title: A Multi-Center Randomised Open-Label Phase 2 Study to Assess the Safety, Tolerability and Efficacy of Fimaporfin-Induced Photochemical Internalisation of Gemcitabine Complemented by Gemcitabine/Cisplatin Chemotherapy Versus Gemcitabine/Cisplatin Alone in Patients With Inoperable Cholangiocarcinoma

acronym: RELEASE

summary: This study will assess the safety and effectiveness of fimaporfin-induced photochemical internalisation (PCI) of gemcitabine complemented by systemic gemcitabine/cisplatin chemotherapy compared to gemcitabine/cisplatin alone, in patients with inoperable cholangiocarcinoma (CCA). Participants will be randomly assigned to one of the treatment groups and will receive study treatment for 6 months, followed by assessments every 3 months, as applicable.

lead_sponsor: PCI Biotech AS

location_country:
Italy
Sweden
Germany
Finland
France
Poland
Norway
Belgium
Spain
Denmark
United States
Korea, Republic of
Taiwan
Ukraine

location_facility: Hospital Universitario HM Sanchinarro - CIOCC

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Kyungpook National University Chilgok Hospital, 807 Hoguk-ro, Buk-gu

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital, 222 Banpo-Daero Seocho-gu

location_facility: National Cancer Center, 323 Ilsan-ro, Ilsandong-gu

location_facility: Oslo Universitetssykehus HF Radiumhospitalet

location_facility: Pusan National University Hospital, 179 Gudeok-ro, Seo-gu

location_facility: University of Chicago Medical Center, 5841 South Maryland Avenue

location_facility: MNPE of Kharkiv Regional Council Regional Clinical Specialized Dispensary of Radiation Protection

location_facility: Karolinska Universitetssjukhuset Solna, P.O Bäckencancer, Karolinska Universitetssjukhuset

location_facility: Chang Gung Memorial Hospital, Linkou, Dept. of Medical Oncology, 5 Fuxing Street, Guishan

location_facility: Institut Gustave Roussy, Département de gastro-entérologie

location_facility: The Mayo Clinic Hospital - Saint Mary's Campus, 1216 Second Street Southwest

location_facility: Taipei Veterans General Hospital, No. 201, Sction 2, Shi-pai Road

location_facility: SI "National Institute of Surgery and Transplantology n.a. O.O. Shalimov " of NAMS of Ukraine

location_facility: Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon

location_facility: Zaklad Opieki Zdrowotnej MSW z Warminsko-Mazurskim Centrum Onkologii

location_facility: Municipal Nonprofit Enterprise City Hospital #3 of Zaporizhzhia City Council

location_facility: Tampereen yliopistollinen sairaala, Syöpätautien klinikka

location_facility: Severance Hospital Yonsei University Health System, 50-1, Yonsei-Ro, Seodaemun-Gu

location_facility: Azienda Ospedaliero Universitaria Di Modena Policlinico

location_facility: SI Institute for General and Urgent Surgery n.a. V.T. Zaitseva of NAMS of Uktraine

location_facility: CHU Dupuytren, 2 Avenue Martin Luther King

location_facility: Asan Medical Center, 88 Olympic-ro 43-gil, Songpa-gu

location_facility: Universitätsklinikum Hamburg Eppendorf, I. Medizinische Klinik und Poliklinik (Gastroenterologie mit Sektionen Infektiologie und Tropenmediz)

location_facility: Klinikum Mannheim Universitätsklinikum gGmbH

location_facility: Taichung Veterans General Hospital, No. 1650 Taiwan Boulevard, Sec. 4

location_facility: Klinikum der Ludwig-Maximilians-Universität MünchenKlinik

location_facility: Emory University Hospital, 1365C Clifton Road NE

location_facility: Klinikum Nürnberg Nord, Medizinische Klinik 6 - (Schwerpunkte Gastroenterologie, Hepatologie, Endokrinologie)


title: Benefits of Microcor in Ambulatory Decompensated Heart Failure

acronym: BMAD-TX

summary: To assess investigator engagement of μCor system data in the context of heart failure management. The μCor system includes a sensor and wearable patch for fluid management.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Diagnostic

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Zoll Medical Corporation

location_country:
Germany
United States
France

location_facility: "Universitätsklinikum Gießen und Marburg GmbH"

location_facility: Chu Montpellier - Hopital Arnaud de Villeneuve

location_facility: CHU Montpellier - Hopital Arnaud de Villeneuve

location_facility: Methodist Physicians Clinical Heart Consultants

location_facility: Mercer Bucks Cardiology at Jefferson Health

location_facility: Accel Research Sites- Daytona Heart Group

location_facility: Westchester Research Center at Westchester General Hospital

location_facility: Hôpital Européen Georges Pompidou - Centre d'Investigations Cliniques - Pôle D - étage 5

location_facility: BronxCare Health System at BronxCare Hospital Center

location_facility: Gateway Cardiovascular Research Center, Inc

location_facility: Cardiovascular Research of Northwest Indiana, LLC

location_facility: Macklenberg Heart Specialists / Focus Clinical Research Solutions

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Ongoing


type: Other Identifier

type: Registry Identifier

title: Efficacy and Safety of Concizumab Prophylaxis in Patients With Haemophilia A or B With Inhibitors

summary: This study will test how well a new medicine called concizumab works in the body of people with haemophilia A or B with inhibitors. The purpose is to show that concizumab can prevent bleeds in the body and is safe to use. Participants who usually only take medicine to treat bleeds (on-demand) will be placed in one of two groups. In one group participants will get study medicine from the start of the study. In the other group participants will continue with their normal medicine and get study medicine after 6 months. The group will be decided by chance. Participants who usually take medicine to prevent bleeds (prophylaxis treatment) or who are already being treated with concizumab (study medicine) will receive the study medicine from the start of the study. Participants will have to inject themselves with study medicine every day under the skin. This can be done at home. The study doctor will hand out the medicine in the form of a pen-injector. The pen-injector will contain the study medicine. The study will last for about three years. Participants will have to come to the clinic for up to 33 times. The time between visits will be approximately 4 weeks for the first 6 to 12 months depending on the group participants are in and approximately 8 weeks for the rest of the study. At all visits, blood samples will be taken. Participants will be asked to record information into an electronic diary during the study and may also be asked to wear an activity tracker.

status: Active, not recruiting

design_allocation: Randomized

primary_purpose: Treatment

ipd_sharing: Yes

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

lead_sponsor: Novo Nordisk A/S

location_country:
Malaysia
Australia
Russian Federation
Denmark
Ukraine
India
Croatia
France
Japan
Poland
Slovakia
Norway
Thailand
Canada
Korea, Republic of
South Africa
Sweden
Bulgaria
Algeria
Portugal
United States
United Kingdom
Italy
Austria
Serbia
Mexico
Czechia
Spain
Turkey

intervention_type: Drug


title: Aldose Reductase Inhibition for Stabilization of Exercise Capacity in Heart Failure (ARISE-HF): A Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy

summary: This is a multicenter, randomized, placebo-controlled, 2-part study to evaluate the safety and efficacy of AT-001 in adult patients (N=675) with Diabetic Cardiomyopathy at high risk of progression to overt heart failure.

lead_sponsor: Applied Therapeutics, Inc.

location_country:
United States
Hong Kong
Germany
France
Czechia
Poland
Australia
Spain
Canada
United Kingdom

location_facility: Centre for Studies in Family Medicine, Western Centre for Public Health and Family Medicine, Western University

location_facility: 4 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny ZOZ we Wroclawiu

location_facility: Hospital de la Santa Creu i Sant Pau Barcelona

location_facility: Juno Research, LLC - Southwest Houston Site

location_facility: Prywatny Gabinet Lekarski Centrum Medyczne Diabetika

location_facility: LMC Diabetes & Endocrinology Ltd. - Thornhill

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: Barts and The London School of Medicine & Dentistry

location_facility: LMC Diabetes & Endocrinology Ltd. - Etobicoke

location_facility: NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny

location_facility: Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center

location_facility: CHU de Nantes, Clinique d'Endocrinologie

location_facility: Institut Universitaire de Cardiologie et de Pneumologie De Quebec

location_facility: Barwon Health-University Hospital Geelong

location_facility: University of California, San Diego (UCSD)

location_facility: LMC Diabetes & Endocrinology Ltd. - Brampton

location_facility: Herz-und Diabeteszentrum NRW Universitaetsklinik der Ruhr-Universitaet Bochum

location_facility: ZKS - Zentrum Klinische Studien Sudbrandenburg GmbH

location_facility: Prince of Wales Hospital; Chinese University of Hong Kong; Dept of Medicine and Therapeutics

location_facility: Topolowa MEDICENTER Mrózek & wspólnicy sp.j.

location_facility: Westside Medical Associates of Los Angeles

location_facility: University of California - Irvine Medical Center

location_facility: Hôpital Jean-Verdier - AP-HP; Service Endocrinologie Diabétologie Nutrition

location_facility: Nemocnice Pardubickeho kraje, a.s., Nemocnice Pardubice

location_facility: Hospital Abente y Lago (Complejo Universitario de la Coruña)

location_facility: LMC Diabetes & Endocrinology Ltd. - Toronto

location_facility: Centrum Medyczne Medyk Stanislaw Mazur Sp. z o.o. SK

location_facility: Hospital Clinico Universitario de Valencia


title: A 24-week Multi-center, Double-blind, Placebo Controlled Dose-range Finding Study to Investigate the Efficacy and Safety of Oral QBW251 in COPD Patients on Triple Inhaled Therapy (LABA / LAMA / ICS)

summary: The purpose of this study is to support the dose selection for future studies by evaluating efficacy and safety of different QBW251 doses in COPD patients with chronic bronchitis and a history of exacerbations, compared to placebo, when added to a triple combination therapy of LABA, LAMA and ICS with respect to trough FEV1 change from baseline after 12 weeks of treatment.

