title: HONEST-PREPS: Hospital Network Study - Preparation for a Randomized Evaluation of Anti-Pneumonia Strategies

acronym: HONEST-PREPS

summary:
Hospital Acquired and Ventilator Associated Pneumonia (HAP/VAP) pose a significant burden to patients admitted to the Intensive Care Unit (ICU). Reported incidence ranges from 10-16% in all ICU patients (including HAP and VAP) and around 20-30% in ventilated patients (VAP). Patients with HAP/VAP have a high mortality rate. The estimated attributable mortality of VAP is 6-13%.

Randomized Controlled Trials (RCTs) are the gold standard for evaluating medical interventions, but are difficult to perform in this population. Several preventive and therapeutic treatment options are being developed that will require evaluation in phase-III trials. These trials are challenging due to the relatively low incidence of the outcome (e.g. HAP/VAP) or of the domain under study (e.g. specific antibiotic resistant infections) and the requirement of informed consent in critically ill patients. There is a need for a well-organized and well-trained international RCT network that enables efficient execution of a series of RCTs in this population.

The aim of the current study is to set up an infrastructure to prospectively enroll patients at risk of HAP/VAP in ICUs in several European countries. Site personnel will be trained to obtain a GCP (Good Clinical Practice) certification (if not already done), to timely identify and enroll patients at risk of HAP/VAP, to timely identify occurrence of HAP/VAP, collect informed consent forms, collect source data, enter data into a clinical database, and use a dedicated system to reply to queries. Site sample collection, processing, identifying the causative organism, and antibiotic susceptibility testing will be validated and adapted if required where possible. Where site infrastructure and regulations allow, the possibility of automated data collection of included participants will be explored to ensure sustainability of the future platform. Furthermore, collected data will be used to inform future diagnostic, preventive and therapeutic trials. E.g. they may support assumptions in sample size calculations and expected number of enrolled participants, they may help in prioritizing interventions, or they may be used in simulations of adaptive trials to optimize decision rules.

lead_sponsor: UMC Utrecht

location_country: Croatia Albania Serbia Latvia Hungary France Romania Czechia

location_facility: Paul Stradins Clinical University Hospital

location_facility: Central Military Emergency University Hospital "Dr. Carol Davila "

location_facility: General Hospital Dr Josip Bencevic Slavonski Brod

location_facility: Markusovszky Teaching Hospital Szombathely

location_facility: Institute for Pulmonary Diseases of Vojvodina


type: EudraCT Number

title: Avelumab Master Protocol: An Open-label Continuation Study for Participants Continuing From Pfizer-sponsored Avelumab Clinical Studies.

summary: This Master Protocol for Avelumab Continuation Sub-Studies is to provide continued treatment access, safety follow-up, and when applicable, overall survival follow-up for eligible participants who continue to derive a benefit from study intervention in the Pfizer-sponsored Avelumab parent studies.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Yes

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:
Denmark
Poland
Taiwan
Spain
Italy
Russian Federation
Australia
United Kingdom
Canada
Hungary
Korea, Republic of
United States
France
Belgium
Japan

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi

location_facility: Hospital of the University of Pennsylvania

location_facility: Kingston Health Sciences Centre-Kingston General Hospital Site

location_facility: Chang Gung Medical Foundation-Linkou Branch

location_facility: Ronald Reagan UCLA Medical Center - Drug Information Center, Pharmaceutical Services

location_facility: Seoul National University Bundang Hospital

location_facility: Memorial Sloan Kettering Cancer Center 53rd street.

location_facility: GBUZ SK Pyatigorsk Interdistrict Oncology dispensary

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: National Hospital Organization Kyushu Cancer Center

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

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: UCLA Hematology/Oncology - Administrative Office

location_facility: Institut de Cancérologie de Lorraine Alexis Vautrin

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase 2, Open-Label, Multicenter Study of the Combination of RMC-4630 and Sotorasib for Non-Small Cell Lung Cancer Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies

summary: The purpose of this study is to evaluate the antitumor effects of sotorasib and RMC-4630 in subjects with KRASG12C mutant NSCLC

ipd_sharing: No

lead_sponsor: Revolution Medicines, Inc.

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

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Charite Benjamin Franklin Comprehensive Cancer center

location_facility: Comprehensive Cancer Center Mainfranken, University Wuerzburg

location_facility: University of New Mexico Comprehensive Cancer Center

location_facility: Kaohsiung Medical University Chung Ho Memorial Hospital

location_facility: Hospital Larrey Universite Paul Sabatier

location_facility: Lung Cancer Center, University of Saarland

location_facility: American Oncology Partners of Maryland, PA

location_facility: CHRISTUS St. Michael-Colom and Carney Clinic P.A


title: A Phase 3 Randomized, Active-Controlled, Double-Masked Study to Evaluate the Safety and Efficacy of TRS01 Eye Drops in the Treatment of Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma

summary: The primary objective of this study is to evaluate the efficacy and safety of TRS01 eye drops compared to active comparator in subjects with active non-infectious anterior uveitis with or without uveitic glaucoma

design_allocation: Randomized

lead_sponsor: Tarsier Pharma

location_country:
Germany
United States
France

location_facility:
Lakewood
San Antonio 2
La Jolla
Winter Haven
Plano
Freiburg
San Antonio
Norfolk
Nashville
Palisades Park
Nantes
Los Angeles 2
Marietta
Tübingen
Düsseldorf
Los Angeles
Waltham
Washington, MO
Boston
Bonn
Aurora
Munster
Jacksonville
Austin
Winston-Salem


acronym: PIVOINE

title: Rollover Study; Multicentre, Phase III, Open-label Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ≥14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed Study PVO-1A-301 or PVO-1A-202/PVO-1A-204 and May Benefit From Palovarotene Therapy.

lead_sponsor: Ipsen

source: euctr

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, annotated 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 study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

location_country:
United Kingdom
Italy
Australia
Argentina
Canada
United States
France
Sweden

location_facility: The Perelman School of Medicine - The University of Pennsylvania

location_facility: University of California San Francisco (UCSF)

location_facility: Groupe Hospitalier Necker Enfants Malades

summary:
The main objective of this study is to further evaluate the safety and efficacy of palovarotene in adult and paediatric participants with FOP.

The aim of the study is also to ensure treatment continuity to participants who have completed one of the parent studies (Study PVO-1A-301, Study PVO-1A-202 and Study PVO-1A-204) and who, in the investigator's judgement, may benefit from palovarotene therapy.


type: Other Identifier

title: A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

summary:
This study will test a drug called enfortumab vedotin in participants with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC).

