title: A Long Term Prospective Observational Post Market Clinical Follow-Up (PMCF) Registry of Ethicon Gynecare Pelvic Mesh Products for The Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse

summary: The objective of this post market, clinical registry is to evaluate the performance of the products of the TVT family of products or vaginal vault or uterine prolapse repair (with laparotomic or laparoscopic approach including robotic assisted) using either Gynemesh PS Mesh or Artisyn Mesh in women undergoing surgery for SUI and POP.

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

lead_sponsor: Ethicon, Inc.

location_country:
Germany
Italy
Poland
Denmark
Sweden
Austria
United States
France

location_facility:
Herlev Hospital
Hopital Jeanne de Flandres
Bio-Medical University Rome
Duke University
University of Pennsylvania
Yale University
Karolinska Institute
UPMC
Universitatsklinikum Tubingen
Żelazna Medical Center
Krankenhaus der barmherzigen Schwestern


title: Assessment of the DiAgnostic Performance of DeepVessel FFR in SuspecTed Coronary Artery Disease

acronym: ADAPT

summary: DEEPVESSEL FFR is a medical device that is designed to extract three- dimensional coronary tree structures and generate computed tomography-derived fraction flow reserve (FFR) values from coronary CT angiogram images. The primary objective of this multi-center clinical validation study is to validate the clinical performance of DEEPVESSEL FFR in identifying patients with myocardial ischemia due to significant obstructive coronary artery diseases.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: Keya Medical

sponsor_collaborators:
Keya Medical
Medical University of South Carolina

location_country:
Italy
Poland
Austria
United States
France

location_facility:
Holy Cross Health
Vanderbilt University Medical Center
Medical University Innsbruck
University of Kansas Medical Center
Oregon Health & Science University
Institute of Arnualt Tzanck
University of Ferrara
Medical University of South Carolina
University of Milan
National Institute of Cardiology

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Completed


title: An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)

summary: This open-label extension study will evaluate the long-term effects of GB002 (seralutinib) in subjects who previously participated in a GB002 PAH study.

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Anticipated

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

location_country:
Germany
United Kingdom
Australia
United States
Spain
Czechia
France

location_facility: Dept. of Veterans Affairs Greater Los Angeles Healthcare System

location_facility: St Vincent's Hospital, Heart & Lung Transplant Unit

location_facility: Lundquist Institute for Biomedical Innovation at Harbor UCLA

location_facility: Royal Papworth Hospital NHS Foundation Trust

location_facility: The Ohio State University Wexner Medical Center

location_facility: Klinik für Pneumologie, Klinisches Studienzentrum Medizinische Hochschule

location_facility: University of California, Davis Medical Center

location_facility: Washington University School of Medicine

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: New York Presbyterian Hospital - Weill Cornell Medicine

location_facility: Klinik und Poliklinik f. Innere Medizin II Universitätsklinikum Regensburg

intervention_type: Drug

status_simplified: Ongoing


title: Drug-Coated Balloon in Anticoagulated and Bleeding Risk Patients Undergoing PCI

acronym: DEBATE

summary: The purpose of this study is to compare DCB with DES in stable CAD or ACS patients who are at high risk of bleeding. The hypothesis of the DEBATE trial is that the strategy using DCB and a shorter DAPT regimen is non-inferior to the treatment using DES and longer DAPT duration on patients with high bleeding risk. If non-inferiority is shown, the superiority of the DCB strategy over DES strategy will be tested.

design_allocation: Randomized

lead_sponsor: North Karelia Central Hospital

collaborators: Norfolk and Norwich University Hospitals NHS Foundation Trust

location_country:
Finland
United Kingdom
Germany
France

location_facility: Norfolk and Norwich University Hospital Nhs Foundation Trust

location_facility: University Hospital of Carl Gustav Carus

intervention_type: Device

lead_sponsor_type: academique


type: Other Identifier

title: Follow-up Phase 3 Randomized, Controlled Study of AAV5-RPGR for the Treatment of X-linked Retinitis Pigmentosa Associated With Variants in the RPGR Gene

summary: A clinical trial of AAV5-RPGR vector for patients with X-linked retinitis pigmentosa (XLRP)

lead_sponsor: Janssen Research & Development, LLC

location_country:
Italy
Israel
United Kingdom
Denmark
Netherlands
Switzerland
Belgium
United States
Spain
Canada
France

location_facility: Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli

location_facility: Shiley Eye Institute / Jacobs Retina Center

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: University of Pittsburgh Medical Center (UPMC)

location_facility: Universite de Lausanne, Hopital ophtalmique Jules-Gonin

location_facility: University Hospital Basel, Eye Clinic/Institute of Molecular and Clinical

location_facility: IRCCS Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia ONLUS

location_facility: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

intervention_type: Biological


type: EudraCT Number

title: A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 Days to Less Than 18 Years of Age With Autosomal Recessive Polycystic Kidney Disease (ARPKD)

summary: The primary objective of this study is to evaluate the safety of tolvaptan in pediatric subjects with autosomal recessive polycystic kidney disease (ARPKD)

design_allocation: Non-Randomized

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Germany
Italy
Poland
United Kingdom
Belgium
United States
France

location_facility: Istituto G.Gaslini, Istituto Pediatrico di Ricovero e Cura a

location_facility: Northwestern University Feinberg School of Medicine - Ann & Robert H. Lurie Children's Hospital of Chicago - Neonatology

location_facility: The Children's Hospital of Philadelphia (CHOP)

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Central Manchester University Hospitals Nhs Foundation Trust

location_facility: Centre Hospitalier Universitaire de Bordeaux (CHU) - Groupe

location_facility: Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa

location_facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico - Clinica De Marchi

location_facility: Université Catholique De Louvain And Cliniques St Luc

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: Great Ormond Street Hospital for Children NHS Trust


title: A Multicenter, Proof-of-concept, Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15912 in Adult Subjects With Short Bowel Syndrome-associated Intestinal Failure (SBS-IF)

summary: This is a randomized, double-blind, placebo-controlled, proof-of-concept (PoC), Phase 2 study to assess the safety, PK, and PD of SC administration of HM15912 in adult subjects with SBS-associated intestinal failure (SBS-IF).

lead_sponsor: Hanmi Pharmaceutical Company Limited

location_country:
Germany
Poland
Denmark
Belgium
United States
Korea, Republic of
France

location_facility: University of Illinois Hospital & Health Sciences System (UI Health)

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: University of Illniois Hospital & Health Sciences System


title: A Phase 1/2, Single-arm Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of Avapritinib in Pediatric Patients With Solid Tumors Dependent on KIT or PDGFRA Signaling

summary: This is a Phase 1/2, multicenter, open-label trial of avapritinib in participants 2 to < 18 years of age with advanced relapsed/refractory (R/R) solid tumors, including central nervous system (CNS) tumors, that harbor a PDGFRA and/or KIT mutation (including non-synonymous point mutations, insertions, and deletions) or amplification, or DMG-H3K27a who have no available curative treatment options. This is a single-arm trial in which all participants will receive avapritinib. The study consists of 2 parts: dose confirmation, safety, and PK (Part 1) and initial efficacy, safety, and PK at the Part 2 recommended dose (Part 2).

lead_sponsor: Blueprint Medicines Corporation

location_country:
Germany
Italy
United Kingdom
Australia
Austria
United States
Korea, Republic of
Canada
France

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Dipartimento di Oncologia Medica ed Ematologia - S.C. Pediatria Oncologica

location_facility: Washington University School of Medicine

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

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

location_facility: Sydney Children's Hospital, Kids Cancer Center

location_facility: Great Ormond Street Hospital For Children


title: A Phase 2, Randomized, Double-blind, Placebo-Controlled Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Dose Levels of Belcesiran in Patients With Alpha-1 Antitrypsin Deficiency-Associated Liver Disease

acronym: ESTRELLA

summary:
This is a multiple dose, randomized, placebo-controlled, double-blind study of belcesiran to evaluate the safety, tolerability, PK, and PD in adult patients with PiZZ AATD-associated liver disease (AATLD).

The study will be conducted in 3 separate cohorts. A total of up to 16 participants may be enrolled in Cohort 1 and 2. A total number of 30 subjects will be enrolled in cohort 3. The 3 cohorts are differentiated by the duration of the treatment period, the number of doses administered, and the timing of the second liver biopsy.

primary_purpose: Other

lead_sponsor: Dicerna Pharmaceuticals, Inc., a Novo Nordisk company

location_country:
Germany
Ireland
Portugal
New Zealand
United Kingdom
Australia
Sweden
Netherlands
Austria
Belgium
United States
Spain
Canada
France

location_facility: Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE

location_facility: Hospital da Senhora da Oliveira - Guimaraes

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM)

location_facility: CTC Clinical Trial Consultants AB Uppsala

location_facility: Royal Free London NHS Foundation Trust, Royal Free Hospital

location_facility: CHU Bordeaux - Hopital Haut-Leveque - Centre François Magendie

location_facility: Addenbrooke's Hospital, Cambridge University

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel

location_facility: Hospital Universitario Marques de Valdecilla Santander

location_facility: Centro Hospitalar Universitario de Sao Joao


title: An Observational Post-marketing Study for Evaluation of Ongoing Safety and Effectiveness of Catheter Mapping and Ablation Using Commercially Approved BWI Medical Devices for the Treatment of Patients With Cardiac Arrhythmias

summary: The purpose of this study is to prospectively collect clinical data evaluating the ongoing safety and performance during routine-use standard cardiac arrhythmia mapping and/or ablation procedures while using commercial Biosense Webster Inc. (BWI) medical devices. Data generated from the study will be used to confirm safety and performance of BWI medical devices in the marketed phase and to expand the body of evidence on the use of these devices and techniques in treatment of cardiac arrhythmias.

time_perspective: Prospective

ipd_sharing: Yes

ipd_sharing_description:
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel

for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

lead_sponsor: Biosense Webster, Inc.

