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

summary:
TThe 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.

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-Körber F, Castro P, P Cerezo M, Chavarría N, Cifuentes OL, Echeverri B, Jácome-Liévano S, Kuzmina I, Lara JS, Manton D, Martínez-Mier EA, Melo P, Muller-Bolla M, Ochoa E, Osorio JR, Ramos K, Sanabria AF, Sanjuán J, San-Martín M, Squassi A, Velasco AK, Villena R, Zandona AF, Beltrán 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.

family: Martignon

full_name: Stefania Martignon

given: Stefania

family: Cortes

full_name: Andrea Cortes

given: Andrea

family: Douglas

full_name: Gail V. A. Douglas

given: Gail V. A.

family: Newton

full_name: J. Timothy Newton

given: J. Timothy

family: Pitts

full_name: Nigel B. Pitts

given: Nigel B.

family: Avila

full_name: Viviana Avila

given: Viviana

family: Usuga-Vacca

full_name: Margarita Usuga-Vacca

given: Margarita

family: Gamboa

full_name: Luis F. Gamboa

given: Luis F.

family: Deery

full_name: Christopher Deery

given: Christopher

family: Abreu-Placeres

full_name: Ninoska Abreu-Placeres

given: Ninoska

family: Bonifacio

full_name: Clarisa Bonifacio

given: Clarisa

family: Braga

full_name: Mariana M. Braga

given: Mariana M.

family: Carletto-Körber

full_name: Fabiana Carletto-Körber

given: Fabiana

family: Castro

full_name: Patricia Castro

given: Patricia

family: P. Cerezo

full_name: María P. Cerezo

given: María

family: Chavarría

full_name: Nathaly Chavarría

given: Nathaly

family: Cifuentes

full_name: Olga L. Cifuentes

given: Olga L.

family: Echeverri

full_name: Beatriz Echeverri

given: Beatriz

family: Jácome-Liévano

full_name: Sofía Jácome-Liévano

given: Sofía

family: Kuzmina

full_name: Irina Kuzmina

given: Irina

family: Lara

full_name: J. Sebastián Lara

given: J. Sebastián

family: Manton

full_name: David Manton

given: David

family: Martínez-Mier

full_name: E. Angeles Martínez-Mier

given: E. Angeles

family: Melo

repository_normalized: University of Melbourne - Minerva Access

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

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

location_facility: ACFF Colombian Chapter Manizales Demonstration Territory

location_facility: Fundación Universitaria de Colegios de Colombia


design_allocation: Randomized

intervention_type: Drug

status: Recruiting

study_start_date_type: Actual

study_type: Interventional

lead_sponsor: Merck Sharp & Dohme Corp.

enrollment_type: Anticipated

primary_purpose: Prevention

location_country:
Brazil
Peru
South Africa
France
Japan
Thailand
United States

location_facility: Midway Immunology and Research Center ( Site 0014)

location_facility: Desmond Tutu HIV Foundation ( Site 0202)

location_facility: Center Hospital of the National Center for Global Health and Medicine ( Site 0101)

location_facility: Wits Reproductive Health and HIV Institute (WRHI)-Research Center ( Site 0201)

location_facility: The University of Mississippi Medical Center ( Site 0012)

location_facility: The Crofoot Research Center ( Site 0025)

location_facility: Centro de Referência e Treinamento DST/AIDS ( Site 0351)

location_facility: University of Miami Miller School of Medicine-Infectious Disease ( Site 0029)

location_facility: UCLA Center for Clinical AIDS Research and Education ( Site 0011)

location_facility: University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 0007)

location_facility: Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 0052

location_facility: Ponce De Leon Center Grady Health ( Site 0032)

location_facility: HIV Netherlands Australia Thailand Research Collaboration ( Site 0056)

location_facility: Rutgers New Jersey Medical School-Clinical Research Center ( Site 0017)

location_facility: The GW Medical Faculty Associates-Medicine ( Site 0033)

location_facility: Perinatal HIV Research Unit (PHRU)-HIV Prevention CRS ( Site 0203)

location_facility: Chulalongkorn University-Pediatrics ( Site 0051)

location_facility: Central Texas Clinical Research ( Site 0002)

location_facility: Hôpital Saint-Louis-Infectious Diseases and tropical diseases ( Site 0151)

location_facility: The University of North Carolina at Chapel Hill ( Site 0019)

location_facility: Bridge HIV - San Francisco Department of Public Health ( Site 0003)

ipd_sharing: Yes

study_completion_date_type: Anticipated

type: Other Identifier

type: EudraCT Number

type: Registry Identifier

source: euctr

title: A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once-Monthly as Preexposure Prophylaxis in Cisgender Men and Transgender Women Who Have Sex With Men, and Are at High Risk for HIV-1 Infection

summary: The main purpose of the study is to evaluate the efficacy and safety of oral Islatravir (ISL) once monthly (QM) as Preexposure Prophylaxis (PrEP) in cisgender men who have sex with men (MSM) and transgender women (TGW) who have sex with men and who are at high risk of HIV-1 infection with a minimum follow-up of 48 weeks and at least 50% of participants have 96 weeks of follow-up after randomization. The primary hypothesis of the study is that the administration of ISL QM as PreP reduces the incidence rate per year of the confirmed HIV-1 infections compared to the background incidence rates.

lead_sponsor_type: industriel

status_simplified: Ongoing


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

ipd_sharing: No

lead_sponsor: Eli Lilly and Company

location_country:
United States
France
Belgium
Spain
Germany
United Kingdom

location_facility: Washington University School of Medicine

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg


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: We 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, we will present the results on national and international conferences.

study_type: Observational

time_perspective: Cross-Sectional

lead_sponsor: Semmelweis University

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

location_facility: Military Medical Academy, Department of Psychiatry

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Department of Liasion Psychiatry, Mater University Hospital

location_facility: Chernivtsi Regional Mental Hospital, Bukovinian State Medical University

location_facility: Vilnius University, Facutly of Medicine, Psychiatric Clinic

location_facility: 3rd Faculty of Medicine, Charles University

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

location_facility: Department and Clinic of Psychiatry, Wroclaw Medical University

location_facility: Psychiatrische Klinik Clienia Littenheid

location_facility: Clinical Centre of Montenegro, Clinic for Psychiatry

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

location_facility: Mental Health Center Prizren, Hospital and University Clinical Service of Kosovo

location_facility: Department of Psychiatry, Ss. Cyril and Methodius University

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

location_facility: SCUC, Child and Adolescent Psychiatry Clinic

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

intervention_type: Other

lead_sponsor_type: academique


title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 in Combination With TL-895 for the Treatment of Relapsed or Refractory Myelofibrosis and KRT-232 for the Treatment of JAK Inhibitor Intolerant Myelofibrosis.

summary: This study evaluates KRT-232 in Combination With TL-895 for the Treatment of Relapsed or Refractory Myelofibrosis and KRT-232 for the Treatment of JAK Inhibitor Intolerant Myelofibrosis.

primary_purpose: Treatment

lead_sponsor: Kartos Therapeutics, Inc.

location_country:
United States
France
Bulgaria
Poland

location_facility: University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski, Pleven

location_facility: University Multiprofile Hospital for Active Treatment Dr. Georgi Plovdiv

location_facility: Nasz Lekarz Medical Outpatient Clinics Slawomir Jeka

location_facility: Memorial Sloan Kettering Cancer Center (MSKCC)


status: Enrolling by invitation

lead_sponsor: bluebird bio

location_country:
United States
France

time_perspective: Prospective

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

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

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.