This study will also evaluate what the side effects are and if the drug works to treat NMIBC. A side effect is anything a drug does to your body besides treating your disease.

In this study enfortumab vedotin will be put into the bladder using a catheter. A catheter is a thin tube that can be put into your bladder.

lead_sponsor: Astellas Pharma Global Development, Inc.

location_country:
United States
Spain
Canada
France

location_facility: University of Texas Southwestern Medical Center

location_facility: University of California at San Francisco

location_facility: Laura & Isaac Perlmutter Cancer Center at NYU Langone Health


status: Terminated

title: Multi-center, Double-blind, Randomized, Placebo-controlled, Phase IIa Trial to Evaluate Spesolimab (BI 655130) Efficacy in Patients With Fibrostenotic Crohn's Disease

study_completion_date_type: Actual

lead_sponsor: Boehringer Ingelheim

ipd_sharing_description:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

enrollment_type: Actual

location_country:
Taiwan
Italy
Canada
United States
France
China
Mexico
Japan
Sweden

location_facility: NewYork-Presbyterian/Weill Cornell Medical Center

location_facility: The First Afiliated Hospital, Sun Yet-sen University

location_facility: Washington University School of Medicine

location_facility: Zhejiang University School of Medicine SIR RUN RUN SHAW Hospital

summary:
This study is open to adults, between 18 and 75 years of age, who have narrowings in the small bowel (strictures) due to Crohn's disease. Strictures can lead to bowel obstruction (blockage). People whose symptoms got worse because of strictures can join the study. Participants get standard treatment for Crohn's disease and the strictures. The purpose of the study is to test whether the strictures improve further when treated with a medicine called spesolimab added to standard treatment.

Participants are in the study for about 1 year and 4 months. In the first 3 months, participants get standard treatment only. After 3 months, participants whose condition improved are put into 2 groups randomly, which means by chance. One group gets spesolimab added to their standard treatment. The other group gets placebo added to their standard treatment. Both spesolimab and placebo are given as infusions into a vein. Placebo infusions look like spesolimab infusions but do not contain any medicine. For the first 2 months, participants get the infusions every month. Thereafter, participants get the infusions every 2 months.

During the study, participants have about 11 visits to the study site. The doctors regularly check participants' health and take note of any unwanted effects. At 3 of the visits, doctors take images of the bowel using Magnetic Resonance Imaging and with an endoscope. At these visits, the doctors also take a small sample of bowel tissue (biopsy). The participants note their symptoms of Crohn's disease and how the symptoms affect daily life in an electronic diary. At the end of the study, results from the diaries and bowel imaging are compared between the spesolimab group and the placebo group.

status_simplified: Unknown


title: A Phase 2 Open-Label, Multicenter Clinical Study of the Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Profiles of CGT9486 as a Single Agent in Patients With Advanced Systemic Mastocytosis

summary: This is an open-label, two-part Phase 2 study investigating CGT9486 for the treatment of patients with Advanced Systemic Mastocytosis (AdvSM), including patients with Aggressive SM (ASM), SM with Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL).

lead_sponsor: Cogent Biosciences, Inc.

location_country:
United Kingdom
United States
Spain
France

location_facility: University of Alabama at Birmingham (UAB) Hospital

location_facility: Centre Hospitalier Universitaire (CHU) de Toulouse

location_facility: Huntsman Cancer Institute - University of Utah Health

location_facility: Columbia University Irving Medical Center

location_facility: Guys' and St. Thomas' NHS Foundation Trust - Guys' Hospital

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: City of Hope Comprehensive Cancer Center


title: An Open-label, Phase 2 Basket Study of SEA-CD40 Combination Therapies in Advanced Malignancies

summary:
This trial is being done to see if an experimental drug (SEA-CD40) works when it's given with other cancer drugs to treat some types of cancer. It will also study side effects from the drug.

There are 2 parts in this trial. In one part, participants have melanoma that has come back after treatment or can't be removed by surgery. Participants in this part will get SEA-CD40 and pembrolizumab. In the other part, participants have non-small cell lung cancer (NSCLC) that has spread through their body. These participants will get SEA-CD40, pembrolizumab, carboplatin, and pemetrexed.

lead_sponsor: Seagen Inc.

location_country:
Spain
Canada
Sweden
United States
France
Germany

location_facility: The Angeles Clinic and Research Institute

location_facility: START Madrid-CIOCC_Hospital HM Sanchinarro

location_facility: Tennessee Oncology-Nashville/Sarah Cannon Research Institute

location_facility: MD Anderson Cancer Center / University of Texas

location_facility: Florida Cancer Specialists - South Region

location_facility: University of Texas Southwestern/Simmons Cancer Center

location_facility: Florida Cancer Specialists - North Region

location_facility: Cleveland Clinic - Taussig Cancer Institute

location_facility: Morristown Medical Center/ Carol G. Simon Cancer Center

location_facility: California Pacific Medical Center Research Institute/Sutter Medical Centre

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Carbone Cancer Center / University of Wisconsin


title: A Randomised Double-Blind Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis

acronym: CONCLUDE

summary: The purpose of the study is to evaluate the efficacy of cobitolimod treatment compared to placebo in inducing clinical remission, in participants with moderate to severe active left-sided UC and to evaluate the efficacy of cobitolimod maintenance treatment compared to placebo in inducing or maintaining clinical remission at week 52, in participants with clinical response at week 6 after induction treatment with cobitolimod.

lead_sponsor: InDex Pharmaceuticals

location_country:
Croatia
Serbia
United Kingdom
Italy
Korea, Democratic People's Republic of
Lithuania
United States
Romania
Belgium
Poland
Portugal
Austria
Australia
Israel
Turkey
Norway
Sweden
Slovakia
Bosnia and Herzegovina
Hungary
Germany
Denmark
Georgia
France
Netherlands

location_facility: Vilniaus Universiteto ligonines Santariskiu Klinikos

location_facility: Kyung Hee University Hospital - Internal Medicine

location_facility: Policlinico Universitario Agostino Gemelli


title: A Randomized, Double-Blind, Placebo-Controlled Study in Cat-Allergic Patients With Allergic Rhinitis Who Live With a Cat to Assess the Efficacy and Safety of Anti-Fel d 1 Antibodies During Natural Cat Exposure in the Home

lead_sponsor: Regeneron Pharmaceuticals

ipd_sharing_description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

location_country:
Poland
Canada
United States
France
Belgium
Germany

location_facility: Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.