location_country:
Germany
Ireland
Italy
Israel
United Kingdom
Austria
Belgium
France

location_facility: Cardioangiologisches Centrum Bethanien (CCB)

location_facility: Centre Hospitalier Universitaire de Bordeaux


type: Registry Identifier

title: A Phase 1/2, Open-label, Multicenter Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of CC-90011 in Combination With Venetoclax and Azacitidine in R/R Acute Myeloid Leukemia (AML) and Treatment-naïve Subjects With AML Who Are Not Eligible for Intensive Induction Chemotherapy

summary: CC-90011-AML-002 is a Phase 1/2, open-label, multicenter study to assess the safety, tolerability, and preliminary efficacy of CC-90011 given concurrently with Venetoclax and Azacitidine. This study will include 3 parts: a dose escalation part in R/R AML, a dose escalation part in ndAML (treatment-naïve participants with AML who are ≥ 75 years of age or are ≥ 18 to 74 years of age and otherwise not eligible for intensive induction chemotherapy), and a randomized dose expansion part in ndAML of Venetoclax and Azacitidine with or without CC-90011.

status: Terminated

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

lead_sponsor: Celgene

location_country:
United States
Spain
Belgium
France

location_facility:
Local Institution - 120
Local Institution - 800
Local Institution - 121
Local Institution - 802
Local Institution - 803
Local Institution - 116
Local Institution - 110
Local Institution - 401
Local Institution - 111
Local Institution - 115
Local Institution - 118
Local Institution - 101
Local Institution - 801
Local Institution - 104
Local Institution - 108
Local Institution - 103
Local Institution - 202

status_simplified: Unknown


title: Open-Label, Phase 2 Study to Assess the Safety of Mogamulizumab Given Every 4 Weeks Following Induction in Participants With Relapsed/Refractory Cutaneous T-Cell Lymphoma (CTCL)

summary: This is an open-label, multicenter, Phase 2 study to evaluate the safety and tolerability of mogamulizumab given Q4W following initial weekly induction in adult participants with relapsed/refractory MF and SS subtypes of CTCL. The study is composed of a 28-day Screening Period during which participants are screened for entry into this study, followed by a treatment period of up to 2 years from Cycle 1 Day 1.

status: Active, not recruiting

lead_sponsor: Kyowa Kirin, Inc.

location_country:
Italy
United Kingdom
United States
Spain
France

location_facility: University of Pittsburgh School of Medicine

location_facility: Hospital Universitario Fundacion Jimenez Diaz

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

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


title: A Phase 3, Randomized, Double-Blind, Placebo/Paclitaxel-Controlled Study of Batiraxcept (AVB-S6-500) in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer (AXLerate-OC)

acronym: AXLerate-OC

summary: This is a randomized, double-blind Phase 3 study to compare the efficacy and safety of batiraxcept (AVB-S6-500) in combination with paclitaxel (PAC) versus placebo in combination with PAC in patients with platinum resistant recurrent ovarian cancer.

lead_sponsor: Aravive, Inc.

collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT)

location_country:
Italy
Poland
United Kingdom
Belgium
United States
China
Spain
Czechia
Canada
Georgia
France

location_facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii

location_facility: Policlinico S. Orsola-Malpighi - SSD Oncologia Medica

location_facility: IRCCS Ist. Romagnolo per lo studio dei Tumori "Dino Amadori"

location_facility: Dana-Farber/Brigham and Women's Cancer Center in Clinical Affiliation with South Shore Hospital

location_facility: Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

location_facility: Royal United Hospital Bath NHS Foundation Trust

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: The Blavatnik Family-Chelsea Medical Center at Mount Sinai

location_facility: Providence Cancer Institute Franz Clinic

location_facility: The Second Hospital of Shanxi Medical University

location_facility: University of Pennsylvania Health System

location_facility: The First Affiliated Hospital of Zhejiang University School of Medicine

location_facility: Pro Healthcare Waukesha Memorial Hospital

location_facility: University of South Alabama Mitchell Cancer Institute

location_facility: Fudan University Shanghai Cancer Hospital

location_facility: Banner MD Anderson Cancer Center/North Colorado Medical Center

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC

location_facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center

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

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

location_facility: Stephenson Cancer Center - University of Oklahoma

location_facility: Southeastern Regional Medical Center, LLC

location_facility: Maine Medical Partners - Women's Health - Division of Gynecologic Oncology

location_facility: Fondazione Policlinico "Agostino Gemelli" IRCCS

location_facility: Abington Memorial Hospital, Hanjani Institute for Gyn Onc

location_facility: Lewis Cancer & Research Pavilion at St. Joseph's/Candler Health System, Inc.

location_facility: First Affiliated Hospital of Soochow University

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

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

location_facility: Metro Minnesota Community Oncology Research Consortium

location_facility: UC Irvine Health-Chao Family Comprehensive Cancer Center

location_facility: Women & Infants Hospital of Rhode Island

location_facility: University of Wisconsin Clinical Science Center

location_facility: SPSK Nr 2 PUM Klinika Ginekologii Operacyjnej i Onkologii Klinicznej

location_facility: Maria Sklodowska - Curie Instytute Oncolgy Center

location_facility: Georgia Cancer Center at Augusta University

location_facility: North Shore Hematology Oncology Assoc. DBA NY Cancer and Blood Specialists

location_facility: The University of Chicago Medical Center

location_facility: Chattanooga's Program in Women's Oncology

location_facility: Washington University School of Medicine - Division of Gynecologic Oncology

location_facility: Clinical Research Unit, Jewish General Hospital

location_facility: St Vincent Hospital and Healthcare Center

location_facility: Mercy Hospital, David C Pratt Cancer Center

location_facility: Hospital Universitario Reina Sofia (Provincial)

location_facility: The Royal Marsden NHS Foundation Trust (Sutton)

location_facility: The Royal Marsden NHS Foundation Trust (Fulham Road)

location_facility: LTD Consilium Medulla - Multiprofile Clinic

location_facility: Ohio State University (OSU) Wexner Medical Center OSU Gynecologic Oncology at Mill Run

location_facility: UCLA Women's Health Clinical Research Unit


title: Validation of Genomic Immune-phenotyping Profiles in Peripheral Blood Gene Signatures to Predict Risk of Kidney Transplant Rejection

summary: Global, non-randomized, observational study for the validation of Verici Dx genomic tests to predict risk of kidney clinical and subclinical acute rejection, and chronic allograft damage or interstitial fibrosis / tubular atrophy by correlating peripheral blood gene expression profiles with graft injury (e.g. cellular / antibody-mediated), rejection and death censored graft loss.

lead_sponsor: Verici Dx

location_country:
United States
Italy
Spain
France

location_facility: University Hospital Vall d'Hebron, Barcelona


title: A Phase 1, Multicenter, Open-label, Dose Exploration and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 994 Monotherapy and Combination of AMG 994 and AMG 404 in Subjects With Advanced Solid Tumors

summary: The primary objective of this study is to evaluate the safety, tolerability, and maximum tolerated dose (MTD)/maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) of AMG 994 as monotherapy and AMG 994 in combination with AMG 404 in participants with advanced solid tumors.

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

lead_sponsor: Amgen

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

location_facility: Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

location_facility: University of Texas MD Anderson Cancer Center

location_facility: University Hospitals Cleveland Medical Center

location_facility: Henry Ford Hospital, Henry Ford Health Systems

location_facility: National Hospital Organization Shikoku Cancer Center


title: Product Surveillance Registry (PSR) - Targeted Drug Delivery (TDD) - SynchroMed II European Post-Market Clinical Follow-up (PMCF)

summary: The purpose of this study is to provide continuing evaluation and reporting of safety and performance of the SynchroMed II Infusion System within its intended use. Data will support post-market surveillance obligations.

lead_sponsor: Medtronic

location_country:
Slovenia
United Kingdom
Netherlands
Switzerland
Belgium
Spain
Czechia
France

location_facility: Morges Enschede Brugge Ljubljana Nottwil Wilrijk Maastricht Leuven Madrid Badalona Praha Marseille Roeselare Sint-Niklaas Middlesbrough


title: A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of Delta-like Protein 3 Half-life Extended Bispecific T-cell Engager AMG 757 in Subjects With De Novo or Treatment Emergent Neuroendocrine Prostate Cancer

summary: To evaluate the safety and tolerability of Tarlatamab and will determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).

location_country:
United Kingdom
Australia
Japan
Netherlands
Austria
Belgium
United States
Spain
France

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Community Health Network MD Anderson Cancer Center - North

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

location_facility: Winship Cancer Institute of Emory University


title: Phase 3 Randomized, Controlled Study of AAV5-RPGR for the Treatment of X-linked Retinitis Pigmentosa Associated With Variants in the RPGR Gene

location_facility: Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli

location_facility: Shiley Eye Institute / Jacobs Retina Center

location_facility: Massachusetts General Hospital - Center for Celiac Research and Treatment

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: University of Pittsburgh Medical Center (UPMC)

location_facility: Universite de Lausanne, Hopital ophtalmique Jules-Gonin

location_facility: University Hospital Basel, Eye Clinic/Institute of Molecular and Clinical

location_facility: IRCCS Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia ONLUS

location_facility: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts


title: Real-Life Chronic Rhinosinusitis Outcome Registry

summary: An international consortium of leading medical experts in the field of chronic respiratory disease, the research team of Galenus Health and the non-profit organization EUFOREA (European Forum for Research and Education in Allergy and Airway diseases) has been conceived to conduct real-life outcome research. The Galenus Health digital platform consisting of a mobile application for patients and an online dashboard for physicians will be implemented in each of the participating centres. The data will be centralized in a pseudonymized database and will be the basis of the Chronic RhinoSinusitis Outcome Registry.

ipd_sharing: Undecided

lead_sponsor: Change Accelerator in Respiratory Care

location_country:
Finland
Germany
Italy
United Kingdom
Denmark
Netherlands
Austria
Belgium
Spain
France

location_facility:
Graz University Hospital
Policlinico Umberto I
UZ Ghent
UZ Leuven
UMC Amsterdam
UCL Saint-Luc
Odense University Hospital
Prof Claire Hopkins private practice
Hospital Clinic de Barcelona
University Hospital Vienna
CHU Lille
Helsinki University Hospital
Dusseldorf University Clinic


title: CariesCare International Adapted for the Pandemic in Children: Caries OUT Multicentre Single-group Interventional Study

summary:
The current understanding of dental caries has not been completely transferred into the clinical practice to control caries lesion progression (severity / activity) and the individual risk of caries. This situation led to the development of the CariesCare International CCI Caries Management System (2018), derived from ICCMS™- International Caries Classification and Management System (2012) and the ICDAS - International Caries Detection and Assessment System (2002) in a consensus among more than 45 cariologists, epidemiologists, public health professionals, researchers and cliniciansfrom all over the world. The consensus aimed to guide dentists and dental teams in clinical practice, facilitating the control of the caries process and the maintenance of oral health in their patients.