enrollment_type: Actual

lead_sponsor: Novartis Pharmaceuticals

location_country:
Guatemala
Greece
Australia
Belgium
Denmark
France
Japan
Poland
Slovakia
Thailand
Argentina
Canada
Korea, Republic of
Colombia
Hong Kong
Netherlands
Philippines
Hungary
Germany
United States
United Kingdom
Italy
Austria
Czechia
Spain
Turkey


title: Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1): A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Extension Period in Participants With Vitiligo

summary: The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adolescent and adult participants with non-segmental vitiligo for whom total body involved vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).

status: Completed

study_completion_date_type: Actual

lead_sponsor: Incyte Corporation

location_country:
Italy
United States
France
Bulgaria
Poland
Spain
Germany
Canada

location_facility: Dermatology Associates of Plymouth Meeting

location_facility: Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu

location_facility: Multiprofile Hospital For Active Treatement - Clinic of Dermatology and Venerology

location_facility: Chu de Toulouse Hopital Larrey Centre de Reference Des Maladies Rares de La Peau Service de Dermatol

location_facility: University Clinic Carl Gustav Carus, Technical University Dresden

location_facility: Poradnia Dermatologiczno-Wenerologiczna Mediderm S.C. Nzoz

location_facility: Dermatology Clinical Research Center of San Antonio

location_facility: Synexus - Polska Sp Z Oo Oddzial W Gdansk

location_facility: Synexus Polska Sp. Z O.O. Oddzial W Poznaniu

location_facility: Forcare Clinical Research Fcr Forward Clinical Trials, Inc

location_facility: Cognitive Clinical Trials Scottsdale Btc Ppds

location_facility: McGill University Health Centre / Carey/Wang Clinic

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Synexus Polska Sp. Z O.O. Oddzial W Gdyni

location_facility: International Clinical Research Tennessee Llc

location_facility: University of California San Francisco Sub Location

location_facility: Hopital Charles Nicolle Chu Rouen - Hopital de Bois-Guillaume

status_simplified: Completed


type: EudraCT Number

title: A Phase 1b, Multicenter, Two-Part, Open-Label Study of Trastuzumab Deruxtecan (DS-8201a), An Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), In Combination With Pembrolizumab, An Anti-PD-1 Antibody, For Subjects With Locally Advanced/Metastatic Breast Or Non-Small Cell Lung Cancer (NSCLC)

summary: This two-part study will include a dose escalation part to determine the recommended dose for expansion of DS8201a and pembrolizumab and a dose expansion part to evaluate efficacy, safety, and tolerability of the combination.

design_allocation: Non-Randomized

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to company policies and procedures, Daiichi Sankyo will continue to protect the privacy of clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
United States
United Kingdom
France
Spain

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Institute Oncologico Baselga Hospital Quiron

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: University of California San Francisco Medical Center

location_facility: Siteman Cancer Center-Washington University


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://www.clinicalstudydatarequest.com/

lead_sponsor: Sanofi

location_country:
Italy
United States
United Arab Emirates
Switzerland
France
Israel
Australia
Spain
Germany
United Kingdom

acronym: DUPISTAD

location_facility:
Investigational Site Number :8400007
Investigational Site Number :3760005
Investigational Site Number :3800005
Investigational Site Number :0360006
Investigational Site Number :2500001
Investigational Site Number :7560001
Investigational Site Number :3800003
Investigational Site Number :7240001
Investigational Site Number :8400003
Investigational Site Number :7240004
Investigational Site Number :2760005
Investigational Site Number :8400002
Investigational Site Number :7840002
Investigational Site Number :7240002
Investigational Site Number :7240006
Investigational Site Number :7240005
Investigational Site Number :8400012
Investigational Site Number :7240010
Investigational Site Number :8260002
Investigational Site Number :7840001
Investigational Site Number :8260004
Investigational Site Number :8400008
Investigational Site Number :7240003
Investigational Site Number :0360001
Investigational Site Number :2500003
Investigational Site Number :0360007
Investigational Site Number :2760001
Investigational Site Number :2760002
Investigational Site Number :7240008
Investigational Site Number :2760006
Investigational Site Number :3760003
Investigational Site Number :3800004
Investigational Site Number :0360003
Investigational Site Number :2760004
Investigational Site Number :8400013
Investigational Site Number :2500002
Investigational Site Number :2500006
Investigational Site Number :8400001
Investigational Site Number :3800006
Investigational Site Number :3800001
Investigational Site Number :3800002
Investigational Site Number :8400005

source: euctr

title: A Randomized Double-blind, Placebo-controlled Study Evaluating the Effect of Dupilumab on Sleep in Adult Patients With Moderate to Severe Atopic Dermatitis (AD)

summary:
Primary Objective:

To evaluate the effect of dupilumab on sleep quality in adult patients with moderate to severe atopic dermatitis (AD)

Secondary Objectives:

To evaluate the effect of dupilumab on objective and subjective quantitative sleep parameters, AD related outcomes, and daytime consequences of sleep deprivation

To continue to assess the safety and tolerability throughout the study


ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the 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 Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Hoffmann-La Roche

location_country:
France
Spain
United States
United Kingdom
Canada

location_facility: University of Texas Health Science Center at San Antonio

location_facility: The Royal Victoria Infirmary; Paediatric and Adolescent Oncology Unit

location_facility: Lucile Packard Children's Hospital at Stanford University; Thoracic Oncology

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Huntsman Cancer Institute at The University of Utah

location_facility: Arkansas Children's Hospital Research Institute

title: A Phase I/II, Multicenter, Open-Label, Multi-Arm Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in the Treatment of Pediatric and Young Adult Patients With Relapsed/Refractory Acute Leukemias or Solid Tumors

summary:
This is a Phase I/II, multicenter, open-label, multi-arm study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of idasanutlin, administered as a single agent or in combination with chemotherapy or venetoclax, in pediatric and young adult participants with acute leukemias or solid tumors.

This study is divided into three parts: Part 1 will begin with dose escalation of idasanutlin as a single agent in pediatric participants with relapsed or refractory solid tumors to identify the maximum tolerated dose (MTD)/maximum administered dose (MAD) and to characterize dose-limiting toxicities (DLTs). Following MTD/MAD identification, three separate safety run-in cohorts in neuroblastoma, acute myeloid leukemia (AML), and acute lymphoblastic leukemia (ALL) will be conducted to identify the recommended Phase 2 dose (RP2D) of idasanutlin in each combination, with chemotherapy or venetoclax. Part 2 will evaluate the safety and early efficacy of idasanutlin in combination with chemotherapy or venetoclax in newly enrolled pediatric and young adult participants in neuroblastoma, AML,and ALL cohorts at idasanutlin RP2D. Part 3 will potentially be conducted as an additional expansion phase of the idasanutlin combination cohorts in neuroblastoma, AML, or ALL for further response and safety assessment.


title: A Phase IB Multicenter, Open-label Study To Determine The Recommended Dose And Regimen Of Durvalumab (MEDI4736) Either As Monotherapy or In Combination With Pomalidomide (POM) With Or Without Low-Dose Dexamethasone (DEX) In Subjects With Relapsed And Refractory Multiple Myeloma (RRMM)

summary:
This is a multicenter, open-label, Phase 1b study to determine the recommended dose and regimen of durvalumab either as monotherapy or in combination with POM with or without low dose dex in subjects with RRMM. The study will consist of a dose-finding portion as well as a parallel dose-expansion portion to determine the optimal dose and regimen.

On 05 Sep 2017, a Partial Clinical Hold was placed on this study by the United States (US) Food and Drug Administration (FDA). The decision by the FDA was based on data related to risks of anti-programmed cell death-1 (PD-1) antibody, pembrolizumab, in combination with IMiDs® immunomodulatory drugs in patients with multiple myeloma. As a result, enrollment into this study has been discontinued. Subjects who are receiving clinical benefit, based on the discretion of the investigator, may remain on study treatment after being reconsented.

ReferenceType: derived

ReferenceCitation: Young MH, Pietz G, Whalen E, Copeland W, Thompson E, Fox BA, Newhall KJ. Immunomodulation by durvalumab and pomalidomide in patients with relapsed/refractory multiple myeloma. Sci Rep. 2021 Aug 12;11(1):16460. doi: 10.1038/s41598-021-95902-x.

family: Young

full_name: Mary H. Young

given: Mary H.

sequence: first

family: Pietz

full_name: Greg Pietz

given: Greg

sequence: additional

family: Whalen

full_name: Elizabeth Whalen

given: Elizabeth

family: Copeland

full_name: Wilbert Copeland

given: Wilbert

family: Thompson

full_name: Ethan Thompson

given: Ethan

family: Fox

full_name: Brian A. Fox

given: Brian A.

family: Newhall

full_name: Kathryn J. Newhall

given: Kathryn J.

