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

summary:
This trial will look at a drug called SGN-B6A to find out whether it is safe for people who have solid tumors. It will study SGN-B6A to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether SGN-B6A works to treat solid tumors.

The study will have two parts. Part A of the study will find out how much SGN-B6A should be given to participants. Part B will use the dose found in Part A to find out how safe SGN-B6A is and if it works to treat solid tumors.

lead_sponsor: Seagen Inc.

location_country:
United Kingdom
Spain
Switzerland
United States
France

location_facility: South Texas Accelerated Research Therapeutics

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

location_facility: MD Anderson Cancer Center / University of Texas


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

acronym: POLAR

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

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

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

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

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

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Anticipated

ReferenceType: background

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

ipd_sharing: Yes

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

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

lead_sponsor: Murdoch Childrens Research Institute

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

location_facility: Hospital of the University of Pennsylvania

location_facility: The Royal Women's Hospital, Melbourne Australia

location_facility: University of Arkansas for Medical Sciences

location_facility: Antoine Beclere Medical Center / South Paris University Hospitals

location_facility: Sharp Mary Birch Hospital for Women & Newborns

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

intervention_type: Procedure

lead_sponsor_type: industriel

status_simplified: Ongoing


type: EudraCT Number

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

acronym: AFFINE

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

primary_purpose: Treatment

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

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

location_facility: McMaster University Medical Centre - Hamilton Health Sciences

location_facility: Gaziantep University Sahinbey Research and Training Hospital

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

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

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

location_facility: King Faisal Specialist Hospital & Research Center

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

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

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

location_facility: Nagoya University Hospital - Transfusion Medicine

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

location_facility: Ege University Medical Faculty, Pediatric Hematology

location_facility: Clinical and Translational Research Unit (CTRU)

location_facility: Kyung Hee University Hospital at Gangdong

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

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

location_facility: Juravinski Hospital - Hamilton Health Sciences

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

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

intervention_type: Biological


ipd_sharing: Undecided

status: Completed

acronym: CAN-COVID

intervention_type: Drug

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

study_completion_date_type: Actual

lead_sponsor: Novartis Pharmaceuticals

source: euctr

ReferenceType: derived

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

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

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.

enrollment_type: Actual

location_country:
Spain
Italy
Russian Federation
United Kingdom
United States
France

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

status_simplified: Completed


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

acronym: CALAVI

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

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

lead_sponsor: AstraZeneca

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


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

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

status: Active, not recruiting

lead_sponsor: ObsEva SA

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

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

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

location_facility: Chattanooga Medical Research LLC/ ID# 602

location_facility: Gynekologicko - Porodnicka Ambulance/ ID # 162

location_facility: Zaporizhzhya Regional Clinical Hospital/ ID # 505

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

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

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

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

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

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

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

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

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

location_facility: Prywatna Klinika Ginekologiczno - Położnicza/ ID # 404

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

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

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

location_facility: Hospital General Universitario Reina Sofia/ ID # 304

location_facility: Centrum Medyczne Chodźki Lublin/ ID # 403

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

location_facility: Specjalistyczny Gabinet Lekarski Krzysztof Dynowski / ID # 401

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

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

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

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

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

location_facility: Hospital Regional Universitario de Málaga/ ID # 303

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

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

location_facility: Niepubliczny Zaklad Opieki Zrowotnej GynCentrum/ ID # 407

location_facility: Lubelskie Centrum Diagnostyczne/ ID # 402


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

acronym: SAVER

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

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

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

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

ipd_sharing: No

lead_sponsor: Ottawa Hospital Research Institute

location_country: Ireland Italy Canada France Norway Netherlands

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

lead_sponsor_type: academique


status: Enrolling by invitation

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

lead_sponsor: Gilead Sciences

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

location_country:
United States
France
Belgium

location_facility: Florida Cancer Specialists & Research Institute

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

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

location_facility: Christiana Care Health Services, Christiana Hospital

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

status_simplified: Unknown


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

acronym: FORMaT

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

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

lead_sponsor: The University of Queensland

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

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


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

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

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

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

study_type: Observational

time_perspective: Prospective

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

lead_sponsor: National Cancer Institute, Naples

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

location_facility: AGO-AUST Arbeitsgemeinschaft Gynaekologische Onkologie

location_facility: PMHC (Princess Margaret Hospital Consortium)

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

location_facility: NSGO (Nordic Society of Gynecologic Oncology)

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

location_facility: GOTIC - Gynecologic Oncology Trial and Investigation Consortium

location_facility: SGCTG (Scottish Gynaecological Cancer Trials Group)

location_facility: ANZGOG - Australia and New Zealand Gynecological Oncology Group

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

location_facility: KGOG - Korean Gynecologic Oncology Group

location_facility: JGOG - Japanese Gynecologic Oncology Group

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

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

location_facility: ICORG - Ireland Cooperative Oncology Research Group

location_facility: AGO-De Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom

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

location_facility: SGOG (Shanghai Gynecologic Oncology Group)

intervention_type: Other


type: Other Identifier

title: Registry of Asthma Patients Initiating DUPIXENT® (RAPID)

acronym: RAPID

summary:
The primary objective of the study is to characterize the patients who initiate treatment for asthma with DUPIXENT® in a real-world setting to understand the attributes of treated patients in real life.

This includes characterization of:

Patient demographics (eg, gender, age, and race)
Patient baseline characteristics (eg, prior medications and procedures, medical history, asthma history, weight, height)

The secondary objectives of the study are:

To characterize real-world use patterns of DUPIXENT® for asthma
To assess the long-term effectiveness of DUPIXENT® in asthma patients in a real-world setting
To assess effectiveness on comorbid type 2 inflammatory conditions in asthma patients treated with DUPIXENT®
To collect long-term safety data on study participants in the real-world setting

lead_sponsor: Regeneron Pharmaceuticals

location_country:
Denmark
Italy
Canada
Puerto Rico
United States
France
Japan
Sweden

location_facility: Instituto Pulmonary Diseases Torre Medica San Lucas

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

location_facility: Nebraska Medical Research Institute, Inc.

location_facility: Northwestern Medical Group Allergy & Immunology Clinic

location_facility: Suffolk Multispecialty Research David Ramstad & Associates

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Medical Research of Arizona, a Division of Allergy, Asthma & Immunology Associates, Ltd.