The general lack of implementation of an updated management of dental caries is evident in Colombia, in the survey of 1094 clinicians, teachers and students, failures were reported to adopt related behaviours, motivation barriers (remuneration), opportunity (in terms of relevance, physical/infrastructure resources, time) and training. As an additional barrier, the Colombian Chapter of the Alliance for a Cavity-Free Future (ACFF), evidences the absence of a facilitating Oral Health Record (OHR), this situation lead to stablish a new Alliance between the Ministry of Health and Social Protection (MSPS) and the AFLC to develop an inter-institutional consensus at the national level, of a clinical history for diagnosis and management of lesions and caries risk. Finally, 55 institutions participated in this consensus, and we have just finished a pilot test of the forms to submit a proposal for national standardization from the MSPS.

The aim of this multicentre case series is to assess after 3, 6 and 12 months in children oral health outcomes, caregivers' satisfaction and in dentists' process outcomes, after the implementation of the CCI system adapted for the COVID-19 era -non-aerosol generating procedures. Oral health outcomes will be evaluated in terms of:

Effectiveness of CCI to control bacterial plaque, caries progression and caries risk, and to achieve behavioural change in oral health in children.
Acceptance of CCI caries management adapted for COVID-19 through Treatment Evaluation Interventory in dentists, and in children/parents through satisfaction questionnaire.
Costs of CCI adapted for caries management, in economic terms, number and appointment time.

ReferenceType: result

ReferenceCitation: Martignon S, Cortes A, Douglas GVA, Newton JT, Pitts NB, Avila V, Usuga-Vacca M, Gamboa LF, Deery C, Abreu-Placeres N, Bonifacio C, Braga MM, Carletto-Korber F, Castro P, P Cerezo M, Chavarria N, Cifuentes OL, Echeverri B, Jacome-Lievano S, Kuzmina I, Lara JS, Manton D, Martinez-Mier EA, Melo P, Muller-Bolla M, Ochoa E, Osorio JR, Ramos K, Sanabria AF, Sanjuan J, San-Martin M, Squassi A, Velasco AK, Villena R, Zandona AF, Beltran EO. CariesCare International adapted for the pandemic in children: Caries OUT multicentre single-group interventional study protocol. BMC Oral Health. 2021 Jul 1;21(1):329. doi: 10.1186/s12903-021-01674-1.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: Indiana University - IUScholarWorks

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

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repository_institution: RCAAP Project by FCT - Portuguese National Funding Agency for Science, Research and Technology - RCAAP Search Portal

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

version: acceptedVersion

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;eprints.whiterose.ac.uk;pure.rug.nl;repositorio-aberto.up.pt;scholarworks.iupui.edu

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ipd_sharing_description: All IPD

lead_sponsor: Universidad El Bosque, Bogotá

sponsor_collaborators:
Universidad El Bosque, Bogotá
King's College London
University of Leeds
University of Sheffield

location_country:
Colombia
Portugal
United Kingdom
Argentina
Brazil
Netherlands
Mexico
United States
Uruguay
Peru
Dominican Republic
Russian Federation
France

location_facility: Fundación Universitaria de Colegios de Colombia

location_facility: ACFF Colombian Chapter Manizales Demonstration Territory

intervention_type: Procedure


title: A Phase 1 Study of SGN-STNV in Advanced Solid Tumors

summary:
This trial will look at a drug called SGN-STNV to find out whether it is safe for patients with solid tumors. It will study SGN-STNV to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study how well SGN-STNV works to treat solid tumors.

The study will have two parts. Part A of the study will find out how much SGN-STNV should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-STNV is and if it works to treat certain types of solid tumors.

lead_sponsor: Seagen Inc.

location_country:
Italy
United Kingdom
United States
Spain
Canada
France

location_facility: University of California at San Francisco

location_facility: The Angeles Clinic and Research Institute

location_facility: University Hospitals Cleveland Medical Center

location_facility: University Health Network, Princess Margaret Hospital

location_facility: South Texas Accelerated Research Therapeutics Midwest

location_facility: University of Ottawa / Ottawa General Hospital

location_facility: Shands Cancer Center / University of Florida


title: EMBER-2: A Phase 1, Open-Label, Preoperative Window Study Evaluating the Biological Effects of LY3484356 in Post-menopausal Women With Stage I-III Estrogen Receptor-Positive, HER2-Negative Breast Cancer

summary: The purpose for this study is to see if the study drug, LY3484356, is safe and to determine what effects it has on breast cancer in participants with Estrogen Receptor Positive (ER+), HER2 Negative (HER2-) early stage (stage I-III) breast cancer, when given prior to surgery. Participation in this study could last up to 2.5 months.

primary_purpose: Basic Science

lead_sponsor: Eli Lilly and Company

location_country:
Germany
United Kingdom
Belgium
United States
Spain
France

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Washington University School of Medicine


title: European Study on the Attitude of Psychiatrists Towards Their Patients

acronym: Eustigma

summary:
Background: Many people think that people with mental disorders might be dangerous or unpredictable. These patients face various sources of disadvantages and experience discrimination on job interviews, in education, and housing. Mental health-related stigma (MHS) occurs not only within the public community, it is a growing issue among professionals as well.

Aim: The investigators designed a prospective, observational, multi-centre, international study of 35 European countries to investigate the MHS among medical specialists and trainees in the field of general adult and child and adolescent psychiatry.

Methods: An internet-based, anonymous survey will measure the stigmatizing attitude by using the local version of the Opening Minds Stigma Scale for Health Care Providers.

Presentation of the Results: The results of the research will be published in an international peer-reviewed journal. Furthermore, the research team will present the results at national and international conferences.

time_perspective: Cross-Sectional

lead_sponsor: Semmelweis University

location_country:
Germany
Ireland
Malta
Turkey
Croatia
Czechia
Serbia
France
Slovenia
Belarus
Lithuania
Portugal
Montenegro
Hungary
Slovakia
Denmark
Switzerland
Latvia
Ukraine
Azerbaijan
Estonia
Italy
Cyprus
Albania
United Kingdom
Netherlands
Austria
Spain
Greece
Bulgaria
Russian Federation

location_facility: Department of Psychiatry and Psychotherapeutic Medicin, Medical University of Graz

location_facility: Clinical Centre of Montenegro, Clinic for Psychiatry

location_facility: Military Medical Academy, Department of Psychiatry

location_facility: Department of Psychiatry, Faculty of Medicine, School of Health Sciences, University of Ioannina

location_facility: Psychiatrische Klinik Clienia Littenheid

location_facility: Chernivtsi Regional Mental Hospital, Bukovinian State Medical University

location_facility: The Serbsky State Scientific Center for Social and Forensic Psychiatry

location_facility: 3rd Faculty of Medicine, Charles University

location_facility: Research Unit for Child and Adolescent Psychiatry, Psychiatry- Aalborg University Hospital

location_facility: Centre for Clinical Psychiatry, University Psychiatric Clinic and Children's hospital Ljubljana

location_facility: Vilnius University, Facutly of Medicine, Psychiatric Clinic

location_facility: Institute of Psychological Medicine, Faculty of Medicine of University of Coimbra

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Department of Liasion Psychiatry, Mater University Hospital


lead_sponsor: AstraZeneca

summary: This is a modular, multicentre, open-label, non-randomised, Phase I/II, dose-setting and expansion study including an intra-participants dose ramp up. AZD4573 will be administered intravenously, in novel combinations with anti-cancer agents, to participants with relapsed/refractory (r/r) haematological malignancies.

sponsor_collaborators: AstraZeneca Parexel

title: A Modular Phase I/II, Open-label, Multicentre Study to Assess AZD4573 in Novel Combinations With Anti-cancer Agents in Patients With Advanced Haematological Malignancies

source: euctr

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

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Ireland
Poland
United Kingdom
Australia
United States
Korea, Republic of
Spain
Canada
France


lead_sponsor: bluebird bio

summary: This is a multi-center, long-term safety and efficacy follow-up study for subjects with sickle cell disease who have been treated with ex vivo gene therapy drug product in bluebird bio-sponsored clinical studies. After completing the parent clinical study (approximately 2 years), eligible subjects will be followed for an additional 13 years for a total of 15 years post-drug product infusion. No investigational drug product will be administered in the study.