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Scientific Reports

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 pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Celgene

location_country:
Italy
United States
Netherlands
France
Spain
Germany
Canada

location_facility: Policlinico San Matteo Universita Di Pavia

location_facility: Weill Medical College of Cornell University

location_facility: Massachusetts General Hospital / Dana-Farber Cancer Institute

location_facility: CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Universitaetsklinikum EssenZentrum fuer Innere Medizin

location_facility: VU University Medical Center VU Medisch Centrum

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

location_facility: Institut universitaire du cancer de Toulouse (IUCT) - Oncopole

location_facility: Froedtert Hospital BMT Medical College of Wisconsin

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale"


title: A Phase 1, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0022, a Novel MET/CSF1R/SRC Inhibitor, in Patients With Advanced Solid Tumors Harboring Genetic Alterations in MET

summary: A phase 1, first-in-human, open-label study to determine the safety, tolerability, PK, and preliminary efficacy of the novel MET/CSF1R/SRC inhibitor TPX-0022 in adult subjects with advanced solid tumors harboring genetic alterations in MET. The study will proceed in three parts: a dose-escalation, a food effect, and dose-expansion.

lead_sponsor: Turning Point Therapeutics, Inc.

location_country:
United States
Korea, Republic of
France
Spain

location_facility: Washington University School of Medicine in St. Louis

location_facility: HM Centro Integral Oncológico Clara Campal - START Madrid

location_facility: University of Michigan Rogel Cancer Center

location_facility: University California San Diego Moores Cancer Center

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Hopital d'Instruction des Armees de Begin - Clinical Research Unit

location_facility: Sarah Cannon Research Institute at HealthONE

location_facility: University of California Irvine Chao Family Comprehensive Cancer Center

location_facility: Yonsei Cancer Center, Severance Hospital


ReferenceCitation: Jungels C, Deleporte A. State of the art and future directions in the systemic treatment of neuroendocrine neoplasms. Curr Opin Oncol. 2021 Jul 1;33(4):378-385. doi: 10.1097/CCO.0000000000000740. Review.

family: Jungels

full_name: Christiane Jungels

given: Christiane

family: Deleporte

full_name: Amélie Deleporte

given: Amélie

journal_name: Current Opinion in Oncology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

intervention_type: Other

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: Advanced Accelerator Applications

location_country:
Italy
United States
Netherlands
France
Korea, Republic of
Spain
Germany
United Kingdom
Canada

location_facility: Fondazione Irccs Istituto Nazionale Tumori

location_facility: Sir Mortimer B Davis/Jewish General Hospital

location_facility: Seoul National University Hospital - Department of Internal Medicine

location_facility: London Health Sciences Centre, University of Western Ontario - Oncology

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

location_facility: Centre Hospitalier Universitaire de Quebec

location_facility: Azienda Ospedaliera Sant'Andrea - Università La Sapienza U.O.C. Mal App. Digerente e - Oncology

location_facility: Seoul National University Bundang Hospital

location_facility: Severance Hospital, Yonsei University Health System - Medical Oncology

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Institut du Cancer de Montpellier - Oncology

location_facility: Hospices Civils de Lyon (HCL) - Hopital Edouard Herriot

location_facility: University of Iowa Hospitals and Clinics - Oncology

location_facility: USF - H. Lee Moffitt Cancer Center and Research Institute

location_facility: Universitätsklinikum Essen - Klinik für Nuklearmedizin

location_facility: Arcispedale Santa Maria Nuova, Reggio Emilia - Oncology

title: A Phase III Multi-center, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET

summary: The aim of NETTER-2 is to determine if Lutathera in combination with long-acting octreotide prolongs PFS in GEP-NET patients with high proliferation rate tumors (G2 and G3), when given as a first line treatment compared to treatment with high dose (60 mg) long-acting octreotide. Somatostatin analog (SSA) naive patients are eligible, as well as patients previously treated with SSAs in the absence of progression.


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

name: Dermatologist, Masters of Public Health Program; Harvard School of Public Health; Boston Massachusetts USA

family: Hannon

full_name: Cora W Hannon

given: Cora W

name: Department of Dermatology; Royal Victoria Hospital; Belfast UK

family: McCourt

full_name: Collette McCourt

given: Collette

name: Department of Dermatology, Clinical Unit for Research Trials and Outcomes in Skin (CURTIS); Massachusetts General Hospital; Boston Massachusetts USA

family: Lima

full_name: Hermenio C Lima

given: Hermenio C

name: Emory University Hospital; Emory Healthcare; Atlanta Georgia USA

family: Chen

full_name: Suephy Chen

given: Suephy

name: Office of Research and Innovation; Royal College of Surgeons in Ireland Coláiste Ríoga na Máinleá in Éirinn; Dublin Ireland

family: Bennett

full_name: Cathy Bennett

given: Cathy

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

status: Terminated

ipd_sharing_description:
De-identified individual patient data (IPD) can be made available to researchers in a closed environment for a specified period of time.

Data sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.

lead_sponsor: LEO Pharma

location_country:
Denmark
United States
Germany
France

location_facility:
LEO Pharma Investigational Site
LEO Pharma Investigational site

title: Efficacy and Safety of Twice-daily Application of Delgocitinib Cream 20 mg/g for 6 Weeks in Subjects With Active Discoid Lupus Erythematosus.

summary: This was a double-blind, multi-centre, randomised, vehicle-controlled, within-subject phase 2a trial. The trial was designed to establish the efficacy and safety of delgocitinib cream in the treatment of adult subjects with discoid lupus erythematosus (DLE).

status_simplified: Unknown


ReferenceType: background

ReferenceCitation: Eron JJ Jr, Lelievre JD, Kalayjian R, Slim J, Wurapa AK, Stephens JL, McDonald C, Cua E, Wilkin A, Schmied B, McKellar M, Cox S, Majeed SR, Jiang S, Cheng A, Das M, SenGupta D. Safety of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in HIV-1-infected adults with end-stage renal disease on chronic haemodialysis: an open-label, single-arm, multicentre, phase 3b trial. Lancet HIV. 2018 Dec 13. pii: S2352-3018(18)30296-0. doi: 10.1016/S2352-3018(18)30296-0. [Epub ahead of print]

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

lead_sponsor: Gilead Sciences

location_country:
Austria
United States
Germany
France

location_facility: Wake Forest University Baptist Medical Center

location_facility: University of North Carolina at Chapel Hill / UNC School of Medicine

location_facility: Prime Health Care Services - St Michael's LLC d/b/a Saint Michael's Medical Center

location_facility: Infectious Disease Consultants, M.D., P.A. d/b/a Orlando Immunology Center

location_facility: North Texas Infectious Diseases Consultants

location_facility: Infectious Disease Specialists of Atlanta

location_facility: Midway Immunology & Research Center, LLC

title: A Phase 3b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Subjects on Chronic Hemodialysis

summary: The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV-1) infected adults with end-stage renal disease (ESRD) on chronic hemodialysis (HD).


lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Germany
France
Czechia
Japan
Poland
Hungary
Belgium
Australia
Russian Federation
United States
United Kingdom
Korea, Republic of

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Spring Gastroenterology Associates - Houston

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

location_facility: Centre Hospitalier Universitaire de Saint-Etienne - Hopital Nord

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: New York University Langone Medical Center

location_facility: Tokyo Medical and Dental University, Medical Hospital

location_facility: National Hospital Organization Hirosaki National Hospital

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico SantOrsola-Malpighi

location_facility: Policlinico Universitario Campus Bio-Medico

location_facility: H-T. Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia

location_facility: Shiga University of Medical Science Hospital

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Gastroenterology Research of San Antonio

location_facility: Charite Universitatsmedizin Berlin - Campus Virchow-Klinikum

location_facility: Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi

location_facility: Multidisciplinary Consultative and Diagnostic Center

location_facility: Advanced Research Institute - New Port Richey

location_facility: New York Langone Long Island Clinical Research Associates

location_facility: Azienda Ospedaliero-Universitaria Mater Domini

location_facility: Texas Digestive Disease Consultants - Southlake

location_facility: Osrodek Badan Klinicznych CLINSANTE Ewa Galczak-Nowak Malgorzata Trzaska

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel

location_facility: Twoja Przychodnia Szczecinskie Centrum Medyczne

location_facility: Centre Hospitalier Universitaire Saint-Pierre

location_facility: Southern Star Research Institute - Medical Center Office

location_facility: Connecticut Clinical Research Foundation

location_facility: Santa Familia - Centrum Badan Profilaktyki i Leczenia

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Digestive Health Associates of Texas - Richardson

location_facility: Centrum Zdrowia Matki Dziecka i Mlodziezy

location_facility: Clinica Medica Azienda Ospedaliera Universitaria

location_facility: Texas Digestive Disease Consultants - Gastroenterology Associates - Baton Rouge

location_facility: National Hospital Organization Takasaki General Medical Center

location_facility: Nizhniy Novgorod Regional Clinical Hospital N.A. Semashko

location_facility: Universitatsklinikum Carl Gustav Carus Dresden

location_facility: Penn State Health Milton S. Hershey Medical Center

location_facility: Novosibirsk State Regional Clinical Hospital

title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis

summary: The purpose of this study is to assess the safety and efficacy of oral deucravacitinib in participants with moderate to severe ulcerative colitis (UC).


title: A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-blind Study in Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP) to Evaluate the Pharmacokinetics,Safety and Efficacy of rADAMTS-13 (SHP655) Administered in Addition to Standard Of Care (SoC) Treatment

acronym: SOAR-HI

summary: The purpose of this study is to evaluate the pharmacokinetics, safety, and efficacy of rADAMTS-13 (SHP655) administered in addition to standard of care (SoC) treatment of acquired thrombotic thrombocytopenic purpura (aTTP) participants.

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: Shire

location_country:
Italy
United States
France
Spain
Germany
United Kingdom
Canada

location_facility: Hospital Universitari i Politècnic la Fe

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

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: The Ohio State University Wexner Medical Center

location_facility: University Hospitals Cleveland Medical Center

location_facility: Hospital General Universitario de Alicante

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Medical University of South Carolina (MUSC)


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis

summary: The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab for the treatment of participants with generalized myasthenia gravis (gMG).

lead_sponsor: Alexion Pharmaceuticals

location_country:
Italy
Austria
Switzerland
Netherlands
Spain
Germany
France
Czechia
Japan
Israel
Korea, Republic of
Portugal
Denmark
United States
Canada


title: Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation

summary:
Expanded access for participants with cancer with RET activation who are ineligible for an ongoing selpercatinib (also known as LOXO-292) clinical trial or have other considerations that prevent access to selpercatinib through an existing clinical trial.