status_simplified: Unknown


title: A Phase 2 Study of VS-6766 (Dual RAF/MEK Inhibitor) Alone and In Combination With Defactinib (FAK Inhibitor) in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

summary: This study will assess the safety and efficacy of VS-6766 monotherapy and in combination with Defactinib in subjects with recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

lead_sponsor: Verastem, Inc.

location_country:
United States
United Kingdom
Belgium
France

location_facility: Miami Cancer Institute at Baptist Health, Inc.

location_facility: H. Lee Moffitt Cancer Center and Research Institute - Center for Women's Oncology

location_facility: Washington University School of Medicine

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: University of New Mexico Comprehensive Cancer Center

location_facility: Cleveland Clinic Women's Health Institute

location_facility: The Ohio State University Wexner Medical Center


title: An Adaptive, Randomized, Placebo-controlled, Double-blind, Multi-center Study of Oral Etavopivat, a Pyruvate Kinase Activator in Patients With Sickle Cell Disease (HIBISCUS)

summary: This clinical trial is a Phase 2/3 study that will evaluate the efficacy and safety of etavopivat and test how well etavopivat works compared to placebo to improve the amount of hemoglobin in the blood and to reduce the number of vaso-occlusive crises (times when the blood vessels become blocked and cause pain).

lead_sponsor: Forma Therapeutics, Inc.

location_country:
United States
France
Spain

location_facility: University of Alabama at Birmingham (UAB)

location_facility: University of Connecticut (UCONN) Health

location_facility: Foundation for Sickle Cell Disease Research

location_facility: Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz

location_facility: Collaborative Neuroscience Research, LLC.

location_facility: Washington University School of Medicine Barnes - Jewish Hospital

location_facility: UC Davis Medical Center - UC Davis Comprehensive Cancer Center - Hemotology/Oncology Clinic

location_facility: University of Illinois College of Medicine (UICM) - Chicago - Outpatient Care Center (OCC) - Pediatric Clinic

location_facility: University of Maryland School of Medicine

location_facility: Children's Healthcare of Atlanta - Pediatric Research Center


title: Host Response Mediators in Coronavirus (COVID-19) Infection - Is There a Protective Effect of Losartan 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 we call "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 ARB, losartan, limits lung injury in murine influenza H7N9 and decreases viral titre and RNA.

We have 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 (ARB, losartan) to decrease the mortality of hospitalized COVID-19 patient.

lead_sponsor: University of British Columbia

location_country:
United States
France
Japan
Belgium
Spain
Canada

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

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

location_facility: University of Utah Hospitals and Clinics

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

location_facility: Centrum Opieki Zdrowotnej ORKAN-MED Stec-Michalska

location_facility: Medical center limited liability Harmoniya Krasy

location_facility: Medical Center Ok!Clinic+ International Institute

location_facility: CI of Kyiv RC Regional Clinical Hospital No 2

location_facility: Toronto Digestive Disease Associates Inc.

location_facility: Semmelweis Egyetem Altalanos Orvostudomanyi Kar

location_facility: CHU Saint-Etienne - Hospital Nord Gastroenteroloy

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

location_facility: London Health Sciences Centre - Victoria Hospital

location_facility: Javorszky Odon Korhaz, Gasztroenterologiai Osztaly


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).

status: Active, not recruiting

enrollment_type: Actual

lead_sponsor: PTC Therapeutics

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

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)

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

location_facility: CBR Neurogenetic Research Clinic, University of Auckland


title: A Randomized, Double-blind, Placebo-controlled, Phase 2b Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Alcoholic Hepatitis

acronym: AHFIRM

summary: This is a randomized, double-blind, placebo-controlled, phase 2b clinical Trial evaluating Safety and Efficacy of DUR-928 (an experimental medication) in Patients with Alcoholic Hepatitis (AH).

lead_sponsor: Durect

location_country:
United States
United Kingdom
Australia
France

location_facility:
Site 32
Site 09
Site 28
Site 31
Site 07
Site 11
Site 02
Site 08
Site 21
Site 37
Site 35
Site 30
Site 53
Site 15
Site 70
Site 27
Site 50
Site 23
Site 10
Site 12
Site 39
Site 05
Site 01
Site 77
Site 24
Site 20
Site 06
Site 74
Site 33
Site 14
Site 72
Site 75
Site 73
Site 16
Site 36
Site 38
Site 19
Site 22
Site 71
Site 52
Site 29
Site 76
Site 51
Site 18
Site 17
Site 34
Site 26
Site 04
Site 13
Site 03
Site 25


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

design_allocation: Non-Randomized

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.

lead_sponsor: AstraZeneca

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


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)

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

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


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
Australia
France
Spain


title: A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)

summary: This is a Phase 2, multicenter, open-label study to provide continued supply of parsaclisib as monotherapy or in combination therapy with itacitinib to participants from Incyte-sponsored studies of parsaclisib.

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:
France
Belgium
Spain
Denmark
United States

location_facility: California Cancer Associates For Research and Excellence

location_facility: Texas Oncology-Baylor Charles A. Sammons

location_facility: University Hospitals Case Medical Center

location_facility: Hospital General Universitario Gregorio Maranon


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.

lead_sponsor: Reneo Pharma Ltd

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

location_facility: Instytut Matki i Dziecka Klinika Wrodzonych Wad Metabolizmu i Pediatrii

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

location_facility: Oddział Kliniczny Chorób Metabolicznych i Diabetologii Szpital Uniwersytecki w Krakowie

location_facility: Oregon Health & Science University (OHSU)

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

location_facility: Rigshospitalet, Klinik for nerve- og muskelsygdomme

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


title: The Parkinson's Progression Markers Initiative (PPMI) 2.0 Clinical -Establishing a Deeply Phenotyped PD Cohort

acronym: PPMI

summary:
The Parkinson Progression Marker Initiative 2.0 (PPMI 2.0) is a longitudinal, observational, multi-center natural history study to assess progression of clinical features, digital outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD) progression in study participants with manifest PD, prodromal PD, and healthy controls

The overall goal of PPMI 2.0 is to identify markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability.

time_perspective: Other

ipd_sharing: Undecided

lead_sponsor: Michael J. Fox Foundation for Parkinson's Research

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

location_facility: Institute For Neurodegenerative Disorders

location_facility: University of Colorado Anschutz Medical Campus

location_facility: Parkinson's Disease& Movement Disorder Center of Boca Raton

location_facility: University of Cincinnati/Cincinnati Children's Hospital

location_facility: Foundation for Biomedical Research of the Academy of Athens

location_facility: Mayo Foundation for Medical Education and Research

location_facility: Cleveland Clinic Lou Ruvo Center for Brain Health

location_facility: Univ of Washington and VA Puget Sound Health Care System

location_facility: John Radcliffe Hospital Oxford and Oxford University


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.

location_country:
United States
France
Poland
Spain
Germany
Canada

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


title: Distal Evaluation of Functional Performance With Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting

acronym: DEFINE GPS

summary: Multi-center, prospective, randomized controlled study comparing PCI guided by angiography versus iFR Co-Registration using commercially available Philips pressure guidewires and the SyncVision co-registration system, employing an adaptive design study for interim sample size re-estimation.

lead_sponsor: Philips Clinical & Medical Affairs Global

location_country:
United States
France
Netherlands

location_facility: Tampa Cardiovascular Innovations and Research

location_facility: Albert Schweitzer Ziekenhuis / Hartcentum Dordrecht- Gorinchem

location_facility: Baylor Scott & White, The Heart Hospital Plano

intervention_type: Device


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

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

location_facility: Integra RGH Centro de Investigación/ Hospital MAC Puebla

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

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

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

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

location_facility: Hospital Santa Casa de Misecórdia de Sorocoba

location_facility: Hospital Universitario Dr. José Eleuterio Gonzalez

location_facility: University of Massachusetts Memorial Health Care

location_facility: Central Clinic Hospital of the MSWiA in Warsaw

location_facility: Centro Hospitalar Unimed (CHU) - Joinville

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

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.