ReferenceType: derived

ReferenceCitation: Magrin E, Semeraro M, Hebert N, Joseph L, Magnani A, Chalumeau A, Gabrion A, Roudaut C, Marouene J, Lefrere F, Diana JS, Denis A, Neven B, Funck-Brentano I, Negre O, Renolleau S, Brousse V, Kiger L, Touzot F, Poirot C, Bourget P, El Nemer W, Blanche S, Treluyer JM, Asmal M, Walls C, Beuzard Y, Schmidt M, Hacein-Bey-Abina S, Asnafi V, Guichard I, Poiree M, Monpoux F, Touraine P, Brouzes C, de Montalembert M, Payen E, Six E, Ribeil JA, Miccio A, Bartolucci P, Leboulch P, Cavazzana M. Long-term outcomes of lentiviral gene therapy for the beta-hemoglobinopathies: the HGB-205 trial. Nat Med. 2022 Jan;28(1):81-88. doi: 10.1038/s41591-021-01650-w. Epub 2022 Jan 24.

oa_host_type: closed

repositories_concat: closed

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

location_facility: UCSF Benioff Children's Hospital Oakland

status: Enrolling by invitation

title: Long-term Follow-up of Subjects With Sickle Cell Disease Treated With Ex Vivo Gene Therapy Using Autologous Hematopoietic Stem Cells Transduced With a Lentiviral Vector

location_country:
United States
France


title: FaR-RMS: An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcoma

acronym: FaR-RMS

summary: FaR-RMS is an over-arching study for children and adults with newly diagnosed and relapsed rhabdomyosarcoma (RMS)

lead_sponsor: University of Birmingham

location_country:
Ireland
New Zealand
Australia
Czechia
France
Slovenia
Portugal
Slovakia
Denmark
Switzerland
Belgium
Italy
Norway
United Kingdom
Netherlands
Austria
Spain
Greece
Israel

location_facility: Hellenic Society of Pediatric Hematology- Oncology

location_facility: University Hospital of North Norway - Paediatric

location_facility: Hospital Regional Universitario De Malaga

location_facility: Children's General Hospital P and A Kyriakou

location_facility: Haukeland University Hospital - Paediatric

location_facility: Instituto Portugues De Oncologia De Losbona Francisco Gentil, Epe

location_facility: Royal Belfast Hospital for Sick Children

location_facility: Prinses Maxima Centrum Voor Kinderoncologie

location_facility: Bratislava, National Institute for Children's Diseases

location_facility: Luzerner Kantonspital - Kinderspital Luzern

location_facility: Oslo University Hospital - Radiumhospitalet

location_facility: Universitats-kinderspital Bieder Basel (UKBB)

location_facility: Ippokratio General Hospital of Thessaloniki

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne

location_facility: Hopital Universitaire Des Enfants Reine Fabiola

location_facility: Hematology-oncology Children's Clinic, University General Hospital of Heraklion

location_facility: Dana Children's Hospital, Tel Aviv Sourasky Medical Center

location_facility: Hospital Universitario Miguel Servet Materno - infantil

location_facility: Department of Pediatric Hematology-oncology - Aghia Sophia Children's Hospital

location_facility: University Unit of Pediatric Oncology-hematology - Children's Hospital Agia Sophia

location_facility: Ahepa University General Hospital of Thessaloniki

location_facility: Royal Hospital for Children and Young People

location_facility: Noah's Ark Children's Hospital for Wales

location_facility: Great Ormond Street Hospital for Children

location_facility: University Hospital of Padova (azienda Ospedaliera of Padua)

location_facility: Children's and Adolescent's Oncology Clinic, "MITERA" Children's Hospital

appel_a_projets: PHRCK

region: Île-de-France

nom_etablissement: INSTITUT GUSTAVE ROUSSY

type_etablissement: CLCC

titre: Etude internationale multi-bras multi-étapes des rhabdomyosarcomes de l'enfant et de l'adulte, au diagnostic et en rechute

discipline_principale: cancer

nom_porteur: MINARD-COLIN

prenom_porteur: Véronique


title: A Phase 1, Open-Label, Dose-Escalation Study to Determine an Appropriate Starting Dose of Sacituzumab Govitecan in Subjects With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment

summary: The goals of this clinical study are to learn more about the safety and dosing of the study drug, sacituzumab govitecan-hziy, in participants with solid tumors and moderate liver problems.

ReferenceType: background

ReferenceCitation: Cardillo TM, Govindan SV, Sharkey RM, Trisal P, Goldenberg DM. Humanized anti-Trop-2 IgG-SN-38 conjugate for effective treatment of diverse epithelial cancers: preclinical studies in human cancer xenograft models and monkeys. Clin Cancer Res. 2011 May 15;17(10):3157-69. doi: 10.1158/1078-0432.CCR-10-2939. Epub 2011 Mar 3.

ReferenceCitation: Cardillo TM, Govindan SV, Sharkey RM, Trisal P, Arrojo R, Liu D, Rossi EA, Chang CH, Goldenberg DM. Sacituzumab Govitecan (IMMU-132), an Anti-Trop-2/SN-38 Antibody-Drug Conjugate: Characterization and Efficacy in Pancreatic, Gastric, and Other Cancers. Bioconjug Chem. 2015 May 20;26(5):919-31. doi: 10.1021/acs.bioconjchem.5b00223. Epub 2015 May 8.

ReferenceCitation: Cardillo TM, Sharkey RM, Rossi DL, Arrojo R, Mostafa AA, Goldenberg DM. Synthetic Lethality Exploitation by an Anti-Trop-2-SN-38 Antibody-Drug Conjugate, IMMU-132, Plus PARP Inhibitors in BRCA1/2-wild-type Triple-Negative Breast Cancer. Clin Cancer Res. 2017 Jul 1;23(13):3405-3415. doi: 10.1158/1078-0432.CCR-16-2401. Epub 2017 Jan 9.

ReferenceCitation: Goldenberg DM, Cardillo TM, Govindan SV, Rossi EA, Sharkey RM. Trop-2 is a novel target for solid cancer therapy with sacituzumab govitecan (IMMU-132), an antibody-drug conjugate (ADC). Oncotarget. 2015 Sep 8;6(26):22496-512. doi: 10.18632/oncotarget.4318. Erratum In: Oncotarget. 2020 Mar 10;11(10):942.

ReferenceCitation: Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41. doi: 10.1159/000180580.

ReferenceCitation: Kwapisz D. Sacituzumab Govitecan-hziy in Breast Cancer. Am J Clin Oncol. 2022 Jul 1;45(7):279-285. doi: 10.1097/COC.0000000000000919. Epub 2022 May 12.

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Gilead Sciences

location_facility: The University of Texas M.D. Anderson Cancer Center


title: A Phase 1b, Multicenter, 2-Part, Open-Label Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Immunotherapy With or Without Carboplatin in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (Tropion-Lung04)

summary: This study will assess safety, tolerability, and treatment activity of datopotamab deruxtecan (Dato-DXd) in combination with immunotherapy in participants with advanced or metastatic non-small cell lung cancer (NSCLC).

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 requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

sponsor_collaborators:
AstraZeneca
Daiichi Sankyo, Inc.

location_country:
Italy
Poland
Japan
Belgium
United States
Korea, Republic of
Spain
Turkey
Taiwan
France


title: Host Response Mediators in Coronavirus (COVID-19) Infection - Is There a Protective Effect of Losartan and Other ARBs on Outcomes of Coronavirus Infection?

acronym: ARBs CORONA II

summary:
SARS-CoV-2 is a member of a class of viruses: angiotensin converting enzyme 2 (ACE2)-binding viruses that study calls "ABVs". The World Health Organization (WHO) and others are performing randomized controlled trials (RCTs) of vaccines and novel antivirals to address SARS-CoV-2 directly. However, the critical illness complications of COVID-19 are caused in part by SARS-CoV-2's binding and inhibiting ACE2 and the consequent host response.

ACE 2 is the receptor for H1N1, H5N1, and SARS-CoV-2. After binding ACE2, SARS-CoV-2 is endocytosed, and surface ACE2 is down-regulated, increasing angiotensin II (ATII a potent vasoconstrictor) in COVID-19. The original ARBs limits lung injury in murine influenza H7N9 and decreases viral titre and RNA.

Study has a unique opportunity to complement vaccine and anti-viral RCTs with an RCT modulating the host response using an angiotensin II type 1 receptor blocker (ARBs) to decrease the mortality of hospitalized COVID-19 patient.

lead_sponsor: University of British Columbia

collaborators: Canadian Institutes of Health Research (CIHR)

location_country: Canada France

location_facility: Centre Hospitalier Universitaire d'Angers


title: A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects With Moderate to Severe Ulcerative Colitis (LOMBARD)

summary: Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis.

lead_sponsor: Applied Molecular Transport

location_country:
Germany
Belarus
Moldova, Republic of
Poland
Hungary
United Kingdom
Switzerland
United States
Georgia
Ukraine
Bulgaria
Canada
Russian Federation
France

location_facility: University of Utah Hospitals and Clinics

location_facility: Medical and Diagnostic Centre of Private Enterprise of Private Manufacturing Company "Acinus"

location_facility: Gastromed Kopon, Zmudziski I Wspolnicy Sp.j.

location_facility: CHU Saint-Etienne - Hospital Nord Gastroenteroloy

location_facility: Medical Center Ok!Clinic+ International Institute

location_facility: Javorszky Odon Korhaz, Gasztroenterologiai Osztaly

location_facility: Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska S.J.

location_facility: Universitätsklinikum Jena Klinik fuer Innere Medizin IV

location_facility: Indywidualna Praktyka Lekarska Maciej Zymła

location_facility: Centrum Medyczne LUKAMED Joanna Luka-Wendrowska

location_facility: London Health Sciences Centre - Victoria Hospital

location_facility: Toronto Digestive Disease Associates Specialty Research

location_facility: Semmelweis Egyetem Altalanos Orvostudomanyi Kar

location_facility: Clinical Republican Hospital "Timofei Mosneaga", ARENSIA E.M.

location_facility: Nowe Zdrowie CK Kieltucki I Wspólnicy sp.j.

location_facility: Medical center limited liability Harmoniya Krasy

location_facility: CI of Kyiv RC Regional Clinical Hospital No 2


title: A Randomized, Parallel-Arm, Double-Blind, Placebo-Controlled Study With Open-Label Extension to Assess the Efficacy and Safety of Vatiquinone for the Treatment of Friedreich Ataxia (MOVE-FA)

acronym: MOVE-FA

summary: The primary objective of the study is to evaluate the efficacy (using the modified Friedreich Ataxia Rating Scale [mFARS]) and safety of vatiquinone in participants with Friedreich ataxia (FA).