The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.

status: Available

study_type: Expanded Access

lead_sponsor: Loxo Oncology, Inc.

location_country:
Italy
United States
Hong Kong
Switzerland
France
Japan
Poland
Israel
Singapore
Australia
New Zealand
Spain
Germany

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

location_facility: CHU - l'Assistance Publique - Hôpitaux de Marseille

location_facility: Soroka Medical Center - Pediatric Outpatient Clinic

location_facility: University of Chicago Medicine-Comprehensive Cancer Center

location_facility: ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C

location_facility: Centrum Onkologii Instytut im Marii Curie w Warszawie

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Queensland Health - Metro North Hospital and Health Service

location_facility: University of Wisconsin-Madison Hospital and Health Clinic

location_facility: NSW Health - Sydney Local Health District

location_facility: Azienda Ospedaliero Universitaria Pisana


lead_sponsor: Hansa Biopharma AB

location_country:
Austria
Germany
France
Australia
United States

location_facility: Charité-Universitätsmedizin. Dept. of Nephrology and Medical Intensive Care

location_facility: New York University Grossman School of Medicine

location_facility: Hôpital Necker - Service de Néphrologie - Transplantation

location_facility: CHU Grenoble Alpes - Néphrologie, dialyse et transplantation

location_facility: Hôpital Saint-Louis. Service de Néphrologie et Transplantation

location_facility: Universitätsklinik für Innere Medizin III, Klinische Abteilung für Nephrologie MUW

title: A Randomized, Open-Label, Multi-Centre, Active Control, Efficacy and Safety Study of Imlifidase in Eliminating Donor Specific Anti-HLA Antibodies in the Treatment of Active Antibody-Mediated Rejection in Kidney Transplant Patients

summary:
The purpose of this study is to investigate how efficiently the study medication imlifidase reduces the amount of donor specific antibodies (DSA) in comparison with plasma exchange (PE) therapy, in patients who have an active or chronic active antibody mediated rejection (AMR) after recently been kidney transplanted. The purpose is also to investigate and compare safety for these two treatments.

20 patients will be treated with imlifidase and 10 with PE.


lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
France
Bulgaria
Israel
United States
Canada

location_facility:
Teva Investigational Site 14405
Teva Investigational Site 59149
Teva Investigational Site 14391
Teva Investigational Site 14809
Teva Investigational Site 14863
Teva Investigational Site 14862
Teva Investigational Site 14861
Teva Investigational Site 14859
Teva Investigational Site 14821
Teva Investigational Site 14807
Teva Investigational Site 14416
Teva Investigational Site 35257
Teva Investigational Site 14814
Teva Investigational Site 14776
Teva Investigational Site 11170
Teva Investigational Site 14783
Teva Investigational Site 14788
Teva Investigational Site 14785
Teva Investigational Site 14818
Teva Investigational Site 11169
Teva Investigational Site 14805
Teva Investigational Site 11173
Teva Investigational Site 11171
Teva Investigational Site 14786
Teva Investigational Site 14415
Teva Investigational Site 14816
Teva Investigational Site 14794
Teva Investigational Site 14777
Teva Investigational Site 14793
Teva Investigational Site 14826
Teva Investigational Site 59146
Teva Investigational Site 14876
Teva Investigational Site 14400
Teva Investigational Site 80156
Teva Investigational Site 59150
Teva Investigational Site 14801
Teva Investigational Site 14869
Teva Investigational Site 80157
Teva Investigational Site 35260
Teva Investigational Site 59151
Teva Investigational Site 14414
Teva Investigational Site 80161
Teva Investigational Site 14774
Teva Investigational Site 14865
Teva Investigational Site 14390
Teva Investigational Site 14832
Teva Investigational Site 14867
Teva Investigational Site 59154
Teva Investigational Site 14770
Teva Investigational Site 14871
Teva Investigational Site 14799
Teva Investigational Site 14780
Teva Investigational Site 14868
Teva Investigational Site 14792
Teva Investigational Site 14875
Teva Investigational Site 14866
Teva Investigational Site 14772
Teva Investigational Site 14787
Teva Investigational Site 14764
Teva Investigational Site 14810
Teva Investigational Site 59144
Teva Investigational Site 14860
Teva Investigational Site 35256
Teva Investigational Site 35259
Teva Investigational Site 80162
Teva Investigational Site 14395
Teva Investigational Site 14773
Teva Investigational Site 14791
Teva Investigational Site 14827
Teva Investigational Site 14817
Teva Investigational Site 14763
Teva Investigational Site 14815
Teva Investigational Site 14811
Teva Investigational Site 14856
Teva Investigational Site 14771
Teva Investigational Site 14802
Teva Investigational Site 59152
Teva Investigational Site 14396
Teva Investigational Site 14796
Teva Investigational Site 80160
Teva Investigational Site 59148
Teva Investigational Site 14393
Teva Investigational Site 14401
Teva Investigational Site 11174
Teva Investigational Site 14829
Teva Investigational Site 14782
Teva Investigational Site 14778
Teva Investigational Site 14813
Teva Investigational Site 80155
Teva Investigational Site 14389

title: A Study to Evaluate the Safety, Tolerability, and Effect of Risperidone Extended-Release Injectable Suspension (TV-46000) for Subcutaneous Use as Maintenance Treatment in Adult and Adolescent Patients With Schizophrenia

summary:
The primary objective of the study is to evaluate the long-term safety and tolerability of TV-46000. The primary safety and tolerability endpoint is the frequency of all adverse events, including serious adverse events. For new patients, the total duration of patient participation in the study is planned to be up to 80 weeks (including a screening period of up to 4 weeks, a 12-week oral conversion/stabilization stage [Stage 1], a 56-week double-blind maintenance stage [Stage 2], and a follow-up period [8 weeks]). For roll-over patients, the total duration of patient participation in the study is planned to be up to 64 weeks (including up to 56 weeks in the maintenance stage [Stage 2] and a follow-up period [8 weeks]). Patients who started Stage 2 who relapse or meet 1 or more of the withdrawal criteria should be invited to perform the Early Termination visit as soon as possible within 4 weeks of the last injection. Patients who withdraw from the study before completing the 56-week maintenance stage will have follow-up procedures and assessments performed at their follow-up visits. During the follow-up period, patients will be treated according to the investigator's judgment.

All subjects will be treated with active drug.


title: A Phase 2b Dose-finding Study for SAR442168, a Bruton's Tyrosine Kinase Inhibitor, in Participants With Relapsing Multiple Sclerosis

summary:
Primary Objective:

To determine the dose-response relationship for SAR442168 to reduce the number of new active brain lesions.

Secondary Objectives:

To evaluate efficacy of SAR442168 on disease activity as assessed by imaging measures.
To evaluate the safety and tolerability of SAR442168.

ReferenceCitation: Reich DS, Arnold DL, Vermersch P, Bar-Or A, Fox RJ, Matta A, Turner T, Wallström E, Zhang X, Mareš M, Khabirov FA, Traboulsee A; Tolebrutinib Phase 2b Study Group. Safety and efficacy of tolebrutinib, an oral brain-penetrant BTK inhibitor, in relapsing multiple sclerosis: a phase 2b, randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2021 Sep;20(9):729-738. doi: 10.1016/S1474-4422(21)00237-4.

family: Reich

full_name: Daniel S Reich

given: Daniel S

family: Arnold

full_name: Douglas L Arnold

given: Douglas L

family: Vermersch

full_name: Patrick Vermersch

given: Patrick

family: Bar-Or

full_name: Amit Bar-Or

given: Amit

full_name: Robert J Fox

given: Robert J

family: Matta

full_name: Andre Matta

given: Andre

family: Turner

full_name: Timothy Turner

given: Timothy

family: Wallström

full_name: Erik Wallström

given: Erik

family: Zhang

full_name: Xinyan Zhang

given: Xinyan

family: Mareš

full_name: Miroslav Mareš

given: Miroslav

family: Khabirov

full_name: Farit A Khabirov

given: Farit A

family: Traboulsee

full_name: Anthony Traboulsee

given: Anthony

family: Grand'Maison

full_name: Francois Grand'Maison

given: Francois

family: Jacques

full_name: Francois Jacques

family: Tyblova

full_name: Michaela Tyblova

given: Michaela

family: Meluzinova

full_name: Eva Meluzinova

given: Eva

family: Ampapa

full_name: Radek Ampapa

given: Radek

family: Valis

full_name: Martin Valis

given: Martin

family: Hradilke

full_name: Pavel Hradilke

given: Pavel

family: Stourac

full_name: Pavel Stourac

family: Gross-Paju

full_name: Katrin Gross-Paju

location_country:
Netherlands
France
Czechia
Slovakia
Russian Federation
Spain
Estonia
United States
Canada
Ukraine

location_facility:
Investigational Site Number 8400003
Investigational Site Number 1240001
Investigational Site Number 8400008
Investigational Site Number 8040003
Investigational Site Number 2030002
Investigational Site Number 8400009
Investigational Site Number 6430004
Investigational Site Number 2500002
Investigational Site Number 2030004
Investigational Site Number 8400004
Investigational Site Number 7030001
Investigational Site Number 8400001
Investigational Site Number 7240003
Investigational Site Number 2030007
Investigational Site Number 2030003
Investigational Site Number 1240002
Investigational Site Number 2500003
Investigational Site Number 2030001
Investigational Site Number 5280001
Investigational Site Number 6430007
Investigational Site Number 2030005
Investigational Site Number 6430003
Investigational Site Number 6430001
Investigational Site Number 2500001
Investigational Site Number 8040007
Investigational Site Number 7030002
Investigational Site Number 6430006
Investigational Site Number 2500004
Investigational Site Number 8040002
Investigational Site Number 8400006
Investigational Site Number 7240004
Investigational Site Number 5280002
Investigational Site Number 7240005
Investigational Site Number 8040009
Investigational Site Number 8040005
Investigational Site Number 8400002
Investigational Site Number 7240006
Investigational Site Number 2030006
Investigational Site Number 1240003
Investigational Site Number 7240001
Investigational Site Number 6430005
Investigational Site Number 6430002
Investigational Site Number 2330001
Investigational Site Number 8040006
Investigational Site Number 8400005
Investigational Site Number 8040001
Investigational Site Number 7240002
Investigational Site Number 8400007


title: A Randomized Controlled Non-inferiority Trial to Evaluate the Safety and Efficacy of the Passeo-18 Lux Drug-coated Balloon of Biotronik in the Treatment of Subjects With Stenotic, Restenotic or Occlusive Lesions of the Femoropopliteal Artery Compared to the Medtronic IN.PACT Admiral Drug-coated Balloon

acronym: BIOPACT-RCT

summary:
The BIOPACT RCT tiral investigates the efficacy and safety of stenosis, restenosis or occlusions in the femoropopliteal artery of patients presenting a rutherford classification 2,3 or 4 with a Passeo-18 Lux drug-coated balloon of Biotronik. The Paclitaxel eluting balloons are designed for percutaneous transluminal angioplasties in which the balloon will dilate the artery upon inflation and deliver the paclitaxel locally.