location_facility: Asthma and Allergy Center of Chicago Sc-Oak Park

location_facility: Nebraska Medical Research Institute, Inc. - CRN - PPDS

location_facility: SUNY Downstate Health Science University

location_facility: Allergy and Asthma Associates of Southern California - CRN - PPDS

location_facility: Allergy and Clinical Immunology Associates

location_facility: Aventiv Research Inc - Columbus - HyperCore - PPDS

location_facility: Asthma and Allergy Associates PC - CRN - PPDS

location_facility: Peninsula Research Associates - CRN - PPDS

location_facility: Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna

location_facility: Seattle Allergy & Asthma Research Institute

location_facility: LMC Manna Research - Quebec - HyperCore - PPDS

location_facility: Colorado Allergy and Asthma Centers PC - CRN - PPDS

location_facility: Respiratory Medicine Research Institute of Michigan PLC

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

location_facility: Allergy and Asthma Medical Group and Research Center - CRN - PPDS

location_facility: Clinical Research Institute, Inc - CRN - PPDS

location_facility: Allergy Asthma and Clinical Research Center

location_facility: Clinique Spécialisée en Allergie de la Capitale

location_facility: Asthma, Nasal Disease and Allergy Research Center of New England

location_facility: Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej Centralny Szpital Weteranow

location_facility: Velocity Clinical Research, Inc. (Meridan)

location_facility: SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

location_facility: Allergy Partners of Western North Carolina

location_facility: Asthma & Allergy Physicians of Rhode Island Clinical Research Institute (AAPRI CRI)

location_facility: Private Practice Dr Jean Benoit Martinot

location_facility: Joel Liem Medicine Professional Corporation

location_facility: AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

location_facility: Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z.o.o

location_facility: ALL-MED - Specjalistyczna Opieka Medyczna - Medyczny Instytut Badawczy

location_facility: Centre d'investigation Clinique Mauricie

location_facility: Riverside Medical Group - Circuit - PPDS

location_facility: Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z.o.o

location_facility: Princeton Center For Clinical Research - CRN - PPDS

summary:
The primary objective of the study is to determine the efficacy of REGN1908-1909, as compared to placebo, to reduce allergic rhinitis/conjunctivitis symptoms and allergy rescue medication use during natural cat exposure.

The Secondary Objectives are:

To assess the reduction of allergic symptoms and use of allergy rescue medications after treatment with REGN1908-1909 versus placebo, as measured by the individual components of the CSMS
To assess health-related quality of life (HRQoL) as measured by the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ[S])
To determine the efficacy of REGN1908-1909, as compared to placebo, to inhibit a wheal-and-flare response to a skin prick test with cat allergen
To assess the durability of effect in allergic rhinitis and conjunctivitis symptom and medication scores after multiple doses of REGN1908-1909 compared to placebo given every 12 weeks (Q12W)
To determine the efficacy following multiple doses of REGN1908-1909 compared to placebo at inhibiting a wheal-and-flare response to a skin prick test with cat allergen
To estimate the effect of REGN1908-1909 on lung function, as compared to placebo, in patients with asthma
To determine the efficacy of REGN1908-1909 as compared to placebo to reduce asthma symptoms in patients with asthma
To assess whether there is a difference in asthma rescue medication use in patients with asthma who are treated with REGN1908-1909 compared to placebo
To assess whether there is a difference in nighttime awakenings in patients with asthma treated with REGN1908-1909 compared to placebo
To evaluate the short-term and long-term safety and tolerability of REGN1908-1909, including the incidence of hypersensitivity reactions, local injection site reactions, and asthma exacerbations
To determine systemic exposure of total (free and antigen-bound) antibodies as measured by concentration of REGN1908 and REGN1909
To assess the immunogenicity of REGN1908 and REGN1909


title: SELECT-LIFE (SELECT Follow-up Study to Evaluate Long-term Impact oF Anti-obEsity Medication)

acronym: SELECT-LIFE

summary:
Participants are being asked to participate in SELECT-LIFE study because participants take part in the SELECT trial.

SELECT-LIFE study is a survey-based study that will start when the SELECT trial ends.

SELECT-LIFE looks at the long-term effects of participants taking part in the SELECT trial including the trial medicine participants have been taking.

When the SELECT trial ends, participants will no longer get the medicine participants got in the study, even if participants decide to take part in the SELECT-LIFE study.

Participants will not get any specific treatment or medicine as part of the SELECT-LIFE study, and participants will be treated as participants normally would by their own doctor.

The SELECT-LIFE study will last for up to 10 years after SELECT trial ends, and participants will be asked to fill in a questionnaire about their health every 6 months.

status: Enrolling by invitation

study_type: Observational

time_perspective: Prospective

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

lead_sponsor: Novo Nordisk A/S

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
South Africa
Portugal
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Norway
Malaysia
Sweden
Brazil
Canada
Hungary
Germany
Bulgaria
Denmark
Taiwan
Greece
Ireland
Latvia
Finland
Thailand
Algeria
France
Colombia
Netherlands

intervention_type: Other


title: A Phase 2/3, Randomized, Open-label Study to Compare Bempegaldesleukin (NKTR-214) Combined With Pembrolizumab vs. Pembrolizumab Alone in First-Line Treatment of Patients With Metastatic or Recurrent HNSCC With PD-L1 Expressing Tumors

summary: This is a multicenter, randomized, open-label, Phase 2/3 study that will evaluate the efficacy and safety of bempegaldesleukin (BEMPEG; NKTR-214) combined with pembrolizumab compared with pembrolizumab monotherapy in patients with recurrent or metastatic HNSCC with positive PD-L1 expression (CPS ≥ 1).

lead_sponsor: Nektar Therapeutics

location_country:
Greece
Austria
Australia
Italy
United States
France
Israel
Singapore
Netherlands

location_facility: Hygeia Diagnostic and Therapeutic Centre of Athens

location_facility: Universitair Medisch Centrum Utrecht Cancer Center - PPDS


title: A Phase 2b/3 Prospective, Randomized, Double-Blind, Sham-Controlled 3-Part Trial of VTS-270 (2-hydroxypropyl-β-cyclodextrin) in Subjects With Neurologic Manifestations of Niemann-Pick Type C1 (NPC1) Disease

summary:
Due to different study designs, the sponsor separated Part C into this separate registration (NCT04958642), leaving Parts A/B in NCT02534844. The trial's final results for the primary outcome measure of Adverse Events (AE) will be reported here.

The primary and study completion dates are based on the anticipated last date safety data will be collected from Part C participants.