lead_sponsor: PTC Therapeutics

location_country:
Germany
Italy
New Zealand
Australia
Brazil
United States
Spain
Canada
France

location_facility: Hospital Sant Joan de Déu Barcelona Unidad de Enfermedades Neuromusculares

location_facility: Hôpital Pitié-Salpêtrière, Institut du Cerveau (Paris Brain Institute)

location_facility: CBR Neurogenetic Research Clinic, University of Auckland

location_facility: Department of Neurology and Hertie-Institute for Clinical Brain Research German Center of Neurodegenerative Diseases (DZNE)

location_facility: University of Campinas (UNICAMP) - School of Medical Sciences, Dept of Neurology

location_facility: Centre de Recherche du Centre Hospitalier de l'Université de Montreal (CRCHUM)


lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan in primary IgA nephropathy participants who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials. The open-label design of the current study is appropriate to provide study participants the opportunity to receive treatment with iptacopan until marketing authorizations are received and the drug product becomes commercially available while enabling collection of long-term safety and tolerability data for the investigational drug. Furthermore efficacy assessments conducted every 6 months will afford the opportunity to evaluate the clinical effects of iptacopan on long-term disease progression.

title: A Multicenter Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan in Adult Participants With Primary IgA Nephropathy Who Have Completed Study CLNP023X2203 or CLNP023A2301

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

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

location_country:
Germany
Australia
Brazil
Japan
Thailand
Turkey
Czechia
France
Hong Kong
Denmark
United States
Belgium
China
Malaysia
Italy
Norway
Singapore
United Kingdom
Netherlands
Korea, Republic of
Taiwan
Russian Federation
Israel


title: A Phase 1b Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination With Other Anti-cancer Agents in Patients With Metastatic HER2-low Breast Cancer (DESTINY-Breast08)

summary: DESTINY-Breast 08 will investigate the safety, tolerability, PK and preliminary anti-tumour activity of T-DXd in combination with other therapies in patients with Metastatic HER2-low Advanced or Metastatic Breast Cancer

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

sponsor_collaborators:
AstraZeneca
Daiichi Sankyo Co., Ltd.
Daiichi Sankyo Company, Limited

location_country:
Australia
Brazil
Mexico
Belgium
United States
Korea, Republic of
Taiwan
Canada
Russian Federation
France


title: An Open-label, Multicenter, Phase 1a/1b Study of Aplitibart (IGM-8444) as a Single Agent and in Combination in Participants With Relapsed, Refractory, or Newly Diagnosed Cancers

summary: This study is a first-in-human, Phase 1a/1b, multicenter, open-label study to determine the safety, tolerability, and pharmacokinetics of aplitibart as a single agent and in combination in participants with relapsed and/or refractory solid or hematologic cancers, as well as newly diagnosed cancers, and an open-label, randomized study of aplitibart+FOLFIRI+bevacizumab.

lead_sponsor: IGM Biosciences, Inc.

location_country:
Australia
United States
Spain
Korea, Republic of
France

location_facility: Severance Hospital - Yonsei Cancer Center

location_facility: US Oncology- Virginia Oncology - Norfolk

location_facility: US Oncology- Texas Oncology - Fort Worth

location_facility: Madrid CIOCC - HM Universitario Sanchinnarro

location_facility: Cancer and Blood Specialty Clinic (CBSC)

location_facility: Washington University School of Medicine

location_facility: Seoul National University Bundang Hospital

location_facility: Maryland Oncology Hematology, PA - Columbia

location_facility: City of Hope Comprehensive Cancer Center


title: Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease

acronym: ADAPT-PD

summary: The purpose of the study is to demonstrate the safety and effectiveness of adaptive DBS (aDBS) for Parkinson's disease.

ReferenceCitation: Swinnen BEKS, Buijink AW, Pina-Fuentes D, de Bie RMA, Beudel M. Diving into the subcortex: The potential of chronic subcortical sensing for unravelling basal ganglia function and optimization of deep brain stimulation. Neuroimage. 2022 Jul 1;254:119147. doi: 10.1016/j.neuroimage.2022.119147. Epub 2022 Mar 27.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories_concat: LIRIAS (KU Leuven)

publisher_dissemination: Elsevier

lead_sponsor: MedtronicNeuro

location_country:
United States
Canada
Netherlands
France

location_facility:
University of California San Francisco
Massachusetts General Hospital
Vanderbilt University Medical Center
Stanford University Medical Center
Toronto Western Hospital
UJF Grenoble
Duke University
Amsterdam UMC, location AMC
Cleveland Clinic
University of Florida


lead_sponsor: Medical University of Graz

summary:
This study has been set up within the framework of the INNODIA network. INNODIA is a global partnership between 31 academic institutions, 6 industrial partners, a small sized enterprise and 2 patient organizations, bringing their knowledge and experience together with one common goal: "To fight type 1 diabetes". (www.innodia.eu) The overall aim of INNODIA is to advance in a decisive way how to predict, stage, evaluate and prevent the onset and progression of type 1 diabetes (T1D).

For this, INNODIA has established a comprehensive and interdisciplinary network of clinical and basic scientists, who are leading experts in the field of T1D research in Europe and UK (United Kingdom), with complementary expertise from the areas of immunology, Beta-cell biology, biomarker research and T1D therapy, joining forces in a coordinated fashion with industry partners and two foundations, as well as with all major stakeholders in the process, including regulatory bodies and patients with T1D and their families.

ReferenceCitation: Lachin JM, McGee P, Palmer JP; DCCT/EDIC Research Group. Impact of C-peptide preservation on metabolic and clinical outcomes in the Diabetes Control and Complications Trial. Diabetes. 2014 Feb;63(2):739-48. doi: 10.2337/db13-0881. Epub 2013 Oct 2.

ReferenceCitation: Sorensen JS, Johannesen J, Pociot F, Kristensen K, Thomsen J, Hertel NT, Kjaersgaard P, Brorsson C, Birkebaek NH; Danish Society for Diabetes in Childhood and Adolescence. Residual beta-Cell function 3-6 years after onset of type 1 diabetes reduces risk of severe hypoglycemia in children and adolescents. Diabetes Care. 2013 Nov;36(11):3454-9. doi: 10.2337/dc13-0418. Epub 2013 Aug 29.

ReferenceCitation: Ovalle F, Grimes T, Xu G, Patel AJ, Grayson TB, Thielen LA, Li P, Shalev A. Verapamil and beta cell function in adults with recent-onset type 1 diabetes. Nat Med. 2018 Aug;24(8):1108-1112. doi: 10.1038/s41591-018-0089-4. Epub 2018 Jul 9.

ReferenceCitation: Yin T, Kuo SC, Chang YY, Chen YT, Wang KK. Verapamil Use Is Associated With Reduction of Newly Diagnosed Diabetes Mellitus. J Clin Endocrinol Metab. 2017 Jul 1;102(7):2604-2610. doi: 10.1210/jc.2016-3778.

ReferenceCitation: Cooper-Dehoff R, Cohen JD, Bakris GL, Messerli FH, Erdine S, Hewkin AC, Kupfer S, Pepine CJ; INVEST Investigators. Predictors of development of diabetes mellitus in patients with coronary artery disease taking antihypertensive medications (findings from the INternational VErapamil SR-Trandolapril STudy [INVEST]). Am J Cardiol. 2006 Oct 1;98(7):890-4. doi: 10.1016/j.amjcard.2006.04.030. Epub 2006 Aug 7.

ReferenceCitation: Chen J, Saxena G, Mungrue IN, Lusis AJ, Shalev A. Thioredoxin-interacting protein: a critical link between glucose toxicity and beta-cell apoptosis. Diabetes. 2008 Apr;57(4):938-44. doi: 10.2337/db07-0715. Epub 2008 Jan 2.

ReferenceCitation: Xu G, Chen J, Jing G, Shalev A. Preventing beta-cell loss and diabetes with calcium channel blockers. Diabetes. 2012 Apr;61(4):848-56. doi: 10.2337/db11-0955.

ReferenceCitation: Seaquist ER, Anderson J, Childs B, Cryer P, Dagogo-Jack S, Fish L, Heller SR, Rodriguez H, Rosenzweig J, Vigersky R. Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care. 2013 May;36(5):1384-95. doi: 10.2337/dc12-2480. Epub 2013 Apr 15.

ReferenceCitation: Workgroup on Hypoglycemia, American Diabetes Association. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care. 2005 May;28(5):1245-9. doi: 10.2337/diacare.28.5.1245. No abstract available.

sponsor_collaborators:
Medical University of Graz
Juvenile Diabetes Research Foundation

location_facility: Medical University of Graz, Department of Internal Medicine Division of Endocrinology and Metabolism

location_facility: Institut National de la Santé et de la Recherche Médicale

location_facility: Université Libre de Bruxelles/ Hôpital Erasme

location_facility: NHS Greater Glasgow and Clyde-Queen Elizabeth University Hospital, Department of Diabetes

location_facility: Krankenhaus der Barmherzigen Brüder Linz

location_facility: Klinik Landstraße Wiener Gesundheitsverbund

location_facility: Klinik Hietzing Wiener Gesundheitsverbund

location_facility: Slaski Uniwersytet Medyczny w Katowicach

location_facility: NHS Tayside - Ninewells Hospital, NRS Diabetes - Diabetes Support Unit

location_facility: NHs-Manchester Royal Infirmary, Diabetic Medicine

title: A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multi-centre Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of Verapamil SR on Preservation of Beta-cell Function (Ver-A-T1D)

location_country:
Germany
Italy
Poland
United Kingdom
Austria
Belgium
France


title: A Phase 1 Study to Compare Bempegaldesleukin Combined With Nivolumab and Tyrosine Kinase Inhibitor (TKI) to Nivolumab and TKI Alone in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (mRCC) (PIVOT IO 011)

acronym: PIVOT IO 011

summary: The purpose of this study is in Part 1, to determine the safety of nivolumab, bempegaldesleukin (BEMPEG: NKTR-214), and Tyrosine Kinase Inhibitor (TKI) combination.