location_facility: University of Puerto Rico Medical Sciences Campus

location_facility: Centre Hospitalier du Pays d'Aix - Maladies Respiratoires

location_facility: Allergy, Asthma and Clinical Research Center

location_facility: Dr. Henry J. Kanarek Allergy, Asthma & Immunology

location_facility: Ocean Allergy & Respiratory Research Center

location_facility: Banner University of Arizona Medical Center

location_facility: Sygehus Lillebaelt - Vejle Sygehus - Lungemedicinsk afdeling

location_facility: Seattle Allergy & Asthma Research Institute

location_facility: Dr. Syeed Anees Medicine Professional Corporation

location_facility: Sugar Land Allergy, Asthma, and Immunology Center

location_facility: Allergy & Asthma Medical Group and Research, A PC

location_facility: Riley Hospital for Children at Indiana University Health

location_facility: University of Michigan Allergy Specialty Clinic and Food Allergy Clinic

location_facility: Incorporated Medical Corporation, Jinyukai, Jinyu Clinic

location_facility: Vital Prospects Clinical Research Institute, PC

location_facility: Clinical Research Center of Alabama, LLC

location_facility: Columbo Asthma, Allergy and Immunology, LLC

location_facility: Georgia Pollens Clinical Research Centers, Inc.

location_facility: University of Mississippi Medical Center

location_facility: Allergy Partners of Western North Carolina

location_facility: Northwell Health Division of Allergy & Immunology

location_facility: Karolinska Universitetssjukhuset - Astrid Lindgrens barnsjukhus

location_facility: Allergy & Asthma Diagnostic Treatment Center

location_facility: Kansas City Allergy and Asthma Associates, PA

location_facility: Oklahoma Institute of Allergy and Asthma Clinical Research, LLC

location_facility: Istituto Clinico Himanitas, Humanitas Mirasole S.p.a.

location_facility: Incorporated Medical Corporation, Shishin Iryokai, Respiratory Care Clinic Tokyo

location_facility: Javara Inc. and Tryon Medical Partners, PLLC

location_facility: National Allergy and Asthma Research, LLC


title: A Phase 3, Double-blind, Placebo-controlled, Efficacy and Safety Study of Firibastat (QGC001) Administered Orally, Twice Daily, Over 12 Weeks in Difficult-to-treat/Resistant Hypertensive Subjects

acronym: FRESH

summary: This is a double-blind, placebo-controlled, multicenter, efficacy and safety study of firibastat (QGC001) administered po bid over 12 weeks in male and female subjects ≥18 years of age at Screening, with uncontrolled primary HTN. Subjects will be randomized 1:1 to investigational product (IP) and will receive either firibastat (QGC001) or matching placebo on top of their current chronic antihypertensive treatments.

ReferenceCitation: Khosla J, Aronow WS, Frishman WH. Firibastat: An Oral First-in-Class Brain Aminopeptidase A Inhibitor for Systemic Hypertension. Cardiol Rev. 2022 Jan-Feb 01;30(1):50-55. doi: 10.1097/CRD.0000000000000360.

lead_sponsor: Quantum Genomics SA

location_country:
Poland
Spain
United States
France
Germany
Czechia

location_facility: Les Hôpitaux Universitaires de Strasbourg

location_facility: Jacksonville Center for Clinical Research

location_facility: Universitätsklinikum Schleswig-Holstein - Campus Kiel

location_facility: Sterling Research Group - Cincinnati / Mount Auburn


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

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

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

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

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

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

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

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

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

lead_sponsor: Fulcrum Therapeutics

location_country:
United States
Spain
Canada
France

location_facility: University of Massachusetts Memorial Medical Center

location_facility: University of California Los Angeles (UCLA)

location_facility: Washington University School of Medicine

location_facility: Montreal Neurological Institute and Hospital


title: A Phase 1 Study of SEA-TGT (SGN-TGT) in Subjects With Advanced Malignancies

summary:
This trial will look at a drug called SEA-TGT (also known as SGN-TGT) to find out whether it is safe for patients with solid tumors and lymphomas. It will study SEA-TGT to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether SEA-TGT works to treat solid tumors and lymphomas.

The study will have three parts. Part A of the study will find out how much SEA-TGT should be given to patients. Part B will use the dose found in Part A to find out how safe SEA-TGT is and if it works to treat solid tumors and lymphomas. Part C will study how well SEA-TGT with sasanlimab works to treat solid tumors.

design_allocation: Non-Randomized

location_country:
Spain
Italy
United Kingdom
Canada
United States
France

location_facility: HM Centro Integral Oncologico Clara Campal

location_facility: Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care

location_facility: University of California at San Francisco

location_facility: Texas Oncology - Baylor Sammons Cancer Center

location_facility: MD Anderson Cancer Center / University of Texas

location_facility: University Health Network, Princess Margaret Hospital

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: University of Cincinnati Cancer Institute

location_facility: University of Mississippi Medical Center

location_facility: Carbone Cancer Center / University of Wisconsin

location_facility: University of Alberta / Cross Cancer Institute

location_facility: University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center

location_facility: Wake Forest Baptist Medical Center / Wake Forest University


status: Terminated

title: A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

lead_sponsor: UCB Biopharma SRL

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

location_country:
Poland
Taiwan
Spain
United Kingdom
Russian Federation
Ukraine
United States
France
China
Germany
Bulgaria

summary: The purpose of this study is to demonstrate the clinical efficacy of rozanolixizumab in maintenance treatment and assess safety and tolerability of rozanolixizumab in adult study participants with primary immune thrombocytopenia (ITP).