This study is to evaluate how safe and effective adrabetadex is for participants with Niemann-Pick Type C1 (NPC1) disease who experience neurologic symptoms (listed under Keywords).

In Parts A/B (NCT02534844), two out of every three participants will receive the study drug. The third participant will receive 1 to 2 small needle pricks at the location where the IT injection is normally made (sham control).

In Part C, all participants will receive study drug.

lead_sponsor: Mandos LLC

location_country:
United Kingdom
New Zealand
Australia
Switzerland
United States
France
Singapore
Turkey
Germany

location_facility: Multicare Institute for Research and Innovation

location_facility: Dell Children's Medical Center of Central Texas

location_facility: National University Hospital (Singapore) Pte, Ltd

location_facility: Children's Hospital of Orange County: CHOC Children's

location_facility: Birmingham Children's Hospital NHS Foundation Trust

location_facility: CHU Paris Est - Hopital d'Enfants Armand-Trousseau

location_facility: Eunice Kennedy Shriver National Institute of Child Health and Human Development


title: An International, Non-Drug Interventional, Real-world Cohort of PAH Patients Newly Initiating PAH Therapy With Guideline-directed Assessments of Disease Severity

acronym: CARE PAH

summary: This study is designed to describe pulmonary arterial hypertension (PAH) participants in terms of their clinical characteristics, therapies used, disease progression, and outcomes (example, death, hospitalization, risk category for predicted mortality risk, and patient-reported outcomes [PROs]) in real-world clinical practice. This study will collect high-quality real-world data that may be used as a stand-alone dataset or in combination with other studies to address relevant research questions (example, serve as an external control dataset to another study) to support development and access to PAH therapies, as well as to contribute to the knowledge base of PAH through publications.

primary_purpose: Other

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and 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:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Poland
Austria
Australia
Argentina
Puerto Rico
Turkey
Mexico
Malaysia
Singapore
Sweden
Brazil
Canada
China
Germany
Korea, Republic of
France
Colombia
Netherlands

location_facility: Instituto Nacional de Cardiologia Dr. Ignacio Chavez

location_facility: Washington University School of Medicine

location_facility: Instituto Modelo De Cardiología Privado Srl

location_facility: LSUHSC Shreveport Feist-Weiller Cancer Center

location_facility: National Waiting Times Centre Board Golden Jubilee National Hospital

location_facility: The Second Xiangya Hospital of Central South Hospital

location_facility: University of Cinncinnati Physicans- UC Health Physicnas Office

location_facility: Universita degli Studi di Roma 'La Sapienza' - Umberto I Policlinico di Roma

location_facility: National Cerebral and Cardiovascular Center Hospital

location_facility: Istanbul Universitesi Istanbul Tip Fakültesi

location_facility: Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ

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

location_facility: Hospital das Clínicas - Universidade Federal de Minas Gerais

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

location_facility: Unidad de Investigacion Clinica en Medicina S.C. (UDICEM)

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

location_facility: Hospital Das Clinicas Da Faculdade De Medicina Da USP

location_facility: Universitätsklinikum Hamburg-Eppendorf - Pneumologie

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Krakowski Szpital Specjalistyczny im Jana Pawla II

location_facility: Universitatsklinikum Carl Gustav Carcus Dresden

location_facility: University Of Iowa - Hospitals & Clinics

location_facility: IRCCS Policlinico San Matteo, Università degli studi di Pavi

location_facility: London Health Sciences Centre - Victoria Hospital

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Renji Hospital Shanghai Jiao Tong University School of Medicine(Eastern)

location_facility: Royal Brompton and Harefield NHS Foundation Trust

location_facility: Universidade Estadual Paulista 'Julio De Mesquita Filho'


title: Natural History of the Progression of X-Linked Retinitis Pigmentosa

acronym: XOLARIS

summary: The objective of the study is to gain a better understanding of disease progression over time in participants with X-linked retinitis pigmentosa (XLRP).

status: Active, not recruiting

lead_sponsor: NightstaRx Ltd, a Biogen Company

location_country:
United Kingdom
Netherlands
Finland
Canada
United States
France
Germany


title: A Phase 3 Randomized, Multi-center, Open Label Study to Assess the Efficacy, Safety, and Tolerability of Monoclonal Antibody VIR-7831 (Sotrovimab) Given Intramuscularly Versus Intravenously for the Treatment of Mild/Moderate Coronavirus Disease 2019 (COVID-19) in High-risk Non-hospitalized Patients; Safety Substudy Assessing the Safety and Tolerability of Single Ascending Dose Monoclonal Antibody VIR-7831

summary: A Phase 3 randomized, multi-center, open label study to assess the efficacy, safety, and tolerability of monoclonal antibody VIR-7831 (sotrovimab) given intramuscularly versus intravenously for the treatment of mild/moderate coronavirus disease 2019 (COVID-19) in high-risk non-hospitalized patients; Safety Substudy assessing the safety and tolerability of single ascending dose monoclonal antibody VIR-7831

ReferenceType: derived

ReferenceCitation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9:CD013825. doi: 10.1002/14651858.CD013825.pub2. Review.

lead_sponsor: Vir Biotechnology, Inc.

location_country:
United States
Ukraine
France

location_facility:
Investigative Site
Investigative Sites

intervention_type: Biological


title: A Phase I/Ib, Open-label, Multi-center Study of DFF332 as a Single Agent and in Combination With Everolimus or IO Agents in Patients With Advanced/Relapsed ccRCC and Other Malignancies With HIF2α Stabilizing Mutations

summary: This is first in human study of DFF332, a small molecule that targets a protein called HIF2α. By acting on HIF2α, DFF332 may be able to stop the growth of certain types of cancer. DFF332 will be tested at different doses as single agent and in combination with Everolimus (RAD001, an mTOR inhibitor), and also in combination with Spartalizumab (PDR001, an anti-PD1) plus Taminadenant (NIR178, an adenosine A2A receptor antagonist), in patients with advanced clear cell renal cell carcinoma and other malignancies with HIF stabilizing mutations.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
United States
France
Japan
Singapore
Czechia

location_facility: University of Texas MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(8)

location_facility: Washington University School of Medicine Main Center


status: Completed

title: Phase 3 Study Investigating the Efficacy and Safety of TAVT-45 (Abiraterone Acetate) Granules for Oral Suspension (Novel Abiraterone Acetate Formulation) Relative to a Reference Abiraterone Acetate Formulation in Patients With mCSPC & mCRPC

lead_sponsor: Tavanta Therapeutics

ipd_sharing_description:
According to the Informed Consent Form:

The health information that may be used and disclosed includes:

All information collected during the research described in the Informed Consent Form for the study; and
Health information in my medical records that is relevant to the study.