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

acronym: RESTORE

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).

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

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

lead_sponsor: Actelion

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

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Queen Mary Hospital, University of Hong Kong

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

location_facility: Instituto Cardiovascular de Buenos Aires

location_facility: Robert-Bosch-Krankenhaus - Klinik Schillerhoehe

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

location_facility: University of California at San Francisco

location_facility: Ruhr-Universität Bochum / Diabeteszentrum

location_facility: Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul


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: Triplet Therapeutics, Inc.

location_country:
United States
France
Germany
United Kingdom
Canada

location_facility: Rocky Mountain Movement Disorders Center

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

location_facility: University of California, San Diego (UCSD)

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


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.

ReferenceType: background

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

location_country:
Italy
Austria
Netherlands
France
Australia
United States
United Kingdom

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

location_facility: Hospital of the University of Pennsylvania

location_facility: Sharp Mary Birch Hospital for Women & Newborns

location_facility: University of Arkansas for Medical Sciences

location_facility: Antoine Beclere Medical Center / South Paris University Hospitals

location_facility: The Royal Women's Hospital, Melbourne Australia

intervention_type: Procedure


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

location_facility: King Faisal Specialist Hospital & Research Center

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: Centro de Hematologia e Hemoterapia de Campinas - Hemocentro UNICAMP

location_facility: Nagoya University Hospital - Transfusion Medicine

location_facility: Ege University Medical Faculty, Pediatric Hematology

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

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

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

location_facility: Juravinski Hospital - Hamilton Health Sciences

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

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

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

location_facility: Kyung Hee University Hospital at Gangdong

location_facility: Clinical and Translational Research Unit (CTRU)

location_facility: Gaziantep University Sahinbey Research and Training Hospital

location_facility: McMaster University Medical Centre - Hamilton Health Sciences

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

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

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

intervention_type: Biological


ReferenceType: derived

ReferenceCitation: Sedhai YR, Sears M, Vecchiè 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.

apc_source: doaj

family: Sedhai

full_name: Yub Raj Sedhai

given: Yub Raj

sequence: first

family: Sears

full_name: Melissa Sears

given: Melissa

sequence: additional

family: Vecchiè

full_name: Alessandra Vecchiè

given: Alessandra

family: Bonaventura

full_name: Aldo Bonaventura

given: Aldo

family: Greer

full_name: Joan Greer

given: Joan

family: Spence

full_name: Kathryn Spence

given: Kathryn

family: Tackett

full_name: Hilary Tackett

given: Hilary

family: Turner

full_name: Juanita Turner

given: Juanita

family: Pak

full_name: Mary Pak

given: Mary

family: Patel

full_name: Nimesh Patel

given: Nimesh

family: Black

full_name: Mellisa Black

given: Mellisa

family: Wohlford

full_name: George Wohlford

given: George

family: Clary

full_name: Rick Earle Clary

given: Rick Earle

family: Duke

full_name: Christina Duke

given: Christina

family: Hardin

full_name: Mary Hardin

family: Kemp

full_name: Heather Kemp

given: Heather

family: Priday

full_name: Anna Priday

given: Anna

family: Sims

full_name: Earl Kenneth Sims

given: Earl Kenneth

suffix: Jr

family: Mihalick

full_name: Virginia Mihalick

given: Virginia

family: Ho

full_name: Ai-Chen Ho

given: Ai-Chen

family: Ibe

full_name: Ikenna Ibe

given: Ikenna

family: Harmon

full_name: Mary Harmon

family: Markley

full_name: Roshanak Markley

given: Roshanak

family: Van Tassell

full_name: Benjamin Van Tassell

given: Benjamin

family: Abbate

journal_name: Journal of Clinical and Translational Science

ReferenceCitation: Caricchio R, Abbate A, Gordeev I, Meng J, Hsue PY, Neogi T, Arduino R, Fomina D, Bogdanov R, Stepanenko T, Ruiz-Seco P, Gónzalez-García 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.

name: Division of Rheumatology, Department of Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania

name: Wright Center for Clinical and Translational Research, Virginia Commonwealth University, Richmond

name: City Clinical Hospital No. 15 Named After O.M. Filatov, Moscow, Russian Federation

name: Maimonides Medical Center, Brooklyn, New York

name: University of California, San Francisco, Zuckerberg San Francisco General Hospital, San Francisco

name: Boston Medical Center and Boston University School of Medicine, Boston, Massachusetts

name: McGovern Medical School at The University of Texas Health Science Center at Houston

name: Center of Allergy and Immunology, Clinical City Hospital No. 52, Moscow, Russian Federation

name: Department of Allergy and Clinical Immunology, I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Moscow, Russian Federation

name: Therapeutic Department, Aleksandrovskaya Hospital, St Petersburg, Russian Federation

name: City Multi-specialty Hospital No. 2, St Petersburg, Russian Federation

name: Unidad Medicina Interna, Hospital Universitario Infanta Sofía, Madrid, Spain

name: Unidad de Enfermedades Sistémicas Autoinmunes y Minoritarias, Servicio de Medicina Interna, Hospital Ramón y Cajal, Madrid, Spain

name: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey

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
France
Russian Federation
Spain
United States
United Kingdom

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)

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).


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.

status: Completed

study_completion_date_type: Actual

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.

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

status_simplified: Completed


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: ObsEva SA

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

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

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

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

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

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

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

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

location_facility: Specjalistyczny Gabinet Lekarski Krzysztof Dynowski / ID # 401

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

location_facility: Gynekologicko - Porodnicka Ambulance/ ID # 162

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

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

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: Hospital Regional Universitario de Málaga/ ID # 303

location_facility: Centrum Medyczne Chodźki Lublin/ ID # 403

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

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

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

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

location_facility: Lubelskie Centrum Diagnostyczne/ ID # 402

location_facility: Niepubliczny Zaklad Opieki Zrowotnej GynCentrum/ ID # 407

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

location_facility: Chattanooga Medical Research LLC/ ID# 602

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

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

location_facility: Zaporizhzhya Regional Clinical Hospital/ ID # 505

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

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

location_facility: Prywatna Klinika Ginekologiczno - Położnicza/ ID # 404

location_facility: Hospital General Universitario Reina Sofia/ ID # 304

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


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: Italy Netherlands France Norway Ireland Canada

location_facility:
St. Joseph's Healthcare
Hamilton General Hospital
Brest University Hospital Centre
University of Insubria
Amsterdam University
Mater Misericordiae University Hospital
Juravinski Hospital
Jewish General Hospital
McGill Univeristy Health Centre
CHU de Quebec-Université Laval
Ostfold Hopsital
The Ottawa Hospital


lead_sponsor: Gilead Sciences

location_country:
United States
Belgium
France

location_facility: New York Cancer & Blood Specialists - Setauket Medical Oncology

location_facility: Florida Cancer Specialists & Research Institute

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

title: Open-label Rollover Study to Evaluate Long-Term Safety in Subjects With Metastatic Solid Tumors That Are Benefiting From Continuation of Therapy With Sacituzumab Govitecan

summary: The primary objective of this study is to evaluate long-term safety in participants with metastasis solid tumors that are benefitting from continuation with sacituzumab govitecan-hziy.