An expected total of 151 patients will be treated with the Passeo-18 Lux and compared to a control group of another 151 patients that will be treated with the IN.PACT Admiral drug-coated balloon of Medtronic. Assignment to the treatment groups will be at random. The study will be conducted in two phases. A first pilot study phase of 120 patients distributed evenly over both treatment groups and a second phase to formally test the non-inferiority hypothesis.

The balloon is coated with Paclitaxel intended to avoid cellular proliferation. The drug is released by means of rapid inflation as to release a high dose in a short amount of time. Patients will be invited for a follow-up visit at 1, 6 and 12 months post-procedure.

The primary efficacy endpoints are defined as follows. Freedom from clinically-driven target lesion revascularization at 12 months. Freedom from device- and procedure-related death through 30 days post-index procedure, major target limb amputation through 12 months post-procedure and clinically-driven target vessel revascularization through 12 months post-index procedure. The secondary endpoints are defined as acute device success, acute procedural success , freedom from all cause of death, major target limb amputation and clinically driven target vessel revascularisation through 30 days post-procedure, sustained clinical improvement, no major adverse events through 6 and 12 months post-procedure, primary patency, target lesion revascularisation, target vessel revascularisation, binary restenosis, major target limb amputation, thrombosis at target lesion, change of walking impairment questionnaire score from baseline, change in target limb rutherford classification or ABI.

lead_sponsor: ID3 Medical

location_country: Austria Belgium France Switzerland

location_facility: Centre Hospitalier Universitaire Vaudois


title: An Open-label Extension Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease Patients With Motor Fluctuations

summary: The purpose of this study is to evaluate the long-term safety and clinical utility of IPX203 in the treatment of subjects with advanced Parkinson's disease (PD) who have motor fluctuations.

status: Enrolling by invitation

lead_sponsor: Impax Laboratories, LLC

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

location_facility: CHU de Clermont-Ferrand-Hopital Gabriel Montpied (404)

location_facility: Azienda Ospedaliero-Universitaria Pisana (602)

location_facility: Hospital Universitari Mutua Terrassa (506)

location_facility: NZOZ Neuromed M. i M. Nastaj Sp.p. (800)

location_facility: Hospital Universitari General de Catalunya (504)

location_facility: Department "G. F. Ingrassia" section of neuroscience - Policlinico "Vittorio Emanuele" (608)

location_facility: Premiere Research Institute at Palm Beach Neurology (174)

location_facility: Dr. med. Reinhardt Ehret Neuroloqie Berlin Schlobstr. 29 (309)

location_facility: Hospital Universitario Vall d'Hebron (505)

location_facility: Hospital de Ia Santa Creu i Sant Pau (502)

location_facility: Cleveland Clinic Lou Ruvo Center for Brain Health (142)

location_facility: Henry Ford West Bloomfield Hospital(100)

location_facility: Centre d'lnvestigation Clinique 1436- CHU Purpan- Hopital Pierre Paul Riquet (403)

location_facility: University of Texas Southwestern Medical Center (143)

location_facility: CHU de Montpellier, Hopital Gui de Chauliac (405)

location_facility: Hospital Universitario y Politecnico La Fe Avenida Fernando Abril Martorell (515)

location_facility: Germanes Hospitalaries Del Sagrat Cor De Jesus Hospital Sant Rafael (516)

location_facility: Centre Hospitalier Universitaire de Nice (400)

location_facility: ChristianaCare Neurology Specialists (153)

location_facility: Medical Professional Clinical Research Center, Inc. (163)

location_facility: Neurologicka ordinace FORBELI s.r.o. (706)

location_facility: Parkinson's Disease Treatment Center of Southwest Florida (131)

location_facility: Fondazione I st ituto Neurologico Nazionale "C. Mondino" (606)

location_facility: The Movement Disorder Clinic of Oklahoma (115)

location_facility: NZOZ Neuro-Kard Ilkowski i Partnerzy Spolka Partnerska Lekarzy (801)

location_facility: University of Colorado Hospital Anschutz Outpatient Pavilion (120)

location_facility: Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice, Neurologicka klinika (702)

location_facility: Hospital Universitario Ramon y Cajal (500)

location_facility: Klinikum rechts der lsar der Technischen Universitat Munchen Klinik und Poliklinik fur Neurologie (303)

location_facility: Hospital Universitario Quiron Dexeus (501)

location_facility: University of Rome Tor Vergata/Hospital Tor Vergata (605)

location_facility: Kliniken Beelitz GmbH, neurologisches Fachkrankenhaus fur Bewegungsstorungen/Parkinson (300)

location_facility: St. Joseph's Hospital & Medical Center - Barrow Neurological Institute (156)

location_facility: Hospital Universitario de Ia Princesa (508)

location_facility: Fakultni nemocnice u sv. Anny v Brne, I. neurologicka klinika (704)

location_facility: Department of neuroscience, mental health and sensory system (NeSMOS), "Sapienza" University (603)

location_facility: Indiana University Health Neuroscience Center(164)

location_facility: Neurology Consultants of Dallas, PA (108)

location_facility: Keek School of Medicine of USC/ University of Southern California (106)

location_facility: Roseman Medical Research Institute / Roseman Medical Group (154)

location_facility: Gemeinschaftspraxis Dr. med. J. Springub/W. Schwarz, Studienzentrum Nordwest (306)

location_facility: Hospital Universitario Virgen del Rocio (503)

location_facility: University of Toledo, Gardner-McMaster Parkinson Center (122)

location_facility: Klinik Haag i. OB Geriatric Hospital Krankenhausstrabe 4 (305)

location_facility: University of Florida Health Science Center (129)

location_facility: Houston Methodist Neurological Institute/Movement Disorders Clinic (135)

location_facility: University of Arkansas for Medical Sciences (117)

location_facility: Imperial College Healthcare NI-lS Trust (200)

location_facility: Centro Ricerca Parkinson San Raffaele Cassino (601)

location_facility: Hospital Universitario Infanta Sofia(513)

location_facility: VCU Health- Neuroscience Orthopaedic and Wellness Center(124)

location_facility: Hospital General Universitario de Elche (509)

location_facility: Krakowska Akademia Neurologii Sp. Zo.o.(802)

location_facility: Hoag Memorial Hospital Presbyterian (134)

location_facility: University of Kansas Medical Center (118)

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton (121)

location_facility: University Hospitals Cleveland Medical Center (123)

location_facility: St. Josef-Hospital, Universitatsklinik fur Neurologie Klinisches Forschungszentrum fur Neurodegeneration (301)

location_facility: Northwestern Medical Group Neurology Clinic (145)

location_facility: Booth Gardner Parkinson's Care Center (112)


title: An Open-Label, Multicenter, Phase Ib Study To Evaluate Safety And Therapeutic Activity Of RO6874281, An Immunocytokine, Consisting Of Interleukin-2 Variant (IL-2v) Targeting Fibroblast Activation Protein-Α (FAP), In Combination With Pembrolizumab (Anti-PD-1), In Participants With Advanced Or Metastatic Melanoma

summary: This is an open-label, multicenter, Phase Ib study to evaluate the safety and therapeutic activity of RO6874281 in combination with pembrolizumab. The study will consist of 3 parts: a safety run-in (Part I: Cohorts 1.1. and 1.2) and two expansion parts (Parts II and III). Part II will start once all participants in Cohort 1.1 have completed the observation period. Part III will start once all participants in Cohorts 1.1 and 1.2 have completed the observation period.

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

location_country:
United States
France
Belgium
Australia
Russian Federation
Spain
Canada

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Russian Oncology Research Center n.a. N.N. Blokhin

location_facility: Clinica Universidad de Navarra Madrid; Servicio de Oncología

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Main Military Clinical Hospital named after N.N. Burdenko

location_facility: Hospital Clínic i Provincial; Servicio de Oncología

location_facility: Centre Eugene Marquis; Service d'oncologie

location_facility: Peter Maccallum Cancer Institute; Clinical Trial Unit

location_facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

location_facility: P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept


ReferenceCitation: Boinpally R, McNamee B, Yao L, Butler M, McGeeney D, Borbridge L, Periclou A. A Single Supratherapeutic Dose of Atogepant Does Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized, Single-Dose, Phase 1 Crossover Trial. Clin Pharmacol Drug Dev. 2021 Sep;10(9):1099-1107. doi: 10.1002/cpdd.940. Epub 2021 May 4.

family: Boinpally

full_name: Ramesh Boinpally

given: Ramesh

family: McNamee

full_name: Brian McNamee

given: Brian

family: Yao

full_name: Li Yao

given: Li

family: Butler

full_name: Matthew Butler

given: Matthew

family: McGeeney

full_name: Danielle McGeeney

given: Danielle

family: Borbridge

full_name: Lisa Borbridge

given: Lisa

family: Periclou

full_name: Antonia Periclou

given: Antonia

journal_name: Clinical Pharmacology in Drug Development

oa_colors: green hybrid

evidence: open (via crossref license)

title: A Single Supratherapeutic Dose of Atogepant Does Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized, Single‐Dose, Phase 1 Crossover Trial