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

acronym: AMETHIST

summary:
Primary Objectives:

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

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

Secondary Objectives:

Primary population:

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

Secondary population:

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

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

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

lead_sponsor: Genzyme, a Sanofi Company

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

location_facility: Emory Genetics - Investigational site number 8400006

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

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

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

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

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

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

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

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

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

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

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

location_facility: Clínica Universitaria Reina Fabiola Córdoba_investigational site number 0320001

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

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

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

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

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

location_facility: Tohoku Medical and Pharmaceutical University Hospital_investigation site number 3920002

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

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

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


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

acronym: HOPE Kids 2

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

lead_sponsor: Global Blood Therapeutics

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

location_facility: Barau Dikko Teaching Hospital / Kaduna State University

location_facility: Washington University School of Medicine

location_facility: St Mary's Hospital - Dept of Haematology

location_facility: Abu El Rich Hospital, Cairo University Hospital

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: Sultan َQaboos University Hospital - Pediatrics

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

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

location_facility: King Abdullah Children's Specialist Hospital

location_facility: Seconda Università degli Studi di Napoli

location_facility: University of Mississippi Medical Center

location_facility: Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

location_facility: Children's Healthcare of Atlanta-Hughes Spalding

location_facility: Sultan َQaboos University Hospital - Adults/Adolescents

location_facility: Komfo Anokye Teaching Hospital Research and Development Unit

location_facility: CREATES - Strathmore University Medical Centre

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

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


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

acronym: PULSED AF

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

ReferenceCitation: Verma A, Boersma L, Haines DE, Natale A, Marchlinski FE, Sanders P, Calkins H, Packer DL, Hummel J, Onal B, Rosen S, Kuck KH, Hindricks G, Wilsmore B. First-in-Human Experience and Acute Procedural Outcomes Using a Novel Pulsed Field Ablation System: The PULSED AF Pilot Trial. Circ Arrhythm Electrophysiol. 2022 Jan;15(1):e010168. doi: 10.1161/CIRCEP.121.010168. Epub 2021 Dec 29.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

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

location_facility: Saint Luke's Mid America Heart Institute

location_facility: University of Pittsburgh Medical Center- UPMC Presbyterian

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital of the University of Pennsylvania

location_facility: Northwell Health - North Shore University Hospital

location_facility: NYU Langone Health - Heart Rhythm Center

location_facility: Ordensklinikum Linz GmbH / Elisabethinen

location_facility: The Ohio State University Wexner Medical Center

location_facility: Tokyo Medical and Dental University, Medical Hospital

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

intervention_type: Device


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

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

lead_sponsor: Boston Scientific Corporation

location_country:
Japan
United States
Canada
France

location_facility: Northwestern University-Department of Urology

location_facility: New York Presbyterian Hospital-Columbia University Medical Center

location_facility: Penn State Milton S. Hershey Medical Center


acronym: PRIME

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

lead_sponsor: Sanofi

type: Registry Identifier

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

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

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

summary:
Primary Objective:

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

Secondary Objectives:

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


title: A Phase III, Double-blind, Placebo-controlled, Randomized Study Of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer.

lead_sponsor: Hoffmann-La Roche

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

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Costa Rica
Peru
Belgium
Japan
Romania
South Africa
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Singapore
Brazil
Canada
Switzerland
Bulgaria
Denmark
Taiwan
Greece
New Zealand
Finland
Thailand
Korea, Republic of
France
Colombia

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Nowotworow Piersi i Chirurgii Rekonstr

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: Songklanagarind Hospital; Department of Oncology

location_facility: Sahyadri Super Specialty Hospital Hadapsar

location_facility: Calvary Mater Newcastle; Medical Oncology

location_facility: Wellington Regional Hospital; Clinical Trials Unit

location_facility: Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

location_facility: Centro Integral Oncologico Clara Campal; Servicio de Oncología

location_facility: IRCCS Istituto Clinico Humanitas; Oncologia

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

location_facility: ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica

location_facility: ASU FC S. M. DELLA MISERICORDIA; Oncologia

location_facility: Ordensklinikum Linz Barmherzige Schwestern; Interne 1 - Hämato-Onkologie

location_facility: KYS Sadesairaala; Syopatautien poliklinikka

location_facility: VAASAN KESKUSSAIRAALA; Onkologian poliklinikka

location_facility: Hospital Clínico Universitario de Valencia; Servicio de Oncología

location_facility: Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA

location_facility: Centro Hospitalar do Porto - Hospital de Santo António; Oncologia

location_facility: Hospital da Luz; Departamento de Oncologia Medica

location_facility: Rajavithi Hospital; Division of Medical Oncology

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

location_facility: BEATSON WEST OF SCOTLAND CANCER CENTRE; Clinical Research Unit - Level 1

location_facility: Ospedale Civile; Unita Operativa Di Oncologia Medica

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: VETERANS GENERAL HOSPITAL; Department of General Surgery

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: St John of God Hospital; Bendat Cancer Centre

location_facility: Nancy N. and J.C. Lewis Cancer & Research Pavillion -St. Josephs / Candler Health System-CCD PRIME

location_facility: Peter MacCallum Cancer Centre; Medical Oncology

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Tauranga Hospital, Clinical Trials Unit; BOP Clinical School

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie

location_facility: National Cancer Centre; Medical Oncology

location_facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.

location_facility: Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU

location_facility: MI Kyiv Regional Council Kyiv Regional Oncological Dispensary; Department of Mammology

location_facility: Medipol University MF; Oncology Department

location_facility: Instyt. Centrum Zdrowia Matki Polki; Klinika Chirurgii Onk. Chorób Piersi z Podod. Onko Klinicznej

location_facility: Memorial Cancer Institute at Memorial West

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia

location_facility: Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; Centr.Diagn.i Lecz.Chor.Piersi

location_facility: Universitätsspital Zürich Gynäkologische Klinik; Klinik für Gynäkologie

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Memorial Healthcare System - Memorial Regional Hospital

location_facility: Kyungpook National University Medical Center

location_facility: Regional Oncology Center; Department of Mammology

location_facility: RCI Sumy Regional Clinical Oncological Dispensary

location_facility: Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel

location_facility: Unidad de Investigación Oncologica; Hospital Nacional Daniel Alcides Carrion

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

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

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Centre Eugene Marquis; Service d'oncologie

location_facility: Hospital Beatriz Angelo; Departamento de Oncologia

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: FSAI Treatment and rehabilitation Centre Ministry of Health; Clinical research and chemotherapy.