title: Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT)

acronym: FORMaT

summary: Mycobacterium abscessus (MABS) is a group of rapid-growing, multi-drug resistant non-tuberculous mycobacteria (NTM) causing infections in humans. MABS pulmonary disease (MABS-PD) can result in significant morbidity, increased healthcare utilisation, accelerated lung function decline, impaired quality of life, more challenging lung transplantation, and increased mortality. While the overall numbers affected is small, the prevalence of infections is increasing worldwide. The Finding the Optimal Regimen for Mycobacterium abscessus Treatment (FORMaT) trial aims to produce high quality evidence for the best treatment regimens to maximise health outcomes and minimise toxicity and treatment burden, as well as developing biomarkers (serology, gene expression signatures, and radiology) to guide decisions for starting treatment and measuring disease severity in patients with MABS PD

ipd_sharing_description: All de-identified raw data measured during the trial will be made available.

lead_sponsor: The University of Queensland

location_country:
Netherlands
France
Ireland
Australia
New Zealand
Denmark
Canada
United Kingdom

location_facility:
Monash Medical Centre
Sydney Children's Hospital
Perth Children's Hospital
Rigshospitalet
Rockhampton Hospital
Sunshine Coast University Hospital
Royal Brompton Hosptial
Skejby University Hospital
Erasmus MC Sophia Children's Hospital
St Michaels Hospital
Princess Alexandra Hospital
Starship Children's Hosptial
Gladstone Hospital
Sir Charles Gardiner Hospital
The Hospital for Sick Kids
Townsville Hospital
St Vincent's University Hospital
Greenslopes Private Hospital,
Monash Children's Hospital
The Prince Charles Hospital
John Hunter Hospital
Royal Brisbane & Women's Hospital
Royal Hobart Hospital
Queensland Children's Hospital
Royal Prince Alfred Hospital
The Alfred
Hospital Cochin
Mackay base Hospital
Concord Repatriation Hospital
Cairns Base Hospital
The Children's Hospital at Westmead
Westmead Hospital
Royal Adelaide Hospital
Mater Adult Hospital
St George's Hospital
Nottingham Children's Hosptial
Gold Coast University Hospital


title: Endometrial Cancer Conservative Treatment (E.C.Co). A Multicentre Archive

summary:
Approximately one fourth of cases of endometrial cancer (EC) are diagnosed in premenopausal women, of whom approximately 40% wish to preserve their fertility. When arising in young women, EC usually presents with favorable prognostic features, as a focal, well differentiated endometrioid tumor, with minimal or absent myometrial invasion. This profile corresponds to the Type 1 EC, which correlates with the estrogen/progesterone receptor positive (ER+/PR+) pattern. On the other hand, these patients frequently present with clinical signs of a hyperestrogenism (chronic anovulation, infertility, obesity). Primary progestin therapy has been demonstrated to be effective in early well differentiated tumors and in poor operative candidates with response rates ranging from 58-100%.Currently, the therapeutic approach to an early stage EC consists of a staging laparotomy/laparoscopy, including a total abdominal hysterectomy and bilateral salpingo-oophorectomy (TAH-BSO), peritoneal washings, and lymphadenectomy (pelvic and aortic), depending on the pathological risk profile pre- and intraoperatively determined. Therefore, the current standard of surgical approach is preclusive of fertility.

The worldwide experience and data on conservative management of EC are, however, still limited. Most of reports based on cases retrospectively collected, harboring potential methodological bias, using different treatments and drugs, and with insufficient follow-up.

Some systematic reviews have been published in the last decade, trying to summarize the literature data. Therapeutic results seem to be promising with a regression rate of approximately 75% and relapse occurring in 25-40% of cases, with anecdotical reports of deaths of disease (DOD). The fertility outcome was, however, not satisfying with about 30% pregnancy rate in patients attempting to conceive, and an overall low rate of assisted reproductive techniques (ART) despite the subfertile clinical profile.Therefore, there is a need for a prospective, multicentre cooperative project able to systematically collect data from consecutive patients treated according to defined (not necessarily identical) protocols, concerning the oncological, as well as, the obstetrical outcomes. Moreover, this project could represent the "template" in which a pretreatment fertility counseling, psychological support, and definitive surgery are routinely included according to shared criteria.

ipd_sharing_description: Data generated are property of all investigators and will be object of publication after general agreement.

lead_sponsor: National Cancer Institute, Naples

location_country:
Italy
Austria
United States
Netherlands
Spain
Germany
France
Japan
Ireland
Australia
Belgium
China
Denmark
Canada
United Kingdom
Korea, Republic of

location_facility: SGOG (Shanghai Gynecologic Oncology Group)

location_facility: SGCTG (Scottish Gynaecological Cancer Trials Group)

location_facility: GEICO - Grupo Espanol de Investigacion en Cancer de Ovario

location_facility: NOGGO (Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie)

location_facility: GINECO - Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens

location_facility: NSGO (Nordic Society of Gynecologic Oncology)

location_facility: NCIC Clinical Trials Group (Canadian Cancer Society Research Institute)

location_facility: EORTC - European Organization for Research and Treatment of Cancer

location_facility: JGOG - Japanese Gynecologic Oncology Group

location_facility: AGO-AUST Arbeitsgemeinschaft Gynaekologische Onkologie

location_facility: PMHC (Princess Margaret Hospital Consortium)

location_facility: KGOG - Korean Gynecologic Oncology Group

location_facility: AGO-De Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom

location_facility: GOTIC - Gynecologic Oncology Trial and Investigation Consortium

location_facility: ANZGOG - Australia and New Zealand Gynecological Oncology Group

location_facility: ICORG - Ireland Cooperative Oncology Research Group

location_facility: MITO (Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies)


title: A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis (EXPEDITION OLE)

acronym: Expedition

summary: The purpose of this OLE Study D5272C00002 (Legacy #3151-202-008) is to permit participants who previously enrolled in the double-blind Study D5272C00001 (Legacy #3151-201-008) to receive brazikumab, allowing for long-term observation of safety in these participants treated with brazikumab. There are no formal hypotheses to be tested. Safety data obtained in this study will be included in regulatory product submissions as appropriate.

location_country:
Romania
Belgium
Russian Federation
Taiwan
Ukraine
India
France
Japan
Poland
Canada
Korea, Republic of
South Africa
Bulgaria
Hungary
Puerto Rico
United States
Germany
United Kingdom
Italy
Austria
Czechia
Israel
Spain


title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 48-Week, Parallel-Group Study of the Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD) With Open-Label Extension (OLE)

summary: This study is an open-label extension to evaluate the safety and tolerability of long-term dosing of Losmapimod in patients with FSHD1 who participated in the ReDux4 study.

ReferenceCitation: Barbour AM, Sarov-Blat L, Cai G, Fossler MJ, Sprecher DL, Graggaber J, McGeoch AT, Maison J, Cheriyan J. Safety, tolerability, pharmacokinetics and pharmacodynamics of losmapimod following a single intravenous or oral dose in healthy volunteers. Br J Clin Pharmacol. 2013 Jul;76(1):99-106. doi: 10.1111/bcp.12063.

ReferenceCitation: Cheriyan J, Webb AJ, Sarov-Blat L, Elkhawad M, Wallace SM, Mäki-Petäjä KM, Collier DJ, Morgan J, Fang Z, Willette RN, Lepore JJ, Cockcroft JR, Sprecher DL, Wilkinson IB. Inhibition of p38 mitogen-activated protein kinase improves nitric oxide-mediated vasodilatation and reduces inflammation in hypercholesterolemia. Circulation. 2011 Feb 8;123(5):515-23. doi: 10.1161/CIRCULATIONAHA.110.971986. Epub 2011 Jan 24.

ReferenceCitation: de Greef JC, Lemmers RJ, van Engelen BG, Sacconi S, Venance SL, Frants RR, Tawil R, van der Maarel SM. Common epigenetic changes of D4Z4 in contraction-dependent and contraction-independent FSHD. Hum Mutat. 2009 Oct;30(10):1449-59. doi: 10.1002/humu.21091.