lead_sponsor: Bristol-Myers Squibb

sponsor_collaborators:
Bristol-Myers Squibb
Nektar Therapeutics

location_country:
Germany
Argentina
Brazil
Mexico
United States
Canada
Russian Federation
France

location_facility:
Local Institution - 0075
Local Institution - 0030
Local Institution - 0029
Local Institution - 0009
Local Institution - 0041
Local Institution - 0035
Local Institution - 0059
Local Institution - 0044
Local Institution - 0015
Local Institution - 0007
Local Institution - 0055
Local Institution - 0040
Local Institution - 0032
Local Institution - 0058
Local Institution - 0024
Local Institution - 0028
Local Institution - 0005
Local Institution - 0014
Local Institution - 0052
Local Institution - 0001
Local Institution - 0022
Local Institution
Local Institution - 0008
Local Institution - 0085
Local Institution - 0049
Local Institution - 0056
Local Institution - 0026
Local Institution - 0025
Local Institution - 0045
Local Institution - 0050
Local Institution - 0048
Local Institution - 0079
Local Institution - 0051
Local Institution - 0087
Local Institution - 0046
Local Institution - 0036
Local Institution - 0042


summary: DESTINY-Breast07 will investigate the safety, tolerability, and anti-tumour activity of trastuzumab deruxtecan (T-DXd) in combination with other anti-cancer agents in patients with HER2-positive Metastatic Breast Cancer

sponsor_collaborators:
AstraZeneca
Daiichi Sankyo Company, Limited

title: A Phase 1b/2 Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination With Other Anti-cancer Agents in Patients With HER2-positive Metastatic Breast Cancer (DESTINY-Breast07)

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Germany
Italy
Poland
India
United Kingdom
Australia
Brazil
United States
Korea, Republic of
Spain
Turkey
Taiwan
Canada
Russian Federation
France


title: Pulsed Field Ablation (PFA) System for the Treatment of Paroxysmal Atrial Fibrillation (PAF) by Irreversible Electroporation (IRE)

acronym: inspIRE

summary: The primary objective is to demonstrate safety and long-term effectiveness of the irreversible electroporation (IRE) system (Circular IRE Catheter and IRE Generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF).

lead_sponsor: Biosense Webster, Inc.

location_country: Italy Lithuania Austria Belgium Croatia Czechia Canada France

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux

location_facility: Ziekenhuis Oost-Limburg Genk Campus Sint-Jan


title: A Phase 1b, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI5752 in Combination With Axitinib in Subjects With Advanced Renal Cell Carcinoma

summary: The purpose of this study is to evaluate MEDI5752 in combination with Lenvatinib (or Axitinib), in subjects with advanced renal cell carcinoma.

lead_sponsor: MedImmune LLC

location_country:
United States
Spain
Australia
France


title: An Open Label, Two-Arm Study to Evaluate the Effect of Rilzabrutinib (PRN1008/SAR444671) on Safety and Disease Activity in Patients With IgG4-Related Disease

summary: This is a Phase 2a, multi-center, open-label, two-arm study of approximately 25 patients with active IgG4-related disease (IgG4-RD). The two arms include (1) Experimental: rilzabrutinib with glucocorticoids and (2) Active Comparator: glucocorticoids only.

ReferenceCitation: Wallace ZS, Zhang Y, Perugino CA, Naden R, Choi HK, Stone JH; ACR/EULAR IgG4-RD Classification Criteria Committee. Clinical phenotypes of IgG4-related disease: an analysis of two international cross-sectional cohorts. Ann Rheum Dis. 2019 Mar;78(3):406-412. doi: 10.1136/annrheumdis-2018-214603. Epub 2019 Jan 5.

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

lead_sponsor: Principia Biopharma, a Sanofi Company

sponsor_collaborators:
Principia Biopharma, a Sanofi Company
Massachusetts General Hospital

location_country:
Italy
United States
Spain
Canada
France

location_facility:
Investigational Site Number 84036
Investigational Site Number 84016
Investigational Site Number 84019
Investigational Site Number 72415
Investigational Site Number 84030
Investigational Site Number 25013
Investigational Site Number 12403
Investigational Site Number 38016
Investigational Site Number 84018


title: A Prospective, Multicenter, Non-interventional Study to Investigate the Disease Characteristics of Adult Patients With Long Chain Fatty Acid Oxidation Disorders (FAOD)

acronym: FORWARD

summary: The purpose of the study is to collect information on disease characteristics from adult patients diagnosed with fatty acid oxidation disorders (FAOD).

lead_sponsor: Reneo Pharma Ltd

location_country:
Italy
Poland
Hungary
United Kingdom
Denmark
Austria
Belgium
United States
Spain
Czechia
France

location_facility: Rigshospitalet, Klinik for nerve- og muskelsygdomme

location_facility: Vseobecna fakultni nemocnice v Praze, Klinika pediatrie a dedicnych poruch metabolizmu

location_facility: Unidad de Diagnóstico y Tratamiento de Enfermedades Metabólicas Complejo Hospitalario Universitario de Santiago Travesía de Choupana s/n

location_facility: Azienda Ospedaliera Universitaria Policlinico "G. Martino" di Messina

location_facility: Oregon Health & Science University (OHSU)


title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa

summary: To evaluate the efficacy and safety of INCB054707 in participants with hidradenitis suppurativa over a 16-week placebo-controlled treatment period followed by a 36-week open-label extension period. All eligible participants will be invited to continue treatment for an additional 48-week Long-term extension period (also open label).

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

lead_sponsor: Incyte Corporation

location_country:
Germany
Poland
United States
Spain
Canada
France

location_facility:
Investigative Site 017
Investigative Site 026
Investigative Site 405
Investigative Site 002
Investigative Site 014
Investigative Site 004
Investigative Site 015
Investigative Site 008
Investigative Site 011
Investigative Site 402
Investigative Site 003
Investigative Site 701
Investigative Site 025
Investigative Site 703
Investigative Site 552
Investigative Site 022
Investigative Site 018
Investigative Site 551
Investigative Site 404
Investigative Site 401
Investigative Site 304
Investigative Site 553
Investigative Site 019
Investigative Site 016
Investigative Site 009
Investigative Site 013
Investigative Site 006
Investigative Site 007
Investigative Site 702
Investigative Site 027
Investigative Site 403
Investigative Site 010
Investigative Site 012
Investigative Site 406
Investigative Site 001
Investigative Site 005
Investigative Site 102
Investigative Site 101
Investigative Site 023
Investigative Site 021


lead_sponsor: Shire

summary: The purpose of this study is to evaluate the long-term safety and efficacy of repeated subcutaneous (SC) administration of lanadelumab in adolescents and adults with non-histaminergic angioedema with normal C1-inhibitor who completed study SHP643-303 (NCT04206605).

sponsor_collaborators: Takeda Development Center Americas, Inc.

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

location_facility: "ALL-MED" Specjalistyczna Opieka Medyczna Filia

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

location_facility: Seattle Allergy & Asthma Research Institute

location_facility: NZOZ Homeo Medicus, Poradnia Alergologiczna

location_facility: A.O. Ospedali riuniti Villa Sofia - Cervello,

location_facility: Clinique Specialisee en Allergie de la Capitale

location_facility: Allergy and Asthma Clinical Research Inc

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet pt

location_facility: Azienda Ospedaliera Universitaria "Federico II"

title: An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)

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

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


summary: This is a randomized, double-blind, placebo-controlled, multicenter, 28-day study of adult participants hospitalized with COVID-19, with a safety follow-up telephone call at Day 60.

location_facility: Centro Hospitalar de Entre o Douro e Vouga, EPE (CHEDV)

location_facility: Hospital Universitario Dr. José Eleuterio Gonzalez

location_facility: Integra RGH Centro de Investigación/ Hospital MAC Puebla

location_facility: Central Clinic Hospital of the MSWiA in Warsaw

location_facility: SOMECO - Sociedad de Metabolismo y Corazón S.C.

location_facility: Centro Hospitalar Universitário de Lisboa Norte (CHULN), E.P.E - Hospital de Santa Maria

location_facility: Centro Hospitalar Unimed (CHU) - Joinville

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE (CHVNG/E)

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto

location_facility: University of Massachusetts Memorial Health Care

location_facility: Hospital Santa Casa de Misecórdia de Sorocoba

title: Evaluation of the Efficacy and Safety of PTC299 in Hospitalized Subjects With COVID-19 (FITE19)

location_country:
Poland
Colombia
Portugal
Australia
Brazil
Mexico
Belgium
United States
Spain
South Africa
France


acronym: RESTORE

lead_sponsor: Actelion

summary: The purpose of the study is to assess the effects of selexipag on right ventricular (RV) function in participants with Pulmonary arterial hypertension (PAH).

location_facility: SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo

location_facility: Queen Mary Hospital University of Hong Kong

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: Instituto Cardiovascular de Buenos Aires

location_facility: Hospital Das Clinicas Da Faculdade De Medicina Da USP

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

location_facility: National Medical Research Center of Cardiology of MoH of Russian Federation

title: A Prospective, Multicenter, Single-Arm, Open-Label, Phase 4 Study of the Effects of Selexipag on Right Ventricular Remodeling in Pulmonary Arterial Hypertension Assessed by Cardiac Magnetic Resonance Imaging

ipd_sharing_description:
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

location_country:
Germany
Israel
Argentina
Hong Kong
Singapore
Brazil
Netherlands
United Kingdom
United Arab Emirates
United States
Korea, Republic of
Saudi Arabia
Malaysia
Russian Federation
France


acronym: HAVEN 7

lead_sponsor: Hoffmann-La Roche

summary: This is a Phase IIIb, multicenter, open-label, single-arm study of prophylactic emicizumab in previously untreated and minimally treated patients at study enrollment from birth to ≤12 months of age with severe hemophilia A (intrinsic factor VIII [FVIII] level <1%) without FVIII inhibitors. The study is designed to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of emicizumab administered at 3 milligrams per kilogram of body weight (mg/kg) once every 2 weeks (Q2W) for 52 weeks. After 1 year of treatment, participants will continue to receive emicizumab (1.5 mg/kg once every week [QW], 3 mg/kg Q2W or 6 mg/kg once every 4 weeks [Q4W]) over a 7-year long-term follow-up period under this study frame.