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU; Purulent Surgery department

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

location_facility: Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF

location_facility: China Medical University Hospital; Surgery

location_facility: St. Joseph Mercy Hospital; Cancer Care Center.

location_facility: Chemotherapy SI Dnipropetrovsk MA of MOHU

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Wake Forest University Baptist Medical Center

location_facility: Prince of Wales Hospital; Department of Clinical Onocology

location_facility: Royal North Shore Hospital; Department of Medical Oncology

location_facility: Fraser Valley Centre British Columbia Cancer Agency

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Kaiser Permanente-SCPMG; Oncology Research

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: National Taiwan Uni Hospital; General Surgery

location_facility: Auckland City Hospital, Cancer and Blood Research

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan

location_facility: Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial

location_facility: Instituto Regional de Enfermedades Neoplasicas

location_facility: Masarykův onkologický ústav; Klinika komplexní onkologické péče

location_facility: Hospital Provincial de Castellon; Servicio de Oncologia

location_facility: ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department

location_facility: Municipal Institution Odesa Regional Clinical Hospital

location_facility: SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"

summary: This study will evaluate the efficacy and safety of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer (TNBC) previously untreated in this setting.


acronym: LLSAT

title: Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis

lead_sponsor: GlaxoSmithKline

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

location_country:
Poland
Spain
Italy
Russian Federation
United Kingdom
Argentina
United States
France
China
Mexico
Japan
Germany

summary: This is an open-label, non-comparator, global, multi-center, long-term safety study for evaluating safety and tolerability of linerixibat in participants with cholestatic pruritus in primary biliary cholangitis (PBC) who participated in a prior clinical trial with linerixibat (BAT117123 [NCT01899703], 201000 GLIMMER [NCT02966834] (group 1) or 212620 GLISTEN [NCT00210418]) (group 2). All participants will receive open-label linerixibat for the duration of the study. The study duration is expected to last until the study's end or until linerixibat can be lawfully made available to participants. However, the total duration of study participation will vary by participant depending upon the time of entry relative to study end in their respective country.


type: U.S. NIH Grant/Contract

title: Alzheimer's Clinical Trial Consortium for Down Syndrome (ACTC-DS) Trial-Ready Cohort - Down Syndrome (TRC-DS)

acronym: TRC-DS

summary:
The purpose of the Trial-Ready Cohort - Down Syndrome (TRC-DS) is to enroll 120 non-demented adults (ages 35-55) with Down syndrome (DS) into a trial ready cohort (TRC). Participants enrolled in the TRC-DS will undergo longitudinal cognitive and clinical assessment, genetic and biomarker testing, as well as imaging and biospecimen collection. Using these outcome measures, researchers will analyze the relationships between cognitive measures and biomarkers of Alzheimer's disease (AD) to identify endpoints for AD clinical trials in DS that best reflect disease progression.

To learn more about the study and participating sites, visit our study website at: https://www.trcds.org/.

TRC-DS is collaborating with the Alzheimer's Disease Biomarker Consortium-Down Syndrome (ABC-DS) to allow study participants to be concurrently enrolled in both ABC-DS and TRC-DS, referred to as "co-enrollment". ABC-DS is a longitudinal, observational research study that is overseen at University of Pittsburgh Coordinating Center. ABC-DS participants who express interest in potentially joining a clinical trial in the future and who meet TRC-DS eligibility criteria, may choose to co-enroll in TRC-DS at an ABC-DS Site. Co-enrolled participants will adhere to the ABC-DS protocol and schedule of activities, but agree to share their data with the TRC-DS team and to receive invitations for future participation in clinical trials. Fore more information on ABC-DS please visit https://www.nia.nih.gov/research/abc-ds or http://abcds.pitt.edu/.

ReferenceCitation: Hardy J. The discovery of Alzheimer-causing mutations in the APP gene and the formulation of the "amyloid cascade hypothesis". FEBS J. 2017 Apr;284(7):1040-1044. doi: 10.1111/febs.14004. Review.

ReferenceCitation: Selkoe DJ, Hardy J. The amyloid hypothesis of Alzheimer's disease at 25 years. EMBO Mol Med. 2016 Jun 1;8(6):595-608. doi: 10.15252/emmm.201606210. Print 2016 Jun. Review.

ReferenceCitation: Handen BL, Cohen AD, Channamalappa U, Bulova P, Cannon SA, Cohen WI, Mathis CA, Price JC, Klunk WE. Imaging brain amyloid in nondemented young adults with Down syndrome using Pittsburgh compound B. Alzheimers Dement. 2012 Nov;8(6):496-501. doi: 10.1016/j.jalz.2011.09.229.

ReferenceCitation: Rafii MS, Wishnek H, Brewer JB, Donohue MC, Ness S, Mobley WC, Aisen PS, Rissman RA. The down syndrome biomarker initiative (DSBI) pilot: proof of concept for deep phenotyping of Alzheimer's disease biomarkers in down syndrome. Front Behav Neurosci. 2015 Sep 14;9:239. doi: 10.3389/fnbeh.2015.00239. eCollection 2015.

ReferenceCitation: Lao PJ, Betthauser TJ, Hillmer AT, Price JC, Klunk WE, Mihaila I, Higgins AT, Bulova PD, Hartley SL, Hardison R, Tumuluru RV, Murali D, Mathis CA, Cohen AD, Barnhart TE, Devenny DA, Mailick MR, Johnson SC, Handen BL, Christian BT. The effects of normal aging on amyloid-β deposition in nondemented adults with Down syndrome as imaged by carbon 11-labeled Pittsburgh compound B. Alzheimers Dement. 2016 Apr;12(4):380-90. doi: 10.1016/j.jalz.2015.05.013. Epub 2015 Jun 13.

ReferenceCitation: Rafii MS, Lukic AS, Andrews RD, Brewer J, Rissman RA, Strother SC, Wernick MN, Pennington C, Mobley WC, Ness S, Matthews DC; Down Syndrome Biomarker Initiative and the Alzheimer's Disease Neuroimaging Initiative. PET Imaging of Tau Pathology and Relationship to Amyloid, Longitudinal MRI, and Cognitive Change in Down Syndrome: Results from the Down Syndrome Biomarker Initiative (DSBI). J Alzheimers Dis. 2017;60(2):439-450. doi: 10.3233/JAD-170390.

ReferenceCitation: McCarron M, McCallion P, Reilly E, Dunne P, Carroll R, Mulryan N. A prospective 20-year longitudinal follow-up of dementia in persons with Down syndrome. J Intellect Disabil Res. 2017 Sep;61(9):843-852. doi: 10.1111/jir.12390. Epub 2017 Jun 29.

ReferenceCitation: Firth NC, Startin CM, Hithersay R, Hamburg S, Wijeratne PA, Mok KY, Hardy J, Alexander DC; LonDownS Consortium, Strydom A. Aging related cognitive changes associated with Alzheimer's disease in Down syndrome. Ann Clin Transl Neurol. 2018 May 20;5(6):741-751. doi: 10.1002/acn3.571. eCollection 2018 Jun.

ReferenceCitation: Startin CM, Hamburg S, Hithersay R, Al-Janabi T, Mok KY, Hardy J; LonDownS Consortium, Strydom A. Cognitive markers of preclinical and prodromal Alzheimer's disease in Down syndrome. Alzheimers Dement. 2019 Feb;15(2):245-257. doi: 10.1016/j.jalz.2018.08.009. Epub 2018 Nov 28.