ReferenceCitation: Han JJ, Kurillo G, Abresch RT, de Bie E, Nicorici A, Bajcsy R. Reachable workspace in facioscapulohumeral muscular dystrophy (FSHD) by Kinect. Muscle Nerve. 2015 Feb;51(2):168-75. doi: 10.1002/mus.24287. Epub 2014 Nov 19.

ReferenceCitation: Jagannathan S, Shadle SC, Resnick R, Snider L, Tawil RN, van der Maarel SM, Bradley RK, Tapscott SJ. Model systems of DUX4 expression recapitulate the transcriptional profile of FSHD cells. Hum Mol Genet. 2016 Oct 15;25(20):4419-4431. doi: 10.1093/hmg/ddw271.

ReferenceCitation: Statland JM, Tawil R. Risk of functional impairment in Facioscapulohumeral muscular dystrophy. Muscle Nerve. 2014 Apr;49(4):520-7. doi: 10.1002/mus.23949. Epub 2014 Feb 10.

ReferenceCitation: Wang LH, Friedman SD, Shaw D, Snider L, Wong CJ, Budech CB, Poliachik SL, Gove NE, Lewis LM, Campbell AE, Lemmers RJFL, Maarel SM, Tapscott SJ, Tawil RN. MRI-informed muscle biopsies correlate MRI with pathology and DUX4 target gene expression in FSHD. Hum Mol Genet. 2019 Feb 1;28(3):476-486. doi: 10.1093/hmg/ddy364.

lead_sponsor: Fulcrum Therapeutics

location_country:
United States
Canada
France
Spain

location_facility: University of California Los Angeles (UCLA)

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Montreal Neurological Institute and Hospital

location_facility: Washington University School of Medicine


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

lead_sponsor: Eli Lilly and Company

location_country:
Romania
Australia
Belgium
Russian Federation
Denmark
Ukraine
India
Croatia
France
Japan
Lithuania
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Switzerland
Netherlands
Hungary
China
Germany
United States
Italy
Austria
Brazil
Serbia
Mexico
Czechia
Israel
Spain
Turkey
Latvia

location_facility: Unidad de Atención Médica e Investigación en Salud (UNAMIS)

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas

location_facility: PanAmerican Clinical Research Mexico S.A. de C.V.

location_facility: Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU

location_facility: Instituto de Assistencia Medica ao Servidor Publico Estudo Estadual

location_facility: HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas

location_facility: Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Spitalul Universitar de Urgență București

location_facility: Communal Enterprise "Odesa Regional Clinical Hospital"

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda

location_facility: Centro de Alta Especialidad en Reumatologia e Investigación del Potosi,S.C

location_facility: Kharkiv Regional Council Regional Clinical Hospital

location_facility: Praxis Balsiger, Seibold & Partner und Crohn-Colitis-Zentrum

location_facility: Midland Florida Clinical Research Center, LLC

location_facility: Eskisehir Osmangazi University Gastroenterology

location_facility: Care Access Research LLC - Salt Lake City

location_facility: Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.

location_facility: Santa Casa de Misericórdia de Porto Alegre

location_facility: St. Marienkrankenhaus-Medizinische Klinik I

location_facility: University of Oklahoma Health Sciences Center

location_facility: HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2

location_facility: Irkutsk State Medical Academy of Continuing Education

location_facility: Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej

location_facility: Instituto de Investigaciones Clínicas para la Salud

location_facility: Saint Petersburg State Medical University n.a. Pavlov I.P.

location_facility: Policlinico Gemelli - Università Cattolica del Sacro Cuore

location_facility: The Sixth Affiliated Hospital, Sun Yat-Sen University

location_facility: The First Hospital Affiliated to AMU (Southwest Hospital)

location_facility: GOU VPO St-Petersburg SMA n/a Mechnikov Fed. Agen of Health

location_facility: Hospital Moinhos de Vento - Instituto de Educação e Pesquisa

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

location_facility: Hamburgisches Forschungsinstitut fuer Chronisch Entzuendliche Darmerkrankungen

location_facility: Synexus Polska Sp. z o.o. Oddzial w Gdansku

location_facility: Pauls Stradins Clinical Univeristy Hospital

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

location_facility: NonState Healthcare Institution Central Clinical Hospital

location_facility: Gastroenterology Associates of Pensacola, PA

location_facility: Siloah St. Trudpert Klinikum-Zentrum für Innere Medizin

location_facility: Karelia Republican Hospital V.A. Baranova

location_facility: Hatay Namik Kemal University Hospital Gastroenterology

location_facility: Associacao Paranaense de Cultura - PUCPR

location_facility: Gastroenterology Associates of Orangeburg

location_facility: LLC Multidisciplinary Medical Clinic Anthurium

location_facility: Medical Center Ok!Clinic of Intl Inst of Clinical Trials LLC

location_facility: Clinical Research of West Florida, Inc. (Clearwater)

location_facility: LLC Scientific Research Centre EKO-Bezopasnost

location_facility: Cliagen - Clinica de Atencao em Gastroenterologia, Especialidades e Nutricao

location_facility: University of North Carolina Center for Inflammatory Bowel Disease

location_facility: First affiliated Hospital of Sun Yat-Sen University

location_facility: Saint-Petersburg City Hospital of Saint Elizabeth

location_facility: Kocaeli University Medical Faculty Hospital

location_facility: First Affiliated Hosp of College of Med, Zhejiang University

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Depto Gastroenterología

location_facility: Synexus Polska Sp. z o.o. Oddzial w Katowicach

location_facility: Marmara University Pendik Research and Training Hospital

location_facility: Ruby Hall Clinic and Grant Medical Foundation

location_facility: The Third Xiangya Hospital of Central South University

location_facility: S.C Centrul de Gastroenterologie Dr. Goldis S.R.L

location_facility: The First People's Hospital of Changzhou

location_facility: Practice Dr.med. Denger and Dr.med. Pfitzner

location_facility: AKH - Gastroenterologie und Hepatologie - Interne Medizin III

location_facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni

location_facility: Lviv Clinical Hospital at Railway Transport of Division Healthcare Center PJSC Ukrainian Railway Sta

location_facility: Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech

location_facility: Nizhegorodskiy Regional Clinical Hospital N.A.Semashko

location_facility: Instituto de Pesquisa em Saúde - Fundação Universidade de Caxias do Sul

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

location_facility: Medical Center of Limited Liability Company Medical Center Clinic of Family Medicine

location_facility: Woodholme Gastroenterology Associates PA

location_facility: L2IP - Instituto de Pesquisas Clinicas Ltda.

location_facility: Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

location_facility: Loema Instituto de Pesquisa Clinica e Consultores Ltda

location_facility: A. Novak Transcarpathian Regional Clinical Hospital

location_facility: Université Libre de Bruxelles - Hôpital Erasme

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: Galilee Medical Center Department of Internal Medicine A

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Tokyo Medical And Dental University Medical Hospital

location_facility: Synexus Clinical Research - St. Petersburg

location_facility: Gastro I s.r.o., Gastroenterologická ambulancia

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: University Hospitals Cleveland Medical Center

location_facility: Center Hospital of the National Center for Global Health and Medicine

location_facility: Centrum Zdrowia Matki, Dziecka i Młodzieży (CZMDM) Przychodnie

location_facility: The Catholic University of Daejeon St. Mary's Hospital

location_facility: Nucleo de Pesquisa Clínica do Rio Grande do Sul-NPCRS

location_facility: The Second Affiliated Hospital of Wenzhou Medical College

location_facility: Ukrayins'kyy Derzhavnyy Naukovo-Doslidnyy Instytut Rebilitatsiyi Invalidiv

location_facility: Hacettepe University Faculty of Medicine

location_facility: Konya Necmettin Erbakan Gastroenterology

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

location_facility: PanAmerican Clinical Research S.A.de C.V. Guadalajara

location_facility: Gujarat Hospital - Gastro and Vascular Centre

location_facility: Upeclin - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UNESP

location_facility: Clinical Research Institute of Michigan, LLC

title: A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients With Crohn's Disease

summary: The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.