ReferenceCitation: Min KC, Kraft WK, Bondiskey P, Colón-González F, Liu W, Xu J, Panebianco D, Mixson L, Dockendorf MF, Matthews CZ, Boinpally R. Atogepant Is Not Associated With Clinically Meaningful Alanine Aminotransferase Elevations in Healthy Adults. Clin Transl Sci. 2021 Mar;14(2):599-605. doi: 10.1111/cts.12917. Epub 2020 Nov 24.

name: Formerly of Merck & Co., Inc. Kenilworth New Jersey USA

family: Min

full_name: K. Chris Min

given: K. Chris

name: Thomas Jefferson University Philadelphia Pennsylvania USA

family: Kraft

full_name: Walter K. Kraft

given: Walter K.

name: Merck & Co., Inc. Kenilworth New Jersey USA

family: Bondiskey

full_name: Phung Bondiskey

given: Phung

family: Colón‐González

full_name: Francheska Colón‐González

given: Francheska

family: Liu

full_name: Wen Liu

given: Wen

family: Xu

full_name: Jialin Xu

given: Jialin

family: Panebianco

full_name: Deborah Panebianco

given: Deborah

family: Mixson

full_name: Lori Mixson

given: Lori

family: Dockendorf

full_name: Marissa F. Dockendorf

given: Marissa F.

family: Matthews

full_name: Catherine Z. Matthews

given: Catherine Z.

journal_name: Clinical and Translational Science

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

location_country:
Italy
United States
Sweden
Spain
Germany
France
Czechia
Japan
Poland
Australia
Russian Federation
China
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Dokkyo Medical University Hospital /ID# 236810

location_facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 237835

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 237847

location_facility: Tri-Service General Hospital /ID# 237657

location_facility: Pusan National University Hospital /ID# 237120

location_facility: King's College Hospital NHS Foundation Trusts /ID# 236301

location_facility: State Autonomous Healthcare Institution Republican Clinical Neurology Centre /ID# 236354

location_facility: Premiere Research Institute - Palm Beach /ID# 238192

location_facility: George Washington University Medical Faculty Associates /ID# 238011

location_facility: Northwest Clinical Research Center /ID# 237581

location_facility: Albuquerque Clinical Trials, Inc /ID# 236853

location_facility: Tianjin Huanhu Hospital (THH) /ID# 236524

location_facility: Nowon Eulji Medical Center, Eulji University /ID# 236306

location_facility: Sentara Neurology Specialists - Virginia Beach /ID# 234349

location_facility: The Second Hospital of Shanxi Medical University /ID# 236529

location_facility: J. Lewis Research, Inc. Foothill Family Clinic South /ID# 236297

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 237291

location_facility: Higashi Sapporo Neurology and Neurosurgery Clinic /ID# 234549

location_facility: California Headache and Balance Center /ID# 236246

location_facility: Stortorgets Neurologmottagning /ID# 236454

location_facility: Guangzhou First People's Hospital /ID# 236510

location_facility: Kazan State Medical University /ID# 236298

location_facility: Vancouver Island Health Authority /ID# 238053

location_facility: Dartmouth-Hitchcock Medical Center /ID# 237444

location_facility: Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 237256

location_facility: Taipei Veterans General Hosp /ID# 237236

location_facility: The Second Affiliated Hospital of Soochow University /ID# 234296

location_facility: Baptist Health Center for Clinical Research /ID# 237361

location_facility: Central Clinical Hospital RZHD Medicine /ID# 237024

location_facility: DOI Internal Medicine-Neurology Clinic /ID# 234562

location_facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 236500

location_facility: Specjalistyczne Gabinety Sp. z o.o. /ID# 236348

location_facility: Chinese PLA General Hospital /ID# 238237

location_facility: The Royal Melbourne Hospital /ID# 236859

location_facility: Yonsei University Health System, Severance hospital. /ID# 237839

location_facility: Dongtan Sacred Heart Hospital /ID# 238097

location_facility: MedStar Georgetown Neurology /ID# 236324

location_facility: Seoul National University Hospital /ID# 237786

location_facility: Preferred Primary Care Physicians, Inc. /ID# 236439

location_facility: Hospital Clinico Universitario de Valencia /ID# 237400

location_facility: Saitama Neuropsychiatric Institute /Id# 234550

location_facility: Azienda Ospedaliero Universitaria Careggi /ID# 237598

location_facility: Albany Medical Center Rheumatology /ID# 236540

location_facility: Centrum Medyczne Pratia Gdynia /ID# 237077

location_facility: Clinique des cephalees de Montreal /ID# 236266

location_facility: Peking University Third Hospital /ID# 238150

location_facility: The First Affiliated Hospital of Soochow University /ID# 234297

location_facility: Hospital Clinico Universitario de Valladolid /ID# 234406

location_facility: The Second Affiliated Hospital of Guangzhou Medical University /ID# 238133

location_facility: Dent Neurosciences Research Center, Inc. /ID# 237040

location_facility: Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 236289

location_facility: Josephson-Wallack-Munshower Neurology - NE /ID# 238234

location_facility: The second Affiliated hospital of Zhejiang University school of Medicine /ID# 238260

location_facility: Beth Israel Deaconess Medical Center /ID# 237540

location_facility: Raleigh Neurology Associates /ID# 237141

location_facility: CH Annecy Genevois Site Annecy /ID# 236385

location_facility: The Second Hospital of Jilin University /ID# 236520

location_facility: Japanese Red Cross Shizuoka Hospital /ID# 234372

location_facility: University of Texas Southwestern Medical Center /ID# 236941

location_facility: Hospital Universitario Virgen del Rocio /ID# 237106

location_facility: Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 236723

location_facility: The First Affiliated Hospital of Zhengzhou University /ID# 237025

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 237645

location_facility: Sendai Headache and Neurology Clinic Medical Corporation /ID# 234496

location_facility: Accel Research Sites - St Petersburg Clinical Research Unit /ID# 237161

location_facility: Abington Neurological Associates - Abington /ID# 236258

location_facility: AP-HM - Hopital de la Timone /ID# 236285

location_facility: Alpine Clinical Research Center /ID# 234346

location_facility: Hospital Clinico Universitario Lozano Blesa /ID# 237373

location_facility: Ottawa Headache Centre Research Inc /ID# 236432

location_facility: Clinical Research Institute, Inc /ID# 238299

location_facility: Stetson-University of Cincinnati /ID# 236453

location_facility: Centrum Leczenia Padaczki i Migreny /ID# 236386

location_facility: Montreal Neurological Institut /ID# 236329

location_facility: Peking University First Hospital /ID# 236537

location_facility: Schuster Medical Research Institute /ID# 236447

location_facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 237623

location_facility: Atsuchi Neurosurgical Hospital /ID# 234779

location_facility: Clinical Neuroscience Solutions - Memphis /ID# 237478

location_facility: Saitama Medical University Hospital /ID# 237019

location_facility: Accel Research Sites - Tampa Clinical Research Unit /ID# 237485

location_facility: LMU Klinikum Campus Grosshadern /ID# 236293

location_facility: J. Lewis Research, Inc. / Foothill Family Clinic /ID# 236395

location_facility: AOU Università degli Studi della Campania Luigi Vanvitelli /ID# 236361

location_facility: Hospital Universitario y Politecnico La Fe /ID# 237087

location_facility: Vall d'Hebron University Hospital /ID# 236467

location_facility: Rigshospitalet Glostrup Danish Headache center /ID# 236411

title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine (Progress)

summary: This study will evaluate the efficacy, safety and tolerability of atogepant in participants with chronic migraine. This study includes a 12-week treatment period.


title: Establishing the Safety and Efficacy of Reloxaliase (Oxalate Decarboxylase) in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Double-Blind, Placebo-Controlled Study (URIROX-2)

summary: The purpose of this study is to determine the efficacy, durability and long-term safety of reloxaliase in patients with enteric hyperoxaluria.

ReferenceCitation: Langman CB, Grujic D, Pease RM, Easter L, Nezzer J, Margolin A, Brettman L. A Double-Blind, Placebo Controlled, Randomized Phase 1 Cross-Over Study with ALLN-177, an Orally Administered Oxalate Degrading Enzyme. Am J Nephrol. 2016;44(2):150-8. doi: 10.1159/000448766. Epub 2016 Aug 17.