ReferenceCitation: Hithersay R, Startin CM, Hamburg S, Mok KY, Hardy J, Fisher EMC, Tybulewicz VLJ, Nizetic D, Strydom A. Association of Dementia With Mortality Among Adults With Down Syndrome Older Than 35 Years. JAMA Neurol. 2019 Feb 1;76(2):152-160. doi: 10.1001/jamaneurol.2018.3616.

lead_sponsor: University of Southern California

location_country:
United Kingdom
United States
Spain
France

location_facility: Massachusetts General Hospital, Co-Enrolling through ABC-DS Only

location_facility: Sant Pau Biomedical Research Institute (IIB Sant Pau)

location_facility: University of Wisconsin - Madison, Waisman Center, Co-Enrolling through ABC-DS Only

location_facility: New York State Institute for Basic Research in Developmental Disabilities (SIBRDD), Co-Enrolling through ABC-DS Only

location_facility: University of Pittsburgh, Co-Enrolling through ABC-DS Only

location_facility: University of Texas Health San Antonio, Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases

location_facility: Linda Crnic Institute for Down Syndrome, University of Colorado

location_facility: King's College London, Institute of Psychiatry, Psychology & Neuroscience

location_facility: University of Cambridge, Co-Enrolling through ABC-DS Only

location_facility: Vanderbilt University Medical Center Center for Cognitive Medicine

location_facility: University of Kentucky, Co-Enrolling through ABC-DS Only

location_facility: University of California, Irvine School of Medicine, Co-Enrolling through ABC-DS Only

intervention_type: Radiation


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

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

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

lead_sponsor: Eisai Inc.

location_country:
United Kingdom
Spain
Korea, Republic of
United States
France

location_facility: University of Miami Hospital Sylvester Comprehensive Cancer Center

location_facility: INCLIVA Hospital Clínico Universitario de Valencia

location_facility: University of Pittsburgh Medical Center and Hillman Cancer Center

location_facility: Massachusetts General Hospital Cancer Center


title: PrOspective Non-interventional Study in Patients With Locally Advanced or Metastatic TRK Fusion Cancer Treated With Larotrectinib

acronym: ON-TRK

summary: In this observational study researcher want to learn more about the effectiveness of drug VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use in patients with TRK fusion cancer which is locally advanced or spread from the place where it started to other places in the body. TRK fusion cancer is a term used to describe a variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or fuses, with a different gene. This joining results in the activation of certain proteins (TRK fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the decision to treat their disease with VITRAKVI has been made by their treating physicians. During the study, patients' medical information such as treatment information with VITRAKVI, other medication or treatments, changes in disease status and other health signs and symptoms will be collected within the normal medical care by the treating doctor. Participants will be observed over a period from 24 to 60 months.

ReferenceCitation: Yang JCH, Brose MS, Castro G, Kim ES, Lassen UN, Leyvraz S, Pappo A, López-Ríos F, Reeves JA, Fellous M, Penault-Llorca F, Rudzinski ER, Tabatabai G, Vassal G, Drilon A, Trent J. Rationale and design of ON-TRK: a novel prospective non-interventional study in patients with TRK fusion cancer treated with larotrectinib. BMC Cancer. 2022 Jun 7;22(1):625. doi: 10.1186/s12885-022-09687-x.

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

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

lead_sponsor: Bayer

location_country:
Luxembourg
Spain
Italy
United Kingdom
United States
Belgium
Japan
Austria
Australia
Russian Federation
Argentina
Norway
Singapore
Sweden
Brazil
Canada
Switzerland
China
Germany
Denmark
Taiwan
Greece
Ireland
Finland
Korea, Republic of
France

location_facility: Univ. of Maryland / Greenebaum Comp. Cancer Ctr.

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

location_facility: Stanford Univ Med Ctr. / Lucile Packard Children's Hosp

location_facility: UT Southwestern Medical Center / Children's Health

location_facility: UCSF Benioff Children's Hospital Oakland

location_facility: Frederick Health-James M Stockman Cancer Institute

location_facility: Providence Health System - Southern California

location_facility: SSM Health Cancer Center - Dean Medical Group

location_facility: East Carolina University / Vidant Health

location_facility: Intermountain Healthcare - Intermountain Medical Center

location_facility: Ohio State Comp. Cancer Ctr. / James Cancer Hospital

location_facility: Johns Hopkins / Sidney Kimmel Cancer Center

location_facility: Atlantic Hem Onc / Morristown Medical Center

location_facility: USC / Norris Comprehensive Cancer Center

location_facility: Memorial Sloan Kettering Children's Cancer Center

location_facility: Staten Island Univ. Hospital (Northwell Health)

location_facility: Intermountain Healthcare - Dixie Regional Medical Center


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

summary:
The primary objective of this study is:

• To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).

lead_sponsor: Rigel Pharmaceuticals

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

location_facility: Universitätsklinik f. Innere Medizin I - Klin. Abt. f. Hämatologie u. Hämostaseologie

location_facility: University of Southern California - Janice and Robert Hall Clinical Trials Biospecimen Laboratory

location_facility: SCDU Ematologia AOU "Maggiore della Carità"

location_facility: Clinical Centre of Vojvodina, Clinic for Hematology

location_facility: Fakultni nemocnice Brno Interni hematologicka a onkologicka klinika

location_facility: Princess Alexandra Hospital - Cancer Trials Unit

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

location_facility: LTD Multiprofile Clinic Consilium Medulla

location_facility: Fakultni nemocnice Ostrava Klinika hematoonkologie

location_facility: City Clinical Hospital № 4, Hematology Center

location_facility: Vitebsk Regional Clinical Oncology Dispensary

location_facility: American Oncology Network Vista Oncology Division

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, UO Ematologia

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

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

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

location_facility: University Multiprofile Hospital for Active Treatment Sv. Ivan Rilski EAD, Varna, Clinic of Clinical Haematology

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

location_facility: Specialized Hospital for Active Treatment of Hematological Disease EAD,