title: A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Venglustat in Late-onset GM2 Gangliosidosis (Tay-Sachs Disease and Sandhoff Disease) Together With a Separate Basket for Juvenile/Adolescent Late-onset GM2 Gangliosidosis and Ultra-rare Diseases Within the Same and Similar Glucosylceramide-based Sphingolipid Pathway

acronym: AMETHIST

summary:
Primary Objectives:

Primary population (adult participants with late-onset GM2 gangliosidosis): To assess the efficacy and pharmacodynamics (PD) of daily oral dosing of venglustat when administered over a 104-week period

Secondary population (participants with juvenile/adolescent late-onset GM2 gangliosidosis, GM1 gangliosidosis, saposin C deficiency, sialidosis type 1 or juvenile/adult galactosialidosis): To assess PD response (plasma and CSF GL-1 biomarker and disease specific biomarkers) of venglustat when administered once daily over a 104-week period

Secondary Objectives:

Primary population:

To assess the effect of venglustat on selected performance test and scale over a 104-week period
To determine the safety and tolerability of venglustat when administered orally once daily over a 104-week period
To assess the pharmacokinetics (PK) of venglustat in plasma and cerebrospinal fluid (CSF)

Secondary population:

To assess the effect of venglustat on selected performance tests and scale over a 104-week period
To determine the safety and tolerability of venglustat when administered once daily over a 104-week period
To assess the PK of venglustat in plasma and CSF

ReferenceCitation: Nicoli ER, Annunziata I, d'Azzo A, Platt FM, Tifft CJ, Stepien KM. GM1 Gangliosidosis-A Mini-Review. Front Genet. 2021 Sep 3;12:734878. doi: 10.3389/fgene.2021.734878. eCollection 2021. Review.

family: Nicoli

full_name: Elena-Raluca Nicoli

given: Elena-Raluca

family: Annunziata

full_name: Ida Annunziata

given: Ida

family: d’Azzo

full_name: Alessandra d’Azzo

given: Alessandra

family: Platt

full_name: Frances M. Platt

given: Frances M.

family: Tifft

full_name: Cynthia J. Tifft

given: Cynthia J.

family: Stepien

full_name: Karolina M. Stepien

given: Karolina M.

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Frontiers in Genetics

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

title: GM1 Gangliosidosis—A Mini-Review

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

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Italy
Austria
Brazil
Spain
Germany
France
Czechia
Japan
Argentina
Russian Federation
Portugal
Turkey
United States
United Kingdom

location_facility: Hospital de Clinicas de Porto Alegre _investigational site number 0760001

location_facility: Research Center Of Neurology 80, Volokolamskoye shosse_investigational site number 6430001

location_facility: Hospital Clínico Universitario de Santiago-CHUS. Travesia de Chopuana, s/n_investigational site number 7240002

location_facility: Massachusetts General Hospital - Charles River Plaza 175 Cambridge St. Ste 340 - Investigational site number 8400002

location_facility: Gazi Universitesi Tip Fakultesi Emniyet Street Mevlana Blv Besevler Yenimahalle_investigational site number 7920001

location_facility: Universitätsklinikum der Justus-Liebig-Universität Gießen Zentrum für Kinderheilkunde und Jugendmedizin Feulgenstraße 10-12_investigational site number 2760001

location_facility: Salford Royal NHS Foundation Trust Salford Royal Hospital Stott Lane_investigational site number 8260002

location_facility: Tohoku Medical and Pharmaceutical University Hospital_investigation site number 3920002

location_facility: NYU Langone - 550 First Avenue-Investigational site number 8400001

location_facility: Vseobecna Fakultni Nemocnice V Praze Metabolicke centrum U Nemocnice 2_investigational site number 2030001

location_facility: APHP - Centre Hospitalier la Pitié Salpetrière, Service de Neurologie, 47-83 Boulevard De l'Hôpital_Investigational site number 2500001

location_facility: Japanese Red Cross Akita Hospital 222-1 Nawashirosawa, Kamikitatesaruta_investigational site number 3920001

location_facility: NIH National Human Genome Research Institute - 10 Center Dr - Bldg. 10 CRC3-2551 MSC 1205 - Investigational site number 8400005

location_facility: Clínica Universitaria Reina Fabiola Córdoba_investigational site number 0320001

location_facility: Emory Genetics - Investigational site number 8400006

location_facility: Hospital Maternoinfantil Sant Joan de Déu Paseo de Sant Joan de Déu, 2_investigational site number 7240001

location_facility: Hospital Universitari de Bellvitge. Feixa Llarga, S / N_investigational site number 7240004

location_facility: Ataxia Center and HD Center of Excellence, 300 UCLA Med Plaza, Suite B200 - Investigational site number 8400004

location_facility: Hospital Universitario Austral Pilar, Buenos Aires_Unidad de Investigación Clínica_investigational site number 0320002

location_facility: Centro Hospitalar Universitário Lisboa Norte- Hospital Santa Maria Avenida Professor Egas Moniz_investigational site number 6200002

location_facility: Cambridge University Hospitals NHS Foundation Trust Addenbrookes Hospital Hills Road_investigational site number 8260001

location_facility: AKH Wien_Universitätsklinik für Innere Medizin III Klinische Abteilung für Endokrinologie & Stoffwechsel Währinger Gürtel 18-20_investigational site number 0400001


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Voxelotor (GBT440) in Pediatric Participants With Sickle Cell Disease

acronym: HOPE Kids 2

summary: This study is a Phase 3, randomized, double-blind, placebo-controlled study of voxelotor in pediatric participants, aged ≥ 2 to < 15 years old, with Sickle Cell Disease. The primary objective is to evaluate the effect of voxelotor on the TCD (Transcranial Doppler Ultrasound) measurements in SCD participants in this age range.

lead_sponsor: Global Blood Therapeutics

location_country:
Italy
Saudi Arabia
France
Nigeria
Ghana
Egypt
Oman
United States
United Kingdom
Kenya

location_facility: Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

location_facility: KEMRI - Centre for Respiratory Disease Research (CRDR)

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

location_facility: Children's Health Care d/b/a Children's Minnesota

location_facility: Washington University School of Medicine

location_facility: Seconda Università degli Studi di Napoli

location_facility: University of Mississippi Medical Center

location_facility: Sultan َQaboos University Hospital - Pediatrics

location_facility: Children's Healthcare of Atlanta- Scottish Rite/ EMORY

location_facility: Abu El Rich Hospital, Cairo University Hospital

location_facility: CREATES - Strathmore University Medical Centre

location_facility: Children's Healthcare of Atlanta-Hughes Spalding

location_facility: St Mary's Hospital - Dept of Haematology

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: Sultan َQaboos University Hospital - Adults/Adolescents

location_facility: King Abdullah Children's Specialist Hospital

location_facility: Barau Dikko Teaching Hospital / Kaduna State University

location_facility: Komfo Anokye Teaching Hospital Research and Development Unit


title: Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF

acronym: PULSED AF

summary: The study is a prospective, multi-center, non-randomized, unblinded worldwide pre-market clinical study. The purpose of the study is to provide data demonstrating the safety and effectiveness of the PulseSelect™ PFA System for the treatment of atrial fibrillation (AF). The study will also provide first in human insights into clinical safety and device function of the PulseSelect PFA System for pulmonary vein isolation (PVI) as a treatment for AF. To this end, the clinical study has been designed into phases (Pilot and Pivotal), with each phase comprising a separate data set that will be analyzed and reported on per the below objectives.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