ReferenceCitation: Hart DP. Commentary on "Development of a novel fully functional coagulation factor VIII with reduced immunogenicity utilizing an in silico prediction and deimmunization approach" - Will we ever be able to avoid inhibitor formation in hemophilia A? J Thromb Haemost. 2021 Sep;19(9):2125-2126. doi: 10.1111/jth.15404. No abstract available.

oa_host_type: publisher

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

unpaywall_oa_status: hybrid

location_facility: Ege University, School of Medicine; Pediatrics Department

location_facility: IRCCS Ca' Granda Ospedale Maggiore Policlinico; Centro Emofilia e Trombosi "Angelo Bianchi e Bonomi"

location_facility: Hospital Sant Joan de Deu; Servicio de Oncologia y Hematologia

location_facility: Medizinische Universität Wien; Univ. Klinik für Kinder und Jugendheilkunde

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Charlotte Maxeke Johannesburg Hospital; Haemophilia Comprehensive Care Center

location_facility: Universitätsklinikum Bonn; Institut für Experimentelle Hämatologie und Transfusionsmedizin

location_facility: University of Colorado Denver, Children's Hospital

location_facility: Hospital das Clínicas Faculdades Médicas de Ribeirão Preto

location_facility: Tulane University Health Sciences Center

location_facility: Sheba Medical Center - National Hemophilia Center

location_facility: Hacettepe University Medical Faculty; Hacettepe University Medical Faculty

location_facility: Adana Acibadem Hospital; Pediatric Hematology

location_facility: AORN Santobono Pausilipon; UOC di Ematologia ? Centro Emofilia e Trombosi

location_facility: AOU di Parma; Dip Emergenza-Urgenza Centro Riferimento Regionale per l'emofilia

location_facility: Groupe Hospitalier Necker Enfants Malades

title: A Phase IIIb, Multicenter, Open-Label, Single-Arm Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Emicizumab in Patients From Birth to 12 Months of Age With Hemophilia A Without Inhibitors

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).

location_country:
Germany
Italy
Israel
United Kingdom
Australia
Brazil
Austria
Belgium
United States
Spain
South Africa
Turkey
Canada
France


title: A Prospective, Randomized, Double-Blind, Sham-Controlled, Multi-Center Pivotal Study to Evaluate the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita® System in Subjects With Type 2 Diabetes on Insulin Therapy

acronym: REVITALIZE 1

summary: The Revita® system is being investigated to assess the efficacy of DMR versus Sham on improvement in Glycemic, Hepatic and Cardiovascular endpoints for patients with Type 2 Diabetes who are inadequately controlled with insulin therapy. The purpose of this study is to demonstrate the efficacy and safety of the Fractyl DMR Procedure using the Revita® System compared to a sham. Subjects randomized to the DMR procedure will be followed per protocol till 48 weeks post treatment. Subjects in the Sham treatment arm will be offered cross over to receive the DMR treatment at 48 weeks and will be followed per protocol for 48 weeks post treatment.

lead_sponsor: Fractyl Health, Inc.

location_country:
Ireland
Italy
United Kingdom
Netherlands
Switzerland
Belgium
United States
Spain
France

location_facility: Universiteit Van Amsterdam Academisch Medisch Centrum

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme

location_facility: Virginia Commonwealth University Medical Center

location_facility: Washington University School of Medicine


title: Natural History Study in Prodromal and Manifest Huntington Disease Gene Expansion Carriers (HDGECs) - SHIELD HD

acronym: SHIELD HD

summary:
SHIELD HD is an international, multisite, prospective, longitudinal cohort natural history study to assess the natural history of HD and its biomarkers that are associated with modulation of the number of cytosine-adenine-guanine (CAG) repeats in the mutant Huntingtin (HTT) gene.

Approximately 60 patients will be enrolled into the study and followed for up to 24 months at clinical sites in North America and Europe.

The results of this study will inform assessments for a future interventional treatment trial.

lead_sponsor: CHDI Foundation, Inc.

sponsor_collaborators:
CHDI Foundation, Inc.
Medpace, Inc.

location_country:
Germany
United Kingdom
United States
Canada
France

location_facility: University of California, San Diego (UCSD)

location_facility: Rocky Mountain Movement Disorders Center

location_facility: ICM - Institut du Cerveau et de la Moelle épinière

location_facility: University College London - Institute of Neurology & The National Hospital for Neurology and Neurosurgery


title: A Phase 1 Study of SGN-B6A in Advanced Solid Tumors

summary:
This trial will look at a drug called SGN-B6A alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people who have solid tumors. It will study SGN-B6A to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether SGN-B6A works to treat solid tumors.

The study will have four parts.

Part A of the study will find out how much SGN-B6A should be given to participants.
Part B will use the dose found in Part A to find out how safe SGN-B6A is and if it works to treat solid tumors.
Part C of the study will find out how safe SGN-B6A is in combination with these other drugs.
Part D will include people who have not received treatment. This part of the study will find out how safe SGN-B6A is in combination with these other drugs and if these combinations work to treat solid tumors.

In Parts C and D, participants will receive SGN-B6A with either:

Pembrolizumab or,
Pembrolizumab and carboplatin, or
Pembrolizumab and cisplatin.

lead_sponsor: Seagen Inc.

location_country:
United Kingdom
Switzerland
United States
Spain
France

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: South Texas Accelerated Research Therapeutics

location_facility: University Hospitals Cleveland Medical Center

location_facility: MD Anderson Cancer Center / University of Texas


title: Positive End-Expiratory Pressure (PEEP) Levels During Resuscitation of Preterm Infants at Birth (The POLAR Trial).

acronym: POLAR

summary:
Premature babies often need help immediately after birth to open their lungs to air, start breathing and keep their hearts beating. Opening their lungs can be difficult, and once open the under-developed lungs of premature babies will often collapse again between each breath. To prevent this nearly all premature babies receive some form of mechanical respiratory support to aid breathing. Common to all types of respiratory support is the delivery of a treatment called positive end-expiratory pressure, or PEEP. PEEP gives air, or a mixture of air and oxygen, to the lung between each breath to keep the lungs open and stop them collapsing.

Currently, clinicians do not have enough evidence on the right amount, or level, of PEEP to give at birth. As a result, doctors around the world give different amounts (or levels) of PEEP to premature babies at birth.

In this study, the Investigators will look at 2 different approaches to PEEP to help premature babies during their first breaths at birth. At the moment, the Investigators do not know if one is better than the other. One is to give the same PEEP level to the lungs. The others is to give a high PEEP level at birth when the lungs are hardest to open and then decrease the PEEP later once the lungs are opened and the baby is breathing.

Very premature babies have a risk of long-term lung disease (chronic lung disease). The more breathing support a premature baby needs, the more likely the risk of developing chronic lung disease. The Investigators want to find out whether one method of opening the baby's lungs at birth results in them needing less breathing support.

This research has been initiated by a group of doctors from Australia, the Netherlands and the USA, all who look after premature babies.

primary_purpose: Prevention

ReferenceCitation: Jensen EA, Dysart K, Gantz MG, McDonald S, Bamat NA, Keszler M, Kirpalani H, Laughon MM, Poindexter BB, Duncan AF, Yoder BA, Eichenwald EC, DeMauro SB. The Diagnosis of Bronchopulmonary Dysplasia in Very Preterm Infants. An Evidence-based Approach. Am J Respir Crit Care Med. 2019 Sep 15;200(6):751-759. doi: 10.1164/rccm.201812-2348OC.

ipd_sharing_description:
The de-identified data set collected for this analysis of the POLAR trial will be available six months after publication of the primary outcome.

The study protocol, statistical analysis plan and consent forms will also be available. The data may be obtained from the Murdoch Children's Research Institute by emailing david.tingay@rch.org.au and mctc@mcri.edu.au.

lead_sponsor: Murdoch Childrens Research Institute

collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

location_country:
Italy
Poland
United Kingdom
Australia
Netherlands
Austria
United States
France

location_facility: The Royal Women's Hospital, Melbourne Australia

location_facility: Joan Kirner Women & Children's Hospital - VIC

location_facility: Sharp Mary Birch Hospital for Women & Newborns

location_facility: Rady Children's at Rancho Springs Medical Center/UCSD

location_facility: Rady Children's at Scripps Memorial Hospital La Jolla/UCSD

location_facility: Hospital of the University of Pennsylvania

location_facility: Antoine Beclere Medical Center / South Paris University Hospitals

location_facility: University of Arkansas for Medical Sciences

location_facility: Vittore Buzzi Children's Hospital / Ospedale dei Bambini

location_facility: Indiana University / Riley Children Health at Indiana University Health


title: Phase 3, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of PF-07055480 (Recombinant AAV2/6 Human Factor VIII Gene Therapy) in Adult Male Participants With Moderately Severe to Severe Hemophilia A(FVIII:C≤1%)

acronym: AFFINE

summary: C3731003 is a pivotal Phase 3 study to evaluate the clinical efficacy and safety of a single IV infusion of PF-07055480 / giroctocogene fitelparvovec (Recombinant AAV2/6 Human Factor VIII Gene Therapy) in adult male participants with moderately severe or severe hemophilia A (FVIII:C≤1%) for the study duration of 5 years. The study will enroll eligible participants who have been followed on routine prophylaxis with FVIII products in the Lead-In study C0371004.