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


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

acronym: Pro-EYS

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

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

lead_sponsor: Jaeb Center for Health Research

location_country:
Netherlands
Finland
Canada
United States
France
Israel
Germany

location_facility: Oregon Health Science University Casey Eye Institute

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

location_facility: Kellogg Eye Center, University of Michigan

location_facility: University of Miami: Neuro-ophthalmology Department

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


title: Global Prospective Case Series Using a Single-Use Duodenoscope

summary: Confirm procedural performance of the ExaltTM Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures

primary_purpose: Other

location_country:
Hong Kong
Italy
Australia
Netherlands
Canada
United States
France
India
Singapore
South Africa
Germany

location_facility: Erasmus University Medical Center of Rotterdam

location_facility: The University of Texas Health Science Center at San Antonio

location_facility: Metro North Hospital and Health Services

location_facility: University of California Los Angeles Medical Center


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

acronym: CLEAR

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

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

time_perspective: Retrospective

ReferenceType: result

ReferenceCitation: Nguyen TN, Abdalkader M, Nagel S, Qureshi MM, Ribo M, Caparros F, Haussen DC, Mohammaden MH, Sheth SA, Ortega-Gutierrez S, Siegler JE, Zaidi S, Olive-Gadea M, Henon H, Möhlenbruch MA, Castonguay AC, Nannoni S, Kaesmacher J, Puri AS, Seker F, Farooqui M, Salazar-Marioni S, Kuhn AL, Kaliaev A, Farzin B, Boisseau W, Masoud HE, Lopez CY, Rana A, Kareem SA, Sathya A, Klein P, Kassem MW, Ringleb PA, Cordonnier C, Gralla J, Fischer U, Michel P, Jovin TG, Raymond J, Zaidat OO, Nogueira RG. Noncontrast Computed Tomography vs Computed Tomography Perfusion or Magnetic Resonance Imaging Selection in Late Presentation of Stroke With Large-Vessel Occlusion. JAMA Neurol. 2022 Jan 1;79(1):22-31. doi: 10.1001/jamaneurol.2021.4082. Erratum in: JAMA Neurol. 2022 Jan 1;79(1):93.

ReferenceCitation: Seker F, Qureshi MM, Möhlenbruch MA, Nogueira RG, Abdalkader M, Ribo M, Caparros F, Haussen DC, Mohammaden MH, Sheth SA, Ortega-Gutierrez S, Siegler JE, Zaidi SF, Olive-Gadea M, Henon H, Castonguay AC, Nannoni S, Kaesmacher J, Puri AS, Farooqui M, Salazar-Marioni S, Kuhn AL, Kiley NL, Farzin B, Boisseau W, Masoud HE, Lopez CY, Rana A, Abdul Kareem S, Sathya A, Klein P, Kassem MW, Cordonnier C, Gralla J, Fischer U, Michel P, Strambo D, Jovin TG, Raymond J, Zaidat OO, Ringleb PA, Nguyen TN, Nagel S. Reperfusion Without Functional Independence in Late Presentation of Stroke With Large Vessel Occlusion. Stroke. 2022 Oct 14. doi: 10.1161/STROKEAHA.122.039476. [Epub ahead of print]

ReferenceCitation: Siegler ASJE, Qureshi MM, Nogueira RG, Tanaka K, Nagel S, Michel P, Vigilante N, Ribo M, Yamagami H, Yoshimura S, Abdalkader M, Haussen DC, Mohammaden MH, Nannoni S, Möhlenbruch M, Henon H, Sheth SA, Gutierrez SO, Olive-Gadea M, Caparros F, Şeker F, Zaidi S, Castonguay A, Uchida K, Sakai N, Puri AS, Farooqui M, Toyoda K, Salazar-Marioni S, Takeuchi M, Farzin B, Masoud HE, Kuhn AL, Rana A, Morimoto M, Shibata M, Nonaka T, Klein P, Sathya A, Kiley NL, Cordonnier C, Strambo D, Demeestere J, Ringleb PA, Roy D, Zaidat OO, Jovin TG, Kaesmacher J, Fischer U, Raymond J, Nguyen TN. Endovascular vs Medical Management for Late Anterior Large Vessel Occlusion With Prestroke Disability: Analysis of CLEAR and RESCUE-Japan. Neurology. 2022 Nov 4. pii: 10.1212/WNL.0000000000201543. doi: 10.1212/WNL.0000000000201543. [Epub ahead of print]

lead_sponsor: Boston Medical Center

location_country:
Spain
Canada
Switzerland
United States
France
Japan
Germany

location_facility: National Cerebral and Cardiovascular Center

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Grady Health; Marcus Stroke & Neuroscience Center


acronym: OAK

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

lead_sponsor: Theravance Biopharma

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

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

location_facility: Specjalistyczna Praktyka Lekarska prof.Grzegorz Opala

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

location_facility: Montreal Neurological Institute & Hospital

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

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

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

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

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

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

location_facility: Limited Liability Company City Neurological Center Sibneiromed

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

location_facility: University of Cincinnati Medical Center (UCGNI)

location_facility: Concord Hospital, Neurosciences Department

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

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

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

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

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

location_facility: UO Farmacia Centralizzata OM (SC) Ospedale Maggiore

location_facility: Perron Institute for Neurological and Translational Science

location_facility: University of Texas Southwestern Medical Center

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

location_facility: Oregon Health & Science University (OHSU)

location_facility: The National Hospital for Neurology & Neurosurgery

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

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

location_facility: Colorado Springs Neurological Associates

location_facility: Universitätsklinikum Tulln Abteilung fur Neurologie

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

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


title: A Phase 1, Randomized, Dose and Schedule Evaluation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Belantamab Mafodotin Administered in Combination With Standard of Care in Participants With Newly Diagnosed Multiple Myeloma

acronym: DREAMM 9

summary: This study will evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of belantamab mafodotin in combination with Velcade (bortezomib), Revlimid (lenalidomide), dexamethasone (VRd) and will determine recommended phase 3 dose (RP3D) in adult participants with newly diagnosed multiple myeloma (NDMM). Participants will receive the combination of bortezomib, lenalidomide and dexamethasone (VRd) on a 3-week cycle until cycle 8, followed by the combination of lenalidomide and dexamethasone (Rd) on a 4-week cycle thereafter as per dosing schedule. Participants will receive belantamab mafodotin on a schedule that is dependent on the cohort to which they are assigned. Belantamab mafodotin will be administered in combination with VRd every 3 weeks (Q3W), every 6 weeks (Q6W), or every 9 weeks (Q9W) to Cycle 8, and then in combination with Rd every 4 weeks (Q4W), every 8 weeks (Q8W), or every 12 weeks (Q12W) thereafter. Participants will complete an End of Treatment (EOT) visit at the point of study treatment discontinuation, followed by a Safety Follow-up visit 70 days after EOT.