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

location_facility: Hospital of the University of Pennsylvania

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

location_facility: Northwell Health - North Shore University Hospital

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: The Ohio State University Wexner Medical Center

location_facility: Saint Luke's Mid America Heart Institute

location_facility: Tokyo Medical and Dental University, Medical Hospital

location_facility: Ordensklinikum Linz GmbH / Elisabethinen

location_facility: University of Pittsburgh Medical Center- UPMC Presbyterian

location_facility: NYU Langone Health - Heart Rhythm Center


title: Boston Scientific Double-J PLUS Ureteral Stent Postmarket Patient Registry

summary: A multi-center global registry to obtain post-market safety and efficacy data on Boston Scientific Ureteral and Urinary Diversion Stents

lead_sponsor: Boston Scientific Corporation

location_country:
United States
Canada
France
Japan

location_facility: New York Presbyterian Hospital-Columbia University Medical Center

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Northwestern University-Department of Urology


lead_sponsor: Sanofi

location_country:
Mexico
France
Japan
Argentina
Russian Federation
China
United States
Korea, Republic of

acronym: PRIME

location_facility:
Investigational Site Number :3920010
Investigational Site Number :8400007
Investigational Site Number :4840001
Investigational Site Number :2500005
Investigational Site Number :4100002
Investigational Site Number :0320005
Investigational Site Number :0320002
Investigational Site Number :8400003
Investigational Site Number :8400025
Investigational Site Number :0320001
Investigational Site Number :3920002
Investigational Site Number :4100001
Investigational Site Number :8400022
Investigational Site Number :8400016
Investigational Site Number :8400002
Investigational Site Number :8400024
Investigational Site Number :0320003
Investigational Site Number :4100005
Investigational Site Number :4100004
Investigational Site Number :4840005
Investigational Site Number :6430008
Investigational Site Number :6430007
Investigational Site Number :8400019
Investigational Site Number :3920009
Investigational Site Number :6430010
Investigational Site Number :1560001
Investigational Site Number :1560003
Investigational Site Number :8400014
Investigational Site Number :3920007
Investigational Site Number :0320008
Investigational Site Number :4840003
Investigational Site Number :6430006
Investigational Site Number :3920004
Investigational Site Number :4840006
Investigational Site Number :8400004
Investigational Site Number :1560004
Investigational Site Number :3920005
Investigational Site Number :6430005
Investigational Site Number :0320009
Investigational Site Number :3920001
Investigational Site Number :6430001
Investigational Site Number :0320004
Investigational Site Number :8400009
Investigational Site Number :1560002
Investigational Site Number :8400018
Investigational Site Number :6430009
Investigational Site Number :4840002
Investigational Site Number :8400011
Investigational Site Number :3920006
Investigational Site Number :8400017
Investigational Site Number :6430002
Investigational Site Number :8400026
Investigational Site Number :8400013
Investigational Site Number :4100007
Investigational Site Number :0320007
Investigational Site Number :8400001
Investigational Site Number :8400015
Investigational Site Number :0320006
Investigational Site Number :8400006
Investigational Site Number :3920003
Investigational Site Number :4100003
Investigational Site Number :8400005
Investigational Site Number :8400010

title: A Randomized, Double Blind, Placebo-controlled, Multi-center, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Prurigo Nodularis Who Are Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable

summary:
Primary Objective:

To demonstrate the efficacy of dupilumab on itch response in patients with prurigo nodularis (PN), inadequately controlled on topical prescription therapy or when those therapies are not advisable

Secondary Objectives:

To demonstrate the efficacy of dupilumab on additional itch endpoints in patients with PN, inadequately controlled on topical prescription therapy or when those therapies are not advisable To demonstrate efficacy of dupilumab on skin lesions of PN To demonstrate the improvement in health-related quality of life To evaluate safety outcome measures To evaluate immunogenicity of dupilumab


title: An Open-Label, Multicenter Phase 1/1b Study of Intratumorally Administered STING Agonist E7766 in Subjects With Advanced Solid Tumors or Lymphomas - INSTAL-101

summary: This is an open label, multicenter, phase 1/1b study to assess safety/tolerability and preliminary clinical activity of E7766 as a single agent administered intratumorally in participants with advanced solid tumors or lymphomas.

ipd_sharing_description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

lead_sponsor: Eisai Inc.

location_country:
United States
United Kingdom
France

location_facility:
UPMC
Institut Gustave Roussy
Sylvester Cancer Center
Imperial College Healthcare NHS Trust
Beth Israel Deaconess Medical Center
Center for Immuno-Oncology , DFCI
MGH
Yale


title: A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

summary:
The primary objective of this study is:

• To evaluate the long-term safety of fostamatinib

The secondary objectives are:

To compare the proportion of subjects with wAIHA who achieve a durable hemoglobin response
To estimate the durability of response in subjects receiving fostamatinib for wAIHA To assess steroid use in subjects with wAIHA treated with fostamatinib.

lead_sponsor: Rigel Pharmaceuticals

location_country:
Italy
Austria
Serbia
Netherlands
Spain
Germany
France
Bulgaria
Czechia
Georgia
Norway
Australia
Belgium
Russian Federation
Belarus
United States
United Kingdom
Ukraine

location_facility: Vitebsk Regional Clinical Oncology Dispensary

location_facility: Clinical Centre of Vojvodina, Clinic for Hematology

location_facility: "University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD, Plovdiv, Clinic of Medical oncology

location_facility: Roald Dahl Haemostasis and Thrombosis Centre, Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust

location_facility: Fakultni nemocnice Brno Interni hematologicka a onkologicka klinika

location_facility: State Budgetary Healthcare Institution Oncology Dispensary No. 2 of the Ministry of Health of the Krasnodar Territory

location_facility: City Clinical Hospital № 4, Hematology Center

location_facility: LTD Multiprofile Clinic Consilium Medulla

location_facility: "University Multiprofile Hospital for Active Treatment "Sveta Marina"" EAD, Varna, Clinic of Clinical Haematology

location_facility: CHU de Bordeaux - GH Sud- Hôpital Haut Lévêque Service Médecine Interne et Maladies Infectieuses

location_facility: Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico di Milano - UO Ematologia

location_facility: Fakultni nemocnice Ostrava Klinika hematoonkologie

location_facility: Kyiv City Clinical Hospital №9, hematology department №1


title: Rate of Progression in EYS Related Retinal Degeneration (Pro-EYS)

acronym: Pro-EYS

summary: The overall goal of this project funded by the Foundation Fighting Blindness is to characterize the natural history of disease progression in patients with EYS mutations in order to accelerate the development of outcome measures for clinical trials.

ipd_sharing_description: A de-identified database is placed in the public domain on the FFB/Jaeb public website after the completion of each protocol and publication of the manuscript.

lead_sponsor: Jaeb Center for Health Research

location_country:
United States
Netherlands
Finland
France
Israel
Germany
Canada

location_facility: University of Miami: Neuro-ophthalmology Department

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

location_facility: Oregon Health Science University Casey Eye Institute

location_facility: Kellogg Eye Center, University of Michigan

location_facility: University of Pittsburgh School of Medicine: Department of Ophthalmology

location_facility: University of Wisconsin-Madison: McPherson Eye Research Institute


title: Non-Contrast CT vs CTP or MRI Selection vs Medical Management in Late Presentation of Large Vessel Occlusion Stroke, 6-24 Hours. A Multicenter Retrospective Study

acronym: CLEAR

summary:
The objective of this multicenter, retrospective, cross-sectional, chart review study is to compare outcomes (disability, complications and mortality) of patients with large vessel occlusion stroke presenting at late time window selected by either Non-Contrast CT (NCCT) only, advanced imaging with CTP (Computed Tomography Perfusion), MRI (Magnetic Resonance Imaging), or medical management.