The Providers may disclose health information in my medical records to:

Researchers;
The Sponsor of the study and its agents and contractors; and
Representatives of government agencies, Advarra IRB, and other persons who watch over the safety, effectiveness, and conduct of research.

The Researchers may:

Use and share patient health information among themselves, with the Sponsor, and with other participating researchers and laboratories to conduct the study; and
Disclose health information to representatives of government agencies, review boards

location_country:
Poland
Spain
United Kingdom
Hungary
Puerto Rico
United States
France
Sweden

summary: The purpose of this study is to investigate the safety and efficacy of a new formulation of an existing drug product called TAVT-45 in patients with metastatic prostate cancer.

status_simplified: Completed


title: A Phase 1, Multicenter, Open-Label, Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered FHD-286 in Subjects With Metastatic Uveal Melanoma

summary: This Phase 1, multicenter, open-label, dose escalation and expansion study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of FHD-286 oral monotherapy in subjects with metastatic Uveal Melanoma (UM).

lead_sponsor: Foghorn Therapeutics Inc.

location_country:
Netherlands
United States
France

location_facility: Columbia University, Herbert Irving Comprehensive Cancer Center

location_facility: The Angeles Clinic and Research Institute

location_facility: Sidney Kimmel Cancer Center - Jefferson Health

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


title: Study of Four-factor Prothrombin Complex Concentrate, OCTAPLEX, in Patients With Acute Major Bleeding on Direct Oral Anticoagulant (DOAC) Therapy With Factor Xa Inhibitor

summary: This is a multicentre, prospective, randomised, double-blinded, group-sequential, parallel-group, adaptive design, phase 3 study to demonstrate the haemostatic efficacy and safety of four-factor prothrombin complex concentrate, OCTAPLEX, in patients with acute major bleeding on DOAC therapy with factor Xa inhibitor. Patients will be randomised 1:1 to either of two study groups: low-dose vs. high-dose OCTAPLEX.

lead_sponsor: Octapharma

location_country:
Spain
Italy
United States
France
Germany

location_facility: Ospedale Maggiore - IRCCS Istituto di Scienze Neurologiche di Bologna

location_facility: Universitaetsklinikum Frankfurt - Klinik fuer Anaesthesiologie, Intensivmedizin und Schmerztherapie

location_facility: Centre Hospitalier Universitaire Francois Mitterand

location_facility: University of Mississippi Medical Center

location_facility: OU Health - University of Oklahoma Medical Center

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Universitaetsklinikum Aachen, Klinik fuer Anaesthesiologie


title: An Open-label, Multi-center, Phase I Study of Oral IAG933 in Adult Patients With Advanced Mesothelioma and Other Solid Tumors

summary: The purpose of this study is to characterize the safety and tolerability of IAG933 in patients with mesothelioma, NF2/LATS1/LATS2 mutated tumors and tumors with functional YAP/TAZ fusions and to identify the maximum tolerated dose and/or recommended dose.

location_country:
Spain
Italy
United Kingdom
Australia
Canada
Switzerland
United States
France
Japan
Germany

location_facility: Massachusetts General Hospital Massachusetts General Hospital

location_facility: MD Anderson Cancer Center/University of Texas


acronym: ATLAS

title: A Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation

lead_sponsor: Biogen

ReferenceCitation: Benatar M, Wuu J, Andersen PM, Bucelli RC, Andrews JA, Otto M, Farahany NA, Harrington EA, Chen W, Mitchell AA, Ferguson T, Chew S, Gedney L, Oakley S, Heo J, Chary S, Fanning L, Graham D, Sun P, Liu Y, Wong J, Fradette S. Design of a Randomized, Placebo-Controlled, Phase 3 Trial of Tofersen Initiated in Clinically Presymptomatic SOD1 Variant Carriers: the ATLAS Study. Neurotherapeutics. 2022 Jul;19(4):1248-1258. doi: 10.1007/s13311-022-01237-4. Epub 2022 May 18. Erratum In: Neurotherapeutics. 2022 Sep 29;:

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

location_country:
Poland
Brazil
Spain
Italy
United Kingdom
Australia
Canada
Sweden
Korea, Republic of
United States
France
Belgium
Japan
Germany

location_facility: Washington University School of Medicine

location_facility: Cresla "Rita Levi Montalcini" Department of Neuroscience

location_facility: Holy Cross Hospital Phil Smith Neuroscience Institute

summary: The primary objective of this study is to evaluate the efficacy of BIIB067 when initiated in presymptomatic adult carriers of a superoxide dismutase 1 (SOD1) mutation with elevated neurofilament (NF). The secondary objectives of this study are to evaluate the safety and tolerability of BIIB067 and to evaluate the effect of BIIB067 on pharmacodynamics (PD)/treatment response biomarkers when initiated prior to versus at the time of emergence of clinically manifest amyotrophic lateral sclerosis (ALS).


acronym: START

title: Evaluation of the Risk of Atrophic Acne Scar Formation During Treatment of Acne Vulgaris Subjects With Trifarotene 50 μg/g Cream Versus Vehicle Cream Over 24 Weeks

lead_sponsor: Galderma R&D

location_country:
United States
Canada
France

location_facility:
Galderma Investigational Site #8367
Galderma Investigational Site #6167
Galderma Investigational Site #8873
Galderma Investigational Site #8838
Galderma Investigational Site #9928
Galderma Investigational Site #8189
Galderma Investigational Site #9918
Galderma Investigational Site #8447
Galderma Investigational Site #8608
Galderma Investigational Site #9936
Galderma Investigational Site #8886
Galderma Investigational Site #9927
Galderma Investigational Site #8881
Galderma Investigational Site #8295
Galderma Investigational Site #8108
Galderma Investigational Site #9920
Galderma Investigational Site #8601
Galderma Investigational Site #8883

summary: The purpose of this study is to evaluate the safety and efficacy of trifarotene 50 microgram per gram (mcg/g) cream compared to its vehicle on the risk of formation of atrophic acne scars after 24 weeks of treatment in facial acne participants assessed by atrophic acne scars count.