ReferenceCitation: Lingeman JE, Pareek G, Easter L, Pease R, Grujic D, Brettman L, Langman CB. ALLN-177, oral enzyme therapy for hyperoxaluria. Int Urol Nephrol. 2019 Apr;51(4):601-608. doi: 10.1007/s11255-019-02098-1. Epub 2019 Feb 19.

lead_sponsor: Allena Pharmaceuticals

location_country:
Italy
Austria
United States
Brazil
Switzerland
Mexico
Spain
Germany
Croatia
France
Romania
Belgium
Russian Federation
Portugal
Canada
United Kingdom

location_facility: New York University School of Medicine- Langone Medical Center

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV) Lausanne Nephrology Department

location_facility: Alliance for Multispecialty Research, LLC

location_facility: UVC Brugmann University Hospital- Centre Hospitalier Universitaire

location_facility: Clinical Research Solutions- Middleburg Heights

location_facility: ICARO Investigaciones en Medicina SA de CV/Hospital Christus Muguerza

location_facility: Mayo Clinic- Department of Nephrology Hyperoxaluria Center

location_facility: University of California, San Diego (UCSD) Health System

location_facility: University of Cincinnati (UC) - Department of Nephrologyv

location_facility: South Tyneside District Hospital - South Shields

location_facility: University of Alabama- Department of Urology

location_facility: Medizinische Universitat Wien, Innere Medizin III

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

location_facility: Centro Hospitalar Universitario de Sao Joao

location_facility: Lifespan Physician Group Minimally Invasive Urology Institute

location_facility: University of Wisconsin - Division of Nephrology

location_facility: Inselspital, Universitaetsspital Bern Inselspital Bern University Hospital

location_facility: University of California- San Francisco (UCSF)

location_facility: Long Island Gastrointestinal Research Group

location_facility: Chesapeake Urology Associates, LLC d/b/a/ Chesapeake Urology Research Associates

location_facility: Baylor Scott and White Research Institute- Temple

location_facility: Ohio State University (OSU)-Renal Division

location_facility: Centre de Recherche Du Centre Hospitalier de l'Universite de Montreal

location_facility: Arizona Kidney Disease and Hypertension Center (AKDHC)- Phoenix

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino IST

location_facility: University of North Carolina (UNC) - Chapel Hill

location_facility: The Urology Center, P.C./ GU Research Network

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Urological Associates of Southern Arizona

location_facility: Universite Libre de Bruxelles -Hospital Erasme

location_facility: Arizona Kidney Disease and Hypertension Center (AKDHC)- Glendale

location_facility: University of Alberta- Division of Urology

location_facility: Centro specializado en Diabetes, Obesidad y Prevencion de Enfermedades Cardiovasculares

location_facility: Spitalul Clinic Universitar de Urgenta Bucuresti

location_facility: Saratov State Medical University, n.a. V.I. Razumosky

location_facility: Centru de Diagnostic si Tratament Affidea- Medicina Interna

location_facility: Azienda USL Toscana Centro-Ospedale Santa Maria Nuova

location_facility: South Florida Nephrology Group PA Research Div


title: ASSIST Registry to Assess the Procedural Success and Clinical Outcomes Associated With Various Operator Techniques for Mechanical Thrombectomy in Large Vessel Occlusions (LVO).

summary: The purpose of this Registry is to assess the procedural success and clinical outcomes associated with various operator techniques for mechanical thrombectomy in large vessel occlusions (LVO).

study_type: Observational

time_perspective: Prospective

lead_sponsor: Stryker Neurovascular

location_country:
Italy
United States
Switzerland
Germany
France
Czechia
Belgium
Spain
Canada
United Kingdom
Korea, Republic of

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: WellStar Health System/ Kennestone Hospital

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

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: University of Oklahoma Medical Center (OU - OKC)

location_facility: Hospital Universitario Central de Asturias - HUCA


title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative Colitis

summary: Study CYC-202 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of ST-0529 in subjects with moderately to severely active UC, defined as a score of 5 to 9 on the 3-Component Adapted Mayo Score (comprised of rectal bleeding, stool frequency and endoscopy sub-scores; score range 0-9).

ipd_sharing: Undecided

lead_sponsor: Sublimity Therapeutics Holdco Limited

location_country:
Italy
Serbia
Spain
Germany
France
Bulgaria
Poland
Israel
Romania
Hungary
Ireland
Russian Federation
Belarus
United States
United Kingdom
Canada
Ukraine

location_facility: North-Western State Medical University n.a. I.I.Mechnikov

location_facility: Communal Nonprofit Enterprise "Odesa Regional Clinical Hospital"

location_facility: CHU de Saint-Etienne - Service de Gastro-Entérologie-Hépatologie

location_facility: Communal Nonprofit Entreprise, "Lviv Clinical Emergency Care Hospital", 1st Therapeutic Dpt

location_facility: Clinical-Hospital Centre Bezanijska Kosa - Gastroenterology Department

location_facility: A.0.U. di Modena - Policlinico S.C. di Gastroenterologia

location_facility: Communal Nonprofit Enterprise "Lviv Clinical Emergency Care Hospital"

location_facility: Municipal Institution "Uzhhorod Central District Hospital"

location_facility: University College London Hospital NHS Foundation Trust

location_facility: Dalhousie University - Queen Elizabeth II Health Sciences Centre

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

location_facility: South Eastern Health & Social Care Trust, Ulster Hospital

location_facility: Ivano-Frankivsk National Medical University, Regional Clinical Hospital

location_facility: Kharkiv City Clinical Hospital No 2 n.a. prof. O.O.Shalimov

location_facility: Non state Public Health Institution "Railway clinical hospital on station Samara" of joint stock company Russian railways

location_facility: Communal Non-profit Enterprise "Vinnytsia City Clinical Hospital #1"

location_facility: Hôpital de Brabois Service d'Hépato-Gastro-Entérologie

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Agaplesion Markus Krankenhaus Medizinischen Klinik I, Gastroenterologie, Hepatologie, Onkologie, lnfektiologie

location_facility: Ukrainian-German Gastroenterology Center "BYK-Kyiv"

location_facility: Klinik für Gastroenterologie, Pulmologie und allg. lnnere Medizin

location_facility: Fondazione Casa Sollievo della Sofferenza

location_facility: Semmelweis University, AOK Varosmajori Sziv- es Ergyogyaszati Klinika,

location_facility: Universität Leipzig, Klinik f. Gastroenterologie und Rheumatologie

location_facility: Communal Nonprofit Enterprise "Ternopil University Hospital" of Ternopil Regional Council

location_facility: Communal Institution of Kyiv Regional Council "Kyiv Regional Clinical Hospital"

location_facility: Krankenhaus Walfriede, Akademisches Lehrkrankenhaus der Charite

location_facility: Gastroenterology Institute, Emek Medical Center

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Clinical Hospital Center "Dr Dragisa Misovic-Dedinje"

location_facility: Royal Liverpool & Broadgreen University Hospitals NHS Trust

location_facility: Institute of Gastroenterology, Meir Medical Center

location_facility: Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Zentrym für Innere Medizin

location_facility: Universitatsklinikum Freiburg, Medizinische Klinik

location_facility: Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego UM

location_facility: Scientific Research Center Eco-Safety LLC

location_facility: Fondazione IRCCS Policlinico San Matteo - Medicina Generale I

location_facility: Hospital Universitario Virgen de la Macarena

location_facility: Medizinische Klinik für Gastroenterologie, Infektiologie, Rheumatologie charite

location_facility: Saint-Petersburg State Medical Academy n.a. I.I. Mechnikov of Federal Agency of Healthcare & Social Development

location_facility: CHU Amiens Picardie - Service Hépato-Gastroentérologie


intervention_type: Radiation

ipd_sharing_description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Brazil
Netherlands
Spain
Germany
France
Czechia
Japan
Korea, Republic of
Belgium
Argentina
Australia
China
United States
Canada
Taiwan

location_facility: Cancer Institute Hospital of JFCR - Dept of Respiratory Medicine

location_facility: University of Texas MD Anderson Cancer Center - Unit 432 Thoracic Head and Neck Medical Oncology

location_facility: Hospital Universitario 12 de Octubre - Servicio de Oncologia

location_facility: Kanagawa Cancer Center - Dept of Respiratory Medicine

location_facility: University of Colorado Health - Memorial Hospital - Memorial Hospital

location_facility: National Cancer Center Hospital East - Dept of Respiratory Medicine

location_facility: The University of Chicago Medical Center

location_facility: Hospital Universitari Quiron Dexeus - Servicio de Oncologia Medica

location_facility: Hospital Regional Universitario de Malaga

location_facility: Hospital Universitario Virgen Macarena - Servicio de Oncologia

location_facility: Hospital Alvaro Cunqueiro - Servicio de Oncologia

location_facility: UCLA Hematology Oncology - Main Site - 2020 Santa Monica

location_facility: South West Healthcare - South West Oncology

location_facility: Saitama Medical University International Medical Center - Dept of Respiratory Medicine

location_facility: Baptist Health Lexington Oncology Associates

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Kobe City Hospital Organization Kobe City Medical Center General Hospital - Dept of Respiratory Medicine

location_facility: Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica

location_facility: HGB - Hospital Giovanni Battista - Mãe de Deus Center - Centro de Pesquisa Clínica - Instituto do Câncer

location_facility: Hospital Universitario Nuestra Señora de Valme - Servicio de Oncologia

location_facility: University of Maryland - DUPLICATE/Pediatric Surgery

location_facility: Holy Cross Hospital - Michael and Dianne Bienes CCC

location_facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital - Dept of Respiratory Medicine

location_facility: Hospital de Câncer de Barretos - Fundação Pio XII

location_facility: Meander Medisch Centrum - Dep of Pulmonology

location_facility: A. C. Camargo Cancer Center - Fundação Antônio Prudente

location_facility: Nippon Medical School Hospital - Dept of Respiratory Medicine

location_facility: St. Antonius Ziekenhuis - Dept Pulmonology - Nieuwegein

location_facility: Clinica Universidad de Navarra (MAD) - Oncology Service

location_facility: Aichi Cancer Center Hospital - Dept of Respiratory Medicine

location_facility: Hospital Universitario Clinico San Carlos - Servicio de Oncologia

location_facility: Complejo Hospitalario Universitario de Santiago - Servicio de Oncologia Medica

location_facility: Hospital Universitario Virgen del Rocio - Servicio de Oncologia

location_facility: The James Cancer Hospital and Solove Research Institute

location_facility: CHU Nantes - Hôpital Guillaume et René Laënnec - Service de Pneumologie

location_facility: Hematology Oncology Center of Nyack Hospital

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

location_facility: BC Cancer Agency Center for the Southern Interior

location_facility: Seoul National University Bundang Hospital

location_facility: Clinique et Maternite St Elisabeth Namur

location_facility: Centro Polivalente de Asistencia e Inv. Clinica CER

location_facility: University of California Irvine Medical Center

location_facility: Hospital Universitari Vall d'Hebron - Dept of Oncology

location_facility: Hôpital Nord - AP-HM Marseille# - Service d'Oncologie Multidisciplinaire

location_facility: Hospital del Mar - Servicio de Oncologia

location_facility: Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia

location_facility: Pius-Hospital Oldenburg - Klinik f. Haematologie und Onkologie

location_facility: Kurume University Hospital - Dept of Lung Cancer Center

location_facility: Franciscan St. Francis Health Cancer Center

location_facility: St Vincent's Hospital Melbourne - PARENT

location_facility: Fakultni nemocnice Olomouc - Dept of Onkologicka klinika

location_facility: Centre Hospitalier de la Côte Basque - Service de Pneumologie

location_facility: Asklepios Klinik Harburg - Medizinische Abteilung I

location_facility: Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris - Service d'Oncologie Médicale

location_facility: ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira

location_facility: Sylvester Comprehensive Cancer Center - University of Miami Health System

location_facility: Osaka Medical Center for Cancer and Cardiovascular Diseases

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia

location_facility: Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica

title: A Multicenter, Double Blind, Randomized, Controlled Study of M7824 With Concurrent Chemoradiation Followed by M7824 Versus Concurrent Chemoradiation Plus Placebo Followed by Durvalumab in Participants With Unresectable Stage III Non-small Cell Lung Cancer

summary: The main purpose of this study is to evaluate safety and efficacy in participants treated with concomitant chemoradiation therapy (cCRT) plus M7824 followed by M7824 compared to cCRT plus placebo followed by durvalumab.