Boston Medical Center (BMC) will serve as the main data coordinating site. Fifteen additional sites will seek local IRB approval or ethics approval. The aggregated de-identified data will be analyzed comparing types of interventions and outcomes by type of imaging or medical management.

time_perspective: Retrospective

lead_sponsor: Boston Medical Center

location_country:
United States
Switzerland
France
Japan
Spain
Germany
Canada

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: Grady Health; Marcus Stroke & Neuroscience Center

location_facility: National Hospital Organization Osaka National Hospital

location_facility: National Cerebral and Cardiovascular Center


title: A Phase 3, 182-week, Open-Label, Extension Study to Investigate the Safety and Tolerability of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension (Symptomatic nOH) in Subjects With Primary Autonomic Failure

acronym: OAK

summary: A Phase 3, multi-center, open-label study to evaluate the safety and tolerability of ampreloxetine in subjects with primary autonomic failures (MSA, PD, and PAF) and symptomatic nOH over 182 weeks.

ipd_sharing_description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

lead_sponsor: Theravance Biopharma

location_country:
Italy
Austria
United States
Spain
Germany
France
Bulgaria
Poland
Israel
Australia
Russian Federation
New Zealand
Portugal
Estonia
Denmark
Canada
United Kingdom
Ukraine

location_facility: Montreal Neurological Institute & Hospital

location_facility: Clinical Trials Centre, Level 3 Monash Health Translational Precinct Building Monash Medical Centre

location_facility: University of Cincinnati Medical Center (UCGNI)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS / Istituto di Neurologia - Ambulatorio Disturbi del Movimento

location_facility: SBEI APE Russian Medical Academy of Postgraduate Education of the MoH of the RF

location_facility: CNE Acad O.I. Yushchenko Vinnytsia Reg Psychoneurological Hospital of Vinnytsia Regional Council, Department of Neurology

location_facility: Limited Liability Company City Neurological Center Sibneiromed

location_facility: Federal State Budgetary Institution Federal Sibirian Scientific and Clinical Center of Federal Medico-Biological Agency

location_facility: State Budgetary Institution of Healthcare of Novosibirsk region City Clinical Hospital No. 34

location_facility: Fondazione IRCCS CA Granda Ospedale Maggiore Pliclinico - U.O. Neurologia

location_facility: MHATNP Sv. Naum EAD Clinic of Neurological Diseases for Locomotor Disorders

location_facility: AOU San Giovanni di Dio e Ruggi d'Aragona

location_facility: The National Hospital for Neurology & Neurosurgery

location_facility: Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii Klinicznej

location_facility: Universitätsklinikum Tulln Abteilung fur Neurologie

location_facility: Oregon Health & Science University (OHSU)

location_facility: Colorado Springs Neurological Associates

location_facility: Specjalistyczna Praktyka Lekarska prof.Grzegorz Opala

location_facility: Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche Ospedale Bellaria

location_facility: Perron Institute for Neurological and Translational Science

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

location_facility: FSBI "National Medical Research Centre of psychiatry and neurology named after V.M. Bekhterev" of the MOH of the Russian Federation

location_facility: Fondazione PTV - Policlinico Tor Vergata I U.0.C. Neurologia

location_facility: Concord Hospital, Neurosciences Department

location_facility: UO Farmacia Centralizzata OM (SC) Ospedale Maggiore

location_facility: Instytut Zdrowia Dr Boczarska-Jedynak SP. Z 0.0., SP. K.

location_facility: Charite - Campus Virchow- Klinikum, Klinik fur Neurologie

location_facility: University of Texas Southwestern Medical Center

location_facility: Municipal Instituion of Health: Kharkiv Public Outpatient Clinic 9, Kharkiv Medical Academy of Post-Graduate Education, Department of General Practice - Family Medicine


title: Optimize PRO Transcatheter Aortic Valve Replacement Post Market Study

summary: The purpose of this study is to collect clinical evidence on valve performance and procedural outcomes associated with an "optimized" TAVR care pathway and post-TAVR conduction disturbance pathway while using the Evolut™ PRO and Evolut™ PRO+ devices.

lead_sponsor: Medtronic Cardiovascular

location_country:
Italy
United States
France
Israel
Belgium
Spain
Canada
United Kingdom

location_facility: St. John's Hospital/Prarie Education and Research Cooperative

location_facility: California Pacific Medical Center - Sutter Health

location_facility: New York Presbyterian - Columbia University Medical Center

location_facility: St. Vincent's Hospital / Cardiology Associates of Fairfield County, P.C.

location_facility: Laval University Institute of Cardiology and Respirology of Quebec

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: University of Alabama at Birmingham Hospital

location_facility: Hospital Universitario Central de Asturas

location_facility: Hôpitaux Universitaires - Hôpital Henri Mondor


title: A Phase 1b/2 Study of IMGN632 as Monotherapy or Combination With Venetoclax and/or Azacitidine for Patients With CD123-Positive Acute Myeloid Leukemia

summary: This is an open-label, multicenter, Phase 1b/2 study to determine the safety and tolerability of IMGN632 and assess the antileukemia activity of IMGN632 when administered in combination with azacitidine and/or venetoclax in patients with relapsed and frontline CD123-positive AML, and antileukemia activity of IMGN632 when administered as monotherapy in patients with MRD+ AML after frontline treatment.

lead_sponsor: ImmunoGen, Inc.

location_country:
Italy
United States
France
Spain
Germany

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University

location_facility: Istituto di Ematologia "Lorenzo e A. Seragnoli" - Policlinco S. Orsola - Malpighi

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

location_facility: Azienda Ospedaliera Universitaria Maggiore Della Carita Novara

location_facility: Hospital Universitario y Politécnico de La Fe


title: Medtronic Cardiac Surgery Post Market Clinical Follow-up Registry

summary: This registry is being conducted to support ongoing post-market surveillance activities.

location_country:
Italy
Austria
Germany
France
Greece
Belgium
United States

location_facility: Deutsches Herzzentrum München Klinik an der TU München

location_facility: Allgemeines Krankenhaus - Universitätskliniken Wien

location_facility: Herzzentrum Dresden GmbH Universitätsklinik


title: The NODE-303 Study: Multi-Centre, Multi-National,Open Label, Safety Study of Etripamil Nasal Spray for Patients With Paroxysmal Supraventricular Tachycardia.

summary: NODE-303 is a multi-center, open label (OL) study to evaluate the safety of etripamil NS in patients with Paroxysmal Supraventricular Tachycardia (PSVT). Patients will be provided with an ambulatory Cardiac Monitoring System (CMS) to help document PSVT episodes. The CMS will be self-applied by the patient, when PSVT symptoms begin. Patients will self-administer etripamil NS if vagal maneuver is ineffective. After an episode of PSVT where drug is administered, the patient will return to the investigative site for a study visit and will be given the option to continue in NODE-303 and manage subsequent episodes of PSVT with etripamil NS.

lead_sponsor: Milestone Pharmaceuticals Inc.

location_country:
Belgium
Denmark
France
Poland
Slovakia
Argentina
Canada
Colombia
South Africa
Chile
Netherlands
Hungary
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
Spain