title: REVEAL-CKD: A Retrospective, Multinational Observational Study to Determine the Prevalence and Consequences of Undiagnosed Chronic Kidney Disease

acronym: REVEAL-CKD

summary: This is a retrospective, multinational, non-interventional, observational study. A series of cohort studies will be conducted to assess the prevalence of undiagnosed stage 3 CKD in each region. The study will also assess the current state of CKD management in patients with undiagnosed CKD

time_perspective: Retrospective

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:
Brazil
Spain
Italy
United Kingdom
Australia
Canada
United States
France
Japan
Germany


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

acronym: ADAPT

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

lead_sponsor: Keya Medical

location_country:
Poland
Italy
Austria
United States
France

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


title: A Phase 2, Multi-Arm Study of Magrolimab in Patients With Solid Tumors

summary:
The primary objectives of the study are to evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of magrolimab + docetaxel combination therapy in solid tumors (Safety Run-in Cohort 1, Phase 2 Cohorts 1a,

1b, and 1c) and to evaluate the efficacy of magrolimab + docetaxel combination therapy in solid tumors as determined by investigator-assessed objective response rate (ORR) (Phase 2 Cohorts 1a, 1b, and 1c)

lead_sponsor: Gilead Sciences

location_country:
Poland
United States
Spain
France

location_facility: Saint Alphonsus Cancer Institute Caldwell

location_facility: Virginia Piper Cancer Center (Alliant Health)

location_facility: Hospital Regional Universitario de Malaga

location_facility: Tallahassee Memorial Healthcare Cancer Center

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy

location_facility: Medical Oncology Associates,PS (dba Summit Cancer Center) (includes IP Shipment)

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Comprehensive Cancer Centers of Nevada- Twain Office

location_facility: Wojewodzki Szpital Specjalistyczny w Siedlcach

location_facility: Huntsman Cancer Institute, University of Utah

location_facility: St. Jude Hospital Yorba dba St. Joseph Heritage Healthcare


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

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

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

location_country:
Spain
United Kingdom
Australia
United States
France
Germany
Czechia

location_facility: Klinik für Pneumologie, Klinisches Studienzentrum Medizinische Hochschule

location_facility: Washington University School of Medicine

location_facility: Lundquist Institute for Biomedical Innovation at Harbor UCLA

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

location_facility: University of California, Davis Medical Center

location_facility: The Ohio State University Wexner Medical Center

location_facility: New York Presbyterian Hospital - Weill Cornell Medicine

location_facility: Royal Papworth Hospital NHS Foundation Trust

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

location_facility: Hospital Universitario Marqués de Valdecilla

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

intervention_type: Device


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

acronym: DEBATE

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

lead_sponsor: North Karelia Central Hospital

location_country:
Germany
Finland
United Kingdom
France

location_facility: University Hospital of Carl Gustav Carus

location_facility: Norfolk and Norwich University Hospital Nhs Foundation Trust

lead_sponsor_type: academique


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

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

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Poland
United Kingdom
Italy
United States
France
Belgium
Germany

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

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: Great Ormond Street Hospital for Children NHS Trust

location_facility: Central Manchester University Hospitals Nhs Foundation Trust

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

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa

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

location_facility: Université Catholique De Louvain And Cliniques St Luc

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

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


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

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

lead_sponsor: Hanmi Pharmaceutical Company Limited

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

location_facility: University of Illniois Hospital & Health Sciences System

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

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


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

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

lead_sponsor: Kyowa Kirin, Inc.

location_country:
United Kingdom
Italy
Spain
United States
France

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

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: University of Pittsburgh School of Medicine

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Hospital Universitario Fundacion Jimenez Diaz

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


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

acronym: AXLerate-OC

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

lead_sponsor: Aravive, Inc.

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

location_facility: First Affiliated Hospital of Soochow University

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

location_facility: The University of Chicago Medical Center

location_facility: Abington Memorial Hospital, Hanjani Institute for Gyn Onc

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC

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

location_facility: Chattanooga's Program in Women's Oncology

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

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

location_facility: Royal United Hospital Bath NHS Foundation Trust

location_facility: University of South Alabama Mitchell Cancer Institute

location_facility: UC Irvine Health-Chao Family Comprehensive Cancer Center

location_facility: The Royal Marsden NHS Foundation Trust (Sutton)

location_facility: Southeastern Regional Medical Center, LLC

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

location_facility: Providence Cancer Institute Franz Clinic

location_facility: Fondazione Policlinico "Agostino Gemelli" IRCCS

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

location_facility: Hospital Universitario Reina Sofia (Provincial)

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

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

location_facility: Metro Minnesota Community Oncology Research Consortium

location_facility: St Vincent Hospital and Healthcare Center

location_facility: The Second Hospital of Shanxi Medical University

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

location_facility: Georgia Cancer Center at Augusta University

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

location_facility: Pro Healthcare Waukesha Memorial Hospital

location_facility: Stephenson Cancer Center - University of Oklahoma

location_facility: University of Wisconsin Clinical Science Center

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

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

location_facility: Women & Infants Hospital of Rhode Island

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

location_facility: Fudan University Shanghai Cancer Hospital

location_facility: UCLA Women's Health Clinical Research Unit

location_facility: Maria Sklodowska - Curie Instytute Oncolgy Center

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

location_facility: University of Pennsylvania Health System

location_facility: Mercy Hospital, David C Pratt Cancer Center

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

location_facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii

location_facility: LTD Consilium Medulla - Multiprofile Clinic

location_facility: Clinical Research Unit, Jewish General Hospital

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

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

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

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


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

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

lead_sponsor: Verici Dx

location_facility: University Hospital Vall d'Hebron, Barcelona


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

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

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

lead_sponsor: Amgen

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

location_facility: Henry Ford Hospital, Henry Ford Health Systems

location_facility: University of Texas MD Anderson Cancer Center

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

location_facility: University Hospitals Cleveland Medical Center

location_facility: National Hospital Organization Shikoku Cancer Center


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

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

lead_sponsor: Medtronic

location_country:
Slovenia
Spain
United Kingdom
Switzerland
France
Belgium
Netherlands
Czechia

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


title: A Multicenter Open-label Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine (GEP-NET) Tumors, Pheochromocytoma and Paragangliomas (PPGL)

summary: This is a multicenter, open-label, single-arm study to evaluate the safety and dosimetry of Lutathera in adolescent patients 12 to <18 years old with somatostatin receptor positive GEP-NETs and PPGLs. The study will enroll at least 8 patients in the GEP-NET cohort and as many adolescents with PPGL as possible in the exploratory PPGL cohort.

