the Treatment of Anemia Associated With Chronic Kidney Disease in Male and Female Children and Adolescents Aged 3 Months to Under 18 Years Requiring or Not Requiring Dialysis

acronym: ASCEND-P

summary:
This is an international, multicenter trial, evaluating pharmacokinetics (PK) (4 weeks), safety (52 weeks), and hemoglobin (Hgb) response (52 weeks) to daprodustat in children and adolescent participants with anemia associated with chronic kidney disease (CKD) incorporating 2 independent sub-trials (Non dialysis [ND] and Dialysis [D]). This study will enroll participants with anemia associated with CKD, in 2 distinct sub-populations differing only by their CKD stage and dialysis requirement (ND: CKD stage 3 to 5 not yet receiving dialysis and D: CKD stage 5d undergoing peritoneal dialysis [PD] or hemodialysis [HD]).

The maximum duration of the study will be approximately 60 weeks, including Screening period (up to 4 weeks), treatment period (52 weeks), and follow-up period (4 weeks).

Outcome measures are identical for the ND and D sub-trials, but will be separately assessed in each sub- trials, overall and within each age subgroups (12 to less than [<] 18 years, 6 to <12 years, 2 to <6 years, and 3 months to <2 years). Except for PK and dose change, which is within each age group only.

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
Japan
Netherlands
Austria
Belgium
United States
Korea, Republic of
Spain
Turkey
Canada
France


title: A Three-year, Multi-center, Double-blind, Extension Study to Evaluate the Long-term Safety and Efficacy of Ligelizumab in Patients Who Completed Ligelizumab's Phase III Studies in Food Allergy

summary: This is an extension study to evaluate the long-term safety and efficacy of ligelizumab in particiants who have completed a ligelizumab Phase III study in food allergy.

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Australia
Japan
Netherlands
United States
Spain
Canada
France


title: A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Vamikibart Administered Intravitreally in Patients With Uveitic Macular Edema

acronym: Sandcat

summary: This study will assess the efficacy and safety of vamikibart in participants with uveitic macular edema.

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Argentina
Singapore
Australia
Japan
Switzerland
United States
Spain
Turkey
Czechia
France

location_facility: Hospital Universitari de Bellvitge; Servicio de Oftalmologia

location_facility: Tokyo Medical and Dental University Hospital

location_facility: National University Hospital; Ophthalmology Department

location_facility: University of Michigan, Kellogg Eye Center

location_facility: Fundacion Jimenez Diaz-UTE; Servicio Oftalmologia

location_facility: Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum; Ophthalmology

location_facility: Städtisches Klinikum Dessau; Augenklinik

location_facility: Universitätsklinikum Freiburg, Klinik für Augenheilkunde

location_facility: Nippon Medical School Tama Nagayama Hospital

location_facility: Hacettepe University Medical Faculty; Department of Ophthalmology

location_facility: University Retina and Macula Associates, PC

location_facility: California Eye Specialists Medical group Inc.

location_facility: Retina Consultants of Texas; Katy Retina Center

location_facility: Jichi Medical University Saitama Medical Center

location_facility: University of Wisconsin; Ophthalmology and Visual Sciences

location_facility: National Defense Medical College Hospital

location_facility: Inselspital Bern Ophthalmologische Klinik

location_facility: Hopital de la croix rousse; Ophtalmologie

location_facility: Cleveland Clinic Foundation; Cole Eye Institute

location_facility: Kobe University Hospital; Endocrine Internal Medicine

location_facility: Hospital Clinic Barcelona; Servicio Oftalmologia

location_facility: General Teaching Hospital Prague; Ophthalmology clinic

location_facility: Ankara University Medical Faculty; Department of Ophthalmology

location_facility: Japan Community Health care Organization Osaka Hospital

location_facility: Centre Paradis Monticelli; Ophtalmologie

location_facility: Northern California Retina Vitreous Associates

location_facility: Istanbul University Cerrahpasa Faculty of Medicine

location_facility: Kaiser Permanente Riverside Medical Center

location_facility: Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde

location_facility: Stadtspital Triemli Ophthalmologische Klinik

location_facility: University of California, Davis, Eye Center

location_facility: University of Arkansas For Medical Sciences

location_facility: Retina Consultants of Southern California

location_facility: Hospital Universitario Miguel Servet; Servicio de Oftalmologia