title: Phase I/II, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Durvalumab Monotherapy or in Combination With Tremelimumab in Pediatric Patients With Advanced Solid Tumors and Hematological Malignancies

summary: The purpose of the study is to determine the recommended dose of durvalumab and tremelimumab (immunotherapy drugs) in pediatric patients with advanced solid and hematological cancers and expand in a second phase to test the efficacy of these drugs once this dose is determined

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

lead_sponsor: AstraZeneca

location_country:
Italy
United States
Netherlands
France
Spain
Germany
United Kingdom


title: A Randomized, Subject and Investigator Blinded, Placebo-controlled and Multi-center Platform Study, to Assess Efficacy and Safety of Different Investigational Drugs in Patients With Moderate to Severe Hidradenitis Suppurativa

summary: The main purpose of this study is to assess preliminary efficacy and safety of CFZ533, LYS006 and MAS825 in patients with moderate to severe hidradenitis suppurativa and to determine if CFZ533, LYS006 and MAS825 have an adequate clinical profile for further clinical development.

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:
Austria
Netherlands
Germany
France
Czechia
Hungary
Belgium
Spain
Denmark
United States
Iceland


title: A Phase 1 First-in Human, Multi-Center, Open Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and RP2D of ABBV-151 as a Single Agent and in Combination With ABBV-181 in Subjects With Locally Advanced or Metastatic Solid Tumors

summary: The study will determine the recommended Phase 2 dose (RP2D) of ABBV-151 administered as monotherapy and in combination with budigalimab (ABBV-181) as well as to assess the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-151 alone and in combination with budigalimab. The study will consist of 2 phases: dose escalation and dose expansion.

lead_sponsor: AbbVie

location_country:
United States
France
Japan
Israel
Belgium
Australia
Puerto Rico
Spain
Canada
Korea, Republic of
Taiwan

location_facility: Tel Aviv Sourasky Medical Center /ID# 222199

location_facility: National Taiwan University Hospital /ID# 218490

location_facility: Yonsei University Health System Severance Hospital /ID# 218512

location_facility: National Cancer Center Hospital East /ID# 224808

location_facility: China Medical University Hospital /ID# 218492

location_facility: Princess Margaret Cancer Centre /ID# 209423

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 220928

location_facility: Indiana Univ School Medicine /ID# 208384

location_facility: Hospital Clinic de Barcelona /ID# 221106

location_facility: AdventHealth Cancer Institute - Orlando /ID# 226953

location_facility: CHU Toulouse - Hopital Purpan /ID# 218667

location_facility: Hospital Clinico Universitario de Valencia /ID# 221107

location_facility: Pan American Center for Oncology Trials, LLC /ID# 217475

location_facility: Carolina BioOncology Institute /ID# 208358

location_facility: The Chaim Sheba Medical Center /ID# 209037

location_facility: The Ohio State University - The James /ID# 217611

location_facility: Seoul National University Hospital /ID# 218513

location_facility: National Cancer Center Hospital /ID# 209421


title: A Randomized, Controlled, Open-labeled, Multi-center Clinical Trial to Evaluate the Safe and Effective Performance of the Lungpacer Diaphragm Pacing Therapy System in Patients Who Have Failed to Wean From Mechanical Ventilation.

summary:
This clinical investigation is an open-label, multi-center RCT to demonstrate the safety and effective performance of the Lungpacer DPTS (plus standard of care) as compared to Control (standard of care only) in patients aged 18 years or older who are receiving mechanical ventilation. Eligible Subjects will have received mechanical ventilation for ≥96 hours (4 days) and failed two weaning attempts.

The goal or outcome is to show a numerically greater proportion of subjects weaned in the Treatment (Lungpacer DPTS) group as compared to the Control group.

ipd_sharing_description: Only investigators participating in this clinical trial will be able to see final de-identified participant data at the completion of the study.

lead_sponsor: Lungpacer Medical Inc.

location_country:
Germany
United States
France

location_facility: University of Colorado Anschutz Medical Campus

location_facility: University of Texas Southwestern, Zale Lipshy Hospital

location_facility: Joseph M Still Burn Center at Doctors Hospital Augusta

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Indiana University Health Methodist Hospital

location_facility: Western Michigan University Homer Stryker M.D. School of Medicine

location_facility: CHI Health Creighton University Medical Center - Bergan Mercy

location_facility: Northwell Health; Long Island Jewish Medical Center

location_facility: University of North Carolina School of Medicine


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:
Italy
United States
Germany
France
Belgium
Puerto Rico
Canada

acronym: DISCREET

location_facility: Azienda Sanitaria Locale 1 Ospedale Regionale San Salvatore

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Luebeck

location_facility: ISA - Interdisciplinary Study Association GmbH

location_facility: Universita degli Studi di Roma La Sapienza Ospedale A Fiorini di Terracina

location_facility: Azienda Sanitaria Universitaria Integrata di Trieste

location_facility: Azienda Ospedaliera Bianchi Melacrino Morelli

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux - Hopital Saint-Andre

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: Centre Hospitalier Universitaire Saint Pierre

title: A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double Blind-Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis

summary:
This Phase 3 multicenter, randomized, placebo-controlled, double-blind study is designed to evaluate the efficacy and safety of apremilast in subjects with moderate to severe genital psoriasis (modified sPGA-G ≥3, moderate or severe).

Approximately 286 subjects with moderate to severe genital psoriasis will be randomized 1:1 to receive either apremilast 30 mg BID or placebo for the first 16 weeks.


title: An Open-label, Multi-center, Phase IV Roll-over Study in Patients With ALK Positive Malignancies Who Have Completed a Novartis-sponsored Ceritinib (LDK378) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Ceritinib

summary: The rollover study will provide ceritinib to patients who are currently receiving treatment with ceritinib within a Novartis-sponsored study and in the opinion of the investigator, would benefit from continued treatment with ceritinib.

location_country:
Malaysia
Belgium
Australia
Russian Federation
Taiwan
France
Japan
Poland
Korea, Republic of
Colombia
Hong Kong
Bulgaria
Singapore
China
Germany
United States
Italy
Brazil
Lebanon
Czechia
Spain

location_facility: Maryland Oncology Hematology, P.A. Dept. of Assoc. Onc/Hem


title: A 52-Week Multicenter, Randomized, Blinded, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Ustekinumab in Patients With Moderate-to-Severe Plaque Psoriasis

acronym: IXORA-S

summary: The main purpose of this study is to evaluate the efficacy of the study drug ixekizumab compared to ustekinumab in participants with moderate-to-severe-plaque psoriasis.

ReferenceCitation: Wasel N, Thaçi D, French LE, Conrad C, Dutronc Y, Gallo G, Berggren L, Lacour JP. Ixekizumab and Ustekinumab Efficacy in Nail Psoriasis in Patients with Moderate-to-Severe Psoriasis: 52-Week Results from a Phase 3, Head-to-Head Study (IXORA-S). Dermatol Ther (Heidelb). 2020 Aug;10(4):663-670. doi: 10.1007/s13555-020-00383-x. Epub 2020 May 15.

family: Wasel

full_name: Norman Wasel

given: Norman

family: Thaçi

full_name: Diamant Thaçi

given: Diamant

family: French

full_name: Lars E. French

given: Lars E.

family: Conrad

full_name: Curdin Conrad

given: Curdin

family: Dutronc

full_name: Yves Dutronc

given: Yves

family: Gallo

full_name: Gaia Gallo

given: Gaia

family: Berggren

full_name: Lovisa Berggren

given: Lovisa

family: Lacour

full_name: Jean-Philippe Lacour

given: Jean-Philippe

journal_name: Dermatology and Therapy

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: PubMed Central - Europe PMC

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:
Italy
Austria
Sweden
Switzerland
Netherlands
Germany
France
Poland
Hungary
Belgium
Spain
Canada
United Kingdom

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

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


title: A Phase III Multicenter, Randomized, Open Label Study of APR-246 in Combination With Azacitidine Versus Azacitidine Alone for the Treatment of (Tumor Protein) TP53 Mutant Myelodysplastic Syndromes

summary: A Phase III, multicenter, randomized study to compare the rate of complete response (CR) and duration of CR, in patients with TP53-mutated MDS who will receive APR-246 and azacitidine or azacitidine alone.

lead_sponsor: Aprea Therapeutics

location_country:
United States
France

location_facility: Memorial Health Care System South Florida

location_facility: University of Pittsburgh Medical Center, Hillman Cancer Center

location_facility: Robert H Lurie Comprehensive Cancer Center, Northwestern University

location_facility: University of Pennsylvania, Abramson Cancer Center

location_facility: University of Iowa Hospitals and Clinics, Holden Cancer Center

location_facility: Stanford University Cancer Research Center