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

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

lead_sponsor: Advanced Accelerator Applications

location_country:
Poland
Portugal
Spain
Italy
United Kingdom
Canada
Sweden
United States
France
Belgium
Netherlands

location_facility: University of Iowa Carver College of Medicine

location_facility: Maria Sklodowska-Curie National Research Institute of Oncology


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

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

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

location_facility: Hospital Clinic i Provincial de Barcelona

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

location_facility: Winship Cancer Institute of Emory University


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.

ipd_sharing_description: All IPD

lead_sponsor: Universidad El Bosque, Bogotá

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

location_facility: Fundación Universitaria de Colegios de Colombia

location_facility: ACFF Colombian Chapter Manizales Demonstration Territory

intervention_type: Procedure


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

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

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

lead_sponsor: Seagen Inc.

location_country:
Spain
Italy
United Kingdom
Canada
United States
France

location_facility: The Angeles Clinic and Research Institute

location_facility: Shands Cancer Center / University of Florida

location_facility: Case Western Reserve University / University Hospitals Cleveland Medical Center

location_facility: University of Ottawa / Ottawa General Hospital

location_facility: University Health Network, Princess Margaret Hospital

location_facility: University of California at San Francisco

location_facility: South Texas Accelerated Research Therapeutics Midwest


title: An Open-label, Multi-center, Phase IV, Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study

summary: This is a multi-center multi-national rollover study to allow continued access to crizanlizumab for patients with sickle cell disease (SCD) who are on crizanlizumab treatment in a Novartis-sponsored study (parent study) and are benefiting from the treatment as judged by the investigator.

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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Brazil
Belgium
Spain
Italy
Oman
Lebanon
France
United States
Turkey
Colombia
Germany


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

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

primary_purpose: Basic Science

lead_sponsor: Eli Lilly and Company

location_country:
Spain
United Kingdom
United States
France
Belgium
Germany

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Washington University School of Medicine


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

acronym: Eustigma

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

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

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

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

time_perspective: Cross-Sectional

lead_sponsor: Semmelweis University

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

location_facility: Psychiatrische Klinik Clienia Littenheid

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

location_facility: Clinical Centre of Montenegro, Clinic for Psychiatry

location_facility: Military Medical Academy, Department of Psychiatry

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

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

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

location_facility: Klinikum rechts der Isar der Technischen Universität München

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

location_facility: 3rd Faculty of Medicine, Charles University

location_facility: Department of Liasion Psychiatry, Mater University Hospital

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

location_facility: Vilnius University, Facutly of Medicine, Psychiatric Clinic

location_facility: Chernivtsi Regional Mental Hospital, Bukovinian State Medical University


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

lead_sponsor: bluebird bio

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

location_country:
United States
France

location_facility: UCSF Benioff Children's Hospital Oakland

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

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.


type: Registry Identifier

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

acronym: FaR-RMS

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

lead_sponsor: University of Birmingham

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

location_facility: Great Ormond Street Hospital for Children

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne

location_facility: Hospital Universitario Miguel Servet Materno - infantil

location_facility: Hospital Regional Universitario De Malaga

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

location_facility: Bratislava, National Institute for Children's Diseases

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

location_facility: University Hospital of North Norway - Paediatric

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

location_facility: Ahepa University General Hospital of Thessaloniki

location_facility: Prinses Maxima Centrum Voor Kinderoncologie

location_facility: Haukeland University Hospital - Paediatric

location_facility: Hellenic Society of Pediatric Hematology- Oncology

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

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

location_facility: Royal Belfast Hospital for Sick Children

location_facility: Universitats-kinderspital Bieder Basel (UKBB)

location_facility: Children's General Hospital P and A Kyriakou

location_facility: Hopital Universitaire Des Enfants Reine Fabiola

location_facility: Oslo University Hospital - Radiumhospitalet

location_facility: Luzerner Kantonspital - Kinderspital Luzern

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

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

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

location_facility: Royal Hospital for Children and Young People

location_facility: Ippokratio General Hospital of Thessaloniki

intervention_type: Radiation


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

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

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

lead_sponsor: AstraZeneca

location_country:
Japan
United States
France
Belgium


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.

status: Unknown status

lead_sponsor: University of British Columbia

location_country:
Spain
Canada
United States
France
Belgium
Japan

location_facility: Centre Hospitalier Universitaire d'Angers


title: A Multicenter, Multinational Extension of Study PRV-031-001 to Evaluate the Long-Term Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adolescents With Recent-Onset Type 1 Diabetes Mellitus

summary: The purpose of this non-interventional extension study is to continue to collect long-term safety and other clinical data for an additional 42 months in participants who completed the PROTECT study.

lead_sponsor: Provention Bio, Inc.

location_country:
Poland
United Kingdom
Canada
France
United States
Belgium
Germany
Czechia

location_facility: University of Florida Health (UF Health) 1600 SW Archer Road, PO Box 100278 (Site 840015)

location_facility: University Hospital Carl Gustav Carus Fetscherstrasse 74 (Site 276601)

location_facility: Children's Memorial Health Institute Al. Dzieci Polskich 20 (Site 616801)

location_facility: University Teaching Centre, Department of Pediatrics, Diabetology and Endocrinology (Site 616803)

location_facility: Evangelic Clinic Bethel, Children's Clinic Grenzweg 14/Hs 2 (Site 276602)

location_facility: Pediatric Hospital on the Bult Janusz-Korczak-Allee 12 (Site 276604)

location_facility: UCL Namur University Hospital Place Louise Godin 15 (Site 056205)

location_facility: Columbus Regional Research Institute 2425 Brookstone Parkway (Site 840006)

location_facility: Institute of Diabetology ul. Raclawicka 129/2U, 02-117 (Site 616802)

location_facility: Lenval Hospital, 57 Avenue de la Californie (Site 250508)

location_facility: MultiCare Health System, Gateway Medical Building (Site 840003)

location_facility: Washington University School of Medicine One Children's Place, Suite 11W19 (Site 840018)

location_facility: University Teaching Centre of the Medical University of Warsaw, 63A, ul. Zwirki i Wigur (Site 616804)

location_facility: University of Iowa Hospitals and Clinics 200 Hawkins Drive (Site 840023)

location_facility: UBMD Pediatrics 1001 Main Street, 4th Floor (Site 840010)

location_facility: AM Diabetes & Endocrinology Center 3025 Kate Bond Rd. (Site 840008)

location_facility: University Hospital Brussels (Site 056202)

location_facility: Rady Children's Hospital 3020 Children's Way (Site 840004)

location_facility: Diablo Clinical Research2255 Ygnacio Valley Road, Ste. M (Site 840002)