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


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

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

lead_sponsor: ImmunoGen, Inc.

location_country:
Spain
Italy
United States
France
Germany

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

location_facility: Azienda Ospedaliera Universitaria Maggiore Della Carita Novara

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

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

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: Hospital Universitario y Politécnico de La Fe

location_facility: City of Hope Comprehensive Cancer Center


title: Sickle Cell Disease and CardiovAscular Risk - Red Cell Exchange Trial (SCD-CARRE)

acronym: SCD-CARRE

summary: The SCD-CARRE trial is a Phase 3, prospective, randomized, multicenter, controlled, parallel two-arm study aimed to determine if automated exchange blood transfusion and standard of care administered to high mortality risk adult SCD patients reduces the total number of episodes of clinical worsening of SCD requiring acute health care encounters (non-elective infusion center/ER/hospital visits) or resulting in death over 12 months as compared with standard of care.

ipd_sharing_description: Results from research conducted under this project will be shared in several ways. Manuscripts will be submitted for publication in high-quality peer-reviewed journals, following the NIH Public Access Policy guidelines. Findings will be presented at relevant national conferences, public lectures, scientific institutions and meetings. The timeline for participant recruitment, data collection and analysis will foster publication, facilitated by the investigators' Publications Committee, of critically important and clinically relevant data throughout the trial. The study datasets will be archived and made available to qualified individuals after a period of exclusive use by the SCD-CARRE trial research team and after publication of the primary manuscripts, following NIH guidelines.

lead_sponsor: Gladwin, Mark, MD

location_country:
United States
United Kingdom
France

location_facility: UCSF Benioff Children's Hospital Oakland

location_facility: Imperial College Healthcare NSH Trust-Hammersmith Hospital

location_facility: University of North Carolina at Chapel Hill

location_facility: University of Texas Health Science Center at Houston

location_facility: Howard University Center for Sickle Cell Disease


title: A Phase 1/2 Open-label, Multicenter Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of IGM-2323 in Subjects With Relapsed/Refractory Non-Hodgkin Lymphomas

summary:
This is a Phase 1/2 study of IGM-2323 in adult subjects with relapsed or refractory B-cell Non-Hodgkin Lymphoma. This study will consist of a dose-escalation stage and a randomized dose-expansion stage where subjects will be enrolled into indication-specific expansion cohorts. IGM-2323 will be administered intravenously (IV).

Additional CD20-positive NHL histologies (e.g. MZL and MCL), may be allowed with Medical Monitor approval during the Dose-Escalation Phase of the study.

lead_sponsor: IGM Biosciences, Inc.

location_country:
Spain
Australia
Korea, Republic of
United States
France

location_facility:
Linear Clinical Resaerch
Dana Farber Cancer Institute (DFCI)
St. Vincent's Hospital Melbourne
Monash Health
Seoul National University Hospital
City of Hope
Tennessee Oncology
NYU
Asan Medical Center
Hospital Del Mar
Fred Hutch
MSKCC
Norton Cancer Institute
Samsung Medical Center
MD Anderson Cancer Center
Gustave Roussy


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

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

time_perspective: Other

lead_sponsor: Medtronic Cardiac Surgery

location_country:
Greece
Austria
Italy
Netherlands
United States
France
Belgium
Germany

location_facility: Allgemeines Krankenhaus - Universitätskliniken Wien

location_facility: Deutsches Herzzentrum München Klinik an der TU München

location_facility: Herzzentrum Dresden GmbH Universitätsklinik


title: A Phase I, Open-label, Dose Finding Study to Assess the Safety, Tolerability, PK, and Preliminary Efficacy of OBT076, a CD205-directed ADC, in Recurrent and/or Metastatic CD205+ Solid Tumors

summary:
The purpose of this study is to evaluate OBT076, which is a drug that combines an antibody with an anti-cancer drug. This class of drugs are called Antibody-Drug Conjugates (ADC). Antibodies are normally produced in the human body by the immune system to fight infections but can be designed to target cancer cells and deliver an anti-cancer drug. OBT076 is composed of an antibody that targets the CD205 protein on cancer cells and delivers an anti-cancer drug which can kill them. OBT076 is an "Investigational Drug", which means that it is still being studied and has not yet been approved by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) or any other regulatory authorities to be prescribed by doctors for the treatment of metastatic or recurrent solid tumors. The use of OBT076 in this study is investigational.

This is a Phase I research study designed to look at several dose levels of the study drug to find the highest dose level that is safe and well-tolerated (does not cause unacceptable side effects), and to examine the effects of the study drug in a small group of research participants. The study will also look at the effectiveness of OBT076 as an anti-cancer therapy. Once the optimal dose is determined and safety is assessed, additional research participants will be treated at the optimal dose level to further evaluate safety and effectiveness.

lead_sponsor: Oxford BioTherapeutics Ltd

location_country:
United States
France

location_facility: University of Mississippi Medical Center


title: An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

lead_sponsor: UCB Biopharma SRL

location_country:
Denmark
Spain
United Kingdom
Netherlands
United States
France
Belgium
Germany

summary: The purpose of the study is to assess long-term safety and tolerability of weekly doses of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).


title: A Phase 1 Study of SGN-CD228A in Select Advanced Solid Tumors

summary: This trial will study SGN-CD228A to find out whether it is an effective treatment for different kinds of cancer. It will also look at what side effects (unwanted effects) may occur. The study will have two parts. Part 1 of the study will find out how much SGN-CD228A should be given for treatment and how often. Part 2 of the study will use the dose found in Part 1 and look at how safe and effective the treatment is.

lead_sponsor: Seagen Inc.

location_country:
United Kingdom
Italy
Spain
United States
France

location_facility: The Angeles Clinic and Research Institute

location_facility: South Texas Accelerated Research Therapeutics

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

location_facility: MD Anderson Cancer Center / University of Texas

location_facility: University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center

location_facility: Wake Forest Baptist Medical Center / Wake Forest University


acronym: not applicable

title: A Long-term Follow-up Study of Patients in the Clinical Trials for Spinal Muscular Atrophy Receiving AVXS-101

lead_sponsor: Novartis Gene Therapies

ReferenceCitation: Day JW, Mendell JR, Mercuri E, Finkel RS, Strauss KA, Kleyn A, Tauscher-Wisniewski S, Tukov FF, Reyna SP, Chand DH. Clinical Trial and Postmarketing Safety of Onasemnogene Abeparvovec Therapy. Drug Saf. 2021 Oct;44(10):1109-1119. doi: 10.1007/s40264-021-01107-6. Epub 2021 Aug 12. Erratum in: Drug Saf. 2022 Feb;45(2):191-192.