title: A Phase 2 Double-blind, Randomized, Placebo-controlled Study Evaluating the Effect of SAR443820 on Serum Neurofilament Levels in Participants With Multiple Sclerosis, Followed by an Open-label Long-term Extension Period

summary:
This is a Phase 2, randomized, double-blind, placebo-controlled 2 parallel-arm study to assess the effect on serum neurofilament light chain (sNfL), safety and tolerability of oral SAR443820 compared to placebo in male and female participants aged 18 to 60 years with relapsing-remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS) (relapsing or non-relapsing), or primary progressive multiple sclerosis (PPMS) followed by an open-label long-term extension period.

The total study duration is approximately 100 weeks and includes the following:

4-week screening period 48-week double-blind treatment period (Part A) 48-week open-label long-term extension period (Part B)

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: Sanofi

location_country: Germany Italy Poland Belgium China Spain Chile Bulgaria Canada France

location_facility:
Investigational Site Number : 3800002
Investigational Site Number : 2500004
Investigational Site Number : 1000003
Investigational Site Number : 1560002
Investigational Site Number : 3800001
Investigational Site Number : 3800004
Investigational Site Number : 2760002
Investigational Site Number : 1240001
Investigational Site Number : 0560001
Investigational Site Number : 2500001
Investigational Site Number : 1560004
Investigational Site Number : 7240002
Investigational Site Number : 6160005
Investigational Site Number : 2760006
Investigational Site Number : 6160003
Investigational Site Number : 7240006
Investigational Site Number : 7240005
Investigational Site Number : 2500003
Investigational Site Number : 1560003
Investigational Site Number : 7240004
Investigational Site Number : 1240002
Investigational Site Number : 2500002
Investigational Site Number : 7240003
Investigational Site Number : 6160004
Investigational Site Number : 7240001
Investigational Site Number : 6160006
Investigational Site Number : 3800005
Investigational Site Number : 1520002
Investigational Site Number : 2760004
Investigational Site Number : 1000002
Investigational Site Number : 6160001
Investigational Site Number : 1240004
Investigational Site Number : 2760005
Investigational Site Number : 1520001
Investigational Site Number : 1560001
Investigational Site Number : 1240003
Investigational Site Number : 1000001
Investigational Site Number : 0560002
Investigational Site Number : 3800003
Investigational Site Number : 6160002
Investigational Site Number : 0560003


title: A Phase 1, Open-label, Multicenter Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors

summary: The aim of this study is to assess the safety and tolerability of BMS-986360 as monotherapy and in combination with chemotherapy or nivolumab in participants with advanced solid tumors.

location_country:
Italy
Argentina
Australia
Mexico
United States
Spain
Chile
Canada
France

location_facility: St Vincent's Hospital - The Kinghorn Cancer Center

location_facility: South Texas Accelerated Research Therapeutics (START)

location_facility: The Angeles Clinic and Research Institute - West Los Angeles Office

location_facility: John Theurer Cancer Center at Hackensack University Medical Center


title: A Phase 2, Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of SOT101 in Combination With Cetuximab in Patients With RAS Wild-type Colorectal Cancer

summary: The primary objective of the study is to estimate the antitumor efficacy of nanrilkefusp alfa (SOT101) in combination with cetuximab in RAS wild-type colorectal cancer.

lead_sponsor: SOTIO Biotech AG

location_country: Italy Belgium Spain Czechia France

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Grand Hopital de Charleroi - Hopital Notre Dame

location_facility: Universitaire Ziekenhuizen (UZ) Leuven - Campus Gasthuisberg - Klinische Digestieve Oncologie

location_facility: Vseobecna fakultni nemocnice v Praze (VFN)

location_facility: Fakultni nemocnice Hradec Kralove (FNHK)

location_facility: Vall d'Hebron Institut d'Oncologia (VHIO)


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-1)

acronym: POETYK SLE-1

summary: The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.

ipd_sharing_description:
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.

Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at:

https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

location_country:
Germany
Ireland
Poland
Argentina
Brazil
Turkey
Canada
France
Lithuania
Colombia
Portugal
Hong Kong
United States
India
Romania
China
Peru
Puerto Rico
Italy
Mexico
Korea, Republic of
Bulgaria

location_facility: The Feinstein Institute for Medical Research

location_facility: Private Practice - Dr. Chandrakant V. Mehta

location_facility: The University of Arizona Arthritis Center

location_facility: Advanced Rheumatology of Houston - Woodlands

location_facility: University of Washington Medical Center - Montlake

location_facility: The First Affiliated hospital of Xiamen University

location_facility: The First People's Hospital of Changzhou

location_facility: Arthritis & Osteoporosis Medical Center - La Palma

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Atlantic Health System Overlook Medical Center

location_facility: Private Practice - Dr. Carina Anna Triff

location_facility: Indiana University Health University Hospital

location_facility: The First Affiliated Hospital of Henan University of Science &Technology

location_facility: University of Florida College of Medicine

location_facility: Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau

location_facility: UCLA Clinical & Translational Research Center (CTRC)

location_facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

location_facility: Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

location_facility: Instituto De Investigaciones Clinicas Quilmes

location_facility: University of Miami Hospital and Clinics, Sylvester Cancer Center

location_facility: APRILLUS Asistencia e Investigacion Clinica

location_facility: Private Practice - Dr. Hans Richard Barthel

location_facility: The first Affiliated Hospital, Zhejiang University School of Medicine

location_facility: Arthritis & Rheumatology Research Institute


title: A Global, Non-interventional Study to Prospectively Evaluate Bleeding Episodes and Treatment Use in Patients With Hemophilia

summary: The primary objective of this study is to obtain prospective baseline documentation of annualized bleeding rates (ABRs) and treatment under standard-of-care (SOC) therapy among participants with hemophilia A or B. Participants in the study may be eligible to enroll in future planned interventional studies to be conducted by Sponsor.

lead_sponsor: ApcinteX Ltd

sponsor_collaborators:
ApcinteX Ltd
Centessa Pharmaceuticals plc

location_country:
Germany
Barbados
Italy
Poland
India
United Kingdom
Australia
Brazil
United States
Spain
Armenia
South Africa
Turkey
Taiwan
Canada
Egypt
France

location_facility: Fundacao de Desenvolvimento da Unicamp FUNCAMP

location_facility: Klinik fur Angiologie Hamostaseologie Haus 12 A Gerinnungssprechstunde

location_facility: Hospital Regional Universitario de Malaga Hospital Carlos Haya - Hospital Materno-Infantil

location_facility: Hospices Civils de Lyon (HCL) - Hopital Femme-Mere-Enfant (HFME)

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

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

location_facility: Centre of Haematology named after prof. R. O. Yeolian

location_facility: HEMOES - Centro de Hemoterapia e Hematologia do ES

location_facility: University Hospitals Birmingham NHS FOUNDATION TRUST

location_facility: Hospital Clínico Universitario Virgen de la Arrixaca

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie

location_facility: The Centre for Haemostasis and Thrombosis St Thomas Hospital

location_facility: Barts and London School of Medicine and Dentistry

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Ege University Medical Faculty Pediatric Hospital

location_facility: AOU Ospedale S. Maria della Misericordia

location_facility: K J Somaiya Super Speciality Hospital & Research Centre

intervention_type: Other


title: An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Shoulder Arthroplasty Clinical and Radiographic Outcomes

summary: The objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data in order to better understand the safety and performance of the shoulder arthroplasty over time. This study will follow subjects long-term for a minimum of 10-years, without an early-term restriction on the amount of time they will be followed.

time_perspective: Other

lead_sponsor: Exactech

location_country:
United States
Italy
United Kingdom
France

location_facility: UF Health Orthopaedics and Sports Medicine Institute

location_facility: Yeovil District Hospital NHS Foundation Trust

location_facility: Steadman Hawkins Clinic of the Carolinas

location_facility: Gloucester Royal Hospital Foundation Trust

location_facility: Southeastern Sports Medicine and Orthopedics

location_facility: Orthopaedic and Spine Center of the Rockies

location_facility: Hospital for Joint Diseases - NYU Langone Health