location_facility: Endocrinology Service Northwest, LLC 929 SW Simpson Ave. Suite 220 (Site 840034)

location_facility: Hospital Augsburg, Stenglinstrasse 2 (Site 276606)

location_facility: Rocky Mountain Clinical Research, LLC 3910 Washington Parkway, Suite E (Site 840007)

location_facility: Children's Hospital of Philadelphia, Division of Endocrinology 3500 Civic Center Blvd., Buerger Center 12th Floor (Site 840021)

location_facility: Alberta Diabetes Institute, 2-004 Li Ka Shing Centre for Health Research Innovation 8602 (Site 124103)

location_facility: Virginia Mason Medical Center, Benaroya Research Institute 1201 9th Ave, MS: D4-CRP (Site 840016)

location_facility: Atlanta Diabetes Associates 1800 Howell Mill Road. Suite 450 (Site 840009)

location_facility: Sheffield Children's Hospital Western Bank, S10 2TH (Site 826903)

location_facility: Vanderbilt University Medical Center 1500 21st Avenue, Suite 1514, Village At Vanderbilt (Site 840024)

location_facility: University Hospital Heidelberg, Im Neuenheimer Feld 430 (Site 276608)

location_facility: Barbara Davis Center for Diabetes - Pediatrics 1775 Aurora Court (Site 840005)

location_facility: UT Southwestern Children's Medical Center of Dallas 1935 Medical District Drive (Site 840033)

location_facility: UCSF Medical Center Gateway Medical Building, 1825 Fourth Street (Site 840001)

location_facility: Capital Medical Research Associates (Site 840029)

location_facility: University Hospital Motol V Uvalu 84, Praha 5 - Motol (Site 203301)


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

location_facility: University of Utah Hospitals and Clinics

location_facility: Universitätsklinikum Jena Klinik fuer Innere Medizin IV

location_facility: Toronto Digestive Disease Associates Specialty Research

location_facility: Medical center limited liability Harmoniya Krasy

location_facility: CHU Saint-Etienne - Hospital Nord Gastroenteroloy

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

location_facility: Semmelweis Egyetem Altalanos Orvostudomanyi Kar

location_facility: London Health Sciences Centre - Victoria Hospital

location_facility: Javorszky Odon Korhaz, Gasztroenterologiai Osztaly

location_facility: Medical Center Ok!Clinic+ International Institute

location_facility: Centrum Medyczne LUKAMED Joanna Luka-Wendrowska

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

location_facility: Indywidualna Praktyka Lekarska Maciej Zymła

location_facility: CI of Kyiv RC Regional Clinical Hospital No 2

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

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

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


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

acronym: MOVE-FA

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

lead_sponsor: PTC Therapeutics

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

location_facility: CBR Neurogenetic Research Clinic, University of Auckland

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: 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)


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

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


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

acronym: ADAPT-PD

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

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

lead_sponsor: MedtronicNeuro

location_country:
Netherlands
United States
Canada
France

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


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

acronym: PIVOT IO 011

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

lead_sponsor: Bristol-Myers Squibb

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

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


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

acronym: inspIRE

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

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

lead_sponsor: Biosense Webster, Inc.

location_country: Croatia Italy Austria Canada Lithuania France Belgium Czechia

location_facility: Ziekenhuis Oost-Limburg Genk Campus Sint-Jan

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux


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.

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: MedImmune LLC

location_country:
Australia
United States
Spain
France


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

location_facility: Oregon Health & Science University (OHSU)

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

location_facility: Rigshospitalet, Klinik for nerve- og muskelsygdomme

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

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


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

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

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

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

lead_sponsor: Incyte Corporation

location_country:
Poland
Spain
Canada
United States
France
Germany

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


ipd_sharing: Undecided

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

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

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

location_facility: Hospital Santa Casa de Misecórdia de Sorocoba

location_facility: Integra RGH Centro de Investigación/ Hospital MAC Puebla

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

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

location_facility: Hospital Universitario Dr. José Eleuterio Gonzalez

location_facility: Central Clinic Hospital of the MSWiA in Warsaw

location_facility: Centro Hospitalar Unimed (CHU) - Joinville

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

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

location_facility: University of Massachusetts Memorial Health Care

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

location_facility: Queen Mary Hospital, University of Hong Kong

location_facility: University of California at San Francisco

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

location_facility: Ruhr-Universität Bochum / Diabeteszentrum

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa

location_facility: Instituto de Medicina Integral Professor Fernando Figueira

location_facility: Hospital Das Clinicas Da Faculdade De Medicina Da USP

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

location_facility: Instituto Cardiovascular de Buenos Aires

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

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

location_facility: União Brasileira de Educação e Assistência-Hospital São Lucas da PUCRS

location_facility: Robert-Bosch-Krankenhaus - Klinik Schillerhoehe


acronym: HAVEN 7

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

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Hart DP. Commentary on "Development of a novel fully functional coagulation factor VIII with reduced immunogenicity utilizing an in silico prediction and deimmunization approach" - Will we ever be able to avoid inhibitor formation in hemophilia A? J Thromb Haemost. 2021 Sep;19(9):2125-2126. doi: 10.1111/jth.15404.

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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

location_facility: Tulane University Health Sciences Center

location_facility: Hacettepe University Medical Faculty; Hacettepe University Medical Faculty

location_facility: Sheba Medical Center - National Hemophilia Center

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

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

location_facility: Groupe Hospitalier Necker Enfants Malades

location_facility: University of Colorado Denver, Children's Hospital

location_facility: Universitätsklinikum Bonn; Institut für Experimentelle Hämatologie und Transfusionsmedizin

location_facility: Ege University, School of Medicine; Pediatrics Department

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

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: Adana Acibadem Hospital; Pediatric Hematology

location_facility: Charlotte Maxeke Johannesburg Hospital; Haemophilia Comprehensive Care Center

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Hospital das Clínicas Faculdades Médicas de Ribeirão Preto

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

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

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


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

acronym: REVITALIZE 1

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

lead_sponsor: Fractyl Health, Inc.

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

location_facility: Washington University School of Medicine

location_facility: Virginia Commonwealth University Medical Center

location_facility: Digestive Disease Medicine of Central New York

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme

location_facility: Universiteit Van Amsterdam Academisch Medisch Centrum


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

acronym: SHIELD HD

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

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

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

lead_sponsor: CHDI Foundation, Inc.

location_country:
United Kingdom
Canada
United States
France
Germany

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: Rocky Mountain Movement Disorders Center

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