location_country:
Taiwan
United Kingdom
Italy
Australia
Canada
United States
France
Belgium
Japan

location_facility: Great Ormond Street Hospital for Children NHS Foundation Trust

location_facility: John Hopkins Hospital - David M. Rubenstein Child Health Building

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

location_facility: Children's Hospital of Eastern Ontario Research Institute

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Centre de Référence des Maladies Neuromusculaires

location_facility: Children's Health Specialty Center Dallas Campus

location_facility: Children's Hospital of The King's Daughters

location_facility: Tokyo Women's Medical University Hospital

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: Spectrum Health Hospitals Helen DeVos Children's Hospital

location_facility: Washington Unviersity School of Medicine in Saint Louis

summary: This is a long-term follow-up safety and efficacy study of participants in clinical trials for spinal muscular atrophy (SMA) who were treated with onasemnogene abeparvovec-xioi. Participants will roll over from their respective previous (parent) study into this long-term study for continuous monitoring of safety as well as monitoring of continued efficacy and durability of response to onasemnogene abeparvovec-xioi treatment.


title: An Open-Label, Multi-Center Extension Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis

acronym: POETYK PSO-LTE

summary: The main purpose of this study is to characterize the long-term safety and efficacy of the drug Deucravacitinib (BMS-986165) in patients who have been previously enrolled in an applicable Phase 3 psoriasis study.

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Taiwan
Spain
United Kingdom
Russian Federation
Australia
New Zealand
Canada
Finland
Sweden
Hungary
Korea, Republic of
United States
France
China
Israel
Puerto Rico
Japan
Germany
Czechia

location_facility: Washington University School of Medicine - West County Dermatology

location_facility: State budgetary institution of Ryazan region - Regional Clinical Skin and Venereal Dispensary

location_facility: Northwest Arkansas Clinical Trials Center, PLLC

location_facility: Polyclinic of Private Security Personnel

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Treasure Valley Dermatology & Skin Cancer Center

location_facility: Dermatology Treatment and Research Center

location_facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato - Zalaegerszeg

location_facility: Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spolka Partnerska

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska

location_facility: Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft.

location_facility: ZDROWIE OSTEO-MEDIC s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik

location_facility: The Centre for Dermatology - Richmond Hill

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: Marietta Dermatology & The Skin Cancer Center

location_facility: Olympian Clinical Research - Tampa Office

location_facility: Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus

location_facility: University of California San Diego Health Systems

location_facility: Clinic of Skin Diseases of Pierre Wolkenstein

location_facility: Dermatology and Skin Surgery Center - Exton

location_facility: Alliance Dermatology and Mohs Center - Phoenix

location_facility: University Hospital - Kyoto Preferctural University of Medicine

location_facility: Centre de Recherche Dermatologique du Quebec Metropolitain

location_facility: Guys and Saint Thomas NHS Foundation Trust

location_facility: Saint-Petersburg SBHI Dermatological and Venereological Dispensary No. 10 - Clinic of Dermatology

location_facility: NIARMEDIK - Clinic on Clinic on Kitai Gorod

location_facility: Klinika Kozhnykh I Venericheskikh Bolezney

location_facility: First OC Dermatology & Belle-Aimee Skincare Clinic Fountain Valley

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Clinical Research Center of the Carolinas

location_facility: Josa Andras Oktatokorhaza - Szabolcs Szatmar-Bereg Megyei Onkormanyzat

location_facility: Psoriasis Treatment Center of Central New Jersey

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: MUZ Clinical Hospital of Emergency Medical Care n.a. N.V. Soloviev

location_facility: Krajska zdravotni - Masarykova nemocnice v Usti nad Labem

location_facility: Ural Scientific Research Institute of Dermatovenereology and Immunopathology

location_facility: SBHI Clinical Skin and Venereology Dispensary of the Ministry of Health of Krasnodar Region

location_facility: Synexus - Lancashire Clinical Research Centre

location_facility: Clinical Research Consortium - Las Vegas

location_facility: Dermatology Clinical Research Center of San Antonio

location_facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato - Gyula

location_facility: Austin Institute for Clinical Research - Pflugerville

location_facility: Synexus - Merseyside Clinical Research Centre

location_facility: Total Skin and Beauty Dermatology Center

location_facility: Dermatology Research Associates - Los Angeles

location_facility: Clinical Medical Center of Moscow State Medico-Stomatological University named after AI Evdokimov

location_facility: Center for Clinical Studies - Texas Medical Center

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej MED-LASER

location_facility: Ars Vitae Multidisciplinary Medical Center

location_facility: St. George Dermatology & Skin Care Centre

location_facility: Interspond - Houston Center for Clinical Research

location_facility: Japan Community Health Care Organization Tokyo Yamate Medical Center

location_facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato - Debrecen Affiliated Site

location_facility: Synexus - Manchester Clinical Research Centre

location_facility: Centre Hospitalier Universitaire de Nice Hopital lArchet

location_facility: Associated Skin Care Specialists - Minnesota Clinical Study Center

location_facility: Coastal Carolina Research Center - Mount Pleasant

location_facility: Dermoklinika Centrum Medyczne S.C. M. Kierstan, J. Narbutt, A. Lesiak

location_facility: Clinical Research Advantage - Evansville - South Kenmore Drive


title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Immune-Mediated Necrotizing Myopathy

lead_sponsor: Ra Pharmaceuticals

location_country:
Netherlands
United States
United Kingdom
France

location_facility: Salford Royal NHS Barnes Clinical Research Facility

location_facility: University of Florida Health Jacksonville

location_facility: The University of Texas Health Science Center at Houston

location_facility: Washington University School of Medicine in Saint Louis

location_facility: University College London Hospitals NHS Foundation Trust

summary: The purpose of the study is to evaluate the safety and efficacy of zilucoplan in patients with Immune-Mediated Necrotizing Myopathy (IMNM). Subjects will be randomized in a 1:1 ratio to receive daily SC doses of 0.3 mg/kg zilucoplan or matching placebo for 8 weeks.