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

lead_sponsor: Pfizer

location_country:
Germany
Italy
United Kingdom
Australia
Brazil
Japan
Sweden
United States
Korea, Republic of
Saudi Arabia
Spain
Greece
Turkey
Taiwan
Canada
France

location_facility: Juravinski Hospital - Hamilton Health Sciences

location_facility: Imaging Clinic at Stanford Medicine Outpatient Center in Redwood City

location_facility: Azienda Ospedaliero Universitaria Careggi SODc Malattie Emorragiche e della Coagulazione

location_facility: University of California, San Francisco - Clinical Research Center

location_facility: General Hospital of Athens "Hippokration"

location_facility: Dip. di Medicina Clinica e Chirurgia, Università degli Studi di Napoli Federico II - UOC di Medicin

location_facility: McMaster University Medical Centre - Hamilton Health Sciences

location_facility: Nagoya University Hospital - Transfusion Medicine

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet, Medizinische Klinik II

location_facility: Centro de Hematologia e Hemoterapia de Campinas - Hemocentro UNICAMP

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: Università degli studi di Roma "La Sapienza"- Policlinico Umberto I

location_facility: University of Washington Medical Center - Translational Research Unit (TRU)

location_facility: University of California, San Francisco - Moffitt/Long Inpatient Hematology

location_facility: General Hospital of Athens "LAIKO", 2nd Regional Blood Transfusion Center

location_facility: Gaziantep University Sahinbey Research and Training Hospital

location_facility: Ege University Medical Faculty, Pediatric Hematology

location_facility: Clinical and Translational Research Unit (CTRU)

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

location_facility: University of California, San Francisco - Outpatient Hematology Clinic

location_facility: Kyung Hee University Hospital at Gangdong


acronym: CAN-COVID

lead_sponsor: Novartis Pharmaceuticals

summary: This was a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of canakinumab plus standard-of-care (SOC) compared with placebo plus SOC in patients with COVID-19-induced pneumonia and cytokine release syndrome (CRS).

ReferenceCitation: Sedhai YR, Sears M, Vecchie A, Bonaventura A, Greer J, Spence K, Tackett H, Turner J, Pak M, Patel N, Black M, Wohlford G, Clary RE, Duke C, Hardin M, Kemp H, Priday A, Sims EK Jr, Mihalick V, Ho AC, Ibe I, Harmon M, Markley R, Van Tassell B, Abbate A. Clinical trial enrollment at a rural satellite hospital during COVID-19 pandemic. J Clin Transl Sci. 2021 Apr 8;5(1):e136. doi: 10.1017/cts.2021.777. eCollection 2021.

repositories_concat: PubMed Central

publisher_dissemination: Cambridge University Press

ReferenceCitation: Caricchio R, Abbate A, Gordeev I, Meng J, Hsue PY, Neogi T, Arduino R, Fomina D, Bogdanov R, Stepanenko T, Ruiz-Seco P, Gonzalez-Garcia A, Chen Y, Li Y, Whelan S, Noviello S; CAN-COVID Investigators. Effect of Canakinumab vs Placebo on Survival Without Invasive Mechanical Ventilation in Patients Hospitalized With Severe COVID-19: A Randomized Clinical Trial. JAMA. 2021 Jul 20;326(3):230-239. doi: 10.1001/jama.2021.9508.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: American Medical Association

title: Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Canakinumab on Cytokine Release Syndrome in Patients With COVID-19-induced Pneumonia (CAN-COVID)

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

location_country:
Italy
United Kingdom
United States
Spain
Russian Federation
France


title: A Phase 2, Open Label, Randomized Study of the Efficacy and Safety of Acalabrutinib With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19

acronym: CALAVI

summary: CALAVI will investigate the safety, efficacy and pharmacokinetics of acalabrutinib together with Best Supportive Care in the treatment of COVID-19.

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

sponsor_collaborators:
AstraZeneca
Acerta Pharma BV

location_country:
Germany
Italy
Poland
India
Argentina
Japan
Brazil
Mexico
South Africa
Turkey
Chile
Peru
Russian Federation
France


title: A Double-blind Randomized Extension Study to Assess the Long-term Efficacy and Safety of Linzagolix in Subjects With Endometriosis-associated Pain

summary: The primary objective of this extension study is to assess the maintenance of efficacy of linzagolix administered orally once daily for up to an additional 6 months (for up to 12 months of treatment in total) in women who have already completed 6 months of linzagolix treatment at a dose of 75 mg alone or of 200 mg in combination with ABT (E2 1 mg / NETA 0.5 mg), in the management of moderate to severe endometriosis-associated pain (EAP) in women with surgically confirmed endometriosis.

lead_sponsor: Kissei Pharmaceutical Co., Ltd.

location_country:
Poland
Romania
Austria
United States
Spain
Czechia
Bulgaria
Ukraine
France

location_facility: Hospital General Universitario Reina Sofia/ ID # 304

location_facility: Clinical Medical Research sp. Z o. O/ ID # 406

location_facility: Kyiv City Clinical Hospital #9/ ID # 501

location_facility: Centrum Ginekologii Endokrynologii i Medycyny Rozrodu "Artemida"/ ID # 409

location_facility: Hospital Regional Universitario de Málaga/ ID # 303

location_facility: Centrum Medyczne Chodźki Lublin/ ID # 403

location_facility: Multiprofile Hospital for Active Treatment Sliven/ ID # 131

location_facility: Lubelskie Centrum Diagnostyczne/ ID # 402

location_facility: Prywatna Klinika Ginekologiczno - Położnicza/ ID # 404

location_facility: Niepubliczny Zaklad Opieki Zrowotnej GynCentrum/ ID # 407

location_facility: City clinical maternity hospital №1/ ID # 502

location_facility: Ternopil' Communal City Hospital#2 / ID # 511

location_facility: Universal Axon - Homestead, LLC/ ID # 620

location_facility: University Multiprofile Hospital for Active Treatment "Sofiamed"/ ID # 133

location_facility: Group Practice for Specialized Medical Assistance in GINART/ ID # 132

location_facility: Kyiv City Maternity Hospital #6/ ID # 504

location_facility: Kotarski Jan Specjalistyczny Gabinet Ginekologiczno Polozniczy/ ID # 405

location_facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu/ ID # 410

location_facility: Gynekologicko - Porodnicka Ambulance/ ID # 162

location_facility: Zaporizhzhya Regional Clinical Hospital/ ID # 505

location_facility: Specjalistyczny Gabinet Lekarski Krzysztof Dynowski / ID # 401

location_facility: Institute of Pediatrics Obstetrics and Gynecology/ ID # 508

location_facility: Gynekologie MU Dr.Lubomir Mikulasek / ID # 160

location_facility: Ivano-Frankivsk regional perinatal center, Family planning center/ ID # 506

location_facility: Spitalul Clinic "Nicolae Malaxa"/ ID # 352

location_facility: Chattanooga Medical Research LLC/ ID# 602

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Wilk/ ID # 411

location_facility: Medical center of LLC "Medical Center "Verum"/ ID # 503

location_facility: Sp Cl de Obstetrica si Ginecologie "Prof. Dr. Panait Sirbu"/ ID # 354

location_facility: Kyiv City Center of Reproductive and Perinatal Medicine/ ID # 509

location_facility: Vinnytsia City Clinical Hospital "Center of Mother and the Child "/ ID # 510

location_facility: Women's & Family Care, LLC dba GTC Research/ ID # 608


title: A Prospective, Concurrent Controlled, Open-Label, Multicenter Clinical Study to Assess the Long-Term Safety of the PRESERFLO® MicroShunt in Subjects With Primary Open-Angle Glaucoma Who Have Completed Participation in the INN-005 Randomized Controlled Study.

summary: This prospective, concurrent controlled, open-label, multicenter study is designed to collect additional safety data through 5 years of follow-up for subjects randomized to either the treatment arm (PRESERFLO® MicroShunt with MMC) or the control arm (Trabeculectomy with MMC) of the INN-005 clinical study.

lead_sponsor: InnFocus Inc.

location_country:
Italy
United Kingdom
United States
Spain
France

location_facility: Glaucoma Consultants of the Capital Region

location_facility: Arizona Advance Eye Research Institute, LLC.

location_facility: University of California at Davis Eye Center

location_facility: Ophthalmic Surgeons and Consultants of Ohio

location_facility: New York Eye and Ear Infirmary of Mt. Sinai

location_facility: UCLA Medical Center Jules Stein Eye Institute

location_facility: Pôle Ophtalmologique de la Clinique Mutualiste

location_facility: A. O.U.P (Azienda Ospedaliere Universitaria Pisana) Stabilimento di Cisanello

location_facility: Stiles Eye Care Excellence & Glaucoma Institute


title: Statins for Venous Event Reduction in Patients With Venous Thromboembolism

acronym: SAVER

summary:
The standard or usual treatment for patients diagnosed with deep vein thrombosis or pulmonary embolism is treatment with blood thinners (called anticoagulants).

While treatment of blood clots with blood thinners is effective, some research has shown that adding a statin (medication used to lower cholesterol) may give extra protection. It is thought that statins can improve how cells along the walls of the vein control inflammation, which can prevent new blood clots from forming.

The medication in this study, rosuvastatin, is approved in Canada for use as a cholesterol-lowering medication. The use of rosuvastatin in this study is considered investigational. This means that Health Canada has not approved the use of rosuvastatin as a treatment for blood clots. However, it has been approved for use in this research study.

The purpose of this study is to examine if adding a statin (rosuvastatin) to the usual blood thinner treatment will decrease the risk of another blood clot forming. The investigators also hope to discover if taking a statin reduces damage to your veins. To do this, some of the participants in this study will get rosuvastatin and others will receive a placebo (a substance that looks like the study rosuvastatin but does not have any active or medicinal ingredients). The placebo in this study is not intended to have any effect on your blood clot. A placebo is used to make the results of the study more reliable.

lead_sponsor: Ottawa Hospital Research Institute

location_country: Ireland Italy Norway Netherlands Canada France

location_facility:
Amsterdam University
Queen Elizabeth II Hospital
Mater Misericordiae University Hospital
CHU de Quebec-Université Laval
Foothills Medical Centre
Hôpital Montfort
St. Joseph's Healthcare
Ostfold Hopsital
Jewish General Hospital
Niagara Health - St. Catharines Site
University Health Network
Juravinski Hospital
The Ottawa Hospital
Brest University Hospital Centre
McGill Univeristy Health Centre
Sunnybrook Hospital
Hamilton General Hospital
University of Insubria